Abstract: An apparatus and method are provided for sampling the distal tube, fimbria and/or ovary, includes advancing a device into the peritoneal cavity and sampling material on or adjacent to the distal tube, fimbria or ovary.

Abstract: A gonadotropin is administered within a surprisingly effective narrow range for the purpose of treating chronic pain or other central sensitization sequelae. In one aspect, a recipient is provided with at least one of human chorionic gonodotropin (uHCG and/or rHCG), a pharmaceutically active HCG analogue, and a pharmaceutically active metabolite of the HCG or analogue at a dosage selected to provide, or be equivalent to, a human subcutaneous dosage of between 120 IU/day and 170 IU/day of HCG, and more preferably between 140 IU/day and 160 IU/day of HCG. A kit is also described, which includes a supply of the HCG-related drug, a delivery device, and a label that identifies chronic pain or central sensitization as an indication of the drug.

Abstract: A trocar system for providing access across a body wall includes a trocar and an anchor provided in the form of a first helix. The anchor is adapted for placement in an operative position wherein the anchor extends at least partially through the body wall. A second helix formed on the trocar is size and configured to engage the first helix of the anchor so that rotation of the trocar relative to the anchor moves the second helix along the first helix. In this manner, the trocar is drawn into the anchor as it moves into the body wall. A proximal force applied to the anchor resists tenting of the abdominal wall. The anchor also holds the layers of the body wall together thereby resisting peritoneal separation.

Abstract: An auto-injector device for administering a liquid pharmaceutical composition, in which an end-user can select between doses that the device is capable of delivering. The end-user choices that translate into the selected doses can be based on end-user perceived severity of symptoms, end-user weight and other such factors. In some embodiments the auto-injector is configured to administer the one chosen dose only. In other embodiments, the auto-injector can deliver second and subsequent doses up to full dose of the pharmaceutical composition disposed in the injector. The auto-injector can provide visual, audio, and tactile feedback, alone or in combination, to the user to indicate the dose selected, instructions for use, and when the dose has been administered.

Abstract: A pre-filled, single-use injection device includes a passive dual shield on the patient end of the needle. The device is self-contained so that the entire needle is shielded after use without a separate passive shield system for the non-patient end.

Abstract: The present invention relates to medical devices, in particular autoinjectors and syringes having one or more thermochromic response indicators that are sensitive to temperature changes of a drug formulation or solution. The present invention provides for a pre-filled delivery device comprising a syringe, a cartridge, or a capsule having a barrel, where the barrel is marked on the outer surface with a first thermochromic indicator, and wherein the thermochromic indicator is responsive to temperature changes of the drug formulation or solution within the barrel.

Abstract: A system and method is provided for an injectable substance delivery pen comprising a microneedle hub assembly removably engaged with a pen device body which includes a cartridge, a plunger, and a drive mechanism. The hub assembly includes at least one microneedle for intradermal or shallow subcutaneous injection of the contents of the cartridge. The cartridge, plunger and drive mechanism components of the pen body are fabricated of non-compliant and non-compressible materials to allow effective communication of the cartridge contents via the microneedle patient interface.

Abstract: An apparatus includes a housing coupled to a medicament container, which is coupled to a needle. An injection assembly is disposed within the housing and includes an energy storage member and an actuation rod. A distal end portion of the actuation rod is disposed within the medicament container. The energy storage member can produce a force on a proximal end portion of the actuation rod sufficient to move the distal end portion of the actuation rod within the medicament container. This can convey at least a portion of a substance from the medicament container via the needle when a distal tip of the needle is disposed within a first region of a target location. The force is insufficient to move the distal end portion of the actuation rod within the medicament container when the distal tip of the needle is disposed within a second region of the target location.

Abstract: The present invention provides an infusion-patch comprising; a cannula; a base; at least one adhesive region in said base suitable for skin attachment; at least one skin-access area within said base; and at least one conduit in fluid connection with said at least one skin access area, wherein said at least one conduit in fluid connection with said at least one skin access area facilitates the transfer of an anesthetic substance within at least a first anesthetic-reservoir which may be removably attached and in fluid connection with said at least one contact area, promoting delivery of said anesthetic substance to said at least one skin-access areas, and wherein said anesthetic substance delivered to said skin-access areas may be at least partially replenished without removing said in fusion-patch.

Abstract: Embodiments relate to systems, methods and devices for delivering a drug or other therapy to a patient with an ambulatory infusion pump configured to provide a series of tolerance-building steps leading up to a plateau delivery rate. The plateau delivery rate is maintained until the prescribed amount of drug or therapy fluid is delivered to the patient. Embodiments of the invention include providing the patient or other user with a mechanism to decrease, or step down, the therapy delivery rate if a tolerance was not achieved at a lower rate, and providing notifications prior to a step up in a dosage delivery rate.

Abstract: Techniques, kits and a delivery instrument for providing a material at a defect repair site. The instrument is a combined delivery needle/elevator/paddle that includes a delivery needle and a paddle/elevator tip attached to the end of the needle and around the most distal opening of the needle. The combined needle/elevator/paddle instrument allows both delivery (insertion or injection) of the material/mixture as well as leveling/flattening of the delivered material. The mixture/material may be micronized allograft tissue such as BioCartilage® and the surgical site may be a defect site such as a microfracture site or cartilage defect.

Abstract: Systems and methods for non-serial, substantially simultaneous or simultaneous tissue sampling and placement of multiple markers/fiducials in a non-linear, distributed or three dimensional configuration. The systems and methods can be applicable to other forms and combinations of distributed/3 dimensional/spherical localization which may include a single procedure or combination of procedures that may include 3D biopsy, fiducial placement, brachytherapy seed placement, injection/infusion of bioactive materials (e.g., chemotherapy, small molecules, cellular materials, cells, caustic materials, proteolytics, embolic material, glue, etc.), thermally or electrically derived ablation.

Abstract: Provided herein is an injection device that can be used in minimally invasive procedures, such as laparoscopic surgeries, for direct administration of a fluid, such as a therapeutic, to a target tissue or organ.

Abstract: Embodiments of various aspects described herein are directed to silk-based compositions for ocular delivery of at least one active agent, e.g., at least one therapeutic agent and methods of using the same. In some embodiments, the silk-based compositions can provide sustained release of at least one therapeutic agent to at least a portion of an eye. Thus, some embodiments of the silk-based compositions can be used for treatment of an ocular condition, e.g., age-related macular degeneration.

Abstract: A retractable syringe is proposed having a cutting head mounted on a plunger of the syringe. When the plunger is advanced to expel fluid from the syringe, the cutting crown cuts a retention mechanism which holds a needle unit of the syringe, allowing a drive mechanism to drive the needle unit into the syringe. The cutting crown is shaped to reduce the force which has to be applied to cut the retention mechanism. Furthermore, a disposable needle assembly for attachment to a syringe unit is proposed. The disposable needle assembly has a needle and connector element for connecting the needle to the syringe unit. The connector element encircles the needle and has a thread on its outer surface for mating with the syringe unit.

Abstract: An orthopaedic implant system includes an external fixation device implantable at a selected location within a corporeal body and configured for delivering at least one therapeutic agent to the corporeal body. The external fixation device includes an implantable pin, a sheath coupled with the pin, a reservoir coupled with the sheath and a plurality of channels. The pin defines the plurality of channels. The reservoir is configured for receiving the at least one therapeutic agent. The plurality of channels are configured for conveying the at least one therapeutic agent from the reservoir to a treatment site relative to the corporeal body.

Abstract: A pen needle assembly (111) includes an outer shell (151) having a first end adapted to contact a patient's skin at an injection site. A hub (131) is movably disposed within the outer shell. A needle (121) is fixed to the movable hub and has a patient end for piercing the skin at the injection site. An inner shell (171) is disposed within the outer shell and adapted to engage the pen needle assembly with a drug delivery pen (100). A first spring (141) has a first end connected to the outer shell and a second end connected to the inner shell. A second spring (161) has a first end connected to the inner shell and a second end connected to the hub. An adhesive layer (191) is disposed on the movable hub for contacting and raising the skin at the injection site.

Abstract: An access port for the introduction of a needle cannula tip into an IV tube set includes a rigid tubular housing and a resilient member disposed adjacent an inlet of the housing. The resilient member includes an axial perforation extending through the resilient member, and is normally closed by a resilient character of the resilient member. A depression is defined in a proximal face of the resilient member, and includes sidewalls extending between the proximal face and the axial perforation to guide the needle cannula tip toward the axial perforation as a needle cannula associated with the needle cannula tip is introduced into the access port.

Abstract: A syringe and needle assembly includes a needle that extends through the barrel of the syringe and is attached to a proximal portion of the syringe. The distal end of the needle extends through a sleeve attached to the distal end of the syringe. The proximal end of the needle includes a spring which biases the needle proximally, so that the distal tip of the needle is normally retracted within the sleeve. The assembly can be used for injections in portions of a patient's body including delicate tissues that could be damaged if contacted by the needle tip.

Abstract: A method and apparatus are disclosed for delivery of a drug to a recipient. In some embodiments, the delivery apparatus may unseal a drug containing reservoir. In some embodiments, the delivery rate may be controlled and/or adjustable. Optionally the apparatus may be disposable. Optionally, the apparatus may have a low profile and/or be wearable and/or attachable to the recipient. Optionally, discharge of the drug and/or unsealing of the reservoir may be driven by a plunger moving parallel to the base of the apparatus. Optionally, the apparatus may release a hypodermic needle into the recipient. Optionally, release of the hypodermic needle may be in a direction non-parallel and/or orthogonal to the direction of movement of the plunger. Optionally, prior to release, the hypodermic needle may be preserved in an aseptic state by a needle opening septum sealing a needle opening. Optionally, upon release, the hypodermic needle may pierce the needle opening septum.

Abstract: A simple method and device enabling a unit dose from a reservoir is provided. The dose is drawn into the reservoir and is then expelled from the device by depressing a plunger. The plunger has features which divide the dose into discrete intervals. As the plunger is moved during delivery, the features on the plunger and features connected to a barrel interact to provide for intermittent stops to the delivery. Other aspects of the device provide for reduced dead space, safety and selective interconnection with other devices. Thus, the device divides the dose.

Abstract: Apparatus are provided for infusion devices and related systems and operating methods. An exemplary system includes a motor, a sensing arrangement coupled to the motor to provide output indicative of a detected characteristic of the motor when the sensing arrangement is enabled, and a module coupled to the sensing arrangement to periodically enable the sensing arrangement while the motor is idle and detect potential unintended motion of the motor based on the output from the sensing arrangement while periodically enabling the sensing arrangement. In some embodiments, the motor includes a rotor configured such that its rotation provides translational displacement of a plunger in a fluid reservoir, and the sensing arrangement includes one or more sensors configured to provide output indicative of a detected magnetic field of the rotor magnet.

Abstract: A system allows for rapid intraosseous delivery of fluids from a fluid reservoir via an intraosseous port having a tip disposed within the bone marrow of a patient. The system includes a housing with a chamber and a plunger. An actuator is moveable between first and second positions to move the plunger between the distal and proximal positions. A valve housing includes a first one-way valve fluidly coupled to the fluid reservoir, and a second one-way valve fluidly coupled to the intraosseous port. The valves of the valve housing are oriented such that movement of the actuator from the first to the second position moves the plunger from the distal to the proximal position, drawing fluid from the fluid reservoir through the first valve and into the chamber. Movement of the actuator from the second to the first position moves the plunger from the proximal to the distal position, driving fluid from the chamber through the port and second valve and through the intraosseous port.

Abstract: A novel neural injection system and related methods are herein disclosed. Various embodiments of an embodiment of a neural injection system of the present invention provide for at least one benefit of enhanced injection characteristics, increased operational efficiency, reduced cost per unit, reduced incidence of injury through intraneural/intravascular injection, reduced incidence of injury through pricking/piercing, and/or the like.

Abstract: Some embodiments of an infusion pump system may be configured to wirelessly communicate with other devices using near field communication (NFC). In particular embodiments, by incorporating near field communication capabilities into the infusion pump system, user communications with the infusion pump system can be enhanced and simplified.

Abstract: Apparatuses, systems and methods for the wireless communication of medical devices in a subcutaneous fluid delivery system are disclosed. A system for subcutaneous fluid delivery includes a primary patch pump adapted to attach a first infusion cannula to a user and to perform a plurality of primary patch pump functions, and a secondary patch pump adapted to attach a second infusion cannula to a user. The secondary patch pump is further adapted to perform a plurality of secondary patch pump functions substantially similar to the plurality of primary patch pump functions if an error condition associated with the primary patch pump is determined.

Abstract: The present invention provides compositions of matter suitable for the prevention of and/or treatment of a spinal disorder and/or spinal pain, e.g., caused by and/or associated with intervertebral disc (IVD) degeneration, and methods of treatment of a spinal disorder and/or spinal pain. For example, the compositions of the present invention comprise a modulator of growth differentiation factor (GDF)-6 signaling sufficient to reduce or prevent or delay IVD degeneration and/or to enhance or induce IVD regeneration. The present invention also provides medical devices comprising such compositions, and methods of treatment making use of such compositions.

Abstract: A patient care system is configured for infusing fluid to a patient. The system includes at least one fluid infusion pump connected to a respective fluid supply for pumping the contents of a fluid supply to a patient via fluid supply lines. The system includes a programming module that determines the efficiency of the fluid infusion pumps and dynamically adapt the infusion pumps based on one or more system parameters.

Abstract: A syringe cradle for holding a syringe, the syringe cradle comprising a syringe holder at a proximal end for engaging a barrel of a syringe and a rider for pressing on a plunger of the syringe, a cylindrical body for surrounding the syringe, a distal cap for closing a distal end of the cylindrical body, a stepwise advancing mechanism for advancing the rider along the cylindrical body towards the proximal end, and a stopping mechanism to prevent the rider from moving backwards towards the distal end of the cylindrical body.

Abstract: Fluid storage apparatus for medical use is described that includes a length of tubing having a first end and a second end. A first sealable connector portion is provided at the first end and a second sealable connector portion is provided at the second end. The volume of fluid that can be stored within the apparatus is known and an infusate or therapeutic agent is contained within the apparatus. In this manner, a known volume of therapeutic agent can be infused to a patient. The use in neurosurgical applications is described.

Abstract: A needle device including a housing. The housing includes a first housing element provided towards a proximal end of said needle device and a second housing element provided towards a distal end of said needle device. A cutting element having a sharp proximal end is arranged at a proximal end of said first housing element. A cannula having a blunt proximal end is fitted to the second housing element and an opening for the cannula is provided at the proximal end of the first housing element. The first housing element and the second housing element are moveable relative to each other between an extended position where the proximal end of the cannula does not extend beyond the proximal end of the cutting element and a compressed position where the cannula extends through the opening of the first housing element and past the proximal end of the cutting element.

Abstract: A delivery device (10) includes a roller (12) rotatably mounted on an axle (14), a reservoir (40), and one or more hollow needles (16) positioned in the roller (12) in fluid communication with the reservoir (40). As the roller (12) rotates about the longitudinal axis (17) of the axle (14), a piston (30) pushes contents of the reservoir (40) through the needles (16). An actuator (36) is operatively connected to the piston (30) for increasing a pushing force of the piston (30).

Abstract: A surgical seal assembly, includes a seal housing defining a longitudinal housing axis and having a longitudinal opening therethrough, a seal having an inner seal portion defining a passage and being adapted to form a substantial seal about a surgical instrument disposed within the passage and a guide mounted to the seal housing. The guide has an inner guide portion proximal of the inner seal portion of the seal and spaced therefrom. The inner guide portion defines a channel adapted to generally direct the surgical instrument toward the inner seal portion of the seal upon entry of the surgical instrument within the longitudinal opening of the seal housing. The inner guide portion is relatively compliant to accommodate initial offset or angled entry of the surgical instrument.

Abstract: Some embodiments of a medical system include a subcutaneous anchor device that extends outwardly from side wall of an intravenous cannula so as to secure the intravenous cannula in a position relative to a skin penetration point.

Abstract: The present invention provides a puncture needle device, comprising a light source assembly, an optic fiber assembly, an ejection assembly, and a puncture needle assembly, wherein the light source assembly comprises a light source sleeve configured with a light source, the optic fiber assembly comprises an optic fiber sleeve configured with an optic fiber, the ejection assembly comprises an ejection sleeve configured with an ejection spring, and the puncture needle assembly comprises a puncture needle with a catheter.

Abstract: A needle tip assembly for a pre-loaded syringe or a pen needle injection device, the needle tip assembly including a body comprising a double-ended needle and being installable and removable from the pre-loaded syringe or pen needle injection device. A needle cap is configured to cover a skin puncturing end of the double-ended needle and is removable to exposed the skin puncturing end. An outer safety member has a first portion that surrounds the body and a second portion that surrounds the skin puncturing end.

Abstract: A method for inhibiting formation of adhesions following abdominal surgery which involves application of an anti-static fatty acid ethoxylated amide (Cocamide DEA) in a matrix that is placed in the peritoneal cavity at the conclusion of an abdominal surgery and which releases this anti-adhesive chemical over a predetermined time in a range up to seven days. Tests conducted on laboratory rats established that the method reduced the incidence of adhesions from 100 percent (100%) in a test model to near zero in the majority of treated animals. In an alternative embodiment, andrographalide was delivered via a pump with similar results. In still another embodiment, an effective amount of 50% phosphatidylchorene and propylene glycol was delivered, via a pump, into the abdominal cavity, again with similar results.

Abstract: Certain exemplary embodiments comprise can comprise an auto-injector, which can comprise: a vial configured to store and/or contain an injectable medicament, the vial defining a vial longitudinal axis, and a housing comprising the vial. In various embodiments, the injectable medicament can be a medicine, medication, drug, pharmaceutical, prescriptive, agent, antidote, anti-venom, hormone, stimulant, vasodilator, anesthetic, and/or nutritional supplement that is substantially ready for injection.

Abstract: A syringe assembly which has a barrel for containing one or more medicaments and a stopper disposed in the barrel defining and separating a first volume and a second volume within the syringe assembly. The stopper includes a permanent seal fluidly sealing the stopper to the barrel about the entire perimeter of the stopper intermediate the first volume and second volume, and a channel bypassing the permanent seal, the channel having a first opening in fluid communication with the second volume and a second opening selectively sealed from the first volume by a resilient seal. The resilient seal is moveable between a sealing configuration and an open configuration to selectively seal the channel from the first volume and is moveable from the sealing configuration to the open configuration upon fluid pressure in the first volume or second volume exceeding a first pressure threshold.

Abstract: The present invention presents an apparatus and methods to generate and deliver resonant vibrations to a hypodermic needle penetration site of a human body to reduce pain of needle prick by activating inhibitory neuronal mechanisms for pain perception. The apparatus comprises a longitudinal syringe carriage assembly which releasably holds and slidably moves a proximal portion of a syringe and a vibration assembly which generates and delivers vibrations to a vibration resonance enclosure located at a proximal end of the apparatus. The vibration assembly adjoins in parallel the syringe carriage assembly. A syringe with a needle moves forward in the syringe carriage assembly along a longitudinal axis and the needle penetrates a recipient's tissue which is in direct contact with and is vibrated by the proximal end of the apparatus.

Abstract: An active agent or drug injecting device (10) includes a main housing (16) containing a trigger mechanism (24) which can be manually activated via release bar (32) or remotely triggered via wireless receiver (70) activating motor (74), and a second housing (80) containing an injection- and needle-assembly (22). The needle (30) encloses a dry carrier (26) having an active agent (12) disposed thereon. The trigger mechanism triggers the injection assembly to propel the needle into the skin (via spring (54)), to inject the active agent into a living organism (either by letting the active agent diffuse out of the needle or by actively flushing it out), and to subsequently retract the needle back into the housing (80) (via spring (64)).

Abstract: Thermochemical ablation techniques may provide ablation of bodily tissue using chemical reaction energy.

Abstract: Instruments, systems 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. Systems include a combination of one or more of such instruments with or without injectable agents. Embodiments of various methods for performing the procedures are also provided. In accordance with one aspect there is provided a submucosal implant device for diagnosing and treating disorders of the body. The submucosal implant device may take the form of a gastric stimulator in which signals are supplied to the muscular wall of a mammal to treat motility disorders. In accordance with yet another aspect there is provided a method for performing a submucosal medical procedure to deploy a submucosal implant device in the digestive tract of a mammal.

Abstract: According to an embodiment of the present disclosure, a medical device for injecting one or more substances may include a proximal handle assembly. The proximal handle assembly may include a housing, a rotatable member rotatably coupled to the housing, and a port configured to receive one or more substances. The medical device may also include an inner member coupled to the rotatable member and extending distal to the proximal handle assembly. The medical device may also include an outer member coupled to the housing, surrounding at least a portion of the inner member, and extending distal to the proximal handle assembly. The medical device may also include a helical needle coupled to the inner member and extending distal to the inner member.

Abstract: Compositions that include microthreads are provided. The compositions can be fully or partially encased in a sleeve along at least a portion of their length and can include biological cells and, optionally, therapeutic agents. Also provided are methods for using the compositions to repair or ameliorate damaged or defective tissue, including cardiovascular tissue (e.g., the myocardium).

Abstract: A medical needle includes a needle body including a needle tip on a front end of the needle body; a shaft provided on a base end of the needle body; a housing pipe including a first tube, and a second tube; and a lock member that includes at least one engaging unit that is releasably engaged with the shaft, and at least one engagement release unit. The shaft is slidable from a first position at which the front end of the needle body protrudes from the housing pipe by a predetermined length, to a second position at which the front end of the needle body is located in the housing pipe. Engagement of the at least one engaging unit with the shaft is releasable by pressing the at least one engagement release unit inward.

Abstract: One embodiment is directed to a method for safe injection, comprising: providing an injection assembly and inserting a plunger tip of the injection assembly to a final insertion state and releasing an associated manual insertion load. A retraction load developed sufficient to cause the plunger tip to be proximally withdrawn pulls the retractable needle proximally relative to the needle housing to a retracted state wherein a distal tip of the needle becomes mechanically locked into an encapsulated configuration wherein it is no longer exposed for injection.

Abstract: Techniques, devices, and systems may include screening effective therapies using cortical evoked potentials. In one example, a system may be configured to receive a first sensed cortical evoked potential of a patient that occurred in response to an induced sensation at an anatomical region different from a brain region of the patient and receive a second sensed cortical evoked potential that occurred in response to electrical stimulation delivered to one or more nerves associated with the anatomical region. The electrical stimulation may be at least partially defined by a set of therapy parameter values. The system may also compare a first value of a characteristic of the first sensed cortical evoked potential to a second value of the characteristic of the second sensed cortical evoked potential and determine, based on the comparison, efficacy of a therapy configured to treat a condition associated with the anatomical region.

Abstract: The present invention presents an apparatus and methods to generate and deliver circumferential mechanical vibrations to a hypodermic needle penetration site of a human body to reduce pain of needle prick by activating inhibitory neuronal mechanisms for pain perception. The apparatus comprises a detachably disposable proximal end that contacts with a tissue of a recipient and encircles a needle penetration site, a distal end that is configured as a conduit for electric power to the apparatus and a longitudinally tubular handle assembly that is connected to both proximal and distal ends and that houses a vibration assembly and a control and power assembly. The vibration assembly generates and delivers resonant vibrations to the recipient through the proximal end. A needle penetrates the recipient's tissue circumferentially surrounded by vibrations transmitted by the proximal end.

Abstract: Methods and devices for delivering an agent to a solid tissue in vivo for assessment of efficacy are described. One method involves withdrawing of a needle from and injecting of the agent into the solid tissue; another method involves delivering the agent using a plurality of microdialysis probes to a solid tissue.