Abstract: A system and method for localized delivery of a therapeutic or diagnostic agent within a vessel is provided. The system and method provide for adjustability of the length of the treatment area and for reducing of pressure within the treatment area. A catheter system includes an inner elongated element, an outer elongated element positioned coaxially with respect to the inner elongated element, and a blood-release element at a distal end of the inner elongated element. A proximal occlusion element is positioned at the distal end of the outer elongated element, proximal to an outlet port. A distal occlusion element is positioned at a distal end of the inner elongated element. The distal end of the inner elongated element is distal to and movable with respect to the outer elongated element distal end.

Abstract: Devices and methods for balloon delivery of rapamycin and other hydrophobic compounds to the wall of blood vessels. Balloon catheters, such as those used for balloon angioplasty, are modified with the addition of a reservoir of dry micelles, disposed at a suitable location within the balloon or catheter. The reservoir may be installed within the angioplasty balloon, within a lumen in communication with the angioplasty balloon, either as a loose or packed powder or as a film coating. The micelle preparation is reconstituted and the micelles are mobilized when the aqueous solution used to inflate the balloons is injected into the catheter. The micelles are infused into tissue surrounding the balloon when pressurized fluid within the balloon leaks through the wall of the balloon.

Abstract: Methods and systems for delivering toxin and toxin fragments to a patient's nasal cavity provide for both release of the toxin and delivery of energy which selectively porates target cells to enhance uptake of the toxin. The use of energy-mediated delivery is particularly advantageous with light chain fragment toxins which lack cell binding capacity.

Abstract: In one aspect, the present invention provides therapeutic-agent-releasing medical devices which comprise at least one region of piezoelectric material. Therapeutic agent release is initiated or increased when the piezoelectric material is subjected to mechanical stress, which leads to the development of a voltage across the piezoelectric material. This voltage is used to initiate or increase therapeutic agent release.

Abstract: A medical device for the treatment and irrigation of a sinus opening is described. The device allows for single-handed operation to access, dilate and irrigate a sinus opening. The device includes a sinus guide catheter, a guiding element, a balloon dilation catheter, a balloon catheter movement mechanism and a guiding element movement mechanism. A method for treating a sinus opening and irrigating a sinus is also described.

Abstract: Devices and methods for balloon delivery of rapamycin and other hydrophobic compounds to the wall of blood vessels. Balloon catheters, such as those used for balloon angioplasty, are modified with the addition of a reservoir of dry micelles, disposed at a suitable location within the balloon or catheter. The reservoir may be installed within the angioplasty balloon, within a lumen in communication with the angioplasty balloon, either as a loose or packed powder or as a film coating. The micelle preparation is reconstituted and the micelles are mobilized when the aqueous solution used to inflate the balloons is injected into the catheter. The micelles are infused into tissue surrounding the balloon when pressurized fluid within the balloon leaks through the wall of the balloon.

Abstract: Medical devices for delivering a bioactive agent and methods of use thereof are provided. The device includes a balloon having micro-needles for delivery of the bioactive agent.

Abstract: Enhanced dual purpose systems enable dilating of at least a lesion within a blood vessel and providing an anti-proliferative medicament in a non-attached form directly into the lumen of the vessel. Likewise provided is the ability to stop blood flow to prevent wash-out of the medicament during dwell time within the body lumen, and the ability to remove the medicament after the dwell time of the device to prevent unwanted exposure of the same within the body.

Abstract: A medical device for the delivery of treatment fluid to body vessels is described. The device has a distal (21) and a proximal (20) end with a self-expanding, hollow tubular member (9) and a delivery catheter (10) suitable for deploying a self-expanding, tubular member (9). The tubular member (9) is configured to expand radially to form a central part (11) flanked by two annular ridges, which creates, in situ, an annular lumen that can apply treatment fluid locally to a vessel and a passageway that can maintain the flow of blood through the vessel. The device is particularly suited for minimally invasive and repeatable organ perfusion. A method for organ perfusion is also disclosed.

Abstract: Catheter or guidewire mounted automatic vessel occlusion and fluid dispersion devices that expand to occlude or partially occlude a vessel when a fluid is flowing in the catheter or guidewire, and that automatically collapse when fluid flow is stopped. Each occlusion device has an elastic skeleton covered with a flexible cover coupled thereto and may have a hole(s) or openings in its distal or proximal end thereof to allow controlled flow through the desired end of the occlusion device. The fluid may be a flush fluid for enabling or improving the performance of imaging devices and image enhancing fluids, of treatment fluids for localized treatment of a vessel or tissues in communication with the vessel and/or of the transmission of energy to the vessel wall and adjacent tissues. Various embodiments are disclosed.

Abstract: A drug eluting angioplasty balloon (1, 101) suitable to adopt a deployed configuration and a collapsed configuration, the balloon having an outer wall (10) disposed around a core (11) defining an axis (X). The balloon (1, 101) comprising in the collapsed configuration a plurality of folds (12, 12?, 112) that are laid in a tangential direction about the core (11) and form a plurality of cavities (13a, 13b, 113) loaded with a drug (14), the cavities (13a, 13b, 113) are comprised between the folds (12, 12?, 112), wherein the folds (12, 12?, 112) originates from distinct longitudinal lines (25, 25?, 125, 125?) along the outer wall (10), are arranged in pairs and are circumferentially wrapped about the core (11) in such a way that a fold of one pair overlaps an adjacent fold of another pair and are wrapped in opposite directions.

Abstract: A delivery device that allows for the sustained release of an agent, particularly useful for the sustained release of a therapeutic agent to limited access regions, such as the posterior chamber of the eye and inner ear. The delivery device is minimally invasive, refillable and may be easily fixed to the treatment area. The delivery device includes a hollow body with an inlet port at its proximal end for insertion of the agent, a reservoir for holding the agent and a delivery mechanism for the sustained delivery of the agent from the reservoir to the patient.

Abstract: Medical devices including a substrate that are expandable from a compressed state to an expanded state; a coating on the substrate, the coating having a drug agent incorporated therein; and a sheath over the coating. The sheath is expandable from a compressed state to an expanded state and has at least one perforation therein. The medical devices are configured such that when the substrate is in a compressed state, the sheath is also in a compressed state and the perforation is substantially closed. When the substrate is in an expanded state, the sheath is also in an expanded state and the perforation is substantially open. The invention also includes a method of using the medical devices for the controlled, localized delivery of a drug agent to a target location within a mammalian body.

Abstract: The invention relates generally to devices and methods for local delivery of therapeutic agents to the wall of a bodily lumen with minimal shearing damage to the therapeutic agents, more specifically to the wall of a blood vessel following atherectomy. A preferred delivery mechanism comprises a balloon, or double balloon, though any distal catheter design may be used to reduce shear stress and to conserve and/or isolate the therapeutic substance.

Abstract: Methods and apparatus are provided for renal neuromodulation using a pulsed electric field to effectuate electroporation or electrofusion. It is expected that renal neuromodulation (e.g., denervation) may, among other things, reduce expansion of an acute myocardial infarction, reduce or prevent the onset of morphological changes that are affiliated with congestive heart failure, and/or be efficacious in the treatment of end stage renal disease. Embodiments of the present invention are configured for percutaneous intravascular delivery of pulsed electric fields to achieve such neuromodulation.

Abstract: A drug delivery system that can be deployed from a catheter and retained within the bladder for delivery of treatment drug solutions over a period of time. The delivery system includes an inflatable or expandable delivery element that can be collapsed within the catheter tip for navigation into the bladder before being inflated or expanded within the bladder. The inflated or expanded delivery element can engage the bladder walls or sized to be too large to be passed from the bladder such that the delivery element is retained within the bladder after inflation or expansion to administer a treatment drug solution over an extended period of time.

Abstract: Devices for the isolation of a selected portion of a vessel are described. In some embodiments, the device comprises an introducer sheath and a sealing catheter that are movable relative to each other to create an isolated volume with adjustable size and location. The methods for the treatment of vascular aneurysms using the devices are described. The treatment is achieved through the delivery of an effective amount of stabilization agent to an isolated volume that encompass the aneurysm. The device optionally has an aspiration means to improve the effectiveness of the treatment.

Abstract: There are disclosed apparatus and methods for treating tissue by delivering at least one therapeutic agent into the tissue. In one embodiment, the apparatus comprises a catheter and a balloon member disposed on a distal region of the catheter. A plurality of pockets are disposed on the balloon member, and a plurality of needles are associated with each of the plurality of pockets. The plurality of needles are configured to engage tissue when the balloon is in the inflated state, and further are configured to disperse a therapeutic agent from an associated pocket into the tissue when the balloon is in the inflated state. A first needle of the plurality of needles may comprise a length that is different than a second needle, permitting the delivery of first and second therapeutic agents to different depths within the tissue.

Abstract: Methods and devices are disclosed that, in various embodiments and permutations and combinations of inventions, diagnose and treat Multiple Sclerosis, Deep Vein Thrombosis, and/or Pulmonary Embolism or symptoms associated with these maladies. In one series of embodiments, the invention consists of methods and devices for identifying patients whose Multiple Sclerosis, Deep Vein Thrombosis, and/or Pulmonary Embolism or associated symptoms are caused or exacerbated, at least in part, by blockages of one or more of the patient's veins. In some instances, stenoses or other flow limiting structures or lesions in the patient's affected veins are identified. Further, in some instances the nature of such lesions and whether there is a significant disruption of blood pressure, or both, is ascertained. In some embodiments, methods and devices for applying one or more therapies to the blockages in the patient's veins are provided.

Abstract: In various embodiments, a device is provided comprising a balloon configured to expand to an expanded state in response to introduction of a fluid at a first pressure, wherein the fluid perfuses through the balloon above a second pressure, the second pressure being the same or greater than the first pressure. In various embodiments, a method comprising fabricating a balloon configured to expand to an expanded state in response to introduction of a fluid at a first pressure, wherein the fluid perfuses through the balloon above a second pressure, the second pressure being at or greater than the first pressure, disposing the balloon on an elongate member having a lumen, placing the lumen in fluid communication with an interior volume of the balloon.

Abstract: A method and apparatus to treat regions of a vessel is described. A protein elastin-based polymer is released from the apparatus to coat the vessel lining as a primary therapy or an adjunct therapy with the delivery and deployment of a stent with or without drug coating. The protein elastin-based polymer may include a triblock structure having an elastin pentapeptide as the flanking block and a hydrophilic variant of the pentapeptide as the middle block. Both the flanking and middle blocks can be modified to change the structural and chemical properties of the polymer. In particular, the protein elastin based polymer is adapted to perform at least one of controlling release of a treatment agent, stimulating endothelial cell growth and stabilizing the vulnerable plaque to prevent rupture of the vulnerable plaque.

Abstract: A catheter configured for delivering an agent to a patient's vessel wall is described. The catheter includes an inflatable balloon substantially covered by a expandable cage such that when the inflatable balloon is inflated the expandable cage substantially surrounds an outer surface of the inflated balloon. The inflatable balloon is configured to be deployed within a lumen against a lumen wall and separated from the lumen wall by the expandable cage in an expanded state, and is adapted to provide an agent delivery to a treatment site, and the expandable cage is further collapsible and is removable from said lumen.

Abstract: A medical device, at least a portion of which is formed from a polymer composition including at least one liquid crystal block copolymer having at least one A block and at least one B block wherein the A block is formed of mesogenic repeat units and the B block is a soft block.

Abstract: A device and method for administering a bioactive agent to internal tissue in a body, by introducing a balloon in a deflated condition into the body, inflating the balloon, introducing the bioactive agent into the balloon at the time of, after, or before the inflation of the balloon, and delivering the bioactive agent from the balloon to the tissue.

Abstract: Embodiments of the invention are related to devices and methods for modulating renal function, amongst other things. In an embodiment, the invention includes a method of modulating renal function in a patient including implanting an occlusive device in the patient, the occlusive device comprising a semi-permeable membrane and configured to expand or contract based on the passage of a fluid across the semi-permeable membrane. Other aspects and embodiments are provided herein.

Abstract: A drug delivery catheter and method for delivering microcapsules or microspheres containing a drug, pharmacological or other bioactive agent includes a balloon catheter having a coating on the balloon of a soluble biocompatible polymer containing a plurality of microcapsules or microspheres containing a drug or other agent. The balloon is porous to allow it to be inflated with a solvent fluid that passes through the porous wall of the balloon and dissolves the polymer, releasing the microspheres.

Abstract: A system and method of treating urinary incontinence including a catheter and injection guide operatively disposed together. At least one needle is operatively disposed within at least one lumen and at least one channel extending through the catheter and injection guide respectively. The injection guide is transformable from a pre-injection configuration for placement in the bladder to an injection configuration for injection of a pharmaceutical such as botulinum toxin into the bladder tissue. Upon introduction of the pharmaceutical to the bladder tissue, symptoms of incontinence are alleviated.

Abstract: One disclosed embodiment comprises a method for treating lesions in the carotid artery of a mammalian body. The method comprises transcervical access and blocking of blood flow through the common carotid artery (with or without blocking of blood flow through the external carotid artery), shunting blood from the internal carotid artery and treating the lesion in the carotid artery.

Abstract: The invention comprises a method and apparatus for treatment of a body part. More particularly, a method and apparatus for heat treatment of tissue using a catheter inserted into a body part is described along with means for positioning the catheter and means for positioning a set of electrodes relative to a tissue sample for treatment. Still more particularly, radio frequency energy at about 400 to 500 kilohertz is used to provide heat for the tissue treatment.

Abstract: A fluid delivery system including a first balloon and a second balloon at least partially positioned within the first balloon, wherein the second balloon has an inner surface, an outer surface, and at least one micro-needle extending outwardly from the outer surface of the second balloon. The delivery system can further include a fluid source in communication with at least one of the micro-needles of the second balloon.

Abstract: A catheter configured for delivering an agent to a patient's vessel wall is described. The catheter includes an inflatable balloon substantially covered by a expandable cage such that when the inflatable balloon is inflated the expandable cage substantially surrounds an outer surface of the inflated balloon. The inflatable balloon is configured to be deployed within a lumen against a lumen wall and separated from the lumen wall by the expandable cage in an expanded state, and is adapted to provide an agent delivery to a treatment site, and the expandable cage is further collapsible and is removable from said lumen.

Abstract: A method for delivering a therapeutic substance to a treatment site within a body lumen includes advancing a balloon catheter to the treatment site. A balloon of the balloon catheter is inflated and while the balloon is inflated, a primer that coats the treatment site and attracts the therapeutic substance thereto is delivered through a first fluid delivery lumen of the balloon catheter. The balloon of the balloon catheter is deflated for a predetermined period of time. The balloon of the balloon catheter is reinflated and while the balloon is reinflated, the therapeutic substance is delivered through a second fluid delivery lumen of the balloon catheter. The primer improves adherence of the therapeutic substance to the treatment site.

Abstract: Apparatus for accessing a bodily passageway, the apparatus comprising: a flexible tube having a distal end and a proximal end, a longitudinal axis extending between the distal end and the proximal end, and a lumen extending from the distal end to the proximal end, the lumen being sized to receive matter to be transported through the bodily passageway; and an external thread disposed over the distal end of the tube, the external thread having a sufficient structural integrity, and a sufficient surface profile, such that when the tube is disposed in a bodily passageway, rotation of the tube about the longitudinal axis will result in longitudinal motion of the tube along said bodily passageway.

Abstract: There are disclosed apparatus and methods for treating tissue by delivering at least one therapeutic agent into the tissue. In one embodiment, the apparatus comprises a catheter (30, 40) and a balloon member (150) disposed on a distal region of the catheter. A plurality of pockets (164) are disposed on the balloon member (150), and a plurality of needles (180) are associated with each of the plurality of pockets. The plurality of needles (180) are configured to engage tissue when the balloon (150) is in the inflated state, and further are configured to disperse a therapeutic agent from an associated pocket (164) into the tissue when the balloon (150) is in the inflated state. A first needle (180a) of the plurality of needles may comprise a length that is different than a second needle (180b), permitting the delivery of first and second therapeutic agents to different depths within the tissue.

Abstract: Medical devices including a substrate that are expandable from a compressed state to an expanded state; a coating on the substrate, the coating having a drug agent incorporated therein; and a sheath over the coating. The sheath is expandable from a compressed state to an expanded state and has at least one perforation therein. The medical devices are configured such that when the substrate is in a compressed state, the sheath is also in a compressed state and the perforation is substantially closed. When the substrate is in an expanded state, the sheath is also in an expanded state and the perforation is substantially open. The invention also includes a method of using the medical devices for the controlled, localized delivery of a drug agent to a target location within a mammalian body.

Abstract: A kit of parts comprises a system and instructions for use for controlling patient temperature which uses a central venous line catheter having a heat exchange element. The central venous line catheter is provided with one or more lumens for providing access to the central blood supply of the patient and with additional lumens for communicating heat exchange fluid to the heat exchange element. Heat exchange fluid temperature is controlled through a feed back loop iii which patient temperature is sensed and used to control a temperature control unit comprising a heating device and/or a cooling device in heat exchange relationship with the heat exchange fluid. A tubing set transports the heat exchange fluid between the central venous line and the temperature control unit, with a pump serving to circulate the fluid in a closed fluid circuit in the system.

Abstract: Devices capable of deterring or preventing bulk extraction of drugs from, for example, drug-delivery systems are exemplarily disclosed. In one embodiment, such a device may include a package releasably retaining a drug and an agent. The agent is configured to suppress a physiological effect of the drug when the agent contacts the drug or is coadministered with the drug. The cell package is configured such that an amount of the drug is selectively releasable with respect to the agent when the package is operably proximate to an encoded key. The package, however, may be configured to impose a relatively high likelihood that either the drug will not be accessed or the drug will be contaminated by the agent if access to the contents of the package is sought without the use of an encoded key.

Abstract: An agent delivery catheter configured to deliver an agent to an inner surface of a patient's body lumen wall by forming an array of cells defining agent containment chambers at multiple locations along the catheter's shaft, while minimizing ischemic conditions during the procedure.

Abstract: An inflatable bone tamp for performing a minimally invasive surgical procedure includes an inflatable structure that exhibits an outwardly tapering expansion profile. The outward taper can beneficially allow the inflatable bone tamp to exert greater targeted force in difficult environments. For example, in a vertebra with a compression fracture, the outwardly tapering expansion profile of the inflatable bone tamp can result in greater lifting force being applied to the endplates of the vertebra, thereby increasing the likelihood of restoring the height lost due to the compression fracture.

Abstract: A balloon catheter for delivering a therapeutic and/or diagnostic agent to tissue is described including an outer balloon having a wall with an opening therethrough and an inner surface, an inner balloon disposed in the outer balloon, enclosing an inflation chamber and having an outer surface defining a space between the outer surface of the inner balloon and the inner surface of the outer balloon, a catheter having a first lumen in fluid communication with the space between the inner balloon and the outer balloon for supplying the agent thereto, and a second lumen through which fluid is supplied to the inflation chamber for inflating the inner balloon to urge the agent out of the opening in the outer balloon, wherein the outer balloon and/or the inner balloon comprise at least one protrusion for directing the agent.

Abstract: Methods and devices are disclosed that, in various embodiments and permutations and combinations of inventions, diagnose and treat Multiple Sclerosis, Deep Vein Thrombosis, and/or Pulmonary Embolism or symptoms associated with these maladies. In one series of embodiments, the invention consists of methods and devices for identifying patients whose Multiple Sclerosis, Deep Vein Thrombosis, and/or Pulmonary Embolism or associated symptoms are caused or exacerbated, at least in part, by blockages of one or more of the patient's veins. In some instances, stenoses or other flow limiting structures or lesions in the patient's affected veins are identified. Further, in some instances the nature of such lesions and whether there is a significant disruption of blood pressure, or both, is ascertained. In some embodiments, methods and devices for applying one or more therapies to the blockages in the patient's veins are provided.

Abstract: A catheter for delivering a stent includes an outer tube having a proximal end, a distal end and a wall defining a lumen; an inner tube disposed within the outer tube and defining a lumen for a guidewire, wherein a portion of a length of the inner tube is wrapped around with a spiral-shaped wire; a balloon sealingly connected to the inner tube and the outer tube adjacent the distal ends thereof, the balloon defining an interior volume and having an exterior surface; and a marker made from a wire of a highly radiopaque and ductile material, wherein the wire is wrapped in a plurality of at least partially overlapping layers such that the marker is flexible along the length of the catheter.

Abstract: A dilatation catheter for delivering a therapeutic agent within a body lumen having a wall with a thickness is provided having a balloon having a flexible wall including a polymer with dispersed nanotubes and pores configured to close below a predefined pressure and to open at or above a predefined pressure. In some embodiments, an actuator is provided to controllably inflate the balloon with a fluid at a pressure sufficient to bring the flexible wall of the balloon into contact with at least a portion of the wall of the body lumen but below the predefined pressure, and to controllably increase the pressure of the fluid within the inflated balloon to at least the predefined pressure at a rate and with a force sufficient to deliver the therapeutic agent from the pores and through at least a portion of the thickness of the wall of the body lumen.

Abstract: A dilatation catheter for delivering a therapeutic agent within a body lumen having a wall with a thickness is provided having a balloon having a flexible wall including a polymer with dispersed nanotubes and pores configured to close below a predefined pressure and to open at or above a predefined pressure. In some embodiments, an actuator is provided to controllably inflate the balloon with a fluid at a pressure sufficient to bring the flexible wall of the balloon into contact with at least a portion of the wall of the body lumen but below the predefined pressure, and to controllably increase the pressure of the fluid within the inflated balloon to at least the predefined pressure at a rate and with a force sufficient to deliver the therapeutic agent from the pores and through at least a portion of the thickness of the wall of the body lumen.

Abstract: A method and apparatus of treating tissue adjacent a bodily conduit using thermotherapy, while preventing obstructions of the bodily conduit due to edema, includes injection of a drug-encapsulated within a heat-sensitive carrier, such as a liposome, within a region of tissue to be treated. The heat produced by the energy-emitting source heats a portion of the tissue surrounding the bodily conduit to a temperature of approximately 43° C. for a time sufficient to destroy the heated portion of the tissue. In addition, the heat produced by the energy-emitting source activates the heat-sensitive carrier to activate the release of the encapsulated drug and the drug targets the tissue to be heated. The focused energy of the energy-emitting source together with the compression acting on the target area can assist in delivering drugs to the target area so that a natural stent has a long term efficacy.

Abstract: An inflatable bone tamp for performing a minimally invasive surgical procedure includes an inflatable structure having at least three contiguous lobes, that when inflated, cause the inflatable structure to exhibits an outwardly tapering expansion profile. By forming the inflatable structure such that the reduced-diameter junction(s) between the lobes has a greater wall thickness then the adjacent lobes, the durability and abrasion-resistance of the inflatable bone tamp can be increased.

Abstract: Apparatuses and methods for coating and/or loading a medical device with a therapeutic agent prior to or during the placement of the medical device within the patient's body. In one variation, the medical device is coated and/or loaded with a therapeutic agent while the device is positioned in a delivery apparatus. In another variation, the delivery apparatus comprises a reservoir for retaining a therapeutic agent. The user may release the therapeutic agent from the reservoir prior to or during the placement of the device to coat and/or load the device with the therapeutic agent.

Abstract: Catheter or guidewire mounted automatic vessel occlusion and fluid dispersion devices that expand to occlude or partially occlude a vessel when a fluid is flowing in the catheter or guidewire, and that automatically collapse when fluid flow is stopped. Each occlusion device has an elastic skeleton covered with a flexible cover coupled thereto and may have a hole(s) or openings in its distal or proximal end thereof to allow controlled flow through the desired end of the occlusion device. The fluid may be a flush fluid for enabling or improving the performance of imaging devices and image enhancing fluids, of treatment fluids for localized treatment of a vessel or tissues in communication with the vessel and/or of the transmission of energy to the vessel wall and adjacent tissues. Various embodiments are disclosed.

Abstract: A dilatation catheter for delivering a therapeutic agent within a body lumen having a wall with a thickness is provided having a balloon having a flexible wall including a polymer with dispersed nanotubes and pores configured to close below a predefined pressure and to open at or above a predefined pressure. In some embodiments, an actuator is provided to controllably inflate the balloon with a fluid at a pressure sufficient to bring the flexible wall of the balloon into contact with at least a portion of the wall of the body lumen but below the predefined pressure, and to controllably increase the pressure of the fluid within the inflated balloon to at least the predefined pressure at a rate and with a force sufficient to deliver the therapeutic agent from the pores and through at least a portion of the thickness of the wall of the body lumen.

Abstract: Methods, devices and systems for in situ formation of an implant within a post-surgical cavity. A balloon is provided within the cavity and a gelling initiator such as a cross-linking agent is introduced into the balloon. A polymer susceptible to solidifying in the presence of the gelling initiator is then introduced into the balloon. The introduced polymer is allowed solidify through contact with the introduced gelling initiator to form the implant while the balloon isolates the solidifying implant from the cavity. The balloon is then ruptured and extracted from the cavity such that the formed implant remains within and directly contacts an interior surface of the cavity.