Guide device and guiding system

Abstract

The present invention relates to a guiding device for loading or conveying a pushing unit, which includes an introduction sheath unit and a buckle unit. The two ends of the introduction sheath unit are respectively a proximal end and a distal end. The buckle unit is arranged at the proximal end. The introduction sheath unit includes a sheath tube and a lumen penetrating through the sheath tube. The buckle unit includes a buckle portion and a through hole penetrating through the buckle portion. The buckle portion is detachably connected to the sheath tube, and the pushing unit is fixed by passing through the lumen and into the through hole. The present invention also provides a guiding system, which includes the guiding device of the present invention and a pushing unit penetrating into the guiding device. The present invention can limit and fix the pushing unit through the cooperation of the introduction sheath unit and the buckle unit, so as to avoid the situation that the pushing unit shakes and slips in the introduction sheath unit during long-distance transportation.

Description

Technical Field

[0001] The present invention relates to the technical field of interventional therapy devices, and particularly to a guiding device and a guiding system. Background Art

[0002] In recent years, the incidence of vascular diseases has been increasing, and related treatment programs have also become a research hotspot. Among them, interventional therapy has been widely recognized, entering the cardiovascular and cerebrovascular systems through peripheral blood vessels to avoid traumatic thoracotomy or craniotomy.

[0003] While developing interventional therapy, it is also accompanied by the development of a large number of specific devices and tools specifically designed for passing through peripheral blood vessels. The guiding device is the most commonly used device, including catheters, microcatheters, introducer sheaths, etc. Generally, an interventional therapy instrument (such as a vascular stent, etc.) is connected to the distal end of a pushing device (such as a pushing unit, etc.), and the operator pushes the pushing device through the introducer sheath at the proximal end and into the microcatheter, and the microcatheter is further used to push the interventional therapy instrument in the blood vessel until the lesion site.

[0004] Commonly used introducer sheaths are generally cylindrical tubes, connected to the microcatheter through a connecting piece, and only require their inner diameters to be the same as that of the microcatheter, facilitating the pushing device to be pushed from the introducer sheath into the microcatheter. However, it is found during use that when the pushing product (including the interventional therapy instrument and the pushing unit connected thereto) enters the microcatheter from the introducer sheath, it is prone to jamming. Moreover, during long-distance transportation and storage, the pushing product often shakes or even slips off in the introducer sheath, bringing inconvenience to use and even damaging the pushing product therein. Summary of the Invention

[0005] The purpose of the present invention is to provide a guiding device and a guiding system to solve the problems of shaking and slipping of the pushing product in the introducer sheath during long-distance transportation.

[0006] To achieve the above purpose, the present invention provides a guiding device for loading or transporting a pushing unit, including an introducer sheath unit and a buckle unit. The two ends of the introducer sheath unit are respectively a distal end portion and a proximal end portion, the buckle unit is arranged at the proximal end portion of the introducer sheath unit, the introducer sheath unit includes a sheath tube and a lumen penetrating through the sheath tube, the buckle unit includes a buckle portion and a through hole penetrating through the buckle portion, the buckle portion is detachably connected to the sheath tube, and the pushing unit passes through the lumen and into the through hole for fixation.

[0007] Optionally, the buckle portion is sleeved outside the sheath tube or snapped into the lumen of the sheath tube to be detachably connected to the sheath tube.

[0008] Optionally, a notch is provided at a position near the proximal end of the sheath tube close to the introduction sheath unit. The notch extends radially along the sheath tube to communicate with the inner cavity. After the pushing unit penetrates into the inner cavity, it passes through the notch and enters the through hole of the snap part simultaneously with the proximal end of the introduction sheath unit, and is fixed in an interference fit manner.

[0009] Optionally, the shape of the notch is arc-shaped or square.

[0010] Optionally, the through hole includes a first section and a second section that communicate with each other. The diameter of the first section is larger than the diameter of the second section. The first section and the second section are coaxially arranged or eccentrically arranged.

[0011] Optionally, the snap part includes a first end and a second end. The outer diameter of the snap part gradually shrinks along the direction from the first end to the second end. 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 snap part enters the proximal end of the inner cavity.

[0012] Optionally, the material of the snap part is an elastic material, so that when the second end of the snap part approaches the distal end along the axial direction of the inner cavity, the diameter of the through hole decreases until the pushing unit is fixed.

[0013] Optionally, the snap part 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.

[0014] Optionally, the snap part includes a tear section and a heat-shrinkable section that are connected to each other. The tear section includes a plurality of circumferentially arranged tear sheets. The snap part is sleeved outside the sheath tube, and the tear section covers the proximal end of the sheath tube. The pushing unit is clamped in the heat-shrinkable section.

[0015] Optionally, the tear 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.

[0016] and / or

[0017] The heat-shrinkable section has an initial state and a heat-shrunk 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-shrunk state. In the heat-shrunk state, the pushing unit is clamped in the heat-shrinkable section.

[0018] Optionally, the outer diameter of the distal end of the introduction sheath unit gradually shrinks along the direction from the proximal end to the distal end.

[0019] Optionally, the materials of both the introduction sheath unit and the snap unit are flexible materials.

[0020] The present invention also provides a guiding system, including the guiding device and the pushing unit as described above. The pushing unit penetrates into the guiding device and is fixed by the buckle part.

[0021] Through the cooperation of the introduction sheath unit and the buckle unit, the present invention can limit and fix the pushing unit to avoid the situation that the pushing unit shakes or slips in the introduction sheath unit during long-distance transportation. Further, the structure at the distal end of the introduction sheath unit can cooperate with the conical inner cavity of the microcatheter connector to avoid jamming. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 It is a schematic diagram of the overall structure of the introduction sheath unit provided by an embodiment of the present invention;

[0023] Figure 2a It is a schematic cross-sectional view of the introduction sheath unit provided by an embodiment of the present invention with an arc-shaped notch;

[0024] Figure 2b It is a schematic cross-sectional view of the introduction sheath unit provided by an embodiment of the present invention with a square notch;

[0025] Figure 3a It is a schematic diagram of the structure of the coaxial first buckle unit provided by an embodiment of the present invention;

[0026] Figure 3b It is a schematic diagram of the structure of the non-coaxial first buckle unit provided by an embodiment of the present invention;

[0027] Figure 4 It is a schematic diagram of the cooperation of the first buckle unit with the introduction sheath unit and the pushing unit provided by an embodiment of the present invention;

[0028] Figure 5 It is a schematic diagram of the structure of the second buckle unit provided by an embodiment of the present invention;

[0029] Figure 6 It is a schematic diagram of the cooperation of the second buckle unit with the introduction sheath unit provided by an embodiment of the present invention;

[0030] Figure 7a It is a schematic diagram of the structure of the third buckle unit before heat shrinkage provided by an embodiment of the present invention;

[0031] Figure 7b It is a schematic diagram of the structure of the third buckle unit after heat shrinkage provided by an embodiment of the present invention;

[0032] Figure 8 It is a schematic diagram of the cooperation of the third buckle unit with the introduction sheath unit provided by an embodiment of the present invention;

[0033] In the figure: 10 - introduction sheath unit; 11 - sheath tube; 12 - inner cavity; 13 - proximal end; 14 - distal end; 15 - notch; 20 - pushing unit; 30 - first snap unit; 31 - snap part; 32 - through hole; 321 - first section; 322 - second section; 40 - second snap unit; 41 - snap part; 411 - first end; 412 - second end; 413 - boss; 42 - through hole; 50 - third snap unit; 51 - snap part; 511 - tearing section; 512 - heat shrinkable section; 52 - through hole. Detailed implementation manners

[0034] The following will describe the detailed implementation manners of the present invention in more detail with reference to the schematic diagrams. According to the following description, the advantages and features of the present invention will be clearer. It should be noted that the drawings are all in a very simplified form and use non-precise scales, only for the purpose of facilitating and clearly assisting in explaining the purpose of the embodiments of the present invention.

[0035] A guiding device for loading or conveying a pushing unit 20, comprising an introduction sheath unit 10 and a snap unit. The two ends of the introduction sheath unit 10 are respectively a distal end 14 and a proximal end 13. The snap unit is arranged at the proximal end 13 of the introduction sheath unit 10. The introduction sheath unit 10 includes a sheath tube 11 and an inner cavity 12 penetrating through the sheath tube 11. The snap unit includes a snap part 31 and a through hole 32 penetrating through the snap part. The snap part 31 is detachably connected to the sheath tube 11. The pushing unit 20 penetrates into the through hole 32 from the inner cavity 12 for fixation.

[0036] Furthermore, the snap part is sleeved outside the sheath tube 11 or snapped into the inner cavity 12 of the sheath tube 11 to be detachably connected to the sheath tube 11.

[0037] Specifically, referring to Figure 1 , which is the overall structural schematic diagram of the introduction sheath unit 10 provided by the embodiment of the present invention. The introduction sheath unit 10 is tubular, and a through inner cavity 12 is provided inside the sheath tube 11. The snap unit is used to be arranged at the proximal end 13 of the introduction sheath unit 10 to limit the pushing unit 20 penetrating into the introduction sheath unit 10.

[0038] Furthermore, the outer diameter of the distal end portion 14 of the introducer sheath unit 10 gradually contracts along the direction from the proximal end portion 13 to the distal end portion 14. Specifically, the proximal end portion 13 is the end close to the operator, and the distal end portion 14 is the end away from the operator. The distal end portion 14 of the introducer sheath unit 10 is conical, and its taper matches the conical inner cavity of a microcatheter connector, so that the distal end portion 14 can be inserted into the conical inner cavity. In this way, it is convenient for the distal end portion 14 of the introducer sheath unit 10 to be smoothly connected to the microcatheter connector, enabling the pushing unit 20 to quickly enter the microcatheter from the introducer sheath unit 10 and avoiding jamming.

[0039] Furthermore, the material of the introducer sheath unit 10 includes high-density polyethylene. Specifically, the material of the introducer sheath unit 10 can also be other materials commonly used for medical catheters, such as flexible materials like polyethylene terephthalate (PET) and polypropylene (PP). Additionally, the color of the introducer sheath unit 10 is not limited and can be blue-green.

[0040] Furthermore, referring to Figure 2a , Figure 2b and Figure 4 , a notch 15 is provided at a position of the sheath tube 11 close to the proximal end portion 13 of the introducer sheath unit 10. The notch 15 extends from the outer surface of the sheath tube 11 along the radial direction of the sheath tube 11 to communicate with the inner cavity 12. The buckle 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 the through hole 32 penetrating the buckle portion 31 simultaneously with the proximal end portion 13 of the introducer sheath unit 10, and is fixed in an interference fit manner.

[0041] Among them, the distance between the notch 15 and the distal end portion 14 is greater than the distance between the notch 15 and the proximal end portion 13. Specifically, the notch 15 is provided at a set distance (for example, 10 mm) from the proximal end portion 13 of the introducer sheath unit 10 on the sheath tube 11. 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 portion 13, and this section can be called the auxiliary limiting tube.

[0042] Furthermore, the shape of the notch 15 is arc-shaped or square. The specific shape is not limited, as long as the notch 15 opened on the outer wall of the sheath tube 11 can enable the pushing unit 20 to pass through the notch 15.

[0043] Furthermore, referring to Figure 3a and Figure 3b, which are respectively schematic structural diagrams of the coaxial and eccentric first snap units 30 provided in the embodiments of the present invention. Both adopt a variable diameter design and are divided into two-step steps. The first snap unit 30 includes a snap portion 31 and a through hole 32 passing through the snap portion 31. The through hole 32 includes a first section 321 and a second section 322 that communicate with each other. The first section 321 is closer to the notch 15 than the second section 322. The diameter of the first section 321 is greater than the diameter of the second section 322. The first section 321 and the second section 322 are coaxially arranged or eccentrically arranged; the pushing unit 20 and the proximal end 13 of the introduction sheath unit 10 enter from the first section 321 of the through hole 32. Specifically, Figure 3a In it, the first section 321 and the second section 322 are coaxially arranged; Figure 3b In it, the first section 321 and the second section 322 are eccentrically arranged.

[0044] Refer to Figure 4 , which is Figure 3b A schematic diagram of the cooperation of the first snap unit 30 with the introduction sheath unit 10 and the pushing unit 20. One end of the pushing unit 20 passes through the notch 15 of the introduction sheath unit 10 and enters the first section 321 of the first snap unit 30 together with the proximal end 13 of the introduction sheath unit 10, so that the auxiliary limiting tube (a section of the sheath tube 11 from the notch 15 to the proximal end 13) and the pushing unit 20 are simultaneously clamped in the first section 321, and the end of the pushing unit 20 further extends out from the second section 322. The diameter of the second section 322 only allows the pushing unit 20 to pass through. The first section 321 is in close fit with the auxiliary limiting tube and the pushing unit 20, for example, an interference fit, which can play a role in limiting and fixing the pushing unit 20, so as to avoid the pushing unit 20 from shaking in the introduction sheath unit 10. And Figure 3a When the coaxial first snap unit 30 shown in

[0045] is in use, one end of the pushing unit 20 is moderately bent during the process of entering the second section 332 from the first section 321. The auxiliary limiting tube is clamped in the first section 321, and the first section 321 is in close fit with the auxiliary limiting tube and the pushing unit 20, which also plays a role in limiting and fixing the pushing unit 20. When actually using the pushing unit 20, only need to remove the first snap unit 30 from the proximal end 13 of the introduction sheath unit 10.

[0046] Furthermore, refer toFigure 5 and Figure 6 , in this embodiment, the second buckle unit 40 includes a buckle portion 41 and a through hole 42 penetrating through the buckle portion 41. The buckle portion 41 is snapped into the inner cavity 12 of the sheath 11 to be detachably connected to the sheath 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 along the direction from the first end 411 to the second end 412. And the diameter of the inner cavity 12 is greater than the outer diameter of the second end 412 and less than the outer diameter of the first end 411. The second end 412 of the buckle portion 41 enters the proximal end of the inner cavity 12. And, the material of the buckle portion 41 is preferably an elastic material, so that when the second end 412 of the buckle portion 41 approaches the distal end portion 14 along the axial direction of the inner cavity 12, the buckle portion 41 is deformed by extrusion, and the diameter of the through hole 42 gradually decreases until the pushing unit 20 is fixed.

[0047] Specifically, in this embodiment, the introduction sheath unit 10 does not need to be provided with a notch 15, but maintains a complete tubular structure. The pushing unit 20 penetrates into the introduction sheath unit 10 from the proximal end portion 13 and penetrates out of 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 snapped on the proximal end portion 13 of the introduction sheath unit 10. The diameter of the through hole 42 of the second buckle unit 40 is slightly larger than the diameter of the pushing unit 20, so that the pushing unit 20 can pass through the through hole 42. The diameter of the inner cavity 12 is greater than the outer diameter of the second end 412 and less than the outer diameter of the first end 411, so that the buckle portion 41 can enter the inner cavity 12, and as the depth of entry increases, the diameter of the through hole 42 gradually decreases to play a role in limiting and fixing the pushing unit 20.

[0048] During the process that the buckle portion 41 enters the inner cavity 12 and axially penetrates and gradually approaches the distal end portion 14, the diameter of the through hole 42 of the buckle portion 41 gradually decreases due to being extruded by the proximal end portion 13 of the introduction sheath unit 10, thereby playing a role in limiting the pushing unit 20 disposed in the through hole 42. For reference, see Figure 6 . Preferably, the second buckle unit 40 has elasticity and can be deformed when being extruded, so that the diameter of the through hole 42 decreases.

[0049] Further, the buckle portion 41 further includes a boss 413. The boss 413 is connected to the first end 411, and the diameter of the boss 413 is greater than the outer diameter of the first end 411. In this way, the boss 413 can be clamped outside the inner cavity 12 of the introduction sheath unit 10. The provision of the boss 413 facilitates the operator to pick up the second buckle unit 40 or take out the second buckle unit 40 from the introduction sheath unit 10.

[0050] Among them, the material of the second buckle unit 40 can be flexible materials such as cis-butadiene rubber BR, nitrile rubber NBR, and fluorinated ethylene propylene copolymer FEP, mainly meeting the requirement of easy shrinkage.

[0051] Further, referring to Figure 7a 、 Figure 7b and Figure 8 In this embodiment, the third buckle unit 50 includes a buckle portion 51 and a through hole 52 penetrating through the buckle portion 51. The buckle portion 51 is sleeved outside the sheath tube 11 to be detachably connected to the sheath tube 11. The buckle portion 51 includes a tearing section 511 and a heat-shrinkable section 512 that are connected to each other. The tearing section 511 includes a plurality of tearing pieces arranged circumferentially. The buckle portion 51 is sleeved outside the sheath tube 11, and the tearing section 511 covers the proximal end of the sheath tube 11. The pushing unit 20 passes through the proximal end of the sheath tube 11 and is clamped in the heat-shrinkable section 512.

[0052] Specifically, the buckle portion 51 of the third buckle unit 50 is tubular. A tearing opening is provided in an axial direction or an approximately axial direction at a section of the buckle portion 51, thus forming the tearing section 511. Among them, the tearing section 511 includes a plurality of tearing pieces arranged circumferentially, and the tearing pieces can be two or more. The tearing section 511 of the third buckle unit 50 covers the proximal end portion 13 of the introduction sheath unit 10.

[0053] Further, the tearing section 511 further includes a transition section connected to the heat-shrinkable section 512. The transition section is a tubular structure for being sleeved outside the sheath tube 11; and / or the heat-shrinkable section 512 has an initial state and a heat-shrunk state. The inner diameter of the heat-shrinkable section 512 in the initial state is greater than the inner diameter of the heat-shrinkable section 512 in the heat-shrunk state, and in the heat-shrunk state, the pushing unit 20 is clamped in the heat-shrinkable section 512.

[0054] Specifically, when the heat-shrinkable section 512 of the third buckle unit 50 is sleeved on the pushing unit 20, that is, during and before the process of the pushing unit 20 passing through the through hole 52, the heat-shrinkable section 512 is Figure 7athe initial state in; after the pushing unit 20 is inserted into the heat-shrinkable section 512, the heat-shrinkable section 512 is heated, so that the diameter of the heat-shrinkable section 512 shrinks after being heated and tightly wraps the pushing unit 20, and the heat-shrinkable section 512 is Figure 7b and Figure 8 the heat-shrinkable state in, so that the third buckle unit 50 can play a role in limiting and fixing the pushing unit 20.

[0055] When the pushing unit 20 needs to be used, the tearing section 511 of the third buckle unit 50 is torn off, and the third buckle unit 50 is removed, and the pushing unit 20 can be pushed out of the introduction sheath unit 10. Among them, the material of the third buckle unit 50 can be flexible materials such as silica gel, polyethylene PE, ethylene propylene rubber EPDM, etc., and mainly needs to meet the requirements of heat shrinkability.

[0056] The present invention also provides a guiding system, including the guiding device and the pushing unit as described above, and the pushing unit penetrates into the guiding device and is fixed by the buckle portion.

[0057] In summary, in a guiding device and a guiding system provided by an embodiment of the present invention, through the cooperation of the introduction sheath unit and the buckle unit, the pushing unit can be limited and fixed to avoid the situation that the pushing unit shakes and slips in the introduction sheath unit during transportation. Further, the structure of the distal end of the introduction sheath unit can cooperate with the tapered inner cavity of the microcatheter connector to avoid jamming.

[0058] The above is only a preferred embodiment of the present invention and does not play any limiting role on the present invention. Any person skilled in the art, without departing from the scope of the technical solution of the present invention, makes any form of equivalent replacement or modification and other changes to the technical solution and technical content disclosed by the present invention, all of which belong to the content of the technical solution of the present invention and still fall within the protection scope of the present invention.

Claims

1. A guiding device for loading or conveying a pushing unit, characterized in that, It includes an introducer sheath unit and a buckle unit. The two ends of the introducer sheath unit are a distal end and a proximal end respectively. The buckle unit is arranged at the proximal end of the introducer sheath unit. The introducer sheath unit includes a sheath tube and a lumen penetrating through the sheath tube. The buckle unit includes a buckle portion and a through hole penetrating through the buckle portion. The buckle portion is detachably connected to the sheath tube. The pushing unit penetrates into the through hole from the lumen for fixation; The sheath tube is provided with a notch at a position close to the proximal end of the introducer sheath unit. The notch extends along the radial direction of the sheath tube to communicate with the lumen. After the pushing unit penetrates into the lumen, it exits from the notch and enters the through hole of the buckle portion of the proximal end of the introducer sheath unit at the same time, and is fixed in an interference fit manner.

2. The guiding device according to claim 1, characterized in that, The buckle portion is sleeved outside the sheath tube to be detachably connected to the sheath tube.

3. The guiding device according to claim 1, characterized in that, The shape of the notch is arc-shaped or square.

4. The guiding device according to claim 1, characterized in that, The through hole includes a first section and a second section that communicate with each other. The diameter of the first section is larger than that of the second section. The first section and the second section are coaxially arranged or eccentrically arranged.

5. The guiding device according to claim 1, wherein, The outer diameter of the distal end of the introducer sheath unit gradually shrinks along the direction from the proximal end to the distal end.

6. The guiding device according to claim 1, wherein, The materials of the introducer sheath unit and the buckle unit are both flexible materials.

7. A guiding system, characterized in that, It includes the guiding device and the pushing unit according to any one of claims 1-6. The pushing unit penetrates into the guiding device and is fixed through the buckle portion.

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