Apparatus for treating subcutaneous tissues

• US 20070055181A1
• Filed: 01/17/2006
• Published: 03/08/2007
• Est. Priority Date: 09/07/2005
• Status: Active Grant

• Current Assignee: Ulthera Inc. (Merz Pharma GmbH & Company Kgaa)
• Original Assignee: Douglas Sutton, Hanson Gifford, Mark Deem
• Inventors: Gifford, Hanson, Sutton, Douglas, Deem, Mark
• Granted Patent: US 7,601,128 B2
• Time in Patent Office: Days
• US Class Current: 601/2
• CPC Class Codes: A61B 2017/00747 Dermatology
• CPC Class Codes: A61B 2017/22008 used or promoted
• CPC Class Codes: A61K 41/0028 Disruption, e.g. by heat or ultrasounds, sonophysical or sonochemical activation, e.g. thermosensitive or heat-sensitive liposomes, disruption of calculi with a medicinal preparation and ultrasounds
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
• CPC Class Codes: A61N 1/0412 Specially adapted for transcutaneous electroporation, e.g. including drug reservoirs
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation
• CPC Class Codes: A61N 2007/0008 Destruction of fat cells
• CPC Class Codes: A61N 2007/0039 using microbubbles
• CPC Class Codes: 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

Abstract

An apparatus and method for treating subcutaneous tissues using acoustic waves in the range of low acoustic pressure ultrasound waves is disclosed. The method includes injections of enhancing agents, wherein disruption of subcutaneous tissues and subcutaneous cavitational bioeffects are produced by ultrasound waves having a power that will not produce tissue cavitation in the absence of the enhancing agents. The apparatus and method of use is useful for treatment of subcutaneous abnormalities including cellulite, lipomas, and tumors.

Claims

1-87. -87. (canceled)

88. An assembly for treating subcutaneous tissue, comprising:

an acoustic wave generator for generating acoustic waves;

an acoustic wave transducer configured to apply the acoustic waves to the subcutaneous tissue of a patient;

a source of a gas;

a source of a solution; and

a solution injection member configured to inject the gas and the solution into the subcutaneous tissue of the patient, wherein application of the acoustic waves to the subcutaneous tissue produces subcutaneous cavitational bioeffects.

89. The assembly of claim 88, wherein the acoustic wave generator produces acoustic waves having a frequency in the range of about 0.25 MHz to about 20 MHz.

90. The assembly of claim 88, wherein the acoustic wave generator produces acoustic waves having a peak negative pressure in the range of 0.1 Mpa to 10.0 MPa.

91. The assembly of claim 88, wherein the source of gas is room air.

92. The assembly of claim 88, further including a gas housing configured to retain the source of gas therein.

93. The assembly of claim 88, further including a solution housing configured to retain the source of solution therein.

94. The assembly of claim 88, further including a solution agitator.

95. The assembly of claim 88, wherein the solution injection member includes a housing and a plurality of hollow injection members.

96. The assembly of claim 95, wherein a distal end of at least one of the hollow injection members is movable between a first configuration inside the solution injection member housing and a second configuration outside the solution injection member housing.

97. The assembly of claim 88, wherein the solution injection member includes a fanned needle array.

98. The assembly of claim 88, wherein the acoustic wave transducer is a planar transducer.

99. The assembly of claim 98, wherein a focal zone of the planar transducer extends from a near zone in a tissue depth extending from about 1 to about 15 mm below the epidermis to a far zone in a tissue depth of between about 15 mm and about 30 mm below the epidermis.

100. The assembly of claim 98, further including an acoustically coupled acoustic stand-off that places a focal zone of the planar transducer at a desired tissue depth.

101. The assembly of claim 88, further including a tissue cooling module, wherein discomfort, swelling, scarring or other undesired effects associated with cosmetic or dermatologic treatment with the assembly is reduced.

102. The assembly of claim 88, further including a control module configured to coordinate injection of the solution with application of the acoustic waves.

103. The assembly of claim 102, wherein the control module is configured to provide staged sequences of injections at various tissue depths coordinated with applications of the acoustic waves.

104. The assembly of claim 88, further including:

a solution agitator configured for mixing the solution with the gas; and

a control module configured to coordinate agitation of the solution, injection of the solution into the subcutaneous tissue, and application of the acoustic waves to the subcutaneous tissue.

105. The assembly of claim 104, wherein the solution agitator agitates the gas with the solution to produce a solution including microbubbles.

106. An assembly for treating subcutaneous tissue, comprising:

an acoustic wave generator for producing acoustic waves having a frequency in the range of about 0.25 MHz to about 20 MHz and a peak negative pressure in the range of 0.1 Mpa to 10.0 MPa;

an acoustic wave transducer configured to apply the acoustic waves to the subcutaneous tissue of a patient;

a source of a gas;

a solution agitator configured for mixing the gas with a solution to produce a solution including gaseous bodies; and

a solution injection member configured for injecting the solution including the gaseous bodies into the subcutaneous tissue of the patient, wherein the acoustic waves interact with the solution including the gaseous bodies.

107. The assembly of claim 106, further comprising:

a gas housing configured to retain the source of the gas therein; and

a solution housing configured to retain a source of the solution therein.

108. The assembly of claim 106, wherein the source of the gas is room air.

109. The assembly of claim 106, wherein the solution injection member includes a housing and a plurality of hollow injection members.

110. The assembly of claim 109, wherein a distal end of at least one hollow injection member is movable between a first configuration inside the solution injection member housing and a second configuration outside the solution injection member housing.

111. The assembly of claim 106, wherein the acoustic wave transducer is a planar transducer.

112. The assembly of claim 106, further including a tissue cooling module, wherein discomfort, swelling, scarring or other undesired effects associated with cosmetic or dermatologic treatment with the assembly is reduced.

113. An assembly for treating subcutaneous tissue, comprising:

an ultrasonic wave generator for producing ultrasonic waves having a frequency in the range of about 0.25 MHz to about 20 MHz and a peak negative pressure in the range of 0.1 Mpa to 10.0 MPa;

a planar ultrasonic wave transducer configured to apply the generated ultrasonic waves to the subcutaneous tissue of a patient;

;

a source of a gas;

a source of a solution;

a solution agitator configured for mixing the gas with the solution to form a microbubble solution;

a solution injection member having at least one hollow injection member movable between a first configuration inside the solution injection member housing and a second configuration outside the solution injection member housing;

a control module configured to integrate and coordinate generation of the microbubble solution, injection of the microbubble solution into the tissue to be treated, dispersion of the microbubble solution in the tissue to be treated, and insonation of the microbubble solution in the tissue to be treated.

114. The assembly of claim 113, wherein the control module is further configured to provide staged depths of injection of the microbubble solution followed by application of the ultrasonic waves.

115. The assembly of claim 113, further including a cooling module.