In-situ stent forming catheter device and fluid delivery system

Abstract

The present application relates to an in situ stenting catheter device and a fluid delivery system wherein the in situ stenting catheter device has opposite proximal and distal ends, including a delivery tube and an inner tube providing a guidewire lumen. The far end of the conveying pipe is fixed to the far end of the inner pipe, the near end of the conveying pipe is in sliding fit with the near end of the inner pipe, the conveying pipe comprises a working section located at the far end of the conveying pipe and an extending section connected and extending from the working section to the near end of the conveying pipe, and the working section is spirally wound around the inner pipe and provided with a wall penetrating hole. The wall penetrating hole is configured to convey fluid outwards after the working section is inflated by the fluid, and the working section is of a deformable structure and has an initial state and a working state: in the initial state, the working section is attached to the inner pipe; in the working state, the working section is inflated by fluid and expands outwards in the radial direction relative to the initial state. After the delivery pipe is filled with fluid, the inflation working section is inflated and swelled, and a columnar bag abutting against in-vivo blood vessels is integrally formed. The through-wall hole delivers fluid outwards to form an intravascular stent in situ.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and particularly to an in-situ stent forming catheter device and a fluid delivery system. Background Art

[0002] Angioplasty balloons can be used to open calcified lesions in the arterial wall and are one of the main methods for revascularization of arterial stenosis. However, blood vessel dilation can cause damage to the blood vessel wall, leading to thrombus formation and the release of growth factors, which will result in restenosis or the re-closure of the dilated blood vessel later.

[0003] Currently, the above problems are mainly solved by implanting vascular stents into blood vessels. Existing vascular stents are mainly divided into two categories. One category is made of biocompatible metals, but it may cause thrombus formation and immunogenicity, and this permanently existing stent may interfere with subsequent treatments, resulting in corrosion perforation and potential aneurysms. The other category is biodegradable stents. Although they solve the problem of the permanent existence of metal stents, the degraded acidic products will cause severe inflammatory reactions and at the same time lead to the atrophy and degradation of the muscle elastic elements of the arterial wall, causing arterial dilation. In order to reduce the restenosis rate after implanting stents in diseased blood vessels, drug-eluting stents are widely used. Although drug-eluting stents can reduce the proliferation of vascular smooth muscle cells and vascular restenosis, they also prevent the long-term recovery of the endothelial cell layer, thus causing thrombus formation on the blood vessel wall. Summary of the Invention

[0004] Based on this, it is necessary to provide an in-situ stent forming catheter device for the above technical problems.

[0005] The in-situ stent forming catheter device of the present application has opposite proximal and distal ends. The in-situ stent forming catheter device includes:

[0006] An inner tube that provides a guide wire lumen;

[0007] A delivery tube. The distal end of the delivery tube is fixed to the distal end of the inner tube, and the proximal end of the delivery tube is slidably engaged with the proximal end of the inner tube. The delivery tube includes a working section at its distal end and an extension section that extends from the working section to its proximal end. The working section is helically wound around the inner tube and is provided with through-wall holes, and the through-wall holes are configured to deliver fluid outward after the working section is inflated with fluid. The working section is a deformable structure and has an initial state and a working state:

[0008] In the initial state, the working section adheres to the inner tube;

[0009] In the working state, the working section is inflated with fluid and expands radially outward relative to the initial state.

[0010] The following also provides several optional methods, which are not additional limitations to the above overall solution, but only further supplements or optimizations. On the premise of no technical or logical contradictions, each optional method can be combined with the above overall solution alone, or multiple optional methods can be combined with each other.

[0011] Optionally, the in-situ stent forming catheter device includes:

[0012] A fixed handle, fixed to the proximal end of the inner tube, and the fixed handle is provided with a wire port communicating with the wire cavity;

[0013] A first sliding handle, fixed to the proximal end of the delivery tube, and the first sliding handle is provided with a through hole for filling fluid and communicating with the extension section. The first sliding handle is sleeved outside the inner tube and is located on the distal side of the fixed handle.

[0014] Optionally, after the delivery tube is filled with fluid, it expands to reach the working state;

[0015] After the fluid is withdrawn from the delivery tube, it exits the working state, and under the relative sliding action of the extension section and the inner tube, it switches to the initial state.

[0016] Optionally, in the working state, the helically coiled working section bulges radially and integrally forms a columnar sac, and the through-wall holes are opened on the peripheral wall of the columnar sac;

[0017] In the initial state, after the fluid is withdrawn from the working section, it is in a wrinkled shape.

[0018] Optionally, the in-situ stent forming catheter device includes an outer tube, the outer tube is simultaneously sleeved on the outer peripheries of the inner tube and the delivery tube, and the outer tube is slidably matched with both the inner tube and the delivery tube, and the delivery tube is located between the inner tube and the outer tube;

[0019] The outer tube slides relative to the inner tube to expose or shield the working section.

[0020] Optionally, the in-situ stent forming catheter device includes: a second sliding handle, the second sliding handle is connected to the proximal end of the outer tube, and the second sliding handle is sleeved outside the inner tube and is located on the distal side of the first sliding handle.

[0021] Optionally, the inner tube is provided with a first imaging mark and a second display mark for marking the position of the working section.

[0022] Optionally, the working section extends in parallel with a deformable member, the extension section extends in parallel with a driving member for driving the deformation of the deformable member, and the deformable member is used to assist in switching the state of the working section.

[0023] Optionally, the deformable member has the initial state and the working state corresponding to the working section, and the driving member deforms the deformable member in any one of the following ways:

[0024] First: the deformable member is a pre-shaped material and returns to the working state in the body temperature range, and the deformable member returns to the initial state under the traction of the driving member;

[0025] Second: the deformable member is a thermosensitive material, and the driving member is a heating wire.

[0026] The present application provides a fluid delivery system, including the in-situ stent-forming catheter device as described in the present application and the fluid for inflating the delivery tube, and the fluid is at least one of an anti-proliferative drug, a drug for inducing cross-linking of collagen or elastin, and an anti-vascular spasm drug.

[0027] The in-situ stent-forming catheter device and the fluid delivery system of the present application at least have the following technical effects:

[0028] The guide wire lumen of the present application can allow a guide wire to penetrate, and the inner tube can reach the expected position along the intervention path provided by the guide wire through the guide wire lumen. After the delivery tube is filled with fluid, it expands, and the extension section transports the fluid to the working section, and the working section bulges after being inflated, forming a columnar sac that abuts against the blood vessels in the body as a whole, and switches to the working state. Under the action of the fluid pressure, the through-wall holes transport the fluid outwards, slowly release the fluid to the blood vessel wall, and cross-link with proteins, amino acids, etc. on the blood vessel wall at the lesion site to form a blood vessel stent in-situ, so that the blood vessel wall can still maintain the expanded shape after the delivery system is withdrawn. Description of the Drawings

[0029] Figure 1 It is a schematic diagram of the use of the in-situ stent-forming catheter device in an embodiment of the present application;

[0030] Figure 2 It is a schematic diagram of the structure of the working section of the in-situ stent-forming catheter device in an embodiment of the present application in the working state;

[0031] Figure 3 It is a schematic diagram of the structure of the working section of the in-situ stent-forming catheter device in an embodiment of the present application in the initial state;

[0032] Figure 4 It is a schematic diagram of the structure of the working section of the in-situ stent-forming catheter device in an embodiment of the present application in the working state;

[0033] Figure 5 It is a schematic diagram of the structure of the working section of the in-situ stent-forming catheter device in an embodiment of the present application in the initial state;

[0034] Figure 6 It is a schematic diagram of the functional structure of the in-situ stent forming catheter device in an embodiment of the present application;

[0035] Figure 7 It is a schematic diagram of the structure of the deformable part of the in-situ stent forming catheter device in an embodiment of the present application;

[0036] The descriptions of the reference numerals in the figure are as follows:

[0037] 100, inner tube; 110, guide wire cavity; 120, guide wire; 101, first imaging mark; 102, second imaging mark; 200, delivery tube; 210, working section; 211, through-wall hole; 212, deformable part; 213, driving part; 220, extension section; 300, outer tube; 410, fixed handle; 411, guide wire opening; 420, first sliding handle; 421, through hole; 430, second sliding handle. Detailed implementation manners

[0038] Next, the technical solutions in the embodiments of the present application will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present application.

[0039] It should be noted that when a component is referred to as being "connected" to another component, it can be directly connected to the other component or there may also be an intermediate component. When a component is considered to be "disposed on" another component, it can be directly disposed on the other component or there may be an intermediate component at the same time.

[0040] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the technical field to which this application belongs. The terms used in the description of this application herein are only for the purpose of describing specific embodiments and are not intended to limit this application. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0041] In this application, terms such as "first" and "second" are only used for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly specifying the quantity or order of the indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include one or more of such features. In the description of this application, the meaning of "a plurality of" is at least two, such as two, three, etc., unless otherwise specifically defined.

[0042] In this application, the terms "comprising" and "having" and any variations thereof are intended to cover non-exclusive inclusion. For example, a system, product, or device that comprises a series of units need not be limited to those units clearly listed, but may include other units not clearly listed or inherent to such products or devices.

[0043] An embodiment of this application provides an in-situ stent-forming catheter device. The in-situ stent-forming catheter device has opposite proximal and distal ends. In each embodiment of this application, the proximal end or proximal side refers to the end or side that is relatively closer to the operator when the in-situ stent-forming catheter device is in use, and the distal end or distal side refers to the end or side that is relatively farther from the operator when the in-situ stent-forming catheter device is in use. Specifically, the proximal side is the left side relative to each drawing, and the distal side is the right side relative to each drawing.

[0044] See Figures 1 to 5 , the in-situ stent-forming catheter device includes a delivery tube 200 and an inner tube 100 for providing a guide wire lumen 110. The distal end of the delivery tube 200 is fixed to the distal end of the inner tube 100, and the proximal end of the delivery tube 200 is slidably engaged with the proximal end of the inner tube 100. The delivery tube 200 includes a working section 210 at its own distal end and an extension section 220 that extends from the working section 210 to its own proximal end. The working section 210 is helically coiled around the inner tube 100 and is provided with a through-wall hole 211. The through-wall hole 211 is configured to deliver fluid outward after the working section 210 is inflated by fluid. The working section 210 is a deformable structure and has an initial state and a working state. In the initial state, the working section 210 adheres to the inner tube 100, and in the working state, it is inflated by fluid and expands radially relative to the initial state. Specifically, in the working state, the helically coiled working section 210 bulges radially and integrally forms a columnar sac, and the through-wall hole 211 is provided on the peripheral wall of the columnar sac. In the initial state, the working section 210 is in a wrinkled state after being evacuated of fluid. In the initial state and the working state, the number of helical coils per unit axial length is different. Specifically, the number of helical coils is 2 coils / 5 mm in the initial state and 3 coils / 5 mm in the working state.

[0045] In this embodiment, the guide wire lumen 110 can be penetrated by a guide wire 120, and the inner tube 100 can reach an expected position along the intervention path provided by the guide wire 120 through the guide wire lumen 110, such as a lesion in a blood vessel in the body. The working section 210 of the delivery tube 200 reaches the expected position simultaneously with the inner tube 100. The working section 210 is arranged in parallel with the inner tube 100. After the in-situ stent-forming catheter device is in place, at this time, the working section 210 is in the initial state.

[0046] The delivery tube 200 expands after being filled with fluid. The extension section 220 delivers the fluid to the working section 210, and the working section 210 bulges after being inflated, forming a columnar sac that abuts against the blood vessels in the body as a whole, reaching the working state. The columnar sac refers to the structural form presented by the entire working section 210 that is helically coiled around the inner tube 100. The aperture configuration of the through-wall holes 211 can refer to the prior art, and the working section 210 can be made of a polymer material. After the columnar sac is formed, the through-wall holes 211 deliver the fluid outward, slowly releasing the fluid to the blood vessel wall. The fluid cross-links with proteins, amino acids, etc. on the blood vessel wall at the lesion site, forming a blood vessel stent in situ, so that the blood vessel wall can still maintain the expanded form after the delivery system is withdrawn.

[0047] After the in-situ blood vessel stent is formed, the fluid is withdrawn from the delivery tube 200, causing the working section 210 to exit the working state. The working section 210 is in a wrinkled state. Under the relative sliding action of the extension section 220 and the inner tube 100, for example, by fixing the inner tube 100 and pulling the delivery tube 200 relative to the inner tube 100, the working section 210 is switched to the initial state.

[0048] The inner tube 100 is provided with a first imaging marker 101 and a second imaging marker 102 for marking the position of the working section 210. The first imaging marker 101 and the second imaging marker 102 are respectively located at the proximal end and the distal end of the working section 210.

[0049] The in-situ stent forming catheter device includes an outer tube 300. The outer tube 300 is sleeved on the outer peripheries of both the inner tube 100 and the delivery tube 200, and the outer tube 300 is slidably engaged with both the inner tube 100 and the delivery tube 200. The delivery tube 200 is located between the inner tube 100 and the outer tube 300. The outer tube 300 slides relative to the inner tube 100 to expose or shield the working section 210.

[0050] See Figure 6 , the in-situ stent forming catheter device includes a fixed handle 410, a first sliding handle 420, and a second sliding handle 430. The fixed handle 410 is fixed to the proximal end of the inner tube 100, and the fixed handle 410 is provided with a guide wire port 411 communicating with the guide wire cavity 110. The first sliding handle 420 is fixed to the proximal end of the delivery tube 200. The first sliding handle 420 is provided with a through hole 421 for filling the fluid and communicating with the extension section 220. The through hole 421 is used to input the fluid into the delivery tube 200. The first sliding handle 420 is sleeved outside the inner tube 100 and is located on the distal side of the fixed handle 410. The second sliding handle 430 is connected to the proximal end of the outer tube 300. The second sliding handle 430 is sleeved outside the inner tube 100 and is located on the distal side of the first sliding handle 420.

[0051] See Figure 7, in one embodiment, the working section 210 extends in parallel with a deformable member 212, the extension section 220 extends in parallel with a driving member 213 for driving the deformation of the deformable member 212, and the deformable member 212 is used to assist in switching the state of the working section 210. The deformable member can be made of nitinol wire, and the diameter of the rod is 0.1-0.3 mm.

[0052] The deformable member 212 is connected to the driving member 213, for example, they are partially arranged in parallel to achieve connection. The deformable member 212 has an initial state and a working state corresponding to the working section 210. The driving member 213 drives the deformation of the deformable member 212 in any of the following ways: First, the deformable member 212 is a pre-shaped material and returns to the working state in the body temperature range, and the deformable member 212 returns to the initial state under the traction of the driving member 213. Second, the deformable member 212 is a thermosensitive material and the driving member 213 is a heating wire. Correspondingly, the in-situ stent forming catheter device further includes a fourth sliding handle, which is fixedly connected to the driving member 213. The fourth sliding handle is sleeved on the inner tube 100 and is located between the first sliding handle 420 and the fixed handle 410. When the driving member 213 is a heating wire, the fourth sliding handle is also provided with a circuit interface for supplying energy to the heating wire.

[0053] An embodiment of the present application provides a fluid delivery system, including the in-situ stent forming catheter device provided in each embodiment of the present application and a fluid for inflating the delivery tube. The fluid is at least one of an anti-proliferative drug, a drug for inducing collagen or elastin cross-linking, and an anti-vascular spasm drug.

[0054] The use process of the in-situ stent forming catheter device in each embodiment of the present application includes: Intervene the in-situ stent forming catheter device as shown in Figure 3 into the blood vessel under the traction of a guide wire and reach the lesion site. After reaching the lesion site, withdraw the outer tube to expose the working section of the delivery tube into the blood vessel. Inject the fluid drug solution from the proximal end of the extension section of the delivery tube, so that the working section expands under the fluid pressure and radially expands to the state as shown in Figure 2 . When a certain pressure value is reached (usually 2-6 ATM), due to the pressure difference inside and outside the delivery tube, the fluid drug solution sputters out through the small holes (0.1-0.2 mm) of the through-wall holes, so that the drug reacts with the blood vessel wall to complete the treatment of the target lesion site and form an in-situ blood vessel stent. After the treatment is completed, draw negative pressure on the proximal end of the extension section, and the fluid flows out of the delivery tube. At this time, the wall of the working section contracts. Push the outer tube so that the outer tube wraps the working section and returns to the state as shown in Figure 3 . Then the whole is withdrawn from the body together with the inner tube. Finally, withdraw the guide wire to complete the entire operation process.

[0055] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as falling within the scope described in this specification. When the technical features in different embodiments are shown in the same drawing, the drawing can be regarded as simultaneously disclosing the combination examples of the respective embodiments involved.

[0056] The above-described embodiments merely represent several implementation manners of the present application. The description is relatively specific and detailed, but it should not be construed as a limitation on the scope of the patent application. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present application, several modifications and improvements can still be made, and these all belong to the protection scope of the present application.

Claims

1. In-situ stent-forming catheter device, characterized in that, it has opposite proximal and distal ends, and the in-situ stent-forming catheter device includes: an inner tube providing a guide wire lumen; a delivery tube, the distal end of the delivery tube is fixed to the distal end of the inner tube, and the proximal end of the delivery tube is slidably engaged with the proximal end of the inner tube. The delivery tube includes a working section at its distal end and an extension section connected and extending from the working section to its proximal end. The working section is helically coiled around the inner tube and is provided with through-wall holes configured to deliver fluid outward after the working section is inflated with fluid. The working section is a deformable structure and has an initial state and a working state: In the initial state, the working section adheres to the inner tube; In the working state, the working section is inflated with fluid and expands radially relative to the initial state.

2. The in-situ stent-forming catheter device according to claim 1, characterized in that, the in-situ stent-forming catheter device includes: a fixed handle fixed to the proximal end of the inner tube, and the fixed handle is provided with a guide wire opening communicating with the guide wire lumen; a first sliding handle fixed to the proximal end of the delivery tube. The first sliding handle is provided with a through-hole for filling fluid and communicating with the extension section. The first sliding handle is sleeved outside the inner tube and is located on the distal side of the fixed handle.

3. The in-situ stent-forming catheter device according to claim 1, characterized in that, the delivery tube is inflated after being filled with fluid and reaches the working state; the delivery tube withdraws from the working state after the fluid is withdrawn, and under the relative sliding action of the extension section and the inner tube, it switches to the initial state.

4. The in-situ stent-forming catheter device according to claim 1, characterized in that, in the working state, the helically coiled working section bulges radially and integrally forms a columnar sac, and the through-wall holes are provided on the peripheral wall of the columnar sac; in the initial state, the working section is in a wrinkled state after the fluid is withdrawn.

5. The in-situ stent-forming catheter device according to claim 2, characterized in that, the in-situ stent-forming catheter device includes an outer tube. The outer tube is simultaneously sleeved on the outer peripheries of the inner tube and the delivery tube, and the outer tube is simultaneously slidably engaged with the inner tube and the delivery tube. The delivery tube is located between the inner tube and the outer tube; the outer tube slides relative to the inner tube to expose or shield the working section.

6. The in-situ stent-forming catheter device according to claim 5, characterized in that, the in-situ stent-forming catheter device includes: a second sliding handle, and the second sliding handle is connected to the proximal end of the outer tube. The second sliding handle is sleeved outside the inner tube and is located on the distal side of the first sliding handle.

7. The in-situ stent-forming catheter device according to claim 1, characterized in that, the inner tube is provided with a first imaging mark and a second display mark for marking the position of the working section.

8. The in-situ stent-forming catheter device according to claim 1, characterized in that, The working section is provided with deformable members extending in parallel, the extending section is provided with driving members for driving the deformation of the deformable members, and the deformable members are used to assist in switching the state of the working section.

9. The in-situ stent forming catheter device according to claim 8, characterized in that the deformable member has the initial state and the working state corresponding to the working section, and any one of the following methods is adopted for the driving member to drive the deformation of the deformable member: First: the deformable member is a pre-shaped material and returns to the working state in the body temperature range, and the deformable member returns to the initial state under the traction of the driving member; Second: the deformable member is a thermosensitive material and the driving member is a heating wire.

10. A fluid delivery system, characterized in that it includes the in-situ stent forming catheter device according to any one of claims 1 to 9, and the fluid for inflating the delivery tube, and the fluid is at least one of an anti-proliferative drug, a drug for inducing cross-linking of collagen or elastin, and an anti-vascular spasm drug.

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