WO2018137632A1 - 一种阴茎起搏器及其控制方法 - Google Patents

一种阴茎起搏器及其控制方法 Download PDF

Info

Publication number
WO2018137632A1
WO2018137632A1 PCT/CN2018/073902 CN2018073902W WO2018137632A1 WO 2018137632 A1 WO2018137632 A1 WO 2018137632A1 CN 2018073902 W CN2018073902 W CN 2018073902W WO 2018137632 A1 WO2018137632 A1 WO 2018137632A1
Authority
WO
WIPO (PCT)
Prior art keywords
penile
segment
pump
pacemaker
fluid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2018/073902
Other languages
English (en)
French (fr)
Inventor
孙颖浩
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shanghai Clinical-Engine Technology Development Co Ltd
Original Assignee
Shanghai Clinical-Engine Technology Development Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shanghai Clinical-Engine Technology Development Co Ltd filed Critical Shanghai Clinical-Engine Technology Development Co Ltd
Priority to EP18744632.3A priority Critical patent/EP3574869A4/en
Publication of WO2018137632A1 publication Critical patent/WO2018137632A1/zh
Priority to US16/455,743 priority patent/US20190321180A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/26—Penis implants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/48—Operating or control means, e.g. from outside the body, control of sphincters
    • A61F2/482—Electrical means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0001—Body part
    • A61F2007/0048—Genitals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0054—Heating or cooling appliances for medical or therapeutic treatment of the human body with a closed fluid circuit, e.g. hot water
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0086—Heating or cooling appliances for medical or therapeutic treatment of the human body with a thermostat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0001—Means for transferring electromagnetic energy to implants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0001—Means for transferring electromagnetic energy to implants
    • A61F2250/0002—Means for transferring electromagnetic energy to implants for data transfer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • A61F2250/0013—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting fluid pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0019—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in hardness, e.g. Vickers, Shore, Brinell
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0065—Additional features; Implant or prostheses properties not otherwise provided for telescopic

Definitions

  • Embodiments of the present invention relate to the field of medical device technologies, and in particular, to a penile pacemaker and a control method thereof.
  • a skeleton prosthesis made of a temperature-sensitive shape memory alloy wrapped in a penile sponge which is provided in the patent US20130131443.
  • the prosthesis also has a large surgical trauma, and the corpus cavernosum needs to be completely separated at the time of implantation.
  • the implant can be completed, and because it is made of metal material, the foreign body is obvious and the use is poor.
  • the biggest drawback of this invention is that the pacing and pacing need to provide the temperature conditions for metal deformation, and The inconvenience; in combination with the various problems existing in the current technology, there is an urgent need for a penile erection aid that is simple and minimally invasive, has an erectile auxiliary effect, and is easy to use, safe, and stable.
  • the present invention provides a penile pacemaker and a method of controlling the same to overcome the above problems or at least partially solve the above problems.
  • the penile implanting mechanism is used between the subcutaneous and the corpus cavernosum, the penile implanting mechanism has a hollow cavity, and is axially extendable and fixed to the proximal end of the penis;
  • the liquid storage chamber being in communication with a cavity of the penile implant mechanism through at least one conduit;
  • the pump is coupled to the reservoir and the penile implant mechanism for providing power to the fluid for transfer between the reservoir and the penile implant mechanism.
  • a power source is further included, and the power source is electrically connected to the pump for supplying power to the pump.
  • the pump includes a pump body, a pump head and a spring, and the pump head is connected to the pump body through a spring, and the pump head adjusts the volume of the liquid storage chamber by reciprocating activities.
  • the spring at least partially drives the pump head to adjust the volume of the reservoir.
  • a control device is further included, the control device for controlling operation of the pump.
  • the patient controls the control device from outside the body.
  • control device comprises a travel switch, the travel switch being connected in series with the pump for limiting the stroke of the pump.
  • the catheter is further provided with a valve for changing the flow direction of the fluid.
  • the duct is further provided with at least one valve, the valve obtains electric energy from the power source, and changes the flow direction of the fluid under the control of the control device.
  • control device includes an external wireless remote control device and an in-vivo sensing device
  • the internal sensing device is configured to wirelessly couple with the external wireless remote control device, and perform the power supply according to the coupling signal. Charging.
  • the extracorporeal wireless remote control device includes an activation button, and the activation button is used to control activation of the pump.
  • the duct is further provided with at least one valve, the valve obtains electric energy from the power source, and changes the flow direction of the fluid under the control of the control device.
  • the proximal end of the penile implant mechanism is provided with a fixation device coupled to the pubic bone.
  • the fixing device is at least one fixing plate, and the fixing plate is provided with a through hole, and the fixing member fixes the fixing plate to the pubic bone through the through hole.
  • the proximal end of the penile implant mechanism is provided with a base, the fixing device is coupled to the base, the base has a hollow cavity, and the cavity of the base The body is in communication with the cavity of the penile implant mechanism.
  • the shape of the base matches the sponge.
  • the base includes a raised upper surface and a recessed lower surface.
  • the penile implant mechanism comprises a segment-type structure in which at least two outer surfaces are expandable and contractable along the axial direction of the penis.
  • the penile implant mechanism comprises two segment-type structures, and the end caps of the two segment-type structures are coupled to each other.
  • one side of the two segment type structures are coupled to each other.
  • each segment type structure comprises at least two and/or at least three bellows.
  • each segment type structure comprises at least three bellows.
  • each segment type structure comprises at least one outer layer segment and at least one inner layer segment, the at least one outer layer segment and the at least one inner layer segment being nested with each other And can slide relative to each other in the axial direction.
  • a restriction means is provided between each outer segment and the inner segment for preventing slippage between the outer segment and the inner segment.
  • the at least one outer layer segment and the at least one inner layer segment each comprise at least one first hardness segment and at least one second hardness segment, the first hardness segment and the second hardness segment alternate Distribution, the hardness of the first hardness segment is greater than the hardness of the second hardness segment.
  • each of the two ends of each segment structure includes an outer segment, and the outer segments of the two ends respectively comprise a segment unit, and each of the two ends
  • the outer segment and each inner segment each comprise two segment units, wherein each segment unit includes two first hardness segments and one second hardness segment, and the second hardness segment is located at two Between the first hardness segments.
  • each segment type structure comprises at least one hollow length variable structure and at least one hollow length variable structure, the length variable structure and the length immutable structure being connected in series with one another.
  • a support structure is provided between the upper surface and the lower surface of the length immutable structure for supporting the penile implant mechanism in the circumferential direction and the axial direction.
  • the support structure comprises an integral pull structure distributed in the circumferential and axial directions of the segment structure.
  • each segment type structure comprises at least one flexible foldable structure
  • the folded portion of the flexible foldable structure is expanded to cause the penile implant mechanism to elongate when the fluid is injected
  • the flexible foldable structure is folded into a predetermined shape by its own elastic force to cause the penile implant mechanism to contract.
  • a support structure is respectively arranged between the flexible foldable structures for supporting the penile implant mechanism in the circumferential direction and the axial direction.
  • the support structure comprises an integral pull structure distributed in the circumferential and axial directions of the segment structure.
  • the segment type structure when the segment type structure is extended, is a closed structure composed of a convex outer surface and a concave outer surface.
  • the cross-section of the segment-type structure when expanded is a crescent shape.
  • the segment-type structure is sealed by the end cap near the distal end portion of the penis, and the shape of the end cap matches the sponge body.
  • the end cap includes a raised upper surface and a recessed lower surface.
  • the proximal end of the penile implant mechanism is provided with a base, the fixing device is coupled to the base, the base has a hollow cavity, and the cavity of the base The body is in communication with the cavity of the penile implant mechanism.
  • the shape of the base matches the sponge.
  • the base includes a raised upper surface and a recessed lower surface.
  • the penis implant mechanism has a thickness of 0.5 to 5 mm.
  • the penile implanting mechanism has a thickness of 2 to 3 mm.
  • the outer surface of the penile implanting mechanism is provided with a coating layer having biocompatibility and ductility.
  • a trip switch is further included, and the stroke switch is connected in series with the pump for limiting the stroke of the pump.
  • the patient controls the control device from outside the body.
  • control device includes an external wireless remote control device and an in-vivo sensing device
  • the internal sensing device is configured to wirelessly couple with the external wireless remote control device, and control penile erection and weakness according to the coupling signal.
  • control device charges the power source according to the coupling signal, and the power source supplies power to the pump.
  • the catheter is further provided with a valve for changing the flow direction of the fluid.
  • the power source provides electrical energy to the valve
  • the control device controls the valve to change the direction of flow of the fluid.
  • the proximal end of the penile implant mechanism is provided with a fixation device coupled to the pubic bone.
  • the fixing device is at least one fixing plate, and the fixing plate is provided with a through hole, and the fixing member fixes the fixing plate to the pubic bone through the through hole.
  • the proximal end of the penile implant mechanism is provided with a base, the fixing device is coupled to the base, the base has a hollow cavity, and the cavity of the base The body is in communication with the cavity of the penile implant mechanism.
  • the shape of the base matches the sponge.
  • the base includes a raised upper surface and a recessed lower surface.
  • the penile implant mechanism comprises a segment-type structure in which at least one outer surface is expandable and contractable along the axial direction of the penis.
  • the penile implant mechanism comprises two segment-type structures, and the end caps of the two segment-type structures are coupled to each other.
  • one side of the two segment type structures are coupled to each other.
  • each segment type structure comprises at least two bellows.
  • each segment type structure comprises at least three bellows.
  • the segment type structure includes at least one outer layer segment and at least one inner layer segment, and the at least one outer layer segment and the at least one inner layer segment are nested with each other And can slide relative to each other in the axial direction.
  • a restriction means is provided between each outer segment and the inner segment for preventing slippage between the outer segment and the inner segment.
  • the at least one outer layer segment and the at least one inner layer segment each comprise at least one first hardness segment and at least one second hardness segment, the first hardness segment and the second hardness segment alternate Distribution, the hardness of the first hardness segment is greater than the hardness of the second hardness segment.
  • each of the two ends of each segment structure includes an outer segment, and the outer segments of the two ends respectively comprise a segment unit, and each of the two ends
  • the outer segment and each inner segment each comprise two segment units, wherein each segment unit includes two first hardness segments and one second hardness segment, and the second hardness segment is located at two Between the first hardness segments.
  • each segment type structure comprises at least one hollow length variable structure and at least one hollow length variable structure, the length variable structure and the length immutable structure being connected in series with one another.
  • a support structure is provided between the upper surface and the lower surface of the length immutable structure for supporting the penile implant mechanism in the circumferential direction and the axial direction.
  • the support structure comprises an integral pull structure distributed in the circumferential and axial directions of the segment structure.
  • each segment type structure includes at least one flexible foldable structure, the folded portion is opened when the fluid is injected, and the penile implant mechanism is elongated; the fluid When discharged, it is folded into a predetermined shape under the action of its own elastic force, and the penile implanting mechanism contracts.
  • a support structure is respectively provided between the flexible foldable structures for supporting the penile implant mechanism in the circumferential direction and the axial direction.
  • the support structure comprises an integral pull structure distributed in the circumferential and axial directions of the segment structure.
  • the segment type structure when the segment type structure is extended, is a closed structure composed of a convex outer surface and a concave outer surface.
  • the cross-section of the segment-type structure when expanded is a crescent shape.
  • the segment-type structure is sealed by the end cap near the distal end portion of the penis, and the shape of the end cap matches the sponge body.
  • the end cap includes a raised upper surface and a recessed lower surface.
  • the proximal end of the penile implant mechanism is provided with a base, the fixing device is coupled to the base, the base has a hollow cavity, and the cavity of the base The body is in communication with the cavity of the penile implant mechanism.
  • the shape of the base matches the sponge.
  • the base includes a raised upper surface and a recessed lower surface.
  • the penis implant mechanism has a thickness of 0.5 to 5 mm.
  • the penile implanting mechanism has a thickness of 2 to 3 mm.
  • the outer surface of the penile implanting mechanism is provided with a coating layer having biocompatibility and ductility.
  • the pump delivers fluid in the reservoir to the penile implant mechanism via electrical energy, and the fluid is transported back to the reservoir via the catheter under mechanical energy.
  • an embodiment of the present invention provides a method for controlling a penile pacemaker, including a penile implant mechanism, a liquid storage chamber, a catheter, and a pump;
  • the penile implanting mechanism is used between the subcutaneous and the corpus cavernosum, wherein the penile implanting mechanism has a hollow cavity and is axially extendable and fixed to the proximal end of the penis;
  • the pump is coupled to the reservoir and the penile implant mechanism, the pump providing power to the fluid to transfer between the reservoir and the penile implant mechanism to cause the penis to erect or the penis to weaken;
  • the pump provides power to the fluid to transfer between the reservoir and the penile implant mechanism to cause the penis to erect or the penis to weaken, including:
  • the pump drives the fluid from the reservoir to the cavity of the penile implant mechanism via a catheter, and the penile implant mechanism is axially elongated to cause the penis to erect;
  • the pump drives the fluid from the lumen of the penile implant mechanism through a catheter to a reservoir, the penile implant mechanism axially contracting to weaken the penis.
  • a penile pacemaker including a penile implant mechanism, a reservoir, a catheter, a pump, and a heating device, wherein
  • the penile implanting mechanism is used between the subcutaneous and the corpus cavernosum, the penile implanting mechanism has a hollow cavity, and is axially extendable and fixed to the proximal end of the penis;
  • the liquid storage chamber being in communication with a cavity of the penile implant mechanism through at least one conduit;
  • the pump is coupled to the reservoir and the penile implant mechanism, the pump for providing power to the fluid to be transferred between the reservoir and the penile implant mechanism;
  • the heating device is coupled to the reservoir for heating a fluid output by the reservoir to the penile implant mechanism.
  • a power source is further included, the power source being electrically coupled to the pump and/or the heating device for providing electrical energy to the pump and/or heating device.
  • a power source is further included, the power source being electrically coupled to the pump and the heating device for providing electrical energy to the pump and heating device.
  • a control device is further included, the control device for controlling the operation of the pump and/or the operation of the heating device.
  • the control device is for controlling the operation of the pump and the heating device.
  • the method further includes a temperature sensor coupled to the heating device for detecting the temperature of the fluid heated by the heating device in real time; the control device detecting according to the temperature sensor The temperature controls the heating device to stop heating.
  • the pump delivers fluid in the reservoir to the penile implant mechanism via electrical energy, and the fluid is transported back to the reservoir via the catheter under mechanical energy.
  • the pump comprises a pump body, a pump head and a spring, the pump head being connected to the pump body by a spring, the pump head adjusting the volume of the reservoir by reciprocating movement, the spring at least partially driving the pump head Adjust the volume of the reservoir.
  • control device is further configured to control the heating device and control the heating device and the pump independently of each other.
  • a delay circuit is coupled between the heating device and the pump, and the delay circuit is configured to control the startup time of the heating device to be earlier than the time when the pump is started.
  • At least one capacitor is provided between the heating device and the pump, the heating device is connected in series with the pump, and the at least one capacitor is connected in parallel with the pump.
  • the patient controls the control device from outside the body.
  • control device includes an external wireless remote control device and an in-vivo sensing device
  • the internal sensing device is configured to wirelessly couple with the external wireless remote control device, and perform the power supply according to the coupling signal. Charging.
  • control device charges the power source according to the coupling signal, and the power source supplies power to the pump.
  • control device is further configured to control the heating device and simultaneously control the heating device and the pump.
  • a delay circuit is coupled between the heating device and the pump, and the delay circuit is configured to control the startup time of the heating device to be earlier than the time when the pump is started.
  • At least one capacitor is provided between the heating device and the pump, the heating device is connected in series with the pump, and the at least one capacitor is connected in parallel with the pump.
  • a trip switch is further included, and the stroke switch is connected in series with the pump for limiting the stroke of the pump.
  • control device includes an external wireless remote control device and an in-vivo sensing device
  • the internal sensing device is configured to wirelessly couple with the external wireless remote control device, and perform the power supply according to the coupling signal. Charging.
  • the extracorporeal wireless remote control device includes a start button for controlling activation of the pump and/or activation of the heating device.
  • the extracorporeal wireless remote control device includes a start button that simultaneously controls the pump and the heating device, and the heating device is activated earlier than the pump is activated.
  • a trip switch is further included, and the stroke switch is connected in series with the pump for limiting the stroke of the pump.
  • the conduit is further provided with at least one valve that receives electrical energy from the power source and changes the flow direction of the fluid under the control of the control device.
  • the heating device is disposed on an upper surface of the liquid storage chamber.
  • the method further includes a temperature sensor, wherein the temperature sensor is coupled to the heating device for detecting the temperature of the fluid heated by the heating device in real time; the control device is configured according to the temperature The temperature detected by the sensor controls the heating device to stop heating.
  • the temperature sensor is provided with a threshold, and when the temperature detected by the temperature sensor reaches the threshold, the heating device is turned off, and the threshold is 34 ° C to 38 ° C.
  • the threshold is 36.5 ° C to 37.5 ° C.
  • the patient controls the control device from outside the body.
  • the duct is further provided with at least one valve, the valve obtains electric energy from the power source, and changes the flow direction of the fluid under the control of the control device.
  • the proximal end of the penile implant mechanism is provided with a fixation device coupled to the pubic bone.
  • the fixing device is at least one fixing plate, and the fixing plate is provided with a through hole, and the fixing member fixes the fixing plate to the pubic bone through the through hole.
  • the proximal end of the penile implant mechanism is provided with a base, the fixing device is coupled to the base, the base has a hollow cavity, and the cavity of the base The body is in communication with the cavity of the penile implant mechanism.
  • the shape of the base matches the sponge.
  • the base includes a raised upper surface and a recessed lower surface.
  • the penile implant mechanism comprises a segment-type structure in which at least one outer surface is expandable and contractable along the axial direction of the penis.
  • the penile implant mechanism comprises two segment-type structures, and the end caps of the two segment-type structures are coupled to each other.
  • one side of the two segment type structures are coupled to each other.
  • each segment type structure comprises at least two and/or at least three bellows.
  • each segment type structure comprises at least three bellows.
  • the segment type structure includes at least one outer layer segment and at least one inner layer segment, and the at least one outer layer segment and the at least one inner layer segment are nested with each other And can slide relative to each other in the axial direction.
  • a restriction means is provided between each outer segment and the inner segment for preventing slippage between the outer segment and the inner segment.
  • the at least one outer layer segment and the at least one inner layer segment each comprise at least one first hardness segment and at least one second hardness segment, the first hardness segment and the second hardness segment alternate Distribution, the hardness of the first hardness segment is greater than the hardness of the second hardness segment.
  • each of the two ends of each segment structure includes an outer segment, and the outer segments of the two ends respectively comprise a segment unit, and each of the two ends
  • the outer segment and each inner segment each comprise two segment units, wherein each segment unit includes two first hardness segments and one second hardness segment, and the second hardness segment is located at two Between the first hardness segments.
  • each segment type structure comprises at least one hollow length variable structure and at least one hollow length variable structure, the length variable structure and the length immutable structure being connected in series with one another.
  • a support structure is provided between the upper surface and the lower surface of the length immutable structure for supporting the penile implant mechanism in the circumferential direction and the axial direction.
  • the support structure comprises an integral pull structure distributed in the circumferential and axial directions of the segment structure.
  • the segment-type structure comprises at least one flexible foldable structure; the folded portion of the flexible foldable structure is opened during fluid injection to elongate the penile implant mechanism When the fluid is discharged, the flexible foldable structure is folded into a predetermined shape by its own elastic force to cause the penile implant mechanism to contract.
  • a support structure is respectively provided between the flexible foldable structures for supporting the penile implant mechanism in the circumferential direction and the axial direction.
  • the support structure comprises an integral pull structure distributed in the circumferential and axial directions of the segment structure.
  • the segment type structure when the segment type structure is extended, is a closed structure composed of a convex outer surface and a concave outer surface.
  • the cross-section of the segment-type structure when expanded is a crescent shape.
  • the segment-type structure is sealed by the end cap near the distal end portion of the penis, and the shape of the end cap matches the sponge body.
  • the end cap includes a raised upper surface and a recessed lower surface.
  • the proximal end of the penile implant mechanism is provided with a base, the fixing device is coupled to the base, the base has a hollow cavity, and the cavity of the base The body is in communication with the cavity of the penile implant mechanism.
  • the shape of the base matches the sponge.
  • the base includes a raised upper surface and a recessed lower surface.
  • the penis implant mechanism has a thickness of 0.5 to 5 mm.
  • the penile implanting mechanism has a thickness of 2 to 3 mm.
  • the outer surface of the penile implanting mechanism is provided with a coating layer having biocompatibility and ductility.
  • an embodiment of the present invention provides a method for controlling a penile pacemaker, including a penile implant mechanism, a liquid storage chamber, a catheter, a pump, and a heating device; and the penile implant mechanism is used for Between the penis and the corpus cavernosum, wherein the penile implanting mechanism has a hollow cavity and is axially extendable and fixed to the proximal end of the penis;
  • the pump is coupled to the reservoir and the penile implant mechanism, the pump providing power to the fluid to transfer between the reservoir and the penile implant mechanism to cause the penis to erect or the penis to weaken;
  • the heating device is coupled to the reservoir to heat fluid output by the reservoir to the penile implant mechanism.
  • the pump provides power to the fluid to transfer between the reservoir and the penile implant mechanism to cause the penis to erect or the penis to weaken, including:
  • the pump drives the fluid from the reservoir to the cavity of the penile implant mechanism via a catheter, and the penile implant mechanism is axially elongated to cause the penis to erect;
  • the pump drives the fluid from the lumen of the penile implant mechanism through a catheter to a reservoir, the penile implant mechanism axially contracting to weaken the penis.
  • the traditional penile implant mechanism consists of two water sacs.
  • the water sac is directly implanted into the two corpus cavernosums.
  • the corpus cavernosum tissue needs to be completely detached before the implantation, and the anatomy of the corpus cavernosum itself is completed. Therefore, the patient is destroyed and the patient may even lose the possibility of recovery.
  • the penile implanting mechanism is implanted between the subcutaneous and the corpus cavernosum, and the thickness is much smaller than the diameter or thickness of the conventional water sac, and the anatomy of the corpus cavernosum is hardly damaged.
  • the end of the conventional penile implanting mechanism water balloon is inserted into the body through two conical structures, and the penile implanting mechanism of the present invention is implanted between the subcutaneous and the cavernous body of the penis, and is not suitable for being inserted into the body in a tapered structure.
  • the fixing device is fixed to the pubic bone by a fixing device such as a fixing plate, and the fixing is more firm, and the penile implanting mechanism is less likely to be displaced.
  • the outer surface of the penile implant mechanism is designed as a segment-type structure that can expand and contract along the axial direction of the penis, for example, a plurality of bellows structures and segment-type hollow structures of different hardness are nested with each other, The variable length structure and the length immutable structure are connected in series with each other, so that the penis implantation mechanism can be elongated when the penis is erected, and the penis is elongated, and when the penis is weak, the penile implanting mechanism contracts to a length consistent with the penis.
  • a hollow base is disposed at the proximal end of the segment-type structure, and the cavity of the base communicates with the cavity of the segment-type structure, and the base can firmly fix the segment-type structure between the skin of the penis and the sponge.
  • the segment type structure is plural, after the pump is started, the fluid is first output to the susceptor, and then uniformly distributed in the segment type structure via the susceptor.
  • the pedestal simultaneously functions to secure the penile implant mechanism and distribute the fluid evenly.
  • a heating device is added to the penile pacemaker to heat the fluid output from the reservoir to the penile implanting mechanism, thereby eliminating the difference in temperature between the fluid and the penis in the reservoir, thereby making the patient More comfortable.
  • a temperature sensor is further added to the penile pacemaker, the heating device is powered by the power source, the heating device and the temperature sensor are controlled by the control device, the threshold is set in the temperature sensor, and when the fluid reaches the threshold, the signal is transmitted to the control device, and the control is performed.
  • the device then controls the pump to deliver fluid from the reservoir to the penile implant mechanism, thereby effectively controlling the fluid heating temperature.
  • the heating device and the temperature sensor are controlled by a remote control to make the operation of the patient more convenient. Further, by providing a delay circuit between the heating device and the pump, for example, connecting the capacitor in parallel with the pump, the heating device is started earlier than the pump is started, and the fluid in the liquid storage chamber is prevented from being heated. It flows into the penis implant mechanism and also simplifies the structure of the remote control. For example, the buttons that control the heating device and the pump can be combined into one.
  • FIG. 1 is a schematic view of a penile pacemaker of a water bladder structure in the prior art.
  • 2A-2E are schematic views of five embodiments of a penile pacemaker of the present invention.
  • Figure 3 is a schematic illustration of a preferred embodiment based on Figures 2B-2E.
  • FIGS. 2C and 2E are schematic diagrams of an embodiment of an in vitro charging control device and an in vivo sensing device based on FIGS. 2C and 2E.
  • Figure 5 is a schematic illustration of a preferred embodiment of the penile pacemaker of the present invention based on Figure 2E.
  • Fig. 6 is a schematic view showing an embodiment of a control circuit of the penile pacemaker of the present invention based on Fig. 5.
  • Figure 7 is a schematic illustration of a preferred embodiment of a pump for a penile pacemaker of the present invention based on Figures 2D-2E.
  • Figure 8 is a schematic illustration of an embodiment of the penis implant mechanism based on Figures 2A-2E secured to the proximal end of the penis.
  • FIGS. 9A-9D are schematic views of an embodiment of a penile implant mechanism based on Figs. 2A-2E.
  • Figure 10A is a top plan view of an embodiment of a 9A-based penile implant mechanism.
  • Figure 10B is a schematic cross-sectional view of the 9A-based penile implant mechanism perpendicular to the axial direction.
  • Figure 11A is a schematic cross-sectional view of the 9B-based penile implant mechanism perpendicular to the axial direction.
  • Fig. 11B is a partial enlarged view of the cross section of the 9B-based penile implant mechanism in the axial direction.
  • Figure 12 is a schematic cross-sectional view of the 9C-based penile implant mechanism perpendicular to the axial direction.
  • Figure 13A is a schematic cross-sectional view of a 9D-based penile implant mechanism perpendicular to the axial direction.
  • Fig. 13B is a partially enlarged view showing a state in which the segment type structure of the 9D-based penile implanting mechanism is contracted.
  • 14A-14B are overall schematic views of the penile implantation mechanism in the penis of the penile pacemaker of the present invention.
  • Figure 15 is a schematic cross-sectional view of the penile implantation mechanism in the penis of the penile pacemaker of the present invention.
  • the “distal end of the penis” refers to the end of the penis away from the human body.
  • the "proximal end of the penis” refers to the end of the penis that is close to the human body.
  • the “segment type structure” means a structure in which at least one section or section is combined.
  • the "proximal end of the penile implant mechanism” refers to the end of the penile implant mechanism close to the human body.
  • the “proximal end of the segment-type structure” refers to the end of the segment-type structure close to the human body.
  • the “axial direction” refers to the direction extending along the length of the penis.
  • the “thickness of the penile implant mechanism” refers to the maximum distance between the upper surface and the lower surface of the penile implant mechanism when the penis is erected.
  • the “fluid” includes, but is not limited to, a liquid, a gas, such as a disinfectant, physiological saline, air, and the like.
  • 1 is a prior art penile pacemaker of a water bladder structure, which is composed of two water bladders having a radial diameter of between 8 mm and 10 mm, and the water bladder is directly implanted into the two sponge bodies.
  • the anatomy of the cavernous tissue itself is destroyed, and the patient may even permanently lose the possibility of recovery.
  • 2A-2E are five embodiments of a penile pacemaker of the present invention.
  • 2A is a manual non-electric penile pacemaker, including a penile implanting mechanism 1, a catheter 2, a reservoir 35, and a pump 302, wherein the penile implanting mechanism 1 is used between the subcutaneous and the corpus cavernosum.
  • the penile implanting mechanism 1 has a hollow cavity and is axially extendable and fixed to the proximal end of the penis; the fluid storage chamber 35 stores a fluid, and the liquid storage chamber 35 passes through the at least one conduit 2
  • the cavity of the penile implant mechanism 1 is in communication; the pump 302 is coupled to the reservoir 35 and the penile implant mechanism 1 for transferring fluid between the reservoir 35 and the penile implant mechanism 1 .
  • a predetermined volume of fluid is contained in the reservoir 35.
  • the volume of the fluid is at least completely filled with the cavity of the penile implant mechanism 1.
  • the conduit is further provided with a valve for changing the flow direction of the fluid.
  • the conduit 2 is a hollow conduit, and the wall lining can have a strength-increasing structure, such as a mesh-like woven structure that increases strength.
  • the conduit 2 is one or more.
  • the reservoir 35 and the pump 302 may be two separate devices, or the reservoir 35 and the pump 302 may be of a unitary structure.
  • the pump can be a one-way pump or a two-way pump.
  • the pump 302 is between the reservoir 35 and the penile implanting mechanism 1, the pump is connected to the reservoir 35 and the penile implanting mechanism 1, respectively, and the pump 302 can be a one-way pump or a two-way pump.
  • the pump 302 pumps the fluid out of the reservoir 35 and re-delivers the fluid to the penile implant mechanism 1 to cause the penis to erect.
  • the pump 302 pumps the fluid back from the penile implant mechanism 1 and then It is transported back into the reservoir 35.
  • a valve may be provided between the pump and the reservoir 35 and the penile implant mechanism 1 to control the flow of fluid.
  • liquid storage chamber 35 and the pump 302 are integrated:
  • the pump 302 and the reservoir 35 are integrated, separated by a diaphragm, a piston or other suitable structure.
  • the pump 302 presses the reservoir 35, so that the volume of the reservoir 35 is reduced, and the fluid is discharged. It flows out of the liquid storage chamber 35.
  • the reservoir 35 and the pump 302 are individually (independently mounted) or collectively (integrally constructed) covered by the housing 31.
  • the casing 31 is made of a material having a biocompatible material, such as stainless steel, titanium alloy, cobalt chromium alloy, and the surface of the casing can be sprayed or plated with parylene, Teflon, Materials such as polysaccharide polymers and modified silicones are used to improve the surface properties of the shell and enhance biocompatibility and stability.
  • FIG. 2B is a manual electric penile pacemaker, and FIG. 2B adds a power source 32 that is electrically coupled to the pump 302 for providing electrical power to the pump 302 as compared to FIG. 2A.
  • the power source 32 is a battery or other device capable of providing electrical energy.
  • the power source 32 may be separate from the liquid storage chamber 35, the pump 302, or the pump 302, or integrated with the liquid storage chamber 35 and the pump 302.
  • the power source 32 can be disposed in the scrotum or other parts of the human body with the reservoir 35 and the pump 302.
  • a control device 702 is also included, the control device for controlling the operation of the pump and/or the operation of the heating device.
  • the control device is for controlling the operation of the pump and the heating device.
  • the patient controls the control device 702 from outside the body.
  • the control device 702 is located in the scrotum.
  • the power source 32 provides, for example, electrical energy to the pump 302, and the pump 302 is activated to push the reservoir 35.
  • the fluid flows into the cavity of the penile implanting mechanism 1 through the catheter 2, so that the penile implanting mechanism 1 is extended, and when the switch is opened, the fluid flows from the cavity of the penile implanting mechanism 1 back to the reservoir 35, so that The penile implanting mechanism 1 contracts.
  • the fluid in the reservoir 35 just satisfies the full extension of the penile implanting mechanism 1, and when the fluid completely flows into the penile implanting mechanism 1, the switch is opened and the pump 302 is stopped.
  • the pump 302 further comprises a motor or a motor and a transmission mechanism capable of converting electrical energy into mechanical motion
  • the motor may be a rotating electrical machine, a linear motor
  • the transmission mechanism may be a gear, a turbine, or a ball.
  • Commonly used transmission mechanisms such as lead screws.
  • the pump delivers fluid in the reservoir to the penile implant mechanism via electrical energy, and the fluid is transported back to the reservoir via the catheter under mechanical energy.
  • the pump comprises a pump body, a pump head and a spring, the pump head being connected to the pump body by a spring, the pump head adjusting the volume of the reservoir by reciprocating movement, the spring at least partially driving the pump head Adjust the volume of the reservoir.
  • FIG 3 is a schematic illustration of a preferred embodiment based on Figures 2B-2D.
  • the conduit 2 is further provided with a valve 22, which is electrically connected to the power source 32, the valve taking electrical energy from the power source and changing the flow direction of the fluid under the control of the control device.
  • the valve 22 is a solenoid valve or other valve 22 that is controllable by electrical energy. For example, when the pump 302 pumps the fluid from the liquid storage chamber 35 into the penile implanting mechanism 1, the valve 22 can be automatically opened under the action of hydraulic pressure. When the fluid flows back to the liquid storage chamber 35 by the penile implanting mechanism 1, the valve 22 is energized.
  • the control device 702 controls the opening of the valve 22 to complete the drainage of the penile implanting mechanism 1.
  • the valve 22 can be located at one end of the catheter 2 near the penile implant mechanism 1 or near the end of the catheter 2 of the reservoir 35. Although the valve 22 is provided here on the catheter 2, the valve 22 can still be provided in the penile implanting mechanism 1. Valve 22 can be a valve or a plurality of valves. In an embodiment of the invention, when the conduit 2 is one, the valve 22 is a valve. When there are two conduits, one one-way valve is placed on each conduit, or a common directional control valve is placed on the two conduits.
  • control device 702 includes an external wireless remote control device 44 and an in-vivo sensing device 304 for wirelessly coupling with the external wireless remote control device 44, and according to The coupled signal controls penile erection and weakness.
  • the control device 702 charges the power source according to the coupling signal, and supplies power to the pump from the power source.
  • the power source 32 is a rechargeable battery, and may be a battery or other rechargeable battery.
  • the types of the battery include a lithium ion battery, a lithium-iodine battery, and a graphene battery.
  • the extracorporeal wireless remote control device 44 is correspondingly provided with at least one button for controlling the external wireless remote control device 44 to send a signal, and the internal sensing device 304 receives the signal and converts the signal into a current to charge the power source.
  • the structure of the external wireless remote control device 44 is the structure of the existing remote controller, and details are not described herein again.
  • the extracorporeal wireless remote control device 44 includes a signal transmitting antenna
  • the in vivo sensing device 304 includes a receiving antenna that can be implanted in a patient, such as the abdomen or the subcutaneous.
  • the antenna coil can be smaller than the implant. The coil of the antenna when entering the abdomen.
  • the conduit 2 is further provided with a valve 22, the valve 22 is electrically connected to the power source 32, the valve obtains electric energy from the power source, and the control device Under the control of the flow direction of the fluid.
  • the valve 22 is a solenoid valve or other valve 22 that is controllable by electrical energy. Valve 22 can be controlled by extracorporeal wireless remote control 44.
  • control device 702 is provided with a fluid flow detecting unit that also stores a fluid flow threshold value, when the fluid flows from the reservoir 35 into the flow of the penile implanting mechanism 1 or flows from the penile implanting mechanism 1 When the flow rate of the return liquid chamber 35 reaches a certain threshold, the valve 22 is automatically closed.
  • the threshold is preferably the volume of fluid just filling the penile implant mechanism 1.
  • control device 702 is not provided with a fluid flow detecting unit, and the patient controls the valve 22 to be opened or closed directly via the control device 702 by experience.
  • the pump delivers fluid in the reservoir to the penile implant mechanism via electrical energy, and the fluid is transported back to the reservoir via the catheter under mechanical energy.
  • the pump comprises a pump body, a pump head and a spring, the pump head being connected to the pump body by a spring, the pump head adjusting the volume of the reservoir by reciprocating movement, the spring at least partially driving the pump head Adjust the volume of the reservoir.
  • 2D is a heated electric penile pacemaker comprising a penile implanting mechanism 1, a reservoir 35, a catheter 2, a pump 302 and a heating device 36 for the subcutaneous and corpus cavernosum
  • the penile implanting mechanism 1 has a hollow cavity and is axially extendable and fixed to the proximal end of the penis; the fluid chamber 35 stores fluid, and the liquid storage chamber 35 passes through at least one catheter 2 Communicating with the cavity of the penile implanting mechanism 1;
  • the pump 302 is coupled to the reservoir 35 and the penile implant mechanism 1 for transferring fluid between the reservoir 35 and the penile implant mechanism 1;
  • the heating device 36 is coupled to the reservoir 35 for heating the fluid output from the reservoir 35 to the penile implant mechanism 1.
  • a power source 32 is further included, the power source 32 being electrically connected to the pump 302 and/or the heating device for providing the pump 302 and/or the heating device Electrical energy.
  • the power source provides electrical energy to the heating device.
  • control device not only controls the pump but also controls the heating device and controls the heating device and the pump independently of each other.
  • the control device not only controls the pump but also controls the heating device and simultaneously controls the heating device and the pump.
  • the heating device is activated earlier than the pump is started.
  • a delay circuit is coupled between the heating device and the pump, and the delay circuit is configured to control the startup time of the heating device to be earlier than the time when the pump is started.
  • at least one capacitor is provided between the heating device and the pump, the heating device is connected in series with the pump, and the at least one capacitor is connected in parallel with the pump.
  • the pump is connected in series with a travel switch for limiting the stroke of the pump.
  • the travel switch is normally closed, and when the pump completely pumps fluid into the penile implant mechanism 1, the travel switch is opened and the pump is stopped.
  • the heating device is disposed on an upper surface of the liquid storage chamber.
  • the method further includes a temperature sensor, wherein the temperature sensor is coupled to the heating device for detecting the temperature of the fluid heated by the heating device in real time, and the control device is configured according to the temperature The temperature detected by the sensor controls the heating device to stop heating.
  • the temperature sensor is provided with a threshold, and when the temperature detected by the temperature sensor reaches the threshold, the heating device is turned off, and the threshold is 34 ° C to 38 ° C.
  • the threshold is from 36.5 ° C to 37.5 ° C.
  • the user controls the control device from outside the body.
  • the pump delivers fluid in the reservoir to the penile implant mechanism via electrical energy, and the fluid is transported back to the reservoir via the catheter under mechanical energy.
  • the pump comprises a pump body, a pump head and a spring, the pump head being connected to the pump body by a spring, the pump head adjusting the volume of the reservoir by reciprocating movement, the spring at least partially driving the pump head Adjust the volume of the reservoir.
  • the 2E is a remotely heated electric penile pacemaker including a penile implanting mechanism 1, a reservoir 35, a catheter 2, a pump 302, a heating device 36, a power source 32, a control device 702, and a temperature sensor 305.
  • the device 702 includes an extracorporeal wireless remote control device 44 and an in-vivo sensing device 304, wherein the penile implant mechanism 1 is used between the penis implant and the sponge, the penile implant mechanism 1 has a hollow cavity and is axially Telescopically fixed to the proximal end of the penis; fluid is stored in the reservoir 35, the reservoir 35 is in communication with the lumen of the penile implant mechanism 1 via at least one catheter 2; the pump 302 is coupled to a power source 32, a reservoir 35 and a penile implanting mechanism 1 for receiving electrical energy from the power source 32 to transfer fluid between the reservoir 35 and the penile implanting mechanism 1; the in vivo sensing device 304, The heating device 36 and the temperature sensor are respectively electrically connected to the power source
  • the extracorporeal wireless remote control device 44 includes an activation button that simultaneously controls the pump and the heating device, and the heating device is activated earlier than the pump is activated.
  • a delay circuit is coupled between the heating device and the pump, and the delay circuit is configured to control the startup time of the heating device to be earlier than the time when the pump is started.
  • at least one capacitor is provided between the heating device and the pump, the heating device is connected in series with the pump, and the at least one capacitor is connected in parallel with the pump.
  • the pump is connected in series with a travel switch for limiting the stroke of the pump.
  • the heating device 36 may be disposed inside or outside the liquid storage chamber 35.
  • the heating device 36 is disposed on an upper surface of the liquid storage chamber 35, and the fluid is heated by the heating device 36 to be pumped 302. Squeeze into the catheter 2.
  • the temperature sensor may be provided inside or outside the heating device 36.
  • the temperature sensor is provided inside the heating device 36.
  • the body of the heating device 36 can be any suitable shape including, but not limited to, a full sheet, a plurality of strips arranged side by side, a spherical plate, and the like.
  • the heating device 36 and the pump 302 are simultaneously activated or not activated at the same time.
  • the heating device 36 is activated earlier than the pump 302 is activated.
  • the fluid is not squeezed to the catheter 2 by the pump 302 without being heated to a specified temperature or temperature range, resulting in a poor patient experience.
  • the heating device 36 first initiates heating to a desired specified temperature or temperature range, such as the temperature of the penile erection, the pump 302 is restarted, which causes the fluid temperature to align with the patient's penile erection temperature, and the patient does not feel uncomfortable.
  • the ideal specified temperature or temperature range is based on the difference in each patient, and the patient is free to decide which temperature is the ideal or suitable temperature.
  • the temperature sensor is provided with a threshold, and when the temperature detected by the temperature sensor reaches the threshold, the heating device 36 is turned off, and the threshold is any value or range of values between 34 ° C and 38 ° C, preferably, The threshold is any value or range of values between 36.5 ° C and 37.5 ° C.
  • DETAILED DESCRIPTION A signal is transmitted to control device 702, for example, when the temperature detected by the temperature sensor reaches the threshold, and control device 702 turns off heating device 36.
  • the conduit 2 is further provided with a valve 22, the valve 22 is electrically connected to the power source 32, the valve obtains electric energy from the power source, and changes the flow direction of the fluid under the control of the control device.
  • the valve 22 is a solenoid valve or other valve that is controllable by electrical energy.
  • the pump delivers fluid in the reservoir to the penile implant mechanism via electrical energy, and the fluid is transported back to the reservoir via the catheter under mechanical energy.
  • the pump comprises a pump body, a pump head and a spring, the pump head being connected to the pump body by a spring, the pump head adjusting the volume of the reservoir by reciprocating movement, the spring at least partially driving the pump head Adjust the volume of the reservoir.
  • FIGS. 2C and 2E are schematic diagrams of an embodiment of an extracorporeal wireless remote control device 44 and an in-vivo sensing device 304 based on FIGS. 2C and 2E.
  • the external wireless remote control device 44 includes a signal generator and an induction coil. Accordingly, the in-vivo sensing device 304 further includes an induction coil 701.
  • the induction coil 701 is wirelessly coupled with the induction coil of the external wireless remote control device 44 to convert the external energy source into a current signal. And transmitted to the control device 702; the control device 702 is configured to receive and store an external current signal, and control the power source 32 according to the current signal; the power source 32 is electrically connected to the pump 302 for transmitting power to the device Pump 302.
  • the induction coil can be implanted in any suitable position in the human body.
  • the induction coil can be implanted under the skin of the lower abdominal wall of the human body.
  • the extracorporeal wireless remote control device 44 emits a wireless signal, such as an electromagnetic wave signal or other type of wireless signal, to the induction coil, which converts the wireless signal into a current that is transmitted to the power source 32 and the control device 702.
  • Control device 702 simultaneously receives and stores external signals and programs and controls operation of pump 302, such as activation and deactivation of pump 302, based on the external signals.
  • Figure 7 is a schematic illustration of a preferred embodiment of a pump 302 of the penile pacemaker of the present invention based on 2D-2E.
  • the pump 302 comprises a pump body 33, a pump head 34 and a spring 37, which is connected to a pump body 33 by a spring 37 which regulates the volume of the reservoir by reciprocating movement, said spring 37
  • the pump head 34 is at least partially driven to adjust the volume of the reservoir.
  • the pump 302 is composed of a pump body 33 and a pump head 34.
  • the housing 31, the battery 32, the pump body 33, the pump head 34, the liquid storage chamber 35, and the electric heating module 36 form an integrated structure.
  • the battery 32 may be made of a lithium ion battery, a lithium-iodine battery, a graphene battery, or the like, and the battery 32
  • the pump body 33 can be powered to achieve pressurized output of the liquid in the reservoir 35 into the penile implanting mechanism 1 for extensional movement;
  • the battery can be a solenoid valve 22 disposed on the catheter 2. Power is supplied to effect switching control of the liquid path in the conduit 2; the battery can
  • the pump body 33 is a power system composed of a motor or a motor and a transmission mechanism for converting electrical energy into mechanical motion.
  • the motor may be a rotating electrical machine or a linear motor
  • the transmission mechanism may be a gear, a turbine, or a ball wire.
  • a linear motor is preferably used as the pump body power system, and the pump body 33 is used to drive the pump head 34 to move away from the pump body, so that the plunger on the pump head squeezes the liquid storage chamber.
  • the liquid in 35 is filled into the penile implanting mechanism 1 via the catheter 2; the pump head 34 is composed of a push rod 341 and a plunger 342, and the push rod 341 is driven by the pump body to push the plunger 342 to the reservoir
  • the liquid in the 35 applies pressure and is poured into the penile implanting mechanism 1 through the catheter 2; the plunger 342 and the inner wall of the reservoir 35 can form a sealed cavity, and under the push-pull movement of the plunger 342,
  • the liquid in the liquid storage chamber 35 is pushed out of the liquid storage chamber 35 and the liquid recovery chamber 35; preferably, a tension spring 37 is provided between the pump head 34 and the pump body 33 in the present invention, and the pump head 34 is pumped.
  • the tension spring 37 is stretched and The body 33 is in a non-excited state and the solenoid valve on the catheter 2 is in a liquid circuit open state.
  • the pump head 34 is slowly pulled back to the starting position, and the penile implant mechanism 1 is simultaneously
  • the liquid inside is slowly drawn back into the liquid storage chamber 35; the pump 302 is driven by the electric motor to the external pumping process, and the water returning process is applied by the spring pulling force without any other energy consumption, so that the energy efficiency of the battery is maximized. , thereby reducing the number of times the system is charged.
  • 9A-9D are schematic views of an embodiment of a 2A-2E based penile implant mechanism.
  • the penile implant mechanism 1 includes a segment-type structure in which at least two outer surfaces are expandable and contractible in the axial direction of the penis.
  • the penile implanting mechanism 1 has a thickness of 0.5 to 5 mm. More preferably, the penile implanting mechanism 1 has a thickness of 2 to 3 mm.
  • the penile implanting mechanism 1 is implanted between the subcutaneous part of the penis and the corpus cavernosum.
  • the thickness of the penile implanting mechanism 1 of the present invention is much smaller than the thickness (or radial diameter) of the conventional water bladder of 8 mm to 10 mm, so that it can be implanted between the subcutaneous layer of the penis and the gap of the sponge body without destroying the structure of the sponge body. And the operation is simple, and the physical damage to the patient is minimized.
  • the outer surface of the penile implanting mechanism 1 is provided with a coating having biocompatibility and ductility so that the penile implanting mechanism 1 forms good compatibility and stability with the surrounding tissue.
  • the coating layer can be made of a polymer material such as PTFE, TPU, PU, silica gel, silicone, thermoplastic elastomer, modified material, composite material and the like.
  • the penile implant mechanism comprises two segment-type structures, each segment-type structure comprising at least two and/or at least three bellows.
  • the bellows structure has a pleated surface in a contracted state, and the surface is flared to form a smooth surface upon elongation.
  • each segment type structure comprises at least three bellows.
  • the bellows is a cylindrical thin wall corrugated casing having a plurality of transverse corrugations, the bellows being elastic and capable of generating displacement under the action of pressure, axial force, lateral force or bending moment.
  • the segment-type structure is sealed near the distal end portion of the penis by an end cap whose shape matches the sponge.
  • the end cap includes a raised upper surface and a recessed lower surface.
  • the end caps of the two segment-type structures are coupled to each other to avoid displacement of the two segment-type structures.
  • the end cap coupling manner of the two segment type structures includes the end caps of the two segment type structures integrated into one body, that is, one whole end cap without gaps therebetween; the end caps of the two segment type structures are mutually welded by means of welding, etc.
  • the connection is such that the joint is spaced apart by the walls of the two end caps; and other coupling means suitable for use in the present invention.
  • the two-segment structure coupling method includes two segment-type structures integrated from the proximal end to the distal end of the penis; two segment-type structures are connected to each other by welding, etc.; two segment-type structures and their ends
  • the covers are all integrated (in this case, can be regarded as a segment-type structure), or at least one of the segment-type structures and their end caps are connected to each other by welding or the like; and other coupling means suitable for the present invention.
  • each of the three bellows constitutes a segment-type structure. 6 consisting of two segment-type structures, each segment-type structure is sealed by an end cap near the distal end of the penis, and each of the three bellows is close to the distal end of the penis and is sealed by the same end cap.
  • the cap is fixed at the distal end of the penis or near the distal end of the penis, and all bellows are evenly distributed between the penis and the corpus cavernosum.
  • Each bellows can be regularly or irregularly distributed between the penis and the sponge. The more the number of bellows structures, the more uniform the distribution of the penile implant mechanism 1 between the penis and the sponge, and the better the erection effect.
  • the section of the segment-type structure is a closed structure composed of a convex outer surface and a concave outer surface.
  • the cross-sectional shape of the bellows structure in a non-expanded state may be a closed crescent shape, a semicircular shape, a circular shape, a quadrangular shape, a circular arc shape, or an elliptical shape.
  • the bellows can perform an elongation movement in the axial direction.
  • the penile implant mechanism includes two segment-type structures, each segment-type structure including at least one outer segment and at least one inner segment, the at least one outer segment and At least one of the inner layer segments are nested with each other and are slidable relative to each other in the axial direction.
  • the at least one outer layer segment and the at least one inner layer segment each comprise at least one first hardness segment and at least one second hardness segment, the first hardness segment and the second hardness segment alternate Distribution, the hardness of the first hardness segment is greater than the hardness of the second hardness segment.
  • each of the two ends of each segment structure includes an outer segment, and the outer segments of the two ends respectively comprise a segment unit, and each of the two ends
  • the outer segment and each inner segment each comprise two segment units, wherein each segment unit includes two first hardness segments and one second hardness segment, and the second hardness segment is located at two Between the first hardness segments. That is, each segment unit includes a first hardness segment, a second hardness segment, and a first hardness segment that are sequentially connected.
  • each of the outer segments and the two segment units of each inner segment are joined together to include two first hardness segments. This design facilitates the interaction of the inner and outer segments.
  • the section of the segment-type structure is a closed structure composed of a convex outer surface and a concave outer surface.
  • the outer layer and the inner layer of the segment-type structure are alternately connected by the hard segment 121 and the soft segment 122, respectively, and the soft and hard segments nested with each other when the inside is filled with a liquid having a certain pressure.
  • the hollow structure can be relatively slid in the axial direction, so that the soft segments of the outer and inner soft and hard segment-type hollow structures are mutually staggered, thereby ensuring rigidity in an arbitrary axial section.
  • a restriction means is provided between each outer segment and the inner segment for preventing slippage between the outer segment and the inner segment.
  • the restriction means may be designed such that the outer segment and the inner segment are connected by a soft material or may be designed in other suitable forms.
  • Figure 11A is a schematic cross-sectional view of the penile implanting mechanism 1 corresponding to Figure 9B.
  • the penile implant mechanism is a closed structure composed of a convex outer surface and a recessed outer surface.
  • the cross-sectional shape of the closed structure is not limited to the shape shown in FIG. 11, and may be other shapes such as a circular shape, a quadrangular shape, a circular arc shape, or an elliptical shape.
  • the cross-section of the segment-type structure when expanded is a crescent shape.
  • the segment-type structure is sealed from the distal end portion of the penis by an end cap having a shape that matches the body of the sponge.
  • the end cap includes a raised upper surface and a recessed lower surface.
  • the end caps of the two segment-type structures are coupled to each other to avoid displacement of the two segment-type structures.
  • the end cap coupling manner of the two segment type structures includes the end caps of the two segment type structures integrated into one body, that is, one whole end cap without gaps therebetween; the end caps of the two segment type structures are mutually welded by means of welding, etc.
  • the connection is such that the joint is spaced apart by the walls of the two end caps; and other coupling means suitable for use in the present invention.
  • the two-segment structure coupling method includes two segment-type structures integrated from the proximal end to the distal end of the penis (this can be regarded as a segment-type structure); two segment-type structures are welded, etc.
  • the manners are interconnected; the two segment-type structures and their end caps are integrated into one body, or at least one of the segment-type structures and their end caps are connected to each other by welding or the like; and other coupling modes suitable for the present invention.
  • the penile implanting mechanism 1 has a thickness of 0.5 to 5 mm. More preferably, the penile implanting mechanism 1 has a thickness of 2 to 3 mm.
  • the penile implant mechanism includes two segment-type structures, each segment-type structure including at least one hollow length-variable structure and at least one hollow length-variable structure, the length being variable Structures and lengths of immutable structures are connected in series. From the outer surface, the variable length structure and the length immutable structure are alternately and connected to each other. For ease of production, the variable length structure and the length non-variable structure are one-shot molded structures and the same materials are used.
  • the variable length structure can be made of a pleated structure or a corrugated tubular structure, and the length immutable structure is made of a hollow thin-walled tubular structure.
  • the section of the segment-type structure when the segment-type structure is extended, is a closed structure composed of a convex outer surface and a concave outer surface.
  • the cross-section of the segment-type structure when expanded is a crescent shape.
  • a support structure is provided between the upper surface and the lower surface of the length immutable structure for supporting the penile implant mechanism in the circumferential direction and the axial direction. More preferably, the support structure comprises an integral pull structure distributed in the circumferential and axial directions of the segment structure.
  • FIG 12 is a schematic cross-sectional view of the penile implanting mechanism 1 corresponding to Figure 9C.
  • the penile implanting mechanism 1 is a closed structure composed of a convex outer surface and a concave outer surface, and a support structure is provided between the upper surface and the lower surface of the length immutable structure.
  • the support structure surrounds the inner surface of the segment structure, and an axially distributed support structure is connected between the upper surface and the lower surface of the length immutable structure, and the support structures in the circumferential direction and the axial direction are integrated.
  • the sectional shape of the segment type structure is not limited to the shape shown in FIG. 12, and may be other shapes such as a circle, a quadrangle, a circular arc, or an elliptical shape.
  • the cross-section of the segment-type structure when expanded is a crescent shape.
  • the segment-type structure is sealed by an end cap near the distal end portion of the penis, the end cap being shaped to match the sponge.
  • the end cap includes a raised upper surface and a recessed lower surface.
  • the end caps of the two segment-type structures are coupled to each other to avoid displacement of the two segment-type structures.
  • the end cap coupling manner of the two segment type structures includes the end caps of the two segment type structures integrated into one body, that is, one whole end cap without gaps therebetween; the end caps of the two segment type structures are mutually welded by means of welding, etc.
  • the connection is such that the joint is spaced apart by the walls of the two end caps; and other coupling means suitable for use in the present invention.
  • the two-segment structure coupling method includes two segment-type structures integrated from the proximal end to the distal end of the penis (this can be regarded as a segment-type structure); two segment-type structures are welded, etc.
  • the manners are interconnected; the two segment-type structures and their end caps are integrated into one body, or at least one of the segment-type structures and their end caps are connected to each other by welding or the like; and other coupling modes suitable for the present invention.
  • the penile implanting mechanism 1 has a thickness of 0.5 to 5 mm. More preferably, the penile implanting mechanism 1 has a thickness of 2 to 3 mm.
  • the penile implant mechanism includes two segment-type structures, each segment-type structure including at least one flexible foldable structure, the folded portion of the flexible foldable structure when fluid is injected
  • the penile implanting mechanism is opened to expand; when the fluid is discharged, the flexible foldable structure is folded into a predetermined shape by its own elastic force to cause the penile implanting mechanism to contract.
  • the section of the segment-type structure is a closed structure composed of a convex outer surface and a concave outer surface.
  • the cross-section of the segment-type structure when expanded is a crescent shape.
  • a support structure is respectively provided between the flexible foldable structures for supporting the penile implant mechanism in the circumferential direction and the axial direction.
  • the support structure comprises an integral pull structure distributed in the circumferential and axial directions of the segment structure.
  • the segment-type structure has a one-piece outer surface, and the outer surface includes a plurality of flexible foldable structures, and the flexible foldable structures are respectively provided with support structures.
  • the folded portion is opened, and when the fluid is discharged, it is folded into a predetermined shape by its own elastic force, for example, a folded structure as shown in Fig. 13B, and the foldable structures are separated by the support structure.
  • the folded structure shown in Fig. 13B is only used to illustrate the configuration of the folded structure, and the folded structure of the present invention is not limited to the configuration shown in Fig. 13B.
  • the segment-type structure is sealed by an end cap near the distal end portion of the penis, the end cap being shaped to match the sponge.
  • the end cap includes a raised upper surface and a recessed lower surface.
  • the end caps of the two segment-type structures are coupled to each other to avoid displacement of the two segment-type structures.
  • the end cap coupling manner of the two segment type structures includes the end caps of the two segment type structures integrated into one body, that is, one whole end cap without gaps therebetween; the end caps of the two segment type structures are mutually welded by means of welding, etc.
  • the connection is such that the joint is spaced apart by the walls of the two end caps; and other coupling means suitable for use in the present invention.
  • the two-segment structure coupling method includes two segment-type structures integrated from the proximal end to the distal end of the penis (this can be regarded as a segment-type structure); two segment-type structures are welded, etc.
  • the manners are interconnected; the two segment-type structures and their end caps are integrated into one body, or at least one of the segment-type structures and their end caps are connected to each other by welding or the like; and other coupling modes suitable for the present invention.
  • the segmented structure of the present invention can be printed by a 3D printer using a suitable material.
  • the penile implantation mechanism 1 is used between the subcutaneous and the corpus cavernosum.
  • Fig. 8 is a schematic view showing an embodiment in which the penis implantation mechanism 1 based on 2A-2E is fixed to the proximal end of the penis.
  • the proximal end of the penis of the penile implant mechanism 1 is provided with a fixation device that is coupled to the pubic bone.
  • the fixing device is at least one fixing plate, and the fixing plate is provided with a through hole, and the fixing member fixes the fixing plate to the pubic bone through the through hole.
  • the fixing member is a medical screw, a fastener or the like.
  • the fixing device is two fixing plates, and each fixing plate is provided with a through hole.
  • the shape of the fixing plate is not limited.
  • the fixation plate is fixed to the pubic bone here, the fixation plate can also be fixed to other positions of the human body.
  • the proximal end of the penile implant mechanism is provided with a base, the fixing device is coupled to a base, the base has a hollow cavity, and the cavity of the base is implanted with the penis The cavity of the mechanism is connected.
  • the proximal end of the segment-type structure is coupled to a base that is in communication with the interior of the segment-type structure.
  • the base may be one, as shown in FIG. 8, the base is further provided with two protruding interfaces, which are respectively coupled with each segment type structure.
  • the shape of the base matches the sponge body, thereby preventing the base shape from being mismatched with the shape of the sponge to give the patient an uncomfortable feeling.
  • the base includes a raised upper surface and a recessed lower surface such that the outer contour of the base matches the outer contour of the segmented structure to enable the penile implant mechanism 1 and the penis The shape is consistent and the patient is more comfortable.
  • the base may also be two, each base being coupled to each segment type structure.
  • the portion of the segment-type structure near the distal end of the penis is sealed by an end cap having a shape that matches the sponge.
  • the end cap includes a raised upper surface and a recessed lower surface to match the outer contour of the end cap to the outer contour of the base and/or segment structure for greater patient comfort.
  • FIG. 5 is a schematic illustration of a preferred embodiment of the penile pacemaker of the present invention based on Figure 2E.
  • 5 is a remotely heated electric penile pacemaker, including a penile implant mechanism 1, a reservoir 35, a catheter 2, a pump 302, a power source 32, a control device 702, a heating device, a temperature sensor, an external wireless remote control device 44, and an internal body.
  • the sensing device 304, the proximal end of the penis of the penile implanting mechanism 1 is provided with a base 11, and a portion close to the distal end of the penis is provided with an end cap 13.
  • the penile subcutaneous implant mechanism 1 is implanted between the subcutaneous and the corpus cavernosum and is connected to the pump 302 through the catheter 2.
  • the pump 302 is placed in the scrotum, and the opening and closing of the pump 302 enables water injection and drainage to the subcutaneous implant mechanism of the penis, thereby achieving two physiological states of erection and weakness of the penis.
  • the base body 111 is a cavity-type structure for connecting the catheter 2 and the penile implanting mechanism 1.
  • the base 11 is further provided with a pubic fixing plate 112 for fixing the base for fixing the base to the pubis. In order to provide a fulcrum force when the penile implanting mechanism 1 performs an extension movement, it is ensured that the length change of the penile implanting mechanism 1 is an extensional movement in the direction of the end cap 13 along the susceptor 11.
  • the conduit 2 is a hollow liquid conduit, the tube wall is lined with a mesh woven structure for increasing strength, the conduit 2 is connected at one end to the pump 302, and at one end is connected to the base 11 for communicating the water path between the two; the conduit 2 is provided with a solenoid valve 22 that can control the opening and closing of the liquid path.
  • the liquid storage chamber 35, the pump 302, the power source 32, the control device 702, the heating device, and the temperature sensor comprise an integrated structure, the integrated structure is surrounded by the housing 31, and the heating device 36 is disposed on the inner surface of the liquid storage chamber 35. It is used to heat the liquid in the liquid storage chamber 35, and the heating device has a built-in temperature sensor, which can precisely control the temperature of the liquid in the liquid storage chamber 35.
  • the casing 31 is made of a material having a biocompatible material, such as stainless steel, titanium alloy, cobalt chromium alloy, and the surface of the casing can be sprayed or plated with parylene, Teflon, A material such as a polysaccharide polymer or a modified silicone for improving the surface properties of the casing and enhancing biocompatibility and stability;
  • the power source 32 is a battery 32, and the battery 32 may be a pump body 33 of the pump 302.
  • Power is supplied to thereby pressurize the liquid in the liquid storage chamber 35 into the penile implanting mechanism 1 to cause an extension movement thereof; the battery can supply power to the solenoid valve 22 disposed on the catheter 2, thereby implementing the catheter 2 Switching control of the internal liquid path; the battery can supply power to the heating device 36 for changing the temperature of the liquid in the liquid storage chamber 35, thereby improving the comfort of use of the prosthesis.
  • the external wireless remote control device 44 includes a signal generator and an induction coil. Accordingly, the in-vivo sensing device 304 further includes an induction coil 701.
  • the induction coil 701 is wirelessly coupled with the induction coil of the external wireless remote control device 44 to convert the external energy source into a current signal. And transmitted to the control device 702; the control device 702 is configured to receive and store an external current signal, and control the power source 32 according to the current signal; the power source 32 is electrically connected to the pump 302 for transmitting power to the device Pump 302.
  • the induction coil can be implanted in any suitable position in the human body.
  • the induction coil can be implanted under the skin of the lower abdominal wall of the human body.
  • the extracorporeal wireless remote control device 44 emits a wireless signal, such as an electromagnetic wave signal or other type of wireless signal, to the induction coil, which converts the wireless signal into a current that is transmitted to the power source 32 and the control device 702.
  • the control device 702 simultaneously receives and stores external signals and programs, and controls the operation of the pump 302, the solenoid valve 22, and the heating device 36 in accordance with the external signals.
  • Fig. 6 is a schematic view showing an embodiment of a control circuit of the penile pacemaker of the present invention based on Fig. 5.
  • At least one capacitor is disposed between the heating device and the pump, the heating device is connected in series with the pump, and the at least one capacitor is connected in parallel with the pump.
  • the pump is connected in series with a travel switch to limit the stroke of the pump.
  • the battery 32 is wirelessly coupled to the extracorporeal wireless remote control unit 44 via the induction coil 41 to complete charging and to provide electrical energy to the pump 302, the heating device 36, and the solenoid valve 22.
  • the control device 702 controls the switch S1 to be turned off, the heating device 36 heats the liquid in the liquid storage chamber 35, the capacitor starts to be charged, the pump 302 is short-circuited, and does not work.
  • the pump 302 is turned on, and the pump 302 is turned on.
  • the liquid that has been heated in the reservoir 35 is injected into the penile implanting mechanism 1 through the catheter 2, and the solenoid valve is automatically opened under the action of the liquid.
  • control device 702 controls the switch S1 to be turned off, S2 is closed, and the solenoid valve 22 is energized. At this time, the liquid is returned to the liquid storage chamber 35 by the spring 37 between the pump head 34 and the pump body 33, and the penis implant mechanism is completed. 1 drainage.
  • the present invention also provides a method of simulating penile erection and weakness using the penile pacemaker of the present invention, comprising:
  • the pump 302 drives the fluid to be transported from the reservoir 35 through the catheter 2 to the cavity of the penile implant mechanism 1, the penile implant mechanism 1 is axially elongated, and the penis is erect;
  • the pump 302 drives the fluid from the cavity of the penile implant mechanism 1 to the reservoir 35 via the catheter 2, the penile implant mechanism 1 is axially contracted, and the penis is weak.
  • the present invention also provides a method of simulating penile erection and weakness using the penile pacemaker of the present invention, comprising:
  • the pump 302 drives the fluid to be transported by the reservoir 35 through the catheter to the cavity of the penile implant mechanism 1, the penile implant mechanism 1 is axially elongated, and the penis is erected, wherein the heating device 36 is The fluid output from the liquid storage chamber 35 to the penile implanting mechanism 1 is heated;
  • the pump 302 drives the fluid to be transported by the lumen of the penile implant mechanism 1 to the reservoir 35 via the catheter, and the penile implant mechanism 1 is axially contracted and the penis is weak.
  • the above method can be implemented by executing the apparatus provided by the embodiments of the present invention, and has the corresponding functional modules and beneficial effects of the executing apparatus.
  • the apparatus provided by the embodiments of the present invention For technical details that are not described in detail in this embodiment, reference may be made to the apparatus provided by the embodiments of the present invention.
  • the traditional penile implant mechanism consists of two water sacs, and the water sac is directly implanted into the two corpus cavernosums.
  • the corpus cavernosum tissue needs to be completely detached before the implantation, the corpus cavernosum The anatomy of the tissue itself is thus destroyed and the patient may even permanently lose the possibility of recovery.
  • the penile implanting mechanism is used between the subcutaneous and the corpus cavernosum, and the thickness is much smaller than the diameter or thickness of the conventional water sac, and the anatomy of the corpus cavernosum is hardly damaged.
  • the end of the conventional penile implanting mechanism water balloon is inserted into the body through two conical structures, and the penile implanting mechanism of the present invention is implanted between the subcutaneous and the cavernous body of the penis, and is not suitable for being inserted into the body in a tapered structure.
  • the fixing device is fixed to the pubic bone by a fixing device such as a fixing plate, and the fixing is more firm, and the penile implanting mechanism is less likely to be displaced.
  • the outer surface of the penile implant mechanism is designed as a segment-type structure that can expand and contract along the axial direction of the penis, for example, a plurality of bellows structures and segment-type hollow structures of different hardness are nested with each other, The variable length structure and the length immutable structure are connected in series with each other, so that the penis implantation mechanism can be elongated when the penis is erected, and the penis is elongated, and when the penis is weak, the penile implanting mechanism contracts to a length consistent with the penis.
  • a hollow base is disposed at the proximal end of the segment-type structure, and the cavity of the base communicates with the cavity of the segment-type structure, and the base can firmly fix the segment-type structure between the skin of the penis and the sponge.
  • the segment type structure is plural, after the pump is started, the fluid is first output to the susceptor, and then uniformly distributed in the segment type structure via the susceptor.
  • the pedestal simultaneously functions to secure the penile implant mechanism and distribute the fluid evenly.
  • a heating device is added to the penile pacemaker to heat the fluid output from the reservoir to the penile implanting mechanism, thereby eliminating the difference in temperature between the fluid and the penis in the reservoir, thereby making the patient More comfortable.
  • a temperature sensor is further added to the penile pacemaker, the heating device is powered by the power source, the heating device and the temperature sensor are controlled by the control device, the threshold is set in the temperature sensor, and when the fluid reaches the threshold, the signal is transmitted to the control device, and the control is performed.
  • the device then controls the pump to deliver fluid from the reservoir to the penile implant mechanism, thereby effectively controlling the fluid heating temperature.
  • the heating device and the temperature sensor are controlled by a remote control to make the operation of the patient more convenient. Further, by connecting the heating device in series with the pump, and providing a capacitance between the heating device and the pump, the heating device is started earlier than the pump is started, and the fluid in the liquid storage chamber is prevented from being heated. Flowing into the penis implant mechanism also simplifies the structure of the remote control, for example, the buttons that control the heating device and the pump can be combined.

Landscapes

  • Health & Medical Sciences (AREA)
  • Reproductive Health (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Percussion Or Vibration Massage (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

一种阴茎起搏器及控制方法，阴茎起搏器包括阴茎植入机构（1）、储液室（35）、导管（2）和泵（302），其中：阴茎植入机构（1）用于阴茎皮下与海绵体之间，阴茎植入机构（1）具有中空的腔体，并且可轴向伸缩地固定于阴茎的近端；储液室（35）中储存流体，储液室（35）通过至少一根导管（2）与阴茎植入机构（1）的腔体连通；泵（302）耦合至储液室（35）和阴茎植入机构（1），泵（302）用于为流体在储液室（35）和阴茎植入机构（1）之间传输提供动力。

Description

一种阴茎起搏器及其控制方法 技术领域
本发明实施例涉及医疗器械技术领域，尤其涉及一种阴茎起搏器及其控制方法。
背景技术
男性勃起功能障碍患者，阴茎往往不能自主勃起或勃起硬度欠佳，目前市场上存在一种植入式阴茎假体，如专利US4651721和US5062417中所述的，主要由海绵体内植入式水囊、储液囊和单向阀组成，由于该植入装置结构复杂，手术创伤大，尤其是其用水囊完全替代阴茎海绵体的做法，完全破坏了海绵体组织自身的解剖结构，手术风险大，术后恢复时间长，综合以上因素，海绵体内植入式阴茎假体并不是理想的勃起辅助治疗装置。
再有如专利US20130131443中提供的一种在阴茎海绵体外包裹的由温敏形状记忆合金制成的骨架式假体，该种假体同样具有手术创伤大，在植入时需要将阴茎海绵体分别完全游离开方可完成植入，而且由于采用了金属材料制成，异物感明显，使用感受差，这一发明最大的缺点就是起搏与去起搏需要提供金属发生形变的温度条件，使用起来及其不便；综合目前技术所存在的各种问题，急需一种植入方式简便创伤小，勃起辅助效果确切，使用简便、安全、稳定的阴茎勃起辅助器械。
发明内容
鉴于上述问题，本发明提供一种阴茎起搏器及其控制方法，以克服上述问题或者至少部分地解决上述问题。
所述阴茎植入机构用于阴茎皮下与海绵体之间，所述阴茎植入机构具有中空的腔体，并且可轴向伸缩的固定于阴茎的近端；
所述储液室中储存流体，所述储液室通过至少一根导管与所述阴茎植入机构的腔体连通；
所述泵耦合至所述储液室和阴茎植入机构，所述泵用于为所述流体在储液室和阴茎植入机构之间传输提供动力。
可选地，在本发明实施例中，还包括电源，所述电源与所述泵电连接，用于为所述泵提供电能。
可选地，在本发明实施例中，所述泵包括泵体、泵头和弹簧，所述泵头通过弹簧 与泵体连接，所述泵头通过往复性活动调节储液室的体积，所述弹簧至少部分地驱动泵头调节储液室的体积。
可选地，在本发明实施例中，还包括控制装置，所述控制装置用于控制所述泵的运行。
可选地，在本发明实施例中，患者从体外控制所述控制装置。
可选地，在本发明实施例中，所述控制装置包括行程开关，所述行程开关与泵串联，用于限制泵的行程。
可选地，在本发明实施例中，所述导管上还设有阀门，所述阀门用于改变流体的流动方向。
可选地，在本发明实施例中，所述导管上还设有至少一个阀门，所述阀门从所述电源获取电能，并在所述控制装置的控制下改变流体的流动方向。
可选地，在本发明实施例中，所述控制装置包括体外无线遥控装置和体内感应装置，所述体内感应装置用于与体外无线遥控装置进行无线耦合，并根据耦合信号对所述电源进行充电。
可选地，在本发明实施例中，所述体外无线遥控装置包括启动按钮，所述启动按钮用于控制泵的启动。
可选地，在本发明实施例中，所述导管上还设有至少一个阀门，所述阀门从所述电源获取电能，并在所述控制装置的控制下改变流体的流动方向。
可选地，在本发明实施例中，所述阴茎植入机构的近端设有固定装置，所述固定装置耦合至耻骨。
优选地，所述固定装置为至少一个固定板，固定板上设有通孔，固定件通过通孔将所述固定板固定至耻骨。
可选地，在本发明实施例中，所述阴茎植入机构的近端设有一基座，所述固定装置耦合至基座，所述基座具有中空的腔体，所述基座的腔体与阴茎植入机构的腔体连通。
优选地，所述基座的形状与海绵体相匹配。
更优选地，所述基座包括一凸起的上表面和凹陷的下表面。
可选地，在本发明实施例中，所述阴茎植入机构包括至少两个外表面可沿阴茎轴向伸缩的节段型结构。
可选地，在本发明实施例中，所述阴茎植入机构包括两个节段型结构，所述两个节段型结构的端盖相互耦合。
优选地，所述两个节段型结构的一侧相互耦合。
可选地，在本发明实施例中，每个节段型结构包括至少两个和/或至少三个波纹管。
优选地，每个节段型结构包括至少三个波纹管。
可选地，在本发明实施例中，每个节段型结构包括至少一个外层节段和至少一个内层节段，所述至少一个外层节段和至少一个内层节段相互嵌套，并可沿轴向相对滑动。
优选地，每个外层节段与内层节段之间设有限制装置，用于防止外层节段与内层节段之间滑脱。
优选地，所述至少一个外层节段和至少一个内层节段均包括至少一个第一硬度节段和至少一个第二硬度节段，所述第一硬度节段和第二硬度节段交替分布，第一硬度节段的硬度大于第二硬度节段的硬度。
可选地，在本发明实施例中，每个节段型结构的两端分别包括一个外层节段，所述两端的外层节段分别包括一个节段单元，两端之间的每个外层节段和每个内层节段均包括两个节段单元，其中，每个节段单元包括两个第一硬度节段和一个第二硬度节段，第二硬度节段位于两个第一硬度节段之间。
可选地，在本发明实施例中，每个节段型结构包括至少一个中空的长度可变结构和至少一个中空的长度不可变结构，所述长度可变结构和长度不可变结构相互串联。
优选地，所述长度不可变结构的上表面和下表面之间具有支撑结构，用于在周向和轴向上支撑阴茎植入机构。
优选地，所述支撑结构包括一体式牵拉结构，所述一体式牵拉结构分布在节段型结构的周向和轴向上。
可选地，在本发明实施例中，每个节段型结构包括至少一个挠性可折叠结构，在流体注入时所述挠性可折叠结构的折叠部分张开以使阴茎植入机构伸长；流体排出时，所述挠性可折叠结构在自身弹力作用下折叠成预定的形状以使阴茎植入机构收缩。
优选地，所述挠性可折叠结构之间分别设有支撑结构，用于在周向和轴向上支撑阴茎植入机构。
优选地，所述支撑结构包括一体式牵拉结构，所述一体式牵拉结构分布在节段型结构的周向和轴向上。
可选地，在本发明实施例中，所述节段型结构伸开时，所述节段型结构是由凸起的外表面和凹陷的外表面组成的封闭结构。
优选地，所述节段型结构伸开时的横截面为月牙形。
可选地，在本发明实施例中，所述节段型结构靠近阴茎的远端部分由端盖密封，所述端盖的形状与海绵体相匹配。
优选地，所述端盖包括一凸起的上表面和凹陷的下表面。
可选地，在本发明实施例中，所述阴茎植入机构的近端设有一基座，所述固定装置耦合至基座，所述基座具有中空的腔体，所述基座的腔体与阴茎植入机构的腔体连 通。
优选地，所述基座的形状与海绵体相匹配。
优选地，所述基座包括一凸起的上表面和凹陷的下表面。
可选地，在本发明实施例中，所述阴茎植入机构的厚度为0.5～5mm。
优选地，所述阴茎植入机构的厚度为2～3mm。
可选地，在本发明实施例中，阴茎植入机构的外表面设有具有生物相容性与延展性能的包覆层。
可选地，在本发明实施例中，还包括行程开关，所述行程开关与泵串联，用于限制泵的行程。
可选地，在本发明实施例中，患者从体外控制所述控制装置。
可选地，在本发明实施例中，所述控制装置包括体外无线遥控装置和体内感应装置，所述体内感应装置用于与体外无线遥控装置进行无线耦合，并根据耦合信号控制阴茎勃起和疲软。
可选地，在本发明实施例中，所述控制装置根据所述耦合信号对所述电源进行充电，由电源向泵提供电能。
可选地，在本发明实施例中，所述导管上还设有阀门，所述阀门用于改变流体的流动方向。
可选地，在本发明实施例中，所述电源向阀门提供电能，所述控制装置控制阀门改变流体的流动方向。
可选地，在本发明实施例中，所述阴茎植入机构的近端设有固定装置，所述固定装置耦合至耻骨。
可选地，在本发明实施例中，所述固定装置为至少一个固定板，固定板上设有通孔，固定件通过通孔将所述固定板固定至耻骨。
可选地，在本发明实施例中，所述阴茎植入机构的近端设有一基座，所述固定装置耦合至基座，所述基座具有中空的腔体，所述基座的腔体与阴茎植入机构的腔体连通。
优选地，所述基座的形状与海绵体相匹配。
优选地，所述基座包括一凸起的上表面和凹陷的下表面。
可选地，在本发明实施例中，所述阴茎植入机构包括至少一个外表面可沿阴茎轴向伸缩的节段型结构。
可选地，在本发明实施例中，所述阴茎植入机构包括两个节段型结构，所述两个节段型结构的端盖相互耦合。
优选地，所述两个节段型结构的一侧相互耦合。
可选地，在本发明实施例中，每个节段型结构包括至少两个波纹管。
优选地，每个节段型结构包括至少三个波纹管。
可选地，在本发明实施例中，所述节段型结构包括至少一个外层节段和至少一个内层节段，所述至少一个外层节段和至少一个内层节段相互嵌套，并可沿轴向相对滑动。
优选地，每个外层节段与内层节段之间设有限制装置，用于防止外层节段与内层节段之间滑脱。
优选地，所述至少一个外层节段和至少一个内层节段均包括至少一个第一硬度节段和至少一个第二硬度节段，所述第一硬度节段和第二硬度节段交替分布，第一硬度节段的硬度大于第二硬度节段的硬度。
可选地，在本发明实施例中，每个节段型结构的两端分别包括一个外层节段，所述两端的外层节段分别包括一个节段单元，两端之间的每个外层节段和每个内层节段均包括两个节段单元，其中，每个节段单元包括两个第一硬度节段和一个第二硬度节段，第二硬度节段位于两个第一硬度节段之间。
可选地，在本发明实施例中，每个节段型结构包括至少一个中空的长度可变结构和至少一个中空的长度不可变结构，所述长度可变结构和长度不可变结构相互串联。
优选地，所述长度不可变结构的上表面和下表面之间具有支撑结构，用于在周向和轴向上支撑阴茎植入机构。
优选地，所述支撑结构包括一体式牵拉结构，所述一体式牵拉结构分布在节段型结构的周向和轴向上。
可选地，在本发明实施例中，每个节段型结构包括至少一个挠性可折叠结构，所述挠性可折叠结构在流体注入时折叠部分张开，阴茎植入机构伸长；流体排出时，在自身弹力作用下折叠成预定的形状，阴茎植入机构收缩。
优选地，挠性可折叠结构之间分别设有支撑结构，用于在周向和轴向上支撑阴茎植入机构。
优选地，所述支撑结构包括一体式牵拉结构，所述一体式牵拉结构分布在节段型结构的周向和轴向上。
可选地，在本发明实施例中，所述节段型结构伸开时，所述节段型结构是由凸起的外表面和凹陷的外表面组成的封闭结构。
优选地，所述节段型结构伸开时的横截面为月牙形。
可选地，在本发明实施例中，所述节段型结构靠近阴茎的远端部分由端盖密封，所述端盖的形状与海绵体相匹配。
优选地，所述端盖包括一凸起的上表面和凹陷的下表面。
可选地，在本发明实施例中，所述阴茎植入机构的近端设有一基座，所述固定装置耦合至基座，所述基座具有中空的腔体，所述基座的腔体与阴茎植入机构的腔体连 通。
优选地，所述基座的形状与海绵体相匹配。
优选地，所述基座包括一凸起的上表面和凹陷的下表面。
可选地，在本发明实施例中，所述阴茎植入机构的厚度为0.5～5mm。
优选地，所述阴茎植入机构的厚度为2～3mm。
可选地，在本发明实施例中，阴茎植入机构的外表面设有具有生物相容性与延展性能的包覆层。
可选地，在本发明实施例中，所述泵在电能驱动下将储液室中的流体经导管输送至阴茎植入机构，在机械能驱动下将流体经导管输送回所述储液室。
相应地，本发明实施例提供一种阴茎起搏器的控制方法，所述阴茎起搏器包括阴茎植入机构、储液室、导管和泵；
将所述阴茎植入机构用于阴茎皮下与海绵体之间，其中，所述阴茎植入机构具有中空的腔体，并且可轴向伸缩的固定于阴茎的近端；
在所述储液室中储存流体，所述储液室通过至少一根导管与所述阴茎植入机构的腔体连通；
所述泵耦合至所述储液室和阴茎植入机构，所述泵为所述流体在储液室和阴茎植入机构之间传输提供动力以使阴茎勃起或阴茎疲软；
其中，所述泵为所述流体在储液室和阴茎植入机构之间传输提供动力以使阴茎勃起或阴茎疲软，包括：
所述泵驱动所述流体由储液室经导管传输至所述阴茎植入机构的腔体，阴茎植入机构轴向伸长以使阴茎勃起；
所述泵驱动所述流体由所述阴茎植入机构的腔体经导管传输至储液室，阴茎植入机构轴向收缩以使阴茎疲软。
本发明另一实施例中提供一种阴茎起搏器，包括阴茎植入机构、储液室、导管、泵和加热装置，其中，
所述阴茎植入机构用于阴茎皮下与海绵体之间，所述阴茎植入机构具有中空的腔体，并且可轴向伸缩的固定于阴茎的近端；
所述储液室中储存流体，所述储液室通过至少一根导管与所述阴茎植入机构的腔体连通；
所述泵耦合至所述储液室和阴茎植入机构，所述泵用于为所述流体在储液室和阴茎植入机构之间传输提供动力；
所述加热装置与所述储液室耦合，用于对由储液室输出至所述阴茎植入机构的流体进行加热。
可选地，在本发明实施例中，还包括电源，所述电源与所述泵和/或所述加热装 置电连接，用于为所述泵和/或加热装置提供电能。
优选地，还包括电源，所述电源与所述泵和所述加热装置电连接，用于为所述泵和加热装置提供电能。
可选地，在本发明实施例中，还包括控制装置，所述控制装置用于控制所述泵的运行和/或所述加热装置的运行。优选地，所述控制装置用于控制所述泵和所述加热装置的运行。
可选地，在本发明实施例中，还包括温度传感器，所述温度传感器与所述加热装置耦合，用于实时检测经加热装置加热的流体的温度；所述控制装置根据所述温度传感器检测的所述温度控制所述加热装置停止加热。
可选地，在本发明实施例中，所述泵在电能驱动下将储液室中的流体经导管输送至阴茎植入机构，在机械能驱动下将流体经导管输送回所述储液室。
优选地，所述泵包括泵体、泵头和弹簧，所述泵头通过弹簧与泵体连接，所述泵头通过往复性活动调节储液室的体积，所述弹簧至少部分地驱动泵头调节储液室的体积。
可选地，在本发明实施例中，所述控制装置还用于控制加热装置，并且彼此独立地控制所述加热装置和所述泵。
可选地，在本发明实施例中，所述加热装置与所述泵之间耦合延时电路，所述延时电路用于控制所述加热装置启动的时间早于泵启动的时间。
优选地，所述加热装置与泵之间设有至少一个电容，加热装置与泵串联，所述至少一个电容与泵并联。
可选地，在本发明实施例中，患者从体外控制所述控制装置。
可选地，在本发明实施例中，所述控制装置包括体外无线遥控装置和体内感应装置，所述体内感应装置用于与体外无线遥控装置进行无线耦合，并根据耦合信号对所述电源进行充电。
可选地，在本发明实施例中，所述控制装置根据所述耦合信号对所述电源进行充电，由电源向泵提供电能。
可选地，在本发明实施例中，所述控制装置还用于控制加热装置，并且同时控制所述加热装置和所述泵。
可选地，在本发明实施例中，所述加热装置与所述泵之间耦合延时电路，所述延时电路用于控制所述加热装置启动的时间早于泵启动的时间。
优选地，所述加热装置与泵之间设有至少一个电容，加热装置与泵串联，所述至少一个电容与泵并联。
可选地，在本发明实施例中，还包括行程开关，所述行程开关与泵串联，用于限制泵的行程。
可选地，在本发明实施例中，所述控制装置包括体外无线遥控装置和体内感应装置，所述体内感应装置用于与体外无线遥控装置进行无线耦合，并根据耦合信号对所述电源进行充电。
可选地，在本发明实施例中，所述体外无线遥控装置包括启动按钮，所述启动按钮用于控制泵的启动和/或加热装置的启动。
优选地，所述体外无线遥控装置包括启动按钮，所述启动按钮同时控制泵和加热装置，并且加热装置启动的时间早于泵启动的时间。
可选地，在本发明实施例中，还包括行程开关，所述行程开关与泵串联，用于限制泵的行程。
所述导管上还设有至少一个阀门，所述阀门从所述电源获取电能，并在所述控制装置的控制下改变流体的流动方向。
可选地，在本发明实施例中，所述的加热装置设于所述储液室内部的上表面。
可选地，在本发明实施例中，还包括温度传感器，其中，所述温度传感器与所述加热装置耦合，用于实时检测经加热装置加热的流体的温度；所述控制装置根据所述温度传感器检测的所述温度控制所述加热装置停止加热。
可选地，在本发明实施例中，所述温度传感器设有阈值，当温度传感器检测到的温度达到所述阈值时，所述加热装置关闭，所述阈值为34℃～38℃。
优选地，在本发明实施例中，所述阈值为36.5℃～37.5℃。
可选地，在本发明实施例中，患者从体外控制所述控制装置。
可选地，在本发明实施例中，所述导管上还设有至少一个阀门，所述阀门从所述电源获取电能，并在所述控制装置的控制下改变流体的流动方向。
可选地，在本发明实施例中，所述阴茎植入机构的近端设有固定装置，所述固定装置耦合至耻骨。
可选地，在本发明实施例中，所述固定装置为至少一个固定板，固定板上设有通孔，固定件通过通孔将所述固定板固定至耻骨。
可选地，在本发明实施例中，所述阴茎植入机构的近端设有一基座，所述固定装置耦合至基座，所述基座具有中空的腔体，所述基座的腔体与阴茎植入机构的腔体连通。
优选地，所述基座的形状与海绵体相匹配。
优选地，所述基座包括一凸起的上表面和凹陷的下表面。
可选地，在本发明实施例中，所述阴茎植入机构包括至少一个外表面可沿阴茎轴向伸缩的节段型结构。
可选地，在本发明实施例中，所述阴茎植入机构包括两个节段型结构，所述两个节段型结构的端盖相互耦合。
优选地，所述两个节段型结构的一侧相互耦合。
可选地，在本发明实施例中，每个节段型结构包括至少两个和/或至少三个波纹管。
优选地，每个节段型结构包括至少三个波纹管。
可选地，在本发明实施例中，所述节段型结构包括至少一个外层节段和至少一个内层节段，所述至少一个外层节段和至少一个内层节段相互嵌套，并可沿轴向相对滑动。
优选地，每个外层节段与内层节段之间设有限制装置，用于防止外层节段与内层节段之间滑脱。
优选地，所述至少一个外层节段和至少一个内层节段均包括至少一个第一硬度节段和至少一个第二硬度节段，所述第一硬度节段和第二硬度节段交替分布，第一硬度节段的硬度大于第二硬度节段的硬度。
可选地，在本发明实施例中，每个节段型结构的两端分别包括一个外层节段，所述两端的外层节段分别包括一个节段单元，两端之间的每个外层节段和每个内层节段均包括两个节段单元，其中，每个节段单元包括两个第一硬度节段和一个第二硬度节段，第二硬度节段位于两个第一硬度节段之间。
可选地，在本发明实施例中，每个节段型结构包括至少一个中空的长度可变结构和至少一个中空的长度不可变结构，所述长度可变结构和长度不可变结构相互串联。
优选地，所述长度不可变结构的上表面和下表面之间具有支撑结构，用于在周向和轴向上支撑阴茎植入机构。
优选地，所述支撑结构包括一体式牵拉结构，所述一体式牵拉结构分布在节段型结构的周向和轴向上。
可选地，在本发明实施例中，所述节段型结构包括至少一个挠性可折叠结构；在流体注入时所述挠性可折叠结构的折叠部分张开以使阴茎植入机构伸长；流体排出时，所述挠性可折叠结构在自身弹力作用下折叠成预定的形状以使阴茎植入机构收缩。
优选地，挠性可折叠结构之间分别设有支撑结构，用于在周向和轴向上支撑阴茎植入机构。
优选地，所述支撑结构包括一体式牵拉结构，所述一体式牵拉结构分布在节段型结构的周向和轴向上。
可选地，在本发明实施例中，所述节段型结构伸开时，所述节段型结构是由凸起的外表面和凹陷的外表面组成的封闭结构。
优选地，所述节段型结构伸开时的横截面为月牙形。
可选地，在本发明实施例中，所述节段型结构靠近阴茎的远端部分由端盖密封，所述端盖的形状与海绵体相匹配。
优选地，所述端盖包括一凸起的上表面和凹陷的下表面。
可选地，在本发明实施例中，所述阴茎植入机构的近端设有一基座，所述固定装置耦合至基座，所述基座具有中空的腔体，所述基座的腔体与阴茎植入机构的腔体连通。
优选地，所述基座的形状与海绵体相匹配。
优选地，所述基座包括一凸起的上表面和凹陷的下表面。
可选地，在本发明实施例中，所述阴茎植入机构的厚度为0.5～5mm。
优选地，所述阴茎植入机构的厚度为2～3mm。
可选地，在本发明实施例中，阴茎植入机构的外表面设有具有生物相容性与延展性能的包覆层。
相应地，本发明实施例提供一种阴茎起搏器的控制方法，所述阴茎起搏器包括阴茎植入机构、储液室、导管、泵和加热装置；将所述阴茎植入机构用于阴茎皮下与海绵体之间，其中，所述阴茎植入机构具有中空的腔体，并且可轴向伸缩的固定于阴茎的近端；
在所述储液室中储存流体，所述储液室通过至少一根导管与所述阴茎植入机构的腔体连通；
所述泵耦合至所述储液室和阴茎植入机构，所述泵为所述流体在储液室和阴茎植入机构之间传输提供动力以使阴茎勃起或阴茎疲软；
所述加热装置与所述储液室耦合，对由所述储液室输出至所述阴茎植入机构的流体进行加热。
其中，所述泵为所述流体在储液室和阴茎植入机构之间传输提供动力以使阴茎勃起或阴茎疲软，包括：
所述泵驱动所述流体由储液室经导管传输至所述阴茎植入机构的腔体，阴茎植入机构轴向伸长以使阴茎勃起；
所述泵驱动所述流体由所述阴茎植入机构的腔体经导管传输至储液室，阴茎植入机构轴向收缩以使阴茎疲软。
由以上技术方案可见，本发明实施例的优点如下：
传统的阴茎植入机构由两个水囊组成，水囊直接植入两个海绵体中，手术过程中需要将海绵体组织分别完全游离开，方可完成植入，海绵体组织自身的解剖结构因此被破坏，病人甚至会永久性失去恢复的可能性。而本发明实施例中阴茎植入机构植入阴茎皮下与海绵体之间，并且厚度远小于传统水囊的直径或厚度，对海绵体组织的解剖结构几乎没有伤害。
传统的阴茎植入机构水囊的末端通过两个锥形的结构插入体内，而本发明的阴茎植入机构是植入阴茎皮下与海绵体之间，不适合再以锥形的结构插入体内，而通过固 定板等固定装置固定于耻骨上，固定的更加牢固，阴茎植入机构不易发生移位。
进一步地，在本发明实施例中将阴茎植入机构外表面设计成可沿阴茎轴向伸缩的节段型结构，例如多个波纹管结构、不同硬度的节段型中空结构相互嵌套组成、长度可变结构与长度不可变结构相互串联等方式，从而阴茎在勃起时阴茎植入机构可伸长，带动阴茎伸长，阴茎疲软时，阴茎植入机构收缩成和阴茎一致的长度。
另外，在节段型结构的近端设置中空的基座，基座的腔体与节段型结构的腔体连通，基座可牢固地将节段型结构固定于阴茎皮下与海绵体之间，不会出现移位的现象，另一方面，当节段型结构为多个时，泵启动后，流体先输出至基座，再经由基座均匀地分布于节段型结构中。基座同时起到固定阴茎植入机构和均匀分布流体的作用。
在本发明一实施例中，阴茎起搏器中增加了加热装置，对由储液室输出至阴茎植入机构的流体加热，消除了储液室中的流体与阴茎部位温度的差异，使得患者更加舒适。
再进一步地，阴茎起搏器中还增加了温度传感器，加热装置由电源供电，由控制装置控制加热装置和温度传感器，温度传感器中设置阈值，流体达到阈值时，将信号传输至控制装置，控制装置随即控制泵将流体由储液室输送至阴茎植入机构，从而有效地控制流体加热温度。
在本发明又一实施例中，通过遥控方式控制加热装置和温度传感器，使得患者的操作更加的便捷。进一步地，通过在加热装置与所述泵之间设置延时电路，例如将电容与泵并联等方式使得加热装置启动的时间早于泵启动的时间，避免了储液室中的流体没来得及加热便流入阴茎植入机构，同时也可以简化遥控器的结构，比如可以将控制加热装置和泵的按钮合二为一。
附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本发明实施例中记载的一些实施例，对于本领域普通技术人员来讲，还可以根据这些附图获得其他的附图。
图1为现有技术中水囊结构的阴茎起搏器示意图。
图2A-2E为本发明的阴茎起搏器的5个实施例示意图。
图3为基于图2B-2E的优选实施例的示意图。
图4为基于图2C和2E的体外充电控制装置和体内感应装置的实施例示意图。
图5为基于图2E的本发明阴茎起搏器的优选实施例示意图。
图6为基于图5的本发明阴茎起搏器的控制电路的实施例示意图。
图7为基于图2D-2E的本发明阴茎起搏器的泵的优选实施例示意图。
图8为基于图2A-2E的阴茎植入机构固定于阴茎的近端的实施例示意图。
图9A-9D为基于图2A-2E的阴茎植入机构的实施例示意图。
图10A为基于9A的阴茎植入机构的部件的实施例俯视图。
图10B为基于9A的阴茎植入机构垂直于轴向的横截面示意图。
图11A为基于9B的阴茎植入机构垂直于轴向的横截面示意图。
图11B为基于9B的阴茎植入机构沿轴向的横截面局部放大图。
图12为基于9C的阴茎植入机构垂直于轴向的横截面示意图。
图13A为基于9D的阴茎植入机构垂直于轴向的横截面示意图。
图13B为基于9D的阴茎植入机构的实施例节段型结构收缩时的局部放大图。
图14A-14B为本发明阴茎起搏器中阴茎植入机构在阴茎中的整体示意图。
图15为本发明阴茎起搏器中阴茎植入机构在阴茎中的横截面示意图。
具体实施方式
当然，实施本发明实施例的任一技术方案不必一定需要同时达到以上的所有优点。
为了使本领域的人员更好地理解本发明实施例中的技术方案，下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅是本发明实施例一部分实施例，而不是全部的实施例。基于本发明实施例中的实施例，本领域普通技术人员所获得的所有其他实施例，都应当属于本发明实施例保护的范围。
所述“阴茎的远端”是指阴茎远离人体的一端。所述“阴茎的近端”是指阴茎靠近人体的一端。所述“节段型结构”是指由至少一个节或段组合而成的结构。所述“阴茎植入机构的近端”是指阴茎植入机构靠近人体的一端。所述“节段型结构的近端”是指节段型结构靠近人体的一端。所述“轴向”是指沿阴茎长度延伸的方向。所述“阴茎植入机构的厚度”是指阴茎勃起时阴茎植入机构的上表面与下表面之间的最大距离。所述“流体”包括，但不限于液体、气体，例如消毒液、生理盐水、空气等。
下面结合本发明实施例附图进一步说明本发明实施例具体实现方式。
图1为现有技术中水囊结构的阴茎起搏器，其由两个水囊组成，水囊的径向直径在8mm～10mm之间，水囊直接植入两个海绵体中，手术过程中需要将海绵体组织分别完全游离开，方可完成植入，海绵体组织自身的解剖结构因此被破坏，病人甚至会永久性失去恢复的可能性。
图2A-2E为本发明的阴茎起搏器的5个实施例。
图2A为手动非电动式阴茎起搏器，包括阴茎植入机构1、导管2、储液室35、泵302，其中，所述阴茎植入机构1用于阴茎皮下与海绵体之间，所述阴茎植入机构1 具有中空的腔体，并且可轴向伸缩的固定于阴茎的近端；所述储液室35中储存流体，所述储液室35通过至少一根导管2与所述阴茎植入机构1的腔体连通；所述泵302耦合至所述储液室35和阴茎植入机构1，所述泵302用于在储液室35和阴茎植入机构1之间传输流体。储液室35中容纳有预定体积的流体。优选地，所述流体的体积至少能完全充满阴茎植入机构1的腔体。
患者用手挤压泵302，使得泵302推动储液室35中的流体，通过所述导管2流入阴茎植入机构1的腔体，使得阴茎植入机构1伸长，也可以手动地控制流体从阴茎植入机构1的腔体流回储液室35，使得阴茎植入机构1收缩。优选地，在本发明一实施例中，所述导管上还设有阀门，所述阀门用于改变流体的流动方向。
导管2为中空导管，管壁内衬可具有强度增加结构，例如增加强度的网状编织结构。所述导管2为一根或多根。
所述储液室35和泵302可以是独立的两个装置，或者储液室35和泵302为一体结构。所述泵可以为单向泵或双向泵。
以下是储液室35和泵302为独立的两个装置的实施例：
泵302在储液室35和阴茎植入机构1之间，泵与储液室35和阴茎植入机构1分别通过导管连接，泵302可以为单向泵或双向泵。泵302从储液室35中将流体泵出，并将流体再输送至阴茎植入机构1，使得阴茎勃起，当需要阴茎疲软时，泵302从阴茎植入机构1将流体泵回，并再输送回储液室35中。泵与储液室35和阴茎植入机构1之间可以设一个阀门，以控制流体的流动。
以下是储液室35和泵302为一体结构的实施例：
泵302和储液室35合为一体，中间通过隔膜、活塞或其他适当的结构隔开，当泵302启动时，泵302挤压储液室35，使得储液室35的体积缩小，流体便从储液室35中流出。
储液室35和泵302单独的(独立装置)或共同地(一体式结构)由壳体31包覆。所述的壳体31由具有生物相容性材料制成，如不锈钢、钛合金、钴铬合金等材料制成，并且所述壳体表面可喷涂或镀覆聚对二甲苯、特氟龙、多糖类聚合物、改性硅酮等材料，用于提高壳体表面性能，增强生物相容性与稳定性。
图2B为手动电动式阴茎起搏器，图2B与图2A相比增加了一电源32，所述电源32与所述泵302电连接，用于为所述泵302提供电能。所述电源32为电池或其他能提供电能的装置。
所述电源32可以与储液室35、泵302分开，或与泵302两者合为一体，或与储液室35、泵302三者合为一体。所述电源32可以与储液室35、泵302设于阴囊中或 人体其他部位。
优选地，还包括控制装置702，所述控制装置用于控制所述泵的运行和/或所述加热装置的运行。优选地，所述控制装置用于控制所述泵和所述加热装置的运行。可选地，在本发明实施例中，患者从体外控制所述控制装置702。
在本发明一实施例中，所述控制装置702位于阴囊中，当患者从体外通过对阴囊施加外力而启动开关时，电源32向泵302提供例如电能，泵302启动，推动储液室35中的流体，通过所述导管2流入阴茎植入机构1的腔体，使得阴茎植入机构1伸长，开关断开时，流体从阴茎植入机构1的腔体流回储液室35，使得阴茎植入机构1收缩。优选地，储液室35里的流体刚好满足阴茎植入机构1完全伸长，当流体完全流入阴茎植入机构1时，开关断开，泵302停止运行。
优选地，泵302还包括能将电能转换为机械运动的电动机或电动机与传动机构组成的动力系统，所述的电动机可为旋转电机、直线电机，所述的传动机构可为齿轮、涡轮、滚珠丝杠等常用传动机构。
可选地，在本发明实施例中，所述泵在电能驱动下将储液室中的流体经导管输送至阴茎植入机构，在机械能驱动下将流体经导管输送回所述储液室。
优选地，所述泵包括泵体、泵头和弹簧，所述泵头通过弹簧与泵体连接，所述泵头通过往复性活动调节储液室的体积，所述弹簧至少部分地驱动泵头调节储液室的体积。
图3为基于图2B-2D的优选实施例的示意图。所述导管2上还设有阀门22，所述阀门22与所述电源32电连接，所述阀门从所述电源获取电能，并在所述控制装置的控制下改变流体的流动方向。所述阀门22为电磁阀或其他由电能可控制的阀门22。例如泵302将流体由储液室35泵入阴茎植入机构1时，阀门22在液压作用下即可自动开启，当流体由阴茎植入机构1流回储液室35时，阀门22通电，控制装置702控制阀门22开启，完成阴茎植入机构1的排水。
阀门22可以位于靠近阴茎植入机构1的导管2一端，或靠近储液室35的导管2一端。虽然此处在导管2上设置阀门22，但阀门22仍可设于阴茎植入机构1中。阀门22可为一个阀门或多个阀门。在本发明一实施例中，当导管2为一根时，阀门22为一个阀门。当导管为两根时，在每根导管上设置一个单向阀门，或在两根导管上设置一个共同的换向阀。
图2C为一种遥控式电动阴茎起搏器，所述控制装置702包括体外无线遥控装置44和体内感应装置304，所述体内感应装置304用于与体外无线遥控装置44进行无线耦合，并根据耦合信号控制阴茎勃起和疲软。
可选地，在本发明实施例中，所述控制装置702根据所述耦合信号对所述电源进 行充电，由电源向泵提供电能。所述电源32为可充电电池，可以为蓄电池或其他可充电电池，蓄电池的类型包括锂离子电池、锂-碘电池、石墨烯电池。
优选地，所述体外无线遥控装置44相应地设有至少一个按钮，控制体外无线遥控装置44发出信号，体内感应装置304接收信号，并把所述信号转换为电流，对电源进行充电。体外无线遥控装置44的结构为现有遥控器的结构，在此不再赘述。
优选地，所述体外无线遥控装置44包括一信号发射天线，体内感应装置304包括一接收天线，所述接收天线可以植入患者体内，例如腹部或皮下，植入皮下时天线的线圈可以小于植入腹部时天线的线圈。
可选地，在本发明实施例中，所述导管2上还设有阀门22，所述阀门22与所述电源32电连接，所述阀门从所述电源获取电能，并在所述控制装置的控制下改变流体的流动方向。所述阀门22为电磁阀或其他由电能可控制的阀门22。阀门22可由体外无线遥控装置44控制。
在本发明另一实施例中，控制装置702设置流体流量检测单元，该单元中还存储流体流量阈值，当流体从储液室35流入阴茎植入机构1的流量或从阴茎植入机构1流回储液室35的流量，达到一定的阈值时，阀门22自动关闭。所述阈值优选地为流体刚好充满阴茎植入机构1的体积。
在本发明另一实施例中，控制装置702不设流体流量检测单元，患者通过体验直接经由控制装置702控制阀门22开启或关闭。
可选地，在本发明实施例中，所述泵在电能驱动下将储液室中的流体经导管输送至阴茎植入机构，在机械能驱动下将流体经导管输送回所述储液室。
优选地，所述泵包括泵体、泵头和弹簧，所述泵头通过弹簧与泵体连接，所述泵头通过往复性活动调节储液室的体积，所述弹簧至少部分地驱动泵头调节储液室的体积。
图2D为一种加热型电动阴茎起搏器，包括阴茎植入机构1、储液室35、导管2、泵302和加热装置36，所述阴茎植入机构1用于阴茎皮下与海绵体之间，所述阴茎植入机构1具有中空的腔体，并且可轴向伸缩的固定于阴茎的近端；所述储液室35中储存流体，所述储液室35通过至少一根导管2与所述阴茎植入机构1的腔体连通；
所述泵302耦合至所述储液室35和阴茎植入机构1，所述泵302用于在储液室35和阴茎植入机构1之间传输流体；
所述加热装置36与储液室35耦合，用于对由储液室35输出至所述阴茎植入机构1的流体进行加热。
可选地，在本发明实施例中，还包括电源32，所述电源32与所述泵302和/或所述加热装置电连接，用于为所述泵302和/或所述加热装置提供电能。
可选地，在本发明实施例中，所述电源为所述加热装置提供电能。
可选地，在本发明一实施例中，所述控制装置不但控制泵，还用于控制加热装置，并且彼此独立地控制所述加热装置和所述泵。
可选地，在本发明另一实施例中，所述控制装置不但控制泵，还用于控制加热装置，并且同时控制所述加热装置和所述泵。优选地，所述加热装置启动的时间早于泵启动的时间。可选地，在本发明实施例中，所述的加热装置与泵之间耦合延时电路，所述延时电路用于控制所述加热装置启动的时间早于泵启动的时间。优选地，所述加热装置与泵之间设有至少一个电容，加热装置与泵串联，所述至少一个电容与泵并联。
可选地，在本发明实施例中，所述的泵串联了行程开关，用于限制泵的行程。例如，所述行程开关在通常情况下为闭合状态，当泵将流体完全泵入阴茎植入机构1时，行程开关断开，泵停止运行。
可选地，在本发明实施例中，所述的加热装置设于所述储液室内部的上表面。
可选地，在本发明实施例中，还包括温度传感器，其中，所述温度传感器与所述加热装置耦合，用于实时检测经加热装置加热的流体的温度，所述控制装置根据所述温度传感器检测的所述温度控制所述加热装置停止加热。优选地，所述温度传感器设有阈值，当温度传感器检测到的温度达到所述阈值时，所述加热装置关闭，所述阈值为34℃～38℃。优选地，所述阈值为36.5℃～37.5℃。
可选地，在本发明实施例中，使用者从体外控制所述控制装置。
可选地，在本发明实施例中，所述泵在电能驱动下将储液室中的流体经导管输送至阴茎植入机构，在机械能驱动下将流体经导管输送回所述储液室。
优选地，所述泵包括泵体、泵头和弹簧，所述泵头通过弹簧与泵体连接，所述泵头通过往复性活动调节储液室的体积，所述弹簧至少部分地驱动泵头调节储液室的体积。
图2E为一种遥控加热型电动阴茎起搏器，包括阴茎植入机构1、储液室35、导管2、泵302、加热装置36、电源32、控制装置702和温度传感器305，所述控制装置702包括体外无线遥控装置44和体内感应装置304，其中，所述阴茎植入机构1用于阴茎皮下与海绵体之间，所述阴茎植入机构1具有中空的腔体，并且可轴向伸缩的固定于阴茎的近端；所述储液室35中储存流体，所述储液室35通过至少一根导管2与所述阴茎植入机构1的腔体连通；所述泵302耦合至电源32、储液室35和阴茎植入机构1，所述泵302用于接收电源32的电能，以在储液室35和阴茎植入机构1之间传输流体；所述体内感应装置304、加热装置36和温度传感器分别与所述电源32电连接，所述温度传感器用于检测储液室35内液体的温度，将检测结果传输至体外无线遥控装置44，所述体外无线遥控装置44根据检测结果控制加热装置36加热。所述体外无线遥控装置44包括启动按钮，所述启动按钮同时控制泵和加热装置，并且 加热装置启动的时间早于泵启动的时间。可选地，在本发明实施例中，所述的加热装置与泵之间耦合延时电路，所述延时电路用于控制所述加热装置启动的时间早于泵启动的时间。优选地，所述加热装置与泵之间设有至少一个电容，加热装置与泵串联，所述至少一个电容与泵并联。
可选地，在本发明实施例中，所述的泵串联了行程开关，用于限制泵的行程。
所述加热装置36可以设于所述储液室35的内部或外部，优选地，所述加热装置36设于所述储液室35内部的上表面，流体经过加热装置36加热后被泵302挤压至导管2中。
温度传感器可以设于加热装置36的内部或外部，优选地，温度传感器设于加热装置36的内部。所述加热装置36的主体可为任何合适的形状，包括但不限于一整张平板、多张条状板并排排列、球形板等。
所述加热装置36和泵302同时启动或不同时启动，优选地，所述加热装置36启动的时间早于泵302启动的时间。由此，流体不会未被加热至指定温度或温度范围而被泵302挤压至导管2，造成患者体验不好。而加热装置36先启动加热至理想的指定温度或温度范围后，例如阴茎勃起的温度，泵302再启动，会使得流体温度与患者阴茎勃起温度趋于一致，患者不会有不舒服的感觉。
所述理想的指定温度或温度范围是根据每个患者的差异，由患者自由决定何种温度是理想的或合适的温度。
所述温度传感器设有阈值，当温度传感器检测到的温度达到所述阈值时，所述加热装置36关闭，所述阈值为34℃～38℃之间的任何一个数值或数值范围，优选的，所述阈值为36.5℃～37.5℃之间的任何一个数值或数值范围。具体实施方式例如当温度传感器检测到的温度达到所述阈值时将信号传输至控制装置702，控制装置702关闭加热装置36。
优选地，所述导管2上还设有阀门22，所述阀门22与所述电源32电连接，所述阀门从所述电源获取电能，并在所述控制装置的控制下改变流体的流动方向。所述阀门22为电磁阀或其他由电能可控制的阀门。
可选地，在本发明实施例中，所述泵在电能驱动下将储液室中的流体经导管输送至阴茎植入机构，在机械能驱动下将流体经导管输送回所述储液室。
优选地，所述泵包括泵体、泵头和弹簧，所述泵头通过弹簧与泵体连接，所述泵头通过往复性活动调节储液室的体积，所述弹簧至少部分地驱动泵头调节储液室的体积。
图4为基于图2C和2E的体外无线遥控装置44和体内感应装置304的实施例示意图。
体外无线遥控装置44包括一信号生成器和感应线圈，相应地，体内感应装置304还包括感应线圈701，感应线圈701与体外无线遥控装置44的感应线圈进行无线耦合，将外部能源转化为电流信号并传输至控制装置702；所述控制装置702用于接收和存储外部电流信号，并根据所述电流信号控制电源32；所述电源32与所述泵302电连接，用于将电能传输至所述泵302。
感应线圈可以埋植于人体内任何合适的位置，优选地，感应线圈可以埋植于人体内下腹壁皮下。体外无线遥控装置44对感应线圈发出无线信号，例如电磁波信号或其他类型的无线信号，感应线圈将所述无线信号转换为电流，所述电流传输至电源32和控制装置702。控制装置702同时接收与存储外部信号和程序，并根据所述外部信号控制泵302的运行，例如泵302的启动和关闭。
图7为基于2D-2E的本发明阴茎起搏器的泵302的优选实施例示意图。
所述泵302包括泵体33、泵头34和弹簧37，所述泵头34通过弹簧37与泵体33连接，所述泵头34通过往复性活动调节储液室的体积，所述弹簧37至少部分地驱动泵头34调节储液室的体积。
所述的泵302由泵体33和泵头34组成，壳体31、蓄电池32、泵体33、泵头34、储液室35、电加热模块36组成一体式结构，所述的壳体31由具有生物相容性材料制成，如不锈钢、钛合金、钴铬合金等材料制成，并且所述壳体表面可喷涂或镀覆聚对二甲苯、特氟龙、多糖类聚合物、改性硅酮等材料，用于提高壳体表面性能，增强生物相容性与稳定性；所述蓄电池32可为锂离子电池、锂-碘电池、石墨烯电池等制成，所述蓄电池32可为泵体33供电，从而实现将储液室35内的液体加压输出至阴茎植入机构1中，从而使其发生伸长运动；所述蓄电池可为设置在导管2上的电磁阀22供电，从而实现导管2内液路的开关控制；所述的蓄电池可为加热装置36供电，用于改变储液室35内液体的温度，从而提高假体使用的舒适性。
所述的泵体33为将电能转换为机械运动的电动机或电动机与传动机构组成的动力系统，所述的电动机可为旋转电机、直线电机，所述的传动机构可为齿轮、涡轮、滚珠丝杠等常用传动机构，本发明中优选为选用直线电机作为泵体动力系统，所述泵体33用于驱动泵头34做远离泵体运动，从而使得泵头上的柱塞挤压储液室35内的液体，经导管2灌入阴茎植入机构1内；所述的泵头34由推杆341和柱塞342组成，推杆341受泵体驱动从而可以推动柱塞342对储液室35内的液体施加压力，并使之经导管2灌入阴茎植入机构1内；所述柱塞342与储液室35内壁可形成密封腔，在柱塞342的推拉运动下，可实现将储液室35内的液体推出储液室35和抽回储液室35；优选的，本发明中的泵头34与泵体33之间设有拉伸弹簧37，既当泵头34被泵体33推向最大行程处过程中，该拉伸弹簧37被拉伸，又当泵体33处于非激励状态且导管2上的电磁阀处于液路打开状态，此时在拉伸弹簧37的拉力作用下，泵头34被慢慢 拉回至起始位置，同时阴茎植入机构1内的液体被缓慢抽回至储液室35内；所述的泵302向外泵水过程由电动机驱动，回水过程靠弹簧拉力作用，而无需其他能量消耗，以致将蓄电池的能效发挥到最大，从而减少系统的充电次数。
图9A-9D为基于2A-2E的阴茎植入机构的实施例示意图。
所述阴茎植入机构1包括至少两个外表面可沿阴茎轴向伸缩的节段型结构。优选地，所述阴茎植入机构1的厚度为0.5～5mm。更优选地，所述阴茎植入机构1的厚度为2～3mm。阴茎植入机构1植入在阴茎皮下与海绵体之间。本发明的阴茎植入机构1的厚度远小于传统水囊的厚度(或径向直径)8mm～10mm，因此可以植入阴茎皮下与海绵体的缝隙之间，而并不会破坏海绵体的结构，并且手术操作简单，对病人身体伤害降到最小化。
优选地，阴茎植入机构1的外表面设有具有生物相容性与延展性能的包覆层，以使得阴茎植入机构1与周围组织形成良好的相容性与稳定性。包覆层可由高分子聚合材料制成，如PTFE，TPU，PU，硅胶，硅酮，热塑性弹性体、改性材料、复合材料等材料。
如图9A所示，所述阴茎植入机构包括两个节段型结构，每个节段型结构包括至少两个和/或至少三个波纹管。所述波纹管结构在收缩状态下具有褶皱的表面，伸长时表面张开形成光滑的表面。优选地，每个节段型结构包括至少三个波纹管。
所述波纹管是具有多个横向波纹的圆柱形薄壁折皱的壳体，波纹管具有弹性，在压力、轴向力、横向力或弯矩作用下能产生位移。
如图10A所示，优选地，所述节段型结构靠近阴茎的远端部分由端盖密封，所述端盖的形状与海绵体相匹配。优选地，所述端盖包括一凸起的上表面和凹陷的下表面。优选地，所述两个节段型结构的端盖相互耦合，以避免两个节段型结构出现移位。两个节段型结构的端盖耦合的方式包括两个节段型结构的端盖集成为一体，即一整个端盖，中间没有间隔；两个节段型结构的端盖通过焊接等方式相互连接，因此连接处是被两个端盖的壁间隔开；以及其他适用于本发明的耦合方式。优选地，所述两个节段型结构的一侧相互耦合。两个节段型结构耦合的方式包括两个节段型结构由阴茎近端至远端均集成为一体；两个节段型结构通过焊接等方式相互连接；两个节段型结构及其端盖均集成为一体(此时可以看成是一个节段型结构)，或节段型结构与其端盖之至少其中一者通过焊接等方式相互连接；以及其他适用于本发明的耦合方式。
如图10B所示，在本发明一优选实施例中，每个节段型结构靠近阴茎的远端的部分分别由一个端盖密封，对应图9A，每3个波纹管组成一个节段型结构，6个组成两个节段型结构，每个节段型结构靠近阴茎的远端部分由一个端盖密封，每3个波纹管靠近阴茎的远端的部分共同由同一个端盖密封，端盖固定在阴茎的远端或靠近阴茎的 远端，所有波纹管均匀地分布在阴茎和海绵体之间。每个波纹管可规则地或不规则地分布在阴茎和海绵体之间。波纹管结构的数量越多，阴茎植入机构1在阴茎与海绵体之间的分布越均匀，勃起的效果越好。
优选地，所述节段型结构伸开时，所述节段型结构的截面是由凸起的外表面和凹陷的外表面组成的封闭结构。所述波纹管结构非膨胀状态时的截面形状可为封闭的月牙形、半圆形、圆形、四边形、圆弧形或类椭圆形。当内部充满具有一定压力的液体时，波纹管可做沿轴向的伸长运动。
如图9B所示，所述阴茎植入机构包括两个节段型结构，每个节段型结构包括至少一个外层节段和至少一个内层节段，所述至少一个外层节段和至少一个内层节段相互嵌套，并可沿轴向相对滑动。优选地，所述至少一个外层节段和至少一个内层节段均包括至少一个第一硬度节段和至少一个第二硬度节段，所述第一硬度节段和第二硬度节段交替分布，第一硬度节段的硬度大于第二硬度节段的硬度。
可选地，在本发明实施例中，每个节段型结构的两端分别包括一个外层节段，所述两端的外层节段分别包括一个节段单元，两端之间的每个外层节段和每个内层节段均包括两个节段单元，其中，每个节段单元包括两个第一硬度节段和一个第二硬度节段，第二硬度节段位于两个第一硬度节段之间。即每个节段单元包括依次连接的一个第一硬度节段、一个第二硬度节段和一个第一硬度节段。因此每个外层节段和每个内层节段的两个节段单元连接在一起后连接处就包括了两个第一硬度节段。这种设计便于内外层节段相互配合。
优选地，所述节段型结构伸开时，所述节段型结构的截面是由凸起的外表面和凹陷的外表面组成的封闭结构。
如图11B所示，所述节段型结构的外层和内层分别由硬节段121与软节段122交替连接，当内部充满具有一定压力的液体时，相互嵌套的软硬节段型中空结构可做沿轴向相对滑动，实现外部与内部软硬节段型中空结构的软节段相互错开，从而保证在轴向任意截面的上的刚性。
优选地，每个外层节段与内层节段之间设有限制装置，用于防止外层节段与内层节段之间滑脱。所述限制装置可以设计成外层节段与内层节段之间由柔软的材料连接，也可以设计成其他适合的形式。
图11A是图9B所对应的阴茎植入机构1的横截面示意图。所述阴茎植入机构是由凸起的外表面和凹陷的外表面组成的封闭结构。所述封闭结构的截面形状不限于图11所示的形状，也可以是其他的形状，例如圆形、四边形、圆弧形或类椭圆形等。优选地，所述节段型结构伸开时的横截面为月牙形。
优选地，所述节段型结构靠近阴茎的远端部分由端盖密封，所述端盖的形状与海 绵体相匹配。优选地，所述端盖包括一凸起的上表面和凹陷的下表面。优选地，所述两个节段型结构的端盖相互耦合，以避免两个节段型结构出现移位。两个节段型结构的端盖耦合的方式包括两个节段型结构的端盖集成为一体，即一整个端盖，中间没有间隔；两个节段型结构的端盖通过焊接等方式相互连接，因此连接处是被两个端盖的壁间隔开；以及其他适用于本发明的耦合方式。优选地，所述两个节段型结构的一侧相互耦合。两个节段型结构耦合的方式包括两个节段型结构由阴茎近端至远端均集成为一体(此时可以看成是一个节段型结构)；两个节段型结构通过焊接等方式相互连接；两个节段型结构及其端盖均集成为一体，或节段型结构与其端盖之至少其中一者通过焊接等方式相互连接；以及其他适用于本发明的耦合方式。
优选地，所述阴茎植入机构1的厚度为0.5～5mm。更优选地，所述阴茎植入机构1的厚度为2～3mm。
如图9C所示，所述阴茎植入机构包括两个节段型结构，每个节段型结构包括至少一个中空的长度可变结构和至少一个中空的长度不可变结构，所述长度可变结构和长度不可变结构相互串联。从外表面来看，长度可变结构和长度不可变结构是相互交替且连接在一起。为了便于生产，长度可变结构与长度不可变结构为一次性成型的结构，并且采用相同的材料。长度可变结构可以为褶皱结构或类似波纹管状结构制成，长度不可变结构为中空薄壁管状结构制成。优选地，所述节段型结构伸开时，所述节段型结构的截面是由凸起的外表面和凹陷的外表面组成的封闭结构。优选地，所述节段型结构伸开时的横截面为月牙形。
优选地，所述长度不可变结构的上表面和下表面之间具有支撑结构，用于在周向和轴向上支撑阴茎植入机构。更优选地，所述支撑结构包括一体式牵拉结构，所述一体式牵拉结构分布在节段型结构的周向和轴向上。
图12是图9C所对应的阴茎植入机构1的横截面示意图。所述阴茎植入机构1是由凸起的外表面和凹陷的外表面组成的封闭结构，所述长度不可变结构的上表面和下表面之间具有支撑结构。所述支撑结构围绕节段型结构的内表面一周，并且长度不可变结构的上表面和下表面之间连接有沿轴向分布的支撑结构，周向和轴向上的支撑结构为一体式。所述节段型结构的截面形状不限于图12所示的形状，也可以是其他的形状，例如圆形、四边形、圆弧形或类椭圆形等。优选地，所述节段型结构伸开时的横截面为月牙形。
优选地，所述节段型结构靠近阴茎的远端部分由端盖密封，所述端盖的形状与海绵体相匹配。优选地，所述端盖包括一凸起的上表面和凹陷的下表面。优选地，所述两个节段型结构的端盖相互耦合，以避免两个节段型结构出现移位。两个节段型结构的端盖耦合的方式包括两个节段型结构的端盖集成为一体，即一整个端盖，中间没有 间隔；两个节段型结构的端盖通过焊接等方式相互连接，因此连接处是被两个端盖的壁间隔开；以及其他适用于本发明的耦合方式。优选地，所述两个节段型结构的一侧相互耦合。两个节段型结构耦合的方式包括两个节段型结构由阴茎近端至远端均集成为一体(此时可以看成是一个节段型结构)；两个节段型结构通过焊接等方式相互连接；两个节段型结构及其端盖均集成为一体，或节段型结构与其端盖之至少其中一者通过焊接等方式相互连接；以及其他适用于本发明的耦合方式。
优选地，所述阴茎植入机构1的厚度为0.5～5mm。更优选地，所述阴茎植入机构1的厚度为2～3mm。
如图9D所示，所述阴茎植入机构包括两个节段型结构，每个节段型结构包括至少一个挠性可折叠结构，在流体注入时所述挠性可折叠结构的折叠部分张开以使阴茎植入机构伸长；流体排出时，所述挠性可折叠结构在自身弹力作用下折叠成预定的形状以使阴茎植入机构收缩。优选地，所述节段型结构伸开时，所述节段型结构的截面是由凸起的外表面和凹陷的外表面组成的封闭结构。优选地，所述节段型结构伸开时的横截面为月牙形。
优选地，挠性可折叠结构之间分别设有支撑结构，用于在周向和轴向上支撑阴茎植入机构。优选地，所述支撑结构包括一体式牵拉结构，所述一体式牵拉结构分布在节段型结构的周向和轴向上。
如图13A所示，所述节段型结构具有一片式外表面，外表面包括多个挠性可折叠结构，挠性可折叠结构之间分别设有支撑结构。流体注入节段型结构时折叠部分张开，流体排出时，在自身弹力作用下折叠成预定的形状，例如如图13B所示的折叠结构，可折叠结构之间被支撑结构隔开。图13B所示的折叠结构仅用于示意折叠结构的构型，本发明的折叠结构不限于图13B所示的构型。
优选地，所述节段型结构靠近阴茎的远端部分由端盖密封，所述端盖的形状与海绵体相匹配。优选地，所述端盖包括一凸起的上表面和凹陷的下表面。优选地，所述两个节段型结构的端盖相互耦合，以避免两个节段型结构出现移位。两个节段型结构的端盖耦合的方式包括两个节段型结构的端盖集成为一体，即一整个端盖，中间没有间隔；两个节段型结构的端盖通过焊接等方式相互连接，因此连接处是被两个端盖的壁间隔开；以及其他适用于本发明的耦合方式。优选地，所述两个节段型结构的一侧相互耦合。两个节段型结构耦合的方式包括两个节段型结构由阴茎近端至远端均集成为一体(此时可以看成是一个节段型结构)；两个节段型结构通过焊接等方式相互连接；两个节段型结构及其端盖均集成为一体，或节段型结构与其端盖之至少其中一者通过焊接等方式相互连接；以及其他适用于本发明的耦合方式。
本发明的节段型结构可由3D打印机采用适合的材料打印出来。
如图15所示，阴茎植入机构1用于阴茎皮下与海绵体之间。
图8为基于2A-2E的阴茎植入机构1固定于阴茎的近端的实施例示意图。
在本实施例中，所述阴茎植入机构1阴茎的近端设有固定装置，所述固定装置耦合至耻骨。如图8所示，可选地，在本发明实施例中，所述固定装置为至少一个固定板，固定板上设有通孔，固定件通过通孔将所述固定板固定至耻骨。所述固定件为医用螺钉、紧固件等。优选地，所述固定装置为两个固定板，每个固定板上均设有通孔。所述固定板的形状不限。虽然在此处将固定板固定至耻骨，但也可将固定板固定至人体其他位置。
如图8所示，所述阴茎植入机构的近端设有基座，所述固定装置耦合至基座，所述基座具有中空的腔体，所述基座的腔体与阴茎植入机构的腔体连通。所述节段型结构的近端耦合至基座，所述基座与所述节段型结构内部连通。当泵302启动时，将流体先输出至基座上，再经由基座均匀地分布于一个或多个节段型结构中。基座同时起到固定阴茎植入机构1和均匀分布流体的作用。
所述基座可以为一个，如图8所示，基座上又设有两个凸出接口，分别与每个节段型结构耦合。优选地，所述基座的形状与海绵体相匹配，从而避免基座形状与海绵体形状不匹配给患者带来不舒适感。优选地，所述基座包括一凸起的上表面和凹陷的下表面，从而使所述基座的外部轮廓与节段型结构的外部轮廓相匹配，以使阴茎植入机构1与阴茎的外形相一致，患者更加舒适。所述基座还可以为两个，每个基座分别与每个节段型结构耦合。
优选地，所述节段型结构靠近阴茎的远端的部分由端盖密封，所述端盖的形状与海绵体相匹配。
优选地，所述端盖包括一凸起的上表面和凹陷的下表面，从而使端盖的外部轮廓与基座及/或节段型结构的外部轮廓相匹配，患者更加舒适。
图5为基于图2E的本发明阴茎起搏器的优选实施例示意图。图5为遥控加热型电动阴茎起搏器，包括阴茎植入机构1、储液室35、导管2、泵302、电源32、控制装置702、加热装置、温度传感器、体外无线遥控装置44和体内感应装置304，阴茎植入机构1阴茎的近端设有基座11、靠近阴茎的远端的部分设有端盖13。
如图14A-14B所示，阴茎皮下植入机构1植入在阴茎皮下与海绵体之间，通过导管2与泵302连接。泵302置于阴囊中，泵302的开启与关闭可实现向阴茎皮下植入机构的注水和排水，从而实现阴茎的勃起和疲软两种生理状态。
其中基座主体111为空腔型结构用于连通导管2和阴茎植入机构1，基座11上还设有用于固定基座的耻骨固定板112，用于将基座整体固定在耻骨上，以便当阴茎植 入机构1作伸长运动时提供支点作用力，从而保证阴茎植入机构1的长度变化均是沿基座11向端盖13方向作伸长运动。
导管2为中空液体导管，其管壁内衬用于增加强度的网状编织结构，该导管2一端连接泵302，一端连接基座11，用于连通二者之间的水路；所述的导管2上设有可控制液路开闭的电磁阀22。
所述储液室35、泵302、电源32、控制装置702、加热装置、温度传感器组成一体式结构，一体式结构由壳体31包围，所述的加热装置36设置在储液室35内表面，用于给储液室35内的液体加热，该加热装置内置温度传感器，可以精确控制储液室35内液体的温度。所述的壳体31由具有生物相容性材料制成，如不锈钢、钛合金、钴铬合金等材料制成，并且所述壳体表面可喷涂或镀覆聚对二甲苯、特氟龙、多糖类聚合物、改性硅酮等材料，用于提高壳体表面性能，增强生物相容性与稳定性；所述电源32为蓄电池32，所述蓄电池32可为泵302的泵体33供电，从而实现将储液室35内的液体加压输出至阴茎植入机构1中，从而使其发生伸长运动；所述蓄电池可为设置在导管2上的电磁阀22供电，从而实现导管2内液路的开关控制；所述的蓄电池可为加热装置36供电，用于改变储液室35内液体的温度，从而提高假体使用的舒适性。
体外无线遥控装置44包括一信号生成器和感应线圈，相应地，体内感应装置304还包括感应线圈701，感应线圈701与体外无线遥控装置44的感应线圈进行无线耦合，将外部能源转化为电流信号并传输至控制装置702；所述控制装置702用于接收和存储外部电流信号，并根据所述电流信号控制电源32；所述电源32与所述泵302电连接，用于将电能传输至所述泵302。
感应线圈可以埋植于人体内任何合适的位置，优选地，感应线圈可以埋植于人体内下腹壁皮下。体外无线遥控装置44对感应线圈发出无线信号，例如电磁波信号或其他类型的无线信号，感应线圈将所述无线信号转换为电流，所述电流传输至电源32和控制装置702。控制装置702同时接收与存储外部信号和程序，并根据所述外部信号控制泵302、电磁阀22以及加热装置36的运行。
图6为基于图5的本发明阴茎起搏器的控制电路的实施例示意图。
所述加热装置与泵之间设有至少一个电容，加热装置与泵串联，所述至少一个电容与泵并联。泵串联了行程开关，用于限制泵的行程。
蓄电池32通过感应线圈41与体外无线遥控装置44进行无线耦合完成充电，并为泵302、加热装置36和电磁阀22提供电能。勃起过程中，控制装置702控制开关S1关闭，加热装置36对储液室35中的液体加热，电容开始充电，泵302被短路，不工作，当电容充电完成后，泵302开启，泵302将储液室35中已经加热的液体通过 导管2注入到阴茎植入机构1，电磁阀在液体冲击作用下自动开启。疲软过程中控制装置702控制开关S1断开，S2闭合，电磁阀22通电，此时液体在泵头34与泵体33之间弹簧37的作用下回流到储液室35，完成阴茎植入机构1的排水。
相应地，本发明还提供了一种利用本发明的阴茎起搏器模拟阴茎勃起和疲软的方法，包括：
所述泵302驱动所述流体由储液室35经导管2传输至所述阴茎植入机构1的腔体，阴茎植入机构1轴向伸长，阴茎勃起；
所述泵302驱动所述流体由所述阴茎植入机构1的腔体经导管2传输至储液室35，阴茎植入机构1轴向收缩，阴茎疲软。
相应地，本发明还提供了一种利用本发明的阴茎起搏器模拟阴茎勃起和疲软的方法，包括：
所述泵302驱动所述流体由储液室35经导管传输至所述阴茎植入机构1的腔体，阴茎植入机构1轴向伸长，阴茎勃起，其中，所述加热装置36对由储液室35输出至所述阴茎植入机构1的流体进行加热；
所述泵302驱动所述流体由所述阴茎植入机构1的腔体经导管传输至储液室35，阴茎植入机构1轴向收缩，阴茎疲软。
上述方法可通过执行本发明实施例所提供的装置实现，具备执行装置相应的功能模块和有益效果。未在本实施例中详尽描述的技术细节，可参见本发明实施例所提供的装置。
综上所述，传统的阴茎植入机构由两个水囊组成，水囊直接植入两个海绵体中，手术过程中需要将海绵体组织分别完全游离开，方可完成植入，海绵体组织自身的解剖结构因此被破坏，病人甚至会永久性失去恢复的可能性。而本发明实施例中阴茎植入机构用于阴茎皮下与海绵体之间，并且厚度远小于传统水囊的直径或厚度，对海绵体组织的解剖结构几乎没有伤害。
传统的阴茎植入机构水囊的末端通过两个锥形的结构插入体内，而本发明的阴茎植入机构是植入阴茎皮下与海绵体之间，不适合再以锥形的结构插入体内，而通过固定板等固定装置固定于耻骨上，固定的更加牢固，阴茎植入机构不易发生移位。
进一步地，在本发明实施例中将阴茎植入机构外表面设计成可沿阴茎轴向伸缩的节段型结构，例如多个波纹管结构、不同硬度的节段型中空结构相互嵌套组成、长度可变结构与长度不可变结构相互串联等方式，从而阴茎在勃起时阴茎植入机构可伸长，带动阴茎伸长，阴茎疲软时，阴茎植入机构收缩成和阴茎一致的长度。
另外，在节段型结构的近端设置中空的基座，基座的腔体与节段型结构的腔体连通，基座可牢固地将节段型结构固定于阴茎皮下与海绵体之间，不会出现移位的现象， 另一方面，当节段型结构为多个时，泵启动后，流体先输出至基座，再经由基座均匀地分布于节段型结构中。基座同时起到固定阴茎植入机构和均匀分布流体的作用。
在本发明一实施例中，阴茎起搏器中增加了加热装置，对由储液室输出至阴茎植入机构的流体加热，消除了储液室中的流体与阴茎部位温度的差异，使得患者更加舒适。
再进一步地，阴茎起搏器中还增加了温度传感器，加热装置由电源供电，由控制装置控制加热装置和温度传感器，温度传感器中设置阈值，流体达到阈值时，将信号传输至控制装置，控制装置随即控制泵将流体由储液室输送至阴茎植入机构，从而有效地控制流体加热温度。
在本发明又一实施例中，通过遥控方式控制加热装置和温度传感器，使得患者的操作更加的便捷。进一步地，通过将加热装置与泵串联，并且在加热装置与所述泵之间设置电容等方式使得加热装置启动的时间早于泵启动的时间，避免了储液室中的流体没来得及加热便流入阴茎植入机构，同时也可以简化遥控器的结构，比如可以将控制加热装置和泵的按钮合二为一。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (33)

  1. 一种阴茎起搏器，其特征在于,包括阴茎植入机构、储液室、导管和泵，其中：
    所述阴茎植入机构用于阴茎皮下与海绵体之间，所述阴茎植入机构具有中空的腔体，并且可轴向伸缩的固定于阴茎的近端；
    所述储液室中储存流体，所述储液室通过至少一根导管与所述阴茎植入机构的腔体连通；
    所述泵耦合至所述储液室和阴茎植入机构，所述泵用于为所述流体在储液室和阴茎植入机构之间传输提供动力。
  2. 根据权利要求1所述的阴茎起搏器，其特征在于,还包括一加热装置，所述加热装置与所述储液室耦合，用于对由储液室输出至所述阴茎植入机构的流体进行加热。
  3. 根据权利要求1所述的阴茎起搏器，还包括电源，所述电源与所述泵电连接，用于为所述泵提供电能。
  4. 根据权利要求2所述的阴茎起搏器，还包括电源，所述电源与所述泵和/或所述加热装置电连接，用于为所述泵和/或加热装置提供电能。
  5. 根据权利要求1所述的阴茎起搏器，其特征在于,所述泵包括泵体、泵头和弹簧，所述泵头通过弹簧与泵体连接，所述泵头通过往复性活动调节储液室的体积，所述弹簧至少部分地驱动泵头调节储液室的体积。
  6. 根据权利要求1所述的阴茎起搏器，其特征在于,还包括控制装置，所述控制装置用于控制所述泵的运行。
  7. 根据权利要求3所述的阴茎起搏器，其特征在于,还包括控制装置，所述控制装置用于控制所述泵和/或所述加热装置的运行。
  8. 根据权利要求7所述的阴茎起搏器，其特征在于,所述控制装置包括行程开关，所述行程开关与所述泵串联，用于限制泵的行程。
  9. 根据权利要求2所述的阴茎起搏器，其特征在于,所述加热装置与所述泵之间耦合延时电路，所述延时电路用于控制所述加热装置启动的时间早于泵启动的时间。
  10. 根据权利要求9所述的阴茎起搏器，其特征在于,所述加热装置与所述泵之间设有至少一个电容，所述加热装置与所述泵串联，所述至少一个电容与所述泵并联。
  11. 根据权利要求2所述的阴茎起搏器，所述加热装置设于所述储液室内部的上表面。
  12. 根据权利要求2所述的阴茎起搏器，其特征在于,还包括温度传感器，所述温度传感器与所述加热装置耦合，用于实时检测经加热装置加热的流体的温度；所述控制装置根据所述温度传感器检测的所述温度控制所述加热装置停止加热。
  13. 根据权利要求12所述的阴茎起搏器，所述温度传感器设有阈值，当温度传感器检测到的温度达到所述阈值时，所述加热装置关闭，所述阈值为34℃～38℃。
  14. 根据权利要求6所述的阴茎起搏器，其特征在于,所述控制装置包括体外无线遥控装置和体内感应装置，所述体内感应装置用于与体外无线遥控装置进行无线耦合，并根据耦合信号对所述电源进行充电。
  15. 根据权利要求7所述的阴茎起搏器，其特征在于,所述控制装置包括体外无线遥控装置和体内感应装置，所述体内感应装置用于与体外无线遥控装置进行无线耦合，并根据耦合信号对所述电源进行充电。
  16. 根据权利要求15所述的阴茎起搏器，其特征在于,所述体外无线遥控装置包括启动按钮，所述启动按钮用于控制泵的启动和/或加热装置的启动。
  17. 根据权利要求7所述的阴茎起搏器，其特征在于,所述导管上还设有至少一个阀门，所述阀门从所述电源获取电能，并在所述控制装置的控制下改变流体的流动方向。
  18. 根据权利要求1所述的阴茎起搏器，其特征在于,所述阴茎植入机构的近端设有固定装置，所述固定装置耦合至耻骨。
  19. 根据权利要求1所述的阴茎起搏器，其特征在于,所述阴茎植入机构包括至少两个外表面可沿阴茎轴向伸缩的节段型结构。
  20. 根据权利要求19所述的阴茎起搏器，其特征在于,每个节段型结构
    包括至少两个和/或至少三个波纹管。
  21. 根据权利要求19所述的阴茎起搏器，其特征在于,所述节段型结构包括至少一个外层节段和至少一个内层节段，所述至少一个外层节段和至少一个内层节段相互嵌套，并可沿轴向相对滑动。
  22. 根据权利要求21所述的阴茎起搏器，其特征在于,每个外层节段与内层节段之间设有限制装置，用于防止外层节段与内层节段之间滑脱。
  23. 根据权利要求21所述的阴茎起搏器，其特征在于,所述至少一个外层节段和至少一个内层节段均包括至少一个第一硬度节段和至少一个第二硬度节段，所述第一硬度节段和第二硬度节段交替分布，第一硬度节段的硬度大于第二硬度节段的硬度。
  24. 根据权利要求23所述的阴茎起搏器，其特征在于,每个节段型结构的两端分别包括一个外层节段，所述两端的外层节段分别包括一个节段单元，两端之间的每个外层节段和每个内层节段均包括两个节段单元，其中，每个节段单元包括两个第一硬度节段和一个第二硬度节段，第二硬度节段位于两个第一硬度节段之间。
  25. 根据权利要求19所述的阴茎起搏器，其特征在于,每个节段型结构包括至少一个中空的长度可变结构和至少一个中空的长度不可变结构，所述长度可变结构和长度不可变结构相互串联。
  26. 根据权利要求25所述的阴茎起搏器，其特征在于,所述长度不可变结构的上表面和下表面之间具有支撑结构，用于在周向和轴向上支撑阴茎植入机构。
  27. 根据权利要求19所述的阴茎起搏器，其特征在于,每个节段型结构包括至少一个挠性可折叠结构；在流体注入时所述挠性可折叠结构的折叠部分张开以使阴茎植入机构伸长；流体排出时，所述挠性可折叠结构在自身弹力作用下折叠成预定的形状以使阴茎植入机构收缩。
  28. 根据权利要求27所述的阴茎起搏器，其特征在于,所述挠性可折叠结构之间分别设有支撑结构，用于在周向和轴向上支撑阴茎植入机构。
  29. 根据权利要求26或28所述的阴茎起搏器，其特征在于,所述支撑结构包括一体式牵拉结构，所述一体式牵拉结构分布在节段型结构的周向和轴向上。
  30. 根据权利要求19所述的阴茎起搏器，其特征在于,所述节段型结构靠近阴茎的远端部分由端盖密封，所述端盖的形状与海绵体相匹配。
  31. 根据权利要求30所述的阴茎起搏器，其特征在于,所述端盖包括一凸起的上表面和凹陷的下表面。
  32. 根据权利要求30所述的阴茎起搏器，其特征在于,所述阴茎植入机构包括两个节段型结构，所述两个节段型结构的端盖相互耦合。
  33. 根据权利要求18所述的阴茎起搏器，其特征在于,所述阴茎植入机构的近端设有基座，所述固定装置耦合至基座，所述基座具有中空的腔体，所述基座的腔体与阴茎植入机构的腔体连通。
PCT/CN2018/073902 2017-01-24 2018-01-24 一种阴茎起搏器及其控制方法 Ceased WO2018137632A1 (zh)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP18744632.3A EP3574869A4 (en) 2017-01-24 2018-01-24 PENIAL STIMULATOR AND ITS CONTROL PROCESS
US16/455,743 US20190321180A1 (en) 2017-01-24 2019-06-28 Penis pacemaker and control method thereof

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201710054327.0A CN108338855B (zh) 2017-01-24 2017-01-24 一种阴茎起搏器
CN201710054327.0 2017-01-24

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US16/455,743 Continuation US20190321180A1 (en) 2017-01-24 2019-06-28 Penis pacemaker and control method thereof

Publications (1)

Publication Number Publication Date
WO2018137632A1 true WO2018137632A1 (zh) 2018-08-02

Family

ID=62962864

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2018/073902 Ceased WO2018137632A1 (zh) 2017-01-24 2018-01-24 一种阴茎起搏器及其控制方法

Country Status (4)

Country Link
US (1) US20190321180A1 (zh)
EP (1) EP3574869A4 (zh)
CN (1) CN108338855B (zh)
WO (1) WO2018137632A1 (zh)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12533236B2 (en) * 2019-06-19 2026-01-27 Boston Scientific Scimed, Inc. Attachment plates and implants for penile construction
US11819412B2 (en) * 2020-02-04 2023-11-21 Coloplast A/S Penile prostheses for treatment of erectile dysfunction

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0182574A1 (en) * 1984-11-13 1986-05-28 Said Ismail Hakky Penile implant
WO2002051339A2 (en) * 2000-12-27 2002-07-04 American Medical Systems, Inc. Pressure based spontaneous inflation inhibitor with penile pump improvements
CN1400884A (zh) * 2000-02-14 2003-03-05 波滕西亚医疗公司 带有无线能量供给的男性阳痿假体设备
CN1513425A (zh) * 2003-07-25 2004-07-21 孙颖浩 植埋于皮下与白膜之间的人工阴茎假体
CN101160106A (zh) * 2005-03-08 2008-04-09 性福诊所株式会社 帮助阴茎勃起和增大的膨胀假体
CN103565572A (zh) * 2012-07-27 2014-02-12 文壹 勃起辅助设备
CN106038031A (zh) * 2016-05-12 2016-10-26 李明超 一种使用电动微泵控制的假体阴茎

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4572168A (en) * 1983-12-20 1986-02-25 Fischell Robert Fully implantable vapor pressure actuated penile erection device and method
CA2397933C (en) * 2000-02-14 2009-06-02 Potencia Medical Ag Controlled penile prosthesis
US7527589B2 (en) * 2006-04-10 2009-05-05 John B Squicciarini Therapeutic prosthetic device
EP3922212A1 (en) * 2007-10-11 2021-12-15 Implantica Patent Ltd Apparatus for controlling flow of blood in a vessel
WO2009094431A2 (en) * 2008-01-23 2009-07-30 Ams Research Corporation Inflatable medical implant system
US9173739B2 (en) * 2009-01-29 2015-11-03 Peter Forsell Implant comprising an expandable section
ES2984632T3 (es) * 2010-02-03 2024-10-30 Coloplast As Implante de pene inflable
US20140039251A1 (en) * 2012-07-31 2014-02-06 Shoham Golan Method, system and device for automatic operating vibrator for sexual proposes
CN203753379U (zh) * 2014-02-19 2014-08-06 大连大学 一种具有弹性伸缩功能的游泳救生杆

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0182574A1 (en) * 1984-11-13 1986-05-28 Said Ismail Hakky Penile implant
CN1400884A (zh) * 2000-02-14 2003-03-05 波滕西亚医疗公司 带有无线能量供给的男性阳痿假体设备
WO2002051339A2 (en) * 2000-12-27 2002-07-04 American Medical Systems, Inc. Pressure based spontaneous inflation inhibitor with penile pump improvements
CN1513425A (zh) * 2003-07-25 2004-07-21 孙颖浩 植埋于皮下与白膜之间的人工阴茎假体
CN101160106A (zh) * 2005-03-08 2008-04-09 性福诊所株式会社 帮助阴茎勃起和增大的膨胀假体
CN103565572A (zh) * 2012-07-27 2014-02-12 文壹 勃起辅助设备
CN106038031A (zh) * 2016-05-12 2016-10-26 李明超 一种使用电动微泵控制的假体阴茎

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP3574869A4 *

Also Published As

Publication number Publication date
CN108338855B (zh) 2021-08-20
US20190321180A1 (en) 2019-10-24
EP3574869A4 (en) 2020-10-14
CN108338855A (zh) 2018-07-31
EP3574869A1 (en) 2019-12-04

Similar Documents

Publication Publication Date Title
JP7728019B2 (ja) 体内で泌尿器を制御するための植込み可能なデバイス
US12336952B2 (en) Apparatus, system and operation method for the treatment of male sexual dysfunction
CN101888816B (zh) 用于体外泌尿控制的可植入装置
US20200390643A1 (en) System, an apparatus, and a method for treating a sexual dysfunctional female patient
JP2025092663A (ja) 哺乳類患者の尿閉を治療するシステム
US20170361109A1 (en) Apparatus for the treatment of female sexual dysfunction
US8636645B2 (en) Method of treating erectile dysfunction with peristaltically inflatable penile prosthetic
US20190328501A1 (en) Tissue compression device
JP7248742B2 (ja) 体内で泌尿器を制御するための植込み可能なデバイス
WO2018137632A1 (zh) 一种阴茎起搏器及其控制方法
EP2214570B1 (en) Apparatus and system for the treatment of female sexual dysfunction
CN207821950U (zh) 一种阴茎起搏器
CN207575292U (zh) 一种组织压缩装置

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 18744632

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 2018744632

Country of ref document: EP

Effective date: 20190826