CN114504413A

CN114504413A - Implantable medical device and implantable medical device kit

Info

Publication number: CN114504413A
Application number: CN202210058239.9A
Authority: CN
Inventors: 胡佳
Original assignee: West China Hospital of Sichuan University
Current assignee: West China Hospital of Sichuan University
Priority date: 2022-01-19
Filing date: 2022-01-19
Publication date: 2022-05-17
Anticipated expiration: 2042-01-19
Also published as: CN114504413B

Abstract

The invention provides an implantable medical device and an implantable medical device kit, wherein the implantable medical device comprises a main body lumen structure, the main body lumen structure comprises a main body stent and a covering film, the covering film is coated on the main body stent to form a conveying channel with openings at two ends, the covering film is provided with at least one opening which can be opened and closed, the opening divides the main body lumen structure into a proximal part and a distal part, and when the proximal part or the distal part is radially compressed and the distal part or the proximal part is not radially compressed, the opening is in an open state; when the main body lumen structure is in a radially expanded state, the opening is in a closed state; in the open state, the opening communicates with the delivery passage. The implanted medical device can keep the blood flow smooth in the operation process, and can avoid or reduce the occurrence of internal leakage after the operation is finished.

Description

Implantable medical device and implantable medical device kit

Technical Field

The invention relates to the technical field of medical instruments, in particular to an implantable medical instrument and an implantable medical instrument suite.

Background

This section provides background information related to the present disclosure only and is not necessarily prior art.

Aortic dissection, also known as aortic dissection aneurysm, refers to hematoma formed by blood in the aortic lumen entering the middle layer of the aortic wall through the rupture of the intima, and is a highly risky arterial disease with high mortality and complication rate.

Conventional methods for treating aortic dissection are generally surgical procedures, usually by removing intimal tears, preventing massive bleeding from dissection, and reconstructing blood flow paths through artificial blood vessels.

Currently, a stent graft is implanted in a diseased site in a minimally invasive intervention manner to isolate blood flow and maintain a normal blood flow channel. Minimally invasive interventions have become a suitable routine treatment because of their definite therapeutic effect, low trauma, rapid recovery, and few complications.

When the lesion is involved in or near a branch vessel, e.g., the lesion is involved in or near a branch vessel at the aortic arch; for another example, the lesion is near a coronary vessel. In order to cover the lesion site or to increase a sufficient anchoring area, the stent graft may cover or occlude the opening of a branch vessel, a coronary vessel, or the like. In such a case, it is usually necessary to implant a main stent and a branch stent (or called a bypass stent), which cooperate with each other to maintain the smooth blood flow of the aorta and the branch vessel or the coronary vessel. This adds difficulty to the implantation procedure. Generally, the implantation procedure is performed as follows: the main body support is firstly conveyed to a corresponding position, then the main body support is partially released, the branch supports are conveyed to the corresponding position, then the branch supports are released, the branch supports are matched with the main body support, and finally the main body support is completely released, so that the operation is completed.

However, during the release of the branch stent, since the main stent is located in the blood vessel, in a semi-released state, and is not completely opened, it may block the blood flow to some extent. When the blood flow is blocked for too long, the health of the patient is adversely affected, and even life-threatening is serious. Moreover, for the matching condition of the main body bracket and the branch bracket, the condition of internal leakage is avoided or reduced after the operation is finished.

Thus, during surgery, blood flow is maintained unobstructed; and after the operation is completed, it is important to avoid or reduce the occurrence of endoleaks.

Disclosure of Invention

In view of the above, there is a need for an implantable medical device that can maintain a smooth blood flow during a surgical procedure and avoid or reduce the occurrence of endoleaks after the surgical procedure is completed.

Further, an implantable medical device kit which can keep blood flow smooth in the operation process and can avoid or reduce the occurrence of internal leakage after the operation is completed is provided.

An implantable medical device, comprising: the main body lumen structure comprises a main body stent and a covering film, wherein the covering film covers the main body stent to form a conveying channel with two open ends, at least one opening capable of being opened and closed is formed in the covering film, the opening divides the main body lumen structure into a proximal part and a distal part, and when the proximal part or the distal part is radially compressed and the distal part or the proximal part is not radially compressed, the opening is in an open state; when the main body lumen structure is in a radially expanded state, the opening is in a closed state; in the open state, the opening communicates with the delivery passage.

In one embodiment, the implantable medical device further comprises a seal disposed inside the main body lumen structure and surrounding the main body lumen structure longitudinal central axis, the seal configured to cover the opening to close the opening.

In one embodiment, the radial support force of the seal is less than the radial support force of the body mount.

In one embodiment, the sealing member comprises a sealing support and a sealing membrane connected to the sealing support, wherein a projection of the sealing membrane on the inner wall of the main body lumen structure covers the opening.

In one embodiment, the implantable medical device further comprises a retainer disposed outside the main body lumen structure; when the proximal part or the distal part is radially compressed and the distal part or the proximal part is not compressed, the abutting piece abuts against the film to enable the opening to be in an open state.

In one embodiment, the holding part comprises a wave ring surrounding the main body lumen structure, the wave ring is positioned at the proximal end or the distal end of the opening, and the projection of the wave ring on the main body lumen structure is not overlapped with the opening.

In one embodiment, the wave ring comprises a plurality of abutting parts and a plurality of connecting parts, the abutting parts and the connecting parts are alternately connected to form the wave ring, and the axial distance between the abutting parts and the opening is smaller than the axial distance between the connecting parts and the opening.

In one embodiment, the radial support force of the wave ring is less than the radial support force of the body support.

In one embodiment, the abutting member includes a plurality of abutting rods, the plurality of abutting rods are disposed outside the main body lumen structure, one end of each abutting rod is connected to the main body lumen structure, the other end of each abutting rod extends in a direction close to the opening, and one end of each abutting rod close to the opening is located at a proximal end or a distal end of the opening.

In one embodiment, the opening is arc-shaped, in-line, S-shaped, saw-tooth, cross-shaped, or semi-cross-shaped.

In one embodiment, the main body support comprises a first support and a second support connected with the first support, the diameter of one end, connected with the first support, of the second support is larger than that of one end, far away from the first support, of the second support, the coating covers the first support and the second support, and the opening is located at the second support.

In one embodiment, the implantable medical device further comprises a valve structure coupled to the main body stent; alternatively, the implantable medical device further comprises a valve structure for use with the main body stent.

An implantable medical device kit comprising:

at least one bypass bracket; and

in the implantable medical device according to any of the above embodiments, one end of each of the bypass stents may extend into the opening.

The embodiment of the disclosure has the following beneficial effects:

in the implantation operation, the proximal part or the distal part of the main body lumen structure is released, the distal part or the proximal part is kept in a radially compressed state, and the opening is opened to communicate with the delivery channel, so that blood flow can flow along the delivery channel, through the opening or from the opening into the delivery channel, and the blood flow can be kept open in the operation process. And after the operation is finished, the main body cavity structure is in a radial expansion state, so that the opening is in a closed state, the communication between the opening and the conveying channel is disconnected, namely the side surface of the conveying channel is closed, and the occurrence of internal leakage is avoided or reduced.

In the implantable medical device kit of the present disclosure, the implantable medical device of any of the above embodiments is used in conjunction with a bypass stent, one end of which is extendable into an opening of the implantable medical device and the other end of which is implanted in a bypass anatomy or a branch anatomy. Alternatively, the implantable medical device of any of the above embodiments is used in conjunction with a bypass stent using chimney stent technology. Whether one end of the bypass stent extends into the opening or not, the implantable medical device of any embodiment is provided with the opening which can be opened and closed, the opening mode is associated with the implantation, so that the blood flow can be kept smooth in the process of implementing the implantation, and after the operation is completed, the opening is in a closed state, so that the side surface of the conveying channel is closed, and the occurrence of internal leakage is avoided or reduced.

Drawings

In order to more clearly illustrate the embodiments of the present disclosure or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present disclosure, and other drawings can be obtained by those skilled in the art without creative efforts.

Wherein:

FIG. 1 is a schematic structural diagram of an implantable medical device kit according to an embodiment;

FIG. 2 is a schematic structural diagram of an implantable medical device according to one embodiment;

FIG. 3 is a schematic perspective view of an implantable medical device according to one embodiment;

FIG. 4 is a schematic diagram of a first waveform of a first wavy ring of an embodiment;

fig. 5 is a top view of an embodiment implantable medical device;

FIG. 6 is a schematic structural diagram of an implantable medical device in another embodiment;

FIG. 7 is an enlarged view of a portion of FIG. 2;

FIG. 8 is a schematic structural view of a seal of an embodiment;

FIG. 9 is a schematic view of a seal holder of the seal of an embodiment;

FIG. 10 is a schematic illustration of a partial structure of an implantable medical device according to an embodiment;

FIG. 11 is a schematic structural diagram of another embodiment implantable medical device;

fig. 12 is a state diagram illustrating an implantation procedure of an implantable medical device according to an embodiment.

Detailed Description

To make the objects, technical solutions and advantages of the present disclosure more clear, the technical solutions of the present disclosure will be described clearly and completely below with reference to the accompanying drawings in the present disclosure, and it is obvious that the described embodiments are some, but not all embodiments of the present disclosure. All other embodiments, which can be derived by a person skilled in the art from the embodiments disclosed herein without making any creative effort, shall fall within the protection scope of the present disclosure.

In the field of interventional medical devices, the end located close to the heart is defined as the proximal end and the end located far from the heart is defined as the distal end. "axial" generally refers to the length of the medical device as it is being delivered, and "radial" generally refers to the direction of the medical device perpendicular to its "axial" direction, and defines both "axial" and "radial" directions for any component of the medical device in accordance with this principle.

Referring to fig. 1, an embodiment of the present invention provides an implantable medical device kit 1 including an implantable medical device 10 and a bypass stent 20. The implantable medical device 10 is for implantation in a body lumen anatomy, such as in the aorta. The bypass stent 20 is for implantation into a branch lumen anatomy, such as a branch vessel.

Referring to fig. 2, the implantable medical device 10 includes a main body lumen structure 100, and the main body lumen structure 100 includes a main body stent 110 and a covering membrane 120. The main body support 110 is a tubular structure, and the coating film 120 covers the main body support 110 to form a conveying channel 100a (shown in fig. 3) with two open ends. The two open ends of the conveying passage 100a are axially opposed.

The covering film 120 is provided with at least one opening 122, and the opening 122 can be opened and closed. When the opening 122 is in an open state, the opening 122 is in communication with the delivery channel 100a, such that when one open end of the delivery channel 100a is not open, blood flow can flow out of the opening 122 or into the delivery channel 100a from the opening 122, i.e., blood flow can flow out or in from the side of the implantable medical device 10, and a blood flow free state can be maintained even when one open end of the body lumen structure 100 is occluded. When the opening 122 is closed, blood flow cannot exit the side of the implantable medical device 10.

When it is not necessary to pass the bypass bracket 20 through the opening 122, the number of the opening 122 is at least one. When it is desired to pass the bypass stents 20 through the openings 122, the number of openings 122 is at least 1 greater than the number of bypass stents 20 to ensure blood flow through the openings 122.

In one embodiment, the opening 122 is a plurality of openings, and the plurality of openings 122 are spaced apart along the circumference of the cover film 120. In the axial direction, the opening 122 divides the main body lumen structure 100 into a proximal portion 100b and a distal portion 100 c. Proximal portion 100b is located proximal to opening 122 and distal portion 100c is located distal to opening 122.

When the proximal portion 100b is radially compressed, and the distal portion 100c is not radially compressed (i.e., in a radially expanded state), the opening 122 assumes an open state. Alternatively, when the proximal portion 100b is radially expanded and the distal portion 100c is radially compressed, the opening 122 assumes an open state. When both the proximal portion 100b and the distal portion 100c are radially expanded, the opening 122 assumes a closed state. When the openings 122 are in a closed position, the sides of the implantable medical device 10 are in a closed position, and the delivery channel 100a has only two axially opposed open ends, with blood flowing in the delivery channel 100a from one open end to the other open end.

In the implantation procedure, the proximal portion 100b or the distal portion 100c is released to maintain the distal portion 100c or the proximal portion 100b in a radially compressed state (e.g., the proximal portion 100b or the distal portion 100c is pushed out of the delivery sheath, while the distal portion 100c or the proximal portion 110b is not yet released from the delivery sheath, but still radially constrained by the delivery sheath to be in a radially compressed state), or the distal portion 100c or the proximal portion 100b is pushed out of the delivery sheath but radially constrained by the restriction member, e.g., constrained by a tether to be in a radially compressed state), the opening 122 is in an open state and is in communication with the delivery channel 100a, so that blood can flow along the delivery channel 100a through the opening 122 or from the opening 122 into the delivery channel 100a, thereby maintaining open blood flow during the procedure. After the operation is completed, the main body lumen structure 100 is in a radially expanded state, so that the opening 122 is in a closed state, and the communication between the opening 122 and the delivery channel 100a is disconnected, that is, the side surface of the delivery channel 100a is closed, thereby avoiding or reducing the occurrence of internal leakage.

During the implantation procedure, either the first release of proximal portion 100b or the first release of distal portion 100c, the opening 122 is opened to allow for the passage of blood. And, after completion of the surgery, the opening 122 is closed. Thus, the implantable medical device 10 can be adapted to different implantation paths to facilitate selection of an appropriate implantation path based on the patient's actual condition. For example, when the implantable medical device kit 1 is used to treat aortic disorders involving coronary arteries, the implantable medical device kit may be implanted transapically, transfemoral, etc.

Referring to fig. 2, the main body support 110 includes a plurality of first wavy rings 111 arranged along an axial direction, and the coating film 120 covers the plurality of first wavy rings 111 to form the conveying passage 100a with two open ends.

In one embodiment, adjacent first undulating rings 111 are connected to each other. As shown in fig. 2, the first wavy ring 111 and another first wavy ring 111 adjacent thereto are connected by means of mutual hanging of peaks and valleys. In one embodiment, the first plurality of undulating rings 111 are connected by an axially extending connecting rod (not shown) such that the main body frame 110 is directional and easily bendable on the side opposite the connecting rod to accommodate curved luminal anatomy. Or, the plurality of first wavy rings 111 are connected by a plurality of connecting rods, each connecting rod connects two adjacent first wavy rings 111, and the plurality of connecting rods form a straight line in the axial direction, so that the main body support 110 has directionality and is easily bent at the side opposite to the connecting rods to adapt to the bent lumen anatomy structure. Alternatively, the plurality of first wavy rings 111 are connected by a plurality of connecting rods, each connecting rod connects two adjacent first wavy rings 111, and the adjacent connecting rods are axially displaced, so that the main body support 110 has better flexibility and can easily reach a target position through a curved lumen anatomical structure.

In one embodiment, the main body stent 110 may be woven from elastic wires, such as nitinol wires or cobalt chromium wires. In another embodiment, the main body support 110 may be formed by cutting and shaping a flexible metal tube, such as a nickel-titanium alloy tube or a cobalt-chromium alloy tube.

The position of the opening 122 is set according to practical conditions, so that after implantation, when the opening 122 is required to be matched with the bypass stent 20, the position of the opening 122 is suitable for the end of the bypass stent 20 far away from the opening 122 to extend into a branch vessel, and the proximal end part 100b and the distal end part 100c can cover a lesion site and have enough anchoring length.

With continued reference to fig. 2, in one embodiment, the main body support 110 further includes a second wavy ring 112. The first wavy ring 111 and the second wavy ring 112 are arranged in this order in the axial direction. In one embodiment, the second wavy ring 112 and the adjacent first wavy ring 111 are connected by hooking the peaks and valleys, and the coating film 120 is simultaneously coated on the first wavy ring 111 and the second wavy ring 112 to form the conveying passage 100a with two open ends.

The number of the second wavy rings 112 may be one or plural. When there are a plurality of second wavy rings 112, the connection manner between the second wavy rings 112 may be that the wave crests and the wave troughs are hooked and connected with each other, or one connection rod or a plurality of connection rods are used for connection.

The first wavy ring 111 includes a plurality of first waves 1111 (as shown in fig. 4), and the first waves 1111 are connected end to form the first wavy ring 111. The second wave ring 112 includes a plurality of second waves 1121, and the plurality of second waves 1121 are connected end to form the second wave ring 112. The number of the first waveforms 1111 is greater than the number of the second waveforms 1121, and the width L of the first waveforms 1111 is smaller than the width of the second waveforms 1121. A gap is formed between any adjacent two of the second waveforms 1121, and the opening 122 is located in the gap between the adjacent two of the second waveforms 1121. The second waveform ring 112 including the second waveform 1121 having a larger width is provided so that the larger size of the opening 122 can be provided to facilitate maintaining open blood flow during the procedure. In addition, the radial support performance of the main body support 110 is better by including a larger number of the first wavy rings 111 of the first wavy 1111 at an advance of the first wavy rings 111 and the second wavy rings 112 having the same wire diameter.

In an embodiment, the implantable medical device 10 further includes a valve structure 200, the valve structure 200 includes a valve stent 210 and a covering film 220 covering the valve stent 210, the covering film 220 covers the valve stent 210 to form a lumen structure with two open ends, and the lumen structure is communicated with the delivery channel 100 a. Referring to fig. 5, the valve structure 200 further includes three leaflets 230. When the implantable medical device 10 is implanted in the body, the three leaflets 230 close and open as the heart relaxes and contracts, thereby closing or opening the delivery channel 100 a. The material of the leaflet 230 may be a biomaterial or a polymeric material. It should be noted that in other embodiments, the leaflets 230 are not limited to three, and may be two or four, for example.

Referring back to fig. 2, the valve holder 210 includes a plurality of third wave-shaped rings 211 arranged axially. In one embodiment, the third plurality of undulating rings 211 are connected by hooking at the peaks and valleys. In one embodiment, third wavy ring 211 and second wavy ring 112 are connected by connector 114 such that valve stent 210 is connected to main body stent 110. The connection member 114 winds the peaks and valleys to connect the third wavy ring 211 and the second wavy ring 112. The connector 114 may be a flexible connection or a rigid connection. In one embodiment, the flexible connection member may be a flexible wire, for example, a flexible polymer wire connecting the third wavy ring 211 and the second wavy ring 112. The rigid connection may be, for example, a wire or the like.

In another embodiment, suturing may be used to join the valve structure 200 to the main body lumen structure 100. For example, the covering film 220 of the valve structure 200 is extended into the inner cavity of the main lumen structure 100, or the covering film 220 of the valve structure 200 is sleeved on the main lumen structure 100 and sewn with a suture to connect the valve structure 200 and the main lumen structure 100.

It should be noted that, in other embodiments, the valve structure 200 is used in cooperation with the main body lumen structure 100, and before use, the valve structure 200 with a suitable specification is selected according to the actual situation of the patient, and then the valve structure 200 is connected with the main body lumen structure 100.

In one embodiment, the diameters of the first, second and third

corrugated rings

111, 112, 211 are equal.

The materials of the cover membrane 120 and the cover membrane 220 are flexible materials capable of blocking blood flow and suitable for implantation into the human body, including but not limited to expanded polytetrafluoroethylene, polyurethane, silicone, and the like.

The materials of the cover film 120 and the cover film 220 may be non-absorbable materials and absorbable materials.

Referring to fig. 6, another embodiment of an implantable medical device 10 is shown having a body 110 that differs slightly from the embodiment shown in fig. 2. The main body bracket 110 includes a first bracket 110a and a second bracket 110b coupled to the first bracket 110 a. The diameter of the end of the second bracket 110b connected to the first bracket 110a is larger than the diameter of the end of the second bracket 110b remote from the first bracket 110 a. In one embodiment, the first stent 110a has a hollow cylindrical shape, the second stent 110b has a hollow truncated cone shape, and the larger diameter end of the second stent 110b is connected to the first stent 110a, so that the implantable medical device 10 can be applied to the non-uniform lumen anatomy. For example, when the aortic lesion is proximate to the aortic valve, the implantable medical device 10 extends from the aortic valve to the ascending aorta, and the implantable medical device 10 is adapted for use in cases where the ascending aorta has a larger diameter than the aortic annulus.

In an embodiment, the first support 110a includes a plurality of first wavy annular structures 115 arranged axially, and the connection manner of the plurality of first wavy annular structures 115 is the same as that of the plurality of first wavy annular objects 111 of the above-described embodiment, and is not repeated herein.

The second stent 110b includes at least one second undulating annular structure 116. When the second stent 110b includes one second wavy annular structure 116, the second wavy annular structure 116 is connected to the adjacent first wavy annular structure 115 by hooking peaks and valleys. When the second stent 110b includes a plurality of second wavy annular structures 116, the second wavy annular structure 116 closest to the first stent 110a is adjacent to the adjacent first wavy annular structure 115 by hooking peaks and valleys. Adjacent second wavy annular structures 116 may also be connected by hooking peaks and valleys.

Alternatively, in one embodiment, the first bracket 110a and the second bracket 110b are integrally formed by integrally cutting and shaping.

In this embodiment, the coating film 120 covers the first support 110a and the second support 110b to form the conveying passage 100a with two open ends. The opening 122 is located at the second bracket 110 b.

The first wavy annular structure 115 includes a plurality of first waves 1151, and the plurality of first waves 1151 are connected end to form the first wavy annular structure 115. The second waveform ring structure 116 includes a plurality of second waveforms 1161, and the plurality of second waveforms 1161 are connected end to form the second waveform ring structure 116. The number of first waveforms 1151 is greater than the number of second waveforms 1161, and the width of the first waveforms 1151 is less than the width of the second waveforms 1161. The openings 122 are located between adjacent second waveforms 1161. The second waveforms 1161 having a greater width are configured to provide larger sized openings 122 between adjacent second waveforms 1161 to facilitate maintaining unobstructed blood flow during the surgical procedure.

With continued reference to fig. 6, in this embodiment, the implantable medical device 10 further includes a valve structure 300. The valve structure 300 is identical to the valve structure 200 and will not be described in detail here. When aortic dissection patients suffer from aortic valve lesions simultaneously and need to replace the native aortic valve, the use of the implantable medical device 10 can treat aortic dissection and replace the native aortic valve simultaneously. By using the implantable medical device kit 1, the implantable medical device 20 is matched with the bypass stent 20, and the bypass stent 20 is implanted into the coronary artery, so that coronary artery ischemia caused by the occlusion of the coronary artery orifice by the covering film 120 is avoided.

Referring back to fig. 1, in one embodiment, the plurality of openings 122 are distributed on two axially spaced cross sections, dividing the main lumen structure 100 into a proximal portion 100-1, a distal portion 100-2, and an intermediate portion 100-3 between the proximal portion 100-1 and the distal portion 100-2, and the proximal portion 100-1 may be connected with a valve structure 200 or a valve structure 300. When aortic valvular lesions are simultaneously developed in an aortic dissection patient and the aortic dissection involves the aortic arch, using the implantable medical device kit 1 of this embodiment, it is possible to simultaneously treat aortic dissection and replace the native aortic valve without obstructing the branch vessels of the aortic arch and the coronary vessels of the aortic valve.

It should be noted that the number of the bypass brackets 20 is not limited and can be selected according to the requirement.

It should be noted that the application site of the implantable medical device kit 1 is not limited to the aorta, and may be applied to other sites with branched blood vessels, for example, to the renal artery. It will be appreciated that the

valve structure

200 or 300 is omitted when applied to other locations, such as the renal arteries, where replacement of the native valve is not desired.

It should also be noted that in the implantable medical device kit 1 shown in fig. 1, the bypass stent 20 is mated with the implantable medical device 10 in such a manner that one end of the bypass stent 20 extends into the opening 122. In other embodiments, the implantable medical device 10 and the bypass stent 20 may be used in combination in a chimney-based manner.

Referring back to fig. 2, in one embodiment, the opening 122 is curved. It should be noted that, in other embodiments, the shape of the opening 122 is not limited to an arc shape, and may be, for example, a straight shape, an S shape, a zigzag shape, a cross shape, a half cross shape, or the like.

Referring to fig. 7, in one embodiment, the opening 122 includes a first edge 1221 and a second edge 1222, and when one end of the main lumen structure 100 is squeezed, the distance between the first edge 1221 and the second edge 1222 is increased to open the opening 122.

It is understood that when the opening 122 is in-line shape, the first edge 1221 and the second edge 1222 are both linear. When the opening 122 is S-shaped, the first edge 1221 and the second edge 1222 are each S-shaped. Similarly, when the opening 122 is serrated, the first edge 1221 and the second edge 1222 are both serrated. When the opening 122 is shaped as a cross or a semi-cross, the opening 122 includes a plurality of edges.

Referring back to fig. 3, in an embodiment, the implantable medical device 10 further includes a sealing member 130, the sealing member 130 is disposed inside the main body lumen structure 100, and the sealing member 130 surrounds the longitudinal central axis of the main body lumen structure 100. The seal 130 is used to cover or conceal the opening 122 when the main body lumen structure 100 is in a radially expanded state.

Referring to fig. 8, in one embodiment, the sealing member 130 includes a sealing support 131 and a sealing film 132 connected to the sealing support 131. Referring to fig. 9, the sealing bracket 131 has a waveform ring structure, which may be a sine wave structure, a Z-wave structure, etc. The sealing film 132 is fixed to the sealing holder 131. In one embodiment, the sealing stent 131 is located on the side of the sealing membrane 132 facing the lumen of the main body lumen structure 100. In another embodiment, the sealing membrane 132 includes an outer membrane and an inner membrane, with the sealing bracket 131 positioned therebetween.

The edge of one end of the sealing film 132 is rounded and the edge of the other end is shaped to match the shape of the sealing holder 131. Also, both the proximal and distal edges of the sealing membrane 132 extend beyond the sealing support 131 so that the sealing membrane 132 covers the opening 122.

In one embodiment, the seal 130 is secured to the inner wall of the main body lumen structure 100 by suturing. For example, the suture sites are located at the peaks and valleys of the sealing stent 131. In another embodiment, the sealing member 130 is affixed to the inner wall of the main body lumen structure 100 by means of an adhesive.

It should be noted that regardless of the manner in which the sealing member 130 is affixed to the inner wall of the main body lumen structure 100, the projection of the sealing membrane 132 onto the inner wall of the main body lumen structure 100 covers the opening 122, as shown in fig. 10. Also, the projection of the part of the sealing member 130 fixedly connected with the main body lumen structure 100 on the inner wall of the main body lumen structure 100 does not cover the opening 122, so as to avoid causing difficulty in opening the opening 122. Meanwhile, the projection of the sealing support 131 on the inner wall of the main body lumen structure 100 is located at the proximal end or the distal end of the opening 122, so as to avoid the interference of the sealing support 131 on the opening of the opening 122. The arrangement is such that when one end of the main body lumen structure 100 is radially compressed and the other end is not radially compressed, the opening 122 can assume an open state. And the sealing supporter 131 is woven of an elastic wire, the sealing membrane 132 is abutted against the inner wall of the main body lumen structure 100 by the radial supporting force of the sealing supporter 131, so that the sealing membrane 132 can cover the opening 122 in a radially expanded state to prevent inner leakage.

In one embodiment, the radial support force of the seal holder 131 is less than the radial support force of the body holder 110. The implantable medical device 10 is anchored to the lesion site by means of the radial supporting force of the main body stent 110, and thus the radial supporting force of the main body stent 110 needs to be large. The radial support force of the seal holder 131 is sufficient, without being too great, to enable the sealing membrane 132 to cover the opening 122. Accordingly, the seal holder 131 may be formed from a relatively thin wire to reduce the compressed radial dimension of the implantable medical device 10.

The sealing member 130 is a ring structure including a sealing support 131 and a sealing membrane 132, such that when a plurality of openings 122 are spaced apart along the circumference of the main body lumen structure 100, one sealing member 130 can cover all of the openings 122.

In other embodiments, the seal holder 131 is not limited to a sine wave structure or a wave structure such as a zigzag wave, and may be configured to be capable of abutting against the seal film 132 in a radially expanded state so that the seal film 132 can cover the opening 122. For example, in one embodiment, the seal holder 131 is an annular structure. However, providing the seal holder 131 in a wave structure such as a sine wave or a Z wave is advantageous in compressing the seal holder 131 for easy transportation.

Referring back to fig. 6, in an embodiment, the implantable medical device 10 further includes a supporting member 140, the supporting member 140 is disposed outside the main body support 110, when one end of the main body lumen structure 100 where the supporting member 140 is located is radially compressed, the supporting member 140 supports the covering film 120, so that the distance between the first edge 1221 and the second edge 1222 of the opening 122 is increased, and the opening 122 is in an open state. The supporting member 140 is disposed outside the main body support 110, and may be covered by the covering film 120 or may be sleeved on the covering film 120. The retaining member 140 can be fixedly connected to the main lumen structure 100 by sewing, bonding, etc.

In one embodiment, the retaining member 140 includes an annular wave ring. The support member 140 is sleeved outside the main body support 110. The wave ring comprises a plurality of abutting parts and a plurality of connecting parts, and the abutting parts and the connecting parts are alternately adjacent to form an annular wave ring. The abutting portion abuts against the film 120 to open the opening 122. With reference to fig. 6, the supporting member 140 includes a plurality of high waveforms 141 and a plurality of low waveforms 142, and the high waveforms 141 and the low waveforms 142 are alternately connected to form a closed ring-shaped wave ring. The high waveform 141 serves as a butting portion, and the low waveform 142 serves as a connecting portion. The wave height of high waveform 141 is greater than the wave height of low waveform 142. At the position where the opening 122 is formed, the high waveform 141 axially extends to be close to the opening 122, so that the axial distance between one end of the abutting portion close to the opening 122 and the opening 122 is smaller than the axial distance between one end of the connecting portion close to the opening 122 and the opening 122. When one end of the main body lumen structure 100 is radially compressed, so that the abutting member 140 is in a radially compressed state or one end of the abutting member 140 away from the opening 122 is in a radially compressed state, and one end close to the opening 122 is in a radially compressed state, the high waveform 141 abuts against the covering film 120, so that the opening 122 is opened.

It should be noted that, in other embodiments, the abutting member 140 includes a plurality of equal-height waveforms, and the plurality of equal-height waveforms are connected end to form a closed annular wave ring. However, since the plurality of openings 122 are spaced in the circumferential direction of the main body lumen structure 100, the high waveform 141 and the low waveform 142 are provided, and the low waveform 142 plays a connecting role by the opening 122 being driven to be opened by the high waveform 141. In one aspect, the high waveform 141 and the low waveform 142 are connected, so that when the abutting member 140 is subjected to radial compression, the high waveform 141 can better abut against the film 120 to promote the opening 122 to be opened; on the other hand, the low waveform 142 has a lower wave height, which is beneficial to reducing the amount of the metal wire and reducing the local radial dimension of the implanted medical device 10 after radial compression.

In one embodiment, the radial support force of the wave ring is less than the radial support force of the body support 110. When in the radially compressed state, the high waveform 141 of the wave ring can abut against the coating film 120 to open the opening 122, and there is no need to provide a wave ring having a large radial supporting force. Thus, the undulating ring may be formed using relatively thin wires to reduce the compressed radial dimension of the implantable medical device 10.

It should be further noted that, in other embodiments, the low wave 142 may be omitted, and the abutting member 140 includes a plurality of discrete high waves 141, and when the plurality of discrete high waves 141 are compressed radially, the closed end of the high wave 141 can also abut against the film 120, so that the opening 122 is opened. Moreover, the closed end of the high-wave shape 141 is a closed structure without a sharp end, and does not pierce the film 120. Further, the two free ends of the high-waveform 141 are passivated to avoid puncturing the coating.

Referring to fig. 11, in an embodiment, the supporting member 140 has another structure. The supporting member 140 includes a plurality of discrete supporting rods 143, one end of each supporting rod 143 is connected to the second wavy annular structure 116, and the other end extends axially to be close to the opening 122, when the supporting rods 143 are radially constrained in the sheath or partially constrained in the sheath, and the other end of the main lumen structure 100 located at the opening 122 is in a radially expanded state, the supporting rods 143 support the covering membrane 122, so that the opening 122 is opened.

In an embodiment, the holding member 140 further includes a connecting portion 144, and the connecting portion 144 is connected to an end of the holding rod 143 away from the opening 122. In one embodiment, the connecting portion 144 is a ring structure, and the connecting portion 144 is hooked on the second wavy ring structure 116. The connecting portion 144 and the retaining rod 143 are further connected to the covering membrane 120 by means of sewing.

It should be noted that, in other embodiments, the connecting portion 144 may be omitted, and one end of the abutting rod 143 may be connected to the second wavy annular structure 116, for example, by welding. Then, the end of the abutment rod 143 near the opening 122 is attached to the cover film 120 by sewing.

In one embodiment, the supporting member 140 further includes a passivation portion 145, and the passivation portion 145 is connected to an end of the supporting rod 143 near the opening 122. The passivation 145 has a rounded surface to avoid the piercing of the coating film 120 against the rod 143.

Referring to fig. 12, implantable medical device 10 is loaded into delivery sheath 30. At the time of surgery, the implantable medical device 10 is delivered to the site of the lesion through the delivery sheath 30. The distal portion 100c of the main body luminal structure 100 is then released, as shown in fig. 12, and the proximal portion 100b is at least partially radially compressed by the delivery sheath 30, with the opening 122 now in an open state. The bypass stent 20 (not shown in fig. 12) is delivered to the appropriate location with one end of the bypass stent 20 passing through one of the openings 122 and the other end implanted in a branch vessel or coronary vessel. Alternatively, the bypass stent 20 may be implanted in a branch vessel or coronary vessel using a chimney technique. Then, continued release of the proximal portion 100b of the main body luminal structure 100 results in the proximal portion 100b assuming a radially expanded state with the opening 122 closed. If the implantable medical device 10 further includes a valve structure 200 or a valve structure 300, the valve structure 200 or the valve structure 300 is continued. Finally, the delivery sheath 30 is withdrawn, completing the procedure.

During implantation of the bypass stent 20, at least one of the openings 122 is in an open state to allow blood flow from the opening 122 into the delivery channel 100 a. Or from the transfer passage 100a through the opening 122. Thus, even if one open end of the delivery channel 100a is temporarily occluded during the procedure by at least partial radial compression or radial constraint of the proximal portion 100b by the delivery sheath 30 due to the need to implant the bypass stent 20, the presence of the opening 122 allows for the clearance of blood flow. Moreover, when the main lumen structure 100 is completely released, the opening 122 is in a closed state, thereby avoiding internal leakage.

By providing the sealing member 130, the sealing member 130 can cover the opening 122 in a radially expanded state of the main lumen structure 100, which is beneficial to avoiding inner leakage. By arranging the abutting piece 140, the covering film 120 can be abutted to open the opening 122 or open the opening 122 to a greater extent, which is beneficial to ensuring smooth blood flow in the operation process. The opening of the opening 122 is promoted through the abutting piece 140, the sealing performance is further improved through the sealing piece 130, and the opening 122, the sealing piece 130 and the abutting piece 140 are matched, so that the smooth blood flow can be guaranteed, the internal leakage is avoided, and the safety and the success rate of the operation are improved.

It should be noted that, in other embodiments, the abutting element 140 may be omitted, and when the abutting element 140 is omitted, the opening 122 may also be opened in a state where one end of the main body lumen structure 100 is radially compressed and the other end is not radially compressed. However, the retaining member 140 is advantageously configured to retain the cover film 120 such that the distance between the first edge 1221 and the second edge 1222 of the opening 122 is greater, even though the opening 122 is more open, thereby providing a more open flow of blood.

In the description of the embodiments of the present disclosure, it should be noted that the terms "center", "longitudinal", "lateral", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", and the like indicate orientations or positional relationships based on those shown in the drawings, and are only for convenience in describing the embodiments of the present disclosure and simplifying the description, but do not indicate or imply that the referred devices or elements must have a specific orientation, be constructed in a specific orientation, and be operated, and thus should not be construed as limiting the embodiments of the present disclosure. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the embodiments of the present disclosure, it should be noted that the terms "connected" and "connected" are used broadly and can be, for example, a fixed connection, a detachable connection, or an integral connection, unless explicitly stated or limited otherwise; can be mechanically or electrically connected; may be directly connected or indirectly connected through an intermediate. Specific meanings of the above terms in the embodiments of the present invention can be understood in specific cases by those of ordinary skill in the art.

In the embodiments of the present disclosure, unless otherwise explicitly specified or limited, a first feature "on" or "under" a second feature may be directly contacting the first and second features, or indirectly contacting the first and second features through an intermediate. Also, a first feature "on," "over," and "above" a second feature may be directly or diagonally above the second feature, or may simply indicate that the first feature is at a higher level than the second feature. A first feature being "under," "below," and "beneath" a second feature may be directly under or obliquely under the first feature, or may simply mean that the first feature is at a lesser elevation than the second feature.

In the description herein, references to the description of the term "one embodiment," "some embodiments," "an example," "a specific example," or "some examples," etc., mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of an embodiment of the disclosure. In this specification, the schematic representations of the terms used above are not necessarily intended to refer to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples. Furthermore, various embodiments or examples and features of different embodiments or examples described in this specification can be combined and combined by one skilled in the art without contradiction.

Finally, it should be noted that: the above examples are only intended to illustrate the technical solutions of the present disclosure, not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; such modifications and substitutions do not depart from the spirit and scope of the technical solutions of the embodiments of the present disclosure.

Claims

1. An implantable medical device, comprising: the main body lumen structure comprises a main body stent and a covering film, wherein the covering film covers the main body stent to form a conveying channel with two open ends, at least one opening capable of being opened and closed is formed in the covering film, the main body lumen structure is divided into a proximal part and a distal part by the opening, and when the proximal part or the distal part is radially compressed and the distal part or the proximal part is not radially compressed, the opening is in an open state; when the main body lumen structure is in a radially expanded state, the opening is in a closed state; in the open state, the opening communicates with the delivery passage.

2. The implantable medical device of claim 1, further comprising a seal disposed inside the body lumen structure and surrounding the body lumen structure longitudinal central axis, the seal configured to cover the opening such that the opening is in a closed state.

3. The implantable medical device of claim 2, wherein a radial support force of the seal is less than a radial support force of the body scaffold.

4. The implantable medical device of claim 2, wherein the seal comprises a seal holder and a sealing membrane coupled to the seal holder, a projection of the sealing membrane onto an inner wall of the body lumen structure covering the opening.

5. The implantable medical device of claim 1, further comprising a retaining member disposed outside of the main body luminal structure; when the proximal part or the distal part is radially compressed and the distal part or the proximal part is not compressed, the abutting piece abuts against the film to enable the opening to be in an open state.

6. The implantable medical device of claim 5, wherein the retaining member comprises a wave ring surrounding the main body lumen structure, the wave ring being located proximal or distal to the opening, and a projection of the wave ring onto the main body lumen structure being non-overlapping with the opening.

7. The implantable medical device according to claim 6, wherein the wave ring comprises a plurality of abutting portions and a plurality of connecting portions, the abutting portions and the connecting portions are alternately connected to form the wave ring, and an axial distance between the abutting portions and the opening is smaller than an axial distance between the connecting portions and the opening.

8. The implantable medical device of claim 6, wherein a radial support force of the wave ring is less than a radial support force of the body scaffold.

9. The implantable medical device of claim 6, wherein the retaining member comprises a plurality of retaining rods, the plurality of retaining rods are disposed outside the main lumen structure, one end of each retaining rod is connected to the main lumen structure, the other end of each retaining rod extends in a direction close to the opening, and the end of each retaining rod close to the opening is located at a proximal end or a distal end of the opening.

10. The implantable medical device of claim 1, wherein the opening is arc-shaped, in-line-shaped, S-shaped, saw-tooth-shaped, cross-shaped, or semi-cross-shaped.

11. The implantable medical device of claim 1, wherein the main body stent comprises a first stent and a second stent connected to the first stent, wherein a diameter of an end of the second stent connected to the first stent is larger than a diameter of an end of the second stent far away from the first stent, the covering membrane covers the first stent and the second stent, and the opening is located at the second stent.

12. The implantable medical device of any one of claims 1-11, further comprising a valve structure coupled to the main body stent; alternatively, the implantable medical device further comprises a valve structure for use with the main body stent.

13. An implantable medical device kit, comprising:

at least one bypass bracket; and

the implantable medical device of any one of claims 1-11, wherein one end of each of the bypass stents is extendable into the opening.