CN215688774U

CN215688774U - Combined type support device

Info

Publication number: CN215688774U
Application number: CN202120394842.5U
Authority: CN
Inventors: 鲁海涛; 李明华; 朱悦琦
Original assignee: Shanghai Sixth Peoples Hospital
Current assignee: Shanghai Sixth Peoples Hospital
Priority date: 2021-02-22
Filing date: 2021-02-22
Publication date: 2022-02-01
Anticipated expiration: 2031-02-22

Abstract

The utility model discloses a composite bracket device, which comprises: the balloon is used for the balloon-expanding type support with the targeted positioning, an outer coating film material used for being attached to a blood vessel wall, the self-expanding type support and the movable balloon used for propping up the balloon-expanding type support, the length of the outer coating film material is larger than that of the balloon-expanding type support, the outer coating film material is wound on the peripheral part of the balloon-expanding type support, and the end part of the self-expanding type support is overlapped with that of the propped-up balloon-expanding type support so as to prop up the outer coating film material of a free part. The ball expands formula support and fixes the outer covering membrane material on the ball expands formula support, can effectively improve the ability in place of target pathological change, and the outer covering membrane material of inflation formula support and free part can effectively avoid the damage that causes the bending segment vascular wall. The application range of the covered stent can be effectively enlarged, and the compliance of the covered stent can be improved. Therefore, the device is suitable for the treatment condition of the curved section of the blood vessel, and can avoid the damage to the wall of the curved section of the blood vessel.

Description

Combined type support device

Technical Field

The utility model relates to the technical field of minimally invasive interventional medical instruments, in particular to a composite bracket device.

Background

Intracranial aneurysmal subarachnoid hemorrhage is one of the most common cerebrovascular diseases, and the incidence rate is second only to cerebral infarction and hypertensive cerebral hemorrhage; the death rate after the aneurysm is ruptured reaches 40 percent, and the disability rate reaches 33 percent. The traditional endovascular intervention treatment of aneurysm mostly adopts the spring coil tumor-filling cavity technology, but the spring coil embolism has many defects in materials and technology, such as: the therapeutic action is in the aneurysm cavity, which may cause intraoperative hemorrhage; the embolization material is in the aneurysm cavity, so that the occupation effect after operation is easily caused; the complete compact occlusion rate is low; high recurrence rate after operation.

The ideal blood vessel reconstruction technology is to transfer the therapeutic target from the aneurysm cavity to the artery carrying the aneurysm or the blood vessel with pathological change section, thereby achieving the real dissection and healing of the pathological change. The full-covered stent researched and reported at present is an intracranial vascular intraluminal isolation product designed based on the treatment concept, can directly isolate aneurysm, keep the artery carrying the aneurysm unobstructed, recover the normal hemodynamics of a lesion area, and promote the formation and organization of thrombus in the aneurysm, so that the lesion is automatically occluded.

Because the cranial segment blood vessel is tortuous, and the blood vessel is positioned in a bony pipeline, the requirement on the flexibility of the stent is extremely high, and the design of the existing full-covered stent system has certain defects and shortcomings. For example, balloon expandable full-stent-graft systems have a large profile and stiffness, often causing vasospasm and/or intimal injury, even failure to reach, in cases of excessive tortuosity of a portion of the internal carotid artery. Moreover, if the full-coated stent is released in a curved section of a blood vessel, defects such as poor adherence of the stent, shrinkage and angulation of the coated stent and the like are easily caused, and the poor adherence is an important cause for internal leakage, recurrence and progression of lesions, stent restenosis and acute thrombosis. In addition, the full-covered stent has uneven acting force on all parts of the blood vessel in the expansion process of the bent section of the blood vessel, and can form vertical shearing force on the blood vessel to cause damage to the intima of the blood vessel and even cause full-layer tearing of the blood vessel. The existing full-film covered stent has the defects of poor compliance, low arrival rate, poor wall sticking release at a bending section, film shrinkage angulation, easy stent internal leakage, acute thrombosis risk and the like in intracranial application.

In summary, how to provide a stent graft suitable for a curved segment of a blood vessel is a problem to be solved urgently by those skilled in the art.

SUMMERY OF THE UTILITY MODEL

In view of the above, the present invention provides a composite stent device, which is suitable for the treatment of a curved section of a blood vessel and can avoid the damage to the wall of the curved section of the blood vessel.

In order to achieve the above purpose, the utility model provides the following technical scheme:

a composite stent device comprising: a ball expands formula support, is used for with the outer covering membrane material of vascular wall laminating, self-expanding formula support and mobilizable be used for strutting that is used for the target location the sacculus of ball expands formula support, the length that covers the membrane material is greater than the length that the ball expands formula support, it is around locating to cover the membrane material outer peripheral part that the ball expands formula support, from expanding the formula support with strut the end part overlap of ball expand formula support to strut free part cover the membrane material.

Preferably, the ball-expanding type stent comprises two main support rods and a plurality of connecting rods, the two main support rods are spirally wound, and the connecting rods are wound on the main support rods to form a mesh tubular framework together with the main support rods.

Preferably, each connecting rod is uniformly and symmetrically wound on the main supporting rod, and a plurality of uniformly arranged diamond-shaped connecting rings are formed between the connecting rods and the main supporting rod.

Preferably, developing blocks are provided at both ends of the main supporting bar.

Preferably, the length of the mesh tubular framework is 4-6 mm.

Preferably, the length of the outer coating film material is 10mm, 13mm, 16mm or 19 mm.

Preferably, the outer covering membrane and the main support rod are connected through medical suture.

Preferably, the developing blocks are provided at both ends of the self-expandable stent.

Preferably, the frameworks of the ball-expanding stent and the self-expanding stent are both a nickel-titanium shape memory alloy material, a nickel-titanium alloy superelastic alloy material, a 316 medical stainless steel material or a cobalt-chromium-nickel-molybdenum-iron alloy material.

Preferably, the outer covering film material is an expanded polytetrafluoroethylene film, a polylactic acid high molecular film or a nano film.

When the composite stent device provided by the utility model is used, firstly, the balloon, the ball-expanding stent and the outer coating film material can be conveyed to a preset position by using a coaxial micro-catheter system, then, the balloon is controlled to expand to gradually expand the ball-expanding stent, when the ball-expanding stent is completely expanded, the balloon is removed, then, the self-expanding stent is conveyed to the end part of the ball-expanding stent by using the coaxial micro-catheter system, the proximal end of the self-expanding stent is overlapped with the distal end part of the ball-expanding stent, the self-expanding stent can be automatically expanded after being released, and further, the outer coating film material of the free part can be expanded and fixed.

Because ball expands formula support and covers membrane material fixed connection, so also can make the outer membrane material of covering fixed on ball expands formula support after ball expands formula support struts, can fully laminate with the vascular wall after covering membrane material struts and contact, and the outer membrane material of the free portion that is not fixed by ball expands formula support, then can be strutted by super-elastic self-expanding formula support. The spherical expansion type stent and the outer coating film fixed on the spherical expansion type stent can effectively improve the target lesion in-place capability, and the self-expansion type stent and the outer coating film of the free part can effectively avoid the damage to the wall of a bent section blood vessel. The application range of the covered stent can be effectively enlarged, and the compliance of the covered stent can be improved.

In summary, the composite stent device provided by the utility model is suitable for treating a curved section of a blood vessel, and can avoid damage to the wall of the curved section of the blood vessel.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the provided drawings without creative efforts.

FIG. 1 is a schematic structural view of a composite stent device according to the present invention;

FIG. 2 is a schematic structural diagram of a balloon stent and an outer coating material;

FIG. 3 is a schematic structural view of a self-expanding stent;

FIG. 4 is a schematic diagram of a deployed planar structure of the balloon expandable stent;

FIG. 5 is a schematic view of the sewing connection between the outer covering film and the main supporting rods;

FIG. 6 is a schematic cross-sectional shape of a main support strut;

FIG. 7 is a schematic cross-sectional view of a diamond shaped connecting ring;

FIG. 8 is a schematic plan view of a self-expanding stent after deployment;

FIG. 9 is a schematic cross-sectional view of a splice bar.

In fig. 1-9:

1 is a spherical expanding bracket, 11 is a main support rod, 12 is a connecting rod, 13 is a diamond connecting ring, 2 is an outer coating film material, 3 is a self-expanding bracket, 31 is a splicing rod, 4 is a developing block and 5 is a medical suture.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

The core of the utility model is to provide a composite stent device which is suitable for the treatment condition of a curved section of a blood vessel and can avoid the damage to the wall of the curved section of the blood vessel.

Please refer to fig. 1 to fig. 9.

This embodiment provides a combined type support device, includes: the balloon expanding type stent comprises a ball expanding type stent 1 for targeted positioning, an outer coating film material 2 for being attached to a blood vessel wall, a self-expanding type stent 3 and a movable balloon for expanding the ball expanding type stent 1, wherein the length of the outer coating film material 2 is larger than that of the ball expanding type stent 1, the outer coating film material 2 is wound on the peripheral part of the ball expanding type stent 1, and the self-expanding type stent 3 is partially overlapped with the end part of the expanded ball expanding type stent 1 so as to expand the outer coating film material 2 of a free part.

It should be noted that the outer coating film is only coated and fixed on the skeleton of the spherical expansion stent 1, and the self-expandable stent 3 is released to expand and then is used for opening and pressing the outer coating film 2 of the free part, so that the skeleton of the spherical expansion stent 1 can be set to be a net tubular closed-loop structure, and the skeleton of the self-expandable stent 3 can be set to be a net tubular open-loop structure. Moreover, the ball-expanding type stent 1 can be set to be a stent with a shorter framework length so as to improve the targeting positioning effect, and the ball-expanding type stent is suitable for a bent section blood vessel and avoids the damage phenomenon to the bent section blood vessel.

In addition, it should be added that the balloon and the stent delivery device for expanding the balloon-expandable stent 1 are of an integrated structure, and when the balloon-expandable stent 1 is completely expanded, the balloon can be withdrawn synchronously with the stent delivery device. Furthermore, the outer coating material 2 at the far end of the balloon is in a tapered state, that is, the outer coating material 2 at the free part is in a tapered state, so as to reduce the damage of the device to the curved vessel when the balloon expands and expands the expandable stent 1.

In the actual application process, the shapes, structures, sizes, materials, positions and the like of the balloon-expandable stent 1, the outer coating film 2, the self-expandable stent 3 and the balloon can be determined according to actual conditions and actual requirements.

When the composite stent device provided by the utility model is used, firstly, the balloon, the ball-expanding stent 1 and the outer coating film material 2 can be conveyed to a preset position by using a coaxial microcatheter system, then, the balloon is controlled to expand to gradually expand the ball-expanding stent 1, when the ball-expanding stent 1 is completely expanded, the balloon is removed, then, the self-expanding stent 3 is conveyed to the end part of the ball-expanding stent 1 by using the coaxial microcatheter system, the near end of the self-expanding stent 3 is overlapped with the far end part of the ball-expanding stent 1, the self-expanding stent 3 can be automatically expanded after being released, and further, the outer coating film material 2 of the free part can be expanded and fixed.

Because the spherical expansion type stent 1 and the outer coating film material 2 are fixedly connected, the outer coating film material 2 fixed on the spherical expansion type stent 1 can be propped open after the spherical expansion type stent 1 is propped open, the outer coating film material 2 can be fully attached and contacted with the blood vessel wall after being propped open, and the outer coating film material 2 of the free part which is not fixed by the spherical expansion type stent 1 can be propped open by the self-expansion type stent 3 with hyperelasticity. The spherical expansion type stent 1 and the outer coating film material 2 fixed on the spherical expansion type stent 1 can effectively improve the target lesion in-place capability, and the self-expansion type stent 3 and the outer coating film material 2 of the free part can effectively avoid the damage to the vessel wall of the bending section. The application range of the covered stent can be effectively enlarged, and the compliance of the covered stent can be improved.

Preferably, the ball expanding stent 1 comprises two main support rods 11 and a plurality of connecting rods 12, the two main support rods 11 are spirally wound, and the connecting rods 12 are wound on the main support rods 11 to form a mesh tubular framework together with the main support rods 11.

Preferably, each connecting rod 12 is uniformly and symmetrically wound on the main supporting rod 11, and a plurality of uniformly arranged diamond-shaped connecting rings 13 are formed between the connecting rods 12 and the main supporting rod 11, as shown in fig. 2. Therefore, when the balloon expansion type support 1 is expanded by the balloon, the outer covering film material 2 can be uniformly expanded at each position of the balloon expansion type support 1, so that the attaching degree of the balloon expansion type support 1 and the vessel wall is improved.

Preferably, the main supporting bar 11 is provided at both ends thereof with the developing blocks 4. The developing block 4 can be made of a material which cannot be penetrated by X rays, when the ball-expanding type support 1 is released, the position of the developing block 4 can be detected through an X-ray detection instrument, namely the position of the near end and the position of the far end of the ball-expanding type support 1 can be detected, wherein the position of the far end of the ball-expanding type support 1 is also the position of the outer coating material 2 of the free part, so that the releasing operation of the self-expanding type support 3 can be accurately positioned. For example, the developing blocks 4 may be provided at both ends of the main supporting bar 11.

It should be noted that, here, the proximal end refers to the end near the input position of the coaxial microcatheter system, and the distal end refers to the end far from the input position of the coaxial microcatheter system.

The shape, structure, size, position, material, etc. of the main support rod 11, the connecting rod 12, and the developing block 4 can be determined in the actual application process according to the actual situation and the actual requirements.

Preferably, the length of the mesh tubular framework is 4-6 mm. For example, the skeleton length of the ball-expanded stent 1 may be set to 5 mm.

Preferably, the length of the outer covering film 2 is 10mm, 13mm, 16mm or 19 mm. That is, the outer coating material 2 can have various dimensions to improve the applicability of the device, so that the device is suitable for treatment operation with various dimensions and vascular walls.

Since the scaffold length of the balloon stent 1 is short, only a part of the outer coating material 2 is fixed to the balloon stent 1, and the other part of the outer coating material is in a free state. When the composite stent device provided by the utility model is used, two stents need to be released twice, firstly, the spherical stent 1 needs to be released, and the spherical stent 1 can be conveyed into a blood vessel through a coaxial microcatheter system. Because the skeleton length of ball expands formula support 1 is shorter, is only 5mm, is favorable to expanding formula support 1 compression with the ball to reduce the section of whole support system, improve the target location ability of device. Then, the self-expandable stent 3 is released by the microcatheter, and the free part of the outer coating film 2 can be expanded and fixed by the self-expandable stent 3, so as to avoid the injury of the segmented stent to the vessel wall caused by the angulation of the stent in the process of releasing the bent segment vessel.

Preferably, the outer covering film 2 and the main support rod 11 are connected by a medical suture 5. That is, the outer covering film 2 and the main support rods 11 may be coupled and fixed by a microsurgical suture method, as shown in fig. 5. Adopt medical stylolite 5 to closely fix between the both ends of covering membrane material 2 and main tributary vaulting pole 11, can guarantee that ball expands formula support 1 and covers closely linking to each other of membrane material 2, increase and cover the adherence effect of membrane material 2 in the curved segment blood vessel outward.

Preferably, both ends of the self-expandable stent 3 are provided with developing blocks 4.

It should be noted that, the self-expandable stent 3 may be configured as a bare metal stent, and includes a plurality of splicing rods 31 spirally wound, and developing blocks 4 impermeable to X-rays may be disposed at two ends of the splicing rods 31, as shown in fig. 3, the self-expandable stent 3 is easily released through a microcatheter, and partially overlaps with the spherical stent 1 to unfold and fix the outer coating material 2 of the free portion, thereby preventing the segmental stent from damaging the blood vessel wall due to the excessive stiffness of the stent in the process of releasing the curved blood vessel.

The shape, structure, position, material, number and the like of the splicing rod 31 and the developing block 4 can be determined in the actual application process according to the actual situation and the actual requirement.

Preferably, the frameworks of the ball-expanding stent 1 and the self-expanding stent 3 are both made of a nickel-titanium shape memory alloy material, a nickel-titanium alloy superelastic alloy material, a 316 medical stainless steel material or a cobalt-chromium-nickel-molybdenum-iron alloy material. The material pieces are all metal alloy wires meeting medical implantation standards, and framework materials can be selected according to actual conditions and actual requirements in the actual application process. Moreover, the support framework of the device is formed by adopting laser engraving and cutting and electrochemical polishing processes so as to effectively ensure the use effect of the support.

Preferably, 316 medical stainless steel can be used to make the stent framework, because 316 medical stainless steel is a common, non-allergic medical stainless steel on the market.

Preferably, the outer coating material 2 is an expanded polytetrafluoroethylene film, a polylactic acid polymer film or a nano film. Other biological membranes can also be adopted to prepare the outer coating membrane material 2, and the materials are all medical flexible implantable material membranes, so that the material of the outer coating membrane material 2 can be determined according to the actual situation and the actual requirement in the actual application process.

For example, an expanded polytetrafluoroethylene membrane can be used to make the outer covering membrane material 2, because the expanded polytetrafluoroethylene membrane is the most common medical implant membrane material, which is convenient for material selection and popularization.

To further illustrate the composite stent device provided by the present invention, the method of use thereof is illustrated below.

The skeleton length of the ball-expanding type bracket 1 of the device is 5mm, and the balloon is a transition type expansion balloon, so that the balloon can completely expand and strut the 5mm near end of the ball-expanding type bracket 1, and the outer coating material 2 of the free part at the far end of the ball-expanding type bracket 1 needs to be stretched by a self-expanding type bracket 3. Therefore, after the first ball-expanding type stent 1 is in place and the saccule is expanded and released, the ball-expanding type stent 1 at the part of 5mm at the near end is expanded and has the function of targeted positioning, and the outer coating film material 2 at the free part at the far end is correspondingly expanded. Then, after the first balloon is withdrawn, the proximal balloon-expandable stent 1 can be completely expanded and anchored, and the free part of the distal outer coating material 2 is slightly expanded. Thereafter, a second self-expanding stent 3 is implanted, the proximal end of the self-expanding stent 3 overlaps the distal end of the balloon-expandable stent 1 by at least 2mm, and the free portion of the outer cover 2 can be expanded and fixed after release of the self-expanding stent 3. Therefore, the composite stent device provided by the utility model can avoid the damage to the vascular wall of the bending section in the one-time release process of the segmental spherical expansion type stent 1, also enlarges the application range of the covered stent, simultaneously improves the flexibility of the covered stent, and can effectively improve the use effect of the covered stent on the vascular section of the bending section.

It should be noted that the directions and positional relationships indicated by "far and near", "left and right" and the like in the present application are based on the directions and positional relationships shown in the drawings, and are only for the convenience of simplifying the description and facilitating the understanding, and do not indicate or imply that the device or element referred to must have a specific direction, be configured and operated in a specific direction, and thus, should not be construed as limiting the present invention.

The embodiments in the present description are described in a progressive manner, each embodiment focuses on differences from other embodiments, and the same and similar parts among the embodiments are referred to each other. Any combination of all the embodiments provided by the present invention is within the scope of the present invention, and will not be described herein.

The composite bracket device provided by the utility model is described in detail above. The principles and embodiments of the present invention are explained herein using specific examples, which are presented only to assist in understanding the method and its core concepts. It should be noted that, for those skilled in the art, it is possible to make various improvements and modifications to the present invention without departing from the principle of the present invention, and those improvements and modifications also fall within the scope of the claims of the present invention.

Claims

1. A composite stent device, comprising: a ball expands formula support (1), be used for with the outer coating film material (2) of vascular wall laminating, from expansion formula support (3) and mobilizable be used for strutting the sacculus of ball expands formula support (1), the length that covers film material (2) is greater than the length of ball expands formula support (1), it is around locating to cover film material (2) the periphery of ball expands formula support (1), from expansion formula support (3) with prop up after the tip part of ball expands formula support (1) overlaps to prop open free part cover film material (2).

2. The composite stent device as claimed in claim 1, wherein the ball-expanding stent (1) comprises two main struts (11) and a plurality of connecting rods (12), the two main struts (11) are spirally wound, and the connecting rods (12) are wound around the main struts (11) to form a mesh-tube-shaped framework together with the main struts (11).

3. The composite bracket device as claimed in claim 2, wherein each connecting rod (12) is uniformly and symmetrically wound around the main supporting rod (11), and a plurality of uniformly arranged diamond-shaped connecting rings (13) are formed between the connecting rods (12) and the main supporting rod (11).

4. The composite type rack device according to claim 3, wherein both ends of the main support bar (11) are provided with developing blocks (4).

5. The composite stent device of claim 2, wherein the mesh tubular skeleton has a length of 4-6 mm.

6. The composite stent device as claimed in claim 5, wherein the length of the outer covering film (2) is 10mm, 13mm, 16mm or 19 mm.

7. The composite stent device as claimed in claim 2, wherein the outer coating material (2) and the main stent rod (11) are connected by a medical suture (5).

8. The composite stent device according to any one of claims 1 to 7, wherein both ends of the self-expandable stent (3) are provided with developing blocks (4).

9. The composite stent device as claimed in any one of claims 1 to 7, wherein the skeletons of the ball-expanded stent (1) and the self-expandable stent (3) are made of a nickel-titanium shape memory alloy material, a nickel-titanium alloy superelastic alloy material, a 316 medical stainless steel material or a cobalt-chromium-nickel-molybdenum-iron alloy material.

10. The composite stent device as claimed in any one of claims 1 to 7, wherein the outer coating material (2) is an expanded polytetrafluoroethylene film, a polylactic acid polymer film or a nano film.