EP2370013A1 - Fixation faciale sous-musculaire (fixation myo-osseuse) utilisant un dispositif de micro-incision à micro-vis, colles et adhésifs injectables et procédés et indications d utilisation - Google Patents

Fixation faciale sous-musculaire (fixation myo-osseuse) utilisant un dispositif de micro-incision à micro-vis, colles et adhésifs injectables et procédés et indications d utilisation

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Publication number
EP2370013A1
EP2370013A1 EP09761052A EP09761052A EP2370013A1 EP 2370013 A1 EP2370013 A1 EP 2370013A1 EP 09761052 A EP09761052 A EP 09761052A EP 09761052 A EP09761052 A EP 09761052A EP 2370013 A1 EP2370013 A1 EP 2370013A1
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EP
European Patent Office
Prior art keywords
facial
muscle
surgical method
bioadhesive
tissue
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP09761052A
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German (de)
English (en)
Inventor
Gary E. Borodic
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Individual
Original Assignee
Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of EP2370013A1 publication Critical patent/EP2370013A1/fr
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491—Surgical glue applicators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8875—Screwdrivers, spanners or wrenches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00792—Plastic surgery

Definitions

  • the present invention is directed to a method and supporting devices to accomplish soft tissue fixation in the face or other body regions for the purpose of treating movement disorders as well as accomplishing alteration of facial contour and position relative to supporting facial bone or elevating or contouring other body regioins.
  • a microincision microscrew device and methods of using the device in surgical procedures is described. Described herein are methods of osseous bolting and osseous screws for soft tissue elevation via deep facial plate compression fixation; suspension of upper, mid, and lower facial soft tissue structures; and other body regions. Described herein also are injectable materials that require puncture and no incision to accomplish suspension of upper, mid, and lower facial soft tissue structures; and other body regions.
  • Some embodiments of the present invention involve either a microincision or puncture as opposed to conventional larger tissue plan dissections. This results in rapid healing, reduced recovery period, and ease of use for the treated subject and the surgeon or physician.
  • Some embodiments of the invention use the concept that the a planar joint lies on the undersurface of facial and other muscles consisting of fibro fatty tissue which provides a low resistance plane for movement. This plane is targeted for alteration by screw or adhesive
  • »4847-8914-9445v4 material to elevate or proportionally alter, for example, cheek, jowl, and brow over facial bones, therefore creating a more vital and youthful appearance.
  • Facelift, brow lift, and mid facelift are all cosmetic procedures practiced and advocated by plastic surgeons for aesthetic improvement. These procedures involve various methods of subcutaneous tightening of the facial plane to achieve elevation of critical structures of the face such as the brow, jowl region, and cheek areas. Such elevations produce a more youthful and aesthetically pleasing appearance.
  • glue or bioadhesives are used as an injectable delivered into a critical anatomic tissue plane, i.e., between bone and the undersurface of muscle, followed by external manipulation.
  • a critical anatomic tissue plane i.e., between bone and the undersurface of muscle, followed by external manipulation.
  • the need for an incision is eliminated or radically reduced.
  • the invention described herein is directed to novel methods of fixating soft tissue to bone structures wherein the methods do not involve a hook mechanism or projection device to suspend the soft tissue. Instead, the instant invention is directed to a bolt or a screw-type device that is placed directly under a deep facial plane, such as the gala of the scalp, or the SMAS or suborbicularis orbital fascia or other portion of the body where the patient is in need of tissue elevation, support, or contouring. Additionally, certain bioadhesives can be used to accomplish similar goals. Surprisingly, the methods of the instant invention provide a large, highly noticeable, consistent in degree improvement in facial contour elevation in the cheeks, forehead, brow and jowls using a rapidly-performed small incision method which requires less tissue
  • Injectable fixation implants using tissue adhesive administered without surgical incisions but rather simple needle puncture represents another embodiment of the invention.
  • Certain embodiment of the present invention involve altering the anatomic origin, and/or structure of a muscle and enveloping tendon and fascial structure to achieve a surface contour change using specific small incision or even no incision fixation devices.
  • the gala or SMAS or other forms of deep or superficial facial connective tissue is fixated to bone by direct placement of a screw and, optionally a compression plate over the screw (which is analogous to a washer), such that the compression plate and screw or bolt are used to create a flush fixation of the soft tissue to the osseous tissue without free suspension of the soft tissue as by a hook or projection device.
  • the screws of the present invention require an incision size of from about 1 to about 15 mm per screw, preferably from about 1 to about 3 mm per screw.
  • Certain embodiments of the invention are directed to a surgical method for elevating and/or contouring facial soft tissue in a human patient in need thereof comprising altering or reinforcing attachment of muscle to underlying skull or facial bone by one or both of placing a screw through microincisions or injecting a bioadhesive to the undersurface of said muscle, thereby fixating said muscle and overlying facial soft tissue to said underlying skull or facial bone; wherein said facial soft tissue is elevated and/or a contour, a proportion, dynamic facial wrinkles, static facial wrinkles, and a movement pattern of said patient's face are redefined.
  • the screw comprises a compression plate or washer.
  • the screw is a self-tapping or self drilling screw.
  • the head of said impaled screw is positioned close to flush continuity with the osseous surface.
  • the head of said screw is convex or flat.
  • the compression plate is positioned close to flush continuity with the osseous surface.
  • the screw is placed into said underlying skull or facial bone with a screw wrench.
  • the skull bones are selected from the group consisting of maxillae, frontal, mandible, nasal, zygomatic and temporal bones.
  • screws of the instant invention may be comprised of a material selected from the group consisting of, but not limited to, hard silicon, porous polyethylene, ceramic, steel, titanium, gold, platinum, resorbable poly-L-lactic acid, polyglycolic acid, polymethyl methacrylate, and a composite of these materials
  • the soft tissue is selected from one or more members of the group consisting of facial muscle, gala, SMAS, subcutaneous facial tissue and periosteum.
  • the methods described herein comprise multiple points of fixation.
  • the compression plate may be comprised of an absorbable material selected from the group consisting of porous polyethylene, nylon, collagen, cyanoacrylate glue and hyaluronidatev.
  • the surgical methods are directed to elevated or contoured facial soft tissue that is the human brow or forehead.
  • the surgical methods are directed to elevated or contoured facial soft tissue that is the human midface or cheek region.
  • the surgical methods are directed to elevated or contoured facial soft tissue that is the human jowl region.
  • the bioadhesive is a cyanoacrylate.
  • the cyanoacrylate or an injection amount thereof is selected on the basis of its inflammatory response in patients.
  • the inflammatory response is less than about 5% of patients, preferably less than about 2% of patients, and most preferably less than about 0.5% of patients.
  • 2-cyanoacrylate 2-octyl 2-cyanoacrylate, 2-methoxyethyl 2-cyanoacrylate, 2-ethoxyethyl 2- cyanoacrylate, 2-propoxyethyl 2-cyanoacrylate, and combinations thereof.
  • the bioadhesive is absorbable, for example absorbable cyanoacrylate.
  • a tip of the injection is in the fibrofatty plane between facial muscle and bone, thereby creating a new muscle to bone adhesion not previously present.
  • the invention is directed to a surgical method for elevating or contouring tissue within the waist region in a patient in need thereof comprising the one or both of placing a screw through microincisions in the subcutaneous connective tissue, fascia, and muscle into an underlying pelvic bone or injecting a bioadhesive to an undersurface of said tissue, thereby fixating said tissue to said underlying pelvic bone; wherein said tissue is elevated and/or contoured.
  • the invention is directed to a surgical method for elevating or contouring soft tissue within the upper arm region in a patient in need thereof comprising one or both of placing a screw through microincisions in the subcutaneous connective tissue, fascia, and muscle into an underlying humerous bone or injecting a bioadhesive to an undersurface of said tissue, thereby fixating said tissue to said underlying humerous bone; wherein said tissue is elevated and/or contoured.
  • the invention is directed to surgical method for elevating and/or contouring tissue within a breast region in a human patient in need thereof comprising one or both of placing a screw through microincisions in the subcutaneous connective tissue, fascia, and muscle into an underlying clavicle bone or injecting a bioadhesive to an undersurface of said tissue, thereby fixating said tissue to said underlying clavicle bone; wherein said tissue is elevated and/or contoured
  • the invention is directed to a surgical method for elevating and/or contouring facial tissue in a human patient afflicted with facial paralysis comprising one or both of placing a screw through microincisions in the subcutaneous connective tissue, fascia, and muscle into an underlying facial, orbital or frontal bones or
  • the invention is directed to a surgical method for elevating and/or contouring soft tissue in a brow region in a human patient afflicted with blepharospasm comprising one or both of placing a screw through microincisions in the subcutaneous connective tissue, fascia, and muscle into an underlying facial, orbital or frontal bones or injecting a bioadhesive to an undersurface of said tissue, thereby fixating said tissue to said underlying facial, orbital or frontal bones; wherein said soft tissue in a brow region is elevated and/or contoured.
  • the invention is directed to a surgical method for reducing or preventing abnormal facial movement in a human patient in need thereof comprising one or both of placing a screw through microincisions in the subcutaneous connective tissue, fascia, and muscle into an underlying skull or facial bone or injecting a bioadhesive to an undersurface of facial soft tissue, thereby fixating said facial soft tissue to said underlying skull or facial bone; wherein abnormal facial movement is reduced or prevented.
  • the invention is directed to a surgical cosmetic method for reducing or eliminating facial wrinkles or rhytides in a human patient in need thereof comprising one or both of placing a screw through microincisions in the subcutaneous connective tissue, fascia, and muscle into an underlying skull or facial bone or injecting a bioadhesive to an undersurface of facial soft tissue, thereby fixating said facial soft tissue to said underlying skull or facial bone; wherein facial wrinkles or rhytides are reduced or eliminated.
  • the invention is directed to a screwdriver that is attached to an implantable self drilling device for the purpose of compressing soft tissue directly to skull table.
  • the invention is directed to a method comprising fixating a facial muscle to facial bone to decrease contractility of said muscle by immobilizing said muscle and causing a myo-osseous scar to thereby reduce or decrease dynamic facial lines or wrinkles.
  • the method is directed to the reduction of facial lines or wrinkles associated with aging.
  • said fixation is accomplished with a compression screw impaled through said facial muscle or the surrounding fascia.
  • said fixation is accomplished with a combination of a screw and bioadhesive accomplished via puncture or microincision.
  • the fixation is accomplished by inducing a scar by applying cautery, a lipolytic agent, radiofrequency, ultrasonic means, or laser energy to induce a scar within the pre-periosteal fat to fixate the undersurface of facial muscle to bone.
  • the fixation is accomplished using bioadhesive.
  • the bioadhesive comprises polymethyl methyacrylate, cyanoacrylate, a fibrinogen-thrombin combination, albumin gluteraldehyde combination, acrylic, or absorbable cyanoacrylate.
  • the dynamic facial lines are crowsfeet, glabellar lines or forehead transverse lines.
  • the invention is directed to a device comprising a metallic or ceramic screw shaft and a compression head, which when applied over the skin or through an incisional site, engages said screw shaft into facial bone to fixate facial muscle and decrease contractility of said muscle and induce sub-muscular scarring and adhesion of said
  • the device may be used to reduce dynamic facial lines or wrinkles that are crowsfeet, forehead lines or glabellar lines.
  • the device may further comprise bioadhesive.
  • the invention is directed to a surgical method for elevating and/or contouring facial soft tissue in a human patient in need thereof comprising altering or reinforcing attachment of muscle to underlying skull or facial bone by injecting a bioadhesive to the undersurface of said muscle, thereby fixating said muscle and overlying facial soft tissue to said underlying skull or facial bone; wherein said facial soft tissue is elevated and/or a contour, a proportion, and a movement pattern of said patient's face are redefined.
  • the bioadhesive is selected from the group consisting of fibrinogen, fibrin, thrombin, bovine albumin, collagen, gluteraldehyde, autogenous blood clot, polyethylene spheres, hydroxyappetite, onyx, polyethylene glycol based sealants, cyanoacrolyte, human serum albumin, and combinations thereof.
  • said fibrinogen, fibrin, thrombin, bovine albumin, collagen, gluteraldehyde or human serum albumin are recombinantly produced.
  • the invention is directed to a method of compacting and reshaping human muscles comprising steps of: injecting a bioadhesive into a muscle; allowing spreading and curing of said bioadhesive in said muscle; externally manipulating said muscle during bioadhesive curing; creating a synthetic connective matrix within said muscle; and altering a shape and volume of said muscle, thereby improving superficial contour, wrinkle pattern, proportionality, and/or volume of a body region.
  • the invention is directed to a method of compacting and reshaping human muscles comprising steps of: injecting a bioadhesive into a muscle; allowing spreading and curing of said bioadhesive in said muscle; externally manipulating said muscle during bioadhesive curing; creating a synthetic connective matrix within said muscle; and altering a shape and volume of said muscle, thereby improving superficial contour, wrinkle pattern, proportionality, and/or volume of a body region.
  • the bioadhesive is selected from the group consisting of fibrinogen, fibrin, thrombin, bovine albumin, collagen, gluteraldehyde, autogenous blood clot, polyethylene spheres, hydroxyappetite, onyx, polyethylene glycol based sealants, cyanoacrolyte, human serum albumin, and combinations thereof.
  • said fibrinogen, fibrin, thrombin, bovine albumin, collagen, gluteraldehyde or human serum albumin are recombinantly produced.
  • the invention is directed to method of altering the viable contractility of muscles to treat movement disorders comprising steps of: injecting a bioadhesive into a muscle;externally manipulating said muscle during bioadhesive curing; accomplishing an internal tethering of fibers within said muscle of fibers within said muscles to each other and to a synthetic connective matrix; and altering a shape and volume of said muscle, thereby decreasing contractility of the muscle to relieve symptoms of the movement disease.
  • the movement disease is selected from the group consisting of dystonia, cerebral palsy, painful spasmodic disorder, spasticity, development movement disease, scoliosis, chronic cramping, internal organ smooth muscle spasms, bladder spasticity, external bladder spasm associated with prostate hypertrophy, intentesinal spasms, esophageal spasms, and stomach spasms.
  • the bioadhesive is selected from the group consisting of fibrinogen, fibrin, thrombin, bovine albumin, collagen, gluteraldehyde, autogenous blood clot, polyethylene spheres, hydroxyappetite, onyx, polyethylene glycol based sealants, cyanoacrolyte, human serum albumin, and combinations thereof.
  • the fibrinogen, fibrin, thrombin, bovine albumin, collagen, gluteraldehyde or human serum albumin are recombinantly produced.
  • the invention is directed to a method of altering the viable contractility muscles to alter a surface contour or wrinkle pattern of a human body region comprising steps of : injecting a thermal cautery into the undersurface of a muscle;effecting fat coagulations and an inflammatory bioadhesion between muscle, bone, or muscle to muscle ; and altering a shape and volume of said muscle, thereby decreasing contractility of the muscle to alter a surface contour or wrinkle pattern.
  • the invention contemplates repeated injections.
  • Figure 1 Typical approach to face lift using skin resection and SMAS tightening.
  • the conventional facelift requires deep and superficial planes of dissection which are inherently more traumatic causing a greater degree of post-operative inflammation, and the potential for injury to critical vascular and nervous structures. Facial nerve injury is a serious complication of the conventional facelift.
  • Figure 2 Diagram of the human skull. Red indicates facial muscle attachment points to the skull. Facial muscle is part of the SMAS, facial muscle is in turn attached to the deep skin.
  • Figure 3 Improvement in facial contouring and cosmetic facial appearance.
  • Patient is a 72 year old female with a history of parotid cancer.
  • Patient underwent radical resection 20 years before pictures were taken.
  • she needed to have the entire facial nerve removed on the right side. Subsequently, the face became paralyzed with
  • Figure 5 Treatment of involuntary blepharospasm - improvement in cosmetic appearance and facial contouring. Patient is similar to the patient in Figure 4 with involuntary blepharospasm who underwent implantable soft tissue compression bolts in three locations Figure 5a. Figure 5b is her appearance one month post implantation showing substantial elevation of the brow and improvements in facial contour
  • Figure 6 Treatment of paralyzed eyelids for improved cosmetic appearance and facial contouring.
  • Patient is a person with paralyzed eyelids (Figure 6a) who underwent fixation of the lateral orbicular and surrounding connective tissues. This caused tightening of the lateral canthal tendon and elevation of the eyelid which improved cosmetic appearance facial contouring.
  • the procedure also increased the functional closure which was accomplished by a second weight implanted in the upper eyelid ( Figures 6b, 6c and 6d).
  • FIG. 7 Sagittal view of the human face trasecting the eye.
  • the white configuration under the skin represents f ⁇ brofatty tissue.
  • the f ⁇ brofatty tissue is seen anterior and posterior to facial muscles and below the eye.
  • the figure illustrates the extent of the pre- periosteal, sub-aponeurotic and sub dermal fat can be seen on the magnetic resonance image of the forehead scalp and skull table.
  • the Tl weighted image demonstrates the high contrast fat layer in the pre-periosteal, sub-aponeurotic region and in the anterior region of the orbicularis frontalis muscle region above the eyebrow.
  • the fat pads in front and behind the muscle represent a low resistance "sandwich" by which these facial muscles move without substantial resistance.
  • Increasing friction within these fat planes by fixation or scarring alters tone and contractility of the muscle leading to surface changes and changes in functional performance
  • Figure 8 Map of the human facial anatomy to identify facial muscles and enveloping fascia subject to the micro incision screw or glue injection.
  • Figure 9 Demonstrates the vast area of facial bone not containing an origin of a facial muscle or a critical nerve or vessels at risk from the screw placements.
  • Figure 10 Displays muscles that could be subject to fixation, redirecting support of the facial muscular mask
  • Figure 11 Displays endomysium of a muscle.
  • Figure 12 Displays areas where glue can influence intermuscular adhesion and intramuscular cohesiveness to effect contour and surface changes on the human head and neck region.
  • Figure 13 This patient underwent treatment for blepharsopasm using a myo- osseous fixation procedure. Unlike prior procedures the fixation was accomplished with a cyanoacrylate glue (2-Octyl cyanoacrylate). Post operatively blpeharsoapsm was 90% improved in the first week. Lateral orbicularis muscles fixation accomplished with tissue glue was excellent and functioned in lieu of an mechanical fixation device to tether muscle to bone and effect improvement of involuntary eyelid closure. Serendipitously, the crowsfeet wrinkle pattern usually present in this location was significantly improved.
  • a cyanoacrylate glue (2-Octyl cyanoacrylate).
  • the "superficial muscular aponeurotic system” or (SMAS) refers to an area of musculature of the face. This muscular system is manipulated during facial cosmetic surgery, especially rhytidectomy.
  • a "self-tapping or self drilling screw” is a screw that has the ability to advance when turned, while creating its own thread.
  • Self-tapping or self drilling screws are commonly used with sheet metal and plastic components. This ability is created sometimes by having a gap in the continuity of the thread on the screw. These edges can cut their own threads as the screw is driven into the material, usually wood or plastic.
  • Self tapping or self drilling or self drilling screws also exist for metal. They function by having a cutting edge which drills away the material, making a hole for the screw to go into. Self tapping or self drilling screws are most useful when doing metal and wood work.
  • a “compression plate” is a surface that squeezes, compresses or pushes layers of soft tissue directly against bone to thereby cause fixation of the tissue, inclusive of muscular tissue, and alters the muscular tissue's relation to a low-friction perimuscular environment.
  • the term "flush continuity with the osseous surface” means the screw or compression plate is placed tightly against bone such that the degree of palpable ridge from the skin surface is minimized.
  • bioadhesive is any liquid or gel which when placed in a plane between muscles and bone causes adhesion. This allows a plastic surgeon to remodel the soft tissue to bone using free movement of the muscle overlying the bone facilitated by the low resistance fibro fatty plane underlying the muscle. A bioadhesive is able to be injected under muscle. This allows adherence of muscle to the bone structure which in turn alters the origin of the muscle, functional contractility of the muscle, and support of overlying soft tissues generated by muscle tone and support.
  • low resistance plane or “low friction plane” is the fibro fatty plane between bone and the undersurface of a muscle overlying the bone.
  • skin puncture is a puncture through skin made with a medical needle between 4-32 gauge.
  • a skin puncture is made with a medical needle between 25-30 gauge.
  • small incision is an incision less than 10 mm. In a preferred embodiment of the present invention, a small incision is less than 3 mm.
  • external manipulation after bioadhesive injection refers to movement of soft tissues (or muscle) over bone, facilitated by the low resistance fibrofatty tissue plane underlying the muscle, which is performed after injection of a bioadhesive. This allows binding of the undersurface of the muscle to bone thereby creating an alteration of surface soft tissues with respect to proportion, contour, function, skin wrinkle pattern, elevation, or other configuration desired by patient or surgeon.
  • a "method of injection as to avoid nerves, arteries, and veins" refers to anatomic knowledge possessed by the surgeon, which contemplates natural variations of usual and unusual positions of critical nerves and vessels which can be injured by microincisions, implantable devices, or injections of bioadhesives.
  • body proportionality refers to size or volume of a body region relative to another body region. For instance, upper cheek size relative to lower cheek size, upper neck size relative to lower neck size, and buttock size relative to thigh size, and so on.
  • muscle compacting or “muscle reshaping" by bioadhesive, refers to the process of injecting a muscle with a bioadhesive and shaping the muscle to alter the contour of the face or other body part by external manipulation, by which the injected bioadhesive functions as a connective synthetic matrix replacing the lax collagen forming endomysium, perimysium, and epimysium.
  • cautery refers to another approach to cause fixation of muscle to bone.
  • the method involves application of cautery via fine needle to the undersurface of the muscle, which results in fat deletion and contraction followed by inflammation and scarring in deep facial layers, or other body part layers. The result is an adhesion endogeneously created by the body, which results in adhesion and alteration in surface configuration.
  • the cautery can be unipolar microbipolar, or battery powered device which transmitted energy through a puncture site to the undersurface of the muscle which created a adhesive scare. This method may be used singly or in conjunction with screws or bioadhesive methods as described elsewhere in this disclosure.
  • agents include bile acids or bile salts or other such agents which achieve lipolysis
  • Use of physical energy systems such as radiofrequency or ultrasonic devices can also be used to dissolve fat cell membranes. This diminishes the fatty layers surrounding the muscles and
  • the "origin" of a muscle is the point at which it attaches to a bone or another muscle.
  • the structure that the origin is attached to is not moved by contraction of the muscle.
  • the opposite end of the muscle is the insertion.
  • the "insertion" of a muscle is the point at which it attaches to the skin, a bone, or another muscle.
  • the insertion attaches the structure that will be moved by the contraction of the muscle.
  • the opposite end of the muscle is the origin.
  • altered origin or insertion of a muscle is creating an adhesion of muscle in area, for example in an area of bone, where normally no adhesion is present.
  • the screw plate screw and the compression fixation plate can involve the use of tapping or self-tapping or self drilling or self drilling screws that are placed in a strategic area in such a fashion that a facial plane is compressed.
  • the facial plane could include the gala or the
  • the gala if used, is fixated to the skull over the frontal bone medially or laterally to achieve brow elevation, or over the zygomatic bone to achieve mid face and lower mid face elevation, and in regions of the zygoma or the mandible and jowl elevation.
  • Such screws are designed so that full penetration to the skull over the neurocranium does not occur.
  • the length of such screws can vary from between about 0.25 mm to about 10 mm, and preferably from about 2 to about 8 mm for skull and facial bones. In another embodiment, the length of such screws can vary between from about 1 to about 50 mm, depending on the body region of interest.
  • the screw is customized to the portion of the skull being used. Thicknesses of the skull are determined anatomically and also with neuroradiography using computerized axial tomography for design.
  • the screws are placed with a fixation wrench after a small incision is made, and adequate mobilization of the subcutaneous connective tissues are accomplished. This can be done with the patient awake, unlike former procedures for brow lifts in which the patients are often under general anesthesia.
  • the fixation points are marked off and local anesthesia is used with diffusion enhancing agents such as hyaluronidase.
  • Alternative forms of anesthesia involving regional nerve blocks are also possible to limit soft tissue distortion so that the osseous fixation can be more accurately accomplished.
  • the facial plane is dissected and a small buttonhole is placed through the facial plane.
  • the facial plane is then pulled to a desirous location and the bolt is placed into the bone, essentially lifting soft tissues below.
  • brow lift this is done in a fashion to achieve both accurate elevation and contouring of the brow.
  • the placement is over the zygoma, fixating the suborbicularis fascia to points of fixation on the lateral orbital
  • the compression plate used is a conventional washer over a screw, to achieve a large platform fixation over bone to further enhance the strength of the elevation and fixation point.
  • Screws may be absorbing or non absorbing materials.
  • Preferred materials include titanium, stainless steel, or absorbable material such as chromic, nylon, polymethylmethacrylate, or hardened forms of silicone.
  • Glue arrangements may be arranged with various forms of epoxy to further enhance fixation of the screw's endplate.
  • the screw and/or compression plate may be used in combination with a glue or adhesive.
  • the glue may not only cause an increase in tensile strength of the screw's attachment to the bone, but also may cause adherence of the undersurface of the facial or targeted muscle to the bone. It is important to note that in order to facilitate natural contour and feel over a healed wound, the screws are placed flush with the skull so raised elevations are minimally perceived by the patient, or any potential observer.
  • Advantages of such approaches include a small incision or needle puncture incision with minimal suture closure and minimal surface scarring.
  • Diameter of screws can vary from between about 0.25 mm to about 4 mm, depending on the fixation point.
  • the head of the screw can vary from between about 0.25 mm to about 10 mm in diameter.
  • the screw washer plate can vary in size from about 2 mm to about 25 mm in diameter, preferably between about 2 mm to about 10 mm in diameter. It can also have various
  • Screw head configurations can be philips, linear or any geometric configuration which enhances mechanical integration to the driver.
  • the driver must be able to fixation the screw head in such a fashion to allow impalement of the facial plane to be fixated so that the deep or superficial facial planes can be elevated and fixated along a higher position on the facial bones.
  • blepharospasm patients suffer from involuntary contractions of the orbicularis muscles.
  • the orbicularis muscle has three basic segments: pre-tarsal, pre-septal, and pre-orbital.
  • the pre-orbital section is the most well developed, eliciting the most forceful contraction on stimulation.
  • the origin and insertion of this segment of this muscle are the medial canthal ligaments and adjacent bone.
  • Proprioceptive sensory feedback to the central nervous system may be changed such that involuntary movements are mitigated
  • fibers in the pre-orbital segment are oriented in a circular fashion except at medial points of attachment to tendon and bone.
  • the titanium peg, or screw, or bolt or self-tapping or self drilling or self drilling screw, or compression plate or bioadhesive re-orients the fibers into a direction such that the fibers are no longer circular in orientation but rather, obliquely configured as well as fixed to the undersurface of the bone, thereby producing immobilization of the fibers.
  • This change in orientation and configuration depresses the contractility of the muscle, thereby altering function as well as surface appearance of the region.
  • This arrangement also increases the frictional surface under the muscle to thereby restrict muscle contraction and increase inertia to movement.
  • Elevating the brow further functions to fixate the orbicularis to the frontal bone along the superior orbital rim both medially and laterally.
  • the orbicularis muscle is a sphincter muscle that works by closing space in the middle.
  • the effect of fixating the orbicularis muscle is to increase resting tension on the muscle fibers much like pulling on the inside of an elastic band. This fixation of the orbicularis muscle prevents sphincter muscle contraction.
  • the method and technique require use of a sharply tapered screw or pin capable of penetrating both soft tissue and bone structure without undue trauma to surrounding tissues.
  • a sharply tapered screw or pin capable of penetrating both soft tissue and bone structure without undue trauma to surrounding tissues.
  • firm fixation of the compression pin, screw head, or screw plate is necessary. This allows adequate control of placement which is critical to appropriate soft tissue osseous integration and fixation which drives the change in surface structure elevation and contour changes.
  • the driver must firmly grasp the screw head via a circular holding device which is adequately tapered to fixate the screwhead and attach the head to the driver.
  • a circular holding device which is adequately tapered to fixate the screwhead and attach the head to the driver.
  • Such devices which may be referred to as “screw wrenches,” “fixation devices,” or “fixation wrenches” herein are conventionally engineered to the placement of screws to fixed fracture plates, however such
  • Screw driver wrenches used for bone plates for fracture repair can be adapted to achieve this soft tissue function via a micro-incision to snare, impale and ultimately fixate connective tissue directly into the bone structures under a compression plate.
  • the screw wrench can resist lateral torque produced by the surgeon's hands and therefore can hold the screw in tight potion allowing directional control.
  • the screw wrench can secure a screw at different angulations. Analogy is made between the screw wrench and screw to the surgeon's needle holder and needle.
  • the needle must be held with precise control and fixation in order to avoid impaling or otherwise hurting, for example, arteries, veins, eyes and the like.
  • the screw head In the case of screws, the screw head must be able to resist substantial torques and forces, for example substantial lateral torques on the screw head.
  • the screw cannot be allowed to "tiddlywink" away from the surgeon's desired placement. It is contemplated that repeated adjustments of the screws may be possible or necessary.
  • An example of a fixation system is given in Figure 3c.
  • the implantable device consists of a compression plate (screw head with and without washer ring), and drilling-fixation shaft for soft tissue stabilization.
  • the drilling shaft may vary from 1 mm to 50 mm, preferably 2 mm to 8 mm when used on the facial or skull bones.
  • the diameter of the drill shaft may vary from 0.2 mm to 10 mm, but is preferably 1 mm to 3 mm.
  • the compression plate may substantially vary in size and configuration, however it is
  • Compression plates can vary between 3 cm to 1 mm.
  • Depth of penetration into the skeletal structure may result in unnecessary pain and risk of the insertion and soft tissue fixation procedure.
  • Use of screw lengths appropriate to the anatomic thickness and position of the bone is critical in preventing excessive penetration of the fixation shaft of the compression screw and plate to the bone, excessive penetration may:
  • the facial muscles are contained within the superficial muscular aponeurotic system as has been described above.
  • the connective tissue (collagen) component of this tissue becomes increasingly lax resulting in diminished support of soft tissues associated with sagging.
  • Tissues may also intrinsically age with fat redistribution, muscle atrophy, bone remodeling and dermal laxity.
  • An age related change often not cited on the human face is integrity and strength of deep facial muscle attachment to the facial and skull bone. These tissue origins essentially hold the highly motile SMAS to the bone lending support to facial movement and resting facial position.
  • the implantable devices described herein provide a method for increased facial muscular support which leads to alterations in facial contour and surface configuration in a more youthful and vital direction. Reinforcement of natural attachments (muscle origins) results in more youthful and functional performance of facial muscles, as well as other muscle groups targeted for attachment reinforcement. Natural critical attachments can be studied for optimum placement of implantable devices. Bioadhesives
  • an injectable material preferably comprising a substantially inert material with quick drying dynamic is used.
  • This injectable material is capable of sustaining a strong adhesion between the undersurface of facial muscle and underlying bony structures. This allows for fixation of the muscle and support. This muscle fixation is useful to control involuntary movements and also to allow for support of soft tissue to restore a youthful and aesthetically original contour surface structure to the human face.
  • the method reduces or eliminates wrinkle patterns during dynamic facial movements.
  • targeted areas would include placing the glue over the surface of the frontal bone, zygomatic and lateral orbital bone, face of the maxillae, and rim anterior or posterior surface of the mandible.
  • the amount of glue injected should be limited by inflammatory response, surface bumps or bulging, and anatomic consideration to avoid nerves, arteries and veins. Multiple injection sessions over a defined period of time can limit the risk of uncontrolled spread of the glue and excessive
  • FIG. 8 A map of the human facial anatomy is given in Fig. 8 to identify facial muscles and enveloping fascia subject to the micro incision screw or glue injection.
  • Fig 9 demonstrates the vast area of facial bone not containing an origin of a facial muscle or a critical nerve or vessels at risk from the screw placements.
  • any of the listed muscles could be subject to fixation, redirecting support of the facial muscular mask (see Fig. 10) .
  • These muscles with attachments and enveloping fascia comprise the foundation for the individual contour,
  • FIG. 10 display the characteristic taper or V-shape of the human skull and face.
  • the overlying soft tissue tends to sag as humans age, thereby distorting the natural shape and proportionality of the human face. Methods and devices described herein can correct or counteract this distortion.
  • the correct anatomic plane of the injection must include the fibro fatty plane between the undersurface of the facial muscle or other anatomically defined muscles and the underlying bone covered by periosteum.
  • This plane should be fixated by either injectable glue, placement of compression screw or fixated by adhesion based implant for the purpose of altering contractility of muscle, and/or altering facial contour, and/or influencing wrinkle patterns of skin during dynamic muscular activity.
  • the optimal method is least invasive, requiring the smallest incision. In one embodiment, the incision is merely a puncture site.
  • Any anatomic plane between bone and muscle represents an important target for reducing muscular activity by increasing friction, inducing tethering, and functional resistance to the internal forces produced by the muscle itself.
  • Internal muscular activity is conventionally defined by neuromuscular relationships, muscle mass, and effective chemical reaction between actin and myosin proteins.
  • bioadhesive or glue types which can be used in various embodiments as an injectable to achieve myo-oseous fixation to control contour changes, wrinkle pattern reduction, and/or elevation of the human face via injection
  • agents are qualified by adhesive properties, inflammatory response and duration of adhesion.
  • #4847-8914- 9445v4 34 based products limit potential contamination with hepatitis B, C and HIV as well as prion based disease.
  • Fibrin based sealant have the potential to induce growth factor for fibrocytes which can enhance sealing capability over time. These materials can control bleeding which can be beneficial when injected into a vascularized muscle.
  • sealant consist of purified albumin with gluteraldehyde which when mixed forms a covalent bond between the matrix and cell surfaces.
  • BioGlue-TM is a non-limiting example.
  • Non-limiting examples are 2-octyl cyanoacrylate, N-butyl 2 cyanoacrylate, and absorbable cyanoacrylates, known under the trademark OMNEX-TM. These agent can effectively stop bleeding. Binding strength is better than fibrin based sealants. Low volume of agent can be effective. Inflammatory potential can potentially enhance long term nature of seal when place under a thin facial muscle. Absorbable cyanoacrylates such as OMNEX ,ay be preferred based on reversibility and lack of long term potential for scarring and foreign body reactions. The use of cyanoacrylate is described in more detail below.
  • plasma polymerized N-isopropyl acrylamide p ⁇ IPAM
  • p ⁇ IPAM plasma polymerized N-isopropyl acrylamide
  • O ⁇ YX-TM are suitable bioadhesives for the present invention.
  • Cyanoacrylate glues are well known adhesives which are known to produce strong bonding during polymerization and forming tight bonding with a degree of heat release. Medical applications have commonly included skin approximation as an alternative to conventional sutures for which the material is currently commercialized. Deep tissue implantation has also been advocated for neural trunk repair during soft tissue surgery, vascular repair, fixation of extraocular muscles to the ocular globe or implanted prosthesis after globe removal, embolization for vascular malformation using neuroradiologic techniques. [00112] Major concerns from regulators have included excessive inflammatory reactions from chemical breakdown of implanted glue which can form formaldehyde, a chemical toxic to tissues. Heat generation during polymerization and hardening has also been noted but represents a lesser problem.
  • cyanoacryolate derivative which have a reduced rate of formaldyhyde generation.
  • Non-limiting examples of cyanoacrylastes suitable for use with the present invention included: alkyl 2-cyanoacrylate, alkenyl 2-cyanoacrylate, alkoxyalkyl 2- cyanoacrylate, and carbalkoxyalkyl 2-cyanoacrylate.
  • the alkyl group may have 1 to 16 carbon atoms and is preferably a Ci -C 8 alkyl 2-cyanoacrylate.
  • Suitable cyanoacrylates include, for example, methyl 2-cyanoacrylate, ethyl 2-cyanoacrylate, n-propyl 2-cyanoacrylate, iso-propyl 2- cyanoacrylate, n-butyl 2-cyanoacrylate, iso-butyl 2-cyanoacrylate, hexyl 2-cyanoacrylate, n-octyl 2-cyanoacrylate, 2-octyl 2-cyanoacrylate, 2-methoxyethyl 2-cyanoacrylate, 2-ethoxyethyl 2- cyanoacrylate and 2-propoxyethyl 2-cyanoacrylate, methyl .alpha.-cyanoacrylate, ethyl .alpha.- cyanoacrylate, propyl .alpha.-cyanoacrylate, butyl .alpha.-cyanoacrylate, and cyclohexyl .alpha.-
  • a preferred cyanoacrylate is 2-octyly cyanoacrylate because of its slow degradation and reduced rate of formaldyhyde generation.
  • multiple forms of delivery devices may be used to inject adhesives through a puncture site for the purpose of glue placement in the defined fibro fatty plane on the undersurface of the muscle tissue.
  • These include pref ⁇ lled syringes with sterilized liquid adhesive which remain air tight until the moment preceding use.
  • Tube enveloping containers capable of deilivering a fixed volume of liquid adhesive also may be used.
  • Diaphragm shaped containers containing a fixed amount of glue may alos be used. Any container forms mentioned are not limiting as multiple devices are possible so long as the device maintains sterility of the injectable and is able to deliver a fixed and consistent volume of adhesive agent.
  • a class of cyanoacrylate glues characterized as "absorbable tissue glue” has been advanced and advocated.
  • a limiting factor of cycanoacrylate glues is granuloma formation from breakdown into toxic subcompoents such as formaldehyde.
  • Glue designed to absorb with lesser chances of foreign body inflammatory reaction have lesser chance to induce this form of complication and have improved tolerability.
  • the mechanical adhesion may be temporary, adjuctive inflammatory reaction from single or multiple injections can induce fibrosis which can function as an endogenous glue and adhesive achieving the sam e effect as an foreign substance. The net effect would be to create a more permanent or lasting adhesion.
  • a device is a linear implant with extending side barbs.
  • the extending side barbs may be hard and stiff, and may be of various lengths relative to the length of the linear implant.
  • the clinician injects the liquid adhesive, it would be important to manipulate the soft tissue overlying the bony surface over which the injection has been administered so that the alteration in contour and suspension is placed in a desirable configuration.
  • the method of application using a liquid adhesive would be organized in the following steps:
  • the amount of glue or adhesives used is limited by the critical amount which will cause inflammatory, granulomatous reactions or excessively cuase tissue contractions with dimpling of the skin surface. In one embodiment, the amount may vary from between about 0.001 mL to about 10 mL per injection site.
  • the amounts may vary (all given on a per injection site basis) from between about 0.001 ml to about 8 mL, from between about 0.001 mL to about 6 mL, from between about 0.001 mL to about 4 mL, from between about 0.001 mL to about 2 mL, from between about 0.001 mL to about 1 mL, and from between about 0.001 mL to about 0.5 mL.
  • the amount per injection site is between about 0.1 mL to about 0.2 mL. Multiple injections are needed depending on the
  • #4847-8914- 9445v4 41 targeted region and strength of adhesion sought per given anatomic region. Multiple injection point per region are anticipated.
  • the device comprises a single use device comprising a needle or micropuncture device, with a bioadhesive, for example but not limited to, cyanoacrylate glue.
  • a bioadhesive for example but not limited to, cyanoacrylate glue.
  • Other forms of bioadhesives or tissue glues such as thrombin fibrinogen may involve compounded needle bores with individual ports corresponding to a given component of the glue substance needed for curing.
  • a syringe with predetermined injection neddle or micropuncture would be the preferred embodiment of the delivery system with the intention for single puncture per syringe use.
  • a multiple use delivery syringe may be used for more rapid administration techniques.
  • some embodiments of the present invention may make use of intramuscular glue to establish a support to the endomysium, perimysium, and/or other intramuscular and intermuscular support of connective tissue.
  • the function is to compact muscule groups, alter intermuscular adhesions, and/or elevate muscular dissent with repect to bone and intermuscular attacvhments for the purpose of elevating, tightening and altering the contour of surface structures for aesthetic purpose.
  • #4847-8914- 9445v4 42 type of application is gluing the submental platysmal muscle to the digastrics muscles for the purpose of improving the angulation between the neck and undersurface of the jaw.
  • the glue in this situation is placed between a flat flimsy muscles which is poorly compacted by aging collagen within the muscle proper to the well compacted and well supported deeper muscles effectively compacting the muscle groups and achieving a more youthful surface appearance.
  • Similar enhancement of the jowl tissues to deeper muscle fascia of the temoralis muscle can be used to elevate the jowl region and gluing the lower portion of the jowl to digastric, sternomastoid, sclene muscles effectively achieve the same purpose.
  • Glue may be placed over the masseter muscles, into adjacent parotid gland, or related fascial surfaces.
  • Direct injection of glue into muscle functions to causes a compacting effect on the muscles volume. This is accomplished by providing a sunthetic matrix which function like the natural endomysium of the muscle as shown in Fig. 11.
  • the muscle endomycium is structurally supported by collagen protein which loosens with age.
  • the synthetic matrix serves to reinforce the lossening supporting structure within the muscle allowing the injecting physician and surgeon to control the muscle volume and supporting surface contour formed by muscle volume.
  • the glue needs to be diffusely distributed throughout the target muscle followed by external surface manipulation to shape and contour the muscle to an appropriate and desired configuration. Care must be placed not to allow glue to cure at puncture or micro incision sites as healing can be impaired allowing a conduit for infection.
  • Bioadhesives injected via puncture with needle or micro incision within muscle can function as a synthetic perimysium, endomysium and epimysium for a targeted muscle or muscle group. Bioadhesive injection directly into a muscle can create a restriction of
  • the glue may be for instance, placed under the platysma muscle to flatten neck bands, to decrease volume of the platysma muscle, and to effect a compression of the platysma muscle to the firmly adherent digastrics muscles and muscles in proximity to the hyoid bone, causing a more youthful acute neck angle and a reduction in the hanging jowl.
  • deeper injection of glue into the masseter muscle can be used to compress this muscle reduce its volume and reduce a square lower face deformity commonly seen with aging.
  • the masseter muscle accounts for a substantial portion of the lower face volume.
  • the methods and materials described herein are ideal for accomplishing a mid face lift.
  • the SMAS layer encompasses the zygomatic major and minor muscles as well as adjacent facial muscles.
  • the malar eminence is formed by the zygomatic bone which contains
  • the zygomatic major and minor muscles are impaled with associated SMAS with the self-tapping or self drilling or self drilling screw via a small incision site over the lateral orbital region in the vicinity on or superior to the zygomatic bone.
  • the muscles associated with its surrounding fascia are elevated and fixated superior to the malar eminence effectively lifting the attachments (insertions) of the zygomaticus muscles (malar eminence) and fixating the soft tissue lift to the facial bone.
  • Once fixation has been established supporting fixation can be accomplished by use of one or more additional self tapping or self drilling compression fixation bolts to the bony platforms in this region. Additional self tapping or self drilling bolts may be placed in small incisions in the nasolabial fold, or inferior orbital rim, along natural cutaneous tension lines in order to increase fixation under small cutaneous puncture sites.
  • the concept of osseous soft tissue integration under a screw head or compression plate can be applied outside the facial regions.
  • age-related breast sagging breast ptosis in the female
  • Use of compression fixation to the clavicle via deep fascial can serve as a method to treat breast ptosis.
  • Ptosis defined as progressive dropping of the apex of the breast with age, can be modified with volume expanders such as breast implants (for example, silicone gel implants) as well as superior suspension with fascial fixation.
  • osseous fixation can be used to modify breast
  • #4847-8914- 9445v4 45 contour that is relative configuration of tissue curves by fixation to ribs, sternum or clavicle.
  • Small incisions can be made under the clavicular region and the superficial and/or deep fascial can be impaled by the self-tapping or self drilling screw system and fixated to the inferior border of the clavicle creating effectively a breast lift.
  • Self-tapping or self drilling screws within this anatomic region for such a procedure by necessity should be longer than those used on the facial region so that this larger anatomic region can be adequately fixated.
  • Fixation point should be the inferior, inferior anterior or anterior surface of the clavicle, the rib or the sternum.
  • the clavicle and sternum are relatively immobile fixation points (as are the facial bones and pelvis) and serve as excellent regions for soft tissue osseous fixation under a compression plate or screw head.
  • Example 3 Adaptability of Techniques to other Body Regions - Buttock Elevation [00128] Buttock elevation and contour changing can be accomplished with osseous fixation using compression plates or self-tapping or self drilling screw fixation to pelvic osseous ridge both superiorly and posteriorly.
  • Use of soft tissue compression over regions not containing critical nerves or vessels allows safe fixation tissue contouring and/or contour curve alterations.
  • Adjunctive elements to the compression plates may include suspension cables passed through soft tissue to achieve a greater lift. The cable extensions may be fixated to the compression screws.
  • Alteration of bulge around the waist line may be accomplished via multiple soft tissue compression plates to the upper portions of the pelvis effectively reducing waist bulge.
  • Example 5 Adaptability of Techniques to other Body Regions - Floppy Posterior Arm Soft Tissue Contour Fixation
  • Soft tissue fixation may be enhanced using a tissue fixation cable passed through a soft tissue structure and stabilized under a fixation plate.
  • a tissue fixation cable passed through a soft tissue structure and stabilized under a fixation plate.
  • An example would be a non absorbable material such as orolene fixated to a compression plate, or screw head on the underside of the mandibular bone to reduce jowl contour with the fixation cable passed across the submandibular region to the fixation screwhead on opposite side to sling the submandibular region causing enhancement on angulations of the neck, an aesthetically more youthful appearance.
  • the fixation screw not only improves the contour of the jowl region but also serves to be an anchor for a suspension cable or suspension mesh.
  • Chronic facial palsy can have major impact on quality of life resulting from disfigurement from asymmetric facial movements and laxity of facial structures at rest. The latter situation results in brow ptosis, dropping angle of the mouth and cheek asymmetry.
  • Reasons for chronic facial palsy include Bell's palsy, traumatic skull injury, surgery (for example, acoustic neuroma resection), Ramsy Hunt syndrome, Mastoiditis, Lyme disease, stroke as well as other nosologic entities.
  • Treatment of paralyzed lid closure associated with facial paralysis often involves the use of an implantable gold weight into the upper lid which serves to aid in closure of the eye with the normal blink.
  • the weight works on the principle that the levator palebrae superioris muscles have the natural brainstem impulse momentarily turned off during lid closure occurring during a natural blink.
  • the gold loaded lid is much heavier than the normal lid and the weight is projected away from the fulcrum point on the superior surface of the eye, hence torque is
  • Benign essential blepharospasm is a condition characterized by involuntary closure of the eyelids in the absence of primary eye disease. This condition, although treated with various medications, often requires surgical management. The surgical management may include brow lift. The condition is also characterized by a phenomenon known as geste antagonist. Geste antagonist is a French derivative word construction to describe a rubbing gesture on the brow or near the brow region which mitigates the involuntary movements.
  • compression screw or compression plate can provide a nidus or point source for sensory stimulation often self-applied by the patient to relieve symptoms. Additionally brow lifting surgery is often a component of various surgical procedures which are used for therapy of this condition.
  • the compression plate has been used in complicated management problems in patients afflicted with blepharospasm who have failed conventional therapy. The procedure is minimally invasive with quick recovery time.
  • Myo osseous fixation accomplished by screw fixation devices, various forms of tissue glue, or scarring sclerosis agents or other methods to fixate facial muscles to bone can be used as a method to reduce static and dynamic frown lines crows-feet lines, transverse forehead wrinkles, cheek wrinkles, as well as alterations in facial cheek, jowl, chin, and lip contours.
  • the principle creating this effect is weakening muscles that create lines in the surface associated with facial expression. Such lines and wrinkles are associated with aging and suppression of the appearance of such lines has been deemed pleasing to many of the middle aged and elderly population.
  • Dynamic lines are associated with the contraction of muscle, for example during smiling, crows-feet lines may appear.
  • Static lines are those that are not associated with contraction of muscle.
  • crowsfeet can be eliminated or reduced by pinning lateral orbicularis muscle to lateral orbital rim or surrounding bones
  • glabellar lines can be limited by fixating glabellar muscles to the glabellar bone
  • frontalis fixation into frontal bone can limit transverse forehead creases.
  • fixation glue - like substances can be used to fixate facial muscle to bone, as well as create scarring in the fibro fatty lubricated sub- muscular tissue plane which can result in decreased facial motility, reduce unwanted facial movement and treat static and dynamic facial lines (such as those in the facial glabellar region, lateral orbital crow's feet, and the transverse lines in the forehead).
  • the principle creating facial lines is weakening muscles that create lines in the surface associated with facial expression. Such lines and wrinkles are associated with aging and suppression of the appearance of such lines has been deemed pleasing to many of the middle aged and elderly population. Dynamic lines are associated with the contraction of muscle, for example during smiling, crows-feet lines may appear. Static lines are those that are not associated with contraction of muscle.
  • Tissue glue can be made of various substances, such as polymethyl methyacrylate
  • cyanoacrylates as well as a fibrinogen fibrin conversion with human thrombin.
  • glues may be used in addition to bolting devices to achieve a reduction in facial tone, movement, and surface wrinkles as well as to alter facial configuration such as contour, cheek browlift, chin alteration, lip augmentation.
  • tissue glue is available as Tisseel- TM, (fibrinogen-thrombin to fibrin) double chamber arrangement, 2 octly cyanoacrylate, n-butyl cyanoacrylate, as well as other formulations of cyanoacrylate mentioned herein. .
  • the use of glues and adhesive devices within the pre-periosteal fat layers of the facial bone can be useful in altering facial contours such as configuration and shape of the malar eminences, jowl configuration, forehead configuration as well as submental contours (under the mandible and chin).
  • facial contours such as configuration and shape of the malar eminences, jowl configuration, forehead configuration as well as submental contours (under the mandible and chin).
  • To accomplish alteration in jowl configuration and hanging fixation is accomplished using between 1-8 compression botls on each side (preferably lor 2 per side) fixated to undersurface, outer surface or internal surface of the mandible, with care taken to avoid the mandibular branch of the facial nerve.
  • the location best be close to the symphesis of the mandible or the angle of the mandible.
  • bioadhesives may be injected followed by mechanical support allowing fixation of the facial muscles to the mandible and therefore altering configuration of the jowl.
  • Mechanical support may involve a temporary compression bandage or manual fixation and support by the surgeons hand.
  • submental skin hang "loose turkey neck syndrome” can also be treated with submental support allowing facial muscle adhesion to bone. Wrinkles within the neck region may also be addressed with a similar method. Lip rotation may also be accomplished allowing for eversion of the red fleshy lip by fixing the orbicularis ori muscle to bone. It is anticipated that various method of face
  • glues may be used independently or with other fixation devices such a bolts, screws, screw washer arrangements to achieve, screw with expendable heads, or fixation plates.
  • fixation devices such as bolts, screws, screw washer arrangements to achieve, screw with expendable heads, or fixation plates.
  • Glues or other fibrosis inducing agents can be place under the facial muscles producing the dynamaic lines so that the lines or wrinkles can be reduced.
  • Example 12 Myo-osseous integration with compression plate for the treatment of blepharospasm (specific procedure)
  • the orbiclaris oculii is conceptually divided into three components, the pre-tarsal, pre-septal and the pre-orbital components.
  • the pre-tarsal and pre-septal components generally contribute to voluntary and involuntary blinking whereas the pre-orbital contributes to voluntary squeezing of the eyelids.
  • Involuntary contraction of the pre-orbital components accounts for the severe squeezing associated with various forms of involuntary blepharospasm and serves as the target for the surgical modification.
  • the orbiclaris muscle is a sphincter muscle receiving innervations from temporal, zygomatic and buccal branches of the facial nerve and originates from the maxillary process of the frontal bone and the medial canthal tendon, fibrous lacrimal sac, and posterior lacrimal crest.
  • the pre-tarsal and pre-septal areas intertwine at the lateral raphe whereas the pre-orbital component sweeps around the lateral orbital region forming a continuous sphincter.
  • the orbicularis muscle superiorly and super temporally is tightly attached to the dermis on its superficial surface and is separated from the bone by a fat pad and the galea aponeurotica.
  • the galea aponeurotica and the eyebrow fat pad above the orbital rim are loose allowing for a "lubricated slide" during frontalis contraction to achieve brow elevation during facial expression.
  • the galea aponeurotica divides into superficial and deep layers which engulf the orbicularis and frontalis muscles above the brow in the forehead region.
  • the posterior galea is attached more firmly to the inner two thirds of the orbital rim with almost no attachment to the lateral orbital rim.
  • Pre periosteal fat in other regions of the face allows for variable points of reduced resistance allowing for active movement during various facial expressions. For instance, cheek elevation during active zygomaticus muscle group contraction is facilitated by the loose pre- periosteal fat pads of the maxillary face.
  • the fat pads allowing for low friction movement along the upper orbital rim are identified with arrows on a Tl weighted surface coil MRI noted below ( Figure 7).
  • Fat interposed between the anterior surface of the frontalis and orbicularis muscle further can contribute to reduction in muscle resistance and also facilitate the effect of facial muscle contraction on facial expression, brow elevation, blink function, and other forms of facial movement.
  • a graphic of the extent of the pre-periosteal, sub-aponeurotic and sub dermal fat can be seen on the magnetic resonance image of the forehead scalp and skull table.
  • the Tl weighted image demonstrates the high contrast fat layer in the pre-periosteal, sub-aponeurotic region and in the anterior region of the orbicularis frontalis muscle region above the eyebrow.
  • Myo-osseous fixation for the treatment of hanging jowl is accomplished by fixation to the border of the mandible close the its symphesis, or angle with efforts to avoid damage to the mandibular branch of the facial nerve or other sensory nerves in the region.
  • the injection will involve the mandibular border, anterior or posterior surface. Multiple injections points are usually necessary and multiple treatment cycle during various time intervals would be needed in many cases.
  • the improvement in method over conventional facelifts related to the elimination of the surgical incision, use of extensive suturing, and extended post operative heal time as well as the ease of multiple touch up or maintenance injections session.
  • implantable screw allows for a very short post operative period with reduced pain, edema, erythema, and disfigurement associated with conventional surgical facelifts. Even in the situation of inconsistent muscle bone adherence, the opportunity to easily repeat the procedure without the morbidity of incisional surgery is ever present.
  • the orbicularis muscle is fixated to skin on its superficial surface and more importantly overlies a fibro-fatty layer on its undersurface consisting of posterior extensions of the galea aponeurotica and brow fat pads.
  • the layers of the brow can be grouped into a tightly connected skin, orbicularis-frontalis units overlaying a loose fat pad galea unit.
  • the motility of the brow is dependent on both muscle contraction as well as a low resistance undersurface of fat and galea. Brow and lid movement contraction of the orbicularis is dependent on the ease of slide between the skin-orbicularis-frontalis unit and the underlying fat pad-galea unit.
  • Direct immobilization of the orbicularis muscle shortening via fixation of its segments by pinning or gluing (for example with bioadhesive) the pre-orbital portions to the frontal bone represents another mechanism by which the procedure dampens the contractility of this muscle. Elevation of the superior portion of the muscle also may serve to alter fiber angulations contrary to optimal force generation. The horizontal fibers directed perpendicular to the eyelid fulcrum are now directed diagonally causing an alteration in force component directed toward the vertical plane.
  • #4847-8914- 9445v4 57 identify the superior neurovascular bundle to avoid positioning the compression screws directly over the superior ophthalmic artery.
  • the brow area is infiltrated with a 50:50 solution of 2% lidocaine and marcaine containing hyaluronidase at a concentration of 5.0 U/cc.
  • About 3-5 cc's of anesthetic per brow are injected along the superior orbital rim on each side and about 10 minutes with gentle pressure is allowed to elapse.
  • Incisions are made through epidermis and superficial dermis, taking care not to penetrate the dermis and impale the orbicularis muscle.
  • the orbicularis muscle is densely attached to dermis in this region and connective tissue under the head of the screw facilitates the muscle fixation.
  • the Philips head driver wrench is rotated clockwise boring a track into the frontal bone between 2-3 mm in depth, producing a tight fixation between the orbicularis and bone.
  • the screw head is rotated firmly to insure a flush relationship with the bony plane (failure to do so results in a palpable even visible bump, a technical complication). Skin distortion around the entry point is eliminated by gentle undermining of the surrounding dermis. Care is taken not to produce excessive pressure on the wrench as the out table of the skull can infracture producing more post operative pain. Screws with a length greater than 5 mm may penetrate through the
  • #4847-8914- 9445v4 58 diploe into the posterior table of the frontal bone causing increased post operative pain and increases the risk of full thickness skull table penetration.
  • the brow is generally more difficult to elevate medially because of tighter attachments of the galea aponeurotica to the medial orbital rim, however, elevation is still possible. Over-correction is desirable and descent of the brow tends to occur over a two-week period post-operatively. Generally three screws per brow are used for the male brow and two screws are used for smaller female brows. A fourth screw may be considered along the lateral orbital rim for severe cases. Skin closure is accomplished with 1, 6-0 silk suture per puncture site.
  • Example 13 Myo osseous Fixation for the Purpose of Altering Facial Contour and Wrinkles without the Use of a Fixation Device
  • a permanent fixation device may not be necessary and that (2) fixation may be able to be achieved with a fibrosis agent or plate without direct drilling into bone.
  • the fibrosis agent may include injected glues, or fibrous provoking materials placed for the limited purpose of causing an adhesion of the undersurface of facial muscle to facial bone beyond the usual extent.

Abstract

La présente invention concerne une procédure pour modifier la surface de la face humaine ou d’autres parties du corps par attachement d’origines de muscle, extension des attaches et origines musculaires, et attachement des muscles en causant l’adhésion de muscles faciaux qui ne sont pas naturellement présents en utilisant des procédés, matériaux et dispositifs spécifiques. La présente invention concerne en outre un dispositif de micro-incision à micro-vis et des procédés d’utilisation du dispositif dans des procédures chirurgicales. La présente invention concerne en outre l’utilisation d’une injection de bioadhésif par piqûre dans un plan fibro-adipeux fonctionnel décrit sur la sous-face et l’ensemble du muscle approprié sans utilisation de chirurgie incisionnelle. La présente invention concerne en outre un boulonnage osseux et des vis osseuses fixant l’élévation de tissu mou par attachement du muscle profond à l’os facial causant la suspension de structures de tissu mou facial supérieures, intermédiaires et inférieures dans un procédé qui est adaptable à d’autres régions du corps. De plus, l’utilisation combinée de vis avec des bioadhésifs et l’utilisation unique de bioadhésifs injectables peuvent produire les mêmes résultats.
EP09761052A 2008-11-21 2009-11-20 Fixation faciale sous-musculaire (fixation myo-osseuse) utilisant un dispositif de micro-incision à micro-vis, colles et adhésifs injectables et procédés et indications d utilisation Withdrawn EP2370013A1 (fr)

Applications Claiming Priority (2)

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US11706908P 2008-11-21 2008-11-21
PCT/US2009/006219 WO2010059230A1 (fr) 2008-11-21 2009-11-20 Fixation faciale sous-musculaire (fixation myo-osseuse) utilisant un dispositif de micro-incision à micro-vis, colles et adhésifs injectables et procédés et indications d’utilisation

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EP2370013A1 true EP2370013A1 (fr) 2011-10-05

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EP (1) EP2370013A1 (fr)
CA (1) CA2744015A1 (fr)
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RU2715096C1 (ru) * 2019-06-05 2020-02-25 Ольга Геннадьевна Жукова Малоинвазивный одномоментный способ фиксации мягких тканей лица и шеи

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RU2613786C1 (ru) * 2016-03-22 2017-03-21 Ольга Геннадьевна Жукова Малоинвазивный способ фиксации связок поверхностной мышечно-апоневротической системы лица
RU2679871C1 (ru) * 2018-01-26 2019-02-13 Ольга Геннадьевна Жукова Малоинвазивный комплексный способ фиксации мягких тканей лица
US10537509B2 (en) * 2018-04-03 2020-01-21 Tristar Colors, Llc Nail glue compositions

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FR2735677B1 (fr) * 1995-06-26 1997-12-26 Landanger Landos Ensemble tournevis et vis destine a la microchirurgie du type maxillo-faciale
US6605090B1 (en) * 2000-10-25 2003-08-12 Sdgi Holdings, Inc. Non-metallic implant devices and intra-operative methods for assembly and fixation
US6666870B2 (en) * 2001-01-05 2003-12-23 Robert A Dixon Method utilizing chemical bonding to improve the bone screw fixation interface

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RU2715096C1 (ru) * 2019-06-05 2020-02-25 Ольга Геннадьевна Жукова Малоинвазивный одномоментный способ фиксации мягких тканей лица и шеи

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WO2010059230A1 (fr) 2010-05-27

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