WO2012139593A2 - Système et procédé pour l'injection d'une substance dans un corps humain - Google Patents

Système et procédé pour l'injection d'une substance dans un corps humain Download PDF

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Publication number
WO2012139593A2
WO2012139593A2 PCT/DK2012/050129 DK2012050129W WO2012139593A2 WO 2012139593 A2 WO2012139593 A2 WO 2012139593A2 DK 2012050129 W DK2012050129 W DK 2012050129W WO 2012139593 A2 WO2012139593 A2 WO 2012139593A2
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WO
WIPO (PCT)
Prior art keywords
substance
tubular member
pump
movement
string
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/DK2012/050129
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English (en)
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WO2012139593A3 (fr
Inventor
Pavia Christoffer LUMHOLT
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Rigshospitalet
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Rigshospitalet
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Filing date
Publication date
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Publication of WO2012139593A2 publication Critical patent/WO2012139593A2/fr
Publication of WO2012139593A3 publication Critical patent/WO2012139593A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/46—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for controlling depth of insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/08—Lipoids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2206/00—Characteristics of a physical parameter; associated device therefor
    • A61M2206/10—Flow characteristics
    • A61M2206/22—Flow characteristics eliminating pulsatile flows, e.g. by the provision of a dampening chamber
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1007—Breast; mammary
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14212—Pumping with an aspiration and an expulsion action
    • A61M5/14216—Reciprocating piston type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14212—Pumping with an aspiration and an expulsion action
    • A61M5/14228—Pumping with an aspiration and an expulsion action with linear peristaltic action, i.e. comprising at least three pressurising members or a helical member
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons

Definitions

  • the invention relates to systems and syringes for injecting a substance, in particular a viscous or filling substance such as adipose tissue or a synthetic filling substance, into a recipient body, e.g. a human body, for therapeutic and/or cosmetic purposes.
  • a substance in particular a viscous or filling substance such as adipose tissue or a synthetic filling substance
  • Lipofilling or fat transplantation is a technique implying liposuction of one part of the body, refining of the fat, and re-injection into the same patient at another anatomical site.
  • the fat-transplant serves as a more or less permanent autologous filler and is currently used in e.g. breast reconstruction or breast augmentation.
  • Lipofilling with current methods is usually carried out in one of the following three ways:
  • the surgeon injects a small amount of fat (approx. 0.2 ml) at multiple sites along the path of the injection-cannula, while retracting it through the tissue; either by hand or by the use of a dosage-handle that injects the same small volume each time the handle is compressed and thereby producing a bead.
  • fat approximately 0.2 ml
  • dosage-handle that injects the same small volume each time the handle is compressed and thereby producing a bead.
  • the surgeon holds a fat-containing syringe in his/her hand, and injects the fat by applying pressure onto the syringe-plunger during retraction of the cannula.
  • the surgeon thus controls both the speed of the cannula moving through the recipient tissue, and the injection of fat along its path. Every surgeon tries to match the cannula's speed and the flow-rate of injection as well as possible. But obviously this manual procedure is not likely to be reproducible between surgeons, or even reproducible between surgeries performed by the same surgeon.
  • the diameter of injected fat strings - and therefore the diffusion distance from surrounding tissue to fat cells - will inherently vary.
  • the last technique represents injection of fat at a constant flow-rate by means of an electric dosing mechanism.
  • the speed of the needle or cannula inherently decreases at each turn between the advancing and retracting motion, thus delivering larger amounts of fat around the turning points.
  • damage to the fat cells may occur from friction between the cannula and the tissue, since injection with this method is not only performed during retraction, but also during advancement of the cannula.
  • the texture of human tissue is not completely homogenous, larger amounts of fat will be delivered at sites, where the cannula is slowed down by harder tissues in its path.
  • injection is inherently either irregular or slow.
  • examples 2) and 3) injection can be faster, but also more irregular.
  • No current techniques offer both a high speed of injection, minimal damage to fat-cells, an evenly distributed injection-pattern and reproducibility between surgeons and between surgeries.
  • the invention addresses these problems by synchronizing the volume of injected fat with the retracted length of the injection cannula. This way, the volume and diameter of injected fat is constant along the path of the cannula, no matter how fast or slow the surgeon retracts it through the tissue. This allows the surgeon to concentrate on where the substance should be injected, and to work fast with no compromises regarding the quality of injection.
  • the invention makes it possible to carry out standardized clinical trials with multiple procedures performed by many different surgeons, thus highly facilitating clinical research in this field. Furthermore successful fat-transplantation is not automatically dependent on 100% survival of the transplant. In some cases it may be advantageous to obtain a minor degree of cell-death and subsequent fibrosis and firmness in the transplant, e.g. when trying to match the natural texture of a breast, which can be somewhat firmer than adipose tissue. Attempts to nail this balance perfectly will be a challenging task demanding highly standardized methods.
  • One embodiment of the present invention solves this problem by offering a mechanical version, which is activated by a string wound on a bobbin, which offers flexibility and a greater range of freedom in operating the device.
  • Another disadvantage of the above known system is that the reservoir is integrated in the pump, which is unpractical when procedures demand injection of larger volumes of substance. In such cases, a large reservoir will make the device heavy and unhandy to operate, and a small and handier reservoir will demand frequent changes of the reservoir during procedures and interrupt the "flow" of the procedure. Finally, the smaller dosage-to-stroke-volume ratio becomes, the larger the risk of inaccuracy and unwanted tolerance in the system, due to mechanical compliance of the reservoir-walls.
  • the invention solves these problems by offering a system where a small, handy and mechanically simple device is interconnected between the injection cannula and a supply of the injection substance, possibly via a flexible tube which allows is connection to a distant reservoir that can be dimensioned as large as desired, without interfering with the handiness of the device. And by providing a system with a positive displacement pump with minimum tolerances due to very little mechanical compliance of the pump.
  • a further disadvantage of the above known systems is that it is difficult to precisely monitor the function of the device during operation; for every stroke of the injection cannula, the piston only moves a short distance such as a millimeter or two, which makes monitoring elusive and difficult and the accuracy of dosage becomes sensitive to tolerances in the system.
  • the invention solves this problem by offering a system, where the active and moving part of the pump both has a clearly visible range of motion and is transparent, thereby allowing the operator to clearly see the injection-substance flowing through the pump.
  • the active and moving part of the pump both has a clearly visible range of motion and is transparent, thereby allowing the operator to clearly see the injection-substance flowing through the pump.
  • none of the known device or systems offers both the precision, patient-safety and range of options in design and user-friendliness as the present invention.
  • the invention solves the above problems by providing a system for injecting a substance into a human body comprising a tubular member with an outlet opening for injecting the substance, a pump with an inlet connectable to a supply of the substance and to receive the substance from the supply, and an outlet connectable to the tubular member for delivering the substance to the tubular member, means for sensing a movement and/or a position of the tubular member relative to the body, and control means for controlling the pump to deliver the substance at a rate related to the sensed movement and/or position of the tubular member relative to the body.
  • the invention exploits the reciprocating motion taking place between the surgeon's hand and the patient while the hypodermic needle is moved back and forth in the tissue.
  • the reciprocating movement is coupled via a mechanical or other transmission to a delivery mechanism, which during retraction of the needle within the patient will be activated and deliver a volume of injection substance corresponding to the movement of the needle.
  • the transmission system can be unidirectionally controlled, so that the delivery mechanism is only affected when the needle enters the body or is withdrawn.
  • the invention can be bidirectionally controlled, activating the delivery mechanism on both entry and withdrawal. It can be reversed, so that the invention serves as a suction unit suitable for e.g. liposuction. And injection/suction can be combined in any desired manner corresponding to any movement of the needle.
  • a unique advantage of the invention is that delivery of the injection volume of adipose tissue is controlled in dependence on a sensed movement and/or position of the needle in the body of the recipient, i.e. controlled by the needle movement in the tissue, thus giving a uniform and regular injection of fat, no matter at what speed the surgeon moves the needle. And the added possibility of connecting the invention to a distant reservoir, providing a small and handy device even for large-volume injections.
  • the system of the invention has a non-touching sensor for direct and contact free measurement of the distance to the patient's skin and how changes in this distance is used to control the dosing mechanism.
  • the non-touching sensing can be optical, IR, video camera, laser, ultrasound, or based on sensed electrical impedance in an electrical circuit involving the cannula when inserted in the patient etc.
  • senses by non-touching means is preferably to be understood widely as electrical sensoring means, with no physical contact between the invention and the injection-site of the patient, other than the contact between the tubular member and the patient, necessary for injecting the substance.
  • Figure 1 shows a first embodiment of the invention where a syringe for injecting adipose tissue and an attached hollow needle is used for injecting the adipose tissue into a portion of a human body such as a female breast;
  • Figure 2 shows the system in figure 1 where a string of adipose tissue has been injected and deposited or implanted into the breast;
  • Figure 3 shows a second embodiment with a peristaltic pump driven by the relative movement between the pump and a receiving breast;
  • Figure 4 shows the system in figure 3 where a string of adipose tissue has been injected and deposited or implanted into the breast;
  • Figure 5 shows an embodiment of the invention where the movement and/or the position of the injecting needle relative to a breast is sensed wirelessly;
  • Figure 6 shows the system in figure 5 where a string of adipose tissue has been injected and deposited or implanted into the breast;
  • Figures 7 and 8 show an embodiment with a double-action plunger where the injection substance is drawn from a supply through a flexible tube;
  • Figures 9 and 10 show another embodiment with a double-action plunger where the injection substance is drawn from a supply through a flexible tube;
  • Figures 11 and 12 show an embodiment with a double-action pumping element; and Figures 13 and 14 illustrate a collapsible structure for use in some or all of the above embodiments.
  • FIG 1 a syringe 10 with a barrel 11 and a plunger 12 inside the barrel.
  • a hollow needle 13 is connected to the barrel 11 e.g. by means of a Luer lock fitting.
  • the needle can be a tubular member with an outlet opening 14 for injecting the substance.
  • the barrel 11 holds a substance 50 to be injected into a breast 100.
  • a dosing mechanism 20 comprises a bobbin 21 with a piece of flexible string or cord 22 wound thereon. The free end of the string 22 is held in a fixed position in relation to the breast, e.g. at the skin of the breast.
  • a gear wheel 23 connected to the bobbin 21 will thereby also rotate and a reduction gear of a train of meshing double gearwheels 24, 25, 26, 27 will be driven by the rotation of the bobbin 21.
  • the gearwheel 27 has a pinion 28 meshing with a rack 29.
  • the rack 29 engages with the outer end of the plunger 12.
  • the needle 13 has been inserted into the breast 100.
  • the syringe can be held by one active hand and the free end of the string can suitably be attached to the patient or to the other hand resting passively on the patient.
  • the free end of the string is held at the same fixed position in relation to the breast, whereby more string will be unwound from the bobbin and the bobbin will thereby rotate correspondingly.
  • the gear train will cooperate to move the rack 29 which in turn will push the plunger 12 into the barrel 11, whereby the substance 50 in the barrel 11 will be forced through the needle 13 and out through an opening 14 near the end of the needle 13.
  • Figure 2 shows that a string 51 of the injection substance has been deposited in the breast tissue.
  • the dosing mechanism 20 ensures that the string 51 has a uniform density along its length.
  • the dosage measured as the injected volume per unit length of the injected string can be varied in a simple manner by selecting a syringe with a barrel having a proper diameter or by changing the diameter of the bobbin or elements in the gear train.
  • the bobbin 21 is spring loaded so that unwinding the string 22 from the bobbin is against the spring.
  • the bobbin has a ratchet mechanism that will rewind the string without rotating the gear wheel 23.
  • a release button 30 can be activated manually to release the gear train and will allow the string to unwind from the bobbin without moving the rack 29 and the plunger 12. Repeated insertion and withdrawal of the needle will result in the substance 50 being delivered in multiple strings of uniform thickness or uniform volume per unit length each time the syringe is withdrawn.
  • Activation of the release button 30 will also allow manual retraction of the plunger 12 in the syringe for refilling the barrel 11 with injection substance, either after uncoupling from the tubular member and reconnecting to a second reservoir (not shown), or by connecting said reservoir to a chamber 35 (see figures 3 and 4), preventing injection into the reservoir during use of the invention by insertion of a valve (not shown) between the reservoir and the chamber 35.
  • FIG 3 is shown another embodiment of the system according to the invention.
  • a peristaltic pump is shown as an example, but other positive displacement pumps such as a Roots type pump or a Sinus pump can be used correspondingly.
  • the needle 13 is connected to a length of flexible tube 33 which is connected to a reservoir (not shown) which holds a substance to be injected into a breast 100.
  • the bobbin 31 is spring loaded so that unwinding the string 32 from the bobbin is against the spring. When the needle is inserted or re-inserted into the breast tissue the string will exert less force on the bobbin and the bobbin will rewind the string.
  • the bobbin has a ratchet mechanism that will rewind the string without rotating the rollers 34.
  • the flexible tube 33 is wound a peristaltic pumping mechanism comprising rollers 34 which are in solid connection to the bobbin 31 and in contact with the flexible tube 33 and compress it.
  • a bobbin 31 has a string 32 or the like wound thereon.
  • the system is withdrawn from the breast 100, and the free end of the string is held at the same fixed position in relation to the breast, whereby more string will be unwound from the bobbin, and the bobbin will thereby rotate correspondingly.
  • the rollers 34 will exert a peristaltic pumping function on the flexible tube 33, and a string 51 of injection substance will be deposited in the breast tissue.
  • the bobbin 31 may also have a release button (not shown) that can be activated to release the mechanism in the bobbin and will allow the string to unwind from the bobbin without rotating the rollers 34 so that no substance is delivered.
  • the dosage measured as the injected volume per unit length of the injected string can be varied in a simple manner by varying the diameter of the bobbin 31 or the peristaltic pump, by arranging a suitable gearing, or by varying the diameter of the flexible tube 33.
  • Peristaltic pumps like the one illustrated in figures 3 and 4 usually result in a more or less pulsating stream delivered from the pump, which may or may not be desired, whereas other positive displacement pumps offer a more non-pulsating flow.
  • Pulsations in a peristaltic pump may be reduced or avoided by arranging a chamber 35 between the peristaltic pump and the needle or by using an off-set double-barreled peristaltic pump.
  • US 5,709,539 discloses a peristaltic pump with a flexible tube between a set of rollers and an outer presser plate having a profile that minimises pulsations in the output flow. Such arrangement may be used in the invention to reduce pulsations.
  • the resulting delivery with uniform volume per unit length should then be understood as a uniform volume of the beads or the average volume per unit length of the string of beads.
  • the length of each bead is controlled by the length of the flexible tube between neighbouring rollers 34, and if short beads are desired, the number of rollers should be increased or their action radius reduced.
  • the diameter of the flexible tube may also be varied to control the size of the beads.
  • FIGS 5 and 6 is shown an embodiment that senses the movement of the needle by non-touching means.
  • the syringe has a barrel 61 with a plunger 62 that can be moved inside the barrel to drive the injection substance 50 through a needle 63 and into the tissue of the breast 100.
  • a wireless transceiver 65 transmits wireless signals 66 towards the skin of the patient.
  • the wireless signals can be optical, infrared (IR), visible light, a laser beam, ultrasound, radio frequency electromagnetic waves, etc.
  • the signals can also be electrical current running in a circuit involving the invention and the patient, wherein the term "wireless" means, that besides the inserted needle, no further physical contact is added between the invention and the injection-site of the patient, as in the case of a string or a rod.
  • the wireless signals interact with the patient and a portion of the signals is received by a receiver e.g. in the transceiver 65.
  • a controller 67 communicates with the wireless transceiver 65 and controls its operation. The controller 67 receives a signal from the transceiver 65 representing the received portion of the signals reflected by or otherwise interacting with the patient.
  • the controller 67 determines movements of the syringe and/or of the needle relative to the patient and possibly also the position of the tip of the needle.
  • the controller 67 communicates with a delivery mechanism 68 and controls the delivery mechanism to push the plunger 62 into the barrel 61 at a controlled rate so that the injection substance 50 is injected with a volume at a 5 predetermined relation to the determined movement and/or the determined
  • the delivery mechanism 68 can be controlled to deliver the injection substance so that the delivered volume depends on the actual speed of the needle, e.g.
  • the delivery mechanism 68 can be controlled to deliver intermittently or pulsating whereby the injection substance will form a string of beads or a string 15 with a thickness varying as the pulsations. Again, the resulting delivery with
  • uniform volume per unit length should then be understood as a uniform volume of the beads or the average volume per unit length of the string of beads.
  • Figures 7 and 8 show an injection system where the delivery mechanism is a 20 pump with a plunger 72 which is movable in a barrel 71.
  • injection substance is drawn into the barrel 71 from a remote reservoir or supply (not shown) of injection substance through a flexible tube (not shown) connected to an inlet valve 73 which will open due to a pressure difference on its two sides, while an outlet valve 25 74 is closed.
  • the plunger is moved into the barrel 7 as indicated in figure 8 whereby the inlet valve 73 will close, and the outlet valve 74 will open, and the injection substance is pressed through the outlet valve 74 and a needle 76 connected to the system.
  • This process can be repeated as a reciprocating movement where the active members 30 in the pump are driven in a corresponding reciprocating movement causing
  • the plunger 72 is connected to a plunger rod which can have an extension out of 35 the barrel and long enough so that its end opposite the plunger can be held manually at a fixed or reference point relative to the patient, whereby it is ensured that the injection substance is injected as a string with constant thickness.
  • the barrel 71 is relatively long and slender and the barrel may have a volume corresponding to the volume to be injected in one movement of the system.
  • the system in figures 7 and 8 has a driving wheel 75 which cooperates with the plunger rod e.g. as a rack-and-pinion.
  • the driving wheel 75 can be driven by a controlled motor such as a stepping motor so as to deliver the injection substance as desired and to withdraw the plunger and thereby draw injection substance into the barrel.
  • the driving wheel 75 can be driven by a system like in figures 1 and 2. Mechanical and electronic systems can control the driving wheel 75 to give a homogenous string of injected substance or a string with a thickness that varies with the position.
  • Figures 9 and 10 show a system much like in figures 7 and 8 but with a different layout.
  • a plunger 92 is driven by a driving wheel 95, and injection substance is drawn in through the inlet valve 93 and leaves the barrel through the outlet valve 94.
  • Figures 11 and 12 show an injection system where the controllable delivery mechanism includes a pump with an inlet 1101 with an inlet valve 1102 for receiving injection substance from a supply of injection substance, and an outlet 1103 with an outlet valve 1104 for outputting injection substance.
  • the inlet and outlet valves are preferably made of a resilient material such as silicone rubber and will allow flow in one direction and prevent flow in the opposite direction.
  • the inlet is connectable to the supply by suitable means such as internal or external treads as shown, and the outlet is connectable, by suitable means such as external or internal tread as shown, to a needle, a cannula or other tubular member for injecting the injection substance.
  • the inlet valve 1102 and the outlet valve 1104 may each have an annular flange which form a sealing at the inlet and outlet, respectively, of the pump.
  • a string 1106 is wound on a bobbin 1107 and protrudes through an opening in a housing 1108.
  • a cup-shaped member 1110 has external threads 1111 in engagement with corresponding internal threads 1112 on the bobbin. Rotation of the cup-shaped member may be restricted by one or more longitudinal flanges on the external surface of the cup, interacting with corresponding internal notches in the opening of the housing.
  • the bobbin is biased by a spring 1113 such as a coil spring whereby the string can be pulled out of the housing against the force of the spring 1113 and can be wound on the bobbin due to the force of the spring.
  • FIG 11 the system is shown in a situation where the tubular member 1105 is inserted and advanced into a human body and the free end of the string 1106 is held e.g. manually against the skin of the body.
  • the spring 1113 will rotate the bobbin 1107 and rewind the string 1106 on the bobbin, and due to the engagement of the threads 1111 and 1112 the rotation of the bobbin will cause the cup-shaped member 1110 to move upwards whereby the volume in the pump below the cup-shaped member 1110 will increase and injection substance will be drawn in from the supply through the inlet valve 1102.
  • FIG 12 the system is shown in a situation where the tubular member 1105 is retracted from human body and the free end of the string 1106 is held e.g.
  • the movements of the cup-shaped member 1110 involve sliding contact between the cup-shaped member and the housing. Such sliding contact should be a sealing contact.
  • the pump chamber can have a limiting element in the form of a bladder or a bellows or other collapsible structure whereby the inner surface of the pump chamber is a continuous structure.
  • Figures 13 and 14 illustrate a bellows suitable for being arranged inside the pump in figures 7, 8, 9, 10, 11 and 12.
  • the operating doctor will perform a reciprocating movement advancing and retracting the system with the tubular member inserted in the body, whereby the reciprocating movement controls the pumping action.
  • the pump When advancing the system and inserting the tubular member into the body the pump will be filled with injection substance, and when the system is retracted the pump will deliver the injection substance through the tubular member with a volume per second proportional to the speed, which is equivalent to a constant volume per unit length travelled by the system.
  • the volume of injection substance in the system is delimited by the movable plunger and the movable cup-shaped member, respectively, and the inlet and outlet valves.
  • the inlet of the pump is connectable to a (not shown) supply of injecting substance which can be the barrel of a syringe directly connected to the inlet of the pump or indirectly by means of a suitable length of flexible tube.
  • injecting substance can be the barrel of a syringe directly connected to the inlet of the pump or indirectly by means of a suitable length of flexible tube.
  • the barrel constitutes the reservoir of injection substance it may either be necessary to detach and refill the barrel several times which takes time, or to use a large barrel which can hold the predetermined volume of injection substance which is heavy and inconvenient, in particular when larger volumes are to be injected.
  • the movements of the system is transformed purely mechanically to the active member(s) of the pump.
  • the embodiment in figures 5 and 6 have an electronic system with a wireless transceiver 65 for contactless sensing (i.e. with no additional physical contact between the invention and the injection-site of the patient, other than the inserted needle) of the movements of the system relative to the patient, and a controller 67 in communication with the transceiver and the delivering mechanism 68.
  • the movements of the string and the rod or rack can be transformed into corresponding electrical signals by any suitable means, e.g.
  • rotary or linear motion and/or position encoder such as a potentiometer or a tacho disc, for use in a controller to control a motor such as a stepping motor to drive the movable element(s) of the pump directly or indirectly via a suitable gearing.
  • the outlet of the pump is connected directly, or via a short distance, to the tubular member which is inserted into the body of the patient.
  • a short distance from the outlet of the pump to the point of delivery at the distal end of the tubular member is advantageous since it allows higher precision of the injected volume.
  • all movable parts can be enclosed in a housing preventing such contact.
  • the housing and other parts of the system can advantageously be transparent which allows the operator to monitor the flow of injection substance. This may apply to each of the embodiments disclosed herein.
  • the system can advantageously have a flow indicator which indicates the volume of injected substance.
  • a flow indicator which indicates the volume of injected substance.
  • Such flow indicator can measure the flow directly and it can be situated in the flow path either before or after the pump. Or it can have an arrangement which counts or registers the number of strokes of the plunger and the lengths of the strokes, which in combination with the internal diameter of the barrel enables calculation of the injected volume.
  • the volume holding the injection substance can be at least partially delimited by a flexible or collapsible structure such as a flexible membrane or a bellows forming the interface between the injection substance and a driving element acting on the collapsible structure to change the volume.
  • the driving element can be a mechanical structure such as a piston, a gear transmission, e.g. a worm drive, a spindle gear driven by a pulley or otherwise powered mechanical means as discussed in fig. 1-10, or it can be a fluid force acting on the collapsible structure.
  • a fluid force can be applied using air or a liquid such as water.
  • the collapsible structure can have elastic properties and be biased towards an expanded state where the volume holding the injection substance is larger than when it is in a collapsed state, whereby filling the volume with injection substance is assisted.
  • the collapsible structure can extend into the barrel or into the passage between the inlet valve and the outlet valve depending on its degree of collapse.
  • the thickness of the injected string has a specific profile and varies along its length, e.g. it might be desirable to have a thinner string, smaller beads or fewer beads per unit length near the opposite edges of the breast.
  • the controller 67 can control the delivery mechanism 68 accordingly.
  • the delivery mechanism 68 preferably has a stepping motor for moving the plunger in the barrel.
  • the wireless transceiver 65 can use infrared (IR), visible light, invisible light, a laser beam, electrical current or ultrasound for sensing the distance to the skin, e.g. along the longitudinal direction of the needle, or it can be directed
  • IR infrared
  • visible light visible light
  • invisible light invisible light
  • laser beam electrical current or ultrasound
  • Markers can be placed on the skin at appropriate places and such markers can be used as reference or calibration marks and measurements can be made with reference to such marks. Or a reflector can be placed on the patient.
  • the transmitter and the receiver of the wireless transceiver 65 can be separate units that can be arranged at a distance from each other, and any one of them can be placed at a distance from the syringe.
  • the transmitter can be a lamp emitting visible or invisible light
  • the receiver can then be a video camera. Movement and position can be calculated by proper analysis of the video images and the delivery mechanism 68 can be controlled accordingly.
  • the syringe can have a string wound on a spring loaded bobbin as in figures 1 and 2. By moving the syringe relative to the patient's body the corresponding movement of the string will rotate the bobbin, and the bobbin has a rotation encoder which converts the rotation of the bobbin to an electrical signal representing the movement and/or the position of the needle in the body. This signal is
  • the rotation encoder functions as a motion encoder and/or as a position encoder.
  • the string 22, 32 and the bobbin 21, 31 may be replaced by a rack-and-pinion for driving the gear train, the peristaltic pump and the rotation encoder, respectively.
  • a rod interacting with a linear motion and/or position encoder can be used instead of a rack interacting with a rotation encoder.
  • the invention can be used to inject a substance also (or solely) during advancement of the needle, e.g. while injecting tumescent fluid in fat-tissue immediately before a liposuction procedure.
  • the delivery mechanism can be controlled to deliver the injection substance 50 when inserting or advancing the needle and/or when withdrawing it.
  • the invention can be inverted into a suctioning device, where suctioning is controlled in relation to the movement of the tubular member, following the same principle as for injection of substance.
  • the delivery or suctioning of substance can be servo-supported by a second working force, e.g. electrical, hydraulic or air-driven. The principle being that said force is not strong enough in itself to drive the system, but just strong enough to nearly overcome the resistance in the system.
  • the tubular member can be multiple members, identical or different in size and shape, arranged in parallel or pointing in different directions.
  • the substance to be injected is a fluid and can thus be a viscous or non-viscous liquid or gaseous.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un système pour l'injection d'une substance dans un corps humain qui comprend un élément tubulaire avec une ouverture de sortie pour l'injection de la substance, une pompe avec une entrée connectable à une amenée de la substance et pour recevoir la substance provenant de l'amenée, et une sortie connectable à l'élément tubulaire pour libérer la substance à l'élément tubulaire, des moyens pour détecter un mouvement et/ou une position de l'élément tubulaire par rapport au corps, et des moyens de contrôle pour contrôler la pompe pour libérer la substance à une vitesse liée au mouvement et/ou à la position détectés de l'élément tubulaire par rapport au corps. Le système est particulièrement utile pour l'injection d'une substance de charge comme des cellules de tissu adipeux ou une substance de remplissage synthétique pour des buts cosmétiques, reconstructifs ou autrement thérapeutiques.
PCT/DK2012/050129 2011-04-15 2012-04-16 Système et procédé pour l'injection d'une substance dans un corps humain Ceased WO2012139593A2 (fr)

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US8632498B2 (en) 2011-02-11 2014-01-21 TauTona Group Research and Development Company, L.L.C. Tissue transfer systems
US9278165B2 (en) 2012-05-30 2016-03-08 Lifecell Corporation Device for harvesting, processing, and transferring adipose tissue
EP2914105A4 (fr) * 2012-10-31 2016-05-25 Lifecell Corp Systèmes de transfert de tissu
US10092711B2 (en) 2014-05-02 2018-10-09 Lifecell Corporation Injection sensor with feedback mechanism
US10184111B2 (en) 2015-02-19 2019-01-22 Lifecell Corporation Tissue processing device and associated systems and methods
US10286122B2 (en) 2015-10-21 2019-05-14 Lifecell Corporation Systems and methods for tube management
US10314955B2 (en) 2015-10-21 2019-06-11 Lifecell Corporation Systems and methods for medical device control
CN109876201A (zh) * 2019-03-07 2019-06-14 杭州百桥医疗技术有限公司 一种自体脂肪抽吸、纯化、精准注射与安全监测系统
EP3501571A1 (fr) * 2017-12-22 2019-06-26 Gambro Lundia AB Ensemble de perfusion destiné à mesurer des signaux vitaux d'un patient comprenant un élément de conformité et un élément réfléchissant
WO2019144187A1 (fr) * 2018-01-24 2019-08-01 M. Attalla Pty Ltd Appareil et procédé d'injection de matériau dans un tissu organique
US10472603B2 (en) 2016-08-30 2019-11-12 Lifecell Corporation Systems and methods for medical device control
US10729827B2 (en) 2015-12-22 2020-08-04 Lifecell Corporation Syringe filling device for fat transfer
US11090338B2 (en) 2012-07-13 2021-08-17 Lifecell Corporation Methods for improved treatment of adipose tissue
US11261418B2 (en) 2012-09-06 2022-03-01 The Gid Group, Inc. Tissue processing apparatus and method for processing adipose tissue

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US8632498B2 (en) 2011-02-11 2014-01-21 TauTona Group Research and Development Company, L.L.C. Tissue transfer systems
US10300183B2 (en) 2012-05-30 2019-05-28 Lifecell Corporation Device for harvesting, processing and transferring adipose tissue
US9278165B2 (en) 2012-05-30 2016-03-08 Lifecell Corporation Device for harvesting, processing, and transferring adipose tissue
US10549018B2 (en) 2012-05-30 2020-02-04 Lifecell Corporation Device for harvesting, processing and transferring adipose tissue
US11090338B2 (en) 2012-07-13 2021-08-17 Lifecell Corporation Methods for improved treatment of adipose tissue
US11261418B2 (en) 2012-09-06 2022-03-01 The Gid Group, Inc. Tissue processing apparatus and method for processing adipose tissue
EP2914105A4 (fr) * 2012-10-31 2016-05-25 Lifecell Corp Systèmes de transfert de tissu
US10092711B2 (en) 2014-05-02 2018-10-09 Lifecell Corporation Injection sensor with feedback mechanism
US10940273B2 (en) 2014-05-02 2021-03-09 Lifecell Corporation Injection sensor with feedback mechanism
US10184111B2 (en) 2015-02-19 2019-01-22 Lifecell Corporation Tissue processing device and associated systems and methods
US10550368B2 (en) 2015-02-19 2020-02-04 Lifecell Corporation Tissue processing device and associated systems and methods
US10286122B2 (en) 2015-10-21 2019-05-14 Lifecell Corporation Systems and methods for tube management
US10314955B2 (en) 2015-10-21 2019-06-11 Lifecell Corporation Systems and methods for medical device control
US10729827B2 (en) 2015-12-22 2020-08-04 Lifecell Corporation Syringe filling device for fat transfer
US10472603B2 (en) 2016-08-30 2019-11-12 Lifecell Corporation Systems and methods for medical device control
US11091733B2 (en) 2016-08-30 2021-08-17 Lifecell Corporation Systems and methods for medical device control
US11717602B2 (en) 2016-08-30 2023-08-08 Lifecell Corporation Systems and methods for medical device control
WO2019122348A1 (fr) * 2017-12-22 2019-06-27 Gambro Lundia Ab Ensemble de perfusion pour la mesure de signaux vitaux d'un patient comprenant un élément de conformité et un élément réfléchissant
EP3501571A1 (fr) * 2017-12-22 2019-06-26 Gambro Lundia AB Ensemble de perfusion destiné à mesurer des signaux vitaux d'un patient comprenant un élément de conformité et un élément réfléchissant
US11701463B2 (en) 2017-12-22 2023-07-18 Baxter International Inc. Infusion set for measuring vital signals of a patient comprising a compliance element and a reflective element
WO2019144187A1 (fr) * 2018-01-24 2019-08-01 M. Attalla Pty Ltd Appareil et procédé d'injection de matériau dans un tissu organique
US20210038808A1 (en) * 2018-01-24 2021-02-11 M. Attalla Pty Ltd. Apparatus and method for injecting material into organic tissue
AU2019211466B2 (en) * 2018-01-24 2024-10-24 M. Attalla Pty Ltd Apparatus and method for injecting material into organic tissue
US12186532B2 (en) 2018-01-24 2025-01-07 M. Attalla Pty Ltd Apparatus and method for injecting material into organic tissue
CN109876201A (zh) * 2019-03-07 2019-06-14 杭州百桥医疗技术有限公司 一种自体脂肪抽吸、纯化、精准注射与安全监测系统
CN109876201B (zh) * 2019-03-07 2024-11-15 杭州百桥医疗技术有限公司 一种自体脂肪抽吸、纯化、精准注射与安全监测系统

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