Abstract: Methods and apparatus are provided for treating an injured or severed nerve pathway, wherein one or more microporous tubes are implanted into the nerve pathway to bridge the injured or severed region. A bioactive matrix including stem cells and nutrients is disposed within the microporous tube to facilitate growth of the stem cells and reestablishment of the sensory and motor conductive pathways through the injured or severed region. The microporous tube protects the bioactive matrix during development of the stem cells, and also retains the end regions in proper alignment during the nerve pathway regeneration.

Abstract: A system and method for delivering one or more implantable members, such as metal coils, via an introducer member, such as an endoscopic needle, into a space created within the submucosal layers of the LES to augment and bulk the sphincter to improve compliance in patients with gastroesophageal reflux disease. The implantable member comprises a first substantially straightened configuration when carried by the introducer member, whereby it assumes a more curvilinear or coiled configuration following deployment such that it expands against adjacent submucosal tissue, creating a bulge at the implantation site. In another embodiment, the implantable member can serve as an anchoring port for sutures or other elements introduced for gastroplication of the LES to create tissue folds that increase sphincter compliance. The implantable members may be configured to include an external portion that interconnects with an adjacent implantable member, thereby creating tension that also increases compliance of the LES.

Abstract: Apparatus is provided that includes a swallowable medical treatment device, which is configured to initially assume a contracted state having a volume of less than 4 cm3. The device includes a gastric anchor, which initially assumes a contracted size, and which is configured to, upon coming in contact with a liquid, expand sufficiently to prevent passage of the anchor through a round opening having a diameter of between 1 cm and 3 cm. The device also includes a duodenal unit, which is configured to pass through the opening, and which is coupled to the gastric anchor such that the duodenal unit is held between 1 cm and 20 cm from the gastric anchor. Other embodiments are also described.

Abstract: The bioinjection device has a housing including a pistol grip and an elongated barrel. A trigger is pivotally mounted to the housing. A plunger and needle are slidable between a first position in which the plunger and needle are slidably disposed in the barrel and a second position in which the plunger and needle extend from an opening in the end of the barrel. A retaining member is disposed about the opening at the end of the barrel. A spring-biased actuation mechanism connects the trigger with the plunger and needle. A membranous cartridge containing bone morphogenic protein, antibiotics, and/or other medication is loaded into the retaining member. A surgeon can inject the cartridge into a bone fracture or degenerative bone tissue during surgery to deliver the medicament directly to the affected site.

Abstract: An object-delivery shuttle for delivering an object over an elongate medical device, such as a wire guide, to a desired location within a body.

Abstract: The invention concerns a device for back injecting an implant (30) into the skin (22) of a subject, said device (1) include a hollow main body (10), to which a hollow needle (28) is fixed into which the implant (30) is introduced, a secondary body (12; 114) coaxially arranged inside the main body (10) and surrounding the needle (28) and a piston rod (88) able to slide coaxially inside said hollow needle (28) and whose position relative to said needle (28) remains unchanged when the back injection device (1) is pressed against the subject's skin (22) to allow the needle (28) to penetrate said subject's skin and when the secondary body (12) retracts inside the main body (10), the piston rod (88) penetrating the interior of the hollow needle (28) to hold the implant (30) at the required depth in the subject's skin (22) during withdrawal of the hollow needle (28) from the subject's skin (22), during which the secondary body (12; 114) exits the main body (10), characterized in that it includes means for the elasti

Abstract: Systems and methods of co-injecting a solid object and an amount of fluid into a patient's tissue includes separably coupled syringe and needle portions. The syringe portion includes a barrel, a plunger, and a pushrod for disposing the solid object that is capable of independent movement with respect to the plunger. The needle portion includes a hollow needle configured to allow both the object and the fluid to pass out of the needle and into the patient's tissue. The needle portion may include a housing located behind the needle that is configured to hold the solid object. Once the needle portion and the syringe portion are coupled together, the device is operated in accordance with methods of the present invention to effectively co-inject the patient with the object and the amount of fluid.

Abstract: An implantation instrument for implanting a substantially solid material, including solid medication or drugs, in a subcutaneous location and method are described. An incising shaft includes a beveled tip with a cutting edge along a distal end. A syringe body is affixed to a proximal end of the incising shaft. The syringe body and the incising shaft each define a substantially non-circular hollow bore extending continuously along a shared longitudinal axis. The incising shaft bore does not exceed the syringe body bore in girth. Both the incising shaft bore and the syringe body bore are sized to receive the solid material. A plunger is conformably shaped to the syringe body bore and has an end piece facilitating deployment of the plunger assembly. The plunger slidably fits within the syringe body bore and advances the solid material through the syringe body bore and the incising shaft bore into the subcutaneous location.

Abstract: A device for sealing a puncture in a patient includes a sealing component including an elongate control member configured to pass through a puncture in skin of a patient. The sealing component also includes an expandable member disposed near a distal end of the control member, and a tip releasably attached to the elongate control member distal to the expandable member. The device also includes a sealing material delivery component including a delivery tube through which the control member of the sealing component is configured to extend. The delivery tube is configured to deliver sealing material through an opening in a distal end of the delivery tube.

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 percutaneous surgical tool comprises a cannula with an open slot at the distal end and a closed tip. A variety of articulated and solid tamps with different tip geometries are used to push bone aside to open up a void for filling. Bone pellets are rammed down the hollow interior, lumen, of the cannula by a tamper. A ramp inside the closed end causes the bone pellets to eject out to the side into a void to-be-filled. Variations in the shapes of the pellets and the ends of the tampers vary the orientations of the pellets as they are ejected through the end slot out from the cannula. One tamper with a sharp flat diagonal cut end can be twisted to push the rear end of the pellet harder sideways and out parallel to the cannula. Curved cannulas allow better access to all parts of the void to-be-filled.

Abstract: Method and apparatus for limiting absorption of food products in specific parts of the digestive system is presented. A gastrointestinal implant device is anchored in the pyloric portion of the gastrointestinal system and extends beyond the ligament of Treitz. All food exiting the stomach is funneled through the device. The gastrointestinal device includes an anchor for anchoring the device in the pyloric portion and a flexible sleeve that extents into the duodenum. The anchor is collapsible for endoscopic delivery and removal.

Abstract: A pill plunger includes a hollow tube having a forward end and a rearward end. A rod or plunger has a forward end having a dished out portion for receiving medication and a rearward end having a button. The plunger occupies the tube with the dished out portion at the forward end of the tube and the button extending from the rearward end of the tube. Medication is placed in the dished out portion, which is then retracted into the tube. After insertion of the tube into a patient's mouth, the button is depressed to extend the plunger and dispense the medication. A spring can be used to retract the plunger upon release of the button. The dished out portion can be sealed to carry a fluid or powder. A dual dished out portion can be provided in the rod, and a window can be formed in the hollow tube.

Abstract: Described herein are implantable composites, kits comprising the composites, implant devices comprising the composites, and methods of making and using same, including point of use methods.

Abstract: Described herein are implantable composites, kits comprising the composites, implant devices comprising the composites, and methods of making and using same, including point of use methods.

Abstract: In one embodiment of the present invention, a device for delivering an embolization coil into a microcatheter for deployment of the embolization coil from the microcatheter into a body vessel of a patient is provided. The device comprises a cannula that has a proximal portion extending to a distal portion. The cannula has a lumen formed through the proximal and distal portions. The distal portion has a distal tip that is formed from metal and is configured to interface with the microcatheter for advancing the embolization coil from the lumen into the microcatheter. The proximal portion is at least partially formed of a transparent material for viewing into the lumen to facilitate delivery of the embolization coil into the microcatheter.

Abstract: A subcutaneous implantation instrument with dissecting tool and method of construction are described. An incising shaft longitudinally defines a substantially non-circular bore continuously formed to communicatively receive an implantable object and further includes a beveled cutting blade formed on a distal end. A dissecting tool includes a needle tip forming a pair of longitudinal cutting edges progressively defined outwardly from the needle tip planar to the beveled cutting blade and removably affixable to the distal end of the incising shaft through a proximal coupling. A delivery mechanism longitudinally defines a substantially non-circular bore formed to deploy the implantable object into the incising shaft. One goal is to reduce the subcutaneous sensor insertion of implantable objects and devices, such as sensors, having non-conforming shapes to be the functional equivalent of an injection.

Abstract: The invention relates to a novel drug delivery technology. More particularly the invention relates to a method of delivering at least one therapeutic compound or a formulation comprising the at least one therapeutic compound to a patient: to a throwaway or reusable device for delivering at least one therapeutic compound or a formulation comprising the at least one therapeutic compound to a patient in a manner as set out by the method; to a pioneer projectile form use in said method; to formulations for use in said method and to an injectate comprising a pioneer projectile and formulation. It also relates to a disposable component containing either a pioneer projectile or an injectate.

Abstract: A vented needle assembly is provided for sealably injecting biomaterial into an intradiscal space interiorly of the annulus of a spinal disc and for providing an exhaust for the intradiscal space. The vented needle assembly comprises a compressible seal body for pressing against an outer surface of the annulus, and a needle extending through the seal. The needle may be configured to connect to a syringe for pressure injection of the biomaterial. The seal includes a vent extending therethrough with an opening for communication with the intradiscal space and an opening for the discharge of excess biomaterial filling the intradiscal space. A kit of parts is also provided for use in the treatment of a spinal disc, the kit comprising the vented needle assembly and an inflatable trial device. The trial device is removably introduced into the intradiscal space and inflated to determine the available size of the intradiscal space.

Abstract: An applicator for delivering pharmaceutical products or the like to a bodily cavity includes a barrel member having a distal end which is equipped with an opening. The applicator also includes a plurality of petals extending outwardly from the distal end in a generally axial direction. The petals cooperate with the opening so as to form a receptacle for releasably receiving a pharmaceutical product in the distal end of the barrel member. Each of the petals has a truncated flexible tip sized and shaped so as to engage a substantially central portion of the pharmaceutical product such that a large section of the pharmaceutical product extends outwardly beyond the petals so as to facilitate the release of the pharmaceutical product from the receptacle. The device also includes a plunger member for releasing the pharmaceutical product from the receptacle. In accordance with the present invention, the device can be packaged in a package together with the pharmaceutical product received in the receptacle.

Abstract: Reagents useful in nucleic acid immunization techniques are described. More particularly, adjuvanted genetic vaccine compositions are described, as are methods of using those compositions for inducing an enhanced immune response against a selected antigen.

Abstract: Devices, systems, and methods for localized drug delivery. In at least one embodiment of a method of localized drug delivery, the method comprises the steps of placing a resorbable device within a tube, introducing the tube within a mammalian body at or near a tissue and/or organ within the mammalian body, and anchoring the resorbable device to the tissue and/or organ. Devices and systems useful for performing such a method are also disclosed herein, wherein an exemplary device comprises at least one drug release portion having at least one drug to be released over time and a binder intermixed with the at least one drug, and at least one resorbable anchor portion coupled to the at least one drug release portion.

Abstract: A drug delivery device for local administration of a solution or suspension of a drug, such as a bone modulating drug, to a bone surface, comprising a ductile, absorbent material comprising said drug and being of a shape adapted or adaptable to the bone surface. The drug delivery device may additionally comprise a support of a non-absorbent material and a handle piece. The bone modulating drug may be chosen from bisphosphonates, statins, growth factors, signaling proteins and bone morphogenic protein. The device may be used in peroperatively treating a bone surface by local administration to the surface of the drug.

Abstract: A medical product for treatment of sinusitis including an absorption body for bodily fluids.

Abstract: A surgical device comprising a container and a tether used for delivering a sterile appliance into a body cavity during endoscopic procedures. Once positioned in the body cavity, a force is applied to the container through the tether. The force opens the container and releases the sterile appliance into the body cavity. In various embodiments, gas or liquid may be used to open the container.

Abstract: An implantable medical device can be configured to directly or indirectly release nitric oxide during its insertion in a patient. Such a device can reduce the amount of time required for implantation as well as reduce or prevent damage to the region surrounding the implanted device.

Abstract: The apparatus for deployment of a therapeutic device such as a micro-coil detachably mounts the therapeutic device to a distal portion of a pusher member. In one embodiment, the therapeutic device is detachably mounted to the distal portion of the pusher member by a tubular collar that can be heated by a heater such as an electrical resistance coil to expand the collar and release and deploy the therapeutic device. The apparatus for deployment of a therapeutic device such as a micro-coil may also provide for a pusher member and a connector fiber for securing the therapeutic device to the pusher member. The connector fiber passes through a heater within the distal portion of the pusher member, for heating and breaking the connector fiber to release the therapeutic device when a desired placement of the therapeutic device within the vasculature is achieved.

Abstract: A cellular delivery device comprising a cellular carrier and an insertion device is provided. The cellular carrier includes at least one elongate strand of biocompatible material with a distal end and a proximal end. A stop member is connected to the proximal end of the elongate strand. The insertion device includes a needle attached to a hollow tubular body. The hollow tubular body is sized to receive the cellular carrier such that at least a portion of the elongate strand may be located within the hollow tubular body and the stop member protrudes from the proximal end of the hollow tubular body.

Abstract: The Human Immunodeficiency Virus posses a significant threat to the world's population. Current strategies have not been adequate to contain and eradicate this deadly viral infection. HIV utilizes a T-Helper cell as a host to generate replicas of itself. Reversing HIV's own biologically deadly tactics and developing blood filtering techniques that incorporate filter mediums that engage the cell-surface receptors uniquely located on the surface of a T-Helper cell infected with the HIV genome can lead to terminating the infected T-Helper cells. Filter mediums possessing cell-surface receptors intended to terminate infected T-Helper cells by triggering apoptosis, is an effective means to eliminate HIV's host cells and thus provides a valuable strategy to prevent and treat AIDS. Similar techniques can be utilized to terminate other types of cells that act as hosts for pathogens as well as terminating cancer cells.

Abstract: An in-vivo bioreactor device producing a dialysis effect by acting within the gastrointestinal tract for the removal of undesirable concentrated intestinal or blood substances or metabolites is disclosed. The ingestible device is comprised of a body wall that surrounds an internal compartment. Along the wall of the shell are openings located around the periphery that allow bodily fluids to enter and exit device. The wall of the device is comprised in whole or at least in part of materials that are impermeable to the passage of external fluids and maintains its physical and chemical integrity in the environment of use during its activity. Semi-permeable membranes located either internally or externally of the device are able to withstand all physiological temperatures and pH and act in a similar manner to dialysis membranes that are used for the separation of substances in suspensions, solutions, tissue cultures, etc.

Abstract: Parts of a powdered medicine multi-dose administering device are assembled, powdered medicine is filled and assembly that is obtained is inspected all on an automatic production line to increase productivity while preventing the production of defective products. The powdered medicine multi-dose administering device is produced through automated steps of inserting a filter (12) in a filter-fitting portion (11a) of a container (10), inserting an inner cylinder (15) in the container body (10), filling the container with the powdered medicine through a ring-like opening between an opening in the upper part of the container and the inner cylinder, fitting an inner closure (19) to the container and to the inner cylinder, fitting a nozzle (20) to the container while coupling it to the inner cylinder, and inspecting the thus obtained assembly.

Abstract: An instrument for controlling bleeding includes an outer shaft having a proximal end, a distal end, and a central lumen extending to the distal end thereof, an intermediate shaft telescopically received within the central lumen of the outer shaft, the intermediate shaft having a proximal end, a distal end, and a central lumen extending to the distal end thereof, and an inner shaft telescopically received within the central lumen of the intermediate shaft, the inner shaft having a proximal end and a distal end that extends distally from the intermediate shaft. The instrument includes a hemostat disposed at the distal end of the inner shaft, and a fluid-resistant element connected to the distal end of the outer shaft and surrounding the hemostat. The fluid-resistant element has a breakable, fluid-resistant seal at a distal end thereof that protects the hemostat from fluids until the hemostat is delivered and deployed onto tissue.

Abstract: Provided herein is a wound closure device comprising a plug adaptable to be inserted into an opening formed in two or more tissue layers, one tissue layer transposable relative to a second layer, the plug comprising a material having a first configuration and a second configuration, wherein the plug is adaptable to be inserted into the opening in the first configuration and further adaptable to transition from the first configuration to the second configuration after being inserted into the opening. The wound closure device can be used in cases where ocular surgery has been preformed.

Abstract: A process is provided for sterilizing brachytherapy devices with Ethylene Oxide gas and releasing the devices on a parametric release basis. Devices that can be sterilized with this process include interstitial radiation seed strand implants and the needles used for implantation. In order to be sterilized effectively by EtO gas, the devices are constructed such that surfaces not readily infused with EtO gas are made to be gas permeable, and will not retain the gas after the sterilization process. Performance qualification of the sterilization process is performed through physical and microbiological studies, and set of established physical process parameters. Maintaining the physical process parameters in subsequent sterilization cycles will consistently yield the desired sterility assurance level without having to test the devices for sterility.

Abstract: The present invention relates to ultrafiltration. In particular, the present invention provides nanoporous membranes having pores for generating in vitro and in vivo ultrafiltrate, devices and bioartificial organs utilizing such nanoporous membranes, and related methods (e.g., diagnostic methods, research methods, drug screening). The present invention further provides nanoporous membranes configured to avoid protein fouling with, for example, a polyethylene glycol surface coating.

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: The present invention discloses a cross-linked hyaluronic acid/collagen formulation which has improved composition for dermal filling and higher persistence than cross-linked collagen or HA alone. Also disclosed are methods for preparing cross-linked hyaluronic acid/collagen formulations and using such for augmenting soft tissues in mammals.

Abstract: An implant assembly comprises an elongated pusher member, and an implantable device (e.g., a vaso-occlusive device) mounted to the distal end of the pusher member. The implant assembly further comprises an electrolytically severable joint disposed on the pusher member, wherein the implantable device detaches from the pusher member when the severable joint is severed, and a return electrode carried by the distal end of the pusher member (e.g., a coil disposed about the pusher member) in proximity to, but electrically isolated from, the severable joint. The implant assembly further comprises a terminal carried by the proximal end of the pusher member in electrical communication with the severable joint.

Abstract: A device for cell grafting is disclosed. The device comprises a compartment enclosed by a semipermeable envelope made at least in part of nonwoven polymer fibers, and at least one inlet port formed in the envelope. The inlet port(s) are accessible from the exterior of the envelope and configured for establishing fluid communication with the compartment.

Abstract: An implantable embolic device having a stretch-resistant member passing therethrough that also serves as a tether for connecting the device to a delivery system. The stretch-resistant member is attached at a proximal and distal end of the device and extends proximally to the delivery device. The proximal attachment point serves to isolate a distal, stretch resisting segment of the member from axial tension placed on a proximal, connecting section of the member. Thus, the portion of the stretch-resistant member being used to connect the embolic device to a delivery device may be placed under tension without placing tension or distorting the implant.

Abstract: An implantable drug delivery device including at least one flexible elongate element, the flexible elongate element including a polymeric carrier for a drug and anchors for attachment to a vessel wall of the patient.

Abstract: A disposable device for treatment of infections of human limbs, particularly limbs having long bones susceptible to stabilization by intramedullary nailing. The device comprises a tubular member (2) made of a relatively rigid and biologically compatible base material, having pores (2?) for impregnation with drugs or medicaments for infection treatment prior to or during insertion thereof in the stabilization site. An assembly for treatment of human limb infections comprising such device.

Abstract: A device and method for using the device is used for clotting volumes created postoperatively. The device is inserted into a cavity formed by removal of tissue or organ within a patient. The device may have a flexible tubing having a surface material; a blood clotting material enclosed within the surface material of the tubing; a guidewire associated with the device that when placed under tension, stabilizes the tubing radially or longitudinally; and the surface material of the tubing being removable from the enclosed blood clotting material while the guidewire is under tension.

Abstract: The system is composed of two inseparable parts that both make up one Device: I) A container for collecting staminal cells and for their growth factors which is the same as the portcat system with sylicon button to enable the entrance of the Huber needle through a hole. 2) “Active fixation” catheter/s, hollow inside, to permit a rapid flow of the staminal cells into the myocardiac muscular mass and also a rapid flow of the growth factors involved: the various catheters can be fixed to the myocardio by means of an appendix somewhat like a “mouse tail”; they resemble the atrial active fixation catheters that used to be used before the introduction of the J type catheters. The only “but substantial” difference with those mentioned before, is the internal cavity, which should involve even the terminal anchorage part in order to allow the free flowing of any biological material inside the heart without the need for a surgical intervention to open the thorax.

Abstract: A new reversibly gelling polyurethane (RGP) polymer composition is described, as well as novel processes for its preparation, and its medical uses for filling spaces in tissue, or bulking tissue, or for restoring organ function. The novel RGP polymer forms a gel on standing, liquefies during shear and reversibly reforms a macroscopic gel on standing after being sheared. Methods of use include delivering the improved gel to a site on the body to fill voids or to augment local tissue bulk.

Abstract: A device that is secured inside a human or animal joint. The device may include, but not limited thereto, the following components: 1) eyelets for suture; 2) endcaps; 3) a longitudinal core; 4) optional additional longitudinal members; and 5) a space for carrying a payload of controlled release drug. Numerous preparations of controlled release drugs have been proposed. This device acts as a platform for said preparations and drugs. It is distinguished by, among other things, its geometry and structural elements which are optimized for: 1) surgical passage into a joint; 2) stable attachment inside of a joint; and 3) secure carriage of the payload device for controlled release of drug.

Abstract: Medicinal applicator suitable for delivering medicinal material in a measured dose and concentration to a body cavity, having an elongate support body with an external surface and a blunt distal end to facilitate insertion into a body cavity and a support element receiving zone located towards the distal end for receiving the support element. The support element receiving zone is configured to receive a correspondingly shaped support element for carrying medicinal material, whereby upon insertion of the elongate body into the body cavity, medicinal material supported on the support element located in the receiving zone is released to a desired location within the cavity.

Abstract: There are disclosed methods and apparatus for attachment and reinforcement of tissue, and methods and apparatus for reinforcement of tissue. In an embodiment, the apparatus includes an energy applicator configured to apply energy to generate heat within a target tissue to evaporate water to create dried tissue, and denature at least one of collagen and elastin to attach portions together, and a biopolymer applicator configured for to receive the heat generated to allow biopolymer material to change from solid to molten, and to allow the biopolymer to fill dried tissue to reinforce portions of the target tissue and provide a hermetic seal. In another embodiment, the method includes applying energy to tissue surfaces with an energy applicator, and applying a biopolymer material into the tissue surfaces with a biopolymer applicator disposed on a housing in connection with the energy applicator. Other embodiments are also disclosed.

Abstract: Systems and methods provide intraluminal delivery of a bandage structure within a body lumen or hollow body organ.

Abstract: Methods, systems, and kits for subcutaneously implanting articles, such as drug inserts and reservoirs. The methods rely on percutaneously forming a tissue tract and radially dilating the tract to a diameter which permits introduction of the article. By fully expanding the lumenal diameter of the tissue tract prior to introduction of the article, damage to the article resulting from passage through a partially expanded tissue tract can be avoided. In the exemplary embodiment, a radially expandable sleeve is first percutaneously introduced to the subcutaneous target site. An assembly of a cannula and dilator is then passed through the sleeve, effecting radial expansion. The dilator is removed and the article is then introduced through a lumen of the cannula.