Disclosure of Invention
Therefore, the invention aims to provide a delivery system of a heart assist device, which has the advantages of simple structure, convenient operation, easy timely adjustment and secondary adjustment, and strong applicability, can reduce the implantation difficulty of the heart assist device and reduce the risk caused by misoperation in operation.
The aim of the invention is realized by the following technical scheme:
a delivery system for a heart assist device, comprising: the retractable assembly comprises a retractable handle, a retractable strip assembly positioned at the far end of the retractable handle and a retractable connecting piece used for fixedly connecting the retractable handle and the retractable strip assembly, and the retractable strip assembly is composed of a plurality of retractable strips which are circumferentially arranged along the central axis of the retractable connecting piece and are diverged towards the far end; the delivery system of the heart assist device is further provided with a traction assembly comprising: the traction connecting piece and a traction handle connected with the proximal end of the traction connecting piece, and the retraction strip assembly is connected with the traction connecting piece; and operating the traction handle or the retraction handle to change the relative positions of the traction handle and the retraction handle, so as to realize the expansion or contraction amplitude adjustment of the retraction strip assembly.
The aim of the invention can be further realized by the following technical scheme:
in one embodiment, the traction connection piece is a plurality of traction wires, and the plurality of winding and unwinding strips are respectively and correspondingly connected with the plurality of traction wires.
In one embodiment, the traction connection piece is composed of a plurality of traction wires and a traction connection translation piece fixedly connected with the proximal ends of the traction wires, the traction connection translation piece is coaxial with the retraction connection piece and can move relative to the retraction connection piece, a plurality of retraction strips are respectively and correspondingly connected with the traction wires, and the proximal ends of the traction connection translation piece are connected with the traction handle.
In a preferred embodiment, when the traction wires are in a stressed state, the projections of the traction wires and the retraction strips on a plane perpendicular to the central axis of the retraction connector are concentric.
In a preferred embodiment, the traction connection translation member includes a fixed disk disposed at a distal end of the traction connection translation member and fixedly connected to the traction connection translation member, the fixed disk being connected to proximal ends of the plurality of traction wires.
In a preferred embodiment, a plurality of fixing plate connecting holes which are rotationally symmetrical along the central axis of the fixing plate are arranged on the fixing plate, and a plurality of traction wires pass through the fixing plate connecting holes to be connected with the fixing plate.
In a preferred embodiment, a plurality of implant release holes are provided in the holding disk, which holes are rotationally symmetrical along the center axis of the holding disk.
In one embodiment, the delivery system of the heart assist device further comprises a release assembly consisting of an implant release handle slidable relative to the traction connection or the retraction connection and an implant release wire, the implant release wire or wires; in an unreleased state of the implant, the distal end of the implant release wire is attached to the distal end of the retraction strap, or the implant release wire passes through the implant release hole.
In one embodiment, the traction connection piece comprises a traction pressure plate arranged in a space surrounded by the plurality of retraction strips, the traction pressure plate is coaxial with the retraction connection piece, and the traction pressure plate is connected with the traction handle through the traction connection piece.
In a preferred embodiment, the traction platen is disc-shaped or the traction platen is funnel-shaped with an inner concave surface that conforms to the outer surface of the apex region of the heart.
In a preferred embodiment, the traction platen is provided with a plurality of platen connecting holes which are rotationally symmetrical along the central axis of the traction platen, a plurality of traction wires pass through the platen connecting holes, and when the traction wires are in a stressed state, each traction wire can be coplanar with the central axis of the traction platen.
In a preferred embodiment, the same number of platen limit grooves or platen limit holes as the number of the retraction strips are provided on the circumferential edge of the traction platen.
In a preferred embodiment, the traction connection member is a plurality of traction wires, one ends of the traction wires are connected with the traction pressure plate, and the other ends of the traction wires are connected with the traction handle.
In a preferred embodiment, the traction connection member is a traction connection translation member capable of moving in parallel relative to the central axis of the retraction connection member, one end of the traction connection translation member is connected with the traction pressure plate, and the other end of the traction connection translation member is connected with the traction handle.
In a preferred embodiment, the traction connection member is composed of one or more traction wires and a traction connection translation member fixedly connected with the proximal end of the traction wires, the traction connection translation member is coaxial with the retraction connection member and can move relative to the retraction connection member, one end of the traction wires is connected with the traction pressure plate, the other end of the traction wires is connected with the traction connection translation member, and the proximal end of the traction connection translation member is connected with the traction handle.
Preferably, a sliding fit structure or a key groove fit structure or a thread fit structure is adopted between the retraction handle or the retraction connecting piece of the retraction assembly and the traction handle or the traction connecting piece of the traction assembly.
More preferably, a self-locking structure can be further arranged on the sliding fit structure or the key groove fit structure.
In one embodiment, the delivery system of the heart assist device further comprises a positioning assembly, wherein the positioning assembly comprises a positioning head positioned outside the distal end of the retraction connecting piece, a luer connector positioned outside the proximal end of the retraction handle and detachably connected with the pressure pump, and a positioning connecting piece, wherein the two ends of the luer connector are respectively fixedly connected with the positioning head and the luer connector, and the positioning assembly is arranged in the retraction assembly.
In one embodiment, an implant fixture for detachable connection to a heart assist device is provided on the retraction strip.
Compared with the prior art, the invention has the beneficial effects that:
1. the invention is provided with the traction component, so that an operator can conveniently change the relative positions of the traction component and the retraction component by operating the traction handle of the traction component or the retraction handle of the retraction component, and the amplitude of the distal opening of the retraction strip component is expanded or reduced. The magnitude of the applied force can be changed in time, so that an operator can timely change the expansion or contraction magnitude, and the operator can timely operate and adjust the heart auxiliary device from the apex of the heart to a series of sheathing processes of the cardiac chamber, through the outer surface of the cardiac chamber, to the inter-chamber ditch of the heart, and after the heart auxiliary device is fed to a certain position, for example, when the circumference rotation conveying system is adjusted, friction generated by contact between the retraction strip assembly and the far end of the retraction strip assembly and the inner surface of the heart auxiliary device and the outer surface of the heart is reduced or avoided, friction generated by contact between the retraction strip assembly and the conveying channel of the conveying system, such as certain tissues outside the heart, is reduced, the difficulty of sheathing the heart by the heart auxiliary device and secondarily or repeatedly adjusting the heart to a final target position is reduced, the operation success rate is improved, the process of operating the conveying system to implant the heart auxiliary device by the operator is simplified and easy, the applicability defect of the conveying system in the prior art is greatly overcome, and the application range is enlarged.
2. The traction component with various structures and shapes comprises a fixed disk connecting hole arranged on a fixed disk, a retracting strip connecting hole arranged on a retracting strip, a pressure disk connecting hole arranged on a traction pressure disk and the like, so that an operator selectively adjusts the shape of a distal end opening of the retracting strip component to be the same as or similar to the shape of a heart, the matching difficulty of the retracting component in the prior art to the shape (or the size) of the heart of each patient, which is different, is effectively reduced or avoided, the applicability of the conveying system is further enhanced, the process of implanting the heart auxiliary device by the conveying system by the operator is facilitated to be easier, and the structural design is simple and the manufacturing is convenient.
3. The invention can selectively adopt sliding fit connection or key slot fit connection or screw fit connection, so that an operator can rapidly or accurately control the expansion and contraction amplitude of the retractable strip assembly.
4. The invention is also provided with a positioning component, so that an operator can limit the position of the conveying system relative to the heart during operation, reduce the influence of the pulsation of the heart on the implantation of the heart auxiliary device, increase the positioning precision of the heart auxiliary device and also be beneficial to the pushing of the conveying system in the whole process of sleeving the heart.
Drawings
Fig. 1a is a schematic structural diagram of a retractable assembly according to a first embodiment of the present invention;
FIG. 1b is a schematic view showing only one of the retractable strips in FIG. 1 a;
FIG. 2 is a schematic overall structure of an embodiment of the present invention;
FIG. 3 is a schematic view of the traction handle of FIG. 2;
FIG. 4 is a schematic overall structure of another embodiment of the first embodiment of the present invention;
FIG. 5 is a schematic view of the structure of the fixed disk in FIG. 4;
figure 6 is a schematic overall structure of an implementation of the second embodiment of the present invention,
FIG. 7 is a schematic perspective view of the distal portion of the traction link translation shown in FIG. 6;
figure 8 is a schematic overall structure of another implementation of the second embodiment of the present invention,
FIG. 9 is another schematic view of the traction assembly of FIG. 8, wherein the shaded portion illustrates the traction platen as funnel-shaped;
FIG. 10 is a schematic perspective view of another embodiment of the distal portion of the traction connection translator of the second embodiment of the present invention;
FIG. 11 is a schematic perspective view of a distal portion of a traction link translation member according to a second embodiment of the present invention;
FIG. 12 is a schematic overall structure of a third embodiment of the present invention;
FIG. 13 is a schematic view of a positioning assembly according to a third embodiment of the present invention after the positioning assembly is connected to a pressure pump;
fig. 14 is a schematic view showing the distal end portion of the traction connection translator of the present invention after being assembled with a heart assist device and placed in a target position in the heart.
Wherein: 5 is a heart assist device (implant), 6 is a heart, 10 is a retraction assembly, 20 is a traction assembly, 40 is a positioning assembly, 50 is an implant connection coil, 100 is a retraction bar assembly, 101 is a retraction handle, 102 is a retraction connector, 200 is a traction connector, 201 is a traction handle, 201a traction handle hole, 202 is a traction platen, 202a is a platen connection hole, 202b is a platen limit slot, 202c is a platen limit hole, 204 is a fixed disk, 204a is a fixed disk connection hole, 204b is an implant release hole, 301 is an implant release handle, 401 is a positioning head, 402 is a positioning connector, 403 is a luer connector, 404 is a pressure pump, 1000 is a retraction bar connection hole, 1000b is an implant upper fixture, 1000c is an implant lower fixture, 1001 is a retraction bar sleeve, 2000 is a traction wire, 2001 is a traction connection translation member, 3000 is an implant release wire.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention will be described in detail below with reference to the accompanying drawings and specific embodiments. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the invention.
In order to more clearly describe the structure of the delivery system of the heart assist device provided by the present invention, the terms "distal" and "proximal" are defined herein as conventional terms in the field of interventional medical devices. Specifically, "proximal" refers to the end of the procedure that is proximal to the operator and "distal" refers to the end of the procedure that is distal to the operator.
The invention will be described in further detail with reference to the drawings and a number of specific embodiments.
Embodiment one:
as shown in fig. 1a, a delivery system (hereinafter referred to as "the present delivery system") of a heart assist device provided by the present invention includes a retraction assembly 10 and a traction assembly 20, wherein the retraction assembly 10 includes a retraction handle 101, a retraction bar assembly 100 located at a distal end of the retraction handle 101, and a retraction connecting piece 102 for fixedly connecting the retraction handle 101 and the retraction bar assembly 100, the retraction bar assembly 100 is composed of a plurality of retraction bars 1000 circumferentially arranged along a central axis m of the retraction connecting piece 102 and diverged distally, and a proximal end of the retraction bar assembly 100 is fixedly connected with the retraction connecting piece 102; the traction assembly 20 comprises a traction connecting piece 200 and a traction handle 201 connected with the proximal end of the traction connecting piece 200, the retraction strip assembly 100 is connected with the traction connecting piece 200, the traction handle 201 or the retraction handle 101 is operated, the relative positions of the traction handle and the retraction handle are changed, and the extension or contraction amplitude adjustment of the retraction strip assembly 100 can be realized.
In one embodiment, the number of the retractable strips 1000 is at least 3, and the retractable strips are disposed in a rotationally symmetrical manner along the central axis m of the retractable connector 102.
The traction connection 200 of the present invention should have good tension transmissibility, and the retraction connection 102 should have good pressure transmissibility, so the traction connection 200 should be preferably made of a material having good anti-extension performance, and the retraction connection 102 should be preferably made of a material having good anti-compression performance.
As shown in fig. 2, the distal end of the traction connection piece 200 is fixedly connected or movably connected with one or more retraction strips 1000 of the retraction strip assembly 100 in a non-proximal end region on the retraction strip 1000, so that when an operator operates the traction handle 201 and the retraction handle 101, if the relative positions of the traction handle 201 and the retraction handle 101 are close to each other, for example, the positions of the retraction handle 101 are kept unchanged, the whole retraction connection piece 102 and the position of the proximal end of the retraction strip assembly 100 are unchanged, a certain force is applied to the traction handle 201 to enable the traction handle 201 to move along the direction a shown in fig. 2, the traction connection piece 200 is pulled and is in a stretched state, and the force is transmitted to the retraction strip 1000 connected with the traction connection piece 200, and because the position of the proximal end of the retraction strip assembly 100 is kept unchanged, the distal end part of the retraction strip 1000 is pulled towards the direction a, and thus the opening of the retraction strip assembly 100 is enlarged, and the amplitude of the applied force is changed, so that the amplitude of the extension strip assembly 100 can be adjusted in time; on the contrary, if the relative positions of the pulling handle 201 and the retracting handle 101 are kept away from each other on the premise that the pulling connecting piece 200 has good pressure transmissibility and the retracting connecting piece 102 has good pulling transmissibility, for example, the position of the retracting handle 101 is kept unchanged, a certain force is applied to the pulling handle 201 to enable the pulling handle 201 to move along the direction B shown in fig. 2, the pulling connecting piece 200 is stressed and is in a compressed state, and the force is transmitted to the retracting strip 1000 connected with the pulling connecting piece 200, so that the amplitude of the distal opening of the retracting strip 1000 is reduced, the applied force is changed, and the reduced amplitude of the retracting strip assembly 100 can be timely changed, so that the reduced amplitude adjustment of the retracting strip assembly 100 can be realized. In view of this, the expansion or contraction amplitude adjustment of the retraction strip assembly 100 can be timely realized, so that the operator needs to perform timely operation adjustment from the apex of the heart to the outside surface of the ventricle until a series of procedures of inserting the heart auxiliary device into the inter-atrial septum and then feeding the heart auxiliary device into a certain position, for example, when adjusting the circumferential rotation conveying system, friction generated by contact between the retraction strip assembly 100 and the distal end thereof and the inner surface of the heart auxiliary device and the outer surface of the heart is reduced or avoided, friction generated by contact between the retraction strip assembly 100 and the conveying channel of the conveying system, for example, certain tissues outside the heart, is reduced, difficulty of inserting and secondarily or repeatedly adjusting the heart auxiliary device to the target position is reduced, the success rate of operation is improved, the procedures of operating the conveying system to implant the heart auxiliary device by the operator are simplified and easy, the applicability defect of the conveying system in the prior art is greatly overcome, and the application range is enlarged.
In one embodiment, the traction connection piece 200 is a plurality of traction wires 2000, the plurality of retraction strips 1000 are respectively connected with the plurality of traction wires 2000 correspondingly, in a preferred embodiment, the plurality of retraction strips 1000 are respectively connected with the plurality of traction wires 2000 in a one-to-one correspondence manner, and all the traction wires 2000 are fixedly connected or movably connected with the non-proximal end regions of the corresponding retraction strips 1000 on the retraction strips 1000. In this embodiment, a plurality of traction handle holes 201a may be provided on the traction handle 201, and as shown in fig. 3, a plurality of traction wires 2000 are fixedly connected with the traction handle 201 through the traction handle holes 201 a. When the traction wires 2000 are in a stressed state, the projections of the traction wires 2000 and the retractable strips 1000 on the plane perpendicular to the central axis m of the retractable connector 102 are concentric, which is beneficial to maximizing the force transmission efficiency of the traction wires 2000, and reducing the force required for adjusting the expansion and contraction amplitude of the retractable strip assembly 100 as much as possible, thereby facilitating the operator to easily perform the adjustment operation.
In addition, in order to facilitate the operator to rapidly or precisely control the expansion or contraction of the retraction bar assembly 100, a sliding fit connection structure or a key groove fit connection structure or a screw fit connection structure may be selectively adopted between the retraction handle 101 or the retraction connecting member 102 of the retraction assembly 10 and the traction handle 201 or the traction connecting member 200 of the traction assembly 20, and preferably, a self-locking structure may be further provided on the sliding fit connection structure or the key groove fit connection structure, so that the state of the retraction bar assembly 100 after expansion or contraction can be continuously maintained.
In order to make the operator feel comfortable to the operation of the traction handle 201 and the retraction handle 101, the traction handle 201 and the retraction handle 101 should have good ergonomic design, while in order to facilitate the operator to realize the maximum expansion or contraction of the retraction bar assembly 100, the retraction bar 1000 should have good rebound resilience and shape memory property, which can naturally restore the shape and distal opening state of the retraction bar assembly 100 to the original state when the force applied to the traction handle 201 or the retraction handle 101 is removed, so that the materials used for manufacturing the retraction bar 1000 include but are not limited to titanium and its alloy, 316L stainless steel, 304 stainless steel, 303 stainless steel, nickel-titanium alloy, nichrome, cobalt-chromium alloy, tantalum, tungsten, platinum-iridium alloy, or high polymer materials with high elastic modulus, if cobalt-chromium alloy, tantalum, tungsten, iridium alloy, or other materials with developable property are used, the visualization of the present delivery system during operation can be enhanced. In addition, a protective structure, such as a receiving strip sleeve 1001 shown in fig. 8 and 13, may be provided at the distal end region of the receiving strip, so that the operator can prevent the distal end region of the receiving strip assembly 100 of the present delivery system from damaging the surface of the heart and reduce the difficulty of the insertion during a series of insertion of the heart assist device from the apex, through the outer surface of the ventricle, and to the inter-atrial septum.
In another embodiment, the traction connection piece 200 is composed of a plurality of traction wires 2000 and a traction connection translation piece 2001 fixedly connected with the proximal ends of the traction wires 2000, the traction connection translation piece 2001 is coaxial with the retraction connection piece 102 and can move relative to the retraction connection piece 102, a plurality of retraction strips 1000 are respectively connected with the traction wires 200 correspondingly, and the proximal ends of the traction connection translation piece 2001 are connected with the traction handles 201, so that the same effects as those of the previous embodiment can be achieved, the plurality of traction wires 2000 can be made to be as close to the plurality of retraction strips 100 as possible, the length of the traction wires 2000 is shortened, and the length of the traction wires 2000 is facilitated: a) The space occupied by the delivery system is reduced, the trauma caused by contact between the traction wire 2000 of the delivery system and the tissues of a human body in the process of implanting a heart auxiliary device or withdrawing the delivery system by an operator is reduced, the influence of the traction wire 2000 on the operation of the operator in the operation is also reduced, and the use performance of the delivery system is improved; b) Compared with the above embodiment, in order to obtain the same expansion or contraction amplitude of the retraction bar assembly 100, the amount of change of the relative positions of the traction handle 201 and the retraction handle 101 is reduced, so that the adjustment and control operation is faster and more efficient, and the design of minimizing the overall length of the present conveying system is facilitated. In one embodiment, as shown in fig. 4, the traction connection translator 2001 includes a fixed disk 204 disposed at a distal end of the traction connection translator 2001 and fixedly coupled to the traction connection translator 2001, the fixed disk 204 being coupled to proximal ends of the plurality of traction wires 2000 to facilitate coupling of the traction wires 2000 to the traction connection translator 2001. In particular, as shown in fig. 5, a plurality of fixing plate connection holes 204a rotationally symmetrical along a central axis of the fixing plate 204 are provided on the fixing plate 204, and a plurality of traction wires 2000 are connected to the fixing plate 204 through the fixing plate connection holes 204 a. Correspondingly, the retractable strip 1000 is further provided with retractable strip connecting holes 1000a, which is designed to facilitate that one traction wire 2000 passes through all the retractable strip connecting holes 1000a and all the fixed disc connecting holes 204a, finally, the head and tail of the traction wire 2000 are fixedly connected to form a closed loop, a plurality of traction wires 2000 pass through the fixed disc connecting holes 204a and are connected with the fixed disc 204, so that the fixing piece 204 and the retractable strip assembly 100 form movable connection, on the premise that when an operator operates the traction handle 201 and the retractable handle 101, if the relative positions of the traction handle 201 and the retractable handle 101 are close to each other, for example, the positions of the retractable handle 101 are kept unchanged, a certain force is applied to the traction handle 201 to enable the traction handle 201 to move along the direction A shown in fig. 4, and the traction connection translation piece 2001 with good tension transmission is subjected to the tension and is in a stretched state, and is transmitted to the fixing piece 204, at this time, the length of the traction wire 2000 between the retractable strip connecting holes 1000a and the fixed disc connecting holes 204a can be automatically adjusted to be optimal, when the operator operates the traction wire 2000 is in the process of operating the traction handle 201 and the retractable strip assembly 100, for keeping the retractable strip assembly 100 in a uniform range of opening is continuously stressed in the process of the retractable strip assembly 100. Of course, one or more wires can be selectively used, and a small number but not all of the wires pass through the receiving and releasing strip connecting holes 1000a and the fixing disc connecting holes 204a, the receiving and releasing strip connecting holes 1000a and the fixing disc connecting holes 204a are in one-to-one correspondence, and finally the head and the tail of the one or more wires are fixedly connected to form one or more closed loops, so that the expansion amplitude of the distal ends of the receiving and releasing strips 1000 of the receiving and releasing strip assembly 100 is different, and the shape of the distal opening of the receiving and releasing strip assembly 100 is adjusted to be elliptical or other shapes. The shape of the distal opening of the retraction strip assembly 100 is selectively adjusted to be the same or similar to the heart, so that the process of implanting the heart assist device by an operator operating the delivery system is further simplified and easy, the matching difficulty of the retraction assembly in the prior art to the shape (or the size) of the heart of each patient which is different is effectively reduced or avoided, the applicability of the delivery system is further enhanced, and the invention is simple in design and convenient to manufacture.
Embodiment two:
as shown in fig. 6 to 11, the second embodiment differs from the first embodiment in that: the traction connection member 200 comprises a traction pressure plate 202 arranged in a space surrounded by a plurality of retraction strips 1000, the traction pressure plate 202 is coaxial with the retraction connection member 102, the traction pressure plate 202 is connected with the traction handle 201 through the traction connection member 200, and in this case, the retraction strip assembly 100 is connected with the traction pressure plate 202 of the traction connection member 200. In one embodiment, the traction connection 200 is a plurality of traction wires 2000, one end of the plurality of traction wires 2000 is connected to the traction platen 202, and the other end of the plurality of traction wires 2000 is connected to the traction handle 201. In one embodiment, the traction connection 200 is composed of one or more traction wires 2000 and a traction connection translation 2001 fixedly connected to a proximal end of the traction wires 2000, the traction connection translation 2001 is coaxial with the retraction connection 102 and is capable of moving relative to the retraction connection 201, one end of the traction wires 2000 is connected to the traction platen 202, the other end of the traction wires 2000 is connected to the traction connection translation 2001, and a proximal end of the traction connection translation 2001 is connected to the traction handle 201. Preferably, the traction platen 202 is disk-shaped, or the traction platen is funnel-shaped, having an inner concave surface that conforms to the outer surface of the apex region of the heart, as shown in fig. 9.
In the first embodiment, the traction pressing plate 202 is completely located in a space surrounded by the plurality of retractable strips 1000, as shown in fig. 6 and 7, two ends of the plurality of traction wires 2000 are fixedly connected with the traction pressing plate 202 and the fixed plate 204 respectively, so that the traction pressing plate 202, the fixed plate 204 and the traction pressing plate form a whole with unchanged shape and relative position. When the traction handle 201 and the retraction handle 101 are operated to make the relative positions thereof approach each other, a certain force is applied to the traction handle 201 to move the traction handle 201 along the direction a shown in fig. 6, the outer peripheral edge of the traction pressure plate 202 is in abutting connection with the inner surfaces of the plurality of retraction bars 1000 facing the distal ends, further, the force is transmitted from the traction pressure plate 202 to the retraction bars 1000 in contact with the traction pressure plate 202 in a sliding abutting connection manner, and the opening amplitude of the retraction bar assembly 100 is enlarged.
In the second embodiment, the traction platen 202 is completely located in a space surrounded by the plurality of retraction cords 1000, the traction connection member 200 is a traction connection translation member 2001 capable of moving in parallel with respect to the central axis m of the retraction connection member 102, one end of the traction connection translation member 2001 is connected to the traction platen 202, and the other end of the traction connection translation member 2001 is connected to the traction handle 201, as shown in fig. 8 and 9, in which case, preferably, the traction connection translation member 2001 passes through the retraction connection member 102 and the retraction handle 101, as shown in fig. 8. This design also achieves the same effects as the first embodiment of the first embodiment and allows for a simpler design of the traction assembly 20.
In the third embodiment, as shown in fig. 10, the circumferential edge of the traction platen 202 is provided with platen limiting grooves 202b the same as the number of the retraction bars 1000, and each retraction bar 1000 passes through the corresponding platen limiting groove 202b, so that a partial area of the traction platen 202 is located outside the space surrounded by the retraction bars 1000, and preferably, the central axes of the plurality of platen limiting grooves 202b in the radial direction and the projections of the plurality of retraction bars 1000 on the plane perpendicular to the central axis m of the retraction connector 102 are concentric and correspond to each other one by one. Because the pressure plate limiting groove 202b has a limiting effect in the circumferential direction, the shaking of the retractable strip 1000 in the circumferential direction can be prevented, and the working stability of the conveying system is improved. In one embodiment, a plurality of platen connecting holes 202a corresponding to the plurality of traction wires 2000 one by one may be further disposed on the traction platen 202, the plurality of platen connecting holes 202a are rotationally symmetrical along the central axis of the traction platen 202, the plurality of traction wires 2000 pass through the platen connecting holes 202a to be connected with the traction platen 202, when the plurality of traction wires 2000 are in a stressed state, each traction wire 2000 can be coplanar with the central axis of the traction platen 202, if one wire is used to pass through all the platen connecting holes 202a and all the fixing plate connecting holes 204a on the fixing plate 204, and finally, the head and the tail of the wire are fixedly connected to form a closed loop, which can achieve the same efficacy as another embodiment of the embodiment.
In the fourth embodiment, as shown in fig. 11, the circumferential edge of the traction platen 202 is provided with platen limiting holes 202c the same as the number of the retraction strips 1000, and each retraction strip 1000 passes through the corresponding platen limiting hole 202c, so that a partial area of the traction platen 202 is located outside a space surrounded by a plurality of retraction strips 1000, preferably, the central axes of the plurality of platen limiting holes 202c in the radial direction are concentric with the projections of the plurality of retraction strips on a plane perpendicular to the central axis m of the retraction connector 102, and correspond to each other one by one, and before and after or during the operation of the conveying system, all the retraction strips 1000 pass through the platen limiting holes 202c corresponding to the retraction strips, so that the expansion amplitude adjustment of the retraction strip assembly 100 can be realized, and the contraction amplitude adjustment of the retraction strip assembly 100 can also be realized.
Embodiment III:
as shown in fig. 12, based on the first embodiment, the third embodiment is different from the first embodiment in that the present delivery system further includes an implant release assembly, which is composed of an implant release handle 301 and an implant release wire 3000, wherein the implant release handle 301 can slide relative to the traction connection 200 or the retraction connection 102, and the implant release wire 3000 is one or more; in the unreleased state of the heart assist device (i.e., implant), the distal end of the implant release wire 3000 is attached to the distal end of the retraction rod 1000, and further, to enable better attachment, the retraction rod sleeve 1001 may be selectively wrapped around the retraction rod 1000 and the implant release wire 3000, at least at the distal end regions of both. In addition, as shown in fig. 1b and 14, in one embodiment, the retraction strip 1000 may further be provided with an implant fixing member for detachably connecting the implant 5, so as to facilitate the insertion of the implant 5 into the heart 6, and a plurality of implant fixing members may be further provided on the retraction strip 1000, such as an implant upper fixing member 1000b located at a distal end region of the retraction strip 1000 and an implant lower fixing member 1000c located at a proximal end region of the retraction strip 1000, so as to not only detachably connect the implant 5, but also realize connection of the proximal end of the implant 5 with a delivery system, thereby reducing the sliding difficulty of the implant 5 into the heart 6 and facilitating the secondary adjustment of the implant 5 on the heart surface. Preferably, the implant upper fixing member 1000b and the implant lower fixing member 1000c are in a through hole structure, the implant 5 or the implant connecting coil 50 arranged on the implant 5 passes through the implant fixing member, the part of the implant 5 which has passed through the implant fixing member or the part of the implant connecting coil 50 arranged on the implant 5 is further passed through by the implant release wire 3000, so that the implant 5 and the retraction bar 1000 are in limit connection, and the implant 5 can be separated from the present conveying system by pulling the implant release handle 301 to keep the position of the retraction handle 101 unchanged during operation.
As shown in fig. 5, a plurality of implant release holes 204b rotationally symmetrical along the central axis of the fixed plate 204 are provided on the fixed plate 204, and the plurality of implant release holes 204b are in one-to-one correspondence with the plurality of implant release wires 30000 so that the implant release wires 3000 can pass therethrough, ensuring that each implant release wire 3000 is in a plane during the process of pulling back the implant release handle 301, and the plane passes through the central axis of the fixed plate 204, which allows an operator to easily perform the implant release operation.
The second difference is that, as shown in fig. 13, the present delivery system further includes a positioning assembly 40, where the positioning assembly 40 includes a positioning head 401 located outside the distal end of the retractable connector 102, a luer connector 403 located outside the proximal end of the retractable handle 101 and detachably connected to a pressure pump 404, and a positioning connector 402 disposed in the retractable assembly, where two ends of the positioning connector 402 are fixedly connected to the positioning head 401 and the luer connector 403, respectively, and preferably, the positioning connector 402 of the positioning assembly 40 is at least partially located inside the present delivery system. In operation, the distal end of the positioning head 401 abuts against the surface of the apex region of the heart 6, and the positioning member 401 is tightly adsorbed to the surface of the heart 6 by operating the pressure pump 404, so that the position of the delivery system relative to the heart 6 is limited, the influence of the pulsation of the heart 6 on the implantation of the implant 5 is reduced, the positioning accuracy of the implant 5 is increased, and the delivery of the delivery system in the whole process of sleeving the heart is facilitated.
The working process of the delivery system of the heart assist device of the invention is as follows:
s1: implant 5 or implant connecting coil 50 provided on implant 5 is previously limitedly connected to implant release wire 3000 through implant upper fixture 1000b and implant lower fixture 1000c on retraction rod 1000, so that implant 5 is coupled to the present delivery system.
S2: after the open chest operation, the distal end of the conveying system is pushed to enter the vicinity of the apex of the heart through the open chest incision. The present delivery system is in an unstretched state (implant 5 in an unreleased state).
S3: the positioning assembly 40 is pushed so that the positioning head 401 is tightly attached to the apex of the heart. A pressure pump 404 is connected to the proximal end of the luer fitting 403, and the pressure pump 404 is operated to evacuate the lumen of the positioning assembly 40, with the positioning head 401 being adsorbed onto the apex of the heart.
S4: the positioning assembly 40 is held in place, and the retraction assembly 10 of the present delivery system is then pushed distally to bring the implant 5 into close proximity with the heart. When the distal opening of the retraction strap assembly 100 is engaged with the heart 7, an adjustment operation is performed: the position of the retraction handle 101 is kept unchanged, the traction handle 201 is operated, the position between the traction handle 201 and the retraction handle 101 is changed, and the adjustment of the expansion amplitude of the retraction strip assembly 100 is realized. The opening of the implant 5 is then sized and the retraction assembly 10 is then further advanced to bring the distal end of the implant 5 to the target location, such as the atrioventricular groove region of the heart. In the pushing process, if the pushing is difficult, the adjustment operation can be performed in time: the position of the retraction handle 101 is kept unchanged, the traction handle 201 is operated, the position between the traction handle 201 and the retraction handle 101 is changed, the expansion or contraction amplitude adjustment of the retraction strip assembly 100 is realized, and the process of sleeving the implant 5 into the heart is smooth.
S5: pushing stops when the distal end of the implant 5 approaches the inter-atrial groove of the heart 6. When the shape of the implant 5 does not completely correspond to the shape of the heart 6, if the relative position of the implant 5 in the circumferential direction of the heart needs to be adjusted, the adjustment operation can still be performed at this time: the position of the retraction handle 101 is kept unchanged, the traction handle 201 is operated, so that the position between the traction handle 201 and the retraction handle 101 is changed, and the adjustment of the expansion amplitude of the retraction strip assembly 100 is realized; subsequently, the delivery system is rotated while maintaining the expansion amplitude, facilitating the adjustment of the implant in the circumferential direction of the heart.
S6: after the implant 5 reaches the final target position as shown in fig. 14, the implant release handle 301 is pulled to disengage the implant 5 from the present delivery system, at which point the implant 5 has been successfully released to the outer surface of the heart 6.
S7: the pressure pump 404 is operated to disengage the positioning head 401 from the heart, the delivery system is withdrawn, and the chest incision is sutured open, completing the entire procedure.
Finally, it should be understood that the foregoing description is merely illustrative of the preferred embodiments of the present invention, and that no limitations are intended to the scope of the invention, as defined by the appended claims.