US-12622720-B2 - Device for generating shockwaves

US12622720B2US 12622720 B2US12622720 B2US 12622720B2US-12622720-B2

Abstract

The invention relates to a device for generating shockwaves. The device comprises a pressure pulse source comprising a chamber housing defining a chamber ( 22 ) and a shockwave opening ( 21 ). The chamber ( 22 ) is configured to be filled with a liquid. The device comprises a plurality of electrodes disposed in the chamber ( 22 ) and configured to be coupled to a pulse-generation system, the plurality of electrodes including a first electrode and a second electrode, the first electrode and the second electrode defining a spark gap. The chamber ( 22 ) additionally includes a maintenance opening ( 16 ), wherein the maintenance opening ( 16 ) is sealed by a port ( 30 ) for manipulating the chamber ( 22 ) through the port ( 30 ).

Inventors

Christian Dorfmüller
Johannes Holfeld

Assignees

HEART REGENERATION TECHNOLOGIES GMBH

Dates

Publication Date: 20260512
Application Date: 20240823
Priority Date: 20230904

Claims (16)

1 . A device for generating shockwaves, comprising: a pressure pulse source comprising a chamber housing defining a chamber and a shockwave opening, the chamber being configured to be filled with a liquid; and a plurality of electrodes disposed in the chamber and configured to be coupled to an electrical pulse-generation system, the plurality of electrodes including a first electrode and a second electrode, the first electrode and the second electrode defining a spark gap, wherein the chamber additionally includes a maintenance opening, wherein the maintenance opening is sealed by a port for manipulating the chamber through the port.
2 . The device according to claim 1 , wherein the port is self-sealing.
3 . The device according to claim 1 , wherein the port comprises an elastic material.
4 . The device according to claim 3 , wherein the port defines a port channel and wherein the elastic material seals the port channel.
5 . The device according to claim 4 , wherein the elastic material extends over the entire cross-section of the port channel.
6 . The device according to claim 3 , wherein the elastic material is disk-shaped or cylindrically shaped.
7 . The device according to claim 3 , wherein the elastic material is radially compressed.
8 . The device according to claim 3 , wherein the elastic material is silicone.
9 . The device according to claim 1 , wherein the port comprises a bushing for releasably connecting the port to the housing.
10 . The device according to claim 1 , further comprising: a reflector for redirecting and shaping a shockwave pattern generated by the pressure pulse source; and a membrane or lens covering the reflector for transmitting the shockwave pattern.
11 . A system, comprising: the device for generating the shockwaves according to claim 1 ; and a needle for penetrating the port.
12 . The system according to claim 11 , wherein the needle is a Huber needle or Gripper needle.
13 . A method of manipulating a device for generating shockwaves, comprising: providing the device for generating the shockwaves according to claim 1 ; and manipulating a content of the chamber through the port.
14 . The method according to claim 13 , wherein manipulating comprises adding a liquid or solid to the chamber and/or removing liquid from the chamber.
15 . The method according to claim 13 , wherein the port defines a port channel and wherein an elastic material seals the port channel, the method further comprising: providing a needle; penetrating the elastic material with the needle; manipulating a content of the chamber through the needle; and removing the needle from the port.
16 . The method according to claim 15 , wherein the needle comprises a Huber or Gripper needle.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application claims priority to European Application Serial No. 23195028.8, filed Sep. 4, 2023, which is incorporated herein by reference in its entirety. FIELD OF THE INVENTION The present invention relates to a device for generating shockwaves. Further, the present invention relates to a set comprising the device and to a method of manipulating the device. INTRODUCTION For several decades shockwaves at low-energy levels have been known, mainly in orthopedics and wound healing. The first human medical application of high-energy extracorporeal shockwaves was in the field of urology using its mechanical characteristics in liquids to destroy urinary concernments within the patient's body. For example, such shockwaves are used to destroy kidney stones. This medical procedure is known as lithotripsy. A further application of shockwaves is Direct Epicardial Shock Wave Application, DESWT. DESWT induces tissue regeneration in infarcted heart muscle and thereby significantly improves and restores heart function (left ventricular ejection fraction). The shockwaves initiate biological responses like new heart muscle tissue formation. Shockwaves in the above applications may be generated electro-hydraulically. Electro-hydraulic shockwave generation means that a liquid is held in a closed chamber with at least two electrodes inside. A high voltage is applied between the two electrodes, for example a multiple of 1 kV (including 1 kV). Upon an electrical discharge between the two electrodes a part of the liquid is vaporized by a plasma generated by the electrical discharge between the electrodes. This causes an acoustic shock wave pressure pulse in the liquid (typically water) which is then transferred via a membrane to the patient's skin or tissue. Some shockwave generators additionally include a reflector for focusing the shockwaves energy to a certain point or a geometrical form like a ring or a line, depending on the designated treatment area within the patient's body. For example, an ellipsoidal reflector may focus the point like shockwave generated between the tips of the electrodes in the first focal point of into a second focal point. The second focal point which is typically positioned within the patient's body and defined as the treatment area. Alternatively, a parabolic reflector may generate flat unfocused parallel shockwave pressure fronts like in the treatment of skin burns and other superficial occurring treatment indications. If there is no reflector, the shockwaves radiate spherically from the electrical discharge between the electrode tips. These unfocused shock waves are used in the treatment of arteriosclerosis within coronary arteries by electrodes inserted via a coronary catheter. Many of the above medical indications can be treated by using a small handheld shock wave applicator (shock wave probe). The electrodes in the probe are eroded by the energies generated during the electrical discharge for the shockwave generation. Therefore, the electrodes must be exchanged or refurbished after a certain number of generated shockwaves. The amount of erosion of the electrodes increases with the applied electrical energy and therefore depends on the selected acoustic energy level of the shockwaves. This causes a limit to the maximum number of shock wave released by a single shockwave probe. The probe has by this limitation a predefined capacity of shock wave releases before the distance between the electrode tips is enlarged by the erosion to an amount that the electrical discharge will no longer ignite properly with a resulting imperfect shockwave generation. To achieve a reliable functioning of the electro-hydraulic therapeutic shockwaves system the probes are exchangeable to a basic control and power unit. This concept allows to have several probes in stock at the medical site with a defined number of shockwaves to be generated for therapeutic purposes as described above. If one probe has reached its maximum number (capacity) of shock wave releases, it can be unplugged from the basic power and control unit and exchanged by the user. This allows to use probes with different specific and adapted shock wave characteristics by different focusing reflectors, different liquids compositions for physical different pathways of shock wave generation, different penetration depths by different filling levels of the probe's liquid. The used probes can be technically refurbished by exchanging the eroded electrodes and by exchanging the liquid level for different penetration depths and by changing the liquid composition. It might also be necessary for certain probes to refurbish, because theirs shelf lifetime has been reached by losing liquid by diffusion through the flexible coupling membrane. The liquid will be refilled, and the composition adjusted in an alternative refurbishment procedure. For different application schemes there might be different probes as a part of a pro