WO2020135275A1

WO2020135275A1 - Guiding device and guiding system

Info

Publication number: WO2020135275A1
Application number: PCT/CN2019/127200
Authority: WO
Inventors: 于凯; 彭云飞; 朱家琪; 李爱勤
Original assignee: 微创神通医疗科技（上海）有限公司
Priority date: 2018-12-29
Filing date: 2019-12-20
Publication date: 2020-07-02
Also published as: CN111375118A

Abstract

Provided is a guiding device for carrying or conveying a pushing unit (20), the guiding device comprising an introducer sheath unit (10) and a snap-fitting unit, wherein the two ends of the introducer sheath unit (10) are respectively a proximal part (13) and a distal part (14); the snap-fitting unit is arranged on the proximal part (13); the introducer sheath unit (10) comprises a sheathing canal (11) and an inner cavity (12) penetrating through the sheathing canal (11); the snap-fit unit comprises a snap-fitting part (31) and a through hole (32) penetrating through the snap-fitting part (31), with the snap-fitting part (31) being detachably connected to the sheathing canal (11); and the pushing unit (20) penetrates the through hole (32) from the inner cavity (12) for fixing, so as to prevent the pushing unit from shaking or slipping in the introducer sheath unit. Further provided is a guiding system, comprising the guiding device and the pushing unit (20) penetrating through the guiding device.

Description

Guiding device and guiding system

Technical field

The invention relates to the technical field of interventional therapy devices, in particular to a guiding device and a guiding system.

Background technique

In recent years, the incidence of vascular diseases has become higher and higher, and related treatment options have also become popular in research. Among them, interventional therapy has been widely recognized, through the peripheral blood vessels to enter the cardiovascular system to avoid traumatic thoracotomy or craniotomy.

The development of interventional therapy is accompanied by the development of a large number of specific devices and tools specifically designed to pass through peripheral blood vessels. Guiding devices are the most commonly used devices, including catheters, microcatheters, introduction sheaths, etc. Generally, interventional treatment instruments (such as blood vessel stents) are connected to the distal end of the pushing device (such as a pushing unit, etc.), and the surgeon is pushed into the microcatheter through the introduction sheath by pushing the pushing device at the proximal end. The microcatheter is further used in the blood vessel Push the interventional treatment device to the lesion.

The commonly used introduction sheath is generally a cylindrical tube, which is connected to the microcatheter through a connecting piece, and only requires that the inner diameter is the same as the inner diameter of the microcatheter, which is convenient for the pushing device to push the introduction catheter into the microcatheter. However, during use, it will be found that the push product (including the interventional therapy device and the push unit connected thereto) is prone to be stuck when it enters the microcatheter from the introduction sheath. Moreover, during long-distance transportation and storage, the push product often shakes or even slips in the introduction sheath, which brings inconvenience to use and even damages the push product therein.

Summary of the invention

The purpose of the present invention is to provide a guide device and a guide system to solve the problem of sloshing and slipping generated in the introduction sheath during the long-distance transportation.

In order to achieve the above object, the present invention provides a guide device for loading or transporting a pushing unit. The guide device includes an introduction sheath unit and a snap unit, and both ends of the introduction sheath unit are distal ends And the proximal end, the snap unit is provided at the proximal end of the introduction sheath unit, the introduction sheath unit includes a sheath tube and an inner cavity penetrating the sheath tube, the snap unit includes a snap part And a through hole penetrating through the buckle portion, the buckle portion is detachably connected to the sheath tube, and the inner cavity allows the pushing unit to pass through and penetrate into the through hole to fix the pushing unit .

Optionally, the buckle portion is sleeved outside the sheath tube or snapped into the inner cavity of the sheath tube to be detachably connected with the sheath tube.

Optionally, a gap is formed in the sheath tube, and compared to the distal end, the gap is close to the proximal end, and the gap is from the outside of the sheath tube along the radial direction of the sheath tube The surface extends to communicate with the inner cavity, the inner cavity allows the pushing unit to penetrate through the notch, and the through hole allows the pushing unit and the proximal end portion of the introducing sheath unit to penetrate simultaneously Input, fix the push unit in an interference fit.

Optionally, the shape of the notch is an arc or a square.

Optionally, the through hole includes a first segment and a second segment communicating with each other, the diameter of the first segment is greater than the diameter of the second segment, the first segment is coaxially disposed with the second segment Or eccentric setting.

Optionally, the buckle portion includes a first end and a second end, the outer diameter of the buckle portion gradually shrinks in the direction from the first end to the second end, and the diameter of the inner cavity is greater than The outer diameter of the second end is smaller than the outer diameter of the first end; the second end of the buckle portion extends into the proximal end of the inner cavity.

Optionally, the material of the buckle portion is an elastic material, so that when the second end of the buckle portion approaches the distal end portion along the axial direction of the inner cavity, the diameter of the through hole Reduce until the push unit is fixed.

Optionally, the buckle portion further includes a boss, the boss is connected to the first end, and the diameter of the boss is larger than the outer diameter of the first end.

Optionally, the buckle portion includes a torn section and a heat-shrinkable section that are connected to each other, and the torn section includes a plurality of circumferentially provided tear pieces; when the buckle section is sleeved on the sheath tube When outside, the tearing section is wrapped around the proximal end of the sheath tube, and the pushing unit is stuck in the heat shrinking section.

Optionally, the tearing section further includes a transition section connected to the heat-shrinkable section, the transition section is a tubular structure, and is sleeved outside the sheath tube;

and / or,

The heat-shrinkable section has an initial state and a heat-shrinkable state, the inner diameter of the heat-shrinkable section in the initial state is larger than the inner diameter of the heat-shrinkable section in the heat-shrinkable state, and under the heat-shrinkable state , The push unit card is set in the heat shrinkable section.

Optionally, the outer diameter of the distal end of the introduction sheath unit gradually shrinks in the direction from the proximal end to the distal end.

Optionally, the materials of the introduction sheath unit and the snap unit are both flexible materials.

The present invention also provides a guiding system, including the above-mentioned guiding device and a pushing unit, the pushing unit penetrates into the guiding device and is fixed by the buckle portion.

In the present invention, the cooperation between the introduction sheath unit and the buckle unit can limit and fix the push unit to avoid the shaking and slipping of the push unit in the introduction sheath unit during long-distance transportation. Further, by introducing the sheath unit far The structure of the end can cooperate with the conical lumen of the microcatheter connector to avoid the occurrence of jamming.

BRIEF DESCRIPTION

1 is a schematic diagram of the overall structure of an introduction sheath unit provided by an embodiment of the present invention;

2a is a schematic cross-sectional view of an arc-shaped notch provided on an introduction sheath unit provided by an embodiment of the present invention;

2b is a schematic cross-sectional view of a square notch formed on an introduction sheath unit provided by an embodiment of the present invention;

3a is a schematic structural diagram of a coaxial first snap unit provided by an embodiment of the present invention;

3b is a schematic structural diagram of a non-coaxial first snap unit provided by an embodiment of the present invention;

4 is a schematic diagram of cooperation between a first snap unit, an introduction sheath unit, and a pushing unit according to an embodiment of the present invention;

5 is a schematic structural diagram of a second snap unit provided by an embodiment of the present invention;

6 is a schematic diagram of cooperation between a second snap unit and an introduction sheath unit provided by an embodiment of the present invention;

7a is a schematic structural diagram of a third snap unit before heat shrinkage according to an embodiment of the present invention;

7b is a schematic structural diagram of a third snap unit after heat shrinkage according to an embodiment of the present invention;

8 is a schematic diagram of cooperation between a third snap unit and an introduction sheath unit provided by an embodiment of the present invention;

In the picture: 10-introduction sheath unit; 11-sheath tube; 12-lumen; 13-proximal end; 14-distal end; 15-notch; 20-push unit; 30-first snap unit; 31- Snap section; 32-through hole; 321-first section; 322-second section; 40-second buckle unit; 41- buckle section; 411-first end; 412-second end; 413-convex Table; 42-through hole; 50-third snap unit; 51- snap part; 511-tearing section; 512-heat shrink section; 52-through hole.

detailed description

The specific embodiments of the present invention will be described in more detail below with reference to schematic diagrams. The advantages and features of the present invention will be clearer from the following description. It should be noted that the drawings are in a very simplified form and all use inaccurate scales, which are only used to conveniently and clearly assist the purpose of explaining the embodiments of the present invention.

A guiding device for loading or transporting a pushing unit 20, including an introduction sheath unit 10 and a snap unit, and two ends of the introduction sheath unit 10 are a distal portion 14 and a proximal portion 13, respectively, the card A buckle unit is provided at the proximal end portion 13 of the introduction sheath unit 10, the introduction sheath unit 10 includes a sheath tube 11 and an inner cavity 12 penetrating the sheath tube 11, the buckle unit includes a buckle portion 31 and a penetration The through hole 32 of the locking portion 31 is detachably connected to the sheath tube 11, and the pushing unit 20 penetrates into the through hole 32 from the inner cavity 12 for fixing.

Further, the locking portion 31 is sleeved outside the sheath tube 11 or is inserted into the inner cavity 12 of the sheath tube 11 to be detachably connected to the sheath tube 11.

Specifically, referring to FIG. 1, which is a schematic diagram of the overall structure of an introduction sheath unit 10 provided by an embodiment of the present invention, the introduction sheath unit 10 is in a tubular shape, and the interior of the sheath tube 11 is provided with a penetrating lumen 12, the card The buckle unit is provided at the proximal end 13 of the introduction sheath unit 10 to limit the pushing unit 20 inserted into the introduction sheath unit 10.

Further, the outer diameter of the distal portion 14 of the introduction sheath unit 10 gradually shrinks from the proximal portion 13 to the distal portion 14. Specifically, the proximal portion 13 is the end close to the operator, and the distal portion 14 is the end far from the operator. The distal end portion 14 of the introduction sheath unit 10 is tapered, and its taper matches the conical lumen of a microcatheter connection piece, so that the distal end 14 is inserted into the conical lumen. In this way, it is convenient for the distal end portion 14 of the introduction sheath unit 10 to be smoothly connected with the microcatheter connector, so that the pushing unit 20 quickly enters the microcatheter from the introduction sheath unit 10, avoiding the stuck situation.

Further, the material introduced into the sheath unit 10 includes high-density polyethylene. Specifically, the material introduced into the sheath unit 10 may also be other materials commonly used for medical catheters, such as polyethylene terephthalate PET, polypropylene PP and other flexible materials. In addition, the color of the introduction sheath unit 10 is not limited, and may be blue-green.

Further, referring to FIG. 2 a, FIG. 2 b and FIG. 4, the sheath tube 11 is provided with a notch 15 at a position near the proximal end 13 of the introduction sheath unit 10, and the notch 15 is along the diameter of the sheath tube 11 Extending from the outer surface of the sheath tube 11 to communicate with the inner cavity 12, the locking portion 31 is sleeved outside the proximal end portion 13 of the sheath tube 11 and extends to the opening position of the notch 15, After the pushing unit 20 penetrates into the inner cavity 12, it passes through the notch 15 and enters into the through hole 32 penetrating through the buckling portion 31 at the same time as the proximal end portion 13 of the introduction sheath unit 10, and Fix with interference fit.

Wherein, the distance between the notch 15 and the distal portion 14 is greater than the distance from the proximal portion 13. Specifically, the sheath tube 11 is provided with a notch 15 at a set distance (for example, 10 mm) from the proximal end 13 of the introduction sheath unit 10, and one end of the pushing unit 20 passes through the notch 15, then There is no pushing unit 20 passing through a section of the inner cavity 12 of the sheath tube 11 from the notch 15 to the proximal end 13, and this section may be called an auxiliary limit tube.

Further, the shape of the notch 15 is an arc or a square. The specific shape is not limited, as long as the notch 15 opened on the outer wall of the sheath tube 11 allows the pushing unit 20 to pass through the notch 15.

Further, the buckle unit may be in the form of a first buckle unit. Refer to FIGS. 3a and 3b, which are schematic structural views of a coaxial and eccentric first buckle unit 30 provided by an embodiment of the present invention. The diameter design is divided into two steps. The first buckling unit 30 includes a buckling portion 31 and a through hole 32 penetrating through the buckling portion 31, the through hole 32 includes a first segment 321 and a second segment 322 communicating with each other, the first segment 321 is relatively The second section 322 is closer to the notch 15, the diameter of the first section 321 is larger than the diameter of the second section 322, the first section 321 and the second section 322 are arranged coaxially or eccentrically ; The push unit 20 and the proximal end portion 13 of the introduction sheath unit 10 enter from the first section 321 of the through hole 32. Specifically, in FIG. 3a, the first segment 321 and the second segment 322 are arranged coaxially; in FIG. 3b, the first segment 321 and the second segment 322 are arranged eccentrically.

Referring to FIG. 4, it is a schematic diagram of the cooperation of the first snap unit 30 of FIG. 3 b with the introduction sheath unit 10 and the pushing unit 20. One end of the pushing unit 20 passes through the opening 15 of the introduction sheath unit 10, and The proximal end 13 of the introduction sheath unit 10 penetrates from the first section 321 of the first snap unit 30 together, so that the auxiliary limit tube (the sheath tube 11 extends from the notch 15 to all A section of the proximal end 13) is snapped into the first section 321 at the same time as the push unit 20, and the end of the push unit 20 further extends from the second section 322, the second The diameter of the segment 322 only allows the pushing unit 20 to pass through. The first section 321 closely cooperates with the auxiliary limit tube and the pushing unit 20, for example, is an interference fit, and can play a role of limiting and fixing the pushing unit 20, which can prevent the pushing unit 20 from being introduced into the sheath unit Shake occurs within 10. When the coaxial first buckling unit 30 shown in FIG. 3a is in use, one end of the pushing unit 20 bends moderately from the first section 321 into the second section 332, and the auxiliary limit The position tube is clamped in the first section 321, and the first section 321 closely cooperates with the auxiliary limit tube and the pushing unit 20, and also plays a role in limiting and fixing the pushing unit 20. When the push unit 20 is actually used, it is only necessary to remove the first snap unit 30 from the proximal end 13 of the introduction sheath unit 10.

Preferably, the material of the first snap unit 30 includes polytetrafluoroethylene. Specifically, the first snap unit 30 may also be other materials, such as polyetheretherketone PEEK, polyphenylene sulfide PPS, etc., or may be the same as the material introduced into the sheath unit 10.

Further, referring to FIGS. 5 and 6, in this embodiment, the buckling unit may be in the form of a second buckling unit, and the second buckling unit 40 includes a buckling portion 41 and a through hole penetrating through the buckling portion 41 42. The locking portion 41 is inserted into the inner cavity 12 of the sheath tube 11 to be detachably connected to the sheath tube 11. The buckle portion 41 includes a first end 411 and a second end 412, the outer diameter of the buckle portion 41 gradually shrinks in the direction from the first end 411 to the second end 412, and the inner cavity The diameter of 12 is larger than the outer diameter of the second end 412 and smaller than the outer diameter of the first end 411. The second end 412 of the locking portion 41 enters the proximal end of the inner cavity 12. Moreover, the material of the locking portion 41 is preferably an elastic material, so that when the second end 412 of the locking portion 41 approaches the distal portion 14 along the axial direction of the inner cavity 12, the The buckling portion 41 is deformed by being pressed, and the diameter of the through hole 42 gradually decreases until the pushing unit 20 is fixed.

Specifically, in this embodiment, the introduction sheath unit 10 does not need to open the notch 15, but maintains a complete tubular structure. The pushing unit 20 penetrates from the proximal end portion 13 of the introduction sheath unit 10 and exits from the distal end portion 14 of the introduction sheath unit 10. The second buckle unit 40 is sleeved on the proximal end of the pushing unit 20 and is stuck on the proximal end 13 of the introduction sheath unit 10. The diameter of the through hole 42 of the second buckle unit 40 may be slightly larger than the diameter of the pushing unit 20, so that the pushing unit 20 passes through the through hole 42. The diameter of the inner cavity 12 is larger than the outer diameter of the second end 412 and smaller than the outer diameter of the first end 411, so that the locking portion 41 can enter the inner cavity 12, and The depth continues to increase, so that the diameter of the through hole 42 gradually decreases to play a role of limiting and fixing the pushing unit 20.

After the buckle portion 41 enters the inner cavity 12 and deepens in the axial direction and gradually approaches the distal end portion 14, the buckle portion 41 is compressed by the proximal end portion 13 introduced into the sheath unit 10 The diameter of the through-hole 42 is gradually reduced, so as to limit the pushing unit 20 provided in the through-hole 42, as shown in FIG. 6. Preferably, the second buckling unit 40 has elasticity and can be deformed when pressed, thereby reducing the diameter of the through hole 42.

Further, the locking portion 41 further includes a boss 413 connected to the first end 411, and the diameter of the boss 413 is larger than the outer diameter of the first end 411. In this way, the boss 413 can be locked outside the inner cavity 12 of the introduction sheath unit 10. The setting of the boss 413 facilitates the operator to pick up the second buckle unit 40, or The two snap units 40 are taken out from the introduction sheath unit 10.

Wherein, the material of the second snap unit 40 may be flexible materials such as butadiene rubber BR, nitrile butadiene rubber NBR, perfluoroethylene propylene copolymer FEP, etc., which mainly needs to meet the requirement of easy shrinkage.

Further, referring to FIGS. 7a, 7b, and 8, in this embodiment, the buckling unit may be in the form of a third buckling unit, and the third buckling unit 50 includes a buckling portion 51 and penetrates the buckling portion 51 The through hole 52, the locking portion 51 is sleeved outside the sheath tube 11 to be detachably connected to the sheath tube 11. The locking portion 51 includes a tearing section 511 and a heat shrinking section 512 connected to each other. The tearing section 511 includes a plurality of circumferentially provided tearing pieces. The locking section 51 is sleeved on the sheath tube 11 outside, and the tearing section 511 is wrapped around the proximal end of the sheath tube 11, the pushing unit 20 passes through the proximal end of the sheath tube 11 and is locked in the heat shrinkable section 512.

Specifically, the buckling portion 51 of the third buckling unit 50 has a tubular shape, and a tearing opening is provided at a section of the piping of the buckling portion 51 along the axial direction or near the axial direction, that is, a tearing section 511 is formed . Wherein, the tearing section 511 includes a plurality of circumferentially arranged tearing pieces, and the tearing pieces may be two or more pieces. The tearing section 511 of the third snap unit 50 covers the proximal end 13 of the introduction sheath unit 10.

Further, the tearing section 511 further includes a transition section connected to the heat-shrinkable section 512, the transition section is a tubular structure, which is used to be sleeved on the outside of the sheath tube 11; and/or The heat-shrinkable section 512 has an initial state and a heat-shrinkable state. The inner diameter of the heat-shrinkable section 512 in the initial state is larger than the inner diameter of the heat-shrinkable section 512 in the heat-shrinkable state, and in the heat-shrinkable state, The pushing unit 20 is installed in the heat-shrinkable section 512.

Specifically, when the heat shrinkable section 512 of the third snap unit 50 is sleeved on the pushing unit 20, that is, during and before the pushing unit 20 passes through the through hole 52, the heat The shrink section 512 is the initial state in FIG. 7a; after the pushing unit 20 is inserted into the heat shrink section 512, the heat shrink section 512 is heated to shrink the diameter of the heat shrink section 512 after heating. Covering the pushing unit 20 tightly, the heat-shrinkable section 512 is in the heat-shrinkable state in FIG. 7b and FIG. 8, so that the pushing unit 20 can be fixed and fixed by the third snap unit 50 .

When the push unit 20 needs to be used, the tearing section 511 of the third snap unit 50 is torn apart to remove the third snap unit 50, and the push unit 20 can be pushed out of the introduction sheath unit 10. Wherein, the material of the third snap unit 50 may be flexible materials such as silica gel, polyethylene PE, ethylene-propylene rubber EPDM, etc., which mainly need to meet the heat shrinkability requirements.

In summary, in a guide device and guide system provided by an embodiment of the present invention, through the cooperation of the introduction sheath unit and the snap unit, the pushing unit can be limited and fixed to avoid the introduction of the pushing unit during transportation Shaking and slipping occurred in the sheath unit. Further, the structure introduced into the distal end of the sheath unit can be matched with the conical lumen of the microcatheter connector to avoid the occurrence of jamming.

The above are only preferred embodiments of the present invention, and do not limit the present invention in any way. Any person skilled in the art of the art, without departing from the scope of the technical solutions of the present invention, makes any equivalent replacement or modification of the technical solutions and technical contents disclosed in the present invention, which are not departing from the technical solutions of the present invention. The content still falls within the protection scope of the present invention.

Claims

A guide device for loading or transporting a pushing unit, characterized in that the guide device includes an introduction sheath unit and a snap unit, and both ends of the introduction sheath unit are a distal end and a proximal end, respectively The buckle unit is provided at the proximal end of the introduction sheath unit. The introduction sheath unit includes a sheath tube and an inner cavity penetrating the sheath tube. The buckle unit includes a buckle portion and the card. A through hole of the buckle portion, the buckle portion is detachably connected to the sheath tube, and the inner cavity is used for the pushing unit to pass through and penetrate into the through hole to fix the pushing unit.
The guide device according to claim 1, wherein the buckle part is sleeved outside the sheath tube or is caught in the inner cavity of the sheath tube to be detachably connected with the sheath tube .
The guide device according to claim 1 or 2, wherein the sheath has a gap formed therein, and compared with the distal end, the gap is close to the proximal end, and the gap is along the The radial direction of the sheath tube extends from the outer surface of the sheath tube to communicate with the inner cavity, the inner cavity is provided for the pushing unit to pass through the gap, and the through hole is used for pushing The unit and the proximal end portion of the introduction sheath unit penetrate at the same time, and the push unit is fixed in an interference fit manner.
The guiding device according to claim 3, wherein the shape of the notch is an arc or a square.
The guiding device according to claim 3, wherein the through hole includes a first segment and a second segment communicating with each other, the diameter of the first segment is greater than the diameter of the second segment, the first One section is arranged coaxially or eccentrically with the second section.
The guide device according to claim 1 or 2, wherein the buckle portion includes a first end and a second end, and an outer diameter of the buckle portion extends from the first end to the second end The direction of the end gradually shrinks, and the diameter of the inner cavity is larger than the outer diameter of the second end and smaller than the outer diameter of the first end; the second end of the buckle portion extends into the vicinity of the inner cavity end.
The guiding device according to claim 6, wherein the material of the locking portion is an elastic material, so that when the second end of the locking portion approaches the axial direction of the inner cavity, At the distal end, the diameter of the through hole decreases until the pushing unit is fixed.
The guiding device according to claim 6, wherein the locking portion further comprises a boss, the boss is connected to the first end, and the diameter of the boss is larger than the first end Outer diameter.
The guide device according to claim 1 or 2, wherein the buckle portion includes a tearing section and a heat shrinking section connected to each other, and the tearing section includes a plurality of circumferentially provided tearing pieces;

When the buckle portion is sleeved on the outside of the sheath tube, the tearing section is wrapped around the proximal end of the sheath tube, and the pushing unit is stuck in the heat shrinkable section.
The guiding device according to claim 9, characterized in that

The tearing section further includes a transition section connected with the heat shrinking section, the transition section is a tubular structure, and is sleeved outside the sheath tube;

and / or,

The heat-shrinkable section has an initial state and a heat-shrinkable state, the inner diameter of the heat-shrinkable section in the initial state is larger than the inner diameter of the heat-shrinkable section in the heat-shrinkable state, and under the heat-shrinkable state , The push unit card is set in the heat shrinkable section.
The guide device according to claim 1 or 2, wherein the outer diameter of the distal end portion of the introduction sheath unit gradually contracts in the direction from the proximal end portion to the distal end portion.
The guide device according to claim 1 or 2, wherein the materials of the introduction sheath unit and the snap unit are both flexible materials.
A guiding system, characterized in that it includes the guiding device according to any one of claims 1-12 and a pushing unit, the pushing unit penetrates into the guiding device and passes through the buckle portion To be fixed.