Peripheral shockwave balloon system

Abstract

This invention discloses a peripheral shockwave balloon system, belonging to the field of medical devices. It includes a control unit, a handle, a balloon, a dressing mechanism, and a catheter. One end of the catheter slides through the dressing mechanism and connects to the handle. The other end of the handle is connected to the control unit, and the other end of the catheter extends into and connects to the balloon. The dressing mechanism is located on one side of the control unit. This invention enables rapid drug delivery after the balloon reaches the lesion site, avoiding the limitations of traditional balloons that rely on surface coatings or a single chamber to hold the drug, thus ensuring the amount of drug delivered. The dressing mechanism also allows for rapid flushing and dressing changes after a single drug administration, facilitating precise control of the delivery sequence and dosage of multiple drugs according to treatment needs during combined drug administration.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically a peripheral shockwave balloon system. Background Technology

[0002] Peripherally used shockwave balloon systems are primarily used for shockwave therapy of calcification in peripheral arteries. Vascular calcification is a lesion in which calcium deposits on the vessel wall, leading to hardening of the vessel wall and reduced compliance. Shockwave balloon systems deliver pulsed sound pressure waves to the calcified site through a balloon catheter, "loosening" the calcified plaque and restoring the vessel's elasticity and blood flow. In this process, drug-coated technology distributes the drug evenly on the surface of the balloon catheter, and then the balloon delivers the drug directly to the lesion site, effectively inhibiting excessive proliferation of smooth muscle cells and reducing the risk of restenosis.

[0003] The invention patent with publication number CN115463321B can store drugs between a first balloon and a second balloon. It uses a microneedle structure to puncture the first balloon and penetrate the tunica media of the blood vessel wall to allow the first drug to enter the lesion site. Although this can improve the drug delivery effect, the technology is highly complex. If not properly controlled, it can easily lead to balloon rupture or drug leakage, which will affect the surgical outcome. At the same time, because the position and depth of the microneedle puncturing the tunica media of the blood vessel wall are different, the drug distribution at the lesion site will be uneven, making it impossible to achieve precise drug delivery and affecting the treatment effect. In the case of multi-type drug delivery, the drug is coated on the imaging material coating, resulting in a limited amount of drug delivery, and the punctured balloon cannot be reused.

[0004] Therefore, it is necessary to provide a peripheral shockwave balloon system to solve the problems mentioned in the background art. Summary of the Invention

[0005] To achieve the above objectives, the present invention provides the following technical solution: a peripheral shockwave balloon system, comprising a control unit, a handle seat, a balloon, a dressing mechanism, and a catheter, one end of which slides through the dressing mechanism and is connected to the handle seat, the other end of which is connected to the control unit, and the other end of which extends into the balloon and is connected to the balloon.

[0006] The catheter is provided with a guidewire lumen and a fluid delivery lumen. The handle seat is provided with multiple interfaces, two of which are respectively connected to the guidewire lumen and the fluid delivery lumen. An electrode unit is provided on the catheter in the balloon, and the electrode unit includes at least one electrode.

[0007] Furthermore, as a preferred embodiment, the balloon has a tip at the end away from the catheter, and the balloon wall is composed of a combination of a hard wall layer and a soft wall layer, with the hard wall layer and the soft wall layer being distributed alternately.

[0008] The soft wall layer is squeezed inward toward the balloon axis as the balloon contracts, forming a cylindrical drug cavity;

[0009] The inner wall of the hard wall layer has symmetrical slots on the left and right sides, and magnetic strips are inserted into the slots.

[0010] Furthermore, as a preferred embodiment, the soft wall layer of the balloon is uniformly distributed with multiple convex shafts along the axial direction of the balloon, and each convex shaft is embedded and fixed in the soft wall layer. When the soft wall layer is compressed and retracted, the convex shafts divide the cylindrical drug cavity into intervals.

[0011] Furthermore, as a preferred embodiment, the catheter is slidably provided with two bushings inside the balloon, the two bushings are fixed together by a bracket, and an expansion balloon is also sleeved between the bushings; an outer sheath is slidably sleeved on the outside of the catheter, a slip ring is fixed at the end of the balloon away from the tip, the outer sheath is slidably connected to the slip ring in a sealing manner, and one end of the outer sheath is connected to one of the bushings;

[0012] The bushing has multiple air channels, and the outer sheath is connected to the expansion airbag through the air channels.

[0013] Furthermore, preferably, the dressing change mechanism includes:

[0014] A housing with an outer base on one side, and a shaft cylinder is horizontally fixed between the housing and the outer base;

[0015] The feeding pipe channel is vertically installed inside the machine housing. The feeding pipe channel is configured as a 90° bent pipe structure. A shaft tube is rotatably connected to the side of the machine housing near the shaft cylinder. One end of the shaft tube is sealed and connected to the feeding pipe channel.

[0016] The outlet pipe channel is horizontally installed in the outdoor unit base, and the outlet pipe channel and the shaft tube are concentrically arranged.

[0017] Infusion tube one and infusion tube two are both installed in the outdoor unit base, and one end of each of the infusion tube one and infusion tube two is connected to the shaft cylinder;

[0018] The drain pipe is located inside the lower part of the outdoor unit base;

[0019] The inner disc is coaxially fixed on the shaft tube and located in the shaft cylinder, and a cleaning brush plate is horizontally fixed on the inner disc.

[0020] Furthermore, as a preferred embodiment, the outer casing is also provided with a flushing pipe that communicates with the shaft tube; the housing is provided with a drive unit, the output end of which is connected to the shaft tube for transmission through gear meshing.

[0021] Furthermore, as a preferred embodiment, a guide wheel seat is also fixed inside the housing on the pipe delivery channel, and multiple pipe delivery wheels are symmetrically rotatably connected to the guide wheel seat.

[0022] Furthermore, as a preferred embodiment, a brush plate is horizontally slidably mounted on the cleaning brush plate, a connecting sleeve is fixed to one end of the brush plate, and a guide shaft is rotatably connected to one end of the cleaning brush plate near the connecting sleeve, with one end of the guide shaft extending into and connected to the connecting sleeve.

[0023] A shaft pin is vertically fixed on the guide shaft, and a corrugated groove is provided on the inner wall of the connecting sleeve. The shaft pin is slidably connected to the corrugated groove.

[0024] Furthermore, as a preferred embodiment, a transmission tooth is coaxially fixed on the guide shaft, and a ring tooth is fixed on the inner wall of the shaft cylinder, wherein the transmission tooth meshes with the ring tooth.

[0025] Compared with the prior art, the beneficial effects of the present invention are:

[0026] The balloon used in this invention is composed of a combination of hard and soft wall layers. Therefore, during balloon contraction, the soft wall layer can be compressed inwards towards the balloon axis to form cylindrical drug-eluting chambers. Multiple cylindrical drug-eluting chambers can temporarily store the medication, enabling rapid drug delivery once the balloon reaches the lesion site. This avoids the limitations of traditional balloons that rely on surface coatings or single chambers to carry the drug, ensuring sufficient drug delivery. The balloon also includes an expansion balloon, which allows for on-demand drug release, adjusting the release location and dosage according to the specific condition of the lesion site for more precise local drug delivery. Furthermore, a dressing-changing mechanism allows for rapid flushing and dressing changes after a single drug administration, facilitating precise control of the delivery order and dosage of multiple drugs in combined administration, avoiding cross-contamination or adverse reactions between different drugs. Attached Figure Description

[0027] Figure 1 This is a schematic diagram of the overall structure of the present invention;

[0028] Figure 2 This is a schematic diagram of the internal structure of the balloon in this invention;

[0029] Figure 3 This is a schematic diagram of the cross-sectional structure of the balloon in the contracted state in this invention;

[0030] Figure 4 This is a schematic diagram of the balloon structure in its inflated state according to the present invention;

[0031] Figure 5 This is a schematic diagram of the distribution structure of the convex shaft in the balloon under contraction state in this invention;

[0032] Figure 6 This is a schematic diagram of the internal structure of the dressing change mechanism in this invention;

[0033] Figure 7This is a schematic diagram of the structure of infusion tube one, infusion tube two, and drain tube in this invention;

[0034] Figure 8 This is a partial structural diagram of the cleaning brush plate and the bristle brush plate in this invention;

[0035] Figure 9 for Figure 6 Enlarged schematic diagram of the structure at point A in the middle;

[0036] Figure 10 This is a schematic diagram of the overall structure of the balloon during drug delivery in this invention;

[0037] In the diagram: 1. Catheter; 11. Control unit; 12. Handle seat; 13. Electrode unit; 14. Tip; 2. Balloon; 21. Hard wall layer; 22. Soft wall layer; 23. Cylindrical drug chamber; 24. Slot; 25. Magnetic strip; 26. Convex shaft; 3. Drug changing mechanism; 31. Housing; 32. External base; 33. Shaft cylinder; 34. Infusion channel; 35. Shaft tube; 36. Outlet channel; 37. Infusion tube one; 38. Infusion tube two; 39. Drain tube; 4. Outer sheath; 41. Bushing; 42. Support; 43. Expansion airbag; 44. Slip ring; 45. Airway; 5. Inner disc; 51. Cleaning brush plate; 52. Brush plate; 53. Connecting shaft sleeve; 54. Guide shaft; 55. Transmission gear; 56. Ring gear; 6. Guide wheel seat; 61. Infusion wheel; 62. Drive unit. Detailed Implementation

[0038] Please see Figures 1-10 In this embodiment of the invention, a peripheral shockwave balloon system includes a control unit 11, a handle seat 12, a balloon 2, a dressing mechanism 3, and a catheter 1. One end of the catheter 1 slides through the dressing mechanism 3 and is connected to the handle seat 12. The other end of the handle seat 12 is connected to the control unit 11. The control unit 11 is used to start, stop, and adjust the intensity, frequency, and other parameters of the shockwave. The other end of the catheter 1 extends into the balloon 2 and is connected to the balloon 2.

[0039] The catheter 1 has a guidewire lumen and a fluid delivery lumen. The handle seat 12 has multiple interfaces, two of which are respectively connected to the guidewire lumen and the fluid delivery lumen. The fluid delivery lumen is used to inject fluid into the balloon 2 to inflate it. It can also be used to withdraw fluid after treatment to shrink the balloon, making it easier to withdraw the device. The fluid delivery lumen is also used to inject contrast agent to help doctors observe the position and state of the balloon and its effect on surrounding tissues more clearly through imaging equipment. An electrode unit 13 is provided on the catheter 1 inside the balloon 2. The electrode unit 13 includes at least one electrode.

[0040] The dressing change mechanism 3 is used to change the balloon 2 with various types of drugs, which facilitates the combined administration of multiple drugs for treatment.

[0041] In this embodiment, a tip 14 is provided at one end of the balloon 2 away from the catheter 1, and the balloon wall of the balloon 2 is composed of a hard wall layer 21 and a soft wall layer 22, with the hard wall layer 21 and the soft wall layer 22 distributed alternately.

[0042] The soft wall layer 22 is compressed inward toward the axis of the balloon 2 as the balloon 2 contracts, forming a cylindrical drug cavity 23; the multiple cylindrical drug cavities 23 are distributed in a circular pattern, which can maximize the drug storage capacity in a limited space, while the overall structure of the balloon 2 is compact, making it easy to operate and use;

[0043] The inner wall of the hard wall layer 21 has symmetrical slots 24 on the left and right sides. Magnetic strips 25 are inserted into the slots 24. The magnetic strips 25 can attract each other with opposite polarities, thereby achieving overall sealing of the cylindrical drug cavity 23 in the balloon 2 for drug storage and preventing drug leakage.

[0044] In a preferred embodiment, the soft wall layer 22 of the balloon 2 is uniformly distributed with multiple convex shafts 26 along the axial direction of the balloon 2. Each convex shaft 26 is embedded and fixed within the soft wall layer 22. When the soft wall layer 22 is compressed and retracted, the convex shafts 26 divide the cylindrical drug-eluting cavities 23 at intervals. The convex shafts 26, on the one hand, can provide mechanical stimulation to the blood vessel wall or diseased tissue during the full expansion of the balloon 2, helping to improve local blood circulation and promote drug absorption; on the other hand, they can increase the friction between the balloon 2 and the blood vessel wall, preventing the balloon 2 from sliding or shifting during expansion, thereby ensuring the stability and precision of the treatment process. On the other hand, the convex shafts 26 can divide the cylindrical drug-eluting cavities 23 at intervals during the full contraction of the balloon 2, making the cylindrical drug-eluting cavities 23 evenly divided into multiple drug delivery points, facilitating precise control of the drug release location and dosage, and reducing the possibility of drug overdose or underdose caused by a single drug delivery point, effectively reducing drug waste; thus achieving uniform drug distribution and precise control.

[0045] In this embodiment, two bushings 41 are slidably disposed on the catheter 1 inside the balloon 2. The two bushings 41 are fixed together by a bracket 42, and an expansion balloon 43 is also sleeved between the bushings 41. An outer sheath 4 is slidably sleeved on the outside of the catheter 1. A slip ring 44 is fixed at one end of the balloon 2 away from the tip 14. The outer sheath 4 and the slip ring 44 are slidably and sealingly connected, and one end of the outer sheath 4 is connected to one of the bushings 41.

[0046] The bushing 41 has multiple airways 45 inside, and the outer sheath 4 is connected to the expansion balloon 43 through the airways 45. The other end of the outer sheath 4 can be connected to the interface of the handle seat 12. Therefore, the air pressure regulating device connected to the interface can adjust the expansion of the expansion balloon 43 through the outer sheath 4. Specifically, when the balloon 2 reaches the designated drug delivery position, the outer sheath 4 slides and adjusts the expansion balloon 43 to be located at the relevant drug delivery point of the balloon 2. At this time, the expansion balloon 43 can squeeze out the drug at the relevant position in the cylindrical drug cavity 23 during expansion, thereby adjusting the position and dosage of drug release based on the specific situation of the lesion site, and achieving a more precise local drug delivery treatment effect.

[0047] In this embodiment, the dressing change mechanism 3 includes:

[0048] A housing 31 has an outer base 32 on one side, and a shaft cylinder 33 is horizontally fixed between the housing 31 and the outer base 32.

[0049] The pipe feeding channel 34 is vertically installed inside the housing 31. The pipe feeding channel 34 is configured as a 90° bent pipe structure. The guide tube 1 can slide through the pipe feeding channel 34. A shaft tube 35 is rotatably connected to the side of the housing 31 near the shaft cylinder 33. One end of the shaft tube 35 is sealed and connected to the pipe feeding channel 34.

[0050] The outlet pipe channel 36 is horizontally arranged in the outdoor unit base 32, and the outlet pipe channel 36 and the shaft tube 35 are concentrically arranged.

[0051] Infusion tube 1 37 and infusion tube 2 38 are both installed in the external unit base 32. One end of each infusion tube 1 37 and infusion tube 2 38 is connected to the shaft cylinder 33. Infusion tube 1 37 and infusion tube 2 38 can deliver different types of drugs to the shaft cylinder 33. Therefore, during the drug delivery process, when the balloon 2 is located in the shaft cylinder 33, the balloon 2 is in an inflated state. The corresponding drug is delivered to the shaft cylinder 33 through infusion tube 1 37 or infusion tube 2 38, so that the drug submerges the balloon 2. Then the balloon 2 gradually contracts to achieve drug storage.

[0052] Drain pipe 39 is located inside the lower part of the outdoor unit base 32;

[0053] The inner disc 5 is coaxially fixed on the shaft tube 35 and located in the shaft cylinder 33. A cleaning brush plate 51 is horizontally fixed on the inner disc 5.

[0054] In this embodiment, the outer base 32 is also provided with a flushing pipe that is connected to the shaft tube 35; the flushing pipe is used to rinse the surface of the balloon 2 with clean water. The housing 31 is provided with a drive unit 62. The output end of the drive unit 62 is connected to the shaft tube 35 through gear meshing, so that the shaft tube 35 can clean the surface of the balloon 2 through the cleaning brush plate 51 on the inner disk 5 during rotation.

[0055] In a preferred embodiment, a guide wheel seat 6 is also fixed inside the housing 31 on the tube delivery channel 34. Multiple tube delivery wheels 61 are symmetrically rotatably connected to the guide wheel seat 6 to control the traction and recovery of the tube 1, so that the balloon 2 can enter the shaft cylinder 33 autonomously without manual intervention.

[0056] In this embodiment, a brush plate 52 is horizontally slidably mounted on the cleaning brush plate 51. A connecting sleeve 53 is fixed to one end of the brush plate 52. A guide shaft 54 ​​is rotatably connected to one end of the cleaning brush plate 51 near the connecting sleeve 53. One end of the guide shaft 54 ​​extends into and is connected to the connecting sleeve 53.

[0057] A shaft pin is vertically fixed on the guide shaft 54, and a corrugated groove is provided on the inner wall of the connecting sleeve 53. The shaft pin is slidably connected to the corrugated groove, so that the connecting sleeve 53 can reciprocate and slide through the sliding action of the shaft pin and the corrugated groove while the guide shaft 54 ​​is continuously rotating, so that the brush plate 52 can efficiently clean the entire surface of the balloon 2.

[0058] In this embodiment, a transmission tooth 55 is coaxially fixed on the guide shaft 54, and a ring tooth 56 is fixed on the inner wall of the shaft cylinder 33, wherein the transmission tooth 55 meshes with the ring tooth 56.

[0059] The above description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. A peripheral shockwave balloon system comprising a control unit (11), a handle seat (12), a balloon (2), a dressing mechanism (3), and a catheter (1), characterized in that: One end of the catheter (1) slides through the dressing change mechanism (3) and is connected to the handle seat (12), the other end of the handle seat (12) is connected to the control unit (11), and the other end of the catheter (1) extends into the balloon (2) and is connected to the balloon (2). The catheter (1) is provided with a guidewire cavity and a liquid delivery cavity. The handle seat (12) is provided with multiple interfaces, two of which are respectively connected to the guidewire cavity and the liquid delivery cavity. An electrode unit (13) is provided on the catheter (1) in the balloon (2). The electrode unit (13) includes at least one electrode. The balloon (2) is provided with a tip (14) at one end away from the catheter (1). The balloon (2) is composed of a hard wall layer (21) and a soft wall layer (22), and the hard wall layer (21) and the soft wall layer (22) are distributed alternately. The soft wall layer (22) is squeezed inward toward the axis of the balloon (2) as the balloon (2) contracts and forms a cylindrical drug cavity (23); The inner wall of the hard wall layer (21) is symmetrically provided with slots (24) on the left and right sides, and a magnetic strip (25) is inserted into the slot (24); The soft wall layer (22) of the balloon (2) has a plurality of protruding shafts (26) evenly distributed along the axial direction of the balloon (2). Each of the protruding shafts (26) is embedded and fixed in the soft wall layer (22). When the soft wall layer (22) is squeezed inward, the protruding shafts (26) divide the cylindrical drug cavity (23) into intervals. The catheter (1) has two bushings (41) that slide inside the balloon (2). The two bushings (41) are fixed together by a bracket (42), and an expansion balloon (43) is also fitted between the bushings (41). An outer sheath (4) is slidably fitted outside the catheter (1). A slip ring (44) is fixed at one end of the balloon (2) away from the tip (14). The outer sheath (4) is slidably connected to the slip ring (44) in a sealed manner, and one end of the outer sheath (4) is connected to one of the bushings (41). The bushing (41) has multiple air passages (45) inside, and the outer sheath (4) is connected to the expansion airbag (43) through the air passages (45).

2. The peripheral shockwave balloon system according to claim 1, characterized in that: The dressing change mechanism (3) includes: A housing (31) has an outer base (32) on one side, and a shaft cylinder (33) is horizontally fixed between the housing (31) and the outer base (32); The pipe feeding channel (34) is vertically installed inside the housing (31). The pipe feeding channel (34) is configured as a 90° bent pipe structure. A shaft tube (35) is rotatably connected to the side of the housing (31) near the shaft cylinder (33). One end of the shaft tube (35) is sealed and connected to the pipe feeding channel (34). The outlet pipe channel (36) is horizontally arranged in the outdoor unit base (32), and the outlet pipe channel (36) and the shaft tube (35) are concentric. Infusion tube one (37) and infusion tube two (38) are both installed in the outdoor unit base (32), and one end of infusion tube one (37) and infusion tube two (38) are connected to the shaft cylinder (33); The drain pipe (39) is located inside the lower part of the outdoor unit base (32); The inner disc (5) is coaxially fixed on the shaft tube (35) and located in the shaft cylinder (33). A cleaning brush plate (51) is horizontally fixed on the inner disc (5).

3. The peripheral shockwave balloon system according to claim 2, characterized in that: The outer base (32) is also provided with a flushing pipe that communicates with the shaft tube (35); the housing (31) is provided with a drive unit (62), and the output end of the drive unit (62) is connected to the shaft tube (35) for transmission through gear meshing.

4. The peripheral shockwave balloon system according to claim 2, characterized in that: Inside the housing (31), a guide wheel seat (6) is fixed on the pipe delivery channel (34), and multiple pipe delivery wheels (61) are symmetrically rotatably connected to the guide wheel seat (6).

5. The peripheral shockwave balloon system according to claim 2, characterized in that: A brush plate (52) is horizontally slidably mounted on the cleaning brush plate (51). A connecting sleeve (53) is fixed to one end of the brush plate (52). A guide shaft (54) is rotatably connected to one end of the cleaning brush plate (51) near the connecting sleeve (53). One end of the guide shaft (54) extends into and is connected to the connecting sleeve (53). A shaft pin is vertically fixed on the guide shaft (54), and a corrugated groove is provided on the inner wall of the connecting sleeve (53), and the shaft pin is slidably connected to the corrugated groove.

6. The peripheral shockwave balloon system according to claim 5, characterized in that: A transmission tooth (55) is coaxially fixed on the guide shaft (54), and a ring tooth (56) is fixed on the inner wall of the shaft cylinder (33). The transmission tooth (55) meshes with the ring tooth (56).

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