CN215535329U - In-situ windowing instrument - Google Patents

Abstract

The utility model relates to an in-situ windowing instrument which comprises a sheath core assembly, a sheath tube and a handle assembly, wherein the sheath core assembly is arranged in the sheath tube in a penetrating mode and can move axially relative to the sheath tube; the sheath core assembly comprises a puncture piece, a sheath core pipe and an expansion piece, the puncture piece is arranged at the far end of the sheath core pipe, the expansion piece is close to the near end of the puncture piece, and when the expansion piece extends out of the far end of the sheath core pipe, the expansion piece can be in an expansion state. According to the in-situ windowing instrument, after the puncture piece extends out of the far end of the sheath tube assembly to puncture and window a coated membrane of the coated stent, the expansion piece can be expanded to enlarge a window hole through axial relative movement of the sheath tube and the sleeve, the puncture and expansion operations are continuous, the time of branch blood vessel ischemia is shortened, and the injury to a patient is reduced.

Description

In-situ windowing instrument

Technical Field

The utility model relates to the technical field of medical instruments, in particular to an in-situ windowing instrument.

Background

With the development of aging society, the incidence of cardiovascular diseases is increasing, wherein diseases of the aortic system including aortic aneurysm and aortic dissection are in a high-incidence and critical state. The most common current method of treating aortic disease is by intraluminal intervention. The intraluminal interventional therapy measures the diseased position of the aorta by means of radiation equipment, selects a vascular stent with proper specification according to measured data, then sends the vascular stent into a blood vessel by means of the radiation equipment through a conveying system to be placed at the diseased position, and has a therapeutic effect by isolating a tumor cavity or a dissection of a dissection through a tectorial membrane after the stent is implanted at the diseased position. The aortic stent is required to cover the opening of the branch vessel towards the near end to increase the distance of the near-end anchoring area so as to cover the lesion position, but the blood circulation of the branch vessel needs to be reconstructed when the branch blood supply is recovered, the stent is mainly windowed by adopting a windowing technology, the branch blood circulation can be opened quickly by adopting the windowing technology, the operation is simple, and the probability of later-stage complications is low.

The windowing technology is divided into in-vitro windowing and in-situ windowing, the in-vitro windowing (namely windowing before stent implantation) has the problems of difficulty in resheathing and aligning the stent, high requirements on the operation of doctors and high risks. In-situ windowing (i.e., windowing in vivo after stent implantation) is the mainstream technology at present, and the prospect is better. In-situ fenestration requires puncturing an opening on a stent by using an in-situ fenestration instrument after the aortic stent is released, then expanding the window by using a balloon, and then implanting a branch stent at the puncturing opening to reconstruct branch blood circulation. However, in this way, the puncturing and expanding operations are not consistent, resulting in a long time consuming process, and the branch vessels are ischemic for a long time to hurt the health of patients.

SUMMERY OF THE UTILITY MODEL

The utility model provides an in-situ windowing instrument, which aims to solve the problem of long-time branch vessel ischemia caused by long time consumption of in-situ windowing operation.

The utility model provides an in-situ windowing instrument, which comprises a sheath core assembly, a sheath tube and a handle assembly, wherein the sheath core assembly is arranged in the sheath tube in a penetrating way and can move axially relative to the sheath tube; the sheath core assembly comprises a puncture piece, a sheath core pipe and an expansion piece, the puncture piece is arranged at the far end of the sheath core pipe, the expansion piece is close to the near end of the puncture piece, and when the expansion piece extends out of the far end of the sheath core pipe, the expansion piece can be in an expansion state.

In one embodiment, the sheath core assembly further comprises a sleeve, the sheath core tube is axially movably disposed in the sleeve, the distal end of the expansion element is connected to the sheath core tube, the proximal end of the expansion element is connected to the distal end of the sleeve, the proximal end of the sleeve is connected to the handle assembly, and the expansion element is caused to contract when the sleeve is moved proximally relative to the sheath core tube.

In one embodiment, the expansion element comprises a mesh structure formed by sizing nickel titanium wires.

In one embodiment, the expansion member comprises a plurality of expandable rods, two ends of each rod are close to the central axis of the sheath core assembly, and the middle parts of the rods are outwards protruded away from the central axis of the sheath core assembly.

In one embodiment, the distal, medial and proximal ends of the stent are provided with visualization points, respectively.

In one embodiment, the handle assembly includes a fixed handle and a puncturing handle located at a proximal side of the fixed handle, a proximal end of the sheath core tube passes through the fixed handle and is connected with the puncturing handle, a proximal end of the sheath core tube is connected with the fixed handle, and when the puncturing handle moves towards a distal end relative to the fixed handle, the puncturing handle can drive the sheath core assembly to move axially relative to the sheath tube and enable the distal end of the sheath core assembly to extend out of the distal end of the sheath tube.

In an embodiment, the handle subassembly still includes knob and bushing spare, the knob cover is established puncture handle periphery and with puncture handle threaded connection, bushing spare with the sleeve pipe near-end is connected, and at least part is located in the fixed handle, bushing spare can drive sleeve pipe relatively fixed handle axial displacement, bushing spare with the block is spacing in the knob axial, the knob can be for bushing spare circumferential direction, when the rotating during the knob, the knob can drive bushing spare is relative puncture handle axial displacement.

In one embodiment, the fixing handle is provided with a sliding groove, and the sleeve connecting piece is circumferentially limited in the sliding groove.

In one embodiment, the knob may cause the expansion member to contract or expand when moved axially relative to the piercing handle.

In one embodiment, finger rings are arranged on the fixing handle and the puncture handle.

The in-situ windowing instrument comprises a sheath core assembly, a sheath tube assembly and a handle assembly, wherein the sheath core assembly comprises a puncture piece, a sheath core tube, a sleeve and an expansion piece, and can axially move relative to the sheath tube assembly under the control of the handle assembly so as to puncture and window a coated membrane of a branch coated membrane stent when the puncture piece extends out of the far end of the sheath tube assembly, and the expansion piece is expanded through the axial relative motion of the sheath core tube and the sleeve so as to expand a window hole, so that the puncturing and expanding operations are continuous, the ischemia time of branch blood vessels is reduced, and the injury to a patient is reduced.

Drawings

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

FIG. 1 is a schematic cross-sectional view of an in-situ window opening apparatus according to an embodiment of the present invention;

FIG. 2 is a schematic view of the combination of the puncturing element, the expansion element, the sheath-core tube and the cannula of the in-situ window opening device according to an embodiment of the present invention;

FIG. 3 is an enlarged partial schematic view of the in situ fenestration instrument shown in FIG. 1 at A;

FIG. 4 is a schematic view of the sheath assembly retracted within the sheath assembly prior to puncturing in an in situ fenestration apparatus in accordance with an embodiment of the utility model;

FIG. 5 is a schematic view of the distal end of the sheath core assembly extending out of the sheath assembly during a windowing operation using the in situ windowing instrument such that the penetrating member penetrates a stent graft within an aortic vessel;

FIG. 6 is an enlarged partial schematic view of an in situ fenestration instrument of an embodiment of the utility model during puncture;

FIG. 7 is a schematic view illustrating the use of a guidewire passing from the interior of the sheath assembly into the aortic vessel and the stent graft after the puncture is completed by the in situ fenestration apparatus according to one embodiment of the utility model;

fig. 8 is a schematic view of the in-situ window opening instrument according to an embodiment of the present invention applied to enlarge the window after puncturing.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein.

In the description of the present invention, it is to be understood that the terms "central," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," "circumferential," and the like are used in the orientations and positional relationships indicated in the drawings for convenience in describing the utility model and to simplify the description, and are not intended to indicate or imply that the referenced device or element must have a particular orientation, be constructed and operated in a particular orientation, and are not to be considered limiting of the utility model.

Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In the description of the present invention, "a plurality" means at least two, e.g., two, three, etc., unless specifically limited otherwise.

In the present invention, unless otherwise expressly stated or limited, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can, for example, be fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or they may be connected internally or in any other suitable relationship, unless expressly stated otherwise. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

It should be noted that the terms "distal" and "proximal" are used as terms of orientation that are commonly used in the medical device art, wherein "distal" refers to the end that is distal from the operator during operation, and "proximal" refers to the end that is proximal to the operator during operation. Axial, meaning a direction parallel to the line connecting the center of the distal end and the center of the proximal end of the medical device; radial, means a direction perpendicular to the above-mentioned axial direction.

Referring to fig. 1, an in situ fenestration instrument 100 according to an embodiment of the utility model includes a sheath core assembly 10, a sheath tube 20 and a handle assembly 30. Wherein, sheath pipe 20 is the cavity body, and sheath core subassembly 10 wears to establish in sheath pipe 20, and can be relative sheath pipe 20 axial displacement, and handle assembly 30 sets up at the near-end for control sheath core subassembly 10 and sheath pipe 20's relative movement.

Referring to fig. 2, the sheath core assembly 10 includes a piercing member 101, a sheath core tube 102, an expansion member 103, and a sheath tube 104. The puncture member 101 is disposed at the distal end of the sheath core tube 102 and can be connected by welding, and the puncture member 101 and the sheath core tube 102 are both hollow structures so that a guide wire can pass through the puncture member 101 and the sheath core tube 102.

The expansion member 103 comprises a self-expandable structure and can be made of a super-elastic material, such as a nickel-titanium wire, which is shaped to provide good expansion properties by utilizing the elastic advantages of the nickel-titanium wire. Specifically, the expansion member 103 contracts when being pressed by an external force, and when the pressing of the external force is released, the expansion member 103 can self-expand and is in an expanded state after being expanded.

The distal end of the expansion element 103 is fixed to the sheath tube 102, and the proximal end of the expansion element 103 is fixedly connected to the sleeve 104. The connection mode may be welding, or other connection modes such as glue bonding or sewing connection, which is not limited herein.

The sleeve 104 is a hollow structure, and the sheath-core tube 102 passes through the lumen of the sleeve 104 and extends from the distal end of the sleeve 104 with a gap therebetween to allow axial sliding movement with respect to each other, thereby controlling the expansion or contraction of the expansion member 103.

In this embodiment, the expansion member 103 includes a plurality of expandable rods 1031, both ends of which are connected to the piercing member 101 and the cannula 104, respectively. In a natural state, the rod bodies 1031 are bent, and both ends of the rod bodies 1031 are close to the central axis of the sheath core assembly 10, and the middle part of the rod bodies 1031 is far away from the central axis and protrudes outwards, so that the expansion member 103 formed by combining the plurality of rod bodies 1031 is expanded.

In some embodiments, the expansion element 103 is in a natural expansion state, wherein the middle is in an expansion state, and the two ends are in natural transition with the puncture element 101 and the cannula 104, respectively, so that when the expansion element 103 moves in the sheath 20, the inner wall of the sheath 20 is not easily scraped, so that the expansion element 103 moves along the sheath 20 more smoothly.

The extension member 103 is further provided with developing spots, for example, 3 developing spots are provided from the distal end to the proximal end of the extension member 103, including a first developing spot 105, a second developing spot 106 and a third developing spot 107. Wherein the first visualization point 105 and the third visualization point 107 are respectively disposed at the distal end and the proximal end of the expansion member 103 to respectively indicate the starting position and the ending position of the expansion member. The second developing point 106 is provided at the middle position of the expansion member 103 to indicate the middle position of the expansion member 103.

When the sheath core tube 102 and the sleeve 104 move axially relative to each other, the two ends of the expansion member 103 are pulled by the sheath core tube 102 and the sleeve 104, and the expansion member 103 expands or contracts. For example, relative movement of the sheath/core tube 102 and the sleeve 104 to move the distal ends away from each other can cause a tensile force to be applied to the ends of the expansion member 103, thereby causing the expansion member 103 to radially contract and reduce its overall profile. Accordingly, when the relative movement of the sheath-core tube 102 and the sleeve 104 causes the distal ends of each other to approach each other, a compressive force is applied to the two ends of the expansion member 103, so that the expansion member 103 radially expands and the overall profile increases.

In this embodiment, the sleeve 104 is axially movably disposed through the sheath 20, so that when the sheath core assembly 10 is moved proximally relative to the sheath 20 with the expansion member 103 in the contracted state, the expansion member 103 is retracted into the sheath 20. Accordingly, with the expansion member 103 in the contracted state, the sheath core assembly 10 is moved distally relative to the sheath 20, and the expansion member 103 can be pushed out distally along the sheath assembly 103.

Referring again to fig. 1, handle assembly 30 includes a stationary handle 301, a piercing handle 302, a knob 303, and a cannula connector 304. For convenient operation, finger rings are arranged on the fixed handle 301 and the puncture handle 302.

The fixed handle 301 is fixedly connected to the proximal end of the sheath 20 (see fig. 3). The piercing handle 302 is fixedly attached to the proximal end of the sheath-core tube 102. The knob 303 is sleeved on the periphery of the puncture handle 302 and is in threaded connection with the puncture handle 302, and the knob 303 is screwed to realize axial relative movement between the knob 303 and the puncture handle 302. The sleeve connector 304 and the knob 303 are axially locked and limited (i.e. they cannot move axially relative to each other), but can rotate relative to each other in the circumferential direction. When knob 303 is turned, knob 303 moves axially relative to piercing handle 302, thereby causing sleeve connector 304 to move axially relative to piercing handle 302. In this embodiment, the cannula connector 304 is fixedly connected to the proximal end of the cannula 104, and since the puncture handle 302 is fixedly connected to the proximal end of the sheath core tube 102, the cannula connector 304 drives the cannula 104 to move axially relative to the sheath core tube 102 by turning the knob 303, so as to control the expansion or contraction of the expansion member 103.

In some embodiments, the sleeve connector 304 is circumferentially constrained to the fixed handle 301. The sleeve connector 304 is clamped in a slide groove 305 at the proximal end of the fixed handle 301, and the slide groove 305 extends in the axial direction, so that when the knob 303 is turned, the sleeve connector 304 slides axially along the slide groove 305 relative to the fixed handle 301 under the driving of the knob 303. It will be appreciated that to prevent piercing handle 302 from escaping from slide channel 305 of stationary handle 301, cooperating stop structures may be provided in slide channel 305 and on cannula coupling member 304 to limit the maximum distance piercing handle 302 can be moved proximally.

Referring to fig. 1 and 4, when the puncture handle 302 is fixed, and the knob 303 is rotated clockwise, the knob 303 moves towards the proximal end relative to the puncture handle 302, at this time, the sleeve connector 304 moves towards the proximal end relative to the puncture handle 302 along with the knob 303, because the sleeve connector 304 is fixedly connected with the sleeve 104, the puncture handle 302 is fixedly connected with the sheath core tube 102, so as to drive the sleeve 104 to move towards the proximal end axially relative to the sheath core tube 102, and then the sleeve 104 axially stretches the expansion member 103 towards the proximal end, so that the expansion member 103 is in a contracted state, and finally, the expansion member 103 is radially contracted to be attached to the sheath core tube 102. At this time, the fixing handle 301 is fixed, and then the puncturing handle 302 is operated to move toward the proximal end, since the cannula coupling member 304 can slide along the sliding groove of the fixing handle 301, so that the sheath core assembly 10 can be entirely accommodated in the sheath core 20 when the puncturing handle 302 is pulled toward the proximal end.

The operation of the in situ fenestration instrument 100 will be further described in conjunction with the fenestration procedure performed with a stent graft previously delivered to the branched vessel.

As shown in FIG. 5, during the fenestration procedure using the in situ fenestration instrument 100, the in situ fenestration instrument 100 is now able to access the desired location of the ostium of the branch vessel along the guidewire 60 because the stent graft 40 has been previously released into the branched vessel 50. As shown in FIG. 6, the sheath 20 is pressed against the stent graft 40, the index finger and the middle finger of the operator penetrate into the two rings of the fixing handle 301 to fix the fixing handle 301, the thumb penetrates into the ring of the puncturing handle 302, and the puncturing handle 30 is pushed towards the fixing handle 301 with a little force, so that the sheath core assembly 10 moves towards the far end relative to the sheath 20, the puncturing part 101 extends out of the far end of the sheath 20, and the film of the stent graft 40 is punctured.

As shown in FIG. 7, after the piercing member 101 has ruptured the stent graft 40, the guidewire 60 is pushed proximally within the sheath core 102 and into the stent graft 40 to create a passageway with the window 401 being only the needle size. Then, the puncture handle 302 is fixed, and the fixed handle 301 is retracted proximally, so that the distal end of the sheath 20 is retracted to the position of the third visualization point 107, and the stent 103 is completely exposed from the distal end of the sheath 20.

As shown in FIG. 8, with the stationary handle 301 and the piercing handle 302 held stationary, the knob 303 is rotated counterclockwise to move the sleeve 104 distally relative to the sheath tube 102, thereby gradually reducing the axial pull on the expansion member 103, causing the expansion member 103 to radially expand and thereby expand the window 401, and the second visualization point may identify the expanded state of the expansion member to accurately enlarge the window 401 of the stent graft 40.

After the expansion member 103 has been expanded once, the knob 303 can be turned clockwise to reduce the expansion member 103, the puncture handle 302 can be pushed or pulled slightly to shift the axial position of the expansion member 103, and then the knob 303 can be turned counterclockwise again to release the expansion member 103, and the assembly can be repeatedly manipulated to expand the window 401 such that the window 401 is expanded sufficiently.

After the window 401 of the covered stent 40 is enlarged, the knob 303 is screwed clockwise, so that the expansion element 103 is radially contracted to be attached to the sheath core tube 102, the fixing handle 301 is moved towards the far end relative to the puncture handle 302, so that the fixing handle 301 drives the sheath tube 20 to move towards the far end relative to the sheath core assembly 10, finally the sheath core assembly 10 is retracted into the sheath tube 20, and at this time, the in-situ windowing device 100 is withdrawn from the body for the next implantation operation of the branch stent. It will be appreciated that the sheath core assembly may also be retracted into the sheath by pulling the piercing handle back proximally.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the claims. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims (10)

1. An in-situ windowing instrument, comprising a sheath core assembly, a sheath tube and a handle assembly, wherein the sheath core assembly is arranged in the sheath tube in a penetrating way and can move axially relative to the sheath tube, and the handle assembly is arranged at the proximal end and used for controlling the relative movement of the sheath core assembly and the sheath tube; the sheath core assembly comprises a puncture piece, a sheath core pipe and an expansion piece, the puncture piece is arranged at the far end of the sheath core pipe, the expansion piece is close to the near end of the puncture piece, and when the expansion piece extends out of the far end of the sheath core pipe, the expansion piece can be in an expansion state.

2. The in situ fenestration instrument of claim 1, wherein the sheath core assembly further comprises a cannula through which the sheath core tube is axially movably disposed, wherein the distal end of the expansion member is coupled to the sheath core tube, wherein the proximal end of the expansion member is coupled to the distal end of the cannula, wherein the proximal end of the cannula is coupled to the handle assembly, and wherein the expansion member is caused to contract when the cannula is moved proximally relative to the sheath core tube.

3. The in situ windowing instrument according to claim 2, wherein the expansion member comprises a mesh shaped of nitinol wires.

4. The in situ windowing instrument according to claim 2, wherein the expansion element comprises a plurality of expandable rods, wherein the ends of the rods are close to the central axis of the sheath core assembly and the middle of the rods project outwardly away from the central axis of the sheath core assembly.

5. The in situ windowing instrument according to claim 1, wherein the distal, middle and proximal ends of the expansion member are provided with visualization points, respectively.

6. The in situ windowing instrument according to any of claims 1-5, wherein the handle assembly comprises a fixed handle and a puncturing handle located at a proximal side of the fixed handle, wherein a proximal end of the sheath core tube extends out of the fixed handle and is connected to the puncturing handle, wherein a proximal end of the sheath core tube is connected to the fixed handle, and wherein when the puncturing handle is moved distally relative to the fixed handle, the puncturing handle is capable of driving the sheath core assembly to move axially relative to the sheath tube and causing the distal end of the sheath core assembly to protrude from the distal end of the sheath tube.

7. The in-situ window opening apparatus according to claim 6, wherein the handle assembly further comprises a knob and a sleeve connector, the knob is sleeved on the periphery of the puncture handle and is in threaded connection with the puncture handle, the sleeve connector is connected with the proximal end of the sleeve and is at least partially disposed in the fixed handle, the sleeve connector can drive the sleeve to axially move relative to the fixed handle, the sleeve connector is axially and upwardly engaged with the knob for limiting, the knob can circumferentially rotate relative to the sleeve connector, and when the knob is rotated, the knob can drive the sleeve connector to axially move relative to the puncture handle.

8. The in situ windowing instrument as recited in claim 7, wherein said stationary handle defines a chute, and said sleeve connection member is circumferentially retained in said chute.

9. The in situ windowing instrument of claim 8, wherein axial movement of the knob relative to the piercing handle causes the expansion member to contract or expand.

10. The in situ windowing instrument of claim 6, wherein finger rings are provided on both the stationary handle and the piercing handle.

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