CN214485274U

CN214485274U - Balloon dilation catheter and drug delivery device

Info

Publication number: CN214485274U
Application number: CN202022811341.0U
Authority: CN
Inventors: 曹春红; 胡燕; 李俊菲; 李猛
Original assignee: Shanghai Microport Medical Group Co Ltd
Current assignee: Shanghai Microport Medical Group Co Ltd
Priority date: 2020-11-27
Filing date: 2020-11-27
Publication date: 2021-10-26
Anticipated expiration: 2030-11-27

Abstract

The utility model relates to a balloon dilatation catheter and a drug delivery device, which comprises a catheter body and a balloon fixed on the catheter body, wherein a linear body is arranged outside the balloon, the linear body extends from the near end to the far end of the balloon along the outer surface of the balloon, and the two ends of the linear body are connected with the catheter body; wherein the surface of the linear body and/or the balloon carries the drug. The pressure to the vascular wall has been increased through the linear body for medicine on the linear body and/or the sacculus can be better permeate the blood vessel, improves the transfer rate of medicine, and the linear body can also further support the vascular wall, has strengthened vascular expansion effect.

Description

Balloon dilation catheter and drug delivery device

Technical Field

The utility model relates to the technical field of medical equipment, in particular to sacculus expansion pipe and drug delivery device.

Background

Since the 20 th 70 s to date, coronary intervention techniques have benefited greatly from the initial percutaneous balloon angioplasty (POBA) to the placement of Bare Metal Stents (BMS) and Drug Eluting Stents (DES), and new problems have also arisen. Although DES significantly reduces the incidence of in-stent restenosis, restenosis is still not completely avoided, resulting in not only recurrence of the angina symptoms, but also acute coronary syndrome in some patients, and even more difficult treatment once DES restenosis occurs. In addition, delayed vascular endothelial healing, late stent malapposition, intrastent thrombosis, new onset atherosclerosis, etc. caused by DES are new problems affecting clinical prognosis.

In recent years, a Drug-Coated Balloon (DCB) is pushed out, so that not only is the serious coronary lesion treated and the coronary blood supply and the blood vessel function improved, but also a permanent implant is not left in the blood vessel, a series of problems caused by the implantation of a stent are avoided, and the possibility of receiving retreatment of the lesion blood vessel is provided. Has the remarkable unique advantages that:

(1) direct contact with the vessel wall, allowing for uniform release of the drug to the vessel wall injury area, not just the stent coverage area;

(2) when the vascular wall is injured, and at the moment, the neointimal process is the most active period, the drug concentration of the vascular wall is the highest, and the intimal hyperplasia can be effectively inhibited; the later stage of the vessel wall is greatly reduced, which is beneficial to the endothelialization process and reduces the risk of thrombosis;

(3) the drug release is independent of the polymer matrix, so that the generation of inflammatory reaction is reduced;

(4) the operation process is simplified, the ray exposure time and the dosage of the contrast agent are shortened, and the safety of interventional therapy is improved;

(5) in small vessel lesions, tortuosity lesions and bifurcation lesions, the DCB has high passing rate and no metal framework, the original anatomical form of the vessel is kept to the maximum extent after treatment, and the influence on the blood flow mode is reduced; the problem that the double-layer stent reduces the lumen of the blood vessel when treating the stenosis in the stent is avoided;

(6) the foreign body is avoided being placed, and the necessary subsequent treatment opportunity is reserved for the patient;

(7) can shorten the administration time of the dual antiplatelet drugs, thereby reducing the occurrence of bleeding complications and the medical cost, and is particularly suitable for patients who are intolerant to platelet therapy and who receive surgical treatment recently.

However, the current drug-coated balloon has the problems of low drug release and low drug utilization rate.

SUMMERY OF THE UTILITY MODEL

In order to solve the technical problem, an object of the present invention is to provide a balloon dilatation catheter and drug delivery device, which can safely and effectively extrude the blood vessel wall by using the linear body outside the balloon, on the one hand, the blood vessel wall can be further supported, on the other hand, the drug can better permeate into the blood vessel wall, thereby improving the release and utilization rate of the drug.

In order to achieve the purpose, the utility model provides a balloon dilatation catheter, which comprises a catheter body and a balloon fixed on the catheter body; a linear body is arranged on the outer side of the balloon, the linear body extends from the near end to the far end of the balloon along the outer surface of the balloon, two ends of the linear body are connected with the catheter body, and at least one end of the linear body is movably connected with the catheter body; wherein the surface of the linear body and/or the balloon carries a drug.

Optionally, one end of the linear body is movably connected with the tube section of the catheter body located on the proximal end side of the balloon, and the other end of the linear body is fixedly connected with the tube section of the catheter body located on the distal end side of the balloon.

Optionally, the catheter body includes a connecting sleeve, the connecting sleeve is disposed on one side of the proximal end of the balloon, the connecting sleeve has an installation cavity, the one end of the linear body is disposed in the installation cavity, and the one end of the linear body is movably or fixedly connected with the installation cavity;

when the one end of the linear body is fixedly connected with the installation cavity, the connecting sleeve is used for moving relative to the balloon;

when the one end of the linear body is movably connected with the installation cavity, the connecting sleeve is used for moving or being static relative to the balloon.

Optionally, the catheter body further comprises an outer tube and an inner tube, the inner tube being inserted into the outer tube; the near end of the balloon is connected with the outer tube, and the far end of the balloon is connected with the inner tube;

the other end of the linear body is fixedly connected with a pipe section of the inner pipe extending out of the far end of the balloon; the connecting sleeve is sleeved on the outer tube, and the end of the linear body is inserted into the connecting sleeve from the connecting sleeve towards one end of the balloon and then is movably or fixedly connected with the mounting cavity.

Optionally, the cross section of the linear body is circular, and the diameter of the linear body is 0.1 mm-0.35 mm.

Optionally, the outer surface of the linear body is smooth, or the outer surface of the side of the linear body facing away from the balloon is formed with protrusions distributed continuously or at intervals.

Optionally, the shape of the protrusion is a sawtooth shape.

Optionally, the number of the linear bodies is one or more, and the plurality of linear bodies are uniformly or non-uniformly arranged around the longitudinal axis of the balloon.

In order to achieve the above object, the present invention further provides a drug delivery device, comprising a catheter body and a balloon fixed on the catheter body; a linear body is arranged on the outer side of the balloon, the linear body extends from the near end to the far end of the balloon along the outer surface of the balloon, and the two ends of the linear body are connected with the catheter body; wherein the surface of the linear body and/or the balloon carries a drug.

Optionally, the height of the cross section of the linear body is 0.1 mm-0.35 mm.

Above-mentioned sacculus expansion pipe and drug delivery device can be applicable to the intervention treatment of peripheral blood vessel or coronary artery, is particularly useful for the intervention treatment of coronary artery, and it further carries out safe and effectual support to the vascular wall of pathological change through the linear body in the sacculus outside, and the expansion effect of blood vessel is better, but also can avoid the damage such as intimal tear, intermediate layer, acute occlusion that the sacculus expansion caused, and the security of apparatus is better.

Above-mentioned sacculus expansion pipe and drug delivery device carry out the medicine carrying through the linear body in the sacculus outside, and the linear body is along with the extrusion vascular wall that the expansion of sacculus can be better, makes better infiltration of medicine to the vascular wall in, has improved the release and the utilization ratio of medicine to suppression inner membrance hyperplasia that can be better reduces the restenosis in the blood vessel, improves medical treatment.

The balloon dilatation catheter and the drug delivery device carry out drug loading and supporting through the linear body, particularly the linear body with the cross section height (such as the diameter) of 0.1 mm-0.35 mm, so that the part contacted by the linear body only generates slight and safe damage to the intima of the blood vessel wall, and the safety is better.

The balloon dilatation catheter and the drug delivery device enable the linear body to adapt to the moving position along with the dilatation of the balloon through the movable at least one end of the linear body, effectively prevent the influence of the linear body on the dilatation of the balloon, ensure that the balloon can be completely opened, and improve the reliability of the device.

Drawings

Those skilled in the art will appreciate that the drawings are provided for a better understanding of the invention and do not constitute any limitation on the scope of the invention. In the drawings:

FIG. 1 is a schematic view of a balloon dilation catheter in accordance with a preferred embodiment of the present invention;

fig. 2 is a schematic view of a balloon provided with two symmetrically arranged linear bodies on the outer side thereof according to a preferred embodiment of the present invention;

fig. 3 is a partial schematic view of the proximal end of the wire-like body movable within the mounting cavity in a preferred embodiment of the invention;

FIG. 4 is a partial schematic view of the movable connection sleeve of the preferred embodiment of the present invention;

fig. 5a is a schematic view of a smooth-surfaced linear body in a preferred embodiment of the invention;

fig. 5b is a schematic view of a linear body with straight saw teeth on the surface according to a preferred embodiment of the present invention;

fig. 5c is a schematic view of a linear body with oblique saw teeth on the surface according to a preferred embodiment of the present invention;

fig. 6 is a schematic view of a balloon fold in a preferred embodiment of the invention;

FIG. 7 is a schematic view of a balloon dilation catheter in accordance with a preferred embodiment of the present invention being delivered to a lesion site and being used after balloon dilation;

fig. 8 is a schematic view showing a first usage state in which the linear body presses the vessel wall when viewed from a direction perpendicular to the axis of the vessel in the preferred embodiment of the present invention;

fig. 9 is a schematic diagram of the use state of the linear body in the preferred embodiment of the present invention, which is viewed from the isometric view direction and presses the blood vessel wall;

fig. 10 is a schematic view showing a second usage state in which the linear body presses the blood vessel wall when viewed in a direction perpendicular to the axis of the blood vessel in the preferred embodiment of the present invention.

The reference numerals are explained below:

1-a catheter body; 11-an inner tube; 12-an outer tube; 121-proximal outer tube; 122-distal outer tube; 123-a guide wire port; 124-catheter identification band; 2-a balloon; 21-balloon folding wings; 3-a linear body; 31-the distal end of the wireform; 32-the proximal end of the wireform; 4-a proximal connector; 5-a stress diffusion tube; 6-development marking; 13-connecting sleeve; 14-a mounting cavity; 15-a head; 10-blood vessels; 20-lesion.

The same or similar reference numbers in the drawings identify the same or similar elements.

Detailed Description

The following description of the embodiments of the present invention is provided for illustrative purposes, and other advantages and effects of the present invention will be readily apparent to those skilled in the art from the disclosure herein. The present invention can also be implemented or applied through other different specific embodiments, and various details in the present specification can be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the drawings provided in the present embodiment are only for illustrating the basic idea of the present invention, and the drawings only show the components related to the present invention rather than being drawn according to the number, shape and size of the components in actual implementation, and the form, quantity and proportion of each component in actual implementation may be changed at will, and the layout of the components may be more complicated.

Furthermore, each embodiment described below has one or more technical features, which does not mean that all technical features of any embodiment need to be implemented simultaneously by a person using the present invention, or that all technical features of different embodiments can be implemented separately. In other words, in the implementation of the present invention, based on the disclosure, and depending on design specifications or actual requirements, a person skilled in the art can selectively implement some or all of the technical features of any embodiment, or selectively implement a combination of some or all of the technical features of a plurality of embodiments, thereby increasing the flexibility in implementing the present invention.

As used in this specification, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the meaning of "a plurality" generally includes two or more unless the content clearly dictates otherwise. As used herein, "distal" generally refers to the end that enters the body first, and "proximal" is the end opposite the "distal". As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. It should also be understood that the present invention repeats reference numerals and/or letters in the various embodiments. This repetition is for the purpose of simplicity and clarity and does not in itself dictate a relationship between the various embodiments and/or configurations discussed. It will also be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or one or more intervening elements may be present.

Fig. 1 is a schematic structural view of a balloon dilatation catheter according to a preferred embodiment of the present invention. As shown in fig. 1, the present embodiment provides a balloon dilatation catheter (i.e., a drug delivery device) including a catheter body 1 and a balloon 2 fixed to the catheter body 1; wherein the outer side of the sacculus 2 is provided with a linear body 3, the linear body 3 extends from the near end to the far end of the sacculus 2 along the outer surface of the sacculus 2, and the two ends of the linear body 3 are connected with the catheter body 1. Specifically, one end of the linear body 3 is connected to the tube section of the catheter body 1 located on the distal end side of the balloon 2, and the other end is connected to the tube section of the catheter body 1 located on the proximal end side of the balloon 2. Here, the linear body 3 refers to an elongated member, and the shape of the elongated member is not limited, and may be in the form of a strip, a belt, a thread, a sheet, and the like, and the cross section thereof may be square, triangular, and the like. Preferably, the linear body 3 is a circular slender member, and has less damage to the intima of the blood vessel wall. The linear body 3 is made of medical metal material or medical polymer material, and has no special requirement on the selected medical polymer material or medical metal material. For example, the medical metal material for preparing the linear body 3 is at least one of medical stainless steel, medical cobalt-based alloy, medical nickel-titanium alloy and medical magnesium alloy. For example, the medical polymer material for preparing the linear body 3 is at least one of polyethylene terephthalate (PET), a block copolymer of polyamide and polyether (Pebax), polypropylene, and polyurethane.

The surface of the linear body 3 and/or the balloon 2 carries a drug. The manner in which the drug is disposed on the balloon 2 and/or the linear body 3 is not particularly limited, and the drug is prepared by, for example, electrostatic spraying, atomized spraying, dip coating, drop coating, or crystal self-growth. In addition, the drug on the surface of the linear body 3 and/or the balloon 2 can be a pure drug or a mixture of a drug and a carrier matrix. The drug may be selected as desired, such as antiproliferative, antirestenotic, anti-inflammatory, antibacterial, antineoplastic, antimitotic, antimetastatic, antithrombotic, anti-osteoporotic, antiangiogenic, cytostatic, microtubule-inhibiting drugs. Drugs include, but are not limited to, rapamycin and its derivatives (including zotarolimus, everolimus, bimesomus, 7-O-desmethylrapamycin, temsirolimus, ridaforolimus, etc.), paclitaxel derivatives, docetaxel, angiostatin, angiopeptin, aspirin, acimetrine, dexamethasone, corticosterone, prednisolone, budesonide, estrogens, selective estrogen receptor modulators, hormones, sulfasalazine, 5-fluorouracil, aminopterin, aminosalicylic acid, escin, antimycosin, arsenic trioxide, aristolochic acid, mini- base, ginkgol, endostatin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, anti-cancer drugs, doxorubicin, levofloxacin, hydroxycamptothecin, vincristine, cisplatin, thymidine kinase inhibitor antibiotics (particularly actinomycin-D), Strontium ranelate, cyclosporine A, cyclosporine C, brefeldin A and bisphosphonate. Further, the drug is preferably rapamycin, rapamycin derivative, paclitaxel, and one or more combinations of paclitaxel derivatives. The carrier matrix can be one or more of iopromide, iopamidol, iohexol, shellac, urea, lecithin, polylactic acid, polyvinylpyrrolidone (PVP), polyvinyl alcohol (PVA), chitosan, gelatin, glucose, polyarginine, butyryl tri-n-hexyl citrate (BTHC), tween 80, etc.

The longitudinal axis of the linear body 3 after being unfolded is parallel or not parallel to the longitudinal axis of the balloon 2 after being unfolded. Preferably, the longitudinal axis of the linear body 3 after being unfolded is parallel to the longitudinal axis of the balloon 2 after being unfolded, that is, after the balloon 2 is expanded, the linear body 3 is also unfolded, and the extending direction of the linear body 3 after being unfolded is parallel to the longitudinal axis of the balloon 2 after being expanded, so that the balloon 2 is not easily affected by the linear body 3, can be completely opened or contracted, and has better use reliability. It should also be understood herein that the term "parallel" does not mean that the two (i.e., the wire and the balloon) are perfectly parallel. It will be appreciated by those skilled in the art that in practice a bias between the deployed longitudinal axis of the wire 3 and the deployed longitudinal axis of the balloon 2 is permitted.

Next, the operation principle of the balloon dilation catheter of the present embodiment will be described with reference to fig. 7 to 9.

As shown in fig. 7, after the balloon dilatation catheter is delivered to the lesion site in the blood vessel by a conventional operation means and the site is confirmed without error, external gas or liquid is introduced into the balloon 2 to inflate and expand the balloon 2, thereby achieving the purpose of dilating the blood vessel 10 and finally effectively adhering the balloon 2 to the lesion 20 of the blood vessel 10. As shown in fig. 8-10, in the process of expanding the balloon 2, when the linear body 3 outside the balloon 2 is subjected to the radially outward acting force of the balloon 2, the inner wall of the diseased blood vessel 10 can be further supported, so that the supporting force of the balloon dilatation catheter on the diseased blood vessel 10 is enhanced, and the blood vessel dilatation effect is better. Simultaneously through the expansion of sacculus 2 for the linear body 3 further extrudees the vascular wall, through the squeezing effect of linear body 3 with the vascular wall, has increased the extrusion force of sacculus 2 to the vascular wall, thereby make the infiltration that the medicine on linear body 3 and/or 2 surfaces of sacculus can be better in the vascular wall, improve the release and the utilization ratio of medicine. It should be understood that in the conventional balloon dilatation catheter, although the surface of the balloon is attached to the blood vessel wall, the surface of the balloon is smooth, the pressure applied to the blood vessel wall is limited, and therefore the medicine cannot better permeate into the blood vessel wall, and the transfer rate of the medicine is low. And the utility model discloses a line body 3 in the sacculus outside extrudes the vascular wall, has increased the effort of sacculus to the vascular wall, and this effort makes infiltration that medicine on sacculus 2 and/or the line body 3 can be better in the vascular wall to improve the transfer rate of medicine. Further, the thread-like body 3 is small in size (preferably, a filament having a cross-sectional height of 0.1mm to 0.35mm, for example, a filament having a diameter of 0.1mm to 0.35 mm), and even if a lesion is formed in a lesion site of a blood vessel which the thread-like body contacts, the lesion is slightly safe, and therefore, the safety is high.

Further, both ends of the linear body 3 are fixedly connected with the catheter body 1, or one end of the linear body is connected with the catheter body 1, and the other end of the linear body is movably connected with the catheter body 1, or both ends of the linear body 3 are movably connected with the catheter body 1. Preferably, one end of the linear body 3 is fixedly connected with the catheter body 1, and the other end of the linear body is movably connected with the catheter body 1, so that the linear body 3 can move along with the expansion and contraction of the balloon 2. It should be understood that, when both ends of the linear body 3 are fixedly connected with the catheter body 1, the length of the portions of the linear body 3 located at the proximal end and the distal end of the balloon 2 should be ensured to have a certain elongation amount so as to prevent the balloon 2 from being restrained by the linear body 3 during expansion, and further, the minimum length of the linear body 3 is greater than the length along the single-sided contour line from the proximal end to the distal end of the expanded balloon 2, so as to prevent the length of the linear body 3 from being too short to affect the expansion of the balloon 2. In this embodiment, in order to increase the folding size of the balloon 2, increase the reliability of use, and reduce the difficulty of manufacturing, it is preferable to movably connect one end of the wire-shaped body 3 to the catheter body 1, and fixedly connect the other end of the wire-shaped body 3 to the catheter body 1, in this case, the wire-shaped body 3 itself can move along with the expansion and contraction of the balloon 2, so as to better ensure the opening, contraction, or folding of the balloon 2.

Further, as shown in fig. 1, the length of the head 15 is defined as the length of the catheter body 1 extending out of the distal end of the balloon 2, the length of the head 15 is usually not long, and there is a certain difficulty in designing the head 15 to be movable, and in order to overcome this difficulty, it is preferable that the proximal end 32 of the linear body 3 is movably connected to the tube section of the catheter body 1 located on the proximal end side of the balloon 2, and the distal end 31 of the linear body 3 is fixedly connected to the tube section of the catheter body 1 located on the distal end side of the balloon 2. The movable connection between the proximal end 32 of the wire-like body 3 and the catheter body 1 is not limited, and the fixed connection between the distal end 31 and the catheter body 1 is not limited. Furthermore, the distal end 31 of the linear body 3 is welded with the pipe section (head 15) of the catheter body 1 at one side of the distal end of the balloon 2, so that the process is convenient and the manufacturing difficulty is low.

The utility model discloses there is not special requirement to the quantity of the line body 3, can be one or many, and the axis of ordinates that many line bodies 3 centers on sacculus 2 is even or inhomogeneous arranges. As further shown in fig. 2, the number of the linear bodies 3 is plural, more preferably 2 to 6, and the plural linear bodies 3 are uniformly or non-uniformly distributed, preferably uniformly distributed, around the longitudinal axis of the balloon 2. Here, the "uniform" or "non-uniform" generally refers to a usage state after being developed.

With continued reference to fig. 1, the catheter body 1 includes an inner tube 11 and an outer tube 12, the inner tube 11 is inserted into the outer tube 12, and a medium cavity is formed between the inner tube and the outer tube 12, and gas or liquid for filling the balloon 2 is introduced into the medium cavity, and the gas or liquid enters and exits the balloon 2 through the medium cavity. The lumen of the inner tube 11 is used for insertion of a guide wire. The balloon 2 has a proximal end connected to the outer tube 12 and a distal end connected to the inner tube 11. The distal end 31 of the wire 3 is connected, for example welded, to the section of the inner tube 11 extending beyond the distal end of the balloon 2. The proximal end 32 of the wire-like body 3 is connected to a section of the outer tube 12 adjacent to the proximal end of the balloon 2.

As further shown in fig. 3 and 4, the catheter body 1 further includes a connecting sleeve 13, and the connecting sleeve 13 is disposed on one side of the proximal end of the balloon 2 and sleeved on the outer tube 12. The connecting sleeve 13 has a mounting cavity 14, the proximal end 32 of the linear body 3 is disposed in the mounting cavity 14, and the proximal end 32 of the linear body 3 is movably connected or fixedly connected with the mounting cavity 14. When the proximal end 32 of the linear body 3 is fixedly connected with the installation cavity 14, the connection sleeve 13 is movably sleeved on the outer tube 12, so that the connection sleeve 13 can move relative to the balloon 2 (i.e. the outer tube 12). When the proximal end 32 of the linear body 3 is movably connected to the mounting cavity 14, the connecting sleeve 13 may be movably sleeved on the outer tube 12, or may be fixedly sleeved on the outer tube 12, that is, the connecting sleeve 13 may be movable or fixed, and preferably, the connecting sleeve 13 is fixedly disposed at this time.

In some embodiments, as shown in fig. 3, the proximal end 32 of the linear body 3 is movable in the mounting cavity 14, and the connecting sleeve 13 is fixedly disposed, during preparation, the proximal end 32 of the linear body 3 is movably connected to the mounting cavity 14 after being inserted into the connecting sleeve 13 from the connecting sleeve 13 toward one end of the balloon 2, at this time, the length of the mounting cavity 14 along the axial direction of the outer tube 12 is a movable distance of the linear body 3, and the distance needs to ensure that the balloon 2 can be smoothly opened or contracted or folded, and at the same time, the opening at one end of the mounting cavity 14 can prevent the proximal end 32 of the linear body 3 from coming off the connecting sleeve 13. Therefore, when the balloon 2 is deployed, the proximal end 32 of the linear body 3 can move towards the balloon 2 (i.e. towards the distal end) in the installation cavity 14, so that the balloon 2 can be completely opened without being constrained by the linear body 3, and the deployed balloon 2 has a radially outward acting force on the linear body 3, so that the linear body 3 is attached to a blood vessel wall (i.e. pressure of the blood vessel wall is ensured), the blood vessel wall is effectively supported, and the proximal end 32 of the linear body 3 is constrained by the installation cavity 14 and cannot fall off from the installation cavity 14. When the saccule 2 is folded, the proximal end 32 of the linear body 3 can move towards the direction far away from the saccule 2 (namely the proximal end), but the length of the proximal end does not exceed the length of the installation cavity 14, so that the linear body 3 can not hang over the catheter and the blood vessel wall. Further, the proximal end of the wire-shaped body 3 has a size (diameter) slightly larger than that of the remaining portion.

In some embodiments, as shown in fig. 4, the proximal end 32 of the linear body 3 is immovable in the installation cavity 14, and the connection sleeve 13 is movably disposed, during preparation, the proximal end 32 of the linear body 3 is also fixedly connected to the installation cavity 14 after being inserted into the connection sleeve 13 from the connection sleeve 13 toward one end of the balloon 2, and at this time, the moving distance of the connection sleeve 13 along the axial direction of the outer tube 12 is the movable distance of the linear body 3, and the distance needs to ensure that the balloon 2 can be smoothly opened or contracted or folded. Further, when the proximal end 32 of the linear body 3 is fixedly connected to the connecting sleeve 13, the connection can be performed by using a heat shrinkage method, i.e., the connecting sleeve 13 is designed as a heat shrinkage pipe. The working principle of the design is similar to that of the design, namely when the saccule 2 is unfolded, the connecting sleeve 13 moves towards the saccule 2 to drive the proximal end 32 of the linear body 3 to move towards the saccule 2, so that the saccule 2 can be completely opened, and the proximal end 32 of the linear body 3 is fixed with the mounting cavity 14 and cannot fall off from the mounting cavity 14. In addition, when the balloon 2 is folded, the connecting sleeve 13 moves in the direction away from the balloon 2, so that the proximal end 32 of the linear body 3 also moves in the direction away from the balloon 2, and the folding of the balloon 2 is not affected.

Further, the linear body 3 is preferably a circular filament having a filament diameter of preferably 0.10 to 0.35mm, more preferably 0.15 to 0.25mm, and causing less damage to the intima of the blood vessel wall. Further, the proximal end portion of the filament body 3 has a larger diameter than the remaining portion, and the diameter of the proximal end portion is 0.12mm to 1.0mm, more preferably 0.17mm to 0.90mm, for example, 0.12mm to 0.50mm, more preferably 0.17mm to 0.40 mm. When the cross section of the filament body 3 is non-circular, the height of the cross section is preferably 0.10mm to 0.35mm, more preferably 0.15mm to 0.25 mm.

Further, the outer surface of the linear body 3 is smooth and has a cylindrical shape as a whole (fig. 8), or a triangular prism shape as a whole (fig. 10). Or, as shown in fig. 5b and 5c, the outer surface of the side of the linear body 3 facing away from the balloon 4 is uneven, and the uneven surface is used for being attached to the blood vessel wall, so that the pressure on the blood vessel wall is further increased through the protrusions on the surface of the linear body 3, and the medicine can better penetrate into the blood vessel wall. The utility model discloses do not limit to bellied shape, including but not limited to sawtooth shape. Preferably, the shape of the protrusion is a saw-tooth shape, such as a straight saw-tooth type of fig. 5b, or a slanted saw-tooth type of fig. 5 c. It will be appreciated that the wire-like body 3 having the uneven surface is configured to have a slight safety damage to the inner wall of the blood vessel, and the safety of use can be ensured. In addition, the oblique saw teeth have the advantages that the catheter can not scratch non-pathological blood vessels when being withdrawn from the blood vessels, and the safety is better. Furthermore, the protrusions may be distributed continuously, such as triangular prisms as shown in fig. 10, or the protrusions may be distributed at intervals along the length of the linear body, such as a serrated surface as shown in fig. 5b and 5 c.

In this embodiment, the balloon dilation catheter has a collapsed state and an expanded state; when the balloon 2 is expanded or inflated, the balloon dilatation catheter is in an expanded state; the balloon dilation catheter is in a folded state prior to the balloon 2 being expanded or inflated. After folding, the number of the folding wings 21 of the balloon 2 is at least two, and the folding wings can be arranged at equal angles or different angles. For example, as shown in fig. 6, the balloon 2 has 3 folding wings 21 arranged at equal angles. Further, when the balloon 2 is folded, the linear body 3 may be wrapped with the folding wings 21 or may not be wrapped. Particularly when the linear bodies 3 are plural, all the linear bodies 3 are wrapped by the folding wings 21, or partially wrapped, or not wrapped at all. The utility model discloses do not add the restriction to the size of sacculus 2, according to actual treatment needs set up can, for example in coronary artery intervention treatment, diameter after sacculus 2 expandes is preferred 1.5mm ~ 4.0mm, and length is preferred 6mm ~ 40 mm.

With continued reference to fig. 1, the balloon dilatation catheter further comprises a proximal connector 4 connected to the proximal end of the catheter body 1, in particular to the proximal end of the outer tube 12, and the outer tube 12 may be connected to the proximal connector 4 via a stress diffusion tube 5. Further, the outer tube 12 includes a proximal outer tube 121 and a distal outer tube 122, and a distal end of the proximal outer tube 121 is connected to a proximal end of the distal outer tube 122. The balloon dilatation catheter can be of a coaxial whole Exchange type (Over The Wire, OTW) or a Rapid Exchange type (Rapid Exchange System), and The specific Exchange form is not limited. In this embodiment, a guide wire port 123 is disposed between the proximal outer tube 121 and the distal outer tube 122, and a guide wire is inserted into the inner tube 11 through the guide wire port 123. Further, the inner tube 11 is provided with two developing marks 6 on the tube section inside the balloon 2, wherein one developing mark 6 corresponds to the proximal position of the balloon 2, and the other developing mark 6 corresponds to the distal position of the balloon 2. The developing mark 6 is integrally formed with the inner tube 11, a part of the inner tube 11 is made of a developing material, or the developing mark 6 and the inner tube 11 are separately formed, for example, a developing ring is separately formed and is nested on the inner tube 11. Further, a catheter identification band 124 is provided on the proximal outer tube 121 for marking the length of the balloon dilatation catheter entering the body.

The balloon dilatation catheter of the present invention will be further described with reference to the experimental data and the experimental results to further highlight the features and characteristics of the above embodiments, but should not be limited to the following preparation methods.

Example 1

Firstly, a balloon dilatation catheter without carrying drugs is provided, wherein the linear body is made of filaments, the diameter of each filament is 0.151mm, the number of the filaments is 2, the filaments are made of medical stainless steel, and the surfaces of the filaments are smooth.

Then a drug solution was prepared: dissolving paclitaxel and vehicle matrix iopromide in solvent, and mixing to obtain medicinal solution; wherein the solvent is ethanol and water, and the specific formula of the medicinal solution is shown in Table 1.

Table 1: pharmaceutical solution formulation

And then, spraying a medicinal solution on the surface of the bare balloon provided with the filaments by adopting an atomization spraying mode to obtain the balloon dilatation catheter carrying the medicine.

Then, the balloon is folded (e.g., balloon folding machine), and the balloon folding wings 21 have 3 wings arranged at equal angles, wherein 1 filament is wrapped by the balloon flaps 21.

And finally, filling the folded balloon into a protective sleeve for fixing, and sterilizing to obtain the drug-loaded balloon dilatation catheter.

Example 2

Firstly, a balloon dilatation catheter without carrying drugs is provided, wherein the number of filaments is 3, the diameter of the filaments is 0.210mm, the material of the filaments is medical stainless steel, and the surfaces of the filaments are in a straight sawtooth shape.

Then a drug solution was prepared: dissolving the drug rapamycin and the carrier matrix polylactic acid in a solvent and mixing to obtain a drug solution; wherein the solvent is ethyl acetate, and the specific formulation of the medicinal solution is shown in Table 2.

Table 2: pharmaceutical solution formulation

Components	Substance(s)	Concentration of
			Medicine	Rapamycin	4mg/ml
Carrier	Polylactic acid	4mg/ml

The balloon is then folded, with the flaps of balloon folding wings 21 being 3 and equiangularly aligned, with all filaments being wrapped by the balloon flaps.

Example 3

There is provided a balloon dilatation catheter not carrying drugs in which the number of filaments is 4, the diameter of the filaments is 0.160mm, the material of the filaments is polyethylene terephthalate (PET), and the surface of the filaments is smooth.

The balloon is then folded, with the flaps of balloon folding wings 21 being 4 and equiangularly aligned, with all filaments being wrapped by the balloon flaps.

Example 4

Firstly, preparing a medicine solution: dissolving paclitaxel and vehicle matrix iopromide in solvent, and mixing to obtain medicinal solution; wherein the solvent is ethanol and water, and the specific formula of the medicinal solution is shown in Table 1.

Then, 4 filaments are selected, the diameter of each filament is 0.210mm, the filament material is a block copolymer (Pebax) of polyamide and polyether, and the drug-loaded filaments are obtained by spraying a drug solution on the surfaces of the filaments in an atomization spraying mode.

After the drug-loaded filaments are obtained, the balloon dilatation catheter is prepared, wherein the drug-loaded filaments are 4, and the surfaces of the filaments are in a straight sawtooth shape.

Example 5

And then, selecting 3 filaments, wherein the filaments are made of medical cobalt-based alloy, and spraying the surfaces of the filaments with a medicinal solution in an atomization spraying mode to obtain the medicament-carrying filaments.

After the drug-loaded filaments are obtained, the balloon dilatation catheter is prepared, wherein the drug-loaded filaments are the drug-loaded filaments, the diameter of each filament is 0.155mm, the number of the filaments is 3, and the surfaces of the filaments are smooth.

Example 6

And then, spraying the surface of the balloon with a medicinal solution by adopting an atomization spraying mode to obtain the medicine-carrying balloon.

After the drug-loaded balloon is obtained, a balloon dilatation catheter is prepared, wherein the number of the filaments is 3 without drug-loaded coatings, the diameter of the filaments is 0.245mm, the filaments are made of medical cobalt-based alloy, and the surfaces of the filaments are in an oblique sawtooth type.

The balloon was then folded with 3 flaps of balloon folding wings arranged at equal angles, with all filaments wrapped by the balloon flaps.

Example 7

Firstly, preparing a medicine solution: dissolving the drug rapamycin and the carrier matrix polylactic acid in a solvent and mixing to obtain a drug solution; wherein the solvent is ethyl acetate, and the specific formulation of the medicinal solution is shown in Table 2.

After the drug-loaded balloon is obtained, the balloon dilatation catheter is prepared, wherein the filaments are free of drug-loaded coatings, the diameter of each filament is 0.105mm, the number of the filaments is 4, the filaments are made of polyamide-polyether block copolymer (Pebax), and the surfaces of the filaments are smooth.

The balloon was then folded with 4 flaps of balloon folding wings in equal angular alignment, with all filaments wrapped by the balloon flaps.

Example 8

Firstly, a balloon dilatation catheter without medicine is provided, wherein the number of filaments is 3, the diameter of the filaments is 0.349mm, the material of the filaments is medical cobalt-based alloy, and the surface of the filaments is in an oblique sawtooth type.

Then a drug solution was prepared: dissolving rapamycin and lecithin serving as a carrier matrix in a solvent, and mixing to obtain a medicinal solution; wherein the solvent is ethanol, and the specific formulation of the medicinal solution is shown in Table 3.

TABLE 3 pharmaceutical solution formulations

Example 9

Firstly, preparing a medicine solution: dissolving the drug rapamycin and the carrier matrix lecithin in a solvent and mixing to obtain a drug solution; wherein the solvent is ethanol, and the specific formulation of the medicinal solution is shown in Table 3.

After the drug-loaded balloon is obtained, the balloon dilatation catheter is prepared, wherein the number of the filaments is 4 without a drug-loaded coating, the diameter of the filaments is 0.250mm, the filaments are made of medical cobalt-based alloy, and the surfaces of the filaments are in a straight sawtooth type.

Example 10

The animal experiments of the above examples were carried out, and the drug concentrations in the resulting tissue vessels are shown in Table 4.

In addition, the animal experiment also adds a control example 1 and a control example 2:

comparative example 1, the filament diameter was 0.710mm, and the rest was the same as example 1;

comparative example 2, the filament diameter was 0.653mm, and the rest was the same as example 2.

1) Content of the experiment

Healthy domestic white pigs are selected as an animal model, a balloon dilatation catheter is implanted into coronary arteries, and drug release conditions and overall device safety at different time points after implantation are evaluated.

2) Results of the experiment

Firstly, the safety of the drug balloon carrying the filaments is evaluated, and according to the observation in the operation and after the operation of the domestic pig for experiments, the balloon dilatation catheters in examples 1-9 have small injury to the intima of the blood vessel wall and no obvious injury, while the balloon dilatation catheters in comparative examples 1 and 2 have obvious tearing condition to the intima of the blood vessel wall, which is probably due to the excessive extrusion to the blood vessel wall caused by the overlarge diameter of the filaments. Therefore, the size of the linear body is reasonably controlled, light injury can be guaranteed to occur only at the extrusion point, serious injury to the intima of the blood vessel wall can not be caused, and the middle layer membrane of the blood vessel wall can be kept intact without obvious injury. Therefore, the balloon dilatation catheter of the utility model is safe to use.

The drug concentration in the tissue vessels was then evaluated, see table 4.

TABLE 4 drug concentration in tissue vessels (unit: μ g/g)

As can be seen from Table 4, the balloon dilatation catheter of the utility model can play an effective drug release role, and the drug transfer rate is higher. More specifically, in examples 1 to 3, the balloon surface and the filament surface were both sprayed with the drug, and the filament surface in example 2 was straight serrated, and the drug concentration in the tissue was relatively higher compared to smooth-surfaced filaments. In examples 4 and 5, the surface of the balloon is not sprayed with the drug, only the surface of the filament is loaded with the drug, and the surface of the filament in example 4 is in a straight sawtooth shape, so that the concentration of the drug in the tissue is relatively higher compared with the filament with a smooth surface. Example 6, example 7 and example 9, the balloon surface was coated with drug, the filament surface was not coated with drug, the filament surface in example 6 was in the form of a beveled serration, and the filament surface in example 9 was in the form of a straight serration, and the drug concentration in the tissue was relatively higher compared to smooth-surfaced filaments. Therefore, the drugs on the surface of the filament and/or the balloon 2 can better permeate into the vessel wall along with the extrusion of the filament and the vessel wall, the transfer and the utilization rate of the drugs are high, and the treatment effect of the drugs is better.

To sum up, the utility model discloses a sacculus expansion pipe loads the medicine through the linear body, has improved the load capacity of medicine, and especially the surperficial medicine of linear body and/or sacculus permeates the vascular wall in can be better along with the extrusion of linear body and vascular wall in, makes better performance of medicine, effectively prevents the inner membrance hyperplasia, reduces restenosis probability. In addition, the balloon with the linear body on the surface is used for safely and effectively supporting the blood vessel wall with pathological changes, so that injuries such as intimal tear, interlayer, acute occlusion and the like can be avoided, and the safety is better.

The above description is only for the preferred embodiment of the present invention, and not for any limitation of the scope of the present invention, and any modification and modification made by those skilled in the art according to the above disclosure all belong to the protection scope of the present invention.

Claims

1. The balloon dilatation catheter is characterized by comprising a catheter body and a balloon fixed on the catheter body; a linear body is arranged on the outer side of the balloon, the linear body extends from the near end to the far end of the balloon along the outer surface of the balloon, two ends of the linear body are connected with the catheter body, and at least one end of the linear body is movably connected with the catheter body; wherein the surface of the linear body and/or the balloon carries a drug.

2. The balloon dilation catheter according to claim 1 wherein one end of the wire is movably connected to the tube section of the catheter body on the proximal side of the balloon and the other end of the wire is fixedly connected to the tube section of the catheter body on the distal side of the balloon.

3. The balloon dilatation catheter of claim 2 wherein the catheter body comprises a connection sleeve disposed on one side of the proximal end of the balloon, the connection sleeve having a mounting cavity, the one end of the wire body being disposed within the mounting cavity and the one end of the wire body being movably or fixedly connected to the mounting cavity;

4. The balloon dilation catheter according to claim 3 wherein the catheter body further comprises an outer tube and an inner tube, the inner tube being inserted into the outer tube; the near end of the balloon is connected with the outer tube, and the far end of the balloon is connected with the inner tube;

5. The balloon dilation catheter according to claim 1 wherein the cross-sectional shape of the wire-like body is circular and the wire-like body has a diameter of 0.1mm to 0.35 mm.

6. The balloon dilatation catheter of claim 1 wherein the outer surface of the wire is smooth or the outer surface of the side of the wire facing away from the balloon is formed with continuous or spaced protrusions.

7. The balloon dilation catheter of claim 6 wherein the shape of the projections is a saw tooth shape.

8. The balloon dilation catheter according to claim 1, wherein the number of the wire-shaped bodies is one or more, and a plurality of the wire-shaped bodies are arranged uniformly or non-uniformly around the longitudinal axis of the balloon.

9. A drug delivery device comprising a catheter body and a balloon secured to the catheter body; a linear body is arranged on the outer side of the balloon, the linear body extends from the near end to the far end of the balloon along the outer surface of the balloon, and the two ends of the linear body are connected with the catheter body; wherein the surface of the linear body and/or the balloon carries a drug.

10. The drug delivery device of claim 9, wherein the cross-section of the wire-like body has a height of 0.1mm to 0.35 mm.

11. The drug delivery device of claim 9, wherein the outer surface of the wire-like body on the side facing away from the balloon is formed with a line or spaced protrusions.