CN112716666A

CN112716666A - Handle type bracket system

Info

Publication number: CN112716666A
Application number: CN202110094127.4A
Authority: CN
Inventors: 贾晶; 张捷捷; 吴重草; 胡天宙; 刘振全; 孙冰
Original assignee: Jiangsu Nuanyang Medical Instruments Co ltd
Current assignee: Jiangsu Nuanyang Medical Instruments Co ltd
Priority date: 2021-01-22
Filing date: 2021-01-22
Publication date: 2021-04-30
Anticipated expiration: 2041-01-22
Also published as: CN112716666B

Abstract

The present invention provides a handle-type bracket system, comprising: a release handle, the release handle includes: a handle body and a release switch arranged thereon; a delivery mechanism connected with the release handle, the delivery mechanism comprising: a sleeve and a fixed mandrel extending through it, the sleeve is connected to the handle body, the proximal end of the fixed mandrel is connected to the release switch, and the fixed mandrel is connected to the sleeve under the action of the release switch relative movement of the tube; and a self-expanding stent clamped by the delivery mechanism, the proximal end of the self-expanding stent has a protruding fixing portion formed by the distal end of the fixing mandrel and the cannula clamping unit clamping. According to the present invention, a handle-type stent is provided, which reduces the pushing resistance, ensures that the stent can be completely recovered and re-implanted during the implantation process, greatly improves the fault tolerance rate, and greatly reduces the operation difficulty of the dense mesh stent implantation. system.

Description

Handle type bracket system

Technical Field

The invention relates to the field of medical instruments, in particular to a handle type bracket system.

Background

Intracranial aneurysms, a common and highly lethal and disabling cerebrovascular disease, are widely believed to be caused by local vascular abnormalities leading to the formation of a neoplastic-like protrusion under the impact of blood flow. The fatality rate of the ruptured intracranial aneurysm is very high and almost reaches 50%, the traditional treatment method adopts the clamping and closing operation of the intracranial aneurysm, but the operation difficulty is higher, the operation risk is large, and the restriction by the experience of doctors and other factors is larger; compared with the traditional treatment, the interventional therapy has the obvious advantages of minimal invasion, safety, effectiveness and the like, and is widely accepted and approved by doctors and patients.

The blood flow guiding device is an emerging intracranial aneurysm interventional therapy method in recent years, and the principle of the blood flow guiding device is to reconstruct the correct path of a blood vessel at an aneurysm and restore the blood flow direction. The blood flow guiding device reduces blood entering a tumor body in a mode of remodeling the blood flow direction of intracranial blood vessels, so that the aneurysm is gradually reduced until the aneurysm disappears. The blood flow guiding device is generally used by matching a self-expanding type support with a conveying device, the self-expanding type support is conveyed to the position of an intracranial aneurysm and released through a micro-catheter, however, the support in the current blood flow guiding device is not mechanically connected with a conveying component, but is conveyed to a target position through the friction force between a conveying component and one end of the support, and due to the fact that the inner diameter of the micro-catheter is small, one end of the support is greatly stressed in the pushing process, the support is easily extruded and deformed in the pushing process due to uneven stress, the lesion position cannot be completely covered after release, falling or blocking is caused, certain operation failure risks exist, and even the life safety of a patient is endangered.

Disclosure of Invention

The invention aims to provide a handle type support system, so that the problems of uneven support stress, larger resistance and easy deformation and falling of a support in the conveying process caused by dragging the support to a target position by using a friction assembly on a traditional blood flow guide support are solved.

In order to solve the technical problems, the invention adopts the following technical scheme:

there is provided a handle bracket system comprising: a release handle, the release handle comprising: the handle body and a release switch arranged on the handle body; a delivery mechanism connected to the release handle, the delivery mechanism comprising: the handle comprises a sleeve and a fixed mandrel extending through the sleeve, the sleeve is connected with the handle body, the proximal end of the fixed mandrel is connected with the release switch, and the fixed mandrel and the sleeve move relatively under the action of the release switch; and a self-expanding stent clamped by the delivery mechanism, wherein the proximal end of the self-expanding stent is provided with a protruding fixing part, and the fixing part is clamped by a clamping unit formed by the distal end of the fixing mandrel and the sleeve.

According to a preferred aspect of the present invention, the release switch includes: the far ends of the sleeve and the fixing mandrel form a closed structure at two sides of the fixing part of the self-expanding bracket to fix the self-expanding bracket when the self-expanding bracket is in the 'closed' state; when in the "on" state, the fixed mandrel is displaced relative to the sleeve to release the self-expanding stent.

According to a preferred embodiment of the invention, the proximal end of the fixing mandrel is welded, glued or mechanically connected to the release switch.

According to a preferred aspect of the present invention, the distal end of the sleeve has a stepped structure extending radially inward from the inner wall, and the distal end of the fixing mandrel has a disk structure extending radially outward from the axial center, the stepped structure and the disk structure forming the clamping unit to clamp the fixing portion of the self-expanding stent therebetween.

When the self-expanding bracket is clamped, the far end plane of the step structure is contacted with the near end plane of the fixing part, and the near end plane of the disc structure is contacted with the far end plane of the fixing part.

The fixing mandrel provided by the invention has the advantages that the far end is enlarged to form a disc-shaped structure, and the rest part is a wire or rod-shaped structure with certain flexibility and can be made of metal, alloy or high polymer material; when the front push or the back pull release switch, the fixed mandrel can move forwards or backwards in linkage with the fixed mandrel, so that the relative position of the fixed mandrel and the sleeve is changed, and the self-expansion support is clamped and released.

The self-expansion support comprises a keel support and a dense net support, the keel support and the dense net support are connected in a sleeved mode through a structure in which the keel support is arranged outside and the dense net support is arranged inside, and the self-expansion support is fixed through laser welding, adhesion and mechanical connection. The inner diameter of the keel bracket is slightly larger than the outer diameter of the dense-net bracket.

The wire diameter of the keel support is larger than that of the dense net support, and the mesh size of the keel support is larger than that of the dense net support.

According to a preferable scheme of the invention, the wire diameter of the keel bracket is 0.01-1 mm, and the metal coverage rate is 1-50%; the wire diameter of the dense mesh support is 0.01-0.8 mm, and the metal coverage rate is 10% -60%.

The keel bracket and the dense-mesh bracket are made of the same or different alloy with a memory function, or metal with high elasticity, or high polymer material with high elasticity, wherein the alloy and the metal comprise: stainless steel, platinum-tungsten alloy, platinum-iridium alloy, nickel-titanium alloy, or cobalt-chromium alloy; the polymer material includes: polyethylene, polyoxymethylene, polyurethane, polyester, polytetrafluoroethylene, fluorinated ethylene propylene copolymer, polyamide, polyimide or nylon.

The fixing part of the self-expanding bracket is a structure formed by gathering weaving wires or cutting wires of the keel bracket; the both ends of fossil fragments support extend for the protrusion in loudspeaker column structure outside the dense net support helps the improvement of support anchor performance, prevents to take place to shift or shorten.

Preferably, the distal end of the self-expanding stent is also provided with a fixing portion in which the weaving wire or the cutting wire is gathered. The fixing part at the near end or the far end of the bracket plays a role in binding the weaving wire or the cutting wire at the port of the keel bracket, and the fixing part at the near end can also play a role in fixing the bracket on a system by matching with a conveying mechanism.

The self-expanding stent includes a visualization element made of a radiopaque material comprising: gold, platinum-tungsten alloy, platinum-iridium alloy, or developable polymer material; the developing element is a developing wire woven into the bracket, or a point-shaped element fixed on a network node of the bracket, or a block-shaped element arranged on a fixed part at the end part of the bracket.

Preferably, the grip handle is coated with a friction-increasing coating such as silicone, which facilitates the delivery operation by the physician.

Preferably, both the cannula and the fixation mandrel have a varying compliance that increases from the proximal end to the distal end.

According to the handle type bracket system provided by the invention, the self-expansion effect of the self-expansion bracket is embodied as follows: when the stent is conveyed by the conveying mechanism, the stent is bound in the microcatheter in a press-holding state, and the head end of the stent is held by the stent release handle; as long as the stent is released, the stent maintains a crimped state when pushed or withdrawn by the release handle, and the outer diameter of the crimped state is equal to the inner diameter of the microcatheter. When the stent is directly pushed out of the microcatheter, the radial clamping force provided by the inner wall of the microcatheter disappears, the stent can automatically expand, and the outer diameter of the stent is adaptive to the wall of a blood vessel. In the process, the pressing and the self-expansion of the keel bracket and the dense-net bracket occur simultaneously. The trumpet-shaped structures on the two sides of the keel bracket bring further anchoring effect for the bracket.

The structural improvement and the advantages of the handle type bracket system provided by the invention compared with the prior art mainly comprise the following aspects:

1) the sleeve and the fixed mandrel are matched and clamped to convey the self-expanding support, so that the pushing efficiency of the support is improved, the problems of uneven stress and large resistance of the support in the conveying process and difficulty in deformation and falling of the support caused by dragging the support to a target position by using a friction assembly on a conveying system of the traditional blood flow guide support are solved;

2) the release switch on the handle is used for releasing the stent, the stent is firmly held and cannot be separated in a closed state, complete recovery and re-implantation in the implantation process are ensured, the fault tolerance rate in the operation process is increased, and the operation difficulty of dense mesh stent implantation is effectively reduced;

3) through the support that expands certainly that provides a bilayer structure, make the support can cooperate the use better with handle formula conveying mechanism, the area of contact between the outer fossil fragments support of double-deck support that expands certainly and the little pipe simultaneously compares in the area of contact between close net support of individual layer and the little pipe and reduces, has further reduced propelling movement resistance.

In conclusion, the invention provides a handle type stent system which reduces pushing resistance, ensures that the stent can be completely recycled and re-implanted in the implantation process, improves the fault tolerance rate and reduces the operation difficulty of dense-mesh stent implantation.

Drawings

FIG. 1 is a schematic view of the overall structure of a handle bracket system in a clamping state according to a preferred embodiment of the invention;

FIG. 2 is an enlarged detail view of the handle bracket system of FIG. 1 in a clamping position;

FIG. 3 is a schematic view of the handle stent system shown in FIG. 1 in a released state;

FIGS. 4A and 4B are schematic structural views of a bushing according to two preferred embodiments of the present invention, respectively;

FIG. 5 is a schematic structural view of a self-expanding stent according to a preferred embodiment of the present invention;

figure 6 is a schematic structural view of a keel support according to a preferred embodiment of the invention.

Detailed Description

The present invention will be further described with reference to the following specific examples. It should be understood that the following examples are illustrative only and are not intended to limit the scope of the present invention.

Referring to fig. 1, 2 and 3, a handle-type stent system according to a preferred embodiment of the present invention is mainly composed of a release handle 1, a delivery mechanism 2 and a self-expanding stent 3.

Wherein the release handle 1 comprises: a handle body 101 and a release switch 102 disposed thereon. According to the preferred embodiment, the release switch 102 has two states of "on" and "off" for controlling the release action of the self-expanding stent 3. The conveying mechanism 2 includes: a sleeve 201 and a fixed mandrel 202 extending through the sleeve 201, wherein the sleeve 201 is connected with the handle body 101, the proximal end of the fixed mandrel 202 is connected with the release switch 102, so as to realize the axial relative movement of the fixed mandrel 202 relative to the sleeve 201, and the distal end of the fixed mandrel 202 and the sleeve 201 form a clamping unit for clamping the self-expanding stent 3, which is described in detail below. It should be noted that the proximal end herein refers to the direction close to the release handle 1, and the distal end refers to the direction close to the self-expanding stent 3.

Specifically, as shown in fig. 2 and 3, the distal end of the sleeve 201 has a step structure 201a extending radially inward from the inner wall of the sleeve, and the distal end of the fixed mandrel 202 has a disc structure 202a extending radially outward from the axial center, and the step structure 201a and the disc structure 202a may form a clamping unit. It will be appreciated that the maximum radial dimension of the disc structure 202a is less than the inner diameter dimension of the sleeve 201, so that the disc structure 202a is free to enter and exit the sleeve 201. Accordingly, the proximal end of the self-expanding stent 3 has fixing portions 303, two in fig. 3, for facilitating the clamping of the clamping unit, but it should be understood that the fixing portions 303 are not limited to two but may be other numbers.

Preferably, the handle body 101 may be coated with a coating such as silicone to increase friction, thereby facilitating the delivery operation of the doctor.

According to a preferred embodiment of the present invention, the proximal end of the stationary mandrel 202 may be welded, bonded, or mechanically connected to the release switch 102.

According to the preferred embodiment of the present invention, the sleeve 201 is made of non-uniform material, the flexibility of the sleeve gradually increases from the proximal end to the distal end, the better flexibility of the distal end is beneficial to the advancement of the head of the delivery mechanism 2 in the tortuous blood vessels, and the rigid proximal end can provide the mechanical strength required by the advancement. Further, the sleeve 201 may be made of metal, alloy or polymer; when the sleeve 201 is made of metal or alloy, it is preferably formed into a helical tube shape with a varying pitch of the thread so that the compliance property varies in the axial direction, as shown in fig. 4A; when the sleeve 201 is formed by using a polymer material, it is preferable to use a non-uniform material, or to realize the difference of the flexibility performance of different sections by splicing and combining different materials, as shown in fig. 4B.

As shown in fig. 5 and 6, according to the preferred embodiment, the self-expanding stent 3 includes a keel stent 301, a dense mesh stent 302 and a fixing portion 303 at the proximal end of the keel stent 301, and the distal end of the keel stent 301 further includes a fixing portion 304. Wherein, the keel bracket 301 and the dense mesh bracket 302 are respectively prepared by weaving or cutting.

According to the preferred embodiment, the inner diameter of the keel bracket 301 is slightly larger than the outer diameter of the dense mesh bracket 302, the keel bracket 301 and the dense mesh bracket 302 are connected in a sleeved mode through a structure that the keel bracket 301 is arranged outside and the dense mesh bracket 302 is arranged inside, and the keel bracket 301 and the dense mesh bracket 302 are fixed through laser welding, adhesion, mechanical connection and the like. Compared with the existing single-layer dense-mesh stent, the double-layer structure stent provided by the invention reduces the contact area between the self-expanding stent and the micro catheter, and greatly reduces the pushing resistance of the stent.

Further, the outer-layer keel support 301 is of a sparse net structure with larger wire diameter and larger meshes, and the inner-layer dense net support 302 is of a dense net structure with smaller wire diameter and smaller meshes.

It should be understood that the fixing

portions

303, 304 at both ends of the bracket are fixing parts formed by binding woven wires or cut wires at the end portions of the keel bracket, and may be welding points formed by welding, or connecting parts or kink structures formed by mechanical fixing, or adhesive points formed by adhesion, and the shape thereof is not particularly limited. The anchoring portion 303 of the proximal end of the self-expanding stent 3 is held by the sleeve 201 and the anchoring mandrel 202, while the distal end is a free end, it being understood that the microcatheter used to establish the channel to assist stent delivery is not connected to the anchoring portion 304 of the distal end of the stent.

According to the preferred embodiment of the present invention, the keel frame 301 and the dense mesh frame 302 may be made of the same or different memory alloys or metal or polymer materials with high elasticity, the metal or alloy includes but is not limited to stainless steel, platinum-tungsten alloy, platinum-iridium alloy, nickel-titanium alloy or cobalt-chromium alloy; polymeric materials include, but are not limited to, polyethylene, polyoxymethylene, polyurethane, polyester, polytetrafluoroethylene, fluorinated ethylene propylene copolymer, polyamide, polyimide, or nylon.

Further, the proximal fixing portion 303 and the distal fixing portion 304 may have the same or different structures, and the positions of the two may be interchanged when they are the same, and the direction of stent placement is not limited thereby.

Further, the self-expanding stent 3 preferably further comprises a developing element made of a radiopaque material, including but not limited to gold, platinum-tungsten alloy, platinum-iridium alloy or a developing polymer material; the developing elements may be developing filaments woven into the stent, dot-like elements fixed to the stent network, or fixed portions mounted at both ends of the stent.

As shown in fig. 6, the keel bracket 301 has two ends protruding beyond the dense mesh bracket 302 and is shaped into a trumpet structure to improve the anchoring performance of the bracket and prevent the bracket from shifting or shortening during use.

Further, the handle type bracket system can be operated and used under the existing technical means.

Furthermore, the forming process and the performance of the handle type bracket system are easy to control and guarantee.

According to the preferred embodiment, a handle-type support system is provided, which has the following working principle:

as shown in fig. 2, which is a structural schematic diagram of the self-expanding stent 3 in a clamped state, when the system is in a pushing configuration, the distal end of the sleeve 201 and the distal end of the fixing mandrel 202 form a closed structure on both sides of the fixing part 303 of the self-expanding stent 3, the distal plane of the step structure 201a is in contact with the proximal plane of the fixing part 303, and the proximal plane of the disc structure 202a is in contact with the distal plane of the fixing part 303; by pushing and pulling the release handle 1, the step structure 201a of the sleeve 201 transmits a forward pushing force, and the disc structure 202a of the fixed mandrel 202 provides a withdrawing pulling force, so that the self-expanding stent 3 has a small pushing resistance when advancing and withdrawing in the microcatheter.

With continued reference to figure 2, when the release switch 102 is in the "off" configuration, the anchoring portion 303 at the proximal end of the keel support is restrained from movement and the self-expanding support 3 is not released, facilitating complete retrieval and re-implantation of the self-expanding support 3. During the delivery process, the stent needs to be matched with a micro catheter, and the micro catheter firstly builds a channel in the blood vessel, so that the system can be smoothly delivered to the hemangioma. In the initial release stage, the self-expanding stent 3 is always conveyed in the micro catheter in a pressed and held state until the tumor neck, and the self-expanding stent 3 is released from the micro catheter and is in a state to be released.

As shown in fig. 3, which is a schematic structural diagram of the self-expanding stent 3 in a released state, that is, when the release switch 102 is in an "on" configuration, the fixing mandrel 202 is linked with the release switch 102, and the closed structures formed at the two sides of the fixing portion 303 by the distal end of the sleeve 201 and the distal end of the fixing mandrel 202 are released, that is, the fixing mandrel 202 no longer provides the required supporting force for fixing the fixing portion 303 of the keel stent, the fixing portion 303 at the proximal end of the keel stent is pulled out, and the self-expanding stent 3 is released at a required position.

In summary, according to the handle-type stent system provided by the invention, the contact area between the stent and the microcatheter is reduced by counting the keel stent with larger aperture outside the dense-mesh stent, and the pushing resistance is reduced; the sleeve and the fixed mandrel are matched with the pushing support, so that the loss of pushing force is reduced, the support is firmly held and cannot be separated when the support release switch is in a closed state, the support can be completely recovered and re-implanted in the implantation process, the fault tolerance rate in the operation process is increased, and the operation difficulty of implanting the single-layer dense-mesh support is effectively reduced.

It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of example embodiments according to the present application. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, and it should be understood that when the terms "comprises" and/or "comprising" are used in this specification, they specify the presence of stated features, steps, operations, devices, components, and/or combinations thereof, unless the context clearly indicates otherwise.

The relative arrangement of the components and steps, the numerical expressions, and numerical values set forth in these embodiments do not limit the scope of the present application unless specifically stated otherwise. Meanwhile, it should be understood that the sizes of the respective portions shown in the drawings are not drawn in an actual proportional relationship for the convenience of description. Techniques, methods, and apparatus known to those of ordinary skill in the relevant art may not be discussed in detail but are intended to be part of the specification where appropriate. In all examples shown and discussed herein, any particular value should be construed as merely illustrative, and not limiting. Thus, other examples of the exemplary embodiments may have different values. It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, further discussion thereof is not required in subsequent figures.

In the description of the present application, it is to be understood that the orientation or positional relationship indicated by the directional terms such as "front, rear, upper, lower, left, right", "lateral, vertical, horizontal" and "top, bottom", etc., are generally based on the orientation or positional relationship shown in the drawings, and are used for convenience of description and simplicity of description only, and in the case of not making a reverse description, these directional terms do not indicate and imply that the device or element being referred to must have a particular orientation or be constructed and operated in a particular orientation, and therefore, should not be considered as limiting the scope of the present application; the terms "inner and outer" refer to the inner and outer relative to the profile of the respective component itself.

Spatially relative terms, such as "above … …," "above … …," "above … …," "above," and the like, may be used herein for ease of description to describe one device or feature's spatial relationship to another device or feature as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is turned over, devices described as "above" or "on" other devices or configurations would then be oriented "below" or "under" the other devices or configurations. Thus, the exemplary term "above … …" can include both an orientation of "above … …" and "below … …". The device may be otherwise variously oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

The above embodiments are merely preferred embodiments of the present invention, which are not intended to limit the scope of the present invention, and various changes may be made in the above embodiments of the present invention. All simple and equivalent changes and modifications made according to the claims and the content of the specification of the present application fall within the scope of the claims of the present patent application. The invention has not been described in detail in order to avoid obscuring the invention.

Claims

1. A handle bracket system, comprising:

a release handle, the release handle comprising: the handle body and a release switch arranged on the handle body;

a delivery mechanism connected to the release handle, the delivery mechanism comprising: the handle comprises a sleeve and a fixed mandrel extending through the sleeve, the sleeve is connected with the handle body, the proximal end of the fixed mandrel is connected with the release switch, and the fixed mandrel and the sleeve move relatively under the action of the release switch; and

the self-expanding stent is clamped by the conveying mechanism, the near end of the self-expanding stent is provided with a protruding fixing part, and the fixing part is clamped by a clamping unit formed by the far end of the fixing mandrel and the sleeve.

2. The handle bracket system of claim 1, wherein the release switch comprises: the far ends of the sleeve and the fixing mandrel form a closed structure at two sides of the fixing part of the self-expanding bracket to fix the self-expanding bracket when the self-expanding bracket is in the 'closed' state; when in the "on" state, the fixed mandrel is displaced relative to the sleeve to release the self-expanding stent.

3. A handle bracket system according to claim 1, wherein the proximal end of the securing mandrel is welded, bonded or mechanically connected to the release switch.

4. The handle stent system according to claim 1, wherein the distal end of the sleeve has a step structure extending radially inward from the inner wall, and the distal end of the fixing mandrel has a disk structure extending radially outward from the hub, the step structure and the disk structure forming the clamping unit to clamp the fixing portion of the self-expanding stent therebetween.

5. A handle holder system according to claim 4, wherein when said self-expanding holder is clamped, said step formation distal flat surface contacts said retainer proximal flat surface and said disc formation proximal flat surface contacts said retainer distal flat surface.

6. The handle bracket system of claim 1, wherein the self-expanding bracket comprises a keel bracket and a dense mesh bracket which are sequentially sleeved from outside to inside, and the keel bracket and the dense mesh bracket are fixed by laser welding, adhesion or mechanical connection.

7. A handle stent system according to claim 6 wherein the keel stent has a wire diameter greater than the wire diameter of the dense mesh stent and the keel stent has a mesh size greater than the mesh size of the dense mesh stent.

8. The handle stent system according to claim 6, wherein the keel stent and the dense mesh stent are made of the same or different alloy with memory function, or metal with high elasticity, or polymer material with high elasticity, and the alloy and the metal comprise: stainless steel, platinum-tungsten alloy, platinum-iridium alloy, nickel-titanium alloy, or cobalt-chromium alloy; the polymer material includes: polyethylene, polyoxymethylene, polyurethane, polyester, polytetrafluoroethylene, fluorinated ethylene propylene copolymer, polyamide, polyimide or nylon.

9. The handle stent system according to claim 6, wherein the fixing portion of the self-expanding stent is a structure formed by gathering the woven wires or the cutting wires of the keel stent; the both ends of fossil fragments support extend for the protrusion in loudspeaker column structure outside the dense net support.

10. A handle holder system according to claim 1, wherein said self-expanding holder comprises a visualization element made of a radiopaque material comprising: gold, platinum-tungsten alloy, platinum-iridium alloy, or developable polymer material; the developing element is a developing wire woven into the bracket, or a point element fixed on the bracket network, or a block element arranged on the fixed part.