Cardiac patch delivery devices, systems, and corresponding delivery methods and methods of use

Abstract

The invention discloses a heart patch conveying device and system and a corresponding conveying method and a using method. The heart patch conveying device comprises a sheath tube, a conveying device and a conveying device, the first conveying assembly comprises a conveying seat; the second conveying assembly comprises a positioning piece; in the working state, the heart patch is unfolded and is provided with a first side and a second side which are opposite in the thickness direction of the heart patch, and the conveying base and the positioning piece support the heart patch on the two sides of the thickness direction of the heart patch. According to the technical scheme, through optimization of the heart patch conveying device, the defects in the prior art are effectively overcome, the safe, stable and efficient conveying process can be achieved, and a solid foundation is provided for the treatment effect.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to cardiac patch delivery devices, systems, and corresponding delivery methods and usage methods. Background Art

[0002] As heart disease research deepens, the advantages of cardiac patches are becoming increasingly apparent. Currently, the main steps in cardiac patch repair include chest incision, sheath implantation, patch delivery, patch release, patch compression to complete the repair, sheath removal, and wound suturing.

[0003] The inventors discovered that since heart patches are usually soft in texture, if the combination with the carrier is not tightly connected and easy to release, the patch may fall off during transportation and become entangled during the repair process, making it impossible to complete the entire repair process, resulting in prolonged surgery and greater surgical risks. There is room for improvement in the existing heart patch delivery system. Summary of the Invention

[0004] In order to solve the above technical problems, the present application discloses a cardiac patch delivery device, comprising:

[0005] Sheath, to establish the delivery channel;

[0006] A first conveying assembly includes a conveying seat at the distal end and a first control member extending from the conveying seat to the proximal end;

[0007] A second delivery assembly includes a positioning member located at the distal end and a second control member extending from the positioning member to the proximal end;

[0008] The first conveying assembly and the second conveying assembly have a working state extending out of the distal end of the sheath. In the working state, the heart patch is unfolded and has a first side and a second side relative to each other in the thickness direction of itself. The conveying seat and the positioning member support the heart patch on both sides of the thickness direction of the heart patch.

[0009] Several optional methods are also provided below, but they are not intended to be additional limitations on the above-mentioned overall solution. They are merely further supplements or optimizations. Under the premise that there are no technical or logical contradictions, each optional method can be combined separately for the above-mentioned overall solution, or multiple optional methods can be combined.

[0010] Optionally, the delivery seat is an elastic or deformable structure, and in the working state, the delivery seat is spatially expanded into a ring shape to support the heart patch.

[0011] Optionally, the first conveying component is a split structure or an integrated structure;

[0012] When the first conveying component is an integrated structure, the first conveying component is a slender strip component with a distal end pre-shaped into a ring structure, the ring structure forms the conveying seat, and the portion of the slender strip component passing through the sheath forms the first control component.

[0013] Optionally, the positioning member is an elastic or deformable structure, and in the working state, the positioning member is spatially expanded into a ring shape to position the cardiac patch, and the ring shape defines a central area.

[0014] Optionally, in the working state, the positioning member is spatially expanded into a ring shape having an open area in the circumference, and the open area is located at the distal end.

[0015] Optionally, the positioning member is a slender strip member and extends continuously to form the ring shape.

[0016] Optionally, the positioning member includes two independently movable branches, each branch forming a ring, and in the working state, each branch is located on the same side of the heart patch.

[0017] Optionally, in the working state, each branch is arc-shaped.

[0018] Optionally, the two branches are substantially coplanar.

[0019] Optionally, in the working state, the distal ends of the branches are adjacent to each other, and the proximal ends are close to each other and are respectively configured with the second control member.

[0020] Optionally, the second conveying component is a split structure or an integrated structure; when the second conveying component is an integrated structure, the second conveying component is a slender strip component with a distal pre-shaped annular structure, the annular structure forms the positioning member, and the part of the slender strip component passing through the sheath forms the second control member.

[0021] The present application also discloses a cardiac patch delivery device, comprising:

[0022] Sheath, to establish the delivery channel;

[0023] A second conveying assembly includes a positioning member at a distal end and a second control member extending from the positioning member toward a proximal end, wherein the positioning member includes two independently movable branches, each branch forming a ring;

[0024] The second delivery component has a working state extending out of the distal end of the sheath, in which the heart patch is unfolded and has a first side and a second side opposite to each other in its thickness direction, and each branch supports the heart patch on the same side of the heart patch.

[0025] The present application also discloses a cardiac patch implantation system, comprising

[0026] The cardiac patch delivery device is the cardiac patch delivery device in the above technical solution;

[0027] A cardiac patch is connected to a cardiac patch delivery device.

[0028] The present application also discloses a cardiac patch implantation system, comprising

[0029] A cardiac patch delivery device including a positioning member;

[0030] a heart patch connected to the positioning member, wherein the heart patch has a first side and a second side opposite to each other in a thickness direction thereof after being unfolded;

[0031] a restraining wire, one end of which cooperates with the cardiac patch and the other end of which extends along the delivery channel to the proximal end;

[0032] The restraint wire passes through the first side, penetrates the cardiac patch at least once, passes through the second side, and then returns to the first side to form a restraint ring. The positioning element passes through the restraint ring and holds the restraint ring on the second side.

[0033] Optionally, the constraint line forms a plurality of constraint rings, and the positioning member passes through each constraint ring in sequence in its own extension direction.

[0034] Optionally, the cardiac patch delivery device further includes a delivery seat. In a working state, the positions of the delivery seat and the positioning member correspond to each other. A wire hole is provided on the cardiac patch near the positions corresponding to the delivery seat and the positioning member, and the constraint wire forms the constraint ring through the wire hole.

[0035] Optionally, there are multiple wire-passing holes on the heart patch and they are arranged in groups, each group of wire-passing holes contains at least two wire-passing holes, the constraint wire forms a constraint ring through one of the wire-passing holes and then forms another constraint ring through another wire-passing hole in the same group, and the positioning member passes through each constraint ring in turn.

[0036] Optionally, relative to the position of the positioning member, at least one wire-passing hole in the same group is located on a different side from the other wire-passing holes; in the radial direction of the heart patch, the constraint rings formed by the wire-passing holes in the same group are arranged opposite to each other.

[0037] Optionally, each group of wire holes is arranged at intervals near the outer edge of the heart patch.

[0038] Optionally, the positioning member includes two independently movable branches, each branch forming a ring;

[0039] There are two restraining lines, which are respectively matched with corresponding branches to complete the restraint.

[0040] Optionally, the constraint rings are arranged in groups, each group of constraint rings contains at least two, and each branch runs through at least three groups of constraint rings.

[0041] Optionally, the distal end of the constraint line is in a free state.

[0042] Optionally, the cardiac patch is provided with a positioning structure for positioning itself at a treatment position.

[0043] Optionally, the positioning structure is arranged on the first side and at least a portion thereof protrudes to invade the treatment position.

[0044] Optionally, the positioning structure is a microneedle.

[0045] Optionally, the cardiac patch is a cell-loaded patch or a drug-loaded patch.

[0046] Optionally, the cardiac patch delivery device includes a positioning member, which, in a working state, is spatially expanded into a ring shape to position the cardiac patch, wherein the ring defines a central area, and the positioning structure is located within the central area.

[0047] Optionally, the cardiac patch delivery device further comprises a balloon catheter, wherein the balloon catheter comprises:

[0048] an expansion body, disposed at the distal end, which, in a working state, can drive the cardiac patch to move in its own thickness direction by changing its own volume;

[0049] A pushing tube extending from the expansion body to the proximal end;

[0050] A driving device drives the expansion body to expand or contract.

[0051] The present application also discloses a cardiac patch implantation system, comprising

[0052] cardiac patch delivery devices;

[0053] A cardiac patch connected to the cardiac patch delivery device, wherein one side of the cardiac patch in the thickness direction is provided with a positioning structure for positioning the cardiac patch at a treatment position;

[0054] The balloon catheter, in a working state, acts on the other side of the cardiac patch and drives the positioning structure to be combined with the treatment position.

[0055] The present application also discloses a method for pre-installing a cardiac patch, comprising:

[0056] Providing a cardiac patch, wherein the cardiac patch has a first side and a second side in a thickness direction thereof;

[0057] Providing an annular positioning member, and pre-positioning the positioning member on the second side of the cardiac patch;

[0058] A restraint wire is provided, which passes through the first side, penetrates the cardiac patch at least once, passes through the second side, and then returns to the first side to form a restraint ring, and the positioning member passes through the restraint ring and holds the restraint ring on the second side.

[0059] The present application also discloses a method for using a cardiac patch implantation system, wherein the cardiac patch implantation system includes a cardiac patch, a balloon catheter, and a cardiac patch delivery device including a sheath, a first delivery component, and a second delivery component:

[0060] The cardiac patch is constrained on the first delivery component and the second delivery component by a constraining wire and is delivered to a treatment site via the sheath;

[0061] driving the first conveying assembly and the second conveying assembly to achieve relative movement between the first conveying assembly and the sheath tube and to deploy the cardiac patch;

[0062] driving the balloon catheter to drive the cardiac patch to move in the thickness direction so as to achieve the combination of the positioning structure on the cardiac patch and the treatment position;

[0063] withdrawing the second delivery assembly to release the constrained relationship between the constraining wire and the cardiac patch;

[0064] withdrawing the restraining wire to release the restraining relationship between the cardiac patch and the first delivery assembly;

[0065] The cardiac patch implantation system is withdrawn.

[0066] The technical solution disclosed in this application effectively overcomes the shortcomings of the existing technology by optimizing the cardiac patch delivery device, can achieve a safe, stable and efficient delivery process, and provides a solid foundation for better therapeutic effects.

[0067] The specific beneficial technical effects will be further explained in conjunction with specific structures or steps in the specific implementation methods. BRIEF DESCRIPTION OF THE DRAWINGS

[0068] Figure 1 and Figure 2 Schematic diagrams of the delivery device and implantation system in the first embodiment respectively;

[0069] Figure 3 and Figure 4 Schematic diagrams of the delivery device and implantation system in the second embodiment respectively;

[0070] Figure 5 This is a schematic diagram of the implantation system in the third embodiment;

[0071] Figures 6 and 7 This is a schematic diagram of the implantation system in the fourth embodiment;

[0072] Figure 8 for Figure 6 Enlarged view of the corresponding part;

[0073] Figure 9 for Figure 7 Enlarged view of the corresponding part;

[0074] Figures 10 to 12 This is a schematic diagram of the implantation system in the fifth embodiment;

[0075] Figures 13 and 14 Schematic diagram of the use process of the implant system in one embodiment.

[0076] The reference numerals in the figures are described as follows:

[0077] 1. Sheath;

[0078] 2. First conveying assembly; 21. Conveying seat;

[0079] 3. Second conveying assembly; 31. Positioning member; 311. Central area; 312. Open area; 313. Branch; 32. Second control member;

[0080] 4. Constraint line; 41. Constraint ring;

[0081] 5. Balloon catheter; 51. Expander; 52. Push tube;

[0082] 6. Control handle; 61. Bending handle; 62. Delivery handle; 63. Expander; 631. Small incision;

[0083] 9. Heart patch; 91. Positioning structure; 911. Treatment location; 912. Pericardial structure; 92. Wire hole. DETAILED DESCRIPTION

[0084] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0085] It should be noted that when a component is referred to as being "connected" to another component, it may be directly connected to the other component or there may be an intermediate component. When a component is referred to as being "disposed on" another component, it may be directly disposed on the other component or there may be an intermediate component.

[0086] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this application pertains. The terms used herein in the specification of this application are for the purpose of describing specific embodiments only and are not intended to limit this application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0087] Reference Attachment Figure 1 As shown, the present application discloses a cardiac patch delivery device, comprising:

[0088] Sheath 1, establishes the delivery channel;

[0089] The first conveying assembly 2 includes a conveying seat 21 at the distal end and a first control member extending from the conveying seat 21 to the proximal end;

[0090] The second conveying assembly 3 includes a positioning member 31 at the distal end and a second control member 32 extending from the positioning member 31 to the proximal end;

[0091] The first conveying component 2 and the second conveying component 3 have a working state extending out of the distal end of the sheath 1. In the working state, the heart patch 9 is unfolded and has a first side and a second side relative to each other in the thickness direction of itself. The conveying seat 21 and the positioning member 31 support the heart patch 9 on both sides of the thickness direction of the heart patch 9.

[0092] The term "support" as used herein should be understood to mean that the delivery base 21 and the positioning member 31 are capable of maintaining the cardiac patch 9 in its deployed state and positioning it relative to the patient in space. The coordination of the first and second delivery components 2 and 3 (particularly the delivery base 21 and the positioning member 31) stabilizes the cardiac patch 9 throughout the delivery process, thereby improving the delivery efficiency.

[0093] The specific configuration of the first delivery assembly 2 can be selected from existing delivery structures, or refer to the embodiment shown in the accompanying drawings. In the drawings, the delivery seat 21 is elastically configured. In the operating state, the delivery seat 21 spatially expands into a ring to support the cardiac patch 9. The elasticity of the delivery seat 21 can also be configured as a deformable structure to meet the needs of different operating conditions. Regarding the overall structure, the first delivery assembly 2 can be configured as a split structure, or as shown in the accompanying drawings, the first delivery assembly 2 can be a single-piece structure. In the drawings, the first delivery assembly 2 is a slender strip member with a pre-formed ring structure at the distal end. The ring structure forms the delivery seat 21, and the portion of the slender strip member that passes within the sheath 1 forms the first control element. The ring structure describes the overall shape of the distal end of the first delivery assembly 2, and some details can be adjusted. For example, the ring structure can be non-enclosed in the circumferential direction and have an open area 312; another example is that the entire ring structure is not in a coplanar plane. In terms of molding, the first delivery assembly 2 can be obtained through separate processing to obtain separate components, and then assembled through a separate or single-piece structure. Alternatively, the configuration shown in the accompanying drawings shows the first delivery assembly 2 being molded as a single piece. For example, the first conveying component 2 is a memory metal wire with a pre-shaped ring structure at the far end, which realizes switching between different states through its own elasticity.

[0094] In the specific setting of the second conveying component 3, an existing conveying structure can be selected, or reference can be made to the embodiment shown in the reference drawings, in which the positioning member 31 is elastically set. In the working state, the positioning member 31 is spatially expanded into a ring to position the cardiac patch 9, and the ring defines a central area 311. Similarly, the elastic setting of the positioning member 31 can also be set as a deformable structure to meet the use requirements in different states. The ring shape of the positioning member 31 also describes the overall shape of the positioning member 31, and some details can be adjusted. In addition to the setting methods mentioned above, you can also refer to the attached Figure 1 In the illustrated embodiment, in the operating state, the positioning member 31 spatially expands into a ring-shaped shape with an open area 312 circumferentially located at the distal end. The provision of the open area 312 allows for more flexible adjustment of the spatial representation of the ring-shaped shape of the positioning member 31. For example, the positioning member 31 shown in the accompanying drawings includes two independently movable branches 313, each of which encloses a ring. In the operating state, each branch 313 is located on the same side of the cardiac patch 9. Regarding the configuration details of the branches 313, in the operating state, each branch 313 is arc-shaped and substantially coplanar. In the operating state, the distal ends of each branch 313 are adjacent to each other. The term "adjacent" should be understood as meaning that the distal ends of each branch 313 are spatially close to each other. For example, the two branches overlap or align with each other; another example is that they abut against each other or have a gap. In the accompanying drawings, the size of the open area 312 on the circumference of the positioning member 31 ranges from 1 to 7 degrees relative to the central angle of the ring. The range may further preferably be 2.5 degrees to 5.5 degrees.

[0095] In the embodiment of the positioning member 31 having two branches 313, the positioning member 31 can be controlled by a single second control member 32, or, as shown in the accompanying drawings, the proximal ends of the positioning members 31 can be brought closer together and each of the second control members 32 can be configured separately. In this embodiment, the second conveying assembly 3 is essentially provided with two completely independent positioning members 31 and second control members 32.

[0096] In terms of the molding method of the second conveying component 3, separate parts can be obtained by separate processing, and then a separate or integrated structure can be realized through an assembly process; or it can be integrally molded into an integrated structure; when the second conveying component 3 is an integrated structure, the second conveying component 3 is a slender strip member with a pre-shaped annular structure at the distal end, the annular structure forms the positioning member 31, and the portion of the slender strip member that passes through the sheath 1 forms the second control member 32. The specific molding process can be, for example, first forming an integral annular positioning member 31, and then connecting it to the elongated second control member 32; or first forming two independent branches 313, and then connecting the two independent branches 313 to the elongated second control member 32; or first integrally molding a branch 313 and a second control member 32 to form an integrated structure, and then connecting an independent branch 313 to the above-mentioned integrated structure; or as shown in the accompanying drawings, an integrated structure of a branch 313 and a second control member 32 is obtained by integral molding, and two such integrated structures are independently provided to realize the second conveying component 3. It can be understood that the positioning member 31 shown in the drawings is a slender strip member that extends continuously to form a ring shape.

[0097] It is not difficult to understand the above, refer to the attached Figure 2 The present application also discloses a cardiac patch implantation system, comprising

[0098] A cardiac patch delivery device, which is the cardiac patch delivery device in the above technical solution;

[0099] The heart patch 9 is connected to the heart patch delivery device.

[0100] In addition to the above-mentioned conveying devices, see Appendix Figure 3 As shown, the present application also discloses a cardiac patch delivery device, comprising:

[0101] Sheath 1, establishes the delivery channel;

[0102] The second conveying assembly 3 includes a positioning member 31 at the distal end and a second control member 32 extending from the positioning member 31 to the proximal end. The positioning member 31 includes two independently movable branches 313, and each branch 313 is surrounded to form a ring.

[0103] The second conveying component 3 has a working state extending out of the distal end of the sheath 1. In the working state, the heart patch 9 is unfolded and has a first side and a second side relative to each other in the thickness direction of itself, and each branch 313 supports the heart patch 9 on the same side of the heart patch 9.

[0104] In this solution, the support effect for the cardiac patch 9 is achieved only by the second conveying assembly 3. The arrangement of the branches 313 of the positioning member 31 can be referred to the above description and will not be repeated here.

[0105] Similarly, refer to the attached Figure 4 The present application also discloses a cardiac patch implantation system, comprising

[0106] A cardiac patch delivery device, which is the cardiac patch delivery device in the above technical solution;

[0107] The heart patch 9 is connected to the heart patch delivery device.

[0108] In addition to the implant systems mentioned above, see Appendix Figure 5 As shown, the present application also discloses a cardiac patch implantation system, comprising

[0109] A cardiac patch delivery device comprising a positioning member 31;

[0110] The cardiac patch 9 is connected to the positioning member 31. When the cardiac patch 9 is unfolded, it has a first side and a second side opposite to each other in its thickness direction.

[0111] The restraining wire 4 has one end that cooperates with the cardiac patch 9 and the other end that extends along the delivery channel to the proximal end;

[0112] The restraint wire 4 passes through the first side, penetrates the cardiac patch 9 at least once to the second side, and then returns to the first side to form a restraint ring 41. The positioning member 31 passes through the restraint ring 41 and holds the restraint ring 41 on the second side.

[0113] In this embodiment, the cardiac patch 9 and the positioning member 31 are mutually constrained by the restraining wire 4. When the positioning member 31 passes through the restraining loop 41 formed by the restraining wire 4, the restraining wire 4 cannot be removed from the cardiac patch 9, thereby achieving a stable connection. When the positioning member 31 is removed from the restraining loop 41, the restraining wire 4 can be removed from the cardiac patch 9 because the topological structure of the restraining wire 4 does not contain any knots that would hinder its removal from the cardiac patch 9, thereby achieving contact and constraint between the cardiac patch 9 and the positioning member 31. This arrangement can simultaneously ensure sufficient restraint strength and low difficulty in releasing the restraint, thereby meeting delivery requirements and improving the operating experience.

[0114] In the specific setting of the restraint line 4, the restraint line 4 forms a plurality of restraint rings 41, and the positioning member 31 passes through each restraint ring 41 in its own extension direction. This setting can improve the restraint effect of the heart patch 9 and the positioning member 31, while ensuring the flatness of the heart patch 9. The restraint line can refer to Figure 5 The scheme shown in the figure is to directly puncture the cardiac patch to achieve the passage. Figure 6 To the attached Figure 9 In the embodiment shown, wire holes 92 are provided on the cardiac patch 9 near the portions corresponding to the delivery seat 21 and the positioning member 31, and the constraint wire 4 forms a constraint ring 41 through the wire holes 92. In coordination with the above, each group of wire holes 92 is spaced apart near the outer edge of the cardiac patch 9. That is, the mutual constraint positions of the positioning member 31 and the cardiac patch 9 are arranged in the circumferential direction of the cardiac patch 9. It can be observed in the figure that the distal end of the constraint wire 4 is in a free state. The proximal end of the constraint wire 4 can extend all the way to the proximal end of the sheath, thereby achieving a control effect. In some embodiments, the proximal end of the constraint wire 4 can be provided on a control handle, and the operation of the constraint wire can be achieved by the action of the control handle; you can also refer to the attached Figure 13 Or attach Figure 14 As shown in FIG, the proximal end of the restraining wire is directly exposed, and when the restraining effect of the restraining ring is released, the restraining wire can be withdrawn through the sheath.

[0115] Regarding the details of the arrangement of the wire holes 92, referring to the embodiment shown in the accompanying drawings, the cardiac patch 9 is provided with multiple wire holes 92 arranged in groups. Each group of wire holes 92 includes at least two wire holes 92. The constraint wire 4 passes through one of the wire holes 92 to form a constraint loop 41, and then passes through another wire hole 92 in the same group to form another constraint loop 41. The positioning member 31 passes through each constraint loop 41 in sequence. Relative to the position of the positioning member 31, at least one wire hole 92 in the same group is located on a different side from the other wire holes 92. In the radial direction of the cardiac patch 9, the constraint loops 41 formed by the wire holes 92 in the same group are arranged opposite each other.

[0116] Reference Attachment Figure 5 To the attached Figure 9 As shown in FIG, the cardiac patch delivery device can be provided with a positioning member 31 separately. The cardiac patch is supported by the restraining wire and the positioning member. Figure 7 The figure shows the coordination between the cardiac patch and the restraining wire when the positioning member is retracted. In this state, the restraining wire can be directly withdrawn from the vicinity of the cardiac patch, thereby separating the cardiac patch from the delivery device.

[0117] Reference Attachment Figure 10 To the attached Figure 12As shown in , the cardiac patch delivery device can also adopt the setting method mentioned above. The cardiac patch delivery device in the figure also includes a delivery seat 21. In the working state, the positions of the delivery seat 21 and the positioning member 31 correspond to each other. A wire hole 92 is provided near the corresponding delivery seat 21 and the positioning member 31 on the cardiac patch 9, and the constraint line 4 forms a constraint ring 41 through the wire hole 92. The positioning member 31 includes two independently moving branches 313, and each branch 313 is surrounded to form a ring; there are two constraint lines 4, and they cooperate with the corresponding branches 313 to complete the constraint. Each constraint ring 41 is arranged in a group, and each group of constraint rings 41 includes at least two, and each branch 313 passes through at least three groups of constraint rings 41. In this embodiment, when the constraint line 4 passes through the first side, it is located on the side of the delivery seat 21 facing away from the cardiac patch 9. This feature can be seen from the attached Figure 11 It is clearly observed in . Figure 12 Figure 3 shows the coordinated state of the restraint wire and the delivery base after the positioning member is retracted. In this state, the restraint wire can be directly withdrawn from the vicinity of the cardiac patch.

[0118] For details on the setting of the heart patch 9, refer to the attached Figure 14 In the illustrated embodiment, the cardiac patch 9 is provided with a positioning structure 91 for positioning itself at a treatment location 911. The positioning structure 91 can take various forms, such as adhesive, snap-on, or adsorption. In the accompanying drawings, the treatment location 911 is the myocardial surface, located within the pericardial structure 912. In the drawings, the positioning structure 91 is disposed on a first side, with at least a portion protruding to intrude into the treatment location 911. For example, the positioning structure 91 is a microneedle. The microneedle can be provided with barbs to prevent dislodgment and facilitate positioning at the treatment location 911. Regarding the coordination with the delivery device, the cardiac patch delivery device includes a positioning member 31. In operation, the positioning member 31 spatially expands into a ring to position the cardiac patch 9. The ring defines a central region 311, within which the positioning structure 91 is located. In addition to providing enhanced support and restraint, the annular positioning member 31 also provides space for the positioning structure 91 and a degree of protection.

[0119] The cardiac patch 9 can play a therapeutic role through the microneedles themselves, or it can cooperate with the therapeutic substances on the cardiac patch 9. For example, the cardiac patch 9 is a cell-loaded patch, that is, seed cells are planted on a scaffold with a certain structure, cultured in vitro and then transplanted in vivo. The seed cells can be cardiomyocytes induced and differentiated from stem cells, etc. For another example, the cardiac patch 9 is a drug-loaded patch, that is, the patch is attached with a drug with a therapeutic effect. For example, the cardiac patch 9 is a structural patch, that is, a scaffold of different structures constructed from polymers or biomaterials, which is dedicated to modifying the mechanical properties, three-dimensional structure and surface properties of the scaffold itself to promote tissue repair.

[0120] After the cardiac patch 9 is delivered to the treatment position 911, it can be coupled to the treatment position 911 by driving the delivery device or the implant system. This process can be achieved by adjusting the bend of the delivery device, or by referring to the attached diagram. Figure 13 And attached Figure 14 In the illustrated embodiment, the cardiac patch delivery device further comprises a balloon catheter 5, which comprises:

[0121] The expansion body 51 is provided at the distal end. In the working state, the expansion body 51 can drive the cardiac patch 9 to move in its thickness direction by changing its own volume;

[0122] The push tube 52 extends from the expansion body 51 to the proximal end;

[0123] The driving device drives the expansion body 51 to expand or contract.

[0124] In this embodiment, the action of the expansion body 51 can enable the heart patch 9 to move in a predetermined direction and ensure a certain driving torque, thereby ensuring the bonding strength between the heart patch 9 and the treatment position 911 .

[0125] Combined with the above and attached Figure 13 , Attachment Figure 14 It is not difficult to understand that the present application also discloses a cardiac patch implantation system, including

[0126] cardiac patch delivery devices;

[0127] A cardiac patch 9 is connected to a cardiac patch delivery device, and a positioning structure 91 is provided on one side of the cardiac patch 9 in the thickness direction for positioning the cardiac patch 9 at a treatment position 911;

[0128] The balloon catheter 5 , in working state, acts on the other side of the cardiac patch 9 and drives the positioning structure 91 to combine with the treatment position 911 .

[0129] The details of the arrangement of the cardiac patch delivery device, the positioning structure 91 and the balloon catheter 5 can be found in the above description and will not be elaborated here.

[0130] Reference Attachment Figure 13 and attached Figure 14 As shown, each of the above-mentioned cardiac patch implantation systems may further include a control handle 6, which includes a bending handle 61, a delivery handle 62, and a flare 63. The bending handle 61 is used to achieve bending of the distal end of the delivery device. The delivery handle 62 is linked to the first control member to achieve movement of the first delivery assembly relative to the sheath. The flare 63 is used to cooperate with the small incision 631 to establish an access channel. In the figure, an outer sheath is provided outside the sheath to establish a larger access channel.

[0131] In combination with the above, it is not difficult to understand that the present application also discloses a method for pre-installing a cardiac patch 9, comprising providing a cardiac patch 9, wherein the cardiac patch 9 has a first side and a second side in its thickness direction;

[0132] Providing an annular positioning member 31, the positioning member 31 is preset on the second side of the cardiac patch 9;

[0133] A restraining wire 4 is provided and passes through the first side. The restraining wire 4 passes through the cardiac patch 9 at least once to the second side and then returns to the first side to form a restraining ring 41. The positioning member 31 passes through the restraining ring 41 and holds the restraining ring 41 on the second side.

[0134] It can be understood that the cardiac patch 9 pre-installation method in the present application can be implemented by the cardiac patch delivery device or cardiac patch implantation system mentioned above.

[0135] In one embodiment, a delivery base 21 is provided with a pre-positioned positioning element 31 on a first side of the cardiac patch 9. The restraining wire 4 at least passes through the side of the delivery base 21 facing away from the cardiac patch 9 after forming a restraining loop 41 and before forming another restraining loop 41.

[0136] Combined with attachment Figure 13 , Attachment Figure 14 The present application also discloses a method for using a cardiac patch implantation system, wherein the cardiac patch implantation system includes a cardiac patch 9, a balloon catheter 5, and a cardiac patch delivery device including a sheath 1, a first delivery component 2, and a second delivery component 3:

[0137] The cardiac patch 9 is constrained on the first delivery component 2 and the second delivery component 3 by the constraining wire 4 and delivered to the treatment position 911 via the sheath 1;

[0138] Drive the first conveying assembly 2 and the second conveying assembly 3 to achieve relative movement between the first conveying assembly 2 and the sheath 1 and to deploy the cardiac patch 9;

[0139] Driving the balloon catheter 5 to drive the cardiac patch 9 to move in the thickness direction so that the positioning structure 91 on the cardiac patch 9 is combined with the treatment position 911;

[0140] Retracting the second delivery assembly 3 to release the restraining relationship between the restraining wire 4 and the cardiac patch 9;

[0141] Retracting the restraining wire 4 to release the restraining relationship between the cardiac patch 9 and the first delivery assembly 2;

[0142] Withdraw the cardiac patch implant system.

[0143] It is understandable that the method for using the cardiac patch implantation system in the present application can be implemented by the cardiac patch implantation system mentioned above. Detailed descriptions are given above and will not be expanded here.

[0144] The technical features of the above-described embodiments may be combined in any manner. To simplify the description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as no contradiction exists between these combinations of technical features, they should be considered to be within the scope of this specification. When technical features of different embodiments are embodied in the same drawing, it can be deemed that the drawing also discloses examples of combinations of the various embodiments involved.

[0145] The above-described embodiments merely represent several implementation methods of the present application. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that a person skilled in the art may make various modifications and improvements without departing from the spirit of the present application, and such modifications and improvements are all within the scope of protection of the present application.

Claims

1. A cardiac patch delivery device, characterized in that: include: Sheath, to establish the delivery channel; A first conveying assembly includes a conveying seat at the distal end and a first control member extending from the conveying seat to the proximal end; A second delivery assembly includes a positioning member located at the distal end and a second control member extending from the positioning member to the proximal end; The first conveying assembly and the second conveying assembly have a working state extending out of the distal end of the sheath. In the working state, the heart patch is unfolded and has a first side and a second side relative to each other in the thickness direction of itself. The conveying seat and the positioning member support the heart patch on both sides of the thickness direction of the heart patch.

2. The cardiac patch delivery device according to claim 1, wherein: The delivery seat is an elastic or deformable structure. In the working state, the delivery seat is spatially expanded into a ring shape to support the heart patch.

3. The cardiac patch delivery device according to claim 1, wherein: The first conveying component is a split structure or an integrated structure; When the first conveying component is an integrated structure, the first conveying component is a slender strip component with a distal end pre-shaped into a ring structure, the ring structure forms the conveying seat, and the portion of the slender strip component passing through the sheath forms the first control component.

4. The cardiac patch delivery device according to claim 1, wherein: The positioning member is an elastic or deformable structure. In the working state, the positioning member is spatially expanded into a ring shape to position the cardiac patch, and the ring shape defines a central area.

5. The cardiac patch delivery device according to claim 4, characterized in that: In the working state, the positioning member is spatially expanded into a ring shape having an open area in the circumferential direction, and the open area is located at the distal end.

6. The cardiac patch delivery device according to claim 5, characterized in that: The positioning member is a slender strip member and extends continuously to form the ring shape.

7. The cardiac patch delivery device according to claim 1, wherein: The positioning member includes two independently movable branches, each branch forming a ring. In the working state, each branch is located on the same side of the heart patch.

8. The cardiac patch delivery device according to claim 7, characterized in that: In the working state, each branch is arc-shaped.

9. The cardiac patch delivery device according to claim 7, characterized in that: The two branches are roughly coplanar.

10. The cardiac patch delivery device according to claim 1, wherein: The second conveying component is a split structure or an integrated structure; when the second conveying component is an integrated structure, the second conveying component is a slender strip component with a distal pre-shaped annular structure, the annular structure forms the positioning member, and the part of the slender strip component that passes through the sheath forms the second control member.

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