WO2022179005A1 - 一种植入物连接装置及植入物输送系统 - Google Patents

一种植入物连接装置及植入物输送系统 Download PDF

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Publication number
WO2022179005A1
WO2022179005A1 PCT/CN2021/099455 CN2021099455W WO2022179005A1 WO 2022179005 A1 WO2022179005 A1 WO 2022179005A1 CN 2021099455 W CN2021099455 W CN 2021099455W WO 2022179005 A1 WO2022179005 A1 WO 2022179005A1
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Prior art keywords
implant
release member
release
connection
delivery system
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PCT/CN2021/099455
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English (en)
French (fr)
Inventor
赵婧
闻靖
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上海臻亿医疗科技有限公司
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Publication of WO2022179005A1 publication Critical patent/WO2022179005A1/zh

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    • 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
    • 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

Definitions

  • the utility model belongs to the technical field of medical instruments, in particular to an implant connection device and an implant delivery system for fixing implants.
  • the heart is the most important organ of the human body. However, due to various reasons, it can lead to acquired damage or lesions of the heart valve, such as rheumatism and atherosclerosis.
  • the traditional treatment method is to open the chest. After cardiac arrest, under the support of low-temperature cardiopulmonary bypass, the heart is opened for surgical repair of the diseased valve or replacement with an artificial heart valve.
  • traditional surgical methods for heart replacement surgery are traumatic, high-risk, prone to complications such as bleeding, infection, and stroke, and require a longer recovery and treatment time for patients.
  • Interventional heart valve surgery is a medical technology that has developed rapidly in recent years. The operation has the characteristics of less trauma, quick recovery and low risk, and is especially suitable for elderly patients with heart valves.
  • the existing devices have problems such as poor connection stability, large space occupation, and difficulty in recycling during adjustment.
  • the delivery system uses a hook structure to connect with the implant.
  • This hook connection method requires high cooperation between the hook and the implant. When the implant is pushed to the curved part, there is a certain decoupling risk.
  • the delivery system uses a hanging ear structure to connect with the implant. This connection method requires the sheath to hold the implant to achieve fixation. During the operation, when the sheath is completely separated from the implant, Recovery of the implant could not be achieved.
  • the utility model provides an implant connection device and an implant delivery system, which can solve the above-mentioned defects in the prior art, realize the fixation, delivery and release of the implant, and have the advantages of simple structure, firm connection, stable release and occupation. The advantages of small space and recyclability can be realized.
  • An implant connecting device configured in a delivery system for releasably connecting an implant implanted in a body, the implant being configured to have a mesh hole structure, the connecting device configured to be inserted through The mesh of holes in the implant secures the implant within the delivery system.
  • the connecting device of the present invention has the advantage of being more stable in connection with the mesh holes of the implant, and has a wider application range.
  • the interpenetrating connection method between the connecting device and the implant has little interference to the implant and does not affect the diameter of the self-expanding stent.
  • the insertion connection method of the connection device has better compliance, so that the implant can stably pass through the curved channel and reach the release position.
  • the attachment device includes at least one release member configured to have a first state and a second state, the release member having a stable configuration for securing the implant in the first state, In the second state, the release member has a relaxed configuration to easily release the implant.
  • the release member in the first state, has a relatively high deformation resistance and has a relatively stable shape, which can achieve the effect of fixing the implant.
  • the release member In the second state, has a lower deformation resistance, so that the release member can easily self-separate from the implant. withdraw in.
  • the release member is at least partially made of a biocompatible material with shape memory.
  • the release piece made of shape memory material can have greater rigidity in the first state, so as to provide a firm fixation effect and prevent the release piece from being detached from the implant during the delivery process.
  • the release member In the second state, the release member is in a relaxed state to realize its release and complete the release of the implant.
  • the convertibility of the two states allows the release member to be retrievable when the implant is fully released, i.e. leaving the release member in the first state to withdraw the implant to reposition in the delivery system.
  • the shape memory material makes it possible to realize the transition of the release member between the first state and the second state through the control of factors such as magnetic field, electric field, temperature field, etc.
  • the control method is simple and easy to implement.
  • At least one end of the release member connected to the implant is made of shape memory alloy
  • the delivery system further includes a temperature control device for controlling the temperature of the release member, the temperature control device adjusting the temperature of the release member.
  • the temperature of the release member is set to switch between the first state and the second state.
  • the temperature of the release part is controlled by the temperature control device, and the release part is in the first state with good binding force when the phase transition temperature is above, so as to realize the fixation of the implant and facilitate the transportation or recovery of the implant;
  • the release member is in a second state with low stiffness, so as to facilitate the release of the release member from the implant.
  • the attachment device includes at least one release member for attaching the implant, the release member being configured to be at least partially elastic, the release member being elastically changed to be in the first state or second state.
  • the distal end of the release member is configured to have elasticity, because the distal end of the release member is interpenetratingly connected with the implant, and when the implant is expanded and opened, the elastic release member can be deformed according to the situation, which can reduce the amount of implantation. Interference of the release member with the implant mesh during expansion.
  • the release member is configured as an axially extending rod-like structure, or the release member is configured as having at least one axially extending U-shaped structure.
  • the release member has the advantages of simple structure and easy molding, and the release of the release member is relatively easy to achieve.
  • the release member is configured to have an axially extending helical structure, or the release member is configured to have an axially extending wave-like structure, or the release member is configured to have an axially extending wavy structure Extend the grid-like structure.
  • Such a structure makes the connection between the release member and the implant more stable, and can provide a certain elasticity to reduce the interference to the stent during the expansion of the implant.
  • the distal end of the release member is configured as a hook structure for hooking the implant.
  • the hook structure at the distal end of the release piece realizes the stable connection with the implant, and prevents the release piece from being detached from the implant during the delivery process.
  • the release member is configured to have a developing function, so that the release member can realize under-DSA development to increase the visibility of the operation.
  • the connecting device and the grid hole are connected by at least one of: rolling connection, hooking connection, and shuttle connection.
  • the release element is configured as a helical structure
  • the helical coil at the distal end of the release element is rolled into the mesh hole of the implant, thereby realizing the connection with the implant.
  • the release member is configured as a rod-shaped structure or as a U-shaped unit
  • the distal end of the release member shuttles in the mesh hole of the implant, thereby realizing the connection with the implant.
  • the present invention also provides an implant delivery system, comprising the implant connecting device as described above.
  • the delivery system includes an inner elongated member, a tapered head end secured to an end of the inner elongated member, a sheath, an outer tubular member, and a manipulation device, the sheath, the outer
  • the tubular member is sleeved outside the inner elongated member, the proximal end of the outer tubular member and the proximal end of the inner elongated member are respectively fixed to the operating device, and the sheath tube is located in the tapered head between the end and the outer tubular member, one end of the sheath is fixed and the other end is engaged with the tapered head end or the outer tubular member; wherein the proximal end of the connecting device is fixed to the operating device, The distal end is used for releasably connecting an implant implanted in the body, the implant being loaded in the sheath.
  • the sheath When the proximal end of the sheath is fixedly connected to the outer tubular member, the sheath is in releasable engagement with the tapered head end at the distal end, and the outer tubular member retracts the sheath to release the implant.
  • the distal end of the sheath When the distal end of the sheath is fixedly connected to the tapered head end, the sheath is in releasable engagement with the outer tubular member at the proximal end, and the inner elongated member advances the sheath to release the implant.
  • the connecting device includes a plurality of release members, and the plurality of release members are distributed in the circumferential direction of the inner elongated member.
  • the multiple release members can provide stable fixation for the implant, and at the same time facilitate re-adjustment of the position of the implant.
  • the connecting device further includes a connecting member, one end of the connecting member is fixed to the operating device, and the other end is fixedly connected to the releasing member.
  • the release element can be withdrawn by controlling the operating device, or the release element can be re-fixed with the implant.
  • each of the release members is respectively provided with the connection member.
  • each of the release members can be independently controlled through the corresponding connection member, respectively.
  • connection device of the present invention has the advantage of being more stable in connection with the mesh holes of the implant, and has a wide range of applications.
  • the delivery needs to select the corresponding size, shape and other parameters, which can be adapted to implants without hanging ears.
  • the release member adopts a spiral, wave, grid, rod or U-shaped unit structure, which is simple and ingenious, and the distal end of the release member is inserted into the implant.
  • the proximal size of the release piece can be smaller, compared with the prior art, it can effectively save the size and space in the delivery system.
  • the connecting device of the present invention is connected with the mesh holes of the implant, which has good compliance compared with the traditional connecting method, and can make the implant stably pass through the curved channel and reach the release position.
  • connection device and delivery system of the present invention when the release member is configured to be at least partially made of a shape memory material, it is convenient for the implant to be recovered and released before the implant is completely released.
  • Fig. 1 is the structural representation of the conveying system of Embodiment 1 of the present invention.
  • Fig. 2 is the partial structure schematic diagram of the conveying system of Embodiment 1 of the present invention.
  • Fig. 3 is the structural representation that the implant of the present utility model embodiment 1 is completely released
  • FIG. 4 is a schematic structural diagram of the hook connection of the connecting device according to Embodiment 1 of the present invention.
  • FIG. 5 is a schematic structural diagram of another connecting device according to Embodiment 1 of the present invention.
  • FIG. 6 is a schematic structural diagram of the shuttle connection of the connecting device according to Embodiment 1 of the present invention.
  • catheter assembly 1 and operating device 2 implant 3; tapered tip 11; sheath 12; outer tubular member 13; inner elongated member 14; Fixed end 151b; connecting end 151a; hook structure 151c.
  • the utility model provides an implant connection device, which is used for the releasable connection between the implant and the delivery system.
  • the implant is a prosthetic device implanted in the body, which can be an artificial heart valve used to replace or replace a native valve, or a heart stent used to expand blood vessels Wait.
  • the implant is configured as a grid structure as a whole, or the implant is at least partially configured as a grid structure, or the implant is configured to have a connecting device that can be inserted through The connected mesh holes enable the connection device to be releasably connected to the mesh holes of the implant, thereby realizing the fixation of the implant.
  • the release member includes a fixed end located at the distal end and a connecting end located at the proximal end, the fixed end is inserted between the mesh holes of the implant, and the connecting end is configured to have elasticity .
  • the connecting end can be designed to obtain elasticity through the structure, or can obtain elasticity through the selection of materials.
  • the elastic connection ends allow the connection device to reduce interference with the implant during stent expansion.
  • the fixed end of the release member can be made of shape memory material
  • the release member has a stable shape with good binding force in the first state, and is used to fix the implant.
  • the anti-deformation ability is reduced, so that the release member is easily released from the mesh of the implant, and the release of the implant is completed.
  • the fixed end of the release member is not made of shape memory material, but is made of elastic material. grid interference.
  • rolled-in connection means that the helical coil at the distal end of the helical release element is rolled into one or more mesh holes of the implant to form a hooking force to fix the implant.
  • shuttle connection refers to the fact that the release member shuttles through a plurality of mesh holes of the implant to form a connection structure similar to knitting. Wherein, the release member can shuttle in the axial direction, or can shuttle in a predetermined angle with the axial direction.
  • axial refers to the axial direction of the inner elongated member or outer tubular member
  • radial refers to the radial direction of the inner elongated member or outer tubular member
  • the terms “installed”, “connected” and “connected” should be understood in a broad sense, for example, it may be a fixed connection or a connectable connection.
  • Detachable connection, or integral connection may be mechanical connection or electrical connection; may be direct connection, or indirect connection through an intermediate medium, or internal communication between two components.
  • the specific meanings of the above terms in the present invention can be understood in specific situations.
  • the present embodiment provides an implant connecting device configured in a delivery system for releasably connecting an implant implanted in a body, the implant is configured to have a mesh hole structure, and the connecting device is configured to secure the implant within the delivery system in a manner that penetrates the mesh holes of the implant.
  • connection device and the implant are fixed by means of interspersed connection. Compared with the existing connection method, it has the advantage of more stable connection and a wider range of applications. There are no special requirements for densification, and it can fit implants without hanging ears. In addition, the insertion connection between the connecting device and the implant in this embodiment has little interference to the implant and does not affect the radial expansion of the self-expanding stent.
  • the implant implanted in the body is an artificial heart valve, such as a mitral valve, tricuspid valve, aortic valve or pulmonary valve
  • the artificial heart valve mainly comprises at least A piece of artificial valve leaflet and a frame body for carrying the artificial valve leaflet, wherein the frame body is constructed as a grid structure with a plurality of grid holes.
  • the frame body is constructed as a grid structure with a plurality of grid holes.
  • the delivery system consists of two parts: a catheter assembly 1 and an operating device 2 .
  • the direction toward the catheter assembly 1 is the distal end, and the direction toward the operating device 2 is the proximal end.
  • the catheter assembly 1 includes an inner elongated member 14, a tapered head end 11 fixed to the end of the inner elongated member 14, a sheath tube 12 and an outer tubular member 13, the operating device 2 is an operating handle, and the sheath tube 12.
  • the outer tubular member 13 is sleeved outside the inner elongated member 14, and the proximal end of the outer tubular member 13 and the proximal end of the inner elongated member 14 are respectively fixed to the operating device 2,
  • the sheath tube 12 is located between the tapered head end 11 and the outer tubular member 13 , one end of the sheath tube 12 is fixed, and the other end is engaged with the tapered head end 11 or the outer tubular member 13 .
  • the implant 3 is loaded in the sheath tube 12 and fixed by the connecting device 15 .
  • the sheath 12 is separated from the tapered head end 11 at A, which is called positive release; in this case, one end of the sheath 12 is separated from the outer tubular.
  • the member 13 is fixedly connected and the other end is releasably engaged with the tapered head end 11 .
  • sheath tube 12 and the outer tubular member 13 are separated at B, which is called reverse release; in this case, one end of the sheath tube 12 is fixedly connected with the tapered head end 11, and the other end is releasable with the outer tubular member 13 engagement, wherein the control device 2 controls the inner elongated member 14 to move the sheath 12 distally, thereby releasing the implant 3 at the target position.
  • the present utility model describes the situation of forward release, and the reverse release is also applicable by analogy.
  • the proximal end of the sheath tube 12 is fixedly connected to the outer tubular member 13
  • the proximal end of the outer tubular member 13 is connected to the movable part of the outer tube in the operating device 2
  • the outer tubular member 13 can be operated
  • the device 2 drives axial movement, but cannot rotate in the circumferential direction.
  • the axial movement of the outer tubular member 13 drives the axial movement of the sheath tube 12 to realize the compression and release of the implant 3 .
  • the tapered head end 11 and the inner elongated member 14 are fixedly connected, and the proximal end of the inner elongated member 14 is connected with the fixed part in the operating device 2, limiting the six degrees of freedom of the entire inner elongated member 14 (3 translational movements: Translational movement along x, y, z axes; 3 rotations: rotation around x, y, z axes) to fix and support implant 3.
  • the connecting device 15 includes at least one release member 151 for connecting the implant 3, the release member 151 being configured to have a first state and a second state, in the first state the The release member 151 has a stable shape for fixing the implant 3 . In the second state, the release member 151 has a reduced toughness and has a relaxed shape to easily release the implant 3 .
  • the release member 151 is at least partially made of a biocompatible material with a shape memory function, such as a shape memory alloy such as nickel-titanium alloy, or a shape memory polymer material.
  • the distal end of the release member 151 is made of shape memory alloy, and the delivery system further includes a temperature control device for controlling the temperature of the release member 151 .
  • Shape memory alloy is a special alloy that can automatically restore its own plastic deformation to its original shape at a certain temperature. It has a shape memory effect through thermoelasticity and martensitic transformation and its inversion. The corrosion resistance of shape memory alloy is better than that of medical stainless steel, which can meet the application requirements of various engineering and medicine, and is a functional material with excellent performance. Using this material, the shape change of the release member 151 can be adjusted by controlling the temperature to adapt to its morphological requirements at different stages. For example: Nitinol alloy material, its phase transition temperature is between 20-45 °C, when the temperature is above 45 °C, its structure changes toward the first state, and when it is below 20 °C, its structure tends to the second state.
  • the connecting device 15 of this embodiment can control the temperature of the releasing member 151 so that the releasing member 151 is in a first state with good binding force when the temperature is above the phase transition temperature, and the releasing member 151 can fix the implant 3 in the delivery system Inside. After the implant is released at the target position, the release member 151 can be controlled to be below the phase transition temperature, so that the release member 151 is in a second relaxed state, and the release member 151 can be easily released from the implant 3, thereby removing the implantation. Object 3 is deployed at the target location. In addition, the connecting device of this embodiment can recover and release the implant 3 before the implant 3 is completely released.
  • the connecting device 15 comprises at least one release member 151 for connecting the implant 3, the release member 151 being configured to be at least partially elastic.
  • the distal end of the release member 151 is configured to have elasticity, and the distal end of the release member 151 is interpenetratingly connected to the implant 3.
  • the release member 151 can be pulled to remove the release member 151 from the implant.
  • the elastic release member 151 can be deformed according to the situation, which can reduce the interference of the release member 151 on the implant mesh during the implant expansion process.
  • the release member 151 may be made of a polymer material such as polyurethane.
  • the connection device 15 includes a plurality of release parts 151 , and the plurality of release parts 151 are evenly distributed in the circumferential direction of the inner elongated member 14 , as shown in FIG. 3 .
  • the plurality of evenly distributed release members 151 can provide stable restraint for the implant 3 , so that the implant can be delivered to the target position smoothly, and at the same time, the implant 3 can be smoothly recovered into the sheath tube 12 .
  • the number of the release members 151 is not used to limit the protection scope of the present invention, and can be set according to actual needs.
  • the connecting device 15 in this embodiment further includes a connecting member 152 , one end of the connecting member 152 is fixed to the operating device 2 , and the other end is fixedly connected to the releasing member 151 .
  • the connecting piece 152 is a connecting wire or a connecting rod, which has a high tensile strength.
  • the connecting piece 15 can be controlled to be withdrawn by the operating device 2 .
  • the connecting piece 152 and the releasing piece 151 can pull the implant 3 back to the sheath tube 12 . , the release and recovery of the implant 3 is achieved.
  • each of the release members 151 is respectively provided with the connection member 152, so each of the release members 151 can be independently controlled.
  • the release member 151 is configured as an axially extending helical structure.
  • the connection device 15 is configured with three release members 151 , wherein the release members 151 have a fixed end 151 b located at the distal end and a connecting end 151 a located at the proximal end, and the fixed end 151 b is configured as a spiral
  • the connecting piece 152 is fixedly connected with the connecting end 151a.
  • the helical structure can be releasably connected to the implant 3 by being rolled into the mesh hole of the implant 3 , which is relatively easy to implement, and the helical structure has a more reliable fixation effect on the implant 3 .
  • the helical structure can provide a certain elasticity for the release member 151, so during the release and self-expansion process of the implant 3, the release member 151 can be deformed to a certain extent, thereby reducing the interference to the implant.
  • the release member 151 may be configured to have several equal-diameter helical turns, and such a structure enables the entire release member 151 to be uniformly stressed.
  • the release member 151 can also be configured to have several unequal diameter helical turns, and further, from the proximal end to the distal end, the radial dimensions of the several helical turns gradually increase, so that the helical turn with the largest diameter is close to the tapered head end 11 , several helical coils close to the implant 3 are rolled into the grid of the implant 3 to achieve a releasable connection with the implant 3 .
  • the radial dimensions of several helical turns can also be configured to gradually decrease from the proximal end to the distal end.
  • the helical coil at the distal end is rolled into the crimped implant 3, and the size of the proximal end of the release member 151 can be configured to be smaller, thereby effectively saving the size and space of the delivery system.
  • the relative positions of the helical coil, the outer tubular member 13 and the sheath tube 12 change.
  • the helical coil is at least partially located in the sheath 12, and as the implant 3 is fully released, the coil is gradually separated from the sheath 12.
  • the temperature can be lowered (the temperature is controlled below the phase transition temperature), so that the spiral coil presents a relaxed state that is easy to release, and then control the The device 2 controls the retraction of the connecting device 15 to achieve complete release of the implant.
  • the connecting device 15 can be retracted through the control device 2, and the release member 151 can pull the implant 3 back to the sheath In the tube 12, the retrieval, repositioning and re-release of the implant 3 is effected.
  • the release member 151 is configured to have a wave-like structure along the axial direction. As shown in FIG. 4 , the release member 151 has a fixed end 151b and a connection end 151a at the proximal end. The connection end 151a It is fixedly connected with the connecting piece 152 .
  • the fixed end 151b is configured to have several crests and troughs, and further, the distal end of the release member 151 is configured to be a hook structure 151c for hooking the implant 3. Therefore, in this embodiment, the The releasing member 151 can hook the mesh hole 30 of the implant through the hook structure 151c at the distal end thereof, so as to realize the releasable connection with the implant 3 . Further, the size of the opening of the hook structure 151c should be smaller than the thickness of the mesh hole bracket, so that the implant 3 is not easily separated from the opening of the hook structure 151c.
  • the release member 151 is configured to have a grid-like structure extending in the axial direction.
  • the release member 151 has a fixed end 151b and a connecting end 151a located at the proximal end, the connecting end 151a is fixed to the connecting member 152, and the fixed end 151b is arranged by rhombus geometric units a grid-like structure.
  • the radial dimension of the fixed end 151b can be larger than the radial dimension of the mesh hole of the implant 3, so the fixed end 151b can be inserted into the mesh hole of the implant 3 to realize the connection with the implant 3
  • the radial dimension of the fixed end 151b may also be smaller than or equal to the radial dimension of the mesh holes of the implant 3.
  • the grid-shaped releasing member 151 can also deform, so that it can provide a certain elasticity when the implant 3 is expanded, thereby reducing the interference to the implant.
  • the release member 151 can also be configured as a rod-shaped structure extending in the axial direction, such as a wire or a screw rod, so that the release member 151 of the rod-shaped structure can shuttle between the mesh holes of the implant 3
  • the release member 151 of the rod-shaped structure has the advantages of simple structure and simple molding method.
  • the release member 151 may also be configured to have at least one U-shaped unit extending in the axial direction, as shown in FIG. 6 .
  • the U-shaped unit can be made to shuttle between the mesh holes 30 of the implant in the axial direction, so as to play the role of fixing the implant 3 .
  • the contact area between the U-shaped unit and the implant 3 is larger, so that a better fixation effect can be achieved.
  • the release member 151 when the implant 3 is released and expanded, it will expand in the axial and radial directions. Therefore, when the release member 151 is configured as a rod-shaped or a U-shaped unit with an axial direction, the release member 151 should be at least partially elastic.
  • the distal end or the proximal end of the release member 151 is made of elastic material, or the whole of the release member 151 is made of elastic material.
  • the release member 151 can provide an elastic margin during the expansion process of the implant 3 to reduce interference to the implant.
  • the release member 151 in order to increase the visibility of the operation, is configured to have a development function, which can realize development under DSA.
  • the release member 151 can be selected from a developer-added material or a developable material, such as gold, platinum, PtW alloy, tantalum, or PtIr alloy.
  • the method of cooling and heating is not particularly limited in the present invention, and the temperature control device can adopt the method of electronic refrigeration (also called semiconductor refrigeration), that is, the temperature control device adopts a semiconductor refrigeration chip.
  • the connection member 152 is connected to the temperature control device, so as to conduct the cooling or heat to the release member 151 to achieve temperature control.
  • the temperature control device may also adopt other existing technologies to realize the cooling or heating of the releasing member 151 .
  • connection device 15 of the present invention when the release member 151 is made of a shape memory material, the release member 151 can be connected to the implant 3 in the first state.
  • the temperature of the release member 151 is lowered to below the phase transition temperature by the temperature control device, and the release member 151 is in a second state with low toughness, so that the connecting device 15 is retracted through the operating device 2, and the release member 151 is deformed, thereby automatically
  • the mesh hole of the implant 3 is withdrawn to realize the release of the connecting device 15 and the implant 3 .
  • the connecting device 15 can be directly pulled by the operating device 2, so that the distal end of the releasing member 151 is deformed and withdrawn from the mesh hole of the implant 3 to realize the connecting device 15. Release with implant 3.
  • the connecting device 15 and the mesh holes of the implant are inserted and connected to make the connection of the connecting device 15 to the implant 3 more stable.
  • the release member 151 can be made of wire or screw rod.
  • the traditional connection method has better compliance, so the implant can stably pass through the curved channel to reach the release position; and the interference to the implant is small, and the radial expansion of the self-expanding stent is not affected.
  • the connection device and the delivery system have low requirements on the structure of the implant, and do not need to provide hanging ears or fixing ears.
  • the density is not particularly limited.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
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Abstract

一种植入物连接装置（15）及植入物输送系统，连接装置（15）配置为以穿插植入物（3）的网格孔的方式将植入物（3）固定于输送系统内。连接装置（15）与植入物（3）的网格孔之间穿插连接的方式，具有连接更加稳定的优点，适用范围更广，对于植入物（3）的尺寸、形状、网格大小、疏密没有特殊要求；并且该连接装置（15）可以适配没有挂耳的植入物（3），对植入物（3）的干涉小，不影响自膨支架的径向扩张；穿插连接的方式顺应性更好，因而能够使植入物（3）稳定地通过弯曲通道，到达释放位置。

Description

一种植入物连接装置及植入物输送系统 技术领域
本实用新型属于医疗器械技术领域，特别涉及用于固定植入物的植入物连接装置和植入物输送系统。
背景技术
心脏是人体最重要的器官，但是，由于各种原因，会导致心脏瓣膜的后天性损伤或病变，如风湿，动脉粥样硬化等。对于心脏瓣膜的后天性损伤或病变，传统的治疗方法是开胸，心脏停跳后，在低温体外循环支持下，打开心脏进行病变瓣膜的外科修复或用人工心脏瓣膜置换。然而，传统的外科手段进行心脏置换手术时创伤大、风险高，容易发生出血、感染、中风等并发症，并且患者的恢复和治疗时间较长。
心脏瓣膜介入手术是近年来快速发展的医学技术，其原理是通过微创伤的形式，经心尖或者血管将瓣膜假体植入原生瓣膜位置并替代之，最终达到治疗患者的目的。该手术具有创伤小、恢复快、风险低等特点，特别适合高龄心脏瓣膜患者。
目前用于瓣膜手术的器械种类繁多，特别是用于经血管通路的器械，这些器械大多具有自膨机械结构，各自采用不同的设计方法或材料将人工心脏瓣膜(如人工机械瓣和生物瓣膜)输送至指定位置，其中经皮导管植入式人工心脏瓣膜系统因其输送系统轮廓小、瓣周漏发生率低，且能使主动脉狭窄患者和主动脉关闭不全患者获得显著的临床效益而被广泛采用。
但现有的器械存在连接稳定性较差、占用空间大、在调整时不易回收等问题。比如，已知有输送系统采用钩子结构与植入物进行连接，这种钩挂的连接方式对钩子与植入物的配合要求较高，在植入物被推送至弯曲部分时，存在着一定的脱钩风险。再比如，已知有输送系统采用挂耳结构与植入物进行连接，这种连接方式需要依靠鞘管压握植入物实现固定，手术过程中，当 鞘管与植入物完全脱离后，无法实现植入物的回收。
实用新型内容
本实用新型提供了一种植入物连接装置和植入物输送系统，可以解决现有技术中的上述缺陷，实现植入物的固定、输送和释放，具有结构简单，连接牢固，释放稳定、占用空间小、可实现回收的优点。
本实用新型的技术方案如下：
一种植入物连接装置，配置于输送系统内，用于可释放地连接植入机体内的植入物，所述植入物被构造为具有网格孔结构，所述连接装置配置为以穿插所述植入物的网格孔的方式将所述植入物固定于所述输送系统内。
本实用新型的连接装置与植入物的网格孔之间穿插连接的方式，相对于现有的连接方式，具有连接更加稳定的优点，适用范围更广，对于植入物的尺寸、形状、网格大小、疏密没有特殊要求，可以适配没有挂耳的植入物；该连接装置与植入物之间的穿插连接方式，对植入物的干涉小，不影响自膨支架的径向扩张；另外，相对于传统的连接方式，该连接装置穿插连接的方式顺应性更好，因而能够使植入物稳定地通过弯曲通道，到达释放位置。
在一些实施例中，所述连接装置包括至少一个释放件，所述释放件构造为具有第一状态和第二状态，第一状态下所述释放件具有固定所述植入物的稳定形态，第二状态下，所述释放件具有容易释放所述植入物的松弛形态。其中，第一状态下释放件抗形变能力较高，具有相对稳定的形态，可以达到固定植入物的效果，第二状态下释放件抗形变能力降低，使释放件能够容易的自植入物中撤回。
在一些实施例中，所述释放件至少部分采用具有形状记忆功能的生物相容性材料制成。采用形状记忆材料制成的释放件，能够在第一状态下拥有较大的刚度，以提供牢靠的固定作用，防止输送过程中释放件与植入物脱离。而在第二状态下，释放件呈松弛状态实现其解脱，完成植入物的释放。两种状态的可转化性，使得该释放件能够在植入物完全释放时依然可回收，即让 释放件处于第一状态，将植入物撤回至输送系统内重新定位。最后，形状记忆材料使得可以通过磁场、电场、温度场等因素的控制，以实现释放件在第一状态和第二状态的转变，控制方式简单，容易实施。
在一些实施例中，所述释放件至少连接所述植入物的一端采用形状记忆合金制成，所述输送系统还包括控制所述释放件温度的控温装置，所述控制温装置调节所述释放件的温度，使其在第一状态与第二状态之间转换。其中，通过控温装置控制释放件的温度，在相变温度以上时使释放件处于束缚力好的第一状态，实现植入物的固定，方便植入物的输送或回收；在相变温度以下时使释放件处于刚度低的第二状态，以方便释放件从植入物上解脱。
在一些实施例中，所述连接装置包括至少一个用于连接所述植入物的释放件，所述释放件构造为至少部分具有弹性,所述释放件发生弹性变化使其处于第一状态或第二状态。。优选的，所述释放件的远端构造为具有弹性，因为释放件的远端与植入物穿插连接，植入物膨胀打开时，具有弹性的释放件可以顺势发生形变，可以减少植入物扩张过程中释放件对植入物网格的干涉。
在一些实施例中，所述释放件构造为沿轴向延伸的杆状结构，或所述释放件构造为具有至少一个沿轴向延伸的U型结构。这样的结构，使得释放件具有结构简单、成型容易的优点，并且释放件的解脱也相对容易实现。
在一些实施例中，所述释放件构造为具有沿轴向延伸的螺旋状结构，或所述释放件构造为具有沿轴向延伸的波浪状结构，或所述释放件构造为具有沿轴向延伸网格状结构。这样的结构，使得释放件与植入物之间的连接更加稳定，并且，能够提供一定的弹性，以减少对植入物膨胀过程中对支架的干涉。
在一些实施例中，所述释放件的远端构造为用于钩挂所述植入物的弯钩结构。通过释放件远端的弯钩结构实现与植入物的稳定连接，防止输送过程中释放件与植入物脱离。
在一些实施例中，所述释放件被构造为具有显影功能，因此释放件可以实现DSA下显影，增加操作的可视性。
在一些实施例中，所述连接装置与所述网格孔穿插连接的方式为：卷入 连接、钩挂连接、穿梭连接中的至少一种。当释放件构造为螺旋状结构时，释放件远端的螺旋圈卷入植入物的网格孔内，从而实现与植入物的连接。当释放件构造为杆状结构或构造为具有U型单元时，释放件远端穿梭于植入物的网格孔内，从而实现与植入物的连接。
本实用新型还提供一种植入物输送系统，包含如上任一所述的植入物连接装置。
在一些实施例中，所述输送系统包括内细长构件、固定至所述内细长构件端部的锥形头端、鞘管、外管状构件和操作装置，所述鞘管、所述外管状构件套设于所述内细长构件之外，所述外管状构件的近端、所述内细长构件的近端分别固定至所述操作装置，所述鞘管位于所述锥形头端和所述外管状构件之间，所述鞘管一端固定，另一端与所述锥形头端或所述外管状构件接合；其中，所述连接装置的近端固定至所述操作装置，远端用于可释放地连接植入机体内的植入物，植入物装载于鞘管内。当鞘管的近端与外管状构件固定连接时，鞘管在远端与锥形头端进行可释放接合，外管状构件带动鞘管回撤以释放植入物。当鞘管的远端与锥形头端固定连接时，该鞘管在近端与外管状构件可释放接合，内细长构件带动鞘管前进以释放植入物。
在一些实施例中，所述连接装置包括多个释放件，多个所述释放件均布于所述内细长构件的周向。通过多个释放件能够提供为植入物提供稳定的固定作用，同时有利于重新调整植入物的位置。
在一些实施例中，所述连接装置还包括连接件，所述连接件一端固定至所述操作装置，另一端与所述释放件固定连接。其中，通过控制操作装置可以将释放件撤回，或将释放件重新与植入物进行固定。
优选的，每一所述释放件分别配置有一所述的连接件。因而，每一所述释放件可以分别通过对应的连接件独立控制。
与现有技术相比，本实用新型的有益效果如下：
(1)本实用新型的连接装置与植入物的网格孔之间穿插连接的方式，相对于现有的连接方式，具有连接更加稳定的优点，且适用范围广，可以根据植入物的输送需要来选择相应的尺寸、形状等参数，可以适配没有挂耳的植 入物。
(2)本实用新型的连接装置与植入物的网格孔之间穿插连接的方式，对植入物的干涉小，不影响支架的径向扩张。
(3)本实用新型的连接装置及输送系统，释放件采用螺旋状、波浪状、网格状、杆状或具有U型单元的结构，简单巧妙，释放件的远端穿插于植入物中，释放件的近端尺寸可以更小，相对于现有技术，使其在输送系统中能有效节省尺寸空间。
(4)本实用新型的连接装置与植入物的网格孔之间穿插连接的方式，相对于传统的连接方式顺应性好，能够使植入物稳定地通过弯曲通道，到达释放位置。
(5)本实用新型的连接装置及输送系统，当释放件配置为至少部分采用形状记忆材料制成时，便于在植入物彻底释放前，可回收再释放。
当然，实施本实用新型的任一产品并不一定需要同时达到以上所述的所有优点。
附图说明
图1是本实用新型实施例1的输送系统的结构示意图；
图2是本实用新型实施例1的输送系统的局部结构示意图；
图3是本实用新型实施例1的植入物完全释放的结构示意图；
图4是本实用新型实施例1的连接装置钩挂连接的结构示意图；
图5是本实用新型实施例1的另一连接装置的结构示意图；
图6是本实用新型实施例1的连接装置的穿梭连接的结构示意图。
附图标记：导管组件1和操作装置2；植入物3；锥形头端11；鞘管12；外管状构件13；内细长构件14；连接装置15；释放件151；连接件152；固定端151b；连接端151a；弯钩结构151c。
具体实施方式
本实用新型提供一种植入物连接装置，用于植入物与输送系统的可释放连接。
在本实用新型的描述中，需要说明的是，该植入物为植入机体内的假体装置，其可以为用于替换或置换原生瓣膜的人工心脏瓣膜，或用于扩张血管的心脏支架等。
在本实用新型的描述中，需要说明的是，该植入物整体构造为网格结构，或者该植入物至少部分构造为网格结构，或者该植入物构造为具有使连接装置能够穿插连接的网格孔，使得连接装置与植入物的网格孔可释放连接，从而实现对植入物的固定作用。
在本实用新型的一些实施方式中，释放件包括位于远端的固定端和位于近端的连接端，其固定端穿插连接于植入物的网格孔之间，连接端被构造为具有弹性。其中，连接端可以是通过结构的设计以使其获得弹性，或者可以通过材料的选择以使其获得弹性。弹性的连接端可以使连接装置在支架膨胀过程中降低对植入物的干涉。
在本实用新型的描述中，需要说明的是，释放件的固定端可以采用形状记忆材料制成，该释放件在第一状态下具有束缚力好的稳定形态，用于固定植入物，在第二状态下抗形变能力降低，使释放件容易植入物的网格内解脱，完成植入物的释放。
在本实用新型的描述中，需要说明的是，在一些实施方式中，释放件的固定端并非采用形状记忆材料制成，而是采用弹性材料制成，在植入物释放过程中，降低对网格的干涉。
在本实用新型的描述中，需要说明的是，“卷入连接”指的是螺旋状的释放件中远端的螺旋圈卷入植入物的一个或多个网格孔，形成钩挂力以固定植入物。
在本实用新型的描述中，需要说明的是，“穿梭连接”指的是释放件穿梭于植入物的多个网格孔，形成类似于编织的连接结构。其中，释放件可以沿 轴向穿梭，也可以沿与轴向成预定角度的方式穿梭。
在本实用新型的描述中，需要说明的是，“完全释放”为植入物完全脱离鞘管的状态，但释放件的远端部分还穿插于植入物的网格孔间，释放件没有完全脱离植入物。“彻底释放”为植入物与整个输送系统完全脱离的状态。
在本实用新型的描述中，需要说明的是，“轴向”指的是内细长构件或外管状构件的轴向，“径向”指的是内细长构件或外管状构件的径向。
在本实用新型的描述中，需要说明的是，术语“中心”、“上”、“下”、“左”、“右”、“竖直”、“水平”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本实用新型和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本实用新型的限制。此外，术语“第一”、“第二”、“第三”仅用于描述目的，而不能理解为指示或暗示相对重要性。
在本实用新型的描述中，需要说明的是，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本实用新型中的具体含义。
下面结合具体实施例，进一步阐述本实用新型。
实施例1
本实施例提供一种植入物连接装置，配置于输送系统内，用于可释放地连接植入机体内的植入物，所述植入物被构造为具有网格孔结构，所述连接装置配置为以穿插所述植入物的网格孔的方式将所述植入物固定于所述输送系统内。
连接装置与植入物之间采用穿插连接的方式进行固定，相对于现有的连接方式，具有连接更加稳定的优点，适用范围更广，对于植入物的尺寸、形状、网格大小、疏密没有特殊要求，并且可以适配没有挂耳的植入物。另外， 本实施例的连接装置与植入物之间的穿插连接方式，对植入物的干涉小，不影响自膨支架的径向扩张。
在一个非限制性实施例中，所述植入机体内的植入物为人工心脏瓣膜，如二尖瓣瓣膜、三尖瓣瓣膜、主动脉瓣膜或肺动脉瓣膜，所述人工心脏瓣膜主要包括至少一片人工瓣叶和用于承载该人工瓣叶的框架主体，其中，框架主体构造为网格结构，具有若干网格孔，所述框架主体的结构、材料、成型方式参见CN111904662A、CN111772879A、CN112155788A、CN212395136U，但框架主体的结构并不限于此。其中，图2、图3、图6为所述框架主体的非限制性实施例。
如图1、图2所示的实施例中，该输送系统由导管组件1和操作装置2两个部分组成，往导管组件1的方向为远端，往操作装置2的方向为近端。其中，导管组件1包括内细长构件14、固定至所述内细长构件14端部的锥形头端11、鞘管12和外管状构件13，操作装置2为操作手柄，所述鞘管12、所述外管状构件13套设于所述内细长构件14之外，所述外管状构件13的近端、所述内细长构件14的近端分别固定至所述操作装置2，所述鞘管12位于所述锥形头端11和所述外管状构件13之间，所述鞘管12一端固定，另一端与所述锥形头端11或所述外管状构件13接合。其中，植入物3装载于鞘管12内，由连接装置15固定。
植入物3的装载和释放一般有两种形式：一种为鞘管12与锥形头端11在A处分离，称为正向释放；这种情况下，鞘管12的一端与外管状构件13固定连接，另一端与锥形头端11可释放的接合。一种为鞘管12与外管状构件13在B处分离，称为反向释放；这种情况下，鞘管12的一端与锥形头端11固定连接，另一端与外管状构件13可释放的接合，其中，控制装置2控制内细长构件14带动鞘管12向远端移动，从而将植入物3释放在目标位置。本实用新型针对正向释放的情况进行阐述，反向释放也类比适用。
如图2所示，本实施例中鞘管12的近端与外管状构件13固定连接，外管状构件13的近端与操作装置2中的外管活动部件连接，外管状构件13可以被操作装置2驱动轴向运动，但不能周向旋转运动，通过外管状构件13的 轴向运动带动鞘管12的轴向运动，实现对植入物3的压握和释放。锥形头端11和内细长构件14固定连接，内细长构件14的近端与操作装置2中的固定部件连接，限制整个内细长构件14的六个自由度(3个平移运动：沿x,y,z轴的平移运动；3个转动：绕x,y,z轴的转动)，用以固定支撑植入物3。
在一些实施例中，所述连接装置15包括至少一个用于连接所述植入物3的释放件151，所述释放件151构造为具有第一状态和第二状态，第一状态下所述释放件151具有固定所述植入物3的稳定形态，第二状态下，所述释放件151的韧性降低，具有容易释放所述植入物3的松弛形态。
在一些实施例中，所述释放件151至少部分采用具有形状记忆功能的生物相容性材料制造而成，如镍钛合金等形状记忆合金，或形状记忆高分子材料。
进一步的，释放件151的远端采用形状记忆合金制成，该输送系统还包括控制所述释放件151温度的控温装置。形状记忆合金，是能将自身的塑性变形在某一温度下自动恢复到原始形状的特种合金，其通过热弹性与马氏体相变及其逆变而具有形状记忆效应。形状记忆合金的耐腐蚀性优于医用不锈钢，可以满足各类工程和医学的应用需求，是一种性能优良的功能材料。采用这种材料，可以通过控制温度来调节释放件151的形状变化，以适应其在不同阶段的形态需求。例如：采用镍钛合金材料，其相变温度在20-45℃之间，温度在45℃以上时，其结构朝向第一状态变化，在20℃以下时，其结构趋向第二种状态。
本实施例的连接装置15，可以通过控制释放件151温度的方式，让释放件151在相变温度以上时处于束缚力好的第一状态，释放件151能够将植入物3固定在输送系统内。当植入物释放在目标位置后，可以控制释放件151处于相变温度以下，使释放件151处于松弛的第二状态，释放件151能够容易的从植入物3上解脱，从而将植入物3部署在目标位置。并且，本实施例的连接装置在植入物3彻底释放前，可将植入物3回收再释放。
在一些实施例中，所述连接装置15包括至少一个用于连接所述植入物3的释放件151，所述释放件151构造为至少部分具有弹性。其中，释放件151 的远端构造为具有弹性，释放件151的远端与植入物3穿插连接，当植入物完全释放后，可以通过牵拉释放件151，从而将释放件151从植入物3的网格孔内解脱离。同时，具有弹性的释放件151可以顺势发生形变，可以减少植入物扩张过程中释放件151对植入物网格的干涉。具体的，释放件151可以采用聚氨酯等高分子材料制成。
优选的，所述连接装置15包括多个释放件151，多个所述释放件151均布于所述内细长构件14的周向，如图3所示。通过多个均匀布设的释放件151可以为植入物3提供稳定的束缚作用，使植入物顺利输送至目标位置，同时还有利于植入物3顺利回收至鞘管12内。释放件151的数量并不用于限制本实用新型的保护范围，可以根据实际需要进行设置。
本实施例的连接装置15还包括连接件152，所述连接件152一端固定至所述操作装置2，另一端与所述释放件151固定连接。所述连接件152为连接线或者连接杆，有较高的抗拉强度，通过操作装置2可以控制回撤连接装置15，连接件152、释放件151可以拉动植入物3回收到鞘管12中，实现植入物3的释放和回收。
其中，每一所述释放件151分别配置有一所述的连接件152，因而每一释放件151均可以独立控制。
在一些实施例中，所述释放件151构造为沿轴向延伸的螺旋状结构。参见图3，所述连接装置15配置有3个所述的释放件151，其中，所述释放件151具有位于远端的固定端151b和位于近端的连接端151a，固定端151b构造为螺旋状结构，连接件152与连接端151a固定连接。螺旋状结构通过卷入植入物3的网格孔内即可实现与植入物3的可释放连接，实施相对容易，螺旋状结构对植入物3的固定作用也更加牢靠。并且，螺旋状结构可以为释放件151提供一定的弹性，因而在植入物3释放、自膨胀过程中，释放件151可以产生一定的形变，降低对植入物的干涉。
其中，释放件151可以构造为具有若干等径的螺旋圈，这样的结构使得释放件151整体受力均匀。或者释放件151也可以构造为具有若干非等径的螺旋圈，进一步的，自近端至远端，若干螺旋圈的径向尺寸逐渐增大，使得 直径最大的螺旋圈靠近锥形头端11，靠近植入物3的若干螺旋圈卷入植入物3的网格内，实现与植入物3的可释放连接。当然，若干螺旋圈的径向尺寸也可以配置为自近端至远端逐渐减小。
在输送的过程中，远端的螺旋圈卷入压握的植入物3内，释放件151的近端的尺寸可以构造的更小，因而能够有效节省输送系统的尺寸空间。在释放的过程中，随着外管状构件13带动鞘管12后撤，螺旋圈与外管状构件13和鞘管12的相对位置发生改变。在植入物3完全释放前，螺旋圈至少部分位于鞘管12中，随着植入物3的完全释放，螺旋圈也逐渐脱离鞘管12。
在手术过程中：①如果植入位置恰当，植入物3的位置不需要再进行调整，则可以通过降温(温度控制在相变温度以下)，让螺旋圈呈现易于解脱的松弛形态，然后控制装置2控制回撤连接装置15，实现植入物的彻底释放。②如果在完全释放后(释放距离不大的情况)，发现需要重新调整植入物3的位置，则可以通过控制装置2回撤连接装置15，释放件151可以拉动植入物3回收到鞘管12中，实现植入物3回收、重新定位和重新释放。③如果在完全释放后(释放距离较大的情况)，发现需要重新调整植入物3的位置，可以先通过升温(温度控制在相变温度以上)，让螺旋圈呈现束缚力好的第一状态，再通过控制手柄回撤连接装置15，拉动植入物3回收到鞘管12中，实现回收、重新定位和重新释放。
在一些实施例中，所述释放件151构造为具有沿轴向方向的波浪状结构，如图4所示，所述释放件151具有固定端151b和位于近端的连接端151a，连接端151a与连接件152固定连接。其中，所述固定端151b构造为具有若干波峰和波谷，进一步的，所述释放件151的远端构造为用于钩挂所述植入物3的弯钩结构151c，因此，本实施例的释放件151可以通过其远端的弯钩结构151c勾住植入物的网格孔30，实现与植入物3的可释放连接。进一步的，所述弯钩结构151c的开口尺寸应小于网格孔支架的厚度，使植入物3不容易从弯钩结构151c的开口处脱离。
在一些实施例中，所述释放件151构造为具有沿轴向延伸的网格状结构。在如图5所示的非限制性实施例中，所述释放件151具有固定端151b和位于 近端的连接端151a，连接端151a固定至连接件152，固定端151b为由菱形几何单元排列而成的网格状结构。其中，固定端151b的径向方向的尺寸可以大于植入物3的网格孔的径向尺寸，因而固定端151b可以穿插至植入物3的网格孔内，以实现与植入物3的连接；固定端151b的径向方向的尺寸也可以小于或等于植入物3的网格孔的径向尺寸，该固定端151b穿梭于植入物3的网格孔之间时，能够起到好的固定作用。本实施例中，当释放件151两端受力时，网格状的释放件151还可以产生形变，因而能够在植入物3膨胀时提供一定的弹性，降低对植入物的干涉。
在一些实施例中，所述释放件151还可以构造为沿轴向延伸的杆状结构，如丝线或丝杆，可以使杆状结构的释放件151穿梭于植入物3的网格孔之间，从而起到固定植入物3的作用，杆状结构的释放件151具有结构简单、成型方式简单的优点。或者，所述释放件151还可以构造为具有至少一个沿轴向方向延伸的U型单元，如图6所示。可以使U型单元沿轴向穿梭于植入物的网格孔30之间，从而起到固定植入物3的作用。相对于杆状的释放件151，U型单元与植入物3之间的接触面积更大，因而能够起到更好的固定作用。
进一步的，当植入物3释放并膨胀时，会沿轴向、径向产生扩张，因而当释放件151构造为杆状或具有轴向的U型单元时，释放件151应至少部分采用弹性材料制成，如释放件151的远端或近端采用弹性材料制成，或释放件151整体采用弹性材料制成。释放件151可以在植入物3膨胀过程中，提供弹性余量，降低对植入物的干涉。
在一些实施例中，为了增加操作的可视性，所述释放件151构造为具有显影功能，可以实现DSA下显影。具体的，释放件151可以选择添加显影剂的材料或采用可显影的材料，如黄金、铂金、PtW合金、钽或PtIr合金等。
关于制冷制热的方式，本实用新型不做特殊限定，控温装置可以采用电子制冷的方法(也叫半导体制冷)，即控温装置采用半导体制冷芯片。当释放件151采用合金材料制成时，连接件152与控温装置连接，从而将冷量或热量传导至释放件151，实现温度控制。当然，控温装置还可以采用其他现有技术，以实现释放件151的制冷或制热。
本实用新型的连接装置15，当释放件151采用形状记忆材料制成时，释放件151可以在第一状态下实现与植入物3的连接。其中，通过控温装置将释放件151的温度降低至相变温度以下，释放件151处于韧性低的第二状态，从而通过操作装置2回撤该连接装置15，释放件151产生形变，从而自植入物3的网格孔内抽撤出来，实现连接装置15与植入物3的解脱。
当释放件151采用弹性材料制成时，可以直接通过操作装置2牵拉该连接装置15，使释放件151远端产生形变，自植入物3的网格孔内抽撤出来，实现连接装置15与植入物3的解脱。
本实施例的连接装置15与植入物的网格孔之间穿插连接的方式，使连接装置15对植入物3的连接更加稳定，释放件151可以采用丝线或丝杆制成，相对于传统的连接方式顺应性更好，因而能够使植入物稳定地通过弯曲通道，到达释放位置；并且对植入物的干涉小，不影响自膨支架的径向扩张。此外，还具有适用范围广的优点，该连接装置以及输送系统对于植入物的结构的要求低，不需要设置挂耳或固定耳，对于植入物的大小、尺寸、形状以及网格大小、疏密没有特别限制。
以上公开的仅为本实用新型优选实施例，优选实施例并没有详尽叙述所有的细节，应该理解，这些实施例仅用于说明本实用新型，而不用于限定本实用新型的保护范围，本实用新型仅受权利要求书及其全部范围和等效物的限制。
本说明书选取并具体描述这些实施例，是为了更好地解释本实用新型的原理和实际应用，从而使所属领域技术人员能很好地利用本实用新型。在实际应用中本领域技术人员根据本实用新型做出的改进和调整，仍属于本实用新型的保护范围。此外，以上不同实施例中的技术特征在不发生相互冲突的前提下可以任意的结合。

Claims (14)

  1. 一种植入物连接装置，配置于输送系统内，用于可释放地连接植入机体内的植入物，所述植入物被构造为具有网格孔结构，其特征在于，所述连接装置配置为以穿插所述植入物的网格孔的方式将所述植入物固定于所述输送系统内。
  2. 根据权利要求1所述的植入物连接装置，其特征在于，所述连接装置包括至少一个用于连接所述植入物的释放件，所述释放件构造为具有第一状态和第二状态，第一状态下所述释放件具有固定所述植入物的稳定形态，第二状态下，所述释放件具有容易释放所述植入物的松弛形态。
  3. 根据权利要求2所述的植入物连接装置，其特征在于，所述释放件至少部分采用具有形状记忆功能的生物相容性材料制成。
  4. 根据权利要求3所述的植入物连接装置，其特征在于，所述释放件至少连接所述植入物的一端采用形状记忆合金制成；所述输送系统还包括控制所述释放件温度的控温装置，所述控制温装置调节所述释放件的温度，使其在第一状态与第二状态之间转换。
  5. 根据权利要求2所述的植入物连接装置，其特征在于，所述释放件构造为至少部分具有弹性，所述释放件发生弹性变化使其处于第一状态或第二状态。
  6. 根据权利要求5所述的植入物连接装置，其特征在于，所述释放件构造为杆状结构，或所述释放件构造为U型结构。
  7. 根据权利要求2或5所述的植入物连接装置，其特征在于，所述释放件构造为具有沿轴向延伸的螺旋状结构，或所述释放件构造为具有沿轴向延伸的波浪状结构，或所述释放件构造为具有沿轴向延伸的网格状结构。
  8. 根据权利要求7所述的植入物连接装置，其特征在于，所述释放件的远端构造为用于钩挂所述植入物的弯钩结构。
  9. 根据权利要求2或5所述的植入物连接装置，其特征在于，所述释放件被构造为具有显影功能。
  10. 根据权利要求1所述的植入物连接装置，其特征在于，所述连接装置与所述网格孔穿插连接的方式为：卷入连接、钩挂连接、穿梭连接中的至少一种。
  11. 一种植入物输送系统，其特征在于，包含如权利要求1-10任一所述的植入物连接装置。
  12. 根据权利要求11所述的植入物输送系统，其特征在于，所述输送系统还包括内细长构件、固定至所述内细长构件端部的锥形头端、鞘管、外管状构件和操作装置，所述鞘管、所述外管状构件套设于所述内细长构件之外，所述外管状构件的近端、所述内细长构件的近端分别固定至所述操作装置，所述鞘管位于所述锥形头端和所述外管状构件之间，所述鞘管一端固定，另一端与所述锥形头端或所述外管状构件接合；其中，所述连接装置的近端固定至所述操作装置，远端用于可释放地连接植入机体内的植入物。
  13. 根据权利要求12所述的植入物输送系统，其特征在于，所述连接装置包括多个释放件，多个所述释放件均布于所述内细长构件的周向。
  14. 根据权利要求13所述的植入物输送系统，其特征在于，所述连接装置还包括连接件，所述连接件一端固定至所述操作装置，另一端与所述释放件固定连接，每一所述释放件分别配置有一所述的连接件。
PCT/CN2021/099455 2021-02-23 2021-06-10 一种植入物连接装置及植入物输送系统 WO2022179005A1 (zh)

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