Abstract: A hydrogel based occlusion system, a method for occluding vessels, appendages or aneurysms, and a method for hydrogel synthesis are disclosed. The hydrogel based occlusion system includes a hydrogel having a shrunken and a swollen state and a delivery tool configured to deliver the hydrogel to a target occlusion location. The hydrogel is configured to permanently occlude the target occlusion location in the swollen state. The hydrogel may be an electro-activated hydrogel (EAH) which could be electro-activated with a delivery system to control the degree of swelling/shrinking.

Abstract: The invention is directed to a device for delivering an active agent formulation for a predetermined administration period. An impermeable reservoir is divided into a water-swellable agent chamber and an active agent formulation chamber. Fluid from the environment is imbibed through a semipermeable plug into the water-swellable agent chamber and the active agent formulation is released through a back-diffusion regulating outlet. Delivery periods of up to 2 years are achieved.

Abstract: Catheter systems and methods for implanting helical or dart-like implants into the myocardium or other body tissue. The catheter system includes a helix for fixing the distal end of the catheter to the myocardium, an implant held by the helix, mechanisms for driving the fixation helix into the myocardium, and mechanisms for driving the implant into the myocardium, removing the fixation helix and leaving the implant behind. The implant may be coated, filled, or made of a drug or drug eluting compound, or drug delivery matrix of any composition.

Abstract: Embodiments provide apparatus and methods for delivering solid form drug (SFD) to various locations in the body. In one embodiment, the invention provides an apparatus for treatment of arrhythmia comprising a drug delivery member (DDM) coupled to a drug storage device (DSD). The DSD is configured to store and advance SFD (e.g., drug pellets) through the DDM to a target tissue site (TTS) in or on the heart. A drug advancement member may be used to advance the SFD through the DSD. A capture chamber (CC) may be coupled to the DDM. and is configured to be positioned on a heart surface and allow SFD to dissolve to deliver a drug solution to the heart. The DSD can be implanted subcutaneously e.g., in the pectoral area. Embodiments of the apparatus can be used to store and deliver SFD to the heart or other TTS over an extended period of years.

Abstract: Instruments, systems, implants, and methods are provided for performing submucosal medical procedures in a desired area of the digestive tract using endoscopy. Instruments include a safe access needle injection instrument, a submucosal tunneling instrument, a submucosal dissection instrument, and a mucosal resection device. A submucosal implant device for diagnosing and treating disorders of the body may be implanted. A passive submucosal implant device may take the form of a drug delivery depot in which a therapeutic agent within the depot elutes from the depot according to a predetermined elution profile. An active submucosal implant device may take the form of a drug delivery device that incorporates a self-contained diagnostic system to determine the appropriate delivery time and dosage of a therapeutic agent to be administered.

Abstract: The present invention provides endovascular devices and the methods of making and using the same. The endovascular device is a prohealing endovascular device that comprises a super hydrophilic surface. The super hydrophilic surface is generated by a method comprising a step of irradiating a surface of the endovascular device with a high energy radiation for a period of time to cause the surface to become super hydrophilic.

Abstract: Medical devices and related methods are disclosed for delivering an implant into the body of a patient. The devices include a damping assembly having an internal chamber with a varying inner diameter, and a piston slideably disposed therein. The piston is operably connected with a catheter portion such that movement of the piston is associated with concurrent movement of the catheter for implant delivery. The varying inner diameter of the damping assembly results in a decrease in damping force during implant delivery, thus providing a substantially constant velocity of implant delivery.

Abstract: An applicator for delivering brachytherapy includes elongate members movable between collapsed and expanded configurations for delivering brachytherapy within a lumpectomy cavity, a vaginal cavity, or other target region. The elongate members may be expandable into a symmetrical or asymmetrical expanded configuration, e.g., into a generally spherical, pear-shaped, or planar configuration. A system for delivering brachytherapy includes the applicator and an access device for lining and/or dilating a body cavity and/or for receiving the applicator therein. The access device is advanced into a body cavity, an expandable member on the access device is inflated, the applicator is advanced into the access device, and the elongate members are expanded to deliver radiation to the target region.

Abstract: A method of treating the symptoms of Parkinson's disease comprises implanting a reservoir-based drug delivery composition into a subject to systemically deliver a therapeutically effective amount of rasagiline to the subject for a long period of time (e.g., one month or one year). The drug delivery composition may include a rate-controlling excipient (e.g., an elastomeric polymer) defining a reservoir containing at least one discrete solid dosage form (e.g., one or more pellets), which includes rasagiline hemitartrate and optionally, a sorption enhancer.

Abstract: The application provides an injection cannula having an implant which is detachably secured in the cannula. The application also provides a method for detachably securing an implant in an injection cannula.

Abstract: An apparatus for percutaneous delivery of a sealant comprising: at least two fluid reservoirs, an introducer needle having a distal tip that is in fluid communication with at least one reservoir, a fluid delivery tube that is in fluid communication with a second reservoir, wherein the fluid delivery tube has a tip and wherein the fluid delivery tube is configured so that the tip of the fluid delivery tube does not extend past the distal tip of the introducer needle during use.

Abstract: Rectal suppositories are used to administer a predetermined drug dosage to treat a variety of diseases and symptoms in a variety of patient populations. Certain medical conditions, such as digestive disorders, may be more effectively treated when the suppository is placed in a particular location of the patient's anal canal or rectum. A method and apparatus for inserting a suppository into an animal or human may include an applicator having a barrel and plunger. The barrel maintains a first gas flow path during insertion of a suppository and the plunger maintains a second gas flow path during withdrawal of the plunger. By maintaining the first and second gas flow paths, trapped air and suction effects on the suppository are minimized or eliminated. Furthermore, patients may immediately resume day-to-day activities. These benefits may encourage patients to maintain a course of treatment thereby potentially avoiding additional complications, hospitalization, and costs.

Abstract: Structurally supportive material is implanted or injected into cardiac veins as discrete masses at various sites in the cardiac venous system to reinforce the myocardium for the purpose of preventing, moderating, stopping or reversing negative cardiac remodeling due to various adverse cardiac conditions, both acute and chronic, or for the purpose of treating localize anomalies of the heart, or for both purposes. The sites may be arranged in a pattern about one or more chambers of the heart such that the masses cooperatively reduce stress in the chamber wall and reduce chamber size. Some patterns also cause a beneficial global reshaping of the chamber. These changes occur quickly and are sustainable, and have a rapid and sustainable therapeutic effect on cardiac function.

Abstract: A method and kit for treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.

Abstract: Novel methods for the chemical ablation of tissue (e.g. prostatic tissue) are described. These methods include the steps of: (a) providing one or more solid salt dosage form comprising 50-100% w/w salt; and (b) inserting one or more of such solid salt dosage forms into the tissue. The solid salt dosage form is optionally inserted into the tissue under real-time ultrasonic observation. An advantage of the present invention is its ability to eliminate toxic byproducts. For example, where NaCl-based solid salt dosage forms are used to effect localized chemical ablation, the concentration is ultimately reduced to the level of normal saline (i.e., about 0.9%) upon absorption by the body of the subject being treated.

Abstract: Methods and apparatus are provided for delivering a bioactive agent in a needle track formed in a target tissue mass, following formation of the needle track, by avoiding impingement of the agent against target tissue at high velocity or by using capillary action to draw the bioactive agent out of the needle during needle withdrawal. The apparatus comprises a catheter and a needle disposed within the catheter and configured to be selectively extended into the tissue mass to a predetermined depth, while dispensing the agent simultaneously with retraction of the needle along the needle track. Alternatively, or in addition, the needle may be configured to create a tissue space surrounding a distal or lateral surface of the needle, into which the bioactive agent to be infused.

Abstract: To provide a cannula device (4) with an implant (3), the cannula device (4) is held at an extrusion die in such a way that the cannula device (4) is in contact with a sealing surface of the extrusion die. A flowable implant material is conveyed through the extrusion die into an implant channel (10) of the cannula device (4). The implant material solidifies in the implant channel, for example by means of cooling.

Abstract: A point-of-care seed stranding device for automating assembly of brachytherapy seed strands for implantation in patients. The device includes a number of features to reduce the potential for mistakes by the user, as well as to reduce the potential for damaging the radioactive seeds during the stranding process. Tactile feedback may be provided to prevent exertion of too much force in the packing step of the stranding process, as well as to indicate that the seed and/or strand cartridges are empty and need to be replaced. The device may also include a mechanism for holding seeds or spacers in place to allow automated packing of seeds or spacers having corresponding geometries. The device may also be provided with a seed counter which can be employed to preset the number of seeds in a strand and which disables the device from dispensing or packing additional seeds once the preset number of seeds has been packed into the strand.

Abstract: A method of repairing a defect in an annulus fibrosus of an intervertebral disc, without excising the entire nucleus pulposus of the disc. The method includes inserting an introducer needle through the annulus fibrosus by puncturing the annulus fibrosus with the introducer needle, injecting an in situ curable, bio-compatible polymerizable or polymeric material composition into the disc through the introducer needle directly or indirectly so that the in situ curable composition contacts a defect in the annulus fibrosus; and curing said material in situ.

Abstract: Embodiments described herein provide a skin penetrating device and method for the subcutaneous delivery of therapeutic agents in solid form. One embodiment provides such a device comprising an elongated shaft having proximal and distal ends and a skin penetrating element detachably coupled to the shaft. At least a portion of the penetrating element is fabricated from a solid form therapeutic agent composition that dissolves in body tissue and is absorbed into the blood stream so as to produce a therapeutic effect. The penetrating element has shape for penetrating and lodging beneath the skin when inserted through the skin by force applied from the shaft. The penetrating element is configured to detach from the shaft when the shaft is pulled away from the skin so as to leave the element in place beneath the skin where it is absorbed by body tissue and the therapeutic agent is released.

Abstract: A delivery system includes a housing along with a tip connected to one end of the housing. A first cannula extending from the tip is provided for inserting a rod implant into tissue. A second cannula, concentrically disposed within the first cannula, is utilized to force the rod implant from the first cannula and for ejecting a fluid behind the inserted rod implant in the tissue.

Abstract: An instrument with a covered bore for subcutaneous implantation is provided. An incising body defines a non-circular coaxial bore and includes a sharpened cutting edge that extends from a bottom distal end beyond the opening of the coaxial bore and an attachment point at a top distal end. A plunger is non-fixedly contained within the coaxial bore and slides longitudinally therein. A cover is pivotally attached at the attachment point and extends down to the bottom distal end and, when closed, the cover encloses the opening proximal to the cutting edge.

Abstract: The invention concerns a device for injecting a solid medicine (10) comprising a body (2) inside which moves along a general forward moving axis (X-X) a bevelled (34) needle (4) wherein is introduced the medicine (10), said injection device (1) further comprising retaining means for preventing the medicine from falling (10) prior to being injected. The invention is characterized in that the medicine (10) is retained through an elastic deformation imparted to the needle (4) by the retaining means or by an elastic deformation of the retaining means themselves, or still by the combined flexibility of those two means.

Abstract: An instrument with a two-part plunger for subcutaneous implantation is provided. An incising body defines a non-circular coaxial bore and includes a cutting edge formed on a distal end. A two-part plunger is non-fixedly contained within the coaxial bore and includes a tongue blade assembly and a plunger assembly. The tongue blade assembly is provided on a bottom surface of the coaxial bore and includes a tongue blade shaft and a thin tongue blade with a sharpened clearing edge on a distal end. The tongue blade assembly has a length exceeding the coaxial bore. The plunger assembly has a length exceeding the coaxial bore and includes a plunger shaft and a plunger affixed on a distal end. The plunger is slidably positioned on a top surface of the tongue blade.

Abstract: Cannula assemblies with pressure sensors made of stacked coplanar layers and ambulatory infusion systems comprising the same are disclosed. The cannula assemblies include a hub and an infusion cannula. The hub includes a pressure sensor and a fluid channel fluidly coupled to the infusion cannula. The pressure sensor is formed from a stack of coplanar layers including a top layer, a base layer an electrode layer and a counter electrode layer. The fluid channel is positioned between the top layer and the base layer. The electrode layer is positioned between the top layer and the base layer and coupled to the fluid channel. The counter-electrode layer is positioned between the top layer and the electrode layer. A spacer layer having a through cut-out defining an electrode cavity is disposed between the top layer and the base layer such that the electrode layer extends across the electrode cavity.

Abstract: A device for delivering a medicated product or the like to a bodily cavity is provided. The device includes a barrel member having a distal end. The barrel member is sized to contain the medicated product. The device includes a plunger sized to extend into the barrel member. A cap is adapted to move between a sealing position, in which the cap is positioned adjacent to the barrel member and seals the distal end of the barrel member, and a dispensing position, in which the cap is moved in a direction away from the barrel member. The cap includes at least one opening sized to allow the medicated product to flow through the cap when the cap is in the dispensing position. A retainer mechanism is provided for retaining the cap on the barrel when the cap is in the dispensing position.

Abstract: The invention provides a drug delivery device for latanoprost or latanoprost acid. The device has a core of latanoprost or latanoprost acid which is surrounded by an internal and external sheath. The external sheath has a first cap that is permeable to latanoprost or latanoprost acid. The first cap may comprise polyvinyl alcohol (PVA), and the PVA may be heat cured. In certain aspects, there are one or more additional caps on the ends of the sheaths formed from one or more polymers. In certain aspects, one or more portions of the drug delivery device is substantially impermeable to latanoprost or latanoprost acid. In certain aspects, the latanoprost or latanoprost acid elutes through the first cap into a biological environment. The invention further provides methods for manufacturing the drug delivery device.

Abstract: Drug depot storage and delivery devices and methods for delivering a drug depot to a site beneath the skin of a patient are provided. In various embodiments, the drug depot storage and delivery device comprises a retaining member that in an open position allows delivery of the drug depot from the drug cartridge to the target tissue site. In various embodiments, the drug depot storage and delivery device comprises a retaining member that in a closed position reduces or prevents delivery of the drug depot from the drug cartridge to the target tissue site.

Abstract: Rectal suppositories are used to administer a predetermined drug dosage to treat a variety of diseases and symptoms in a variety of patient populations. Certain medical conditions, such as digestive disorders, may be more effectively treated when the suppository is placed in a particular location of the patient's anal canal or rectum. A method and apparatus for inserting a suppository into an animal or human may include an applicator having a barrel and plunger. The barrel maintains a first gas flow path during insertion of a suppository and the plunger maintains a second gas flow path during withdrawal of the plunger. By maintaining the first and second gas flow paths, trapped air and suction effects on the suppository are minimized or eliminated. Furthermore, patients may immediately resume day-to-day activities. These benefits may encourage patients to maintain a course of treatment thereby potentially avoiding additional complications, hospitalization, and costs.

Abstract: Implantable drug delivery devices are provided that are deformable between a relatively straightened shape suitable for deployment and a retention shape suited to retain the device within the bladder or other body cavity. While in the body cavity, the devices release drug from solid drug units housed in the devices. The devices are designed to house the solid drug units in a way that exposes one or more sides of the solid drug units to the fluid at the in vivo site of deployment. Methods for using the devices for administering drug and making the devices also are provided.

Abstract: A uterine fibroid treatment device providing for localized delivery of one or more treatment drugs for treating various uterine conditions including, for example, uterine fibroids, abnormal uterine bleeding, pelvic adhesions and endometriosis. Generally, the uterine treatment device comprises a physical positioning element that can be inserted, positioned and maintained in close proximity to the uterine tissue to be treated. The treatment drugs delivered to the treatment location can include various combinations of anti-proliferative agents and angiogenesis inhibitors to provide different treatments concurrently. In some embodiments, the physical element can also serve the dual purpose of delivering the treatment drugs while simultaneously cutting off blood flow to a mature fibroid to initiate hypoxic/ischemic conditions within the mature fibroid.

Abstract: A suppository delivery device that allows for the insertion of a suppository without having contact with the suppository or rectum. The suppository delivery device includes a stabilizing platform, a stabilizer to which the suppository is mounted, and a package, which protects the user's hands and fingers from the suppository and rectum and prevents germs from contacting the suppository before being inserted into the rectum.

Abstract: A device for drug delivery to an orifice of a subject, comprising a shell which is elastically stressed by an active pharmaceutical ingredient, said shell containing and being substantially impermeable to said active pharmaceutical ingredient, wherein said shell has at least one hole sized for in-vivo release of said active pharmaceutical ingredient as a result of elastic stressing.

Abstract: A procedure for treating carpal tunnel syndrome can involve delivering a dehydrating agent into and/or near the carpal tunnel. The dehydrating agent can reduce swelling of the flexor tendons and/or the carpal ligament in the region, thereby reducing pressure on the median nerve that also runs through the carpal tunnel. Through the use of a dehydrating agent that affects proteoglycans without affecting collagen, localized dehydration can be induced without weakening the flexor tendons, carpal ligament, and any other structures in the carpal tunnel region.

Abstract: Implantable medical devices and treatment methods are provided, particularly for use in the bladder. The device is configured for retention in the bladder for at least a portion of the drug delivery period and includes at least one biodegradable component such that following a biodegradation at a selected time, the retention function is lost and the device or portions thereof are resorbed and/or excreted. The method may include deploying into the bladder of a patient a device having a device structure housing a drug formulation comprising at a drug; releasing drug from the device structure into the bladder; and then, changing the composition of urine in the bladder, e.g., by altering the pH, to trigger degradation of at least part of the device structure to enable the device structure or parts thereof to be excreted from the bladder.

Abstract: Devices, systems, and methods for myocardial infarct border zone reinforcement. In at least one embodiment of a suction/infusion catheter for facilitating myocardial infarct border zone reinforcement, the catheter comprises one or more apertures defined along a portion of the catheter at or near a distal end of the catheter, a first configuration when the suction/infusion catheter is at least partially extended from a delivery catheter, and a second configuration when the at least one suction/infusion catheter is positioned within the delivery catheter, the second configuration different from the first configuration, wherein the suction/infusion catheter, when introduced into a pericardial space surrounding a heart at or near a myocardial infarct border zone, is operable to inject a glue-like substance through a lumen of the suction/infusion catheter and out from the one or more apertures to deliver the glue-like substance into the pericardial space at or near the myocardial infarct border zone.

Abstract: A flow regulating implant is provided with one or more grooves for allowing fluid flow. One or more grooves may have a constant or varying cross-section along its length. One or more grooves may have in it biodegradable material, absorbable material, and/or threads or sutures. A resilient band or coating may be placed around the implant or one or more grooves, to act as a pressure regulator. The implant may have a side projection, such as a side pin, for engaging tissue. The implant may comprise two or more parts that are held at a distance from each other to allow fluid flow between the parts.

Abstract: A syringe and a method of using the syringe are disclosed. The syringe includes a longitudinal body having proximal and distal ends and including an aperture between the proximal and distal ends. An injectable material, such as an adhesive bone cement, may be loaded into the body of the syringe through the aperture. After the injectable material is inserted, the aperture may be closed by covering the aperture with an aperture cover. The aperture cover may be configured to slide into a position covering the aperture, or the aperture cover may be placed in a position covering the aperture, such as by pivoting about a hinge. After the aperture is closed, the injectable material may be dispensed from the distal end of the syringe body by depressing a plunger. Depressing the plunger may initiate the closing of the aperture, or the aperture may be closed independently of plunger movement.

Abstract: A reduced pressure delivery system for applying a reduced pressure to a tissue site includes a manifold delivery tube having at least two lumens and a manifold having a plurality of flow channels. The manifold is disposed within a first of the lumens of the manifold delivery tube. A balloon having an inner space and being capable of assuming collapsed and expanded positions is provided. The inner space of the balloon is fluidly connected to a second of the lumens of the manifold delivery tube.

Abstract: An implantable drug delivery device includes a drug reservoir portion, a retention frame portion, and a guide wire portion. The drug reservoir portion houses a drug. The retention frame portion houses a retention frame. The guide wire portion defines a hollow bore for receiving a guide wire.

Abstract: The present invention provides a vaginally administrable tablet useful for treating leiomyomata, leiomyoma, myoma, uterine fibroids, endometriosis, adenomyosis and other related disorders. The tablet comprises mifepristone, at least one non-effervescent excipient or diluent, and at least one effervescent excipient.

Abstract: An electrode lead for a cochlear implant, the electrode lead having a lateral side and a medial side supporting an electrode array, wherein a height of a cross section of the electrode lead is greater in the lateral side than a height of the cross section in the medial side.

Abstract: Apparatus and method utilizing fluid to deliver a bolus of therapeutic material through a lumen to a delivery or discharge control portion of the apparatus, where the bolus may be discharged or delivered to a desired location.

Abstract: A needleless device (10) for delivery of an agent through a biological barrier, the device comprising a microimplant (12) retaining layer (13) holding at least one microimplant for delivery through the biological barrier, a microimplant driving layer including means (21) for providing a motive force to the or each microimplant, and a guide layer having at least one guide channel associated with a microimplant through which the motive force is applied to the or each microimplant, wherein, in use, activation of the microimplant driving layer causes the or each microimplant to be driven away from the retaining layer through the biological barrier.

Abstract: The present invention is directed to a device for implanting a plurality of drug depots at or near a target tissue site beneath the skin of a patient. The device comprises at least three or more drug depots, wherein each of the at least three or more drug depots has a first surface adapted to receive one or more anchoring members so as to limit movement of the at least three or more drug depots at or near the target tissue site, and wherein at least two of the at least three or more drug depots comprise a second surface adapted to receive the anchoring member after the anchoring member contacts the target tissue site. Each drug depot is capable of releasing a therapeutically effective amount of a drug over a period of at least one day.

Abstract: Bezoar-forming units for forming at least one temporary bezoar in a gastrointestinal organ of an animal, including a mammal, to fill a space in the said organ, are provided for weight control. The units include biodegradable fiber-based configurations of various length and shape having a first dimension and a second dimension; whereby when the bezoar-forming units are located in the given gastrointestinal organ, at least one temporary, permeable bezoar is formed.

Abstract: A biomaterial mass is inserted through a punctum into a canaliculus in the lacrimal outflow system with a syringe. The mass has an outer cross section that is less than the inner cross section of the canaliculus. The mass absorbs liquid to swell to form a lacrimal filler or sealing mechanism. The lacrimal filler has an external cross section that conforms to the internal cross section of the canaliculus and a soft outer surface relative to the surrounding tissues to prevent erosion of the canaliculus lining. The lacrimal filler forms an occlusion that prevents the outflow of liquid through the lacrimal outflow system to retain tears within the eye to maintain eye lubrication and wetness. The mass and syringe are provided in kit with a rubber stopper and, optionally, a punctal dilator, an injecting catheter, and an enzyme for dissolving or degrading the lacrimal filler at a later time.

Abstract: Structurally supportive material is implanted or injected into cardiac veins as discrete masses at various sites in the cardiac venous system to reinforce the myocardium for the purpose of preventing, moderating, stopping or reversing negative cardiac remodeling due to various adverse cardiac conditions, both acute and chronic, or for the purpose of treating localize anomalies of the heart, or for both purposes. The sites may be arranged in a pattern about one or more chambers of the heart such that the masses cooperatively reduce stress in the chamber wall and reduce chamber size. Some patterns also cause a beneficial global reshaping of the chamber. These changes occur quickly and are sustainable, and have a rapid and sustainable therapeutic effect on cardiac function.

Abstract: A drug delivery device is provided that includes a device body, a number of solid, compressed drug tablets, and a retention frame. The device body includes a drug reservoir lumen and a retention frame lumen. The number of solid, compressed drug tablets are positioned in the drug reservoir lumen, and the retention frame is positioned in the retention frame lumen. The drug tablets may be mini-tablets aligned in the drug reservoir lumen, with an interstice formed between any two adjacent drug tablets facilitating deformation of the device body. Systems and method are also provided for loading a drug delivery device. In one embodiment, the method includes positioning one or more solid drug units upstream of the drug delivery device; and driving the drug units into the drug delivery device with a flow of pressurized gas.

Abstract: A device for inserting implantable objects beneath the skin of a patient includes a handle for grasping the device and a base connected to the handle. The base comprises a post, a cannula, and a flexible actuator positioned in an angled track. The cannula is positioned coaxially around and is longitudinally slidable over the post from an extended position, where an implantable object is retained in the cannula, to a retracted position, where the implantable object is released from the cannula. A flexible actuator positioned on an angled track in the base is slidably engaged with a boss on the cannula and is used to move the cannula from an extended position to a retracted position to release the implantable object from the cannula; the actuator flexes between a locked and an unlocked position. The angled track provides for control of the release of the implantable object.