SHOCK WAVE APPARATUS

Abstract

The invention relates to a shock wave apparatus for treating the human or animal body with an applicator which is intended to couple strokes into the body and has a hollow shape at a front area intended to be placed on the body and a relatively soft elastomeric material with a maximum Shore hardness of 60 Sh.

Claims

1. An apparatus for treating a human or animal body, having an applicator (9, 11, 16, 22, 25, 25) for being placed on said body from the outside, a housing (1, 2, 3) in which said applicator (9, 11, 16, 22, 25, 25) is held, and a mechanism (6, 13, 21) for generating strokes of said applicator (9, 11, 16, 22, 25, 25) in a stroke direction relative to the housing (1, 2, 3) such that said strokes can be coupled into said body when said applicator is placed on said body, characterised in that said applicator (9, 11, 16, 22, 25, 25) has a front area (17, 38, 39) facing forwards in the stroke direction, adapted to be placed onto said body, having a hollow shape and consisting of an elastomeric material with a maximum Shore hardness of 60 Sh at least at said hollow shape, wherein said elastomeric material has a thickness at said hollow shape in said stroke direction of at least 3 mm.

2. The apparatus according to claim 1, wherein the mechanism (6, 13, 21) for generating said strokes comprises a projectile (13) and a device (6, 21) for accelerating said projectile (13) in such a way that said projectile (13) hits said applicator (9, 11, 16, 22, 25, 25) and generates the stroke, thus preferably a pneumatic device for accelerating said projectile (13).

3. The apparatus according to claim 2 wherein the applicator is made from a non-elastomeric material in the area (16, 22) hit by the projectile (13) on striking, and said material has a minimum thickness in the stroke direction of 2 mm in this area.

4. The apparatus according to claim 1 wherein the front area (17, 38, 39) and preferably a part of the applicator which is visible outside of the housing is overall rotationally symmetric around an axis parallel to the stroke direction.

5. The apparatus according to claim 1 wherein the applicator (9, 11, 16, 22, 25) has a narrowing at the front area (17, 38, 39), and is preferably conical, along the stroke direction.

6. The apparatus according to claim 1 wherein the material of the applicator (9, 11, 16, 22. 25, 25) with the maximum Shore hardness of 60 Sh is silicone rubber.

7. The apparatus according to claim 3, wherein the applicator (9, 11, 16, 22, 25, 25) has, relative to the stroke direction, a proximal part (16, 35) and a distal part (11, 36, 37), wherein the proximal part (16, 35) is made from the non-elastomeric material and the distal part (11, 36, 37) includes the front area (17, 38, 39), and the distal part (11, 36, 37) is held on or in a undercut profile, relative to the stroke direction, of the proximal part (16, 35), preferably in an undercut hollow profile of the proximal part (16, 35).

8. The apparatus according to claim 1 wherein the hollow shape of the front area (17, 38, 39) has a depth in the stroke direction of between 10% and 30% of the average diameter of the hollow shape perpendicular to the stroke direction.

9. The apparatus according to claim 1 wherein the hollow shape of the front area (17, 38, 39) is rounded and concave, preferably spherical and preferably with a radius of curvature of between 5 mm and 20 mm.

10. The apparatus according to claim 1 wherein the hollow shape of the front area (17, 38, 39) is surrounded by a convex edge rounded with a radius of 0.5 mm to 1.0 mm.

11. The apparatus according to claim 1 wherein the material has the maximum Shore hardness of 60 Sh on the one hand and a minimum Shore hardness of 10 Sh on the other hand.

12. The apparatus according to claim 1 wherein the applicator (22, 25, 25) is held in a coupling device (27, 28, 29, 30) in the housing, wherein at least one applicator element (25, 25) is removable from the housing in the stroke direction after releasing the coupling device (27, 28, 29, 30).

13. The apparatus according to claim 12, wherein the applicator (22, 25, 25) comprises at least two parts, whereby a distal applicator element (25, 25) is removable after releasing the coupling device (27, 28, 29, 30) and a proximal applicator element (22) remains in the housing, and wherein the proximal applicator element (22) transfers the strike to the distal applicator element (25, 25).

14. The apparatus according to claim 1 which is designed for a stroke travel in the stroke direction relative to the housing (1, 2, 3) of at least 1 mm.

15. The use of an applicator (9, 11, 16, 22, 25, 25), which has a front area (17, 38, 39) with a hollow shape intended for placing on a human or animal body, which is made, at least at this hollow shape, from an elastomeric material with a maximum Shore hardness of 60 Sh, wherein the elastomeric material at the hollow shape has a minimum thickness in the stroke direction of 3 mm, for an apparatus according to claim 1.

Description

[0033] FIG. 1 shows a shock wave apparatus as a first exemplary embodiment of the invention;

[0034] FIG. 2 shows a second exemplary embodiment, wherein the shock wave apparatus is shown only in part and with regard to an applicator coupling device not forming part of the first exemplary embodiment;

[0035] FIGS. 3 and 4 show exchangeable applicator elements for the second exemplary embodiment in FIG. 2.

[0036] FIG. 1 shows a first exemplary embodiment of the invention. It is an apparatus for coupling strokes and unfocussed (so-called radial) mechanical shock waves into the human or animal body.

[0037] A tube piece 1 forms a housing, namely together with an air inlet cap 2 pointing away from the body in the application and being integrated with the tube piece 1 and an applicator cap pointing towards the body in the application 3. The air inlet cap 2 comprises a compressed air connection 4 for a pneumatic supply. In a manner known as such, a valve controlled by a control unit, in particular a magnetic valve, is connected to this compressed air connection 4 via a pneumatic supply line, with the valve coupling compressed air pulses in a constant repetitive cycle of between, for instance, 1 Hz and 50 Hz. The valve is not shown and can also be integrated into the shown apparatus itself.

[0038] Furthermore, the apparatus is an apparatus designed to be held by hand by an operator, being connected via the aforementioned pneumatic line to a base station, not shown, with the control unit and the compressor and being placeable on the patient manually. It is particularly suitable for treating body parts behind structures within the body such as ribs or shoulder blades.

[0039] In the housing, a guiding tube 6 is held by an inset 5, whose end being distal to the body in the application is terminated by the air inlet cap 2 and communicates with the compressed air connection 4 there. The end of the guiding tube 6 which is proximal to the body in the application ends in a part of the insert 5, with the part projecting into the applicator cap 3 and namely ending just before the end of the insert 5 in the cap and before an inner space 7 in the applicator cap 3.

[0040] In the inner space 7 which merges into an applicator opening proximal to the body in the application, a first part of an applicator 9, shown on the left in FIG. 1, is received, with this part being made from a hard material, stainless steel in this case. Via an elastic tube element 10 made from an elastomer, it rests on a radial collar. An end of the applicator 9, pointing to the side distal to the body and containing the impact area 15, rests on the insert 5 via an O-ring 12, namely at the front face surrounding the end of the insert 5 mentioned above. This O-ring 12 is located between this front face and a collar of the applicator 9. The applicator opening 8 provides a guidance of the applicator 9 with a movability in the longitudinal direction and secures it crosswise to the longitudinal direction. The axial movability is only limited by the deformability of the elastomer element 10 and can be significantly above 1 mm relative to the remaining apparatus when operated in air,

[0041] The applicator 9 comprises, as a second part, the element 11 shown on the right in FIG. 1 which forms the very applicator part to be placed on the skin and is made from silicone rubber with a hardness of approximately 30 Sh. The applicator part 11 is cast into a hollow shape of the applicator part 16 that is undercut on the inside.

[0042] The applicator 9 is replaceable by unscrewing the applicator cap 3.

[0043] In the adjacent region of the guiding tube 6, a projectile 13 is inserted which is in contact with the applicator 9 in FIG. 1. It fits in there with a slight radial clearance (in relation to the guiding tube and the substantially cylindrical geometry of the projectile 13). The projectile 13 can be moved to-and-fro in the guiding tube 6 as a result of pressure differences in the air column in the guiding tube 6 in front of and behind the projectile (i.e. to the right and left of the projectile 13 in FIG. 1), and in particular it can be accelerated onto the applicator 9. To this end, it is accelerated from an initial position (not shown) on the left in FIG. 1 by a surge of compressed air through the compressed air connection 4 and hits the applicator 9 with its front area facing the applicator 9, namely hitting an impact area thereof facing away from the body 15.

[0044] In addition to a rebound after the collision, the backward motion of the projectile 13 is created by air flowing back from an accumulation chamber 14 surrounding the guiding tube 6 within the inset 5. The air is displaced into this accumulation chamber during acceleration of the projectile 13 towards the impact body 9 and compressed therein. When the pressure is released by the magnetic valve, there-by also venting the space behind the projectile, the projectile 13 is moved back into its initial position. In addition, or alternatively, this can also be achieved by pressurising the accumulation chamber 14 or another air volume at a side of the projectile 13 proximal to the body. The end of the guiding tube 6 that is distal to the body in the application ends at a magnet holder for the projectile 13.

[0045] It can be seen that the applicator 9 in respect of its longitudinal extension in the stroke direction consists roughly half (not including the hollow shape) of the hard left-hand applicator part 16 and half of the soft right-hand applicator part 11, wherein both have an axial length of roughly 35 mm and a maximum diameter of roughly 20 mm. Starting roughly from distal end of the hollow shape, the soft applicator part 11 narrows conically down to a diameter of roughly 15 mm over a length of roughly 15 mm (not shown to scale). The adjoining front area 17 is spherically concave with a radius of curvature of roughly 8 mm and therefore a depression in the centre (as opposed to a notional plane front area) of approximately 3 mm. The edge is rounded with a radius of 0.7 mm.

[0046] FIG. 2 shows a second exemplary embodiment wherein (with the right and left inverted compared to FIG. 1) the applicator-side end of an apparatus that otherwise corresponds to FIG. 1 is shown but is fitted with a special coupling de-vice for accommodating particularly easily changeable applicator elements. FIGS. 3 and 4 then show two applicator elements that can be used here. A word about FIG. 2 first, however: A proximal element, in other words an applicator element 22 on the right-hand side in FIG. 2, has a largely conventional shape compared to the prior art and to FIG. 1 and therefore rests with a radially enlarged flange and its distal collar side on an elastomer tube piece 23 which is deformable in the event of collisions and allows a movement in excess of one milli-metre of the proximal applicator part 22. It is also responsible for the rebound and decouples the strokes from the apparatus housing. On the distal side, this proximal applicator element 22 ends in a cylindrical pin which penetrates a guiding sleeve 24 and protrudes beyond this sleeve slightly on the distal side. In the case of conventional apparatuses, the distal front face of this pin would form the area of the applicator that comes into contact with the patient and the guiding sleeve 24 would be created in (or as) an unscrewable cap. The cap would therefore have to be removed, thus destroying a part, before the applicator (in this case the proximal applicator element 22) can be removed. The same applies to the variant from FIG. 1 with the applicator 9.

[0047] FIG. 2 further shows that the left-hand front face of the proximal applicator element 22 is in contact with the right-hand front face of a distal applicator element 25. This distal applicator element 25 will be described in more detail using FIGS. 3 and 4. It is guided into a locking slot 26, fitting positively, for instance in a hexagonal positive fit, and is therefore secured against rotation in this locking slot 26. The locking slot 26 in term must accordingly be held in the rest of the housing so that it is secured against rotation.

[0048] FIG. 2 also shows that openings for positive-fit balls 27 which mesh inwards into corresponding grooves on the outside of the distal applicator 25 are provided in the locking slot 26 (at the top and bottom of FIG. 2). These grooves are longer than necessary on the right in the figure, meaning that the entire applicator 25 and 26 can move to the left following a strike. On the other hand, the positive fit between the balls 27 and the corresponding grooves prevents the distal applicator element from falling or shooting out of the housing. The distal applicator element can in fact be pushed back into its original position as shown on the drawing after a strike simply by pressing it against the patient.

[0049] Radially outside the balls 27, a clamping sleeve 28 can be seen which evidently has an internal oblique area at its left-end end. If this clamping sleeve 28 is moved to the right out of the position shown on the drawing, the balls 27 can veer off outwards radially and the distal applicator part 25 can simply be removed from the housing as an entire entity to the left-hand side. A handy pushing in (to the right) of an externally accessible housing part 29 provides this movement of the clamping sleeve 28, wherein a coil spring 30 pushes against this and/or creates the rebound and this movable housing part 29 is movable in another part 31 of the housing and is guided constrained by an O-ring.

[0050] In FIG. 2 to the left of the movable housing part 29 used to actuate the coupling, there is also a locknut 32 which is screwed onto the receiving part 26 and is sealed against the latter by means of an O-ring and against the part 25 by means of an elastomer flat sealing ring.

[0051] Overall, it is clear that a projectile strike moves the whole applicator to the left and results in an equivalent strike movement of the distal end, not shown on the drawing, of the applicator (on the far left) towards the patient's body, wherein the coupling in of an actual shock wave will occur in parallel to this, but in many cases is not actually essential.

[0052] If the distal applicator element 25 is to be replaced, the user slides the movable housing part 29 to the right and therefore also the clamping sleeve 24, enabling the balls 27 to exit radially. The openings in the locking slot 26 for the balls 27 are also radially too narrow on the inside, preventing the balls from falling out.

[0053] FIGS. 3 and 4 show the embodiments of two distal applicator elements for the exemplary embodiment from FIG. 2. FIG. 3 shows an applicator variant 25 which, apart from the adaptation of the coupling device from FIG. 2, corresponds substantially to the applicator 9 from FIG. 1. It is designed slightly shorter, however. The multi-sided pin 34 is pressed into a stainless steel part 35 in this case, but could, in particular where the actual high-frequency soundwaves are relevant, be designed as a single piece together with the stainless steel part. Otherwise, the statements made in relation to FIG. 1 apply to the soft applicator part 36.

[0054] FIG. 4 shows a variant wherein the conical narrowing of the soft applicator part 36 is omitted and the soft applicator part 37 instead retains the maximum diameter right up to the front area. The front area 38 has a flat annular outer area and a spherical concave depression within this. The latter is slightly larger, but not necessarily deeper than the depression shown in FIG. 3; in the scenario shown in the drawing, however, the radius of curvature of 8 mm is retained.

[0055] With both exemplary embodiments, it is easy to imagine how the front area of the applicator with its depression might be placed on the back of a patient in the spinal area, for example, and pressed down, working ergonomically, without slipping off and with good surface contact thanks to its ability to adapt to the contours of the body and the material chosen. The trials carried out by the inventor have con-firmed this.