A recyclable plugging device system

Abstract

This application provides a recyclable occluder system, comprising: an occluder having a tubular third section and a first and second section capable of switching between tubular and disc-shaped configurations, the two ends of the third section being connected to the first and second sections respectively; a connecting mechanism having a retrieval tube and a connecting tube sequentially sleeved from the inside out, the retrieval tube being movable along the length of the connecting mechanism; an operating mechanism having a gripping element capable of dragging the retrieval tube; one end of a forming auxiliary line fixed to the end of the second section away from the third section, and the other end fixed to the operating mechanism; one end of the connecting tube fixed to the operating mechanism, and the other end detachably connected to the occluder. Implementing the recyclable occluder system of this invention solves the problem of the occluder being unable to be retracted after the umbrella body is formed.

Description

TECHNICAL FIELD

[0001] Embodiments of the present application belong to the field of medical devices, and particularly relate to a retrievable occlusion device system. BACKGROUND

[0002] The current market for patent foramen ovale occlusion device is mainly metal occlusion device, but there are some shortcomings in the metal occlusion device itself, such as the metal occlusion device is implanted for life, which makes the patient lose the access to re-intervention for other heart diseases, and some complications may occur in the human body for a long time, and some people are allergic to nickel-titanium alloy, etc., which makes the degradable occlusion device become the current research hotspot.

[0003] The degradable occlusion device can be degraded in a certain period of time, and there is almost no foreign matter left in the heart after degradation, which not only achieves the occlusion function, but also minimizes the damage to the human body; but the degradable occlusion device also has some defects that cannot be ignored, first of all, the shape memory performance of the degradable occlusion device is not as good as that of the nickel-titanium alloy occlusion device, and the degradable occlusion device is often a double shuttle type shape after passing through the channel to the defect site, which requires the degradable occlusion device to be assisted to form in order to achieve the same occlusion effect as the metal occlusion device. The current technology is generally: by increasing the forming auxiliary line to assist the occlusion device to form, the forming auxiliary line is fixedly connected with the umbrella head end away from the handle end of the occlusion device, and the other end of the forming auxiliary line is outside the body. The operator can pull the forming auxiliary line outside the body to assist the umbrella to form. A flexible knot is generally designed on the forming line, the tail end of the umbrella of the occlusion device is provided with a hole, and the size relationship between the knot and the hole is that the knot is larger than the hole. By pulling the forming auxiliary line, the flexible knot on the forming line passes through the hole at the tail end of the umbrella through elastic deformation, so as to achieve the effect of assisting the umbrella to form and locking the umbrella.

[0004] At this time, another problem that cannot be ignored appears. Because of the existence of the forming auxiliary line and the elastic knot, the elastic knot cannot be withdrawn after passing through the hole at the tail end of the umbrella. If some other factors interfere during the operation, it is impossible to withdraw the umbrella after the umbrella is formed and locked. Only by forcibly pulling or surgical operation can the occlusion device be taken out at the release position of the occlusion device, which is not ideal for the operator and the patient. SUMMARY

[0005] In order to solve the problem that the occlusion device cannot be withdrawn after the umbrella is formed in the prior art, the present application provides a retrievable occlusion device system, which comprises:

[0006] The occlusion device has a third section in a tubular shape, and a first section and a second section capable of switching between tubular and disc shapes, both ends of the third section are connected with the first section and the second section respectively;

[0007] The connecting mechanism is sleeved with the recovery tube and the connecting tube from inside to outside, and the recovery tube can move along the length direction of the connecting mechanism.

[0008] The operating mechanism has a holding member capable of dragging the recovery tube to move.

[0009] The forming auxiliary line has one end fixed at the second section away from the third section and the other end fixed at the operating mechanism.

[0010] One end of the connecting tube is fixed at the operating mechanism, and the other end of the connecting tube is detachably connected with the occluder.

[0011] As a preferred embodiment of the present application, the forming auxiliary line is provided with a knot at the end close to the occluder, and the knot can pass through and be clamped at the outer collar of the first section.

[0012] As a preferred embodiment of the present application, the operating mechanism further comprises a winding assembly, and the forming auxiliary line is fixed on the winding assembly, and rotating the winding assembly can wind the forming auxiliary line.

[0013] As a preferred embodiment of the present application, it further comprises a recovery line, and the recovery line is wound at the end of the second section away from the third section and passes through the first section and the third section, and both ends of the recovery line are fixed on the operating mechanism.

[0014] As a preferred embodiment of the present application, the connecting mechanism further comprises a wire binding tube, and the connecting tube is sleeved in the wire binding tube.

[0015] As a preferred embodiment of the present application, the wire binding tube further comprises a second through hole to facilitate the passing of the forming auxiliary line.

[0016] As a preferred embodiment of the present application, it further comprises a withdrawal line, and the withdrawal line is wound at the end of the first section away from the third section, and both ends of the withdrawal line are fixed on the connecting tube.

[0017] As a preferred embodiment of the present application, a heat shrink tube is arranged at both ends of the withdrawal line to fix the withdrawal line.

[0018] As a preferred embodiment of the present application, the connecting mechanism further comprises a cutting tube, the connecting tube is provided with a first through hole, the cutting tube is sleeved between the recovery tube and the connecting tube and can slide, the withdrawal line passes through the first through hole, when the cutting tube and the connecting tube relatively move, the port of the cutting tube can cut the withdrawal line at the first through hole, and the operating mechanism is a cutting switch for dragging the cutting tube to move.

[0019] In a preferred embodiment of this application, the connecting tube is provided with a first through hole, and the forming auxiliary line passes through the first through hole. When the tangent tube and the connecting tube move relative to each other, the port of the tangent tube can cut off the forming auxiliary line at the first through hole.

[0020] In a preferred embodiment of this application, the connecting tube is provided with a first through hole, and the forming auxiliary line passes through the first through hole. When the tangent tube and the connecting tube move relative to each other, the port of the tangent tube can cut off the forming auxiliary line at the first through hole.

[0021] In a preferred embodiment of this application, the operating mechanism further includes a locking switch, which can lock the grip by pressing the locking switch.

[0022] In a preferred embodiment of this application, the operating mechanism further includes two fixing blocks, which respectively fix one end of the recycling line.

[0023] In a preferred embodiment of this application, the connecting tube includes a flexible section and a rigid section, the first through hole is disposed on the rigid section, and the tangential tube has a cutting element at one end near the plug.

[0024] In a preferred embodiment of this application, the flexible segment and the rigid segment are fixedly connected, and the cutting element and the tangent tube are fixedly connected.

[0025] As a preferred embodiment of this application, it also includes a sheath tube, the cutting element being provided on the outer peripheral surface of the sheath tube.

[0026] Compared to existing technologies, the retrievable occluder system of this invention comprises an occluder, a connecting mechanism, an operating mechanism, and a forming guide line. When the occluder is delivered to the cardiac defect site, the forming guide line is pulled, causing the occluder to press against the connecting structure. This causes the second section to begin deforming from a tubular shape into a disc shape, and the first section also begins to deform from a tubular shape into a disc shape. An elastic knot on the forming guide line passes through the constriction of the first section of the occluder away from the third section, keeping the occluder locked in a locked state, thus blocking both sides of the cardiac defect site. When it is necessary to retrieve the occluder during the procedure, the grip can be moved, causing the retrieval tube to move sequentially through the first and third sections and press against the end of the second section away from the third section. Under the force of the retrieval tube, the first and second sections return from a disc shape to a tubular shape. Finally, the surgeon drags the forming guide line to unfold the entire occluder, positioning the first and second sections in the correct positions. Implementing the retrievable occluder system of this invention solves the problem of the occluder being unable to be retrieved after the umbrella-shaped structure has been formed. Attached Figure Description

[0027] The accompanying drawings, which are included to provide a further understanding of this application and form part of this application, illustrate exemplary embodiments and are used to explain this application, but do not constitute an undue limitation of this application. Some specific embodiments of this application will be described in detail below with reference to the accompanying drawings in an exemplary and non-limiting manner. The same reference numerals in the drawings designate the same or similar parts or components. Those skilled in the art should understand that these drawings are not necessarily drawn to scale. In the drawings:

[0028] Plug-10; Third section-110; First section-120; Second section-130; Connecting mechanism-20; Recycling tube-210; Connecting tube-220; Operating mechanism-30; Gripper-310; Forming auxiliary line-40; Knot-410; Closure-140; Winding assembly-320; Cable bundle tube-230; Recycling line-50; Cutting tube-70; First through hole-2210; Retraction line-80; Heat shrink tubing-90; Locking switch-330; Fixing block-340; Cutting switch-350; Second through hole-2310; Rigid section-2220; Flexible section-2230; Cutting element-710; Sheath tube-100.

[0029] Figure 1 This diagram shows the overall structure of a sealing device of the present invention after it is unfolded into a disc shape;

[0030] Figure 2 The left view of a sealing device of the present invention after it has been unfolded into a disc shape is shown;

[0031] Figure 3 This diagram illustrates a possible connection between the plugging device, the forming auxiliary line, and the recovery line in this invention.

[0032] Figure 4 This invention illustrates a schematic diagram of a recyclable plugging system for removing components near the plugging end.

[0033] Figure 5 An exploded view of the operating mechanism in a recyclable plugging system of the present invention is shown;

[0034] Figure 6 This invention provides a schematic cross-sectional view of a recyclable plugging system after the plugging device has been removed.

[0035] Figure 7A It shows Figure 6 A magnified view of a section at point A (before the tangent is drawn);

[0036] Figure 7B It shows Figure 6 A magnified view of a section at point A (before the tangent is drawn);

[0037] Figure 8A cross-sectional schematic diagram of a recyclable plugging device system according to the present invention is shown;

[0038] Figure 9 It shows Figure 8 A magnified view of a section at point B in the middle;

[0039] Figure 10 It shows Figure 8 A magnified view of a section at point C. Detailed Implementation

[0040] To enable those skilled in the art to better understand the present application, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are merely some, not all, of the embodiments of the present application. All other embodiments obtained by those skilled in the art based on the embodiments of the present application without creative effort should fall within the scope of protection of the present application.

[0041] To address the issue of the plugging device 10 being unable to retract after the umbrella body is formed, please refer to... Figures 1-10 The present invention provides a recyclable plugging device system, comprising:

[0042] The occluder 10 has a tubular third section 110 and a first section 120 and a second section 130 that can switch between tubular and disc-shaped forms, with the two ends of the third section 110 connected to the first section 120 and the second section 130, respectively.

[0043] The connecting mechanism 20 is provided with a recycling pipe 210 and a connecting pipe 220 sequentially from the inside to the outside. The recycling pipe 210 can move along the length of the connecting mechanism 20.

[0044] The operating mechanism 30 has a grip 310 capable of dragging the recovery tube 210.

[0045] The molding auxiliary line 40 has one end fixed to the end of the second section 130 away from the third section 110, and the other end fixed to the operating mechanism 30.

[0046] One end of the connecting tube 220 is fixed to the operating mechanism 30, and the other end of the connecting tube 220 is detachably connected to the plugger 10.

[0047] Compared to existing technologies, the retrievable occluder system of this invention comprises an occluder 10, a connecting mechanism 20, an operating mechanism 30, and a forming auxiliary line 40. When the occluder 10 is delivered to the cardiac defect site, the forming auxiliary line 40 is pulled, causing the occluder 10 to press against the connecting mechanism 20. This causes the second section 130 to begin deforming from a tubular shape into a disc shape, and the first section 120 also begins to deform from a tubular shape into a disc shape. An elastic knot on the forming auxiliary line passes through the constriction of the first section of the occluder away from the third section, keeping the occluder locked in a locked state, thus blocking both sides of the cardiac defect site. When it is necessary to retrieve the occluder 10 during the procedure, the gripping member 310 can be moved. The gripping member 310 drives the retrieval tube 210 to move, allowing the retrieval tube 210 to pass sequentially through the first section 120 and the third section 110, and then press against the end of the second section 130 away from the third section 110. Under the force of the retrieval tube 210, the first section 120 and the second section 130 return from a disc shape to a tubular shape. Finally, the doctor drags the forming guide line 40 to deploy the entire occluder 10, positioning the first section 120 and the second section 130 in the correct positions. Implementing the retractable occluder system of this invention solves the problem of the occluder 10 being unable to be retracted after the umbrella body is formed. The doctor then releases the entire occluder 10 to the correct position, and then assists in forming and releasing the occluder 10 by pulling the forming guide line 40.

[0048] Generally, biodegradable mesh is also provided on the first section 120 and the second section 130 to seal the oval pore. The first section 120 and the second section 130 are made of biodegradable materials.

[0049] Biodegradable materials include: polylactic acid, poly-L-lactic acid, poly-dextrose acid, polyglycolic acid, polycaprolactone, polydioxanone, polyhydroxybutyrate, polyanhydride, polyphosphate, polyurethane, polycarbonate, and silk fibroin, or copolymers of two or more of these.

[0050] Of course, an anticoagulant layer, such as heparin, can also be applied to the occluder 10 to prevent thrombus formation and spread, reduce complications, and lower patient mortality.

[0051] The occluder 10 can also be coated with a contrast agent to help doctors accurately locate the patent foramen ovale during the procedure.

[0052] The recycling pipe 210 and the connecting pipe 220 are generally made of flexible materials, which allows them to be bent.

[0053] In a more preferred embodiment, please refer to Figure 3 The forming auxiliary line 40 has a node 410 at one end near the plugger 10. The node 410 can pass through or be locked at the outer opening 140 of the first section 120.

[0054] The plug 10 initially takes the form of a tube, at which point the node 410 of the forming guide line 40 is located within the second section 130. When the forming guide line 40 is pulled, one end of the forming guide line 40 pulls both ends of the second section 130 of the forming guide line 40 closer together, gradually changing from a tube shape to a disc shape.

[0055] Continue pulling the forming guide line 40. Node 410 passes through the third section 110 and the first section 120. Node 410 squeezes the closing end 140 of the first section 120 and emerges from the closing end 140. At this point, release the forming guide line 40, and node 410 will also be stuck at the outer closing end 140 of the first section 120.

[0056] It should be noted that the node 410 can be a knot, a herringbone pattern, or a spring buckle, etc. The connection method between the second section 130 and the forming auxiliary line 40 is also not unique; it can be a knot, a riveting, or a connection achieved by a single line symmetrically passing through the forming auxiliary line 40, etc.

[0057] In a more preferred embodiment, please refer to Figures 4-6 The operating mechanism 30 also includes a winding assembly 320, and the forming auxiliary line 40 is fixed on the winding assembly 320. Rotating the winding assembly 320 can wind the forming auxiliary line 40.

[0058] In this embodiment, to prevent accidental pulling of the forming auxiliary line 40, a winding assembly 320 is provided on the operating mechanism 30. Rotating the winding assembly 320 can wind up the forming auxiliary line 40. The winding assembly 320 is generally a rotating shaft, on which one end of the forming auxiliary line 40 is fixed.

[0059] Preferably, a knob is provided at the connection shaft to facilitate the doctor's rotation of the winding assembly 320.

[0060] In a more preferred embodiment, please refer to Figures 8-9 It also includes a recovery line 50, which is wound around the end of the second section 130 away from the third section 110 and passes through the first section 120 and the third section 110. Both ends of the recovery line 50 are fixed to the operating mechanism 30.

[0061] Of course, the recovery line 50 also has a guiding function, because the recovery line 50 is installed in the recovery tube 210. The recovery line 50 can guide the movement of the recovery tube 210, thereby ensuring that the plugger 10 can be restored from the double disc shape to the tubular shape.

[0062] In a more preferred embodiment, please refer to Figure 6 , Figure 7A and Figure 7B The connecting mechanism 20 also includes a cable tie tube 230, and a connecting tube 220 is sleeved inside the cable tie tube 230.

[0063] Normally, the forming auxiliary line 40 is located on the outside of the connecting tube 220. The forming auxiliary line 40 can be bundled inside the wire harness tube 230 to avoid possible contamination of the forming auxiliary line 40.

[0064] In a preferred embodiment, the wire harness 230 further includes a second through hole 2310 to facilitate the insertion of the forming auxiliary wire 40.

[0065] Since the forming auxiliary line 40 is located between the wire harness tube 230 and the connecting tube 220, a second through hole 2310 is provided on the wire harness tube 230 to facilitate the insertion of the forming auxiliary line 40.

[0066] In a more preferred embodiment, please refer to Figure 8 and Figure 10 It also includes a retraction line 80, which is wound around the end of the first section 120 away from the third section 110, and both ends of the retraction line 80 are fixed to the connecting pipe 220.

[0067] The purpose of the retraction line 80 is to facilitate the dragging of the occluder 10. One end of the retraction line 80 is tied to the end of the occluder 10 near the connecting tube 220. If the doctor needs to retrieve the occluder 10, the occluder 10 can be repositioned and released after it has become tubular.

[0068] In a preferred embodiment, heat shrink tubing 90 is provided at both ends of the retraction line 80 to fix the retraction line 80.

[0069] The retraction line 80 needs to be fixed, so heat shrink tubing 90 is provided at both ends of the retraction line 80. By heating the heat shrink tubing 90, both ends of the retraction line 80 are fixed to the outside of the connecting tube 220.

[0070] In a more preferred embodiment, please refer to Figure 5 , Figure 6 , Figure 7A and Figure 7B The connecting mechanism 20 also includes a cutting tube 70. The connecting tube 220 is provided with a first through hole 2210. The cutting tube 70 is sleeved between the recovery tube 210 and the connecting tube 220 and can slide. The retraction line 80 passes through the first through hole 2210. When the cutting tube 70 and the connecting tube 220 move relative to each other, the end of the cutting tube 70 can cut the retraction line 80 at the first through hole 2210. The operating mechanism 30 has a cutting switch 350 for dragging the cutting tube 70 to move.

[0071] After the occluder 10 is correctly installed at the patient's site, it is necessary to separate the occluder 10 from the connecting mechanism 20. The occluder 10 and connecting mechanism 20 are typically screwed together; the occluder 10 is separated from the connecting mechanism 20 by rotating it. Although the pullback line 80 is made of a biodegradable material, it is best to minimize the amount left in the body. At this point, the tangent switch 350 is moved, causing the tangent tube 70 to move, creating a shearing force on the pullback line 80 at the first through-hole 2210 of the connecting tube 220. Finally, the pullback line 80, now broken in two, is pulled out at the operating mechanism 30.

[0072] In this application, the plugging device 10 and the connecting mechanism 20 can be connected by a pullback line 80. Disconnecting the plugging device 10 and the connecting mechanism 20 can be achieved by cutting off the pullback line 80.

[0073] In a more preferred embodiment, the connecting tube 220 is provided with a first through hole 2210, and the forming auxiliary line 40 passes through the first through hole 2210. When the cutting tube 70 and the connecting tube 220 move relative to each other, the port of the cutting tube 70 can cut the forming auxiliary line 40 at the first through hole 2210.

[0074] Similarly, the molding guideline 40 can also be cut, but a portion of the molding guideline 40 will inevitably remain inside the body. The molding guideline 40 is also biodegradable.

[0075] In a preferred embodiment, the operating mechanism 30 further includes a locking switch 330, which can lock the grip 310 by pressing the locking switch 330. The grip 310 can be a grip.

[0076] The locking switch 330 is used to lock the gripper 310 to prevent accidental movement of the gripper 310 and change in the shape of the occluder 10 caused by the doctor's operation. The locking switch 330 can be a knob or a button; as long as it restricts the movement of the gripper 310, it falls within the scope of protection of this invention.

[0077] In a preferred embodiment, the operating mechanism 30 further includes two fixing blocks 340, which respectively fix one end of the retraction line 50.

[0078] The fixing block 340 is generally detachably connected to the main body of the operating mechanism 30. The retrieval line 50 is removed by pulling the fixing block 340. Usually, the retrieval line 50 is cut at the operating mechanism 30, and then all the retrieval lines 50 are pulled out.

[0079] In a more preferred embodiment, please refer to Figure 6 , Figure 7A and Figure 7BThe connecting tube 220 includes a flexible section 2230 and a rigid section 2220. A first through hole 2210 is provided on the rigid section 2220. The tangent tube 70 has a cutting element 710 at one end near the plugger 10.

[0080] Since the tangent needs to be rigid, the connecting tube 220 consists of a flexible section 2230 and a rigid section. The tangent tube 70 has a cutting element 710 at one end near the plugger 10. The cutting element 710, in conjunction with the rigid section, can cut the line more effectively. The cutting element 710 and the rigid section can be made of nickel-titanium alloy or stainless steel.

[0081] It should be noted that the diameters of the flexible segment 2230 and the rigid segment 2220 can be different. Generally, the diameter of the rigid segment 2220 is larger.

[0082] In a preferred embodiment, the flexible segment 2230 and the rigid segment 2220 are fixedly connected, and the cutting element 710 and the tangent tube 70 are fixedly connected.

[0083] In this embodiment, the flexible segment 2230 and the rigid segment are fixedly connected, and the cutting component 710 and the tangent tube 70 are fixedly connected. The cutting component 710 and the rigid segment 2220 can be installed later, reducing the difficulty of assembling the connecting mechanism 20 as a single piece.

[0084] In a more preferred embodiment, a sheath 100 is further included, and a cutting element 710 is provided on the outer peripheral surface of the sheath 100.

[0085] The sheath tube 100 serves as a guide for the recovery tube 210, and is generally assembled separately with the cutting part 710 and the rigid section 2220 during the production process.

[0086] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit them. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this application.

Claims

1. A retrievable occlusion device system, comprising: The system comprises: a closure device having a third section in a tubular shape and a first section and a second section capable of switching between a tubular shape and a disc shape, two ends of the third section being connected to the first section and the second section respectively; a connecting mechanism, in which a recovery tube and a connecting tube are sequentially sleeved from inside to outside, the recovery tube being capable of moving along the length direction of the connecting mechanism; an operating mechanism having a holding member capable of dragging the recovery tube to move; a forming auxiliary line, one end of the forming auxiliary line being fixed to the second section away from the third section, and the other end being fixed to the operating mechanism; one end of the connecting tube being fixed to the operating mechanism, and the other end of the connecting tube being detachably connected to the closure device; wherein the recovery tube is configured to sequentially pass through the first section and the third section and push the second section away from one end of the third section when moving distally, so that the first section and the second section in a disc shape return to a tubular shape to realize the recovery of the closure device; the system further comprises a recovery line, the recovery line being wound around one end of the second section away from the third section and passing through the first section and the third section, two ends of the recovery line being fixed to the operating mechanism; the recovery line is arranged in the recovery tube and can guide the movement of the recovery tube.

2. A recoverable occluder system as in claim 1, wherein, The forming auxiliary line is provided with a knot near one end close to the closure device, and the knot can pass through and be clamped at the outer collar of the first section.

3. A recoverable occluder system as in claim 2, wherein, The operating mechanism further comprises a winding assembly, and the forming auxiliary line is fixed to the winding assembly, and rotating the winding assembly can wind the forming auxiliary line.

4. A recoverable occluder system as in claim 1, wherein, The connecting mechanism further comprises a wire binding tube, and the connecting tube is sleeved in the wire binding tube.

5. A recoverable occluder system as defined in claim 4, wherein, The wire binding tube further comprises a second through hole to facilitate the penetration of the forming auxiliary line.

6. A recoverable occluder system as claimed in claim 1 or 2, characterized in that Further comprising a withdrawal line, the withdrawal line being wound around one end of the first section away from the third section, and two ends of the withdrawal line being fixed to the connecting tube.

7. A recoverable occluder system as defined in claim 6, wherein, A heat shrink tube is arranged at two ends of the withdrawal line to fix the withdrawal line.

8. A recoverable occluder system as defined in claim 6, wherein, The connecting mechanism further comprises a cutting tube, the connecting tube is provided with a first through hole, the cutting tube is sleeved between the recovery tube and the connecting tube and is capable of sliding, the withdrawal line passes through the first through hole, and when the cutting tube and the connecting tube relatively move, a port of the cutting tube can cut the withdrawal line at the first through hole, and the operating mechanism has a cutting switch for dragging the cutting tube to move.

9. A recoverable occluder system as defined in claim 8, wherein, The forming auxiliary line passes through the first through hole, and when the cutting tube and the connecting tube relatively move, the port of the cutting tube can cut the forming auxiliary line at the first through hole.

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