Cavity targeted pulse therapy device

Abstract

The invention relates to a cavity targeted pulse therapy device, belongs to the technical field of medical instruments, and solves the problems that in the prior art, a shock wave balloon catheter is poor in passing ability, and calcification lesions which cannot be passed by the balloon catheter cannot be effectively treated. The device comprises a catheter partially penetrating into the body of a patient, the catheter comprises a balloon, a shock wave generator and a directional reinforcing component, the shock wave generator and the directional reinforcing component are arranged in the balloon, the shock wave generator is arranged in front of the directional reinforcing component or arranged in the directional reinforcing component, and the directional reinforcing component shrinks along with expansion of the balloon. By arranging the directional reinforcing component, the reverse shock wave generated by the shock wave generator is reflected and then superposed with the forward shock wave energy, so that the energy loss can be reduced, the forward impact force can be remarkably improved, and the treatment effect can be improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a cavity-targeted pulse therapy device. Background Technology

[0002] Currently, common interventional devices for treating calcified lesions include high-pressure balloons, cutting balloons, spinous process balloons, laser plaque ablation, and rotational atherectomy / penetration devices. However, these devices can only treat superficial calcification of the vascular intima, and their effectiveness is limited for severe calcification or complete calcification blockage. Furthermore, these conventional treatment methods have significant limitations and are often accompanied by risks of vascular damage and complications. For example, high-pressure balloon angioplasty may cause intimal tearing, laser plaque ablation is prone to vascular perforation, and rotational atherectomy requires a high level of operator skill and carries certain risks.

[0003] Intravascular lithotripsy (IVL) has shown promising results as a novel treatment for vascular calcification. Its basic principle involves applying an electric field to a liquid, causing cavitation. The resulting bubbles rapidly expand and burst, generating a shock wave. This shock wave penetrates the balloon and surrounding calcified tissue, breaking up the calcified lesion without damaging the vascular intima, thus achieving the therapeutic goal. Currently, shockwave catheters are available on the market. Although their safety and effectiveness have been thoroughly validated, permeability remains a significant limitation to their application. For calcified lesions with different permeability, as well as CTO (chronic total occlusion) combined with calcification, existing shockwave balloon catheters still cannot provide more effective treatment. Summary of the Invention

[0004] Based on the above analysis, the present invention aims to provide a cavity-targeted pulse therapy device to solve the problem of poor treatment effect caused by the poor permeability of existing shockwave balloon catheters.

[0005] The objective of this invention is mainly achieved through the following technical solutions:

[0006] A cavity-targeted pulse therapy device includes a catheter partially inserted into the patient's body. The catheter includes a balloon and a shock wave generator and a directional enhancement component disposed within the balloon. The shock wave generator is located in front of or within the directional enhancement component, and the directional enhancement component expands and contracts with the balloon.

[0007] Furthermore, the directional reinforcement member has an umbrella-shaped structure.

[0008] Furthermore, the directional reinforcement member has a petal-shaped structure.

[0009] Furthermore, the directional reinforcement member includes multiple overlapping and interlocking lobes.

[0010] Furthermore, the directional reinforcement component is a shielding balloon.

[0011] Furthermore, the shock wave generator is located inside the shielding balloon.

[0012] Furthermore, the directional reinforcement component is a shielding balloon.

[0013] Furthermore, the inflated shielding balloon is cylindrical, trapezoidal, rhomboid, or conical.

[0014] Furthermore, the inflated shielding balloon can be arc-shaped, spherical, elliptical, or concave.

[0015] Furthermore, the material of the directional reinforcement component is a shape memory alloy or a shape memory polymer.

[0016] Furthermore, the directional reinforcement component is an elastic component capable of stretching and compressing. The elastic component includes a variable diameter spiral and an elastic coating layer. The variable diameter spiral is sleeved on the outside of the polymer tube, and the elastic coating layer covers the outside of the variable diameter spiral. One end of the variable diameter spiral is fixedly connected to the polymer tube, and the other end is away from the shock wave generator and can move along the polymer tube.

[0017] Furthermore, one end of the variable diameter screw gradually extends backward from the axis of the variable diameter screw to the axis of the other end, and the outer diameter of the variable diameter screw gradually decreases from the shock wave generator in the direction away from the shock wave generator.

[0018] Furthermore, the directional reinforcement component also includes a cable and a control handle. One end of the cable is connected to the traction cylinder, and the other end passes through the gap between the support tube and the polymer tube and then emerges from the end of the joint component and is connected to the control handle.

[0019] Furthermore, a stepped sealing plug is provided at the connection between the cable and the joint component.

[0020] Furthermore, the stepped sealing plug includes a front section, a middle section, and a rear section. The front section has a funnel-shaped opening facing into the fluid channel, and the inner wall of the front section is provided with gradually increasing wedge-shaped protrusions. The inner wall of the middle section is covered with fluffy protrusions, and the rear section is provided with an annular groove near the middle section, with a medical nickel-titanium alloy elastic ring built into the annular groove.

[0021] Compared with the prior art, the present invention can achieve at least one of the following beneficial effects:

[0022] (1) In this invention, a directional enhancement component is provided in the rear end region of the shock wave generator inside the balloon. When a pulse signal is transmitted to the shock wave generator, it interacts with the contact liquid to generate a shock wave that spreads outward in a spherical shape. The energy of the shock wave transmitted backward is reflected by the directional enhancement component, thus changing its direction of motion and transmitting it forward again. The altered shock wave energy meets the forward shock wave originally generated by the shock wave generator, forming a superposition effect of sound waves, thereby effectively enhancing the intensity of the shock wave. By setting the directional enhancement component to superimpose the reflected reverse shock wave generated by the shock wave generator with the forward shock wave energy, not only can energy loss be reduced, but the impact force can also be significantly increased, thus improving the therapeutic effect.

[0023] (2) The primary shock wave generated by the shock wave generator of the present invention is excited, collides with and is reflected by the directional enhancement component, forming a first reflected shock wave; then, the first reflected shock wave and the first primary shock wave superimpose each other and form constructive interference; subsequently, a second primary shock wave is excited and continues to superimpose with the previous first reflected shock wave and produce constructive interference; similarly, the second reflected shock wave and the third primary shock wave superimpose again and produce constructive interference. The energy of the shock waves is superimposed and converged at the tip of the balloon for maximum release, so that it can exert a stronger therapeutic effect in the target area. At the same time, according to the specific condition of the patient, the energy intensity of multiple shock waves after constructive interference in a single pulse group can be precisely controlled by adjusting the number, interval and frequency of shock waves in the shock wave generator pulse group, so as to achieve the treatment of calcified lesions of different degrees, thereby improving the accuracy and effectiveness of the treatment.

[0024] (3) The present invention is equipped with multiple shock wave generators and directional enhancement components in the balloon, which can generate multi-dimensional, larger-range and stronger shock waves, so that the generated shock wave energy fully covers the head and the whole of the balloon, thereby achieving effective treatment for severe calcification or more extensive calcification lesions.

[0025] (4) The shock wave energy of this invention can form a constructive interference effect. When the shock wave generator in the balloon releases shock waves sequentially from distal to proximal, the generated primary shock waves are blocked by the directional enhancement component, and the resulting reflected shock waves are superimposed in space, significantly enhancing the shock wave energy and forming a cone-shaped energy field that diffuses from proximal to distal, thus more effectively treating severely stenotic calcified lesions. Conversely, if the shock waves are released sequentially from proximal to distal, the constructive interference and enhancement of the shock waves can also be achieved, forming a spherical energy field that diffuses outward, thereby treating a larger area of ​​calcified lesions. By applying a pulse signal of a specific frequency and controlling the start-stop sequence and working time of the shock wave generator, effective treatment of calcified lesions of different degrees or extents can be achieved.

[0026] In this invention, the above-described technical solutions can be combined with each other to achieve more preferred combinations. Other features and advantages of this invention will be set forth in the following description, and some advantages may become apparent from the specification or be learned by practicing the invention. The objectives and other advantages of this invention can be realized and obtained from the content specifically pointed out in the text and accompanying drawings. Attached Figure Description

[0027] The accompanying drawings are for illustrative purposes only and are not intended to limit the invention. Throughout the drawings, the same reference numerals denote the same parts.

[0028] Figure 1 This is a schematic diagram of the cavity-targeted pulse therapy device according to a specific embodiment;

[0029] Figure 2 This is a schematic diagram showing the arrangement of the balloon and the directional reinforcement component in a contracted state according to a specific embodiment.

[0030] Figure 3 This is one of the schematic diagrams showing the balloon and the directional reinforcement component in their inflated state according to a specific embodiment;

[0031] Figure 4 This is one of the schematic diagrams illustrating the working principle of the directional reinforcement component in a specific embodiment;

[0032] Figure 5 This is a schematic diagram of the waveform change process of the directional reinforcement component under impact in a specific embodiment;

[0033] Figure 6 This is a schematic diagram illustrating the connection state between the catheter tip and the protective sleeve in a specific embodiment.

[0034] Figure 7 This is one of the structural schematic diagrams showing the connection between the directional reinforcement component and the polymer tube in a specific embodiment;

[0035] Figure 8 This is the second schematic diagram of the connection between the directional reinforcement component and the polymer tube in a specific embodiment;

[0036] Figure 9 This is the third schematic diagram of the connection between the directional reinforcement component and the polymer tube in a specific embodiment;

[0037] Figure 10 This is the second schematic diagram showing the balloon and the directional reinforcement component in their inflated state according to a specific embodiment.

[0038] Figure 11 This is the second schematic diagram illustrating the working principle of the directional reinforcement component in a specific embodiment;

[0039] Figure 12This is a schematic diagram illustrating the principle of constructive interference of shock wave energy in a specific embodiment.

[0040] Figure 13 This is a schematic diagram of the motion path of the constructive interference of shock wave energy in a specific embodiment;

[0041] Figure 14 A schematic diagram of the shielding balloon structure in a specific embodiment;

[0042] Figure 15 This is a schematic diagram of the balloon catheter portion of the balloon obstruction section in a specific embodiment.

[0043] Figure 16 A schematic diagram of the trapezoidal shielding balloon configuration structure in a specific embodiment;

[0044] Figure 17 This is a schematic diagram of the circular shielding balloon structure in a specific embodiment;

[0045] Figure 18 A schematic diagram of the elliptical shielding balloon configuration structure in a specific embodiment;

[0046] Figure 19 A schematic diagram of the concave shielding balloon configuration structure in a specific embodiment;

[0047] Figure 20 One of the structural schematic diagrams showing multiple sets of shock wave generators and directional reinforcement components in a specific embodiment;

[0048] Figure 21 A second schematic diagram showing the structure of multiple shock wave generators and directional reinforcement components in a specific embodiment;

[0049] Figure 22 The third structural schematic diagram shows the arrangement of multiple shock wave generators and directional reinforcement components in a specific embodiment.

[0050] Figure 23 Fourth schematic diagram of the structure of multiple shock wave generators and directional reinforcement components in a specific embodiment;

[0051] Figure 24 This is a schematic diagram of the connection structure between the variable diameter screw component and the control handle in a specific embodiment.

[0052] Figure 25 This is an exploded view of the control handle in a specific embodiment;

[0053] Figure 26 This is a cross-sectional view of the control handle in a specific embodiment.

[0054] Figure 27 This is a schematic diagram of the connection structure between the stepped sealing plug and the through hole in a specific embodiment.

[0055] Figure label:

[0056] 1-Catheter; 10-Injection tube; 11-Shock wave generator; 12-Directional reinforcement component; 121-Valve flap; 122-Through hole; 123-Variable diameter spiral component; 124-Elastic coating layer; 125-Connecting cylinder; 126-Tethering cylinder; 127-Cable; 128-Control handle; 1281-Force application part; 1282-Rotating part; 1283-Ball; 1284-End cap; 1285-First groove; 1286-Second groove; 13-Balloon; 14-Polymer tube; 15-Protective sleeve; 16-Support tube; 17- Connector components; 171-First interface; 172-Second interface; 173-Third interface; 174-Fourth interface; 175-Fifth interface; 18-Hose; 19-Plug; 101-Stepped sealing plug; 1011-Front section; 1012-Middle section; 1013-Rear section; 1014-Wedge-shaped ridge; 1015-Barbed protrusion; 1016-Fluff-like protrusion; 1017-Annular groove; 1018-Elastic ring; 2-Connecting cable; 21-Cable; 22-Handle; 23-Conduit connector; 3-Pulse device. Detailed Implementation

[0057] The preferred embodiments of the present invention will now be described in detail with reference to the accompanying drawings, which constitute a part of the present invention and are used together with the embodiments of the present invention to illustrate the principles of the present invention, but are not intended to limit the scope of the present invention.

[0058] Example 1

[0059] A specific embodiment of the present invention, such as Figure 1 , Figure 2 , Figure 3 and Figure 4 As shown, a cavity-targeted pulse therapy device (i.e., a balloon catheter device) is disclosed, including a catheter 1 that partially penetrates into the patient's body. The catheter 1 includes a shock wave generator 11, a directional enhancement component 12, a balloon 13, and a polymer tube 14. The shock wave generator 11 and the directional enhancement component 12 are both located inside the balloon 13, and both the shock wave generator 11 and the directional enhancement component 12 are disposed on the polymer tube 14. The two ends of the balloon 13 are closed. The shock wave generator 11 is located in front of the directional enhancement component 12 or inside the directional enhancement component 12. The directional enhancement component 12 can expand and contract with the expansion and contraction of the balloon 13.

[0060] Compared with existing technologies, the cavity-targeted pulse therapy device provided in this embodiment has a directional enhancement member 12 disposed in the rear end region of the shock wave generator 11 within the balloon 13. When a pulse signal is transmitted to the shock wave generator 11, it interacts with the contact liquid to generate a shock wave that spreads outward in a spherical shape. The energy of the shock wave transmitted backward is reflected by the directional enhancement member 12, thus changing its direction of motion and transmitting it forward again. The altered shock wave energy encounters the forward shock wave originally generated by the shock wave generator 11, forming a sound wave superposition effect, thereby effectively enhancing the intensity of the shock wave. By setting the directional enhancement member 12 to superimpose the reflected reverse shock wave generated by the shock wave generator 11 with the forward shock wave energy, not only can energy loss be reduced, but the impact force can also be significantly increased, improving the treatment effect.

[0061] Preferably, both the shock wave generator 11 and the directional enhancement component 12 are located in the distal region of the balloon 13. It should be noted that in this embodiment, the distal end refers to the end of the catheter 1 that enters the body, i.e., the front end, while the corresponding proximal end is the external operating end, i.e., the rear end.

[0062] The directional reinforcement member 12 is made of a polymer material with shape memory function, and it unfolds into an umbrella-like structure. For example... Figure 2 , Figure 3 and Figure 4 As shown, the balloon 13 is initially folded. When the balloon 13 contracts and folds, it can constrain the directional reinforcement member 12, causing it to bend and be bound within the balloon 13. When liquid is injected into the balloon 13, causing it to inflate, the directional reinforcement member 12 returns to its preset shape after losing the external constraint of the balloon 13. After the balloon 13 inflates, it is placed against the calcified lesion tissue. The shock wave generator 11 receives pulse signals, and the shock wave generator 11 generates a cavitation effect with the contact liquid, releasing spherical shock wave energy to the surroundings. The primary shock wave generated by the shock wave generator 11 is transmitted forward to the tip of the balloon 13 and acts on the calcified lesion. The primary shock wave energy transmitted backward is blocked by the directional reinforcement member 12 and changes its trajectory to be reflected in the opposite direction. When the reflected shock wave combines with the primary shock wave, sound wave superposition is formed. The superimposed shock wave energy can be greatly enhanced and then transmitted again to the tip of the balloon 13 and acts on the calcified lesion.

[0063] like Figure 5As shown, after the balloon 13 is inflated, it indirectly causes the directional reinforcement member 12 to return to the preset shape. During the process of the shock wave generator 11 receiving the pulse signal and being excited to generate a shock wave, the original shock wave transmitted backward continuously hits the directional reinforcement member 12, causing it to deform under pressure and gradually open like an umbrella. The greater the shock wave energy output, the greater the impact force on the directional reinforcement member 12, which leads to a larger deformation angle of the directional reinforcement member 12. The larger the deformation angle of the directional reinforcement member 12, the more shock wave energy it can block, resulting in more reflected shock wave energy and a wider release range. When the reflected shock wave is superimposed with the original shock wave, it can generate even stronger shock wave energy. Through the repeated accumulation of energy, the shock wave generator 11 can generate a strong shock wave and act on the tip of the balloon 13, causing the calcified lesions at the tip of the balloon 13 to be shattered. Because the material of the directional reinforcement component 12 has shape memory function, it will gradually return to its preset shape after losing the impact of the shock wave energy. When the balloon 13 is depressurized and shrinks into its folded shape, the directional reinforcement component 12 is also squeezed and contracted by the external force of the balloon 13. Furthermore, during the retraction of the catheter 1 into the guiding sheath, it will squeeze the directional reinforcement component 12 and the balloon 13 again, causing the balloon 13 to completely retract into the guiding sheath, thus completing the treatment of the target site. If the calcified tissue area requires multiple treatments, the catheter continues to advance along the guidewire to the target site, and the above operation process is repeated to gradually expand and extend the vascular access, restore normal blood flow, and ultimately achieve effective treatment for severe stenosis and calcification of occluded vessels.

[0064] like Figure 6 , Figure 7 , Figure 8 , Figure 9 and Figure 10 As shown, the directional reinforcement member 12 is made of a flexible metal material with shape memory function and has a self-expanding petal structure. The directional reinforcement member 12 includes multiple petals 121, and each petal 121 partially overlaps and interlocks with each other to form a tight structure. When the directional reinforcement member 12 is subjected to stress, each petal 121 can wrap around each other and contract like petals towards the distal end of the polymer tube 14.

[0065] To achieve the contraction of the directional reinforcement member 12 and the balloon 13, such as Figure 6As shown, catheter 1 also includes a protective sheath 15, which can be fitted over the outside of balloon 13. The distal end of the protective sheath 15 abuts against the inlet of the sheath, pushing the balloon catheter to allow balloon 13 to enter the sheath lumen. After balloon 13 enters the sheath lumen, the directional enhancement member 12 will continue to contract and fold under the stress of the sheath. When the balloon catheter, guided by the guidewire, is pushed out of the sheath along the guiding sheath lumen and enters the narrowed calcified lesion site, the directional enhancement member 12 will expand and open back into a petal-like state due to its own morphological memory. Balloon 13 and directional enhancement member 12 are in a contracted and folded state under the constraint of the protective sheath 15. After balloon 13 contracts and folds, the protective sheath 15 can move from the proximal end to the distal end of balloon 13. Once the protective sheath 15 moves to the directional enhancement member 12, its stress will cause the directional enhancement member 12 to contract and fold towards the distal end of balloon 13. Finally, balloon 13 and directional enhancement member 12 are constrained within the protective sheath 15.

[0066] Combination Figure 6 and Figure 11 As shown, during the procedure, the shock wave generated by the shock wave generator 11 is reflected after being blocked by the directional enhancement member 12 and superimposed on subsequent shock waves. Through continuous energy accumulation, the shock wave generator 11 can generate a powerful shock wave, thereby fragmenting the calcified plaque at the tip of the balloon 13. After a segment of the calcified plaque at the vascular calcification lesion is fragmented, the guidewire is advanced. At this time, the balloon 13 is depressurized by the infusion pump, and the balloon catheter is pulled backward along the guidewire. When the directional enhancement member 12 contacts the sheath, the stress in the sheath causes the directional enhancement member 12 to contract and retract into the sheath lumen. Subsequently, the sheath is advanced along the guidewire to the calcified plaque that has not yet fragmented, and the balloon catheter is advanced again. When the balloon 13 exits the sheath, the directional enhancement member 12 expands and opens under its own shape memory, sending a pulse signal to the shock wave generator 11 again. The original shock wave and the reflected shock wave are superimposed, and the energy of the superimposed shock wave is transferred to the tip of the balloon 13, fragmenting the calcified plaque again. In this way, if the calcified area requires multiple treatments, the guidewire is advanced to the target site, and the above procedure is repeated to gradually expand and extend the vascular access, restore normal blood flow, and ultimately achieve effective treatment for severe stenosis and calcification of blood vessels that are approaching occlusion.

[0067] Combination Figure 11 and Figure 12As shown, a predetermined distance of 3mm ± 0.5mm is maintained between the directional enhancement component 12 and the shock wave generator 11. This improves the efficiency of the superposition of the primary and reflected shock waves at the crests and troughs, enhancing energy intensity and thus increasing the impact force of the released shock wave. Furthermore, due to the constraint effect of the directional enhancement component 12 on the shock wave, the generated shock wave energy is enhanced while maintaining its gentleness, effectively reducing damage to soft tissues or blood vessels. It can also act directionally on the tip of the balloon 13, showing significant effects on severely calcified lesions. Through the enhancement and targeted control of shock wave energy, it can not only act more effectively on calcified lesions but also significantly improve the performance and efficiency of the catheter.

[0068] like Figure 13 As shown, the pulse signal received by the shock wave generator 11 is of a specific frequency. Based on the principle of constructive interference in physics, when two waves with the same frequency meet, their amplitudes will mutually reinforce each other, thus generating greater energy. Specifically, the shock wave generator 11 first generates primary shock waves A1 and B1. Primary shock wave A1 transmits shock wave energy to the distal end of the balloon 13, while primary shock wave B1 transmits shock wave energy to the proximal end of the balloon 13. When primary shock wave B1 is blocked by the directional reinforcement member 12, its trajectory is changed to form the first reflected shock wave C1. As the reflected shock wave C1 is transmitted, it superimposes with the primary shock wave A1 and produces constructive interference. The enhanced shock wave energy after constructive interference is transmitted to the tip of the balloon 13. Subsequently, the shock wave generator 11 generates primary shock waves A2 and B2 for the second time. The primary shock wave B2 encounters the directional reinforcement component 12 to form a second reflected shock wave C2. As the reflected shock wave C2 propagates, it superimposes with the primary shock wave A2 and produces constructive interference. Simultaneously, as the wave continues to propagate, it superimposes with the first primary shock wave A1 and the first reflected shock wave C1 again and produces constructive interference, forming a double constructive interference shock wave. After superposition, the shock wave energy is amplified again and transmitted to the tip of the balloon 13. Similarly, the third shock wave, the fourth shock wave, and so on, repeatedly superimpose the shock wave energy and form multiple constructive interferences, and then transmit a stronger shock wave to the tip of the balloon 13. Therefore, by adjusting the output frequency, the energy of the shock wave generated by the shock wave generator 11 can be controlled. Combined with the interval time of the transmitted pulse, the original shock wave and the reflected shock wave generated by the shock wave generator 11 can be superimposed and superimposed again with the previously generated constructive interference shock wave to form a stronger shock wave energy. At the same time, by adjusting the number of shock waves in a pulse group, multiple constructive interference can also be achieved, thereby promoting the controllable release of shock wave energy at the tip of the balloon 13, so as to achieve targeted and precise treatment of calcified lesions of different degrees or types.

[0069] like Figure 1As shown, the cavity-targeted pulse therapy device also includes a connecting cable 2 and a pulse device 3. The catheter 1 is detachably connected to the connecting cable 2, and the connecting cable 2 is detachably connected to the pulse device 3. Specifically, the connecting cable 2 includes a cable 21, a handle 22, and a catheter connector 23. The distal end of the cable 21 is connected to the handle 22, and the proximal end of the cable 21 is connected to the catheter connector 23. The handle 22 is detachably connected to the insertion connector 19, and the catheter connector 23 is detachably connected to the pulse device 3.

[0070] like Figure 1 As shown, the catheter 1 also includes a support tube 16 and a connector component 17. The connector component 17 has four interfaces: a first interface 171, a second interface 172, a third interface 173, and a fourth interface 174. The distal end of the support tube 16 is sealed to the proximal end of the balloon 13, and the other end of the support tube 16 is sealed to the first interface 171. The distal end of the polymer tube 14 is sealed to the distal end of the balloon 13, and the proximal end of the polymer tube 14 is sealed to the second interface 172. The polymer tube 14 is disposed inside the support tube 16, and there is a gap between the polymer tube 14 and the support tube 16, which is the fluid channel. The third interface 173 and the fourth interface 174 are both in communication with the fluid channel. Exemplarily, liquid is injected into the fluid channel through the third interface 173 to inflate the balloon 13, or liquid is drawn out of the balloon 13 through the third interface 173 to contract the balloon 13. A guidewire is inserted into the polymer tube 14 through the second interface 172, and the polymer tube 14 serves as the guidewire channel.

[0071] like Figure 1 As shown, the conduit 1 also includes a hose 18 and a connector 19. One end of the hose 18 is sealed to the fourth interface 174, and the other end of the hose 18 is connected to the connector 19. A wire is installed inside the hose 18, with one end of the wire connected to the shock wave generator 11 and the other end connected to the connector 19. The connector 19 communicates with the wire inside and is detachably connected to the handle 22.

[0072] Example 2

[0073] Another specific embodiment of the present invention, such as Figure 14 , Figure 15 As shown, a cavity-targeted pulse therapy device is disclosed. The difference from Embodiment 1 is that the directional enhancement component 12 is a shielding balloon or a blocking balloon. When the shock wave generator 11 is excited to generate shock wave energy, the rearward-transmitting primary shock wave is blocked by the directional enhancement component 12 of the balloon structure at the rear end of the shock wave generator 11 to form a reflected shock wave. The reflected shock wave and the forward-transmitting primary shock wave are superimposed to form a stronger shock wave energy, which acts on the calcified lesion tissue to achieve the therapeutic purpose.

[0074] Specifically, such as Figure 14As shown, a shielding balloon is provided inside the balloon 13. The edge of the shielding balloon is connected to the distal inner wall of the balloon 13, forming a receiving cavity for accommodating the shock wave generator 11. The shock wave generator 11 is disposed within this receiving cavity. The proximal end of the shielding balloon is sealed to the tube body of the polymer tube 14. A through hole 122 is provided on the shielding balloon, which allows it to communicate with the interior of the balloon 13. Inflating or contracting the balloon 13 causes the shielding balloon to inflate or contract accordingly.

[0075] After the balloon catheter, guided by the guidewire, enters the narrow calcified lesion, fluid is injected into the balloon 13 through the fluid channel, causing the balloon 13 to inflate. The fluid inside the balloon 13 flows into the masking balloon through the through-hole 122, causing the masking balloon to inflate simultaneously. After inflation, the balloon 13 is placed against the calcified lesion. The pulse device 3 emits a pulse signal, which is transmitted via the connecting cable 2 to the shock wave generator 11 inside the balloon 13. The shock wave generator 11 generates a cavitation effect with the contacting fluid, releasing spherical shock wave energy to the surrounding area. The primary shock wave generated by the shock wave generator 11 propagates forward to the tips of the masking balloon and balloon 13, acting on the calcified lesion. The primary shock wave energy propagating backward is blocked by the proximal end of the masking balloon, causing it to change its trajectory. Simultaneously, some shock wave energy propagates in the opposite direction. When the reflected shock wave combines with the primary shock wave, sound wave superposition occurs, significantly enhancing the energy of the superimposed shock wave and creating a stronger impact force. Shockwave energy acts on calcified lesions in the distal region of balloon 13, causing them to shatter and restore normal blood flow, ultimately achieving more effective treatment for severe stenosis and calcification of occluded vessels.

[0076] like Figure 15 As shown, the directional reinforcement member 12 is a shielding balloon, located at the rear end of the shock wave generator 11. When liquid is injected into the shielding balloon, it inflates; when the liquid is drawn out, the shielding balloon contracts. To achieve the injection and extraction of liquid from the shielding balloon, the conduit 1 also includes an injection tube 10, and the connector component 17 is provided with a fifth interface 175. One end of the injection tube 10 is sealed to the fifth interface 175. The other end extends into the shielding balloon, and the injection tube 10 is located in the gap between the support tube 16 and the polymer tube 14, i.e., within the fluid channel. Liquid is injected into the injection tube 10 through the fifth interface 175, causing the shielding balloon to inflate. When the liquid is drawn out, the shielding balloon contracts.

[0077] During the procedure, after the shockwave balloon catheter, guided by the guidewire, enters the narrowed calcified lesion, infusion pumps are connected to the third port 173 and the fifth port 175, respectively. First, the infusion pump connected to the third port 173 injects fluid into the balloon 13 through the fluid channel, causing the balloon 13 to inflate. Then, the infusion pump connected to the fifth port 175 injects fluid through the infusion tube 10 into the shielding balloon, causing the shielding balloon to inflate. After balloon 13 inflates, it is placed against the calcified lesion. Shock wave generator 11 receives pulse signals and generates a cavitation effect with the contact liquid, releasing spherical shock wave energy to the surroundings. The primary shock wave generated by shock wave generator 11 is transmitted forward to the tip of balloon 13 and acts on the calcified lesion. The primary shock wave energy transmitted backward is blocked by the balloon, causing it to change its trajectory and form a reflected shock wave in the opposite direction. When the reflected shock wave combines with the primary shock wave, sound wave superposition is formed, and the energy of the superimposed shock wave is significantly enhanced, thus forming a stronger impact force. As the shock wave energy is continuously released and acts on the calcified lesion at the tip of balloon 13, it ruptures and restores normal blood flow, ultimately achieving more effective treatment for severe stenosis and calcification of blood vessels that are approaching occlusion.

[0078] like Figure 16 , Figure 17 , Figure 18 and Figure 19 As shown, the inflated shielding balloon can be configured in different shapes, including but not limited to cylindrical, trapezoidal, rhomboid, conical, arc-shaped, spherical, elliptical, and concave shapes. A spherical shielding balloon, with its curved surface capable of withstanding greater shock wave energy and expanding the dispersion range of the reflected shock wave to cover a larger treatment area, offers better treatment results for severely narrowed lesions with relatively large calcified areas. An elliptical shielding balloon, combining the advantages of a spherical shape, not only withstands strong shock wave energy but also controls the dispersion angle and range of the reflected shock wave, concentrating the shock wave energy release more at the tip of the balloon 13, resulting in significant therapeutic effects for severely narrowed or nearly occluded calcified lesions. The shielding balloon is concave, with an umbrella-like structure. This concave shape concentrates and focuses the energy of the primary shock wave as it is transmitted backward and reflected. This not only ensures greater reflection of the primary shock wave, but also effectively concentrates the reflected shock wave towards the distal end of the balloon 13, where it superimposes with the forward-transmitting primary shock wave to generate a powerful shock wave force at the tip of the balloon 13. This reduces energy loss from the reflected shock wave and improves treatment efficacy. Overall, by designing different shapes for the shielding balloon, the shock wave energy generated by the shock wave generator 11 can be effectively controlled, enabling targeted and precise treatment of different calcified lesions, thereby improving the therapeutic effect and efficiency of the catheter.

[0079] The shielding balloon is made of compliant or semi-compliant materials, including but not limited to polyethylene (PE), polyurethane (PU), polyvinyl chloride (PVC), nylon, and polyether block polyamide (Pebax). When the balloon catheter, guided by the guidewire, enters the narrowed calcified lesion, one infusion pump first injects fluid into the balloon 13 through the fluid channel, causing the balloon 13 to inflate. The other infusion pump then injects fluid into the shielding balloon through the infusion tube 10, causing the shielding balloon to inflate as well. The shielding balloon, influenced by internal pressure, gradually expands until it completely conforms to the inner wall of the balloon 13. This completely blocks the shock wave energy generated by the shock wave generator 11 at the tip of the balloon 13, not only preventing energy loss but also significantly increasing the released impact force. Furthermore, by adjusting the inflation pressure of the shielding balloon, its size and shape after expansion can be changed, thereby effectively controlling the intensity, diffusion range, and convergence path of the shock wave energy release. It has a very significant therapeutic effect on severe stenosis and vascular calcification that tends to be occluded. Similarly, it can also achieve targeted and precise treatment of calcified lesions of different degrees or types, thereby more effectively improving the therapeutic effect and work efficiency of catheters.

[0080] Example 3

[0081] Another specific embodiment of the present invention, such as Figure 20 , Figure 21 , Figure 22 and Figure 23 As shown, a cavity-targeted pulse therapy device is disclosed. The difference from Embodiment 1 is that the shock wave generator 11 and directional enhancement component 12 are configured in multiple groups. The coordination between these groups enhances the energy released by the shock wave, thereby improving catheter performance and adapting to a wider range of calcified lesions. By setting multiple groups of shock wave generators 11 and directional enhancement components 12 within the balloon 13, the energy generated by the constructive interference shock wave is enhanced and effectively transmitted to the distal end of the balloon 13, improving catheter performance and efficiency. This ensures full coverage of the shock wave energy released within the balloon 13, significantly enhancing and increasing the shock wave energy transmitted to the distal end of the balloon 13, thereby effectively improving the therapeutic effect of the catheter and adapting to more stubborn or occluded calcified lesions.

[0082] The function expression of the shock wave generated by shock wave generator 11 is as follows:

[0083] A 1,0 (t)=A 1,0 cos(2πf1t+θ1) (1)

[0084] Among them, A 1,0 Let f1 be the shock wave amplitude, f1 be the shock wave frequency, and θ1 be the initial phase of the shock wave.

[0085] The directional reinforcement member 12 can reflect shock waves, and the reflected shock wave function is expressed as follows:

[0086] A 2,0 (t)=A 2,0 cos(2πf²t+θ²) (2)

[0087] Among them, A 2,0 f2 is the amplitude of the reflected shock wave, f2 is the frequency of the reflected shock wave, and θ2 is the initial phase of the reflected shock wave.

[0088] When two shock waves meet and intersect during propagation, they will superimpose. The superimposed shock wave function is:

[0089] A M (t)=A M,0 cos(2πf M t+θ M (3)

[0090] Among them, A M,0 f represents the amplitude of the superimposed shock wave. M Let θ be the frequency of the superimposed shock wave. M For the initial phase of the superimposed shock wave, A M,0 θ M And it satisfies the following relationship:

[0091]

[0092] It should be noted that since the shock wave remains unchanged, f1 = f2 = f M .

[0093] When the distance L between the shock wave generator 11 and the directional reinforcement member 12 and the shock wave frequency f1 meet the following relationship:

[0094]

[0095] Where N is an integer, V is the propagation speed of the shock wave, θ1 is the initial phase of the shock wave, and θ2 is the initial phase of the reflected shock wave.

[0096] When the distance L satisfies formula (6), the two shock waves have the same phase and frequency, indicating constructive interference. The shock wave function after constructive interference is:

[0097] A M (t)=(A 1,0 +A 2,0 cos(2πf1t+θ1+2kπ) (7)

[0098] The shock wave amplitude in formula (7) is twice that in formula (1). Therefore, the shock wave energy is doubled by setting the directional reinforcement member 12. Similarly, adding the directional reinforcement member 12 to reflect the shock wave can further enhance the shock wave intensity.

[0099] Understandably, by adjusting the size and shape of the expanded directional reinforcement member 12, its fixed angle with the polymer tube 14, the distance between the directional reinforcement member 12 and the shock wave generator 11, the coordination between different structures, and adjusting the interval time of the pulse signal sent between combinations, the magnitude, divergence range, and transmission direction of the superimposed shock wave energy can be effectively controlled.

[0100] For example, such as Figure 21 As shown, among the multiple sets of shock wave generators 11 and directional reinforcement members 12 arranged inside the balloon 13, the directional reinforcement members 12 have the same structure and size, and the distance between the directional reinforcement members 12 and the shock wave generators 11 in front of them is also the same; or, the directional reinforcement members 12 of several sets near the front end of the catheter 1 have the same structure and size, and the distance between the directional reinforcement members 12 and the shock wave generators 11 in front of them is also the same.

[0101] When the first shock wave generator 11 is excited to generate a primary shock wave, part of its energy is released towards the distal end of the balloon 13, and another part is released towards the proximal end of the balloon 13. The energy of the shock wave released backward is blocked by the first baffle directional reinforcement member 12, which changes its trajectory and generates a reflected shock wave. The reflected shock wave and the primary shock wave are superimposed and continue to release a stronger constructive interference shock wave towards the distal end of the balloon 13, generating a greater impact force. By adjusting the excitation time of the first shock wave generator 11 and the second shock wave generator 11, the intensity and diffusion range of the generated shock wave energy can be controlled. That is, when the first shock wave generator 11 is excited to generate a shock wave, the second shock wave generator 11 is excited after an interval of 0.1s-1s. This allows the reflected shock wave from the first shock wave generator 11 to be superimposed with the primary shock wave from the second shock wave generator 11 and accelerated towards the distal end of the balloon 13, thereby forming a stronger shock wave energy. Because the primary shock wave released backward by the first shock wave generator 11 is blocked by the first directional enhancement member 12 to form a reflected shock wave, some shock waves that are not covered by the first directional enhancement member 12 may still be missed and enter the proximal end of the balloon 13, resulting in a loss of shock wave energy. This situation can be effectively avoided by setting a second shock wave generator 11. When the missed shock wave energy diffuses towards the proximal end of the balloon 13, the primary shock wave generated by the second shock wave generator 11 will block and forcibly change its direction of motion, causing the missed shock wave to be twisted back into a reflected shock wave, and then superimposed again with other primary and reflected shock waves, thereby generating a stronger shock wave energy. The multiple sets of shock wave generators 11 and directional enhancement members 12 on the polymer tube 14 can work independently or in combination. Through their combined independent operation or mutual cooperation, not only can the impact force at the distal end of the balloon 13 be effectively controlled, but the intensity and coverage of the shock wave energy can also be adjusted according to the actual situation to meet the treatment needs of different calcified lesions.

[0102] For example, such as Figure 22 As shown, the polymer tube 14 is equipped with multiple sets of shock wave generators 11 and directional reinforcement components 12. The size, shape, fixing angle of the directional reinforcement component 12 with respect to the polymer tube 14, and the distance between it and the shock wave generator 11 are all different, and can be designed according to actual needs. Based on physical characteristics, the unique differential design allows the shock waves generated by the shock wave generator 11 to be more effectively integrated and absorbed, and the divergence path of the shock waves to be controlled, thereby significantly improving the shock wave energy. This makes the impact force of the converged shock wave released towards the distal end of the balloon 13 stronger, resulting in better treatment effects for severely stenotic or nearly occluded vascular calcification lesions, while also increasing work efficiency.

[0103] The pulse device 3 sends a pulse signal to the first shock wave generator 11, exciting it to generate a primary shock wave. The primary shock wave, released backward, encounters the first directional enhancement member 12, which obstructs its trajectory and generates a reflected shock wave. When the primary shock wave and the reflected shock wave superimpose, a constructive interference shock wave is formed, thus enhancing the shock wave energy. At a set interval, the pulse device 3 sends a pulse signal to the second shock wave generator 11. The primary shock wave it generates, which, along with the reflected shock wave generated after being obstructed by the second directional enhancement member 12, superimposes to form a constructive interference shock wave. This constructive interference shock wave, superimposed again with the constructive interference shock waves generated by the first shock wave generator 11 and the first directional enhancement member 12, forms a double constructive interference shock wave, thus significantly enhancing the shock wave energy. Subsequently, the pulse device 3 sends a pulse signal to the third shock wave generator 11 again. The forward-facing primary shock wave and the backward-facing reflected shock wave superimpose to form a constructive interference shock wave. This constructive interference shock wave, along with the constructive interference shock waves generated by the first shock wave generator 11 and the first directional reinforcement member 12, and the second shock wave generator 11 and the second directional reinforcement member 12, superimposes again to form a triple constructive interference shock wave, at which point the shock wave energy is significantly enhanced. Similarly, the fourth and fifth shock wave generators 11 operate in a similar manner. The shock wave generators 11 gradually superimpose and constructively interfere with each other to provide continuous multiple constructive interference shock waves. These multiple constructive interference shock waves have stronger energy and can cover a deeper and wider range. Based on the specific structure of the directional reinforcement member 12 and the control of the start-stop sequence of the shock wave generators 11, combined with the working time constraint, the shock wave energy ultimately generated by the shock wave generators 11 tends towards the distal end of the balloon 13 and forms a cone-shaped energy field, such as... Figure 23 As shown, the impact force is stronger closer to the tip of the balloon 13, resulting in better treatment effects for severe calcification lesions or vascular calcification lesions that are approaching occlusion. By changing the start and stop sequence of the shock wave generator 11, the dispersion range and effective area of ​​the shock wave energy field can be effectively controlled, thereby adapting to the treatment needs of different calcification lesions.

[0104] Example 4

[0105] Another specific embodiment of the present invention, such as Figure 24As shown, a cavity-targeted pulse therapy device is disclosed. The difference from Embodiment 1 is that the directional enhancement component 12 is an elastic component that can be stretched and compressed. The elastic component includes a variable diameter spiral 123 and an elastic covering layer 124. The variable diameter spiral 123 is sleeved on the outside of the polymer tube 14 and located behind the shock wave generator 11. The elastic covering layer 124 covers the outside of the variable diameter spiral 123. One end of the variable diameter spiral 123 is fixedly connected to the polymer tube 14, and the other end is away from the shock wave generator 11. When the far end is pulled, the variable diameter spiral 123 is stretched along the polymer tube 14, and the outer diameter of the variable diameter spiral 123 is reduced as a whole to adapt to the uninflated state of the balloon 13. When the variable diameter spiral 123 is not stretched, the variable diameter spiral 123 retracts to form a roughly umbrella-shaped structure, so that the reverse shock wave generated by the shock wave generator 11 is reflected and superimposed with the energy of the forward shock wave, which significantly increases the impact force and improves the treatment effect.

[0106] It should be noted that in this embodiment, the change in diameter refers to the change in the outer diameter of the cross-section of the diameter-changing spiral 123 perpendicular to the length direction of the polymer tube 14.

[0107] Specifically, one end of the variable diameter screw 123 extends gradually backward from the axis of the variable diameter screw 123 to the axis of the other end, and the outer diameter of the variable diameter screw 123 gradually decreases from the shock wave generator 11 in the direction away from the shock wave generator 11.

[0108] Considering that one end of the variable diameter spiral component 123 is connected to the polymer tube 14, and the other end can move relative to the polymer tube 14, such as Figure 24 As shown, the directional reinforcement member 12 also includes a connecting cylinder 125 and a pulling cylinder 126, which are respectively disposed at both ends of the variable diameter spiral member 123. The connecting cylinder 125 is used for fixed connection with the polymer tube 14, and the pulling cylinder 126 is used for applying force to stretch or retract the variable diameter spiral member 123.

[0109] like Figure 24 As shown, the directional reinforcement member 12 also includes a cable 127 and a control handle 128. One end of the cable 127 is connected to the traction cylinder 126, and the other end passes through the gap between the support tube 16 and the polymer tube 14, exits from the end of the joint component 17, and is connected to the control handle 128. The tension and retraction of the variable diameter spiral component 123 are controlled by the control handle 128. Preferably, three cables 127 are provided, and the three cables 127 are evenly distributed along the circumference of the traction cylinder 126.

[0110] To achieve control of the variable diameter screw component 123 by the control handle 128, such as Figure 25 and Figure 26As shown, the control handle 128 includes a force-applying part 1281, a rotating part 1282, a ball bearing 1283, and an end cap 1284. One end of the force-applying part 1281 is provided with an internal thread, and the force-applying part 1281 is threadedly connected to the part of the connector component 17 for the guide wire to pass through. The middle part of the force-applying part 1281 has an arc-shaped protrusion and is provided with anti-slip texture to facilitate the operator to apply force. The other end of the force-applying part 1281 is provided with a first groove 1285. The outer circumferential surface of the rotating part 1282 is uniformly provided with a second groove 1286, and the ball bearing 1283 is disposed in the second groove 1286 to realize the rotational connection between the rotating part 1282 and the force-applying part 1281. The end cap 1284 is covered on the outside of the rotating part 1282 and connected to the end of the force-applying part 1281.

[0111] It is worth noting that, since the control handle 128 is connected to the part of the connector component 17 through which the guide wire passes, in order to avoid interference with the passage of the guide wire, the end cap 1284, the rotating part 1282 and the force-applying part 1281 are provided with holes communicating with the polymer tube 14 in the middle.

[0112] In this embodiment, the cable 127 is connected to the rotating part 1282, and the rotating part 1282 is rotatably connected to the inside of the force-applying part 1281. When the force-applying part 1281 is rotated, the cable 127 rotates synchronously with the rotating part 1282, preventing the cable 127 from winding around the polymer tube 14. Simultaneously, since the force-applying part 1281 is threadedly connected to the connector component 17, rotating the force-applying part 1281 can control the stretching and retraction of the variable-diameter spiral component 123, resulting in a simple structure and convenient operation. Considering that the cable 127 needs to pass through the fluid channel, to prevent liquid leakage from the holes in the cable 127 and the fluid channel, a through hole is also provided at the end of the connector component 17, such as... Figure 27 As shown, a stepped sealing plug 101 is provided at the through hole. The stepped sealing plug 101 includes a front section 1011, a middle section 1012, and a rear section 1013. The front section 1011 has a funnel-shaped opening facing into the fluid channel. The inner wall of the front section 1011 is provided with gradually increasing wedge-shaped protrusions 1014. Each ring of wedge-shaped protrusions 1014 is a continuous annular protrusion with a right-angled triangle cross-section, with the hypotenuse facing the fluid channel. That is, the first ring of protrusions near the fluid channel is the shortest, and the third ring of protrusions near the middle section is the tallest, forming a gradient compression. The outer wall of the front section 1011 is provided with barbed protrusions 1015, which are connected to the grooves on the through hole wall to prevent the stepped sealing plug 101 from being pushed out by the pressure in the fluid channel.

[0113] like Figure 27As shown, the inner wall of the middle section 1012 is covered with fluffy protrusions 1016, similar to a brush, made of the same silicone material. These protrusions can bend elastically with the movement of the cable 127, filling the tiny textures on the surface of the cable 127. The rear section 1013, near the middle section 1012, has an annular groove 1017 containing a medical-grade nickel-titanium alloy elastic ring 1018. In its natural state, the elastic ring 1018 tightens, pressing the silicone in the middle section 1012 towards the center.

[0114] In this embodiment, when the cable 127 is stationary, the elastic ring 1018 tightens the middle section of silicone, and the fluffy protrusions 1016 on the inner wall of the middle section 1012 tightly adhere to the surface of the cable 127, blocking the liquid channel. Due to the elasticity of the silicone, the three wedge-shaped protrusions 1014 of the front section 1011 naturally press against the cable 127 (the height gradient design increases pressure from the inside out). When the cable 127 is pulled outwards: the middle section of silicone is slightly deformed by the cable 127, but the fluffy protrusions 1016 bend with the direction of the cable 127's movement, always adhering to the surface, similar to a brush sweeping across a rope, without creating gaps. Because the direction of the cable 127's movement (outwards) is consistent with the direction of the protrusion's inclined edge, the wedge-shaped protrusions 1014 of the front section 1011 are slightly pushed away but still remain in contact. When the cable 127 moves inward: the right-angled side of the wedge-shaped protrusion 1014 of the front section 1011 is opposite to the direction of movement. The protrusion is squeezed by the cable 127, making it fit more tightly, similar to a check valve. The further inward it is pushed, the tighter the protrusion is pressed. The elastic ring 1018 of the middle section 1012 continues to tighten due to the elastic reset of the silicone, and the fluffy protrusion 1016 rebounds and fits the cable 127.

[0115] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any changes or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in the present invention should be included within the scope of protection of the present invention.

Claims

1. A cavity-targeted pulse therapy device, characterized in that, The catheter (1) is partially inserted into the patient's body. The catheter (1) includes a balloon (13) and a shock wave generator (11) and a directional enhancement member (12) disposed within the balloon (13). The shock wave generator (11) is disposed in front of or within the directional enhancement member (12). The directional enhancement member (12) is capable of expanding and contracting with the balloon (13).

2. The cavity-targeted pulse therapy device according to claim 1, characterized in that, The directional reinforcement member (12) has an umbrella-shaped structure.

3. The cavity-targeted pulse therapy device according to claim 1, characterized in that, The directional reinforcement member (12) has a petal-shaped structure.

4. The cavity-targeted pulse therapy device according to claim 3, characterized in that, The directional reinforcement member (12) includes multiple overlapping and interlocking lobes (121).

5. The cavity-targeted pulse therapy device according to claim 1, characterized in that, The directional reinforcement component (12) is a shielding balloon.

6. The cavity-targeted pulse therapy device according to claim 5, characterized in that, The shock wave generator (11) is located inside the shielding balloon.

7. The cavity-targeted pulse therapy device according to claim 1, characterized in that, The directional reinforcement component (12) is a shielding balloon.

8. The cavity-targeted pulse therapy device according to claim 7, characterized in that, The shielding balloon, after inflating, takes the shape of a cylinder, trapezoid, rhombus, or cone.

9. The cavity-targeted pulse therapy device according to claim 7, characterized in that, The shielding balloon expands to an arc, sphere, or ellipse shape.

10. The cavity-targeted pulse therapy device according to any one of claims 1-9, characterized in that, The material of the directional reinforcement component (12) is a shape memory alloy or a shape memory polymer.

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