CN220608463U

CN220608463U - Cardiac implant delivery system

Info

Publication number: CN220608463U
Application number: CN202321541642.3U
Authority: CN
Inventors: 王泽涛; 江巍
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2023-06-15
Filing date: 2023-06-15
Publication date: 2024-03-19
Anticipated expiration: 2033-06-15

Abstract

The application provides a cardiac implant delivery system for carrying cardiac implants to a cardiac treatment area, it includes delivery catheter and controller, the delivery catheter is including connecting cardiac implants's distal end section and with the proximal end section that distal end section is connected, the distal end section has first hardness, the proximal end section has the second hardness, first hardness is less than the second hardness, the delivery catheter includes from proximal end section to distal end section main cavity body pipe, a plurality of respectively with main cavity body pipe bonding's vice cavity body pipe, and around in vice cavity body pipe with main cavity body pipe's peripheral integral type restrictive coating, main cavity body pipe protrusion be equipped with cardiac implants detachably connected's connection structure, vice cavity body pipe is used for holding the control cardiac implants's control silk. The controller is coupled to the proximal section of the delivery catheter for manipulating the connection structure and the control wire.

Description

Cardiac implant delivery system

Technical Field

The utility model relates to the technical field of interventional medical instruments, in particular to a heart implant conveying system.

Background

The atrioventricular valves, such as mitral valve, tricuspid valve, are one-way valves within the heart that allow normal healthy atrioventricular valves to control blood flow from the atrium to the ventricle while avoiding blood flow from the ventricle to the atrium. For example: as shown in fig. 1, the mitral valve MV is a one-way valve between the left atrium LA and the left ventricle LV of the heart that can control the flow of blood from the left atrium LA to the left ventricle LV while avoiding the flow of blood from the left ventricle LV to the left atrium LA; the tricuspid valve TV is a one-way valve located between the right atrium RA and the right ventricle RV of the heart that can control the flow of blood from the right atrium RA to the right ventricle RV while avoiding the flow of blood from the right ventricle RV to the right atrium RA.

The mitral valve includes anterior and posterior lobes, and the tricuspid valve includes anterior, posterior and septal lobes. Normally, when the left or right ventricle contracts, the edges of any two adjacent leaflets of the mitral or tricuspid valve should be fully coaptated, avoiding blood flow from the ventricle to the atrium. If the mitral or tricuspid valve is not properly coaptated, the mitral or tricuspid valve may not close completely when the left or right ventricle contracts, resulting in regurgitation of blood from the ventricle to the atrium, causing a series of pathophysiological changes, called "mitral regurgitation" or "tricuspid regurgitation", an example of which is shown in fig. 2.

Transcatheter valve treatment techniques refer to delivering a heart implant, such as a valve repair device, through a catheter to the mitral valve or tricuspid valve, and controlling the function of the heart implant in vivo by remotely operating corresponding function buttons on a control handle outside the patient's body, thereby repairing or replacing the diseased mitral valve or tricuspid valve, and thereby treating mitral or tricuspid valve regurgitation. And operating corresponding function keys on the control handle, wherein the function control keys are connected with the control wires through one or more inner cavities of the catheter of the conveying system, so as to control the function of the internal heart implant. Typical delivery paths for cardiac implants include the transfemoral vein, the right atrium, the septum and the left atrium, eventually reaching the mitral or tricuspid valve, as well as the transapical path, which is also long and has multiple bends. Thus, after the delivery catheter system has been routed through a longer path and bent at multiple locations, the connection control wires located within the delivery catheter may buckle or shift, or even break. Thereby affecting the precise manipulation of the heart implant within the body by operating the control handle.

In summary, it is a technical difficulty in the art to ensure that one or more connection control wires in the delivery catheter system are not abnormal in function after passing through a longer path and bending multiple times, and to enable accurate manipulation of the heart implant in the body by operating the control handle.

Disclosure of Invention

In order to solve the above technical problems, or at least partially solve the above technical problems, the present utility model provides a cardiac implant delivery system.

A cardiac implant delivery system for delivering a cardiac implant to a cardiac treatment area, comprising:

a delivery catheter comprising a distal section for connecting to the cardiac implant and a proximal section for connecting to the distal section, the distal section having a first stiffness and the proximal section having a second stiffness, the first stiffness being less than the second stiffness, the delivery catheter comprising a main lumen extending from the proximal section to the distal section, a plurality of secondary lumen bonded to the main lumen, respectively, and an integral sheath layer surrounding the secondary lumen and the outer periphery of the main lumen, the main lumen protruding with a connecting structure for releasable connection to the cardiac implant, the secondary lumen for receiving a control wire for controlling the cardiac implant; and

a controller coupled to the proximal section of the delivery catheter for manipulating the connection structure and the control wire.

In a preferred embodiment, the heart implant further comprises a driving shaft connected with the controller, the connecting structure is provided with a cavity channel communicated with the main cavity tube, the heart implant is provided with a pair of clamping pieces which can be opened and closed relatively and a control shaft for controlling the opening and the closing of the clamping pieces, and the driving shaft penetrates through the main cavity tube and the cavity channel of the connecting structure to be detachably connected with the control shaft.

In a preferred embodiment, an elastic supporting layer is further arranged in the main cavity tube, the driving shaft is accommodated in the supporting layer, the sheath layer comprises a metal woven mesh and a thermoplastic material layer, the thermoplastic material layer is formed on the metal woven mesh in a hot melting mode and penetrates through meshes of the metal woven mesh to adhere to the periphery of the main cavity tube and the periphery of the auxiliary cavity tube so as to adhere the auxiliary cavity tube and the main cavity tube, and materials of the main cavity tube and the auxiliary cavity tube are different from those of the thermoplastic material layer.

In a preferred embodiment, the auxiliary cavity tube comprises at least one first auxiliary cavity tube and two second auxiliary cavity tubes, the inner diameter of the main cavity tube is equal to the inner diameter of the first auxiliary cavity tube, the inner diameter of the second auxiliary cavity tube is equal to the inner diameter of the second auxiliary cavity tube, the heart implant is provided with a pair of limiting elastic pieces positioned on the inner side of the clamping piece, the main cavity tube is further provided with a locking structure in a protruding mode, the locking structure is movably sleeved outside the connecting structure, the first auxiliary cavity tube is used for accommodating a locking control wire for controlling the locking structure, and the second auxiliary cavity tube is used for accommodating a limiting elastic piece control wire for controlling the limiting elastic pieces.

In a preferred embodiment, the outer diameter of the delivery conduit is less than or equal to 6mm, the inner diameter of the main lumen tube is less than or equal to 2mm, the inner diameter of the first secondary lumen tube is less than 2mm, the inner diameter of the second secondary lumen tube is less than or equal to 1mm, and the wall thickness between the main lumen tube and the first secondary lumen tube ranges between 0.05 and 1mm, and the wall thickness between the main lumen tube and the second secondary lumen tube ranges between 0.05 and 0.5 mm.

In a preferred embodiment, the metal mesh comprises a first mesh segment, a second mesh segment and a third mesh segment from the distal segment to the proximal segment, the first mesh segment having a mesh density < the second mesh segment having a mesh density < the third mesh segment, the thermoplastic material layer having a hardness in the range of 25D to 40D in the distal segment and a hardness in the range of 40D to 80D in the proximal segment.

In a preferred embodiment, the proximal section further has a third durometer, the second durometer catheter section is proximal to the distal section, the third durometer catheter section is proximal to the controller, the first mesh density is 45 PPI-60 PPI, the second mesh density is 35 PPI-45 PPI, and the third mesh density is 20 PPI-35 PPI, the first durometer is 35D, the second durometer is 55D, and the third durometer is 72D.

In a preferred embodiment, the cardiac implant further comprises a spacer positioned between the pair of limiting elastic sheets, the locking structure comprises a first part connected with the main cavity tube, an elastic structure connected with the first part, and a second part connected with the elastic structure, the connecting structure is connected with the spacer, the second part is sleeved outside the spacer and the connecting structure, and the second part can be separated from the connecting structure after the second part compresses the elastic structure by pulling the second part through the locking control wire, so that the connecting structure is separated from the spacer.

In a preferred embodiment, each of said clamping members is a solid clamping piece or a hollow clamping frame.

In a preferred embodiment, the device further comprises a first control elbow pipe and a second control elbow pipe movably sleeved outside the first control elbow pipe, the conveying pipe movably penetrates through the first control elbow pipe, the distal end of the first control elbow pipe is provided with a first steerable bending section, the distal end of the second control elbow pipe is provided with a second steerable bending section, the second steerable bending section is controlled to drive the first control elbow pipe and the conveying pipe to bend, and the first steerable bending section is controlled to drive the conveying pipe to bend.

The valve clamping device provided by the utility model has at least the following beneficial effects:

the main cavity tube and the auxiliary cavity tubes are bonded to form a whole, the conveying guide tube has different hardness sections, the far end section has lower hardness and is suitable for bending in-vivo conveying paths, so that the service life of the connecting structure of the heart implant connected with the guide tube or the control wire accommodated in the guide tube is prolonged, and conveying and controlling are not interfered with each other.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate some embodiments of the utility model and together with the description, serve to explain the principles of the utility model.

In order to more clearly illustrate the embodiments of the utility model or the technical solutions of the prior art, the drawings which are used in the description of the embodiments or the prior art will be briefly described, and it will be obvious to a person skilled in the art that other drawings can be obtained from these drawings without inventive effort.

FIG. 1 is a schematic illustration of the mitral and tricuspid valves in a normal state;

fig. 2 is a schematic view of the tricuspid valve of fig. 1 in the event of a disease;

FIG. 3 is a schematic illustration of a cardiac implant delivery system with a cardiac implant attached, provided in accordance with an embodiment of the present utility model;

FIG. 4 is a schematic cross-sectional view of a delivery catheter of the cardiac implant delivery system of FIG. 3;

FIG. 5 is a schematic perspective view of a different lumen tube of the delivery catheter of FIG. 4;

FIG. 6 is a schematic perspective view of the delivery catheter of FIG. 4;

FIG. 7 is a schematic view of a metal braid mesh layer in the delivery catheter of FIG. 4;

FIG. 8 is a schematic partial cross-sectional view of the delivery catheter of FIG. 6 further provided with a resilient support layer on the inside, a hydrophilic coating on the outside, and a connecting structure and locking structure on the ends;

FIG. 9 is a schematic cross-sectional view of the delivery catheter of FIG. 8;

FIG. 10 is a schematic view of the connecting structure of the delivery catheter of FIG. 8 ready for connection to a cardiac implant;

FIG. 11 is a schematic view of the connection structure of FIG. 10 connected to a cardiac implant, with the locking structure locking the connection structure;

fig. 12 is a schematic diagram of a simulated operation of the cardiac implant delivery system of fig. 3 further including a first control elbow and a second control elbow.

Detailed Description

The following description of the embodiments of the present utility model will be made clearly and fully with reference to the accompanying drawings, in which it is evident that the embodiments described are only some, but not all embodiments of the utility model. All other embodiments, which can be made by those skilled in the art based on the embodiments of the utility model without any inventive effort, are intended to be within the scope of the utility model.

In describing the present utility model, it should be noted that:

the terms "upper," "lower," "inner," "outer," and the like are used for convenience in describing and simplifying the description only, and do not denote or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus should not be construed as limiting the utility model. Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying relative importance;

when an element is referred to as being "fixed" or "disposed on" another element, it can be directly connected to the other element or be indirectly connected to the other element through one or more connecting elements. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or be connected to the other element by one or more connecting elements.

In the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator; the direction of the rotation central axis of the column body, the tube body and other objects is defined as an axial direction; the circumferential direction is the direction (perpendicular to the axis and the radius of the section) around the axis of the cylinder, the pipe body and the like; radial refers to a direction along the wire diameter or radius. It is noted that the term "end" as used in the terms of "proximal", "distal", "one end", "other end", "first end", "second end", "initial end", "terminal", "both ends", "free end", "upper end", "lower end", etc. is not limited to a tip, endpoint or end face, but includes a location extending an axial distance and/or a radial distance from the tip, endpoint or end face over the element to which the tip, endpoint or end face belongs. The above definitions are for convenience of description only and are not to be construed as limiting the utility model.

Referring to fig. 3 and 4, a cardiac implant delivery system 100 for delivering a cardiac implant 200 according to an embodiment of the present utility model includes a delivery catheter 110 and a controller 120, wherein the cardiac implant 200 is detachably connected to a distal end of the delivery catheter 110, and the controller 120 is connected to a proximal end of the delivery catheter 110 in a handle form.

The delivery catheter 110 is broadly divided into a distal section 112 including the distal end and a proximal section 114 including the proximal end. The distal segment 112 and the proximal segment 114 have different durometers, the distal segment 112 having a first durometer and the proximal segment 114 having a second durometer, the first durometer being less than the second durometer such that the distal segment 112 is softer and the proximal segment 114 is stiffer, the proximal segment 114 supporting the distal segment 112, the distal segment 112 being adapted to accommodate curved delivery paths in vascular and cardiac tissue.

The delivery catheter 110 is made primarily of a polymeric material, typically having an outer diameter within 6mm, preferably less than 4mm, so that the overall catheter is flexible and elongate, and is adapted for use in stenotic and tortuous vascular pathways of the human body.

The delivery catheter 110 is formed by bonding a main cavity tube 111 and a plurality of auxiliary cavity tubes 113, each two cavities of the main cavity tube 111 and the plurality of auxiliary cavity tubes 113 are spaced from each other, and a sheath layer 115 is sleeved on the peripheries of the main cavity tube 111 and the plurality of auxiliary cavity tubes 113. In the present embodiment, the main cavity tube 111 is located in the middle, and the plurality of sub cavity tubes 113 are located around the main cavity tube 111. The main cavity tube 111 is larger, the auxiliary cavity tube 113 is smaller, and different numbers and sizes of auxiliary cavity tubes can be arranged according to the different effects of the auxiliary cavity tube 113.

Referring to fig. 5-6, the main cavity tube 111 and the plurality of auxiliary cavity tubes 113 may be formed separately into cavity tubes with different sizes, and this embodiment provides a main cavity tube 111 and three auxiliary cavity tubes 113, and then the main cavity tube 111 and the plurality of auxiliary cavity tubes 113 are bonded and coated into a whole by using the material of the heat-melted sheath layer 113 to form the delivery catheter 110. Preferably, the delivery catheter 110 may be formed in one step using a mold, which is inserted into different small cavities of one mold using different size backing rods, then the body material of the main cavity tube 111 and the plurality of secondary cavity tubes 113, such as polytetrafluoroethylene, may be melt-cast around each backing rod, and then the material of the sheath layer 113 is melt-cast into the large cavity of the mold, so that the material of the sheath layer 113 is bonded to the main cavity tube 111 and the secondary cavity tubes 113 to form a single body. The main cavity tube and the auxiliary cavity tube may be made of the same or different materials. The main cavity tube and the auxiliary cavity tube are made of different materials from the sheath layer.

The hot-melt material of the sheath layer 115 is a thermoplastic material, which is one material selected from nylon, polyamide, block polyamide, polyurethane, or a copolymer composition of several or all of these thermoplastic materials. In this embodiment, the sheath layer 115 includes a metal mesh braid 115a in addition to the thermoplastic material layer 115b, and the thermoplastic material layer 115b includes an outer layer 115c around the metal mesh braid 115a, and an adhesive layer 115d between the metal mesh braid 115a and the main lumen tube 111 and the plurality of sub-lumen tubes 113. The metal mesh 115a plays a reinforcing role for the thermoplastic material layer 115b and the entire delivery catheter 110, and the metal mesh 115a may be previously placed in a mold, the thermoplastic material layer 115b is formed on the metal mesh 115a by hot melt flow, and penetrates between the metal mesh 115a and the main lumen tube 111 and the three sub-lumen tubes 113 through the mesh holes of the metal mesh 115 a.

Referring to fig. 7, the metal mesh grid 115a includes a first mesh grid segment 115e, a second mesh grid segment 115f and a third mesh grid segment 115g, the metal mesh grid 115a is wound around the main cavity tube 111 and the plurality of secondary cavity tubes 113, the first mesh grid segment 115e is close to the distal end, the third mesh grid segment 115g is close to the proximal end, and in this embodiment, the first mesh grid segment 115e, the second mesh grid segment 115f and the third mesh grid segment 115g are continuously woven or wound to form a continuous metal mesh grid 115a, and the weaving density of the first mesh grid segment is less than the weaving density of the second mesh grid segment is less than the weaving density of the third mesh grid segment. This different braid density also allows delivery catheter 110 to be formed with different degrees of flexibility, i.e., with different durometers, from the distal end to the proximal end. In this embodiment, the first woven mesh has a density of 45PPI to 60PPI, the second woven mesh has a woven density of 35PPI to 45PPI, and the third woven mesh has a woven density of 20PPI to 35PPI. The wire of the metal mesh 115a may be a round or flat stainless wire having a size of about 0.03 to 0.30 mm.

The thermoplastic material layer 115b may also be formed with different material densities in the distal section and the proximal section to have a hardness in the range of 25D to 40D, in the proximal section to have a hardness in the range of 40D to 80D, or to further provide a third hardness in the proximal section. In one embodiment, the distal section 112 has a shorter length and the proximal section 114 has a longer length, and the proximal section 114 may further have a third durometer, the second durometer being the conduit section adjacent the distal section 112 and the third durometer being the conduit section adjacent the controller 120, the third durometer being greater than the second durometer. That is, there are at least two durometers, a first durometers and a second durometers, from the distal end to which the cardiac implant is connected to the proximal end closest to the controller 120; or there may be three of a first hardness, a second hardness, and a third hardness, the three hardness may be, for example, 35D for the first hardness, 55D for the second hardness, and 72D for the third hardness.

In this embodiment, the heart implant 200 is used for repairing heart valves, particularly mitral valve and tricuspid valve, and basically includes a pair of clamping members 210 that can be opened and closed relatively, and a pair of limiting elastic pieces 220 located inside the clamping members. The clamping members 210 may be solid or hollow, with two opposing clamping members 210 clamping the valve leaflet that may be used to clamp the valve, and the retainer clip 220 to assist in clamping the leaflet. The clamping member 210 is driven by a driving shaft, the limiting elastic piece 220 is pulled by a control wire, and the control wire has a locking function in addition to the control wire of the limiting elastic piece 220.

The main lumen tube 111 is provided with a connection structure 118 detachably connected to the heart implant 200 in a protruding manner, and the auxiliary lumen tube is used for accommodating the control wire. According to different functions of the control wires, the auxiliary cavity tube 113 of the present embodiment includes at least one first auxiliary cavity tube 113a and two second auxiliary cavity tubes 113b, wherein the first auxiliary cavity tube 113a is used for accommodating the control wires 113h with locking functions, and the two second auxiliary cavity tubes 113b are used for accommodating the control wires 113j for controlling the limiting spring piece 220. The limiting spring 220 is a spring, and is light, so that the thinner control wire 113j can be controlled; while the control wire 113h of the locking function may be thicker, the first auxiliary lumen 113a may be slightly larger in size than the two second auxiliary lumen 113b depending on the thickness of the control wire.

The main cavity tube 111 is used to house a driving shaft 111a (see fig. 10) that drives the opening and closing of the nip 210. The connection structure 118 has a hollow channel in communication with the main lumen tube 111, and the drive shaft can pass through the hollow channel of the main lumen tube 111 and the connection structure 118. The drive shaft is thicker than the control wire, so the inner diameter of the main lumen tube 111 > the inner diameter of the first sub lumen tube 113a > the inner diameter of the second sub lumen tube 113b. Referring again to fig. 4, the inner diameter D of the main lumen tube 111 may be less than or equal to 2mm, preferably less than 1.5mm; the inner diameter D1 of the first secondary lumen tube 113a is less than 2mm, preferably less than 1mm; the second secondary lumen tube 113b has an inner diameter D2 of less than or equal to 1mm, preferably less than 0.6mm. The driving shaft 111a may be detachably connected to the control shaft 230 of the heart implant 200 after passing through the main lumen 111 and the lumen of the connecting structure 118, and the control shaft 230 is driven by the driving shaft 111a to drive the clamping member 210 to open and close.

The delivery catheter 110 has a certain thickness to prevent the control wires from being twisted and folded with each other in order to resist compression and maintain lateral flexibility of the tube body when passing through the bent position, and the main lumen tube 111, the first sub lumen tube 113a and the second sub lumen tube 113b need to have a certain thickness with each other, so as to avoid the lumen from being broken or perforated to be connected to another lumen. The wall thickness range L2 between the main cavity tube 111 and the second cavity channel 113a is between 0.05 and 2mm, preferably between 0.05 and 0.5 mm. The wall thickness range L1 between the main cavity tube 111 and the first cavity 113b is between 0.05 and 2mm, preferably between 0.05 and 1 mm.

Referring to fig. 8 and fig. 9 together, an elastic supporting layer 117 may be further disposed in the main cavity tube 111, the driving shaft 111a is accommodated in the supporting layer 117, after the conveying catheter 110 conforms to the curved and narrowed path when passing through the curved vascular path of the human body, since the tube body does not have the ability to restore the straightness, the supporting layer 117 may provide the supporting function of the conveying catheter after the tube body of the conveying catheter 110 passes through the curved vascular, so as to ensure that the conveying catheter 110 is vertically directed to the lesion position when reaching the lesion position, rather than being bent and twisted to be directed to the lesion position, thereby reducing the operation of adjusting the apparatus by a doctor, reducing the operation time, and improving the accuracy of the operation.

The supporting layer of this embodiment may have a circular structure with rebound resilience of about 0.8 to 3.0mm in outer diameter, or may have an irregular shape such as a flat shape, and this embodiment uses a spring tube with rebound resilience. It is understood that in other embodiments, other structures formed from nickel titanium may be used.

In addition, in order to better pass through the narrow and curved vascular path of the human body, a section of hydrophilic material layer 115h can be coated on the outer surface of the outer layer 115c of the conveying catheter 110, so that friction resistance generated in the using process is reduced, vascular and lumen tissue damage is avoided, meanwhile, the generation of a plurality of bad complications is reduced, and meanwhile, pain and discomfort brought to patients are also reduced. The hydrophilic material layer 115h may be hydrophilic polymer material such as polyvinylpyrrolidone (PVP), polyacrylamide (PAM), polyethylene glycol (PEG), polyvinyl alcohol (PVA), natural polysaccharide, and derivatives.

After the delivery catheter 110 is formed, the distal end of the main lumen tube 111 and the connection structure 118 may be integrally formed by hot melt or bonded in the form of a protruding arrangement of the connection structure 118.

Referring to fig. 10 and 11 together, the connecting structure 118 includes two opposite connecting arms, the cardiac implant 200 has a corresponding mating structure 240, and the connecting arms of the connecting structure 118 and the mating structure 240 may be connected in various manners, in this embodiment, one of the connecting arms and the mating structure 240 may be provided with a buckle, and the other may be provided with a slot to form a buckle-type connection. The heart implant 200 has a spacer 250 between the limit tabs 220, and the mating structure 240 is disposed on the spacer 250.

The main cavity tube 111 is further provided with a locking structure 119 in a protruding manner, the locking structure 119 is movably sleeved outside the connecting structure 118, the locking structure 119 comprises a first portion 119a connected with the main cavity tube 111, an elastic structure 119b connected with the first portion 119a, and a second portion 119c connected with the elastic structure 119b, and the second portion 119c is sleeved outside the spacer 250 and the connecting structure 118 which are connected, so that a locked state (see fig. 10) is formed for the connecting structure, and the locked state can be completed when the heart implant 200 is loaded before an operation. After implantation of the cardiac implant 200 into the cardiac surgical site, the second portion 119c may be separated from the connecting structure 118 by pulling the second portion 119c through the locking control wire 113h to compress the elastic structure 119b, such that the connecting structure 118 is separated from the spacer 250, thus releasing the cardiac implant 200 into the cardiac surgical site.

Referring again to fig. 1, the controller 120 is in the form of a handle for the physician to operate and control, and has a clamp drive shaft control mechanism 120a, a limit spring control wire control mechanism 120b, and a locking mechanism control wire control mechanism 120c. The control mechanism 120a of the clip drive shaft is used to control the axial movement of the drive shaft within the main lumen tube 111 and the drive shaft extends out of the hollow lumen of the connecting structure 118 to be removably connected to the control shaft 230 of the heart implant 200. The control mechanism 120b of the limiting spring piece control wire is used for a doctor to operate the control wire of the limiting spring piece, so that the control wire can independently and axially move in the two auxiliary cavity tubes 113b, and the limiting spring piece is pulled to adjust the position of the limiting spring piece, or the limiting spring piece is released to be used for auxiliary clamping of the valve leaflet. The control mechanism 120c of the locking mechanism control wire is used to provide a physician with access to the locking mechanism control wire so that the locking mechanism may unlock the heart implant 200.

Referring to fig. 12, the delivery catheter 110 may also be loaded into a first control elbow 310 during use, and the first control elbow 310 may in turn be loaded into a second control elbow 410. The first control bend 310 and the second control bend 410 have respective controls 310a,410a, the distal end of the first control bend 310 having a first steerable bend section 310b, the distal end of the second control bend 410 having a second steerable bend section 410b, the first steerable bend section 310b and the second steerable bend section 410b being connectable to the controls 310a,410a by anchor rings and control wires carried thereon, the physician manipulating the controls 310a steering the second steerable bend section 410a to bend the first control bend 310 and the delivery catheter 110, the manipulating controls 410a steering the first steerable bend section 310a to bend the delivery catheter 110.

Taking the treatment of the mitral valve of the heart as an example, by adopting a femoral vein puncture mode, the second control elbow 410 establishes a path from outside the body to enter the left atrium by crossing the atrial septum 400, the first control elbow 310 passes through the inner cavity of the second control elbow 410 to reach the left atrium, and the distal end of the first control elbow 310 is adjusted to face the mitral valve 500 by adjusting the controller 310a of the first control elbow 310; because the delivery catheter 110 is disposed within the lumen of the first control elbow 310, the delivery catheter 110 meets the requirements of the diseased heart mitral valve 500 by controlling the distal end of the first control elbow 310 toward the mitral valve 500.

In summary, the delivery catheter of the cardiac implant delivery system provided by the utility model extends from the proximal end section to the distal end section with the independent main lumen tube and the plurality of auxiliary lumen tubes, the main lumen tube and the plurality of auxiliary lumen tubes are bonded to form a whole, the delivery catheter has different hardness sections, the distal end section has lower hardness and is suitable for bending in an in-vivo delivery path, so that the service life of a connection structure of the cardiac implant connected with the catheter or a control wire accommodated in the catheter is prolonged, and the delivery and the control do not interfere with each other.

The cardiac implant delivery system is suitable for use in mitral valve therapy or tricuspid valve therapy, although it may be adapted for use with other implants in the heart and may be delivered via the transapical route in addition to the transfemoral approach described above.

The foregoing is only a specific embodiment of the utility model to enable those skilled in the art to understand or practice the utility model. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the utility model. Thus, the present utility model is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A cardiac implant delivery system for delivering a cardiac implant to a cardiac treatment area, comprising:

2. The cardiac implant delivery system of claim 1, further comprising a drive shaft coupled to the controller, the coupling structure having a lumen in communication with the main lumen, the cardiac implant having a pair of relatively openable and closable clamps and a control shaft for controlling the opening and closing of the clamps, the drive shaft being removably coupled to the control shaft through the main lumen and the lumen of the coupling structure.

3. The cardiac implant delivery system of claim 2, wherein the main lumen tube is further provided therein with an elastic support layer, the drive shaft being received in the support layer, the sheath layer comprising a metal mesh and a thermoplastic material layer, the thermoplastic material layer being heat fused to the metal mesh and penetrating the mesh of the metal mesh to adhere to the outer periphery of the main lumen tube and the outer periphery of the auxiliary lumen tube to bond the auxiliary lumen tube and the main lumen tube, the main lumen tube and the auxiliary lumen tube being of a material different from that of the thermoplastic material layer.

4. The cardiac implant delivery system of claim 2, wherein the secondary lumen comprises at least a first secondary lumen and two secondary lumens, the primary lumen having an inner diameter greater than the first secondary lumen and an inner diameter greater than the second secondary lumen, the cardiac implant having a pair of spacing domes located inside the clip, the primary lumen further having a locking structure protruding from the connecting structure, the locking structure movably sleeved outside the connecting structure, the first secondary lumen being configured to receive a locking control wire for controlling the locking structure, the second secondary lumen being configured to receive a spacing dome control wire for controlling the spacing domes.

5. The cardiac implant delivery system of claim 4, wherein the delivery catheter has an outer diameter of less than or equal to 6mm, the primary lumen has an inner diameter of less than or equal to 2mm, the first secondary lumen has an inner diameter of less than 2mm, the second secondary lumen has an inner diameter of less than or equal to 1mm, and the primary lumen and the first secondary lumen have a wall thickness in a range of between 0.05 and 1mm, and the primary lumen and the second secondary lumen have a wall thickness in a range of between 0.05 and 0.5 mm.

6. The cardiac implant delivery system of claim 3, wherein the metallic mesh comprises a first mesh segment, a second mesh segment, and a third mesh segment from the distal segment to the proximal segment, the first mesh segment having a mesh density < the second mesh segment having a mesh density < the third mesh segment, the thermoplastic material layer having a durometer in the range of 25D to 40D in the distal segment and a durometer in the range of 40D to 80D in the proximal segment.

7. The cardiac implant delivery system of claim 6, wherein the proximal segment further has a third durometer, the second durometer catheter segment is proximal to the distal segment, the third durometer catheter segment is proximal to the controller, the first braided mesh segment has a braid density of 45-60 PPI, the second braided mesh segment has a braid density of 35-45 PPI, and the third braided mesh segment has a braid density of 20-35 PPI, the first durometer is 35D, the second durometer is 55D, and the third durometer is 72D.

8. The cardiac implant delivery system of claim 4, wherein the cardiac implant further comprises a spacer positioned between the spacing domes, the locking structure comprises a first portion connected to the main lumen, a resilient structure connected to the first portion, and a second portion connected to the resilient structure, the connection structure is connected to the spacer, the second portion is sleeved outside the spacer and the connection structure, and pulling the second portion through the locking control wire causes the second portion to compress the resilient structure, thereby separating the second portion from the connection structure and the spacer.

9. The cardiac implant delivery system of claim 2, wherein each of the clamping members is a solid clamping piece or a hollow clamping frame.

10. The cardiac implant delivery system of claim 1, further comprising a first control elbow and a second control elbow movably sleeved outside the first control elbow, the delivery catheter movably passing through the first control elbow, a distal end of the first control elbow having a first steerable bend section, a distal end of the second control elbow having a second steerable bend section, steering the second steerable bend section to bend the first control elbow and the delivery catheter, steering the first steerable bend section to bend the delivery catheter.