Pressure-pulse therapy apparatus

Surgery: kinesitherapy – Kinesitherapy – Ultrasonic

Reexamination Certificate

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Details

C601S004000, C367S142000, C367S147000, C367S171000, C367S174000

Reexamination Certificate

active

06755796

ABSTRACT:

FIELD OF THE PRESENT INVENTION
The present invention relates generally to apparatus for pressure-pulse therapy. The present invention relates in particular to the generation of compound pressure pulses especially for orthopedic therapy.
BACKGROUND OF THE PRESENT INVENTION
Pressure-pulse therapy, also known as shock-wave therapy, has many uses. It is used in lithotripsy as a non-invasive technique for pulverizing kidney stones and calculi in the bladder and urethra. It is also used for dissolving lipids in cells close to the skin and in the pelvic region. In particular, it has many uses in orthopedic medicine, for example, as a therapeutic means for any of the following:
i. osteoporosis and the inducement of bone growth;
ii. joining of bone fracture, especially, ununion fractures, i.e., fractures that have failed to unite and heal;
iii. disintegration of calculi and (or) calcification in fibers, joints, and tendinitis; and
iv. pain relief in the cases of calcific tendinitis of the shoulder joint, tennis elbow, golf elbow, and plantar fasciitis (with and without heel spur).
U.S. Pat. No. 4,620,545 “Non-Invasive Destruction of Kidney Stones” to Shene et al., whose disclosure is incorporated herein by reference, describes a pressure-pulse therapy apparatus which includes an ellipsoidal reflector, having a first focal point within the reflector's dome and a second focal point outside the reflector's dome. A flexible diaphragm caps the reflector, and the region contained by the reflector and the diaphragm is filled with a liquid medium, for pulse propagation. A pressure-pulse source is located at the first focal point, within the medium. This configuration provides that a portion of a pulse originating from the source, at the first focal point, will impinge on the reflector, be reflected by it, and be brought into focus at the second focal point. The reflector is movable and can be positioned so that the second focal point coincides with a concretion within the body that is to be pulverized. Sonic aiming means are used to detect the concretion and to direct the positioning of the reflector.
In general, pressure-pulse therapy is accompanied by an imaging means, such as the sonic aiming means of U.S. Pat. No. 4,620,545. The region for treatment is generally small, between 0.3 and 1.5 cm, and it is desirous to image the location in order for the therapy to be applied effectively. X-ray imaging may be used; however, with x-rays, the patient and the physician are exposed to radiation doses with each treatment.
PCT patent publication PCT WO 93/14720, “Method and Apparatus Particularly Useful for Treating Osteoporosis,” to Spector, whose disclosure is incorporated herein by reference, offers an alternative to the need for an imaging means. It has a generally parabolic reflector, which has a single focal point within the reflector's dome. A flexible diaphragm caps the reflector and the region contained by the reflector and the diaphragm is filled with a liquid medium, as in the previous patent. A pressure-pulse source is located at the focal point, within the liquid. This configuration provides that a portion of a pulse originating from the source, at the focal point, will impinge on the reflector, and be reflected by it, collimated. In other words, the reflected pulse will be a non-focusing wave, so focusing means are not essential. Pressure pulse therapy can thus be image free.
However, with a collimated beam, some pressure pulse energy is lost, when compared with a beam that is focused at the region for treatment. It would be desirable to direct more of the pressure-pulse energy at the region for treatment, without being dependent on an imaging means.
SUMMARY OF THE PRESENT INVENTION
The present invention seeks to provide a therapeutic pressure pulse formed as a compound pressure pulse of at least two subordinate pulses.
There is thus provided, in accordance with the present invention, a dome-shaped reflector, having:
a center section, having predetermined first curvature and reflective characteristics associated therewith, and formed to reflect a primary pressure pulse propagating thereon, so as to form a first subordinate pressure pulse of a compound pressure pulse; and
at least one ring section, substantially concentric with said center section, having predetermined second curvature and reflective characteristics associated therewith, and formed to reflect the primary pressure pulse propagating thereon, so as to form at least one additional subordinate pressure pulse of said compound pressure pulse.
Additionally, in accordance with the present invention, said center section is substantially parabolic and has a single focal point.
Further in accordance with the present invention, said at least one ring section is substantially ellipsoid and has proximal and distal focal points with respect to said reflector, wherein said focal point of said center section and said proximal focal point of said at least one ring section substantially coincide.
Additionally, in accordance with the present invention, said at least one ring section includes a plurality of substantially ellipsoid ring sections, each having proximal and distal focal points with respect to said reflector, wherein said proximal focal points of said plurality of ring sections substantially coincide, wherein said distal focal points of said plurality of ring sections are adjacent to each other, and wherein said focal point of said center section and said proximal focal points of said plurality of ring sections substantially coincide.
Alternatively, said center section and said at least one ring section are substantially ellipsoid, each having proximal and distal focal points with respect to said reflector, wherein said proximal focal point of said center section and said proximal focal point of said at least one ring section substantially coincide.
Alternatively, said center section is generally parabolic and has a single focal zone.
Additionally, said at least one ring section is generally ellipsoid and has proximal and distal focal zones with respect to said reflector, wherein said focal zone of said center section and said proximal focal zone of said at least one ring section generally coincide.
Additionally, said at least one ring section includes a plurality of generally ellipsoid ring sections, each having proximal and distal focal zones with respect to said reflector, wherein said proximal focal zones of said plurality of ring sections generally coincide, wherein said distal focal zones of said plurality of ring sections are generally adjacent to each other, and wherein said focal zone of said center section and said proximal focal zones of said plurality of ring sections generally coincide.
Alternatively, said center section and said at least one ring section are generally ellipsoid, each having proximal and distal focal zones with respect to said reflector, wherein said proximal focal zone of said center section and said proximal focal zone of said at least one ring section generally coincide.
Alternatively, said predetermined curvatures and reflective characteristics are determined by numerical analysis.
Additionally, said predetermined curvatures and reflective characteristics include a predetermined zone at which both said first subordinate pressure pulse and said at least one additional subordinate pressure pulse are reflected.
Alternatively, said predetermined curvatures and reflective characteristics include:
a predetermined point at which said first subordinate pressure pulse is reflected; and
a predetermined point at which said at least one additional subordinate pressure pulse is reflected.
Alternatively, said predetermined curvatures and reflective characteristics include:
a predetermined zone at which said first subordinate pressure pulse is reflected; and
a predetermined zone at which said at least one additional subordinate pressure pulse is reflected.
Alternatively, said predetermined first curvature is selected from a group which consists of generally parabolic, substantially parabolic, gen

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