Low-Energy Acoustic Pulse Device and Method

Abstract

To provide a low energy acoustic pulse apparatus and method.SOLUTION: An apparatus for generating an acoustic energy pulse and delivering it into a body is described. The apparatus includes a generator for creating an acoustic energy pulse having an energy density field that can be measured at all points within a space in the shape of an imaginary cylinder having a length greater than or equal to 2 cm and a diameter. The cylindrically shaped space has a cylinder longitudinal axis oriented relative to a longitudinal axis of the energy pulse at an angle in the range from zero to twenty degrees. A minimum energy density for the pulse at all locations within the cylindrically shaped space is at least 50% of a maximum energy density for the pulse within the space.SELECTED DRAWING: Figure 4E

Description

Technical Field

[0001] The present invention relates to the field of low energy acoustic pulse (LEAP) therapy. More specifically, the present invention relates to the treatment of the urinary system using LEAP therapy, and even more specifically, to the treatment of the female urethra.

Background Art

[0002] An established form of acoustic pulse therapy, namely extracorporeal shock wave therapy, is used in physical therapy, orthopedics, urology, and cardiology. Shock waves are rapid high-amplitude pulses of mechanical energy similar to sound waves. Shock waves were first used in medicine to break up kidney stones using a procedure known as lithotripsy. This is a high-intensity application of acoustic pulse therapy used to fragment and break up kidney stones.

[0003] LEAP therapy uses acoustic pulses in a much lower energy form than conventional shock waves and can be applied for the treatment of tissues without destroying them. Various forms of LEAP treatment devices are currently available, but there remains a continuing need for LEAP devices tailored to the specific applications to which the therapy is applied. In particular, there is a need for LEAP devices that can deliver a relatively uniform amount of acoustic pulse energy throughout the target tissue.

[0004] U.S. Patent Application Publication No. 2012 / 0239055A1 by Spector et al. discloses a method for treating a female pelvic floor and perineal organs using extracorporeal shock waves. The treatment of urinary incontinence is described in a long list of potential uses, but there are no specific teachings for successfully completing such treatment. Further, generally, a shock wave generating device can be inserted through a vaginal tube to treat urethral syndrome. This can expose the vaginal tube to extracorporeal shock waves and result in damage thereto or other unintended consequences including, but not limited to, pain. Still further, the shock wave device generates a focal zone and thereby applies shock wave energy at substantially different levels to different portions of the target tissue being treated. Also, the device of Spector et al., which is a focusing device, will require applying shock waves from a plurality of different positions along the length of the vaginal tube since the wave width is only sufficient to be applied to only a small portion of the urethra from each application site within the vaginal tube. Due to the substantial differences in the size and geometry of the vaginal tubes among various patients, there will also be a need to adjust the size of the device of Spector et al. to accommodate fitting to different sized vaginal tubes. Patients with vaginal tubes smaller than the minimum achievable size of the probe cannot be treated at all.

[0005] U.S. Patent Application Publication No. 2014 / 0330174A1 by Warlick et al. discloses a method for treating vaginal tissue that becomes inflamed or damaged due to complications from the use of surgical mesh, the method including the emission of acoustic shock waves that can be convergent, divergent, planar, or near-planar. The device of Warlick et al. combines an electrohydraulic device with a parabolic reflector to provide a divergent, planar, or near-planar wave pattern. However, the inventors' observations indicate that an electrohydraulic device with a parabolic reflector does not generate a planar wave. There is also no specification by Warlick et al. regarding the size or shape of the energy field generated by any of the disclosed embodiments, nor any teaching regarding the appearance of a desired or appropriate energy field. Further, when the target site is vaginal tissue or an organ that undergoes a surgical procedure where at least a portion, if not all, of the tissue or organ within the body cavity is exposed, the target site is such that the patient or the source must be reoriented with respect to the site and a second, third, or greater treatment dose can be administered. Thus, since not all of a significant volume of the target site can be captured by the application of shock waves from a single location, this complicates the procedure and also increases the cost of the required procedure. Also, it is disclosed that a major advantage of the method of U.S. Patent Application Publication No. 2014 / 0330174A1 is to complement conventional medical procedures. There is no disclosure of treating female urinary incontinence by this method alone. The method described is primarily directed to early preventive therapies for stimulating tissue or organ modeling to be maintained within acceptable limits prior to the occurrence of exposure to degenerative symptoms. This is disclosed to be important, for example, in the prevention of age-related complications following the implantation of a screen mesh. The shock waves can be emitted through the perineal tissue at the surface of the skin and directed into the pelvic cavity towards the vaginal tissue or pelvic organs. Alternatively, the shock waves can be administered via a vaginal probe that can emit spherical or planar waves. This vaginal probe can simply be directed to contact the vaginal tissue to be treated. Using either method, the emitted waves are directed towards the vaginal tissue or pelvic organs.Treatment of the urethra along its length from either the vaginal or perineal location requires multiple positions of the shock wave emitter, and the vaginal approach will suffer from the same size drawbacks as described above.

[0006] U.S. Patent No. 9,161,768 to Cioanta et al. discloses an extracorporeal shock wave device using reverse application. For example, a long reflector having an elongated shape and a plurality of emission points is disclosed. The penetration depth to be achieved by the shock wave will determine the depth of the reflector shape, which can be shallow for surface application or very deep for an application where the focus is deep within the human body. In each case, the shock wave will not be focused and deliver a relatively uniform amount of energy to the target tissue.

[0007] Applicator information for the DERMAGOLD 100(R) and ORTHOGOLD 100(R) probes by MTS Shockwave Technology and Lithotripsy shows waveforms for probes that generate shock waves by an electrohydraulic principle. Even these waveforms, referred to as "non-focused" (e.g., the OP155 waveform shown on page 2 of the brochure), are somewhat focused as illustrated by red coloring at the central portion of the waveform surrounded by yellow coloring in the remaining waveforms. Due to the lack of waveform uniformity and the inability of the waveforms to achieve sufficient width for a sufficient length at a sufficient power level, these devices are not sufficient to therapeutically treat the female urethra from a single treatment location due to the diameter (including the urethral sphincter) and length of the female urethra, which are about 16 mm and 4 cm on average, respectively. There are waveforms for the DERMAGOLD 100(R) device that include focus diameters of 14 mm, 16 mm, and larger, but these waveforms are not uniform as they are more concentrated along the central axis of the waveform and the overall width of the waveform does not extend beyond a length of 4 cm. These waveforms cannot effectively enclose the urethra and urethral sphincter sufficiently for use in treating the female urethra. Further, 15 mm - 16 mm, i.e., 0.12 - 0.13 mJ / mm 2The energy fluence density (EFD) level required to achieve the focal diameter is too high to be tolerated by patients being treated within the area of the female urethra. As the EFD level decreases, the focal diameter of the waveform of the DERMAGOLD 100(R) device also decreases, thereby further reducing the ability to encompass the urethra and urethral sphincter. There remains a need for improvement in the uniformity of the energy level through the energy field across the space encompassing the target tissue to which the therapy is applied.

[0008] There remains a need for an improved device that applies the LEAP at an appropriate energy level to the target tissue and applies it more uniformly across the target tissue.

[0009] There remains a need for improvement in an improved device that applies a desired amount of energy to the target tissue via the LEAP while minimizing the amount of energy applied to the tissue adjacent to the target tissue.

[0010] There remains a need for an improved device that can achieve therapy results from the application of the LEAP from only one location without the need to reposition the device or the patient and reapply the LEAP.

[0011] There remains a need for an improved device that can achieve therapy results from the application of the LEAP from only one location along the length of the female urethra without the need to reposition the device or the patient and reapply the LEAP from a second or additional location, and effectively treat female urinary incontinence. The applied LEAP is at a power level to generate the maximum energy fluence density that can be tolerated by the patient to the target tissue without generating intolerable pain or tissue damage.

[0012] There remains a need for a device that is easier for the user to use and easier for the user to operate, including in the performance of targeting and applying the therapy.

Prior Art Documents

Patent Documents

[0013] Patent Document 1 U.S. Patent Application Publication No. 2012 / 0239055 SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM

[0014] The present invention provides an apparatus and method for generating and delivering low energy acoustic pulses (LEAP). In one aspect of the present invention, an apparatus for generating an acoustic energy pulse includes a generator for generating an acoustic energy pulse having an energy density field that can be measured at all points within an imaginary cylindrical-shaped space having a length and diameter of 2 cm or more. The cylindrical-shaped space has a proximal end, a distal end, and a cylindrical longitudinal axis, and the cylindrical longitudinal axis is oriented at an angle within the range of 0 to 20 degrees with respect to the longitudinal axis of the acoustic energy pulse. The proximal end is located at a first distance from the generator, the distal end is located at a second distance from the generator, the first distance is less than the second distance, and the minimum energy density of the pulse at all locations within the cylindrical-shaped space is at least 50% of the maximum energy density of the pulse within the space.

[0015] In at least one embodiment, the maximum energy density is in the range of 0.005 mJ / mm 2 to 0.025 mJ / mm 2 and the diameter is in the range of 10 mm to 18 mm.

[0016] In at least one embodiment, the maximum energy density is greater than 0.025 mJ / mm 2 and up to 0.04 mJ / mm 2 and the diameter is greater than 11 mm.

[0017] In at least one embodiment, the maximum energy density is greater than 0.04 mJ / mm 2 and up to 0.05 mJ / mm 2 and the diameter is greater than 12 mm.

[0018] In at least one embodiment, the maximum energy density is greater than 0.05 mJ / mm 2 and less than 0.08 mJ / mm 2 and the diameter is greater than 13 mm.

[0019] In at least one embodiment, the maximum energy density is between 0.08 mJ / mm 2 and 0.11 mJ / mm 2 and the diameter is greater than 15 mm.

[0020] In at least one embodiment, the apparatus comprises a housing, at least a portion of the generator is contained within the housing, and the minimum dimension of the housing perpendicular to the longitudinal axis of the cylinder is 175 mm or less.

[0021] In at least one embodiment, the proximal end is located 100 mm or less from the surface of the generator where the acoustic energy pulse is delivered.

[0022] In at least one embodiment, the length of the cylinder is 3 cm or more.

[0023] In at least one embodiment, the acoustic energy pulse includes a divergent or planar acoustic pulse.

[0024] In at least one embodiment, the acoustic energy pulse is an acoustic shock wave pulse.

[0025] In at least one embodiment, the acoustic pulse is generated electromagnetically.

[0026] In at least one embodiment, the cylindrical space is coaxial with the longitudinal axis of the acoustic energy pulse.

[0027] In another aspect of the present invention, a method of delivering an acoustic energy pulse includes providing an acoustic energy pulse generating device and generating an acoustic energy pulse and delivering the acoustic energy pulse from the acoustic energy pulse generating device, the acoustic energy pulse having an energy density field that can be measured at all points within an imaginary cylindrical-shaped space having a length and diameter of 2 cm or more, the cylindrical-shaped space having a proximal end, a distal end, and a cylindrical longitudinal axis, the cylindrical longitudinal axis being oriented at an angle within the range of 0 to 20 degrees with respect to the longitudinal axis of the acoustic energy pulse, the proximal end being located at a first distance from the generating device, the distal end being located at a second distance from the generating device, the first distance being less than the second distance, and the minimum energy density of the pulse at all locations within the cylindrical-shaped space being at least 50% of the maximum energy density of the pulse within the space.

[0028] In at least one embodiment, the maximum energy density is in the range of 0.009 mJ / mm 2 to 0.044 mJ / mm 2 and the diameter is greater than 12 mm.

[0029] In at least one embodiment, the maximum energy density herein is in the range of 0.009 mJ / mm 2 to 0.044 mJ / mm 2 and the diameter is in the range of 10 mm to 18 mm.

[0030] In at least one embodiment, the maximum energy density is greater than 0.044 mJ / mm 2 and up to 0.07 mJ / mm 2 and the diameter is greater than 13 mm.

[0031] In at least one embodiment, the maximum energy density is greater than 0.07 mJ / mm 2 and up to 0.088 mJ / mm 2 and the diameter is greater than 14 mm.

[0032] In at least one embodiment, the maximum energy density is greater than 0.088 mJ / mm 2 and less than 0.14 mJ / mm 2 and the diameter is greater than 17 mm.

[0033] In at least one embodiment, the acoustic energy pulse generator includes a housing that at least partially surrounds the acoustic energy pulse generator, and the minimum dimension of the housing orthogonal to the longitudinal axis of the acoustic energy pulse is 175 mm or less.

[0034] In at least one embodiment, the proximal end of the cylindrical space is located 100 mm or less from the acoustic energy pulse source.

[0035] In at least one embodiment, the length of the cylinder is 3 cm or more.

[0036] In at least one embodiment, the acoustic energy pulse includes an acoustic shock wave pulse.

[0037] In at least one embodiment, the acoustic energy pulse is divergent or planar.

[0038] In at least one embodiment, the cylindrical space is coaxial with the longitudinal axis of the acoustic energy pulse.

[0039] In another aspect of the present invention, a method of delivering an acoustic energy pulse into the body includes providing an acoustic energy pulse generating device, contacting the acoustic energy pulse generating device with the body, and generating an acoustic energy pulse and delivering the acoustic energy pulse into the body. The acoustic energy pulse has an energy density field that can be measured at all points within an imaginary cylindrical-shaped space having a length and diameter of 2 cm or more. The cylindrical-shaped space has a proximal end, a distal end, and a cylindrical longitudinal axis. The cylindrical longitudinal axis is oriented at an angle within the range of 0 to 20 degrees with respect to the longitudinal axis of the acoustic energy pulse. The proximal end is located at a first distance from the generating device, the distal end is located at a second distance from the generating device, the first distance is less than the second distance, and the minimum energy density of the pulse at all locations within the cylindrical-shaped space is at least 50% of the maximum energy density of the pulse within the space.

[0040] In at least one embodiment, the maximum energy density is in the range of 0.009 mJ / mm 2 to 0.044 mJ / mm 2 and the diameter is greater than 12 mm.

[0041] In at least one embodiment, the maximum energy density is greater than 0.044 mJ / mm 2 and up to 0.07 mJ / mm 2 and the diameter is greater than 13 mm.

[0042] In at least one embodiment, the maximum energy density is greater than 0.07 mJ / mm 2 and up to 0.088 mJ / mm 2 and the diameter is greater than 14 mm.

[0043] In at least one embodiment, the maximum energy density is greater than 0.088 mJ / mm 2 and up to 0.14 mJ / mm 2 and the diameter is greater than 17 mm.

[0044] In at least one embodiment, the proximal end contacts the body surface and the distal end is within the body.

[0045] In at least one embodiment, the acoustic energy pulse is applied longitudinally along the length of the female urethra of the body.

[0046] In at least one embodiment, the acoustic energy pulse includes an acoustic shock wave pulse.

[0047] In at least one embodiment, the acoustic energy pulse is divergent or planar.

[0048] In at least one embodiment, the step of contacting includes contacting the body within the labia, and the cylindrical space therapeutically encompasses at least a portion of the adult female urethral sphincter.

[0049] In at least one embodiment, the step of contacting includes contacting the device to the perineum of the body.

[0050] In at least one embodiment, the step of contacting includes contacting the device to the anus of the body.

[0051] In at least one embodiment, the method further includes mounting the device on a stabilization system.

[0052] In at least one embodiment, the stabilization system maintains the device in contact with the body with a predetermined amount of force.

[0053] In at least one embodiment, the cylindrical space is coaxial with the longitudinal axis of the acoustic energy pulse.

[0054] In another aspect of the present invention, a method of treating a female urethra of a patient includes providing an acoustic energy pulse generator, contacting the acoustic energy pulse generator with the patient's body in contact with or adjacent to the end of the urethra, and generating an acoustic energy pulse and delivering the acoustic energy pulse into the body in a direction along the length of the urethra.

[0055] In at least one embodiment, the urethra is treated only from the end of the urethra.

[0056] In at least one embodiment, the acoustic energy pulse has an energy density field sized to therapeutically encompass the patient's urethral sphincter, and the energy density field is configured to provide a therapeutically effective level of energy density for treatment of the urethral sphincter.

[0057] In at least one embodiment, a first volume of the energy density field, wherein a minimum energy density is at least 50% of a maximum energy density, encompasses at least 30 percent of a second volume of the urethral sphincter.

[0058] In at least one embodiment, the maximum energy density within the second volume is 0.11 mJ / mm 2 or less.

[0059] In at least one embodiment, the maximum energy density is 0.09 mJ / mm 2 or less.

[0060] In at least one embodiment, the maximum energy density has a value within the range of about 0.005 mJ / mm 2 to about 0.035 mJ / mm 2 inclusive.

[0061] In at least one embodiment, the maximum energy density has a value within the range of about 0.035 mJ / mm 2 to about 0.07 mJ / mm 2 inclusive.

[0062] In at least one embodiment, the acoustic energy pulse includes an acoustic shock wave pulse.

[0063] In at least one embodiment, the acoustic shock wave pulse is divergent or planar.

[0064] In another aspect of the present invention, an apparatus for generating an acoustic energy pulse for delivery into a living body is a housing having an opening and a longitudinal axis, the longitudinal axis extending through the opening, the housing, an acoustic energy pulse generator, at least a part of the acoustic energy pulse generator being contained within the housing, the acoustic energy pulse generator being configured to be in contact with or adjacent to the living body, and a contact portion positioned such that the acoustic energy pulse generated by the acoustic energy pulse generator passes through the contact portion, the acoustic energy pulse generator being configured to generate and deliver an acoustic energy pulse along the urethra of the living body in a direction along the length of the urethra, and the acoustic energy pulse being configured to produce a therapy result.

[0065] In at least one embodiment, the acoustic energy pulse generator comprises an acoustic shock wave generator and the acoustic energy pulse includes an acoustic shock wave pulse. The present invention provides, for example, the following. (Item 1) An apparatus for generating an acoustic energy pulse, the apparatus comprising a generator for generating the acoustic energy pulse having an energy density field measurable at all points within an imaginary cylindrical-shaped space having a length and diameter of 2 cm or more comprising the cylindrical-shaped space having a proximal end, a distal end, and a cylindrical longitudinal axis, the cylindrical longitudinal axis being oriented at an angle within the range of 0 to 20 degrees with respect to the longitudinal axis of the acoustic energy pulse, the proximal end being located at a first distance from the generator, the distal end being located at a second distance from the generator, the first distance being less than the second distance, An apparatus in which the minimum energy density of the pulse at all locations within the cylindrical space is at least 50% of the maximum energy density of the pulse within the space. (Item 2) The maximum energy density is in the range of 0.005 mJ / mm 2 to 0.025 mJ / mm 2 and the diameter is in the range of 10 mm to 18 mm, the apparatus according to item 1. (Item 3) The maximum energy density is above 0.025 mJ / mm 2 and up to 0.04 mJ / mm 2 and the diameter is greater than 11 mm, the apparatus according to item 1. (Item 4) The maximum energy density is above 0.04 mJ / mm 2 and up to 0.05 mJ / mm 2 and the diameter is greater than 12 mm, the apparatus according to item 1. (Item 5) The maximum energy density is above 0.05 mJ / mm 2 and up to 0.08 mJ / mm 2 and the diameter is greater than 13 mm, the apparatus according to item 1. (Item 6) The maximum energy density is above 0.08 mJ / mm 2 and up to 0.11 mJ / mm 2 and the diameter is greater than 15 mm, the apparatus according to item 1. (Item 7) The apparatus includes a housing, at least a part of the generator is contained within the housing, and the minimum dimension of the housing perpendicular to the longitudinal axis of the cylinder is 175 mm or less, the apparatus according to any one of items 1 - 6. (Item 8) The proximal end is located 100 mm or less from the surface of the generator where the acoustic energy pulse is delivered, the apparatus according to any one of items 1 - 6. (Item 9) The length is 3 cm or more, the apparatus according to any one of items 1 - 6. (Item 10) The acoustic energy pulse includes a divergent or planar acoustic pulse, and the device according to any one of Items 1-6. (Item 11) The acoustic energy pulse is an acoustic shock wave pulse, and the device according to any one of Items 1-6. (Item 12) The acoustic energy pulse is generated electromagnetically, and the device according to any one of Items 1-6. (Item 13) The cylindrical space is coaxial with the longitudinal axis of the acoustic energy pulse, and the device according to any one of Items 1-6. (Item 14) A method for delivering an acoustic energy pulse, the method comprising: Providing an acoustic energy pulse generating device; Generating an acoustic energy pulse and delivering the acoustic energy pulse from the acoustic energy pulse generating device; and including: The acoustic energy pulse has an energy density field that can be measured at all points within an imaginary cylindrical-shaped space having a length and diameter of 2 cm or more; The cylindrical-shaped space has a proximal end, a distal end, and a cylindrical longitudinal axis, the cylindrical longitudinal axis is oriented at an angle within the range of 0 to 20 degrees with respect to the longitudinal axis of the acoustic energy pulse, the proximal end is located at a first distance from the generating device, the distal end is located at a second distance from the generating device, the first distance is less than the second distance; The minimum energy density of the pulse at all locations within the cylindrical-shaped space is at least 50% of the maximum energy density of the pulse within the space. A method. (Item 15) The maximum energy density is in the range of 0.009 mJ / mm 2 ~0.044 mJ / mm 2 and the diameter is greater than 12 mm, the method according to Item 14. (Item 16) The maximum energy density is greater than 0.044 mJ / mm 2 and less than or equal to 0.07 mJ / mm 2 , and the diameter is greater than 13 mm, the method according to item 14. (Item 17) The maximum energy density is greater than 0.07 mJ / mm 2 and less than or equal to 0.088 mJ / mm 2 , and the diameter is greater than 14 mm, the method according to item 14. (Item 18) The maximum energy density is greater than 0.088 mJ / mm 2 and less than or equal to 0.14 mJ / mm 2 , and the diameter is greater than 17 mm, the method according to item 14. (Item 19) The acoustic energy pulse generator includes a housing that at least partially surrounds the acoustic energy pulse generator, and the minimum dimension of the housing perpendicular to the longitudinal axis of the acoustic energy pulse is 175 mm or less, the method according to any one of items 14-18. (Item 20) The proximal end of the cylindrical space is located 100 mm or less from the acoustic energy pulse source, the method according to any one of items 14-18. (Item 21) The length is 3 cm or more, the method according to any one of items 14-18. (Item 22) The acoustic energy pulse includes an acoustic shock wave pulse, the method according to any one of items 14-18. (Item 23) The acoustic energy pulse is divergent or planar, the method according to any one of items 14-18. (Item 24) The cylindrical space is coaxial with the longitudinal axis of the acoustic energy pulse, the method according to any one of items 14-18. (Item 25) A method of delivering an acoustic energy pulse into the body, the method comprising: To provide an acoustic energy pulse generator, To bring the acoustic energy pulse generator into contact with the body, To generate the acoustic energy pulse and deliver the acoustic energy pulse into the body including The acoustic energy pulse has an energy density field that can be measured at all points within an imaginary cylindrical-shaped space having a length and diameter of 2 cm or more, The cylindrical-shaped space has a proximal end, a distal end, and a cylindrical longitudinal axis, the cylindrical longitudinal axis is oriented at an angle within the range of 0 to 20 degrees with respect to the longitudinal axis of the acoustic energy pulse, the proximal end is located at a first distance from the generator, the distal end is located at a second distance from the generator, and the first distance is less than the second distance, A method in which the minimum energy density of the pulse at all locations within the cylindrical-shaped space is at least 50% of the maximum energy density of the pulse within the space. (Item 26) The maximum energy density is in the range of 0.009 mJ / mm 2 to 0.044 mJ / mm 2 and the diameter exceeds 12 mm, the method according to item 25. (Item 27) The maximum energy density exceeds 0.044 mJ / mm 2 and is up to 0.07 mJ / mm 2 and the diameter exceeds 13 mm, the method according to item 25. (Item 28) The maximum energy density exceeds 0.07 mJ / mm 2 and is up to 0.088 mJ / mm 2 and the diameter exceeds 14 mm, the method according to item 25. (Item 29) The maximum energy density exceeds 0.088 mJ / mm 2 and is up to 0.14 mJ / mm 2 and the diameter exceeds 17 mm, the method according to item 25. (Item 30) The proximal end contacts the surface of the body, and the distal end is within the body. The method according to any one of items 25 - 29. (Item 31) The acoustic energy pulse is applied longitudinally along the length of the female urethra of the body. The method according to any one of items 25 - 29. (Item 32) The acoustic energy pulse includes an acoustic shock wave pulse. The method according to any one of items 25 - 29. (Item 33) The acoustic energy pulse is divergent or planar. The method according to any one of items 25 - 29. (Item 34) The contacting includes contacting the body within the labia, and the cylindrical space therapeutically encompasses at least a part of the adult female urethral sphincter. The method according to any one of items 25 - 29. (Item 35) The contacting includes contacting the device with the perineum of the body. The method according to any one of items 25 - 29. (Item 36) The contacting includes contacting the device with the anus of the body. The method according to any one of items 25 - 29. (Item 37) The method further includes mounting the device on a stabilization system. The method according to any one of items 25 - 29. (Item 38) The stabilization system contacts the body with a predetermined amount of force to maintain the device. The method according to item 37. (Item 39) The cylindrical space is coaxial with the longitudinal axis of the acoustic energy pulse. Items 25 - The method according to any one of 29. (Item 40) A method for treating a patient's female urethra, the method comprising providing an acoustic energy pulse generating device, and Contacting or adjacent to the end of the urethra, bringing the acoustic energy pulse generating device into contact with the body of the patient; Generating an acoustic energy pulse and delivering the acoustic energy pulse into the body in a direction along the length of the urethra; A method comprising the steps of. (Item 41) The method according to item 40, wherein the urethra is treated only from the end of the urethra. (Item 42) The acoustic energy pulse has an energy density field sized to therapeutically encompass the patient's urethral sphincter, The method according to item 40 or item 41, wherein the energy density field is configured to provide a therapeutically effective level of energy density for the treatment of the urethral sphincter. (Item 43) The method according to item 42, wherein a first volume of the energy density field in which the minimum energy density is at least 50% of the maximum energy density encompasses at least 30 percent of a second volume of the urethral sphincter. (Item 44) The maximum energy density within the second volume is 0.11 mJ / mm 2 The method according to item 43, which is less than or equal to the following. (Item 45) The maximum energy density is 0.093 mJ / mm 2 The method according to item 44, which is less than or equal to the following. (Item 46) The maximum energy density is about 0.005 mJ / mm 2 ~ about 0.035 mJ / mm 2 The method according to item 44, having a value within the range of. (Item 47) The maximum energy density is about 0.035 mJ / mm 2 ~ about 0.07 mJ / mm 2 The method according to item 44, having a value within the range of. (Item 48) The method according to item 40 or item 41, wherein the acoustic energy pulse includes an acoustic shock wave pulse. (Item 49) The method according to item 40 or item 41, wherein the acoustic energy pulse is divergent or planar. (Item 50) An apparatus for generating an acoustic energy pulse for delivery into a living body, the apparatus comprising: A housing having an opening and a longitudinal axis, the longitudinal axis extending through the opening; An acoustic energy pulse generator, at least a part of the acoustic energy pulse generator being contained within the housing; A contact portion configured to be in contact with or adjacent to the living body, the acoustic energy pulse generated by the acoustic energy pulse generator being positioned to pass through the contact portion; and The acoustic energy pulse generator is configured to generate and deliver the acoustic energy pulse along the urethra of the living body in a direction along the length of the urethra, the acoustic energy pulse being configured to produce a therapy result. (Item 51) The apparatus according to item 50, wherein the acoustic energy pulse generator comprises an acoustic shock wave generator, and the acoustic energy pulse comprises an acoustic shock wave pulse.

[0066] These and other features of the present invention will become apparent to those skilled in the art upon reading the detailed description of the apparatus, system, and method as fully described below. BRIEF DESCRIPTION OF THE DRAWINGS

[0067] In the course of the following detailed description, reference will be made to the accompanying drawings. These drawings illustrate different aspects of the invention, and where appropriate, reference numerals that identify similar structures, components, materials, and / or elements within different figures are similarly labeled. It is to be understood that various combinations of structures, components, materials, and / or elements other than those specifically shown are contemplated and are within the scope of the invention.

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[0095] Before the apparatus and method are described, it is to be understood that the present invention is not limited to the particular embodiments described, and accordingly may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.

[0096] It is to be understood that when ranges of values are provided, each intervening value, to the tenth of the unit of the lower limit, between the upper and lower limits of that range is specifically disclosed, unless the context clearly dictates otherwise. Each smaller range between any given value or intervening value within the given range and any other given value or intervening value within the given range is also encompassed within the present invention. These smaller ranges may independently include or exclude any of the upper and lower limits of the ranges, and each range that includes any of the limits, excludes any of the limits, or includes both of the limits of the smaller ranges is also encompassed within the present invention, subject to any specifically excluded limit within the given range. When the given range includes one or both of the limits, ranges excluding either or both of those included limits are also encompassed within the present invention.

[0097] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are described herein. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and / or materials in connection with the publications cited.

[0098] As used in this specification and the appended claims, it should be noted that the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a pulse" includes a plurality of such pulses, reference to "the source" includes reference to one or more sources known to those skilled in the art and their equivalents, and the like.

[0099] The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. The dates of the publications provided may be different from the actual publication dates, which may need to be independently verified.

[0100] Definition "Acoustic energy pulse" or "acoustic pulse" as used herein refers to an acoustic compression wave that is a pulse having an initial compression stage immediately followed by an initial rarefaction stage, where: i) the interval between the time when the pressure within the compression stage first increases to 10% of the peak pressure within such stage and the time when the negative pressure within the rarefaction stage decreases to 10% of the peak negative pressure within such stage does not exceed 12 microseconds; ii) the peak pressure within the initial compression stage is at least 2.5 megapascals (MPa); and iii) the absolute value of the peak negative pressure within the rarefaction stage does not exceed 85% of the peak positive pressure within the compression stage. For example, an acoustic energy pulse can be an acoustic shock wave pulse, i.e., a pulse generated by a firing device by accelerating a projectile at high speed into a target for the purpose of treating biological tissue, where the projectile has a maximum width dimension (orthogonal to the direction of acceleration) of 4 cm or less, and which is generally referred to as a ballistic or radiative shock wave, or any other pulse having the characteristics of an acoustic energy pulse as described above.

[0101] "Acoustic shock wave" as used herein refers to an acoustic energy pulse that travels faster than the local speed of sound in the medium through which it is propagating.

[0102] "Energy flux density" or "EFD" at a point in space is defined as the amount of energy contained within a single acoustic energy pulse passing through that point per unit cross-sectional area orthogonal to the direction of pulse propagation. It is mJ / mm 2It is measured in units. All EFD measurements referred to in this specification are calculated from pressure measurements of acoustic pulses as they pass through water. The pressure of the pulse at a point in space and at a time within the water tank is measured using a hydrophone located at that point in space. The hydrophone emits a voltage that varies with the water pressure over time. The voltage signal is digitized and converted to a pressure curve by applying the voltage / pressure relationship of the hydrophone. The EFD of the pulse is calculated by integrating the square of the pressure curve over time, as follows, in accordance with Equation 7.2.3 of International Electrotechnical Commission (IEC) Standard 61846:1998.

[0103] At a spatial point (x, y, z), where x, y, and z are the three-dimensional coordinates of the spatial point,

Chemical formula

[0104] All EFD values disclosed herein for the apparatus related to the present invention of this specification are based on measurements from three hydrophones. The initial pressure curve was derived using a Mueller - Platte 100 - 100 - 1 PVDF needle probe (Mueller Instruments (Oberursel, Germany)) with the manufacturer - specified sensitivity. Equation 7.2.3 of IEC 61846:1998 was applied to calculate the EFD with T = T T used. Frequency response adjustment was not performed when converting the probe voltage to pressure. The additional pressure curve was derived at selected reference points using an ONDA HFO fiber optic hydrophone and an ONDA HNR ceramic hydrophone (both from Onda Corporation (Sunnyvale, California, USA)) that use the frequency domain adjustment specified by the manufacturer. These pressure curves were converted to EFDs by applying Equation 7.2.3 of IEC 61846:1998 with T = T P used. The reference EFD values of the two ONDA hydrophones were substantially the same but 175% higher than the Mueller - Platte hydrophone values. This is due to the lower sensitivity of the Mueller - Platte hydrophone at lower frequencies, which causes an underestimation of the pressure with respect to the type of pulse generated by the apparatus disclosed herein. All EFD values derived from the Mueller - Platte hydrophone were increased by 175% to correct for the underestimation of the pressure.

[0105] As used herein, "low - energy acoustic pulse" ("LEAP") therapy refers to a treatment that involves the application of one or more acoustic energy pulses having a relatively low energy for the treatment of tissue. "Relatively low energy" is defined herein as being within the EFD range of 0.008 / mm 2 to 0.4 mJ / mm 2 .

[0106] "Energy density field" refers to the space through which an acoustic energy pulse travels, along with the EFD values at all points in the space.

[0107] "Cylinder" as used herein refers to an imaginary cylinder used for the purpose of calculating or defining a part of the energy field generated by an acoustic energy pulse generator. Thus, the imaginary cylinder is described as filling a specific volumetric part of the energy field. Preferably, the central longitudinal axis of the cylinder is coaxial or as nearly coaxial as possible with the longitudinal axis of the acoustic energy pulse, although it may be oriented such that the cylinder longitudinal axis is within the range of 0 to 20 degrees with respect to the longitudinal axis of the acoustic energy pulse.

[0108] "Treatment" or "treating" as used herein refers to the application of one or more pulses of low-energy acoustic energy to promote the reconstruction, regeneration, strengthening, and / or restoration of the target tissue being treated to a normally functioning state or a state closer to normal functioning than its state prior to treatment.

[0109] "Therapy outcome" or "successful therapy outcome" as used herein refers to an improvement in reconstructing, regenerating, strengthening, and / or restoring the target tissue being treated, by at least a 30% improvement in the value associated with any of the aforementioned characteristics prior to treatment. With respect to treatment of UI, one non-limiting method of measuring the therapy outcome is the 24-hour pad test, where the patient is instructed to wear a pad for 24 hours prior to treatment, and the pad is weighed after 24 hours and compared to the weight of a dry pad to determine the weight of the leaked urine. After treatment, the same procedure is performed, and the weight of the urine in the pad after treatment is compared to the weight of the urine in the pad before treatment to determine the difference. The percentage improvement can then be calculated by dividing the urine weight difference by the pre-treatment urine weight and multiplying by 100. Alternatively, the 1-hour pad test involves having the patient drink a predetermined volume of water and then moving more actively for a predetermined period, typically about 1 hour. This procedure can be followed before or after treatment, and the urine weight is determined from pads before and after treatment to calculate the improvement rate in the same manner as calculated for the 24-hour test. Note that the means for determining therapy effectiveness are provided only as examples and are by no means limited to these two techniques. Of course, these tests may not even be applicable for the treatment of tissues or organs other than the urethra. A reduction of at least 30% in urine weight between the pre-treatment and post-treatment pads for either the 24-hour or 1-hour test would be a "therapy outcome" or "successful therapy outcome" as used herein.

[0110] "Therapeutically effective" refers to a treatment having the characteristics sufficient to provide a successful therapy outcome when treating a patient.

[0111] "Therapeutically encompass" refers to completely encompassing the target tissue or organ, or encompassing at least a portion of such, using an energy field sufficient to effect a therapeutically effective treatment of the target tissue or organ.

[0112] "Urinary incontinence" ("UI") is defined as the involuntary leakage of urine. There are two basic types of UI, namely, stress urinary incontinence and urge urinary incontinence. Stress urinary incontinence ("SUI") is caused by the inability of the urethral sphincter to keep the urethra closed when pressure is applied to the bladder, such as during exercise, sexual intercourse, coughing, or through prolapse of pelvic organs. Urge urinary incontinence ("UUI") is caused by involuntary contractions of the bladder muscle.

[0113] "Non-focused," as used herein in connection with an energy field generated by an acoustic energy device, refers to an energy field in which the EFD decreases in all directions away from the acoustic energy source or is constant.

[0114] Detailed Description When LEAP is applied at appropriate energy levels, frequencies, and durations, they can stimulate the growth of new tissue, thereby repairing and regenerating damaged and diseased tissue / organs. The present invention is directed to special devices and methods for generating LEAP at appropriate energy levels, frequencies, and durations, delivering them to target tissue, and effecting repair and / or regeneration of the target tissue.

[0115] The method and apparatus, when used in accordance with the details provided herein, activate naturally occurring stem cells and progenitor cells that are resident in substantially all soft tissues within the body. Once activated, the stem cells and progenitor cells begin to divide and differentiate into new mature cells, as they do during normal growth and healing processes. Stem cell therapy is regarded as one of the most promising areas in medicine. However, conventional approaches require tissue removal, enzymatic digestion, isolation, and re-implantation of stem cells into the body. These procedures are difficult and have had limited clinical success. The present apparatus and method can be effective in realizing the potential of stem cell therapy in a non-invasive, safe, relatively painless, and at a fraction of the cost of conventional stem cell therapy.

[0116] The therapeutic range of combinations of energy levels, frequencies, and durations is specific to various types of tissue. Values of combinations that are too low (and thus below the therapeutic range) for a particular type of tissue will not result in the desired activation of stem cells and progenitor cells when applied to the tissue, while values of combinations that are too high (and thus above the therapeutic range) can cause tissue damage.

[0117] LEAP therapy represents a new approach to treating injuries and degenerative diseases because it non-invasively, safely, and painlessly utilizes the body's natural repair mechanisms. Drugs, needles, implants, and invasive surgeries are not required. The device according to the present invention, used to apply LEAP therapy within the therapeutic range to target tissue as described according to the method, can effectively, safely, and inexpensively treat injuries and degenerative diseases of the body.

[0118] The present invention can be applied to treat urinary incontinence (UI), such as SUI and / or UUI.

[0119] Regarding female UI, epidemiological studies have shown that approximately one-third of all adult women (about 39 million women in the United States) experience some form of UI. The incidence increases with age, although younger women often experience UI after childbirth. UI affects women's lives to varying degrees depending on the severity of the symptoms. At the very least, this is uncomfortable and inconvenient. In the worst cases, this causes confusion, discomfort, and the inability to function occupationally and socially. One indicator of the extent of the problem is that approximately 15 billion adult diapers are sold annually in the United States, and the majority of these are used for female urinary incontinence.

[0120] Stress urinary incontinence represents approximately half of all cases of female UI. Mixed urinary incontinence, which is a combination of stress urinary incontinence and urge urinary incontinence, represents an additional 30% of all cases of female UI. Overall, nearly 80% of female urinary incontinence cases involve a weak urethral sphincter. Figure 1 illustrates the location of the urethral sphincter 6 relative to the urethra 4, bladder 2, pelvic floor muscle 7, and urethral orifice 8 in an adult female.

[0121] Urgency urinary incontinence can both be treated using drugs and nerve stimulation devices that modulate nerve impulses causing involuntary bladder contractions. The success rate ranges from 50% to 80%, but 30% of patients stop taking the drugs due to side effects. Currently, there is no effective treatment for stress urinary incontinence other than surgery. Surgery compensates for weak urethral sphincters by supporting the urethra using implanted pieces of material. The success rate averages 80% when performed by a skilled urologist. However, manufacturers of surgical materials aggressively promote the procedure to physicians without the necessary skills and training. Failures are common, and the manufacturers are facing $1.5 billion in litigation regarding their use in primary UI procedures, but specifically regarding their surgical mesh products. Surgery for stress urinary incontinence is also expensive, averaging $35,000 per outpatient procedure and $49,000 per inpatient procedure.

[0122] The present invention provides an alternative to the above-described disadvantages in the treatment of female UI, particularly female SUI using surgery. The device and method may be used to sufficiently reconstruct and strengthen the urethral sphincters such that they are able to keep the urethra closed under typical stress conditions. While the treatment of the female urethral sphincters is the main focus of the present invention, the present invention is not limited to this application as the male urethral sphincters, and / or other sphincters or soft tissues within the urinary and / or anal regions, or any tissue located on or near the surface of the body extending into the body, including but not limited to the penis, may be treated.

[0123] Devices for generating acoustic pulses such as shock waves are known, but there is no existing device known to the inventors that can deliver a desired level of energy to therapeutically encompass the urethral sphincter along the length and width of the urethra (in all directions including diameter) so that the urethral sphincter is effectively treated over its extent from a stationary device. It is believed that a predetermined level of energy needs to be delivered along the entire urethra / urethral sphincter (or a sufficient portion thereof to effect a therapeutic treatment) in order to effect repair and regeneration in the manner described above. The first lithotripters focused high energy shock waves onto kidney stones, overcoming the tension holding the stones together and thereby pulverizing them. This focused energy is strong enough to damage most tissue. Experiments have been conducted for at least 15 years to determine whether low energy shock waves can be used therapeutically. Only four low energy shock wave devices, three for the treatment of orthopedic conditions such as tennis elbow and plantar fasciitis, and one for the treatment of diabetic foot ulcers, are approved for sale in the United States. In all devices currently known to the inventors, including those that could be termed "non-focused", there is in fact a focal point away from the probe / shock wave source. As far as the applicant is aware, no device anywhere in the world is approved for sale for the treatment of female urinary incontinence. No device has been proposed that is optimized for the treatment of the female urethra with respect to urinary incontinence. No known device can therapeutically encompass the female urethra within the field while simultaneously applying an effective and appropriate amount of energy at all locations within the field of the urethra and urethral sphincter to result in a therapeutic outcome from such energy application. As far as the applicant is aware, prior to the present invention, there was no truly non-focused shock wave device available on the market. The present invention provides a non-focused LEAP device.

[0124] Regarding the longitudinal application of LEAP along the female urethra, the probe for delivering LEAP must be relatively small so as to fit comfortably between the legs of the patient to whom LEAP is being delivered. Due to this constraint, currently known shock wave applicators are either too large or, if not too large, do not have sufficient EFD and EFD consistency to effectively deliver a therapeutic treatment longitudinally along the female urethra and thus cannot deliver an energy field.

[0125] All shock wave generators typically employ the principle of converting an electrical high voltage pulse into a mechanical pressure wave inside a water-filled cavity defined within the probe of the treatment device. The pressure wave is shaped and directed through a plastic membrane on one side of the cavity. The membrane is placed against the skin of the patient being treated, typically with a layer of hydrogel interspersed between the membrane and the skin to facilitate the transmission of the acoustic pulse (e.g., shock wave). Most known devices can generate one, three, five, or more pulses per second. The pressure wave (e.g., shock wave) propagates through soft tissue due to the water content of the soft tissue.

[0126] The energy density of a shock wave or other low-energy acoustic pulse depends on the amount of energy released in each electrical pulse and the cross-sectional area of the pressure wave. Currently available shock wave generators typically increase the energy density by focusing the waveform within a smaller cross-sectional area. The focus is also longitudinal. All shock wave generators currently known to the inventors prior to the present invention focus the waveform within a smaller cross-sectional area. Some of these prior art devices are characterized by their manufacturers as "non-focusing" in that they are capable of delivering "plane or divergent" waves, but in fact, even these devices focus the waveform to some extent. In contrast, the present invention generates a waveform that is completely non-focusing.

[0127] Figure 2A is a perspective view of a low energy acoustic pulse (shock wave) LEAP device 10 according to an embodiment of the present invention. Figures 2B and 2C are front and rear views of the device of Figure 2A. The device 10 includes a control unit 12 that contains the electronics required to control the probe 30. The probe 30 is electrically connected to the control unit by a cable 14 and an electrical connector 16. A probe holder or placerack 18 may be provided on the control unit 12 to hold the probe 30 when not in use, as shown in Figure 2C. A display (not necessarily, but preferably, a touch panel) 20 can be used to control the device bidirectionally and to display the operating conditions and other data of the device. A ground plug 22 is provided on the rear of the control unit case to ground the device and connect it to ground to avoid electric shock. A fluid tank filling pipe terminal 24 is provided to fill the tank of the device with water. A footswitch terminal 26 can be provided to optionally allow a footswitch to be connected to the device to enable the operator to fire the device using foot-operated commands. However, these optional features are not necessary for the fabrication and use of the present invention and are currently not preferred. A power switch 28 allows the operator to turn the power to the device on and off. A power supply jack 27 receives a power cord that can also be connected to a power source. A fuse board 25 is provided to protect the circuitry of the device. An indicator 23 indicates the level of filling of the water tank. A water cushion 32 may be provided at the distal end portion of the probe 30, as will be described in more detail below.

[0128] There are at least three different techniques for generating shock waves. The three techniques are electrohydraulic, electromagnetic, and piezoelectric, and all of these techniques are effective for converting electrical energy into mechanical energy. Further explanations of the physics and principles by which these three techniques operate can be found in Ogden et al., “Principles of Shock Wave Therapy”, Clinical Orthopedics and Related Research, Number 387, pp.8-17, 2001 (which is hereby incorporated by reference in its entirety herein). Another type of therapeutic low-energy acoustic pulse, commonly referred to as a ballistic shock wave or a radial shock wave, is generated by accelerating a metal projectile along a barrel using compressed air. The projectile impacts a metal target at the end of the barrel and generates a compression wave that is conducted to the tissue contacting the opposite side of the target.

[0129] Figure 3A is a schematic representation of a partial cutaway view of a probe 30 according to an embodiment of the present invention. The present invention preferably employs an electromagnetic generation principle to generate a LEAP, as illustrated by the embodiment of Figure 3A, but is not limited to this technique as other things and their equivalents described herein may be used if they are capable of functioning according to the specifications described herein. The housing 32 contains the components of the probe and is configured to be gripped by the operator's hand. The width 32W of the housing 32 should be kept to a minimum while still containing the components capable of generating and delivering a LEAP having the specifications described herein so as to adequately treat the target tissue for which the device is designed to treat. In this embodiment, the device is designed for the treatment of a female urethra, and the width 32W is 140 mm or less, preferably 125 mm or less, and even more preferably less than 100 mm. In some embodiments, the width 32W is 90 mm or less, and in some embodiments, the width 32W is in the range of about 70 mm to about 90 mm.

[0130] In one particular example of an acceptable embodiment for the treatment of a female urethra as shown in FIGS. 3B - 3D, the width 32W was approximately 74 mm. The exposed width 42W of the flexible diaphragm was approximately 54 mm, although this width can also vary proportionally to the variation in width 32W. In another particular example, also acceptable for the treatment of the urethra as described herein and shown in FIGS. 3F - 3H, the width 32W was approximately 88 mm. Preferably, in all embodiments, the housing 32 is generally cylindrical with a longitudinal axis that is aligned with the longitudinal axis L - L of the probe 30. Alternatively, the housing can be egg-shaped, oval, polygonal, or some other shape as long as it comfortably fits between the patient's legs and can be applied as described. Thus, a smaller width of the device housing is preferred. Unlike electromagnetic shock wave devices currently available on the market, the probe 30 emits a non-focused LEAP and does not employ a lens.

[0131] As described, the LEAP generator of the probe 30 according to the embodiments of FIGS. 3A-3H is configured to generate LEAP by electromagnetic principles. Coils 34 (FIGS. 3C and 3G) are mounted on a substrate 36 held by a housing 32 (FIGS. 3B and 3F). The substrate 36 may be a glass-reinforced epoxy laminate such as FR4 (a composite material consisting of a woven fiber glass cloth with an epoxy resin binder that is glass-glass reinforced, flame retardant / self-extinguishing), or other materials that may function in a similar manner to an insulator. The coil 34 is mounted on the substrate 36 by an adhesive in at least one embodiment. Additionally, or alternatively, the coil 34 may be adhered to the substrate 36 using a resin layer 36R that can be any of the same materials described below for use in coating the coil 34. The substrate 36 is typically disc-shaped, but is not limited thereto and may have other shapes such as oval, ellipsoid, rectangular, or other polygons, or other shapes. The substrate 36 has an outer dimension (outer diameter when disc-shaped) that is only slightly larger than that of the driver 38. The outer dimension / outer diameter 36D of the substrate 36 can be in the range of about 4.0 cm to about 8.5 cm, preferably in the range of about 4.5 cm to about 7.5 cm. In the example shown in FIG. 3C, the outer diameter 36D is about 5.6 cm and has a thickness 36T of about 8 mm. The thickness 36T may be in the range of about 3 mm to about 16 mm. In the example shown in FIG. 3G, the outer diameter 36D is about 6.3 cm and has a thickness 36T of about 14 mm.

[0132] The coil 34 can be coated with a resin 36R that provides additional electrical insulation between the turns of the coil winding and helps hold the coil in place. Resins with high dielectric strength such as resin 74050T or 724F2 from Von Roll USA, Inc. are preferred. In at least one embodiment, the coil 34 comprises an enameled copper wire having a diameter in the range of about 0.25 mm to about 1.0 mm, preferably in the range of about 0.4 mm to about 0.7 mm. In the examples shown in FIGS. 3C and 3G, the coil 34 comprises a copper wire having a diameter of 0.55 mm.

[0133] Preferably, a driver 38 in the form of a metal disc is mounted on the coil 34 as shown in FIG. 3A. In at least one embodiment, the driver 38 is a disc made of high-performance aircraft-grade aluminum. One such embodiment is 7075T6 aluminum. Of course, the present invention is not limited to this specific material since substitutes can be used. The diameter of the driver 38 is typically less than or equal to the width of the coil 34 and, of course, less than the width 32W of the housing 32. In at least one embodiment, the diameter is about 5 cm. In at least another embodiment, the diameter of the driver is about 6 cm. Alternatively, the diameter can be in the range of about 3.5 cm to about 8.0 cm, preferably about 4.0 cm to about 7.0 cm, or 3.5 cm to 6.5 cm, or 4.0 cm to 6.0 cm, or 4.5 cm to 5.5 cm, or any other range within the range of 4.0 cm to 7.0 cm. In the example shown in FIG. 3C, the diameter 38D of the driver 38 is about 5 cm (i.e., 4.99 cm), the thicknesses of both 40 and 38 are about 1.5 mm, and the driver 38 has a thickness of about 0.6 mm. In the embodiment of FIG. 3G, the diameter 38D of the driver 38 is 6.22 mm and has approximately the same thickness as that of the embodiment of FIG. 3C. The combined thickness of 40 and 38 was about 1.5 mm. The thickness of the driver 38 can be in the range of about 0.4 mm to about 1.0 mm. Further alternatively, other metals capable of generating a pulse of sufficient strength can be used to make the driver, but they are likely to result in a shorter life cycle prior to failure of the driver 38. In a preferred embodiment, the driver 38 is configured to emit at least 100,000 pulses, more preferably 400,000 to 1.5 million pulses prior to failure, more preferably 500,000 to 1.25 million, even more preferably 750,000 to 1.1 million, and in some embodiments, more than 1 million. The life of the driver 38 will vary depending on the energy level generated by the LEAP. In at least one embodiment, the life of the driver 38 is 0.035 mJ / mm 2can exceed 1.2 million pulses when generating the EFD. In at least one embodiment, the life of driver 38 is 0.088 mJ / mm 2 can be in the range of about 700,000 to about 1 million pulses when generating the EFD.

[0134] Elastic gasket 40 (see, for example, FIGS. 3C and 3G), for example, typically rubber, forms a ring-like structure that holds driver 38 in place around its perimeter while allowing driver 38 to move (and deform) simultaneously as coil 34 fires and generates a LEAP. Gasket 40 may be injection molded around driver 38 during manufacture, or alternative methods of integration may be used, including, but not limited to, adhesives, soldering, welding, mechanical fixation, or the like. Alternatively, elastic gasket 40 may completely cover at least the upper side of driver 38, as shown in FIG. 3E. In this variant, elastic gasket 40 acts as an upper coating that seals the upper part of the driver. As a further alternative, the driver may be completely encapsulated in elastic gasket 40 material such that material 40 coats the entire driver 38. As a further alternative, at least both the upper and lower surfaces of driver 38 may be completely coated with elastic gasket 40 material. The coating prevents, or reduces, cavitation corrosion of the metal disc material of driver 38 that can occur with repeated generation of a LEAP, thereby extending the useful life of driver 38.

[0135] The flexible diaphragm or membrane 42 encloses the otherwise open distal end of the housing 32. The flexible diaphragm 42 is configured to provide a non-traumatic interface with the body while contacting the body during use and allowing the LEAP to pass therethrough. The length or height 42L of the distal surface of the flexible diaphragm 42 from the driver 38 is adjustable by adding or removing fluid (water or saline, or other liquid that facilitates the transmission of the LEAP and is preferably biocompatible) from a chamber 44 that forms a cushion such as that enclosed by the flexible diaphragm. A fluid reservoir (not shown) is provided within the device 10 and can be filled via a fluid tank filling pipe terminal 24 (see FIG. 2C). The fluid is delivered through or drawn from the chamber 44 via a cable 14 that includes a lumen connecting the chamber 44 to a fluid reservoir in fluid communication therewith such that the length / height 42L is decreased or increased by the operation of the touch screen 20 and the fluid can be removed from or added to the fluid cushion 44 to control the operation of a fluid pump (not shown) within the device 10. Thus, the length / height can be set to a desired parameter.

[0136] The range of the height / length (measured from the base 42B of the fluid cushion 42 to the apex 42Z of the fluid cushion 42 at the top of the device periphery 32R as shown in FIG. 3A) is generally from about 0 cm to about 10 cm, in some embodiments from about 1 cm to 8 cm, in some embodiments from about 3 cm to 5 cm, and in other embodiments from about 0 cm to 5 cm, although other ranges may also be employed. Typically, the length / height 42L is adjusted for good contact and comfortable fit to the tissue on which the treatment is being performed and is preferably in the range of about 3 cm to about 6 cm, typically about 4 cm. In at least one preferred embodiment, 42L is 4.6 cm. Variations in the length / height 42L directly affect the placement of the treatment zone of the energy density field as will be described in more detail below.

[0137] A pair of terminals 46 are connected to a power supply line so as to provide power to coil 34. FIG. 3C shows a partial exploded view of the embodiment of probe 30 shown in FIG. 3B. As shown in FIG. 3C, terminal 46 may include a pair of pins 46P that are received within socket 46S that is connected to the power supply line. Pins 46P are connected to substrate 36 via a connector 46C, such as a screw or equivalent, that electrically connects to coil 34. In the embodiment of FIGS. 3B - 3D, connector 46C is a screw, but other types of connectors, including but not limited to bolts, rivets, nails, or equivalents, may be used. Coil 34 is typically electrically connected to terminal 46P by soldering.

[0138] Power control is provided by programming contained within the device, using parameters such as energy level and frequency that can be selected by an operator via the touch panel 20. Additionally, or alternatively, mechanical means such as a control knob or equivalent can be provided for selecting the EFD settings and frequency. In at least one embodiment, multiple EFD settings are provided for operator selection. The EFD output is determined by the voltage applied to the coil. In one embodiment, a technician can assign a voltage level, establish an EFD setting, and also define a voltage differential with respect to the difference in voltage between adjacent settings by selecting a single voltage setting (typically a setting for level 1, i.e., the lowest level, but alternatively a setting for the highest level or a certain intermediate level). For example, in one particular embodiment, 10 energy level settings are provided. By selecting setting 1 at 5,500V and a voltage differential of 500V, this results in setting 1 providing 5,500V, setting 2 providing 6,000V, setting 3 providing 6,500V, setting 4 providing 7,000V, setting 5 providing 7,500V, setting 6 providing 8,000V, setting 7 providing 8,500V, setting 8 providing 9,000V, setting 9 providing 9,500V, and setting 10 providing 10,500V. The EFD levels resulting from the voltage assignment are identified to the user in relation to the setting levels. It should be noted that this is only one specific embodiment and the present invention is not limited to specific numbers or settings, or the voltage levels assigned to any one or all of the settings. Additionally, the device 10 can be reprogrammed to assign higher or lower voltage settings to one or more setting levels. For example, setting 1 can be reprogrammed to be as low as 4,500V.

[0139] The actual emission or "firing" of the LEAP can be actuated through a display (e.g., a touch panel) 20. The display 20 is powered on by turning on the main power switch 28. The power button icon 128 (FIG. 2D) on the touch panel 20 is actuated to turn on the high-voltage circuit that powers the LEAP generation. The number of pulses to be fired in a session is selected at 122. The energy level is selected at 124 and the frequency (pulses per second) is set at 126. The LEAP firing session starts in response to actuating the start icon 130. The counter 132 records the actual number of pulses fired during the session. The LEAP firing automatically stops after the total number of selected LEAPs have been fired. The reset button icon 132 resets the counter to zero. The fill icon 136 is selected to add fluid to be extended 42 while actuation of the outflow 138 retreats 42. Degassing 140 is used to remove air bubbles from the fluid and the circulation icon is used to circulate the fluid in relation to a cooling function outside the scope of the present invention. The frequency of firing can be set to a value within the range of 1 Hz to 10 Hz, preferably 1 Hz to 8 Hz, more typically 1 Hz to 6 Hz, with current preference for 3 Hz and 5 Hz selections. The number of pulses can be selected within the range of 1 to 1500, although this can vary. The power source by which the device is powered can be a 110V power source such as an outlet. Alternatively, other power sources, including but not limited to 220V, can also be used.

[0140] Figure 3H is a longitudinal sectional view of the probe 30 according to the embodiment shown in Figure 3F. The lower housing portion 32L joins the lower portion of the probe 30 containing the terminal 46 to the substrate and the coil 34 via the LEAP cap 47C. The LEAP cap 47C has an outer dimension 47CD that is less than the outer dimension 32W of the housings 32U, 32L and is joined thereto using mating threads 47T, 42T. The outer dimension of the LEAP cap 47C, typically the outer diameter, is typically 122 mm or less, preferably 107 mm or less, and even more preferably less than 82 mm. In some embodiments, the outer dimension of the LEAP cap 47C is 78 mm or less, and in some embodiments, it is in the range of about 52 mm to about 72 mm. In one particular example as shown in Figure 3B, the outer dimension (outer diameter) was about 70 mm. In another particular example, the outer diameter was about 66 mm.

[0141] The intermediate housing portion 32I mounts the driver 38 (not visible in Figure 3H) and the gasket 40 (not visible in Figure 3H) on the portion that holds the coil 34, and the upper housing portion 32U mounts the flexible diaphragm 42 on the probe 30. Each housing portion is shown as being connected by mating threads 42T, but other equivalent mechanisms for joining the components may alternatively be used as will be apparent to those skilled in the art. While the housing components can be molded from, for example, plastic or 3D printed, the portion of the probe to which the housing 42 is attached is typically metal such as stainless steel or other compatible metal, but can be a rigid composite material, ceramic, or the like.

[0142] In the embodiment shown in FIG. 3F, the length 30L of the probe 30 was 210 mm. In the embodiment shown in FIG. 3B, the length 30L was 207 mm. However, the length 30L can vary within a range of about 150 mm to about 250 mm, typically about 175 mm to about 225 mm, about 180 mm to about 220 mm, about 185 mm to about 215 mm, about 190 mm to about 210 mm, or any value therebetween. The width (outer diameter) 32W2 of the proximal end of the probe 30 in FIG. 3F was 36 mm, but this dimension can vary within a range of about 25 mm to about 50 mm, for example, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, or any other width value between 25 mm and 50 mm. A connector assembly 49 can form the proximal end of the probe 30, as shown in FIGS. 3B and 3D.

[0143] FIG. 4A shows a schematic view of an energy field 90 radiated by a probe 30 according to an embodiment of the present invention shown in FIGS. 3F-H. In the embodiment shown, the voltage level was 8,500 V, the flexible diaphragm 42 extended 50 mm from the LEAP source as shown, and the location of the driver 38 was at 0 mm. Thus, location 42D is considered to be at 100% energy density value with respect to this schematic view, and the energy density level is 0.035 mJ / mm 2 thereby. Since the energy field 90 is rotationally symmetric, the energy field 90 appears identical to that shown in FIGS. 4A, 4C (and all other figures showing schematic views of the energy field) in all planes including the longitudinal axis L-L of the probe 30 / energy field 90. The energy density value decreases in the direction along the longitudinal axis L-L away from the source of the LEAP, i.e., in the upward direction as shown in FIG. 4A, and never increases. FIG. 4B illustrates this, showing an energy density plot for four different energy level settings (LV1 = 8.0 kV, LV2 = 8.5 kV, LV4 = 9.5 kV, and LV7 = 11.0 kV), starting from the origin and moving outward along the X-axis to plot the energy density levels for these various settings along the vertical axis of the waveform, thus illustrating the principle just described. The Y-axis is mJ / mm 2It shows the energy density value in units. For each level to be plotted, the energy density value decreases (i.e., moving from left to right along the X-axis) in the direction along the vertical axis L-L away from the source of LEAP and never increases.

[0144] Similarly, the energy density value is in a direction normal to the vertical axis with respect to the energy density value on the vertical axis L-L that intersects a line extending in the normal direction from L-L where the energy density value is measured, and in a direction away from the vertical axis (e.g., the left and right directions shown in FIG. 4A (and all other figures showing a schematic diagram of the energy field), and all other directions extending 360 degrees radially around the vertical axis L-L), and it decreases and never increases.

[0145] In this embodiment, the envelope 92 connects energy density values equal to the 100% reference value of 0.035 mJ / mm 2 . Therefore, all locations below and inside the envelope 92 have an energy density of 100% or more of the maximum energy density value in 42D. The envelope 94 connects energy density values having 65% of the reference maximum energy density value generated by this embodiment. In this embodiment, 65% of the reference maximum energy density value was 0.023 mJ / mm 2 . Therefore, all locations below and inside the envelope 94 have an energy density of 65% or more of the maximum energy density value. The envelope 96 connects energy density values having 50% of the maximum energy density value generated by this embodiment. In this embodiment, 50% of the maximum energy density value was 0.0175 mJ / mm 2 . Therefore, all locations below and inside the envelope 96 have an energy density of 50% or more of the maximum energy density value.

[0146] A cylinder 80 having a length of 35 mm and a diameter of 16 mm is shown superimposed on an energy field 90. When the cylinder 80 is contained within the energy density field 90, due to the characteristics of the energy density field 90 described above, the limiting values that define an energy density of 50% or more of the maximum energy density value (with respect to the shown envelope 96 or with respect to any ratio defined by any other envelope) are at the upper left and upper right corners of the distal end 80D of the cylinder 80. Since these values are located on the envelope 96, in this embodiment, they represent 50% of the maximum energy density value. Of course, all locations circumferentially around the distal end 80D of the cylinder also have 50% of the maximum energy density value. The fact that the distal end value of the cylinder (the distal corner of the rectangle representing the cylinder in two dimensions) is a limiting factor for the overall length of the cylinder is a function of the shape of the energy density field 90. The contour / envelope of the energy density field 90 is wider at the base and continuously becomes narrower as the distance from its source increases.

[0147] All locations within or on the cylinder 80 have an energy density that is at least 50% of the reference maximum energy density. Thus, all locations within or on the cylinder 80 in the embodiment shown in FIG. 4A have an energy density value of at least 0.018 mJ / mm 2 of.

[0148] Due to the EFD characteristics of the cylinder 80 described above, an additional cylinder (or any other three-dimensional space within the cylinder 80, and thus a subset of the volume of the cylinder 80) having characteristics similar to those described for the cylinder 80 can be defined within the space occupied by the cylinder 80. That is, the energy density at any location on or within such a subset volume (a smaller cylinder or other smaller volume contained within the cylinder 80) of the volume 80 is at least 50% (-6 dB) of the reference 100% EFD at location 42D. For example, such a space or cylinder may be defined to have a length of 35 mm or less (e.g., 30 mm - 35 mm, 25 mm - 30 mm, 20 mm - 25 mm, 15 mm - 20 mm, 10 mm - 15 mm, 5 mm - 10 mm, or 1 mm - 5 mm, or any length value within these ranges). For any or all of these lengths, the width can be 16 mm, 15 mm, 14 mm - 16 mm, 14 mm, 13 mm, 12 mm, 11 mm, 10 mm, 9 mm, 5 mm - 9 mm, 0.1 mm - 5 mm, or any width value between predetermined values. For a non-radiation symmetric space, the depth can be different from the width and can be 16 mm, 15 mm, 14 mm - 16 mm, 14 mm, 13 mm, 12 mm, 11 mm, 10 mm, 9 mm, 5 mm - 9 mm, 0.1 mm - 5 mm, or any width value between predetermined values. These same principles generally apply to any partial volume of any cylinder described herein with any defined reference maximum EFD.

[0149] FIG. 4C is an explanatory diagram in a cross-section of the application of LEAP characterized by the energy field of FIG. 4A to an adult female patient for the treatment of UI according to an embodiment of the present invention. The probe 30 is positioned with a flexible diaphragm 42 extending in the manner described above, and the flexible diaphragm 42 contacts the body of the patient 1 in contact with or adjacent to the distal end of the urethra 4. The distal end 42D of the flexible diaphragm is positioned to contact the distal end 4D (urethral orifice) of the urethra 4 as shown in FIG. 4C, and the probe 30 is positioned between the legs of the patient 1.

[0150] The LEAP generation system 10 is then operative to generate LEAP90 and deliver it into the patient 1's body in a direction along the length of the urethra 4. Typically, this procedure is repeated at a predetermined number of times and at a predetermined frequency of LEAP application. Since the urethra 4 and the urethral sphincter 6 are preferably treated only from the end of the urethra 4 longitudinally along the urethra 4 and the urethral sphincter, this simplifies the procedure compared to prior art techniques and provides excellent results.

[0151] LEAP90 is dimensioned to therapeutically encompass the patient 1's urethra 4 and urethral sphincter 6 and is configured to provide a therapeutically effective level of energy density for the treatment of the urethra 4 and urethral sphincter 6 with respect to UI, having an energy density field.

[0152] The energy density field 90 is configured to provide a therapeutically effective treatment when applied in a direction along the longitudinal axis of the urethra 4. To accomplish this, at least 30% of the volume of the urethra 4 and urethral sphincter 6 is simultaneously encompassed by the energy density of the energy density field 90 having at least 50% of the reference maximum energy density, located along the central axis of the energy density field at the location of the end of the urethra (i.e., location 4D shown in FIG. 4C). Preferably, at least 40%, more preferably at least 50%, or 60%, 70%, 80%, 90%, or 99% of the volume of the urethra and urethral sphincter is simultaneously encompassed.

[0153] FIG. 4D is, in addition, an enlarged partial view of the schematic representation shown in FIG. 4C, showing a cylinder 80 applied to the female anatomy and superimposed on the energy density field 90 as described with reference to FIG. 4C. FIG. 4D shows that the cylinder 80 simultaneously encompasses approximately 87.5% of the urethra 4 and urethral sphincter 6 (the length of the cylinder 35 mm divided by the length of the 40 mm urethra 4 and 40 mm sphincter 6, the entire diameter of the urethra 4 and urethral sphincter 6 is encompassed over the entire 35 mm length of the cylinder 80), and the cylinder 80 has 0.018 mJ / mm 2It shows having the minimum EFD. Since the main urethral sphincter 6 of the urethra 4 is located approximately in the center of the length of the urethra 4, therapeutic effective treatment can be provided by any of the embodiments of the probe 30 described throughout the above and this disclosure.

[0154] Any ratio value between the predetermined ratio values can also be obtained as the amount of the urethral sphincter 6 simultaneously encompassed by at least 50% of the maximum energy density of the field.

[0155] The maximum energy fluence density (EFD) measured at 42D is 0.175 mJ / mm 2 or less, 0.16 mJ / mm 2 or less, 0.158 mJ / mm 2 or less, 0.15 mJ / mm 2 or less, 0.14 mJ / mm 2 or less, 0.123 mJ / mm 2 or less, 0.005 mJ / mm 2 ~0.04 mJ / mm 2 , 0.008 mJ / mm 2 ~0.05 mJ / mm 2 , 0.05 mJ / mm 2 exceeding 0.07 mJ / mm 2 up to, 0.04 mJ / mm 2 exceeding 0.05 mJ / mm 2 up to, 0.05 mJ / mm 2 exceeding 0.08 mJ / mm 2 up to, 0.08 mJ / mm 2 exceeding 0.10 mJ / mm 2 up to, 0.10 mJ / mm 2 exceeding 0.12 mJ / mm 2 up to, 0.12 mJ / mm 2 exceeding 0.14 mJ / mm 2 up to, 0.14 mJ / mm 2 exceeding 0.16 mJ / mm 2 up to, 0.16 mJ / mm 2 exceeding 0.18 mJ / mm 2 up to, 0.18 mJ / mm 2exceeding 0.20 mJ / mm 2 up to 0.01 mJ / mm 2 ~ about 0.03 mJ / mm 2 0.02 mJ / mm 2 ~ about 0.06 mJ / mm 2 0.01 mJ / mm 2 ~ 0.02 mJ / mm 2 0.02 mJ / mm 2 ~ about 0.04 mJ / mm 2 or may have any value between 0.005 mJ / mm 2 ~ 0.175 mJ / mm 2 The maximum EFD level may be any of the values described above, but an EFD level of 0.12 mJ / mm 2 or higher is generally considered too high to be tolerated by patients being treated within the area of the female urethra, and thus such levels are not recommended for use in the treatment of the female urethra.

[0156] The LEAP90 and LEAP generator configurations described with respect to FIGS. 4A and 4C - 4D are preferably for the treatment of the female urethra, but alternatively can be used for any of the other treatments described herein.

[0157] At the distal location of the cylinder 80, the 50% envelope 96 narrows as the energy density level decreases. The 50% envelope terminates approximately 22 mm distal of the cylinder 80 in FIGS. 4C - 4E. About 100 mm - 110 mm after the driver 38, the energy density significantly decreases as shown in FIG. 4A. This is beneficial to avoid treating or damaging tissue that is not the target tissue. The average length and diameter of the adult female urethra 4, including the urethral sphincter 6, are approximately 4 cm in length and 16 mm in diameter, respectively. The major sphincter 6 extends outward from the smooth muscle of the bladder to the open end of the urethra 4 over most of the length of the urethra 4 and converges around approximately the central third (longitudinally) of the urethra 4, along with the internal sphincter 6. Applying these values to FIGS. 4C - 4D, the 65% envelope 94 (0.023 mJ / mm 2) None of the energy within is applied to any organ other than the bladder 2 or the urethra 4 and the urethral sphincter 6, while only the minimum portion of the 50% envelope 96 (0.018 mJ / mm 2 ) can be observed to reach the bladder 2. This is also shown in FIG. 4E, which is an explanatory view in the sagittal plane of the LEAP treatment of the patient illustrated in FIG. 4C. This is beneficial as it focuses the application of the therapy onto the desired target tissue, while the energy field density at the therapeutic effective level rapidly decreases beyond the location of the target tissue, avoiding treating other organs and tissues, thereby greatly reducing any risk of adverse effects on non-intended target tissues / organs. As described, the bladder 2 receives little energy within the envelope 96 such that only a significantly reduced energy density is applied across it. The colon is not exposed to any significant amount of energy, the uterus is exposed to very little energy below 0.009 mJ / mm 2 and the ovaries and fallopian tubes are not exposed. By providing an energy field that applies a non-increasing intensity LEAP from a source at the opposite (distal) end of the urethra 4, with a significant drop in energy beyond the target area, most of the energy is applied to the therapy target area. The present invention provides a safe and effective alternative to known treatment methods. In this and all other embodiments described herein, the energy density level can be varied by changing the amount of voltage applied to the system, varying the distance that the distal end of the flexible diaphragm 42 extends from the driver 38, etc., such that the disclosed energy density levels are only specific examples of the use of these embodiments. The maximum energy density is at the point of contact of the flexible diaphragm 42 with the patient (e.g., end 42D of the urethra 42 in FIG. 4C, but can be other locations such as the penis, anus, perineum, other locations on the skin, etc.).

[0158] For the embodiments shown in FIGS. 4A and 4C - 4E, the preferred EFD at the end (location 42D) of the urethra 4 is 0.035 mJ / mm 2However, the treatment range for the urethra of adult women with urinary incontinence to achieve treatment results is 0.005 to 0.11 mJ / mm 2 or any sub-range thereof, preferably 0.009 mJ / mm 2 to 0.09 mJ / mm 2 more preferably 0.005 mJ / mm 2 to 0.07 mJ / mm 2 even more preferably 0.005 mJ / mm 2 to 0.07 mJ / mm 2 or 0.08 mJ / mm 2 to 0.035 mJ / mm 2 or 0.035 mJ / mm 2 to 0.07 mJ / mm 2 EFD at 42D, frequency of 1 to 10 Hz over a duration of 2 to 20 minutes, frequency within any sub-range of 1 to 10 Hz over a duration within any sub-range of 2 to 20 minutes, more preferably 0.014 mJ / mm 2 to 0.07 mJ / mm 2 EFD, frequency of 2 to 8 Hz, and duration of 4 to about 15 minutes, or 0.018 mJ / mm 2 to 0.05 mJ / mm 2 EFD may be included, frequency of 3 Hz to 5 Hz, and duration of 6 to 14 minutes. In one specific non-limiting embodiment, the treatment is applied at an EFD of 0.035 mJ / mm 2 and a frequency of 3 Hz for 6 minutes, followed by an EFD of 0.035 mJ / mm 2 at a frequency of 5 Hz for 4 minutes.

[0159] Figure 5 shows a schematic view of the energy field 90 emitted by the probe 30 according to an embodiment of the present invention. In the example shown, the voltage level is 12,500 V, the flexible diaphragm 42 extends 46 mm from the LEAP source as shown, and the location of the driver 38 is at 0 mm. Thus, the location 42D is considered to be at the 100% energy density value with respect to this schematic, and the 100% energy density level is 0.123 mJ / mm 2(Maximum energy density value). Only the envelope 96 (50%) is shown in FIG. 5 to make the visualization clearer.

[0160] The envelope 96 connects the energy density values that have 50% of the maximum energy density value generated by this embodiment. In this embodiment, 50% of the maximum energy density value is 0.061 mJ / mm 2 . Therefore, all locations below and inside the envelope 96 have an energy density of 50% or more of the maximum energy density value.

[0161] The cylinder 80 in FIG. 5 has a length of 33 mm and a width (diameter) of 16 mm. As in the previous embodiment, the energy density inside the cylinder is minimized (in this case, 50% of the maximum EFD, 0.061 mJ / mm 2 ) at the upper left and upper right corners of the rectangle 80 as shown in FIG. 5.

[0162] FIG. 6 shows a schematic view of the energy field 90 radiated by the probe 30 according to an embodiment of the present invention. In the illustrated example, the voltage level is 7,000 V, the flexible diaphragm 42 extends 46 mm from the LEAP source as shown, and the location of the driver 38 is at 0 mm. Therefore, the location 42D is considered to be at the 100% energy density value with respect to this schematic view, and the 100% energy density level is 0.018 mJ / mm 2 (Maximum energy density value). Only the envelope 96 (50%) is shown in FIG. 6 to make the visualization clearer.

[0163] The envelope 96 connects the energy density values that have 50% of the maximum energy density value generated by this embodiment. In this embodiment, 50% of the maximum energy density value is 0.009 mJ / mm 2 . Therefore, all locations below and inside the envelope 96 have an energy density of 50% or more of the maximum energy density value.

[0164] The cylinder 80 in FIG. 6 has a length of 42 mm and a width (diameter) of 16 mm. As in the previous embodiment, the energy density within the cylinder 80 is minimal (in this case, 50% of the maximum EFD, 0.009 mJ / mm 2 ) at the upper left and upper right corners of the rectangle 80 as shown in FIG. 6.

[0165] FIG. 7 shows a schematic diagram of the energy field 90 radiated by the probe 30 according to an embodiment of the present invention. In the example shown, the voltage level is 8,500 V, the flexible diaphragm 42 extends 46 mm from the shock wave source as shown, and the location of the driver 38 was at 0 mm. Thus, the location 42D is considered to be at the 100% energy density value with respect to this schematic diagram, and the 100% energy density level is 0.035 mJ / mm 2 (the maximum energy density value). For clearer visualization, only the envelope 96 (50%) is shown in FIG. 7.

[0166] The envelope 96 connects the energy density values having 50% of the maximum energy density value generated by this embodiment. In this embodiment, 50% of the maximum energy density value was 0.018 mJ / mm 2 . Thus, all locations below and inside the envelope 96 have an energy density of 50% or more of the maximum energy density value.

[0167] The cylinder 80 in FIG. 7 has a length of 40 mm and a width (diameter) of 16 mm. As in the previous embodiment, the energy density within the cylinder 80 is minimal (in this case, 50% of the maximum EFD, 0.018 mJ / mm 2 ) at the upper left and upper right corners of the rectangle 80 as shown in FIG. 7.

[0168] Figure 8 illustrates the 50% envelopes of FIGS. 5 - 7 and an overlay of the cylinders. The envelopes of FIG. 8 are not drawn to scale, but are somewhat exaggerated to show the nesting relationship between them, and the spacing between them is exaggerated for easier and clearer visualization to show the relative expansion and elongation of the 50% envelopes as the 100% energy density level decreases. For clear identification, the 50% envelopes 96 of FIGS. 5 - 7 are labeled 9607, 9601, and 9602, respectively, at the 0.123 mJ / mm 2 , 0.018 mJ / mm 2 , and 0.035 mJ / mm 2 100% energy density levels at which they are measured. Similarly, for clarity, the cylinders 80 are labeled 8007, 8001, and 8002, respectively, corresponding to the 0.123 mJ / mm of FIGS. 5, 6, and 7 2 , 0.018 mJ / mm 2 , and 0.035 mJ / mm 2 examples. For any given cylinder length, its diameter advantageously increases as the 100% energy level decreases, and the diameter is measured between the opposing distal endpoints of the cylinder that intersect the 50% envelope. For example, for cylinder 8007 having a length of 33 mm, the diameter (width as shown two-dimensionally in the figure) when the 100% energy level is 0.123 mJ / mm 2 is 16 mm, as already explained with respect to FIG. 5. At the same length, a cylinder can be defined that includes point 1802 and has a diameter (about 17 mm) greater than 16 mm with respect to the 50% EFD envelope 9602 (when the 100% energy level is 0.035 mJ / mm 2 ), and a cylinder can be defined that includes point 1801 and has a diameter (about 18 mm) greater than that of the cylinder defined by point 1802 with respect to the 50% EFD envelope 9601 (when the 100% energy level is 0.018 mJ / mm 2 ). As another example, for cylinder 8001 having a length of 42 mm, when the 100% energy level is 0.018 mJ / mm 2When it is, the diameter (width as shown two-dimensionally in the figure) is 16 mm as already explained with respect to FIG. 6. At the same length, (when the 100% energy level is 0.035 mJ / mm 2 ), a cylinder can be defined that includes point 2802 and has a diameter of less than 16 mm (about 15 mm) with respect to the 50% EFD envelope 9602, (when the 100% energy level is 0.123 mJ / mm 2 ), a cylinder can be defined that includes point 2807 and has a diameter less than that of the cylinder defined by point 2802 of about 10 mm with respect to the 50% EFD envelope 9607.

[0169] This provides a distinct advantage over prior art devices in that as the power level decreases respectively, the present invention can capture a larger volume of tissue in the 50% (-6 dB) zone, typically reducing the cylinder size within the 50% zone as the 100% energy level decreases. Generally with respect to sensitive soft tissue, particularly with respect to the treatment of the female urethra and urethral sphincter as described herein, this is highly advantageous in order to provide a sufficiently large treatment zone (cylinder) to capture a sufficient volume of soft tissue / urethral sphincter at an energy density level that is low enough to be tolerated by the patient while still providing a therapeutic result. With respect to the treatment of the female urethra and urethral sphincter, a 100% energy level of up to 0.035 mJ / mm 2 has been found to be tolerated by the patient, a 100% energy level of up to 0.05 mJ / mm 2 is possible but difficult, and a 100% energy level of 0.07 mJ / mm 2 is generally not considered clinically acceptable.

[0170] Figure 9 shows system 10 in combination with stabilization system 200 according to an embodiment of the present invention. The stabilization system 200 includes a self - standing mount 202 having an adjustable arm 204 configured to enable a probe 30 to be attached thereto. A cart 212 having wheels 214 and brakes 216 may be provided to support the control unit 12, whereby the cart 212 and the control unit 12 can be moved to a desired treatment location and the brakes 216 can be applied to fix the control unit 12 at a desired location adjacent to the mount 202. Alternatively, the control unit 212 may be supported by a table (not shown) or other relatively stationary support adjacent to the mount 202.

[0171] By fixing the probe 30 to the adjustable arm and fixing the adjustable arm 204 to the stationary mount 202, the probe 30 can be maintained in a stable position relative to the patient 1 during the procedure. Figure 9 shows the cart 212 parked adjacent to the treatment table 300 and the brakes 216 applied to maintain the cart 212 in a fixed position relative to the treatment table 300, which is also maintained in a fixed position. The self - standing mount 202 is positioned between the buttocks 302 extending from the treatment table 300 so as to position the probe 30 at an appropriate location between the legs 3 of the patient 1, which can be contacted by the probe 30 through insertion between the labia as described above.

[0172] The probe is fixedly mounted on the probe holder 228, and the self-standing mounting stand 202 includes adjustable crimping mechanisms 224 and 226 that enable adjustment of the positioning of the probe 30 to the extent of about three when fixed within the probe holder 228 along with the rotation of the stand 202. The height adjustment of the robotic arm 204 / probe 30 can also be performed by sliding the crimping mechanism 224 up or down along the shaft 203 of the stand 202 when the crimping mechanism 224 is in the unlocked configuration. Once appropriately adjusted as desired, the crimping mechanism 224 can be locked to prevent further rotation about the main axis and to prevent sliding of the crimping mechanism 224 with respect to the shaft 203. The crimping mechanism 226 enables rotation of the probe 30 with respect to the connecting arm 204 about the longitudinal axis of the connecting arm 204. The probe 30 can also be moved closer to or further away from the patient 1 / table 300 by sliding the connecting arm 204 axially with respect to the crimping mechanism 224, sliding the crimping mechanism 226 with respect to the connecting arm 204, and / or sliding the stand 202 with respect to the table 300. Once appropriately adjusted as desired, the crimping mechanism 224 can be locked to prevent further rotation about the main axis and to prevent sliding of the connecting arm 204.

[0173] The stabilization mechanism 240 can be provided to maintain the probe 30 (specifically, the flexible diaphragm 42) in contact with the urethra 4 at a relatively fixed position throughout the procedure optionally performed on the patient. FIG. 11 illustrates a stabilization mechanism 240 according to an embodiment of the present invention that can be used to assist in maintaining the probe 30 in contact with the patient with a desired amount of force to optionally maintain the desired location and orientation of the contact. The stabilization mechanism 240 of FIG. 11 includes a piston 242 configured to slide within a cylinder 244. A biasing member 246, such as a coil spring or other elastic member, is provided between the closed end of the cylinder 244 and the piston 242 to apply a counter force to the piston 242 when the piston 242 is driven against the biasing member 246. Optionally, the biasing member 246 can be adjustable to adjust the amount of counter force applied to the piston 242 at any given location of the piston 242 relative to the cylinder 244 as the piston slides therein.

[0174] Mounting features 248, such as crimpable straps, bolts, screws, or other equivalent attachment means, are provided to mount the probe 30 to the stabilization mechanism (specifically, to the piston 242 in the embodiment shown in FIG. 11) to prevent the probe 30 from translating parallel to the movable portion of the stabilization mechanism (e.g., the piston 242). The stabilization mechanism 240 further provides one or more bolts, studs, screws, clamps, or other equivalent attachment means 250 configured to securely mount the stabilization mechanism 240 to the probe holder 228 or other features of the stabilization systems 200, 400, or 500. FIG. 11 shows alternative locations for the attachment means 250 that can extend from an end of the stabilization mechanism (e.g., from the closed end of the cylinder 244) or be positioned along the length of the cylinder 244.

[0175] The stabilization mechanism 240 is fixedly mounted to the stabilization system 200 or 400, and by locking all the adjustable joints of the stabilization system 200 or 400, this secures the cylinder 244 to the patient. The probe 30 is fixed to the piston 242 and can move parallel to the cylinder 244 along with the translational movement of the piston 242. The travel of the piston 242 within the cylinder is limited to a predetermined distance that can be in the range of about 10 mm to about 100 mm, or 15 mm to 85 mm, or 20 mm to 50 mm. In one particular embodiment, the travel limit was 30 mm.

[0176] The components of the stabilization mechanism may be made of hollow or solid steel, aluminum, plastic, or other materials machined for smooth sliding action. The cylinder 244 and the piston 242 have mating cross-sections to allow for smooth sliding and may be, for example, circular, rectangular, oval, egg-shaped, or other polygonal cross-sectional shapes. The diameter of the cylinder 244 (or for non-circular cross-sections, the maximum cross-sectional dimension) may be in the range of about 10 mm to 60 mm, typically about 20 mm to about 50 mm, and more typically about 25 mm to about 35 mm. The length of the cylinder may be in the range of about 5 cm to about 20 cm, typically about 10 cm to about 15 cm, and in one embodiment was about 13 cm.

[0177] FIG. 11 and the above description refer to one specific embodiment of the stabilization mechanism, but are not limiting. The present invention is not limited to this specific embodiment, as alternative stabilization mechanisms may be used that are attached to the probe 30 and configured to function to maintain the probe 30 with a predetermined amount of force, including, but not limited to, electromechanical such as pneumatic, hydraulic, motor-driven with force feedback monitoring, or the like, or equivalents.

[0178] During use, the diaphragm 42 is contacted to the distal end 4D of the urethra 4 at a desired location and orientation. The crimping mechanisms 224 and 226 are placed in a locking configuration to maintain the orientation of the probe 30 with the flexible diaphragm 42 in contact with the distal end 4D of the urethra 4 as desired. Prior to contacting the diaphragm 42 to the patient, the probe 30 / piston 242 is pushed against the cylinder 244 such that the piston 242 reaches the end of its travel and is held there. The diaphragm 42 is then contacted to the patient at the target location and the user releases the hold of the piston 242, whereby the biasing member 246 applies a predetermined amount of force to the piston 242 and also maintains a predetermined amount of force through the diaphragm to the patient. The stabilization mechanism may be configured such that the predetermined amount of force applied to the patient's tissue by the probe 30 / diaphragm 42 is in the range of 0.1 to 5 pounds-force (lbf), typically about 0.5 to 3 lbf. In one particular embodiment, the predetermined amount of force maintained was about 1 lbf. By maintaining a predetermined amount of force on the probe 30 against the urethra 4, this ensures a firm contact and proper orientation of the probe 30 to the target throughout the procedure.

[0179] Figure 10 shows system 10 in combination with a stabilization system 400 according to an embodiment of the present invention. The stabilization system 400 includes an integrated mounting arm 404 configured to enable a probe 30 to be attached thereto. The mounting arm 404 is integrated into a cart 412 such that the mounting arm 404 can slide within a track 413 and allow for height adjustment of the arm 404 relative to the table 300. The cart 412 includes wheels 414 and a brake 416 and, as shown, can be further used to support the control unit 12, whereby the cart 412 and the control unit 12 can be moved to a desired treatment location and the brake 416 can fix the control unit 12 at a desired location adjacent to the treatment table 300, enabling the probe 30 to be appropriately positioned in contact with or adjacent to the end of the urethra between the legs 3 of the patient 1. Alternatively, the control unit 12 can be supported by a table (not shown) adjacent to the cart 412 or other relatively stationary support.

[0180] By fixing the probe 30 to the adjustable arm 404 and fixing the adjustable arm 404 to the cart 412, the probe 30 can be maintained in a stable position relative to the patient 1 during the procedure. Figure 10 shows the cart 412 parked adjacent to the treatment table 300 and the brake 416 applied to maintain the cart 412 in a fixed position relative to the treatment table 300, which is also maintained in a fixed position. The arm 404 is operated to position the probe 30 between the legs 3 of the patient 1 supported by the table 300 in contact with or adjacent to the end of the patient's urethra in the manner described above.

[0181] The probe 30 is fixedly received within a probe holder 228 (which can be locked for fixation and unlocked to allow for axial sliding and / or rotation of the probe 30 relative to the probe holder 228), and the arm 404 functions in the same manner as the arm 204, except that the linear height adjustment is along the track 413 rather than along the shaft 203 of the self-standing mount 202. Alternatively, all adjustable crimping mechanisms and stabilization mechanisms are provided that function in the same manner as those described with respect to the embodiment of FIG. 9. Any of the embodiments of FIGS. 9 - 10 can be modified. For example, the system 10 may be fully integrated into a stabilization system according to certain embodiments of the present invention where the mounting arm and control unit can be integrated within a cart. In any of these embodiments, the probe 30 can be connected via a locking ball joint or other crimping mechanism that allows it to be adjusted relative to the arm and then locked in a desired position and orientation relative to the arm.

[0182] In all of the described embodiments, the adjustment can be made to position the probe 30, but once all adjustable features (e.g., the crimping mechanism) are locked to position and orient the probe 30 as desired, the probe 30 remains stationary relative to the patient during use unless intentionally moved by the operator.

[0183] In an alternative embodiment, the system 10 can be applied to the perineum of a male patient to treat urinary incontinence. In this case, the perineum 302 is the area between the anus 304 and the scrotum 306 of the male patient (see FIG. 12). In the case of a male patient, the urethra 4 and the urethral sphincter 6 are located within approximately 3 - 6 cm from the perineum 302. Thus, a higher power setting is selected on the system 10 to provide a treatment range that extends further to encompass the male urethra compared to what is selected for the treatment of the female urethra within the labia. For example, the maximum energy density value applied at location 42D is approximately 0.105 mJ / mm 2It may also be the case that about 2,000 pulses may be applied. However, either one or both of the maximum energy density applied and the value of the pulse can vary. Also, since the male urethra is not approached axially but rather laterally, only a part of the male urethra will be treated using each application of the shock wave, so the probe 30 needs to be repositioned one, two, or possibly three times along the perineum 302 (in the direction extending from the scrotum 306 to the anus 304 or vice versa). Further, in this regard, it may be beneficial to use a focused probe, and a lens or other focusing element is used to focus the energy field at the depth of the male urethra when the shock wave is applied to the perineum. For example, at the target location, the focused energy field may have an energy density of 0.05 - 0.08 mJ / mm 2 and this energy may be applied to the male urethra with pulses at a frequency of 2 Hz to 10 Hz, preferably 3 Hz to 5 Hz, for a total application of about 2,000 pulses.

[0184] In another embodiment, the present invention can be applied to treat the anal sphincter (anus) 304 and / or rectum of either male or female patients. FIG. 13 illustrates contacting the flexible diaphragm 42 of the probe 30 with the anus 304 of a female patient (which can alternatively be done in the same manner for male patients, see FIG. 14) for treatment of the anal sphincter and / or rectum. The application of LEAP from the probe 30 will use a cylinder of energy having the characteristics described in the previous embodiments of this specification and will encompass at least 50%, 60%, 70%, 80%, 90%, 95%, or preferably all of the volume of the internal anal sphincter. In this case, the anus / anal sphincter is very close to the flexible diaphragm, and thus a therapy range as low as or lower than that used for axial treatment of the female urethra can be applied. However, since the tissue involved in this treatment is not as sensitive as that being treated during treatment of the female urethra, higher therapy ranges can also be applied. Therefore, the 100% EFD values for these described anal sphincter treatments are preferably in the range of 0.01 mJ / mm 2 to 0.175 mJ / mm 2 or within any sub-range within this range, more preferably in the range of 0.05 mJ / mm 2 to 0.123 mJ / mm 2 or 0.05 mJ / mm 2 to 0.088 mJ / mm 2 or 0.05 mJ / mm 2 to 0.07 mJ / mm 2 . Treatment of the internal anal sphincter as described can also require multiple applications of LEAP (in the range of about 1,500 pulses to about 3,000 pulses, preferably in the range of 2,000 to 2,500 pulses for one treatment visit). The frequency of pulse application can be in the range of about 2 Hz to 7 Hz, preferably in the range of about 3 Hz to 5 Hz.

[0185] In both embodiments of FIGS. 13-14, the target tissue being treated by LEAP is therapeutically encompassed by a cylinder having the energy density characteristics of those described above with respect to the embodiment for axial treatment of the female urethra. Alternatively, the energy density characteristics may vary from those described with respect to those described for axial treatment of the urethra.

[0186] All of the embodiments described herein can be used as described to restore or improve the functionality of the tissue being treated, promote tissue development, and / or improve angiogenesis of existing tissue. All embodiments may also be used in combination with stem cell therapy for tissue regeneration and angiogenesis.

Example

[0187] Ten women with SUI were treated using an embodiment of the device in the manner shown and described with respect to FIG. 4C. The average age of the subjects was 57. Their average urine leakage just prior to treatment was 44 g as measured by the standard 24-hour pad test. Each subject received 10 applications of LEAP over a 6-week period. Each application consisted of 2,500 pulses, half at 3 Hz and half at 5 Hz. The EFD at location 42D was 0.035 mJ / mm 2 and the minimum energy density was 0.018 mJ / mm within cylinder 80 with a diameter of 16 mm and a length of 4 cm. 2 After the 10th application, the average urine leakage was 10 g, a 77% improvement. This significantly exceeded the effectiveness of all known non-invasive treatments for SUI and was comparable to surgical intervention. No side effects were observed.

[0188] Although the present invention has been described with reference to its specific embodiments, it should be understood by those skilled in the art that various changes can be made and equivalents can be substituted without departing from the true spirit and scope of the present invention. In addition, many modifications can be made to adapt a particular situation, material, composition, process, or one or more steps of a process to the purpose, spirit, and scope of the present invention. It is intended that all such modifications fall within the scope of the claims appended hereto.

Claims

1. An apparatus for generating a plurality of low - energy acoustic pulses (LEAP) for delivery into a living body, the apparatus comprising: a housing having an opening and a longitudinal axis, the longitudinal axis extending through the opening, the housing; a low - energy acoustic pulse (LEAP) generator, at least a portion of the LEAP generator being contained within the housing, the LEAP being non - focused, the LEAP generator; a contact portion configured to be placed in contact with or adjacent to the living body, the LEAP generated by the LEAP generator being positioned to pass through the contact portion comprising; the LEAP generator is configured to generate the LEAP and deliver the LEAP in a direction along the length of the female urethra of the living body along the length of the female urethra, the LEAP having an energy density field, a minimum energy density of a first volume of the energy density field being at least 50% of a maximum energy density of the energy density field, the first volume being configured to encompass at least 30% of a second volume of the urethral sphincter of a standard female urethra having a length of 40 mm and a diameter of less than 16 mm and the urethral sphincter of the standard female urethra for treating the female urethra of the standard female, as a result of the treating, reducing urinary incontinence, the apparatus.

2. The apparatus of claim 1, wherein the LEAP generator comprises a driver having a maximum dimension in the range of 4.0 cm to 8.5 cm.

3. The apparatus of claim 2, wherein the driver is made of aluminum.

4. The apparatus of claim 3, wherein the aluminum is aircraft - grade aluminum.

5. The apparatus of claim 4, wherein the aircraft - grade aluminum comprises 7075T6 aluminum.

6. The apparatus according to any one of claims 2 - 5, further comprising an elastic member for securing the driver in a position relative to the coil of the LEAP generator.

7. The apparatus of claim 1, wherein the LEAP generator comprises a coil, a driver, and an elastic member for securing the driver in a position relative to the coil, at least one side of the driver being coated by a coating.

8. The device according to claim 7, wherein the coating completely covers at least one side of the driver facing the coil.

9. The device according to claim 7 or claim 8, wherein the coating is configured to prevent or reduce cavitation corrosion of the driver that may occur by repeatedly generating and delivering the LEAP.

10. The device according to any one of claims 1 to 5, 7, and 8, further comprising a stabilization system, the stabilization system comprising a stabilization mechanism configured to maintain contact of the contact portion with the living body under a certain amount of force.

11. The device according to claim 10, wherein the stabilization system is configured to maintain the contact portion in a stable position with respect to the living body during the procedure.

12. The device according to claim 10, wherein the stabilization system comprises an adjustable arm configured to enable the housing to be attached thereto.

13. The device according to claim 10, wherein the stabilization mechanism comprises a base, a movable member, and a biasing member, the movable member being configured to move relative to the base, and the biasing member being configured to apply a counter force to the movable member when the movable member is driven with respect to the biasing member.

14. The device according to claim 13, wherein the stabilization system comprises an adjustable arm configured to enable the housing to be attached thereto, the base being fixed to the adjustable arm, and the movement of the movable member relative to the base moves and / or adjusts the force applied by the contact portion.

15. The device according to claim 10, wherein the stabilization system is configured to maintain the contact portion in contact with the urethra of the living body in a relatively fixed position throughout the procedure performed on the living body.

16. The energy density field has an energy beam density (EFD) within a therapeutic range that can be measured at all points within a space in the shape of an imaginary cylinder configured to enclose at least a portion of the female urethra, the imaginary cylinder having a diameter in the range of 10 mm to 18 mm and a length of 2 cm or more. The apparatus according to any one of claims 1 to 5, 7, and 8, wherein the minimum energy flux density EFD of the LEAP at all locations within the space is at least 50% of the maximum energy flux density EFD of the LEAP within the space.

17. An apparatus for generating a plurality of low-energy acoustic pulses (LEAP) for delivery into a living body for the treatment of a female patient's urethra, each of the plurality of LEAP having an energy density field, the minimum energy density of a first volume of the energy density field being at least 50% of the maximum energy density of the energy density field, the first volume being configured to encompass at least 30% of a second volume of the urethral sphincter of a standard female patient's urethra and the urethral sphincter of the standard female patient, the standard female patient's urethra having a length of 40 mm and a diameter of less than 16 mm for treating the female patient's urethra, and as a result of said treating, reducing urinary incontinence, The apparatus comprises a housing having an opening and a longitudinal axis, the longitudinal axis extending through the opening, the housing, a low-energy acoustic pulse (LEAP) generator, at least a portion of the LEAP generator being contained within the housing, the LEAP generator, a contact portion configured to be positioned in contact with or adjacent to the urethra, the LEAP generated by the LEAP generator passing through the contact portion and being positioned along the length of the urethra, the contact portion, a stabilization system comprising a stabilization mechanism configured to maintain contact of the contact portion with the living body under a certain amount of force, the stabilization system An apparatus comprising.

18. The apparatus according to claim 17, wherein the certain amount of force is an amount of force in the range of 0.4 newtons (N) to 22.2 newtons (N).

19. The apparatus according to claim 17, wherein the certain amount of force is an amount of force in the range of 2.2 newtons (N) to 13.3 newtons (N).

20. The apparatus according to any one of claims 17 to 19, wherein the maximum dimension of the housing in a direction orthogonal to the longitudinal axis is less than 140 mm or equal to 140 mm.

21. The apparatus according to claim 20, wherein a maximum dimension of the housing in a direction orthogonal to the longitudinal axis is less than 125 mm or equal to 125 mm.

22. The apparatus according to claim 21, wherein a maximum dimension of the housing in a direction orthogonal to the longitudinal axis is in a range of 70 mm to 90 mm.

23. The LEAP generator is configured to create a LEAP with an energy fluence density (EFD) within a therapeutic range that can be measured at all points within an imaginary cylindrical-shaped space configured to encompass at least a portion of the urethra of the female patient, the imaginary cylinder having a diameter in the range from 10 mm to 18 mm and a length of 2 cm or more. The apparatus according to any one of claims 17 to 19, wherein a minimum energy fluence density EFD of the LEAP at all locations within the space is at least 50% of a maximum energy fluence density EFD of the LEAP within the space.

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