Drug delivery device and drug delivery system for forming vascular in-situ stent

Abstract

The invention relates to a drug delivery device and a drug delivery system for forming a vascular in-situ stent. The drug delivery device has opposite proximal and distal ends, comprising: a first tube providing a guidewire lumen; the second pipe fitting is arranged on the periphery of the first pipe fitting in a sleeving mode, the far end of the second pipe fitting is fixed to the far end of the first pipe fitting, the near end of the second pipe fitting is in sliding fit with the near end of the first pipe fitting, the far end of the second pipe fitting comprises a medicine carrying section, the periphery of the medicine carrying section is used for being coated with medicine, and the medicine carrying section is made of a deformation material; the medicine carrying section is of a deformation structure capable of expanding outwards in the radial direction after being stacked in the axial direction and has the following characteristics: in an initial state, the medicine carrying section is attached to the first pipe fitting; the working state is radially expanded relative to the initial state; the second pipe fitting and the first pipe fitting move relatively to change the state of the medicine carrying section. The medicine carrying section is attached to the tube wall at the expected position in the working state, the coated medicine is slowly released to the tube wall of the blood vessel, the medicine is crosslinked with protein, amino acid and the like on the tube wall of the blood vessel at the focus, and the in-situ vascular stent is formed.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a drug delivery device and a drug delivery system for forming an in-situ stent for a blood vessel. Background Art

[0002] The conventional balloon catheter used to form an in situ stent of a blood vessel comprises an inner tube and an outer tube, wherein the balloon catheter has a proximal end relatively close to the operator during intervention and a distal end relatively far from the operator. The inner tube and the outer tube are slidably matched at the proximal end and relatively fixed at the distal end. The inner tube provides a guidewire cavity, and a drug channel cavity is provided between the inner tube and the outer tube. When in use, the drug is passed through the fluid channel to inflate the balloon of the outer tube.

[0003] The outer tube is provided with injection holes on its circumferential wall, and the injection holes are configured to flow out drug fluid in an inflated state. For example, when the pressure reaches a certain level (such as 2-8ATM), the drug solution will be affected by the pressure difference and will splash outward from the small holes on the balloon surface (such as 0.1-0.2mm) to the vascular lesion site, so that the drug and the blood vessel wall will produce a cross-linking reaction to form a blood vessel in situ stent, achieving the purpose of treating vascular stenosis. However, in this way, after the drug fluid reaches the inner wall of the blood vessel, it may splash or disperse to unexpected areas, posing a safety hazard. Summary of the invention

[0004] Based on this, it is necessary to provide a drug delivery device and a drug delivery system for forming a vascular in situ stent in order to solve the above technical problems.

[0005] The present application discloses a drug delivery device for forming an in-situ stent of a blood vessel, which has a relative proximal end and a distal end. The drug delivery device comprises:

[0006] A first tube member provides a guidewire lumen;

[0007] The second tube is sleeved on the outer circumference of the first tube, the distal end of the second tube is fixed to the distal end of the first tube, the proximal end of the second tube is slidably matched with the proximal end of the first tube, the distal end of the second tube includes a drug-carrying section for coating the drug on the outer circumference, the drug-carrying section is made of a deformable material, the drug-carrying section is a deformable structure that can be radially expanded after axial stacking, and the drug-carrying section has:

[0008] Initial state, attached to the first pipe;

[0009] Working state, radial expansion relative to the initial state;

[0010] The second tube member moves relative to the first tube member to change the state of the drug-carrying section.

[0011] Several optional methods are also provided below, but they are not intended to be additional limitations on the above-mentioned overall solution, but are merely further supplements or preferences. Under the premise that there are no technical or logical contradictions, each optional method can be combined with the above-mentioned overall solution separately, and multiple optional methods can also be combined.

[0012] Optionally, the drug delivery device comprises:

[0013] A fixed handle fixed to the proximal end of the first tube, the fixed handle being provided with a guide wire port communicating with the guide wire cavity;

[0014] The first sliding handle is fixed to the proximal end of the second tube, and the first sliding handle is sleeved on the outside of the first tube and is located at the distal end side of the fixed handle.

[0015] Optionally, a first development mark is provided at the proximal end of the drug-carrying section, and the first tube is provided with a second development mark corresponding to the position of the first development mark and used to indicate the state of the drug-carrying section;

[0016] A third developing mark is arranged at the distal end of the first tube.

[0017] Optionally, an indicator mark is provided at the proximal end of the first tube, and the indicator mark is used to indicate a sliding distance of the first sliding handle relative to the first tube.

[0018] Optionally, the drug delivery device comprises:

[0019] The third tube is sleeved on the outer circumference of the second tube, and the third tube is slidably matched with the second tube. The third tube is used to keep the drug-carrying section in the initial state and to expose the drug-carrying section after relative movement with the second tube.

[0020] Optionally, a second sliding handle is connected to the proximal end of the third tube, and the second sliding handle is sleeved on the outside of the second tube and is located on the distal side of the first sliding handle.

[0021] Optionally, the second tube member moves relative to the first tube member to switch the drug-carrying section from the working state to the initial state, and to switch the drug-carrying section from the initial state to the working state.

[0022] Optionally, the drug-carrying section is a pre-shaped material, and the deformable member is configured to have a tendency to return to the working state in a body temperature range;

[0023] The second tube member moves relative to the first tube member to switch the drug-carrying section from the working state to the initial state.

[0024] Optionally, in the initial state, the axial peripheral wall of the drug-carrying section is flat; in the working state, the drug-carrying section is folded along the axial direction, and the folded area expands radially outward to form a columnar capsule.

[0025] The present application provides a drug delivery system, comprising a drug delivery device for forming a vascular in situ stent as described in the present application, and a drug coated on the periphery of the drug-carrying section, wherein the drug is at least one of an anti-proliferative drug, a drug that induces collagen or elastin cross-linking, and an anti-vasospasm drug.

[0026] The drug delivery device and drug delivery system for forming an in-situ vascular stent of the present application have at least the following technical effects:

[0027] When the drug-carrying section of the present application is in working state, it expands radially outward and abuts against the tube wall at the expected position, slowly releasing the coated drug to the blood vessel wall, and the drug is bonded with proteins, amino acids, etc. of the blood vessel wall at the lesion site to form an in situ vascular stent.

[0028] The guidewire cavity of the present application can be used for the guidewire to pass through, and the first tube can reach the desired position along the intervention path provided by the guidewire through the guidewire cavity, such as the lesion of a blood vessel in the body. The second tube can arrive at the desired position at the same time as the first tube. The second tube moves relative to the first tube, changing the axial stacking of the drug-carrying segment, thereby changing the state of the drug-carrying segment. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 This is a schematic diagram of a partial structure of a drug delivery device in one embodiment of the present application;

[0030] Figure 2 This is a schematic diagram of a partial structure of a drug delivery device in one embodiment of the present application;

[0031] Figure 3 for Figure 2 A schematic diagram of the structure of the drug-loading section in the initial state;

[0032] Figure 4 This is a schematic diagram of a partial structure of a drug delivery device in one embodiment of the present application;

[0033] Figure 5 for Figure 4 A schematic diagram of the structure after the third pipe is withdrawn;

[0034] Figure 6 This is a schematic diagram of a partial structure of a drug delivery device in one embodiment of the present application;

[0035] Figure 7 This is a schematic diagram of a partial structure of a drug delivery device in one embodiment of the present application;

[0036] The reference numerals in the figures are described as follows:

[0037] 100, first tube; 110, guidewire cavity; 101, guidewire; 102, indicator mark; 120, second development mark; 130, third development mark; 200, second tube; 210, drug-carrying section; 211, first development mark; 300, third tube; 410, fixed handle; 411, guidewire port; 420, first sliding handle; 430, second sliding handle; 500, auxiliary wire. DETAILED DESCRIPTION

[0038] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

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

[0040] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art to which this application belongs. The terms used herein in the specification of this application 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, the terms "first", "second", etc. are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number or order of the indicated technical features. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of this application, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0042] In this application, the terms "comprises" and "having" and any variations thereof are intended to cover non-exclusive inclusions, for example, a system, product or device comprising a series of units is not necessarily limited to those units explicitly listed, but may include other units not explicitly listed or inherent to these products or devices.

[0043] In the present application, the terms "corresponding", "corresponding", "matching", "adaptable", such as "B corresponding to A", "B corresponding to A", "A corresponds to B", or "B corresponds to A", indicate that B has a corresponding relationship with A in shape, position or function, and B can be determined according to A. Determining B according to A does not mean determining B only according to A, but B can also be determined according to A and / or other information.

[0044] See also Figure 1 to Figure 3 The present application provides a drug delivery device for forming an in situ stent of a blood vessel (hereinafter referred to as a drug delivery device), the drug delivery device has a relative proximal end and a distal end. The proximal end or the proximal side described in each embodiment of the present application refers to the end or side of the drug delivery device that is relatively close to the operator when in use, and the distal end or the distal side refers to the end or side of the drug delivery device that is relatively far from the operator when in use. Specifically, the proximal end is the relative left side of each figure, and the distal end is the relative right side of each figure.

[0045] The drug delivery device includes a first tube 100 and a second tube 200. The first tube 100 provides a guidewire cavity 110. The second tube 200 is sleeved on the outer circumference of the first tube 100, the distal end of the second tube 200 is fixed to the distal end of the first tube 100, the proximal end of the second tube 200 is slidably matched with the proximal end of the first tube 100, and the distal end of the second tube 200 includes a drug-carrying section 210 for coating the drug on the outer circumference. The drug-carrying section 210 is made of a deformable material. The drug-carrying section 210 is a deformable structure that can expand radially outward after axial stacking. The drug-carrying section 210 has an initial state and a working state. The initial state is as follows: Figure 3 As shown, the drug-carrying section 210 is attached to the first tube 100; the working state is as follows Figure 2 As shown, the drug-carrying section 210 expands radially outward relative to the initial state. The second tube 200 moves relative to the first tube 100 to change the state of the drug-carrying section 210. In the initial state, the axial circumferential wall of the drug-carrying section 210 is flat; in the working state, the drug-carrying section 210 is folded in the axial direction, and the folded area expands radially outward to form a columnar capsule.

[0046] In this embodiment, the guidewire cavity 110 can be used for the guidewire 101 to pass through, and the first tube 100 can reach the desired position, such as the lesion of the blood vessel in the body, through the guidewire cavity 110 along the intervention path provided by the guidewire. The second tube 200 can arrive at the desired position at the same time as the first tube 100. The second tube 200 moves relative to the first tube 100, for example, the first tube 100 is kept, and the second tube 200 is moved relative to the first tube 100, so as to change the axial stacking of the drug-carrying section 210, and then change the state of the drug-carrying section 210. When the drug-carrying section 210 is in the working state, it expands radially outward and abuts against the wall of the expected position, slowly releasing the coated drug to the blood vessel wall, and the drug is bonded with the protein, amino acid, etc. of the blood vessel wall at the lesion to form an in situ vascular stent.

[0047] The proximal end of the drug loading section 210 is provided with a first developing mark 211, and the first tube is provided with a second developing mark 120 corresponding to the position of the first developing mark 211, which is used to indicate the state of the drug loading section 210. The relative position of the first developing mark 211 and the second developing mark 120 can indicate the current state of the drug loading section 210. The distal end of the first tube is provided with a third developing mark 130.

[0048] See also Figures 4 to 6 The drug delivery device includes a third pipe 300, which is sleeved on the outer circumference of the second pipe 200, and the third pipe 300 is slidably matched with the second pipe 200. The third pipe 300 is used to keep the drug-carrying section 210 in the initial state, and to expose the drug-carrying section 210 after relative movement with the second pipe 200. During the intervention process, the second pipe 200 and the third pipe 300 are accompanied by the first pipe 100 to intervene in the expected position. After reaching the expected position, the third pipe 300 can be withdrawn to expose the drug-carrying section 210. After the exposure is completed, the third pipe 300 can assist the second pipe 200 to change the state of the drug-carrying section 210.

[0049] The drug delivery device includes a fixed handle 410 and a first sliding handle 420. The fixed handle 410 is fixed to the proximal end of the first tube 100, and the fixed handle 410 is provided with a guide wire port 411 connected to the guide wire cavity 110. The first sliding handle 420 is fixed to the proximal end of the second tube 200, and the first sliding handle 420 is sleeved outside the first tube 100 and is located at the distal end of the fixed handle 410. An indication mark 102 is provided at the proximal end of the first tube 100, and the indication mark 102 is used to indicate the sliding distance of the first sliding handle 420 relative to the first tube 100. The drug delivery device includes a second sliding handle 430 connected to the proximal end of the third tube 300. The second sliding handle 430 is sleeved outside the second tube 200 and is located at the distal end of the first sliding handle 420.

[0050] The second tube 200 moves relative to the first tube 100 to change the state of the drug-carrying section 210. Either of the following two methods can be used. The first method is that the second tube 200 moves relative to the first tube 100 to switch the drug-carrying section 210 from the working state to the initial state, and vice versa.

[0051] The second way is that the drug-carrying section 210 is a pre-shaped material and is configured to have a tendency to recover to a working state in a body temperature range. When the drug-carrying section 210 is exposed to a desired position, the drug-carrying section 210 recovers to a working state at a human body temperature to form an in-situ vascular stent.

[0052] The method of switching the drug-carrying section 210 from the working state to the initial state includes the following first method and / or second method, and the first method and the second method can be cycled alternately: the first method: the second tube 200 and the first tube 100 are moved relative to each other, for example, the second tube 200 is withdrawn relative to the first tube 100 to pull the drug-carrying section 210, and the drug-carrying section 210 is switched from the working state to the initial state. The second method: the third tube 300 is moved relative to the second tube 200, for example, the third tube 300 is pushed relative to the second tube 200 to wrap the drug-carrying section 210, and the drug-carrying section 210 is switched from the working state to the initial state.

[0053] See also Figure 7 In one embodiment, the drug delivery device includes an auxiliary wire 500 for assisting in changing the state of the drug carrying segment 210, and the two ends of the auxiliary wire 500 are respectively fixed to the proximal end and the distal end of the drug carrying segment 210. The auxiliary wire 500 includes a plurality of wires arranged in parallel in the circumferential direction, and is used to assist in driving the drug carrying segment 210 to switch from the initial state to the working state.

[0054] The auxiliary wire 500 is a thermosensitive material or a pre-shaped memory metal material. When the memory metal material is used, each auxiliary wire 500 is pre-shaped into an arc shape, and the arc gradually decreases with the withdrawal of the second pipe 200. When the thermosensitive material is used, the second pipe 200 is embedded with a heating wire to change the temperature of the thermosensitive material to achieve the state switching of the auxiliary wire 500. At the same time, the first sliding handle is provided with a circuit interface for supplying energy to the heating wire.

[0055] An embodiment of the present application provides a drug delivery system, which includes a drug delivery device for forming a vascular in situ stent provided in each embodiment of the present application, and a drug coated on the periphery of a drug-carrying segment, wherein the drug is at least one of an anti-proliferative drug, a drug that induces collagen or elastin cross-linking, and an anti-vasospasm drug.

[0056] The technical features of the above-mentioned embodiments can be combined arbitrarily. To make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification. When the technical features in different embodiments are embodied in the same figure, it can be regarded that the figure also discloses the combination examples of the various embodiments involved.

[0057] The above-mentioned embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the patent application. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application.

Claims

1. A drug delivery device for forming an in situ stent in a blood vessel, It is characterized in that Having opposing proximal and distal ends, the drug delivery device comprises: A first tube member provides a guidewire lumen; The second tube is sleeved on the outer circumference of the first tube, the distal end of the second tube is fixed to the distal end of the first tube, the proximal end of the second tube is slidably matched with the proximal end of the first tube, the distal end of the second tube includes a drug-carrying section for coating the drug on the outer circumference, the drug-carrying section is made of a deformable material, the drug-carrying section is a deformable structure that can be radially expanded after axial stacking, and the drug-carrying section has: Initial state, attached to the first pipe; Working state, radial expansion relative to the initial state; The second tube member moves relative to the first tube member to change the state of the drug-carrying section.

2. The drug delivery device according to claim 1, It is characterized in that The drug delivery device comprises: A fixed handle fixed to the proximal end of the first tube, the fixed handle being provided with a guide wire port communicating with the guide wire cavity; The first sliding handle is fixed to the proximal end of the second tube, and the first sliding handle is sleeved on the outside of the first tube and is located at the distal end side of the fixed handle.

3. The drug delivery device according to claim 2, It is characterized in that The proximal end of the drug-carrying section is provided with a first developing mark, and the first tube is provided with a second developing mark corresponding to the position of the first developing mark and used to indicate the state of the drug-carrying section; A third developing mark is arranged at the distal end of the first tube.

4. The drug delivery device according to claim 3, It is characterized in that An indication mark is arranged at the proximal end of the first tube, and the indication mark is used to indicate the sliding distance of the first sliding handle relative to the first tube.

5. The drug delivery device according to claim 2, It is characterized in that The drug delivery device comprises: The third tube is sleeved on the outer circumference of the second tube, and the third tube is slidably matched with the second tube. The third tube is used to keep the drug-carrying section in the initial state and to expose the drug-carrying section after relative movement with the second tube.

6. The drug delivery device according to claim 5, It is characterized in that The second sliding handle is connected to the proximal end of the third tube. The second sliding handle is sleeved outside the second tube and is located at the distal end side of the first sliding handle.

7. The drug delivery device according to claim 1, It is characterized in that The second tube member moves relative to the first tube member to switch the drug-carrying section from the working state to the initial state, and vice versa.

8. The drug delivery device according to claim 1, It is characterized in that The drug-carrying section is a pre-shaped material, and the deformable member is configured to have a tendency to return to the working state in a body temperature range; The second tube member moves relative to the first tube member to switch the drug-carrying section from the working state to the initial state.

9. The drug delivery device according to claim 1, It is characterized in that In the initial state, the axial peripheral wall of the drug-carrying section is flat; in the working state, the drug-carrying section is folded in the axial direction, and the folded area is radially expanded outward to form a columnar capsule.

10. Drug delivery systems, It is characterized in that It comprises a drug delivery device for forming a vascular in situ stent as described in any one of claims 1 to 9, and a drug coated on the periphery of the drug-carrying section, wherein the drug is at least one of an anti-proliferative drug, a drug that induces collagen or elastin cross-linking, and an anti-vasospasm drug.

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