HK1111332A - Tissue augmentation device - Google Patents

Description

Tissue augmentation device

Background

[0001] Cosmetic procedures that enlarge soft tissue to improve the appearance of the face are increasingly being demanded. The American Society for cosmetic and plastic surgery (The American Society for orthopedic plastics Society) reported that nearly 8.3 million plastic surgeries were performed in 2003 and increased by 20% over The previous year. The most common of these procedures is to attempt to remove facial wrinkles and lines or to augment the lips to restore a younger appearance.

[0002] The use of botulinum toxin paralyzes small facial muscles near the dynamic wrinkles on the forehead and around the eyes. Materials that have been used to smooth non-dynamic wrinkles or to augment facial tissue (nasolabial line, lips, etc.) include injectable soft tissue fillers such as silicone, collagen in various forms and formulations, such as CosmoDerm and CosmoPlast from Inamed, hyaluronic acid derivatives such as Restylene and Hyaloform, and calcium hydroxyapatite microspheres such as Radiance. Autologous fat may also be removed from the supply site by liposuction and then injected into the targeted facial tissue. While these injectable fillers are convenient, and some can even be used as a simple office procedure, the results are temporary and once injected, the filler cannot be removed.

[0003] Implantable artificial tissue fillers are well known and are typically placed through a surgical incision. These include ePTFE-based tubes, fibers or sheets, including Gore Subcutaneous automation Material (s.a.m.) sold by atom medical, advnta, and Ultrasoft and Softform sold by Tissue Technologies, now by Integra Life Sciences. The surgical implantable tissue filler may also be from biological sources, such as Alloderm from LifeCell corporation and DuraDerm from collegensis corporation.

[0004] Surgically implantable fillers have limitations such as long recovery time due to unacceptable bruising and swelling in many patients, risk of infection or granuloma formation, erosion, atrophy and migration. Many patients are not receptive to the fact that the implant is harder than the surrounding skin and can be palpated under the skin. Implanted fillers are also difficult to remove if the patient desires, or if complications arise that require removal of the implanted filler.

[0005] The ideal facial tissue filler would be: is completely biocompatible; easy placement through a relatively small needle rather than through a large surgical incision; will be permanent but may also be removed when relocation operations are considered or at some future time; will have a low risk of infection or immune response; will not expand, contract or migrate over time; will not be subject to corrosion; and will not be perceived by the patient.

[0006] Biocompatible medical devices having a sufficiently low profile to fit into a catheter, yet be self-expanding or made expandable when released from the tip of the catheter are ubiquitous in vascular, cardiovascular and neurovascular interventions. Such devices include self-expanding or balloon-expandable stents and embolic coils of various types and configurations. These devices are often made of metal and may be coated with a polymer, such as a sleeve of e-PTFE.

[0007] However, there remains a need for devices of similar nature that can be placed in non-vascular spaces such as dermal tissue, which can be expanded in situ to provide a desired cosmetic or therapeutic effect.

Disclosure of Invention

[0008] In one embodiment of the invention, the invention comprises an implantable tissue augmentation device. In one embodiment, the device comprises an elongated flexible tubular body having a proximal end, a distal end, and a lumen, a valve opening at the proximal end, and a closed distal end. In a preferred embodiment, the device additionally has a first configuration and a second configuration, wherein the tissue augmentation device is changed from the first configuration to the second configuration by introducing a filler into the cavity via the valve opening.

[0009] In another embodiment of the present invention, the present invention comprises a tissue augmentation device having a first configuration and a second configuration, wherein the first configuration is adapted to fit through a tubular access passage and the second configuration is adapted to fill tissue to an increased size and shape, and wherein the tissue augmentation device is changed from the first configuration to the second configuration by introducing a filler into the device after passing the device through the tubular passage into the tissue.

[0010] In further embodiments of the invention, the invention comprises a kit system, or collection of articles for augmenting tissue, comprising at least one tissue augmentation device having an elongated, flexible body that is changeable from a first configuration for implantation to a second configuration for augmentation; a fill tube accessible to an interior of the body; and a filler for changing the body from the first configuration to the second configuration.

[0011] In yet another embodiment of the present invention, the present invention comprises a method of augmenting soft tissue. In one embodiment, the method comprises identifying a treatment site of a patient; introducing a dissection tool into tissue beneath the treatment site; generating a tissue plane using the dissection tool; introducing a variable tissue augmentation device into the tissue plane; and changing the tissue augmentation device from a first, compressed configuration having a first volume to a second, enlarged configuration having a second volume while still in place. In one embodiment, the second configuration is at least 5 times greater than the first configuration.

[0012] In one or more embodiments described herein, the tissue augmentation device further comprises at least one port on the proximal end for accessing the interior of the body.

[0013] In one or more embodiments described herein, the tissue augmentation device changes from the first configuration to the second configuration upon introduction of a filler through the port and into the device after the tissue augmentation device has been delivered into tissue.

[0014] In one or more embodiments described herein, the tissue augmentation device comprises a material that promotes fibrous tissue ingrowth.

[0015] In one or more embodiments described herein, the tissue augmentation device comprises at least one holding device to secure the device in a desired position. In one embodiment, the holding device comprises one or more protrusions.

[0016] In one or more embodiments described herein, the tissue augmentation device comprises an inner layer and an outer layer, wherein the outer layer comprises a porous material that promotes ingrowth of fibrous tissue, and wherein the inner layer comprises an elastomeric-type material that increases the flexibility of the body and is in contact with the filler material.

[0017] In one or more embodiments described herein, the tissue augmentation device comprises at least two layers, wherein an outer layer comprises ePTFE and an inner layer comprises silicone, polyurethane, or a thermoplastic elastomer. In one embodiment, the device comprises only an inner layer and an outer layer. In one embodiment, the device comprises one or more additional layers. In another embodiment, the device comprises only a single layer.

[0018] In one or more embodiments described herein, the tissue augmentation device comprises one or more fluids. The fluid may comprise one or more liquids. The liquid may comprise saline.

[0019] In one or more embodiments described herein, the filler comprises a material that can be manually formed into a desired configuration before the filler is changed to maintain the molded configuration.

[0020] In one or more embodiments described herein, the tissue augmentation device allows the fill tube to pass through, but completely or substantially reseals after the fill tube is removed. In one or more embodiments described herein, resealing occurs without any external intervention (e.g., self-sealing of the device instinctive).

[0021] In one or more embodiments described herein, the tissue augmentation device comprises one or more penetrable septums that allow the fill tube to pass through, but completely or substantially reseal after the fill tube is removed.

[0022] In one or more embodiments described herein, the tissue augmentation device comprises a plurality of internal partitions that divide the internal cavity of the device into a plurality of chambers or compartments. The septum may comprise a permeable membrane that allows the fill tube to pass through, but completely or substantially reseals after the fill tube is removed.

[0023] In one or more embodiments described herein, the tissue augmentation device comprises one or more compartments adapted to be individually filled to alter the contour of the filled region.

[0024] In one or more embodiments described herein, the device can be selectively expanded or contracted to achieve a desired profile.

[0025] In one or more embodiments described herein, the device has a diameter in the range of from about 1mm to about 8 mm.

[0026] In one or more embodiments described herein, the device has a length in the range of from about 1cm to about 6 cm.

[0027] In one or more embodiments described herein, the device has a wall thickness in a range from about 0.003 inches to about 0.020 inches.

[0028] In one or more embodiments described herein, the tissue augmentation device has a second configuration with a diameter of about 1mm to about 10 mm.

[0029] In one or more embodiments described herein, the first configuration of the device is sized to fit through a tubular access passage having a gauge in the range of about 14 gauge to about 20 gauge.

[0030] In one or more embodiments described herein, the first configuration of the device has a diameter of about 1.6mm or less.

[0031] In one or more embodiments described herein, the tissue augmentation device comprises one or more sutures.

[0032] In one or more embodiments described herein, the tissue augmentation device is adapted to be substantially compressed prior to insertion into tissue. In other embodiments, the tissue augmentation device is adapted to be partially expanded prior to insertion into tissue.

[0033] In one or more embodiments described herein, a filler may be added to the tissue augmentation device during the implantation procedure and at least one subsequent implantation, thereby providing a slowly adjustable tissue augmentation device.

[0034] In one or more embodiments described herein, the tissue augmentation device may be internally segmented to allow for filling of the segment with various volumes of filler material to create a specific profile.

[0035] In one or more embodiments described herein, an augmentation system is provided. In one embodiment, such a system includes a tissue augmentation device of one or more embodiments described herein and a dissection tool capable of separating tissue beneath a treatment site and creating a tissue plane.

[0036] In one or more embodiments described herein, a tissue augmentation system comprises the tissue augmentation device of one or more embodiments described herein and provides a tubular access channel. In one embodiment, the tubular access passage comprises a needle, cannula or catheter.

[0037] In one embodiment of the invention, a tissue augmentation system comprises the tissue augmentation device of one or more embodiments described herein and a fill tube is provided to supply a filler.

[0038] In one or more embodiments described herein, the tissue augmentation device is used to treat facial scars, lines, or wrinkles.

[0039] In one or more embodiments described herein, the tissue augmentation device is adapted and operable to augment facial tissue.

[0040] In one or more embodiments described herein, the tissue augmentation device is adapted and operable to augment (augmenting) facial wrinkles.

[0041] In one or more embodiments described herein, the tissue augmentation device is adapted and may be used to fill lines, scars or wrinkles on the body or face.

[0042] In one embodiment of the present invention, a plurality of tissue augmentation devices are provided. In one embodiment, providing the tissue augmentation device in a plurality of different sizes enables a user to select a desired size. In one embodiment, at least one of the tissue augmentation devices has: an expanded diameter of 0.5 to 2mm, 1.5 to 5mm, 2 to 6mm, or 2 to 8 mm.

[0043] In one embodiment of the present invention, the present invention comprises an implantable tissue augmentation device comprising at least two flexible sheets joined to form a plurality of chambers therebetween. The chambers are adapted to receive a filler to expand one or more of the chambers to a desired configuration. In one embodiment, the sheet comprises a material that can be penetrated by a tube for supplying a filling to the chamber and that seals automatically after withdrawal of the tube. In one embodiment, the sheets are bonded together adjacent to and between their peripheries to form the chamber. In one embodiment, the sheets are connected together between the peripheries in a grid-like fashion. In another embodiment, two sheets are provided, each sheet being composed of multiple layers. In one embodiment, the periphery is shaped to generally fit the cheek of a person. In one embodiment, the device has a thickness of about 15mm or less in its pre-filled state.

[0044] In one or more embodiments described herein, the device is positioned in a larger sheet setting from which one or more of the devices can be cut.

[0045] In one embodiment of the invention, the invention comprises a method of augmenting tissue comprising implanting a device comprising at least two flexible sheets connected to form a plurality of chambers therebetween, and selectively filling one or more of the chambers partially or completely to achieve a desired contour in the tissue.

[0046] There is also provided, in accordance with an aspect of the present invention, a tissue augmentation system. The system includes a tubular passage adapted for placement in human tissue, and a tissue expander adapted for passage through the tubular passage. A tissue augmentation device is provided having a first configuration and a second configuration. The first configuration is adapted to fit through the tubular passage and the second configuration is formed to fill tissue. Once the device has been delivered through the tubular passage into the tissue, the device may be changed from the first configuration to the second configuration upon introduction of a filler into the device.

[0047] The tubular passage may be a needle, catheter, cannula or other access device. The tissue to be augmented may be skin.

[0048] According to another aspect of the present invention, a tissue augmentation device is provided. The device comprises an elongated flexible body having a proximal end and a distal end. At least a first port is disposed on the proximal end for accessing the interior of the body. A suture extends from the distal end.

[0049] A needle may also be provided on the suture for percutaneous access to the treatment site. The body may comprise a tubular bushing which may have a circular or flat cross-section. The body may comprise two pieces of material joined together along the periphery. The body may also comprise two concentric tubular layers. At least a second port may be provided for accessing the interior of the body. One or more valves may be provided for closing the port. In a certain embodiment, at least two compartments are provided within the flexible body.

[0050] According to other aspects of the invention, a kit for augmenting tissue is provided. The kit comprises at least one elongated flexible body that is changeable from a first configuration for implantation to a second configuration for augmentation. At least one suture is attached to the body. A fill tube is provided for allowing access to the interior of the body. The term "filler tube" is used interchangeably with the term "filler tube". A filler is additionally provided for changing the body from the first configuration to the second configuration.

[0051] The body may comprise a tubular liner, which may have one or more internal compartments. The body additionally contains a valve. At least a second suture may be additionally attached to the body. The filling may comprise a liquid and may be polymerized in situ. The kit may additionally comprise a syringe for injecting the filling material into the filling tube.

[0052] According to other aspects of the invention, a kit for augmenting tissue is provided. The kit comprises a plurality of elongated flexible bodies, each body being changeable from a first configuration for implantation to a second configuration for augmentation, with a variety of sizes and shapes being available. At least one suture is attached to each body. A deployment tube is provided for delivering the body to a treatment site. A fill tube is provided for allowing access to the interior of the body and a filler is provided for changing the body from the first configuration to the second configuration.

[0053] According to another aspect of the invention, a kit for augmenting tissue is provided. The kit comprises a plurality of elongated flexible bodies, each body being changeable from a first configuration for implantation to a second configuration for augmentation. The flexible body is provided in a plurality of sizes and shapes. At least one suture is attached to each body. A fill tube is provided for allowing access to the interior of the body, and at least two different fillers are also provided for changing the body from a first configuration to a second configuration. The fillers may have different viscosities and/or different hardnesses (durometers).

[0054] According to one aspect of the present invention, a method of filling tissue is provided. The method comprises the steps of inserting a tubular passage within the tissue, and inserting a tissue filling device into the passage. The tubular passage is withdrawn over the tissue filler device, leaving the tissue filler device within the tissue. The device is deformable to remodel tissue.

[0055] The tubular passage may contain a needle, cannula or other access device. The tissue may be skin.

[0056] The step of deforming the device flattens the nasolabial folds. The step of deforming the device may optionally plump the lips.

[0057] According to other aspects of the invention, methods of filling tissue are provided. The method comprises the steps of inserting a needle into tissue, and passing a guide wire (e.g., suture, wire, etc.) through the needle. The needle is removed and a catheter is threaded onto the wire. A tissue filling device is inserted into the catheter and the catheter is withdrawn over the tissue filling device, leaving the tissue filling device within the tissue.

[0058] According to other aspects of the invention, methods of filling tissue are provided. The method comprises the step of inserting a needle containing a tissue filling device into the tissue. As the needle is withdrawn past the tissue filling device, forward pressure is applied through system components contacting the device, such as a filling tube, maintaining the tissue filling device in a substantially constant position relative to the tissue, thereby leaving the tissue filling device within the tissue. The tissue filling device is filled by injecting a filling material through a filling tube into the tissue filling device, and removing the filling tube. The tissue may be skin.

[0059] According to other aspects of the invention, methods of augmenting soft tissue are provided. The method includes the steps of identifying a treatment site in a patient and introducing a deformable tissue augmentation device below the site. Still at this location, the expansion device may change from a first, compressed volume to a second, expanded volume.

[0060] The introducing step further comprises introducing the device over the wire. The introducing step further comprises introducing the device through a tube. The introducing step further comprises pulling the end of the device with an end suture.

[0061] The deforming step may comprise introducing a filler into the device. The identifying step may comprise identifying wrinkles. The site may include nasolabial folds, upper lips, lower lips, facial folds, or other locations where tissue augmentation is desired.

[0062] According to other aspects of the invention, methods of augmenting soft tissue are provided. The method includes the steps of identifying a treatment site on a patient and measuring the size of the site. A tissue augmentation device having a size and shape suitable for the size of the site is selected from a kit of deformable tissue augmentation devices. The selected deformable tissue augmentation device is introduced under the site and the device is changed from a first, compressed volume to a second, expanded volume while still at the site. The measuring step may include passing a suture or other measuring device containing a plurality of markers along the route to be augmented and counting the number of markers or reading the markers.

[0063] According to other aspects of the invention, methods of augmenting soft tissue are provided. The method comprises the steps of identifying a treatment site in a patient and introducing a deformable tissue augmentation device beneath the site. A polymer is injected into the tissue augmentation device and the tissue augmentation device is shaped (e.g., by manual manipulation over the skin surface, application of a mold, etc.) in situ to a desired configuration. The polymer is then caused (e.g., allowed, or actively catalyzed or initiated by application of an external initiator) to maintain the desired configuration.

[0064] According to other aspects of the invention, methods of augmenting soft tissue are provided. The method includes the steps of identifying a treatment site of a patient and introducing an dissection tool into tissue beneath the treatment site. A tissue plane is created using the dissection tool and a deformable tissue augmentation device is introduced into the tissue plane. Where again the expansion device changes from a first, compressed volume to a second, expanded volume.

[0065] According to other aspects of the invention, methods of augmenting soft tissue are provided. The method includes the steps of identifying a treatment site of a patient and introducing a tissue filling device into tissue beneath the treatment site. When the contour of the treatment site is monitored, a filling material is injected into the tissue filling device. Once the desired contour has been achieved at the treatment site, the injection of the filler material is stopped.

[0066] According to other aspects of the invention, methods of augmenting soft tissue are provided. The method includes the steps of identifying a treatment site on a patient, and measuring a size of the site. A deformable tissue augmentation device having a size and shape suitable for the size of the site is selected from a kit having a plurality of tissue augmentation devices. The elasticity of the tissue at the treatment site is assessed and a compatible filler is selected from a kit comprising a plurality of fillers that is suitable for the elasticity of the treatment site. A selected deformable tissue augmentation device is introduced under the site and there changes from a first, compressed volume to a second, expanded volume.

[0067] According to one aspect of the present invention, a method of making an implantable tissue augmentation device is provided. The method comprises the steps of providing a flexible tubular body having a proximal end, a distal end, and an intermediate cavity. A closure element is positioned at the proximal end of the tubular body and the tubular body is everted to position the closure element within the intermediate lumen.

[0068] The closure element may comprise one or more elastomeric bands, sutures, clips, or other biasing elements.

[0069] The method may additionally comprise the step of tying a suture or positioning another closure element about the distal end of the tubular body to form a closed distal end. The method may additionally include the step of positioning a guide wire through the proximal end and into the medial lumen.

[0070] According to another aspect of the present invention, an implantable tissue augmentation device is provided. The device comprises an elongated flexible tubular body having a proximal end, a distal end, and an intermediate cavity. A valve opening is provided at the proximal end and the distal end is closed.

[0071] The device additionally includes a guide wire extending through the valve opening. The valve may comprise a closure member surrounding a portion of the tubular body. The tubular body may be everted to position the closure element within the central cavity. The closure element may comprise a suture loop. Alternatively, the closure element may comprise an elastic ring or a metal ring. The device may additionally include a distal suture attached to the distal end of the tubular body.

[0072] According to one aspect of the present invention, a tissue filling device is provided. The device has a first configuration adapted to fit through a tubular access passage and a second configuration adapted to fill tissue with an increased size and shape of tissue. After the device is delivered into the tissue through the tubular passage, the device is changed from the first configuration to the second configuration by introducing a filler into the device.

[0073] The device may comprise a flexible polymeric tube. The filler may comprise a shape memory wire, various coils, a liquid, a gel, or beads suspended in a liquid. The filler may be polymerized in situ, cross-linked in situ, or otherwise change viscosity in situ. The device may have a proximal end and a distal end that are more flexible than the intermediate portion and may include a balloon. The device may be at least partially coated with a polymer, such as ePTFE or a laminate of ePTFE and a thermoplastic. The thermoplastic may be polyethylene.

[0074] The device may comprise a metal frame, such as a nitinol frame, with a polymeric coating.

[0075] The tubular passage may be a needle, catheter, cannula or other access device.

[0076] The tissue may be skin, gastroesophageal junction, cardiac muscle, or stomach wall. The tissue may also be the area near the nasolabial folds, the right or left side or sides of the upper or lower lip, the cheek, other facial folds, or other locations on the body where augmentation is desired.

[0077] Further features and advantages of the present invention will become apparent to those skilled in the art from a consideration of the following detailed description of the preferred embodiment when taken in conjunction with the associated drawings and claims.

Drawings

[0078] FIG. 1 is a schematic side cross-sectional view through a hollow liner according to one embodiment of the invention.

[0079] Figure 2 is a side sectional view through a part of the expansion liner.

[0080] FIG. 3 is a side cross-sectional view through a filled liner having a uniform outer profile.

[0081] FIG. 4 is a cross-sectional side view through a segmented liner, each segment having a custom fill volume.

[0082] FIG. 5 is a side view through the distal end of the implant depicting a fill tube capable of filling a single segment in place.

[0083] FIG. 6 is a side cross-sectional view through a segment liner having a plurality of internal baffles.

[0084] FIG. 7 is a schematic side view of a fill tube according to one embodiment of the invention.

[0085] FIG. 8 is a side view of an implant movably connected to a fill tube.

[0086] Fig. 9 is a side schematic view of the implant of fig. 8 positioned under the skin.

[0087] FIG. 10 is a side view of an implant movably connected to a fill tube.

[0088] Fig. 11 is a side schematic view of the implant of fig. 10 positioned under the skin.

[0089] FIG. 12 is a side elevational schematic view of the implant and fill tube assembly positioned within the delivery cannula.

[0090] Figures 13A through 13D illustrate an assembly sequence for a soft tissue augmentation device according to one embodiment of the present invention.

[0091] Fig. 14 shows the bulking device as in fig. 13D, with the addition of a guide wire.

Detailed Description

[0092] In general, the present invention is a system and method for tissue volume augmentation in a living body, preferably a human. The system generally comprises a tissue filler device and a method for delivering the tissue filler device into tissue. The tissue augmentation device comprises a tissue augmentation material and an enclosing sheath. Preferably, the closure sheath forms a filled container.

[0093] The volume augmentation methods and devices described in the embodiments of this patent are intended for use in tissue augmentation under various circumstances, as desired. For example: in gastroenterology, where enlarging the volume of tissue at the gastroesophageal junction can be used to treat gastroesophageal reflux disease, and increasing the thickness of the gastric mucosa is used to reduce the volume of the stomach to treat morbid obesity; in urology, where a filler is placed radially around the urethra at the bladder neck can improve incontinence; whereas in cardiology, heart failure is treated by placing a tissue filler within the ventricular wall to reduce the volume of the left ventricular chamber, or placed within the pericardial space to apply pressure to the outside of the heart, and also intended to reduce the volume of the heart chamber; and use in other applications known to those skilled in the art. In any of these clinical applications, the tissue augmentation device may be combined with any number of other bioactive substances that may be released from the filler itself or co-injected with the filler over time.

[0094] One preferred use of the present invention is in the field of cosmetic plastic surgery, where the system is used to augment the dermis or subcutaneous tissue to treat skin contour defects caused by a variety of conditions, including aging, environmental exposure, weight loss, childbirth, surgery, diseases such as acne and cancer, or combinations thereof, or for cosmetic purposes. The tissue augmentation method of the preferred embodiment of the present invention is particularly useful for treating glabellar lines, annoying lines, wrinkles, canthus wrinkles, facial scars or stiff (marionette) lines, or for augmenting facial features such as the lips, cheeks, chin, nose, or under the eyes. Treatment of the patient may involve the use of the tissue augmentation device alone or as part of an additional cosmetic procedure, such as facial or eyebrow lifting. The feature of changing from the first configuration to the second configuration makes the tissue filling device satisfactory for use in endoscopic procedures. The tissue augmentation device may also be used for breast augmentation, as well as areas of the body that require volume augmentation during reconstructive surgery, such as after trauma or tumor resection.

[0095] The liner may take on a variety of configurations and be constructed from a variety of materials. The term "liner" as used herein is intended to include any structure adapted to substantially separate the filling material from the tissue in which the tissue filling device is implanted. The terms "skin" and "skin layer" are used interchangeably and have the same meaning as a liner.

[0096] In one embodiment, the liner is placed within the tissue to be filled and, as a second step, the liner is filled with a material such that, when the liner is filled, the liner produces a volume sufficient to alter the contour of the tissue as needed to produce a clinical effect. As will be discussed, filling may be accomplished by the means for implanting the liner or by separate means or by both. In an alternative embodiment, the tissue filling device is constructed prior to its implantation into tissue by the tissue filler filling liner, and the assembled tissue filling device is placed in tissue. In another alternative embodiment, the tissue filler may be of more than one component, such that one component (or components) of the tissue filler is in place within the liner prior to placement of the liner in the tissue to be augmented, and a second component (or components) is placed within the liner after the liner has been placed in the tissue, the combination of the components thereby constituting the final filler material.

[0097] The liner may be compliant or non-compliant or a combination of compliant and non-compliant components. The liner may be made of a biocompatible but non-biodegradable material. Suitable materials include e-PTFE, polypropylene, polyacrylamide, polyurethane, silicone, polymethylmethacrylate, dacron, metal tubing, or nitinol alloy wire mesh such as nitinol, silver, gold, platinum, or stainless steel. The liner may comprise multiple layers of material. Other biocompatible materials are known in the art as disclosed, for example, in U.S. patent No.5,630,844 to Dogan.

[0098] If fibrous tissue ingrowth is desired, the liner may be made of or coated with ePTFE having a pore size in the range of from about 40 to about 100 μ. If the filling material is or becomes non-flowable, the liner may be made of a biocompatible and biodegradable material selected from any of a variety of polylactides, polyglycolides, polycaprolactones, polyanhydrides, polyamides, polyurethanes, polyesteramides, polyorthoesters, polydioxanones, polyacetals, polyketals, polycarbonates, polyorthocarbonates, polyphosphazenes, polyhydroxybutyrates, polyhydroxyvalerates, polyalkylene oxalates, polyalkylene succinates, poly (malic acid), poly (amino acids), poly (methylvinylether), poly (maleic anhydride), chitin, chitosan and copolymers, terpolymers or higher poly-monomer polymers, or combinations or mixtures thereof, such that the initial implantation of the filling device comprises the liner and the filling material, but over time the liner is absorbed leaving only the filler material to augment the tissue.

[0099] In one embodiment, the liner comprises an outer layer of ePTFE having a pore size of about 40 to about 100 μ and a thickness of about 0.001 to 0.010 inches to promote fibrous tissue ingrowth and an inner layer of polyethylene or similar material having a thickness of about 0.001 to 0.010 inches to enhance the flexibility of the liner and more completely contain the filler material. This double layer structure is particularly suitable where the ePTFE is permeable or semi-permeable to the filler material, such as when the filler material is water or a water-containing component.

[0100] The liner may contain or be contained within a skeletal structure, such as a metallic stent including alloys like nitinol, stainless steel, gold, or platinum, a polymeric stent like PLA or PLG, or a stent of any material with sufficient stiffness or structural integrity to provide liner support or to provide a three-dimensional shape. The stent may extend in an axial direction, a circumferential direction, or both, depending on the desired clinical procedure. In addition, the stent may have anchor elements or hooks that extend out of the sleeve, suitable for stabilizing the tissue filler device within the tissue.

[0101] In one embodiment, the liner itself is highly flexible. Thus, the material should be thin, such as in the range of about 0.001 inch to about 0.010 inch. The liner may be made in a fixed length and shape, and a variety of lengths and shapes may be provided in the kit, depending on the need to fill a particular tissue region of a particular patient, or to cut the liner to the size of a clinical site as part of an implantation procedure. More than one tissue augmentation device may be placed to achieve a given desired contour for a given area to be augmented. In one embodiment, a plurality of bushings are provided that can be bunched together to produce a bunch.

[0102] The tissue filler device provided in the kit includes one or more liners, and one or more filler materials. Or the liner may be supplied separately in one kit while the other kit includes one or more fill materials. Or the kit may contain only one or more liners and the surgeon provides the filler material from a backup source.

[0103] The liner may have a constant expanded diameter, typically between 1-10mm, or it may have an expanded diameter that varies along its length depending on the desired profile of the augmented tissue. For glabellar creases, the expanded diameter is preferably 0.5 to 2 mm. For lips, the expanded diameter is preferably 1.5 to 5 mm. For the upper lip, the expanded diameter preferably varies along its length adapted to form an "m" shaped upper lip. For the lower lip, the liner is generally tapered at the proximal and distal ends, with a diameter of 2 to 8mm larger at the mid-section. In addition, for the lower lip, the profile of the bushing is generally a flat "u" shape adapted to follow the profile of the lower lip. For nasolabial folds, the expanded diameter is preferably 2 to 6mm and tapers proximally and distally. In one embodiment, the liner comprises a series of segments such that the inner diameter of each segment is greater than the inner diameter of the inter-segment cavity portion. Further, the bushing may have an inner section embodied as a series of valves or baffles. In the case of a segmented liner, each segment may be filled with a different volume of filler material in order to create a customized profile along the axial length of the implant to suit a particular clinical need. The liner may have a supporting scaffold, such as a scaffold made of filaments constructed of any biocompatible material suitable for providing a structure.

[0104] A valve or valves may be secured to one or both ends of the liner, or along any portion of the liner wall, to prevent leakage of the filler material into the surrounding tissue. The integrity of the valve required depends on the type and viscosity of the filler material. For example, if the filler material gels in place, or the filler consists of beads of sufficient size, the valve need not be tightly closed. In one embodiment, the valve is one or more elastic bands encircling the proximal end of the sheath. In another embodiment, the valve is one or more elastic bands placed 1 to 4mm away from the proximal end of the sheath during construction of the tissue filling device, and then placed inside the liner when the sheath is turned inside out during construction of the tissue filling device, enhancing the ability of the valve to remain closed while filling the liner with filler material. In another embodiment, the valve is a nitinol band adapted to form a spring closure at the proximal end of the sheath. Other valves known in the art include, for example, U.S. patent No.5,779,672 to dorandy or No.6,102,891 to van Erp. In addition to valve placement at the proximal end of the sheath, valves may be disposed at multiple locations within the sheath to form segments, which allows individual segments to be filled with varying amounts of filler material.

[0105]The filling material may be any of a number of biocompatible substances and may have various physical states or combinations thereof, such as a non-viscous liquid, a gel, a powder, beads, flakes, continuous or discontinuous fibers, coils, fiber spheres, or mixtures thereof. The filler material is changeable from a first state introducible into the sheath to a second state within the sheath. Compositions such as fibers carried in a liquid or gel are suitably included within the intended range. For example, the filler may comprise substantially linear filaments, which themselves may be made of various materials, such as nitinol, various biocompatible polymers known to those skilled in the art, e-PTFE, Proline (Proline), or any material having suitable strength to alter the strength of the material in which it is injectedThe biocompatible material of the tissue contour is inserted. The filling material may comprise a wide variety of materials commercially available and sold as tissue fillers, such as Zyplast available from Iname aerotics^TMRestylane available from Q-Med and Genzyme, Inc^TMHylaform obtained from InamedAestetics^TMArtecoll available from Ares, Inc^TMRadiance, available from Bioform, inc^TM(ii) a Or Sculptura obtained from Aventis, Inc^TMA PLA filler.

[0106] Other embodiments of the filler material include flexible random or regular coils; weaving fibers; weaving a fabric; a series of filaments wound around each other, a compressible or incompressible sponge material, closed or open cell foam, or any other material according to specific needs as known to those skilled in the art. The filler material may be a set of objects attached to the outer membrane or axial filaments, or may be a set of discrete objects. If the tissue augmentation device is desired to be visible using X-ray or fluoroscopic imaging, a radiopaque coating, such as triazole, barium salt, or tantalum, may be included in the augmentation material. If ultrasound visualization is desired, small trapped bubbles or other echogenic contrast material may be included in the filler material. The filling material may contain a colored dye to render the filling device invisible from outside the tissue.

[0107] One type of filler comprises a mixture of solid particles and a carrier. One solid particle comprises a fine particle of e-PTFE. Other materials suitable for use in the present invention include, but are not limited to PDS II (polydioxanone, monofilament), Nurolon (long chain aliphatic polymer nylon 6 or nylon 6, 6) Ethilon (long chain aliphatic polymer nylon 6 or nylon 6, 6), polypropylene textile fibers (polypropylene, isotactic stereoisomeric polypropylene, synthetic linear polyolefin), Vicryl (a copolymer made from 90% glycolide and 10% L-lactide), silk, Monacryl (poly-E-acetolactone), polylactide, polyglycolide, copolymers of lactide glycolide, porous high density polyethylene (biocompatible (thinned) polyethylene), bilass (bioactive glass microparticles), or polyhydroxyvalerate.

[0108]Carriers that may be suitable for use in the present invention, either alone as a filler or in combination with particles, include, but are not limited to, polyvinylpyrrolidone (PVP), silicone oil, vegetable oil, saline, gelatin, collagen, autologous fat, hyaluronic acid, autologous plasma, CO₂Or other gases, and other physiological carriers.

[0109]Another class of fillers includes liquids, gases or gels without discrete solid particles. For example, PVP can be used alone or in combination with other agents. PVP is a water-soluble polyamide possessing unusual complexing and colloidal properties and is physiologically inert. PVP is commercially available as a biocompatible gel that is freely transported through the body and excreted unaltered by the kidneys. The gel has a trade name such as Au24k and Plasdone C-15 and Plasdone C-30 and contains macromolecules from the family of Povidones (Plasdone) with an empirical formula (CHCH)₂)₂N(CH₂)₃-CO. The family of polymers has been used as binders, extenders and excipients for a variety of drugs for nearly fifty years and is expected to be very resistant during the implantation procedure if the liner ruptures or leaks, or if material is misinjected into the tissue rather than into the liner and can be quickly removed from the body if valve failure occurs.

[0110] PVP is commercially available in many molecular weight ranges and is polymerized so as to have an average molecular weight in a particular solution. For example, PVP is available as a solution at average molecular weights of 10,000 daltons, 40,000 daltons, and 360,000 daltons. Preferably, the PVP is below about 60,000 daltons for easier renal excretion. PVP is also defined by its viscosity metric or K value, which ranges from approximately below 12 to 100. Desirable PVP compositions of the present invention range in K value from about 12 to 50. PVP is commercially available from international specialty Products, inc., GAF Chemical corp., Wayne, n.j., USA, and from BASF Aktiengesellschaft, Germany. In use, the gel polymer may be diluted with deionized water or saline to create the desired viscosity, sterilized, and placed into a syringe for injection. Optionally, the dehydrated polymer particles are placed into the liner before the liner is placed in the tissue to be enlarged, and sterile saline is added after the liner has been placed, resulting in gel formation in the liner, thereby dilating the tissue. Alternatively, the dehydrated polymer particles may be supplied in a sterile container and reduced with saline or water alone prior to filling the liner.

[0111] Once the filler material is in the liner, its material state or chemical structure may be changed by a number of mechanisms, such as the addition of a second material acting as a catalyst, heating or cooling, pH change, ultrasound or light, or the change in state may occur naturally over time. If the material changes its state over time, this time is ideally in the range of 10 to 30 minutes from injection, so that the clinician molds the shape by touching it with the hand before the filler deforms to maintain its molded configuration. Alternatively, this change in state will occur within 24 to 48 hours, so that the patient can shape his or her own filler configuration. In one embodiment, the filling material is a biocompatible polymer that is filled into the liner in a relatively fluid state, molded into a desired shape from the skin surface by an operator, and then directed at the skin with light of an appropriate wavelength (e.g., UV) to convert the liquid into a non-flowing gel that maintains the desired pliability. In one embodiment, the gel comprises a backbone of PEG and/or PVA-and, taking into account the biodegradability of any gel that cannot fill the lining or that leaks, has PLA and/or PLG side groups attached to the backbone-and methacrylic subunits attached to the backbone, so as to induce photopolymerization with light of about 400-500nm wavelength.

[0112] The filler material is also capable of reversing its change of state via either of the mechanisms described above to allow for subsequent removal of the filler material by suction from outside the tissue through a channel placed into the liner. In one embodiment, the passageway is a needle containing or surrounded by an ultrasonic crystal such that when the needle is inserted into the bushing and the ultrasonic crystal is energized, which causes it to vibrate in the range of 100khz to 1 mhz, the gelled filler material decomposes into a flowable material to allow aspiration through the needle.

[0113] In another embodiment, the filling material comprises a purified protein such as that obtained from Gel-DelTechnologies, described in U.S. patent No.6,342,250 and U.S. patent application nos. 20030007991, 20020106410, and 20020028243, which becomes a Gel at body temperature and can be changed back to a fluid by cooling.

[0114] In another embodiment of the present invention, the tissue filling device comprises a sheath and a quantity of internal foam. In this embodiment, a valve may not be required, as the foam structure itself acts to prevent leakage of the filler from the liner. The foam may be of an open or closed cell structure. In one embodiment, the foam is a highly compliant closed cell elastomer, and the sheath is also one of the materials mentioned above. The foam may be a biocompatible polyurethane. The sheath may be ePTFE bonded to the outside of the foam. In use, the tissue augmentation device is placed in tissue either directly or via the aforementioned method of suture pulling. Once in place, the tissue augmentation device is infused with a fluid, such as water, saline, silicone, hydrogel, or any of the above-described augmentation materials comprising a combination of solid or gel particles or filaments in a liquid carrier, from a location or locations outside the tissue to be augmented, such as from the skin surface. Preferably, a small hollow structure is used to inject the filling material, such as a 25-32 gauge hypodermic tube (hypo-tube) or needle. This results in a localized enlargement of the tissue augmentation device when filling the closed cell foam in the area where the filler is injected. Injection is performed at additional locations along the tissue filling device to customize the enlarged shape. If too much filler has been injected in one area, the filler can be removed by re-entering the area requiring shrinkage and then drawing the filler out. The entry of a hypodermic tube (hypo-tube) or needle into the area requiring retraction may be via the same path as when the area was filled, or may take another route, such as through the skin, generally perpendicular to the filling axis. Thus, in one embodiment, a device according to any of the embodiments described herein can be selectively expanded or contracted to achieve a desired shape or profile. Optionally, additional filler material may be added during this operation or at any time later as desired.

[0115] Thus, in one embodiment, the filler material is added to the device (according to any of the embodiments described herein) during the implantation procedure and optionally at least once immediately following implantation. In another embodiment, the device is adapted to be at least partially expanded two or more times after insertion into tissue, thereby providing a device that is chronically adjustable. In one embodiment, the device is implanted and expanded (e.g., filled) in one operation or on the same day, and is adapted for further expansion (e.g., filling) on another day. These embodiments are particularly advantageous because they provide the recipient with the ability to fine tune the increased contour and appearance.

[0116] The foam body thus consists of a cellular foam matrix with a high porosity which divides the internal volume of the implant into a number of compartments from 100 to 1,000,000, depending on the chosen filling material and the desired feel of the tissue to be filled. The cellular foam material may be a thermoset or thermoplastic polymer. Preferably, the cellular foam material is of elastomeric quality but may be a non-elastomeric polymer foam. The shape of the foam affects the basic range of implant shapes and for many wrinkle removal applications will be an elongated body having a length in the unexpanded configuration of at least about 5 times and often at least about 20 times its average unexpanded cross-section. The particular material or materials selected for construction of the foam will depend, at least in part, on the density or hardness of the tissue being mimicked.

[0117] In one implementation, the foam may have an "open-cell" structure with the cells interconnected by channels that allow fluid filler communication between the cells. The channels interconnecting the pores 20 allow fluid filler to flow between the pores, which can create a hydraulic dampening effect on the local deformation of the implant by external pressurization. The hydraulic dampening effect created by the inter-orifice fluid communication can help impart realistic shape and tissue-like consistency to the implant. The viscosity of the filling at body temperature is preferably related to the channel size to inhibit excessive free flow between the pores in the absence of external pressure.

[0118] The foam may have a uniform cell density throughout, or may have a cell density that varies throughout one or more regions, i.e., a cell density gradient. In the case of embodiments including one or more regions 30, 32 having a honeycomb density gradient, the regions 30, 32 will have different average honeycomb densities. The average cellular density of the selectable regions cooperates with the viscosity of the filler to affect the response of the implant to external pressure.

[0119] In another embodiment, the open cell structure may be placed within a closed cell structure such that the open cell foam is divided into a plurality of zones such that filler remains in designated zones, and each zone may be individually filled to change the profile of the filled zone. In one embodiment, the apparatus according to any of the embodiments described herein is partitioned and adapted to fill individually to change the outline of the filled region. In some embodiments, some of the compartments remain unfilled or partially filled, and may be filled at a later date to obtain or modify a particular shape or profile.

[0120] The filled foam liner embodiments may comprise any of the materials identified above, as well as linear aliphatic polyether urethanes, linear aliphatic polyester urethanes, cycloaliphatic polyether urethanes, cycloaliphatic urethanes, aromatic polyether urethanes, aromatic polyester urethanes, polybutenes, polypropylenes, cross-linked olefin elastomers, styrene-ethylene/butylene-styrene block copolymers, or any other biocompatible material that is substantially radiolucent under standard mammography protocols and intensity or other imaging protocols and intensities. The fluid filling may comprise a biocompatible triglyceride, serum, saline solution, or another biocompatible material that is substantially radiolucent under standard mammography protocols and intensities.

[0121] The foam may also be made of a material that is substantially radiolucent under standard mammography protocols and intensities or other imaging protocols and intensities. The foam may be constructed of styrene-ethylene-butylene-styrene copolymer, polyethylene, polyurethane, and polytetrafluoroethylene, or another biocompatible material that is substantially radiolucent under standard mammography protocols and intensities or other imaging protocols and intensities.

[0122] The coating may be applied to all or a portion of any of the liners disclosed herein, either to the outer layer thereof or to the inner layer thereof. Methods of applying coatings to biocompatible materials are well known in the art. See, for example, U.S. patent nos.6,660,301, 6,368,658, and 6,042,875 to Vogel. The formation of a hydrogel coating is described in U.S. patent No.6,652,883 to Goupil. If desired, a coating that causes the sheath to become sticky, such as fibronectin or vitronectin or laminin, may be used to inhibit movement of the sheath relative to the tissue. If it is desired that the sheath be visible by X-ray or fluoroscopic imaging, a radiopaque coating such as triazoate, barium salt or tantalum may be used on the sheath.

[0123]Coatings with biological activity or therapeutic effect may also be used as required in clinical applications. For example, growth factors such as fibroblast growth factor, anti-inflammatory agents such as corticosteroids that reduce the total amount of fibrosis, antibiotics that reduce the risk of implant infection, and anesthetics such as lidocaine, procaine, or cocaine that reduce pain. To modulate fibroblast proliferation, the potent angiogenic inhibitor TNP-470 may be used as a coating or co-injection (co-injetate). Alternatively, it may be desirable to coat the sheath with a tissue adhesive, such as Dermabond, available from Ethicon/Johnson and Johnson, Inc^TM(ii) a Or Focalseal available from Focal, Inc^TMTo reduce movement of the tissue implant device relative to the tissue. This is important becauseRelative movement can prevent proper healing of the tissue and anchoring of the device, which will eventually erode. In one embodiment, the sheath is comprised of expandable polytetrafluoroethylene coated with fibrin glue containing fibroblast growth factor 1(FGF1) and heparin.

[0124] Typically, the means for filling the sheath is provided by one or more substantially tubular structures adapted to be placed within the sheath during filling and removed after the sheath has been filled to the required volume. In one embodiment, the fill tube may be placed back into the sheath after the device is removed. The filling tube may comprise a variety of tubular structures, as desired, including needles, compliant or non-compliant plastic tubes, or metal hypodermic tubes comprising stainless steel, nitinol, or any of a variety of materials as appropriate to the implant structure and desired filling scheme. The tube may have a variety of cross-sectional profiles, including circular, oval, and flat, depending on the clinical needs and the shape of the liner to be filled.

[0125] In one embodiment, the tissue augmentation device is constructed and used as follows. The sheath has a proximal end and a distal end. A rail having a distal end and a proximal end is adapted such that the distal end of the rail extends beyond the distal end of the sheath, then extends from the distal end all the way to the proximal end within the sheath, and then emerges from the proximal end of the sheath such that the proximal end of the rail is proximate the proximal end of the sheath. The rail has a very small diameter, preferably 0.1-1.0mm, and can comprise any suitable filamentary material such as absorbable or non-absorbable sutures, metal such as stainless steel or nitinol, or any material or combination of materials suitable for allowing the fill tube to slide over the rail and into the interior of the sheath. The rail may be coated with, for example, hydrogel, silicone, ePTFE, or PTFE to enhance its smoothness.

[0126] A suture-penetrating method of implanting the tissue filling device is as follows. The suture needle is attached to the distal end of the rail using any of a variety of methods known in the art. The needle may be straight or curved and has a very small diameter, preferably 0.1-1.0 mm. At the distal end of the rail engaging bushing, the bushing is substantially adhered to the rail such that the filler material cannot leak from the distal end of the bushing. The rail then remains uncoupled from the bush. The fill tube and attached syringe are adjusted in sequence across the guide rail to place the fill tube in the liner and removed from the liner after the liner has been filled.

[0127] In use, the surgeon measures the path length he wishes to fill and picks out the appropriate length of liner assembly from such a liner kit. The surgeon places the needle in the skin along the path he wishes to augment, stopping before the tip of the hub emerges from the skin, and taking care that the proximal end of the hub is within the tissue. If not, the hub is pulled distally through the tissue, thus completely removing it from the tissue. In this case, the surgeon may choose a different length of the hub, or a closer location to access the tissue with the suture needle so that the entire hub is finally located within the tissue. The surgeon may pull manual traction on the tissue to guide the needle along a desired path. The fill tube is advanced along the guide rail into the interior of the liner until the distal end of the fill tube is at or near the distal end of the liner. The syringe with the filling material slides on the guide rail and is connected to the proximal end of the filling tube. The surgeon then injects a filling material into the filling tube and into the liner. He can withdraw the filling tube along the length of the liner until the appropriate tissue augmentation profile is achieved. The fill tube is then removed from the liner along the guide rails, allowing the valve located at the proximal end of the liner to close. If more enlargement is required, the fill tube can be threaded again onto the guide rail, through the valve and into the bushing, where more fill material can be stored. When the desired amount of filler material is in the liner, the filler tube is removed and the rail is severed flush with the skin at the proximal and distal ends of the liner. The portion of the guide track within the bushing remains in place after the proximal and distal ends are severed.

[0128] In an alternative embodiment, one or more indwelling sutures may also be attached to the proximal end of the sleeve. In use, the indwelling suture extends from the proximal end of the sleeve and out of the tissue. The surgeon may grasp these indwelling sutures to provide a reactive force as the filling tube is advanced. In addition, the surgeon may grasp the indwelling suture and the distal suture, or such a distal indwelling suture is provided, to move the tissue filling device back and forth within the tissue for optimal positioning. When the desired amount of filler material is in the liner, the rail is severed flush with the skin at the proximal and distal ends of the liner, similarly severing the indwelling suture near the skin at the proximal end. The indwelling and guiding suture is desirably a bioresorbable material as is well known in the art.

[0129] In one embodiment, as described above, the holding device for positioning the tissue augmentation device comprises a suture. Other types of holding devices may also be used in accordance with several embodiments of the present invention. In another embodiment, the holding device comprises one or more protrusions or flat areas. In one embodiment, a portion of at least one septum is flattened to provide the physician with a non-inflatable region for holding. One advantage of such an embodiment is that it may reduce the risk of damage (such as puncture) to the expandable portion of the augmentation instrument by minimizing direct contact with the expandable portion. In one embodiment, the flat or convex portion comprises one or more layers sealed with glue or another adhesive. In one embodiment, the flat portion or the convex portion is made of the same material as the at least one membrane of the augmentation apparatus. In another embodiment, the flat portion or the protrusion is made of a different material than the membrane of the augmentation instrument. The flat or convex portion may be made of any shape suitable for the physician to hold. In some embodiments, the tissue augmentation device comprises a single protrusion. In other embodiments, the tissue augmentation device comprises two protrusions. In still other embodiments, more than two projections are provided. The protrusions can be positioned at any location convenient for the physician to hold. In a preferred embodiment, the protrusions are positioned at the proximal and/or distal end of the augmentation instrument.

[0130] In an alternative embodiment and method of use thereof, the tissue filling device is implanted into the tissue to be enlarged by means of an external needle or cannula. The needle has a proximal end and a distal end, and a cavity extending from one end to the other. In one embodiment, the needle is 14-20 gauge. Thus, in one embodiment, a device to be implanted according to any of the embodiments described herein (e.g., a device in a first configuration or unexpanded state) is sized to fit through a 14-20 gauge needle or other tubular access passage. The 14-20 gauge tubular access passage converts to a tubular access passage (14 gauge) having an outer diameter of about 0.083 inches and an inner diameter of about 0.063 inches to a tubular access passage (20 gauge) having an outer diameter of about 0.0355 inches and an inner diameter of about 0.024 inches. Thus, in some embodiments, the device to be implanted has a pre-implant diameter in the range of about 0.024 inches (about 0.61mm) to about 0.063 inches (about 1.6 mm). In one embodiment, the pre-implantation or pre-expansion of the device has a diameter of about 1.6mm or less. In alternative embodiments, the pre-implantation or pre-expansion of the device has a diameter of about 1.6mm or more. These latter embodiments need not be delivered through a 14-20 gauge access channel.

[0131] In one embodiment, the liner assembly comprises a folding liner, a valve, and a fill tube as described above. Optionally, a central guide rail may be supplied. The hub assembly is contained within the needle lumen such that the distal end of the hub assembly terminates adjacent the distal end of the needle lumen. The fill tube is advanced through the hub and emerges at the proximal end of the needle and is then connected to a syringe containing a filling material. The filling tube is adapted to slide on said track if a central guide rail is provided. The filler material may be any of those previously described. In one embodiment, an indwelling suture is provided attached to the proximal end of the hub and emerging through the proximal end of the needle. In use, the surgeon advances the needle along the path from the proximal input end into the tissue to be enlarged. The surgeon may pull manual traction on the tissue to guide the needle along a desired path. The fill tube is advanced along a guide track provided inside the liner until the distal end of the fill tube is positioned at or near the distal end of the liner. The needle may be advanced through the tissue and then emerge from a remote exit location, or the needle advancement may stop in the tissue in a non-exit location. Regardless, once the needle is in the desired position, a forward tension is placed on the fill tube to hold the compressed hub in place while the needle is withdrawn proximally out of the tissue. The surgeon then injects a filler material into the filler tube and thus into the liner. He can withdraw the filling tube along the length of the liner until the appropriate tissue augmentation profile is achieved and can advance the filling tube distally again if desired. The fill tube is then removed from the liner, allowing the valve at the proximal end of the liner to close. If more enlargement is desired, the fill tube can again pass through the valve and into the liner, and if a rail is provided, on the rail, where more fill material can be stored. When the required amount of filler material is in the liner, the filling tube and any guide rails are removed and any indwelling sutures are severed flush with the skin at the proximal and distal ends of the liner.

[0132] In one embodiment, the bushing may take the shape of the upper rim of a "dune bow" configuration, with the valve and fill tube assembly provided above. This upper rim shaped bushing may also be configured to move from a first, compressed state to an expanded state. This upper rim shaped liner is placed into the tissue using either the suture-through method or the external needle method described above. In this embodiment, the liner is typically 3 to 6cm long, 1 to 6mm wide and 1 to 3mm deep. The upper edge has a flat "M" configuration to match the upper lip red border of the lip (Vermilion Border). The liner may be constructed of two sheets of any of the above biocompatible materials, preferably ePTFE, joined to each other along their edges, such as by a heat treated (thermal) adhesive.

[0133] In another embodiment, the liner is adapted to be placed within the cheek to reinforce the zygomatic fossa. In this embodiment, the shape and dimensions are known in the art, such as the description of silicone implants available from McGhan Medical Corporation, a division of Inamed. In a preferred embodiment, the sleeve is approximately ovate and is constructed of two pieces of ePTFE sintered together at their outer edges such that the sleeve, when in its expanded state, has dimensions of 4 to 6cm long, 3 to 4cm wide and 0.3 to 1.5cm thick in the center of the sleeve, and gradually decreases in thickness towards the edges.

[0134] In one embodiment, the device is divided and the compartments are adapted to be filled individually in order to change the contour of the filled area. In some embodiments, certain compartments are left unfilled or partially filled, and may be filled at a later date to achieve or modify a particular profile. In one embodiment, the device has two or more compartments (e.g., 3, 4, 5-10, 10-20, or more than 20 compartments). As described in more detail below, these compartments may be separated by one or more internal membranes. These internal septums can be penetrated to inject the filling and can be resealed after the filling tube has been removed. Optionally, each compartment (which may or may not be separated from the other compartments by an internal septum) is accessible from the outside. In this way, the exterior can be penetrated to provide the one or more compartments with a filling material, which can then be sealed again (with or without external intervention) after the filling tube has been removed. In this way, the physician may selectively fill some or all of the different compartments. The compartments may be of any size or shape (e.g., square, rectangular, circular, oval, elongated, triangular, amorphous, etc.). In one embodiment, the compartments are substantially flat. Thus, in one embodiment, the device for implantation into the cheek (or other suitable location) has a width of less than 3 mm. In other embodiments, the thickness is in the range of about 3 to 15mm, as described above. In other embodiments, the thickness is 15mm or more.

[0135] In another embodiment of the present invention, a tissue augmentation device is provided comprising a generally sheet-like structure of opposing sheets or walls that are interconnected to form a plurality of chambers in the device. These chambers are selectively completely or partially filled so that the device can be shaped to the desired overall profile. The walls comprise a self-sealing material such that once the filling device is withdrawn from any cavity, the cavity can self-seal to retain the filling therein. If desired, the profile of the device may also be modified after filling one or more of the chambers by withdrawing the filling material from the filled chamber.

[0136] Preferably, in this embodiment, the device comprises a pair of sheets of such self-sealing material folded together around their periphery. Such closure may be achieved by any suitable means, such as by heat or chemical bonding. More preferably, the sheets are similarly bonded together in any desired manner to form a plurality of chambers or compartments.

[0137] In a preferred embodiment, one or both of the opposing walls of the sheet means may be formed from a laminate of a plurality of layers.

[0138] Some suitable materials that are self-sealing, such as for needles or syringes, are known in the art. In this embodiment, the sheet or self-sealing material is preferably made of ePTFE and/or polyurethane.

[0139] In a related embodiment, a tissue augmentation device is provided that comprises generally sheet-like or substantially planar structures comprising relatively substantially planar walls joined by adhesion or interior walls forming a plurality of chambers therein. Preferably, these embodiments have the features described above. More preferably, the sheet contains a number of internal chambers that is generally greater than the surgeon would need in a particular application. In this embodiment, the surgeon may make cuts between the chambers to create the desired shape and number of chambers for a particular application.

[0140] The flap or flat spaced embodiment is particularly suitable for facial reconstructive surgery and the like.

[0141] In another embodiment, a liner suitable for placement in the cheek has the dimensions described above, but additionally contains a length of nitinol wire or ribbon in a superelastic state of approximately.003 to.030 inches in diameter, secured in the rim along the outer periphery of the liner between ePTFE sheets sewn into the liner using a thermoplastic adhesive, such as FEP or polyethylene. In this embodiment, deployment of the liner from the first configuration to the second configuration is aided by the shape memory properties of nitinol, and maintains its shape in the second configuration.

[0142] In a similar manner, other embodiments of the liner are suitable in size and shape for use as a tissue augmentation implant in the nasal bridge, chin, area under the eye, breast, or any clinical anatomical location constructed in the above manner with or without nitinol frame structural support.

[0143] Certain specific implementations of the present invention will be described with reference to fig. 1-12. Referring to fig. 1, a schematic representation of a tissue augmentation implant according to one aspect of the present invention is shown. The implant comprises a liner 10 having a proximal end 12 and a distal end 14. The liner 10 may be a hollow liner with single or multiple large compartments, or an outer surface of open or closed cell foam as has been described elsewhere herein.

[0144] The bushing 10 includes a body 16 that defines a central cavity 18 in this embodiment. The body 16 is additionally provided with a distal port 20, the distal port 20 communicating with a proximal port 22 by means of a cavity extending between the two ports. In the illustrated embodiment, the distal port 20 is distal to the body 16 and the proximal port 22 is proximal to the body 16. However, depending on the desired performance and other design considerations, each port may be located along the length of the body 16 away from the respective end. Multiple ports are also required.

[0145] In the illustrated embodiment, the distal port 20 and the proximal port 22 serve as a guidewire access port to allow the body 16 to be slidably advanced along a guidewire 24.

[0146] Ports 20 and 22 are shown communicating with each other via central cavity 18. However, if it is desired to isolate the guidewire lumen from the filling medium, a separate lumen may be provided through the wall of the hub or on the outside of the hub.

[0147] As already discussed herein, the body 16 may vary from a reduced cross-sectional configuration, such as for positioning to a desired treatment site, to an expanded cross-sectional configuration for providing a desired cosmetic effect. In one embodiment, schematically illustrated in FIG. 2, the body 16 is changed to an expanded cross-sectional configuration by filling the central cavity 18 with any of a variety of desired fill materials 30. The fill tube 26 is advanced along the guide wire 24 to position the fill port 28 into the desired portion of the central lumen 18. The proximal end (not shown) of fill tube 26 is connected to a source of fill medium, such as a hypodermic needle syringe or other container, depending on the fill medium properties. Suitable filling materials are disclosed elsewhere herein, and the properties of the filling tube may also be modified in view of the properties of the filling, as will be apparent to those skilled in the art in view of this disclosure.

[0148] The fill tube 26 may be advanced through the length of the liner 10 into the vicinity of the distal end 14. The filler 30 is disposed through the fill port 28 by activation of a fill control (not shown) on the proximal control. The fill tube 26 can be retracted proximally axially through the hub 10 to introduce the filler 30 to various locations along the length of the hub. After a sufficient amount and desired distribution of filler 30 has been introduced into the liner 10 to achieve the desired effect, the fill tube 26 may be proximally retracted from the proximal end 12 and removed from the patient. See fig. 3. The proximal end 12 may be provided with a valve 32 as already described herein, allowing removal of the fill tube 26 and retention of the filling medium 30 in the liner 10. Thereafter the guide wire 24 may also be withdrawn proximally from the hub 10, leaving the filled implant in place at the desired treatment site.

[0149] For some applications, it is preferable for the non-uniform profile liner 10 to be fillable. This may be accomplished using the embodiment of fig. 1-3 in conjunction with a filler having sufficient viscosity or structural features (e.g., wire coils) that retain the filler at a localized location within the liner 10. Referring optionally to fig. 4, a segmented embodiment of the present invention is shown. The liner 10 is divided into a plurality of segments 34 separated by a plurality of necks 36. The fill ports 28 on the fill tube 26 may be disposed on each segment 34 in succession to allow each segment 34 to expand to a unique cross-sectional dimension. In this manner, the cross-sectional dimensions of the implant are customizable along the length of the implant so that a desired cosmetic effect may be desired.

[0150] The neck 36 can be constructed in any of a variety of ways, such as by thermoforming the sleeve 10, or by placing any of a variety of structures, such as straps around the neck 36. Referring to fig. 5, a segmented implant is shown with the fill tube 26 in place within the segment 34. Adjacent segments are separated by a constraint 37 such as an annular elastic band or gasket. The constraint 37 is sufficiently resilient to allow passage through the fill tube 26 and, following removal of the fill tube 26, springs back to the end of substantially closing the passage between adjacent segments 34. In this way, the restriction 37 may be configured to either restrict and control the flow between adjacent segments 34, or completely block the flow of the filler 30 between adjacent segments 34.

[0151] The nature of the constriction 37 in the neck 36 is configured to match the nature of the filling 30, as will be apparent to those skilled in the art in view of this disclosure. For example, if the filler 30 comprises a plurality of coils, fibers, or special materials, the restraint 37 need not provide a tight seal. However, if a less viscous or more fluid filler 30, such as saline, is used, the constraint 37 should be configured to provide a seal between the segments 34 in the event that it is desired to prevent flow of the filler 30 between adjacent segments 34. Optimization of these parameters can be accomplished by routine experimentation by one skilled in the art, taking into account the desired clinical performance of the implanted device.

[0152] Referring to fig. 6, a bushing having a plurality of internal baffles 40 is disclosed. The function of the baffles 40 is to divide the interior cavity 18 of the liner 10 into multiple chambers or compartments 38 without affecting the outer profile of the implant. Similar to the constraints 37, the baffles 40 allow advancement and retraction of the fill tube to reach each compartment 38, then prevent or substantially prevent flow of the filler 30 between adjacent compartments depending on the desired clinical procedure. As a further alternative, the septum 40 or valve may be in the form of a penetrable septum that allows the fill tube 26 to pass therethrough to be completely or substantially resealable upon removal of the fill tube 26. Optionally, each chamber or compartment (which may or may not be separated from the other compartments by an internal septum) is accessible from the outside. In this way, the outside can be penetrated in order to provide one of the compartments with filling material, and then these compartments are sealed again (with or without external intervention) after the filling tube has been removed. In this way, an operator can selectively fill some or all of the different compartments to achieve a desired profile or contour.

[0153] Referring to FIG. 7, one embodiment of the fill tube 26 is shown in additional detail. Fill tube 26 includes a proximal end 50, a distal end 52, and an elongated tube body 54 extending at both ends. The tube body 54 may be flexible or rigid depending on the desired properties. The tube body 54 can be constructed in any of a variety of ways, such as by machining from a metal component (e.g., stainless steel hypodermic tubing) or by extrusion of various polymeric materials known in the intubation art, such as any of PEEK, PEBAX, polyethylene of various densities, among others.

[0154] The tube 54 includes at least one central cavity for receiving the guide wire or rail 24 therethrough. The guidewire lumen communicates with a guidewire entry port 58 on the proximal manifold 56. The proximal manifold 56 is additionally provided with a fill port 60, which may be a luer (luer) connector or other quick release connector (hub), for removable connection to a source 62 of fill 30. In one convenient embodiment, the source 62 is in the form of a manually actuated syringe.

[0155] The body 54 may be provided as a dual cavity structure having concentric or side-by-side cavities as is well known in the art of intubation. Optionally, depending on the nature of the filler 30, the rail 24 may extend through the same cavity as the filler medium, as will also be appreciated by those skilled in the art in view of the disclosure herein.

[0156] Although the fill tube 26 is shown as having a single outflow port 28 for introducing the filler 30 into the liner 10, multiple filler ports 28 may be provided. Additionally, the filler port 28 may be identical to the distal opening through which the rail 24 extends. In embodiments having multiple outflow ports 28, the multiple ports may be arranged circumferentially about the tube 54 in a single transverse plane or axially spaced along the length of the tube 54, so as to be useful in operations requiring simultaneous filling of multiple compartments 38.

[0157] Figure 8 shows a further implementation of the invention. The liner 10 is schematically shown extending from a proximal end 12 to a distal end 14. The liner comprises a flexible body 16 which may comprise the outer surface of an outer fabric liner or foam segment, as discussed elsewhere herein. In the illustrated embodiment, the body 16 defines at least one central cavity 18 having a proximal port 22. The proximal port 22 is provided with a valve 32 for sealing the central cavity 18 after introduction of the filling material 30 and removal of the filling tube 26.

[0158] In the embodiment of the invention shown in fig. 8, the distal end 14 of the hub 10 is provided with a closed end. A distal suture 70 extending from a proximal end 72 to a distal end 74 is attached to the closed distal end 14 of the sleeve 10. In alternative embodiments, the distal end 14 may be provided with an open access port, with or without a valve depending on the desired filling configuration. The suture 70 may also extend throughout the length of the liner 10 and be located proximal to the proximal end 12 of the liner 10, depending on the desired properties.

[0159] In the illustrated embodiment, the distal suture 70 extends from the distal end 14 of the sleeve 10 to a needle 76 that is attached to the distal end 74 of the suture 70. Needle 76 may comprise any of a variety of suturing needles as will be apparent to those skilled in the art in view of the disclosure herein.

[0160] Fig. 9 schematically illustrates the use of the embodiment of fig. 8. Needle 76 is introduced into skin 73 at first entry port 75. The needle is advanced subcutaneously under the area to be treated. The needle 76 is thereafter advanced across the skin surface at the outlet port 77. Further pulling on the needle 76 and suture 70 pulls the tubular sleeve 10 through the access port 75 and into position beneath the area of skin to be treated. Once the liner 10 is in the desired position, the filler material 30 is advanced from a source into the central cavity 18. After introducing the desired volume of filler material 30, the fill tube 26 is withdrawn proximally from the liner 10 and the distal suture 70 is severed at or below the skin surface.

[0161] Referring to fig. 10 and 11, an embodiment similar to that of fig. 8 and 9 is shown with the added feature of a proximal indwelling suture 78. The proximal indwelling suture 78 may be attached to the liner 10 adjacent the valve 32 or may be a continuous suture with the distal suture 70 extending along the outside or inside of the body 16.

[0162] In use, the proximal indwelling suture 78 and the distal suture 70 may be used to manipulate the hub 10 along the shaft of the hub 10 to optimize positioning before, during or after the introduction of the filling material 30 into the central cavity 18.

[0163] Fig. 12 shows a schematic representation of the use of an external introducer needle. In this context, the use of the term "needle" is not intended to imply any particular structural dimension, but rather as necessarily providing access for percutaneous insertion of the implant. The actual size of the introduction needle will be optimized or dictated by the configuration of the implant and the filling tube, as will be apparent to those skilled in the art.

[0164] The placement needle 82 comprises an elongate tubular body 83 extending between a proximal end 84 and a distal end 86. The tubular body 83 includes an elongate central cavity 88 extending therethrough. The tubular body 83 may comprise any of a variety of forms depending on the intended clinical application. For example, the tubular body 83 may comprise a vertical, curved, or flexible configuration. Typically, distal end 86 will be provided with a beveled or otherwise pointed tip to facilitate advancement through soft tissue. Depending on the diameter of the tubular body 83, a separate obturator tip may be positioned within the tubular body 83 to facilitate positioning of the tubular body 83 over the desired treatment site. The obturator can then be removed and the liner 10 pushed into place within the pipe.

[0165] In the embodiment schematically illustrated in fig. 12, tube 83 has a sufficient inner diameter to accommodate a proximal hub 90 on fill tube 26. This allows the placement needle 82 to be retracted proximally over the hub 10 and fill tube 26 assembly after placement at the treatment site. Alternatively, placement needle 82 may be configured to withdraw in a distal direction away from exit point 77 (see fig. 9). Thus, the deployment needle 82 may be retracted proximally or advanced distally out of the hub 10, depending on the desired clinical procedure. In an alternative configuration, the placement needle 82 may be in the form of a peel-away sheath that is proximally removable without requiring a sufficient inner diameter to accommodate the proximal hub 90. Any of a variety of configurations may be utilized for the placement needle 82, as will be apparent to those skilled in the art in view of this disclosure.

[0166] Referring to fig. 13A to 13D, a sequence of operation of the tissue augmentation device is shown in accordance with the present invention. 13A shows a tubular bushing 100 extending between a proximal end 102 and a distal end 104. A central cavity 106 extends therethrough. Tubular liner 100 may comprise any of a variety of materials, such as ePTFE and other materials described elsewhere herein. Typically, the tubular liner will have a sufficient length and diameter to accommodate the desired treatment site. For treating facial wrinkles, tubular insert 100 will typically have a length in the range of from about 1cm to about 6cm, and a diameter in the range of from about 1mm to about 8 mm. The wall thickness of the tubular bushing 100 may also vary accordingly, but is often in the range of about 0.003 to about 0.020 inches.

[0167] Referring to fig. 13B, a first step in constructing the proximal valve 114 is shown. A biasing element 108, such as an elastic band, suture, spring-biased metal clip, or other clip or biasing element, is positioned around the tubular sleeve 100 to create a neck slightly spaced from the proximal end 102, leaving a tail 110 of the tube 100. The biasing element 108 is preferably positioned sufficiently tightly around the tube 100 to provide a suitable seal in view of the required filler material already discussed.

[0168] As seen in fig. 13C, the tubular body 100 is then everted such that the tail 110 is positioned within the central cavity 106. A biasing element 108 is also positioned within the central cavity 106, showing a valve opening 114 on the proximal end 102 of the tubular body 100. As already discussed, the valve opening 114 allows for the introduction and removal of a fill tube.

[0169] Referring to fig. 13D, a distal closed end 120 is formed on the tube 100. The closed end 120 can be disposed in any of a variety of ways, such as by one or more suture loops 118 that can be tied into a knot. Alternatively, any of a variety of adhesives, heat welding, elastic bands, clips, or other biasing structures used to form the valve 114 can be used. In the illustrated embodiment, the closed end 120 may be provided by tightly tying a suture around the distal end 104 of the tube 100. The tail 116 of the left-out suture is attached to the suture knot to assist during positioning as already discussed. This provides distal suture 116 percutaneously introduced to the treatment site with a suture needle (not shown).

[0170] Referring to fig. 14, a tissue augmentation device as in fig. 13D is shown with an optional guide wire 122. The guidewire 122 extends through the valve 114 and at least as far as the distal closed end 120. At the closed distal end 120, a guide wire 122 may be permanently attached or may be removable, such as by proximal traction, depending on the desired clinical procedure. In one embodiment, the guide wire 122 is secured within the suture knot 118 and is not intended to be removed. In this embodiment, the proximal portion of the guide wire 122 is severed around the valve 114 after placement and filling of the implant. The guide wire 122 may comprise any of a variety of filaments, such as a suture or a wire like stainless steel or nitinol. As already discussed, the guide wire 122 may assist in axial repositioning or positioning of the fill tube, causing it to be advanced over the guide wire 122 and into the cannulated liner 100.

[0171] Although the invention has been described in connection with certain specific embodiments, various additional embodiments and modifications to the described embodiments are contemplated within the scope of the invention. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description.

Claims (50)

1. An implantable tissue augmentation device comprising:

an elongate, flexible tubular body having a proximal end, a distal end, and a lumen;

a valve opening on the proximal end;

a closed distal end; and

a first configuration and a second configuration, wherein the tissue augmentation device is changed from the first configuration to the second configuration by introducing a filler into the cavity through the valve opening.

2. A tissue augmentation device having a first configuration and a second configuration, wherein the first configuration is adapted to fit through a tubular access passage and the second configuration is adapted to fill tissue with an increased size and shape of tissue, and wherein the tissue augmentation device is changed from the first configuration to the second configuration by introducing a filler into the device after the device is delivered through the tubular passage into the tissue.

3. A kit for augmenting tissue, comprising:

at least one tissue augmentation device having an elongate, flexible body, the device changing from a first configuration for implantation to a second configuration for augmentation;

a fill tube allowing access to the interior of the body; and

a filler for changing the body from the first configuration to the second configuration.

4. A method of augmenting soft tissue, comprising the steps of:

identifying a treatment site on a patient;

introducing a dissection tool into tissue beneath the treatment site;

generating a tissue plane with the dissection tool;

introducing a deformable tissue augmentation device into the tissue plane; and

at this point the tissue augmentation device is changed from a first, compressed configuration having a first volume to a second, augmented configuration having a second volume, wherein the second configuration is at least about 5 times greater than the first configuration.

5. The tissue augmentation device of any one of the preceding claims further comprising at least one port on the proximal end for accessing an interior of the body.

6. A tissue augmentation device as claimed in claim 5, wherein the device changes from the first configuration to the second configuration upon introduction of a filler through the port and into the device after the device has been delivered into the tissue.

7. A tissue augmentation device as claimed in any one of the preceding claims, wherein the device comprises a material capable of promoting fibrous tissue ingrowth.

8. A tissue augmentation device as claimed in any one of the preceding claims, wherein the device comprises at least one holding means to enable positioning of the device to a desired location.

9. A tissue augmentation device as claimed in claim 8, wherein the holding means comprises one or more protrusions.

10. The tissue augmentation device of any one of the preceding claims wherein the device comprises an inner layer and an outer layer, wherein the outer layer comprises a porous material for promoting fibrous tissue ingrowth and wherein the inner layer comprises an elastomeric type material that increases the flexibility of the body and for contacting a filler material.

11. The tissue augmentation device of claim 10 wherein the outer layer comprises ePTFE and the inner layer comprises silicone, polyurethane, or a thermoplastic elastomer.

12. The tissue augmentation device of any one of the preceding claims, wherein the filler comprises one or more fluids.

13. The tissue augmentation apparatus of claim 12 wherein the one or more fluids comprise one or more liquids.

14. A tissue augmentation device as claimed in claim 13, wherein said one or more liquids comprise saline.

15. The tissue augmentation device of any one of the preceding claims, wherein the filler comprises a material that is manually moldable into a desired configuration prior to the filler being changed to maintain the molded configuration.

16. The tissue augmentation device of any one of the preceding claims, wherein the tissue augmentation device allows passage of a filling tube and is capable of being completely or substantially resealed after removal of the filling tube.

17. The tissue augmentation device of any one of the preceding claims, wherein the tissue augmentation device comprises one or more penetrable septums that allow a filling tube to pass therethrough and that are completely or substantially resealable upon removal of the filling tube.

18. The tissue augmentation device of any one of the preceding claims wherein the tissue augmentation device comprises a plurality of internal partitions that divide the lumen of the device into a plurality of chambers or compartments.

19. The tissue augmentation device of claim 17 wherein the septum comprises a penetrable septum that allows the fill tube to pass therethrough and is capable of being completely or substantially resealed after removal of the fill tube.

20. A tissue augmentation device as claimed in any one of the preceding claims, wherein the device comprises two or more compartments adapted to be individually filled to alter the profile of the filled area.

21. The tissue augmentation device of any one of the preceding claims, wherein the device is selectively expandable or contractible to achieve a desired profile.

22. The tissue augmentation device of any one of the preceding claims, wherein the second configuration has a diameter of about 1mm to about 10 mm.

23. The tissue augmentation device of any one of the preceding claims, wherein the device has a length in the range of from about 1cm to about 6 cm.

24. The tissue augmentation device of any one of the preceding claims, wherein the device has a diameter in the range of from about 1mm to about 8 mm.

25. The tissue augmentation device of any one of the preceding claims, wherein the device has a wall thickness in a range of from about 0.003 inches to about 0.020 inches.

26. The tissue augmentation device of any one of the preceding claims, wherein the first configuration of the device is sized to fit through a tubular access passage having a caliber in the range of about 14 calibers to about 20 calibers.

27. The tissue augmentation device of any one of the preceding claims, wherein the first configuration of the device has a diameter of about 1.6mm or less.

28. The tissue augmentation device of any one of the preceding claims, further comprising one or more sutures.

29. The tissue augmentation device of any one of the preceding claims, wherein the tissue augmentation device is adapted to be substantially non-expanding prior to insertion into the tissue.

30. A tissue augmentation device as claimed in any one of the preceding claims, wherein the tissue augmentation device is adapted to be partially expanded prior to insertion into the tissue.

31. The tissue augmentation device of any one of the preceding claims, wherein a filler is added to the device during the implantation procedure and at least one subsequent implantation to provide a tissue augmentation device capable of long term adjustment.

32. The tissue augmentation device of any one of the preceding claims, wherein the tissue augmentation device is internally compartmentalized to allow filling of the segments with varying volumes of filler material to create a specific profile.

33. A augmentation system comprising the tissue augmentation device of any one of claims 1-3 and a dissection tool capable of separating tissue beneath the treatment site and creating a tissue plane.

34. An augmentation system comprising the tissue augmentation device of any one of claims 1 or 3 and a tubular access channel.

35. A tissue augmentation system as claimed in claim 2 or claim 34, wherein said tubular access passage comprises a needle, cannula or catheter.

36. A tissue augmentation system as claimed in claim 1 comprising a tissue augmentation device as claimed in claim 1 and a filling tube for providing said filler.

37. Use of the tissue augmentation device of any one of the preceding claims for the treatment of facial scars, lines or wrinkles.

38. The tissue augmentation device of any one of the preceding claims, wherein the tissue augmentation device is adapted to augment facial tissue.

39. The tissue augmentation device of any one of the preceding claims, wherein the tissue augmentation device is adapted to develop plane wrinkles.

40. The tissue augmentation device of any one of the preceding claims wherein the tissue augmentation device is adapted to fill lines, scars or wrinkles of the body or face.

41. A plurality of tissue augmentation devices of any one of the preceding claims, wherein the plurality of tissue augmentation devices are provided in a plurality of different sizes to enable a user to select a desired size.

42. The plurality of tissue augmentation devices of claim 41 wherein at least one tissue augmentation device has an expanded diameter: 0.5 to 2mm, 1.5 to 5mm, 2 to 6mm or 2 to 8 mm.

43. An implantable tissue augmentation device comprising:

at least two flexible sheets connected to define a plurality of chambers therebetween, said chambers being adapted to receive a filling material to expand one or more of said chambers into a desired configuration;

the sheet comprises a material that is capable of being penetrated by a tube supplying the chamber with a filling and that is self-sealing once the tube is withdrawn.

44. An implantable tissue augmentation device of claim 43 wherein the sheets are joined together adjacent to and between their peripheries to form the chamber.

45. An implantable tissue augmentation device of claim 44 wherein said sheets are connected together in a grid-like manner between said peripheries.

46. An implantable tissue augmentation device as claimed in any one of claims 43 to 45 comprising two sheets, each sheet being formed of multiple layers.

47. An implantable tissue augmentation device as claimed in any one of claims 43 to 46, wherein the periphery is shaped to generally fit the cheek of a human.

48. The implantable tissue augmentation device of any one of claims 43 to 47, wherein the device has a thickness of about 15mm or less in its pre-filled state.

49. An implantable tissue augmentation device as claimed in any one of the preceding claims in a larger sheet arrangement from which one or more of said devices may be cut.

50. A method of augmenting tissue, comprising implanting a device according to any one of claims 43 to 49, and selectively filling one or more of the chambers partially or completely therein to achieve a desired profile in the tissue.