Ultrasonic apparatus and method for treating obesity or fat-deposits or for delivering cosmetic or other bodily therapy

• US 20060094988A1
• Filed: 10/27/2005
• Published: 05/04/2006
• Est. Priority Date: 10/28/2004
• Status: Abandoned Application

• Current Assignee: Carol A. Tosaya, John W. Sliwa Jr, Lee Blumenfeld
• Original Assignee: Carol A. Tosaya, John W. Sliwa Jr, Lee Blumenfeld
• Inventors: Blumenfeld, Lee, Tosaya, Carol A., Sliwa, John W. Jr.
• Application Number:
  US11/262,452
• Publication Number:
  US 20060094988A1
• Time in Patent Office: Days
• US Class Current: 601/2
• CPC Class Codes: A61H 23/0245 with ultrasonic transducers, e.g. piezoelectric
• CPC Class Codes: A61N 2007/0008 Destruction of fat cells
• 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

Obesity or fat deposits are treated with ultrasound. In one embodiment, a waveguide-based apparatus and method are disclosed for applying ultrasound to a treatment-subject for the purpose of providing treatment or therapy for obesity, fat-deposits, cosmetic benefit or other bodily therapy tasks. In another embodiment, a novel apparatus and method are disclosed for providing at least one such treatment or therapy using a liquid-based waveguide. In yet another embodiment, a wearable apparatus is disclosed that incorporates a waveguide of the invention. Any of the embodiments has application to hospital use, clinical use or home use, for example, and the place of use will likely be determined by which treatment mechanism is employed and at what power-level.

Claims

1. An apparatus for delivering an acoustic or acoustically-aided therapy or treatment to a patient or treatment-subject comprising:

at least one transduction device or acoustic-energy source;

at least one acoustically excitable shell, plate, membrane or flexural member; and

a means to acoustically couple, directly or indirectly, the excitable shell, plate, membrane or member to a patient or subject anatomy, body-material or body-portion, wherein;

at least one said energy device or source delivers acoustic energy into, onto or from within said shell, plate, membrane or member at at least one location thereby acoustically exciting said shell, plate, membrane or member from at one acoustic mode which is at least partly determined by a property or parameter of the shell, plate, membrane or member;

at least some said excited acoustical energy being fed, directed-from, distributed from, or leaked by said excited shell, plate, membrane or member from at least one location through or along the coupling means toward or into said patient or subject; and

the excited shell, plate, membrane or member acting as a waveguide to at least one of a) spread, redirect or redistribute at least some acoustical energy from one or more such localized acoustical energy devices or sources, b) acting to cause acoustical energy from one or more devices or sources to undergo a modal change such as from compressive to shear or vice versa at least once, c) acting to provide additional vibrational modes or mode-patterns not available from the device or source if it were used by itself, or d) allowing one to treat a large area with one or more smaller devices or sources of lesser total area.

2. The apparatus of claim 1 wherein the treatment or therapy is for a purpose related to any one or more of:

a) obesity treatment or surgery, b) fat reduction treatment or surgery, c) cosmetic fat reduction treatment or surgery, d) cosmetic reshaping of any type, e) invasive fat reduction of any type, f) noninvasive fat reduction of any type, g) modification or destruction of one or more adipocytes or their connecting structures, h) encouragement of a lipolyis process, i) delivery or activation of a drug or medicament supportive of a fat-related or obesity-related treatment or therapy, j) visceral fat reduction, k) shallow surface-related fat reduction, l) cellulite reduction or modification, m) a fat-reduction process requiring the subjects body to process and excrete a released or destroyed fat constituent, n) a fat-reduction process involving invasive fat removal, and o) home-use body shaping.

3. The apparatus of claim 1 wherein the treatment or therapy is enabled, activated-by or accelerated by the presence of or exposure to at least some of the acoustical energy.

4. The apparatus of claim 1 wherein the therapy or treatment is any one or more of:

a) delivered in one or more sessions, b) delivered in a manner such that it acts supportively or cooperatively with a drug, medicament or diet, c) delivered in response to sensor feedback or in response to a delivery algorithm, d) delivered in a manner involving maintaining thermal control of at least some treated tissue or tissue surface, e) delivered by a clinician, practitioner or by the subject himself/herself, f) delivered or authorized in response to a diagnostic test or patient exam, and g) delivered with knowledge of a free fatty acid (FFA) concentration.

5. The apparatus of claim 1 wherein any of:

at least one said transduction device is a piezoelectric, piezocomposite, electrostrictive, magnetostrictive, electrostatic, ferroelectric, thermoacoustic, photoacoustic or electromagnetic transducer or is a laminate or active portion of a piezocomposite or piezolaminate; and

at least one said energy source is the output end or an output port of an acoustic conduit or waveguide.

6. The apparatus of claim 1 wherein at least one of:

a shell, plate, membrane or member is malleable or formable to an anatomy in any manner;

the said acoustic coupling means is malleable or formable to an anatomy in any manner;

both the shell, plate, membrane or member and a provided acoustic coupling means are malleable or formable to an anatomy in any manner, each to at least some degree;

a shell, plate, membrane or member has any of a) one or more permanently-attached or coupled or b) one or more temporarily-attached or coupled acoustical energy devices or sources;

the acoustic coupling means includes or utilizes any of a) patient sweat, b) a gel or liquid, c) an acoustic standoff which may or may not offer some conformance, d) a gel or liquid filled container or bag, e) a low-loss rubber, polymeric material or a urethane, f) a skin-coating, cream, oil or ointment g) a skin-covering layer or film which is acoustically transparent, h) an inflatable standoff or spacer inflated with a liquid-like or gel like flowable medium which has low acoustic attenuation, and i) a patient immersion liquid or couplant; and

the shell, plate, membrane or member comprises or includes a flexural, flexible or preshaped strap, band, strip, fabric, braid, or water or gel filled container.

7. The apparatus of claim 1 wherein any one or more of:

(a) a shell, plate, membrane or member is made of or includes any amount of titanium, titanium alloy, aluminum, aluminum alloy, a low acoustic-loss polymer or a superelastic or malleable nickel-containing alloy;

(b) at least some acoustical energy entering the shell, plate, membrane or member from at least one said acoustic energy device or source at least partially exits the shell, plate, membrane or member into or toward the subject at a location not directly opposite said originating source;

(c) a shell, plate, membrane or member is driven into at least one vibrational mode, the mode determined at least partly by a property or parameter of the shell, plate, membrane or member; and

(d) a membrane is any of flexible, polymeric, elastic, tensioned or inflated with a liquid or gel.

8. The apparatus of claim 1 wherein said coupling means includes immersion or flooding of any portion of the patient or treatment subject regardless of whether the subject gets wet, flooded or immersed in regions not requiring treatment.

9. The apparatus of claim 1 wherein at least one of:

(a) the shell, plate, membrane or member serves to contain or prevent spillage of immersion or flooding water or liquid or of other immersion or flooding medium;

(b) the shell, plate, membrane or member or the acoustic coupler serves to isolate the patient or subject from electrical activity associated with the acoustic energy devices or sources; and

(c) the shell, plate, membrane or member and the acoustic coupler are juxtaposed substantially face-to-face.

10. The apparatus of claim 1 wherein said shell, plate, membrane or member is at least one of:

(a) part of or mounted in or on a tub or immersion/flooding container;

(b) mounted or supported on a movable or scannable arm or track for passage across the subject'"'"'s anatomy;

(c) part of a treatment or therapy head or probe wherein said coupling means includes intervening immersion-liquid or streamed or jetted liquid which contacts and couples to the patient;

(d) smaller than a treatment region thereby requiring scanning motion of the patient relative to the apparatus or vice versa;

(e) of a size comparable to the treatment region thereby delivering therapy or treatment with little or no such required relative scanning motion; and

(f) is physically scanned in any of a translational, rotational or angular fashion.

11. The apparatus of claim 1 wherein the shell, plate, membrane or member and the coupling means are substantially the same entity.

12. The apparatus of claim 1 wherein the apparatus is at least one of:

sat upon, laid upon or leaned upon at least for acoustic coupling purposes;

wrapped at least partially around a body member regardless of how it is held there;

inflated into juxtaposition or acoustic-contact with an anatomy portion;

held, pressed against or slid across an anatomy portion in any manner;

shaped or conformed to a body member during manufacture or during use;

provided with or operated in cooperation with a heating or cooling means to control an anatomy temperature;

capable of being assembled by a practitioner or home-user from a kit;

at least partly nondisposable or disposable;

clipped, strapped, suctioned, tied, belted, adhered or otherwise constrained against or on a patient anatomy portion;

used in cooperation with a supporting or cooperating drug, medicament or diet; and

is also capable of driving or urging a drug or medicament into or onto an anatomy portion via any driving means or mechanism, passive or active.

13. The apparatus of claim 1 wherein the one or more energy devices or sources each have an individual area less than said shell, plate, membrane or member total area.

14. The apparatus of claim 1 wherein the one or more energy devices or sources taken together have a total area less than said shell, plate, membrane or member total area.

15. The apparatus of claim 1 wherein the one or more energy devices or sources are separately operable, separately switched or phase-operated to pass acoustical energy into said shell, plate, membrane or member.

16. The apparatus of claim 1 wherein the one or more energy devices or sources are embedded in, encapsulated in, laminated in or otherwise an integral part of the shell, plate, membrane or member.

17. The apparatus of claim 1 wherein the device, devices, source or sources and the accompanying shell, plate, membrane or member collectively comprise a piezoelectric, magnetostrictive, ferroelectric or thermoacoustic composite or laminate material.

18. The apparatus of claim 17 wherein a first subset of all the acoustic energy devices or sources therein or thereon said composite or laminate material is operated at a moment in time differently than a second subset, the effect being such that the composite or laminate material acts like a shell, plate, membrane or member having two or more independent acoustic sources mounted thereon or therein, said shell, plate, membrane or member drivable into an excitation state including nodes and antinodes distributed across or movable across said shell, plate, membrane or member.

19. The apparatus of claim 18 wherein at least one of said nodes or antinodes is located between or away from the location or locations of a source or device responsible for injecting at least a portion of that energy emanating from said node or antinode.

20. The apparatus of claim 1 wherein said shell, plate, membrane or member and said energy devices or sources comprise a piezoceramic composite or piezolaminate incorporating piezoceramic material made from constituent powders or from a sol-gel whisker method.

21. An apparatus for delivering an acoustic or acoustically-aided therapy or treatment to a patient or treatment-subject comprising:

an emitter of moving liquid droplets or flowable-material droplets;

a means for directing said moving droplets upon a patient treatment region;

the droplets traveling with an average droplet diameter, average velocity and average spacing at least at a moment in time;

the repetitive impact of said droplets upon said patient providing an acoustic excitation related to the droplet arrival frequency and an acoustic power related to the arrival velocity and arrival mass; and

said excitation passing into or along a patient tissue portion needing said therapy or treatment.

22. The apparatus of claim 21 wherein the treatment or therapy is for a purpose related to any one or more of:

a) obesity treatment or surgery, b) fat reduction treatment or surgery, c) cosmetic fat reduction treatment or surgery, d) cosmetic re-shaping of any type, e) invasive fat reduction of any type, f) noninvasive fat reduction of any type, g) modification or destruction of one or more adipocytes or their connecting structures, h) encouragement of a lipolyis process, i) delivery or activation of a drug or medicament supportive of a fat-related or obesity-related treatment or therapy, j) visceral fat reduction, k) shallow surface-related fat reduction, l) cellulite reduction or modification, m) a fat-reduction process requiring the subjects body to process and excrete a released or destroyed fat constituent, n) a fat-reduction process involving invasive fat removal, and o) home-use body shaping.

23. The apparatus of claim 21 wherein at least one of:

a) droplets are defined with the aid of an acoustic energy or transducer;

b) droplets are defined, at least in part, using a spray or atomization means;

c) droplets are formed, at least in part, using pressure pulses;

d) multiple droplets travel along a substantially same path to the patient;

e) droplets travel individually or as packets of droplets;

f) the apparatus is used in conjunction with a drug, medicament, diet or with a tissue temperature-controlling means;

g) the apparatus is for one or both of home-use or clinical use; and

h) the treatment subject wears or has an acoustically-transparent protective overlayer to shield some of the droplet irritation.

24. An apparatus for delivering an acoustic or acoustically-aided therapy or treatment to a patient or treatment-subject comprising:

an emitter of at least one moving liquid stream;

a means for directing said moving stream or streams upon a patient treatment region;

a means to inject acoustical energy into said stream or streams at the emitter end such that it propagates along said stream or streams toward the patient;

said injection means including or utilizing an acoustic waveguide in any manner;

at least some treatment acoustical energy contained in said moving stream or streams arriving upon or into said patient as a result of said stream or streams arriving; and

streams not necessarily remaining fluidically attached to said stream emitting means the entire time the stream and its contained acoustic energy impact upon the patient.

25. The apparatus of claim 24 wherein the treatment or therapy is for a purpose related to any one or more of:

a) obesity treatment or surgery, b) fat reduction treatment or surgery, c) cosmetic fat reduction treatment or surgery, d) cosmetic re-shaping of any type, e) invasive fat reduction of any type, f) noninvasive fat reduction of any type, g) modification or destruction of one or more adipocytes or their connecting structures, h) encouragement of a lipolyis process, i) delivery or activation of a drug or medicament supportive of a fat-related or obesity-related treatment or therapy, j) visceral fat reduction, k) shallow surface-related fat reduction, l) cellulite reduction or modification, m) a fat-reduction process requiring the subjects body to process and excrete a released or destroyed fat constituent, n) a fat-reduction process involving invasive fat removal, and o) home-use body shaping.

26. The apparatus of claim 24 wherein one or more emitters emit two or more streams and the waveguide is capable of providing acoustical energy to at least two or more streams any of sequentially, simultaneously or in an interleaved manner.

27. The apparatus of claim 24 wherein at least one of:

a) the streams have a lateral dimension or diameter of D and the stream-to-stream spacing or gap at the patient impact surface is between 0.5D and 100D;

b) two or more impacting streams produce a wetting meniscus which bridges across a span or gap between two said adjacent impact locations;

c) the apparatus is scanned relative to the patient or vice versa;

d) the patient is cooperatively or supportively treated with a drug, medicament or diet; and

e) one or both of the streamed liquid or a patient'"'"'s body portion is controlled or monitored with respect to temperature.

28. A wearable treatment or therapy apparatus for provision of an acoustically enabled or acoustically enhanced treatment or therapy to a patient or treatment subject comprising:

a) at least one acoustic transduction means or acoustic source;

b) a shell, plate, membrane or member serving at least as an acoustical waveguide; and

c) a means to acoustically couple the apparatus to a patient treatment region,

wherein

1) at least one transduction means or acoustic source injects acoustical energy into said waveguide from upon or within said waveguide;

2) said waveguide, in turn, passes at least some of said injected energy into or toward said patient along or through the acoustic coupling means; and

3) said waveguide first distributing, redistributing, redirecting, storing, or causing acoustic mode modification of said at least some of said injected energy before its passage toward or into the coupling means and patient.

29. The apparatus of claim 28 wherein the treatment or therapy is for a purpose related to any one or more of:

a) obesity treatment or surgery, b) fat reduction treatment or surgery, c) cosmetic fat reduction treatment or surgery, d) cosmetic re-shaping of any type, e) invasive fat reduction of any type, f) noninvasive fat reduction of any type, g) modification or destruction of one or more adipocytes or their connecting structures, h) encouragement of a lipolyis process, i) delivery or activation of a drug or medicament supportive of a fat-related or obesity-related treatment or therapy, j) visceral fat reduction, k) shallow surface-related fat reduction, l) cellulite reduction or modification, m) a fat-reduction process requiring the subjects body to process and excrete a released or destroyed fat constituent, n) a fat-reduction process involving invasive fat removal, and o) home-use body shaping.

30. The apparatus of claim 28 wherein at least one of:

at least one said transduction means is a piezoelectric, piezocomposite, electrostrictive, magnetostrictive, electrostatic, ferroelectric, thermoacoustic, photoacoustic or electromagnetic transducer or is a laminate or active portion of a piezocomposite or piezolaminate; and

at least one said energy source is the output end or an output port of an acoustic conduit or waveguide

31. The apparatus of claim 28 wherein at least one of:

a) the waveguide has integral to its structure at least one transduction means or acoustic source;

b) at least two different transduction means or energy sources are operated differently in time or in a driving-parameter in order to create a desirable acoustic vibration pattern in the waveguide;

c) at least one waveguide, transduction means or energy source includes a piezoelectric, piezoceramic, piezocomposite or piezolaminate, electrostrictive or magnetostrictive material;

d) a liquid or gel filled acoustic coupler is utilized;

e) the patient or practitioner can adjust or exchange apparatus components in a manner offering improved fit or formability;

f) at least a portion of the apparatus is disposable or of limited use;

g) the apparatus is strapped, clasped, fastened, tied, adhered, suctioned, buckled or otherwise held in intimate juxtaposition to the patient;

h) acoustical wave patterns having at least one or antinodes, nodes or traveling waveforms are created in the waveguide; and

i) the waveguide serves to spread treatment energy from one or more means or sources across a region of the patient tissue including to locations between or away from said means or source locations.

32. The apparatus of claim 28 wherein at least one of an apparatus portion or a patient tissue portion is controlled or monitored with respect to temperature.

33. The apparatus of claim 28 wherein the apparatus is utilized in cooperation with a drug, medicament or diet.

34. A method for delivering an acoustic or acoustically-aided therapy or treatment to a patient or treatment-subject comprising:

providing an apparatus comprising

at least one transduction device or acoustic-energy source,

at least one acoustically excitable shell, plate, membrane or flexural member which acts as a waveguide, and

a means to acoustically couple, directly or indirectly, the excitable shell, plate, membrane or member waveguide to a patient or subject anatomy, body material or body portion;

operating said at least one said transduction device or acoustic-energy source to deliver acoustic energy into, onto or from within said shell, plate, membrane or member waveguide at at least one waveguide location, thereby acoustically exciting said shell, plate, membrane or member waveguide into at least one acoustic mode which is at least partly determined by a property or parameter of the shell, plate, membrane or member waveguide;

at least some of the excited acoustical energy additionally being fed, directed from, distributed from, or leaked by said excited shell, plate, membrane or member waveguide from at least one different or same waveguide location through or along the coupling means toward or into said patient or subject; and

operating the excited shell, plate, membrane or member thereby as a waveguide to at least one of a) spread, redirect or redistribute at least some acoustical energy from one or more such localized acoustical energy devices or sources, b) act to cause acoustical energy from one or more devices or sources to undergo a modal change such as from compressive to shear or vice versa at least once, c) act to provide additional vibrational modes or mode-patterns not available from the device or source if it were used by itself, and d) allow one to treat a large area with one or more smaller devices or sources of lesser total area.

35. The method of claim 34 wherein at least one of:

a) the patient or treatment subject is at least partially immersed or flooded with a flowable material or liquid which, at-least in part, serves as an acoustic path for said treatment energy;

b) the patient or treatment subject utilizes a liquid-flowable showerhead means which carries treatment energy in said showered, sprayed or streamed liquid emanating therefrom;

c) the patient or treatment subject has an anatomy portion monitored or controlled with respect to a temperature;

d) the waveguide comprises or includes a piezoelectric or magnetostrictive material or composite material;

e) the waveguide laterally distributes treatment energy within the waveguide;

f) the treatment apparatus is at-least partially size or shape-adjustable to the patient; and

g) at least a portion of the treatment apparatus is disposable or consumable.

36. The method of claim 34 wherein at least one of:

a) the patient is treated in one or more sessions;

b) the patient is administered or treated in a cooperative manner with a drug, medicament or diet;

c) a disposable or consumed acoustic coupler is utilized;

d) at least some acoustical energy available from the treatment apparatus is used to urge a drug or medicament to pass into the patient or treatment subject;

e) the treatment apparatus may be used at home or by a nonphysician; and

f) the treatment is delivered over one or more sessions with a knowledge of patient progress such as could be assessed by a clinical test separate from the treatment or by a clinical test or an active or passive feedback-sensor coupled to the patient and assessed at the time of a treatment session.

37. The method of claim 34 wherein the waveguide or waveguides is populated with one or more acoustic transduction devices or energy-sources and the total area of the waveguide is larger than the sum of all the areas of the populated devices or sources operated at a given moment in time such that the waveguide acts to spread or distribute treatment energy to locations between and away from said currently operated devices or sources.

38. The method of claim 34 wherein said waveguide is spaced from said patient anatomy by an intervening acoustic coupler.

39. The method of claim 34 wherein at least one of an acoustic energy device or source, a waveguide, or an acoustic coupler is pliable, formable, shapeable or otherwise conformable to the anatomy.

40. The method of claim 34 wherein at least one of:

a) a patient, subject or caregiver makes a treatment payment online or over a network;

b) a patient, subject or caregiver requests or grants authorization for a treatment online or over a network; and

c) any portion of the treatment apparatus, disposable or not, is custom-fitted or custom-matched to a patient.