Peripheral shock wave balloon system

Abstract

The invention discloses a peripheral shock wave balloon system, and belongs to the field of medical technical instruments.The peripheral shock wave balloon system comprises a control unit, a handle seat, a balloon, a dressing change mechanism and a catheter, one end of the catheter penetrates through the dressing change mechanism in a sliding mode and is connected with the handle seat, and the other end of the handle seat is connected with the control unit; the other end of the catheter extends into the balloon and is connected with the balloon; the dressing change mechanism is positioned on one side of the control unit; according to the invention, rapid drug delivery can be realized after the balloon reaches a diseased region, the limitation that a traditional balloon needs to depend on a surface coating or a single chamber to carry drugs is avoided, and the drug delivery amount is ensured; meanwhile, the arranged medicine changing mechanism can be used for rapidly washing and changing medicine for the balloon after the balloon completes single-time medicine feeding, and the delivery sequence and dosage of the medicine can be accurately controlled according to treatment requirements in combined medicine feeding of multiple types of medicine conveniently.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, in particular to a peripheral shock wave balloon system. Background Art

[0002] The peripheral shock wave balloon system is primarily used for shock wave therapy of peripheral arterial calcification. Vascular calcification is a condition in which calcium deposits in the blood vessel wall, causing the wall to harden and reduce compliance. The shock wave balloon system delivers pulsed acoustic pressure waves to the calcified area through a balloon catheter, "shaking" the calcified plaque loose, restoring blood vessel elasticity and blood flow. The drug coating technology evenly distributes the drug on the balloon catheter surface, which is then delivered directly to the lesion site by the balloon, effectively inhibiting excessive smooth muscle cell proliferation and reducing the risk of restenosis.

[0003] For example, the invention patent with publication number CN115463321B can store drugs between a first balloon and a second balloon, and use 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 improperly controlled, it can easily lead to balloon rupture or drug leakage, thereby affecting the surgical effect. At the same time, due to differences in the position and depth of the microneedle penetration into the tunica media of the blood vessel wall, the drug will be unevenly distributed in the lesion site, making it impossible to achieve accurate drug delivery and affecting the treatment effect. In the administration of multiple types of drugs, since the drugs are coated on the developing material coating, the amount of drug delivery is limited, and the punctured balloon cannot be recycled.

[0004] Therefore, it is necessary to provide a peripheral shock wave balloon system to solve the problems raised in the above background technology. Summary of the Invention

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

[0006] A guidewire cavity and a liquid delivery cavity are provided in the catheter, and a plurality of interfaces are provided on the handle seat, two of which are respectively connected to the guidewire cavity and the liquid delivery cavity; an electrode unit is provided in the balloon on the catheter, and the electrode unit includes at least one electrode.

[0007] Furthermore, preferably, a tip is provided on the end of the balloon away from the catheter, and the balloon wall is composed of a hard wall layer and a soft wall layer, and the hard wall layer and the soft wall layer are spaced apart.

[0008] The soft wall layer is squeezed and retracted toward the balloon axis as the balloon contracts to form a cylindrical medicine cavity;

[0009] The inner wall of the hard wall layer is provided with slots symmetrically on the left and right, and magnetic strips are inserted into the slots.

[0010] Furthermore, preferably, the soft wall layer of the balloon has a plurality of convex shafts evenly distributed along the axial direction of the balloon, each of the convex shafts is embedded and fixed in the soft wall layer, and the convex shafts divide the cylindrical medicine cavity into intervals when the soft wall layer is squeezed and retracted.

[0011] Furthermore, preferably, the catheter is provided with two bushings slidingly disposed in the balloon, the two bushings being fixed to each other by a bracket, and an expansion balloon being sleeved between the bushings; the outer sliding sleeve of the catheter is provided with an outer sheath, an end of the balloon away from the tip is fixed with a slip ring, the outer sheath is sealingly and slidingly connected to the slip ring, and one end of the outer sheath is connected to one of the bushings;

[0012] A plurality of air passages are provided in the sleeve, and the outer covering is communicated with the expansion airbag through the air passages.

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

[0014] A casing, one side of which is provided with an outer base, and a shaft cylinder is horizontally fixed between the casing and the outer base;

[0015] A pipe delivery channel is vertically arranged in the housing, and the pipe delivery channel is configured as a 90° elbow structure. A shaft tube is rotatably connected to one side of the housing near the shaft cylinder, and one end of the shaft tube is sealed and communicated with the pipe delivery channel;

[0016] An outlet pipe channel is horizontally arranged in the outer machine base, and the outlet pipe channel and the shaft tube are in a concentric structure;

[0017] The first and second infusion tubes are both arranged in the outer machine base, and one end of each of the first and second infusion tubes is connected to the shaft cylinder;

[0018] A liquid drain pipe is arranged at the lower inner portion of the outer base;

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

[0020] Furthermore, as a preference, a flushing pipe connected to the shaft tube is further provided in the outer base; a driving unit is provided in the casing, and an output end of the driving unit is connected to the shaft tube for transmission through gear meshing.

[0021] Furthermore, as a preference, a guide wheel seat is fixed on the pipe delivery channel in the casing, and a plurality of pipe delivery wheels are symmetrically rotatably connected to the guide wheel seat.

[0022] Further, as a preference, a brush plate is horizontally slidably mounted on the cleaning brush plate, one end of the brush plate is fixed with a coupling sleeve, an end of the cleaning brush plate close to the coupling sleeve is rotatably connected to a guide shaft, one end of the guide shaft extends into and is connected to the coupling sleeve;

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

[0024] Furthermore, preferably, a transmission tooth is coaxially fixed on the guide shaft, and a ring tooth is fixed on the inner wall of the shaft cylinder, and the transmission tooth is meshed with the ring tooth.

[0025] Compared with the prior art, the present invention has the following beneficial effects:

[0026] The balloon used in the present invention is composed of a combination of a hard wall layer and a soft wall layer. Therefore, when the balloon contracts, the soft wall layer can be squeezed inward toward the balloon axis and form a cylindrical medicine cavity. Multiple cylindrical medicine cavities can temporarily store the medicine so that rapid drug delivery can be achieved after the balloon reaches the lesion site, avoiding the limitations of traditional balloons that rely on surface coatings or single chambers to carry medicines, thereby ensuring the amount of medicine applied; an expansion airbag is also provided in the balloon, which can realize the balloon's on-demand release of medicines, so as to adjust the position and dosage of drug release according to the specific conditions of the lesion site, thereby achieving a more precise local drug delivery treatment effect; at the same time, a dressing change mechanism is also provided, which can quickly flush and change the balloon after the balloon completes a single drug delivery, facilitating the precise control of the delivery order and dosage of drugs according to treatment needs in the combined application of multiple types of drugs, thereby avoiding cross-contamination or adverse reactions between different drugs. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0028] Figure 2 Schematic diagram of the internal structure of the balloon in the present invention;

[0029] Figure 3 Schematic diagram of the cross-sectional structure of the balloon in the contracted state according to the present invention;

[0030] Figure 4 This is a schematic diagram of the structure of the balloon in the expanded state of the present invention;

[0031] Figure 5 Schematic diagram of the distribution structure of the convex axis in the balloon in the contracted state of the present invention;

[0032] Figure 6 Schematic diagram of the internal structure of the dressing changing mechanism of the present invention;

[0033] Figure 7Schematic diagram of the structure of the infusion tube 1, the infusion tube 2 and the drainage tube in the present invention;

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

[0035] Figure 9 for Figure 6 A schematic diagram of the structure at center A;

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

[0037] In the figure: 1. catheter; 11. control unit; 12. handle base; 13. electrode unit; 14. tip; 2. balloon; 21. hard wall layer; 22. soft wall layer; 23. cylindrical medicine cavity; 24. slot; 25. magnetic strip; 26. convex shaft; 3. dressing change mechanism; 31. housing; 32. outer base; 33. shaft cylinder; 34. tube delivery channel; 35. shaft tube; 36. tube outlet channel; 37. infusion tube 1; 38. infusion tube 2; 39. drainage tube; 4. outer covering; 41. bushing; 42. bracket; 43. expansion balloon; 44. slip ring; 45. airway; 5. inner disk; 51. cleaning brush plate; 52. brush plate; 53. coupling sleeve; 54. guide shaft; 55. transmission gear; 56. ring gear; 6. guide wheel seat; 61. tube delivery wheel; 62. drive unit. DETAILED DESCRIPTION

[0038] See also Figures 1-10 In an embodiment of the present invention, a peripheral shock wave balloon system includes a control unit 11, a handle base 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 base 12. The other end of the handle base 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 shock wave. The other end of the catheter 1 extends into the balloon 2 and is connected to the balloon 2.

[0039] The catheter 1 is provided with a guidewire cavity and a liquid delivery cavity, and the handle base 12 is provided with multiple interfaces, two of which are respectively connected to the guidewire cavity and the liquid delivery cavity. The liquid delivery cavity is used to inject liquid into the balloon 2 to expand it, and can also be used to extract liquid to shrink the balloon after the treatment is completed, so as to facilitate the withdrawal of the device. The liquid delivery cavity is also used to inject contrast agent to help doctors more clearly observe the position and status of the balloon and its impact on surrounding tissues through imaging equipment; the catheter 1 is provided with an electrode unit 13 located in the balloon 2, and the electrode unit 13 includes at least one electrode;

[0040] The dressing changing mechanism 3 is used to change the various types of drugs applied to the balloon 2, facilitating multi-drug combined medication treatment.

[0041] In this embodiment, a tip 14 is provided on the end of the balloon 2 away from the catheter 1. The balloon wall of 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 spaced apart.

[0042] The soft wall layer 22 is squeezed and retracted toward the axis of the balloon 2 as the balloon 2 contracts, forming a cylindrical medicine cavity 23. The multiple cylindrical medicine cavities 23 are distributed circumferentially, which can maximize the drug storage capacity within a limited space. At the same time, the overall structure of the balloon 2 is compact, which is easy to operate and use.

[0043] The inner wall of the hard wall layer 21 is symmetrically provided with slots 24, and magnetic strips 25 are inserted into the slots 24. The magnetic strips 25 can attract each other with opposite charges, thereby achieving overall sealing of the cylindrical medicine cavity 23 when the balloon 2 is used to store medicine, thereby preventing medicine leakage.

[0044] As a preferred embodiment, the soft wall layer 22 of the balloon 2 has a plurality of convex shafts 26 evenly distributed along the axial direction of the balloon 2, and each of the convex shafts 26 is embedded and fixed in the soft wall layer 22. The convex shafts 26 divide the cylindrical medicine cavity 23 into intervals when the soft wall layer 22 is squeezed and retracted; on the one hand, the convex shafts 26 can produce a certain mechanical stimulation to the blood vessel wall or diseased tissue when the balloon 2 is fully expanded, which helps to improve local blood circulation and promote drug absorption; at the same time, it can also increase the friction between the balloon 2 and the blood vessel wall, preventing the balloon 2 from sliding or shifting during the expansion process, thereby ensuring the stability and accuracy of the treatment process; on the other hand, the convex shafts 26 can divide the cylindrical medicine cavity 23 into intervals when the balloon 2 is fully contracted, so that the cylindrical medicine cavity 23 is evenly divided into multiple drug application points, so as to facilitate the subsequent precise control of the drug release position and dosage, and reduce the overdose or underdose of drugs that may be caused by a single drug application point, effectively reducing drug waste; achieving uniform distribution and precise control of the drug.

[0045] In this embodiment, the catheter 1 is provided with two bushings 41 that slide inside the balloon 2. The two bushings 41 are fixed to each other by a bracket 42, and an expansion balloon 43 is also sleeved between the bushings 41. The catheter 1 is provided with an outer sheath 4 that slides outside. A slip ring 44 is fixed to the end of the balloon 2 away from the tip 14. The outer sheath 4 is sealed and slidably connected to the slip ring 44, and one end of the outer sheath 4 is connected to one of the bushings 41.

[0046] A plurality of air channels 45 are provided in the sleeve 41, and the outer covering 4 is connected to the expansion balloon 43 through the air channels 45; and the other end of the outer covering 4 can be connected to the interface of the handle seat 12, so that the air pressure regulating device connected to the outside of the interface can adjust the expansion and contraction of the expansion balloon 43 through the outer covering 4; specifically, when the balloon 2 reaches the designated drug delivery position, the expansion balloon 43 is slidably adjusted by the outer covering 4 so as to be located at the relevant drug delivery point of the balloon 2. At this time, the expansion balloon 43 can squeeze out the medicine at the relevant position in the cylindrical medicine 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 changing mechanism 3 includes:

[0048] The 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 delivery channel 34 is vertically arranged in the housing 31. The pipe delivery channel 34 is configured as a 90° elbow structure. The catheter 1 can be slidably connected to the pipe delivery 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 delivery channel 34.

[0050] The outlet pipe channel 36 is horizontally arranged in the outer base 32, and the outlet pipe channel 36 and the shaft tube 35 are cocentric;

[0051] Infusion tube 1 37 and infusion tube 2 38 are both disposed within the outer housing 32 , with one end of each of the infusion tubes 1 37 and 2 38 connected to the shaft barrel 33 . Infusion tube 1 37 and infusion tube 2 38 are capable of delivering different types of medications into the shaft barrel 33 . Therefore, during medication delivery, when the balloon 2 is within the shaft barrel 33 , the balloon 2 is inflated, and the corresponding medication is delivered to the shaft barrel 33 via infusion tube 1 37 or infusion tube 2 38 , causing the medication to submerge the balloon 2 . The balloon 2 then gradually deflates to store the medication.

[0052] A drain pipe 39 is provided at the lower inner portion of the outer housing 32;

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

[0054] In this embodiment, a flushing pipe connected to the shaft tube 35 is also provided in the outer base 32; the flushing pipe is used to flush the surface of the balloon 2 with clean water, and a driving part 62 is provided in the casing 31. The output end of the driving part 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] As a preferred embodiment, a guide wheel seat 6 is fixed on the tube delivery channel 34 in the casing 31, and a plurality of tube delivery wheels 61 are symmetrically connected to the guide wheel seat 6 for rotating so as to control the traction and recovery of the catheter 1 and facilitate the autonomous entry of the balloon 2 into the shaft cylinder 33 without manual intervention.

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

[0057] An axle pin is vertically fixed on the guide shaft 54, and a corrugated groove is provided on the inner wall of the coupling sleeve 53. The axle pin is slidably connected to the corrugated groove, so that the reciprocating sliding of the coupling sleeve 53 can be achieved through the sliding action of the axle pin and the corrugated groove during the continuous rotation of the guide shaft 54, 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 , and the transmission tooth 55 is meshed with the ring tooth 56 .

[0059] The above is only a preferred specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any technician familiar with this technical field, within the technical scope disclosed by the present invention, who makes equivalent replacements or changes based on the technical solutions and inventive concepts of the present invention, should be covered by the scope of protection of the present invention.

Claims

1. A peripheral shock wave balloon system comprising a control unit (11), a handle seat (12), a balloon (2), a dressing changing mechanism (3) and a catheter (1), characterized in that: One end of the catheter (1) slides through the dressing changing 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, and the handle seat (12) is provided with a plurality of interfaces, wherein two of the interfaces are respectively connected to the guidewire cavity and the liquid delivery cavity; an electrode unit (13) is provided in the balloon (2) on the catheter (1), and the electrode unit (13) includes at least one electrode; A tip (14) is provided on the 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), and the hard wall layer (21) and the soft wall layer (22) are distributed at intervals.

2. The peripheral shock wave balloon system according to claim 1, characterized in that: The soft wall layer (22) is squeezed and retracted toward the axis of the balloon (2) as the balloon (2) contracts, thereby forming a cylindrical medicine cavity (23); The inner wall of the hard wall layer (21) is provided with slots (24) symmetrically on the left and right, and magnetic strips (25) are inserted into the slots (24).

3. The peripheral shock wave balloon system according to claim 2, characterized in that: The soft wall layer (22) of the balloon (2) is evenly distributed with a plurality of convex shafts (26) along the axial direction of the balloon (2), and each of the convex shafts (26) is embedded and fixed in the soft wall layer (22). When the soft wall layer (22) is squeezed and retracted, the convex shafts (26) divide the cylindrical medicine cavity (23) into intervals.

4. The peripheral shock wave balloon system according to claim 2, characterized in that: The catheter (1) is provided with two bushings (41) which are slidably positioned inside the balloon (2), the two bushings (41) are fixed to each other via a bracket (42), and an expansion airbag (43) is also provided between the bushings (41); an outer sheath (4) is provided on the outer sliding sleeve of the catheter (1), a slip ring (44) is fixed to the end of the balloon (2) away from the tip (14), the outer sheath (4) is sealingly and slidably connected to the slip ring (44), and one end of the outer sheath (4) is connected to one of the bushings (41); A plurality of air passages (45) are provided in the sleeve (41), and the outer covering (4) is communicated with the expansion air bag (43) through the air passages (45).

5. The peripheral shock wave balloon system according to claim 1, characterized in that: The dressing changing mechanism (3) comprises: A casing (31) is provided with an outer base (32) on one side thereof, and a shaft cylinder (33) is horizontally fixed between the casing (31) and the outer base (32); A pipe delivery channel (34) is vertically arranged in the housing (31), and the pipe delivery channel (34) is configured as a 90° elbow structure. A shaft tube (35) is rotatably connected to one side of the housing (31) close to the shaft cylinder (33), and one end of the shaft tube (35) is sealed and communicated with the pipe delivery channel (34); An outlet pipe channel (36) is horizontally arranged in the outer machine base (32), and the outlet pipe channel (36) and the shaft tube (35) are in a concentric structure; The first infusion tube (37) and the second infusion tube (38) are both arranged in the outer machine base (32), and one end of the first infusion tube (37) and the second infusion tube (38) are both connected to the shaft cylinder (33); A liquid discharge pipe (39) is provided at the lower interior of the outer housing (32); The inner disc (5) is coaxially fixed on the shaft tube (35) and is located in the shaft cylinder (33). A cleaning brush plate (51) is horizontally fixed on the inner disc (5).

6. The peripheral shock wave balloon system according to claim 5, characterized in that: A flushing pipe connected to the shaft tube (35) is also provided in the outer machine base (32); a driving part (62) is provided in the machine housing (31), and an output end of the driving part (62) is connected to the shaft tube (35) for transmission through gear meshing.

7. The peripheral shock wave balloon system according to claim 5, characterized in that: A guide wheel seat (6) is fixed on the pipe delivery channel (34) in the casing (31), and a plurality of pipe delivery wheels (61) are symmetrically rotatably connected to the guide wheel seat (6).

8. The peripheral shock wave balloon system according to claim 5, characterized in that: A brush plate (52) is horizontally slidably mounted on the cleaning brush plate (51), a coupling sleeve (53) is fixed to one end of the brush plate (52), and a guide shaft (54) is rotatably connected to one end of the cleaning brush plate (51) close to the coupling sleeve (53), and one end of the guide shaft (54) extends into and is connected to the coupling sleeve (53); An axle pin is vertically fixed on the guide shaft (54), and a corrugated groove is provided on the inner wall of the shaft coupling sleeve (53), and the axle pin is slidably connected to the corrugated groove.

9. The peripheral shock wave balloon system according to claim 8, 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), and the transmission tooth (55) is meshed with the ring tooth (56).

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