WO2010151619A2

WO2010151619A2 - Devices, systems and methods for treatment of soft tissue

Info

Publication number: WO2010151619A2
Application number: PCT/US2010/039749
Authority: WO
Inventors: Paul Dunleavy; George Adaniya; Stephen May
Original assignee: Optogen Medical Llc
Priority date: 2009-06-24
Filing date: 2010-06-24
Publication date: 2010-12-29
Also published as: WO2010151619A3

Abstract

Devices, systems and methods are disclosed for treatment of soft tissue. A device is disclosed including an elongate member with a proximal end and a distal end. Temperature controlled infusate is delivered from an energy source to treat the soft tissue.

Description

DEVICES, SYSTEMS AND METHODS FOR TREATMENT OF SOFT TISSUE

FIELD

[001] Embodiments of the present invention relate generally to devices and method for the treatment of soft tissue. In particular, embodiments of the present invention provide energy platform devices for soft tissue treatments such as lipolysis and skin tightening.

BACKGROUND

[002] First introduced in the United States in 1982, liposuction has become one of the most commonly performed cosmetic procedures. Liposuction is the removal of unwanted fat tissue through minimally invasive surgery. The surgical procedure is generally described as follows. After providing general anesthesia to the patient, an incision is made near the treatment site to allow a hollow surgical probe, also known as a cannula, to enter the body. The cannula's distal tip is shaped for minimal mechanical tissue resistance. With inlet ports typically along the side of the distal end of the cannula, the proximal end is connected to a negative pressure pump for fat tissue aspiration. After inserting the cannula into the incision, the surgeon begins to aspirate the fatty tissue. The surgeon moves the cannula forward and backward through the adipose layer, slightly changing angular direction periodically. This method forms sweeping fan shape radiating from the incision point. This method of treatment requires significant physical force to manually tear and break up adipose tissue for aspiration and often resulted in unwanted medical complications such as bruising and extensive bleeding. The procedure is also fatiguing to the surgeon. A new adjunct procedure, the tumescent technique, was introduced in 1986 by Dr. Jeffrey Klein. This technique introduced the use of an aqueous saline solution, known as Tumescent. Tumescent is injected into the treatment area prior to liposuction. Tumescent contains dilute amounts of lidocaine for local anesthesia and epinephrine to constrict capillaries. The use of Tumescent eliminated the need for general anesthesia and reduced blood loss. [003] The emergence of energy based lipolysis, such as ultrasound assisted, power assisted and laser assisted lipolysis, has sparked new interest from the consumer. Laser lipolysis in particular, enabled physicians to perform traditional liposuction by treating many patients who wanted more than lotions or laser skin tightening, but were unwilling to make the leap to liposuction.

[004] The current devices and techniques are inadequate to simultaneously address the three liposuction treatment needs: reduced physical fatigue, bulk tissue sculpting and skin tightening. Commercially available devices with marginal energy absorption by fat or water suffer from uncontrolled energy propagation through the tissue. Our unique method provides irradiation right at the distal tip of the cannula in a controlled and safe manner.

[005] In previous approaches, the wavelength is selected for maximum absorption by a singular chromophore of choice. Fibroblast and scar tissue are the most physically demanding tissue to treat for the physician. Fibroblast tissue and multilocular fat cells have an abundance of cytoplasm versus lipids. In this case, water is the chromophore of choice. In the case of unilocular fat tissue, these cells have an abundance of lipid and is the chromophore of choice. However if tumescent is infused into the patient, the volume of tumescent introduced to the treatment area can be equal to the amount of fatty tissue removed. Wavelengths that are highly absorbed by both water and fat are desirable in this case. [006] There is therefore a need for improved devices, systems and methods for treatment of soft tissue.

SUMMARY [007] Several unique soft tissue treatment devices are provided. [008] Systems, methods and devices integrate a laser source emitting optimum wavelengths with an optical design that heats the tissue directly in front of a cannula. The combination of the optimum wavelength and optical design provides tightly controlled spatial distribution, resulting in spatially selective tissue heating. [009] According to a first aspect, a device for treating soft tissue is provided. The device includes an elongate member with a proximal end and a distal end; an energy delivery source; and a source of temperature controlled infusate, such as heated saline. The device may be used for bulk tissue skin tightening or heating.

[010] In a preferred embodiment, the device delivers heated infusate at temperatures that cause apoptosis of the target tissue.

[011] In another preferred embodiment, the device delivers optical energy, such as optical energy at a reduced amount due to the infusion of heated fluid.

[012] According to a second aspect, another device for treating soft tissue is provided. The device includes an elongate member with a proximal end and a distal end and an energy delivery source. The energy deliver source delivers optical energy at a wavelength is chosen to maximize and/or optimize (hereinafter optimize) tissue heating density at the distal end of the elongate member.

[013] In a preferred embodiment, the energy delivered results in optimized spatial selectivity of energy delivery. In another preferred embodiment, a wavelength of 1400nm or longer is used. In yet another preferred embodiment, multiple wavelengths of optical energy are delivered.

[014] According to a third aspect, yet another device for treating soft tissue is provided. The device includes an elongate member with a proximal end and a distal end and an energy delivery source. The energy deliver source is configured to optimize spatial selectivity of energy delivery. [015] According to a fourth aspect, yet another device for treating soft tissue is provided. The device includes an elongate member with a proximal end and a distal end and an energy delivery source. The elongate member includes at least two infusion lumens, such as infusion lumens configured to deliver two or more different fluids, fluids at different temperatures, or fluids delivered at different infusion rate profiles.

[016] According to a fifth aspect, yet another device for treating soft tissue is provided. The device includes an elongate member with a proximal end and a distal end, an energy delivery source, and a hollow core waveguide configured to deliver optical energy.

[017] In a preferred embodiment, the hollow core waveguide is filled with fluid and the optical energy is delivered through the walls of the wave guide. In yet another preferred embodiment, the optical energy is delivered through the hollow core waveguide by means of a reflective surface of the waveguide. In yet another preferred embodiment, multiple hollow cores are used to deliver and/or retrieve material. In yet another preferred embodiment, the hollow core includes an optical fiber configured to provide independent delivery of optical energy.

[018] According to a sixth aspect, yet another device for treating soft tissue is provided. The device includes an elongate member with a proximal end and a distal end and an energy delivery source. The energy delivery source delivers radiofrequency energy configured to perform skin tightening, such as unidirectional, omnidirectional, monopolar and/or bipolar delivery of radiofrequency energy.

BRIEF DESCRIPTION OF THE DRAWINGS

[019] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various embodiments, and, together with the description, serve to explain the principles of the invention. In the drawings: [020] Fig. 1 illustrates a side sectional view of a basic embodiment of a multiple lumen cannula device, consistent with embodiments of the present invention.

[021] Fig. 2 illustrates a side sectional view of a multiple lumen cannula device with alternative optical coupling, consistent with embodiments of the present invention. [022] Fig. 3 illustrates a side sectional view of the distal end of a cannula tip, consistent with embodiments of the present invention.

[023] Fig. 4 illustrates side and end views of the distal end of a cannula tip with radiofrequency electrodes configured to provide omni-directional treatment, consistent with embodiments of the present invention. [024] Fig. 5 illustrates a side view of the distal end of a cannula tip with radiofrequency electrodes configured to provide uni-directional treatment, consistent with embodiments of the present invention.

[025] Fig. 6 illustrates a side view of the distal end of a cannula tip with radiofrequency electrodes configured to provide omni-directional treatment, consistent with embodiments of the present invention.

[026] Fig. 7 illustrates a side sectional view of a cannula tip with radiofrequency electrodes configured to provide uni-directional treatment, consistent with embodiments of the present invention.

[027] Fig. 8 is a plot of absorption coefficients of water and human fatty tissue versus wavelength consistent with embodiments of the present invention.

[028] Fig. 9 is a plot of absorption coefficients of water versus wavelength, consistent with embodiments of the present invention.

[029] Fig. 10 is a plot representing optical modeling of fat tissue illustrating the relative peak irradiation at multiple wavelengths, consistent with embodiments of the present invention. [030] Fig. 11 is a chart of cumulative absorption at maxima wavelengths, consistent with embodiments of the present invention.

[031] Fig. 12 is a chart illustrating the benefit of treatment using heated infusate, such as heated saline, consistent with embodiments of the present invention.

DESCRIPTION OF THE EMBODIMENTS

[032] Reference will now be made in detail to embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

[033]

Definitions. To facilitate understanding, a number of terms are defined below.

[034] As used herein, the terms "subject" and "patient" refer to any animal, such as a mammal like livestock, pets, and preferably a human. Specific examples of "subjects" and "patients" include, but are not limited, to individuals requiring medical assistance, and in particular, requiring tissue fixation.

[035] Embodiments disclosed herein provide devices, systems and methods for the treatment of soft tissue. In particular, energy platform devices are provided for soft tissue treatments such as lipolysis and skin tightening. [036] In a preferred embodiment, a device combines laser, radio frequency and temperature controlled saline delivery modalities to provide a complete solution that offers greater safety, speed and efficacy within a single device for the treatment of soft tissue. This embodiment is intended for but not limited to energy assisted liposuction. The novel approach can be expanded to treat soft tissue consistent with optically targeting multiple chromophores and the heating of tissue with multiple energy sources. Energy sources may be selected from the group consisting of: optical; radiofrequency; laser; microwave; ultrasound; chemical; radiation; cryogenic; thermal, and combinations of these..

[037] Referring to Figure 8 and Figure 9, local peak water absorptions of interest are centered around 960nm, 1180nm, 1440nm and 1920nm. Local peak fat absorption wavelengths of interest are centered at 930nm, HOOnm, 1200nm, 1400nm, 1725nm and 2300nm.

[038] Commercially available diode laser medical devices operate at 920nm and 980nm. Table 1 tabulates the ratio of water and fat absorptions between some wavelengths of interest.

Table 1 - Absorption Coefficient Comparison

[039] Devices using 980nm wavelength have proven to be efficacious. However, devices operating at longer wavelengths provide orders of magnitude higher absorption. Longer wavelengths are expected to provide higher tissue heating density, which is confirmed by our optical modeling of fluid filled fat tissue. [040] Referring to Figure 10, wavelengths 1470nm (wavelength 1) & 1700nm (wavelength 2) have twice the energy density as compared to 920 nm & 980 nm. 2000nm (wavelength 3)has 5x energy density compared to 920 nm & 980 nm. 920 nm & 980 nm have comparable energy densities.

[041] In one embodiment, tissue heating density is maximized by selecting the wavelengths that provide the maximum cumulative absorption characteristics. The optimal wavelengths for the treatment are determined by the required spatial tissue heating density.

[042] First order approximation can be determined by using the attenuation formula I = I_oe-^(αx)

Where: x = distance α = absorption coefficient I = intensity at distance x Io = initial intensity [043] It follows that α can be determined with known intensity ratio (I/ 1₀) and required distance x. In this embodiment, the absorption length is determined to be lmm at 37% intensity level. The resulting total absorption coefficient is required to be > 10 cm^"1.

[044] Referring to Figure 11 , cumulative absorption coefficients are graphed to illustrate the optimal operating wavelengths. For the case of this liposuction embodiment, wavelengths > 1400nm are preferred. In the case of pulsed high peak power versus continuous wave low peak power operation, studies have shown both modalities to be efficacious. In this embodiment, the mechanism for treatment is heating, not ablation. Tissue ablation occurs during high heat delivery within a very short period of time. In this embodiment, the use of CW diode lasers are preferred energy sources offering a linear and consistent control of heating process. Diode lasers are also preferred due to their inherent high optical efficiencies versus solid state lasers such as Nd:YAG lasers.

[045] Key features of implementation are the selection of optical wavelength that results in most of the energy absorbed within the first few adipose cells irradiated. With the absorption area tightly controlled along with an integrated aiming beam illuminating the distal tip of the cannula, the physician knows exactly where the irradiation area is. Optimum optical designs will allow for spatial selectivity while taking advantage of peak absorption characteristics. This embodiment ensures the prevention of treating non-targeted tissue. Selecting maximum peak absorptions results in requiring significantly less optical power. A highly efficient laser source can be small enough to be integrated into the hand piece, eliminating the need for a delivery fiber, and providing a more cost effective technological solution.

[046] Another benefit to our proprietary approach is the use of multiple lumen cannula. This cannula is designed for multiple treatment modalities such as lipolysis, infusion of temperature controlled aqueous solution and aspiration. This aqueous solution may be a therapeutic solution such as Tumescent or simply saline. Energy assisted lipolysis can be considered to an extent as a thermal treatment. Reynaud et al. stated that to achieve optimal lipolysis, enough energy must be cumulatively delivered throughout the different fat layer and into the sub dermal plane so as to reach the collagenous layer. They continue to state that the mechanism of cellular damage is not due to photomechanical action, but instead thermal. In one embodiment, the infusing of temperature-controlled aqueous solution, such as heated saline, minimizes the required optical energy to bring tissue temperatures to >70C. As illustrated in Figure 12, ΔE is the amount of optical energy saved by infusing heated saline.

[047] This approach of infusing heated saline improves the speed and efficacy of the treatment. Large areas of tissue are raised to adequate temperatures to allow for easier liposuction. Fatty tissues that are intentionally or not intentionally left in the body are raised to temperatures in excess of 37C to initiate irreversible apoptosis or lipolysis within the fat cells. These fat cells are eventually metabolized by the patient's body. Saline in excess of 37C can be delivered through the multiple lumen cannula simultaneously with energy delivery or on demand without exchanging surgical tool. Raising bulk tissue to above 37C also provides post operative benefits of better body contour sculpting over time. A multiple lumen cannula allow the delivery of multiple aqueous solutions, each providing similar or individual therapeutic benefits.

[048] Radio Frequency energy combined with temperature controlled aqueous solution, such as heated saline, is optimal for skin tightening. Again referring to Figure 12, temperature controlled saline will raise the bulk tissue to desired base temperature that provides controlled slow bulk tissue tightening. Application of RF will raise the target tissue to required temperatures for localized skin tightening. The cannula is designed with electrodes uniquely positioned for either uni-directional or omni-directional treatment. This embodiment of combining RF and heated saline can be used for collagen coagulation or skin tightening. RF and/or temperature controlled aqueous solution (such as heated saline or tumescence) can be used as adjuncts to laser assisted lipolysis or as independent treatment modalities. The amount and temperature of the infusate delivered may be based on the treatment requirements. Alternatively or additionally, the amount of infusate delivered may be based on the area of treatment. For example, in the case of a small area such as the area under the chin, only a small amount of infusate is required. The abdomen area would require significantly more volume in comparison to under the chin. The temperature of the infusate depends on the treatment duration and the desired effect. Lipolysis apoptosis is achievable both at 45⁰C and at 50⁰C, but the treatment exposure time is longer with the 45°C infusate in comparison with the 50⁰C infusate.

[049] Figure 1 and Figure 2 illustrate a multiple lumen soft tissue aspirating device. Fig. 3 illustrates a side sectional view of the distal end of a cannula tip, consistent with embodiments of the present invention. Fig. 4 illustrates side and end views of the distal end of a cannula tip with radiofrequency electrodes configured to provide omni-directional treatment, consistent with embodiments of the present invention. Fig. 5 illustrates a side view of the distal end of a cannula tip with radiofrequency electrodes configured to provide unidirectional treatment, consistent with embodiments of the present invention. Fig. 6 illustrates a side view of the distal end of a cannula tip with radiofrequency electrodes configured to provide omni-directional treatment, consistent with embodiments of the present invention. Fig. 7 illustrates a side sectional view of a cannula tip with radiofrequency electrodes configured to provide uni-directional treatment, consistent with embodiments of the present invention. [050] The embodiments 1 and 2 of Figures 1 and 2 are representative of preferred embodiments for, but not limited to, body sculpting. Derivations are apparent to those skilled in the art and are thereby included herein. The device utilizes multiple energy sources for treatment of lipolysis and skin tightening. The cannula is a probe assembly that is protected by a mechanically robust exterior tubular wall 3, 4, 5 and 6. The cannula tube 3, 4, 5, and 6 can be made from metals such as stainless steel or biocompatible polymers. The cannula includes a hollow core waveguide 7, 8, 9 and 30 that communicates optical energy from laser source to distal end of cannula. The hollow waveguide can be made from optical transparent material similar to but not limited to material such as quartz, fused silica and optically transparent plastic such as Teflon. An obvious derivation to those skilled in the art is to provide an optically reflective inner surface of the hollow waveguide 7, 8, 9 and 30. In this configuration hollow waveguides can be metal with reflective surface or polymer such as Teflon with lower index of refraction relative to the aqueous solution flowing through hollow core. An apparent derivation to those skilled in the art is to use the hollow wave guide 7, 8, 9 and 30 as the cannula itself. A multiple lumen extrusion made of optically transparent material such as fuses silica or plastic can be used without an external sheathing. Treated tissue is aspirated from the distal tip 10, 11, 12 of the cannula. Negative pressure for aspiration is achieved through connection of a vacuum hose to port 13 and 14. Port 13 and

14 can be used for aspiration or the infusion of temperature controlled aqueous solution. Port

15 provides infusion of temperature controlled aqueous solution that is delivered through the hollow waveguide 7 and 8. Port 15 can also be used for aspiration of treated tissue as well.

Optical energy is delivered proximally from an optical fiber 16, 17 and 21, to connector 18 and 19. Said fibers are connected to laser sources. A derivative embodiment is to provide direct laser coupling to the optical waveguides within the cannula, thus eliminating the need for delivery fibers. The optical energy can be coupled concentrically to hollow waveguide 7 and 9 or coupled directly to the walls 20 of the hollow waveguide. Such configuration can provide a singular energy source or a plurality of energy sources with varying wavelengths and energy levels. A multiplicity of optical fibers similar to 21 can be optically coupled to the waveguide 9. Such embodiment can include a multiplicity of optical waveguides, both hollow and solid core. Optical fiber 16 and 17 can extend through the center of the hollow waveguide 7, 8 and 9 to the distal end of the cannula. Such multiplicity of optical waveguides allows unique spatial distribution both in energy density and geometry along with wavelength spatial distribution. Optical Port 18 and 19 can be designed to provide a source of aqueous solution as well. Distal spatial selectivity is achieved through wavelength selection and optical-mechanical design. Optical waveguide tip 22 and 31 optical-mechanical design can be engineered such that the optical energy is collimated, focused or divergent. Such derivations are apparent to those skilled in the art. The shape of the distal tip 11 also determines the mechanical force of the liposuction treatment and provides protection against treating untargeted tissue. Such design of 11 can include optically reflective features within the distal tip. Such optical reflectivity provides additional optical efficiency of treating tissue along with increasing energy density. Temperature controlled aqueous solution can be delivered through or around the hollow waveguide 7, 8 and 9. Multiple additional lumens can be designed into the embodiment. Additional lumens can provide a multiplicity of aqueous solutions that provide varying treatment benefits and at varying controlled temperatures. Such derivation to this embodiment is apparent to those skilled in the art. Delivery of temperature controlled aqueous solution can be concurrent to energy treatment and aspiration or delivered independently. Energy treatment can be delivered concurrently with aspiration and aqueous solution or delivered independently. Treated tissue can be aspirated concurrently to energy treatment and aqueous solution delivery or aspirate independently. Additional aspiration ports can be included in the side of the cannula of the probe. Such derivation is apparent to those skilled in the art. RF energy is delivered through contacts 23, 24, 25 and 29. RF energy spatial distribution is determined by parameters including but not limited to: the radio carrier frequency, geometry of the electrodes and the impedance characteristics of surrounding tissue. The dispersion of electrically conductive aqueous solution can modify the spatial distribution of RF energy. Delivery of aqueous solution is provided through ports 26, 27 and 28. RF energy can be delivered uni-directional by electrode configuration 24 and 29, or omni-directional for electrodes 23 and 25. Electrodes 24 illustrate a lateral uni-directional delivery of RF energy. Electrodes 29 illustrate the forward uni-directional delivery of RF energy. Electrodes 23 and 25 illustrate the lateral omni-directional delivery of RF energy. Derivations of location, spacing and geometry of RF electrodes are apparent to those skilled in the art, and are thus covered and included herein.

[051 ] Numerous kit configurations are also to be considered within the scope of this application. Multiple configurations of cannula and other device components can be provided in a single kit to treat one or multiple patients.

[052] Other embodiments will be apparent to those skilled in the art from consideration of the specification and practice disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims. In addition, where this application has listed the steps of a method or procedure in a specific order, it may be possible, or even expedient in certain circumstances, to change the order in which some steps are performed, and it is intended that the particular steps of the method or procedure claim set forth here below not be construed as being order-specific unless such order specificity is expressly stated in the claim.

Claims

We Claim:

1. A device for treating soft tissue comprising: an elongate member with a proximal end and a distal end; an energy delivery source; and a source of temperature controlled infusate.

2. The device of claim 1 wherein the temperature controlled infusate is saline heated above room temperature.

3. The device of claim 1 wherein said device is configured for bulk tissue skin tightening or tissue heating.

4. The device of claim 1 wherein said device is configured to raise tissue temperature above 37⁰C.

5. The device of claim 1 wherein said device is further configured to deliver optical energy.

6. The device of claim 5 wherein a smaller amount of optical energy is delivered than with a similar device not also delivering heated saline.

7. The device of claim 1 wherein said device is further configured to deliver RF energy.

8. The device of claim 7 wherein the RF energy is configured to cause localized skin tightening.

9. The device of claim 7 wherein the RF energy is configured to cause bulk tissue skin tightening.

10. A device for treating soft tissue comprising: an elongate member with a proximal end and a distal end; and an energy delivery source; wherein said energy delivery source is configured to deliver optical energy at a wavelength that optimizes tissue heating density at the distal end of the elongate member.

11. The device of claim 10 wherein the energy delivered results in optimized spatial selectivity of energy delivery.

12. The device of claim 10 wherein the optical energy is delivered at a wavelength of 1400 nm or longer.

13. The device of claim 12 wherein the optical energy provides an absorption length of less than or equal to lmm.

14. The device of claim 10 wherein at least two different wavelengths of optical energy are delivered.

15. The device of claim 14 wherein the at least two different wavelength of optical energy are delivered simultaneously or sequentially.

16. The device of claim 14 wherein the two wavelengths of optical energy are chosen based on tissue type to be treated.

17. The device of claim 16 wherein a first wavelength is chosen to treat unilocular or white fat tissue, a second wavelength is chosen to treat multilocular or brown fat tissue; and a third wavelength is chosen to treat fibrous tissue.

18. The device of claim 17 wherein fibrous tissue and/or brown fat tissue are treated with optical energy with a wavelength of approximately 960nm, 1180nm, 1440nm, 1920nm and/or a wavelength greater than 2600nm.

19. The device of claim 18 wherein the optical energy is provided by a diode laser or solid state laser.

20. The device of claim 17 wherein white fat tissue is treated with optical energy with a wavelength of approximately 930nm, 1 lOOnm, 1200nm, 1400nm and/or a wavelength greater than 1700nm.

21. The device of claim 14 wherein multiple wavelengths provide alternative spatial profiles of energy delivered at the distal end of the cannula.

22. The device of claim 10 wherein the wavelength of optical energy delivered is determined by limited propagation distance to be less than or equal to lmm.

23. A device for treating soft tissue comprising: an elongate member with a proximal end and a distal end; and an energy delivery source; wherein the energy delivery source is configured to optimize spatial selectivity of energy delivery.

24. The device of claim 23 wherein the energy is configured to treat any chromophore.

25. The device of claim 23 wherein optimizing spatial selectivity is achieved with the opto-mechanical design of the device.

26. The device of claim 25 wherein the wavelengths delivered are chosen to optimize spatial selectivity of energy delivery.

27. The device of claim 25 wherein the shape of the waveguide end is chosen to optimize spatial selectivity of energy delivery.

28. The device of claim 25 wherein the optical energy is focused, and the focus is chosen to optimize spatial selectivity of energy delivery.

29. The device of claim 23 wherein optimizing spatial selectivity is achieved with mechanical design of the device.

30. The device of claim 29 wherein the shape of the distal end of the cannula is chosen to optimize spatial selectivity of energy delivery.

31. The device of claim 29 wherein the cannula ends includes a reflective surface configured to maximize spatial selectivity of energy delivery.

32. The device of claim 29 wherein the device is configured to infuse an absorbing substance, such as a biocompatible dye, to provide additional absorption and heating at the distal end of the cannula.

33. A device for treating soft tissue comprising: an elongate member with a proximal end and a distal end; and an energy delivery source; wherein the elongate member includes at least two infusion lumens therethrough.

34. The device of claim 33 wherein a first infusion lumen is configured to deliver a first fluid and a second infusion lumen is configured to deliver a second fluid different than the first fluid.

35. The device of claim 34 wherein the first fluid is chosen from the group consisting of: a therapeutic mixture; a biocompatible dye solution; a tumescent fluid; saline; and combinations thereof.

36. The device of claim 34 wherein the first fluid is delivered at a different flow rate than the second fluid.

37. The device of claim 33 wherein a first infusion lumen is configured to deliver a first fluid and a second infusion lumen is configured to deliver a second fluid which is the same fluid.

38. The device of claim 37 wherein the first fluid is infused at a different temperature than the second fluid.

39. The device of claim 37 wherein the first fluid is infused at a different flow rate than the second fluid.

40. The device of claim 33 wherein a first lumen flow rate has a different flow profile than a second lumen flow rate.

41. A device for treating soft tissue comprising: an elongate member with a proximal end and a distal end; an energy delivery source; and a hollow core waveguide configured to deliver optical energy.

42. The device of claim 41 further comprising a protective tubular housing, said housing surrounding the hollow core waveguide.

43. The device of claim 41 wherein the hollow core waveguide is the cannula.

44. The device of claim 41 wherein the hollow core waveguide is integral to the cannula.

45. The device of claim 41 wherein the hollow core waveguide is configured to be filled with fluid.

46. The device of claim 45 wherein the fluid is therapeutic fluid.

47. The device of claim 45 wherein the fluid is configured to transmit optical energy.

48. The device of claim 47 wherein hollow core waveguide includes inner walls, and wherein the fluid has a higher index of refraction relative to said waveguide walls and total internal reflection is achieved.

49. The device of claim 41 wherein the optical energy is delivered through the walls of the hollow core waveguide.

50. The device of claim 41 wherein the hollow core waveguide includes a reflective inner surface and the optical energy is delivered through reflection of said inner surface.

51. The device of claim 41 wherein the hollow core waveguide includes multiple lumens configured to deliver or retrieve material.

52. The device of claim 51 wherein at least one lumen is used to deliver single or multiple liquids.

53. The device of claim 51 wherein at least one lumen is used to aspirate.

54. The device of claim 41 further comprising an optical fiber positioned within the hollow core waveguide and configured to provide independent optical energy delivery.

55. The device of claim 54 wherein the optical fiber is configured to provide secondary optical energy delivery.

56. The device of claim 54 wherein optical energy delivered at the distal end is modified by the energy delivered by the optical fiber.

57. The device of claim 54 wherein optical energy provided by the optical fiber is at the same or different wavelength and/or energy level than the optical energy provided by the hollow core waveguide.

58. The device of claim 57 wherein optical energy of 1064 nm is delivered.

59. The device of claim 58 wherein energy is provided for vascular constriction.

60. A device for treating soft tissue comprising: an elongate member with a proximal end and a distal end; an energy delivery source; and wherein the energy delivered is radiofrequency energy configured to perform skin tightening.

61. The device of claim 60 wherein the radiofrequency energy is provided in unidirectional or omnidirectional form.

62. The device of claim 61 further comprising a first electrode on the distal end and a second electrode, wherein energy is delivered between the first electrode and the second electrode.

63. The device of claim 61 further comprising two or more electrodes positioned circumferentially around the distal end, said electrodes configured to deliver omnidirectional energy.

64. The device of claim 60 further comprising one or more electrodes.

65. The device of claim 60 wherein the radiofrequency energy delivered is monopolar or bipolar radiofrequency energy.

66. The device of claim 60 wherein the radiofrequency energy delivered is delivered at a frequency greater than 100 kHz.

67. The device of claim 1 or 10 or 23 or 33 or 41 or 60, wherein the elongate member is a cannula.

68. The device of claim 67 wherein the cannula comprises a solid core fiber.

69. The device of claim 67 wherein the cannula comprises a hollow core waveguide.

70. The device of claim 67 wherein the cannula comprises two or more lumens.

71. The device of claim 70 wherein the cannula comprises a first lumen configured to aspirate; a second lumen configured to infuse fluid; and a third lumen configured to deliver energy.

72. The device of claim 1 or 10 or 23 or 33 or 41 or 60, further comprising an optical fiber.

73. The device of claim 1 or 10 or 23 or 33 or 41 or 60, wherein the energy source delivers energy selected from the group consisting of: optical; radiofrequency; laser; microwave; ultrasound; chemical; radiation; cryogenic; thermal, and combinations thereof.

74. The device of claim 73 wherein multiple energy forms are delivered.

75. The device of claim 1 or 10 or 23 or 33 or 41 or 60, wherein the energy source is located within the cannula.

76. The device of claim 75 wherein the energy source is located within the proximal end of the cannula.

77. The device of claim 1 or 10 or 23 or 33 or 41 or 60, further comprising a control console, wherein the energy delivery source is located within said control console.

78. The device of claim 1 or 10 or 23 or 33 or 41 or 60, further comprising aspiration means.

79. The device of claim 1 or 10 or 23 or 33 or 41 or 60, further comprising a control console.

80. The device of claim 1 or 10 or 23 or 33 or 41 or 60, further comprising a power supply.

81. The device of claim 1 or 10 or 23 or 33 or 41 or 60, further comprising an embedded controller.

82. A method of using any of the devices of claims 1 through 81.

83. The method of claim 82 wherein the device use is selected from the group consisting of: skin tightening; tissue heating; collagen coagulation; treatment of fibrous tissue; treatment of vascular tissue; and combinations thereof.

84. A method of using any of the device of claims 1 through 81 comprising: choosing wavelength of optical energy to be delivered; delivering the optical energy.

85. A device as described in reference to the above drawings.

86. A method as described in reference to the above drawings.

87. A device for treating soft tissue comprising: an elongate member with a proximal end and a distal end; and a source of temperature controlled infusate.

88. The device of claim 87 wherein a volume of the temperature controlled infusate delivered is based on a characteristic of the soft tissue to be treated.

89. The device of claim 88 wherein the volume of temperature controlled infusate delivered is based on the volume of the soft tissue to be treated.

90. The device of claim 87 wherein the temperature of the temperature controlled infusate delivered is based on one or more of: target procedure time; and a characteristic of the soft tissue to be treated.

91. The device of claim 87 further comprising a source of laser energy.