WO2023208232A1 - 一种介入式心脏瓣膜支架的输送系统 - Google Patents

一种介入式心脏瓣膜支架的输送系统 Download PDF

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Publication number
WO2023208232A1
WO2023208232A1 PCT/CN2023/091868 CN2023091868W WO2023208232A1 WO 2023208232 A1 WO2023208232 A1 WO 2023208232A1 CN 2023091868 W CN2023091868 W CN 2023091868W WO 2023208232 A1 WO2023208232 A1 WO 2023208232A1
Authority
WO
WIPO (PCT)
Prior art keywords
sleeve
axial
tube
heart valve
bending
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/CN2023/091868
Other languages
English (en)
French (fr)
Inventor
陈松
王雪丽
张长东
孙明
吴春林
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.)
Wuhan Weike Medical Technology Co Ltd
Original Assignee
Wuhan Weike Medical Technology 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
Priority claimed from CN202210474024.5A external-priority patent/CN116407363B/zh
Priority claimed from CN202210896187.2A external-priority patent/CN117045396A/zh
Priority claimed from CN202310358575.XA external-priority patent/CN117045397B/zh
Priority claimed from CN202310500068.5A external-priority patent/CN116616957A/zh
Application filed by Wuhan Weike Medical Technology Co Ltd filed Critical Wuhan Weike Medical Technology Co Ltd
Priority to EP23795664.4A priority Critical patent/EP4516264A4/en
Priority to JP2024564528A priority patent/JP7842422B2/ja
Publication of WO2023208232A1 publication Critical patent/WO2023208232A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • 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
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • 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
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2439—Expansion controlled by filaments
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2002/9665—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means

Definitions

  • the present invention relates to the technical field of equipment related to interventional heart valve surgery, and in particular to a delivery system for an interventional heart valve stent.
  • transcatheter aortic valve implantation (TAVR/TAVI) has sufficient evidence-based evidence and greatly reduced trauma. It has gained the reputation of European and American heart valves.
  • the recommendation of disease treatment guidelines is a milestone in the field of interventional treatment of heart valve diseases.
  • Transcatheter aortic valve implantation is a new technology that uses an interventional method to insert a prosthetic aortic valve. It was first reported by Dr. Criber in France in 2002. It is used for patients who have lost the chance of surgery (such as >80 years old). The treatment of patients with severe aortic stenosis (AS) has brought hope and opened a new page in the history of interventional treatment of cardiovascular disease. In the following 10 years, with the improvement of equipment and the accumulation of experience, TAVI technology has been continuously improved and has been carried out in more than 230 heart centers in nearly 40 countries, with the total number of operations exceeding 150,000.
  • TAVI Transcatheter aortic valve implantation
  • TAVI technology has become the preferred treatment method for severe AS patients who cannot undergo surgical valve replacement.
  • Clinically, TAVI mainly uses artificial biological valves, which are balloon-expandable Edwards Sapien (USA) and self-expanding CoreValve (Medtronic, USA).
  • TAVI technology has made remarkable progress internationally and has been initially applied in my country. The prospect is also broad.
  • the domestic heart valve device market is The market is a market highly monopolized by foreign brands, with foreign companies such as Edwards Lifesciences, Medtronic, LivaNova (acquired by Solin), St.
  • the detection rate of moderate or severe aortic regurgitation (AR) in patients aged 65 to 74 years (49,995 cases) and ⁇ 75 years old (34,671 cases) The detection rates of moderate or severe aortic stenosis (AS) were 2.12% and 2.85% respectively. The detection rates of moderate or severe aortic stenosis (AS) were 0.75% and 0.89% respectively.
  • the two groups were more sensitive to severe aortic regurgitation (SAR) and severe aortic stenosis (AS).
  • SAS detection rates were 0.52% VS 0.95%, 0.54% VS 0.57% respectively.
  • the artificial valve stent can be transported to the aortic valve and opened through the delivery system to complete the artificial valve implantation and restore the valve function.
  • the delivery system and the artificial valve stent that affect the accurate release of the artificial valve stent.
  • the present invention provides an interventional heart valve stent delivery device to meet the needs of cardiac Containment and release of visceral valve stents.
  • An interventional heart valve stent delivery system which is characterized by including:
  • the delivery tube assembly includes an inner core, a support tube, an inner sheath tube and an outer sheath tube that are movable in sequence from the inside to the outside.
  • the two ends of the inner core respectively extend from the two ends of the support tube.
  • the distal end of the inner sheath tube has an accommodation cavity;
  • the stent fixing component can be detachably connected to both ends of the heart valve stent, and the stent fixing component includes a capsule cavity, and the distal end of the inner core extends from the opening of the proximal end of the capsule cavity and is fixedly connected to the capsule cavity.
  • the support tube can drive the heart valve stent to move axially so that the heart valve stent can enter and exit the capsule cavity or the accommodation cavity.
  • the delivery system of the interventional heart valve stent provided by the embodiment of the present application is detachably connected to both ends of the heart valve stent through the stent fixing assembly, and the heart valve stent is moved from the heart valve stent to the center through the axial movement of the support tube along the inner core.
  • the capsule cavity or accommodating cavity enters and exits, thereby realizing a bidirectional detachable connection method.
  • the release position of the heart valve stent is more accurate and avoids redundant adjustment work.
  • the present invention can also make the following improvements.
  • bracket fixing assembly also includes a fixing piece, a fixing block and a limiting piece
  • the fixing member has an arm connected to the support tube and extending distally.
  • the fixing block is connected to the distal end of the support tube.
  • the arm and the fixing block are respectively used to connect with the heart valve stent. Detachable connections at the proximal and distal ends;
  • the limiting member is an elongated strip structure.
  • the limiting member axially penetrates the support tube and can extend from both ends of the supporting tube.
  • the distal end of the limiting member is used for the heart.
  • the connection between the proximal end of the valve stent and the support arm is limited to prevent the proximal end of the heart valve stent from being separated from the support arm.
  • the opening diameter of the capsule cavity can be expanded in a radial direction
  • the support tube has a guide near the distal end, and the guide can guide the capsule cavity to move into the outer sheath tube.
  • the guide includes a connecting portion and a plurality of guide arms, and the connecting portion is fixedly connected to On the outer wall of the support tube, the guide arm extends distally and elastically expands outward.
  • the distal end of the guide arm has a transition portion, and the transition portion is bent toward the axis of the support tube relative to the guide arm.
  • the capsule cavity includes a cavity body and a fence opening.
  • the cavity body is a straight cylindrical structure.
  • the fence opening is straight cylindrical without external force and can expand into a bell mouth shape under the action of external force.
  • the inner side of the guide arm can elastically compress the fence opening.
  • the fence opening has a plurality of axial cuts, the axial cuts are evenly distributed around the circumference of the capsule cavity, and the portion between adjacent axial cuts constitutes a fence strip.
  • the side of the cavity body has several arc-shaped cuts of equal length.
  • the arc-shaped cuts are distributed along the axial direction of the cavity body. Adjacent arc-shaped cuts are arranged in an offset manner. Both sides of all arc-shaped cuts are arranged in a staggered position. The gaps between the ends are partially connected to form a spiral connecting rib along the axial direction.
  • the control handle is connected to the proximal end of the support tube and can drive the support tube to move in the axial direction.
  • the control handle has a function for controlling the support.
  • the first stroke component of the axial movement distance of the tube, the two bending handles are respectively provided at the proximal end of the inner sheath tube and the proximal end of the outer sheath tube, and the corresponding inner sheath is moved by a pulling wire.
  • the distal end of the tube and the distal end of the outer sheath tube are bent in the same plane or in different planes, and the bending handle has a third bending arc for controlling the corresponding bending arc of the inner sheath tube or the outer sheath tube.
  • control handle is arranged along the axial direction of the support tube, and the two bending handles are arranged in sequence on the side of the control handle close to the distal end of the support tube, and are used to adjust the inner tube.
  • the bending handle of the sheath tube is arranged closer to the control handle.
  • the bending handle includes an axial part and a branch part.
  • the axial part is arranged along the axial direction of the support tube.
  • the inner sheath tube and the outer sheath tube The proximal end of the tube is fixed to the corresponding axial portion of the bending handle, the branch portion forms an acute angle with the axial portion, and the second stroke component is disposed on the branch portion.
  • control handle includes a handle body sleeve, a control sleeve and a control slider
  • the first stroke component includes a first stroke sleeve and a first stroke indicator
  • the handle body sleeve has an axial Control slide
  • the inner side of the control sleeve drives the control slide block through threaded fit Slide along the axial control slide
  • the support tube is fixed to the distal end of the handle body sleeve
  • the support tube extends from the distal end of the handle body sleeve and is fixed to the control slider
  • the first stroke sleeve is fixedly mounted on the outside of the control sleeve
  • the first stroke sleeve has a first stroke slideway arranged along the axial direction
  • the outside of the control sleeve drives the The first stroke indicator slides along the first stroke slideway.
  • control handle also includes a detachable part, which is detachably installed on the proximal end of the handle body sleeve and connected with the proximal end of the limiting part.
  • the dismounting member can be used to pull the limiting member so that the distal end of the limiting member releases the connection limitation between the proximal end of the heart valve stent and the arm.
  • the axial part includes an axial sleeve, a hemostatic valve and a proximal fixed cover
  • the axial sleeve has an axial through hole inside, and the proximal ends of the inner sheath and the outer sheath are connected from the corresponding The distal end of the axial sleeve is inserted and fixed.
  • the axial sleeve has a lateral wire hole corresponding to the branch part.
  • the hemostatic valve is arranged near the proximal end of the axial sleeve and has an elastically contractible hemostatic channel.
  • the proximal fixed cover is fixed to the proximal end of the axial sleeve and has a pipe through hole.
  • the hemostatic valve includes at least one valve disc group, which includes a valve disc sleeve and a first valve disc, a second valve disc, and a third valve disc arranged coaxially in sequence from the proximal end to the distal end.
  • a first hole is opened in the middle of the first valve plate, non-penetrating notches are formed on both sides of the first valve plate, and the notches on both sides are staggered; the middle part of the second valve plate A second hole protrudes toward the distal end and is opened in the center.
  • the side of the second valve piece close to the third valve piece forms an annular step.
  • the third valve piece includes an elastic cylinder and two elastic flaps.
  • the elastic flaps Connected to the inner wall of the elastic cylinder, the distal ends of the two elastic flaps form an openable orifice.
  • the distal ends of the elastic flaps and the inner wall of the elastic cylinder have elastic support ribs for making the flaps.
  • the opening is elastically closed, the annular step is built into the proximal opening of the elastic sleeve, the valve sleeve is a cylindrical member, the elastic sleeve is partially or completely built into the valve sleeve, and the first The hole, the second hole and the flap constitute the hemostatic channel.
  • the branch part includes a branch body, a bending slider and a bending sleeve
  • the second stroke assembly includes a second stroke sleeve and a second stroke indicator
  • the branch body includes a communication device.
  • the axial fixed tube and the guide tube are arranged coaxially on the outside of the axial sleeve.
  • the guide tube is arranged corresponding to the lateral wire hole.
  • the guide tube extends to the proximal end and is connected with the axial sleeve.
  • the axial fixed tube is arranged at a predetermined acute angle, the inside of the guide tube has a bending guide slide along its axial direction, the proximal end of the pulling wire is fixed on the bending slider, and the bending sleeve The inner side of the bending sleeve is threaded to drive the bending slider to slide along the bending guide slide.
  • the second stroke sleeve is fixedly mounted on the outside of the bending sleeve.
  • the second stroke sleeve has a second Stroke slideway, the outer side of the bending sleeve drives the second stroke indicator to slide along the second stroke slideway through threaded fit.
  • Figure 1 is a schematic structural diagram of an interventional heart valve stent delivery system provided by an embodiment of the present invention
  • Figure 2 is a schematic diagram of the connection between the embodiment of the present application and the heart valve stent
  • FIG. 3 is a schematic structural diagram of the fixing member in the embodiment of the present application.
  • Figure 4 is a schematic structural diagram of the fixed block in the embodiment of the present application.
  • Figure 5 is a schematic diagram of the positional relationship between the guide, the fixing block and the capsule cavity in the embodiment of the present application;
  • Figure 6 is a schematic structural diagram of the guide in the embodiment of the present application.
  • Figure 7 is a schematic structural diagram of the capsule cavity in the embodiment of the present application.
  • FIG. 8 is a schematic diagram of the external structure of the control handle in the embodiment of the present application.
  • FIG. 9 is a schematic cross-sectional view of the control handle in the embodiment of the present application.
  • Figure 10 is a schematic diagram of the external structure of the bending handle in the application embodiment
  • Figure 11 is a schematic diagram of the internal structure of the bending handle in the application embodiment.
  • Figure 12 is a schematic structural diagram of the hemostatic valve in the application embodiment
  • Figure 13 is a schematic structural diagram of the third valve plate in the application embodiment.
  • Embodiments of the present application provide an interventional heart valve stent delivery system, which is mainly used to deliver the heart valve stent from outside the body into the patient's heart. It includes a delivery tube assembly and a stent fixation assembly.
  • the delivery tube assembly As a basic component of the delivery system, the delivery tube assembly, as shown in Figure 1, includes an inner core 11, a support tube 12, an inner sheath tube 13 and an outer sheath tube 14 that are movable in sequence from the inside to the outside.
  • the two ends of 11 protrude from the two ends of the support tube 12 respectively, and the distal end of the inner sheath tube 13 has an accommodation cavity.
  • proximal end referred to in this application and its embodiments is the end closer to the user when the delivery system is used, and the distal end is the end closer to the patient.
  • the stent fixing component can be detachably connected to both ends of the heart valve stent 200 (see Figure 2), thereby positioning the heart valve stent at a certain part of the stent fixing component, generally the distal part, wherein the stent fixing component includes a capsule
  • the distal end of the inner core 11 extends into the cavity 23 from the proximal opening of the capsule cavity 23 and is fixedly connected to the capsule cavity 23.
  • the support tube 12 can drive the heart valve stent 200 to move axially so that the heart valve stent 200 moves from the capsule cavity 23 or the capsule cavity 23. In and out of the cavity.
  • an inner tube (not shown) between the support tube 12 and the inner sheath tube 13. Its main function is to support, allowing the support tube 12 to move within the inner tube.
  • a TIP head is provided at the far end of the capsule cavity 23. The TIP head forms a pigtail shape in its natural state.
  • the stent fixing assembly also includes a limiting member 21, a fixing member 22 and a fixing block 24.
  • the fixing member 22 has a support arm 221.
  • the support arm 221 is connected to the support tube 12 and extends toward the distal end. Extend, for detachable connection with the proximal end of the heart valve stent 200; the fixing block 24 is connected to the distal end of the support tube 12, for detachable connection with the distal end of the heart valve stent 200.
  • the limiter 21 is an elongated strip structure.
  • the limiter 21 axially penetrates the support tube 12 and can extend from both ends of the support tube 12.
  • the distal end of the limiter 21 is used for the proximal end and the end of the heart valve stent 200.
  • the connection of the support arm 221 is limited to prevent the proximal end of the heart valve stent 200 from being separated from the support arm 221 .
  • FIG. 2 it is a schematic diagram of a heart valve stent 200, which includes a stent body 201.
  • the stent body 201 is generally an elastically compressible mesh structure, with a first release member 202 at its proximal end and a second release member 202 at its distal end. Release piece 203.
  • the end of the arm 221 has a limiting ring 2211
  • the first release member has a coil 2021 that can pass through the limiting ring 2211 from outside to inside.
  • the distal end of the member 21 can pass through the inside of the coil 2021 to block the connection between the coil 2021 and the limiting ring 2211, thereby restricting the separation of the coil 2021 and the limiting ring 2211.
  • the fixing member 22 has a plurality of arms 221.
  • the number of the first release members 202 is equal to the number of the arms 221.
  • the distal end of the limiting member 21 can pass through multiple coils 2021 in sequence, as in In a specific usage condition, the number of the arm 22 and the second release member are both three, and the distal end of the limiting member 21 passes through the three coils 2021 in sequence.
  • the proximal end of the stent body 201 needs to be released, from When the three coils 2021 are pulled out, the coil 2021 will break away from the limiting ring 2211 under the action of tension, completing the proximal release of the stent.
  • the number of the support arms 221 and the first release parts 202 is three, and the number of the limiting parts 21 is also three, and the distal ends of the three limiting parts 21 correspond one to one. Passed through three coils 2021, when the proximal end of the stent body 201 needs to be released, pull the three limiting parts 21 to pull out the three coils respectively, and the three first release parts 202 are released at the same time, ensuring that the stent body 201 Quick and smooth release.
  • the fixing block 24 has a limiting groove 24a
  • the first release member 203 has a T-shaped portion 2031 that matches the limiting groove 24a.
  • the limiting groove 24a may be an open groove provided radially along the bracket body 201.
  • the T-shaped portion 2031 is directly connected to the open groove from the outer part of the fixing block 24.
  • the pressure of the inner wall of the accommodation cavity or capsule cavity ensures the stable connection between the limiting groove 24a and the T-shaped portion 2031.
  • the inner wall of the accommodation cavity or capsule cavity 23 no longer covers the opening of the limiting groove 24a.
  • the T-shaped portion 2031 opens outwards with the stent body 201 and is separated from the limiting groove 24a; in other embodiments, it can also be a slot arranged along the axial direction, with the slot opening facing toward the proximal direction.
  • the T-shaped part is inserted into the slot from the proximal end face of the fixed block.
  • the pressure through the inner wall of the accommodation cavity or capsule cavity includes the tendency of the T-shaped part to extend distally, thereby stably inserting into the slot.
  • the proximal end of the stent body 201 has a tendency to stretch under self-expansion tension, driving the T-shaped portion to be pulled out of the slot and separated from the limiting groove.
  • the former solution is preferred in this application.
  • the above-mentioned detachable connection solution can also be that the fixed block 24 has a limiting protrusion, the first release member has an annular portion detachably connected to the limiting protrusion, and the ring portion and the limiting protrusion are sleeved.
  • the connection realizes the detachable connection between the fixing block 24 and the first release member 203, which will not be described again here.
  • the opening caliber of the capsule cavity 23 can be expanded in the radial direction, and the support tube 12 has a guide 121 near the distal end, and the guide 121 can guide the capsule cavity 23 Move into the outer sheath.
  • the capsule cavity 23 is not retracted into the outer sheath tube 14 since the capsule cavity 23 is generally made of stainless steel and has a hard texture, only the capsule cavity 23 made of a harder material can Resist the tension of the artificial valve, but when the capsule cavity 23 is withdrawn, it is easy to scratch the blood vessel wall in the curved blood vessel.
  • the gap between the capsule cavity 23 and the outer sheath 14 There is a certain distance and a certain curvature between them.
  • the opening of the capsule cavity 23 and the opening of the outer sheath 14 can easily become misaligned, causing the capsule cavity 23 to be unable to enter the outer sheath 14. If it is not retracted, the capsule cavity 23 It is harder than the outer sheath 14. When encountering a curved blood vessel during the withdrawal process, it is easy to scratch the blood vessel wall. When the opening of the capsule cavity 23 is in the shape of a bell mouth, the risk of scratching the blood vessel wall is greater. Therefore, it is necessary to The capsule cavity 23 is retracted into the outer sheath tube 14.
  • a guide 121 is designed on the support tube 22 to form a guide for the capsule cavity 23 to be retracted into the outer sheath tube 14 to ensure the smooth retraction of the capsule cavity 23, thereby ensuring smooth operation during and after the release process. to ensure the efficiency and stability of the operation.
  • the guide 121 includes a connecting portion 1211 and a plurality of guide arms 1212.
  • the connecting portion 1211 is fixedly connected to the outer wall of the support tube 22.
  • the guide arms 1212 extend toward the distal end and elastically expand outward.
  • the connecting portion 1211 is an annular structure fixed on the outer wall of the support tube 22, and is connected to six guide arms 1212 evenly arranged in the circumferential direction.
  • the six guide arms 1212 form a ring outside the support tube 22.
  • the distal opening is large and the proximal opening is small.
  • the inner side of the guide arm 1212 can elastically compress the opening of the capsule cavity 23 and then wrap the bell-shaped capsule cavity 23.
  • the cone formed by the guide arm 1212 can realize the retraction of the outer sheath tube 14 into the capsule cavity 23.
  • the guide facilitates the retraction of the capsule cavity 23 after the artificial valve is loaded.
  • the distal end of the guide arm 1212 has a transition portion 1213.
  • the transition portion 1213 is bent toward the axis side of the support tube 30 relative to the guide arm 1212. On the one hand, it is to make it easier to wrap the fence opening 52 and put it into the outer sheath. Inside the tube 14, on the other hand, the outward opening of the guide 121 is smaller, reducing the risk of scratching the heart tissue.
  • the capsule cavity 23 includes a cavity body 231 and a fence opening 232.
  • the cavity body 231 is a straight cylindrical structure.
  • the barrier opening 232 is straight-cylindrical without external force.
  • the artificial valve When the artificial valve is released from the capsule cavity 23, the artificial valve will slowly open and expand the barrier opening 232, forming a bell mouth shape.
  • the inner side of the guide arm 322 can elastically press the fence opening 232 and be retracted into the outer sheath 14 .
  • the outer diameter of the fence opening 232 varies within a range of 5 mm to 9 mm, which can satisfy the smooth insertion of the artificial valve without affecting the in vivo operation during release.
  • the fence opening 232 has a plurality of axial cutouts 232a, the axial cutouts 232a are evenly distributed around the capsule cavity 23 in the circumferential direction, and the portion between adjacent axial cutouts 232a constitutes the fence strips 2321.
  • the fence strips 2321 make it easy for the open end of the capsule cavity 23 to become a bell mouth state during the release of the stent.
  • the fence opening 232 is also provided with a first strip hole 232b and a second strip hole 232c.
  • the first strip hole 232b is provided corresponding to the fence strip 2321.
  • the length of the hole 232b is greater than the depth of the axial cutout 232a
  • the second strip hole 232c is located between two adjacent first strip holes 232b
  • the second strip hole 232b and the axial cutout 232a are spaced apart in the axial direction. .
  • the side of the cavity body 231 has several arc-shaped cuts 231a, the arc-shaped cuts 231a are distributed along the axial direction of the cavity body 231, and the gaps between the two ends of all the arc-shaped cuts 231a are partially connected.
  • the formation of the connecting ribs 2311 and the arrangement of the arc-shaped cutouts 231a can make the cavity body 231 have a certain degree of flexibility, thereby adapting to the complex and varied vascular structure inside the human body.
  • all arc-shaped cuts 231a are equal in length, adjacent arc-shaped cuts 231a are staggered, and the connecting ribs 2311 are spiral in the axial direction. Compared with the linear shape, the connecting ribs 2311 are spiral in shape.
  • the cavity body 231 is universally bent.
  • the inner wall of the cavity body 231 is provided with a first film protective layer to reduce the resistance of the inner wall of the cavity body 231 to the artificial valve.
  • the outer sides of the cavity body 231 and the fence opening 232 are covered with a second film protective layer
  • the first film protective layer and the second film protective layer are elastic films
  • the elasticity of the first film protective layer and the second film protective layer Under the restoring force, the fence opening 232 is retracted from the bellmouth shape, and may even become a straight tube shape.
  • the fence opening 232 can be made of memory alloy, such as nickel-titanium alloy, so that the fence opening 232 can be retracted from a bellmouth shape, or even become a straight tube shape.
  • the above two retractable embodiments further limit the fence opening 232 so that the fence opening 232 can automatically retract after expansion, for the purpose of making it more convenient and safer to retract the outer sheath 14 within, because in actual operation, after the artificial valve is released, the size of the fence opening 232 is different. That is to say, in order to make the system more stable, the opening size of the guide 121 must be able to accommodate the maximum size of the fence opening 232 , and at the heart valve, the larger the guide member 121 is opened, the easier it is to scratch the heart tissue. Therefore, if the fence opening 232 can be retracted under its own restoring force after expansion, the hardware size pressure can be reduced. , and at the same time, it can be inserted into the outer sheath tube 14 more conveniently and safely.
  • the delivery system In order to control the delivery system at the proximal end, as shown in FIG. 1 , the delivery system also includes a control handle 30 and two bending handles 40 .
  • control handle 30 is connected to the proximal end of the support tube 12 and can drive the support tube 12 to move in the axial direction, which in turn can drive the capsule cavity 23 to move.
  • the control handle 30 has an axis for controlling the support tube 11
  • the first stroke component 34 moves the distance.
  • the control handle 30 is arranged along the axial direction of the inner core 11.
  • the control handle 30 includes a handle body sleeve 31, a control sleeve 32 and a control slider 33.
  • the first stroke assembly 34 includes a first stroke sleeve. Barrel 341 and first stroke indicator 342.
  • the handle body sleeve 31 has an axial control slide inside, and the inside of the control sleeve 32 drives the control slide 33 to slide along the axial control slide through threaded fit.
  • the handle body sleeve 31 is a cylindrical structure.
  • the control sleeve 32 is set on the outer side of the handle main sleeve 31 and can rotate coaxially outside the handle main sleeve 31.
  • the inner side of the control sleeve 32 has internal threads, and the two axial control slideways are There is a guide groove on the side, the control slider 33 is axially installed on the axial control slideway, and the outside extends from the guide groove to match the internal thread of the control sleeve 32.
  • the control slider 33 When the control sleeve 32 rotates, the control slider 33 is driven axially slide.
  • the proximal end of the support tube 12 is fixed to the distal end of the handle body sleeve 21 through a compression bolt.
  • the support tube 11 extends from the distal end of the handle body sleeve 21 and is fixed to the control slider 23. Therefore, the axis of the control slider 23 By sliding in the direction, the support tube 12 can be driven to move axially.
  • the first stroke sleeve 341 is coaxially fixed on the outside of the control sleeve 32.
  • the first stroke sleeve 341 has a first stroke slideway.
  • the outside of the control sleeve 32 is provided with external threads.
  • the first stroke indicator 342 Cooperating with the external thread of the control sleeve 32, when the control sleeve 32 rotates, the first stroke indicator 342 slides on the first stroke slide, and the thread specifications on both sides of the control sleeve 32 are set to the same or predetermined settings according to regulations.
  • the sliding distance of the control slider 23 can be known through the sliding distance of the first stroke indicator 342 on the first stroke slideway, and then the sliding distance of the support tube 12 can be determined.
  • the axial movement distance is precisely controlled, and this application adopts a thread drive method, which has high adjustment accuracy and can realize stopping and locking at any time throughout the process. It can accurately monitor the valve stent release process and reduce the difficulty of stent release.
  • the control handle 30 also includes a dismounting member 35.
  • the dismounting member 35 is detachably installed on the proximal end of the handle body sleeve 31 and is connected to the proximal end of the limiting member 21.
  • the dismounting member 35 can be used to pull the limiting member 21 so that the distal end of the limiting member 21 releases the connection limitation between the proximal end of the heart valve stent 200 and the arm 221.
  • the two bending handles 40 are respectively provided at the proximal ends of the inner sheath tube 13 and the outer sheath tube 14, and the distal ends of the corresponding inner sheath tube 13 and the outer sheath tube 14 are made to be on the same plane through the pulling wire 50. Or for bending in different planes, the bending handle 40 has a second stroke component 47 for controlling the bending arc of the corresponding inner sheath 13 or outer sheath 14 .
  • the sheath In some surgical operations, the sheath generally needs to enter through the femoral artery and then pass through the aortic arch, where the blood vessels bend at a larger angle and in the three-dimensional direction. Bending has high requirements for the delivery of heart valve stents. If only a bending sheath is used that can be bent in one plane, when entering the aortic arch, it must first be bent in one plane, and then it needs to pass through the blood vessel The friction and guidance of the wall and the bending on another plane can also be used to enter the heart.
  • the doctor controls the handle operation and the sheath moves in the human body. It can only be displayed on the device through the development of the sheath, which means that the blood vessels cannot be seen on the device. wall, can only Seeing the sheath, how to bend the sheath in the next step can only be estimated by the bending degree of the sheath. Then with stroke control, the bending degree of the sheath can be directly fed back to the stroke. In terms of control, how far the sheath needs to continue to bend can also be accurately bent through stroke control.
  • two bending handles 40 are sequentially disposed on the side of the control handle 30 close to the distal end of the inner tube 10 , and the bending handle 40 used to adjust the inner sheath 13 is disposed closer to the control handle 20 , thus realizing the respective bending of the inner sheath tube 13 and the outer sheath tube 14.
  • the bending handle 40 includes an axial part a and a branch part b.
  • the axial part a is arranged along the axial direction of the inner tube 10.
  • the proximal ends of the inner sheath 13 and the outer sheath 14 are fixed to the corresponding bending handles.
  • the axial part of 40, the branch part b and the axial part a form an acute angle
  • the axial part a and the branch part b form a certain angle, effectively shortening the overall length of the conveying system
  • the second stroke component is arranged at the branch part b, the branch
  • the bend in part b and the corresponding sheath bend belong to the same bending arc, so they can play a guiding role during bending.
  • the linear stroke transforms into a bending arc more smoothly, and there will be no inconsistency in a certain stroke. There is a large bending action to enhance the stability of the equipment.
  • the axial part a includes an axial sleeve 41, a hemostatic valve 42 and a proximal fixed cover 43.
  • the axial sleeve 41 has an axial through hole inside, and the proximal ends of the inner sheath 13 and the outer sheath 14 are opened from the corresponding axial direction.
  • the distal end of the sleeve 41 is inserted and locked and fixed.
  • the axial sleeve 41 has a lateral wire hole 411 corresponding to the branch part b.
  • the hemostatic valve 42 is provided near the proximal end of the axial sleeve 41 and has an elastically contractible hemostatic channel.
  • the end fixing cover 43 is fixed on the proximal end of the axial sleeve 41 and has a pipe through hole.
  • the hemostatic valve 42 is mainly used for the sheath to enter the blood vessel to prevent blood from leaking through the sheath under the action of blood pressure.
  • the hemostatic valve 42 includes at least one valve plate group 420.
  • the hemostatic valve 42 includes two valve disc groups 420 arranged in the axial direction.
  • the valve disc group 420 includes a valve disc sleeve 421 and first valves arranged coaxially from the proximal end to the distal end. plate 422, the second valve plate 423, and the third valve plate 424.
  • a first hole is opened in the middle of the first valve plate 422.
  • Non-penetrating slots are formed on both sides of the first valve plate 422, and the grooves on both sides of the first valve plate 422 are The mouths are staggered.
  • cross grooves are formed on both sides. The two cross grooves are offset by 45 degrees, which can effectively lift the middle part of the first valve plate 422 to axially protrude toward both sides; the middle part of the second valve plate 423 A second hole protrudes toward the distal end and is opened in the center.
  • the side of the second valve plate 423 close to the third valve plate 424 forms an annular step 4231.
  • the third valve plate 424 includes an elastic cylinder 4241 and two elastic flaps 4242.
  • the elastic flaps 4242 is connected to the inner wall of the elastic cylinder 4241.
  • the distal ends of the two elastic flaps 4242 form an openable orifice.
  • the distal ends of the elastic flaps 4242 and the inner wall of the elastic cylinder 4241 have elastic support ribs 4243 for making the flap elastic.
  • the annular step 4231 is built into the proximal opening of the elastic sleeve 4241, the valve sleeve 421 is a cylindrical piece, the elastic sleeve 4241 is partially or completely built into the valve sleeve 421, and the first hole, the second hole and the flap opening are formed.
  • the hemostatic channel with the above-mentioned structure, when the valve disc group 420 and the inner tube 10 or the inner sheath tube 13 move relative to each other, the middle portions of the second valve disc 423 and the third valve disc 424 will convex axially through friction. It can effectively prevent blood leakage.
  • the branch part b includes a branch body 44, a bending slider 45 and a bending sleeve 46.
  • the second stroke assembly 47 includes a second stroke sleeve 471 and a second stroke indicator 472.
  • the branch body 44 includes an axial fixed tube 441 and a guide tube 442 that are connected and arranged.
  • the axial fixed tube 441 is coaxially fixed on the outside of the axial sleeve 41.
  • the guide tube 442 is arranged corresponding to the lateral wire hole.
  • the guide tube 442 extends to the proximal end and is connected with the shaft. It is arranged at a predetermined acute angle toward the fixed tube 441.
  • the inside of the guide tube 442 has a bending guide slide along its axial direction.
  • the proximal end of the pulling wire 50 is fixed on the bending slider 45.
  • the principle of bending is through the bending sleeve 46.
  • the bending slider 45 is driven to produce linear motion, thereby moving the proximal end of the pulling wire, pulling the corresponding inner sheath 13 or the distal end of the outer sheath 14 to bend, where the connection between the bending slider 45 and the bending sleeve 46 Similar to the control sleeve 32 and the control slider 33, that is, the inner side of the bending sleeve 46 drives the bending slider 45 to slide along the bending guide slide through threaded fit.
  • the second stroke sleeve 471 is fixedly mounted on the outside of the bending sleeve 46.
  • the second stroke sleeve 471 has a second stroke slideway.
  • the outside of the bending sleeve 46 drives the second stroke indicator 472 through threaded fit. Slide along the second stroke slide.
  • the second stroke indicator 472 can be judged based on the observed moving distance or the moved thread distance, or a specific stroke scale can be provided on the surface of the second stroke sleeve 471 to adjust the proximal movement distance of the pulling wire. , thereby achieving precise control of the bending arc of the inner sheath 13 or the outer sheath 14.
  • the aortic valve delivery system drives the support tube 12 to move in the axial direction through the control handle 30, and the two bending handles 40 drive the distal ends of the inner sheath 13 and the outer sheath 14 to bend through the corresponding pulling wires 50.
  • a first stroke component 24 is provided on the control handle 20 to accurately control the axial movement distance of the support tube 11.
  • a second stroke component 47 is provided on the bending handle 40 to control the bending arc of the sheath tube, thereby better controlling the bending and Release the prosthetic valve.

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Abstract

一种介入式心脏瓣膜支架（200）的输送系统，通过支架固定组件，分别与心脏瓣膜支架（200）的两端可拆卸连接，通过支撑管（12）沿内芯（11）的轴向运动实现心脏瓣膜支架（200）从胶囊腔（23）或容置腔进出，进而实现双向可拆卸式连接方式，其相较于单边固定的方法使得心脏瓣膜支架（200）的释放位置更准确，避免多余的调整工作。

Description

一种介入式心脏瓣膜支架的输送系统 技术领域
本发明涉及介入式心脏瓣膜手术相关设备技术领域，具体涉及一种介入式心脏瓣膜支架的输送系统。
背景技术
随着人口老龄化，瓣膜性心脏病的发病率明显增加，目前传统外科手术治疗仍是多数重度瓣膜病变患者的首选治疗手段，但存在创伤大、术后死亡率、并发症较高等风险。近年来，经导管瓣膜植入/修复术逐渐成熟并广泛应用，尤其是经导管主动脉瓣植入术(TAVR/TAVI)循证学依据较为充分，创伤大大减少，得到了欧洲和美国心脏瓣膜疾病治疗指南的推荐，是心脏瓣膜疾病介入治疗领域里程碑式的进展。
经导管主动脉瓣植入术(TAVI)，是用介入的方法置入人工主动脉瓣膜的新技术，由法国的Criber医生于2002年首次报道使用，为失去外科手术机会(如>80岁)的严重主动脉瓣狭窄(AS)患者的治疗带来了希望,也掀开了心血管病介入治疗史上新的一页。此后10年来，随着器械的改进和经验的积累，TAVI技术不断完善，在近40个国家的230多个心脏中心相继展开，手术总例数已超过15万例。特别是经过一系列注册研究及随机对照研究相继证实了其有效性、可行性和安全性后，TAVI技术已经成为不能外科换瓣的严重AS患者首选治疗方法。临床上TAVI使用人工生物瓣膜主要是球囊膨胀置入的Edwards Sapien(美国爱德华公司)和自膨胀置入的CoreValve(美国美敦力公司)两种。TAVI技术在国际上已经取得了令人瞩目的进步，在我国已有初步应用，前景同样广阔，目前国内心脏瓣膜器械市 场是一个被外资品牌高度垄断的市场，爱德华兹生命科学(EdwardsLifesciences)、美敦力、LivaNova(已被索林收购)、圣犹达(已被雅培收购)和On-X等外资企业占据约85％的市场份额，其中爱德华兹生命科学与美敦力拥有从机械瓣膜、生物瓣膜到经导管介入瓣膜全产品管线，而国内也已涌现出一批国产器械企业，目前已有三款国产的经导管主动脉瓣膜通过中国CFDA的批准上市，分别是启明医疗的Venus-A和苏州杰成的J-valve，以及微创心通的VitaFlow，但国内企业中尚没有一家企业拥有绝对的领先优势。
根据医院患者的超声心动图数据库统计分析，在65～74岁(49995例病例)和≥75岁(34671例病例)的患者中，中度或重度主动脉瓣关闭不全(AR)的检出率分别为2.12％和2.85％，中度或重度主动脉瓣狭窄(AS)的检出率分别为0.75％和0.89％，两组在严重主动脉瓣关闭不全(SAR)和严重主动脉瓣狭窄(SAS)的检出率分别为0.52％VS0.95％，0.54％VS0.57％。可见，中国老年人在主动脉瓣退行性病变中更倾向于主动脉瓣关闭不全。我国主动脉瓣疾病患者与西方国家存在一定的差异：①我国二叶式主动脉瓣比例较高，二叶式主动脉瓣患者所占率在40％～23％，远高于西方国家的1.6％～9.3％，西方国家多项大规模TAVR临床研究将二叶式主动脉瓣列为排除标准。②我国患者的主动脉瓣钙化程度较高。③我国主动脉瓣反流多于主动脉瓣狭窄。④股动脉内径较细，我国TAVR候选病例的股动脉平均内径为6.5mm。
通过输送系统可将人工瓣膜支架输送至主动脉瓣膜处并打开，完成人工瓣膜置入，使其恢复瓣膜功能，输送系统与人工瓣膜支架的安装仍存在诸多影响人工瓣膜支架精准释放的问题。
发明内容
基于上述表述，本发明一种介入式心脏瓣膜支架的输送装置，以满足心 脏瓣膜支架的收容和释放。
一种介入式心脏瓣膜支架的输送系统，其特征在于，包括：
输送管组件，其包括从内向外依次可活动的套设的内芯、支撑管、内鞘管和外鞘管，所述内芯的两端分别从所述支撑管的两端伸出，所述内鞘管的远端具有容置腔；
支架固定组件，能够与心脏瓣膜支架的两端可拆卸连接，且所述支架固定组件包括胶囊腔，所述内芯的远端从所述胶囊腔近端的开口伸入并与胶囊腔固定连接，所述支撑管可带动所述心脏瓣膜支架轴向运动使所述心脏瓣膜支架从所述胶囊腔或容置腔进出。
本发明解决上述技术问题的技术方案如下：
本申请实施例提供的介入式心脏瓣膜支架的输送系统，通过支架固定组件，分别与心脏瓣膜支架的两端可拆卸连接，通过支撑管沿内芯的轴向运动实现所述心脏瓣膜支架从所述胶囊腔或容置腔进出，进而实现双向可拆卸式连接方式，其相较于单边固定的方法使得心脏瓣膜支架的释放位置更准确，避免多余的调整工作。
在上述技术方案的基础上，本发明还可以做如下改进。
进一步的，所述支架固定组件还包括固定件、固定块和限位件；
所述固定件具有连接于所述支撑管并向远端延伸的支臂，所述固定块连接于所述支撑管的远端，所述支臂和所述固定块分别用于与心脏瓣膜支架的近端和远端可拆卸连接；
所述限位件为细长条状结构，所述限位件轴向贯穿所述支撑管并可从所述支撑管的两端伸出，所述限位件的远端用于所述心脏瓣膜支架的近端和所述支臂的连接限位，以防止所述心脏瓣膜支架的近端和支臂脱开。
进一步的，所述胶囊腔的开口口径可沿径向扩张，所述支撑管靠近远端具有导引件，所述导引件可引导所述胶囊腔移动至所述外鞘管内。
进一步的，所述导引件包括连接部和多个导引臂，所述连接部固定连接 于所述支撑管的外壁，所述导引臂向远端延伸且向外侧弹性扩张。
进一步的，所述导引臂的远端具有过渡部，所述过渡部相对所述导引臂向靠近所述支撑管的轴线一侧弯曲。
进一步的，所述胶囊腔包括腔体本体和栅栏开口部，所述腔体本体为直筒状结构，所述栅栏开口部无外力作用下为直筒状且可在外力作用下扩张成喇叭口状，所述导引臂的内侧可弹性压紧所述栅栏开口部。
进一步的，所述栅栏开口部具有多个轴向切口，所述轴向切口环所述胶囊腔周向均匀分布，相邻的轴向切口之间的部分构成栅栏条。
进一步的，所述腔体本体的侧面具有若干长度相等的弧形切口，所述弧形切口沿所述腔体本体的轴向分布，相邻的弧形切口错位设置，所有弧形切口的两端之间的间隙部分连接形成沿轴向呈螺旋形的连接筋。
进一步的，还包括控制手柄和两个调弯手柄，所述控制手柄连接于所述支撑管的近端且可带动所述支撑管沿轴向运动，所述控制手柄具有用于控制所述支撑管的轴向移动距离的第一行程组件，两个所述调弯手柄分别设置于所述内鞘管的近端和所述外鞘管的近端，通过牵引丝使对应的所述内鞘管的远端和所述外鞘管的远端在同一平面或者不同平面内弯曲，所述调弯手柄具有用于控制对应的所述内鞘管或所述外鞘管的调弯弧度的第二行程组件。
进一步的，所述控制手柄沿所述支撑管的轴向设置，两个所述调弯手柄依次设置于所述控制手柄靠近所述支撑管的远端的一侧，且用于调节所述内鞘管的调弯手柄更靠近所述控制手柄设置，所述调弯手柄包括轴向部分和分支部分，所述轴向部分沿所述支撑管的轴向设置，所述内鞘管和外鞘管的近端固定于对应的所述调弯手柄的轴向部分，所述分支部分与所述轴向部分形成锐角，所述第二行程组件设置于所述分支部分。
进一步的，所述控制手柄包括手柄主体套筒、控制套筒和控制滑块，所述第一行程组件包括第一行程套筒和第一行程指示件，所述手柄主体套筒内部具有轴向控制滑道，所述控制套筒的内侧通过螺纹配合带动所述控制滑块 沿所述轴向控制滑道滑动，所述支撑管固定于所述手柄主体套筒的远端，所述支撑管从所述手柄主体套筒的远端伸入并与所述控制滑块固定，所述第一行程套筒固定套装于所述控制套筒外侧，所述第一行程套筒具有沿轴向设置的第一行程滑道，所述控制套筒的外侧通过螺纹配合带动所述第一行程指示件沿所述第一行程滑道滑动。
进一步的，所述控制手柄还包括卸装件，所述卸装件可拆卸的安装于所述手柄主体套筒的近端并与所述限位件的近端连接，当所述心脏瓣膜支架位于所述胶囊腔内部时，可通过卸装件拉扯限位件使限位件的远端解除对心脏瓣膜支架的近端和支臂的连接限位。
进一步的，所述轴向部分包括轴向套、止血阀和近端固定盖，所述轴向套内部具有轴向通孔，所述内鞘管和外鞘管的近端从对应的所述轴向套的远端插入并固定，所述轴向套对应所述分支部分具有侧向线孔，所述止血阀设置于所述轴向套靠近其近端处且具有可弹性收缩的止血通道，所述近端固定盖固定于所述轴向套的近端且具有管道通孔。
进一步的，所述止血阀包括至少一个阀片组，所述阀片组包括阀片套筒以及从近端向远端依次同轴排列的第一阀片、第二阀片、第三阀片，所述第一阀片的中部开设有第一孔，所述第一阀片的两侧形成有不穿透的槽口且其两侧的槽口交错设置；所述第二阀片的中部向远端突出并中心位置开设有第二孔，所述第二阀片靠近第三阀片的一侧形成环形台阶，所述第三阀片包括弹性筒和两个弹性瓣，所述弹性瓣连接于所述弹性筒的内壁，两个弹性瓣的远端形成一个可开合的瓣口，所述弹性瓣的远端与所述弹性筒的内壁具有弹性支撑筋，用于使所述瓣口弹性合拢，所述环形台阶内置于所述弹性筒的近端开口，所述阀片套筒为圆筒件，所述弹性筒部分或者完全内置于所述阀片套筒，所述第一孔、第二孔和所述瓣口构成所述止血通道。
进一步的，所述分支部分包括分支主体、调弯滑块和调弯套筒，所述第二行程组件包括第二行程套筒和第二行程指示件，所述分支主体包括连通设 置的轴向固定管和导向管，所述轴向固定管同轴固定于所述轴向套外侧，所述导向管对应所述侧向线孔设置，所述导向管向近端延伸并与所述轴向固定管呈预定锐角设置，所述导向管内部具有沿其轴向的调弯导向滑道，所述牵引丝的近端固定于所述调弯滑块，所述调弯套筒的内侧通过螺纹配合带动所述调弯滑块沿所述调弯导向滑道滑动，所述第二行程套筒固定套装于所述调弯套筒外侧，所述第二行程套筒具有第二行程滑道，所述调弯套筒的外侧通过螺纹配合带动所述第二行程指示件沿所述第二行程滑道滑动。
附图说明
图1为本发明实施例提供的一种介入式心脏瓣膜支架的输送系统的结构示意图；
图2为本申请实施例与心脏瓣膜支架的连接示意图；
图3为本申请实施例中固定件的结构示意图；
图4为本申请实施例中固定块的结构示意图；
图5为本申请实施例中导引件、固定块和胶囊腔的位置关系示意图；
图6为本申请实施例中导引件的结构示意图；
图7为本申请实施例中胶囊腔的结构示意图；
图8为本申请实施例中控制手柄的外部结构示意图；
图9为本申请实施例中控制手柄的剖面示意图；
图10为申请实施例中调弯手柄的外部结构示意图；
图11为申请实施例中调弯手柄的内部结构示意图；
图12为申请实施例中止血阀的结构示意图；
图13为申请实施例中第三阀片的结构示意图。
具体实施方式
为了便于理解本申请，下面将参照相关附图对本申请进行更全面的描述。 附图中给出了本申请的实施例。但是，本申请可以以许多不同的形式来实现，并不限于本文所描述的实施例。相反地，提供这些实施例的目的是使本申请的公开内容更加透彻全面。
除非另有定义，本文所使用的所有的技术和科学术语与属于本申请的技术领域的技术人员通常理解的含义相同。本文中在本申请的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本申请。
本申请实施例提供了一种介入式心脏瓣膜支架的输送系统，主要用于将心脏瓣膜支架从体外送入病人的心脏部位，其包括输送管组件和支架固定组件。
输送管组件作为该输送系统的基本组成部分，如图1所示，其包括从内向外依次可活动的套设的内芯11、支撑管12、内鞘管13和外鞘管14，内芯11的两端分别从支撑管12的两端伸出，内鞘管13的远端具有容置腔。
可以理解的是，本申请及其实施例中所指的近端为该输送系统使用时更靠近使用者的一端，远端为更靠近病例的一端。
支架固定组件能够与心脏瓣膜支架200(见图2)的两端可拆卸连接，从而将心脏瓣膜支架定位在支架固定组件的某一确定部分，一般为远端部分，其中，支架固定组件包括胶囊腔23，内芯11的远端从胶囊腔23近端的开口伸入并与胶囊腔23固定连接，支撑管12可带动心脏瓣膜支架200轴向运动使心脏瓣膜支架200从胶囊腔23或容置腔进出。
其中，支撑管12和内鞘管13之间还有一层内管(未画出)，其主要作用是支撑作用，使支撑管12在内管内移动，胶囊腔23的远端设置有TIP头，TIP头在自然状态下形成猪尾状。
其中，作为本申请心脏瓣膜支架200的一种连接方式，支架固定组件还包括限位件21、固定件22和固定块24。
其中，固定件22具有支臂221，支臂221连接在支撑管12上并向远端 延伸，用于与心脏瓣膜支架200的近端可拆卸连接；固定块24连接在支撑管12的远端，用于与心脏瓣膜支架200的远端可拆卸连接。
限位件21为细长条状结构，限位件21轴向贯穿支撑管12并可从支撑管12的两端伸出，限位件21的远端用于心脏瓣膜支架200的近端和支臂221的连接限位，以防止心脏瓣膜支架200的近端和支臂221脱开。
如图2所示，为一种心脏瓣膜支架200的示意图，其包括支架本体201、支架本体201一般为可弹性压缩的网状结构，其近端具有第一释放件202，远端具有第二释放件203。
作为一种可选的实施例，结合图3和4所示，支臂221的端部具有限位环2211，第一释放件具有可从外向内穿过限位环2211的线圈2021，限位件21的远端可通过穿设线圈2021内部来卡住线圈2021和限位环2211的连接处，进而限制线圈2021和限位环2211脱离。
作为一种优选的实施方式，固定件22具有多个支臂221，第一释放件202的数目与支臂221数目相等，限位件21的远端可依次穿设多个线圈2021，如在一种具体的使用工况中，支臂22和第二释放件的数目均为3个，限位件21的远端依次穿过三个线圈2021，当支架本体201近端需要释放时，从三个线圈2021中抽出，线圈2021会在张力作用下从限位环2211中脱离，完成支架的近端释放。
作为另一种可选的实施方式，支臂221和第一释放件202的数目均为3个，限位件21的数目也为3个，3个限位件21的远端一一对应的穿设于三个线圈2021中，当支架本体201近端需要释放时，拉扯3个限位件21分别从3个线圈中抽出，3个第一释放件202同时释放，保证了支架本体201的快速平稳释放。
作为远端的可拆卸连接方式，固定块24上具有限位槽24a，第一释放件203具有与限位槽24a相配合的T形部2031。
可以理解的是，在一些实施方案中，该限位槽24a可以是沿支架本体201径向设置的开口槽，此时，T形部2031从固定块24的外侧部分直接扣接在开口槽的凹口中，通过容置腔或胶囊腔内壁的压力保证限位槽24a和T形部2031的稳定连接，当释放时，使容置腔或胶囊腔23内壁不再覆盖限位槽24a的开口，在自膨胀的张力作用下，T形部2031随支架本体201向外张开，与限位槽24a脱离；另一些实施方案中，也可以是沿轴向设置的插槽，插槽开口朝向近端设置，此时T形部从固定块的近端端面插入插槽中，通过容置腔或胶囊腔内壁的压力包括T形部具有的向远端延伸的趋势，进而稳定插接在插槽中，当释放时，支架本体201近端在自膨胀张力下具有舒展的趋势，带动T形部从那个插槽中抽出，与限位槽脱离，本申请中优选前一种方案。
与之相似的，上述可拆卸连接方案也可以是固定块24上具有限位凸起，第一释放件具有与限位凸起可拆卸连接的环形部，通过环形部和限位凸起的套接实现固定块24和第一释放件203的可拆卸连接，在此不做赘述。
在本申请的实施例中，如图5和图6所示，胶囊腔23的开口口径可沿径向扩张，支撑管12靠近远端具有导引件121，导引件121可引导胶囊腔23移动至外鞘管内。
人工瓣膜释放后，在回撤过程中，如果胶囊腔23没有收至外鞘管14内，由于胶囊腔23一般采用不锈钢材质，其质地较硬，也只有较硬材质制成的胶囊腔23才能抵住人工瓣膜的张力，但是胶囊腔23回撤时容易在弯曲的血管中刮伤血管壁，采用本申请的输送装置在人体心脏瓣膜处释放人工瓣膜之后，胶囊腔23与外鞘管14之间存在一定距离，且是具有一定弧度，相对移动后，胶囊腔23开口与外鞘管14开口很容易形成错位，导致胶囊腔23无法进入外鞘管14内，如未收入，由于胶囊腔23相对外鞘管14更硬，在回撤过程中遇到弯曲的血管，容易刮伤血管壁，在胶囊腔23开口呈喇叭口状时，刮伤血管壁的风险更大，因此，有必要将胶囊腔23收至外鞘管14内， 为实现更稳定收回，在支撑管22上设计导引件121，对胶囊腔23收入外鞘管14形成导向，保证胶囊腔23的顺利收入，进而保证释放过程中和释放过程后手术均可以顺利进行，保证手术的高效稳定。
具体而言，导引件121包括连接部1211和多个导引臂1212，连接部1211固定连接于支撑管22的外壁，导引臂1212向远端延伸且向外侧弹性扩张，具体的，在本实施例中，连接部1211为固定在支撑管22外壁上的环形结构，其上面连接有6个环周向均匀设置的导引臂1212，6个导引臂1212在支撑管22外侧形成一个远端开口大，近端开口小的锥形结构。
其中，导引臂1212的内侧可弹性压紧胶囊腔23的开口处进而包住处于喇叭口状的胶囊腔23，同时导引臂1212形成的锥形可以实现外鞘管14对胶囊腔23收入的导向，便于人工瓣膜装载后胶囊腔23的收入。
导引臂1212的远端具有过渡部1213，过渡部1213相对导引臂1212向靠近支撑管30的轴线一侧弯曲，一方面是为了更容易包住栅栏开口部52，并使之收入外鞘管14内，另一方面使导引件121向外张开的尺寸较小，减小刮伤心脏组织的风险。
其中，为了实现胶囊腔23开口口径的可扩张，在本申请的实施例中，结合图7所示，胶囊腔23包括腔体本体231和栅栏开口部232，腔体本体231为直筒状结构，栅栏开口部232无外力作用下为直筒状，当人工瓣膜从胶囊腔23中释放出来时，人工瓣膜会慢慢张开，并使栅栏开口部232撑开，并形成喇叭口状，在回撤时，导引臂322的内侧可弹性压紧栅栏开口部232，并收入外鞘管14内。
其中，栅栏开口部232的外径变化范围为5mm-9mm，可以满足人工瓣膜的顺利放入，同时不会影响到释放时的体内操作。
具体的，栅栏开口部232具有多个轴向切口232a，轴向切口232a环胶囊腔23周向均匀分布，相邻的轴向切口232a之间的部分构成栅栏条2321， 栅栏条2321使胶囊腔23的开口端在释放支架过程中容易变成喇叭口状态。
为了保证栅栏开口部232具有更好的形变性能，栅栏开口部232还开设有第一条形孔232b和第二条形孔232c，第一条形孔232b对应栅栏条2321设置，第一条形孔232b的长度大于轴向切口232a的深度，第二条形孔232c位于相邻两个第一条形孔232b之间，且第二条形孔232b和轴向切口232a在轴向上间隔分布。
优选的，在本实施例中，腔体本体231的侧面具有若干弧形切口231a，弧形切口231a沿腔体本体231的轴向分布，所有弧形切口231a的两端之间的间隙部分连接形成连接筋2311，弧形切口231a的设置可以使腔体本体231具有一定的可弯曲性，进而适应人体内部复杂多变得血管结构。
在更优选的实施例中，所有的弧形切口231a长度相等，相邻的弧形切口231a错位设置，连接筋2311沿轴向呈螺旋形，相比直线状，连接筋2311呈螺旋状可以实现腔体本体231的万向弯曲。
由于在腔体本体231上设置有弧形切口231a，人工瓣膜在释放过程中需要沿径向扩张，与弧形切口231a的方向垂直，因此，人工瓣膜在释放移动过程中会因为弧形切口231a的存在而增大阻力，因此，在本申请一些更优选的实施例中，腔体本体231的内侧壁设置有第一薄膜保护层，以减小腔体本体231的内侧壁对人工瓣膜的阻力，腔体本体231和栅栏开口部232的外侧包覆有第二薄膜保护层，第一薄膜保护层和第二薄膜保护层为弹性薄膜，在第一薄膜保护层和第二薄膜保护层的弹性恢复力下，使栅栏开口部232由喇叭口状回缩，甚至可以变成直筒状。
在本申请的另一些实施例中，栅栏开口部232可以采用记忆合金，如镍钛合金材质成型，使栅栏开口部232由喇叭口状回缩，甚至可以变成直筒状。
上述两个可以回缩的实施例是对栅栏开口部232进一步的限定，使栅栏开口部232扩张后可以自动回缩，是为了更方便，更安全的收至外鞘管14 内，因为在实际操作中，人工瓣膜释放后，栅栏开口部232的尺寸不一，也就是说，为了系统更稳定性，导引件121张开的尺寸必须可以容纳栅栏开口部232的最大尺寸，而在心脏瓣膜处，导引件121张开的尺寸越大，越容易刮伤心脏组织，因此如果栅栏开口部232扩展后，能在自身恢复力下回缩，是可以减小硬件尺寸压力，同时也可以更方便、更安全的收入外鞘管14内。
为了实现在近端对输送系统的控制，如图1所示，该输送系统还包括控制手柄30和两个调弯手柄40。
结合图8-13所示，控制手柄30连接于支撑管12的近端且可带动支撑管12沿轴向运动，进而可以带动胶囊腔23运动，控制手柄30具有用于控制支撑管11的轴向移动距离的第一行程组件34。
控制手柄30沿内芯11的轴向设置，在本申请的实施例中，控制手柄30包括手柄主体套筒31、控制套筒32和控制滑块33，第一行程组件34包括第一行程套筒341和第一行程指示件342。
其中，手柄主体套筒31内部具有轴向控制滑道，控制套筒32的内侧通过螺纹配合带动控制滑块33沿轴向控制滑道滑动，作为一种可选的连接方式，手柄主体套筒31为筒状结构，控制套筒32套装在手柄主体套筒31的外侧面并可在手柄主体套筒31的外部同轴转动，控制套筒32的内侧具有内螺纹，轴向控制滑道两侧具有导向槽，控制滑块33轴向安装在轴向控制滑道且外侧从导向槽伸出与控制套筒32的内螺纹匹配，当控制套筒32转动时，带动控制滑块33轴向滑动。
支撑管12的近端通过压紧螺栓固定于手柄主体套筒21的远端，支撑管11从手柄主体套筒21的远端伸入并与控制滑块23固定，因此控制滑块23的轴向滑动就可以带动支撑管12轴向运动。
第一行程套筒341同轴固定套装于控制套筒32外侧，第一行程套筒341具有第一行程滑道，控制套筒32的外侧设置有外螺纹，第一行程指示件342 与控制套筒32的外螺纹配合，当控制套筒32转动时，第一行程指示件342在第一行程滑道滑动，将控制套筒32两侧的螺纹规格设置为一样或者按照规定预定设置，在第一行程滑道设置用于指示移动距离的行程刻度，就可以通过第一行程指示件342在第一行程滑道的滑动距离知晓控制滑块23的滑动距离，进而对支撑管12的轴向运动距离加以精准控制，并且本申请通过螺纹驱动的方式，其调节精度高，可以实现全程随时停止和锁止，可以精准监控瓣膜支架释放过程，减小支架释放难度。
为了便于对限位件21在近端的控制，控制手柄30还包括卸装件35，卸装件35可拆卸的安装于手柄主体套筒31的近端并与限位件21的近端连接，当心脏瓣膜支架200位于胶囊腔23内部时，如上，可通过卸装件35拉扯限位件21使限位件21的远端解除对心脏瓣膜支架200的近端和支臂221的连接限位。
两个调弯手柄40分别设置于内鞘管13的近端和外鞘管14的近端，通过牵引丝50使对应的内鞘管13的远端和外鞘管14的远端在同一平面或者不同平面内弯曲，调弯手柄40具有用于控制对应的内鞘管13或外鞘管14的调弯弧度的第二行程组件47。
需要说明的是人体的血管绝大部分都是在立体方向弯曲，在某些手术操作中，鞘管一般需要通过股动脉进入后，要经过主动脉弓，该处血管弯曲角度较大，且在立体方向弯曲，对心脏瓣膜支架的输送是有较高的要求的，假如只使用一根可以在一个平面内弯曲的调弯鞘，在进入主动脉弓处时，先在一个平面内弯曲，然后需要通过与血管壁的摩擦和指引，弯道另一个平面，此方式也可以进入心脏，但是如果是靠与血管较大的摩擦和指引进行弯曲，容易对血管壁造成损伤，同时操作的时间也会增加很多，会有很多风险，其次，我们在做介入手术时，医生在控制手柄操作，鞘管在人体内移动，只能通过鞘管的显影在设备上显示，也就是说在设备上是看不到血管壁的，只能 看到鞘管，那么鞘管下一步该怎么弯曲，只能通过鞘管的弯曲程度进行预估下一步的弯曲情况，那么在具有行程控制的情况下，鞘管的弯曲程度可以直接反馈到行程控制上，那么鞘管需要继续弯曲多大的弧度，也可以通过行程控制进行精准的弯曲，因此综上，在鞘管进入主动脉弓这种弯曲角度较大，且在立体方向上弯曲的血管时，就非常需要双层调弯以及行程控制一起，可以快速的通过主动脉弓到达心脏，同时节约时间。
在本申请的实施例中，两个调弯手柄40依次设置于控制手柄30靠近内管10的远端的一侧，且用于调节内鞘管13的调弯手柄40更靠近控制手柄20设置，这样实现内鞘管13和外鞘管14的分别调弯。
具体而言，调弯手柄40包括轴向部分a和分支部分b，轴向部分a沿内管10的轴向设置，内鞘管13和外鞘管14的近端固定于对应的调弯手柄40的轴向部分，分支部分b与轴向部分a形成锐角，轴向部分a和分支部分b呈一定角度，有效缩短了输送系统的整体长度，第二行程组件设置于分支部分b，述分支部分b弯曲和对应的鞘管弯曲属于同一个弯曲弧内，从而可以在调弯时具有引导作用，并且在第二行程组件上，直线行程转变为调弯弧度更平稳，不会出现一段行程内有较大的调弯动作，加强设备稳定性。
其中，轴向部分a包括轴向套41、止血阀42和近端固定盖43，轴向套41内部具有轴向通孔，内鞘管13和外鞘管14的近端从对应的轴向套41的远端插入并锁紧固定，轴向套41对应分支部分b具有侧向线孔411，止血阀42设置于轴向套41靠近其近端处且具有可弹性收缩的止血通道，近端固定盖43固定于轴向套41的近端且具有管道通孔。
止血阀42主要用于鞘管进入血管中，防止血液在血压的作用下通过鞘管外漏，在本申请的实施例中，止血阀42包括至少一个阀片组420，在本申请优选的实施例中部，止血阀42包括两个沿轴向排列的阀片组420。
阀片组420包括阀片套筒421以及从近端向远端依次同轴排列的第一阀 片422、第二阀片423、第三阀片424，第一阀片422的中部开设有第一孔，第一阀片422的两侧形成有不穿透的槽口且其两侧的槽口交错设置，在本申请中，两侧均形成和十字槽，两个十字槽错位45度设置，可以有效提升第一阀片422中部朝两侧轴向凸起；第二阀片423的中部向远端突出并中心位置开设有第二孔，第二阀片423靠近第三阀片424的一侧形成环形台阶4231，第三阀片424包括弹性筒4241和两个弹性瓣4242，弹性瓣4242连接于弹性筒4241的内壁，两个弹性瓣4242的远端形成一个可开合的瓣口，弹性瓣4242的远端与弹性筒4241的内壁具有弹性支撑筋4243，用于使瓣口弹性合拢，环形台阶4231内置于弹性筒4241的近端开口，阀片套筒421为圆筒件，弹性筒4241部分或者完全内置于阀片套筒421，第一孔、第二孔和瓣口构成止血通道，上述结构的设置，在阀片组420和其内部的内管10或者内鞘管13发生相对移动时，第二阀片423、第三阀片424中部会通过摩擦力延轴向凸起，可以有效的防止血液外漏。
在本申请的实施例中，分支部分b包括分支主体44、调弯滑块45和调弯套筒46，第二行程组件47包括第二行程套筒471和第二行程指示件472，分支主体44包括连通设置的轴向固定管441和导向管442，轴向固定管441同轴固定于轴向套41外侧，导向管442对应侧向线孔设置，导向管442向近端延伸并与轴向固定管441呈预定锐角设置，导向管442内部具有沿其轴向的调弯导向滑道，牵引丝50的近端固定于调弯滑块45，调弯的原理为通过调弯套筒46带动调弯滑块45产生直线运动，进而使牵引丝的近端运动，拉动对应的内鞘管13或者外鞘管14的远端弯曲，其中调弯滑块45和调弯套筒46的连接与控制套筒32和控制滑块33相似，即调弯套筒46的内侧通过螺纹配合带动调弯滑块45沿调弯导向滑道滑动。
第二行程套筒471固定套装于调弯套筒46外侧，第二行程套筒471具有第二行程滑道，调弯套筒46的外侧通过螺纹配合带动第二行程指示件472 沿第二行程滑道滑动。
第二行程指示件472可以根据观察移动的距离或者移动的螺纹距离进行判断，或者可以在第二行程套筒471表面设置有具体的行程刻度进行判断，进而对牵引丝的近端运动距离加以调节，进而实现内鞘管13或者外鞘管14的弯曲弧度的精准控制。
本申请提供的主动脉瓣膜输送系统，通过控制手柄30带动支撑管12沿轴向运动，两个调弯手柄40通过对应的牵引丝50带动内鞘管13和外鞘管14的远端弯曲，在控制手柄20设置第一行程组件24，精准控制支撑管11的轴向移动距离，在调弯手柄40上设置第二行程组件47控制鞘管的调弯弧度，从而更好的控制调弯和释放人工瓣膜。
以上所述仅为本发明的较佳实施例，并不用以限制本发明，凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。

Claims (15)

  1. 一种介入式心脏瓣膜支架的输送系统，其特征在于，包括：
    输送管组件，其包括从内向外依次可活动的套设的内芯、支撑管、内鞘管和外鞘管，所述内芯的两端分别从所述支撑管的两端伸出，所述内鞘管的远端具有容置腔；
    支架固定组件，能够与心脏瓣膜支架的两端可拆卸连接，且所述支架固定组件包括胶囊腔，所述内芯的远端从所述胶囊腔近端的开口伸入并与胶囊腔固定连接，所述支撑管可带动所述心脏瓣膜支架轴向运动使所述心脏瓣膜支架从所述胶囊腔或容置腔进出。
  2. 根据权利要求1所述的介入式心脏瓣膜支架的输送系统，其特征在于，所述支架固定组件还包括固定件、固定块和限位件；
    所述固定件具有连接于所述支撑管并向远端延伸的支臂，所述固定块连接于所述支撑管的远端，所述支臂和所述固定块分别用于与心脏瓣膜支架的近端和远端可拆卸连接；
    所述限位件为细长条状结构，所述限位件轴向贯穿所述支撑管并可从所述支撑管的两端伸出，所述限位件的远端用于所述心脏瓣膜支架的近端和所述支臂的连接限位，以防止所述心脏瓣膜支架的近端和支臂脱开。
  3. 根据权利要求1所述的介入式心脏瓣膜支架的输送系统，其特征在于，所述胶囊腔的开口口径可沿径向扩张，所述支撑管靠近远端具有导引件，所述导引件可引导所述胶囊腔移动至所述外鞘管内。
  4. 根据权利要求3所述的介入式心脏瓣膜支架的输送系统，其特征在于，所述导引件包括连接部和多个导引臂，所述连接部固定连接于所述支撑管的外壁，所述导引臂向远端延伸且向外侧弹性扩张。
  5. 根据权利要求4所述的介入式心脏瓣膜支架的输送系统，其特征在于，所述导引臂的远端具有过渡部，所述过渡部相对所述导引臂向靠近所述支撑管的轴线一侧弯曲。
  6. 根据权利要求3所述的介入式心脏瓣膜支架的输送系统，其特征在于，所述胶囊腔包括腔体本体和栅栏开口部，所述腔体本体为直筒状结构，所述栅栏开口部无外力作用下为直筒状且可在外力作用下扩张成喇叭口状，所述导引臂的内侧可弹性压紧所述栅栏开口部。
  7. 根据权利要求6所述的介入式心脏瓣膜支架的输送系统，其特征在于，所述栅栏开口部具有多个轴向切口，所述轴向切口环所述胶囊腔周向均匀分布，相邻的轴向切口之间的部分构成栅栏条。
  8. 根据权利要求6所述的介入式心脏瓣膜支架的输送系统，其特征在于，所述腔体本体的侧面具有若干长度相等的弧形切口，所述弧形切口沿所述腔体本体的轴向分布，相邻的弧形切口错位设置，所有弧形切口的两端之间的间隙部分连接形成沿轴向呈螺旋形的连接筋。
  9. 根据权利要求1所述的介入式心脏瓣膜支架的输送系统，其特征在于，还包括控制手柄和两个调弯手柄，所述控制手柄连接于所述支撑管的近端且可带动所述支撑管沿轴向运动，所述控制手柄具有用于控制所述支撑管的轴向移动距离的第一行程组件，两个所述调弯手柄分别设置于所述内鞘管的近端和所述外鞘管的近端，通过牵引丝使对应的所述内鞘管的远端和所述外鞘管的远端在同一平面或者不同平面内弯曲，所述调弯手柄具有用于控制对应的所述内鞘管或所述外鞘管的调弯弧度的第二行程组件。
  10. 根据权利要求9所述的介入式心脏瓣膜支架的输送系统，其特征在于，所述控制手柄沿所述支撑管的轴向设置，两个所述调弯手柄依次设置于所述控制手柄靠近所述支撑管的远端的一侧，且用于调节所述内鞘管的调弯手柄更靠近所述控制手柄设置，所述调弯手柄包括轴向部分和分支部分，所述轴向部分沿所述支撑管的轴向设置，所述内鞘管和外鞘管的近端固定于对应的所述调弯手柄的轴向部分，所述分支部分与所述轴向部分形成锐角，所述第二行程组件设置于所述分支部分。
  11. 根据权利要求10所述的介入式心脏瓣膜支架的输送系统，其特征在 于，所述控制手柄包括手柄主体套筒、控制套筒和控制滑块，所述第一行程组件包括第一行程套筒和第一行程指示件，所述手柄主体套筒内部具有轴向控制滑道，所述控制套筒的内侧通过螺纹配合带动所述控制滑块沿所述轴向控制滑道滑动，所述支撑管固定于所述手柄主体套筒的远端，所述支撑管从所述手柄主体套筒的远端伸入并与所述控制滑块固定，所述第一行程套筒固定套装于所述控制套筒外侧，所述第一行程套筒具有沿轴向设置的第一行程滑道，所述控制套筒的外侧通过螺纹配合带动所述第一行程指示件沿所述第一行程滑道滑动。
  12. 根据权利要求11所述的介入式心脏瓣膜支架的输送系统，其特征在于，所述控制手柄还包括卸装件，所述卸装件可拆卸的安装于所述手柄主体套筒的近端并与所述限位件的近端连接，当所述心脏瓣膜支架位于所述胶囊腔内部时，可通过卸装件拉扯限位件使限位件的远端解除对心脏瓣膜支架的近端和支臂的连接限位。
  13. 根据权利要求11所述的介入式心脏瓣膜支架的输送系统，其特征在于，所述轴向部分包括轴向套、止血阀和近端固定盖，所述轴向套内部具有轴向通孔，所述内鞘管和外鞘管的近端从对应的所述轴向套的远端插入并固定，所述轴向套对应所述分支部分具有侧向线孔，所述止血阀设置于所述轴向套靠近其近端处且具有可弹性收缩的止血通道，所述近端固定盖固定于所述轴向套的近端且具有管道通孔。
  14. 根据权利要求13所述的介入式心脏瓣膜支架的输送系统，其特征在于，所述止血阀包括至少一个阀片组，所述阀片组包括阀片套筒以及从近端向远端依次同轴排列的第一阀片、第二阀片、第三阀片，所述第一阀片的中部开设有第一孔，所述第一阀片的两侧形成有不穿透的槽口且其两侧的槽口交错设置；所述第二阀片的中部向远端突出并中心位置开设有第二孔，所述第二阀片靠近第三阀片的一侧形成环形台阶，所述第三阀片包括弹性筒和两个弹性瓣，所述弹性瓣连接于所述弹性筒的内壁，两个弹性瓣的远端形成一 个可开合的瓣口，所述弹性瓣的远端与所述弹性筒的内壁具有弹性支撑筋，用于使所述瓣口弹性合拢，所述环形台阶内置于所述弹性筒的近端开口，所述阀片套筒为圆筒件，所述弹性筒部分或者完全内置于所述阀片套筒，所述第一孔、第二孔和所述瓣口构成所述止血通道。
  15. 根据权利要求13所述的介入式心脏瓣膜支架的输送系统，其特征在于，所述分支部分包括分支主体、调弯滑块和调弯套筒，所述第二行程组件包括第二行程套筒和第二行程指示件，所述分支主体包括连通设置的轴向固定管和导向管，所述轴向固定管同轴固定于所述轴向套外侧，所述导向管对应所述侧向线孔设置，所述导向管向近端延伸并与所述轴向固定管呈预定锐角设置，所述导向管内部具有沿其轴向的调弯导向滑道，所述牵引丝的近端固定于所述调弯滑块，所述调弯套筒的内侧通过螺纹配合带动所述调弯滑块沿所述调弯导向滑道滑动，所述第二行程套筒固定套装于所述调弯套筒外侧，所述第二行程套筒具有第二行程滑道，所述调弯套筒的外侧通过螺纹配合带动所述第二行程指示件沿所述第二行程滑道滑动。
PCT/CN2023/091868 2022-04-29 2023-04-28 一种介入式心脏瓣膜支架的输送系统 Ceased WO2023208232A1 (zh)

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CN120189260A (zh) * 2023-12-21 2025-06-24 深圳市健心医疗科技有限公司 一种主动脉瓣膜
CN120436757A (zh) * 2025-06-17 2025-08-08 启晨复心医疗科技(珠海)有限公司 一种穿刺鞘及医疗设备
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