THERAPY EQUIPMENT FOR THE SHOCK WAVE TREATMENT OF A PATIENT

The invention is in a therapy apparatus for the shock wave treatment of a patient.

A shock wave therapy apparatus is described in EP-A-0 265 741. It comprises at least one therapy head which comprises a shock wave generator, a coupling membrane on the patient side and arranged therebetween a receiving space for coupling fluid. To the receiving space there is connected a fluid circulation which apart from a circulatory pump comprises several valves and a bleeding means in order to keep the coupling fluid flowing through the receiving space in a controlled manner bubble-free also during the treatment. In order to ensure an adequate through-flow of the therapy head and to keep the coupling membrane always pressed tightly on the body of the patient to be treated, it is necessary for the coupling fluid to be circulated in the fluid circulation with an adequate pressure and in a sufficient quantity, for which the conduit cross sections of the circulation must be relatively large. This leads to the further disadvantage that the handling of the therapy head during the patient treatment is unwieldy and awkward on account of the relatively thick fluid conduits.

A further therapy apparatus is described in DE 197 18 511 A1. It comprises a therapy head essentially of the above mentioned type, which via an electronic conduit is connected to a supply and operation unit. The therapy head is a closed constructional unit and contains a coupling medium which cannot be changed in its quantity. In order to permit larger penetration depths of the therapy focus into the body of the patient, coupling attachments are allocated to the therapy head. Coupling attachments are loose parts and may be easily lost. Furthermore the field of application of this therapy head is limited by way of the external coupling attachments or coupling cushions, because the coupling membrane of the therapy head only permits a very small penetration depth of the therapy focus of the therapy head and because the external coupling cushions do not permit an infinitely adjustment of the therapy head. Furthermore the application of the therapy head is very awkward because the surgeon by way of the coupling cushion must gradually feel his way up to the location of therapy.

In DE 44 04 140 A1 there is described a further therapy apparatus. It serves the treatment of pain conditions and the influencing of vegetative nerve system and comprises a shock wave generator, a coupling membrane on the patient side, a receiving space with coupling fluid and a central locating device. The therapy head of the shock wave generator is located completely in the coupling fluid of the receiving space and therefore all around must be protected with respect to the coupling fluid, for which complicated sealings are required. Furthermore there is necessary a complicated adjusting mechanics in order to be able to adjust the therapy head to the region of therapy.

The object of the invention lies in improving a therapy apparatus of the initially cited type as a hand apparatus, such that whilst maintaining an optimal execution of treatment of a patient, during this treatment one may operate simply and comfortably.

The therapy apparatus of the invention for the shock wave treatment of a patient has a main housing with a shock wave generator operable via a supply tubing with energy conduits and with a coupling membrane and a space with a coupling fluid. The quantity of the coupling fluid in the receiving space for the purpose of adjusting the coupling membrane to the patient is controllable. The receiving space containing the coupling fluid communicates with a control space which is likewise filled with coupling fluid and which at least partly comprises a flexible wall region, and wherein the flexible wall region of the control space can be impinged with a gaseous control force.

With the solution according to the invention the convenience of the therapy apparatus is significantly increased since the flow cross section of the control conduit for reducing and enlarging the coupling fluid quantity in the receiving space of the shock wave generator may now be kept very small since it is only necessary to lead a gas medium being under pressure, for example pressurized air, through this conduit which impinges the control space of the therapy apparatus with a gaseous pressure force. By way of the pressure force of the gas medium the flexible wall of the control space may be suitably pressed together or expanded so that the coupling fluid located in this space is pressed into the receiving space of the shock wave generator or may flow back again out of this, in order to be able to apply the coupling membrane of the shock wave generator on the body of a patient in a manner which is correct for the therapy. Thus no relatively sluggishly flowing fluid quantities need to be led through the control conduit of the common supply tubing, but only relatively quickly flowing pressure gases, by which means the concerned pressurized gas control conduit has a considerably smaller diameter than a corresponding fluid conduit, with the result that the supply tubing also containing electrical conduits for the shock wave generator, in its outer diameter may be kept considerably smaller than previously, which considerably increases the handiness of the therapy head whilst maintaining an exact and large-surface positionability of the coupling membrane of the shock wave generator on the patient.

In a preferred embodiment of the therapy apparatus according to the invention the control space is provided as a separate space in a rigid connection housing fastening on the outside to the main housing of the apparatus and that on this housing there is connectable a pressurized air conduit. The main housing is advantageously provided with an elongate handle in which the connection housing is contained and to which there is connectable a supply tubing which contains the pressurized air conduit for the control space, furthermore the handle is provided with an operating keyboard for the operation of the shock wave generator. By way of this the handiness of the therapy apparatus is considerably increased.

In a further preferred embodiment of the therapy head according to the invention there is provided a probing rod, with two end abutments and with a probing tip of X-ray opaque material, which is coaxially movable along an axis running through the focus of the shock wave generator and which from outside the main housing projects into the receiving space, wherein the front end abutment for the distal positioning of the probing tip is arranged in the focus of the shock wave generator. This permits a quick treatment positioning of the therapy apparatus at locations of treatment which are located in the region of the patient close to the skin.

In a further preferred embodiment the probing rod for purposes of bleeding may be designed at least partly as a hollow rod which in the region of its probing tip comprises at least one air inlet opening and in its section located outside the main housing at least one closable outlet opening.

The various features of novelty which characterize the invention are pointed out with particularity in the claims appended to and forming a part of this specification. For a better understanding of the invention, its operating advantages and specific objects obtained by its use, reference should be had to the accompanying drawings and descriptive matter in which there is illustrated and described a preferred embodiment of the invention.

FIG. 1shows a single therapy apparatus1, for the shock wave treatment of a patient, which via a supply tubing2is connected to a supply means3with a monitor4. The supply tubing2contains several supply conduits for the electrical and gaseous actuation of the apparatus1whose operation is controlled by the means3in a manner known per se. The means3is formed as a table apparatus, but may also be designed as a standing apparatus.

FIG. 2shows a supply means3with several therapy apparatus1, for example with three therapy apparatus. This means has three plug locations5for the therapy apparatus in order for the desired treatment, in each case to be able to select the suitable therapy apparatus. Via a button of the means3the desired therapy apparatus is switched ready for operation. The several therapy apparatus according toFIG. 2differ according to the required treatment purpose. Thus for example the size, aperture, penetration depth and the power of the therapy apparatus may be different. Furthermore the apparatus1may comprise a locating means or positioning aids of the known type. Further it is possible for the locating means and/or positioning aids to have differing frequencies for example in the case of ultrasound probes. Furthermore the therapy apparatus may have a coupling membrane adapted anatomically or to the corresponding symptoms, or a correspondingly adapted therapy head housing. Of course it is also possible that the supply tubings2may have a differing length.

FIG. 3the therapy apparatus1is shown in detail. In, for example, a calotte-shaped main housing6, there is arranged a calotte-shaped shock wave generator7. To the main housing there is fastened a calotte-shaped coupling membrane which occludes the shock wave generator to the outside in a closed-walled manner. Between the generator7and the coupling membrane8in the known manner there is formed a space9for receiving a coupling fluid. The quantity of the coupling fluid in the receiving space9is changeable depending on the respective therapy procedure, and is controlled by way of the supply means3via the supply tubing2, as will yet be clear.

To the main housing6there is connected a rigid connection housing10which simultaneously may also be formed as an elongate, tubular handle with which the therapy apparatus during the treatment is held or can be fastened on a stand. It is possible, asFIG. 3shows, in the connection housing10or in the handle to provide a further space11with rigid walls. This space or alternatively the connection housing contains a control space12which is formed at least partly flexible. The wall material of the control space12is a fluid-tight material, wherein this material may for example consist of rubber so that the control space, as shown inFIG. 3, is completely surrounded by a flexible wall13. The thus flexible control space12is furthermore filled with coupling fluid.

Via a communicating passage14the flexible control space12is in flow connection with the receiving space9between the shock wave generator7and the coupling membrane8.

To the other end of the connection housing10or of the handle there is connected the supply tubing2which leads to the mentioned supply means3. In this supply means there runs a gaseous pressure conduit, for example a pressurized air conduit15in order to be able to impinge the flexible wall13of the flexible control space12in the rigid space11with pressurized air. In the condition ready for application the receiving space9and the control space12including the passage14are free of bubbles and completely filled with coupling fluid, wherein the coupling membrane does not necessarily have to have its outermost position.

If now the coupling membrane8is pressed against the treatment location of the patient or is applied thereon, then some coupling fluid flows out of the space9via the passage14back into the control space12whose flexible wall13, or whose flexible wall region accordingly expands. Via the pressurized air conduit15then in a controlled manner pressurized air is introduced into the rigid space11and thus pressure is exerted onto the wall13of the control space12. By way of this the volume of the control space12reduces by which means coupling fluid is pressed out of the control space12via the passage14again into the receiving space9in order to press the coupling membrane8onto the body of the patient in a large surfaced and tight manner. The pressurized air conduit15has in comparison to a previously used fluid conduit a considerably smaller flow cross section, through which however pressurized air may be led with the required rapidity in order to be able to carry out the corresponding volume change of the control space12. By way of such a pressurized air conduit relatively small in cross section the supply tubing which also contains remaining conduits for the therapy apparatus1, for example the electrical leads16for the shock wave generator7, may be kept considerably smaller in cross section than previously, by which means the handiness of the therapy apparatus1is considerably improved.

For the further improved handling and operation of the therapy apparatus1the connection housing10or the handle may be provided with an operating keyboard17which via an electrical control conduit18, which likewise runs through the supply tubing2, is in connection with the supply means3.

The therapy apparatus1may be provided with a positioning aid19for the correct application on the body of the patient. In the embodiment according toFIG. 3this positioning aid consists of an axially movable probing rod20which is actuatable along any axis running through the therapy focus7aof the shock wave generator7. For this the probing rod has a proximal operating part21which is provided outside the main housing6. The distal end of the probing rod20is formed as a probing tip22of X-ray opaque material, for example in the form of a metal ball. Preferably the probing rod20is axially movable along the central axis of symmetry23of the shock wave generator7and is provided with an abutment collar24in order at least to be able to determine the distal end position of the probing tip22of the probing rod20in the therapy focus7aof the shock wave generator7. The probing tip22may thus only be advanced so far until its position corresponds to that of the therapy focus of the shock wave generator. The symmetry axis23of the shock wave generator7is positioned exactly onto the treatment location, by which means the desired penetration depth may be defined. By way of this the treatment location on the patient may be probed with the bio-feedback treatment method.

In a further formation of the positioning aid19this may also be designed as a bleeding means on filling the receiving space9and the control space12. For this the probing rod20is designed at least partly as a hollow rod, and specifically from the region of its probing tip20up to a location outside the main housing6. Along this region there runs a bleeding channel25which in the region of the probing tip22comprises at least one air inlet opening26and at the location outside the main housing at least one air exit opening27. This opening27may be directly closable.

The air exit opening27may however also be provided at the outer end of the probing rod20, e.g. when the bleeding channel25extends through the whole probing rod up to its rear end on which then there is provided a closable connection piece.

Alternatively according to the illustrated embodiment it may be proceeded in that the probing rod20projecting to the rear out of the main housing67is surrounded by an auxiliary housing28connecting to the main housing, by which there is formed an annular space29which opens into an closable outlet connection piece30of the housing28. If it is desired, the auxiliary housing28and the outlet connection piece30may be surrounded by a protective housing31. The outlet opening27of the probing rod30thus opens into the annular space29, and from here coupling fluid during the filling of the therapy apparatus1may flow downstream via the outlet connection piece30. The probing rod20also in this case comprises a length such that it projects to the rear out of the housings28and31and may be actuated via the operating part21.

For the filling of the receiving space9and of the control space12with coupling fluid the walling13of the control space is provided with an inlet connection piece32. For filling these two spaces with coupling fluid the inlet connection piece32and the outlet connection piece30are connected to a filling circulation, for coupling fluid, which may comprise a bleeding means. For the bubble-free filling of the receiving section9the probing rod20is displaced forwards into its distal end position. Thus the coupling membrane8is pretensioned in a conical manner and via the inlet opening26, of the probing rod20, which is located in the frontmost region with a suitable posture of the therapy apparatus1, the receiving space9is entirely bled of air and completely filled with coupling fluid. After a complete, bubble-free filling of the two spaces9and12the corresponding connection pieces30and32are again closed.

FIG. 4shows a schematic circuit representation for the general control of the therapy apparatus1. It will be understood that the shock wave generator7, the spaces9and12for the coupling fluid and the operating keyboard17of the therapy apparatus1via the conduits16,15and18running in the supply tubing2run to the supply means3where the corresponding control units33,34and35for the corresponding parts of the therapy apparatus are provided.

FIG. 5shows a modified embodiment example of the therapy apparatus1. With this embodiment example a locating means or a positioning aid for determining the therapy region on the patient is not shown; known means for this may however be used internally or externally in combination with this embodiment example. Also with this embodiment example the receiving space9filled with coupling fluid is connected via the communicating passage14to a control space12located behind the shock wave generator7. This control space is partly enclosed by a rigid wall36and partly by a flexible wall37. With this there are provided components of the walls36,37for forming the control space12within the main housing6of the therapy apparatus1. The flexible wall part37in the initial condition projects somewhat with respect to the rear wall6aof the main housing6as this is shown in FIG.5. With a vacuum in the pressurized air conduit15the flexible wall part37is pulled in the direction of the rigid rear wall6awith the result that coupling fluid escapes from the coupling space9via the passage14into the control space12, so that the coupling membrane8is set back, thus moves in the direction of the shock wave generator7. By way of this the therapy focus7areaches deeper locations in the patient to be treated. The flexible wall part37may be formed as a membrane of for example rubber material and extend over the whole cross sectional surface of the main housing6, as shown, behind the shock wave generator. In an alternative formation of the flexible wall part a bellows-like balloon is provided at the pressurized air inflow region of the main housing6.

In order to prevent, with the embodiment according toFIG. 5, the communication passage14between the two spaces9and10on the forwards movement and extension of the flexible wall part37from being closed, means38for holding free are provided in the region of the passage14provided here centrally in the shock wave generator. These means for holding free may consist of at least one tube piece which advantageously extends from the edge of the passage14roughly to the rigid wall part36of the control space12. In the extreme case the flexible wall part36bears on the tube piece38so that the passage14is at least partly kept free.

The control leads15and16also in this example run through a supply tubing2which is small in cross section and which may connect directly to the rear wall6aof the main housing6(not shown). They may initially also run through a handle (not shown) which connects to the rear wall6aof the main housing6and then are led further in the tubing2.

FIG. 6shows a pneumatic control39for producing the control force in the pressurized air conduit15for the purpose of impinging the flexible wall parts13and37of the control space12. In a conduit circuit40there are provided two control valves41and42as well as a circulatory pump43arranged between these two valves. According to the position of the control valves pressurized air according to the double arrow44is pumped through the conduit15in order to displace forwards or backwards the flexible wall part13or37of the control space12. Via the passage14by way of this the corresponding quantity of coupling fluid in the receiving space9between the shock wave generator7and the coupling membrane8may be set according to the demand for the patient to be treated.

FIG. 7shows a further modified embodiment of the invention. The main housing6of the therapy apparatus1is designed lengthened to the rear in a manner such that the lengthening comprises the connection housing10, a web-like or elongate handle45and a grip slot46therebetween. In a modification the proximal, partly dashed shown region47of the apparatus1between the housing10and the handle45may also be done away with so that the grip slot46is open to the rear. In the connection housing10the space11with rigid walls, which is impinged with pressurized air from the supply tubing2and the flexible control space12therein is filled with the coupling fluid. The fingers of the surgeon grip through the grip slot46whilst he operates the keyboard17provided distally in the region of the grip45with the thumb. This construction of the therapy apparatus1has the advantage that the connection housing10and thus also the control space12located therein may be formed relatively large so that a relatively large quantity on controllable coupling fluid is made available, however that the apparatus1may be comfortably held and handled.

The terms and expressions which have been employed are used as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding any equivalent of the features shown and described or portions thereof, it being recognized that various modifications are possible within the scope of the invention.