Patent Abstract:
A dermatological device for subcision of sub-epidermic tissues. The device is provided with a blunt dermis contacting surface enabling the operator to lift or cause traction to the skin from underneath the skin, after placement of the dermal contacting surface of the device under the skin. By mere skin lifting from underneath, fibrous bands present within the dermis are detached/disrupted/dissected from their attachments to the skin or from their attachments to deeper layers. Detachment/disruption/dissection of the fibrous bands can be aided by the adjunct of a dissecting arm which by rotation can enhance detachment/disruption/dissection of the fibrous bands. Pathological skin conditions such as edematous-fibrosclerotic panniculopathy known also as cellulite or any depressed scar or deep wrinkle can benefit from the device as dissection of the fibrous bands. which cause depression of skin areas. restitutes a nearly anatomical evened up skin surface.

Full Description:
RELATED CASES  
       [0001]     This application is a Continuation-in-Part of our copeding patent application Ser. No. 11/112,996 filed on Apr. 21, 2005 and now pending. 
     
    
     FIELD OF THE INVENTION  
       [0002]     This invention relates to medical apparatuses and methods for treatment of dermatological pathological conditions, such as the edematous-fibrosclerotic panniculopathy, commonly known as cellulite, acne scars or even physiological conditions such as deep wrinkles.  
       BACKGROUND—DESCRIPTION OF THE PRIOR ART  
       [0003]     Numerous treatments have been devised for the dermatological condition edematous-fibrosclerotic panniculopathy, commonly known as cellulite.  
         [0004]     Some of these treatments have a scientific base, some have a pseudo-scientific, empiric base.  
         [0005]     The edematous-fibrosclerotic panniculopathy commonly named cellulite, a non medical term coined in Europe, is a disorder of the skin and subcutaneous tissue. The edematous-fibrosclerotic panniculopathy is due to the formation of an abnormal fibrous network in the hypoderm. The abnormal fibrous network encapsulates conglomerates of fat cells causing a subcutaneous architectural disruption which results in a dimples and nodules appearance of the skin, known as orange peel skin. Strands of fibrous tissue connect the skin to deeper tissue layers and also separate compartments that contain conglomerates of fat cells. Cellulite affects more commonly the hips, thighs, glutei, abdominal wall and upper arms. Women are commonly more affected than men. Researchers agree that most of cellulite “cures” have been ineffective. Recent researches have confirmed that cellulite is product of faulty anatomy, genes and hormones.  
         [0006]     Anticellulite products with unsubstantiated claims of successful treatment of the condition include creams and gels, brushes, rollers, body wraps toning lotions, electrical stimulation devices, vibrating machines, inflatable hip-high pressurized boots, hormone or enzymes injections and many others.  
         [0007]     More recently, radio frequency and laser devices, cold-laser massage devices, combined radio frequency/infrared devices, fat melting injections, targeted liposuction, tissue fillers have been used for the treatment of cellulite with minimal or marginal success, eventually with only transitory improvements.  
         [0008]     A more recently devised surgical procedure called skin subcision has shown some promising results. The procedure consists of cutting the cellulitic fibrous bands, the tethers which cause the depression in the skin with a special needle having surgical scalpel-like tip. The dimples, freed from their fibrous attachments, pop up and the skin is able to regain the even, pre-cellulitic aspect. Regretfully, the procedure is not void of complications. Pain, bruises, hemosiderosis have been associated with the procedure as reported in the International Journal of Dermatology, Volume 39 Issue 7, Page 539, July 2000.  
       BRIEF SUMMARY OF THE INVENTION  
       [0009]     With the present invention, applicants propose a simple medical-surgical device having the scientific prerequisites of being capable of detaching the fibrous attachments that connect the skin to the deeper layers and cause the typical dimples of a cellulitic skin, via blunt dissection, rather than via sharp dissection as currently in use. Detachment of such fibrous attachments resolves the skin dimples, restituting normal appearance to the skin, minimizing complications more likely to develop with the current technique of sharp dissection.  
         [0010]     The device is composed of a needle having an expandable balloon in proximity of the tip, connected to a syringe provided with a handle. The operator inserts the needle into the skin, inflates the balloon, grossly shaped as a donut. The balloon once inflated has the double finction of dissecting by outward radial expansion the fibrous bands network and of serving as anchoring device for skin traction purposes. The operator gently pulls up the needle acting upon the syringe handle connected to the needle carrying the expanded balloon. In doing so the operator elevates the skin, stretching it to the point of rupture the cellulitic fibrous bands which cause the dimpling of the skin.  
         [0011]     The detachment of the fibrous bands occur by blunt dissection. It is expected that the extensible surrounding blood vessels are just stretched and not severed as in the above mentioned sharp subcision technique. Surrounding structures will be less traumatized being not sharply cut as in the sharp subcision technique. It is reasonable to say that less trauma to the tissue is expected to occur with greater patient comfort and with expectation of lesser complications. In the instances that blunt dissection results insufficient to detach such fibrous bands the device will be able to place the fibrous bands under sufficient tensile traction to be easily detectable at touch by a blindly exploring sharp cutting tool, with consequent economical and efficient severing of such fibrous bands by such cutting tool, or to enable a cutting tool mounted on the skin traction apparatus to economically and efficiently sever such fibrous bands, in both cases with minimal damage to surrounding tissues in a fashion comparable to blunt dissection technique.  
       OBJECT OF THE PRESENT INVENTION  
       [0012]     It is an object of the present invention to provide a simple, rapidly deployable medical device for the treatment of cellulite, the treatment being based on solid anatomic-pathological foundations.  
         [0013]     It is an object of the present invention to provide the consumer with a simple minimally invasive effective, rapidly deployable means and method for improving cosmetic appearance of the skin affected by cellulite.  
         [0014]     It is an object of the present invention to provide a safe, simple and effective apparatus and method to target and to induce mechanical lysis of the fibrous bands which are at the core of the formation and persistence of the cellulite in body areas of patient&#39;s concern.  
         [0015]     It is an object of the present invention to provide the operator with an alternative improved apparatus and method of an already proven effective method of cellulite treatment, i.e. skin subcision: the dissection of the cellulitic fibrous bands. The proposed device dissects the fibrous tissue by blunt, not sharp, dissection, causing less trauma, less bleeding, ultimately less inflammatory reaction in the subcutaneous tissue.  
         [0016]     It is an objective of the present invention to provide the operator with a device which by minimal, needle-like skin invasion ensues an adequate traction on the skin from below without any further puncturing or cutting of the skin.  
         [0017]     It is an objective of this invention to provide the operator with an adequate skin traction device requiring a single skin hole of a diameter comparable to a needle-like element capable of exerting traction pressure to the skin from below without any further puncturing or cutting of the skin.  
         [0018]     It is further objective of this invention to provide the operator with a minimally invasive device for traction of the skin from below to ensue enough tensile traction on fibrous bands responsible of the skin dimpling characterizing the cellulite to cause detachment of such fibrous bands from their attachments to the skin or to deeper layers, and/or to cause easy detection at touch by a blindly exploring sharp cutting tool as a result of the tensile traction applied to them, with consequent economical and efficient severing of such fibrous bands by such cutting tool, or to enable a cutting tool mounted on the skin traction apparatus to economically and efficiently sever such fibrous bands, in both cases with minimal damage to surrounding tissues in a fashion comparable to the blunt dissection technique. 
     
    
     DRAWING FIGURES  
       [0019]      FIG. 1  is a side view of device with the balloon deflated at rest prior to use.  
         [0020]      FIG. 2  is a side view of the device with the balloon inflated.  
         [0021]      FIG. 3  is as side view of the same device with a larger balloon fully inflated.  
         [0022]      FIG. 4  is across sectional view of a detail of the device of  FIG. 2  to  3  specifically the inflatable member or balloon or bluntly dissecting member or anchoring member inflated.  
         [0023]      FIG. 5  shows a detail of the device specifically the locking mechanism for the plunger of device prior to actuation of the locking mechanism.  
         [0024]      FIG. 6  shows a cross sectional view of the skin of a patient with the device in action with the balloon deployed pulled upward by the operator resulting in blunt dissection/disruption of the cellulitic fibrous bands at the skin attachment and or at the deeper layer attachment.  
         [0025]      FIG. 7  is a side view of another embodiment of the device illustrated in  FIG. 1-6   
         [0026]      FIG. 7A  is side view of an enlargement of a detail of the device of  FIG. 7   
         [0027]      FIG. 7B  is an enlarged cross section view of a detail of the device of  FIG. 7 .  
         [0028]      FIG. 7C  is an enlarged cross section view of a detail of the device of  FIG. 7   
         [0029]      FIG. 8  is side view of another embodiment of the device illustrated in  FIG. 1-6   
         [0030]      FIG. 8A  is side view of an enlargement of a detail of the device of  FIG. 8   
         [0031]      FIG. 9  is a side view of another embodiment of the device of  FIG. 1-6 .  
         [0032]      FIG. 9 A  is side view of an enlargement of a detail of the device of  FIG. 9   
         [0033]      FIG. 10  is a side view of another embodiment of the device of  FIG. 1-6 .  
         [0034]      FIG. 10A  is a side view of another embodiment of the device of  FIG. 10   
         [0035]      FIG. 11  is a side view of another embodiment of the device of  FIG. 1-6 .  
         [0036]      FIG. 12  is side view of another embodiment of the device of  FIG. 1-6   
         [0037]      FIG. 12A  is side view of an enlargement of a detail of the device of  FIG. 12   
         [0038]      FIG. 13  is a side view of another embodiment of the device of  FIG. 1-6 .  
         [0039]      FIG. 13A  is side view of an enlargement of a detail of the device of  FIG. 13   
         [0040]      FIG. 13B  is side view of an enlargement of a detail of the device of  FIG. 13   
         [0041]      FIG. 14  is a perspective view of another embodiment the device illustrated in  FIG. 11 .  
         [0042]      FIG. 15  is a perspective view of a component of embodiment of  FIG. 14   
         [0043]      FIG. 16  is a perspective view of another component of embodiment of  FIG. 14 .  
         [0044]      FIG. 17  is a perspective view of the embodiment of  FIG. 14  in a stage of deployment. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0045]     As shown in  FIG. 1 , Infra-epidermic Subcision Device for Blunt Dissection of Sub-epidermic Tissues or Skin blunt Dissector/Elevator  1  consists of hollow hypodermic needle or skin penetrating means  2  sufficiently rigid to allow skin perforation connected to and in flow communication with syringe or inflating means  4 . Needle  2  is in tight sealing connection with syringe  4  via detachable hub  3 . Needle tip segment  3 ′ of needle  2  is imperforated as better shown in  FIG. 4 , while the remaining segment  3 ″ of the needle is hollow. Syringe  4  is formed with barrel  8 , slideable piston or plunger  10  and handle or handling means or traction or pulling means  6 . Syringe is formed at its proximal end with plunger locking mechanism  9  formed with flanges  9 ′ for the release of locking mechanism  9 .  
         [0046]     As shown in  FIG. 1 , balloon or expandable member or bluntly dissecting member or anchoring member  14 , grossly donut shaped once inflated as shown in  FIGS. 2 and 3 ,  4  and  6  is mounted on needle shaft  12  of needle  2 .  
         [0047]     As better shown in shown in  FIG. 4  which is a blown up cross sectional view of needle  2  distal segment, balloon  14 , shown inflated, is in flow communication with hollow needle  2  via needle holes or needle perforations  20 . Needles holes  20  are proximal to imperforated needle tip  3 ′. Balloon  14  of  FIG. 1 , 2 , 4 , 6  or balloon  14 ′ of  FIG. 3 , made of extensible material up to a maximum point of expansion, is sealingly attached to needle shaft  12  via cylindrically shaped balloon extensions or sleeve  22  and  22 ′ as better shown in  FIGS. 1 and 4 .  
         [0048]     Needle  2  can be formed with different sizes balloons allowing variable radial balloon expansions.  
         [0049]      FIG. 3  shows device  1  with larger diameter balloon  14 ′ for radial-lateral blunt dissection/disruption of cellulitic fibrous bands.  
         [0050]     As better shown in  FIG. 5 , plunger locking members or mechanism  9  of plunger  10  is releasable upon pressing down on flanges  9 ′ which disengage locking members  9  from plunger  10 .  
         [0051]     As shown in  FIG. 1 , plunger  10 , at rest prior to use, is withdrawn to a degree just sufficient to fully inflate balloon  14  once plunger  10  is fully downwardly displaced.  
         [0052]     As it can be better understood from  FIG. 6 , which shows the device in use, the operator advances needle  2  with imperforated tip  3 ′ into the patient skin  30 . Local anesthetic can be administered prior to skin insertion of needle tip  3 ′ for pain relief. Needle  2  is preferably inserted in the depressed center of a skin dimple  21 ′ of the cellulitic skin  30 . Dimple  21 ′ is shown before skin traction, while dimple  21  is shown in  FIG. 6  during skin traction, as it will be described below. Once needle tip  3 ′ and distal segment of needle shaft  12  with balloon  14  is at sufficient depth underneath the epidermis, balloon  14  is inflated by the operator by advancement of plunger  10 . Upon full advancement, plunger  10  is locked by locking mechanism  9  in its fully advanced position, as shown in  FIGS. 2, 3  and  6 . Upon full advancement of plunger  10 , balloon  14  inflates and expands radially-laterally. Radial-lateral expansion of balloon  14  and to a larger degree of balloon  14 ′ of larger diameter, will stretch cellulitic fibrous bands  24  to a point of rupture, via blunt dissection or disruption. Cellulitic fibrous bands are shown in  FIG. 6  before blunt disruption  24 ′ and after disruption at  24 . When fully expanded, balloons  14  or  14 ′ act as sub-epidermic anchoring device for skin traction. The operator pulls the device away from the skin surface via handle or traction means  6 . Balloon or expandable member or bluntly dissecting member or anchoring member  14  or  14 ′ grossly donut shaped, sub-epidernically placed indeed act as anchoring member allowing elevation/traction of the skin. By elevating the skin, fibrous bands  24  are bluntly disrupted and dissected from attachments to epidermis  25  or from attachments to the deeper skin layers  25 ′, as shown in  FIG. 6 . Skin dimples  21 , no longer tethered down by fibrous bands  24  and or  24 ′ will be free to rise by natural resiliency to the level of the surrounding skin.  
         [0053]     The operator can repeat the procedure by inserting the needle into each cellulitic skin dimple  21 ′. By operating the device as described, the operator can eliminate, one by one, every skin dimple, restituting normal appearance to the skin.  
         [0054]      FIG. 7  shows another embodiment of device  1  of  FIG. 1-6 , generally indicated at  29 . Device  29  is in all similar to device  1  of  FIG. 1-6  except that hvpodermic needle or elongated member  34  is mounted with coaxial catheter or flexible sleeve  36  formed with balloon or expandable member  35 . Catheter  36  is sealinglv connected via hub  33  to hub  3  of needle  34 . Needle  34  is formed with entry segment  34 ′, L-shaped, provided with tip  31  and dissecting means or blade  39  as better shown in  FIG. 7A . Tip  33  of entry segment  34 ′ is shown blunt in  FIG. 7A , but can be also sharp to allow skin penetration.  
         [0055]     As better shown in  FIG. 7B  which is a cross sectional view of balloon  35 , of catheter  36  and of hollow needle  34 , hollow needle  34  is longitudinally fenestrated via longitudinal opening  37 . Catheter  36  is tightly mounted over needle  34  and is provided with openings  38  which are aligned, and in flow communication, with opening  37  of needle  34 .  
         [0056]     As seen in  FIG. 7B , distal segment  36 ′ of catheter  36  extends into an enlarged and/or expandable segment of such catheter, balloon  35 , whose wall or distensible airtight membrane  35 ′ is folded over catheter shaft  36 ″ and, as best seen in  FIG. 7C , it extends over proximal segment  32  of catheter  36  reducing its diameter into sleeve  32 ′, which is sealingly bound over proximal segment  32  of catheter  36 .  
         [0057]     This version offers manufacturing advantages over versions where balloon is sealingly bound with adhesives over the needle, because in this version no adhesive binding is necessary between needle on one side and catheter/balloon on the other side. In fact, in use, air or fluidous component is delivered, by advancement of plunger  10 , from syringe  4  into needle  34  which is hollow up to its fenestration  37 . Air will preferentially select the pathway of least resistance, and will enter balloon  35  via openings  37  of needle  34 , then via catheter openings  38  which are aligned in flow communication with needle opening  37 , rather than opening its way and escaping along the interface between tightly adherent catheter shaft  36  and needle  34 . Upon air build up within balloon  35 , consequent pressure build up within balloon  35  will result in increased adherence of catheter shaft  36 ″ to needle  34 , which in turn will prevent escape of air between catheter and needle. Inflated balloon  35  will retain needle  34  from exiting out of the skin when the operator will pull in direction away from the skin the syringe secured to the needle. This action will result with elevation of the skin to such extent of disrupting the attachment of the collagen fibers to the dermis and releasing the skin dimples which characterize the cellulite.  
         [0058]      FIG. 8  through  17  illustrate other embodiments of device  1  of  FIG. 1-6 . Despite varying in structure and design, all these apparatuses have the common denominator of being provided, once introduced into the skin of a patient and deployed. as device  1  of  FIG. 1  to  6  and  29  of  FIG. 7-7C , with a blunt surface contacting the sub-epidermic layers such the dermis or deeper tissue layers allowing traction and elevation of the skin from underneath by the operator.  
         [0059]     Elevation of the skin will result in blunt dissection/disruption of the cellulitic fibrous bands at the skin attachment and or at deeper layer attachment such as at attachment on the fascia. Another application of the devices above and below described, in addition to the treatment of cellulite is the treatment of any depressed scar or even deep wrinkles where dissection/disruption of the fibrotic bands from the dermis or deeper attachments, responsible of the scar tissue or deep wrinkles, will result in elevation of the depressed skin surfaces to an even anatomical level with the surrounding skin surface. An example of this application is the correction and cosmetic amelioration of acne scars.  
         [0060]      FIG. 8  illustrates device  40  composed of handle  42  generally of elongated shape such as cylindrical or hexagonal, formed with handle bar  44  to result into a generally T-shaped combination, and entry segment  47  with dermis or blunt skin lifting segment or sub-epidermic contacting member spirally shaped  46  formed with blunt tip  43  as shown in  FIG. 8  and  8 A.  
         [0061]     Elongated member  45  of device  40  can be made of a substantially rigid material such as medical grade steel allowing penetration and manipulation of the device by handle  42 . Elongated member  45  is composed of a stem member  41  and of an arm or lifting means  46  having a blunt surface.  
         [0062]     Handle  42  and handle bar  44  can be made of any suitable material including plastic.  
         [0063]     The device can be made disposable mono-use or re-sterilizable multi-use.  
         [0064]     In operation the skin of a patient is punctured with an ordinary hypodermic needle after proper skin prepping and eventually the skin area is infiltrated with a local anesthetic. Blunt tip  43  of device  40  is then inserted into the skin opening created by the hypodermic needle tip. The operator then rotates device  40  in a clockwise fashion by acting upon handle  42  and handle bar  44  allowing full penetration of entrv segment  46  underneath the skin.  
         [0065]     Once spiral segment or dermis blunt lifting segment  46  is well positioned underneath the skin, the operator will pull upward device  40 . In doing so the cellulitic fibrotic bands present in the dermis as described for device  1  of  FIG. 1-6  or for device  29  of  FIG. 8-8B  will be severed bv traction exerted perpendicularly to the surface of the skin by maintaining the longitudinal axis of the handle oriented perpendicularly to the surface of the skin. The skin will be lifted as dermis lifting segment  46  provides a blunt dermis contacting surface from underneath the skin for skin lifting purposes.  
         [0066]      FIGS. 9 and 9 A illustrates device  40 ′ which, as device  1  of  FIG. 1-6 , is composed of syringe  4  to which hollow needle or elongated member  45 ′ is sealingly connected via hub  3 . Needle  45 ′ is formed with spirally shaped entry segment  47 ′ and blunt skin lifting member  46 ′. Elongated member  45 ′ is hollow, in flow communication with syringe  4  and formed with sharp tip  43 ′. Device  40 ′ is used as device  40  except that, being tip  43 ′ sharp, it allows penetration and placement of dermis or skin blunt lifting segment  46 ′ underneath the skin without prior use of an hypodermic needle for creating a skin opening, as needed for described device  40 . Syringe  4  can be pre-filled with any type of medication that the operator believes is suitable to be delivered into the dermis, subcutaneous tissue or into deeper tissues, including anesthetics. and lipolytic or in general tissue-lysing medications such as, for instance, the enzyme collagenase.  
         [0067]      FIG. 10  illustrates device  50  in all similar to device  40  of  FIGS. 8 and 8 A in structure, use and operation with the difference that elongated member  55  is double L-shaped with tip  53  being blunt. Blunt lifting member is indicated at  56 . With the longitudinal axis of the device being oriented vertically, the first L is oriented on a vertical plane, and composed of vertical segment or stem member  51  and horizontal segment  56 ′, the second L, is oriented on an horizontal plane and is composed of horizontal segments  56 ′ and  56 ″.  
         [0068]      FIG. 10A  illustrates device  50 ′ in all similar to device  50  of  FIG. 10  in structure, use and operation with the difference that double L shaped elongated member  55  is formed with tip  53 ′ being sharp.  
         [0069]     Device  50  and  50 ′ are operated as device  40  of FIG. of  FIGS. 8 and 8 A and  40 ′ of  FIGS. 9 and 9 A.  
         [0070]     To aid fibrous bands detachments being already accomplished by axial upward traction, the operator, beside lifting the skin as already described, can rotate the device by acting upon handle  42 , and handle bar  44 . Rotation of elongated member  55  will dissect any tissue fibrotic attachment met during the rotation.  
         [0071]      FIG. 11  illustrates device  70 , in all similar to device  40  of  FIG. 8-8A  in use and operation, with the difference that elongated member  75  is composed of stem member  71  and arm or lifting means  76  helicoidally shaped. Tip  73  of elongated member  75  can be either blunt as illustrated in  FIG. 11  or sharp.  
         [0072]     The device is operated as device  40  of  FIGS. 8 and 8 A and actually is screwed into the skin as a corkscrew into a cork.  
         [0073]      FIG. 12  shows another embodiment of device  40  of  FIG. 8-8A , generally indicated at  80  in all similar to device  40  in use and operation except that elongated member  85  is grossly Z shaped. As better shown in  FIG. 12A , skin lifting or sub-epidermic contacting member  86  is formed with blunt lifting arm or blunt dermis-contacting arm or member  86 ′, connected via arm  88  to dissecting arm or entry member  87  formed with dissecting blade  84  having edge  84 ′, which can be either sharp blunt or teethed.  
         [0074]     Tip  83  of elongated member  85  is shown blunt but can also be sharp as for the previously described devices.  
         [0075]     Once elongated member  85  is inserted and placed under the skin, and skin lifting or sub-epidermic contacting member  86  is below, or within, the dermis, the operator can pull device  80  upwardly via handle  42 . As a result of the traction exerted on the device, the skin will be also placed under traction by blunt lifting arm or blunt dermis-contacting arm or member  86  engaging the undersurface of the dermis or the inside of the dermis.  
         [0076]     The operator can facilitate or promote detachment of the fibrous bands by imparting rotation to the device by acting upon handle  42  and handle bar  44 . As a result of such rotation, dissecting arm  87  with blade  84  will rotate and, consequently, will sharply or bluntly dissect the fibrous bands attached to the skin, such as fibrotic bands characterizing the skin depressions of cellulite or acne scars, while blunt skin lifting arm  86  will keep the dermis or anything above arm  86 ′ clear from dissection caused bv dissecting arm or member  87 . Arm  87  will induce tensile traction on the fibrous bands, enabling blade  84 , mounted on dissecting arm  87 , to sever such fibrous bands more economically and efficiently than it would be possible without applying tensile traction upon such fibrous bands.  
         [0077]      FIG. 13  shows device  90  in all similar to device  40  of  FIG. 8-8A  in use and operation except that elongated member  95  as better shown in  FIGS. 13A and 13B  is L shaped and composed of stem member  91  and of skin lifting and dissecting arm  97  formed with dissecting blade  94 . being blade edge  94 ′ sharp or blunt as for device  80  of  FIG. 12 . Tip  93  is illustrated blunt.  
         [0078]     The device is operated as device  80  of  FIGS. 12 and 12 A.  
         [0079]      FIG. 14  illustrates device  120 . This embodiment has definite similarities with device  70  of  FIG. 11 . Device  120  has two components, components  121  and component  131 . Component  121 , as best seen in  FIG. 15  is in all similar to device  70  of  FIG. 11  with the only significant difference that vertical segment or stem member  123  is much longer than in device  70  of  FIG. 11 . Handle  124  of component  121  has bar  125  to facilitate rotation of component  121  during use. Helicoidal segment or anchoring means  122  of component  121  is in all similar to helicoidal segment  76  of device  70  of  FIG. 11 . Component  131 , as best seen in  FIG. 16  is also similar to device  70  Of  FIG. 11  with the significant difference that vertical segment or stem member  133  is hollow, with distal opening  137 , and telescopically slides over vertical segment  123  of component  121 . Segment  133  of component  131  is connected to handle  134 . Handle  134  is also hollow in order to slides over segment  123  of component  121 , and has bar  135  to facilitate rotation of component  131  during its use. Helicoidal segment  132  of component  131  is also similar to helicoidal segment  76  of device  70  of  FIG. 11 . Segment  122  of component  121  and segment  132  of component  131  may have either a sharp tip or a blunt tip. The device is operated by inserting segment  122  of component  121  into the skin. If segment  122  has a sharp tip, segment  122  will be inserted directly into the skin after local anesthesia. If segment  122  has a blunt tip, segment  122  will be inserted into the skin by engaging the blunt tip of segment  122  into a skin hole made with a needle after proper local anesthesia.  
         [0080]     Segment  122  will be advanced into the skin bv the operator bv rotating bar  125  of handle  124  which will result with a type of corkscrew advancement of segment  122 . When segment  122  has advanced into the subcutaneous tissue and is in proximity of the muscle layer, the operator will engage the tip of segment  132  of component  131  into the same skin hole where segment  122  of component  121  had entered. Segment  132  will be advanced into the skin in the fashion segment  122  is advanced, by rotating bar  135  of handle  134 . When segment  132  of component  131  has entered the subcutaneous tissue, the operator will hold handle  134  down on the skin while pulling handle  124  of component  121  away from the skin. This action will result in separating further apart segment  122  from segment  132 , as best seen in  FIG. 17 , and, with them the layers they are engaged with. This embodiment has a clear advantage over all the embodiment described above in the fact that it anchors the attachment of the fibrous bands on the deep layers while it exerts traction on the superficial attachments of the fibrous bands avoiding the possibility that traction exerted upon the superficial attachments of the fibrous bands results into an elevation of the deeper layer rather than in detachment of the fibrous bands.

Technology Classification (CPC): 0