Drug delivery device and system
By designing a drug delivery device including deformation parts, the problem of sputtering or dispersion of drug fluid is solved, and the precise sustained release and safety improvement of drug is achieved.
Patent Information
- Application Number
- CN202311606267.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2023-11-27
- Publication Date
- 2025-05-27
AI Technical Summary
After the existing drug delivery device reaches the inner wall of the blood vessel, it may sputter or disperse to an unexpected area, which poses a safety hazard.
A drug delivery device is designed, including a first pipe fitting, a second pipe fitting and a deformation part. The distal end of the second pipe fitting has a deformation structure that can be radially expanded outward. The deformation part uses deformation material, which can be attached to the first pipe fitting in the initial state, expand radially outward when switching to the working state, drives the drug loading section to expand, and abuts against the blood vessel wall to achieve sustained release of the drug.
Through the expansion of deformation parts and the sustained release of the drug, the drug can reach the blood vessel wall more accurately, reducing the impact on undesired areas, and improving safety and therapeutic effects.
Smart Images
Figure CN120037559A_ABST
Abstract
Description
Technical Field
[0001] The present application relates to the technical field of medical devices, and particularly to a drug delivery device and system. Background Art
[0002] Conventional balloon catheters used to form in-situ vascular stents include an inner tube and an outer tube. 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 mated at the proximal end and relatively fixed at the distal end. The inner tube provides a guide wire lumen, and a drug passage lumen is provided between the inner tube and the outer tube. When in use, the drug is inflated at the balloon of the outer tube via a fluid passage.
[0003] The outer tube wall is provided with drug injection holes, which are configured to flow out drug fluid in an inflated state. For example, when the pressure reaches a certain pressure (such as 2-8 ATM), affected by the pressure difference, the drug solution will splash out from the small holes on the balloon surface (such as 0.1-0.2 mm) to the vascular lesion site, so that the drug reacts with the vascular wall to form an in-situ vascular 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 system for the above technical problems.
[0005] The drug delivery device of the present application has opposite proximal and distal ends, and the drug delivery device includes:
[0006] A first pipe fitting, providing a guide wire lumen;
[0007] A second pipe fitting, sleeved on the outer periphery of the first pipe fitting. The distal end of the second pipe fitting is fixed to the distal end of the first pipe fitting. The distal end of the second pipe fitting includes a drug-loading section for coating the drug on the outer periphery. The drug-loading section is a deformable structure that can expand radially outward. The proximal end of the second pipe fitting is slidably mated with the first pipe fitting to adapt to the deformation of the drug-loading section;
[0008] A deformable member, located in the radial gap between the first pipe fitting and the drug-loading section. The deformable member is made of a deformable material, and the deformable member has:
[0009] An initial state, attached to the first pipe fitting;
[0010] A working state, driving the drug-loading section to expand radially outward relative to the initial state.
[0011] The following also provides several optional ways, 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 way can be combined with the above overall solution separately, or multiple optional ways can be combined with each other.
[0012] Optionally, the deformable member is a spiral structure. The distal end of the deformable member is relatively fixed to the distal end of the second pipe fitting. A driving member is connected to the proximal end of the deformable member. A cavity channel is provided between the first pipe fitting and the second pipe fitting. The driving member extends to the proximal end of the drug delivery device through the cavity channel, and the driving member is used to switch the state of the deformable member.
[0013] Optionally, the drug delivery device includes:
[0014] A fixed handle, fixed to the proximal end of the first pipe fitting, and the fixed handle is provided with a wire guide opening communicating with the wire guide cavity;
[0015] A first sliding handle, fixed to the proximal end of the second pipe fitting, and the first sliding handle is sleeved outside the first pipe fitting and is located on the distal side of the fixed handle;
[0016] A second sliding handle, connected to the proximal end of the driving member, and the second sliding handle is sleeved outside the first pipe fitting and is located between the fixed handle and the first sliding handle.
[0017] Optionally, the driving member is a heating wire, the deformable member is made of a thermosensitive deformation material, and the driving member is used to switch the deformable member from the initial state to the working state;
[0018] A circuit interface is provided at the proximal end of the second sliding handle, and the circuit interface is used to supply electric energy to the heating wire.
[0019] Optionally, the heating wire includes a first section arranged in parallel with the deformable member and a second section extending independently.
[0020] Optionally, the driving member is a traction member, the deformable member is a pre-shaped material, and the deformable member is configured to return to the working state in the body temperature range, and the traction member is used to switch the deformable member from the working state to the initial state by traction.
[0021] Optionally, the first pipe fitting is provided with marks for indicating the positions of the first sliding handle and the second sliding handle.
[0022] Optionally, the deformable member includes two parallel rods and forms a double spiral structure.
[0023] Optionally, the drug-loading section is in a flap state in the initial state and is in a columnar sac state in the working state.
[0024] The present application provides a drug delivery system, including the drug delivery device as described in the present application and a drug coated on the outer periphery of the drug-loading section, where the drug is at least one of an anti-proliferative drug, a drug that induces cross-linking of collagen or elastin, and an anti-vascular spasm drug.
[0025] The drug delivery device and system of the present application at least have the following technical effects:
[0026] The guide wire lumen of the present application allows a guide wire to penetrate. The first pipe fitting can reach the expected position along the intervention path provided by the guide wire through the guide wire lumen, such as the lesion of a blood vessel in the body. The second pipe fitting can reach the expected position simultaneously with the first pipe fitting. At this time, the deformable member can be switched to the working state, and after the drug-loading section expands, it abuts against the tube wall at the expected position, and the coated drug is slowly released to the blood vessel tube wall. The drug cross-links with proteins, amino acids, etc. on the blood vessel tube wall at the lesion to form an in-situ vascular stent. Description of the Drawings
[0027] Figure 1 It is a partial structural schematic diagram of the drug delivery device in an embodiment of the present application;
[0028] Figure 2 It is a partial structural schematic diagram of the drug delivery device in an embodiment of the present application;
[0029] Figure 3 It is Figure 2 The structural schematic diagram after omitting the second pipe fitting 200 in
[0030] Figure 4 It is Figure 3 The side view of
[0031] Figure 5 It is a partial structural schematic diagram of the drug delivery device in an embodiment of the present application;
[0032] Figure 6 It is a partial structural schematic diagram of the drug delivery device in an embodiment of the present application (the dotted line indicates the second pipe fitting 200);
[0033] Figure 7 It is a partial structural schematic diagram of the drug delivery device in an embodiment of the present application;
[0034] The descriptions of the reference numerals in the drawings are as follows:
[0035] 100. First pipe fitting; 110. Guide wire cavity; 111. Guide wire; 120. Fixed handle; 130. Working section; 121. Guide wire port; 150. Cavity channel; 200. Second pipe fitting; 201. Drug-carrying section; 210. First sliding handle; 250. Radial clearance; 300. Deformation part; 400. Driving part; 401. First section; 402. Second section; 420. Second sliding handle; 421. Circuit interface; 510. First imaging marker; 520. Second imaging marker. Detailed implementation manners
[0036] 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.
[0037] 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.
[0038] 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.
[0039] In this application, terms such as "first" and "second" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance or implicitly indicating 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, "a plurality of" means at least two, such as two, three, etc., unless otherwise specifically defined.
[0040] In this application, the terms "include" and "have" and any variations thereof are intended to cover non-exclusive inclusion. For example, a system, product, or device that includes a series of units does not necessarily have to be limited to those units clearly listed, but may include other units not clearly listed or inherent to these products or devices.
[0041] In the present application, the terms "corresponding", "matched", "adapted", such as "B corresponding to A", "B matched with A", "A corresponding to B", or "B corresponding to A", indicate that B has a corresponding relationship with the shape, position, or function of A, and B can be determined based on A. Determining B based on A does not mean determining B solely based on A, but B can also be determined based on A and / or other information.
[0042] In an embodiment of the present application, a drug delivery device is provided. The drug delivery device has opposite proximal and distal ends. In each embodiment of the present application, the proximal end refers to the end relatively closer to the operator when the drug delivery device is in use, and the distal end refers to the end relatively farther from the operator when the drug delivery device is in use. Specifically, in each drawing, the left side is the proximal end and the right side is the distal end. The drug delivery device includes a first pipe fitting 100, a second pipe fitting 200, and a deformable member 300.
[0043] See Figures 1 to 5 , the first pipe fitting 100 provides a guide wire cavity 110. The second pipe fitting 200 is sleeved on the outer periphery of the first pipe fitting 100, and the distal end of the second pipe fitting 200 is fixed to the distal end of the first pipe fitting 100. The distal end of the second pipe fitting 200 includes a drug-carrying section 201 for coating the drug on the outer periphery, and the drug-carrying section 201 is a deformable structure that can expand radially outward. The proximal end of the second pipe fitting 200 is slidably engaged with the first pipe fitting 100 to adapt to the deformation of the drug-carrying section 201.
[0044] The deformable member 300 is located in the radial gap 250 between the first pipe fitting 100 and the drug-carrying section 201. The deformable member 300 is made of a deformable material and has an initial state and a working state. The initial state is as Figure 1 and Figure 2 shown, and the working state is as Figure 3 and Figure 4 shown.
[0045] In the initial state, the deformable member 300 adheres to the first pipe fitting 100; in the working state, the deformable member 300 expands radially outward relative to the initial state to drive the drug-carrying section 201 to expand. The drug-carrying section 201 is in a flap state as Figure 1 and Figure 2 shown in the initial state, and the drug-carrying section 201 is in a columnar sac state as Figure 5 shown in the working state.
[0046] In this embodiment, the guide wire lumen allows the guide wire 111 to penetrate. The first pipe fitting 100 can reach the expected position along the intervention path provided by the guide wire 111 through the guide wire lumen, such as the lesion of a blood vessel in the body. The second pipe fitting 200 can reach the expected position simultaneously with the first pipe fitting 100. At this time, the deformable member can be switched to the working state. After the drug-carrying section expands, it abuts against the pipe wall at the expected position, and the coated drug is slowly released to the blood vessel wall. The drug cross-links with proteins, amino acids, etc. on the blood vessel wall at the lesion to form an in-situ vascular stent.
[0047] The drug delivery device includes a driving member 400, and the driving member 400 is connected to the proximal end of the deformable member 300. The deformable member 300 is a spiral structure. The distal end of the deformable member 300 is relatively fixed to the distal end of the second pipe fitting 200. A cavity channel 150 is provided between the first pipe fitting 100 and the second pipe fitting 200. The driving member 400 extends to the proximal end of the drug delivery device through the cavity channel 150. The driving member 400 is used to switch the state of the deformable member 300, such as switching from the initial state to the working state, and / or from the working state to the initial state.
[0048] The first pipe fitting 100 has a working section 130 determined by the drug-carrying section 201, and the radial gap 250 is determined between the working section 130 and the drug-carrying section 201. The proximal and distal ends of the working section 130 are made of imaging material or provided with a first imaging mark 510. The proximal end of the driving member 400 is made of imaging material or provided with a second imaging mark 520. Both the first imaging mark and the second imaging mark are imaging mark rings.
[0049] The deformable member 300 includes two parallel rods, and forms a single spiral structure or a double spiral structure. The deformable member 300 can be made of nitinol wire, and the diameter of the rod is 0.2 - 0.4 mm. For the single spiral structure, the number of spiral coils per unit axial length is different in the initial state and the working state. Specifically, the number of spiral coils is 4 coils / 10 mm in the initial state and 8 coils / 10 mm in the working state.
[0050] The drug delivery device includes a fixed handle 120, a first sliding handle 210, and a second sliding handle 420. Among them, the fixed handle 120 is fixed relative to the first pipe fitting 100, that is, fixed to the proximal end of the first pipe fitting 100. The fixed handle 120 is provided with a guide wire port 121 communicating with the guide wire cavity 110. The first sliding handle 210 is fixed to the proximal end of the second pipe fitting 200 and is slidably engaged with the first pipe fitting 100. The first sliding handle 210 is sleeved outside the first pipe fitting 100 and is located on the distal side of the fixed handle 120. The second sliding handle 420 is connected to the proximal end of the driving member 400. The second sliding handle 420 is sleeved outside the first pipe fitting 100 and is located between the fixed handle 120 and the first sliding handle 210. The first pipe fitting 100 is provided with markings for indicating the positions of the first sliding handle 210 and the second sliding handle 420.
[0051] In some embodiments, the driving member 400 is a heating wire, the deformable member 300 is made of a thermosensitive deformable material, and the driving member 400 is used to switch the deformable member 300 from the initial state to the working state. After the deformable member 300 reaches the expected position, the heating wire transfers heat to the deformable member 300, and the deformable member 300 is deformed by heat and expands radially outward to switch to the working state.
[0052] The proximal end of the second sliding handle 420 is provided with a circuit interface 421, and the circuit interface 421 is used to supply electrical energy to the heating wire. The heating wire includes a first section arranged in parallel with the deformable member 300 and a second section extending independently. Further, if the deformable member 300 has a double helix structure, the first section includes multiple strands arranged in parallel with the double helix structure.
[0053] In some embodiments, the driving member 400 is a traction member, the deformable member 300 is a pre-shaped material, and the deformable member 300 is configured to return to the working state in the body temperature range. The traction member is used to traction-switch the deformable member 300 from the working state to the initial state.
[0054] In an embodiment of the present application, a drug delivery system is provided, including the drug delivery device provided in each embodiment of the present application and a drug coated on the outer periphery of the drug-carrying section. The drug is at least one of an anti-proliferative drug, a drug that induces cross-linking of collagen or elastin, and an anti-vascular spasm drug. Specifically, the drug is paclitaxel or rapamycin.
[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-described embodiments are described. However, as long as the combinations of these technical features do not conflict, they should all be considered as the scope described in this specification. When the technical features in different embodiments are shown in the same drawing, it can be regarded that the drawing also discloses the combination examples of the respective embodiments involved.
[0056] The above-described embodiments merely represent several implementation manners of the present application. The description thereof is relatively specific and detailed, but it should not be construed as a limitation to the scope of the patented 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 fall within the protection scope of the present application.
Claims
1. A drug delivery device, characterized in that, it has opposite proximal and distal ends, and the drug delivery device includes: a first pipe fitting providing a guide wire cavity; a second pipe fitting sleeved on the outer periphery of the first pipe fitting, the distal end of the second pipe fitting being fixed to the distal end of the first pipe fitting, the distal end of the second pipe fitting including a drug-carrying section for coating drugs on the outer periphery, the drug-carrying section being a deformable structure that can expand radially outward, and the proximal end of the second pipe fitting being slidably fitted with the first pipe fitting to adapt to the deformation of the drug-carrying section; a deformable member located in the radial gap between the first pipe fitting and the drug-carrying section, the deformable member being made of a deformable material, and the deformable member having: an initial state, adhering to the first pipe fitting; a working state, driving the drug-carrying section to expand radially outward relative to the initial state.
2. The drug delivery device according to claim 1, characterized in that, the deformable member is a spiral structure, the distal end of the deformable member being relatively fixed to the distal end of the second pipe fitting, a driving member being connected to the proximal end of the deformable member, a cavity channel being provided between the first pipe fitting and the second pipe fitting, and the driving member extending through the cavity channel to the proximal end of the drug delivery device, the driving member being used to switch the state of the deformable member.
3. The drug delivery device according to claim 2, characterized in that, the drug delivery device includes: a fixed handle fixed to the proximal end of the first pipe fitting, the fixed handle being provided with a guide wire opening communicating with the guide wire cavity; a first sliding handle fixed to the proximal end of the second pipe fitting, the first sliding handle being sleeved outside the first pipe fitting and located on the distal side of the fixed handle; a second sliding handle connected to the proximal end of the driving member, the second sliding handle being sleeved outside the first pipe fitting and located between the fixed handle and the first sliding handle.
4. The drug delivery device according to claim 3, characterized in that, the driving member is a heating wire, the deformable member being made of a thermosensitive deformable material, and the driving member being used to switch the deformable member from the initial state to the working state; a circuit interface is provided at the proximal end of the second sliding handle, and the circuit interface is used to supply electrical energy to the heating wire.
5. The drug delivery device according to claim 4, characterized in that, the heating wire includes a first section arranged in parallel with the deformable member and a second section extending independently.
6. The drug delivery device according to claim 3, characterized in that, the driving member is a traction member, the deformable member being a pre-shaped material, and the deformable member being configured to return to the working state in the body temperature range, and the traction member being used to switch the deformable member from the working state to the initial state by traction.
7. The drug delivery device according to claim 3, characterized in that, the first pipe fitting is provided with marks for indicating the positions of the first sliding handle and the second sliding handle.
8. The drug delivery device according to claim 2, characterized in that, the deformable member includes two parallel rods and forms a double spiral structure.
9. The drug delivery device according to claim 1, characterized in that, The drug-loading section is in a petal-fold state in the initial state and is in a columnar sac state in the working state.
10. A drug delivery system characterized in that it includes the drug delivery device according to any one of claims 1 to 9, and a drug coated on the outer periphery of the drug-loading section, and the drug is at least one of an anti-proliferative drug, a drug that induces cross-linking of collagen or elastin, and an anti-vascular spasm drug.