Abstract:
This invention relates to a device and method for improving the surgical procedure of soft tissue removal by aspiration and more particularly to a device and method utilizing laser energy directed substantially across the inlet port to more readily and safely facilitate the separating of soft tissue from a patient in vivo. This invention has immediate and direct application to the surgical procedure of liposuction or body contouring as well as application in the surgical procedures of other soft tissue removal such as brain tissue, eye tissue, and other soft tissue inaccessible to other soft tissue aspiration techniques.

Description:
FIELD OF THE INVENTION 
       [0001]    This invention relates to a device and method for improving the surgical procedure of soft tissue removal by aspiration and more particularly to a device and method utilizing laser energy directed at the edge of the inlet port to more readily and safely facilitate the separating of soft tissue from a patient in vivo. This invention has immediate and direct application to the surgical procedure of liposuction or body contouring as well as application in the surgical procedures of other soft tissue removal such as brain tissue, eye tissue, and other soft tissue. 
       BACKGROUND OF THE INVENTION 
       [0002]    Within the past decade, the surgical use of lasers to cut, cauterize and ablate tissue has been developing rapidly. Advantages to the surgical use of laser energy lie in increased precision and maneuverability over conventional techniques. Additional benefits include prompt healing with less post-operative pain, bruising, and swelling. Lasers have become increasingly important, especially in the fields of Ophthalmology, Gynecology, Plastic Surgery and Dermatology, as a less invasive, more effective surgical therapeutic modality which allows the reduction of the cost of procedures and patient recovery times due to diminished tissue trauma, bleeding, swelling and pain. The CO 2  laser has achieved wide spread use in surgery for cutting and vaporizing soft tissue. The CO 2  laser energy has a very short depth of penetration, however, and does not effectively cauterize small blood vessels. Other means such as electrocautery must be used to control and minimize blood loss. Infrared lasers, such as the Neodymium-YAG laser, on the other hand, because of its greater depth of tissue penetration, is very effective in vaporizing soft tissue and cauterizing small blood vessels. But as a result of this great depth of tissue penetration, infrared lasers, such as the Neodymium-YAG laser, have achieved limited use in the field of soft tissue surgery because of the possibility of unwanted damage to deeper tissues in the path of the laser energy beam. Recently, some infrared wavelength have been shown to have selectivity to lipids and adipose tissue. The potential benefit of these wavelengths it that they can selectively melt or destroy fat with less energy while sparing other surrounding tissues such as nerves and collagen. Various visible light lasers have shorter wavelengths and therefore do not penetrate deeply into tissue, while having the benefit of being able to selectively target structures such as blood vessels to help control bleeding. 
         [0003]    Liposuction, a surgical technique of removing unwanted fat deposits for the purpose of body contouring, has achieved widespread use. In the U.S., over 400,000 liposuction procedures were performed in 2005 alone. This technique utilizes a hollow tube or cannula with a blunt tip and a side hole or tissue aspiration inlet port near its distal end. The proximal end of the cannula has a handle and a tissue outlet port connected to a vacuum aspiration pump. In use, a small incision is made, the cannula tip and adjacent tissue inlet port is passed beneath the surface of the skin into the unwanted fat deposit. The vacuum pump is then activated drawing a small amount of tissue into the lumen of the cannula via the inlet port. Longitudinal motion of the cannula then removes the unwanted fat by a combination of sucking and ripping actions. This ripping action causes excessive trauma to the fatty tissues resulting in considerable blood loss and post-operative bruising, swelling and pain. Proposed advances in the techniques and apparatus in this field have been primarily directed to the design of the aspiration cannula, and more recently have involved the application of ultrasound and irrigation to melt and solubilize fatty tissue or the use of an auger, within the lumen of the cannula, to facilitate soft tissue removal. These proposed advances do not adequately address the goals of the surgical procedure: the efficient and precise removal of soft tissue with minimal tissue trauma and blood loss. 
         [0004]    Other laser energy devices have been developed that are a modification of a suction lipectomy cannula and have already been clinically used. Such devices position soft tissue within a protective chamber, allowing a Neodymium-YAG laser energy beam to cut and cauterize the soft tissue without fear of unwanted damage to surrounding or deeper tissues. Such devices allow the removal of soft tissue while minimizing tissue trauma by eliminating the ripping action inherent in the conventional liposuction method. Furthermore, such devices, by eliminating the ripping action of the conventional liposuction method, expand the scope of soft tissue removal. These earlier methods were limited by the fact that the interior positioning of the Nd:YAG laser fiber caused a decrease in the cross sectional area of the lumen and thus clogging and decreased efficiency. Another drawback if the design was the fact that the Nd:YAG laser fiber was positioned proximal to the opening of the liposuction catheter. Thus, all the suctioned fat would be sucked directly into the firing end of the fiber causing charring and destruction of the laser fiber tip. Further limitation of the earlier invention was the fact that the disclosure was limited to the using a single wavelength Nd:YAG laser. This did not enable one to selectively target specific structures such as fat and blood vessels and also made it necessary to enclose the fiber to minimize injury to surrounding vital structures. Generally, the liposuction method is limited to the aspiration of fat. Other soft tissues, such as breast tissue, lymphangiomas, and hemangiomas are too dense or too vascular to allow efficient and safe removal utilizing the liposuction method. The laser energy devices utilize a precise cutting and coagulating action of the laser or other fiber delivered cautery and coagulating laser, within the cannula, thereby permitting the removal of these dense or vascular soft tissues. 
         [0005]    Additionally the laser energy devices described above, by controlling the depth of penetration of the laser energy either within the protective aspiration cannula, or with focusing the beam or using different spot sizes and or wavelengths, expands the surgical applicability. This laser can be used, for example, in the precise removal of brain tissue without fear of unwanted damage to surrounding or deeper tissues. Furthermore, the CO 2  laser is extensively used for the vaporization of brain tumors, but because of its inability to effectively coagulate blood vessels, other methods such as electrocautery must be used to control blood loss during the procedure. In addition, because the vaporization of tissue generates large volumes of noxious and potentially toxic smoke, expensive, noisy and cumbersome suction devices must be used to eliminate the smoke from the surgical field. However, the laser energy devices, by utilizing the more effective coagulating power of visible and infrared lasers, permits the combined action of tissue cutting, control of blood loss, and elimination of smoke from the surgical field. 
       BRIEF DESCRIPTION OF THE INVENTION 
       [0006]    While the laser energy devices described above have provided many beneficial characteristics and attributes, the chance of occlusion of the cannula has been identified as a potential issue due to the laser fiber guide tube being located totally or partially inside the lumen of the cannula. The inclusion of the laser fiber guide tube inside the cannula results in a decreased cross sectional area within the cannula and thereby a higher potential for occlusion and decreased efficiency. The location of the tip of the laser fiber also increases the likelihood of the aspirated soft tissue coming into direct contact with the laser fiber tip resulting in fiber charring. In general, the devices of the present invention can include many of the same or similar components as the laser energy devices described above. Embodiments of such devices, components and their methods of manufacture and use are disclosed and/or suggested in U.S. Pat. Nos. 4,985,027 and 5,102,410, the contents of which are incorporated by reference herein. However, in various embodiments of the present invention the laser guide tube is located inside the handle at the proximal end of the cannula, but it is located outside of the lumen of the cannula and extends along the length of the cannula to the distal end. In such embodiments, the laser guide tube is positioned near the proximal end of the inlet port at the distal end of the cannula and can be curved inward to allow the laser fiber to direct the laser energy across or slightly into the inlet port. In other embodiments of the present invention the laser fiber enters the cannula but reflects the energy off of a reflective surface, such as a mirror, positioned at the far distal end of the cannula thereby allowing the reflected laser energy to be directed across the inlet port, at the port or outside the port. The geometry of the reflecting surface can be altered to allow for focusing or defocusing the reflected laser energy at near or outside the inlet port. Thus in practice the cannula of these embodiments operate in essentially the same way as in the above described laser energy devices, but without the potential disadvantage of having the laser guide tube within the lumen. In addition, by positioning the laser fiber tip safely out of the soft tissue stream this new laser guide tube design greatly reduces the possibility of laser fiber charring and damage. 
         [0007]    Further embodiments include: the use of different or multiple wavelengths, spot sizes and focusing means in order to selectively target specific tissues and/or localize the depth of the laser penetration; and, adding multiple aspiration ports on the cannula to enhance tissue removal. 
         [0008]    It is noted that the basic design of the present invention can be also scaled down to permit soft tissue aspiration in other parts of the body. For example, an appropriately sized version of the present device can be used for safe removal of scar tissue from within the eye or adjacent to the retina and lens tissue from within the eye. Other appropriately sized and scaled versions of the present device can also be used for the removal of other unwanted soft tissues within the body. For example: removal of unwanted tracheal tissue, such as bronchial adenomas; removal of polyps and other soft tissue from within the lumen of the gastrointestinal tract and nasal cavity; for endometrial ablations within the uterus; in conjunction with laparoscopic techniques to remove endometrial tissue within the abdomen. 
         [0009]    Various embodiments of the present invention provides a soft tissue aspiration device comprising an aspiration cannula and a laser guide tube extending longitudinally along the exterior of the cannula. In such embodiments, the guide tube houses a laser energy transmission guide for conducting the laser energy to the soft tissue removal site within the patient&#39;s body and also housing a fluid flow path around the laser energy transmission guide. The aspiration cannula has a proximal and a distal end. The cannula is provided with a soft tissue aspiration inlet port adjacent to the cannula distal end. The proximal end of the cannula is attached to a handle which is provided with a fluid flow delivery port, a laser energy transmission guide inlet port, and an aspirated soft tissue outlet port. The fluid and laser fiber guide tube extends longitudinally from near the proximal end of the soft tissue aspiration device, along the exterior wall of the cannula, to a point near the inlet port, then curves inward so as to direct laser energy, within the cannula, across the aspiration inlet port. A laser energy transmission guide extends from a laser energy source to the proximal end of the handle and longitudinally within the guide tube to a point immediately prior to the terminal point of the guide tube. In various embodiments, within the soft tissue aspiration device laser guide tube, the laser energy transmission guide is surrounded by fluid flow from a fluid source to the laser guide tube terminal point. However, with some of the embodiments of the present invention it is clear that one could use the device safely without a fluid source, without injuring the fiber tip. 
         [0010]    This invention also provides a surgical method of aspirating soft tissue from a patient in vivo using the device just described. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]      FIG. 1  is a side cut-away elevation view of a soft tissue aspiration device of the present invention. 
           [0012]      FIG. 2  is a side cut-away elevation view of a soft tissue aspiration device of the present invention including a mirror positioned at the cannula tip. 
           [0013]      FIG. 3  is a partial exploded side cut-away elevation view, showing the distal end of the laser fiber guide adjacent the soft tissue aspiration inlet port. 
           [0014]      FIG. 4  is a partial longitudinal section view of the handle and proximal end cap suitable for use with embodiments of the device showing the attachments of the fluid and laser guide tube to the laser fiber and sources of fluid. 
           [0015]      FIG. 5  is a partial longitudinal section view of a handle suitable for use with embodiments of the device showing the fluid and laser fiber guide tube, Teflon coaxial fluid delivery tube and channel, and laser energy transmission guide. 
           [0016]      FIG. 6  is a partial exploded longitudinal section of a laser fiber optic delivery system with Teflon coaxial fluid delivery tube. 
           [0017]      FIG. 7  is a partial exploded longitudinal section view of a handle and proximal end cap suitable for use with embodiments of the device showing the attachments of the laser energy transmission guide to the alternative fiber optic delivery system and alternative fluid source. 
           [0018]      FIG. 8  is a partial exploded longitudinal section of an alternative laser energy transmission guide without Teflon coaxial fluid delivery tube. 
           [0019]      FIG. 9  is a cut-away detail of the first laser soft tissue device illustrated in position for performing liposuction within a fatty deposit of a body intermediate overlying epidermal layer and underlying muscle layer. 
           [0020]      FIG. 10  is a partial longitudinal section of the distal end of a laser guide tube including a cannula and laser energy transmission guide within, according to one embodiment of the invention. 
           [0021]      FIG. 11  is a partial exploded perspective view of the distal end of a laser guide tube including a cannula and laser energy transmission guide within, according to one embodiment of the invention. 
           [0022]      FIG. 12  is a partial perspective view of the distal end of a laser guide tube including a cannula and laser energy transmission guide within, according to one embodiment of the invention. 
           [0023]      FIG. 13  is a perspective view of the distal end of an aspiration device according one embodiment of the invention having aspiration inlet cap remove to expose an unsealed laser guide lumen. 
           [0024]      FIG. 14  is a perspective view of the distal end of an aspiration device according one embodiment of the invention having aspiration inlet cap remove to expose an epoxy-sealed laser guide lumen. 
           [0025]      FIG. 15  is a partial longitudinal section of the distal end of a cannula including a laser energy focusing device and a reflective surface according to one embodiment of the invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0026]    The embodiments of the present invention described below are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art can appreciate and understand the components, principles and practices of the present invention. 
         [0027]      FIGS. 1 ,  2  and  10  depict embodiments of a laser soft tissue aspiration device  100  wherein the device comprises an aspiration cannula  112 , a laser guide tube  36 , an aspiration inlet port  20 , and a laser energy transmission guide  115 . The aspiration cannula  112  includes a lumen  113  providing for fluid and/or soft tissue flow within the cannula  112 . The lumen  113  is in communication with one or more aspiration inlet ports  20  at a distal end  114  of the aspiration cannula  112 . An aspirated soft tissue outlet port  28  at a proximal end  116  of the device  100  and in fluid flow connection to the lumen  1   3 can couple an aspiration source (not shown) with the lumen  113 . The laser guide tube  36  extends longitudinally along the exterior of the cannula  112  to a termination point  40  proximal the aspiration inlet port(s)  20 . Within the laser guide tube  36  and external to the cannula  112 , a laser energy transmission guide  115  extends from a laser energy source (not shown) to the termination point  40  at the distal end  114  of the cannula  112 . The distal end  56  of the laser energy transmission guide  115  can be configured to direct laser energy across the face of the aspiration inlet port(s)  20  such that the laser energy remains within the lumen  113 . In various embodiments, the laser soft tissue aspiration device  100  can include a handle  22  at the proximal end  116  of the aspiration cannula  112 . 
         [0028]    The device  100  in the embodiments of  FIGS. 1 and 2 , includes an aspiration cannula  112  having one or more soft tissue inlet port(s)  20  adjacent to the distal end  114  and cannula tip  118 . A handle  22  retains distal handle end cap  24  and proximal handle end cap  26 . The distal handle end cap  24  retains the cannula proximal end  116  and a laser guide tube  36 . The proximal handle end cap  26  retains the aspirated soft tissue outlet port  28 , and a fluid and fiber guide tube system. The soft tissue outlet port  28  can be connected to an aspiration source by a plastic tubing (not shown). 
         [0029]    It will be apparent to those skilled in this art, that aspiration cannula  112  dimensions can vary for different applications. For example, a shorter and thinner aspiration cannula  112  can be useful for procedures involving more restricted areas of the body, such as under the chin and around small appendages. A longer and larger diameter cannula can be useful in areas such as the thighs and buttocks where the cannula can be extended into soft tissue over a more extensive area. The length of the laser guide tube  36  is determined by the length of the soft tissue aspiration cannula  112 . In various embodiments, aspiration cannulas are made from stainless steel and can be configured in a variety of different lengths. In various embodiments of the present invention, aspiration cannula cross-sectional dimensions include: 0.312″ O.D.×0.016″ wall (0.280″ inner diameter (“I.D.”)), 0.250″ O.D.×0.016″ wall (0.218 ″ I.D.), 0.188″ O.D.×0.016″ wall (0.156″ I.D.), and 0.156″ O.D.×0.016″ wall (0.124″ I.D.). 
         [0030]    As illustrated in  FIG. 1 , some embodiments of the cannula tip  118  can advantageously be a generally rounded, blunt or bullet shaped tip attached to the cannula  112  by welding or soldering. It is noted that the cannula tip  118  can be replaceable and/or disposable. For example, the cannula tip can include a threaded or snapping means that allows a tip cap (not shown) to screw or snap into the distal end of the cannula. In various embodiments the tip  118  can have a polished reflective interior surface, such as a mirror surface, that can be utilized in various embodiments (see e.g.  FIG. 2 ) to direct the laser energy toward the aspiration inlet port  20 . The reflective inner surface of the cap can also be configured to focus or defocus the laser energy depending upon the inner surface geometry. In some embodiments, the cannula tip  118  is made from stainless steel and sized to the same diameter as the aspiration cannula&#39;s outer diameter, machined to a blunt tip, and includes a receiving end machined to fit within the cannula&#39;s inner diameter. 
         [0031]    Numerous variations of the aspiration inlet port(s)  20  are contemplated by the invention. More than one aspiration inlet port  20  can be included in aspiration cannula  112  to provide for more than one location for tissue removal. For example, an embodiment can include two ports spaced at 180 degree intervals, or three inlet ports at 120 degree intervals about a circumference of the distal end of the aspiration cannula  112 . In such embodiments one or more laser guide tube(s)  36  and one or more laser energy transmission guide(s)  115  can diverge at a point within handle  22 , along the cannula  112  or proximate the tip  118  to direct laser energy across each aspiration inlet port  20 . Additionally, aspiration inlet ports can be of any of a variety of shapes (for example oval, circular, squared, angular, parabolic). Additionally, some embodiments can even include a knife (e.g. a quartz or sapphire knife) within or near the aspiration inlet port  20  or tip  118  to mechanically ablate tissue in conjunction with the laser application. However, in various embodiments of the present invention, the edges of the aspiration inlet port(s)  20  are substantially flat or rounded in their cross-section (i.e., not of a sharp nature) such that the ripping action inherent in devices known in the art is avoided. 
         [0032]    In various embodiment, such as the embodiment depicted in  FIG. 1 , one or more laser guide tubes  36  extend longitudinally from the distal handle end cap  24  along the exterior and generally parallel with the aspiration cannula  112  to a termination point  40  immediately proximal to the soft tissue aspiration inlet port  20 . Alternatively, other embodiments of the invention, such as that depicted in  FIG. 2 , can include a laser guide tube  36  that extends longitudinally along the exterior of the aspiration cannula  112  from the proximal handle end cap  26  to a termination point  40 ′ not immediately proximal to the soft tissue aspiration inlet port  20 . For example, the laser guide tube  36  can extend along the cannula  112  and enter on the opposite side of the lumen  113  as the aspiration inlet port  20 . In such embodiments, the laser energy can be directed across the aspiration inlet port  20  by a reflective surface  43 , such as a mirror. Furthermore, in various embodiments, the entry of the laser guide tube  36  can be positioned on the cannula  112  beyond the position of the aspiration inlet port  20  and closer to the distal end, thereby allowing redirection of the laser energy from the reflective surface  43  while remaining outside the path of fluid or soft tissue flow traveling through the lumen  113  of the cannula  112  during operation of the device  100 . 
         [0033]    The laser guide tube  36 , accommodates a laser energy transmission guide  115  which transmits the laser energy from a laser energy source (not shown) to a terminal point  56  proximate the terminal point of the fluid and laser fiber guide tube  40 . An exemplary laser energy transmission guide  115  can be seen in  FIG. 8 . Such a guide can include a laser fiber sheath  50  encasing laser fiber  54 . The sheath  50  and fiber  54  are generally coaxial about longitudinal axis  58 , with the sheath terminating at point  52  and laser energy emanating from fiber end  56 . In various embodiments of the present invention, the laser fiber sheath  50 , is a Teflon laser fiber sheath. Suitable laser fiber  54  materials can include: synthetic laser fibers, glass, quartz, sapphire or other optically transmissible materials. 
         [0034]    Fiber end  56  should be positioned proximate laser guide tube end  36 , near aspiration inlet port  20 . In some embodiments, laser fiber  54  can be curved inward to align fiber end  56  such that the laser energy is directed across and generally toward the internal diameter of aspiration inlet port  20 . Additionally, in some embodiments laser fiber  54  can have a cleaved end such that the fiber end  56  is angled relative to (i.e. not parallel with) longitudinal axis  58 . In embodiments such as that of  FIG. 2 , curving or angling of the fiber end  56  can be used to direct the laser energy to properly reflect off of a reflective surface  43 , such as a mirror, to cross and extend toward the internal diameter of the inlet port  20 . 
         [0035]    Some embodiments of the present invention include a laser energy diffuser or focusing device  70  (see e.g.  FIGS. 10 and 15 ) interposed between fiber end  56 , and aspiration inlet port  20 . A diffuser or focusing device  70  can alter the power density of the light impinging on tissue to prevent charring of the laser energy transmission guide  115  and disperse the laser energy across the aspiration inlet port  20 . In some embodiments, the fiber end  56  can perpendicularly abut a back face of a laser energy diffuser or focusing device  70  (as shown in  FIG. 10 ). Alternatively, the fiber end  56  can protrude into a diffuser or focusing device  70 , or interact at an angle relative to the back face of the diffuser or focusing device  70 . A diffuser or focusing device can be constructed of an optical epoxy, thermoplastic (e.g. Lexan), air, glass, or a combination thereof. 
         [0036]      FIG. 15  shows a sectional view of the distal end of an aspiration device  114  including a laser energy focusing device  70  disposed within the cannula tip  118 , according to some embodiments of the invention. In such embodiments, laser guide tube  36  passing external to lumen  113 , can extend distally along the cannula  112  past aspiration inlet port  112 . The laser guide tube terminal point  40 , can then protrude within the cannula  112 , such that the terminal point  56  of laser energy transmission guide  115  can extend into the laser energy focusing device  70  without being exposed to the tissue stream within the lumen  113 . In such embodiments, the laser energy focusing device  70  includes a dielectric medium such as, for example, a solid piece of optical epoxy, thermoplastic (e.g. Lexan), air, or glass filling, in tip  118 . The tip  118 , can include a reflective surface  43  to direct laser energy back toward lumen  113  and aspiration inlet port  20 . It is noted that in some embodiments of the present invention, a reflective coating can be administered to the tip  118  to produce the reflective surface  43 . In operation, laser energy dispersed from laser energy transmission guide  115 , travels through the dielectric medium and off of the reflective surface  43  (denoted by solid lines  72 ). The energy leaving focusing device  70  (denoted by dashed lines  74 ), can then ablate tissue entering the aspiration inlet port  20 . In such embodiments, laser energy transmission guide  115  and laser guide tube  36  can remain entirely outside the path of fluid or soft tissue flow traveling through the lumen  113 .  FIG. 15  shows a parabolic shaped device centered on the axis of the lumen  113  focusing light at an infinite distance (i.e., collimating), however reflective surface  43  can assume a number of different shapes (e.g., spherical or elliptical) and positions (e.g., tilted or decentered) to otherwise focus and/or steer light to a finite distance within the lumen  113  and aspiration inlet port  20 . 
         [0037]    In some embodiments (such as those in  FIGS. 1 and 2 ) the laser guide tube  36  can accommodate a fluid and laser fiber guide tube system. One such laser guide tube  36 , is shown in  FIG. 3 . In this embodiment, the laser guide tube  36  is of sufficient internal diameter to accommodate the laser energy transmission guide  115  (which in this embodiment includes Teflon laser fiber sheath  50  and laser fiber  54 ) and to provide clearance for a coaxial fluid channel  38 . The coaxial fluid channel  38  can provide for fluid cooling of the laser energy transmission guide  115  along its length. In some embodiments, a sensor (not shown) can be positioned within the laser guide tube  36  to indicate whether cooling fluid is passing over the laser energy transmission guide  115  and can function to activate a safety switch, configured to stop laser energy from being transmitted through the laser energy transmission guide, if such cooling is not detected. Such a sensor can be utilized in all embodiments of the present invention, including embodiments wherein a cooling fluid is not utilized to cool the laser energy transmission guide  115 . 
         [0038]      FIG. 4  depicts a proximal end cap  26  coupled to a handle  22  including a fluid and laser fiber guide tube system. Such an embodiment can receive a fluid and laser fiber optic delivery system  62 . In the embodiment of  FIG. 4 , the laser fiber optic system  62  is retained in the handle  22  by a retaining screw  42  and sealed with an O-ring seal  46  at fluid and laser energy source port  41 . The fluid and laser fiber optic delivery system  62 , can include Teflon coaxial fluid delivery tube  44  and laser energy transmission guide  115 . The Teflon coaxial fluid delivery tube  44  is connected to a saline fluid source and pump integral with the laser energy source (not shown) and passes into the proximal end cap of the handle  26 , through the fluid and laser guide channel  30  and into the large guide tube  32 . Laser energy transmission guide  115  similarly passes through laser guide channel  30  of the proximal end cap  26  and into large guide tube  32 . Laser guide channel further includes a connection to optional fluid delivery port  66  fitted with a fluid and air tight plug  60  when the Teflon coaxial fluid delivery tube  44  is used. In these embodiments, the coaxial fluid channel  30  and large guide tube  32  are of sufficient internal diameter to accommodate the Teflon coaxial fluid delivery tube  44 . 
         [0039]    Turning to  FIG. 5 , other embodiments of the present invention include a large guide tube  32  that proceeds through handle  22  and communicates with a guide tube transition coupler  34 . The guide tube transition coupler  34  is positioned within the handle  22  proximal to the proximal end of the cannula  116  and is drilled to accommodate the external diameters of the large guide tube  32  and the laser guide tube  36 . Intermediate the proximal end cap  26  and guide tube transition coupler  34  and within the large guide tube  32 , the Teflon coaxial fluid delivery tube  44  terminates at point  48 . In this manner, the Teflon coaxial fluid delivery tube  44  can deliver cooling and irrigating fluid into coaxial fluid channel  38 , which allows the fluid to pass distally along the length of the laser energy transmission guide  115  within large guide tube  32 , through guide tube transition coupler  34 , and into laser guide tube  36 . In such embodiments, the guide tube components (large guide tube  32 , guide tube transition coupler  34 , and laser guide tube  36 ) can be joined together, to the proximal end cap  26 , and to the aspiration cannula  112  outer wall utilizing a means such as soldering or welding. 
         [0040]      FIG. 7  illustrates minor modifications of another configuration of the present invention which allows the soft tissue aspiration cannula to accommodate an alternative fiber optic delivery system (such as that of  FIG. 8 ) which does not incorporate a Teflon coaxial fluid delivery tube. A bushing  68  is positioned within the fluid and laser guide channel  30  to allow a fluid and air-tight seal at the fluid and energy source port  41 . Optional fluid delivery port  66  is provided to allow the passage of cooling and irrigating fluid from a fluid source and pump (not shown) into the coaxial fluid channel  38 . 
         [0041]      FIGS. 10-14  illustrate another embodiment of a soft tissue aspiration device according to the present invention.  FIG. 10  shows a perspective view the distal end  114  of a cannula  112 . In this embodiment, both the cannula  112  and laser energy transmission guide  115  are housed within laser guide tube  36 . In various embodiments, an oblong cross-sectional shape of the laser guide tube  36  provides a laser guide lumen  117  adjacent the cannula  112 . The laser energy transmission guide  115  can extend within the laser guide lumen  117  and in parallel along aspiration cannula  112  to terminal end  56 , where laser energy can be dispersed across an aspiration inlet port  20 . Some embodiments can include a laser energy diffuser  70  (see e.g.  FIG. 10 ) interposed between fiber end  56 , and aspiration inlet port  20  as described above. In various embodiments of the present invention, the diffuser  70  can take the form of a flat window with diffusing surface facing fiber end  56  for preventing direct contact with aspirated tissue, as shown in  FIG. 10 . In additional embodiments of the present invention, the diffuser can also take the form of a cylindrical section, one end being in contact with fiber end  56 , the other end near the aspiration inlet port  20 , housed in a protective dielectric sheath in order to preserve its diffusing qualities in the presence of aspirated tissue. 
         [0042]    In some embodiments, the aspiration inlet port  20  is located in aspiration inlet cap  120  interposed between laser guide tube  36  and tip  118 . Aspiration inlet cap  120  can have a proximal end  122  configured to receive the laser guide tube  36 , and a distal end  124  configured to receive the tip  118 . The tip  118  can be a disposable tip as described above. Alternatively, aspiration inlet cap  120  can have a tip incorporated into the cap, i.e. the distal end can be sealed and machined to a rounded, bullet or otherwise shaped end (see e.g.  FIG. 13 ). In operation, suction from such embodiments draws soft tissue to be removed through aspiration inlet port  20  into tip cavity  126 , which is in fluid communication with lumen  113  via cannula inlet port  128 . Laser energy ablates said soft tissue and the ablated tissue can be drawn through cannula inlet port  128 , and into lumen  113 , where it passes through the cannula  112  and out of the device via a soft tissue outlet port  28  (see e.g.  FIG. 1 ). 
         [0043]    In some embodiments, the laser guide lumen  117  (i.e. the cavity between the outer wall of the cannula  112  and the inner wall of the laser guide tube  36 ) can leave a crescent-shaped opening  130  located termination point  40  (see e.g.  FIG. 13 ). Such an opening can allow ablated soft tissue or other material to occlude and/or enter the laser guide lumen  117  which can lead to diminished performance, overheating and/or charring of the laser energy transmission guide  115 . To prevent this, some embodiments include a means to seal the laser guide lumen. In a various embodiments, a filler material  132 , such as an optical epoxy, can be applied at the termination point  40  to seal the crescent-shaped opening  130  (see e.g.  FIG. 14 ) and secure laser energy transmission guide  115 . 
         [0044]    In some embodiments, filler material  132  can be applied not only at termination point  40 , but throughout laser guide lumen  117  along the entire length of the cannula. The filler material  132 , such as an epoxy, used in this manner can have other advantages, for example, an epoxy or similar material affixes the laser energy transmission guide within the laser guide lumen, and joins the cannula to the laser guide tube so that the cannula does not move within the outer laser guide tube  36 . Moreover, an epoxy or similar material surrounding laser energy transmission guide  115  can act as a heat-sink for the guide  115 , thereby eliminating the need for fluid cooling of the guide or fiber. In some embodiments, the filler material  132 , such as an epoxy, can include metal or conductive fragments (e.g. aluminum, copper, etc.) dispersed throughout to increase the thermal conductivity of the filler material  132  and better draw heat away from the laser energy transmission guide  115  to prevent charring of the fiber. Alternatively, the laser guide lumen  117  can have conformal fittings (not shown), adapted to receive the laser energy transmission guide  115  and thereby reduce the size of the lumen such that soft tissue material cannot fit within. One embodiment of the present invention uses a high temperature epoxy available, for example, from Thorlabs, Newton, N.J. 
         [0045]    Because as discussed above, a filler material  132 , such as an epoxy, filling the laser guide lumen  117  can act as a heat sink some embodiments need not use fluid cooled laser energy transmission guides. For example, a guide including a laser fiber sheath  50  and laser fiber  54  (such as that of  FIG. 8 ) can be used. Alternatively, in some embodiments, the laser energy transmission guide can be a laser fiber  54  not having a sheath  50 . With such embodiments, a handle similar to that of  FIG. 7  as discussed above is appropriate. However in such a handle, because no cooling fluid is introduced to the system, alternative inlet port  66  need not be used so cap  60  can be in place, or the alternative inlet port  66  can be removed. 
         [0046]    In various embodiments of the present invention, the handle  22 , distal handle end cap  24 , proximal handle end cap  26 , aspirated soft tissue outlet port  28 , fluid and laser fiber large guide tube  32 , guide transition coupler  34 , laser guide tube  36 , aspiration inlet cap  120  and retaining screw  42  are all of stainless steel. However, other suitable materials can also be utilized in manufacturing these components. Also, in some embodiments, the handle  22  can be a molded plastic handle, being contoured to fit a hand. The handle  22  of various embodiments can be of tubing of 1.125″ O.D.×0.125″ wall (1.0″ I.D.) about 3.25″ long. The distal handle end cap  24  in some embodiments is of 1.125″ diameter, machined to fit the handle inside diameter and drilled to accommodate the aspiration cannula outside diameter. In additional embodiments of the present invention, the proximal handle end cap  26  is 1.125″ diameter, machined to fit the handle inside diameter, drilled to accommodate the aspiration outlet port, fluid and laser guide channel, and large guide tube, and drilled and tapped to accommodate the retaining screw. The aspirated soft tissue outlet port  28  in various embodiments is of 0.75″ diameter, machined to fit the proximal handle end cap and tapered to accommodate ⅜″ I.D.×⅝″ O.D. suction tubing, and drilled to a 0.3125″ diameter hole. The fluid and laser fiber large guide tube  32  is 0.120″ O.D.×0.013″ wall (0.094″ I.D.), about 2″ long in various embodiments of the present invention. The guide tube transition coupler  34  is 0.25″ diameter 0.625″ long, drilled to accommodate large guide tube  32  and laser guide  36  in some embodiments of the present invention. In additional embodiments of the present invention, the laser guide tube  36  is of 0.072″ O.D.×0.009″ wall (0.054″ I.D.) in variable lengths, determined by the length of the cannula  112 . Retaining screw  42  can be ¼″-28 threads/inch Allen head cap screw 0.75″ long, drilled to accommodate the laser fiber optic delivery system. Also, in some embodiments, plug  60  for fluid source port  66  is a Luer-Lock male plug. Alternative fluid delivery port  66 , in various embodiments, is a stainless steel female Luer-Lock. Bushing  68  for laser fiber sheath  50 , in some embodiments, is of Teflon 0.120″ O.D.×0.072″ I.D., 0.187″ diameter flange, 0.5″ long, approximate dimension. Also, various embodiments of the present invention can include fluid and laser fiber optic delivery system  62  (suitable for use with embodiments such as those in  FIGS. 1-2 ) available from, for example, Surgical Laser Technologies, Malvern, Pa., Model number: SFE 2.2 and further includes a 2.2 mm (0.086″) outer diameter (“O.D.”) Teflon coaxial fluid delivery tube, 0.8 mm (0.315″) O.D. Teflon laser fiber sheath, and 0.600 mm (0.023″) diameter laser guide fiber length 4.0 meters (157.5″). Another alternative laser (suitable for use with embodiments such as those in  FIGS. 10-14 ) fiber optic delivery system is available from, for example, Heraeus Laser Sonics, Inc., Santa Clara, Calif., model number: B24D and includes a 0.8 mm (0.315″) O.D. Teflon laser fiber sheath, and a 0.600 mm (0.023″) diameter laser guide fiber length 3.66 meters (144″). 
         [0047]    In various embodiments of the present invention a laser energy source can be used that generates wavelengths having selective absorption for fat and blood tissue. In some embodiments the light wavelengths can be greater than 800 nm. For example, a laser energy source generating wavelengths from between 800 nm-1000 nm can be used. Additionally, wavelengths ranging from 900 nm-1000 nm can be used. Furthermore, wavelengths ranging from 970 nm- 9 80 nm can be used. Longer wavelengths can also be utilized with embodiments of the present invention (for example wavelengths between 1200 nm-1300 nm, or 1700 nm-1800 nm) as these ranges can also have a high selective absorption for fat tissue. 
         [0048]    Additionally, in various embodiments of the present invention the laser energy can be varied during application to direct multiple wavelengths. For example, multiple wavelengths having individual absorption characteristics for blood and fat. Examples of ranges that can be utilized with the devices of the present invention include 532 nm-600 nm and 970 nm- 1 000 nm, 532 nm-600 nm and 1200 nm-1300 nm, and 532 nm-600 nm and 1700 nm-1800 nm. 
         [0049]    Furthermore, the devices of the present invention can further provide pulsed delivery of laser energy. For example, a pulse of laser energy timed with the aspirator suction can provide bursts of higher energy radiation at programmed, intermittent or event activated intervals. In some embodiments, laser sources can be pulsed at different intervals. Various embodiments include laser energy sources operating on duty cycles ranging from 10% to 100%. In one embodiment of the present invention, a laser energy source provides laser energy on a 50% duty cycle. 
         [0050]    An example of a laser source for use with an embodiment of this invention using a fluid and laser fiber guide tube system (such as that of  FIGS. 1  or  2 ) is available, for example, from Surgical Laser Technologies, Malvern, Pa., model number SLT CL60, power delivery 0 to 40 watts, with a fluid delivery pump. An alternative laser source for use with embodiments not using a fluid delivery source (such as that of  FIGS. 7 and 10 ) is available, for example from Cooper Laser Sonics, Inc., Santa Clara, Calif., model number: 800, power delivery 0 to 100 watts. While the embodiments discussed above have generally included laser sources, it should be understood that other embodiments may include other energy sources, such as, for example light emitting diodes. 
         [0051]    A vacuum aspirator (not shown) for providing suction within the lumen  113  can be of any suitable type, such as that available from Wells Johnson Co., Tucson, Ariz., model: General Aspirator, vacuum 0 to 29+ CFM. The aspirator can be coupled with the outlet port  28  with suction tubing available, for example, from Dean Medical Instruments, Inc. Carson, Calif., at ⅜″ I.D.×⅝″ O.D. in various embodiments of the present invention. A fluid pump (not shown) for delivering a cooling and cleaning lavage via the device, can be of any suitable type, such as an IVAC Volumetric Infusion pump, Model No. 590, available from IVAC Corporation, San Diego, Calif. 
         [0052]    To perform one of the methods of the present invention, as illustrated in  FIG. 9 , the surgeon determines the location and extent of soft tissue to be removed. The appropriate size laser soft tissue aspiration device  100  is selected. A short incision is made and the cannula tip  118  and the distal end of the cannula  114  is passed into the soft tissue to be removed. In embodiments including a fluid and laser fiber guide tube system (e.g. the embodiments of  FIGS. 1 and 2 ), the fluid delivery pump is activated, delivering normal saline through the Teflon fluid delivery tube  44 , into the coaxial fluid channel  38 , to the terminal point of the fluid and laser fiber guide tube  40 . The application of a fluid flow of normal saline along the fiber to the fiber tip serves to cool the laser fiber  54  and maintain the terminal point of the laser fiber  56  and terminal point of the laser guide tube  40  free of tissue and other detritus. The aspiration pump is then activated. It is noted that the devices of the present invention can include sensors that indicate proper coolant and suction activity and thereby inhibit the activation of the laser fiber by a safety switch if proper coolant or suction are not present. The negative pressure thus generated is transmitted to the laser soft tissue device  100  via a flexible suction tubing, to the soft tissue outlet port  28 , through the handle  22 , through the cannula  112 , to the soft tissue aspiration inlet port  20 . The resultant negative pressure at the inlet port draws a small portion of the soft tissue into the lumen  113  of the cannula  112 . The laser is then activated. The laser energy is transmitted to the terminal point of the laser fiber  56  and into the soft tissue within the cannula lumen  113 , cleaving the soft tissue and coagulating small blood vessels. Additional soft tissue enters the soft tissue inlet port  20  by virtue of a reciprocating longitudinal motion of the laser soft tissue aspiration device  100  within the soft tissue. This reciprocating motion is applied by the surgeon&#39;s hand on the handle  22 . The reciprocating motion of the laser soft tissue aspiration device, with respect to the surrounding soft tissue, is facilitated by the stabilization of the soft tissue by the surgeon&#39;s other hand placed on the skin overlying the cannula soft tissue inlet port  20 . Soft tissue is removed from the vicinity of the inlet port  20  to the more proximal portion of the lumen  113  of the cannula, and eventually out the cannula to the soft tissue outlet port  28  by the negative pressure generated by the aspiration pump. 
         [0053]    By utilizing the present laser soft tissue aspiration device according to the present method, a variety of advantages are achieved. The ND:YAG laser energy or other fiber delivered laser energy capable of coagulation and cutting will decrease blood loss and render the surgical procedure safer by coagulating small blood vessels in the surgical area. By enabling the cutting of the soft tissue in a straighter line, the scooping, ripping and tearing action characteristic of other devices, will be eliminated, resulting in more precise soft tissue removal, fewer contour irregularities and enhanced patient satisfaction. With the addition of the cutting action of the laser energy provided by the present invention the rate of removal of unwanted soft tissue is greatly enhanced over that of previous devices and techniques thus decreasing operative time. By completely confining the laser energy safely and efficiently within the lumen of the cannula, these benefits are obtained without fear of peripheral laser thermal damage. The fluid flow in some embodiments, in addition to providing cooling and cleaning of the laser fiber, will prevent tissue adherence to and potential damage to the sensitive laser fiber tip. The fluid flow will also assist in solubilizing and emulsifying the fatty tissue serving to further facilitate aspiration and prevent clogging of the cannula throughout the procedure. Moreover, the external positioning of the laser guide tube provides a smooth, undisturbed cannula lumen less susceptible to occlusion from ablated soft tissue material. 
         [0054]    Thus, the present invention provides an improved device for use in surgical removal of soft tissue. Animal studies and clinical studies to date utilizing the present invention for surgical body contouring by removing fat have demonstrated less cannula occlusion, less bleeding, less post-operative pain and bruising, excellent cosmetic results, and generally a more aesthetic procedure than has been possible with previous soft tissue aspiration techniques. 
         [0055]    While the invention has been illustrated and described in detail in the drawings and foregoing description, such an illustration and description is to be considered as exemplary and not restrictive in character, it being understood that only various embodiments of the present invention have been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected.