CN213789516U

CN213789516U - Guide wire cutting medicine balloon

Info

Publication number: CN213789516U
Application number: CN202021382081.3U
Authority: CN
Inventors: 唐强; 姜浩; 史震涛
Original assignee: Individual
Current assignee: Individual
Priority date: 2020-07-14
Filing date: 2020-07-14
Publication date: 2021-07-27
Anticipated expiration: 2030-07-14

Abstract

The utility model discloses seal wire cutting medicine sacculus relates to a medicine sacculus. The utility model aims at providing a tear that can make the plaque lengthens, avoids the appearance of the intermediate layer more than the C type after the medicine sacculus release to the condition that the blood flow appears before the influence reduces, makes medicine better permeate to guide wire cutting medicine sacculus in the lesion area. The utility model discloses seal wire cutting medicine sacculus is including the pipe seat, push rod and the sacculus body that connect gradually, and the both ends of sacculus body are provided with the sacculus pole, and the push rod passes from the sacculus body through the sacculus pole of both sides, and the outside of sacculus body is provided with the medicine coating, and the medicine coating outside is provided with three cutting seal wires, and the direction that the cutting seal wire was laid is the same with the length direction of sacculus body, at sacculus body surface interval 120 settings in proper order.

Description

Guide wire cutting medicine balloon

Technical Field

The utility model relates to a medicine sacculus especially relates to a seal wire cutting medicine sacculus.

Background

Cardiovascular stenosis is one of the major causes of coronary heart disease. Coronary heart disease Intervention (PCI) is an important tool for treating cardiovascular stenosis. The problem of in-stent restenosis (ISR) is becoming more severe as the number of stents used increases. Restenosis not only results in recurrence of angina symptoms, requiring revascularization again to relieve the symptoms, but also may cause acute coronary syndrome in some patients.

In recent years, a new technology, namely a drug balloon, for preventing restenosis in a stent after coronary heart disease interventional therapy has emerged. The medicine balloon is a technology that the medicine for resisting the vascular intimal hyperplasia is coated on the surface of the balloon, and is propped open after reaching the wall of a diseased blood vessel, is in close contact with the intimal of the blood vessel wall, and is pressurized to quickly release and transfer the medicine to a local blood vessel wall. The drug balloon is structurally different from the drug eluting stent, so that side reactions caused by the metal structure and the polymer of the stent are avoided to a certain extent. Drug eluting balloons have significant advantages such as no thrombosis, a lower risk of restenosis, and a relative reduction in thrombosis following drug balloon therapy, stent implantation. The patient after the balloon operation can take the antiplatelet drug for 1-3 months, and the stent needs to be taken for 1 year, so the stent has great advantages for patients with high risk of bleeding or patients who can not tolerate the drug for a long time. However, the following problems have been found with respect to drug balloon applications to date: (1) the C-type or more interlayer is not formed after the sufficient lesion pretreatment, but the C-type or more interlayer is found after the drug balloon with the proper type is expanded within 120 seconds, and the C-type or more interlayer is generated in consideration of further tearing of plaque in the contact process of the drug balloon and the blood vessel, wherein the tearing process is related to nonlinear and irregular tearing; (2) in some special diseases, such as eccentric plaque load-bearing diseases, tortuosity angulation diseases, in-stent restenosis fiber hyperplasia diseases and the like, after the drug balloon is applied, the situations that the balloon slides, the balloon cannot be well attached to the diseases, the drug permeation of the vascular intima is insufficient and the like can occur, so that the recent and long-term effects of the drug are influenced.

Therefore, the above-mentioned conventional drug balloon has still inconvenience and disadvantages in structure and use, and further improvement is needed.

SUMMERY OF THE UTILITY MODEL

An object of the utility model is to overcome the shortcoming that exists among the current medicine sacculus, provide a seal wire cutting medicine sacculus, make it can make tearing of plaque vertically change, avoid the interbedded appearance more than the C type behind the medicine sacculus release to reduce the influence and appear to the condition of blood flow before, make the medicine permeate the pathological change region better in.

The utility model discloses seal wire cutting medicine sacculus, including pipe seat, push rod and the sacculus body that connects gradually, the both ends of sacculus body are provided with the sacculus pole, and the push rod passes from the sacculus body through the sacculus pole of both sides, and the outside of sacculus body is provided with the medicine coating, and the medicine coating outside is provided with three cutting seal wires, and the direction that the cutting seal wire was laid is the same with the length direction of sacculus body, at sacculus body surface interval 120 settings in proper order.

The utility model discloses seal wire cutting medicine sacculus, wherein the junction of push rod and sacculus pole is provided with hydrophilic coating.

The utility model discloses seal wire cutting medicine sacculus, wherein the sacculus body adopts half compliance sacculus.

The utility model discloses seal wire cutting medicine sacculus, wherein the medicine on the medicine coating is paclitaxel.

The utility model discloses seal wire cutting medicine sacculus, wherein three the cross-section of cutting seal wire and the vertical contained angle of direction that makes progress are 0 °, 120 and 240 respectively.

The utility model discloses seal wire cutting medicine sacculus, wherein the both ends of cutting seal wire are attached to respectively on the sacculus pole of both sides.

The utility model discloses seal wire cutting medicine sacculus wherein is located and is provided with two development mark rings on the inside push rod of sacculus body, and two development mark rings respectively are close to the sacculus pole of one side.

The utility model discloses seal wire cutting medicine sacculus, wherein the material of pipe seat is one of polyurethane, tetrafluoroethylene, polyethylene, polypropylene, polyethylene terephthalate or nylon.

The utility model discloses seal wire cutting medicine sacculus, wherein the material of push rod is stainless steel material.

The utility model discloses seal wire cutting medicine sacculus, wherein the cutting seal wire diameter is 0.229-0.356mm, and one of stainless steel, nickel titanium alloy or platinum nickel alloy is chooseed for use to the material.

The utility model discloses seal wire cutting medicine sacculus is different from the prior art in that, the utility model discloses seal wire cutting medicine sacculus is provided with three cutting seal wires in the equidistant outside of sacculus body, cuts during the seal wire "inlays" to the pathological change plaque when using, can make the tearing of pathological change plaque vertically, avoids the medicine sacculus release back C type above intermediate layer the appearance to reduce the condition appearance of blood flow before the influence; after full pretreatment, lesion can be further cut when the medicine balloon is applied, and medicine can better permeate to the vascular intima along the cutting direction of the guide wire;

the three cutting guide wires for cutting the medicine saccule by the guide wires can ensure that the medicine coating on the outer side of the saccule body is more fully contacted with the tube wall, and the fixing effect is good, so that the medicine saccule is particularly suitable for some lesions with tortuosity angulation and lesions such as eccentric plaques, and the situation that the medicine does not enter the lesion plaques is avoided;

the utility model discloses cutting fibrous hyperplasia plaque that seal wire cutting medicine sacculus can be better plays fixed effect to make better infiltration of medicine get into pathological change, consequently have more the advantage in the pathological change to restenosis in the support.

The guide wire cutting drug balloon of the present invention will be further explained with reference to the accompanying drawings.

Drawings

Fig. 1 is a schematic structural view of the guide wire cutting drug balloon of the present invention;

fig. 2 is a schematic structural view of a balloon body in the guide wire cutting medicine balloon of the present invention;

FIG. 3 is a schematic view of the structure in the direction A of FIG. 2;

the notation in the figures means: 1-a balloon body; 2-a hydrophilic coating; 3-a push rod; 4-a catheter hub; 5-balloon rod; 6-drug coating; 7-developing the marker ring; 8-cutting the guide wire.

Detailed Description

The following examples are intended to illustrate the invention, but are not intended to limit the scope of the invention.

As shown in figure 1, the utility model discloses seal wire cutting medicine sacculus is including pipe seat 4, push rod 3 and the sacculus body 1 that connects gradually.

The catheter seat 4 can be externally connected with an injection needle, and required reagents can be introduced into the push rod 3 and the balloon when the catheter is used. The catheter hub 4 is made of polyurethane. In other embodiments, the material of catheter hub 4 may also be selected from polytetrafluoroethylene, polyethylene, polypropylene, polyethylene terephthalate, or nylon.

The push rod 3 is divided into two parts, one side close to the balloon body 1 is a near end, and the other side close to the catheter seat 4 is a far end. The push rod 3 is made of metal, preferably stainless steel.

As shown in fig. 2, balloon rods 5 are arranged at two ends of the balloon body 1, the push rod 3 penetrates through the balloon body 1 through the balloon rods 5 at two sides, and a hydrophilic coating 2 is arranged at the joint of the push rod 3 and the balloon rods 5. The balloon body 1 adopts a semi-compliance balloon, and the material is common material in general clinic. The outer side of the balloon body 1 is provided with a drug coating 6, and the drug of the coating is paclitaxel. Three cutting guide wires 8 are arranged outside the medicine coating 6.

The direction that cutting seal wire 8 laid is the same with the length direction of sacculus body 1, sets up at sacculus body 1 surface interval 120 in proper order, and in this embodiment, as shown in fig. 3, the contained angle of the cross-section of three cutting seal wires 8 and vertical upward direction is 0 respectively, 120 and 240. Two ends of the cutting guide wire 8 are respectively attached to the balloon rods 5 at two sides. When sacculus body 1 expands, but the plaque tissue of regular incision of three cutting seal wires 8, it is little to the intimal damage, can guarantee simultaneously that the sacculus does not shift, can reduce economic cost again, and the external diameter that does not increase the sacculus is favorable to passing through. The diameter of the cutting guide wire 8 is 0.229mm, and the material is selected from metal wires. In other embodiments, the cutting wire 8 may also be made of one of stainless steel, nitinol wire or platinum-nickel alloy, and the diameter may be selected from other values of 0.229-0.356 mm.

The push rod 3 positioned in the balloon body 1 is provided with two developing mark rings 7, and the two developing mark rings 7 are respectively close to the balloon rod 5 on one side.

The utility model discloses seal wire cutting medicine sacculus's application method:

1. preoperative preparation comprising:

1) after the guide wire cutting medicine saccule of the utility model is taken out from the packaging container in an aseptic mode, protective members such as a protective hose and the like are disassembled, and whether damage exists or not is confirmed;

2) carefully look over seal wire cutting medicine sacculus head end, observe the sacculus surface and adhere to the seal wire position condition, have or not skew and seal wire head end and spill etc. the in-process avoids touching the sacculus surface with the hand as far as possible.

2. The utility model discloses seal wire cutting medicine sacculus insert and expansion, include:

1) a guide wire is inserted into the guide catheter through the puncture, and the guide wire is confirmed to pass through the target stenosis and reach the far end of the blood vessel, so that the guide catheter with the guide wire cutting medicine balloon is used for guiding more than 6 Fr;

2) the utility model is carefully inserted along the guide wire to cut the medicine saccule, and the medicine saccule is pushed forward under the X-ray perspective state, and then the saccule body is kept in a complete contraction state and pushed to the position of passing through the target part (the lesion part of the medicine saccule needing to be released);

3) the position of the medicine saccule cut by the guide wire of the utility model is accurately determined under the perspective, and the hemostatic valve is screwed down to prevent the blood from leaking;

4) the utility model cuts the medicine saccule to the target position by the guide wire, slowly expands the saccule by using rated pressure, leads the surface of the saccule to be close to the blood vessel wall as much as possible, and leads the cutting guide wire on the surface of the saccule to be embedded into the plaque load, thereby being beneficial to the medicine to permeate into the blood vessel wall;

5) and after 30-60 seconds of expansion, retracting the balloon body to enable the balloon body to be completely contracted, and loosening the hemostatic valve.

3. The utility model discloses extraction and change of seal wire cutting medicine sacculus, include:

1) loosening the hemostatic valve;

2) the guide wire and hemostatic valve are grasped with one hand and not allowed to move over the position within the coronary artery. Then the catheter seat of the guide wire cutting medicine balloon of the utility model is held by the other hand, and the guide wire cutting medicine balloon of the utility model is withdrawn from the guide catheter;

3) slowly withdraw from the utility model discloses seal wire cutting medicine sacculus, it is up the utility model discloses seal wire cutting medicine sacculus exposes from guide wire entry position. Then, the guide wire cutting medicine sacculus of the utility model is carefully dismounted from the guide wire while keeping the position of the guide wire passing through the lesion part;

4) closing the hemostatic valve;

5) a new guidewire cutting drug balloon is prepared and inserted as needed.

The utility model discloses the equidistant three cutting seal wires that are provided with of seal wire cutting medicine sacculus outside sacculus body, cutting seal wire "inlays" to the pathological change plaque when using, can make the tearing of pathological change plaque vertically, avoids medicine sacculus release back sandwich more than C type to appear, thereby reduces the condition appearance that influences the blood flow before; after full pretreatment, lesion can be further cut when the medicine balloon is applied, and medicine can better permeate to the vascular intima along the cutting direction of the guide wire;

Although the invention has been described in detail with respect to the general description and the specific embodiments, it will be apparent to those skilled in the art that modifications and improvements can be made based on the invention. Therefore, such modifications and improvements are intended to be within the scope of the invention as claimed.

Claims

1. A guide wire cutting medicine balloon is characterized in that: including the pipe seat, push rod and the sacculus body that connect gradually, the both ends of sacculus body are provided with the sacculus pole, and the push rod passes in the sacculus body through the sacculus pole of both sides, and the outside of sacculus body is provided with the medicine coating, and the medicine coating outside is provided with three cutting seal wires, and the direction that the cutting seal wire was laid is the same with the length direction of sacculus body, sets up at sacculus body surface interval 120 in proper order.

2. The guidewire cutting drug balloon of claim 1, wherein: and a hydrophilic coating is arranged at the joint of the push rod and the balloon rod.

3. The guidewire cutting drug balloon of claim 1, wherein: the balloon body is a semi-compliant balloon.

4. The guidewire cutting drug balloon of claim 1, wherein: the drug on the drug coating is paclitaxel.

5. The guidewire cutting drug balloon of claim 1, wherein: the included angles between the cross sections of the three cutting guide wires and the vertical upward direction are respectively 0 degree, 120 degrees and 240 degrees.

6. The guidewire cutting drug balloon of claim 1, wherein: two ends of the cutting guide wire are respectively attached to the balloon rods at two sides.

7. The guidewire cutting drug balloon of claim 1, wherein: be provided with two development mark rings on the push rod that is located sacculus body inside, two development mark rings respectively are close to the sacculus pole of one side.

8. The guidewire cutting drug balloon of claim 1, wherein: the catheter seat is made of one of polyurethane, tetrafluoroethylene, polyethylene, polypropylene, polyethylene terephthalate or nylon.

9. The guidewire cutting drug balloon of claim 1, wherein: the material of push rod is stainless steel material.

10. The guidewire cutting drug balloon of claim 1, wherein: the diameter of the cutting guide wire is 0.229-0.356mm, and the material is one of stainless steel, nickel-titanium alloy or platinum-nickel alloy.