CN219109615U - Intratumoral implant - Google Patents

Abstract

The utility model provides an intratumoral implant, which comprises a woven mesh and a binding sleeve, wherein the woven mesh is a self-expansion woven mesh and comprises an outer layer woven mesh and an inner layer woven mesh, the outer layer woven mesh is provided with opposite broken end parts and connecting parts, the edge of the inner layer woven mesh is connected with the connecting parts to form a connecting mesh surface, and the mesh surface of the inner layer woven mesh is concavely gathered towards the broken end parts to form a gathering part; the binding sleeve is used for fixing the broken end part and the gathering part, the binding sleeve, the broken end part and the gathering part form a rivet head of the intratumoral implant, and the rivet head is arranged as one. When the intratumoral implant is used for treating the bifurcation aneurysm or the side wall aneurysm, as one end of the intratumoral implant is a single rivet, and the other end of the intratumoral implant is of a relatively flat connecting net surface structure, the risk that the rivet is sprung or pokes the tumor top or the tumor wall after the intratumoral implant is released in the aneurysm can be effectively avoided, and the dangerous condition that the aneurysm is ruptured and bleeding occurs in a patient operation and the hemorrhagic cerebral apoplexy is caused is reduced.

Description

Intratumoral implant

Technical Field

The utility model belongs to the technical field of medical instruments, and particularly relates to an intratumoral implant.

Background

Intratumoral implants for treating bifurcated aneurysms or lateral aneurysms typically have two or even three rivets for cinching the broken ends of the braided mesh, and multiple rivet structures, although convenient to manufacture, often present the following potential risks during implant release: the self-expansion force of the intratumoral implant can cause the implant to deform greatly at one moment, and the release force of the rivet at one moment of self-expansion release can damage the weak tumor wall at the top position of the aneurysm, so that the aneurysm breaks and bleeds, and hemorrhagic cerebral apoplexy is caused.

Accordingly, there is a need to provide an improved solution to the above-mentioned deficiencies of the prior art.

Disclosure of Invention

The utility model aims to provide an intratumoral implant which solves the problem of potential risks existing in the current intratumoral implant with a multi-rivet structure.

In order to achieve the above object, the present utility model provides the following technical solutions:

an intratumoral implant, the intratumoral implant comprising:

the woven mesh is a self-expansion woven mesh and comprises an outer layer woven mesh and an inner layer woven mesh, the outer layer woven mesh is provided with opposite broken end parts and connecting parts, the edge of the inner layer woven mesh is connected with the connecting part to form a connecting mesh surface, and the mesh surface of the inner layer woven mesh is concavely gathered towards the broken end part to form a gathering part;

the binding sleeve is used for fixing the broken end part and the gathering part, the binding sleeve, the broken end part and the gathering part form a rivet head of the intratumoral implant, and the rivet head is arranged as one.

In an alternative embodiment of the present utility model, the outer layer mesh grid and the inner layer mesh grid are both woven by a plurality of woven wires, and the outer layer mesh grid and the inner layer mesh grid are in an integral structure.

In an alternative embodiment of the utility model, the outer contour shape of the woven mesh in the self-expansion state is hemispherical, the outer diameter of the woven mesh in the self-expansion state is 4-11mm, and the height is 2-5.5mm.

In an alternative embodiment of the utility model, the outer contour shape of the woven mesh in the self-expansion state is cylindrical, the outer diameter of the woven mesh in the self-expansion state is 3-11mm, and the height is 2-9mm.

In an alternative embodiment of the present utility model, the inner core materials of the knitting wires of the outer layer knitted mesh and the inner layer knitted mesh are both platinum, the outer layer materials are both nickel-titanium alloy, and the mass of the platinum accounts for 30-50% of the total mass.

In an alternative embodiment of the present utility model, the gathering portion is located at a center position of the inner layer mesh grid.

In an alternative embodiment of the present utility model, the binding sleeve is a hollow ring structure; the material of the binding sleeve is a radio-opaque material.

In an alternative embodiment of the present utility model, the rivet is located at a central position of the mesh grid and protrudes in a direction away from the mesh grid.

In an alternative embodiment of the present utility model, the intratumoral implant further includes a connecting rod, wherein one end of the connecting rod is inserted and fixed in the binding sleeve, and the other end of the connecting rod is exposed out of the binding sleeve.

In an alternative embodiment of the utility model, the length of the part of the connecting rod exposed out of the binding sleeve is 0.3-0.5mm; the end part of the connecting rod exposed out of the binding sleeve is in a sphere structure.

The beneficial effects are that:

the intratumoral implant comprises a woven mesh and a binding sleeve, wherein the woven mesh is a self-expansion woven mesh and comprises an outer layer woven mesh and an inner layer woven mesh, the outer layer woven mesh is provided with opposite broken ends and connecting parts, the edge of the inner layer woven mesh is connected with the connecting parts to form a connecting mesh surface, and the mesh surface of the inner layer woven mesh is concavely gathered towards the broken ends to form a gathering part; the binding sleeve is used for fixing the broken end part and the gathering part, the binding sleeve, the broken end part and the gathering part form a rivet head of the intratumoral implant, and the rivet head is arranged as one. When the intratumoral implant is used for treating the bifurcation aneurysm or the side wall aneurysm, as one end of the intratumoral implant is a single rivet, and the other end of the intratumoral implant is of a relatively flat connecting net surface structure, the risk that the rivet is sprung or pokes the tumor top or the tumor wall after the intratumoral implant is released in the aneurysm can be effectively avoided, and the dangerous condition that the aneurysm is ruptured and bleeding occurs in the operation of a patient and the hemorrhagic cerebral apoplexy is caused is reduced; and simultaneously, the safety of the instrument in use is also improved.

Drawings

The accompanying drawings, which are included to provide a further understanding of the utility model and are incorporated in and constitute a part of this specification, illustrate embodiments of the utility model and together with the description serve to explain the utility model. Wherein:

FIG. 1 is a schematic cross-sectional view of an intratumoral implant according to an embodiment of the present utility model in a self-expanding state;

FIG. 2 is a schematic cross-sectional view of another embodiment of the intratumoral implant of the present utility model in a self-expanding state;

fig. 3 is a schematic view of the implantation of the intratumoral implant of the present utility model into a bifurcated aneurysm vessel.

Reference numerals in the drawings: 1-intratumoral implant; 11-a woven mesh; 111-an outer layer woven mesh; 111 a-a connection; 111 b-broken ends; 112-inner layer woven mesh; 112 a-gathering section; 12-bundling; 2-bifurcation aneurysm; 21-infusion of blood vessels; 22-a first output vessel; 23-a second output vessel; 3-microcatheter.

Detailed Description

The following description of the technical solutions in the embodiments of the present utility model will be clear and complete, and it is obvious that the described embodiments are only some embodiments of the present utility model, but not all embodiments. All other embodiments, which are derived by a person skilled in the art based on the embodiments of the utility model, fall within the scope of protection of the utility model.

The present utility model will be described in detail with reference to examples. It should be noted that, without conflict, the embodiments of the present utility model and features of the embodiments may be combined with each other.

In order to solve the potential risk problem of the existing multi-rivet-head structure intratumoral implant, the utility model provides the intratumoral implant.

As shown in fig. 1 to 3, the intratumoral implant 1 of the present utility model comprises a woven mesh 11 and a binding sleeve 12, the woven mesh 11 is a self-expanding woven mesh 11, and comprises an outer woven mesh 111 and an inner woven mesh 112, the outer woven mesh 111 has opposite broken ends 111b and connecting parts 111a, the edge of the inner woven mesh 112 is connected with the connecting parts 111a to form a connecting mesh surface, and the mesh surface of the inner woven mesh 112 is concavely gathered towards the broken ends 111b to form gathering parts 112a; the binding sleeve 12 fixes the broken end 111b and the gathering portion 112a, and the binding sleeve 12, the broken end 111b and the gathering portion 112a form a rivet of the intratumoral implant 1, and the rivet is arranged as one.

Specifically, the woven mesh 11 is a self-expanding woven mesh 11, and is capable of self-expanding and recovering, the woven mesh 11 has a double-layer structure, the outer woven mesh 111 has opposite broken ends 111b and connecting parts 111a (i.e. non-broken ends 111 b), the edge of the inner woven mesh 112 is connected with the connecting parts 111a and forms a smooth connecting mesh surface, no acute angle, no burr and no broken end are formed, and therefore, even after the intratumoral implant 1 is implanted into the bifurcated aneurysm 2, no damage is caused to the inner wall of the aneurysm.

The mesh surface of the inner layer mesh grid 112 is concavely gathered towards the broken end 111b to form a gathered part 112a, the gathered part 112a and the broken end 111b of the outer layer mesh grid 111 are positioned at the same end and are hooped in the binding sleeve 12 together, and the binding sleeve 12 plays a role of simultaneously binding the broken end 111b of the outer layer mesh grid 111 and the gathered part 112a of the inner layer mesh grid 112. In the above structure, the binding sleeve 12, the broken end 111b and the gathering portion 112a form a rivet of the intratumoral implant 1, and the intratumoral implant 1 of the present utility model is provided in a single rivet structure.

It should be noted that, because the woven mesh 11 has a double-layer structure, broken end wires do not exist at the edge of the woven mesh 11 with the double-layer structure, so that the intratumoral implant 1 can not puncture or damage the aneurysm wall after being released in the aneurysm; if the woven mesh 11 has a single-layer structure, the edge portion of the woven mesh must have broken ends of the woven filaments, and the broken filaments may puncture or damage the wall of the aneurysm after being implanted into the aneurysm, resulting in rupture and bleeding of the aneurysm.

It can be understood that when the intratumoral implant 1 of the utility model is used for treating the bifurcation aneurysm 2 or the lateral wall aneurysm, as one end (namely the proximal end) is a single rivet, and the other end (namely the distal end) is of a relatively flat connecting net surface structure, the risk that the rivet breaks or punctures the tumor top or the tumor wall after the intratumoral implant 1 is released in the aneurysm can be effectively avoided, and the dangerous condition that the aneurysm breaks and bleeding and causes hemorrhagic cerebral apoplexy in the operation of a patient is reduced; and simultaneously, the safety of the instrument in use is also improved.

It should be noted that the term "proximal" or similar description as used herein should be understood as: one end of the device, either near the user or remote from the target site of the vessel to be treated; the term "distal" or similar descriptions as used should be understood as: the end of the device remote from the user or near the target site of the vessel to be treated.

In the embodiment of the present utility model, the outer layer mesh grid 111 and the inner layer mesh grid 112 are all woven by a plurality of woven wires, and the outer layer mesh grid 111 and the inner layer mesh grid 112 are in an integrated structure, and when the present utility model is specifically manufactured, the outer layer mesh grid 111 and the inner layer mesh grid 112 can be manufactured into an integrated structure by a heat treatment shaping mold, so that the whole double-layer mesh grid 11 is relatively firm.

In one embodiment of the present utility model, as shown in fig. 1, the outer contour shape of the woven mesh 11 in the self-expanding state is hemispherical, that is, the outer contour of the intratumoral implant 1 is hemispherical after the intratumoral implant 1 is completely released in the aneurysm, and the intratumoral implant 1 with the structure faces the direction of blood flow impact, so that the blood flow can be effectively blocked, the blood flow can be redirected, the impact of the blood flow on the aneurysm can be reduced, and the rupture of the aneurysm can be avoided.

The size of the intratumoral implant 1 in the self-expansion state can be designed according to the size of the aneurysm so as to ensure that the intratumoral implant 1 can fully cover the tumor neck opening of the bifurcation aneurysm 2 after being completely released and is attached to the inner wall of the tumor sac, thereby playing a good role in guiding blood flow. Alternatively, the outer diameter of the mesh 11 in the self-expanded state is 4-11mm (e.g., 4mm, 6mm, 8mm, 10mm, 11mm, and the interval between any two end values), and the height (i.e., the length from the position of the binder 12 to the other end) is 2-5.5mm (e.g., 2mm, 3mm, 4mm, 5mm, 5.5mm, and the interval between any two end values).

In another embodiment of the present utility model, as shown in fig. 2, the outer contour shape of the woven mesh 11 in the self-expanding state is cylindrical, that is, the outer contour of the intratumoral implant 1 is cylindrical after the intratumoral implant 1 is completely released in the aneurysm, and the intratumoral implant 1 with the structure faces the direction of blood flow impact, so that the blood flow can be effectively blocked, the blood flow can be redirected, the impact of the blood flow on the aneurysm can be reduced, and the rupture of the aneurysm can be avoided.

Alternatively, the outer diameter of the mesh 11 in the self-expanded state is 3-11mm (e.g., 3mm, 5mm, 7mm, 9mm, 11mm, and the interval between any two end values), and the height (i.e., the length from the position of the binder 12 to the other end) is 2-9mm (e.g., 2mm, 4mm, 6mm, 8mm, 9mm, and the interval between any two end values). When the aneurysm is specifically selected, the outer diameter of the aneurysm can be selected according to the size of the aneurysm, so that the aneurysm neck opening part of the bifurcated aneurysm 2 can be fully covered after the intratumoral implant 1 is completely released and is attached to the inner wall of the tumor sac, and a better blood flow guiding effect is achieved.

In the embodiment of the present utility model, the inner core materials of the knitting wires of the outer layer knitted mesh 111 and the inner layer knitted mesh 112 are platinum, the outer layer materials are nickel-titanium alloy, and the mass of platinum accounts for 30-50% of the total mass (such as 30%, 35%, 40%, 45%, 50% and the interval value between any two end values). By the design, the developing property of platinum is good, the shape memory property of nickel-titanium alloy is good, and the biocompatibility of the outer layer woven mesh 111 and the inner layer woven mesh 112 is good, namely the biocompatibility of the woven mesh 11 with a double-layer structure is good.

In the embodiment of the utility model, the gathering part 112a is positioned at the center of the inner layer woven mesh 112, that is, the woven mesh 11 with a double-layer structure is of a symmetrical structure, so that the release difficulty of the intratumoral implant 1 can be effectively reduced, and meanwhile, the rivet head area (namely, the mesh dense area) of the intratumoral implant 1 can be ensured to well block the neck of the aneurysm, thereby effectively blocking blood flow, avoiding damaging the inner wall of the aneurysm sac of the aneurysm and being applicable to aneurysms with different sizes. If the woven mesh 11 with the double-layer structure is of an asymmetric eccentric structure, the release difficulty of the intratumoral implant 1 is increased, the intratumoral implant 1 cannot be guaranteed to play a good role in blocking blood flow, and the inner wall of a tumor sac of an aneurysm can be damaged after release, so that the method is not applicable to aneurysms with different sizes.

In the embodiment of the present utility model, the binding sleeve 12 has a hollow ring structure, and the broken end 111b of the outer woven mesh 111 and the gathering portion 112a of the inner woven mesh 112 are wrapped and bound inside the hollow ring structure. The material of the binding sleeve 12 is a radio-opaque material, and can be gold, platinum iridium alloy, stainless steel and the like, so that the developing effect is good, the developing can be clearly performed under X rays, and the accuracy of operation is provided.

In the embodiment of the utility model, the rivet head is positioned at the center of the woven mesh 11, so that the implantation operation of the intratumoral implant 1 can be facilitated, the operability of the operation is improved, and the rivet head protrudes towards the direction away from the woven mesh 11, and the included angle between the woven mesh 11 and the rivet head is designed to be larger than 90 degrees, so that the transportation operation of the intratumoral implant 1 is facilitated.

In the specific embodiment of the present utility model, the intratumoral implant 1 further includes a connecting rod, one end of the connecting rod is inserted and fixed in the binding sleeve 12, and the other end of the connecting rod is exposed out of the binding sleeve 12 and is used for connecting the pushing member. It should be noted that, the pushing member includes, but is not limited to, a pushing rod, an introducing sheath, and a microcatheter 3, as shown in fig. 3, in one embodiment, one end of the connecting rod exposed to the binding sleeve 12 is connected to one end of the pushing rod, the introducing sheath is disposed outside the pushing rod, the intratumoral implant 1 can be completely recovered into the introducing sheath by pulling the pushing rod, the intratumoral implant 1 can be pushed into the microcatheter 3 by the introducing sheath, and the intratumoral implant 1 can be delivered into the aneurysmal sac by means of the pushing guide wire, and after the intratumoral implant 1 is completely released, the rod body at the proximal end of the pushing rod is broken, so that the intratumoral implant 1 is mechanically released.

In the embodiment of the utility model, the connecting rod is approximately in a straight rod shape and is wrapped in the binding sleeve 12, the connecting rod is positioned in the middle of the binding sleeve 12, and the length of the part of the connecting rod exposed out of the binding sleeve 12 is 0.3-0.5mm (such as 0.3mm, 0.4mm, 0.5mm and interval values between any two end values); the end of the connecting rod exposed out of the binding sleeve 1212 is in a sphere structure, and the connecting rod is convenient to connect with the pushing piece by the design.

Fig. 3 shows the structure of a bifurcated aneurysm 2, where the blood vessel at the bifurcated aneurysm 2 comprises an inlet vessel 21, a first outlet vessel 22 and a second outlet vessel 23, where the bifurcated aneurysm 2 is located at the bifurcation of the first outlet vessel 22 and the second outlet vessel 23, and where a portion of the blood flow originating from the proximal end of the inlet vessel 21 flows into the first outlet vessel 22 and another portion into the second outlet vessel 23, while a portion of the blood flow flows into the bifurcated aneurysm 2 where it impinges on the inner wall of the bifurcated aneurysm 2, thereby creating an outward pressure and expanding the bifurcated aneurysm 2. The intratumoral implant 1 is implanted in the area, and the intratumoral implant 1 covers the tumor neck opening part of the bifurcation aneurysm 2 and is attached to the inner wall of the tumor sac, thereby playing a good role in guiding blood flow. Because one end of the intratumoral implant 1 is designed as a single rivet, and the other end is of a relatively flat connecting net surface structure, the risk that the rivet is sprung or poked on the top or wall of the aneurysm after the intratumoral implant 1 is released in the aneurysm can be effectively avoided, and the dangerous situations of rupture and bleeding of the aneurysm and hemorrhagic cerebral apoplexy in the operation of a patient are reduced; and simultaneously, the safety of the instrument in use is also improved.

The above description is only of the preferred embodiments of the present utility model and is not intended to limit the present utility model, but various modifications and variations can be made to the present utility model by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present utility model should be included in the protection scope of the present utility model.

Claims (10)

1. An intratumoral implant, comprising:

the woven mesh is a self-expansion woven mesh and comprises an outer layer woven mesh and an inner layer woven mesh, the outer layer woven mesh is provided with opposite broken end parts and connecting parts, the edge of the inner layer woven mesh is connected with the connecting part to form a connecting mesh surface, and the mesh surface of the inner layer woven mesh is concavely gathered towards the broken end part to form a gathering part;

the binding sleeve is used for fixing the broken end part and the gathering part, the binding sleeve, the broken end part and the gathering part form a rivet head of the intratumoral implant, and the rivet head is arranged as one.

2. The intratumoral implant of claim 1, wherein said outer braided mesh and said inner braided mesh are each braided from a plurality of braided filaments, and wherein said outer braided mesh and said inner braided mesh are of unitary construction.

3. The intratumoral implant of claim 2, wherein said mesh is hemispherical in outer contour shape in a self-expanding state, said mesh having an outer diameter of 4-11mm and a height of 2-5.5mm in a self-expanding state.

4. The intratumoral implant of claim 2, wherein said woven mesh has a cylindrical outer profile in a self-expanding state, an outer diameter of 3-11mm and a height of 2-9mm in a self-expanding state.

5. The intratumoral implant of claim 2, wherein the woven wire inner cores of the outer woven mesh and the inner woven mesh are made of platinum, the outer layers are made of nickel-titanium alloy, and the mass of the platinum accounts for 30-50% of the total mass.

6. The intratumoral implant of claim 1, wherein said gathering section is centrally located within said inner woven mesh.

7. The intratumoral implant of claim 1, wherein said cuff is a hollow annular structure;

the material of the binding sleeve is a radio-opaque material.

8. The intratumoral implant of claim 1, wherein said rivet is centrally located within said mesh and projects away from said mesh.

9. The intratumoral implant of any one of claims 1-8, further comprising a connecting rod having one end inserted and secured within said binding sleeve and the other end exposed to said binding sleeve.

10. The intratumoral implant of claim 9, wherein a portion of the connecting rod exposed to the binding sleeve has a length of 0.3-0.5mm;

the end part of the connecting rod exposed out of the binding sleeve is in a sphere structure.

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