CN112618099A

CN112618099A - In-situ windowing facility

Info

Publication number: CN112618099A
Application number: CN202011634788.3A
Authority: CN
Inventors: 黄新鑫
Original assignee: Shenzhen Xianjian Changtong Medical Co ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2020-12-31
Filing date: 2020-12-31
Publication date: 2021-04-09
Anticipated expiration: 2040-12-31
Also published as: CN112618099B

Abstract

The in-situ windowing device comprises a sheath tube, a catheter and a puncture piece, wherein the interior of the sheath tube is hollow, the side wall of the far end of the sheath tube is provided with a first opening, the catheter is arranged in the sheath tube in a penetrating mode and can move along the axial direction of the sheath tube, the far end of the catheter can extend out of the sheath tube through the first opening, the side wall of the far end of the catheter is provided with a conduction opening, the puncture piece is arranged in the catheter in a penetrating mode and can move along the axial direction of the catheter, the far end of the puncture piece is in a pre-bending shape in a natural state, and when the far end of the puncture piece reaches the position of the conduction opening, the far end of the puncture piece automatically bends and faces the conduction opening. According to the in-situ windowing device, the puncture piece can be effectively ensured to puncture through the conduction opening, the accuracy of the puncture position is ensured, and operation failure caused by the fact that the puncture piece cannot pass through a guide pipe smoothly or the puncture position deviates is reduced or avoided.

Description

In-situ windowing facility

Technical Field

The invention belongs to the technical field of interventional medical instruments, and particularly relates to an in-situ windowing device.

Background

The in-situ windowing technology is to release the aorta covered stent first and then to window the covered stent at the corresponding position of the branch blood vessel to reconstruct the branch artery, thereby ensuring the blood supply of the branch artery. In the in-situ windowing, under the condition that pre-windowing is not performed, the traditional covered stent is transplanted into a main artery, then the opening of a target artery is positioned, and windowing is performed at a branch blood vessel through puncture of a puncture piece or laser perforation and balloon expansion of the covered stent.

Since the aorta is thicker than the branch vessels, if the puncture is made from the aorta (large vessel) to the branch arteries (small vessel) (this is a puncture in the blood flow direction), the puncture site is difficult to determine, the aorta is likely to be punctured, and the risk of the operation is extremely high. The only way to perform puncture windowing from a branch artery (small blood vessel) to an aorta (large blood vessel) (this is puncture in the direction of reverse blood flow and is called reverse windowing) is currently available.

Currently, in-situ windowing techniques (including laser in-situ windowing and needle-punching membrane-rupturing in-situ windowing) are well-established for reconstruction of superior aortic arch branches, because superior aortic arch branches can puncture branched arteries by dissection, thereby realizing reverse in-situ windowing. However, for the visceral branch of the abdominal aortic segment, retrograde in situ windowing from the branch is not possible because the visceral branch of the abdomen cannot be dissected (and thus trauma is too great). Therefore, when reverse in-situ windowing is considered in the visceral branch reconstruction of the abdominal aorta section, reverse in-situ windowing needs to be performed from the outer side of the abdominal aorta stent. In addition, because the needle head of the existing puncture piece is in the shape of a straight rod, and the needle head is not matched with the slot of the sheath core, the puncture piece is not easy to slot through the side edge of the sheath core when the reverse in-situ windowing is carried out, and the puncture position is easy to shift, so that the open position of the abdominal aorta stent is wrong, and the reverse in-situ windowing can not be smoothly carried out.

Disclosure of Invention

The invention aims to at least solve the problem that when the reverse in-situ windowing is carried out, the puncture position is easy to deviate by adopting the needle head of the existing puncture piece for puncture. This object is achieved by:

the invention provides an in-situ windowing facility, which comprises:

the sheath tube is hollow inside, and a first opening is formed in the side wall of the far end of the sheath tube;

the catheter is arranged in the sheath tube in a penetrating mode and can move along the axial direction of the sheath tube, the far end of the catheter can extend out of the sheath tube through the first opening, and a conduction opening is formed in the side wall of the far end of the catheter;

the puncture piece penetrates through the interior of the catheter and can move along the axial direction of the catheter, the far end of the puncture piece is in a pre-bent shape in a natural state, and when the far end of the puncture piece reaches the position of the conduction opening, the far end of the puncture piece automatically bends and faces the conduction opening.

According to the in-situ windowing device, the catheter is moved along the axial direction of the sheath tube, the far end of the catheter extends out of the sheath tube through the first opening, the puncture piece is continuously moved along the axial direction of the catheter, and the far end of the puncture piece reaches the position of the conduction opening of the catheter.

In addition, the in-situ windowing device according to the invention can also have the following additional technical characteristics:

in some embodiments of the invention, the pre-bend angle of the distal end of the piercing member ranges from greater than or equal to 80 ° to less than or equal to 100 °.

In some embodiments of the invention, the piercing element comprises a needle and a connector, the needle being disposed at a distal end of the connector, a portion of the distal end of the connector having a pre-curved shape in a natural state.

In some embodiments of the invention, the distal end of the needle is provided with an inclined surface inclined from outside to inside, and the maximum included angle between the inclined surface and the axial direction of the needle is greater than 90 ° and less than 180 °.

In some embodiments of the invention, the distal end of the piercing member is planar or arcuate.

In some embodiments of the present invention, the in-situ fenestration device further comprises a blocking member, the blocking member is disposed in the catheter lumen of the catheter and faces the conduction port, the blocking member comprises at least a first blocking surface, the first blocking surface is fixed on the inner wall of the catheter opposite to the conduction port, and the hardness of the blocking member is greater than that of the distal end of the puncture member.

In some embodiments of the present invention, the blocking member further includes a second blocking surface and a third blocking surface respectively disposed on two sides of the first blocking surface, and a space enclosed by the first blocking surface, the second blocking surface, and the third blocking surface faces the conduction opening.

In some embodiments of the present invention, a top end of the first barrier face, a top end of the second barrier face, and a top end of the third barrier face are respectively attached to edge positions of the via hole.

In some embodiments of the invention, a guidewire channel is provided in communication with the exterior of the catheter at least in the distal end wall of the distal end of the catheter.

In some embodiments of the present invention, the in-situ window opening device further includes a first handle and a second handle, the first handle is connected to the proximal end of the catheter, the second handle is connected to the proximal end of the puncturing element, the first handle is provided with a first marker having a protruding direction consistent with the opening direction of the guiding opening, and the second handle is provided with a second marker having a protruding direction consistent with the pre-bending direction of the distal end of the puncturing element.

Drawings

Various other advantages and benefits will become apparent to those of ordinary skill in the art upon reading the following detailed description of the preferred embodiments. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the invention. Also, like parts are designated by like reference numerals throughout the drawings. Wherein:

fig. 1 is a partial structural schematic view of an in-situ windowing device in accordance with a first embodiment during retrograde in-situ windowing in an aortic vessel;

FIG. 2 is a schematic view, partially in section, of the distal end of the catheter of FIG. 1 shown without the piercing member exiting the opening;

FIG. 3 is a schematic view, partially in section, of the distal end of the catheter of FIG. 2 after the piercing member has passed through the opening;

FIG. 4 is a partial schematic structural view of the distal end of the sheath of FIG. 1 pre-bent in a natural state;

FIG. 5 is a partial structural view of the sheath of FIG. 4 constrained to a straight configuration;

FIG. 6 is a schematic structural view of the stent in the distal end of the sheath tube of FIG. 1;

FIG. 7 is a schematic cross-sectional view of the distal end of the sheath of FIG. 1;

fig. 8 is a schematic structural view of a support stand according to another example of the present embodiment;

fig. 9 is a partial structural view of a stent of still another example of the present embodiment after being cut and expanded in its axial direction;

FIG. 10 is a partial schematic structural view of the support bracket of FIG. 9 in a natural state;

FIG. 11 is a schematic view of a portion of the puncturing element of FIG. 3 shown in a partially pre-bent configuration in a natural state;

FIG. 12 is a partial schematic view of the distal end of the connector of FIG. 11 in a natural state pre-bent;

FIG. 13 is a schematic view of the needle of FIG. 11;

FIG. 14 is a schematic view, partly in section, of the distal end of the catheter of FIG. 2;

FIG. 15 is a schematic view of the structure of a needle of another example of the present embodiment;

FIG. 16 is a schematic view of an alternate angle of the needle of FIG. 15;

fig. 17 is a partial structural view of the outer side surface of the catheter according to the second embodiment;

FIG. 18 is a schematic view of a partial cross-sectional configuration of the catheter of FIG. 17;

FIG. 19 is a schematic view of the structure of the blocking member of FIG. 18;

fig. 20 is a schematic structural view of a barrier according to another example of the second embodiment;

fig. 21 is a schematic structural view of a barrier of still another example of the second embodiment;

FIG. 22 is a schematic sectional view of a catheter according to a third embodiment;

FIG. 23 is a schematic view of the fourth embodiment with the first handle attached to the catheter and the second handle attached to the penetrating member.

The reference symbols in the drawings denote the following:

100: an in-situ windowing facility;

10: sheath, 11: sheath body, 111: curved section, 112: first opening, 12: support frame, 121: second opening, 13: bending member, 14: positioning piece, 15: a balloon;

20: a conduit, 21: catheter lumen, 22: conduction port, 23: a guidewire channel;

30: piercing member, 31: needle head, 311: inclined plane, 32: a connecting member;

40: stopper, 41: blocking part, 411: first blocking surface, 412: second blocking surface, 413: third stop face, 414: first stopper, 415: second stopper, 42: a transition section;

51: first handle, 511: first marker, 52: second handle, 521: a second marker;

200: covering a membrane stent;

300: the aortic blood vessel;

400: and (4) branching blood vessels.

Detailed Description

Exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the invention are shown in the drawings, it should be understood that the invention can be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.

It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only, and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" may be intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "including," and "having" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order described or illustrated, unless specifically identified as an order of performance. It should also be understood that additional or alternative steps may be used.

Although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first," "second," and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.

For convenience of description, spatially relative terms, such as "inner", "outer", "lower", "below", "upper", "above", and the like, may be used herein to describe one element or feature's relationship to another element or feature as illustrated in the figures. Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Thus, the example term "below … …" can include both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

For purposes of more clearly describing the structure of the present application, the terms "proximal" and "distal" are defined herein as terms commonly used in the interventional medical field. Specifically, "distal" refers to the end that is distal from the operator during a surgical procedure, "proximal" refers to the end that is proximal to the operator during a surgical procedure, "axial" refers to its length, "radial" refers to a direction that is perpendicular to the "axial" direction.

Implementation mode one

Referring to fig. 1 to 3, the present invention provides an in-situ fenestration device 100, wherein the in-situ fenestration device 100 comprises a sheath 10, a catheter 20 and a puncturing element 30. The sheath tube 10 is hollow inside, a first opening 112 is disposed on a distal side wall, the catheter 20 is inserted into the sheath tube 10 and can move along an axial direction of the sheath tube 10, a distal end of the catheter 20 can extend out of the sheath tube 10 through the first opening 112, and a conduction opening 22 is disposed on a distal side wall of the catheter 20. The puncturing member 30 is inserted into the catheter 20 and can move along the axial direction of the catheter 20, the distal end of the puncturing member 30 is pre-bent in a natural state, and when the distal end of the puncturing member 30 reaches the position of the conduction opening 22, the distal end of the puncturing member 30 automatically bends and faces the conduction opening 20 so as to further extend out of the catheter 20 for reverse puncturing.

As shown in fig. 3 to 6, the sheath tube 10 of the present embodiment includes a sheath tube main body 11 having a hollow interior, a support frame 12 having a hollow interior, and a bending piece 13 having a pre-bent shape in a natural state, and the sheath tube 10 is configured to have the pre-bent shape in the natural state by the bending piece 13. The supporting frame 12 is fixedly sleeved in the lumen of the distal end of the sheath tube body 11. The side wall of the distal end of the sheath tube body 11 is provided with a first opening 112, the side wall of the support frame 12 is provided with a second opening 121, and the first opening 112 is arranged right opposite to the second opening 121. In the present embodiment, the second opening 121 is provided along the axial direction of the support frame 12, and the second opening 12 and the first opening 112 at the distal end of the sheath body 11 are identical in shape and size, so that the first opening 112 and the second opening 121 completely overlap each other, thereby constituting the opening at the distal end of the sheath 10. In other examples of the present embodiment, the first opening 112 and the second opening 121 may not be identical in shape and size as long as the first opening 112 is disposed opposite to the second opening 121 and the distal end of the catheter 20 can pass through the first opening 112 and the second opening 121. Thus, the first opening 112 and the second opening 121 may partially coincide.

The bending part 13 is arranged on the support frame 12 along the axial direction of the support frame 12, and the support frame 12 is driven by the bending part 13 to be in a pre-bending shape in a natural state. The bending member 13 is disposed on a side of the supporting frame 12 opposite to the second opening 121 of the supporting frame 12, so that the supporting frame 12 is in a pre-bending state in a natural state. The distal end of the curved member 13 is flush with the distal end of the support 12, or the distal end of the support 12 is more distal than the distal end of the curved member 13. The distal end of the sheath body 11 is wrapped by the support frame 12 and the bending member 13, and the sheath body 11 and the support frame 12 can be fixedly connected by means of thermoplasticity or adhesive bonding. The distal end of the sheath body 11 is flush with the distal end of the support frame 12. Wherein the first opening 112 is provided on the curved section 111 along the axial direction of the sheath body 11. Thus, the distal end of the sheath body 11 is also pre-bent in the natural state by the bending piece 13 and the support frame 12, and thus the sheath 10 is also pre-bent in the natural state.

As shown in fig. 1 and 4, the first opening 112 is at least opposite to the position where the bending section 111 is bent to the maximum extent in the natural state, and the opening size of the first opening 112 is larger than the maximum outer diameter of the distal end of the catheter 20, so as to ensure that the distal end of the catheter 20 can smoothly extend out from the first opening 112. Further, the distance between the proximal edge of the first opening 112 and the distal end surface of the sheath body 11 ranges from 10mm to 30mm, so as to ensure that the distal end of the sheath body 11 extends into the branch vessel 400, so that the position of the sheath 10 in the aortic vessel 300 can be kept relatively fixed, and the deviation is not easy to occur, and the branch vessel 400 is not greatly stimulated due to the excessively long extending portion.

In other examples, the distal end of the sheath body 11 may be pre-bent in a natural state by other means, for example, by providing the sheath body 11 itself with a pre-bent shape by heat treatment or the like depending on the material of the sheath body 11 itself, or by providing the distal end of the sheath body 11 with a pre-bent shape by a bending member in a natural state by incorporating a bending member having a pre-bent shape in the sheath body 11, or the like. In these various embodiments, the distal end of the pulling wire is connected to the distal end of the sheath body 11, and the proximal end of the pulling wire extends out of the sheath body 11 along the axial direction of the sheath body 11, and the distal end of the sheath body 11 can also be made to tend to be linear when the pulling wire is pulled toward the proximal end.

The catheter 20 is axially movably sleeved inside the sheath tube body 11. The distal end of the catheter 20 is inserted into the lumen of the sheath body 11 from the proximal end of the sheath body 11, and protrudes from the inside of the sheath body 11 from the first opening 112. The catheter 20 comprises a catheter cavity 21 inside, a conduction opening 22 communicated with the catheter cavity 21 is arranged on the side wall of the far end of the catheter 20, the puncture member 30 is movably arranged in the catheter cavity 21 of the catheter 20, the far end of the puncture member 30 is in a pre-bending shape in a natural state, and when the far end of the puncture member 30 reaches the position of the conduction opening 22, the far end of the puncture member 30 automatically bends and penetrates through the conduction opening 22 to the outside of the catheter 20 to puncture.

According to the in-situ windowing facility 100 in the present embodiment, with the support frame 12 having the pre-bending shape in the natural state, not only the distal end of the sheath body 11 is pre-bent in the natural state, but also the rigidity and radial supporting force of the sheath body 11 in the bending state can be improved, so that after the sheath 10 enters the branch vessel 400 from the aorta vessel 300, the distal end portion has sufficient radial supporting force, and the first opening 112 is not easily deformed, so that the catheter 20 and the puncturing member 30 can easily pass through the sheath body 11 through the first opening 112 at the distal end of the sheath body 11, and the stent graft 200 in the aorta vessel 300 is punctured from the outside of the stent graft 200 to the inside thereof, thereby achieving reverse windowing, and the distal end of the puncturing member 30 is pre-bent in the natural state, and when the distal end of the puncturing member 30 reaches the position of the conduction opening 22, the distal end of the puncturing element 30 is automatically bent and penetrates through the conduction opening 22 to the outside of the catheter 20, and then the outer surface of the covered stent 200 is aligned for reverse puncturing, so that the puncturing element 30 can be effectively guaranteed to puncture through the conduction opening 22 on the side wall of the catheter 20 smoothly, the accuracy of a puncturing position is guaranteed, and operation failure caused by the fact that the puncturing element 30 cannot pass through the catheter 20 smoothly or the puncturing position deviates is reduced or avoided.

In the prior art, a hole is formed in the wall of the stent graft 200 from the inside of the lumen of the stent graft 200 in the aortic blood vessel 300 to the outside, that is, a puncture is performed to the inner surface of the stent graft 200 to perform a fenestration. In the present application, the wall of the stent graft 200 is perforated from the outside of the stent graft 200 to the inside thereof to realize windowing, that is, the outer surface of the stent graft 200 needs to be aligned to perform puncturing to realize windowing, and the windowing direction is just opposite to that of the prior art, so the stent graft 200 is called as reverse branch in-situ windowing, which is called as reverse windowing for short.

Meanwhile, the distal end of the sheath body 11 entering the branch vessel 400 has sufficient radial supporting force with the aid of the support frame 12, so that the first opening 112 is not easily squeezed and deformed after the distal end portion of the sheath 10 enters the branch vessel 400, thereby not blocking the branch vessel 400 and ensuring normal supply of blood in the branch vessel 400.

By using the in-situ fenestration device 100 in the embodiment and matching with conventional interventional surgical instruments, fenestration reconstruction of the branch vessels of the abdominal aorta can be realized in the whole blood lumen, and the application range of the interventional surgery is expanded.

Referring to fig. 1 and 6, the bending member 13 of the present embodiment is a wire attached to the inner wall of the lumen of the distal end of the sheath body 11 and the support frame 12, and the wire is located on the opposite side of the sheath body 11 from the first opening 112, that is, the bending member 13 is disposed opposite to the first opening 112. When the sheath tube body 11 is in a natural state, the bending angle between the proximal end and the distal end of the bending piece 13 is A, and A is more than or equal to 30 degrees and less than or equal to 135 degrees. Accordingly, the distal end of the sheath body 11 is bent from a straight shape to a natural curved shape, and the bending angle ranges from 45 ° to 150 °, so that the distal end of the sheath body 11 is easily bent and deformed from the aortic blood vessel 300 to extend into the branch blood vessel 400 after the pull wire is released, and the branch blood vessel 400 is not squeezed and stimulated.

The bending form of the traditional sheath tube completely depends on the traction effect of the built-in traction wire, namely, the sheath tube body is linear in a natural state, and after the traction wire is drawn towards the near end, the far end of the sheath tube body is bent under the action of the traction wire. Such a structural form has the following disadvantages: under the pulling of the traction wire, the shape of the whole sheath tube body of the sheath tube can be changed, so that the positioning precision is reduced; the difficulty of bending deformation of the distal end of the sheath tube is high by the traction action of the traction wire, and the radial force of the sheath tube is poor after the sheath tube is bent and deformed, so that the branch vessel 300 is easily blocked; by using the traction effect of the traction wire, the distal end of the sheath tube is bent towards the side of the branch vessel 400 in a gradual change manner, so that the occupied space is large. Compared with the traditional sheath, the distal end of the sheath 10 of the invention is in a pre-bending shape in a natural state, and when the traction wire is pulled towards the proximal end, the distal end of the sheath body 11 tends to be in a straight line shape, so that the distal end of the sheath 10 of the invention is easier to control to bend, the bending degree is larger, and higher requirements can be met, meanwhile, because the sheath body 11 is in the pre-bending shape in the natural state due to the self or by means of the components such as the support frame 12 or the bending piece 13, the bending direction of the distal end of the sheath body 11 is controllable when the distal end of the sheath body 11 needs to be bent, and the bending precision is improved.

As shown in fig. 1 and 6, in the present invention, a bent wire is provided at an inner position of the distal end of the sheath body 11, so that the sheath body 11 is pre-bent in a natural state. In the internal conveying process, a traction wire (not shown in the figure) is arranged in the lumen of the sheath body 11 along the axial direction of the sheath body 11, and the distal end of the traction wire is fixed on the inner wall of the lumen at the far end, preferably, the traction wire is directly connected with the distal end of the metal wire, the distal end of the metal wire is tensioned towards the direction of the near end of the sheath body 11 by pulling the traction wire, the metal wire is gradually straightened, the sheath body 11 is gradually linear, and the distal end of the sheath body 11 is easy to pass through the aorta blood vessel 300. After the distal end of the sheath body 11 reaches the region of the branch vessel 400, the traction of the metal wire is released by the traction wire, and at this time, the metal wire drives the distal end of the sheath body 11 to return to the natural pre-bent shape, so that the distal end of the bent sheath body 11 can more easily enter the branch vessel 400, thereby providing sufficient supporting force for the in-situ windowing device 100. In other embodiments, the distal end of the pull wire may be fixed on the support frame 12, and the distal end of the sheath body 11 may be driven by the support frame 12 to be linear after the pull wire is pulled towards the proximal end, so as to facilitate in vivo delivery.

In general, the outer diameter of the sheath body 11 is smaller than the diameter of the branch vessel 400, and the sheath body 11 is pre-bent in a natural state by the bending member 13, so that it is ensured that a pre-stress is generated between the distal end of the sheath body 11 and the vessel wall of the branch vessel 400 after the distal end is inserted into the branch vessel 400, and a sufficient radial supporting force is provided.

As shown in fig. 1 and 6, the support frame 12 in the present embodiment is a plurality of metal wave rings provided along the axial direction of the sheath body 11, and the plurality of metal wave rings are bonded to the inner wall surface of the lumen at the distal end of the sheath body 11. Of the plurality of metal wave rings, the metal wave rings located at the proximal end of the stent 12 are complete ring wave rings, and the plurality of metal wave rings forming the second opening 121 are not complete ring wave rings. The plurality of metal coils are connected by the bending member 13 to constitute the support frame 12. In other examples, the cage 12 may be obtained by cutting a length of the spring coil off in a portion thereof in the axial direction to form the second opening 121.

Further, the distal end of the sheath body 11 is not provided with a metal wave ring at a position close to the end surface, so that the vessel wall is prevented from being damaged when the distal end of the sheath body 11 enters the branch vessel 400. The support frame 12 constitutes a metal skeleton at the distal end of the sheath body 11, so that the sheath body 11 has a good pre-bending shape, and has sufficient radial support force after entering the branch vessel 400, and does not block the branch vessel 400, thereby ensuring continuous blood supply to the branch vessel 400.

The radial force at the first opening 112 at the distal end of the sheath body 11 is small, and after the support frame 12 is disposed at the first opening 112, the support frame does not block the first opening 112, but can also provide sufficient supporting force for the portion of the sheath body 11 containing the first opening 112, so that after the distal end of the sheath body 11 extends into the branch vessel 400, the portion containing the first opening 112 is not deformed due to the extrusion of the vessel wall of the branch vessel 400, thereby blocking the passage of blood flow in the branch vessel 400.

As shown in fig. 1, 4 and 6, the first opening 112 is disposed along the axial direction of the sheath body 11 and penetrates the distal end surface of the sheath body 11, so that the distal end of the sheath body 11 has better bending performance, and the first opening 112 has a larger space so that the distal end of the catheter 20 can pass through smoothly. The support frame 12 is provided with a length slightly longer than the bending member 13, and the bending member 13 is provided with a length longer than or equal to the first opening 112. Referring to fig. 1 and 7, the central angle corresponding to the first opening 112 is B, and 0 < B is smaller than or equal to 90 °, so that the portion of the sheath body 11 including the first opening 112 can easily pass through the catheter 20, and can maintain a sufficient radial supporting force. In other embodiments, the first opening 112 may not penetrate the distal end surface of the sheath body 11, as long as the first opening 112 has a shape and size that allows the distal end of the catheter 20 to smoothly pass through the first opening 112.

The central angle B corresponding to the first opening 112 may be constant or gradually changed along the axial direction of the sheath body 11. Preferably, the central angle B corresponding to the first opening 112 gradually decreases from the distal end of the sheath body 11 toward the proximal direction, so as to facilitate the passage of the guide wire while ensuring that the support frame 12 has sufficient radial supporting force.

As shown in fig. 1, 4 and 5, the sheath tube 10 of the present embodiment further includes a balloon 15, the balloon 15 is sleeved on the outer peripheral surface of the distal end of the sheath tube body 11 close to the first opening 112, and the first opening 112 is closer to the distal end than the balloon 15, that is, the balloon 15 is closer to the proximal end than the first opening 112. Preferably, balloon 15 is disposed near the proximal end of curved section 111 to avoid interfering with the bending of curved section 111.

The distance between the distal end surface of the balloon 15 and the proximal end edge of the first opening 112 ranges from 0mm to 20mm, and the closer the balloon 15 is to the first opening 122, the better the expansion supporting effect of the balloon 15 is.

In an example thereof, a plurality of balloons 15 may be disposed along the axial direction of the sheath body 11, the plurality of balloons 15 may be disposed at intervals or adjacently, and the distance between the most distal balloon 15 and the most proximal balloon 15 may be in a range of 30mm to 50mm, so as to ensure that the plurality of balloons 15 are disposed sufficiently to space a stent graft 200 having a certain length from the main artery 300 sufficiently for blood flow to flow smoothly from the main artery 300 into the branch vessels 400. In other examples, one balloon 15 having a certain length provided in the axial direction of the sheath body 11 may be used instead of the plurality of balloons 15 provided as described above, and the balloon 15 having a certain length may be shaped so as to allow blood flow to flow in the axial direction of the balloon 15, for example, the balloon 15 may be wavy.

The balloon 15 is arranged on the sheath tube body 11, so that the sheath tube 10 not only has the function of bending the distal end, but also the balloon 15 can provide a certain supporting or expanding function for the distal end part of the sheath tube body 11, for example, a certain gap exists between the stent graft 200 and the vessel wall of the branch vessel 400, and the opening of the stent graft 200 to the branch vessel 400 is prevented from being closed after the stent graft 200 is deployed in the aorta vessel 300, so that the branch vessel 400 is prevented from being ischemic. In other examples, the position and number of the balloons 15 may be adjusted according to the requirement, and are not particularly limited herein. Balloon 15 may be configured in a complete or incomplete annular shape (e.g., a C-shape or semi-annular shape).

As shown in fig. 6, a positioning member 14 is further disposed at the distal end of the supporting frame 12, and the positioning member 14 may be a semi-annular metal wire, and a developer is coated on the metal wire, so that the distal end of the sheath body 11 is positioned by recognizing the position of the positioning member 14, and the positioning accuracy is ensured. In other examples, the positioning member 14 may be made of a material having a developing effect instead of coating the developer.

As shown in fig. 1, 4, and 8 in combination, in other examples of the present embodiment, the bending piece 13 is composed of 3 bent wires, and the 3 wires are respectively disposed along the axial direction of the support frame 12 and spaced apart in the circumferential direction of the support frame 12. The 3 wires can be uniformly distributed on the support frame 12, and at least one bending piece 13 is arranged right opposite to the second opening 121, so that the distal end of the sheath tube body 11 has better bending form and supporting force.

Further, the bending piece 13 may be provided at a position of the support bracket 12 corresponding to a connection with one or both axial edges of the first opening 112 in the axial direction of the support bracket 12, so as to keep the first opening 112 less susceptible to deformation when being pressed while improving the bending performance of the support bracket 12.

In other examples of the present embodiment, the number of the wires is not limited to the two embodiments, and other numbers of the wires may be provided according to actual use conditions, so as to ensure that a better bending form and a better supporting force are provided for the distal end of the sheath body 11, and the sheath body 11 can be in a linear state under the action of the drawing wire.

In other examples of the present application, as shown in conjunction with fig. 1, 6, 9 and 10, the support frame 12 is a cutting frame. The support frame 12 may have a pre-bent shape in a natural state after heat treatment, or may have a pre-bent shape after being fixedly coupled to the bending member 13. The cutting stent is attached to the inner wall surface of the lumen of the distal end of the sheath body 11, and the unclosed part of the support frame 12 corresponds to the first opening 112 of the sheath body 11, so as to provide sufficient radial supporting force for the distal end of the sheath body 11, prevent the distal end of the sheath body 11 provided with the first opening 112 from being deformed under the extrusion of the branch vessel 400, and further prevent the branch vessel 400 from causing unnecessary damage to the patient.

The cutting stent is formed into a support frame 12 with natural and continuous parts after cutting and heat setting due to the adoption of a complete pipe fitting or a sheet-shaped part, so that the cutting stent has better support performance, can provide better bending performance, and can keep the first opening 112 not to be easily deformed under the extrusion of the inner wall of the branch vessel 400 and block the blood flow from passing through after the support frame 12 is fixed to the far end of the sheath vessel body 11. The support frame 12 may also be woven from metal wires, which can ensure that the distal end of the sheath body 11 has sufficient radial support force.

Referring to fig. 1, 3 and 11, the puncturing member 30 of the present embodiment includes a needle 31 and a connecting member 32, the needle 31 is disposed at a distal end of the connecting member 32 and is disposed along the same axis as the distal end of the connecting member 32, and a portion of the distal end of the connecting member 32 is pre-bent in a natural state. The needle 31 and the connector 32 may be made of stainless steel used in surgical operations or other materials with good biocompatibility, and the hardness of the used materials is greater than that of the stent graft 200, so as to ensure that the formed puncture element 30 can effectively puncture the stent graft 200 in the aortic vessel 300. The needle 31 and the connecting piece 32 can be of an integral structure, or can be assembled together after being separately processed.

As shown in fig. 3 and 12, in order to ensure that the needle 31 of the puncturing element 30 can smoothly pass through the conduction opening 22 and ensure the accuracy of the puncturing position, the connecting element 32 of the present embodiment is pre-bent at the connecting end with the needle 31, the pre-bending angle of the connecting element 32 is D, and the range of the pre-bending angle D is greater than or equal to 80 ° and less than or equal to 100 °, preferably, D is 90 °.

Referring to fig. 3, 13 and 14, in order to ensure that the needle 31 of the puncturing element 30 can smoothly puncture the covered stent 200 through the conduction port 22, the distal end of the needle 31 is provided with an inclined surface 311 which forms an angle with the axial direction of the needle 31, the inclined surface 311 inclines from the distal end of the needle 31 from outside to inside, and deviates from the opening direction of the conduction port 22 when being accommodated in the catheter 20 and waiting to extend out of the conduction port 22, a maximum included angle C between the inclined surface 311 and the axial direction of the needle 31 is greater than 90 ° and less than 180 °, an included angle C formed by the inclined surface 311 and the axial direction is required to be less than or equal to a bevel edge angle E of the inner wall of the end of the catheter 20, which surrounds the conduction port 22, preferably, the included angle C is 135 °, and the size of the bevel edge angle E is equal to or the difference between the. When the puncturing element 30 is matched with the guide tube 20, the far end of the puncturing element 30 can smoothly pass through the conduction opening 22 on the side wall of the guide tube 20, and the situation that the needle 31 is too sharp due to the overlarge inclined angle of the needle 31 of the puncturing element 30 and pierces into the bevel edge of the corresponding slot of the conduction opening 22 when the puncturing element 30 passes through the conduction opening 22 on the side wall of the guide tube 20, so that the puncturing element 30 cannot smoothly pass through the guide tube 20, and the operation failure is caused is avoided.

Referring to fig. 15 and 16, in another example of the present embodiment, the distal end of the puncturing element 30 is a plane or an arc, i.e., a flat head structure without a sharp needle point, so as to avoid scratching the catheter 20 when the puncturing element 30 passes through the conduction opening 22 due to the sharp end of the needle 31. While preventing the needle 31 from carrying the scraped material from the catheter 20 into the blood vessel and the scraped material from flowing with the blood under the impact of the blood, thereby causing the blood vessel to be blocked. In addition, because the end of the needle 31 is a flat head structure, in order to avoid that the two ends of the flat head structure at the end of the needle 31 scrape the catheter 20 after the angle of the needle 31 is deviated when the puncturing element 30 is used in cooperation with the catheter 20, the two ends of the flat head structure at the end of the needle 31 can be chamfered or processed by an arc, and the chamfer length or the radius of the arc is less than or equal to the outer diameter of the needle 31.

In this embodiment, a developing member may be provided at the distal end of the catheter 20, so as to facilitate observation of the position of the distal end of the catheter 20 in the body with respect to the sheath 10, and to position the catheter 20.

The puncture device 30 having the pre-curved shape according to the present embodiment can be used not only with the sheath tube 10 having the pre-curved shape but also with other sheath tubes 10 that are in a straight state in a natural state.

The in situ fenestration device 100 of this embodiment is suitable for use in interventional procedures at least when treating aortic aneurysms and significant visceral branches, but may be used for other types of vascular disease. The in-situ fenestration device 100 of the present embodiment is further described below with reference to the specific operation steps of the operation, taking the aorta 300 and the branch vessel 400 as an example where the stent graft 200 is required to be installed. As shown in fig. 1, fig. 2, fig. 3, and fig. 4, the method mainly includes the following steps:

s1, after percutaneous puncture, leading a guide wire a into a branch blood vessel 400, then leading the sheath tube 10 with the pull wire tensioned into the aorta blood vessel 300 by using the guide wire a, leading the distal end of the sheath tube body 11 into the branch blood vessel 400 after loosening the pull wire, and then withdrawing the guide wire a out of the body;

s2, conveying the covered stent 200 to the junction of the aortic blood vessel 300 and the branch blood vessel 400 from the outside of the body, and releasing the covered stent 200 to enable the covered stent 200 to be attached to the inner wall of the aortic blood vessel 300 after being unfolded; then the saccule 15 on the sheath tube 10 is inflated, so that a certain gap is reserved between the vessel wall of the aorta vessel 300 and the covered stent 200, and the blood flows into the branch vessel 400 after passing through the gap;

s3, the guide wire b is conveyed to the first opening 112 of the sheath tube body 11 after penetrating through the proximal end of the sheath tube 10, and the distal end of the guide wire b extends out after passing through the first opening 112 of the sheath tube body 11, enters the aorta vessel 300 and is positioned between the stent graft 200 and the vessel wall of the aorta vessel 300; the catheter 20 is threaded into the sheath 10 from the proximal end by the guide wire b, and the catheter 20 is conveyed to the distal end along the sheath 10 until the distal end of the catheter 20 passes out of the first opening 112 of the sheath body 11, and the distal end of the catheter 20 is located in the aortic blood vessel 300 and between the blood vessel wall of the aortic blood vessel 300 and the covered stent 200; adjusting the position of the distal end of the catheter 20 to enable the through hole 22 of the catheter 20 to be positioned between the branch blood vessel 400 and the stent graft 200 and ensure that the position of the through hole 22 is right opposite to the position of the stent graft 200;

s4, penetrating the puncture element 30 from the proximal end of the catheter 20 to enter the catheter cavity 21 and conveying along the catheter cavity 21 to the distal end of the catheter 20; the distal end of the piercing member 30 automatically bends when it reaches the position of the conduction port 22 and pierces the stent graft 200 through the conduction port 22 from the outside to the inside. Namely, the reverse in-situ windowing is completed on the covered stent 200 of the aorta vessel 300, and the windowing position is just positioned at the connection part of the aorta vessel 300 and the branch vessel 400, thereby effectively ensuring the accuracy of the puncture position of the puncture piece 30.

Other steps can be performed according to the existing in-situ windowing method.

Second embodiment

Referring to fig. 1, 17 and 18, the in-situ fenestration device 100 of the present embodiment is substantially the same as that of the first embodiment, and includes a sheath 10, a catheter 20 and a puncturing element 30. The sheath tube 10 is hollow inside, and a first opening 112 is disposed on a distal side wall, the catheter 20 is inserted into the sheath tube 10 and can move along the axial direction, the distal end of the catheter 20 can extend out of the sheath tube 10 through the first opening 112, and a conduction opening 22 is disposed on the distal side wall of the catheter 20. The puncturing member 30 is inserted into the catheter 20 and can move along the axial direction, the distal end of the puncturing member 30 is pre-bent in a natural state, and when the distal end of the puncturing member 30 reaches the position of the conduction opening 22, the distal end of the puncturing member 30 automatically bends to penetrate through the conduction opening 22 and perform reverse puncturing on the stent graft 200. Further, the in-situ fenestration device 100 of the embodiment further comprises a blocking member 40, the hardness of the blocking member 40 is greater than the hardness of the distal end of the puncturing element 30, that is, greater than the hardness of the needle 31, the blocking member 40 is disposed in the catheter cavity 21 of the catheter 20 and is opposite to the conduction port 22, the blocking member 40 at least comprises a first blocking surface 411, and the first blocking surface 411 is fixed on the inner wall of the catheter 20 opposite to the conduction port 22, so as to ensure that the puncturing element 30 does not puncture the beveled edge of the slot at the conduction port 22 in the axial direction when passing through the conduction port 22, and can move along the first blocking surface 411 toward the conduction port 22, so as to smoothly pass through the conduction port 22 and puncture the stent graft 200.

Referring to fig. 1, 17, 18 and 19, the blocking member 40 of the present embodiment includes a blocking portion 41 and a transition portion 42, wherein the cross section of the transition portion 42 is semi-arc shaped and can match the shape of the inner wall of the catheter lumen 21 to assist in fixing the blocking member 40 and prevent the blocking member 40 from moving in the catheter lumen 21. The blocking portion 41 is disposed at a distal end of the transition portion 42, the blocking portion 41 includes a first blocking surface 411, and a second blocking surface 412 and a third blocking surface 413 respectively located at two sides of the first blocking surface 411, and a space enclosed by the first blocking surface 411, the second blocking surface 412 and the third blocking surface 413 faces the conduction opening 22. The first blocking surface 411, the second blocking surface 412 and the third blocking surface 413 are all angular sheet metal members. The top end of the first blocking surface 411, the top end of the second blocking surface 412 and the top end of the third blocking surface 413 are respectively attached to the edge position of the conduction hole 22, and the top end of the first blocking surface 411, the top end of the second blocking surface 412 and the top end of the third blocking surface 413 surround part of the shape of the conduction hole 22, so that the puncture element 30 can move towards the conduction hole 22 along the blocking part 41 after the distal end reaches the position of the conduction hole 22, and finally puncture of the stent graft 200 is smoothly completed. Meanwhile, the blocking member 40 made of a metal material can play a certain developing role, so that the position of the conduction opening 22 is convenient to locate, and the accuracy of the puncture member 30 through the conduction opening 22 is further improved.

In another example of the present embodiment, as shown in fig. 20 in combination with fig. 1, the stopper 40 includes only the stopper 41, and the first stopper surface 411, the second stopper surface 412, and the third stopper surface 413 are provided on the stopper 41, so that the distal end of the puncture element 30 can be similarly limited and guided, and finally the puncture element 30 can penetrate through the through hole 22 to puncture the stent graft 200.

In another example of the present embodiment, as shown in fig. 1 and 21, the stopper 40 is a bent metal sheet. The metal sheet includes a first blocking portion 414 and a second blocking portion 415 arranged at an angle, wherein a distal end of the first blocking portion 414 is located at the conduction opening 22, the first blocking portion 414 is attached to an inner wall of a distal end of the conduit 20 surrounding the conduction opening 22 and fixedly disposed on the conduit 20, the second blocking portion 415 is attached to a bottom wall of the conduit 20 opposite to the conduction opening 22 and fixedly disposed on the conduit 20, and the first blocking portion 414 and the second blocking portion 415 jointly form a first blocking surface 411. As the distal end of the piercing member 30 moves to the stop 40 position, the distal tip 31 of the piercing member 30 is able to move along the surface of the first stop 414 toward the conduction port 22 and eventually exit the conduction port 22 to reverse pierce the stent graft 200.

Third embodiment

As shown in fig. 1 and 22, at least in the distal end wall of the distal end of the catheter 20, a guide wire channel 23 communicating with the outside of the catheter 20 is provided, and specifically, a proximal end opening of the guide wire channel 23 is provided in the side wall of the catheter 20 and is provided near the stopper 40 in the axial direction of the catheter 20, and a distal end opening of the guide wire channel 23 is provided in the distal end of the catheter 20. Since the catheter 20 is usually pushed through a delivery channel established by a guide wire during delivery and reaches a predetermined position, and the conduction opening 22 of the catheter 20 used for reverse windowing is arranged at the side of the distal end of the catheter 20, when the catheter 20 is delivered by the guide wire, the guide wire needs to pass through the conduction opening 22 at the side of the catheter 20, and when the catheter 20 is pushed towards the distal end along the guide wire, a large pushing resistance exists, which is likely to cause damage to the conduction opening 22, resulting in inaccurate position of the subsequent puncturing member 30 passing through the conduction opening 22, and thus causing inaccurate puncturing position on the covered stent 200. Therefore, the guide wire channel 23 is separately established at the distal end position of the catheter 20 of the present embodiment, the proximal end of the guide wire passes through the guide wire channel 23 of the catheter 20 from far to near in the proximal cavity of the sheath 10, and then the catheter 20 is pushed towards the distal end along the guide wire until the catheter 20 is pushed to the target position in the body, so as to reduce the risk of damaging the conduction port 22 during the process of pushing the catheter 20 by means of the guide wire, reduce the times of the guide wire back and forth shuttle, and reduce the operation steps and the operation time.

Embodiment IV

Referring to fig. 1 and 23, the in situ fenestration device 100 of the present embodiment further comprises a first handle 51 and a second handle 52, the first handle 51 is connected to the proximal end of the catheter 20, the second handle 52 is connected to the proximal end of the penetrating member 30, and the axial movement distance of the penetrating member 30 can be controlled by adjusting the distance between the first handle 51 and the second handle 52.

Specifically, the first handle 51 and the catheter 20 are fixed in a matching manner by threads and the like, so that the first handle 51 and the catheter 20 are not separated after the puncturing element 30 is inserted into the catheter 20, the axial moving distance of the puncturing element 30 is prevented from being changed due to the separation between the first handle 51 and the catheter 20, and the stability of the axial moving distance of the puncturing element 30 is ensured. The axial moving distance of the puncture element 30 is too short to complete the penetration of the stent graft 200; the overlong axial moving distance of the puncture piece can simultaneously penetrate through the two sides of the covered stent 200, so that the covered stent 200 is leaked inwards, and even the blood vessel is punctured to damage the blood vessel.

In the present embodiment, the first handle 51 is provided with the first marker 511 having the projecting direction coincident with the opening direction of the through-hole 22, the second handle 52 is provided with the second marker 521 having the projecting direction coincident with the pre-bending direction of the distal end of the puncturing element 30, the current direction or position of the through-hole 22 can be determined by the current direction in which the first marker 511 projects from the first handle 51, and the current bending direction of the distal end of the puncturing element 30 can be determined by the current direction in which the second marker 521 projects from the second handle 52, so that the relative positions of the distal end of the puncturing element 30 and the through-hole 22 can be adjusted and pre-positioned in vitro. When the catheter 20 is advanced to the target site to be punctured in the stent graft 200, if the conduction port 22 is not opposite the target site to be punctured, the opening of the conduction port 22 can be aligned with the target site to be punctured by adjusting the orientation of the first marker 511 on the first handle 51 located outside the body. After the piercing member 30 has been inserted into the catheter 20, the distal end of the piercing member 30 in the catheter 20 can be adjusted by the second handle 52 outside the body to align with the passage 22 so that the needle 31 can smoothly extend out of the passage 22 and further align with the proper position of the stent graft 200 for piercing.

The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are included in the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

1. An in-situ windowing device, comprising:

2. The in situ windowing device according to claim 1, wherein the pre-bend angle of the distal end of the piercing member ranges from greater than or equal to 80 ° to less than or equal to 100 °.

3. The in situ fenestration device of claim 1 wherein the piercing element comprises a needle and a connector, the needle being disposed at a distal end of the connector, a portion of the distal end of the connector being pre-curved in a natural state.

4. The in situ windowing device according to claim 3, wherein the distal end of the needle is provided with an outwardly and inwardly inclined bevel, the maximum angle between the bevel and the axial direction of the needle being in the range of more than 90 ° and less than 180 °.

5. The in situ windowing device according to claim 1, wherein the distal end of the piercing member is planar or curved.

6. The in situ fenestration device of claim 1, further comprising a blocking member disposed within the lumen of the catheter and facing the opening, the blocking member comprising at least a first blocking surface affixed to an inner wall of the catheter opposite the opening, the blocking member having a durometer greater than a durometer of the distal end of the penetrating member.

7. The in-situ window opening device according to claim 6, wherein the blocking member further comprises a second blocking surface and a third blocking surface respectively disposed at two sides of the first blocking surface, and a space enclosed by the first blocking surface, the second blocking surface and the third blocking surface faces the opening.

8. The in-situ window opening device as claimed in claim 7, wherein the top end of the first blocking surface, the top end of the second blocking surface and the top end of the third blocking surface are respectively attached to the edge positions of the via hole.

9. The in situ fenestration device of claim 1, wherein a guidewire channel is provided in communication with the exterior of the catheter at least within the distal end wall of the distal end of the catheter.

10. The in situ windowing device according to claim 1, further comprising a first handle connected to the proximal end of the catheter and a second handle connected to the proximal end of the piercing member, wherein the first handle is provided with a first marker having a protruding direction corresponding to the opening direction of the opening, and wherein the second handle is provided with a second marker having a protruding direction corresponding to the pre-curved direction of the distal end of the piercing member.