Degradable occlusion device

Abstract

The application provides a degradable occluder, and belongs to the technical field of medical devices. The degradable occluder solves the problem of poor occlusion effect of the existing occluder. The degradable occluder comprises an operating handle and an umbrella-shaped occlusion assembly for occlusion, the umbrella-shaped occlusion assembly is detachably connected with an operating rod, the operating handle is provided with a first control assembly for driving the umbrella-shaped occlusion assembly to move forward and backward relative to the operating handle and a second control assembly for driving the umbrella-shaped occlusion assembly to fold or unfold, and the operating rod is in transmission connection with the second control assembly. The application has the advantage of good occlusion effect.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology and relates to a biodegradable occluder. Background Technology

[0002] The foramen ovale is a small opening between the left and right atria of the heart. It typically forms during embryonic development and usually closes by the time the child is one year old. If it remains open after the child is three years old, it is called patent foramen ovale (PFO). In fact, PFO is not only present in infancy; 20% to 25% of adults also have incompletely closed foramen ovale.

[0003] The existing occlusion device involves inserting an interventional catheter through a large vein in the lower limb, passing through the inferior vena cava to the heart. After the catheter enters the heart and passes through the foramen ovale defect, an artificial membrane is erected. The catheter is then slightly withdrawn, and this artificial membrane is applied to the atrial septum, covering the entire defect. The catheter is then withdrawn slightly further, and a second artificial membrane is erected, firmly adhering to the other side of the atrial septum. Afterward, the device is separated from the occlusion device, and the interventional catheter is withdrawn from the heart and returned via the same route. The main drawback is that the two artificial membranes cannot be released synchronously to seal the foramen ovale, affecting the occlusion effect. Summary of the Invention

[0004] The purpose of this invention is to address the above-mentioned problems by providing a biodegradable plugging device with good plugging effect.

[0005] To achieve the above objectives, the present invention adopts the following technical solutions:

[0006] A biodegradable occluder includes an operating handle and an umbrella-shaped occluder assembly for occlusion. An operating rod is detachably connected to the umbrella-shaped occluder assembly. The operating handle is characterized by having a first control component for driving the umbrella-shaped occluder assembly to move back and forth relative to the operating handle, and a second control component for driving the umbrella-shaped occluder assembly to close or open. The operating rod is kinetically connected to the second control component.

[0007] In the aforementioned biodegradable plugging device, the umbrella-shaped plugging assembly includes an outer shell with two deformable parts and a hollow inner cavity. The inner cavity is provided with an adjustment mechanism for adjusting the retracted or expanded shape of the two deformable parts. One end of the adjustment mechanism is connected to the operating rod via a disengagement structure.

[0008] In the aforementioned biodegradable plugging device, the adjusting mechanism includes a transmission screw disposed in the inner cavity. The front and rear ends of the transmission screw are respectively provided with a forward thread section and a reverse thread section. A transmission nut is provided on both the forward thread section and the reverse thread section. Each transmission nut is provided with several adjusting rings that are linked to the transmission nut. A strap is connected to the end of each adjusting ring away from the transmission nut. The outer end of the strap is located outside the outer shell and abuts against the corresponding deformable part.

[0009] In the aforementioned biodegradable plug, the forward thread section and the reverse thread section are symmetrically distributed on both sides of the drive screw.

[0010] In the aforementioned biodegradable plugging device, each of the drive nuts has two adjusting rings, which are evenly and symmetrically distributed on the drive nut. The drive nut has a nut hole for each adjusting ring to pass through.

[0011] In the aforementioned biodegradable occluder, the outer shell is provided with a set of perforations for each strap to pass through. Each set of perforations includes two connecting holes, which are opened on the same horizontal plane and are spaced apart.

[0012] In the aforementioned biodegradable occluder, the second control component includes an operating knob disposed on an operating handle. The operating knob has a mounting hole at its center. One end of the operating rod passes through the mounting hole and is fixedly connected to the mounting hole. The outer surface of the operating knob has a rotating portion exposed outside the outer shell.

[0013] In the aforementioned biodegradable occlusion device, the first control component includes a drive rod and a drive knob disposed within an operating handle. The drive rod is sleeved on the operating handle, with one end of the drive rod facing the umbrella-shaped occlusion component and the other end of the drive rod connected to the drive knob. The outer surface of the drive knob is threaded. A threaded sleeve that can rotate relative to the operating handle is disposed at a position corresponding to the operating handle and the drive knob. The inner surface of the threaded sleeve is threadedly connected to the drive knob.

[0014] In the aforementioned biodegradable plugging device, the separation structure includes a separation tube, which is disposed between the drive rod and the operating rod and sleeved on the operating rod. The operating handle is provided with a separation knob for driving the separation tube forward or backward, and the front end of the separation tube is provided with a separation protrusion for separating the operating rod from the transmission screw.

[0015] In the aforementioned biodegradable plugging device, one end of the transmission screw has a transmission boss, and the end of the operating rod has a transmission recess for the transmission boss to engage and limit. A separation groove for the separation protrusion to be inserted is provided on the side surface of the transmission recess.

[0016] Compared with existing technologies, the advantages of the present invention are as follows: the occluder consists of an operating handle and an umbrella-shaped occluder assembly, which are connected by an operating rod. The first control component on the operating handle is used to adjust the distance of the umbrella-shaped occluder assembly moving back and forth, and then the second control component is used to adjust the deformation part inside the umbrella-shaped occluder assembly to simultaneously close or expand. It has the advantages of good occlusion effect and strong adjustment flexibility.

[0017] Other advantages, objectives and features of the present invention will become apparent in part from the following description, and in part from those skilled in the art through study and practice of the invention. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the overall structure of the present invention.

[0019] Figure 2 This is a schematic diagram of the umbrella-shaped sealing component in its deployed state according to the present invention.

[0020] Figure 3 This is a schematic diagram of the internal structure of the operating handle in this invention.

[0021] Figure 4 This is a schematic diagram of the internal structure of the umbrella-shaped sealing component in the retracted state in this invention.

[0022] Figure 5 This is a schematic diagram of the internal structure of the umbrella-shaped sealing component in the deployed state of the present invention.

[0023] Figure 6 This is a schematic diagram of the separation structure in this invention.

[0024] In the diagram, 1. Umbrella-shaped sealing assembly; 2. Operating lever; 3. First control assembly; 4. Second control assembly; 5. Outer shell; 6. Deformation part; 7. Inner cavity; 8. Adjustment mechanism; 9. Transmission screw; 10. Forward thread section; 11. Reverse thread section; 12. Transmission nut; 13. Adjusting ring; 14. Connecting hole; 15. Operating knob; 16. Assembly hole; 17. Rotating part; 18. Drive rod; 19. Drive knob; 20. Screw sleeve; 22. Operating handle; 23. Strap; 24. Separation structure; 25. Separation tube; 26. Separation knob; 27. Separation protrusion; 28. Transmission boss; 29. ​​Transmission recess; 30. Separation groove. Detailed Implementation

[0025] The present invention will be further described below with reference to the accompanying drawings.

[0026] like Figures 1 to 6 As shown, a biodegradable occluder includes an operating handle 22 and an umbrella-shaped occluder assembly 1 for occlusion. An operating rod 2 is detachably connected to the umbrella-shaped occluder assembly 1. The operating handle 22 is provided with a first control component 3 for driving the umbrella-shaped occluder assembly 1 to move back and forth relative to the operating handle 22, and a second control component 4 for driving the umbrella-shaped occluder assembly 1 to close or open. The operating rod 2 is kinetically connected to the second control component 4.

[0027] In this embodiment, the occluder consists of an operating handle 22 and an umbrella-shaped occluder assembly 1, which are connected by an operating rod 2. The first control component 3 on the operating handle 22 is used to adjust the distance between the back-and-forth movement of the umbrella-shaped occluder assembly 1, and then the second control component 4 is used to adjust the deformation part 6 inside the umbrella-shaped occluder assembly 1 to simultaneously close or expand. It has the advantages of good occlusion effect and strong adjustment flexibility.

[0028] In this embodiment, the umbrella-shaped sealing assembly 1 includes an outer shell 5, which has two deformable parts 6. The outer shell 5 has a hollow inner cavity 7, and the inner cavity 7 is provided with an adjustment mechanism 8 for adjusting the retracted or unfolded shape of the two deformable parts 6. One end of the adjustment mechanism 8 is connected to the operating rod 2 through a separation structure. The outer shell 5 of the umbrella-shaped sealing assembly is made of polymer material.

[0029] In its initial state, the umbrella-shaped sealing assembly 1 has its outer shell in a long, folded-up state. When the umbrella-shaped sealing assembly is in operation, the two deformable parts 6 are expanded in an umbrella shape under the adjustment of the adjustment mechanism 8 to form a sealing surface. The gap formed between the two deformable parts 6 is used to seal the gap of the oval aperture.

[0030] In this embodiment, the adjustment mechanism 8 includes a transmission screw 9 disposed in the inner cavity 7. The front and rear ends of the transmission screw 9 are respectively provided with a forward thread section 10 and a reverse thread section 11. A transmission nut 12 is provided on both the forward thread section 10 and the reverse thread section 11. Each transmission nut 12 is provided with a plurality of adjustment rings 13 that are linked to the transmission nut 12. The adjustment rings 13 are made of soft material and are deformable in the shape of a rope. A strap 23 is connected to the end of each adjustment ring 13 away from the transmission nut 12. The outer end of the strap 23 is located outside the outer shell 5 and abuts against the corresponding deformable part 6.

[0031] Since the threads of the forward thread section 10 and the reverse thread section 11 are opposite, during the rotation of the transmission screw 9, the transmission nuts 12 on the two thread sections will move closer or further apart. When the two transmission nuts 12 move closer together, the distance between the transmission nuts 12 and the strap 23 will become further and further apart. At this time, the adjusting ring 13 will be tightened by the assembly, and the strap 23 at the other end of the adjusting ring 13 will be pressed tightly against the deformable part 6 and continue to pull the head end of the outer shell towards the transmission screw. At this time, the deformable part will bulge outward due to the compression between the head end of the outer shell and the middle of the outer shell, forming an umbrella-shaped unfolded state.

[0032] Preferably, in order to improve the accuracy of transmission and the synchronicity of the opening of the two deformation parts 6, the forward thread section 10 and the reverse thread section 11 are symmetrically distributed on both sides of the transmission screw 9.

[0033] In this embodiment, each transmission nut 12 has two adjusting rings 13, which are evenly and symmetrically distributed on the transmission nut 12. The transmission nut 12 has a nut hole for each adjusting ring 13 to pass through. By setting two adjusting rings 13 to pull the corresponding strap 23, the force on the deformable part 6 can be more even, improving the constraint effect.

[0034] In this embodiment, the outer casing 5 is provided with a set of perforations for each strap 23 to pass through. Each set of perforations includes two connecting holes 14, which are opened on the same horizontal plane and spaced apart. The strap 23 is generally annular, and a portion of the strap 23 is located outside the outer casing 5 through the two connecting holes 14. The interval between the two connecting holes 14 is the area of ​​the constraint force exerted by the strap 23 on the deformable part 6.

[0035] In this embodiment, the second control component 4 includes an operation knob 15 disposed on the operation handle 22. The operation knob 15 has a mounting hole 16 at its center. One end of the operation rod 2 passes through the mounting hole 16 and is fixedly connected to the mounting hole 16. The outer surface of the operation knob 15 has a rotating part 17 exposed outside the outer shell 5.

[0036] The operating knob 15 can be rotated via the rotating part 17. When the operating knob 15 is rotated, the operating lever 2 will also rotate. The rotation of the operating lever 2 will drive the transmission screw 9 to rotate, thereby controlling the unfolding and retraction of the umbrella-shaped sealing assembly 1.

[0037] In this embodiment, the first control component 3 includes a drive rod 18 and a drive knob 19 disposed in the operating handle 22. The drive rod 18 is sleeved on the operating handle 2, one end of the drive rod 18 faces the umbrella-shaped sealing component 1, and the other end of the drive rod 18 is connected to the drive knob 19. The outer surface of the drive knob 19 is machined with threads. A threaded sleeve 20 is disposed at the corresponding position of the operating handle 22 and the drive knob 19, which can rotate relative to the operating handle 22. The inner surface of the threaded sleeve 20 is threadedly connected to the drive knob 19.

[0038] When the screw sleeve 20 on the operating handle 22 is turned, the drive knob 19 will move forward or backward accordingly. When the drive knob 19 moves forward, the drive rod 18 will also move forward and abut against the outer shell 5, pushing the outer shell 5 forward to fine-tune the position of the outer shell 5, thereby improving the accuracy of the sealing device.

[0039] The separation structure 24 includes a separation tube 25, which is disposed between the drive rod and the operating rod and sleeved on the operating rod. A separation knob 26 is provided inside the operating handle for driving the separation tube 25 forward or backward. A separation protrusion 27 is provided at the front end of the separation tube 25 for separating the operating rod from the transmission screw. By rotating the separation knob 26, the separation protrusion 27 of the separation tube 25 moves towards the transmission screw and acts on the transmission screw, causing the transmission screw to separate from the operating rod.

[0040] Specifically, one end of the transmission screw has a transmission boss 28, which can be a polygonal platform. The end of the operating rod has a transmission recess 29 for the transmission boss 28 to be engaged and limited. When the operating rod is rotated, the transmission screw will be linked with the operating rod. At the same time, since a separation groove 30 is provided on the side surface of the transmission recess 29, part of the transmission boss 28 will be exposed from the separation groove 30. The separation protrusion 27 of the separation tube 25 can abut against the exposed part of the transmission boss 28 through the separation groove 30 and push the transmission boss 28 out of the transmission recess 29, thereby realizing the separation of the umbrella-shaped sealing assembly 1 from the operating rod 2.

[0041] In this embodiment, the transmission screw 9 and the operating rod 2 are provided with through holes for the guide wire to pass through. The guide wire is a commonly used auxiliary tool in the operation of medical devices, which helps the occluder to reach the designated position smoothly. When the occluder is in use, the guide wire can be inserted into the interior of the operating handle 22 from the rear end of the operating handle 22, and can be passed out from the top of the outer shell 5 through the through hole 21, passing through the entire occluder.

[0042] The working principle of this invention is as follows: Before use, the guide wire is inserted into the occluder. Then, the occluder's front end, along with the guide wire, enters the body. When it reaches the designated position, the occluder stops moving. At this point, the drive knob 19 can be rotated to drive the drive rod 18 to finely adjust the position of the umbrella-shaped occlusion assembly 1, ensuring that the two deformable parts 6 on the outer shell 5 are located on the left and right sides of the oval hole. Then, the operation knob 15 is rotated to make the transmission screw 9 rotate, causing the two transmission nuts 12 on the transmission screw 9 to move closer together. At this time, the distance between the transmission nuts 12 and the strap 23 will gradually increase. When the adjusting ring 13 is in the pulled-in state, the pressure of the strap 23 against the deforming part 6 will gradually increase. The strap 23 will stick tightly to the deforming part 6 and continue to pull the head end of the outer shell towards the drive screw. At this time, the deforming part will bulge outward due to the compression between the head end and the middle of the outer shell, forming an umbrella-shaped unfolded state. The two circular sealing parts are located on both sides of the foramen ovale to seal the foramen ovale. Then, the drive screw 9 and the operating rod 2 are separated to achieve the purpose of separating the operating rod 2 from the umbrella-shaped sealing assembly 1. Finally, the guide wire, drive rod 18, and operating rod 2 are pulled out of the patient's body.

[0043] The specific embodiments described herein are merely illustrative of the spirit of the invention. Those skilled in the art to which this invention pertains may make various modifications or additions to the described specific embodiments or use similar methods to substitute them, without departing from the spirit of the invention or exceeding the scope defined by the appended claims.

[0044] Although this document frequently uses terms such as umbrella-shaped sealing assembly 1, operating lever 2, first control assembly 3, second control assembly 4, outer shell 5, deformable part 6, inner cavity 7, adjusting mechanism 8, transmission screw 9, forward thread section 10, reverse thread section 11, transmission nut 12, adjusting ring 13, connecting hole 14, operating knob 15, assembly hole 16, rotating part 17, drive rod 18, drive knob 19, threaded sleeve 20, guide hole 21, operating handle 22, release structure 24, release tube 25, release knob 26, release protrusion 27, transmission boss 28, transmission recess 29, and release groove 30, the possibility of using other terms is not excluded. The use of these terms is merely for the convenience of describing and explaining the essence of the invention, and interpreting them as any additional limitation would be contrary to the spirit of the invention.

Claims

1. A biodegradable occluder, comprising an operating handle (22) and an umbrella-shaped occluder assembly (1) for occlusion, wherein an operating rod (2) is detachably connected to the umbrella-shaped occluder assembly (1), characterized in that, The operating handle (22) is provided with a first control component (3) for driving the umbrella-shaped sealing assembly (1) to move back and forth relative to the operating handle (22) and a second control component (4) for driving the umbrella-shaped sealing assembly (1) to close or open. The operating rod (2) is connected to the second control component (4). The umbrella-shaped sealing assembly (1) includes an outer shell (5), which has two deformable parts (6). The outer shell (5) has a hollow inner cavity (7). The inner cavity (7) is provided with an adjustment mechanism (8) for adjusting the closing or opening shape of the two deformable parts (6). One end of the adjustment mechanism (8) is connected to the operating rod (2) through a disengagement structure (24). The adjustment mechanism (8) includes components disposed in the inner cavity (7). The transmission screw (9) has a forward thread section (10) and a reverse thread section (11) at its front and rear ends, respectively. A transmission nut (12) is provided on both the forward thread section (10) and the reverse thread section (11). Each transmission nut (12) has several adjusting rings (13) that are linked to the transmission nut (12). The end of each adjusting ring (13) away from the transmission nut (12) is connected to a strap (23). The outer end of the strap (23) is located outside the outer shell (5) and abuts against the corresponding deformation part (6). The forward thread section (10) and the reverse thread section (11) are symmetrically distributed on both sides of the transmission screw (9). Each transmission nut (12) has two adjusting rings (13), and the two adjusting rings (13) are evenly and symmetrically distributed on the transmission nut (12). The transmission nut (12) is provided with a nut through hole for each adjusting ring (13) to pass through; the outer shell (5) is provided with a set of through holes for each strap (23) to pass through, each set of through holes including two connecting holes (14), the two connecting holes (14) are opened on the same horizontal plane and the two connecting holes (14) are opened at intervals.

2. The biodegradable plugging device according to claim 1, characterized in that, The second control component (4) includes an operation knob (15) disposed on the operation handle (22). The operation knob (15) has an assembly hole (16) at its center. One end of the operation rod (2) is inserted into the assembly hole (16) and fixedly connected to the assembly hole (16). The outer surface of the operation knob (15) has a rotating part (17) exposed outside the outer shell (5).

3. The biodegradable plugging device according to claim 1, characterized in that, The first control component (3) includes a drive rod (18) and a drive knob (19) disposed in the operating handle (22). The drive rod (18) is sleeved on the operating handle (2). One end of the drive rod (18) faces the umbrella-shaped sealing component (1), and the other end of the drive rod (18) is connected to the drive knob (19). The outer surface of the drive knob (19) is machined with threads. The operating handle (22) is provided with a screw sleeve (20) that can rotate relative to the operating handle (22) at the corresponding position of the drive knob (19). The inner surface of the screw sleeve (20) is threadedly connected to the drive knob (19).

4. The biodegradable plugging device according to claim 3, characterized in that, The separation structure (24) includes a separation tube (25), which is located between the drive rod (18) and the operating rod (2) and sleeved on the operating rod (2). The operating handle (22) is provided with a separation knob (26) for driving the separation tube (25) forward or backward. The front end of the separation tube (25) is provided with a separation protrusion (27) for separating the operating rod (2) from the transmission screw (9).

5. A biodegradable plugging device according to claim 4, characterized in that, One end of the transmission screw (9) has a transmission boss (28), and the end of the operating rod (2) has a transmission recess (29) for the transmission boss (28) to be engaged and limited. The side surface of the transmission recess (29) is provided with a separation groove (30) for the separation protrusion (27) to be inserted.

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