Developing plugging device assembly and unfolding method

Abstract

The invention relates to the technical field of medical instruments, in particular to a developing plugging device assembly and an unfolding method. A developing occluder assembly comprising: a body; and the at least one developing wire strip is wound and fixed on the body. According to the developing plugging device assembly and the unfolding method, the problems that due to the fact that developing marking points are added to a plugging device, the marking points are dispersed, the form position of the plugging device in the releasing process cannot be accurately observed, and the operation failure risk exists are solved, and the developing plugging device assembly and the unfolding method are provided.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to a developing occluder assembly and a deploying method thereof. Background Art

[0002] Cardiovascular interventional occlusion treatment is mainly used for congenital heart diseases. It mainly involves percutaneous puncture of peripheral blood vessels, and under the guidance of X-ray fluoroscopy and the assistance of echocardiography, a catheter is pushed to the corresponding position of the heart lesion, and then through a delivery device, an occluder is delivered through the catheter to the corresponding position of the heart lesion for occlusion treatment.

[0003] Currently, the skeletons of occluder products used in interventional treatment on the market or in research and development are all made of nitinol alloy materials or polymer materials. Nitinol alloy itself can be visualized under X-ray, but when the nitinol alloy wires are relatively thin or the amount is relatively small, the occluder may have unclear visualization and the problem of being unable to clearly observe the occluder; conventional polymer materials are not visible under X-ray. If the polymer materials are specially treated to be visible, the mechanical properties and biocompatibility of the materials may affect the sheath-passing performance of the occluder made, thus affecting the safety and usability of the occluder; and the method of adding developing marker points to the occluder is a scattered point, and the morphological position of the occluder during implantation and release cannot be accurately observed, resulting in the risk of surgical failure. Summary of the Invention

[0004] Therefore, the technical problem to be solved by the present invention is to overcome the defect that adding developing marker points to the occluder in the prior art results in scattered marker points, unable to accurately observe the morphological position of the occluder during implantation and release, and there is a risk of surgical failure, so as to provide a developing occluder assembly and a deploying method thereof.

[0005] To solve the above problems, the present invention provides a developing occluder assembly, including:

[0006] A body;

[0007] At least one developing wire, which is wound and fixed on the body.

[0008] Optionally, the outer periphery of the developing wire is wound and wrapped with a coating layer to form a developing core-spun yarn by core-spun textile technology, and the developing core-spun yarn is sutured or woven and fixed on the body.

[0009] Optionally, it further includes a sheath and a pusher. The body is fixedly connected to the pusher. The body and the pusher are arranged in the sheath. The body is located at the distal end in the sheath, and the pusher is located at the proximal end in the sheath.

[0010] Optionally, the body includes a skeleton and a flow-blocking membrane, and the developing core-spun yarn is sutured to the flow-blocking membrane or the skeleton.

[0011] Optionally, from the distal end to the proximal end of the framework are successively a head end, a first disk surface, a waist portion, and a second disk surface. The flow blocking film is fixedly arranged on the first disk surface. The number of the developing core-spun yarns is four, and one developing core-spun yarn is respectively arranged on the head end, the first disk surface, the waist portion, and the second disk surface.

[0012] Optionally, the shape of the developing filament strip is circular, or wavy, or arc-shaped.

[0013] Optionally, the diameter of the developing filament strip is 0.01 mm - 0.15 mm.

[0014] Optionally, the material of the developing filament strip is platinum wire, and the material of the wrapping layer is a biodegradable polymer material or a metal material.

[0015] A deployment method for a developing occluder assembly. In the developing state, the developing filament strip wound around the body is arranged in a strip shape.

[0016] Optionally, it includes the following steps:

[0017] 1) The framework and the pusher are arranged in the sheath tube, and the sheath tube is moved to a preset position;

[0018] 2) The pusher pushes the body towards the distal end until the body is separated from the sheath tube;

[0019] 3) The developing filament strip in the developing state is used to confirm whether the body is fully released.

[0020] The technical solution of the present invention has the following advantages:

[0021] 1. For the developing occluder assembly provided by the present invention, there is a body; at least one developing filament strip, and the developing filament strip is wound and fixed on the body. In the developing state, the developing filament strip wound around the body is arranged in a strip shape. By adding the strip-shaped developing filament strip, it is possible to more clearly display the position of the body without adding developing marking points on the body, thereby eliminating the risk of surgical failure caused by the inability to observe the morphological position of the occluder during release.

[0022] 2. For the developing occluder assembly provided by the present invention, a wrapping layer is wound around the outer periphery of the developing filament strip, and a developing core-spun yarn is formed by core-spun textile technology, and the developing core-spun yarn is stitched or woven and fixed on the body. The developing filament is wrapped by fibers to form a core-spun yarn, which enhances the strength of the silk thread and at the same time avoids the problem of wear and breakage of the developing filament strip.

[0023] 3. The developing occluder assembly provided by the present invention further includes a sheath tube and a pusher. The body is fixedly connected to the pusher. The body and the pusher are disposed inside the sheath tube. The body is located at the distal end inside the sheath tube, and the pusher is located at the proximal end inside the sheath tube. The body is pushed by the pusher to move towards the distal end of the sheath tube, so that the body unfolds outside the sheath tube.

[0024] 4. The developing occluder assembly provided by the present invention, the body includes a framework and a flow blocking membrane. The developing core-spun yarn is sutured to the flow blocking membrane or the framework, and can be placed at different positions on the body to adapt to different structural positions, which is convenient for operation.

[0025] 5. The developing occluder assembly provided by the present invention, the distal end to the proximal end of the framework are successively a head end, a first disk surface, a waist portion and a second disk surface. The flow blocking membrane is fixedly disposed on the first disk surface. The number of the developing core-spun yarns is four. One developing core-spun yarn is respectively provided on the head end, the first disk surface, the waist portion and the second disk surface. Different developing wire strips are arranged at different positions to observe the unfolding conditions of different positions in the developing state.

[0026] 6. The developing occluder assembly provided by the present invention, the shape of the developing wire strip is circular, or wavy, or arc-shaped, and the unfolding and releasing form can be clearly observed, having the advantages of clear development and accurate judgment.

[0027] 7. The developing occluder assembly provided by the present invention, the material of the developing wire strip is platinum wire, and the material of the wrapping layer is a biodegradable polymer material or a metal material to protect the developing wire strip through the wrapping layer. Description of the Drawings

[0028] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings required to be used in the description of the specific embodiments or the prior art. Obviously, the drawings in the following description are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained according to these drawings without creative efforts.

[0029] Figure 1 It is a schematic diagram of the developing core-spun yarn provided in the embodiments of the present invention;

[0030] Figure 2 It is a schematic diagram of the body provided in the embodiments of the present invention;

[0031] Figure 3 It is a schematic diagram of the developing occluder assembly before unfolding provided in the embodiments of the present invention;

[0032] Figure 4 It is a schematic diagram of the developing occluder assembly before unfolding in the developing state provided in the embodiments of the present invention;

[0033] Figure 5 Schematic diagram of the semi-expanded developing occluder assembly provided in the embodiments of the present invention;

[0034] Figure 6 Front view of the semi-expanded developing occluder assembly in the developing state provided in the embodiments of the present invention;

[0035] Figure 7 Oblique view of the semi-expanded developing occluder assembly in the developing state provided in the embodiments of the present invention;

[0036] Figure 8 Oblique side view of the semi-expanded developing occluder assembly in the developing state provided in the embodiments of the present invention;

[0037] Figure 9 Schematic diagram of the fully-expanded developing occluder assembly provided in the embodiments of the present invention;

[0038] Figure 10 Front view of the fully-expanded developing occluder assembly in the developing state provided in the embodiments of the present invention;

[0039] Figure 11 Oblique view of the fully-expanded developing occluder assembly in the developing state provided in the embodiments of the present invention;

[0040] Figure 12 Oblique side view of the fully-expanded developing occluder assembly in the developing state provided in the embodiments of the present invention;

[0041] Figure 13 is Figure 2 Front view in the developing state;

[0042] Figure 14 is Figure 2 Top view in the developing state;

[0043] Figure 15 is Figure 2 Oblique side view in the developing state.

[0044] Explanation of reference numerals: 1, developing core yarn; 11, developing filament; 12, wrapping layer; 111, head-end developing; 112, first disk developing; 113, waist developing; 114, second disk developing; 2, body; 21, head end; 22, first disk; 23, waist; 24, second disk; 3, sheath tube; 4, pusher. Detailed implementation manners

[0045] The technical solution of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are some but not all of the embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0046] In the description of the present invention, it should be noted that the orientation or positional relationship indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. is based on the orientation or positional relationship shown in the accompanying drawings. It is only for the convenience of describing the present invention 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 thus should not be construed as a limitation to the present invention. In addition, the terms "first", "second", "third" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance.

[0047] In the description of the present invention, it should be noted that unless otherwise clearly specified and defined, the terms "installed", "connected", "connected" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations.

[0048] In addition, the technical features involved in different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0049] As Figure 1 shown in Fig. -15, a specific embodiment of the developing plugging device assembly includes: a body 2 and four developing core yarns 1 wound and fixed on the body 2.

[0050] As Figure 1 shown, the developing core yarn 1 includes a developing filament 11 and a wrapping layer 12, and the wrapping layer 12 is wound around the outer periphery of the developing filament 11. Specifically, the material of the developing filament 11 is platinum wire, the material of the wrapping layer 12 is a biodegradable polymer material, the diameter of the developing filament 11 is 0.01 mm - 0.15 mm, preferably 0.05 mm. For the convenience of observing the clear shape of the unfolded state of the body 2, the shape of the developing core yarn 1 is annular.

[0051] As Figure 2As shown, the body 2 includes a framework and a flow-blocking membrane. The distal end to the proximal end of the framework is successively the head end 21, the first disk surface 22, the waist portion 23, and the second disk surface 24. The flow-blocking membrane is fixedly arranged on the first disk surface 22, and a developing core-spun yarn 1 is respectively fixedly arranged on the head end 21, the first disk surface 22, the waist portion 23, and the second disk surface 24. To fix the developing core-spun yarn 1, the developing core-spun yarn 1 is sutured to the framework. Specifically, the flow-blocking membrane is an electrospun membrane. It should be noted that the proximal end / side refers to the end / side close to the operator's hand, that is, the end / side close to the end where the operator operates; the distal end / side refers to the end / side far from the operator's hand, that is, the end / side far from the end where the operator operates.

[0052] To realize the deployment of the body 2, a sheath tube 3 and a pusher 4 are further included. The body 2 is fixedly connected to the pusher 4. The body 2 and the pusher 4 are arranged in the sheath tube 3 in the undeployed state, and the body 2 is located at the distal end in the sheath tube 3, and the pusher 4 is located at the proximal end in the sheath tube 3.

[0053] A method for deploying a developing occluder assembly includes the following steps:

[0054] 1) The framework and the pusher 4 are arranged in the sheath tube 3, and the sheath tube 3 is moved to a preset position;

[0055] 2) The pusher 4 pushes the body 2 to move towards the distal end until the body 2 is separated from the sheath tube 3;

[0056] 3) In the developing state, X-rays pass through the wrapping layer 12 to show the complete developing filament 11, and the state of the developing filament 11 is used to confirm whether the body 2 is fully released.

[0057] In this application, the developing state means the state when the developing occluder assembly is located in the human body and the occluder assembly is observed under X-rays. As Figure 3 is a diagram when the developing occluder assembly is not deployed (the body 2 is in a linear shape in the sheath tube 3), Figure 4 is an image of the developing occluder assembly in the developing state when it is deployed; Figure 5 a diagram when the developing occluder assembly is semi-deployed (the first disk surface 22 of the body 2 is slowly deployed and the waist portion 23 is at the distal end marking of the sheath tube 3), Figure 6 is a front view of the developing occluder assembly in the developing state when it is semi-deployed, Figure 7 is an oblique view of the developing occluder assembly in the developing state when it is semi-deployed, Figure 8 is an oblique side view of the developing occluder assembly in the developing state when it is semi-deployed. It should be noted that, Figure 6 and Figure 7 are diagrams when the first disk surface 22 is fully deployed, Figure 8 is a diagram when the first disk surface 22 fails to be fully deployed;

[0058] Figure 9The figure of the developed occluder component (when the body 2 is fully developed), Figure 10 The front view of the developed occluder component in the developed state, Figure 11 The oblique view of the developed occluder component in the developed state, Figure 12 The oblique side view of the developed occluder component in the developed state. It should be noted that, Figure 10 and Figure 11 The figure of the fully developed body 2, Figure 12 The figure of the body 2 that fails to be fully developed. Figure 13 is Figure 2 The front view of the body shown in the developed state, showing the head end development 111, the first disc development 112, the waist development 113, and the second disc development 114, Figure 14 is Figure 2 The top view of the body shown in the developed state, Figure 15 is Figure 2 The oblique view of the body shown in the developed state. Through Figure 3 -15, the developed occluder component provided by the present application can observe the cleaned and strip-shaped developed images from different angles in the developed state, facilitating the operation of personnel.

[0059] The developed occluder component provided by the present application has the following advantages: (1) clearly guiding and showing the deployment and release form of the body 2, with clear development and facilitating accurate judgment; (2) the developed core-spun yarn 1 adapts to different structural positions of the body 2, with convenient combination and operation; (3) not affecting the performance of the body 2 and the sheath-passing performance, etc.; (4) the developed core-spun yarn 1 avoids the problem that the developed filaments 11 are exposed outside and are not easily wrapped by tissues, ensuring good endothelialization; (5) the developed core-spun yarn 1 enhances the strength of the silk thread and at the same time avoids the problem of abrasion and breakage of the developed filaments 11.

[0060] As an alternative implementation, the number of the developed core-spun yarns 1 can also be 1, 2, 3, 5 or even more.

[0061] As an alternative implementation, the material of the wrapping layer 12 can also be a metal material.

[0062] As an alternative implementation, the diameter of the developed filaments 11 can also be other sizes such as 0.01mm, 0.02mm, 0.08mm, 0.1mm, 0.15mm, etc.

[0063] As an alternative implementation, the developed core-spun yarn 1 can also be fixed on the flow-blocking membrane by suture or bonding.

[0064] As an alternative implementation, the shape of the developed core-spun yarn 1 can also be other shapes such as wavy, arc-shaped, etc.

[0065] As an alternative embodiment, the flow blocking membrane may also be a flame-sprayed nonwoven membrane, a machine-made or knitted membrane, or a cast film.

[0066] As an alternative embodiment, the developed core-spun yarn 1 may also be fixed to the framework by means of knitting, riveting, bonding, etc.

[0067] Obviously, the above embodiments are merely examples given for clear illustration and are not limitations on the embodiments. For those of ordinary skill in the art, other different forms of changes or variations can be made based on the above description. It is not necessary and impossible to exhaustively list all the embodiments here. And the obvious changes or variations derived therefrom still fall within the protection scope of the present invention.

Claims

1. A developing plugging device assembly, characterized in that, Comprising: A body (2); At least one developing filament (11), which is wound and fixed on the body (2).

2. The developing plugging device assembly according to claim 1, wherein, An outer periphery of the developing filament (11) is wound and wrapped with a coating layer, and a core-spun yarn (1) is formed by core-spun textile technology, and the core-spun yarn (1) is sutured or woven and fixed on the body (2).

3. The developing plugging device assembly according to claim 2, wherein, It further includes a sheath tube (3) and a pusher (4), the body (2) is fixedly connected to the pusher (4), the body (2) and the pusher (4) are arranged in the sheath tube (3), the body (2) is located at the distal end in the sheath tube (3), and the pusher (4) is located at the proximal end in the sheath tube (3).

4. The developing plugging device assembly according to claim 3, wherein, The body (2) includes a framework and a flow-blocking membrane, and the core-spun yarn (1) is sutured to the flow-blocking membrane or the framework.

5. The developing plugging device assembly according to claim 4, wherein, The distal end to the proximal end of the framework are successively a head end (21), a first disk surface (22), a waist portion (23) and a second disk surface (24), the flow-blocking membrane is fixedly arranged on the first disk surface (22), the number of the core-spun yarns (1) is four, and one core-spun yarn (1) is respectively arranged on the head end (21), the first disk surface (22), the waist portion (23) and the second disk surface (24).

6. The developing plugging device assembly according to claim 1, characterized in that, The shape of the developing filament (11) is annular, or wavy, or arc-shaped.

7. The developing plugging device assembly according to claim 1, characterized in that, The diameter of the developing filament (11) is 0.01 mm - 0.15 mm.

8. The developing plugging device assembly according to claim 2, wherein, The material of the developing filament (11) is platinum wire, and the material of the coating layer (12) is a biodegradable polymer material or a metal material.

9. A method for deploying a developing occluder assembly for deploying the developing occluder assembly according to claim 1, characterized in that, In the developing state, the developing filament (11) wound on the body (2) is arranged in a strip shape.

10. The unfolding method of the developing plugging device assembly according to claim 9, characterized in that, Including the following steps: 1) The framework and the pusher (4) are arranged in the sheath tube (3), and the sheath tube (3) is moved to a preset position; 2) The pusher (4) pushes the body (2) to move towards the distal end until the body (2) is separated from the sheath tube (3); 3) The developing filament (11) in the developing state is used to confirm whether the body (2) is fully released.

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