WO2008022172A2

WO2008022172A2 - Apparatus and method for the treatment of tissue with ultrasound by direct contact

Info

Publication number: WO2008022172A2
Application number: PCT/US2007/075962
Authority: WO
Inventors: Eilaz Babaev
Original assignee: Eilaz Babaev
Priority date: 2006-08-17
Filing date: 2007-08-15
Publication date: 2008-02-21
Also published as: WO2008022172A3

Abstract

Apparatus and method for the treatment of tissue, such as hard and soft tissues, wounds, bones, tumors, muscles, and cartilage, through the direct contact of ultrasound energy is disclosed. Ultrasound energy is delivered to a target area through direct contact with an ultrasound tip. Ultrasound energy is also delivered through direct contact with a coupling medium. The ultrasound tip is specially designed to comprise of a cavity area for controlled fragmentation and the simultaneous sonication of a target area. The specially designed ultrasound tip allows greater manipulation of the device in treating tissue. The ultrasound apparatus may be moved in a variety of directions during the treatment of tissue.

Description

Apparatus and Method for the Treatment of Tissue with Ultrasound by Direct Contact

RELATED APPLICATIONS

This application is a CIP application of U.S. Appl. No. 11/449,220, filed June 1, 2006.

BACKGROUND OF THE INVENTION Field of the Invention:

The present invention relates to apparatus and method for the treatment of tissue, such as hard and soft tissue, wounds, bones, tumors, muscles, and cartilage, with ultrasound energy by direct contact.

Description of the Related Art:

There are a variety of known methods for the treatment of tissue. These methods include wound dressings, hyperbaric oxygen treatment, growth factor therapy, antibiotics, surgery, physical therapy, vacuum therapy, electrical stimulation, bioengineered tissue, ultraviolet light therapy, and tissue ultrasound. There are also a variety of known methods for the treatment of wounds with ultrasound energy.

U.S. patents that disclose devices and methods for wound treatment using an ultrasound spray include: 6,478,754 to Babaev; 6,761,729 to Babaev; 6,533,803 to Babaev; 6,569,099 to Babaev; 6,663,554 to Babaev; and finally 6,960,173 to Babaev. These devices and methods can only achieve limited results because there is no sufficient delivery of ultrasound energy to the target because there is no direct contact with the target area. U.S. Patent Nos. 7,025,735 to Soring and 6,916,296 also to Soring disclose a method and device for the treatment of septic wounds that uses both a liquid aerosol and direct contact. U.S. Patent Application 2004/0030254 to Babaev discloses a device and method for ultrasound wound debridement. Babaev discloses a device that causes debridement through mechanical vibration in the ultrasound tip. This device is limited in that it uses only mechanical vibration for debridement. Therefore, there is a need for an ultrasound device and method that can fragment a wound or tissue with greater maneuverability, with the ability to penetrate into tissue, and with the ability to remove bone.

SUMMARY OF THE INVENTION

The present invention is directed towards apparatus and method for the treatment of tissue, such hard and soft tissues, wounds, bone, tumors, muscles, and cartilage, through the direct contact of ultrasound energy. Apparatus and methods in accordance with the present invention may meet the above-mentioned needs and also provide additional advantages and improvements that will be recognized by those skilled in the art upon review of the present disclosure.

The present invention comprises an ultrasound transducer with a specially designed ultrasound tip for the treatment of tissue. The tip is specially designed for controlled fragmentation and the simultaneous sonication of a target area, such as a wound, bone, unwanted tissue layers, or an infected area, via direct contact. The tip is comprised of a cavity area - as used herein, the term "cavity area" means a hollowed out area. An example of an ultrasound tip with a cavity area is where the combination of an ultrasound horn and ultrasound tip forms a shape similar to a shovel or to a partial spoon, and where one side of the cavity area is concave and the other side is convex. Other comparable shapes or combination of shapes such as conical or polygonal may be similarly effective. The cavity area may be located on the radial sides at the distal end of the radiation surface. Additionally, the radiation surface at the distal end may form a tilted cavity area. The edges and surfaces of the ultrasound tip may be smooth, non-smooth such as rough, jagged or sharp, or any combination of smooth and non-smooth. The intersection, connecting the top of the cavity area to the distal end of the cavity are, may be curved, straight, or at any other angle or combination of angles. The ultrasound tip may also be comprised of an orifice or orifices for the delivery and/or extraction of a coupling medium during treatment. An orifice or orifices may also be used to extract the fragmented tissue.

The specially designed ultrasound tip may be used for the treatment of tissue, including the treatment of wounds, the removal of tumors, and the removal of bone and bone layers. The special design of the ultrasound tip allows for greater maneuverability and manipulation of the device in treating wounds and removing tissue. Furthermore, the design of the tip may allow for the more effective removal of bone and bone layers because of a front cutting edge that can be used in conjunction with ultrasound energy. Ultrasound energy is generally delivered from the radial side of the specially designed ultrasound tip. The ultrasound energy may be delivered directly by contacting the target area with the ultrasound tip. The ultrasound energy may also be delivered directly by contacting the target area with a coupling medium such as a fluid flow that may emanate out of an orifice or orifices. Coupling medium, as used herein, is any medium through which ultrasound energy is capable of traveling except for a mist, aerosol spray, or atomized liquid. The use of ultrasound energy with a coupling medium may help fragment tissue through both mechanical vibration and cavitation. There are different treatment methods where the ultrasound apparatus may be moved in various directions such as latitudinal, longitudinal, rotational, vertical or any other similar movement or combination of movements.

The use of ultrasound energy may have multiple beneficial effects that include, but are not limited to, destroying bacteria, disinfecting a wound, stimulating cell growth, increasing blood flow, precise fragmentation of unwanted tissue, painless fragmentation of a wound, exerting less pressure on a wound as compared to mechanical cleansing, and treating fistula and cavities. These effects may aid in the healing process of wounds.

The invention is related to method and device for the treatment of hard and soft tissue, including wounds, bones, and tumors, through the direct contact of ultrasound energy.

One aspect of this invention may be to provide a method and device for more effective treatment of tissue by delivering ultrasound energy by directly contacting the target area.

Another aspect of the invention may be to provide a method and device for the treatment of tissue that has greater maneuverability. Another aspect of the invention may be to provide a method and device for more efficient treatment tissue.

Another aspect of the invention may be to provide a method and device for quicker treatment of tissue.

Another aspect of the invention may be to provide a method and device that may exert less pressure on the target area during the treatment of tissue.

Another aspect of the invention may be to provide a method and device that allows for controllable fragmentation.

Another aspect of the invention may be to provide a method and device that destroys bacteria. Another aspect of the invention may be to provide a method and device for the stimulation of tissue cell growth.

Another aspect of the invention may be to provide a method and device to increase blood flow. Another aspect of the invention may be to provide a method and device for pain relief.

Another aspect of the invention may be to provide a method and device for cleansing wounds.

Another aspect of the invention may be to provide a method and device for cleansing internal and external post-operation areas. Another aspect of the invention may be to provide a method and device treating fistula and cavities.

These and other aspects of the invention will become more apparent from the written descriptions and figures below.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be shown and described with reference to the drawings of preferred embodiments and clearly understood in details.

Fig. 1 is a perspective view an ultrasound apparatus for the treatment of tissue use according to the present invention.

Fig. 2a is a cross-sectional view of an ultrasound apparatus for the treatment of tissue shown in Fig. 1.

Fig. 2b is a cross-sectional view of an ultrasound apparatus with a rear entry port. Fig. 2c is a cross-sectional view of an ultrasound apparatus with a radial entry port. Fig. 2d is a cross-sectional view of an ultrasound apparatus with a rear entry port and a radial exit port.

Fig. 2e is a cross-sectional view of an ultrasound apparatus with a radial entry port and a radial exit port.

Fig. 2f is a cross-sectional view of an ultrasound apparatus with a rear entry port and two radial exit ports.

Figs. 3a-3c are front views of an example tissue treatment method using an ultrasound apparatus.

Figs. 4a-4c is cross-sectional view of an alternative tissue treatment method using an ultrasound apparatus. Figs. 5a-5c are different embodiments of an ultrasound tip with a cavity area.

Fig. 6 are front views of a variety of configurations on the number of orifices on an ultrasound tip.

Figs. 7a-7f are perspective views of a variety of configurations of the edges and back surface of an ultrasound tip. DETAILED DESCRIPTION OF THE INVENTION

The present invention is a method and device for the treatment of tissue through the direct contact of ultrasound energy. Preferred embodiments of the present invention in the context of an apparatus and methods are illustrated in the figures and described in detail below. Fig. 1 is a perspective view an ultrasound apparatus for use according to the present invention that comprises an ultrasound generator 1, a transducer cable 2, an ultrasound transducer 3, an ultrasound horn 4, and a specially designed ultrasound tip 5. The ultrasound generator 1 may be battery powered or powered through an electrical outlet. The intersection 6, which connects the top of the cavity area to the distal end of the cavity area, may be curved, straight, or at any other angle or combination of angles.

Fig. 2a illustrates a cross-sectional view of an ultrasound apparatus for the treatment of tissue as shown in Fig. 1. The ultrasound apparatus comprises an ultrasound transducer 3 that is mechanically connected to the ultrasound horn 4 by threading or other means 7. The ultrasound horn 4 is mechanically connected to the ultrasound tip 5 by threading or other means 8. The preferred embodiment comprises an ultrasound transducer 3 that is connected to the ultrasound horn 4 by a mechanical interface; alternative embodiments could have the ultrasound transducer 3 directly connected to the ultrasound horn 4 to comprise a single piece without a mechanical interface. The preferred embodiment also comprises an ultrasound horn 4 that is connected to the ultrasound tip 5 by a mechanical interface; alternative embodiments could have the ultrasound horn 4 directly connected to the ultrasound tip 5 to comprise a single piece without a mechanical interface.

Fig. 2b is a cross-sectional view of an ultrasound apparatus for the treatment of tissue that comprises a rear entry port 9. The rear entry port 9 is located at the proximal end of the transducer 3. The apparatus also comprises an entry lumen 10 that connects the rear entry port 9 to an exit orifice 11 that is located on the ultrasound tip 5. A coupling medium may be inserted into the rear entry port 9. The preferred coupling medium to use is a fluid. Fluid is inserted in the rear entry port 9 and moves through the entry lumen 10, and then is delivered from the entry orifice 11. A tube or other material can replace a lumen 10. Fluid may be delivered from the entry orifice 11 to a target treatment area. The preferred method of treatment is to deliver a liquid flow to a target area from the entry orifice 11. Fig. 2c is a cross-sectional view of an ultrasound apparatus for the treatment of tissue that comprises a radial entry port 12. The radial entry port 12 is located on a radial side of the ultrasound horn 4. The radial entry port 12 may be perpendicular to or at any other angle to the axis of the ultrasound horn 4. The preferred alignment for the radial entry port 12 is perpendicular to the ultrasound horn 4. The apparatus also comprises an entry lumen 13 that connects the radial entry port 12 to an entry orifice 11 that is located on the ultrasound tip 5. Fluid is inserted into the radial entry port 12, moves through the entry lumen 13, and then is delivered from the entry orifice 11. Fluid may be delivered from the entry orifice 11 to a target treatment area. Fig. 2d is a cross-sectional view of an ultrasound apparatus for the treatment of tissue that comprises rear entry port 9 and a radial exit port 16. The rear entry port 9 is located at the proximal end of the transducer 3, and the radial exit port 16 is located on a radial side of the ultrasound horn 4. The apparatus also comprises an entry lumen 10 that connects the rear entry port 9 to an entry orifice 11 that is located on the ultrasound tip 5. Fluid is inserted in the rear entry port 9, moves through the entry lumen 10, and then is delivered from the entry orifice 11. Fluid may be delivered from the entry orifice 11 to a target treatment area. Fluid may also be extracted from the treatment area through exit orifice 14 that is also located on the ultrasound tip 5. Exit orifice 14 is connected to radial exit port 16 by exit lumen 15. Fluid enters the exit orifice 14, travels through the exit lumen 15, and exits out of the radial exit port 16. Fluid may be extracted from the treatment area in order to continually supply the treatment area with fresh fluid. Fragmented tissue may also be extracted along with the fluid. This embodiment of an ultrasound apparatus for the treatment of tissue comprises a rear entry port and a radial exit port. Alternative embodiments, as described below, may comprise multiple entry and/or exit ports that may be located at different locations with different alignments along the ultrasound apparatus. This embodiment also comprises an entry orifice and an exit orifice. Alternative embodiments may comprise no orifices, one orifice, or multiple orifices.

Fig. 2e illustrates a cross-sectional view of an ultrasound apparatus for the treatment of tissue that comprises radial entry port 12 and a radial exit port 16. The radial entry port 12 is located on a radial side of the ultrasound horn 4, and the radial exit port 16 is located on a radial side of the ultrasound horn 4. This embodiment comprises a radial exit port 16 located on the direct opposite side of the ultrasound horn 4 from the radial entry port 12 with both the exit port

$ 16 and entry port 12 aligned at ninety-degrees to the axis of the horn 4. Alternate embodiments could have an entry port 12 and exit port 16 positioned at any other location on the ultrasound horn 4 or aligned at any other angle to the axis of the horn 4. The apparatus also comprises an entry lumen 13 that connects the radial entry port 12 to an entry orifice 11 that is located on the ultrasound tip 5. Fluid is inserted in the radial entry port 12, moves through the entry lumen 13, and then is delivered from the entry orifice 11, Fluid may be delivered from the entry orifice 11 to a target treatment area. Fluid may also be extracted from the treatment area through an exit orifice 14 that is also located on the ultrasound tip 5. Exit orifice 14 is connected to the radial exit port 16 by exit lumen 15. Fluid enters the exit orifice 14, travels through the exit lumen 15, and exits out of the radial exit port 16. Fluid may be extracted from the treatment area in order to continually supply the treatment area with fresh fluid. Fragmented tissue may also be extracted along with fluid.

Fig. 2f illustrates a cross-sectional view of an ultrasound apparatus for the treatment of tissue that comprises a rear entry port 9 and two radial exit ports 17 and 18. The rear entry port 9 is located at the proximal end of the transducer 3, one radial exit port 17 is located on a radial side of the ultrasound horn 4, and another radial exit port 18 is also located on a radial side of the ultrasound horn 4. This embodiment comprises a radial exit port 17 located on the direct opposite side of the ultrasound horn 4 from the radial exit port 18 with both exit port 17 and exit port 18 aligned at ninety-degrees to the axis of the horn 4. Alternative embodiments could have exit port 17 and exit port 18 positioned at any other location on the ultrasound horn 4 or aligned at any other angle to the axis of the horn 4. This embodiment also comprises an entry lumen 10 that connects the rear entry port 9 to an entry orifice 11 that is located on the ultrasound tip 5. Fluid is inserted in the rear entry port 9, moves through the entry lumen 10, and then is delivered from the entry orifice 11. Fluid may delivered from the entry orifice 11 to a target treatment area. Fluid may also be extracted from the treatment area through exit orifice 21 and exit orifice 22 that are also located on the ultrasound tip 5. Exit orifice 21 and exit orifice 22 are connected to radial exit port 17 and radial exit port 18 by exit lumen 19 and exit lumen 20, respectively. Fluid enters exit orifice 21 and exit orifice 22, travels through exit lumen 19 and exit lumen 20, and exits out of radial exit port 17 and radial exit port 18. Fluid may be extracted from the treatment area in order to continually supply the treatment area with fresh fluid. Fragmented tissue may also be extracted along with fluid. Figs. 3a-3c are front views of an example tissue treatment method where an ultrasound tissue treatment apparatus is rotated and/or moved latitudinally along the treatment area 24 . The rotational and/or latitudinal movement can occur simultaneously or sequentially. The ultrasound tip 5 is specially designed to allow for greater maneuverability and easier removal of tissue. The ultrasound tip 5 in this embodiment comprises a cavity area located on the radial sides at the distal end of the radiation surface. The cavity area in this embodiment is shaped similar to a shovel/partial spoon, where the open side of the cavity area is concave and the back side of the cavity area is convex. Fluid 23 is delivered to the target treatment area 24 from the entry orifice 11. The fluid 23 may then be extracted out of the exit orifice 14. It may be beneficial to extract the used fluid from the treatment area 24 while delivering a fresh fluid to the treatment area 24. Ultrasound energy is delivered to the target treatment area 24 both from the ultrasound tip 5 and through the fluid 23 as the fluid 23 travels to the target area 24. The shape of the cavity area of the ultrasound tip 5 allows for ultrasound energy to be focused when delivered. The ultrasound apparatus may be rotated along the treatment area to both ultrasonically treat the tissue and to remove unwanted tissue 25 with the top edges 26 of the tip 5 as shown in Fig. 3b. As the ultrasound tip 5 to rotated, it delivers ultrasound energy from the back surface 27 of the ultrasound tip 5 as depicted in Fig. 3c. If rotated, ultrasound energy may be delivered from the open side of ultrasound tip 5, the external sides of the ultrasound tip 5, and from the back surface 27 of the ultrasound tip 5. Unwanted tissue 25 is fragmented from the treatment area 25 due to the mechanical vibration in the ultrasound tip 5 and the cavitation that occurs by delivering ultrasound energy through the fluid 23. The ultrasound tip 5 may also comprise an orifice or multiple orifices (not shown) on the back surface 27. The ultrasound tip 5 may also comprise a slit or slits (not shown), which may resemble a potato peeler, on the back surface 27; the slit or slits may also extend through the front edge of the tip so that it the slit or slits are not enclosed by the front edge. Fluid may be delivered from and fragmented tissue may be removed through an orifice on the back surface.

Figs. 4a-4c are cross-sectional views of another example tissue treatment method where an ultrasound tissue treatment apparatus is moved longitudinally and/or lifted along the treatment area 24. The shape of the ultrasound tip 5 in this embodiment allows for the front of tip to remove tissue with front edges 26 of the ultrasound tip 5 as the tip is moved longitudinally across the treatment area 24. Fig. 4a depicts the first motion whereby the front edges 26 of the

IO ultrasound tip 5 are moved across the treatment area 24 while delivering ultrasound energy. While the tip 5 is moved longitudinally, the fluid 23 may be delivered from the entry orifice 11. Unwanted tissue 25 is fragmented from the treatment area 24 due to the mechanical vibration in the ultrasound tip 5 and the cavitation that occurs by delivering ultrasound energy through the fluid 23. The used fluid and fragmented tissue may be extracted through the exit orifice 14. Fig. 4b depicts that as the ultrasound tip 5 is moved longitudinally across the treatment area 24 and begins removing unwanted tissue 25. Ultrasound energy may be delivered from the back surface 27 of the ultrasound tip 5 to the treatment area 24. Fig. 4c shows the ultrasound tip 5 after it has passed along the treatment area 24 and removed unwanted tissue 25. The ultrasound energy that is delivered during this movement is generally radial waves because the ultrasound energy that reaches that target area 24 is mostly from the radial side of the ultrasound tip 5; however, some shear and longitudinal waves may reach the target area 25. The ultrasound tip 5 may also be moved latitudinally and/or rotated across the treatment area before, during, or after the longitudinal and/or lifting movement. Figs. 5a-5c are different embodiments of an ultrasound tip 5 with a cavity area. Fig. 5a is an ultrasound tip 5 where the radial sides at the distal end of the radiation surface forms a cavity area that is in a shape similar to a shovel/partial spoon. The cavity area, in this embodiment, is parallel to the axis of the ultrasound horn 4. Alternative embodiments of the ultrasound tip 5 are shown in figs. 5b and 5c where the radiation surface at the distal end forms a titled cavity area, whereby the cavity area is also in a shape similar to that of a shovel/partial spoon. The cavity areas, in these embodiments, are at angle titled to the axis of the ultrasound horn 4. Alternative embodiments of a cavity area may comprise comparable shapes or combination of shapes such as conical or polygonal that may also be effective. The cavity area may be located on the radial sides at the distal end of the radiation surface. Additionally, the radiation surface at the distal end may form a titled cavity area. Furthermore, the distal end length and/or curvature of the shovel/partial spoon may vary.

Fig. 6 are front cross-sectional views of various embodiments of an ultrasound tip 5. The ultrasound tip 5 may contain no orifices, one orifice, or multiple orifices. The orifices may also be the same or different sizes. The preferred embodiment is to have the exit orifice for extraction larger than the entry orifice for delivery. Figs. 7a-7f are different embodiments of the edges 26 and back surface 27 of an ultrasound tip according to the present invention. The edges 26 of the ultrasound tip 5 may be smooth, non-smooth, or any combination thereof. The preferred embodiment comprises rough/jagged/sharp edges 26, which can be located on the top of the cavity area and/or the distal cavity area, or any portions thereof. The back surface 27 may be smooth, non-smooth, or any combination thereof. The preferred embodiment comprises a rough/jagged/sharp back surface 33.

The ultrasound apparatus shown in Fig. 1 delivers ultrasound energy to a target area for the treatment of tissue, including the treatment of the wounds, bones, and the removal of tumors. The tip is specially designed for controlled fragmentation and the simultaneous sonication of a target area via direct contact, and is specially designed to allow for easy manipulation. The use of ultrasound energy may have multiple beneficial effects that include, but are not limited to, destroying bacteria, disinfecting a wound, stimulating cell growth, increasing blood flow, exerting less pressure on a wound, treating fistula and cavities, and removing unwanted tissue. These effects may aid in the healing process of wounds.

There are multiple methods that may be used to deliver ultrasound energy to a target area. Ultrasound energy may be delivered directly by contacting the target area with the ultrasound tip from areas such as the edges, back surface area, or the cavity area of the tip. Ultrasound energy may also be delivered directly by contacting the target area with a coupling medium. The ultrasound energy is generally delivered from the radial side of the ultrasound tip, but it may also be delivered from the distal end of the ultrasound tip. Therefore, the ultrasound energy that is mainly delivered is radial waves. The use of radial waves, as compared to longitudinal waves from the distal end, may allow for a horizontal vibration in the ultrasound tip on the target area rather than a vertical vibration. The preferred coupling medium to use is a fluid, and the preferred fluid to use is saline.

Other fluids such as drugs, antibiotics, antiseptics, etc may also be used. Both micro and macro cavitation may occur from the delivery of ultrasound energy through the coupling medium. Macro cavitation occurs in the coupling medium and results in sterilizing the target surface, fragmenting tissue, and mechanical cleansing because of the cavitation effect. Micro cavitation creates microstreaming inside tissue, which is beneficial for tissue granulation. Fragmentation of unwanted tissue may result from both the cavitation that occurs and the mechanical vibration of the ultrasound tip on the target area.

The ultrasound tip may comprise an orifice or orifices that may deliver a coupling medium such as a liquid flow to the target area. The orifice or orifices may also be used to extract a coupling medium that is delivered to the target area. The orifice or orifice may be located anywhere on the ultrasound tip; the preferred embodiment comprises an orifice or orifice that is located on the proximal end of cavity area.

The ultrasound tip may be held flat against the target area during treatment or it may be held at an angle. During the treatment, the ultrasound tip, or any portion thereof, may be moved latitudinally, moved longitudinally, rotated, or lifted, or any combination thereof. These movements can occur simultaneously or sequentially. If the ultrasound tip is rotated during treatment, then ultrasound energy may be delivered from the cavity area, the external sides of the cavity area, and the back surface of the cavity area. If the ultrasound tip is lifted during treatment, then ultrasound energy may be delivered from both the radial side of the ultrasound tip and the distal end of the ultrasound tip.

Moving the ultrasound tip longitudinally, with the cavity area facing away from the target, while lifting and/or rotating the tip allows a user remove tissue with greater manipulation. This allows a user to remove tissue at different angles using the edges of the ultrasound tip and the intersection between the edges of the tip. The ultrasound tip may also be moved latitudinally while rotating the tip, thus allowing for ultrasound energy to be delivered from both the sides and the back surface of the cavity area.

The intensity of the ultrasound energy can be controlled through a variation in the ultrasound parameters such as the frequency, the amplitude, and the treatment time. The transducer may operate in a frequency range of 15 kHz to 20 MHz. The preferred low- frequency range in which the transducer operates is 20 kHz - 100 kHz, the more preferred low-frequency range in which the transducer operates is 25 kHz - 50 kHz, and the recommend low-frequency value in which the transducer operates is 30 kHz. The preferred high-frequency range in which die transducer operates is 0.7 MHz - 3 MHz, die more preferred high-frequency range in which the transducer operates is 0.7 MHz - 3 MHz, and the recommend high-frequency value in which the transducer operates is 0.7 MHz. The transducer operating in low-frequency may displace an amplitude 5 microns and above, with transducer operating in low-frequency displaces a preferred amplitude to be in range of 30 microns to 100 microns, and the transducer operating in low- frequency displaces a recommended amplitude value of 100 microns. The transducer operating in high-frequency may displace an amplitude of be 1 micron and above, with the transducer operating in high-frequency displaces a preferred amplitude of at least 5 microns, and the high- transducer operating in frequency displaces a recommended amplitude value of 10 microns. The preferred method of treatment uses low-frequency ultrasound.

There are a variety of factors that may influence the treatment time. These factors may include the type of tissue being treated, the condition of a wound, the size of a wound, and the location of a wound.

Although specific embodiments and methods of use have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that any arrangement that is calculated to achieve the same purpose may be substituted for the specific embodiments and methods shown. It is to be understood that the above description is intended to be illustrative and not restrictive. Combinations of the above embodiments and other embodiments as well as combinations of the above methods of use and other methods of use will be apparent to those having skill in the art upon review of the present disclosure. The scope of the present invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

CLAIMS I claim:

1) An apparatus for the treatment of tissue with ultrasound energy by direct contact, comprising: a) a generator and a transducer for generating ultrasound energy; b) an ultrasound hom and ultrasound tip for delivering ultrasound energy; c) wherein the radial sides at the distal end of the radiation surface forms a cavity area or wherein the radiation surface at the distal end forms a tilted cavity area; d) wherein the ultrasound tip delivers ultrasound energy to a target area; and e) wherein the ultrasound energy has an intensity capable of treating tissue.

2) The apparatus according to claim 1 , wherein the generator and transducer generate the ultrasound energy with particular ultrasound parameters indicative of an intensity capable of treating tissue.

3) The apparatus according to claim 1 , wherein the transducer operates at a frequency in the approximate range of 15 kHz - 20 MHz.

4) The apparatus according to claim 1 , wherein the transducer operates at a preferred low- frequency in the approximate range of 20 kHz - 100 kHz.

5) The apparatus according to claim 1, wherein the transducer operates at a more preferred low-frequency in the approximate range of 25 kHz - 50 kHz. 6) The apparatus according to claim 1 , wherein the transducer operates at a recommended low- frequency ultrasound value of approximately 30 kHz.

7) The apparatus according to claim 1, wherein the transducer operates at a preferred high- frequency in the approximate range of 0.7 MHz - 3 MHz.

8) The apparatus according to claim 1 , wherein the transducer operates at a more preferred high-frequency in the approximate range of 0.7 MHz - 1 MHz.

9) The apparatus according to claim 1, wherein the transducer operates at a recommended high-frequency value of approximately 0.7 MHz. 10) The apparatus according to claim 1, wherein the transducer operating at low-frequency displaces an amplitude of at least 1 micron.

11) The apparatus according to claim 1 , wherein the transducer operating at low-frequency displaces an amplitude range of approximately 30 - 250 microns. 12) The apparatus according to claim 1, wherein the transducer operating at low-frequency displaces a recommended amplitude value of approximately 100 microns.

13) The apparatus according to claim 1 , wherein the transducer operating high-frequency displaces an amplitude of at least 1 micron.

14) The apparatus according to claim 1, wherein the transducer operating at high-frequency displaces a preferred amplitude of at least 5 microns.

15) The apparatus according to claim 1, wherein the transducer operating at high-frequency displaces a recommended amplitude value of approximately 10 microns.

16) The apparatus according to claim I₁ wherein the combination of an ultrasound horn and ultrasound tip form a shape similar to a partial spoon. 17) The apparatus according to claim 1 , further comprised of an orifice or orifices.

18) The apparatus according to claim 17, wherein the orifice or orifices are located on the proximal end of the cavity area, on the distal end of the cavity area, on the middle of the cavity, or any combination thereof.

19) The apparatus according to claim 17, wherein the orifice or orifices are capable of delivering and/or extracting a coupling medium.

20) The apparatus according to claim 17, wherein the orifice or orifices are capable of extracting fragmented tissue.

21 ) The apparatus according to claim 1 , wherein the transducer contains a radiation surface intended to achieve delivery of the ultrasound energy with an intensity capable of treating tissue.

22) The apparatus according to claim 1, wherein the transducer includes a radiation surface having a surface area dimensioned/constructed for achieving delivery of the ultrasound energy with an intensity capable of treating tissue. 23) The apparatus according to claim 1 , wherein shape of the peripheral boundary of the cavity area is circular, oval, elliptical, or any other comparable shape or combination of shapes.

24) The apparatus according to claim 23, wherein the shape of the peripheral boundary of the cavity area of the radiation surface is intended to achieve delivery of the ultrasound energy with an intensity capable of treating tissue.

25) The apparatus according to claim 1, wherein the shape of the peripheral boundary of the distal end of the radiation surface is circular, oval, elliptical, polygonal, a straight-line, a non-straight line, or another comparable shape or combination of shapes.

26) The apparatus according to claim 25, wherein the shape of the peripheral boundary of distal end of the radiation surface is intended to achieve delivery of the ultrasound energy with an intensity capable of treating tissue.

27) The apparatus according to claim 1, wherein the edges of the radiation surface are smooth, non-smooth, or any combination thereof.

28) The apparatus according to claim 1, wherein the back surface area of the radiation surface is smooth, non-smooth, or any combination thereof.

29) The apparatus according to claim 1, wherein the transducer is driven by a continuous or pulsed frequency.

30) The apparatus according to claim 1, wherein the transducer is driven by a fixed or modulated frequency. 31) The apparatus according to claim 1 , wherein the driving wave form of the transducer is selected from the group consisting of sinusoidal, rectangular, trapezoidal and triangular wave form.

32) A method for the treatment of tissue with ultrasound energy by direct contact, comprising the steps of: a) providing a means for delivering ultrasound energy by direct contact to a target area with the radial side of the distal end of a radiation surface that forms a cavity area or the radiation surface at the distal end that forms a tilted cavity area; b) directly contacting the target area; c) delivering ultrasound energy through the direct contact with the target area; d) wherein the ultrasound energy has an intensity capable of treating tissue.

33) The method according to claim 32, further comprising the step of generating the ultrasound energy with particular ultrasound parameters indicative of an intensity capable of treating tissue.

34) The method according to claim 32, wherein the transducer operates at a frequency in the approximate range of 15 kHz - 20 MHz.

35) The method according to claim 32, wherein the transducer operates at a preferred low- frequency in the approximate range of 20 kHz - 100 kHz. 36) The method according to claim 32, wherein the more transducer operates at a preferred low- frequency in the approximate range of 25 kHz - 50 kHz.

37) The method according to claim 32, wherein the transducer operates at a recommended low- frequency value of approximately 30 kHz.

38) The method according to claim 32, wherein the transducer operates at a preferred high- frequency in the approximate range of 0.7 MHz - 3 MHz.

39) The method according to claim 32, wherein the transducer operates at a more preferred high-frequency in the approximate range of 0.7 MHz - 1 MHz.

40) The method according to claim 32, wherein transducer operates at a recommended high- frequency value of approximately 0.7 MHz. 41) The method according to claim 32, wherein the transducer operating at low-frequency displaces an amplitude of at least 1 micron.

42) The method according to claim 32, wherein the transducer operating at low-frequency displaces a preferred amplitude range of approximately 30 - 250 microns.

43) The method according to claim 32, wherein the transducer operating at low-frequency displaces a recommended amplitude value of approximately 100 microns.

44) The method according to claim 32, wherein the transducer operating at high-frequency displaces an amplitude of at least 1 micron.

IS 45) The method according to claim 32, wherein the transducer operating at high-frequency displaces a preferred amplitude of at least 5 microns.

46) The method according to claim 32, wherein the transducer operating at high-frequency displaces a recommended amplitude value of approximately 10 microns. 47) The method according to claim 32, wherein the direct contact with the target area is with the edges and/or back surface area of the ultrasound tip, is with a coupling medium, or any combination thereof.

48) The method according to claim 47, further comprising the step of delivering the coupling medium to the target area. 49) The method according to claim 48, wherein the coupling medium is delivered from an orifice or orifices in the ultrasound tip.

50) The method according to claim 48, further comprising the step of extracting the coupling medium from the target area.

51) The method according to claim 50, wherein the coupling is extracted through an orifice or orifices in the ultrasound tip.

52) The method according to claim 48, wherein the coupling medium is a fluid.

53) The method according to claim 32, wherein the ultrasound apparatus/tip is held stationary, is moved latitudinally, is moved longitudinally, is lifted, or is rotated during the treatment of tissue or any combination thereof. 54) The method according to claim 32, wherein the ultrasound tip is held flat against the target area during the treatment of tissue, is held at an angle to the target area during the treatment of tissue, or any combination thereof.

55) The method according to claim 32, wherein the proximal end of the ultrasound tip is positioned above the target area during the treatment of tissue. 56) The method according to claim 32, wherein the distal end of the ultrasound tip is positioned above the target area during the treatment of tissue.

57) The method according to claim 32, further comprising the step of fragmenting the target area. 58) The method according to claim 57, wherein the fragmentation occurs through mechanical scraping/vibrating the target area, through ultrasound cavitation, or any combination thereof.

59) The method according to claim 57, further comprising the step of removing the fragmented tissue from the target area. 60) The method according to claim 59, wherein the fragmented tissue is removed through an orifice or orifices in the ultrasound tip.

6I)A method for the treatment of tissue with ultrasound energy by direct contact, comprising the steps of: a) providing a means for delivering ultrasound energy by direct contact to a target area with the radial side at the distal end of a radiation surface that forms a cavity area or with the radiation surface at the distal end that forms titled cavity area; b) contacting the target area with the radiation surface that forms a cavity area; c) delivering a coupling medium to the target area; d) delivering ultrasound energy through the direct contact of the radiation surface with the target area; e) delivering ultrasound energy through the direct contact of the coupling medium; and f) wherein the ultrasound energy has an intensity capable of treating tissue.

62) The method according to claim 61 , further comprising the step of generating the ultrasonic energy with particular ultrasound parameters capable of treating tissue. 63) The method according to claim 61 , wherein the transducer operates at a frequency in the approximate range of 15 kHz - 20 MHz.

64) The method according to claim 61 , wherein the transducer operates at a preferred low- frequency in the approximate range of 20 kHz - 100 kHz.

65) The method according to claim 61, wherein the transducer operates at a more preferred low- frequency in the approximate range of 25 kHz - 50 kHz.

66) The method according to claim 61 , wherein the transducer operates at a recommended low- frequency value of approximately 30 kHz. 67) The method according to claim 61 , wherein the transducer operates at a preferred high- frequency in the approximate range of 0.7 MHz - 3 MHz.

68) The method according to claim 61 , wherein the transducer operates at a more preferred high-frequency in the approximate range of 0.7 MHz - 1 MHz. 69) The method according to claim 61 , wherein the transducer operates at a recommended high- frequency value of approximately 0.7 MHz.

70) The method according to claim 61, wherein the transducer operating at low-frequency displaces an amplitude of at least 1 micron.

71) The method according to claim 61, wherein the transducer operating at low-frequency displaces a preferred amplitude range of approximately 30 - 250 microns.

72) The method according to claim 61, wherein the transducer operating at low-frequency displaces a recommended amplitude value of approximately 100 microns.

73) The method according to claim 61 , wherein the transducer operating at high-frequency displaces an amplitude of at least 1 micron. 74) The method according to claim 61 , wherein the transducer operating at high-frequency displaces a preferred amplitude of at least 5 microns.

75) The method according to claim 61, wherein the transducer operating at high-frequency displaces a recommended amplitude value of approximately 10 microns.

76) The method according to claim 61 , wherein the coupling medium is delivered from an orifice or orifices in the ultrasound tip.

77) The method according to claim 62, further comprising the step of extracting the coupling medium from the target area.

78) The method according to claim 77, wherein the coupling medium is extracted through an orifice or orifices in the ultrasound tip. 79) The method according to claim 61 , wherein the coupling medium is a fluid. 80) The method according to claim 61, wherein the ultrasound apparatus/tip is held stationary, is moved latitudinally, is moved longitudinally, is lifted, or is rotated during the treatment of tissue or any combination thereof.

81)The method according to claim 61, wherein the ultrasound tip is held flat against the target area during the treatment of tissue, is held at an angle to the target area during the treatment of tissue, or any combination thereof.

82) The method according to claim 61, wherein the proximal end of the ultrasound tip is positioned above the target area during the treatment of tissue.

83) The method according to claim 61, wherein the distal end of the ultrasound tip is positioned above the target area during the treatment of tissue.

84) The method according to claim 61, further comprising the step of fragmenting the target area.

85) The method according to claim 84, wherein the fragmentation occurs through mechanical scraping/vibrating the target area, through ultrasound cavitation, or any combination thereof. 86) The method according to claim 84, further comprising the step of extracting the fragmented tissue from the target area.

87) The method according to claim 86, wherein the fragmented tissue is extracted through an orifice or orifices in the ultrasound tip.