Abstract:
An apparatus and method for simultaneously applying a compressive and a reciprocating force to underlying adipose cells from a location external to a patient&#39;s skin to rupture or otherwise remove the adipose cells within a subcutaneous tissue region. The adipose cells are ruptured through the mechanical application of compression and shearing forces. The patient&#39;s body then re-absorbs and expels the ruptured cells. This eliminates the need for invasive liposuction and the trauma associated with invasive liposuction. Various mechanical devices may be employed to impart the compressive and shearing forces.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]     This application claims the benefit of U.S. provisional patent application No. 60/862,779 of the same title, filed Oct. 25, 2006 by the same inventor, which application is hereby incorporated by reference in its entirety into this nonprovisional patent application. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]      1 . Field of the Invention  
         [0003]     This invention relates to an apparatus that removes adipose tissue in a noninvasive way. More particularly, it relates to a method for the removal of adipose (fat) tissue through the application of compressive and shearing forces on a target area in a patient.  
         [0004]     2. Description of the Prior Art  
         [0005]     Liposuction is a conventional cosmetic surgical procedure for removing fat (adipose) cells from patients to achieve a desired body shape. Liposuction usually involves an invasive surgical procedure that includes penetrating the skin, melting or shearing adipose tissue, and mechanically removing adipose tissue using a vacuum or other suctioning device.  
         [0006]     Liposuction generally achieves the desired effect through the lysis or destruction of the underlying adipose cells. Traditional liposuction is a generally safe but possibly traumatic procedure with a risk of complications. As the cannula is moved through the tissue region, it may damage nerves and/or blood vessels, as well as fatty tissue. Complications include excessive bleeding and a risk of morbidity or mortality. Another potential problem with liposuction is lack of uniformity of the patient&#39;s final shape due to irregular removal of fatty tissue, with subsequent contour deformities.  
         [0007]     Ultrasound techniques have been coupled to liposuction to enhance the ability to lyse adipose cells in the target region. Ultrasound assisted liposuction (“UAL”) involves introducing a solid stick ultrasound transducer through an incision in the patient&#39;s skin and moving the transducer through a fatty tissue region. The transducer emits ultrasonic energy, generally at frequencies of 20-30 kHz, that heats the tissue in the region until necrosis or cavitation or both occurs, thereby rupturing adipose cells in the region. A cannula is then introduced into the tissue region to perform suction, or a hollow transducer may be used that provides suction simultaneously with the delivery of ultrasonic energy.  
         [0008]     One shortcoming of UAL techniques is that the transducer may become quite hot during its use. This may result in damage or destruction of tissues adjacent to the target region by overheating or melting. To protect tissue outside the target region, the transducer may be introduced through the skin using an insulated sleeve, although this may require a much larger incision, perhaps about ten millimeters (10 mm) or more in length. In addition, the physician will need to exercise extreme caution and move the transducer continuously to avoid burning tissue. Treatment may also be limited to direct contact between the transducer and the adipose tissue, which may result in non-uniform destruction of fat cells in the target region.  
         [0009]     External ultrasound liposuction has been developed as an alternative to invasive techniques. An external ultrasonic generator is used to transmit ultrasound waves through a patient&#39;s skin to underlying adipose tissue. The technique is appropriate for only certain parts of the body that are safely spaced apart from tissues and organs such as larger arteries, the heart and the ovaries. Additionally, it may be difficult to achieve the desired effect due to limitations in the process.  
         [0010]     A vacuum roller device sold under the trademark Endermologic® purports to decrease the appearance of cellulite and to smooth fat contours. Animal studies have indicated, however, that the device does not change fat or fat cells. Accordingly, there is a need for improved apparatus and method for destroying subcutaneous adipose cells or other tissue. However, at the time the present invention was made, it was not obvious to those of ordinary skill in this art, in view of the prior art taken as a whole, how the known procedures could be improved.  
       SUMMARY OF INVENTION  
       [0011]     The long-standing but heretofore unfulfilled need for an improved adipose cell removal apparatus is now fulfilled by a new, useful, and nonobvious invention. The novel apparatus applies a compressive force to underlying adipose cells from a location external to a patient to rupture or otherwise remove cells, such as adipose cells, within a subcutaneous tissue region. The target cells, preferably adipose cells, may be ruptured through the application of shear force and then removed, for example, by natural absorption mechanisms within the body.  
         [0012]     The novel medical device of this invention achieves human body contouring by means of external manipulation of body fat deposits. The inventor has observed that forces applied to areas of fat on the body can lead to fat necrosis with subsequent changes in the shape and volume of the fat. This has been observed in seatbelt injuries to the breasts, fall injuries to the thighs and buttocks, and other traumatic blunt force injuries. The novel device in a similar but controlled fashion creates changes in fat shape and volume through the application of force to the fat.  
         [0013]     Without being bound to a particular theory, the mechanism of action is believed to occur in part at a cellular level. Mechanical rupture of adipocyte (fat cell) membranes is believed to release cellular contents (fat), thereby ultimately reducing or changing fat thickness and concentration to achieve body contouring. The cellular rupture occurs through a combination of pressure and motion (shearing force) and may be supplemented with application of other types of energy.  
         [0014]     The process begins by pinching the skin and fat of the area to be contoured between two opposing surfaces to which variable amounts of compressive force can be applied. After force application, a switch is thrown to an electric motor, which creates motion of at least one of the surfaces in a direction substantially perpendicular to the direction of the compressive force. This motion creates shear forces, which potentiate adipocyte rupture. The process is repeated as necessary to achieve the desired result. The devices and methodologies can be combined with other techniques, such as thermal, ultrasonic, radiofrequency, etc., to achieve the desired effect.  
         [0015]     An important object of the invention is to minimize trauma to the patient of the type caused by conventional liposuction.  
         [0016]     A closely related object is to provide a method of removing adipose tissue from a patient&#39;s body in the absence of invasive surgical procedures.  
         [0017]     Another important object is to accomplish adipose removal with a simple hand-held device that is easy to operate and inexpensive to manufacture.  
         [0018]     These and other important objects, advantages, and features of the invention will become clear as this description proceeds.  
         [0019]     The invention accordingly comprises the features of construction, combination of elements, and arrangement of parts that will be exemplified in the description set forth hereinafter and the scope of the invention will be indicated in the claims. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0020]     For a fuller understanding of the invention, reference should be made to the following detailed description, taken in connection with the accompanying drawings, in which:  
         [0021]      FIG. 1  is a plan view of a liposculpting device according to the present invention;  
         [0022]      FIG. 2  is a partially sectional view of the apparatus depicted in  FIG. 1 ;  
         [0023]      FIG. 3  is a diagrammatic perspective view of some of the parts depicted in  FIG. 2 ; and  
         [0024]      FIG. 4  is a perspective view of a second embodiment;  
         [0025]      FIG. 5  is a side elevational view of said second embodiment; and  
         [0026]      FIG. 6  is a side elevational view of said second embodiment when held by a user. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0027]     Referring now to  FIG. 1 , there it will be seen that an illustrative embodiment of the novel apparatus for removing subcutaneous adipose (“fat”) tissue in accordance with the present invention is denoted as a whole by the reference numeral  10 .  
         [0028]     Device  10  includes hollow handle  12 , pivot pin  14  near the leading end of said hollow handle, lever  16  pivotally mounted to said pivot pin, rod  18  having a proximal end disposed within the interior of hollow handle  12  and a distal end external to said hollow handle, motor driven-plate  20  mounted to the distal end of said rod, and hand-driven plate  22  secured to the distal end of lever  16 .  
         [0029]     The proximal end of lever  16  includes finger guard  24 . A user grasps apparatus  10  by placing a palm in abutting relation to hollow handle  12  and extending his or her fingers through opening  26  defined by said finger guard. The patient&#39;s tissue to be treated is placed between confronting plates  20 ,  22  and said plates are brought towards one another by bringing the fingers toward the palm in a well-known, scissors-type action. The amount and time-duration of the compressive force is therefore controlled by the user.  
         [0030]     In this first embodiment, the opposing surfaces of the plates are sinusoidal in configured when viewed in side elevation. The crest of one sine wave is opposed to the valley of its opposed sine wave so that plates  20  and  22  can be brought close together.  
         [0031]     Although sinusoidal plates are preferred, this invention is not limited to opposing plates having confronting surfaces of that shape because the invention will also work with other shapes, including flat surfaces. The plates may be generally textured with a regular or irregular pattern. The confronting surface of each plate may include other geometrical configurations such as rectangles, hemispheres, waffle patterns and so on. The sinusoidal shape is preferred because it creates repeated increased force application to a particular area of fat as the crests of the two opposing sine wave patterns advantageously pass each other in a reciprocating manner as disclosed hereinafter.  
         [0032]     The interior of hollow handle  12  is depicted in  FIG. 2 . Battery  28  provides DC power to variable speed DC motor  30  having output shaft  32 . First bevel gear  34  is secured to output shaft  32  for conjoint rotation therewith. Second bevel gear  36  meshingly engages first bevel gear  34  and is mounted for rotation about its axis of rotation by an axle, not illustrated in  FIG. 2 .  
         [0033]      FIG. 3  more fully depicts the drive system. The axle not depicted in  FIG. 2  is depicted in  FIG. 3  and is denoted  38 . Pin  40  is secured to second bevel gear  36  near the periphery of said second bevel gear and collar  42  surmounts said pin. Collar  42  receives and engages the proximal end of rod  18  so that said rod reciprocates substantially in coincidence with its longitudinal axis of symmetry as indicated by double-headed arrow  44  as second bevel gear  36  rotates about axle  38 . The distal end of rod  18  is secured to motor driven plate  20  so that said motor driven plate  20  also reciprocates as indicated by double-headed arrow  46 . The distal end of rod  18  should be hingedly connected to motor-driven plate  20  to eliminate forces that would be transverse to the longitudinal reciprocation indicated by double-headed arrow  46 .  
         [0034]     The drive system thus reciprocates motor-driven plate  20  in a direction transverse or perpendicular to the clamping force between opposing plates  20 ,  22 . This provides a shearing action that is applied to the skin and the underlying adipose tissue, in addition to the compressive action provided by the strength of the physician. Each revolution of second bevel gear  36  represents one shearing action. The RPMs of DC motor  30  thus determine the number of shearing actions that will occur in any particular unit of time. In a preferred embodiment, the speed of DC motor  30  is under the control of the user.  
         [0035]     The reciprocating shearing action moves the sinusoidal surfaces of the opposing plates away from their initial matching or complementary position so that the crests and valleys are misaligned. The skin positioned between the opposing plates will thus be subjected to a shearing force of increasing strength as two opposed crests approach each other.  
         [0036]     The motion of the surface of the opposing plates is parallel linear reciprocating, but may include other motions such as circular reciprocating, vibrating, orbital, percussive or others. The speed of the motion is variable. The energy applied to the surfaces and thus to the fat is that of direct mechanical force, but could also include ultrasonic, thermal, laser light, non-laser light, microwave, infrared, radio and others. The motion between opposing plates is relative so either or both plates may be motor-driven.  
         [0037]      FIGS. 4-6  depict a second embodiment, denoted  50  as a whole. Tool  50  includes plates  20  and  22 . Plate  22  is mounted for oscillation as indicated by double-headed directional arrow  52 . Motor  54  could be battery operated but it is preferably in electrical communication with a power source through power cord  56 . Gear box  58  includes a well-known gear train that converts the rotary motion of the power take-off shaft of motor  54  to the reciprocating motion of plate  22 . Clamp  60  has a square-U shape to accommodate link  22   a  and is secured to gear box  58 . Link  22   a  interconnects a gear in gear box  60  that rotates in a vertical plane with reciprocating plate  22 .  
         [0038]     Clamp  60  also accommodates and engages mounting block  62  that performs the function of interconnecting the part of tool  50  having oscillating plate  22  with the part of tool  50  having stationary plate  20 .  
         [0039]     More particularly, the distal free end of elongate adjustment rod  64  is received in a slot formed in mounting block  62  as best depicted in  FIG. 4  and secured in said slot by bolts  65   a ,  65   b  so that there is no rotation between said adjustment rod  64  and said mounting block  62 .  
         [0040]     Stationary plate  20  is secured to handle  66  which is an integrally formed piece that includes a first end  68  having a pistol grip configuration. A second end of said handle forms a flat surface  21  to which is mounted said stationary plate  20 . Flat surface  21  is substantially perpendicular to a longitudinal axis of elongate adjustment rod  64 .  
         [0041]     Central cavity  67  is formed in handle  66 . Trigger  70  also has a pistol grip configuration. It has an upper end disposed in said cavity  67  and is pivotally mounted as at  72  to handle  66 .  
         [0042]     Flat plate  74  is secured to an upper end of trigger  70 . Flat plate  74  is apertured so that adjustment rod  64  extends therethrough. Handle  66  is similarly apertured for the same reason.  
         [0043]     Spring  76  is positioned within cavity  67  and ensleeves adjustment rod  64 . A leading end of spring  76  abuts flat plate  74  and a trailing end abuts flat wall  78  of cavity  67 . When in repose, spring  76  maintains trigger  70  in its position of repose as depicted in  FIGS. 4 and 5 . More particularly, spring  76  is adapted to bear against said flat plate  74  so that said a lower end of trigger  70  is in a pivoted position with respect to handle  66  when spring  76  is in repose.  
         [0044]     Locking clamp  80  is pivotally mounted to handle  66  as at  82  and is also apertured to receive adjustment rod  64  therethrough. Spring  76 , when in repose, also maintains locking clamp  80  in its position of repose, as depicted in  FIGS. 4 and 5 . When locking clamp  80  is in repose, the aperture formed in it engages adjustment rod  64  and prevents said adjustment rod from traveling along its extent, i.e., in the direction indicated by double-headed directional arrow  84 , thereby preventing relative movement between opposing plates  20 ,  22 .  
         [0045]     When squeezed by a user, as depicted in  FIG. 6 , locking clamp  80  releases adjustment bar  64 . Locking clamp  80  is positioned in close proximity to trigger  70  so that a user can squeeze trigger  70  at the same time that locking clamp  80  is squeezed, as best understood in connection with said  FIG. 6 . Squeezing trigger  70  and locking clamp  80  compresses spring  76  and enables the user to apply a compressive, pinching action to tissue, not shown, positioned between plates  20 ,  22 . The user increases the amount of compressive force by squeezing harder on trigger  70  and reduces said compressive force by reducing the squeezing power. To release the tissue from the grip of plates  20 ,  22 , the user releases trigger  70  and locking clamp  80  and spring  76  unloads, returning said trigger and locking clamp to their respective positions of repose as depicted in  FIGS. 4 and 5 .  
         [0046]     Unlike the apparatus of  FIGS. 1-3 , the apparatus of  FIGS. 4-6  applies the compressive force in a linear fashion across the surface of opposing plates  20 ,  22 .  
         [0047]     The force application may be achieved via many different types of conventional mechanisms, including various classes of levers and fulcrums such as first-class levers, double action levers (vice grips), caulking gun type mechanisms, and others. Accordingly, the invention is not limited to any particular mechanical means for creating the compressive force.  
         [0048]     The device that provides the compressive force may be made of metal, plastics, rubbers and other non-specified materials with the various properties and friction coefficients to enable or prevent friction.  
         [0049]     The novel device may further include a means for measuring the force applied to the surface plates. This will ensure that the applied force is sufficient to achieve the desired effect of destroying adipose cells while not harming surrounding tissue.  
         [0050]     It will be seen that the advantages set forth above, and those made apparent from the foregoing description, are efficiently attained. Since certain changes may be made in the above construction without departing from the scope of the invention, it is intended that all matters contained in the foregoing description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.  
         [0051]     It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention herein described, and all statements of the scope of the invention that, as a matter of language, might be said to fall therebetween.