A self-perfused drug eluting balloon and self-perfused drug eluting device

Abstract

The present application relates to the field of medical devices, in particular to a self-perfusion drug-eluting balloon and a self-perfusion drug-eluting device, the self-perfusion drug-eluting balloon comprising a balloon body, the balloon body extending axially and being open at both ends, a blood flow channel being arranged along the axial direction of the balloon body, the blood flow channel being arranged on the wall of the balloon body, the balloon body comprising an outer balloon and an inner balloon arranged in the outer balloon, the blood flow channel being arranged on the wall of the outer balloon. The self-perfusion drug-eluting device comprises the self-perfusion drug-eluting balloon and a delivery assembly. The self-perfusion drug-eluting balloon does not block blood flow in the inflated state, avoiding the situation that the physical rebound of the blood vessel is fast due to short-time adhesion and short support time.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and in particular to a self-infusing drug-eluting balloon and a self-infusing drug-eluting device. Background Technology

[0002] Endovascular angioplasty is a clinically mature endovascular interventional technique that is widely used in the treatment of cardiovascular and cerebrovascular diseases (such as coronary heart disease, myocardial infarction, arteriosclerosis, cerebral infarction, malignant tumors and cancers). It is widely recognized by both doctors and patients due to its minimally invasive, safe and effective characteristics.

[0003] The specific implementation method involves inserting a catheter into a blood vessel percutaneously under the guidance of medical imaging equipment. A guidewire then guides an dilator to the lesion. The dilator expands through external inflation or self-expansion, causing plaque breakdown under pressure to restore the vessel diameter and accelerate blood flow. This allows the medication on the carrier surface to adhere to the lesion for therapeutic effect. However, after endovascular angioplasty, the possibility of restenosis increases due to endothelial damage, excessive smooth muscle cell proliferation, and other complications. Drug-eluting balloons are an emerging technology developed to address this issue. Their main principle is to coat the balloon surface with an anti-cell proliferation drug and guide the balloon along the guidewire to the lesion. Inflation allows the surface drug to adhere to the narrowed area, thus dilating the blood vessel while simultaneously inhibiting vascular stenosis.

[0004] While drug-coated balloon catheters have shown positive effects in treating restenosis, current clinical practice has revealed the following technical challenges: 1. During the insertion of the drug-coated balloon into the blood vessel, friction between the balloon surface and the vessel wall can cause drug detachment, preventing the balloon from effectively delivering the drug to the lesion site; 2. The core principle of drug-eluting balloon technology is local drug delivery. Therefore, a crucial technical indicator for evaluating a drug-eluting balloon is the coating. Balancing drug release rate and vascular absorption while improving the coating's stability within the vessel is key; 3. During both delivery and release phases, a significant amount of drug is washed away by the blood, leaving very little drug at the site of action. Although increasing the drug load on the balloon coating can increase local absorption, the large amount of excess drug flowing distal to the vessel wall has a significant negative impact on patient health. 4. During the expansion of the lesion, the drug-eluting balloon has an obstructive effect on blood vessels, which prevents blood flow and greatly increases the risk of ischemic necrosis of downstream functional tissues. Even if this risk is avoided by reducing the expansion time, the drug is not easily released from the balloon, which still greatly reduces the efficacy. Summary of the Invention

[0005] In view of the shortcomings of the prior art described above, the purpose of this invention is to provide a self-infusing drug elution balloon and a self-infusing drug elution device to solve the problems in the prior art.

[0006] To achieve the above and other related objectives, the present invention provides a self-infusing drug-eluting balloon, the self-infusing drug-eluting balloon comprising a balloon body, the balloon body extending axially and having openings at both ends, and a blood flow channel provided along the axial direction of the balloon body, the blood flow channel being disposed on the wall of the balloon body.

[0007] Preferably, the blood flow channel is located inside the balloon wall of the balloon body.

[0008] Preferably, the balloon body includes an outer balloon and an inner balloon disposed therein, and the blood flow channel is disposed on the wall of the outer balloon.

[0009] The present invention also provides a self-infusing drug elution device, the self-infusing drug elution device comprising a self-infusing drug elution balloon and a delivery assembly, the delivery assembly comprising an outer tube and an inner tube, the inner tube penetrating the balloon body through openings at both ends of the balloon body, the distal end of the outer tube being sleeved with the proximal end of the inner tube, and a gap being left between the outer tube and the inner tube at the sleeve, the inner lumen of the outer tube communicating with the inner lumen of the balloon body through the gap.

[0010] As described above, the self-infusing drug elution balloon and self-infusing drug elution device of the present invention have the following beneficial effects:

[0011] 1. Because the outer balloon surface is coated with a functional drug coating, and the drug is released close to the lesion on the blood vessel wall during the process, the loss of drug due to blood flushing during balloon movement is greatly reduced, and the toxic side effects of the lost drug on the patient are also minimized.

[0012] 2. Because the self-infusing drug-eluting balloon does not block blood flow when inflated, it avoids the situation of rapid physical rebound of blood vessels caused by short-term adhesion and short support time.

[0013] 3. Prolonged adhesion allows the drug to fully diffuse into the lesion site, improving the effective release rate of the drug and enhancing the clinical treatment effect.

[0014] 4. Constantly circulating blood reduces the risk of ischemic necrosis of downstream functional tissues due to poor blood flow within the blood vessels.

[0015] In summary, the self-infusing drug-eluting balloon and self-infusing drug-eluting device of this application have high transfer rate, high release rate, low toxicity, and good blood flow. Attached Figure Description

[0016] Figure 1 The image shown is an axial cross-sectional schematic diagram of the self-infusing drug-eluting balloon of the present invention.

[0017] Figure 2 The diagram shown is a cross-sectional view of the self-inflation drug-eluting balloon of the present invention. The position and direction of the cross-section are shown in the figure. Figure 1 The dashed lines and arrows shown.

[0018] Figure 3 The image shown is an axial cross-sectional view of the self-perfusion drug-eluting balloon of the present invention after it is filled in a blood vessel, where a represents the direction of blood flow.

[0019] Figure 4 The image shown is a transverse cross-sectional view of the self-perfusion drug-eluting balloon of the present invention after intravascular inflation. The cross-sectional position and orientation are shown in [reference needed]. Figure 3 The dashed lines shown and the arrows connected to the dashed lines are shown.

[0020] Component designation explanation

[0021] 1. Balloon body

[0022] 11. Outer balloon

[0023] 12 Inner balloons

[0024] 2. Blood flow channels

[0025] 3. Drug coating

[0026] 4. Outer tube

[0027] 5. Inner tube

[0028] 51 RX port

[0029] 6. Balloon inflation / deflation catheter

[0030] 7. Development Marks

[0031] 71 First developing element

[0032] 72 Second developing element

[0033] 8. Blood vessel wall Detailed Implementation

[0034] The following specific embodiments illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification.

[0035] Please see Figures 1 to 4It should be understood that the structures, proportions, sizes, etc., illustrated in the accompanying drawings are merely for illustrative purposes to aid those skilled in the art and to facilitate understanding and reading. They are not intended to limit the scope of the invention and therefore have no substantial technical significance. Any modifications to the structure, changes in proportions, or adjustments to size, without affecting the effectiveness and purpose of the invention, should still fall within the scope of the technical content disclosed in this invention. Furthermore, the terms such as "upper," "lower," "left," "right," "middle," and "one" used in this specification are merely for clarity and not intended to limit the scope of the invention. Changes or adjustments to their relative relationships, without substantially altering the technical content, should also be considered within the scope of the invention's implementation.

[0036] This patent provides an optimized solution for a self-perfusion drug-eluting balloon. By designing a unique "lotus seedpod" balloon structure and coating its surface with multiple functional coatings, the drug balloon can expand within blood vessels while exhibiting high transfer rate, high release, low toxicity, and good blood flow.

[0037] like Figure 1 and 2 As shown, the present invention provides a self-infusing drug-eluting balloon, the self-infusing drug-eluting balloon including a balloon body 1, the balloon body 1 extending axially and having openings at both ends, and a blood flow channel 2 provided along the axial direction of the balloon body 1, the blood flow channel 2 being provided on the wall of the balloon body 1.

[0038] The two openings at the ends of the balloon body 1 are referred to as the proximal opening and the distal opening, respectively. In this application, "proximal" generally refers to the end of the corresponding component closer to the operator, for example... Figure 1 "Middle left end"; "far end" refers to the end of the corresponding component that is furthest from the operator, for example... Figure 1 Right middle end.

[0039] Specifically, the blood flow channel 2 is located inside the balloon wall of the balloon body 1. The balloon wall of the balloon body 1 includes an outer surface and an inner surface, meaning the blood flow channel 2 is located between the outer surface and the inner surface of the balloon body 1. The thickness of the balloon wall of the balloon body 1 is greater than the diameter of the blood flow channel 2.

[0040] The blood flow channel 2 is provided with at least two.

[0041] In one embodiment, the blood flow channels 2 are symmetrically distributed around the central axis.

[0042] In a preferred embodiment, the balloon body 1 includes an outer balloon 11 and an inner balloon 12 disposed therein, and the blood flow channel 2 is disposed on the wall of the outer balloon 11.

[0043] In a preferred embodiment, the blood flow channel 2 is located inside the balloon wall of the outer balloon 11. The balloon wall of the outer balloon 11 includes an outer surface and an inner surface, meaning the blood flow channel 2 is located between the outer surface and the inner surface of the outer balloon 11. The portion between the outer surface and the inner surface of the outer balloon 11, excluding the blood flow channel 2, is a solid structure. In one embodiment, the wall thickness of the outer balloon 11 (i.e., the thickness between the outer and inner surfaces) is 0.02-0.2 mm.

[0044] The diameter of the blood flow channel 2 is smaller than the wall thickness of the outer balloon 11. In one embodiment, the diameter of the blood flow channel 2 is 0.01-0.1 mm.

[0045] The inner balloon 12 has a hollow structure.

[0046] Both the outer balloon 11 and the inner balloon 12 are compliant balloons. Compliance refers to the change in the balloon's shape or volume with each increase of one atmosphere of pressure during inflation; it is an indicator of the balloon's tensile strength. Before reaching the rupture point, the diameter of a non-compliant balloon increases very little. Therefore, selecting a balloon appropriately matched to the size of the blood vessel almost guarantees that vascular rupture (transmural tearing) will not occur during vascular dilation and shaping.

[0047] The outer surface of the outer balloon 11 is also provided with a drug coating 3. The drug is selected from anti-cell migration drugs, anti-cell mitosis drugs, anti-proliferation drugs, hydrophilic materials, and amphiphilic materials.

[0048] The anti-cell migration drug, anti-mitotic drug, or anti-proliferative drug is selected from one or more of rapamycin, paclitaxel, paclitaxel derivatives, rapamycin derivatives, paclitaxel analogs, rapamycin analogs, repressive RNA, repressive DNA, steroids, or complement inhibitors.

[0049] The hydrophilic material is, for example, one of polyvinylpyrrolidone, polyethylene oxide, polyacrylamide, polyacrylic acid, polyether and its derivatives, urea, polyurethane, polyurethane urea, polyethylene glycol, polypropylene glycol, iopromide, or a combination thereof.

[0050] The amphiphilic material is selected from one or more of surfactants, fatty acids, amino acids, phospholipids, or phospholipid derivatives. Examples of the amphiphilic material include sodium dodecyl sulfate, sodium dodecylbenzenesulfonate, stearic acid, lauric acid, myrcenoic acid, tetradecadienoic acid, octanoic acid, glycine, glutamic acid, sarcosine, alanine, 1,2-bis(eicosenoyl)-sn-glycero-3-phosphate choline, 1,2-diarachidoyl-sn-glycero-3-phosphate choline, 1,2-diergoyl-sn-glycero-3-phosphate choline, 1,2-bis(docohexanoyl)-sn-glycero-3-phosphate choline, 1,2-eicosenoyl-sn-glycero-3-phosphate choline, or 1,2-dinervonicyl-sn-glycero-3-choline phosphate, or complexes thereof.

[0051] The drug coating 3 can be a single layer or multiple layers. The self-infusing drug-eluting balloon coated with one or more layers of drug coating 3 is divided into multiple petals, folded and rolled up to form folds. After drying, the inner and outer balloons are folded to preserve the drug inside the folds. A protective sleeve is then put on to preserve the shape of the drug and the inner and outer balloons.

[0052] The outer balloon 11 or the inner balloon 12 is selected from an elastic material. The elastic material ensures that the outer balloon 11 or the inner balloon 12 can be folded during transport or storage, and can inflate under air pressure after being transported to the destination location. The material of the elastic outer balloon 11 or the inner balloon 12 is selected from elastomers such as polyvinyl chloride, polyethylene, polyethylene terephthalate, nylon, polyisoprene, polystyrene copolymer, polysiloxane, or polyurethane.

[0053] The outer balloon 11 or the inner balloon 12 is selected from spindle-shaped, cylindrical or spherical. The two ends of the outer balloon 11 or the inner balloon 12 are hollowed out, so that the outer tube 4 and / or the inner tube 5 can pass through the hollowed-out parts.

[0054] When a rated pressure is applied to the self-infusing drug-eluting balloon, and the outer balloon 11 is inflated, the blood flow channel 2 inside the outer balloon 11 can achieve the effect of treatment without blocking blood flow.

[0055] like Figure 1 and 2 As shown, the present invention also provides a self-infusing drug elution device, which includes a self-infusing drug elution balloon and a delivery assembly. The delivery assembly includes an outer tube 4 and an inner tube 5. The inner tube 5 penetrates the balloon body 1 through openings at both ends of the balloon body 1. The distal end of the outer tube 4 is sleeved with the proximal end of the inner tube 5, and a gap is left between the outer tube 4 and the inner tube 5 at the sleeve. The inner cavity of the outer tube 4 communicates with the inner cavity of the balloon body 1 through the gap.

[0056] like Figure 2 As shown, the outer tube 4 and the inner tube 5 have a coaxial double-cavity structure.

[0057] In one embodiment, both the outer balloon 11 and the inner balloon 12 cover at least a portion of the outer side of the inner tube 5. The proximal openings of both the outer balloon 11 and the inner balloon 12 are sealed to the outer tube 4, and the distal openings of both the outer balloon 11 and the inner balloon 12 are sealed to the inner tube 5. In one embodiment, the sealed connection is a fixed connection. The fixed connection is selected from welding or bonding.

[0058] The distal end of the outer tube 4 penetrates the proximal opening of the balloon body 1, and the distal port of the outer tube 4 is located within the inner cavity of the balloon body 1; alternatively, the distal port of the outer tube 4 is connected to the proximal opening of the balloon body 1. Specifically, the outer tube 4 can extend from the outside of the drug-eluting balloon to one end of the self-eluting balloon, or extend from the outside of the drug-eluting balloon through one end of the self-eluting balloon to the interior of the inner balloon 12. The outer tube 4 does not penetrate the self-eluting balloon.

[0059] Preferably, the inner surface of the outer balloon 11 is connected to the outer tube 4 and / or the inner tube 5 to ensure that the blood flow channel 2 can expand to allow blood to pass through it.

[0060] The inner diameter of the outer tube 4 is slightly larger than the outer diameter of the inner tube 5. There is a gap between the inner and outer tubes. The inner lumen of the outer tube 4 connects to the inner lumen of the balloon body 1 through this gap, which provides a channel for contrast agent or saline to expand the outer balloon 11 or the inner balloon 12. The inner diameters of both the outer tube 4 and the inner tube 5 can be adjusted as needed using different molds. The material of the outer tube 4 is selected from polyurethane elastomer (TPU), nylon, or block polyetheramide resin (PEBAX). The material of the inner tube 5 is nylon or PEBAX.

[0061] In one embodiment, the delivery assembly further includes a balloon inflation / depression conduit 6, which is connected to the outer tube 4. The balloon inflation / depression conduit 6 and the outer tube 4 are connected by welding or bonding. The balloon inflation / depression conduit 6 is made of plastic. Examples of plastics include polycarbonate, polyurethane, acrylonitrile-butadiene-styrene ester, and polyamide.

[0062] The proximal end of the inner tube 5 penetrates the wall of the outer tube 4 to form an RX port 51 communicating with the outside. The RX port 51 can be used by the self-infusing drug-eluting balloon to deliver the guidewire during delivery. The connection between the RX port 51 and the outer tube 4 is by welding or bonding.

[0063] The self-infusing drug elution device further includes a contrast marker 7, which is a contrast element disposed on the outer surface of the inner tube 5, or the inner tube 5 has a contrast marker 7 formed thereon. Preferably, the contrast marker 7 is a contrast element disposed on the inner tube segment inside the inner balloon 12, or the inner tube segment inside the inner balloon 12 has a contrast marker 7 formed thereon. The contrast element can be a metal ring. Multiple contrast elements are provided. For example, there are two contrast elements, namely a first contrast element 71 and a second contrast element 72. Both contrast elements are located on the inner tube segment inside the inner balloon 12. The inner tube segment inside the inner balloon 12 can be made of a material with contrast function to form the contrast marker 7, or by coating the inner tube segment inside the inner balloon 12 with a contrast agent or winding a contrast fiber, etc. The material of the contrast fiber is selected from gold, platinum, PtW alloy, or PtIr alloy.

[0064] The self-infusing drug elution device of this application can be used in conjunction with existing delivery systems (which include guide wires, etc.).

[0065] The method of using the self-inflation drug elution device of this application is as follows:

[0066] like Figure 3 As shown, the vascular lesion site is first pretreated. Then, a guidewire is inserted into the inner tube 5 through the RX port 51. The self-perfused drug-eluting balloon is placed inside the body. Under X-ray irradiation and the guidance of the guidewire, the position of the first contrast element 71 and the second contrast element 72 within the inner balloon 12 is used to determine whether the self-perfused drug-eluting balloon has reached the lesion site. When the lesion site is between the first contrast element 71 and the second contrast element 72, contrast agent or saline is injected into the inner balloon 12 through the balloon inflation / deflation catheter 6. The inner balloon 12 is inflated to the rated pressure (e.g., Figure 3 and 4 As shown), the inner balloon 12 expands, simultaneously forcing the outer balloon 11 to expand as well. This fully opens the blood flow channels 2 within the outer balloon 11, allowing blood to flow through and circulate normally. Meanwhile, the drug coating 3 on the surface of the outer balloon 11 adheres to the narrowed area of ​​the blood vessel wall 8 during the inflation and expansion of the self-infusing drug-eluting balloon, enabling the drug components to treat the stenotic lesion (e.g., ...). Figure 3 (As shown). After the drug has been fully transferred to the blood vessel, the self-infusing drug-eluting balloon is depressurized to make it unfilled. Then, the self-infusing drug-eluting balloon is withdrawn outward along the guidewire. Due to the design of blood flow channel 2, the drug administration time is not limited. After the drug administration is completed, the balloon can be re-dilated according to the blood vessel recoil. If necessary, a second drug administration can be performed.

[0067] In summary, the self-perfusion drug-eluting balloon and device of this application possess a "lotus-shaped" blood flow channel located inside the outer balloon and integrated with it. When the self-perfusion drug-eluting balloon is inflated through the balloon inflation / deflation catheter, the blood flow channel inside the balloon expands with the balloon's expansion. This allows for drug delivery to the lesion without obstructing blood flow, thus the drug delivery time can be determined based on vasodilation and vasoconstriction. Compared to existing self-perfusion balloons of the same type that have openings at the catheter to facilitate blood flow, the "lotus-shaped" blood flow channel of this application is symmetrically distributed, resulting in better blood flow and blood pressure stability. Therefore, this invention effectively overcomes the various shortcomings of the prior art and has high industrial applicability.

[0068] The above embodiments are merely illustrative of the principles and effects of the present invention and are not intended to limit the invention. Any person skilled in the art can modify or alter the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or alterations made by those skilled in the art without departing from the spirit and technical concept disclosed in the present invention should still be covered by the claims of the present invention.

Claims

1. A self-perfusing drug-eluting balloon, characterized in that, The self-perfusion drug eluting balloon comprises a balloon body (1) extending axially and having two open ends, a blood flow channel (2) arranged along the axial direction of the balloon body (1), the blood flow channel (2) being arranged on the wall of the balloon body (1), the balloon body (1) comprising an outer balloon (11) and an inner balloon (12) arranged in the outer balloon, the blood flow channel (2) being arranged on the wall of the outer balloon, and a drug coating (3) being arranged on the outer surface of the outer balloon (11), the outer balloon (11) or the inner balloon (12) being made of an elastic material.

2. The self-filling drug eluting balloon of claim 1, wherein, The blood flow channel (2) comprises at least two blood flow channels.

3. The self-filling drug eluting balloon of claim 1, wherein, The blood flow channels (2) are symmetrically distributed around the central axis.

4. The self-filling drug eluting balloon of claim 1, wherein, The blood flow channel (2) is arranged inside the balloon wall of the outer balloon (11).

5. A self-filling drug-eluting device, comprising: The self-perfusion drug eluting device comprises the self-perfusion drug eluting balloon according to any one of claims 1-4 and a delivery assembly, the delivery assembly comprising an outer tube (4) and an inner tube (5), the inner tube (5) penetrating the balloon body (1) through the openings at the two ends of the balloon body (1), the distal end of the outer tube (4) being sleeved with the proximal end of the inner tube (5), and a gap being left between the outer tube (4) and the inner tube (5) at the sleeving position, the inner cavity of the outer tube (4) being in communication with the inner cavity of the balloon body (1) through the gap.

6. The self-filling drug eluting device of claim 5, wherein, The distal end of the outer tube (4) penetrates the proximal opening of the balloon body (1), and the distal end port of the outer tube (4) is located in the inner cavity of the balloon body (1), or the distal end port of the outer tube (4) is in communication with the proximal opening of the balloon body (1).

7. The self-filling drug eluting device of claim 5, wherein, The proximal openings of the outer balloon (11) and the inner balloon (12) are in sealed connection with the outer tube (4), and the distal openings of the outer balloon (11) and the inner balloon (12) are in sealed connection with the inner tube (5).

8. The self-filling drug eluting device of claim 5, wherein, The inner surface of the outer balloon (11) is connected with the outer tube (4) and / or the inner tube (5).

9. The self-filling drug eluting device of claim 5, wherein, The delivery assembly further comprises a balloon inflation and pressure relief catheter (6) in communication with the outer tube (4).

10. The self-filling drug eluting device of claim 5, wherein, The proximal end port of the inner tube (5) penetrates the tube wall of the outer tube (4) to form an RX port (51) in communication with the outside; and / or, the self-perfusion drug eluting device further comprises a radiographic marker (7), which is a radiographic element arranged on the outer surface of the inner tube (5), or the inner tube (5) is formed with the radiographic marker (7).

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