# US 10,500,128 B2 · Low energy acoustic pulse apparatus and method > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,500,128 B2 - Document ID: US10500128B2 - Status: Granted - Kind: B2 - Application number: 16/135,863 - Filed: 2018-09-19 - Published: 2019-09-26 - Granted: 2019-12-10 - Earliest claimed: 2018-03-22 - Assignees: Acoustic Wave Cell Therapy, Inc. - Applicants: Acoustic Wave Cell Therapy, Inc. - Inventors: Charles R. Engles; Yung Chen Su - Web page: https://patentgrep.com/patent/US10500128B2 ## CPC - A61H 23/008: {using shock waves} - A61N 7/00: Ultrasound therapy (lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 {; using ultrasound for introducing media into the body A61M37/0092}) - A61B 17/22004: {using mechanical vibrations, e.g. ultrasonic shock waves (A61B17/225 takes precedence)} - A61B 17/2251: {characterised by coupling elements between the apparatus, e.g. shock wave apparatus or locating means, and the patient, e.g. details of bags, pressure control of bag on patient} - A61H 19/44: {Having substantially cylindrical shape, e.g. dildos} - A61H 21/00: Massage devices for cavities of the body {, e.g. nose, ears and anus (for the genitals A61H19/00); Vibration or percussion related aspects A61H23/00} - A61H 23/006: {Percussion or tapping massage (hand percussion A61H23/06)} - A61H 23/0236: {using sonic waves, e.g. using loudspeakers} - G10K 15/043: {producing shock waves (G10K15/046, G10K15/06 take precedence; generating seismic energy G01V1/02)} - A61B 2017/00805: {Treatment of female stress urinary incontinence} - A61B 2018/00523: {Treatment of incontinence} - A61F 2007/005: {female} - A61H 2201/0119: Support for the device - A61H 2201/1238: with hydraulic or pneumatic drive - A61H 2201/1654: Layer between the skin and massage elements, e.g. fluid or ball - A61H: PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY (electrotherapy, magnetotherapy, radiation therapy or ultrasound therapy A61N) - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - G10K: SOUND-PRODUCING DEVICES; METHODS OR DEVICES FOR PROTECTING AGAINST, OR FOR DAMPING, NOISE OR OTHER ACOUSTIC WAVES IN GENERAL; ACOUSTICS NOT OTHERWISE PROVIDED FOR - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) ## Abstract 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. ## Claims ### Claim 1 An apparatus for generating an acoustic energy pulse, said apparatus comprising: a generator for creating the 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; a housing comprising an opening and a longitudinal axis, wherein said longitudinal axis extends through said opening, wherein at least a portion of said generator is contained within said housing; and a contact portion configured to be placed in contact with or adjacent to a living body, and positioned such that said acoustic energy pulse created by said generator passes through said contact portion; wherein said cylindrically shaped space has a proximal end, a distal end and a cylinder longitudinal axis, said cylinder longitudinal axis oriented relative to a longitudinal axis of the acoustic energy pulse at an angle in the range from zero to twenty degrees, said proximal end located at a first distance from said generator, said distal end located at a second distance from said generator, wherein said first distance is less than said second distance; wherein a minimum energy density for said pulse at all locations within said cylindrically shaped space is at least 50% of a maximum energy density for said pulse within said space; and wherein said maximum energy density is in a range from 0.005 mJ/mm2 to 0.123 mJ/mm2, and said diameter is greater than or equal to 10 mm. ### Claim 2 (depends on 1) The apparatus of claim 1, wherein said maximum energy density is in a range from 0.005 mJ/mm2 to 0.025 mJ/mm2, and said diameter is in a range from 10 mm to 18 mm. ### Claim 3 (depends on 1) The apparatus of claim 1, wherein said maximum energy density is in a range from greater than 0.025 mJ/mm2 to 0.04 mJ/mm2, and said diameter is greater than 11 mm. ### Claim 4 (depends on 1) The apparatus of claim 1, wherein said maximum energy density is in a range from greater than 0.04 mJ/mm2 to 0.05 mJ/mm2, and said diameter is greater than 12 mm. ### Claim 5 (depends on 1) The apparatus of claim 1, wherein said maximum energy density is in a range from greater than 0.05 mJ/mm2 to 0.08 mJ/mm2, and said diameter is greater than 13 mm. ### Claim 6 (depends on 1) The apparatus of claim 1, wherein said maximum energy density is in a range from greater than 0.08 mJ/mm2 to 0.11 mJ/mm2, and said diameter is greater than 15 mm. ### Claim 7 (depends on 1) The apparatus of claim 1, wherein said apparatus comprises a housing and at least a portion of said generator is contained within said housing, wherein the minimum dimension of said housing orthogonal to the longitudinal axis of the cylinder is less than or equal to 175 mm. ### Claim 8 (depends on 1) The apparatus of claim 1, wherein said proximal end is located no more than 100 mm from a surface of said generator from which said acoustic energy pulse is delivered. ### Claim 9 (depends on 1) The apparatus of claim 1, wherein said length is greater than or equal to 3 cm. ### Claim 10 (depends on 1) The apparatus of claim 1, wherein said acoustic energy pulse comprises a divergent or planar acoustic pulse. ### Claim 11 (depends on 1) The apparatus of claim 1, wherein said acoustic energy pulse is an acoustic shockwave pulse. ### Claim 12 (depends on 1) The apparatus of claim 1, wherein said acoustic pulse is electromagnetically produced. ### Claim 13 (depends on 1) The apparatus of claim 1, wherein said cylindrically shaped space is coaxial with a longitudinal axis of said acoustic energy pulse. ### Claim 14 (depends on 1) The apparatus of claim 1, wherein said maximum energy density is in a range from 0.018 mJ/mm2 to 0.123 mJ/mm2, and said diameter is greater than 11 mm. ### Claim 15 (depends on 1) The apparatus of claim 1, wherein said maximum energy density is in a range from 0.009 mJ/mm2 to 0.044 mJ/mm2, and said diameter is greater than 12 mm. ### Claim 16 (depends on 1) The apparatus of claim 1, wherein said maximum energy density is in a range from greater than 0.025 mJ/mm2 to 0.04 mJ/mm2, and said diameter is greater than 11 mm. ### Claim 17 A method of delivering an acoustic energy pulse, said method comprising: providing an acoustic energy pulse generating apparatus; generating an acoustic energy pulse and delivering the acoustic energy pulse from the acoustic energy pulse generating apparatus; wherein said delivering comprises delivering the acoustic energy pulse characterized by 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; wherein the cylindrically shaped space has a proximal end, a distal end and a cylinder longitudinal axis, the cylinder longitudinal axis oriented relative to a longitudinal axis of the acoustic energy pulse at an angle in the range from zero to twenty degrees, the proximal end located at a first distance from the generating apparatus, the distal end located at a second distance from the generating apparatus, wherein the first distance is less than the second distance; wherein a minimum energy density for the delivered pulse at all locations within the cylindrically shaped space is at least 50% of a maximum energy density for the pulse within the space; and wherein the maximum energy density is in a range from 0.005 mJ/mm2 to 0.123 mJ/mm2, and the diameter is greater than or equal to 10 mm. ### Claim 18 (depends on 17) The method of claim 17, wherein said maximum energy density is in a range from 0.009 mJ/mm2 to 0.044 mJ/mm2, and said diameter is greater than 12 mm. ### Claim 19 (depends on 17) The method of claim 17, wherein said maximum energy density is in a range from greater than 0.044 mJ/mm2 to 0.07 mJ/mm2, and said diameter is greater than 13 mm. ### Claim 20 (depends on 17) The method of claim 17, wherein said maximum energy density is in a range from greater than 0.07 mJ/mm2 to 0.088 mJ/mm2, and said diameter is greater than 14 mm. ### Claim 21 (depends on 17) The method of claim 17, wherein said maximum energy density is in a range from greater than 0.088 mJ/mm2 to 0.14 mJ/mm2, and said diameter is greater than 17 mm. ### Claim 22 (depends on 17) The method of claim 17, wherein said acoustic energy pulse generating apparatus includes a housing at least partially surrounding an acoustic energy pulse generator, wherein a minimum dimension of said housing orthogonal to the longitudinal axis of the acoustic energy pulse is less than or equal to 175 mm; and wherein said delivering comprises confining the acoustic energy pulse via the housing to have a dimension orthogonal to the longitudinal axis of the acoustic energy pulse that is less than 175 mm at a location of exit from the housing. ### Claim 23 (depends on 17) The method of claim 17, wherein the proximal end of said cylindrically shaped space is located no more than 100 mm from a source of said acoustic energy pulse. ### Claim 24 (depends on 17) The method of claim 17, wherein said length is greater than or equal to 3 cm. ### Claim 25 (depends on 17) The method of claim 17, wherein said acoustic energy pulse comprises an acoustic shockwave pulse. ### Claim 26 (depends on 17) The method of claim 17, wherein said acoustic energy pulse is divergent or planar. ### Claim 27 (depends on 17) The method of claim 17, wherein said cylindrically shaped space is coaxial with the longitudinal axis of said acoustic energy pulse. ### Claim 28 (depends on 17) The method of claim 17, wherein the diameter is greater than 11 mm. ### Claim 29 (depends on 28) The method of claim 28, wherein the maximum energy density is in a range from 0.018 mJ/mm2 to 0.123 mJ/mm2. ### Claim 30 (depends on 28) The method of claim 28, wherein the maximum energy density is in a range from greater than 0.025 mJ/mm2 to 0.04 mJ/mm2. ### Claim 31 A method of delivering an acoustic energy pulse into a body, said method comprising: providing an acoustic energy pulse generating apparatus; contacting the acoustic energy pulse generating apparatus to the body; generating the acoustic energy pulse and delivering the acoustic energy pulse into the body; wherein the acoustic energy pulse has 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; wherein the cylindrically shaped space has a proximal end, a distal end and a cylinder longitudinal axis, the cylinder longitudinal axis oriented relative to a longitudinal axis of the acoustic energy pulse at an angle in the range from zero to twenty degrees, the proximal end located at a first distance from the generating apparatus, the distal end located at a second distance from the generating apparatus, wherein the first distance is less than the second distance; wherein a minimum energy density of the pulse at all locations within the cylindrically shaped space is at least 50% of a maximum energy density of the pulse within the space; and wherein the maximum energy density is in a range from 0.005 mJ/mm2 to 0.123 mJ/mm2, and the diameter is greater than or equal to 10 mm. ### Claim 32 (depends on 31) The method of claim 31, wherein said maximum energy density is in a range from 0.009 mJ/mm2 to 0.044 mJ/mm2, and said diameter is greater than 12 mm. ### Claim 33 (depends on 13) The method of claim 13, wherein said maximum energy density is in a range from greater than 0.044 mJ/mm2 to 0.07 mJ/mm2, and said diameter is greater than 13 mm. ### Claim 34 (depends on 31) The method of claim 31, wherein said maximum energy density is in a range from greater than 0.07 mJ/mm2 to 0.088 mJ/mm2, and said diameter is greater than 14 mm. ### Claim 35 (depends on 13) The method of claim 13, wherein said maximum energy density is in a range from greater than 0.088 mJ/mm2 to 0.123 mJ/mm2, and said diameter is greater than 17 mm. ### Claim 36 (depends on 31) The method of claim 31, wherein said proximal end contacts the surface of the body, and said distal end is within the body. ### Claim 37 (depends on 31) The method of claim 31, wherein said delivering the acoustic energy pulse into the body comprises delivering the acoustic energy pulse longitudinally along a length of a female urethra of the body. ### Claim 38 (depends on 31) The method of claim 31, wherein the acoustic energy pulse comprises an acoustic shockwave pulse. ### Claim 39 (depends on 38) The method of claim 38, wherein said acoustic shockwave pulse is divergent or planar. ### Claim 40 (depends on 31) The method of claim 31, wherein said contacting comprises contacting the body intra-labially and wherein the cylindrically shaped space therapeutically encompasses at least a portion of urethral sphincter muscles of an adult female human. ### Claim 41 (depends on 31) The method of claim 31, wherein said contacting comprises contacting the apparatus to the perineum of the body. ### Claim 42 (depends on 31) The method of claim 31, wherein said contacting comprises contacting the apparatus to the anus of the body. ### Claim 43 (depends on 31) The method of claim 31, further comprising mounting the apparatus to a stabilizing system. ### Claim 44 (depends on 43) The method of claim 43, wherein said stabilizing system maintains the apparatus in contact with the body with a predetermined amount of force. ### Claim 45 (depends on 31) The method of claim 31, wherein said cylindrically shaped space is coaxial with the longitudinal axis of said acoustic energy pulse. ### Claim 46 (depends on 31) The method of claim 31, wherein said diameter is greater than 11 mm. ### Claim 47 (depends on 46) The method of claim 46, wherein said maximum energy density is in a range from 0.018 mJ/mm2 to 0.123 mJ/mm2. ### Claim 48 (depends on 46) The method of claim 46, wherein said maximum energy density is in a range from greater than 0.025 mJ/mm2 to 0.04 mJ/mm2. ### Claim 49 A method of treating the female urethra of a patient, said method comprising: providing an acoustic energy pulse generating apparatus; contacting the acoustic energy pulse generating apparatus to a body of the patient, in contact with or adjacent to an end of the urethra; generating an acoustic energy pulse and delivering the acoustic energy pulse into the body, in a direction along a length of the urethra; and as a result of said treating, improving a function of the urethra by at least 30% compared to the function prior to said treating. ### Claim 50 (depends on 49) The method of claim 49, wherein said method comprises a method of treating urinary incontinence, and wherein said improving a function of the urethra by at least 30% comprises a reduction in urine leakage through the urethra over a predetermined period of time by at least 30%. ### Claim 51 (depends on 49) The method of claim 49, wherein the urethra is treated from the end of the urethra only. ### Claim 52 (depends on 49) The method of claim 49, wherein the acoustic energy pulse has an energy density field that is dimensioned to therapeutically encompass urethral sphincter muscles of the patient; and wherein the energy density field is configured to provide a therapeutically effective level of energy density for treatment of the urethral sphincter muscles. ### Claim 53 (depends on 52) The method of claim 52, wherein a first volume of the energy density field having a minimum energy density that is at least 50% of a maximum energy density of the first volume encompasses a second volume comprising at least thirty percent of the urethral sphincter muscles. ### Claim 54 (depends on 53) The method of claim 53, wherein the maximum energy density in said second volume is less than or equal to 0.11 mJ/mm2. ### Claim 55 (depends on 54) The method of claim 54, wherein said maximum energy density is less than or equal to 0.093 mJ/mm2. ### Claim 56 (depends on 54) The method of claim 54, wherein said maximum energy density has a value in a range from about 0.005 mJ/mm2 to about 0.035 mJ/mm2. ### Claim 57 (depends on 54) The method of claim 54, wherein said maximum energy density has a value in a range from about 0.035 mJ/mm2 to about 0.07 mJ/mm2. ### Claim 58 (depends on 49) The method of claim 49, wherein said acoustic energy pulse comprises an acoustic shockwave pulse. ### Claim 59 (depends on 49) The method of claim 49, wherein said acoustic pulse is divergent or planar. ### Claim 60 An apparatus for generating acoustic energy pulses for delivery into a living body, said apparatus comprising a housing comprising an opening and a longitudinal axis, wherein said longitudinal axis extends through said opening; an acoustic energy pulse generator wherein at least a portion of said acoustic energy pulse generator is contained within said housing; and a contact portion configured to be placed in contact with or adjacent to the living body, and positioned such that an acoustic energy pulse generated by said acoustic energy pulse generator passes through said contact portion; wherein said acoustic energy pulse generator is configured to generate and deliver the acoustic energy pulse along a urethra of the living body in a direction along a length of the urethra, said acoustic energy pulse having an energy density field that is dimensioned to therapeutically encompass urethral sphincter muscles of the patient; and wherein a first volume of said energy density field having a minimum energy density that is at least 50% of a maximum energy density of said first volume is configured to encompass a second volume of at least thirty percent of the urethral sphincter muscles. ### Claim 61 (depends on 60) The apparatus of claim 60, wherein said acoustic energy pulse generator comprises an acoustic shockwave generator and said acoustic energy pulse comprises an acoustic shockwave pulse. ### Claim 62 (depends on 53) The method of claim 53, wherein said maximum energy density is in a range from 0.005 mJ/mm2 to 0.123 mJ/mm2. ### Claim 63 (depends on 62) The method of claim 62, wherein said maximum energy density is in a range from 0.018 mJ/mm2 to 0.123 mJ/mm2. ### Claim 64 (depends on 62) The method of claim 62, wherein said maximum energy density is in a range from 0.009 mJ/mm2 to 0.044 mJ/mm2. ### Claim 65 (depends on 62) The method of claim 62, wherein said maximum energy density is in a range from greater than 0.025 mJ/mm2 to 0.04 mJ/mm2.