Plugging device for patent foramen ovale

Abstract

The patent foramen ovale plugging device comprises a plugging assembly and a conveying assembly, and the plugging assembly is made of degradable materials; the plugging assembly comprises an umbrella disc and a connecting rod; the umbrella tray is of a self-expansion structure and comprises a first umbrella tray and a second umbrella tray which are arranged up and down; the upper end of the connecting rod is connected with the upper end of the first umbrella tray, and a limiting part at the lower end of the connecting rod movably extends out of a lower end connector of the second umbrella tray; a connecting opening in the lower end of the second umbrella tray is provided with a combination buckle, and after the first umbrella tray and the second umbrella tray are expanded, the combination buckle moves upwards and is limited to the limiting part; the conveying assembly comprises a pushing rod and a pushing rod sheath, the upper end of the pushing rod sheath is provided with a pushing part, and the pushing part is used for pushing the lower end of the second umbrella disc to move upwards so as to drive the combination buckle to move upwards. Therefore, a silk thread does not need to be adopted, the problem of silk thread winding can be solved, and the second umbrella disc can be jacked up and expanded simply through the pushing rod sheath, so that the second umbrella disc is matched with the first umbrella disc which is also self-expanded to completely block the oval hole.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, in particular to a patent foramen ovale occlusion device. Background Art

[0002] Many recent studies have shown that patent foramen ovale is closely related to symptoms such as cryptogenic stroke, migraine, and dizziness. Currently, the treatment options for these patients are generally divided into drug treatment and patent foramen ovale occlusion treatment. Data from multiple research centers at home and abroad show that the effect of occlusion is significantly better than drug treatment. Currently available types of patent foramen ovale occlusion umbrellas include: metal occlusion umbrellas (such as: Amplatzer occlusion umbrella of Abbott, cardi-o-fix of Huayi Shengjie, etc.), degradable occlusion umbrellas (such as: MemoSorb of Shanghai Shape Memory Company, etc.), all of which can well occlude the patent foramen ovale. However, metal occlusion umbrellas have many problems: such as residual shunt, metal allergy, release of metal ions, long endothelialization time, long-term presence of foreign bodies, detachment, displacement, hemolysis, abrasion of tissues, obstruction of the normal movement of the atrial septum, etc.; Currently, MemoSorb degradable occlusion umbrella of Shanghai Shape Memory Company is used clinically; However, in the structure of this degradable occlusion umbrella, a locking device needs to be used during the release process, and there is a problem of entanglement between the silk thread and the push rod in the locking device during use, which affects the normal progress of the operation. Summary of the Utility Model

[0003] The purpose of the utility model is to provide a patent foramen ovale occlusion device, which can solve the above-mentioned entanglement problem during use, and has the advantages of convenient use and ensuring the smooth progress of the operation.

[0004] To achieve the above purpose, the solution of the utility model is:

[0005] A patent foramen ovale occlusion device includes an occlusion component and a delivery component, and the occlusion component is made of a degradable material;

[0006] The occlusion component includes an umbrella disc and a connecting rod; the umbrella disc is a self-expanding structure, and the umbrella disc includes a first umbrella disc and a second umbrella disc arranged up and down. There is an umbrella disc waist between the first umbrella disc and the second umbrella disc, and the first umbrella disc and the second umbrella disc can expand separately with the umbrella disc waist as the boundary to form a net disc-shaped structure;

[0007] The connecting rod is located inside the umbrella disc. The upper end of the connecting rod is connected to the upper end of the first umbrella disc, and the lower end of the connecting rod has a limiting part, and this limiting part extends out of the lower connecting port of the second umbrella disc in an active manner; The lower connecting port of the second umbrella disc is provided with a "C"-shaped and elastic coupling buckle. When the first umbrella disc and the second umbrella disc expand, the coupling buckle moves upward and is limited by the limiting part, so that the limiting part extends out of the lower connecting port of the second umbrella disc;

[0008] The conveying assembly includes a push rod and an outer sheath of the push rod. The upper end of the push rod is movably locked to the end face of the limiting portion at the lower end of the connecting rod. The outer sheath of the push rod is sleeved outside the push rod and can reciprocate axially along the push rod. The upper end of the outer sheath of the push rod has a pushing portion, which is used to push the lower end of the second umbrella disc upward to drive the engaging buckle upward. The inner diameter of the pushing portion is larger than the outer diameter of the limiting portion.

[0009] Further, a threaded portion of the push rod is provided at the top of the push rod, and a threaded connection hole is formed on the bottom surface of the limiting portion at the lower end of the connecting rod. The threaded portion of the push rod is in threaded fit with the threaded connection hole.

[0010] Further, the limiting portion has a frustum structure with a narrower lower part and a wider upper part, and a limiting step is formed on the top surface of the limiting portion.

[0011] Further, the reciprocating axial movement between the outer sheath of the push rod and the push rod is realized through threaded fit.

[0012] Further, the length of the push rod is greater than the length of the outer sheath of the push rod. Mark IV and Mark V are arranged at intervals up and down at the lower end of the push rod away from the umbrella disc. When the upper end of the outer sheath of the push rod does not contact the umbrella disc in the initial state, the lower end of the outer sheath of the push rod is flush with Mark V. After the upper end of the outer sheath of the push rod moves upward to push the umbrella disc and the engaging buckle is limited in the limiting portion, the lower end of the outer sheath of the push rod is flush with Mark IV.

[0013] Further, the conveying assembly further includes a guide wire and a transporter. The transporter includes an inner core of the transporter and an outer sheath of the transporter which are sleeved inside and outside. The upper end of the inner core of the transporter is a tapered tip portion. The inner core of the transporter has a through guide wire channel, and the guide wire movably passes through the guide wire channel. The push rod, the outer sheath of the push rod, and the compressed umbrella disc movably pass through the outer sheath of the transporter.

[0014] Further, the length of the push rod is greater than the length of the outer sheath of the transporter. Mark I, Mark II, and Mark III are arranged at intervals up and down at the lower end of the outer sheath of the push rod away from the umbrella disc. When the push rod, the outer sheath of the push rod, and the compressed umbrella disc are placed in the outer sheath of the transporter, when the upper end of the first umbrella disc of the umbrella disc is flush with the upper end of the outer sheath of the transporter, the lower end of the outer sheath of the transporter is flush with Mark I. When the first umbrella disc completely extends out of the upper end of the outer sheath of the transporter, the lower end of the outer sheath of the transporter is flush with Mark II. When the second umbrella disc completely extends out of the upper end of the outer sheath of the transporter, the lower end of the outer sheath of the transporter is flush with Mark III.

[0015] Further, the degradable material is small intestine collagen of sheep or pig, poly-p-dioxanone, or poly-L-lactic acid.

[0016] Further, the upper end of the connecting rod is fixedly connected to the middle of the upper end of the first umbrella disc; the lower end connection port is centrally arranged at the lower end of the second umbrella disc.

[0017] After adopting the above technical solution, since the upper end of the outer sheath of the push rod has a pushing part, the pushing part can push the lower end of the second umbrella disc upward as the outer sheath of the push rod moves, so as to drive the combination buckle upward. Thus, there is no need to use a silk thread to control the second umbrella disc, and the problem of silk thread entanglement can be overcome. Simply using the outer sheath of the push rod can lift and expand the second umbrella disc, so that it cooperates with the first umbrella disc that also expands by itself to completely block the foramen ovale. Moreover, the combination buckle of the second umbrella disc is combined and fixed with the limiting part of the connecting rod to prevent the umbrella disc from detaching. The whole implementation process is simple and reliable, which can effectively ensure the smooth progress of the operation.

[0018] Moreover, the occlusion assembly of the present utility model is made of a biodegradable material. After occluding the foramen ovale in the body for a period of time, it will completely degrade and disappear, so that the defect site is completely repaired and covered by its own tissue, which can reduce the risk of long-term complications. Description of the Drawings

[0019] Figure 1 It is a schematic diagram of an embodiment of the present utility model;

[0020] Figure 2 It is a cross-sectional view of the push rod, the outer sheath of the push rod, the umbrella disc and the outer sheath of the transporter in the embodiment of the present utility model;

[0021] Figure 3 It is Figure 2 an enlarged view of part A of

[0022] Figure 4 It is a schematic diagram of the self-expansion of the occlusion assembly in the embodiment of the present utility model;

[0023] Figure 5 It is Figure 4 a cross-sectional view of

[0024] Figure 6 It is a bottom view of the self-expansion of the umbrella disc in the embodiment of the present utility model.

[0025] Label description: Occlusion assembly B, conveying assembly C, umbrella disc 1, first umbrella disc 11, second umbrella disc 12, lower end connection port 121, combination buckle 122, waist of the umbrella disc 13, connecting rod 2, limiting part 21, threaded connection hole 211, limiting step 212, push rod 3, threaded part of the push rod 31, external thread 32, outer sheath of the push rod 4, internal thread 41, pushing part 42, guide wire 5, transporter 6, inner core of the transporter 61, conical tip 611, guide wire channel 612, outer sheath of the transporter 62, Mark I, Mark II, Mark III, Mark IV, Mark V. Detailed Embodiment

[0026] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the following will clearly and completely describe the technical solutions in the embodiments of this application with reference to the accompanying drawings in the embodiments of this application. Obviously, the described embodiments are some, but not all, of the embodiments of this application. Usually, the components of the embodiments of this application described and shown in the accompanying drawings here can be arranged and designed in various different configurations.

[0027] As Figures 1 to 6 shown, a patent foramen ovale occlusion device of the present utility model includes a plugging assembly B and a delivery assembly C.

[0028] Referring to Figure 1 and Figure 3 , the plugging assembly B includes an umbrella disc 1 and a connecting rod 2, and the plugging assembly B is made of a biodegradable material; the umbrella disc 1 is a self-expanding structure made of a biodegradable material, and the umbrella disc 1 includes a first umbrella disc 11 and a second umbrella disc 12 arranged up and down. There is an umbrella disc waist 13 between the first umbrella disc 11 and the second umbrella disc 12. Referring to Figures 4 to 6 , the first umbrella disc 11 and the second umbrella disc 12 can expand separately with the umbrella disc waist 13 as the boundary to form a net disc-like structure, and this part of the self-expanding structure can be manufactured using existing technologies. The biodegradable material can be small intestine collagen of sheep or pigs, polydioxanone (PDO), or poly-L-lactic acid (PLLA), etc.

[0029] The connecting rod 2 is located inside the umbrella disc 1. The upper end of the connecting rod 2 is connected to the upper end of the first umbrella disc 11 and can be centrally and fixedly connected to the middle of the upper end of the first umbrella disc 11; while the lower end of the connecting rod 2 has a limiting portion 21, and this limiting portion 21 extends out of the lower connecting port 121 of the second umbrella disc 12 in a movable manner. The lower connecting port 121 can be centrally arranged at the lower end of the second umbrella disc 12; the lower connecting port 121 of the second umbrella disc 12 is provided with a "C"-shaped and elastic binding buckle 122. Specifically, the binding buckle 122 is in a "C" shape, so that the diameter of the binding buckle 122 can expand outward under force and then automatically contract and reset by elasticity; and when the first umbrella disc 11 and the second umbrella disc 12 expand, the binding buckle 122 can move upward and be limited to the limiting portion 21. At this time, the limiting portion 21 extends out of the lower connecting port 121 of the second umbrella disc 12; in this embodiment, the binding buckle 122 moves upward under the action of the following delivery assembly C.

[0030] Specifically, referring to Figure 1 and Figure 3 , the delivery assembly C includes a push rod 3 and a push rod outer sheath 4.

[0031] The upper end of the push rod 3 can pass through the lower connection port 121 of the second umbrella disc 12 and be movably locked with the lower end of the connecting rod 2. In this embodiment, the top of the push rod 3 has a push rod thread portion 31, and a threaded connection hole 211 is formed on the bottom end surface of the limiting portion 21 at the lower end of the connecting rod 2. The push rod thread portion 31 is in threaded cooperation with the threaded connection hole 211.

[0032] The outer sheath 4 of the push rod can be sleeved on the push rod 3 and reciprocally move axially along the axis of the push rod 3. In this embodiment, the axial reciprocating movement between the outer sheath 4 of the push rod and the push rod 3 is achieved through threaded cooperation. Specifically, the entire inner part of the outer sheath 4 of the push rod can be provided with internal threads 41, and external threads 32 are provided on the outer wall of the push rod 3. Of course, partial internal threads 41 and external threads 32 can also be provided, as long as the axial displacement distance between the outer sheath 4 of the push rod and the push rod 3 meets the upward movement distance of the engagement buckle 122.

[0033] The upper end of the outer sheath 4 of the push rod has a pushing portion 42. The pushing portion 42 can push the lower end of the second umbrella disc 12 to move upward as the outer sheath 4 of the push rod moves, so as to drive the engagement buckle 122 to move upward. Thus, there is no need to use a silk thread to control the second umbrella disc 12, and the problem of silk thread entanglement can be overcome. Simply using the outer sheath 4 of the push rod can lift and expand the second umbrella disc 12, enabling it to cooperate with the first umbrella disc 11 that also expands by itself to completely block the oval foramen. Moreover, the engagement buckle 122 of the second umbrella disc 12 is combined and fixed with the limiting portion 21 of the connecting rod 2 to prevent the umbrella disc 1 from detaching.

[0034] At the same time, the inner diameter of the pushing portion 42 is larger than the outer diameter of the limiting portion 21 to pass over the limiting portion 21 and push the engagement buckle 122 above the limiting portion 21.

[0035] In order to facilitate the engagement buckle 122 to pass over the limiting portion 21, the limiting portion 21 in this embodiment has a frustum structure that is narrower at the bottom and wider at the top. A limiting step 212 is formed on the top surface of the limiting portion 21. The limiting step 212 can limit the limiting portion 21 to prevent the limiting portion 21 from slipping and separating.

[0036] At the same time, in order to facilitate the operation and positioning during the operation, the following settings are also made in this embodiment.

[0037] Let the length of the push rod 3 be greater than the length of the outer sheath 4 of the push rod. The lower end of the push rod 3 away from the umbrella disc 1 has a mark IV and a mark V arranged at intervals up and down. When the upper end of the outer sheath 4 of the push rod does not contact the umbrella disc 1 in the initial state, the lower end of the outer sheath 4 of the push rod is flush with the mark V. That is, by aligning the outer sheath 4 of the push rod with the mark V, it can be ensured that the outer sheath 4 of the push rod is in the initial state. When the upper end of the outer sheath 4 of the push rod moves upward to push the umbrella disc 1 and the coupling buckle 122 is limited in the limiting part 21, the lower end of the outer sheath 4 of the push rod is flush with the mark IV. Thus, it can be judged that the outer sheath 4 of the push rod has pushed the coupling buckle 122 in place, that is, the unfolding operation of the second umbrella disc 12 is completed.

[0038] The conveying assembly C generally further includes a guide wire 5 and a conveyor 6. The conveyor 6 includes a conveyor inner core 61 and a conveyor outer sheath 62 which are sleeved inside and outside. The upper end of the conveyor inner core 61 is a tapered tip 611. The conveyor inner core 61 has a through guide wire channel 612, and the guide wire 5 is movably inserted into the guide wire channel 612. Through the cooperation of the guide wire 5 and the conveyor inner core 61, the conveyor outer sheath 62 can be pre-fed into the foramen ovale of the atrium in the body, and then the push rod 3, the outer sheath 4 of the push rod, and the compressed umbrella disc 1 are inserted into the conveyor outer sheath 62.

[0039] The length of the push rod 3 can be greater than the length of the conveyor outer sheath 62. The lower end of the outer sheath 4 of the push rod away from the umbrella disc 1 has a mark I, a mark II, and a mark III arranged at intervals up and down. When the push rod 3, the outer sheath 4 of the push rod, and the compressed umbrella disc 1 are inserted into the conveyor outer sheath 62, when the upper end of the first umbrella disc 11 of the umbrella disc 1 is flush with the upper end of the conveyor outer sheath 62, the lower end of the conveyor outer sheath 62 is flush with the mark I, so as to judge that the umbrella disc 1 is inserted in place. When the first umbrella disc 11 completely extends out of the upper end of the conveyor outer sheath 62, the lower end of the conveyor outer sheath 62 is flush with the mark II. When the second umbrella disc 12 completely extends out of the upper end of the conveyor outer sheath 62, the lower end of the conveyor outer sheath 62 is flush with the mark III.

[0040] With the structure of this embodiment, during the operation, the following implementation method can be adopted:

[0041] Puncture the femoral vein, insert a 6F lower limb arterial sheath, and under the guidance of ultrasound or X-ray, pass the guide wire 5 through the foramen ovale and implant it into the left superior pulmonary vein. Assemble and combine the conveyor outer sheath 62 and the conveyor inner core 61, and after reaching the left atrium along the guide wire 5, remove the guide wire 5 and the conveyor inner core 61.

[0042] Compress the umbrella disc 1 and connect the connecting rod 2 with the pushing rod 3; push the umbrella disc 1, the pushing rod 3 and the outer sheath 4 of the pushing rod into the outer sheath 62 of the conveyor together in the direction of the vein; when the mark I of the outer sheath 4 of the pushing rod is flush with the lower end of the outer sheath 62 of the conveyor, withdraw the entire conveyor assembly C as a whole, confirm that the outer sheath 62 of the conveyor is in the middle of the left atrium, and then slowly push it to the mark II of the outer sheath 4 of the pushing rod, so that the first umbrella disc 11 extends out of the upper end of the outer sheath 62 of the conveyor. The first umbrella disc 11 can be self-expanded and released, and by pulling the pushing rod 3 outwards, the first umbrella disc 11 is completely formed into a net disc shape, and then withdraw the conveyor assembly C as a whole again to make the first umbrella disc 11 close to the oval fossa in the left atrium;

[0043] Fix the pushing rod 3, push the outer sheath 62 of the conveyor outwards to the mark III, so that the second umbrella disc 12 extends out of the upper end of the outer sheath 62 of the conveyor. The second umbrella disc 12 can be self-expanded and released, and then rotate and push the outer sheath 4 of the pushing rod in the direction of the vein to expose the mark V, so that the top pushing part 42 pushes the "C"-shaped binding buckle 122 upwards. After the "C"-shaped binding buckle 122 passes over the limiting part 21, it forms a clamping position, and the second umbrella disc 12 is completely expanded at the right atrium. Thus, the first umbrella disc 11 and the second umbrella disc 12 are combined. Gently push and pull the patent foramen ovale occlusion assembly B, confirm the fixation, and then rotate the pushing rod 3 outwards in the opposite direction to the vein to release the patent foramen ovale occlusion assembly B, complete the operation, withdraw the outer sheath 62 of the conveyor, and compress or suture the incision.

[0044] In summary, the implementation of the entire operation process is simple and reliable, there will be no problem of silk thread entanglement, which can effectively ensure the smooth progress of the operation and the occlusion and closure of the patent foramen ovale.

[0045] The above is only the preferred implementation manner of the present invention. The protection scope of the present invention is not limited to the above embodiments. All technical solutions falling within the idea of the present invention belong to the protection scope of the present invention. It should be noted that for those of ordinary skill in the art, equivalent changes and modifications made without departing from the principle of the present invention should still fall within the protection scope of the present invention.

[0046] In the description of the embodiments of the present application, it should be understood that the indicated orientation or positional relationship is based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the product of the application is usually placed during use, or the orientation or positional relationship commonly understood by those skilled in the art. It is only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation to the present application.

[0047] In addition, the terms "first", "second", "third", etc. are only used for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features.

[0048] In addition, the present application provides examples of various specific processes and materials, but those of ordinary skill in the art can recognize the application of other processes and / or the use of other materials.

Claims

1. A patent foramen ovale occlusion device, characterized in that: It comprises a blocking component and a conveying component, wherein the blocking component is made of a degradable material; The blocking assembly comprises an umbrella disc and a connecting rod; the umbrella disc is a self-expanding structure, and comprises a first umbrella disc and a second umbrella disc arranged up and down, and an umbrella disc waist is provided between the first umbrella disc and the second umbrella disc, and the first umbrella disc and the second umbrella disc can be expanded to form a net disc-like structure with the umbrella disc waist as the boundary; The connecting rod is located inside the umbrella plate, the upper end of the connecting rod is connected to the upper end of the first umbrella plate, and the lower end of the connecting rod has a limiting portion, which movably extends out of the lower end connection port of the second umbrella plate; the lower end connection port of the second umbrella plate is provided with a "C"-shaped and elastic coupling buckle, when the first umbrella plate and the second umbrella plate are expanded, the coupling buckle moves upward and is limited to the limiting portion, so that the limiting portion extends out of the lower end connection port of the second umbrella plate; The conveying assembly includes a pushing rod and an outer sheath of the pushing rod. The upper end of the pushing rod is movably locked with the end face of the limiting portion of the lower end of the connecting rod. The outer sheath of the pushing rod is sleeved outside the pushing rod so as to be reciprocatingly movable along the axial direction of the pushing rod. The upper end of the outer sheath of the pushing rod is provided with a pushing portion, which is used to push the lower end of the second umbrella plate upward to drive the coupling buckle to move upward, and the inner diameter of the pushing portion is larger than the outer diameter of the limiting portion.

2. A patent foramen ovale occlusion device according to claim 1, characterized in that: The top of the push rod is provided with a push rod threaded portion, and the bottom surface of the limiting portion at the lower end of the connecting rod is formed with a threaded connection hole, and the push rod threaded portion is threadedly matched with the threaded connection hole.

3. The patent foramen ovale occlusion device according to claim 1, characterized in that: The limiting portion is in the form of a truncated cone structure that is narrow at the bottom and wide at the top, and a limiting step is formed on the top surface of the limiting portion.

4. The patent foramen ovale occlusion device according to claim 1, characterized in that: The outer sheath of the push rod and the push rod are matched with each other through threads to realize axial reciprocating movement.

5. The patent foramen ovale occlusion device according to claim 1, characterized in that: The length of the push rod is greater than the length of the push rod sheath, and the lower end of the push rod away from the umbrella disc has a mark IV and a mark V set at intervals up and down; when the upper end of the push rod sheath does not contact the umbrella disc in an initial state, the lower end of the push rod sheath is flush with the mark V; after the upper end of the push rod sheath moves up to push the umbrella disc so that the combining buckle is limited to the limiting part, the lower end of the push rod sheath is flush with the mark IV.

6. The patent foramen ovale occlusion device according to claim 1, characterized in that: The conveying assembly also includes a guide wire and a conveyor; the conveyor includes a conveyor inner core and a conveyor outer sheath which are arranged inside and outside, the upper end of the conveyor inner core is a conical tip, the conveyor inner core has a through guide wire channel, and the guide wire is movably arranged in the guide wire channel; the push rod, the push rod outer sheath and the compressed umbrella disc are movably arranged in the conveyor outer sheath.

7. A patent foramen ovale occlusion device according to claim 6, characterized in that: The length of the push rod is greater than the length of the conveyor outer sheath; the lower end of the push rod outer sheath away from the umbrella disc has marks I, II and III arranged at intervals up and down; when the push rod, the push rod outer sheath and the compressed umbrella disc are inserted into the conveyor outer sheath, when the upper end of the first umbrella disc is flush with the upper end of the conveyor outer sheath, the lower end of the conveyor outer sheath is flush with mark I, when the first umbrella disc is completely extended from the upper end of the conveyor outer sheath, the lower end of the conveyor outer sheath is flush with mark II, and when the second umbrella disc is completely extended from the upper end of the conveyor outer sheath, the lower end of the conveyor outer sheath is flush with mark III.

8. The patent foramen ovale occlusion device according to claim 1, characterized in that: The degradable material is sheep or pig small intestinal collagen, polydioxanone or poly-L-lactic acid.

9. The patent foramen ovale occlusion device according to claim 1, characterized in that: The upper end of the connecting rod is fixedly connected to the middle of the upper end of the first umbrella plate; the lower end connecting port is centrally arranged at the lower end of the second umbrella plate.

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