WO2022001172A1

WO2022001172A1 - Positioning device, and delivery device comprising same

Info

Publication number: WO2022001172A1
Application number: PCT/CN2021/080236
Authority: WO
Inventors: 朱清; 张军利; 奚利峰; 袁振宇; 朱永锋; 刘群超
Original assignee: 上海微创心脉医疗科技(集团)股份有限公司
Priority date: 2020-06-30
Filing date: 2021-03-11
Publication date: 2022-01-06
Also published as: CN113925651A; AR122821A1

Abstract

Disclosed are a positioning device (2) and a delivery device comprising the positioning device (2). The positioning device (2) comprises a main body (203), wherein the main body (203) is provided with an inner cavity (204) penetrating therethrough in the axial direction, and the outer surface of the main body (203) is further provided with at least one stop block (202). The arrangement of at least one stop block (202) on the periphery of the main body (203) increases the contact area between a stent (3) and an inner tube (1) so as to enable the stent (3) to be connected to the inner tube (1) as a whole by means of the positioning device (2) as much as possible, thereby effectively increasing the contact area between the stent (3) and the inner tube (1) on the premise of not increasing the outer diameter of the stent (3). The arrangement of at least one bulge (201) on the stop block (202) increases the friction between the stent (3) and the inner tube (1) so as to, especially in the case of a blood vessel path being circuitous, further improve the synchronous rotation of the proximal end of the stent (3) when the distal end of the stent (3) rotates with a handle and thus improve the follow-up rotation of the stent (3), thereby improving the positioning accuracy of the stent (3) and effectively reducing the operation time.

Description

Positioning device and conveying device including the same

technical field

The invention relates to the field of medical instruments, in particular to a positioning device used in conjunction with a delivery system and a delivery device comprising the positioning device.

Background technique

Aortic diseases such as aortic aneurysm and aortic dissection are one of the most fatal and difficult vascular surgical diseases. Endovascular repair of aortic dissection using covered metal stents is a minimally invasive and simple interventional method developed in recent years for patients with high-risk thoracic and abdominal aortic dissection. Through the minimally invasive incision of the femoral artery, the stent-graft is delivered to the lesion site of the aorta through the delivery system to protect the diseased blood vessel and repair the aortic lesion.

In the release of the minimally invasive stent system currently used for the treatment of aortic aneurysm and dissection, the stent needs to be positioned while rotating the delivery system, due to the long axial length of the delivery system, the multiple bends in the vascular path that are not straight, the stent and The smooth contact surface of the delivery system has relative sliding and other reasons, which makes the synchronization of the stent with the rotation of the delivery system poor, thus affecting the positioning performance of the stent (such as aligning the branch blood vessels). The performance of this stent rotating with the delivery system can be called a stent followability.

In the prior art, the stent system includes a stent and a delivery system. In clinical operations, the rotating delivery system is tortuous due to the long length of the entire delivery system, the smooth surface of the inner tube, and the non-straight vascular path, resulting in the delivery system or handle being rotated outside the body. , the force transmission at the distal end and the proximal end of the delivery system is not synchronized, which will affect the accuracy of stent positioning, and the operator rotates the delivery system or handle multiple times, which will affect the operation time at light, and the stent cannot be positioned to the appropriate direction and position at worst. , will directly affect the success rate of stent release.

At present, there are several ways to improve the follow-through of the stent:

If the inner tube of the stent is shortened, although the rotational transmission of force is better, it may not make the stent reach the designated part; the overall stiffness of the inner tube and the delivery system is improved, but the flexibility and introduction of the delivery system may be deteriorated; The inner tube wall thickness increases, but may increase the maximum outer diameter of the stent and delivery system of the stent system.

Each patient's physical conditions are inconsistent, such as different degrees of tortuosity of blood vessels, and it is difficult to coordinate the surgical path, which cannot be achieved from this aspect. Under the existing technical conditions, the above methods are not applicable.

SUMMARY OF THE INVENTION

In view of the above-mentioned shortcomings of the prior art, the purpose of the present invention is to provide a positioning device and a conveying device including the positioning device. Compared with the prior art, the present invention can not only improve the contact area between the bracket and the inner tube, but also locally improve the rigidity of the inner tube and improve the follow-up performance of the bracket with the inner tube, thereby improving the accuracy of the positioning of the bracket. The flexibility and introduction of the overall stent system will not be affected, and a positioning device of reasonable size will not increase the diameter of the stent after restraint, nor will it increase the overall outer diameter of the stent system.

For achieving the above object, technical scheme of the present invention is as follows:

The positioning device includes a main body, the main body is provided with an inner cavity passing through in the axial direction, and at least one stopper is further arranged on the outer surface of the main body.

Optionally, the stopper extends along the axial direction of the main body.

Optionally, the outer periphery of the main body is provided with a plurality of stoppers, and the plurality of stoppers are distributed at intervals along the circumference of the main body.

Optionally, the outer surface of the main body is convex in a direction away from the inner cavity to form the stopper.

Optionally, a plurality of protrusions are provided on the stopper.

Optionally, the stopper has a first side surface and a second side surface that extend along the axial direction of the main body and are oppositely arranged, and the plurality of protrusions are arranged on the first side surface and/or the second side surface superior.

Optionally, at least one reserved hole is defined at the end of the block, and the reserved hole penetrates through the block axially.

Optionally, a chamfer is provided at the connection between the block and the inner cavity.

Correspondingly, the present invention also provides a delivery device, comprising an inner tube and at least one positioning device as described above, the positioning device is disposed at the distal end of the inner tube and connected to the inner tube, and the positioning device is used for carrying Medical Implants.

Optionally, the positioning device and the inner tube are of an integral structure.

Compared with the prior art, the beneficial technical effects of the present invention are as follows:

(1) By setting at least one stopper on the outer periphery of the main body, it increases the contact area between the bracket and the inner tube, so that the connection between the bracket and the inner tube through the positioning device is as integrated as possible, and on the premise of not increasing the outer diameter of the bracket, The contact area between the stent and the inner tube is effectively increased.

(2) By increasing the contact area between the stent and the inner tube, the stiffness of the inner tube is locally improved and the follow-up of the stent with the inner tube is improved, and the accuracy of the positioning of the stent is improved, but the flexibility and introduction of the overall stent system will not be affected. sex.

(3) By setting at least one protrusion on the stopper, the protrusion improves the friction between the stent and the inner tube, especially in the circumstance that the blood vessel path is circuitous, further improves the rotation of the proximal stent when the distal end of the stent rotates with the handle The synchronization is improved, that is, the follow-up rotation of the stent is improved, thereby improving the accuracy of the positioning of the stent and effectively reducing the operation time.

Description of drawings

FIG. 1 shows a schematic diagram of the connection between a positioning device, a delivery device and a stent according to an embodiment of the present invention.

FIG. 2 shows a schematic structural diagram of a positioning device in an embodiment of the present invention.

FIG. 3 shows a schematic cross-sectional structure diagram of a positioning device in an embodiment of the present invention.

Figure 4 shows a schematic diagram of the contact area between the inner tube and the stent without the positioning device.

FIG. 5 shows a schematic diagram of the contact area between the positioning device and the bracket in the embodiment of the present invention.

FIG. 6 shows a schematic diagram of the use of the stent system in the embodiment of the present invention.

FIG. 7 shows a partial enlarged view at A of FIG. 6 .

Symbols in the drawings: 1, inner tube; 2, positioning device; 201, protrusion; 202, block; 203, main body; 204, inner cavity; 205, reserved hole; 206, chamfer; 3, bracket; 4 , stent binding wire; 5, outer tube; 6, guide wire.

detailed description

In order to make the objectives, technical solutions and advantages of the present invention clearer, the following describes the positioning device and the conveying device including the positioning device proposed by the present invention in detail with reference to the accompanying drawings and specific embodiments. The advantages and features of the present invention will become more apparent from the following description. It should be noted that the accompanying drawings are in a very simplified form and all use inaccurate scales, and are only used to facilitate and clearly assist the purpose of explaining the embodiments of the present invention. For the purpose, features and advantages of the present invention to be more clearly understood, please refer to the accompanying drawings. It should be noted that the structures, proportions, sizes, etc. shown in the drawings in this specification are only used to cooperate with the contents disclosed in the specification, so as to be understood and read by those who are familiar with the technology, and are not used to limit the implementation of the present invention. Therefore, it does not have technical substantive significance, and any modification of structure, change of proportional relationship or adjustment of size should still fall within the scope of the present invention without affecting the effect that the present invention can produce and the purpose that can be achieved. The scope of the disclosed technical content can be covered.

As shown in FIG. 2 and FIG. 3 , the positioning device 2 includes a main body 203, and the main body 203 is provided with an inner cavity 204 that passes through in the axial direction. Preferably, the inner cavity 204 in the positioning device 2 provided in this embodiment is a cylindrical inner cavity The cylindrical inner cavity is formed along the axial direction of the main body 203 and is used for connecting with the inner tube 1; The stopper 202 extends along the axial direction of the main body 203, and the outer surface of the main body 203 protrudes in a direction away from the inner cavity 204 to form the stopper 202. Each of the stoppers 202 in the positioning device 2 provided in this embodiment is The number is three, and the three stoppers 202 are distributed at intervals along the circumferential direction of the main body 203 . The number of the stoppers 202 can be increased or decreased according to the length of the bracket 3 and actual requirements.

As shown in FIG. 2 and FIG. 3 , at least one protrusion 201 is provided on the stopper 202 , and the stopper 202 has a first side surface and a second side surface which extend along the axial direction of the main body 203 and are oppositely arranged. At least one protrusion 201 is disposed at least on the first side or the second side of the block 202 , and the protrusion 201 can increase the contact surface area between the inner tube 1 and the bracket 3 . Preferably, in the positioning device 2 provided in this embodiment, the protrusions 201 are provided on the first side surface and the second side surface of the block 202 . The thickness of each protrusion 201 in the positioning device 2 provided in this embodiment is the same. Preferably, the protrusion 201 in the positioning device 2 provided in this embodiment is in the shape of a hemisphere, but it is not limited to a hemisphere shape. It can be plum-shaped, snowflake-shaped, leaf-shaped, flower-shaped, wave-shaped, horizontal bar, vertical bar, polygonal protrusion, which can be any shape that can increase the contact surface area between the inner tube 1 and the bracket 3 and improve the strength of the positioning device.

As shown in FIG. 2 and FIG. 3 , preferably, at least one reserved hole 205 is defined at the end of the block 202 , and the reserved hole 205 penetrates through the block 202 in the axial direction. There is one reserved hole 205 in the positioning device 2 provided in this embodiment, and the reserved hole 205 is used to pass the guide wire 6 as required. A chamfer 206 is provided at the connection between the block 202 and the lumen 204 , and the chamfer 206 is used to prevent the blood vessel from being damaged when the stent system enters the blood vessel and avoid stress concentration.

The positioning device 2 composed of the main body 203, the inner cavity 204 and at least one stopper 202 is selected from any one of polymer materials or metal materials. Preferably, the positioning device 2 provided in this embodiment is selected from high-density polymer materials. Either ethylene (HDPE) or low density polyethylene (LDPE).

The polymer materials include but are not limited to nylon elastomer (PEBAX), polytetrafluoroethylene (PTFE), fluorinated ethylene propylene copolymer (FEP), high density polyethylene (HDPE), low density polyethylene (LDPE), Ethylene-tetrafluoroethylene copolymer (ETFE), perfluoroalkoxy polymer (PFA), nylon (NYLON), polycarbonate (PC), polyethylene (PE), polyurethane (PUR), polypropylene (PP) , any one of polyether ether ketone resin (PEEK). The metal material includes, but is not limited to, any one of stainless steel, aluminum alloy, copper alloy or titanium alloy and other alloy materials with excellent performance that are suitable for machining and injection molding.

A delivery device, comprising an inner tube 1 and at least one described positioning device 2, the positioning device 2 is arranged at the distal end of the inner tube 1 and connected with the inner tube 1, and the positioning device 2 is used for Carrying medical implants.

As shown in FIG. 1, a stent system, the stent system includes a stent 3 and the delivery device, the stent 3 is fixed on the inner tube 1 by a stent binding wire 4, and a positioning device 2 is at least one and is connected with the said delivery device. The inner tube 1 is connected. Preferably, the number of positioning devices 2 in the conveying device provided in this embodiment is two, but the number of the positioning devices 2 is not limited to the two in this embodiment. The number of the positioning devices 2 Increase or decrease according to the length of the bracket 3 and actual needs.

Specifically, the positioning device 2 is connected to the inner tube 1 through the inner cavity 204. Preferably, in the stent system provided in this embodiment, the positioning device 2 and the inner tube 1 are connected by glue, specifically using Loctite glue , the model is Loctite1128. The bracket 3 is bound to the outer ring of the inner tube 1 by bracket binding wires 4 .

The delivery device further includes an outer tube 5 and a handle, the handle is connected to the distal end of the inner tube 1 , the bracket 3 is fixed between the inner tube 1 and the outer tube 5 , and the inner tube 1 is arranged in the outer tube 5 . , the outer tube 5 and the handle are well known to those skilled in the art, and will not be described in detail again.

By rotating the handle, the inner tube 1 can be rotated correspondingly with the rotation of the handle. The proximal end of the inner tube 1 is connected with the stent 3 . The distal end is an end close to the handle (ie, the right end in FIG. 1 ), and the proximal end is an end away from the handle (ie, the left end in FIG. 1 ).

Preferably, the positioning device 2 and the inner tube 1 have an integral structure, for example, the inner tube 1 with the positioning device 2 is extruded from a polymer material through a die, or the positioning device can also be made by 3D printing. 2. The one-piece structure with the inner tube 1 is sufficient as long as the contact surface area between the inner tube 1 and the stent 3 can be increased.

Preferably, the connection method between the positioning device 2 and the inner tube 1 includes but is not limited to any one of mechanical connection, hot melt connection, glue connection, welding or integral injection molding. Wherein, the mechanical connection between the positioning device 2 and the inner tube 1 includes but is not limited to mechanical screw connection.

The glue used for the glue connection between the positioning device 2 and the inner tube 1 includes but is not limited to Loctite glue (for example, Loctite 3011, 3321, 3493, 3494, 3321, 3751, 1128, etc.), Dymax glue (Dymax 203a-cth) -f, 204-cth-f, 1201-m-sc, 1128a-m, etc.), Newell glue (NuSil MED-2000P) or Dow Corning SILASTIC MEDICAL ADHESIVE SILICONE, TYPE A) any of the .

In the above positioning device 2, after the bracket 3 is fixed on the inner tube 1 by the bracket binding wire 4, the positioning device 2 increases the contact area between the bracket 3 and the inner tube 1, so that the bracket 3 is connected as much as possible through the positioning device 2 and the inner tube 1. become one, thereby increasing the contact area between the bracket 3 and the inner tube 1, increasing the friction between the bracket 3 and the inner tube 1, and improving the synchronization of the proximal end of the bracket 3 when the distal end of the bracket 3 rotates with the handle, In this way, the followability of the bracket 3 can be improved, and the positioning accuracy of the bracket 3 can be improved. Although the stent 3 is bound, it is not without pores, and the positioning device 2 with a reasonable size will not increase the diameter of the stent 3 after binding, that is, the overall outer diameter will not increase.

The installation position of the positioning device 2 on the inner tube 1 is the same as or different from the binding position of the bracket binding wire 4 on the bracket 3 . The installation position of the positioning device 2 in the bracket system provided in this embodiment is the same as the binding position of the bracket binding wire 4 .

The stent 3 in the positioning device 2 is a covered stent, and the covered stent includes any one of an integrated stent, a stent with branches or a bifurcated stent.

The use process of the above bracket system is as follows:

First, the main body 203 of the positioning device 2 is glued to the inner tube 1 through the inner cavity 204 .

Then, the bracket 3 is bound to the outer periphery of the proximal end of the inner tube 1 installed with the positioning device 2 using bracket binding wires 4, and the distal end of the inner tube 1 is connected to the handle. As shown in FIG. 6 , the proximal end of the delivery device is introduced into the aortic vessel along the guide wire 6 . As shown in Figures 1 and 7, the outer tube 5 is withdrawn, and the handle is rotated. Since the handle is connected to the distal end of the inner tube 1, and the proximal end of the inner tube 1 is connected to the bracket 3, the bracket 3 rotates with the inner tube 1. Adjust the stent 3 to an appropriate position (for example, the main chest stent is aligned with the branch vessel or the main abdominal stent is aligned with the leg side). Finally, the stent 3 is released, the stent 3 and the stent binding wire 4 remain in the body, and the remaining components except the stent 3 and the stent binding wire 4 are withdrawn from the body.

The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity, all possible combinations of the technical features in the above-described embodiments are not described. However, as long as there is no contradiction between the combinations of these technical features, All should be regarded as the scope described in this specification.

The above-mentioned embodiments only represent several embodiments of the present invention, and the descriptions thereof are specific and detailed, but should not be construed as a limitation on the scope of the invention patent. It should be pointed out that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can also be made, which all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention should be subject to the appended claims.

Claims

The positioning device is characterized in that it comprises a main body (203), the main body (203) is provided with an inner cavity (204) passing through in the axial direction, and at least one stopper is further arranged on the outer surface of the main body (203). (202).
The positioning device according to claim 1, wherein the stopper (202) extends along the axial direction of the main body (203).
The positioning device according to claim 1, characterized in that a plurality of stoppers (202) are provided on the outer periphery of the main body (203), and a plurality of the stoppers (202) are arranged along the circumference of the main body (203). distributed to the interval.
The positioning device according to claim 1, wherein the outer surface of the main body (203) is convex in a direction away from the inner cavity (204) to form the stopper (202).
The positioning device according to any one of claims 1 to 4, wherein a plurality of protrusions (201) are provided on the stopper (202).
The positioning device according to claim 5, characterized in that the stopper (202) has a first side surface and a second side surface that extend along the axial direction of the main body (203) and are oppositely arranged, and the plurality of convex A lift (201) is provided on the first side surface and/or the second side surface.
The positioning device according to any one of claims 1 to 4, characterized in that, at least one reserved hole (205) is defined at the end of the block (202), and the reserved hole (205) extends along the block (205). 202) Axial penetration.
The positioning device according to any one of claims 1 to 4, characterized in that, a chamfer (206) is provided at the connection between the block (202) and the inner cavity (204).
A conveying device, characterized in that it comprises an inner tube (1) and at least one positioning device according to any one of claims 1 to 8, wherein the positioning device (2) is arranged on the inner tube (1) The distal end is connected with the inner tube (1), and the positioning device is used to carry the medical implant.
The conveying device according to claim 9, characterized in that: the positioning device (2) and the inner tube (1) are of an integral structure.