CN114504413B - Implantable Medical Devices and Implantable Medical Device Kits - Google Patents

Abstract

The present invention provides an implantable medical device and an implantable medical device kit. The implantable medical device includes a main body lumen structure, the main body lumen structure includes a main body bracket and a covering film, and the covering film covers the A delivery channel with open ends is formed on the main body stent, and at least one openable and closable opening is provided on the covering film, and the opening divides the main body lumen structure into a proximal part and a distal part. When the proximal portion or the distal portion is radially compressed, and the distal portion or the proximal portion is not radially compressed, the opening is in an open state; when the body lumen structure is in a radially expanded state When the opening is in a closed state; in an open state, the opening is connected to the delivery channel. The implantable medical device can keep the blood flow unimpeded during the operation, and can avoid or reduce the occurrence of endoleak after the operation is completed.

Description

Implantable Medical Devices and Implantable Medical Device Kits

technical field

The invention relates to the technical field of medical devices, in particular to an implantable medical device and an implantable medical device kit.

Background technique

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 the hematoma formed when blood in the aortic lumen enters the middle layer of the aortic wall through a breach in the intima. Aortic dissection is a high-risk arterial disease with High mortality and morbidity rates.

The traditional method of treating aortic dissection is generally surgical treatment, usually removing the intima tear, preventing massive bleeding caused by dissection rupture, and reconstructing the blood flow channel through artificial blood vessels.

At present, a covered stent is implanted in the diseased part by means of minimally invasive intervention to isolate the blood flow and maintain the normal blood flow channel. Minimally invasive intervention has become a suitable routine treatment method because of its definite curative effect, small trauma, quick recovery and few complications.

When the lesion involves or is close to branch vessels, for example, the lesion involves or is close to branch vessels at the aortic arch; another example is that the lesion is close to coronary vessels. In order to cover the lesion or increase a sufficient anchoring area, the stent graft may cover or block the opening of branch vessels or coronary vessels. In this case, it is usually necessary to implant a main body stent and a branch stent (or called a bypass stent), and the two cooperate with each other to maintain the blood flow of the aorta and branch vessels or coronary vessels. This increases the difficulty of implantation surgery. In general, the implantation operation is carried out as follows: first, the main stent is delivered to the corresponding part, then the main stent is partially released, and then the branch stent is delivered to the corresponding part, and then the branch stent is released to make the branch stent cooperate with the main stent, and finally Completely release the main body stent to complete the operation.

However, in the process of releasing the branch stent, since the main body stent is located in the blood vessel, it is in a half-released state and not fully opened, which will block the blood flow to a certain extent. When the blood flow is blocked for too long, it will have adverse effects on the patient's health, and it will even be life-threatening in severe cases. Moreover, for the case where the main body stent cooperates with the branch stent, after the operation is completed, the occurrence of endoleak should be avoided or reduced.

Therefore, it is very important to keep the blood flow unobstructed during the operation, and to avoid or reduce the occurrence of endoleak after the operation is completed.

Contents of the invention

Based on this, it is necessary to provide an implantable medical device that can keep the blood flow unblocked during the operation and can avoid or reduce the occurrence of endoleak after the operation is completed.

Further, it provides an implantable medical instrument kit which can keep the blood flow unblocked during the operation and can avoid or reduce the occurrence of endoleak after the operation is completed.

An implantable medical device, comprising: a main body lumen structure, the main body lumen structure includes a main body bracket and a film covering, the covering film is coated on the main body support to form a delivery channel with both ends open, and the There is at least one openable and closable opening on the membrane, and the opening divides the lumen structure of the main body into a proximal portion and a distal portion, and when the proximal portion or the distal portion is radially compressed, and When the distal portion or the proximal portion is not radially compressed, the opening is in an open state; when the body lumen structure is in a radially expanded state, the opening is in a closed state; in an open state, the opening is The opening communicates with the conveying channel.

In one of the embodiments, the implantable medical device further includes a sealing member, the sealing member is arranged inside the lumen structure of the main body, and surrounds the longitudinal center axis of the lumen structure of the main body, the sealing member It is used to cover the opening so that the opening is in a closed state.

In one of the embodiments, the radial support force of the seal is smaller than the radial support force of the main body bracket.

In one of the embodiments, the sealing member includes a sealing bracket and a sealing film connected with the sealing bracket, and the projection of the sealing film on the inner wall of the lumen structure of the main body covers the opening.

In one of the embodiments, the implantable medical device further includes a resisting member, and the resisting member is arranged outside the lumen structure of the main body; when the proximal part or the distal part is radially compressed , and when the distal portion or the proximal portion is not compressed, the resisting member resists the covering film so that the opening is in an open state.

In one of the embodiments, the resisting member includes a corrugated coil surrounding the lumen structure of the main body, the corrugated coil is located at the proximal end or the distal end of the opening, and the corrugated coil is located in the lumen of the main body. The projection on the structure does not overlap the opening.

In one of the embodiments, the wave coil includes a plurality of abutting parts and a plurality of connecting parts, the plurality of abutting parts and a plurality of connecting parts are alternately connected to form the wave coil, and the abutting parts and the The axial distance of the opening is smaller than the axial distance between the connecting portion and the opening.

In one of the embodiments, the radial support force of the wave ring is smaller than the radial support force of the main body bracket.

In one of the embodiments, the resisting member includes a plurality of resisting rods, the plurality of resisting rods are arranged outside the lumen structure of the main body, and one end of each of the resisting rods is connected to the The lumen structure of the main body is connected, and the other end extends toward the direction close to the opening, and the end of the resisting rod close to the opening is located at the proximal end or the distal end of the opening.

In one of the embodiments, the opening is arc-shaped, straight-shaped, S-shaped, zigzag-shaped, cross-shaped or half-cross-shaped.

In one of the embodiments, the main body bracket includes a first bracket and a second bracket connected to the first bracket, and the diameter of the end connected to the first bracket of the second bracket is larger than that of the second bracket. The diameter of the end of the stent away from the first stent, the membrane covering the first stent and the second stent, and the opening located at the second stent.

In one embodiment, the implantable medical device further includes a valve structure connected to the main body stent; or, the implantable medical device further includes a valve structure used in cooperation with the main body stent.

An implantable medical device kit comprising:

at least one bypass bracket; and

According to the implantable medical device in any one of the above embodiments, one end of each bypass stent can extend into the opening.

Implementing the embodiments of the present disclosure has the following beneficial effects:

During the implantation operation, the proximal part or the distal part of the lumen structure of the main body is released first, and the distal part or the proximal part is kept in a radially compressed state, so that the opening is opened to communicate with the delivery channel, so that the blood Flow can flow along the delivery channel through the opening or from the opening into the delivery channel, enabling blood flow to be maintained during the procedure. Moreover, after the operation is completed, the lumen structure of the main body is in a radially expanded state, so that the opening is in a closed state, and the communication between the opening and the delivery channel is disconnected, that is, the side of the delivery channel is closed, thereby avoiding or reducing the occurrence of endoleak.

In the implanted medical device kit of the present disclosure, the implanted medical device in any of the above-mentioned embodiments is used in conjunction with a bypass stent, one end of the bypass stent can extend into the opening of the implanted medical device, and the other end Implants in bypassing or branching anatomy. Alternatively, the implantable medical device in any one of the above embodiments is used in conjunction with a bypass stent by using chimney stent technology. Regardless of whether one end of the bypass stent extends into the opening, an openable and closable opening is provided on the implantable medical device of any of the above-mentioned embodiments, and the opening method is associated with the implantation, so that when the implantation is performed, During the process, the blood flow can be kept unobstructed, and after the operation is completed, the opening is closed, so that the side of the delivery channel is closed, thereby avoiding or reducing the occurrence of endoleak.

Description of drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present disclosure or the prior art, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only These are some embodiments of the present disclosure. Those skilled in the art can also obtain other drawings based on these drawings without creative work.

in:

Fig. 1 is a schematic structural view of an implantable medical device kit of an embodiment;

Fig. 2 is a schematic structural view of an implantable medical device of an embodiment;

Fig. 3 is a three-dimensional structural schematic diagram of an implantable medical device of an embodiment;

Fig. 4 is a structural schematic diagram of a first waveform of a first waveform ring in an embodiment;

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

Fig. 6 is a schematic structural view of an implantable medical device in another embodiment;

Figure 7 is a partial enlarged view of Figure 2;

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

Fig. 9 is a schematic structural view of a seal bracket of a seal according to an embodiment;

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

Fig. 11 is a schematic structural view of an implantable medical device in another embodiment;

Fig. 12 is a schematic view of the implantation process of the implantable medical device according to an embodiment.

Detailed ways

In order to make the purpose, technical solutions and advantages of the present disclosure clearer, the technical solutions in the present disclosure will be clearly and completely described below in conjunction with the drawings in the present disclosure. Apparently, the described embodiments are part of the embodiments of the present disclosure , but not all examples. Based on the embodiments in the present disclosure, all other embodiments obtained by persons of ordinary skill in the art without creative efforts fall within the protection scope of the present disclosure.

In the field of interventional medical devices, the end close to the heart is defined as the proximal end, and the end far away from the heart is defined as the distal end. "Axial" generally refers to the length direction of the medical device when it is being transported, and "radial" generally refers to the direction perpendicular to the "axial" of the medical device, and the "axis" of any part of the medical device is defined according to this principle to" and "radial".

Referring to FIG. 1 , an embodiment of the present invention provides an implantable medical device kit 1 , which includes an implantable medical device 10 and a bypass stent 20 . The implantable medical device 10 is intended to be implanted into a luminal anatomy of a subject, such as an aorta. The bypass stent 20 is used for implanting in branch lumen anatomy, for example, in branch blood vessels.

Referring to FIG. 2 , the implantable medical device 10 includes a body lumen structure 100 , and the body lumen structure 100 includes a body stent 110 and a membrane 120 . The main body stent 110 has a lumen structure, and the covering film 120 covers the main body stent 110 to form a delivery channel 100a with both ends open (as shown in FIG. 3 ). The two open ends of the delivery channel 100a are axially opposed to each other.

At least one opening 122 is opened on the covering film 120, and the opening 122 can be opened and closed. When the opening 122 is in an open state, the opening 122 communicates with the delivery channel 100a, so that when one open end of the delivery channel 100a is not open, the blood flow can flow out from the opening 122 or flow into the delivery channel 100a from the opening 122, that is, the blood flow It can flow out or flow in from the side of the implantable medical device 10 , and even if an opening end of the main lumen structure 100 is blocked, the blood flow can still be kept unobstructed. When opening 122 is closed, blood flow cannot exit the sides of implantable medical device 10 .

When there is no need to pass the bypass support 20 through the opening 122, the number of the opening 122 is at least one. When the bypass stent 20 needs to pass through the opening 122 , the number of the opening 122 is at least 1 greater than the number of the bypass stent 20 , so as to ensure blood flow through the opening 122 .

In one embodiment, there are multiple openings 122 , and the multiple openings 122 are distributed along the circumferential direction of the coating 120 at intervals. Axially, the opening 122 divides the main body lumen structure 100 into a proximal portion 100b and a distal portion 100c. The proximal portion 100b is located at the proximal end of the opening 122 and the distal portion 100c is located at the distal end of the opening 122 .

The opening 122 is in an open state when the proximal portion 100b is radially compressed and the distal portion 100c is not radially compressed (ie, in a radially expanded state). Alternatively, when the proximal portion 100b is radially expanded and the distal portion 100c is radially compressed, the opening 122 is in an open state. When both the proximal portion 100b and the distal portion 100c are radially expanded, the opening 122 is in a closed state. When the opening 122 is in the closed state, the side of the implantable medical device 10 is in the closed state, and the delivery channel 100a has only two axially opposite opening ends, and the blood flows from one of the opening ends to the other opening end in the delivery channel 100a. flow.

During implantation, the proximal portion 100b or the distal portion 100c is first released, and the distal portion 100c or the proximal portion 100b is maintained in a radially compressed state (for example, 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 has not been released from the delivery sheath, and is still radially constrained by the delivery sheath and is in a radially compressed state; or, the distal portion 100c or the proximal portion 100b is pushed out for delivery sheath, but is radially constrained by the restricting member, for example, constrained by a tether and is in a radially compressed state), the opening 122 is in an open state and communicates with the delivery channel 100a, so that the blood flow can pass through the opening 122 along the delivery channel 100a The blood flows or flows from the opening 122 into the delivery channel 100a, so that the blood flow can be maintained during the operation. Moreover, 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. Leakage occurs.

During the implantation operation, regardless of whether the proximal portion 100b or the distal portion 100c is released first, the opening 122 can be opened to allow blood flow. And, after the procedure is completed, the opening 122 is closed. Therefore, the implantable medical device 10 can be adapted to different implantation paths, so as to facilitate selection of a suitable implantation path according to the actual condition of the patient. For example, when the implantable medical device kit 1 is used to treat aortic lesion involving coronary arteries, it can be implanted through the apex of the heart, or implanted through the femoral vein.

Please continue to refer to FIG. 2 , the main body stent 110 includes a plurality of first wave-shaped rings 111 arranged in the axial direction, and the covering film 120 covers the plurality of first wave-shaped rings 111 to form a delivery channel 100a with both ends open. .

In one embodiment, adjacent first wave-shaped rings 111 are connected to each other. As shown in FIG. 2 , the first wave-shaped ring 111 is connected with another first wave-shaped ring 111 adjacent thereto by interlocking crests and troughs. In one embodiment, a plurality of first wave-shaped rings 111 are connected by an axially extending connecting rod (not shown in the figure), so that the main body bracket 110 has directionality and is easy to bend on the side opposite to the connecting rod. , to accommodate curved luminal anatomy. Alternatively, the plurality of first wave-shaped rings 111 are connected by a plurality of connecting rods, each connecting rod connects two adjacent first wave-shaped rings 111, and the plurality of connecting rods form a straight line in the axial direction, which also makes The main body stent 110 has directionality and is easy to bend on the side opposite to the connecting rod to adapt to the curved lumen anatomy. Alternatively, a plurality of first wave-shaped rings 111 are connected by a plurality of connecting rods, each connecting rod connects two adjacent first wave-shaped rings 111, and adjacent connecting rods are axially misaligned, in this way The flexibility of the main body stent 110 is better, and it is easy to reach the target position through the curved anatomical structure of the lumen.

In one embodiment, the main body stent 110 may be formed by weaving elastic metal wires, for example, the elastic metal wires may be nickel-titanium alloy wires or cobalt-chromium alloy wires. In another embodiment, the main body bracket 110 may also be formed by cutting and shaping the elastic metal tube. The elastic metal tube may be, for example, a nickel-titanium alloy tube or a cobalt-chromium alloy tube.

The setting position of the opening 122 is reasonably set according to the actual situation, so that after implantation, when the opening 122 needs to cooperate with the bypass stent 20, the position of the opening 122 is suitable for the end of the bypass stent 20 away from the opening 122 to extend into the branch blood vessel, Moreover, the proximal portion 100b and the distal portion 100c can cover the lesion and have sufficient anchoring length.

Please continue to refer to FIG. 2 , in one embodiment, the main body bracket 110 further includes a second wave-shaped ring 112 . The first wave-shaped ring 111 and the second wave-shaped ring 112 are arranged in sequence along the axial direction. In one embodiment, the second wave-shaped ring 112 is connected to the adjacent first wave-shaped ring 111 through crests and troughs, and the coating 120 covers the first wave-shaped ring 111 and the second wave-shaped ring at the same time. On the wave-shaped ring 112, a delivery channel 100a with both ends opened is formed.

There can be one or more second wave-shaped rings 112 . When there are multiple second wave-shaped rings 112, the connection mode between the multiple second wave-shaped rings 112 can be the way that the crests and troughs are hooked and connected to each other, or can be connected by a connecting rod or multiple Connected with connecting rod.

The first waveform ring 111 includes a plurality of first waveforms 1111 (as shown in FIG. 4 ), and the plurality of first waveforms 1111 are connected end to end to form the first waveform ring 111 . The second waveform ring 112 includes a plurality of second waveforms 1121 connected end to end to form the second waveform 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 two adjacent second waveforms 1121 , and the opening 122 is located in the gap between any two adjacent second waveforms 1121 . The second waveform ring 112 including the second waveform 1121 with a larger width is provided so that a larger opening 122 can be provided, which is beneficial to keep the blood flow unobstructed during the operation. And, under the condition that the wire diameters of the first wave-shaped ring 111 and the second wave-shaped ring 112 are equal, the first wave-shaped ring 111 containing a large number of first waves 1111 makes the diameter of the main body stent 110 Better support performance.

In one embodiment, the implantable medical device 10 further includes a valve structure 200, the valve structure 200 includes a valve support 210 and a covering film 220 coated on the valve support 210, and the covering film 220 covers the valve support 210 to form two A lumen structure with an open end, and the lumen structure communicates with the delivery channel 100a. Referring to FIG. 5 , the valve structure 200 further includes three leaflets 230 . After the implantable medical device 10 is implanted in the body, the three valve leaflets 230 close and open as the heart relaxes and contracts, so that the delivery channel 100a is closed or opened. The material of the leaflet 230 can be biological material or polymer material. It should be noted that, in other embodiments, the leaflets 230 are not limited to three, for example, there may be two or four.

Please return to FIG. 2 , the valve support 210 includes a plurality of third wave-shaped rings 211 arranged axially. In one embodiment, the plurality of third wave-shaped rings 211 are connected by hooking at the crests and troughs. In one embodiment, the third wave-shaped ring 211 and the second wave-shaped ring 112 are connected through the connecting piece 114 , so that the valve support 210 is connected with the main body support 110 . The link 114 wraps around the crests and troughs to connect the third wave-shaped ring 211 and the second wave-shaped ring 112 . The connector 114 may be a flexible connector or a rigid connector. In an embodiment, the flexible connecting member may be a flexible wire, for example, connecting the third wave-shaped ring 211 and the second wave-shaped ring 112 through a flexible polymer wire. The rigid connector can be, for example, a wire or the like.

In another embodiment, the valve structure 200 and the main lumen structure 100 may be connected by suturing. For example, the covering film 220 of the valve structure 200 is inserted into the lumen of the main body lumen structure 100, or the covering film 220 of the valve structure 200 is sleeved on the main body lumen structure 100 and sutured with sutures to connect The valve structure 200 and the body lumen structure 100.

It should be noted that, in other embodiments, the valve structure 200 is used in conjunction with the main lumen structure 100. Before use, according to the actual situation of the patient, select the valve structure 200 of appropriate specifications, and then combine the valve structure 200 with the main lumen structure. 100 to connect.

In one embodiment, the diameters of the first wave-shaped ring 111 , the second wave-shaped ring 112 and the third wave-shaped ring 211 are equal.

The materials of the covering membrane 120 and the covering membrane 220 are flexible materials that can block blood flow and are suitable for implanting into the human body, including but not limited to expanded polytetrafluoroethylene, polyurethane, and silicone.

The material of the covering film 120 and the covering film 220 can be non-absorbable material and absorbable material.

Please refer to FIG. 6 , another embodiment of the implantable medical device 10 , compared with the embodiment shown in FIG. 2 , the body 110 of this embodiment is slightly different. The main frame 110 includes a first frame 110a and a second frame 110b connected to the first frame 110a. The diameter of the end of the second bracket 110b connected to the first bracket 110a is greater than the diameter of the end of the second bracket 110b away from the first bracket 110a. In one embodiment, the first bracket 110a is in the shape of a hollow cylinder, the second bracket 110b is in the shape of a hollow truncated cone, and the end with a larger diameter of the second bracket 110b is connected to the first bracket 110a, so that the implantable medical device 10 Compatible with non-isometric lumen anatomy. For example, when the aortic lesion is close 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 suitable for cases where the diameter of the ascending aorta is larger than that of the aortic valve ring Condition.

In one embodiment, the first bracket 110a includes a plurality of first wave-shaped ring structures 115 arranged in the axial direction, and the connection method of the plurality of first wave-shaped ring structures 115 is the same as that of the plurality of first wave-shaped ring structures 115 in the above-mentioned embodiment. The manner of the wave-shaped ring 111 is the same, and will not be repeated here.

The second bracket 110 b includes at least one second wave-shaped ring structure 116 . When the second bracket 110 b includes a second wave-shaped ring structure 116 , the second wave-shaped ring structure 116 is connected to the adjacent first wave-shaped ring structure 115 through crests and troughs by hooking. When the second bracket 110b includes a plurality of second wave-shaped ring-shaped structures 116, the second wave-shaped ring-shaped structure 116 closest to the first bracket 110a is adjacent to the adjacent first wave-shaped ring-shaped structure 115 through crests and troughs. . Adjacent second wave-shaped ring structures 116 can also be connected by crests and troughs hooked.

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

In this embodiment, the membrane 120 covers the first stent 110a and the second stent 110b to form a delivery channel 100a with both ends open. The opening 122 is located at the second bracket 110b.

The first waveform ring structure 115 includes a plurality of first waveforms 1151 , and the plurality of first waveforms 1151 are connected end to end to form the first waveform ring 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 end to form the second waveform ring structure 116 . The number of the first waveform 1151 is greater than the number of the second waveform 1161 , and the width of the first waveform 1151 is smaller than the width of the second waveform 1161 . The opening 122 is located between adjacent second waveforms 1161 . The second waveform 1161 with a larger width is provided to form a larger opening 122 between adjacent second waveforms 1161, which is beneficial to keep the blood flow unobstructed during the operation.

Please continue to refer to FIG. 6 , in this embodiment, the implantable medical device 10 further includes a valve structure 300 . The structure of the valve structure 300 is the same as that of the valve structure 200 , which will not be repeated here. When a patient with aortic dissection suffers from aortic valve disease and needs to replace the natural aortic valve, the above-mentioned implantable medical device 10 can be used to treat aortic dissection and replace the natural aortic valve at the same time. Using the above-mentioned implantable medical device kit 1, the implantable medical device 20 is matched with the bypass stent 20, and the bypass stent 20 is implanted in the coronary blood vessel, so as to prevent the coronary artery vascular defect caused by the covering film 120 blocking the coronary vascular opening. Blood.

Please return to FIG. 1, in one embodiment, there are multiple openings 122, and the multiple openings 122 are distributed on two axially spaced sections, dividing the main body lumen structure 100 into a proximal portion 100-1, a distal portion The portion 100-2 and the intermediate portion 100-3 between the proximal portion 100-1 and the distal portion 100-2, the proximal portion 100-1 may be connected to the valve structure 200 or the valve structure 300. When patients with aortic dissection have aortic valve disease at the same time, and the aortic dissection involves the aortic arch, using the implantable medical device kit 1 of this embodiment, the aortic dissection and the replacement of the natural aortic valve can be treated simultaneously without blocking the aortic arch The branch vessels of the aortic valve and the coronary vessels of the aortic valve.

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

It should also be noted that the application site of the implantable medical device kit 1 is not limited to the aorta, and can also be applied to other sites with branch vessels, for example, the renal artery. It can be understood that the valve structure 200 or the valve structure 300 is omitted when it is applied to the renal artery and other parts that do not need to replace the natural valve.

It should also be noted that, in the implantable medical device kit 1 shown in FIG. 1 , the shunt stent 20 cooperates with the implantable medical device 10 in such a way that one end of the bypass stent 20 protrudes into the opening 122 . In other embodiments, the cooperation method of the implantable medical device 10 and the bypass stent 20 can be used according to chimney technology.

Please return to FIG. 2 , in one embodiment, the opening 122 is arc-shaped. It should be noted that, in other embodiments, the shape of the opening 122 is not limited to an arc, for example, it may be a straight shape, an S shape, a zigzag shape, a cross shape, or a half cross shape.

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 body lumen structure 100 is squeezed, the distance between the first edge 1221 and the second edge 1222 increases. , making the opening 122 open.

It can be understood that when the shape of the opening 122 is straight, the first edge 1221 and the second edge 1222 are both linear. When the shape of the opening 122 is S-shaped, both the first edge 1221 and the second edge 1222 are S-shaped. Likewise, when the shape of the opening 122 is zigzag, both the first edge 1221 and the second edge 1222 are zigzag. When the shape of the opening 122 is a cross or a half cross, the opening 122 includes a plurality of edges.

Please return to FIG. 3 , in one embodiment, the implantable medical device 10 further includes a seal 130 , the seal 130 is disposed inside the body lumen structure 100 , and the seal 130 surrounds the longitudinal center of the body lumen structure 100 axis. The seal 130 is used to cap or cover the opening 122 when the body lumen structure 100 is in a radially deployed state.

Please refer to FIG. 8 , in one embodiment, the sealing element 130 includes a sealing frame 131 and a sealing film 132 connected with the sealing frame 131 . Please also refer to FIG. 9 , the sealing bracket 131 is a wave-shaped ring structure, which may be a sine wave structure, a Z-shaped wave structure, and the like. The sealing film 132 is fixed on the sealing bracket 131 . In one embodiment, the sealing support 131 is located on the side of the sealing membrane 132 facing the lumen of the body lumen structure 100 . In another embodiment, the sealing membrane 132 includes an outer membrane and an inner membrane, and the sealing bracket 131 is located between the outer membrane and the inner membrane.

The edge of one end of the sealing film 132 is rounded, and the shape of the edge of the other end matches the shape of the sealing bracket 131 . Moreover, both the proximal edge and the distal edge of the sealing film 132 protrude from the sealing bracket 131 , so that the sealing film 132 can cover the opening 122 .

In one embodiment, the sealing member 130 is fixed on the inner wall of the main lumen structure 100 by suturing. For example, the stitching points are located at the peaks and troughs of the seal bracket 131 . In another embodiment, the sealing member 130 is fixed on the inner wall of the lumen structure 100 of the main body by sticking.

It should be noted that no matter what method is used to fix the sealing member 130 on the inner wall of the main body lumen structure 100 , the projection of the sealing film 132 on the inner wall of the main body lumen structure 100 covers the opening 122 , as shown in FIG. 10 . Moreover, the projection of the portion of the sealing member 130 fixedly connected to the main body lumen structure 100 on the inner wall of the main body lumen structure 100 does not cover the opening 122 to avoid difficulties in opening the opening 122 . At the same time, the projection of the sealing bracket 131 on the inner wall of the main lumen structure 100 is located at the proximal end or the distal end of the opening 122 , so as to prevent the sealing bracket 131 from interfering with the opening of the opening 122 . Such arrangement makes the opening 122 open when one end of the body lumen structure 100 is radially compressed while the other end is not radially compressed. And the sealing bracket 131 is braided by elastic metal wires, and the sealing membrane 132 is pressed against the inner wall of the main body lumen structure 100 by the radial support force of the sealing bracket 131, so that in the state of radial expansion, the sealing membrane 132 can cover Opening 122 to avoid internal leakage.

In one embodiment, the radial support force of the sealing support 131 is smaller than the radial support force of the main body support 110 . The implantable medical device 10 is anchored to the lesion by the radial support force of the main body stent 110 , so the radial support force of the main body stent 110 needs to be relatively large. The radial support force of the sealing bracket 131 is large enough to enable the sealing film 132 to cover the opening 122 , and does not need to be too large. Therefore, the sealing bracket 131 can be made of thinner wires to reduce the radial dimension of the implantable medical device 10 after compression.

The sealing member 130 is an annular structure including a sealing bracket 131 and a sealing film 132 , so that when a plurality of openings 122 are distributed along the circumference of the body lumen structure 100 , one sealing member 130 can cover all the openings 122 .

It should be noted that, in other embodiments, the sealing bracket 131 is not limited to a sine wave structure or a wave structure such as a Z-shaped wave. In a radially expanded state, it can resist the sealing film 132 so that the sealing film 132 can cover the opening 122. also can. For example, in one embodiment, the sealing bracket 131 is a ring structure. However, setting the sealing support 131 in a wave structure such as a sine wave or a Z-shaped wave is beneficial to compress the sealing support 131 for easy delivery.

Please return to FIG. 6 , in one embodiment, the implantable medical device 10 further includes a resisting member 140, which is arranged outside the main body bracket 110, when the resisting member 140 of the main body lumen structure 100 is located When one end is radially compressed, the resisting member 140 resists the coating 120 , so that the distance between the first edge 1221 and the second edge 1222 of the opening 122 increases, so that the opening 122 is in an open state. The resisting member 140 is disposed on the outside of the main frame 110 , and can be covered by the covering film 120 or sleeved on the covering film 120 . The resisting member 140 can be fixedly connected with the lumen structure 100 of the main body by suturing, bonding and the like.

In one embodiment, the resisting member 140 includes an annular wave ring. The resisting member 140 is sleeved on the outside of the main frame 110 . The wave coil includes a plurality of abutting portions and a plurality of connecting portions, and the a plurality of abutting portions and a plurality of connecting portions are alternately adjacent to each other to form an annular wave coil. The resisting portion is used for resisting the covering film 120 to open the opening 122 . Please continue to refer to FIG. 6 , the resisting member 140 includes a plurality of high waveforms 141 and a plurality of low waveforms 142 , and the plurality of high waveforms 141 and the plurality of low waveforms 142 are alternately connected to form a closed ring wave. The high waveform 141 serves as the abutting portion, and the low waveform 142 serves as the connecting portion. The wave height of the high waveform 141 is greater than that of the low waveform 142 . At the part where the opening 122 is opened, the high waveform 141 extends axially close to the opening 122, so that the axial distance between the end close to the opening 122 of the abutment part and the opening 122 is smaller than the axial distance between the end close to the opening 122 and the opening 122 of the connecting part. to the distance. When one end of the main body lumen structure 100 is radially compressed, the abutting member 140 is in a radially compressed state or the end of the abutting member 140 away from the opening 122 is in a radially compressed state, and the end close to the opening 122 is in a radially compressed state When , the high waveform 141 presses against the coating 120 , thereby opening the opening 122 .

It should be noted that, in other embodiments, the resisting member 140 includes a plurality of equal-height waves, and the plurality of equal-height waves are connected end-to-end to form a closed ring wave. However, since a plurality of openings 122 are distributed at intervals in the circumferential direction of the main lumen structure 100 , a high waveform 141 and a low waveform 142 are provided, the openings 122 are driven to open by the high waveform 141 , and the low waveform 142 acts as a connection. On the one hand, the high waveform 141 and the low waveform 142 are connected, so that when the resisting member 140 is subjected to radial compression, the high waveform 141 can better support the covering film 120 to promote the opening of the opening 122; on the other hand, the low waveform 142 The wave height is lower, which is beneficial to reduce the amount of metal wire used, and reduce the local radial size of the implantable medical device 10 after radial compression.

In one embodiment, the radial support force of the wave coil is smaller than the radial support force of the main frame 110 . When in a state of radial compression, it is only necessary for the high wave form 141 of the corrugated coil to be able to bear against the covering film 120 to open the opening 122 , and there is no need to provide a corrugated coil with a large radial supporting force. Therefore, the wave ring can be made of thinner metal wires to reduce the radial size of the implantable medical device 10 after compression.

It should also be noted that, in other embodiments, the low waveform 142 can be omitted, and the resisting member 140 includes a plurality of discrete high waveforms 141. When the multiple discrete high waveforms 141 are radially compressed, the closure of the high waveforms 141 The end can also bear against the covering film 120, thereby opening the opening 122. Moreover, the closed end of the high waveform 141 is a closed structure without sharp ends, and will not puncture the coating 120 . Further, the two free ends of the high waveform 141 are passivated to avoid piercing the coating.

Please refer to FIG. 11 , in one embodiment, the resisting member 140 has another structure. The resisting member 140 includes a plurality of discrete resisting rods 143, one end of the resisting rods 143 is connected to the second wave-shaped ring structure 116, and the other end extends axially to be close to the opening 122, when the resisting rods 143 are radially constrained to When the sheath is in or partially bound in the sheath, and the other end of the main body lumen structure 100 located at the opening 122 is in a radially expanded state, the resisting rod 143 resists the membrane 122 to open the opening 122 .

In an embodiment, the resisting member 140 further includes a connecting portion 144 connected to an end of the resisting 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 wave-shaped ring structure 116 . The connection part 144 and the resisting rod 143 are further connected to the membrane 120 by suturing.

It should be noted that, in other embodiments, the connecting portion 144 may be omitted, and it is sufficient to connect the diameter of one end of the resisting rod 143 to the second wave-shaped ring structure 116 , for example, by welding. Then, the end of the resisting rod 143 close to the opening 122 is connected to the membrane 120 by suturing.

In an embodiment, the resisting member 140 further includes a blunt portion 145 connected to an end of the resisting rod 143 close to the opening 122 . The passivation portion 145 has a rounded surface to prevent the resisting rod 143 from piercing the covering film 120 .

Referring to FIG. 12 , the implantable medical device 10 is loaded on the delivery sheath 30 . During surgery, the implantable medical device 10 is delivered to the lesion site through the delivery sheath 30 . Then, the distal portion 100c of the main body lumen structure 100 is first released. As shown in FIG. 12 , the proximal portion 100b is at least partly radially compressed by the delivery sheath 30 , and the opening 122 is in an open state. The bypass stent 20 (not shown in FIG. 12 ) is delivered to the corresponding position, and one end of the bypass stent 20 is passed through one of the openings 122 , and the other end is implanted into a branch vessel or a coronary vessel. Alternatively, the chimney technique is used to implant the bypass stent 20 into branch vessels or coronary vessels. Then, continue to release the proximal portion 100b of the body lumen structure 100, so that the proximal portion 100b is in a radially expanded state, and the opening 122 is closed. If the implantable medical device 10 also includes the valve structure 200 or the valve structure 300 , continue with the valve structure 200 or the valve structure 300 . Finally, the delivery sheath 30 is withdrawn, completing the procedure.

During the implantation of the bypass stent 20, at least one opening 122 is opened, so that blood can flow from the opening 122 into the delivery channel 100a. Alternatively, it flows out from the delivery channel 100a through the opening 122 . Therefore, during the operation, even if one open end of the delivery channel 100a is temporarily blocked due to the need to implant the bypass stent 20 and at least part of the proximal portion 100b is radially compressed or radially constrained by the delivery sheath 30, the opening The presence of 122 can make the blood flow unimpeded. Moreover, when the body lumen structure 100 is completely released, the opening 122 is in a closed state to avoid endoleak.

By providing the sealing member 130, the sealing member 130 can cover the opening 122 when the lumen structure 100 of the main body is radially expanded, which is beneficial to avoid endoleak. By providing the resisting member 140, it is beneficial to resist the membrane 120 to open the opening 122 or to open the opening 122 to a large extent, which is beneficial to ensure smooth blood flow during the operation. The opening of the opening 122 is promoted by the supporting member 140, and the sealing performance is further improved by the sealing member 130. The cooperation of the opening 122, the sealing member 130 and the supporting member 140 can ensure smooth blood flow, avoid internal leakage, and improve the safety of the operation. safety and success rate.

It should also be noted that in other embodiments, the abutting member 140 may be omitted. When the abutting member 140 is omitted, one end of the lumen structure 100 of the main body is radially compressed and the other end is not radially compressed. The opening 122 can also be opened. However, disposing the resisting member 140 is beneficial to resist the covering membrane 120, so that the distance between the first edge 1221 and the second edge 1222 of the opening 122 is larger, even if the opening 122 is opened to a greater degree, so that the blood flow is smoother.

In the description of the embodiments of the present disclosure, it should be noted that the terms "center", "vertical", "transverse", "upper", "lower", "front", "rear", "left", "right" , "vertical", "horizontal", "top", "bottom", "inner", "outer" and other indicated orientations or positional relationships are based on the orientations or positional relationships shown in the drawings, and are only for the convenience of describing this The disclosed embodiments and simplified descriptions do not indicate or imply that the devices or elements referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore should not be construed as limiting the embodiments of the present disclosure. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and should not be construed as indicating or implying relative importance.

In the description of the embodiments of the present disclosure, it should be noted that unless otherwise specified and limited, the terms "connected" and "connected" should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection, Or integrated connection; it can be mechanical connection or electrical connection; it can be direct connection or indirect connection through an intermediary. Those of ordinary skill in the art can understand the specific meanings of the above terms in the embodiments of the present invention in specific situations.

In the embodiments of the present disclosure, unless otherwise specified and limited, the first feature may be in direct contact with the first feature or the first feature and the second feature pass through the middle of the second feature. Media indirect contact. Moreover, "above", "above" and "above" the first feature on the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. "Below", "beneath" and "beneath" the first feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is less horizontally than the second feature.

In the description of this specification, descriptions referring to the terms "one embodiment", "some embodiments", "example", "specific examples", or "some examples" mean that specific features described in connection with the embodiment or example , structure, material or feature is included in at least one embodiment or example of the embodiments of the present disclosure. In this specification, the schematic representations of the above terms are not necessarily directed to the same embodiment or example. Furthermore, the described specific features, structures, materials or characteristics may be combined in any suitable manner in any one or more embodiments or examples. In addition, those skilled in the art can combine and combine different embodiments or examples and features of different embodiments or examples described in this specification without conflicting with each other.

Finally, it should be noted that: the above embodiments are only used to illustrate the technical solutions of the present disclosure, rather than to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: it can still Modifications are made to the technical solutions described in the foregoing embodiments, or equivalent replacements are made to some of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the various embodiments of the present disclosure.

Claims (12)

1. An implantable medical device, characterized in that it comprises: a main body lumen structure, the main body lumen structure includes a main body bracket and a covering film, and the covering film is coated on the main body bracket to form a two-sided opening. A delivery channel, and at least one openable and closable opening is opened on the covering membrane, and the opening divides the lumen structure of the main body into a proximal part and a distal part, when the proximal part or the distal part When radially compressed, the opening is in an open state when the distal portion or the proximal portion is not radially compressed; when the body lumen structure is in a radially expanded state, the opening is in a closed state; In an open state, the opening communicates with the delivery channel; The implantable medical device also includes a seal, the seal is arranged inside the lumen structure of the main body, and surrounds the longitudinal central axis of the lumen structure of the main body, and the seal is used to cover the opening Bring the opening into a closed state. 2 . The implantable medical device according to claim 1 , wherein the radial support force of the sealing member is smaller than the radial support force of the main body bracket. 3 . 3. The implantable medical device according to claim 1, wherein the sealing member comprises a sealing bracket and a sealing film connected with the sealing bracket, and the sealing film is formed on the inner wall of the lumen structure of the main body The projection covers the opening. 4. The implantable medical device according to claim 1, characterized in that, the implantable medical device further comprises an abutment, and the abutment is arranged outside the lumen structure of the main body; when the When the proximal portion or the distal portion is radially compressed, and the distal portion or the proximal portion is not compressed, the resisting member presses against the membrane to make the opening open. 5. The implantable medical device according to claim 4, wherein the resisting member comprises a corrugated coil surrounding the lumen structure of the main body, and the corrugated coil is located at the proximal end or the distal end of the opening , and the projection of the wave coil on the lumen structure of the main body does not overlap with the opening. 6. The implantable medical device according to claim 5, wherein the wave coil comprises a plurality of abutment parts and a plurality of connection parts, and the plurality of abutment parts and a plurality of connection parts are alternately connected to form For the wave ring, the axial distance between the resisting portion and the opening is smaller than the axial distance between the connecting portion and the opening. 7. The implantable medical device according to claim 5, wherein the radial support force of the wave coil is smaller than the radial support force of the main body bracket. 8. The implantable medical device according to claim 4, wherein the resisting member comprises a plurality of resisting rods, and the plurality of resisting rods are arranged outside the lumen structure of the main body, and One end of each of the resisting rods is connected to the lumen structure of the main body, and the other end extends in a direction close to the opening, and one end of the resisting rods close to the opening is located at the proximal or distal end of the opening . 9. The implantable medical device according to claim 1, wherein the opening is arc-shaped, in-line, S-shaped, zig-zag, cross-shaped or semi-cross-shaped. 10. The implantable medical device according to claim 1, wherein the main frame includes a first frame and a second frame connected to the first frame, and the second frame is connected to the first frame. The diameter of the connected end of a stent is greater than the diameter of the end of the second stent away from the first stent, the covering film is coated on the first stent and the second stent, and the opening is located on the at the second bracket. 11. The implantable medical device according to any one of claims 1-10, characterized in that, the implantable medical device further comprises a valve structure connected to the main body stent; or, the implantable The medical device also includes a valve structure used in cooperation with the main frame. 12. An implantable medical device kit, characterized in that it comprises: at least one bypass bracket; and The implantable medical device according to any one of claims 1-10, one end of each bypass stent can extend into the opening.