Abstract:
A surgical apparatus with an insertion tool and fixation device for lifting or remodeling soft tissue as described. A combination of a fixation device and insertion tool allows for incremental release and engagement of the fixation device, which is supplied with prongs to grasp the soft tissue and hold on the other end to allow suture lifting of the soft tissue. The careful deployment of the fixation device and the manipulation and tension on the insertion tool allows a gradual, adjustable, and uniform lifting of the soft tissue that are to be remodeled.

Description:
BACKGROUND OF THE INVENTION 
     The present invention relates generally to surgical devices and methods of soft tissue remodeling. 
     The present invention relates to a new method of soft tissue remodeling to counteract the effects of aging on a person&#39;s face and other parts of the body. As a person ages, the skin begins to loosen, sag, and develop wrinkles. In addition to the skin, the supporting structures also relax. Various cosmetic surgical procedures and techniques have been used to remodel the soft tissue, such as a facelift, browlift, necklift, or blepharoplasty. These surgical procedures can incorporate large incisions. Optimally, it would be best to use a few small incisions. It is difficult to uniformly redistribute the tissue using just one or two small incisions without exerting excessive tension on one area of the soft tissue that would produce an unnatural or pulled result. 
     Consequently, there is a need for further improvement in the relative area including surgical devices and techniques that allow a surgeon to remodel soft tissue to provide a yet produce a pleasing, natural result. The present invention addresses the above-described problems and provides additional benefits and advantages. 
     SUMMARY OF THE INVENTION 
     The present invention includes a fixation device, which is placed within the soft tissue, and has prongs on one end and multiple holes on the other end. It also comprises an insertion tool, which allows deployment of this fixation device within the soft tissue for accurate lifting and fixation of the soft tissue to a higher level. There is a locking mechanism on the insertion tool, which allows the fixation device to be held until engagement into the soft tissue is desired. This allows for accurate and adjustable tension on the various depths of the soft tissue. The surgical treatment will consist of making an incision in the patient&#39;s soft tissue, inserting the fixation device using the insertion tool, and slowly advancing the fixation member through the insertion tool to engage each successive set of prongs into the soft tissue and applying tension to the fixation device as each prong is being engaged. This successive pull will remodel the soft tissue accurately and allow for adjusting to the individual patient. 
     In one form, the present invention provides a medical device for treatment of soft tissue. The device comprises an insertion tool that resembles a hypodermic-like tool defining a lumen therethrough. The insertion tool has an insertion end and an opposite, hub end. The device also includes a fixation member that is slidably received within the lumen. The fixation member includes an elongate shaft having a first end and an opposite second end and includes a plurality of prongs fixedly attached to the shaft adjacent the first end and a plurality of holes adjacent the second end. 
     In preferred embodiments, the insertion tool can also include a locking mechanism or assembly to enable the surgeon to secure the fixation member in the lumen at a first position. The locking mechanism can be released to allow the surgeon to deploy the fixation member to a second position so that the prongs can engage the soft tissue. 
     In another form, the present invention provides a method of surgical treatment for a patient. The treatment comprises: making an incision in the patient&#39;s soft tissue; inserting into the incision a tissue remodeling device including an elongate tissue fixation member having a plurality of tissue engaging prongs disposed within an insertion tool; advancing the tissue fixation member through the insertion tool to engage at least a first one of the plurality of prongs to the soft tissue; and applying tension to the elongate tissue fixation member to effect remodeling of the engaged soft tissue. 
     In still yet another form, the present invention provides a method of surgical treatment to remodel tissue of a patient. The method comprises making an incision in the tissue of the patient; providing an insertion tool having a lumen and locking assembly and including a fixation member having at least one prong extending outwardly therefrom; and deploying a length of said fixation member into said incision, wherein said fixation member attaches to and lifts the patient&#39;s tissue. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective view of one embodiment of the tissue remodeling assembly in accordance with the present invention. 
         FIG. 2  is an exploded view of the tissue remodeling assembly illustrated in  FIG. 1 . 
         FIG. 3  is a cross-sectional view of one embodiment of an insertion tool with a tissue piercing tip in accordance with the present invention. 
         FIG. 4  is a plan view of one embodiment of a tissue fixation member in accordance with the present invention. 
         FIG. 5  is an enlarged view of a portion of the fixation member of  FIG. 4  illustrating two tissue engaging prongs in accordance with the present invention. 
         FIGS. 6   a  and  6   b  are end views of various fixation members having differing patterns and/or numbers of tissue engaging prongs. 
         FIG. 7  is a cross-sectional view of a tissue remodeling assembly having a fixation member disposed in the insertion tool in accordance with the present invention. 
         FIG. 8  is a cross-sectional view of the tissue remodeling assembly of  FIG. 7  illustrating that a portion of the fixation member can extend beyond the end of the insertion tool in accordance with the present invention. 
         FIG. 9  is an illustration of the tissue remodeling assembly in use in accordance with the present invention. 
         FIG. 10  is an illustration of the fixation member holding the remodeled tissue in place in accordance with the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated herein and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any alterations and further modifications in the described devices and/or methods, and any further applications of the principles of the invention as described herein, are contemplated as would normally occur to one skilled in the art to which the invention relates. 
       FIG. 1  illustrates one embodiment of a tissue remodeling assembly  20  in accordance with the present invention. Tissue remodeling assembly  20  includes an insertion tool  21  and fixation member  22 , which is loaded within the insertion tool. In addition, insertion tool  21  includes a locking assembly  24  to secure and engage the fixation member within. 
     Referring now additionally to  FIG. 2 , in the illustrated embodiment insertion tool  21  is a substantially hollow, hyperdermic-like tool or cannula having a lumen extending through it and with a removable cap  23  at its end. The shaft  30  of the insertion tool terminates on a first end in insertion end  26  and on an opposite end in hub end  28 . The outer diameter of insertion tool  21  is sized to permit minimally invasive surgical procedures. The inner diameter or lumen of insertion tool  21  is sized to accept various sizes of fixation members. Examples of specific sizes of fixation devices are preferably between 2 and 5 mm in diameter. 
     Insertion tool  21  is illustrated as a straight shaft. However, it could be configured to compensate for the natural anatomical features of the human anatomy. 
       FIG. 3  is a cross sectional view of insertion tool  21  showing its hollow core or lumen  32  and locking assembly  24  to releasably retain the fixation member  22 . Locking assembly  24  can be configured to releasably secure the fixation member at a fixed location or depth within the lumen  32  of shaft  30 . In the illustrated embodiment, locking assembly  24  includes a pin  34  extending through hub end  28  and into lumen  32 . Pin  34  is configured to engage with a corresponding hole or recess on the fixation member (described more fully below). Locking assembly  24  can be biased to retain its position. In one embodiment, locking assembly  24  is biased to force pin  34  to engage with the fixation member received within lumen  32 . In an alternative embodiment, locking assembly  24  is biased to force pin  34  to be retracted within the body of hub end  28  and in a non-engaging arrangement with the included fixation member. 
     In a preferred embodiment, tissue insertion end  26  can include tissue piercing cap  23  removably secured thereon. Tissue piercing cap  23  can be configured with a sharp point to easily pierce tissue with minimal (if any) tearing. 
     Hub end  28  can be flared and configured to facilitate the gripping and placement of the insertion tool in a desired location. In one embodiment, hub end  28  is provided to have an enlarged exterior diameter to facilitate gripping by the surgeon during use. 
     Insertion tool  21  can be formed of a variety of rigid biocompatible materials as desired. Preferred materials include stainless steel and surgical steel. 
       FIG. 4  is a plan view of one embodiment of a fixation member  22  for use in the present invention. Fixation member  22  is provided as an elongate shaft  40  that can be provided as a flexible, thin biocompatible cord or rod suitable for implantation into a patient to remodel tissue. In the illustrated embodiment, shaft  40  is configured to exhibit a substantially cylindrical configuration, having a preferred diameter of at least about 2 mm and more preferably at least about 4 mm. For larger areas of tissue lifting, a larger fixation device can be used. It will be understood that shaft  40  can be provided in other configurations including, without limitation, configurations that have a cross section including a rectangle, a square, an oval, or the like in various sizes. The length of fixation member  22  can vary depending upon the area of tissue remodeling. 
     Shaft  40  includes a first end  46  and an opposite second end  48 . First end  46  can include one or more eyes or apertures  50  suitable for receiving a length of suture. The suture can be used to either secure the tip to tissue and/or facilitate retrieval of the fixation member. 
     A plurality of tissue engaging prongs  52  are also located adjacent first end  46 . The prongs extend from the external surface  54  of shaft  40  and are spaced axially from each other. In one embodiment, the prongs are grouped into a plurality of sets of prongs with each set of prongs spaced axially from the other sets. The sets of prongs can include two, three, or more prongs extending symmetrically or asymmetrically about shaft  40 . Preferably, the prongs are positioned at 90°, 120°, or 180° from each other. However, it will be understood the prongs can be positioned as needed or desired for the specific tissue to be lifted. Preferably prongs  52  are flexible. Consequently, the prongs  52  may be compressed when inside insertion tool. 
     Second end  48  of shaft  40  is substantially free of any tissue engaging structures. However, second end  48  includes a plurality of holes. Each of holes  66 ,  68 , and  70  can be provided as an aperture extending completely through shaft  40  or as a recess or indent extending partly through shaft  40 . Each hole can be spaced from an adjacent hole that corresponds to the axial spacing between adjacent prongs. 
     The holes can act as a guide for the surgeon to accurately gauge the length of the flexible device that has been pushed out the distal, first end  46 . In addition or in the alternative, the proximal, second end  48  can also include a number of indexing marks or other indicia  86  representative of a unit of length that first end  46  extends beyond insertion end  26  of insertion tool  21 . Alternatively, the indexing marks or other indicia  86  can be representative of the number of sets of prongs, that extend beyond the insertion end  26  of insertion tool  21 . 
     Additionally, second end  48  can include a plurality of apertures  84  extending through shaft  40  through which sutures can be threaded to secure fixation member  22  to soft tissue or bone. In one particularly preferred embodiment, the plurality of apertures  84  can also serve or function as holes  68  to engage with pin  34  of locking assembly  24 . 
       FIG. 5  is an exploded view of one set of prongs  78 . In the illustrated embodiment, set of prongs  78  includes two prongs  80  and  82  extending from shaft  40 . Each of prongs  80  and  82  are provided to exhibit the profile of a barb or tine to engage and grip surrounding soft tissue. Preferably, prongs  80  and  82  are configured to be easily inserted in tissue in a first direction but difficult to remove from that same tissue when moved or pulled in an opposite, second direction. 
       FIGS. 6   a  and  6   b  are illustrations a first end view of various shafts for use in the present invention.  FIG. 6   a  illustrates a fixation member  90  having a two prongs  94 , and  96  arranged symmetric or diametrically each other about shaft  100 . In  FIG. 6   b , fixation member  132  includes three prongs  134 ,  136 , and  138 . As can be seen from the illustrated embodiment, the base of each of prongs  134 ,  136 , and  138  are located on the same hemispherical section of the cylindrical shaped fixation member  132 . Consequently, each of prongs  134 ,  136 , and  138  are asymmetrically distributed about the outer circumference of fixation member  132 . 
     Fixation member  22  can be composed of a biocompatible material. The biocompatible material can either be biodegradable or non-biodegradable. Non-limiting examples of non-biodegradable materials for use in the present invention include TEFLON® and polypropylene. In one form, fixation member  22  is provided as a biodegradable material that can slowly degrade in vivo over a period of time ranging between about 6 months and about 24 months. 
       FIG. 7  is a cross-sectional view of tissue remodeling assembly  20  illustrating fixation member  22  received within lumen  32 . In this illustration, it can be observed that the fixation member and the plurality of prongs  52  are sized such that the plurality of prongs  52  are deflected or compressed against the inner wall  36  of lumen  32 . Tissue piercing cap  23  is secured to the tissue engaging end of insertion tool  21 . On the opposite end of tissue insertion tool  21 , locking assembly  24  is provided in a first position whereby pin  34  engages with an hole  66  to axially lock fixation member  22  within lumen  32 . It can also be observed that second end  48  of fixation member  22  is exposed beyond hub end  28 . Index mark  86  indicates how much of fixation member is exposed. 
       FIG. 8  is an illustration of tissue remodeling assembly  20  in which tissue piercing cap  23  has been removed. Fixation member  22  has been extended such that first end  46  extends beyond insertion end  26 , exposing at least a first set of prongs  56 . Additionally, it can be observed that a thread or suture  50  has been inserted through the opening  51  in first end  46  of fixation member  22 . 
     In the illustration, locking assembly  24  has been adjusted to position pin  34  to end through a second hole  68 , thereby locking fixation member  22  as desired in the interior lumen  32  of insertion tool  21 . In this embodiment, insertion tool  21  can be manipulated to either further insert the insertion tool into tissue or to begin pulling and extracting the insertion tool out of the adjacent soft tissue to begin to effect tissue remodeling. 
       FIG. 9  is a schematic illustration of the tissue remodeling assembly  20  in use to accomplish tissue remodeling such as that prescribed for a face lift. However, it should be understood that tissue remodeling assembly  20  of the present invention could be used in any general surgical procedure to manipulate soft tissue in other areas of the body. 
     A small incision will be made in the temple area of the face and the insertion tool with the loaded fixation device will be placed through this incision and brought down into the buccal or cheek sulcus of the mouth. Because of the removable cap on the insertion end of the tool, non-traumatic passage of this tool can be accomplished. The removable cap is then removed within the mouth and a suture placed through the single hole on the distal end of the fixation device. This is used to stabilize the fixation device initially and to allow removal of the fixation device if it is found not to be in the correct position. The surgeon will then begin the engagement of the fixation device within the soft tissue. This will be accomplished by pushing the fixation device out of the insertion tool slowly. As each prong is released from within the insertion tool, it will then spring open and engage the soft tissue. By placing tension on the insertion tool, elevation of this specific soft tissue can be done. When the proper lift is produced in this part of the soft tissue, another prong can be released and engaged and again, tension and lift can be placed on the second prong, which will then lift this second area of soft tissue. By alternately releasing a prong and lift, an accurate remodeling of the soft tissue can be done. When all the prongs are released, the excess portion of the fixation device can be cut and discarded, leaving the remaining portion with holes to be fixed to the soft tissue in the temple area. The incision in the temple area then can be easily closed ( FIG. 10 ). A second fixation device can be placed in adjacent tissue if desired through the same or a separate incision. Because each of the fixation device prongs can be deployed individually and tension adjusted for each set of prongs, accurate remodeling of the soft tissue can be accomplished. 
     The present invention contemplates modifications to the tissue remodeling assembly and its components as would occur to those skilled in the art. It is also contemplated that processes embodied in the present invention can be altered, rearranged, or added to other surgical procedures or medical treatments as would occur to those skilled in the art without departing from the spirit of the present invention. 
     Unless specifically identified to the contrary, all terms used herein are used to include their normal and customary terminology. Further, while various embodiments of the tissue remodeling assembly, insertion tool, and fixation member having specific components, prongs, dimensions, and structures are described and illustrated herein, it is to be understood that any selected embodiment can include one or more of the specific components and/or structures described for another embodiment where possible. 
     Further, any theory of operation, proof, or finding stated herein is meant to further enhance understanding of the present invention and is not intended to make the scope of the present invention dependent upon such theory, proof, or finding. 
     While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is considered to be illustrative and not restrictive in character, it is understood that only the preferred embodiments have been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected.