CN217612434U

CN217612434U - Efficient composite medicine elution balloon

Info

Publication number: CN217612434U
Application number: CN202120728732.8U
Authority: CN
Inventors: 杨清; 王新萍; 刘文楠; 郭一凡; 孟新民
Original assignee: Individual
Current assignee: Individual
Priority date: 2021-04-09
Filing date: 2021-04-09
Publication date: 2022-10-21
Anticipated expiration: 2031-04-09

Abstract

The utility model relates to the technical field of medical treatment, in particular to a high-efficiency composite drug eluting balloon, which comprises a balloon body and a drug coating; the drug coating is coated on the outer surface of the balloon body; the drug coating comprises CD34 antibody, antiplatelet medicine and taxol, the utility model discloses a provide multiple medicine composite drug elution sacculus for the first time, compare in traditional single medicine elution sacculus, novel composite drug sacculus still possesses the advantages such as repair with higher speed, reduce acute thrombus risk except possessing similar suppression vascular restenosis effect simultaneously, possesses better security.

Description

Efficient composite medicine elution balloon

Technical Field

The utility model belongs to the technical field of the medical treatment technique and specifically relates to a high-efficient compound medicine elution sacculus.

Background

Cardiovascular diseases become the first killer of national health in China in recent years, and cardiovascular disease death accounts for the first cause of total death of urban and rural residents (accounts for 40% of death of resident diseases). The traditional means for treating cardiovascular diseases is to perform pharmacotherapy and surgical operation, and the pharmacotherapy is effective under the condition of mild arterial vascular stenosis and is poor in effectiveness on severe stenosis. The minimally invasive interventional diagnosis and treatment technology is an important contribution of medicine to human civilization at the end of the 20 th century, and is particularly remarkable in the aspect of treating coronary heart disease. Minimally invasive interventional techniques are known as percutaneous transluminal coronary angioplasty and stenting. The occurrence of minimally invasive interventional operations and related precise medical instruments reduces the cardiovascular mortality rate by 40 percent compared with the former, and makes great progress in medicine. The minimally invasive, painless and comfortable treatment is called as a medical concept pursued by people at present, and the adoption of minimally invasive intervention technology for treating diseases accords with the medical concept, becomes the trend of clinical medical development in the 21 st century, particularly the development of coronary stent implantation, and greatly improves the clinical prognosis of patients with coronary heart disease. Currently common stents include bare metal stents, drug coated stents and bioabsorbable stents. However, no matter the metal bare stent or the drug-coated stent, the metal framework is permanently remained in the cardiac vessel after being implanted, so that the long-term risk of the implant inevitably exists; the bio-absorbable stent is limited by the development of the current material science, the ductility and the supportability of an alloy material cannot be achieved, and the current clinical research data generally suggest that the completely bio-absorbable stent has higher risk of thrombus in the stent, so that the clinical application is greatly limited.

Drug-eluting balloons (DCB) combine conventional Balloon-forming technology with Drug-eluting technology to attach drugs that inhibit cell proliferation to the Balloon surface and to deliver drugs on the Balloon into the local vessel wall of a lesion by inflating DCB. The drug balloon can avoid many defects of the stent because the drug balloon does not need to be implanted with foreign substances. At present, a medicine coating balloon adopts a fat-soluble medicine paclitaxel coating, the medicine coating balloon is retained in a lesion area through balloon expansion, the restenosis lesion in a stent and the small vessel lesion with the diameter smaller than 2.75mm are treated, namely, DCB transmits the medicine to the local lesion area of a blood vessel, and paclitaxel is coated in the lesion area of a coronary artery through the expansion of the balloon, so that the proliferation of smooth muscle cells and the restenosis of a lumen are inhibited.

However, the process of balloon dilatation inevitably causes local vascular injury, dissection and laceration, and leads to the exposure of tissue factors, finally causes platelet activation and local thrombosis, and may cause acute coronary thrombosis to induce acute myocardial infarction and serious clinical complications.

SUMMERY OF THE UTILITY MODEL

An object of the utility model is to provide a high-efficient compound medicine elution sacculus to solve the above-mentioned technical problem who exists among the prior art.

In order to solve the technical problem, the utility model provides a high-efficiency composite drug eluting balloon which comprises a balloon body and a drug coating; the drug coating is coated on the outer surface of the balloon body; the drug coating is composed of a CD34 antibody, an antiplatelet drug and paclitaxel.

Further, the antiplatelet drug is tirofiban, abciximab or eptifibatide.

Further, the balloon body is a polymer microcapsule.

Further, an annular groove is formed in the outer wall of the balloon body; a medicine coating is arranged in the annular groove; a first expansion film is arranged on the bottom wall of the annular groove; two opposite side walls of the annular groove are provided with second expansion films; the elastic modulus of the first inflatable membrane is less than the elastic modulus of the second inflatable membrane.

Furthermore, a cross-shaped supporting column is arranged inside the balloon body.

Further, a water-soluble glue layer and an isolation layer are arranged between the balloon body and the drug coating; the water-soluble glue layer, the isolation layer and the drug coating are sequentially arranged from inside to outside.

Further, a balloon catheter is also included; the balloon catheter comprises an outer catheter and an inner catheter; the outer catheter is provided with an exchange port; the inner catheter is positioned in the outer catheter, one end of the inner catheter is communicated with the exchange port, and the other end of the inner catheter penetrates through the balloon body.

Adopt above-mentioned technical scheme, the utility model discloses following beneficial effect has:

the utility model provides a medicine elution sacculus is restoreed to high efficiency, the medicine coating of sacculus body surface is CD34 antibody, antiplatelet medicine and taxol, and wherein, CD34 molecule is the I type transmembrane glycoprotein of high glycosylation, selectively expresses in human and other mammal hemopoietic stem/progenitor cell surface. A plurality of research results show that the CD34 molecule plays an important role in mediating the cell-cell adhesion and can be involved in the transportation and the colonization of hematopoietic stem cells. The CD34 antibody pre-embedded in the conventionally developed COMBO stent can effectively capture endothelial precursor cells, accelerate endothelial repair and prevent thrombosis in the stent. Therefore, in the patent, the CD34 antibody is combined with an antiplatelet drug and used as a coating component added to a drug eluting balloon, the drug eluting balloon has the function of inhibiting the proliferation and migration of smooth muscle cells by paclitaxel, and the CD34 antibody captures endothelial progenitor cells in circulation to accelerate endothelialization of local injury parts, so that the effect of accelerating local injury repair is achieved. Antiplatelet drugs can inhibit platelet activation and reduce the risk of acute thrombotic events. Compared with the traditional paclitaxel drug eluting balloon, the novel CD34 antibody and antiplatelet drug eluting balloon has the advantages of accelerating injury repair, reducing thrombus risk and the like besides the similar effect of inhibiting vascular restenosis, and has better clinical application prospect.

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 embodiments or the prior art descriptions will be briefly described below, it is obvious that the drawings in the following descriptions are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

Fig. 1 is a schematic structural view of a high-efficiency composite drug eluting balloon provided by an embodiment of the present invention;

fig. 2 is another schematic structural diagram of the high-efficiency composite drug eluting balloon provided by the embodiment of the present invention;

fig. 3 is a schematic structural diagram of an annular groove according to an embodiment of the present invention.

Reference numerals:

1-a balloon body; 2-drug coating; 3-a support column;

4-a water-soluble glue layer; 5-an isolating layer; 6-an annular groove;

7-an inner conduit; 8-exchange port; 9-an outer catheter;

10-tube seat; 11-a second intumescent film; 12-a first expanded membrane;

13-gas column.

Detailed Description

The technical solution of the present invention will be described clearly and completely with reference to the accompanying drawings, and obviously, the described embodiments are some, but not all embodiments of the present invention. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without creative efforts all belong to the protection scope of the present invention.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplification of description, but do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, it is to be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present invention can be understood as a specific case by those skilled in the art.

The present invention will be further explained with reference to specific embodiments.

As shown in fig. 1, the high-efficiency composite drug eluting balloon provided by this embodiment includes a balloon body 1 and a drug coating layer 2; the drug coating 2 is coated on the outer surface of the balloon body 1; the drug coating 2 is composed of a CD34 antibody, an antiplatelet drug and paclitaxel.

In the efficient repairing drug eluting balloon provided by the embodiment, the drug coating 2 on the outer surface of the balloon body 1 is a CD34 antibody, an antiplatelet drug and paclitaxel, wherein a CD34 molecule is a highly glycosylated type I transmembrane glycoprotein and is selectively expressed on the surfaces of hematopoietic stem/progenitor cells of humans and other mammals. A plurality of research results show that the CD34 molecule plays an important role in mediating the cell-cell adhesion and can be involved in the transportation and the colonization of hematopoietic stem cells. CD34 antibody pre-embedded in the COMBO stent developed in the past can effectively capture endothelial precursor cells, accelerate endothelial repair and prevent thrombosis in the stent. Therefore, the CD34 antibody is combined with an antiplatelet drug to serve as a coating component added to a drug eluting balloon, the drug eluting balloon has the function of inhibiting smooth muscle cell proliferation and migration of paclitaxel, and the CD34 antibody captures endothelial progenitor cells in circulation to accelerate endothelialization of local injury parts, so that the effect of accelerating local injury repair is achieved. And the antiplatelet drugs can inhibit the activation of platelets and reduce the risk of acute thrombotic events. Compared with the traditional paclitaxel drug eluting balloon, the novel CD34 antibody and antiplatelet drug eluting balloon has the advantages of accelerating injury repair, reducing thrombus risk and the like besides the similar effect of inhibiting vascular restenosis, and has better clinical application prospect.

To sum up, the utility model discloses a provide multiple medicine composite drug elution sacculus for the first time, compare in traditional taxol single medicine elution sacculus, novel composite drug sacculus still possesses to restore with higher speed, lowers advantages such as acute thrombus risk except possessing similar inhibition vascular restenosis effect simultaneously, possesses better security.

Wherein the antiplatelet drug is tirofiban, abciximab or eptifibatide. In this embodiment, the antiplatelet agent may be tirofiban, abciximab, or eptifibatide, and preferably, the antiplatelet agent is tirofiban, which is used as an inhibitor of platelet glycoprotein iibhiia receptor, can effectively inhibit activation of platelets, and has the best effect when used as the drug coating 2 together with the CD34 antibody.

Preferably, the balloon body 1 is a polymer microcapsule. Namely, the balloon body 1 (balloon outer skin) is constructed by adopting the easily folded polymer material film, and the three medicines are wrapped by the polymer micro-capsules and are easier to reside in a local endothelial gap formed after the balloon is expanded, so that the maintenance time of the medicine effect of the injured part is longer, the treatment safety is greatly improved compared with the traditional medicine elution balloon, and the prognosis is improved.

As shown in fig. 2 and 3, further, an annular groove 6 is provided on the outer wall of the balloon body 1; the annular groove 6 is internally provided with a medicine coating 2; the bottom wall of the annular groove 6 is provided with a first expansion film 12; two opposite side walls of the annular groove 6 are provided with second expansion membranes 11; the elastic modulus of the first inflatable membrane 12 is smaller than the elastic modulus of the second inflatable membrane 11.

In this embodiment, the annular groove 6 is provided to increase the dosage of the drug coating 2 covering the exterior of the balloon body 1, after the interior of the balloon body 1 is filled with a pressure medium, the balloon body 1 is gradually inflated, the first inflation film 12 is inflated towards the outside, the first inflation film 12 extrudes the drug in the annular groove 6, so that a part of the drug is released, the pressure is continuously increased, and the second inflation film 11 is inflated and extrudes the drug coating 2, so that a large amount of the drug is released. The first expansion film 12 and the second expansion film 11 enable the medicine on the balloon body 1 to be gradually released, and the medicine utilization rate is improved.

Further, a plurality of air columns 13 are arranged between the first expansion film 12 and the drug coating 2, when the first expansion film 12 expands, the air columns 13 gradually expand and press the drug coating 2, and the power for pushing the drug to be released is improved.

As shown in fig. 1, a cross-shaped support column 3 is further arranged inside the balloon body 1. In this embodiment, cross support column 3 plays the effect of supporting sacculus body 1, improves sacculus body 1's performance.

As shown in fig. 1, further, a water-soluble glue layer 4 and an isolation layer 5 are arranged between the balloon body 1 and the drug coating layer 2; the water-soluble glue layer 4, the isolation layer 5 and the drug coating layer 2 are arranged in sequence from inside to outside.

Set up water-soluble glue film 4 at the surface of sacculus body 1, water-soluble glue film 4 can the direct coating on sacculus body 1 to water-soluble glue film 4 covers sacculus body 1 circumference, and isolation layer 5 coating is in water-soluble glue film 4. After propelling the medicine elution sacculus to disease position, sacculus body 1 expands, and water-soluble glue film 4 dissolves under the washing of blood flow for isolation layer 5 and medicine layer break away from and adhere to on the vascular wall from the surface of sacculus body 1, and isolation layer 5 can take away the medicine on medicine layer at the in-process that dissolves by less water-soluble glue film 4, improves the utilization ratio of medicine, improves treatment.

As shown in fig. 2, further, a balloon catheter is also included; the balloon catheter comprises an outer catheter 9 and an inner catheter 7; the outer catheter 9 is provided with an exchange port 8; the inner catheter 7 is positioned inside the outer catheter 9, one end of the inner catheter 7 is communicated with the exchange port 8, and the other end of the inner catheter 7 penetrates through the balloon body 1. Wherein the exchange port 8 is used for guide wire insertion. Further, a tube seat 10 is provided at one end of the outer catheter 9.

Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; although the present invention has been described in detail with reference to the foregoing embodiments, it should be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; such modifications and substitutions do not depart from the spirit and scope of the present invention.

Claims

1. An efficient composite drug eluting balloon is characterized by comprising a balloon body and a drug coating; the drug coating is coated on the outer surface of the balloon body; the drug coating is composed of a CD34 antibody, an antiplatelet drug and paclitaxel.

2. The highly effective composite drug eluting balloon according to claim 1, wherein the antiplatelet drug is tirofiban, abciximab or eptifibatide.

3. The efficient composite drug eluting balloon according to claim 1, wherein the balloon body is a polymeric microcapsule.

4. The efficient composite drug eluting balloon according to claim 1, wherein an annular groove is provided on the outer wall of the balloon body; a medicine coating is arranged in the annular groove; a first expansion film is arranged on the bottom wall of the annular groove; two opposite side walls of the annular groove are provided with second expansion membranes; the elastic modulus of the first inflatable membrane is less than the elastic modulus of the second inflatable membrane.

5. The efficient composite drug eluting balloon according to claim 1, wherein a cross-shaped supporting column is arranged inside the balloon body.

6. The efficient composite drug eluting balloon according to claim 1, wherein a water soluble glue layer and an isolation layer are further disposed between the balloon body and the drug coating layer; the water-soluble glue layer, the isolation layer and the drug coating are sequentially arranged from inside to outside.

7. The high efficiency composite drug eluting balloon of claim 1, further comprising a balloon catheter;

the balloon catheter comprises an outer catheter and an inner catheter; the outer catheter is provided with an exchange port; the inner catheter is positioned inside the outer catheter, one end of the inner catheter is communicated with the exchange port, and the other end of the inner catheter penetrates through the balloon body.