CN114099063A

CN114099063A - Support device and support system

Info

Publication number: CN114099063A
Application number: CN202010899125.8A
Authority: CN
Inventors: 赵明杰; 朱永锋; 彭大冬; 朱清; 赵淑华
Original assignee: Shanghai Minimally Invasive Heart Pulse Medical Technology Group Co ltd
Current assignee: Shanghai Minimally Invasive Heart Pulse Medical Technology Group Co ltd
Priority date: 2020-08-31
Filing date: 2020-08-31
Publication date: 2022-03-01
Also published as: AR123388A1; WO2022041903A1

Abstract

The invention relates to a bracket device and a bracket system, wherein the bracket device comprises a bracket and a control mechanism, the control mechanism comprises a control guide wire and a traction part arranged on the control guide wire, and the control guide wire is arranged along the axial direction of the bracket and movably arranged on the inner wall of the bracket; the bracket is provided with a window, and is also provided with a connecting part and a limiting part, wherein the connecting part is arranged on one side of the bracket, which is provided with the window, and is used for being connected with the traction part; the limiting part is used for limiting the position of the control guide wire in the circumferential direction and the radial direction of the support; when the stent is in an expanded state, the control guide wire exerts a pulling force on the connecting part through the pulling part, so that the stent wall around the window is sunken towards the inner cavity of the stent, and is separated from the blood vessel wall, and the branch blood vessel is prevented from being ischemic due to the fact that the branch blood vessel is blocked when the window is not aligned with the branch stent.

Description

Support device and support system

Technical Field

The invention relates to the technical field of medical instruments, in particular to a bracket device and a bracket system.

Background

The covered stent windowing technology is generally applied to treatment of diseases affecting bifurcated vessels, and has the advantages of isolating diseased vessels and keeping blood flow of the bifurcated vessels smooth. However, the blood vessel forms of patients are different among individuals, so when the pre-fenestrated stent graft is delivered to a diseased position for release, the misalignment between the window and the bifurcated blood vessel is prone to be inaccurate, and at the moment, if the stent wall around the window is attached to the blood vessel wall, the bifurcated blood vessel is blocked, the bifurcated blood vessel is caused to be ischemic, and serious complications such as cerebral infarction, upper limb ischemia and the like are caused. Moreover, a branch stent is generally arranged at the window, and if the window and the bifurcated vessel are not aligned accurately, the branch stent guide wire passage is difficult to establish, even the branch stent guide wire passage cannot be established.

In view of this, it is essential to maintain the stent wall around the window of the stent graft in a separated state from the blood vessel wall for a certain period of time after the stent graft is released during the clinical operation.

Disclosure of Invention

The invention aims to provide a stent device and a stent system, wherein the stent device can effectively avoid the situation of branch vessel occlusion caused by inaccurate stent position after stent release.

To achieve the above object, the present invention provides a rack apparatus including a rack and a control mechanism, wherein,

the control mechanism comprises a control guide wire and a drawing part arranged on the control guide wire, and the control guide wire is arranged along the axial direction of the bracket and is used for being movably arranged on the inner wall of the bracket;

the bracket is provided with a window, a connecting part and a limiting part; the connecting part is arranged on one side of the bracket, which is provided with the window, and is used for being connected with the traction part; the limiting part is used for limiting the position of the control guide wire in the circumferential direction and the radial direction of the support;

the stent device is configured such that when the pulling portion is connected to the connecting portion and the stent is in an expanded state, the control wire applies a pulling force to the connecting portion through the pulling portion to recess a stent wall around the window toward a lumen of the stent.

Optionally, the connecting portion comprises a first coil, and the proximal end of the pulling portion is connected with a connection point on the control guide wire;

the pulling part passes through the first coil and the distal end of the pulling part is sleeved on the control guide wire on the distal side of the connection point;

the stent device is configured such that when the control wire is moved toward the proximal end of the stent in the axial direction of the stent, the distal end of the pulling portion is disengaged from the control wire and passes through the first coil to release the connection of the pulling portion to the connecting portion.

Optionally, the pulling part comprises a pulling rope and a second coil, wherein the proximal end of the pulling rope is connected with the control guide wire, and the distal end of the pulling rope is connected with the second coil; the traction rope is used for being arranged in the first coil in a penetrating mode, and the second coil is used for being sleeved on the control guide wire.

Optionally, the pulling portion comprises a pulling rope of loop configuration.

Optionally, the number of the connecting parts is one, and the length of the pulling part is greater than the distance from the connecting point to the distal end point of the control guide wire and less than twice the diameter of the bracket at the window in a natural expansion state.

Optionally, the position-limiting part comprises at least two sub-position-limiting parts, and the at least two sub-position-limiting parts are arranged at intervals along the axial direction of the bracket; the far end of the traction part is sleeved on the control guide wire and is positioned between the two adjacent sub limiting parts.

Optionally, the sub-limiting portion comprises a third coil, and the control guide wire is arranged to be movably inserted into the third coil.

Optionally, at least two of the sub-limiting parts are distributed on two axial sides of the connecting part.

Optionally, the bracket has a first side and a second side opposite to each other in the radial direction, the window is disposed on the first side, and the position-limiting portion is disposed on the second side.

Optionally, the stent comprises a stent body and a covering membrane covering the stent body, and the connecting part and the limiting part are both sewn on the stent body.

To achieve the above object, the present invention further provides a stent system comprising a delivery device for delivering the stent device to a predetermined position and the stent device as described in any one of the preceding items.

Compared with the prior art, the bracket device and the bracket system have the following advantages:

the first and the second stent devices comprise a stent and a control mechanism, wherein the control mechanism comprises a control guide wire and a pulling part arranged on the control guide wire, and the control guide wire is arranged along the axial direction of the stent and is used for being movably arranged on the inner wall of the stent; the bracket is provided with a window, a connecting part and a limiting part, and the connecting part is arranged on one side of the bracket, which is provided with the window, and is used for being connected with the traction part; the limiting part is used for limiting the position of the control guide wire in the circumferential direction and the radial direction of the support. The stent device is configured such that when the pulling portion is connected to the connecting portion and the stent is in an expanded state, the control wire applies a pulling force to the connecting portion through the pulling portion to recess a stent wall around the window toward a lumen of the stent. The stent is delivered to the intravascular lesion site and then released, and the stent wall around the window is sunken towards the stent inner cavity under the traction action of the control mechanism to be away from the vascular wall, so that the branch vessel is not blocked, the branch vessel ischemia is avoided, and the adverse effect on the construction of the guide wire passage of the branch stent at the window is also avoided.

Secondly, the connecting part comprises a first coil, and the proximal end of the pulling part is connected with a connecting point on the control guide wire; the pulling part passes through the first coil and the distal end of the pulling part is connected to the control guide wire on the distal side of the connection point to achieve connection of the pulling part with the connecting part; the stent device is configured such that when the control wire is moved toward the proximal end of the stent in the axial direction of the stent, the distal end of the pulling portion is disengaged from the control wire and passes through the first coil to release the connection of the pulling portion to the connecting portion. The connection between the traction part and the connecting part can be released in the process of withdrawing the control guide wire out of the body, so that the stent wall close to the window is attached to the vessel wall, and the operation is simple and convenient.

Drawings

The drawings are included to provide a better understanding of the invention and are not to be construed as unduly limiting the invention. Wherein:

FIG. 1 is a schematic diagram of a rack assembly according to an embodiment of the present invention;

FIG. 2 is a schematic structural diagram of a control mechanism of a stent device according to an embodiment of the present invention;

FIG. 3 is a schematic structural view of a control mechanism of a stent device according to another embodiment of the present invention;

FIG. 4 is a schematic structural view of a stent device according to an embodiment of the present invention;

fig. 5 is a schematic view of a stent device according to an embodiment of the present invention implanted in an aortic arch.

[ reference numerals are described below ]:

100-a control mechanism;

110-a control guidewire;

120-a pulling section;

121-pulling rope, 122-second coil;

200-a scaffold;

201-window;

210-a connecting portion;

221-sub-limiting part.

Detailed Description

The embodiments of the present invention are described below with reference to specific embodiments, and other advantages and effects of the present invention will be easily understood by those skilled in the art from the disclosure of the present specification. The invention is capable of other and different embodiments and of being practiced or of being carried out in various ways, and its several details are capable of modification in various respects, all without departing from the spirit and scope of the present invention. It should be noted that the drawings provided in the present embodiment are only for illustrating the basic idea of the present invention, and the components related to the present invention are only shown in the drawings rather than drawn according to the number, shape and size of the components in actual implementation, and the type, quantity and proportion of the components in actual implementation may be changed freely, and the layout of the components may be more complicated.

Furthermore, each of the embodiments described below has one or more technical features, and thus, the use of the technical features of any one embodiment does not necessarily mean that all of the technical features of any one embodiment are implemented at the same time or that only some or all of the technical features of different embodiments are implemented separately. In other words, those skilled in the art can selectively implement some or all of the features of any embodiment or combinations of some or all of the features of multiple embodiments according to the disclosure of the present invention and according to design specifications or implementation requirements, thereby increasing the flexibility in implementing the invention.

As used in this specification, the singular forms "a", "an" and "the" include plural referents, and the plural forms "a plurality" includes more than two referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise, and the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either fixedly connected, detachably connected, or integrally connected. Either mechanically or electrically. Either directly or indirectly through intervening media, either internally or in any other relationship. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

As used herein, the terms "proximal" and "distal" refer to the relative orientation, relative position, and orientation of elements or actions with respect to one another from the perspective of a clinician using the medical device, and although "proximal" and "distal" are not intended to be limiting, the term "proximal" generally refers to the end of the medical device that is closer to the clinician during normal operation, and the term "distal" generally refers to the end that is first introduced into a patient.

The core idea of the present invention is to provide a stent device which is primarily intended for the treatment of lesions at bifurcated vessels, such as lesions at the aortic arch of an affected branch artery. The support device comprises a support and a control mechanism. The control mechanism comprises a control guide wire and a drawing part arranged on the control guide wire, and the control guide wire is arranged along the axial direction of the support and movably arranged on the inner wall of the support. The bracket is provided with a window, a connecting part and a limiting part, and the connecting part is arranged on one side of the bracket, which is provided with the window, and is used for being connected with the traction part; the limiting part is used for limiting the position of the control guide wire in the circumferential direction and the radial direction of the support. The stent is configured such that when the pulling portion is connected to the connecting portion and the stent is in an expanded state, the control wire applies a pulling force to the connecting portion through the pulling portion to recess a stent wall around the window toward a lumen of the stent. That is, when the stent is released at the lesion site, the control means pulls the connecting portion around the window to separate the stent wall around the window from the blood vessel wall, so that a gap exists between the two, and blood can flow into the branch vessel from the gap, thereby preventing the branch vessel from being occluded due to inaccurate alignment between the window and the branch stent. If the window is also provided with the branch stent, because a gap exists between the stent wall around the window and the vascular wall, the control guide wire channel of the branch stent is not adversely affected even if the alignment between the window and the branch vessel is inaccurate.

In more detail, the connecting part comprises a first coil, and the proximal end of the pulling part is connected with a connecting point on the control guide wire; the pulling part penetrates through the first coil, the far end of the pulling part is sleeved on the far end side of the control guide wire positioned at the connection point, and the pulling part is connected with the connecting part by being repositioned to the far end side of the control guide wire positioned at the connection point of the pulling part and the control guide wire; the stent device is configured such that when the control wire is moved toward the proximal end of the stent in the axial direction of the stent, the distal end of the pulling portion is disengaged from the control wire and passed through the first coil to release the connection of the pulling portion to the connecting portion. That is to say, after the operator finishes the posture adjustment of the stent and the construction of the guide wire passage of the branch vessel (when the branch stent needs to be arranged), the connection between the traction part and the connecting part can be released by withdrawing the control guide wire, so that the stent wall close to the window is attached to the vessel wall, and the operation is simple and convenient.

To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to the appended drawings. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming the embodiments of the present invention. The same or similar reference numbers in the drawings identify the same or similar elements.

Fig. 1 is a schematic structural view of a stent device provided in a preferred embodiment of the present invention, fig. 2 and 3 are schematic structural views of two alternative control mechanisms of the stent device, respectively, and fig. 4 is a schematic structural view of a stent of the stent device.

Referring to fig. 1 to 4, the stand device includes a control mechanism 100 and a stand 200. Wherein the control mechanism 100 comprises a control wire 110 and a pulling part 120 arranged on the control wire 110, the control wire 110 is arranged along the axial direction of the stent 200 and is movably arranged on the inner wall of the stent 200. The stent 200 is generally a covered stent, and is provided with a window 201 communicated with the inner cavity of the stent, and the stent 200 is further provided with a connecting part 210 and a limiting part. The connection part 210 is disposed at a side of the bracket 200 where the window 201 is disposed, and is used to connect with the drawing part 120. The position-limiting portion is used to limit the position of the control guide wire 110 in the circumferential direction and the radial direction of the stent 200. The stent device is configured such that when the pulling part 120 is connected to the connecting part 210 and the stent 200 is in the expanded state, the control wire 110 applies a pulling force to the connecting part 210 through the pulling part 120 to recess the stent wall around the window 201 toward the lumen of the stent 200. It will be understood by those skilled in the art that the connecting portion 210 is disposed at the periphery of the window 201, in some embodiments, the connecting portion 210 is disposed at the edge of the window 201, and in other embodiments, the connecting portion 210 has a predetermined distance from the edge of the window 201, and the predetermined distance is determined according to the actual situation as long as the control wire 110 can recess the stent wall around the window 201 when a pulling force is applied to the connecting portion 210 by the pulling portion.

Fig. 5 shows a schematic view of the stent device applied to aortic arch lesions with involvement of a branch vessel. As shown in fig. 5, when the stent device is implanted into the aortic arch of a patient, the side of the stent 200 provided with the window 201 is disposed toward the greater curvature side of the aortic arch. Ideally, one of the windows 201 should be aligned with one of the branch arteries after the stent 200 is released so that blood flow can flow from the window 201 into the branch artery. However, in the actual operation process, the branch artery of the window 201 is often inaccurately aligned to occlude the branch vessel due to various reasons, and the control mechanism 100 of the stent device provided in this embodiment pulls the connecting portion 210 on the stent 200 through the pulling portion 120, so that the stent wall around the window 201 is recessed toward the lumen of the stent 200 to form a gap with the vessel wall, and thus the blood flow can flow into the gap from the window 201 and then flow into the branch vessel, thereby avoiding ischemia of the branch vessel. When a branch stent needs to be arranged at the window 201, the existence of the gap also makes the construction of the branch vessel guide wire passage easier. In this embodiment, the stent 200 includes a stent body and a covering film disposed on the stent body, and the connecting portion 210 and the limiting portion are both sewn on the stent body of the stent 200. In other embodiments, the connecting portion 210 and the limiting portion may also be sewn to the covering film, which is determined according to actual conditions.

Further, referring with emphasis to fig. 1, the stent 200 has a first side and a second side which are diametrically opposite, the window 201 is disposed on the first side (that is, the first side is the side adjacent to the side of the aortic arch which is curved greatly in actual use, or in other bifurcated vessels, the first side is the side adjacent to the side where the branched vessel is located), then the connecting portion 210 is also disposed on the first side, and the stopper portion is preferably disposed on the second side, so that the control wire 110 is movably disposed on the inner wall of the second side of the stent 200. This has the advantage that when the stent 200 is in the expanded state, the pulling force exerted by the control wire 110 on the connecting portion 210 is maximized, ensuring that the stent wall adjacent to the window 201 can be recessed toward the lumen of the stent 200.

Further, the pulling portion 120 is a flexible elongated structure, and the proximal end thereof can be connected to the connection point on the control wire 110 by heat melting, gluing or other suitable means. The connection portion 210 includes at least one first coil. The pulling part passes through the first coil, and the distal end of the pulling part is sleeved on the distal side of the control guide wire at the connection point, so as to realize the connection of the pulling part 120 and the connecting part 210. Meanwhile, the stent device is configured such that when the control wire 110 is moved toward the proximal end of the stent 200 in the axial direction of the stent 200, the distal end of the pulling part 120 is detached from the control wire 110 and passes through the first coil to release the connection of the pulling part 120 to the connecting part 210. Specifically, the distal end of the pulling part 120 may be connected to the distal end side of the connection point after passing through the first coil from the proximal end side of the first coil, so that the pulling part 120 is connected to the connection part 210. When the connection between the pulling portion 120 and the connecting portion 210 is released, the control wire 110 is moved toward the proximal end of the stent 200 in the axial direction of the stent 200 so that the distal end of the pulling portion 120 is separated from the control wire 110 and passes through the first coil from the distal end side of the first coil. The structure is convenient for an operator to detach the control mechanism 100 from the stent 200 by retracting the control guide wire 110 to the outside of the body after completing the construction of the branched stent guide wire channel, and the tension applied by the control guide wire 110 on the stent wall around the window 201 through the connecting part 210 is released, so that the stent wall around the window 201 is attached to the vessel wall to block the lesion. It will be understood by those skilled in the art that the "proximal side of the first coil" refers to the side of the first coil facing the proximal end of the stent 200 when the first coil is oriented in a plane perpendicular to the axis of the stent 200, and the side of the first coil facing the distal end of the stent 200 when the first coil is oriented in this orientation is the "distal side of the first coil". In addition, the number of the first coils is not limited, and may be two, three or more, and the pulling portion is connected to the control guide wire after passing through at least one of the first coils.

In more detail, referring to fig. 2 in combination with fig. 1, in an exemplary embodiment, the pulling portion 120 includes a pulling rope 121 and a second coil 122 disposed at a distal end of the pulling rope 121. Referring to fig. 4 in conjunction with fig. 1, the position-limiting portion is disposed on an inner wall of the bracket 200 and includes at least two sub-position-limiting portions 221, and the at least two sub-position-limiting portions 221 are disposed at intervals along an axial direction of the bracket 200, for example, the at least two sub-position-limiting portions 221 are disposed on two axial sides of the connecting portion 210. Preferably, each of the sub-limiting portions 221 may include a third coil, and the control wire 110 is disposed on the inner wall of the second side of the stent 200 when passing through the third coil.

In this embodiment, the position-limiting portion may include two sub-position-limiting portions 211. When the stent device is assembled, the head end of the control guide wire 110 is firstly inserted into the inner cavity of the stent 200 from the proximal end of the stent 200 and passes through one of the sub-limiting parts 221 close to the proximal end of the stent 200; then, the distal end of the pulling part 120 is passed through the connecting part 210, and the distal end of the pulling part 120 is sleeved on the control guide wire 110 from the distal end of the control guide wire 110; finally, the control wire 110 is moved toward the distal end of the stent 200, so that the distal end of the control wire 110 passes through the other of the sub-limiting portions 221 (i.e., the sub-limiting portion 221 near the distal end of the stent 200).

Here, in the assembled stent device, the distal end of the pulling part 120 is fitted over the portion of the control wire 110 between the two adjacent sub-stopper parts 221 because the portion of the control wire 110 is restricted by the two sub-stopper parts 211 so that it does not move toward the window 201 due to the reaction force of the connecting part 210 when the stent 200 is expanded, thereby ensuring effective pulling of the connecting part 210.

The completed stent device may be loaded into a delivery system after the stent 200 is crimped and delivered into the diseased vessel. After the stent 200 is released in the stent, the control mechanism 100 pulls the connecting part 210 to form a gap between the stent wall around the window 201 and the vessel wall. After the operator finishes the pose adjustment of the stent 200 and the construction of the branch vessel guide wire pathway, in the process of pulling back the proximal end of the control guide wire 110 to withdraw the control guide wire 110 out of the body, the distal end of the control guide wire 110 sequentially passes through the two sub-limiting parts 221, and meanwhile, after the pulling part 120 is separated from the control guide wire 110, the distal end of the control guide wire 110 passes through the connecting part 210, so that the connection between the pulling part 120 and the connecting part 210 can be released, and at this time, the stent wall near the window 201 is attached to the vessel wall.

In this embodiment, the connecting portion 210, the sub-limiting portion 211 and the pulling portion 120 are made of wires, and are flexible and pliable, so that the crimping of the bracket 200 is not adversely affected, and the bracket 200 is not damaged. And the distal ends of the connecting portion 210, the sub-limiting portion 221 and the pulling portion 120 are all designed as coils, which has the advantages of simple structure and convenient and reliable use.

In an alternative embodiment, the pulling portion 120 comprises a pulling rope of a loop configuration (as shown in fig. 3), which also accomplishes the above-mentioned objectives. In addition, when the number of the connection portions 210 is one, the length of the pulling portion 120 (which means the size of the pulling portion when the pulling portion is stretched in a straight line) should be greater than the distance from the connection point to the distal end point of the control wire 110, so that the pulling portion 120 can be sleeved on the control wire 110 from the distal end of the control wire 110. Also, the length of the pulling part 120 should be less than twice the diameter of the stent 200 at the window 201 in a natural expansion state, which is an expansion state of the stent 200 when the control wire 110 does not apply a tensile force to the connection part 210 through the pulling part 120 (i.e., the state shown in fig. 4).

Further, the stent system provided by the embodiments of the present invention further includes the stent device as described above, and the stent system may further include a delivery guide wire and a delivery sheath, the delivery guide wire is configured to be movably inserted into the lumen of the stent, and the stent device is configured to be compressed in the delivery sheath.

Although the present invention is disclosed above, it is not limited thereto. Various modifications and alterations of this invention may be made by those skilled in the art without departing from the spirit and scope of this invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include such modifications and variations.

Claims

1. A rack apparatus, comprising a rack and a control mechanism, wherein:

2. The stent device of claim 1, wherein the connecting portion comprises a first coil, and a proximal end of the pulling portion is connected to a connection point on the control guidewire;

3. The stent device of claim 2, wherein the pulling portion comprises a pulling cord and a second coil, a proximal end of the pulling cord being connected to the control guidewire and a distal end of the pulling cord being connected to the second coil; the traction rope is used for being arranged in the first coil in a penetrating mode, and the second coil is used for being sleeved on the control guide wire.

4. A stent device according to claim 1 or 2, wherein the pulling means comprises a pulling rope of endless configuration.

5. The stent device according to claim 2, wherein the number of the connecting portions is one, and the length of the pulling portion is greater than the distance from the connecting point to the distal end point of the control guidewire and less than twice the diameter of the stent at the window when in a natural expanded state.

6. The holder device according to claim 2, wherein the position-limiting portion includes at least two sub position-limiting portions, at least two of which are arranged at intervals in an axial direction of the holder; the far end of the traction part is sleeved on the control guide wire and is positioned between the two adjacent sub limiting parts.

7. The stent device of claim 6, wherein the sub-site includes a third coil, the control guidewire being adapted to be movably disposed through the third coil.

8. The holder device according to claim 6, wherein at least two of the sub-stopper portions are distributed on both axial sides of the connecting portion.

9. The holder device of claim 1, wherein said holder has first and second diametrically opposed sides, said window being disposed on said first side and said stop being disposed on said second side.

10. The stent device according to claim 1, wherein the stent comprises a stent body and a covering film covering the stent body, and the connecting part and the limiting part are both sewed on the stent body.

11. A stent system comprising a delivery device for delivering the stent device to a predetermined location and the stent device of any one of claims 1 to 10.