Abstract: A drug delivery device includes a housing defining a shell and an inner volume, a container, a drive mechanism, a needle assembly, a fluid flow connection, and a backflow prevention mechanism. The container has an inner volume to contain a medicament to be administered to a user. The drive mechanism is at least partially disposed within the housing and exerts a force to urge the medicament out the container. The fluid flow connection is coupled to the container and the needle assembly and allows the medicament to flow from the container to the needle assembly to be administered. The backflow prevention mechanism is associated with at least one of the container, the fluid flow connection, or the needle assembly and includes at least one flow restrictor to restrict a fluid from flowing from the needle assembly to the container.

Abstract: The present invention discloses a liquid medicine injection device that is attached to a patient's body to inject liquid medicine such as insulin at an appropriate time. A liquid medicine injection device according to the present invention includes: a case; a liquid medicine tank that is disposed in the case and where liquid medicine is received; an electro-osmosis pump that is connected with the liquid medicine tank and moves the liquid medicine; a needle assembly that receives the liquid medicine by being connected to the electro-osmosis pump and injects the received liquid medicine into a human body; and an adhesive member combined to the case and attached to the human body.

Abstract: An improved injection port identification for injection ports implanted under the skin of a patient. The injection port has an x-ray discernable marker allowing for the determination of a pressure rating for the injection port when so implanted. A plurality of concurrent visual, RF, light emitting and sonic means for signaling the port's pressure rating are also employable to provide multiple concurrent affirmations of the port's readiness for high pressure injections.

Abstract: Embodiments herein describe tools, instruments and methods for aseptic loading, dispensing and/or delivering cells into an implantable device and aseptically and selectively sealing a device inside a sterile package as well as and storing and preparing for shipment the cell-filled device.

Abstract: Systems, apparatuses, and methods for instilling fluid to a tissue site in a negative-pressure therapy environment are described. Illustrative embodiments may include a pneumatically-actuated instillation pump that can draw a solution from a solution source during a negative-pressure interval, and instill the solution to a dressing during a venting interval. A pneumatic actuator may be mechanically coupled to a disposable distribution system that can provide a fluid path between the solution source and a distribution component. A bacterial filter may be disposed in the fluid path between the actuator and the distribution component to prevent contamination of the actuator during operation. The distribution system may be separated from the actuator and disposed of after operation, and the actuator may be re-used.

Abstract: An intravascular implant and methods of using the implant within the vasculature of the body, for example near a vascular aneurysm, are disclosed. A method of treating an aneurysm includes positioning a vascular graft comprising a tubular channel having a first end and a second end in a blood vessel, securing the vascular graft in place with an expandable anchoring member, and filling a seal cuff on the vascular graft, wherein the seal cuff extends radially outward beyond an exterior surface of the vascular graft, wherein the seal cuff comprises a first seal portion and a second seal portion and wherein the first seal portion is separated from the second seal portion by a first gap and a second gap along a circumference of the seal cuff.

Abstract: Broad cerebrospinal fluid (CSF) distribution of an agent is achievable by delivering the agent in a liquid formulation to the CSF at flow rates less than 500 microliters per hour, such as between about 2 microliters per hour and about 100 microliters per hour.

Abstract: A detection and identification system of instruments for use with a surgical navigation system is described. The navigation system contains an instrument assembly containing a coil (of a receiver) having an interior space, an instrument configured to be removably coupled to the coil, and a prong affixed to the instrument and configured to be at least partially disposed within the interior space of the coil when the instrument is coupled to the coil, where the prong has a length corresponding to physical dimensions of the instrument. The navigation system can also contain a transmitter located within the body of a patient.

Abstract: This invention relates to the use of polycarboxylic acid compounds, aqueous compositions comprising the same, cosmetic compositions comprising the same, in particular, hair care compositions, and their use for the treatment of hair, and a process for the treatment of hair comprising the use of said cosmetic compositions.

Abstract: Described herein are subcutaneous medication delivery applicators and adhesive patches with one or more openings in the patches that designate one or more desired injection sites for subcutaneous injection of a medication. The medication delivery applicator and the adhesive patch may both include circuitry and wireless short-range communications interfaces that allow for the two devices to communicate with one another in order to determine if they are pre-associated in some manner, such as would be the case if both devices were packaged in the same injection kit. The medication delivery applicator may have some form of safety interlock that is only disengaged by the circuitry upon verifying that the two devices are pre-associated in some manner. Various other implementations are described as well.

Abstract: A method of enhancing therapeutic/drug transport to the perivascular space of the brain of a patient is disclosed. In one embodiment, the method comprises the step of introducing a therapeutic/drug and an osmolyte of the present invention into a patient's cerebrospinal fluid (CSF), wherein the osmolyte is introduced to the CSF at a concentration of between 0.5 and 12.9 M (dependent on the solubility upper limit of the osmolyte), and wherein the therapeutic/drug delivery to the perivascular spaces of cerebral blood vessels and parenchyma of the central nervous system is facilitated by the presence of the osmolyte.

Abstract: Techniques are disclosed for reducing the accumulation of gases in an implantable infusion device. In one example, an implantable infusion device (IID) includes a housing, an expandable and contractible reservoir, and a standoff member. The expandable and contractible reservoir is configured to store a therapeutic agent and is arranged within the housing. A first end of the reservoir is configured to collapse toward a second end of the reservoir as the reservoir contracts. The standoff member is interposed between the first end and the second end of the reservoir and is configured to hold at least a portion of the first end offset from the second end when the reservoir is in a contracted state.

Abstract: Trapping devices and methods are provided for capturing a medical analyte, in blood or another biological fluid. The device may include a structural substrate and a binding agent, such as an antibody, affixed to the structural substrate, wherein the binding agent is capable of binding or attaching with a medical analyte, such as a viral particle, and the device is configured for placement in a biological cavity or vessel (containing a biological fluid) in a patient. The trapping device, which may be in a twisted coil shape, is configured to trap at least some of the medical analyte, such a viral particle, present in the biological fluid. The method may include deploying a trapping device into the patient's blood vessel; after a period following the deployment, removing the trapping device from the biological cavity or blood vessel; and then analyzing the trapping device for the presence of the medical analyte.

Abstract: In certain embodiments, a vial adaptor comprises a housing member, a connector configured to couple the adaptor with a vial, a regulator channel, and an extractor channel formed in the housing member. The extractor channel is configured to facilitate withdrawal of fluid from the vial when the adaptor is coupled to the vial. The regulator channel is configured to facilitate flow of a regulating fluid to compensate for changes in volume of a medical fluid in the vial. In some embodiments, an expansion member is disposed on the housing member and is configured to expand and contract in accordance with changes in the volume of a medical fluid in the vial.

Abstract: Devices, systems, and methods for providing retroperfusion to at least one ischemic tissue in a minimally invasive manner are disclosed. At least some of the embodiments disclosed herein enable an anastomosis to be formed between a vein and an artery without the use of sutures and through a non-invasive procedure. In addition, various disclosed embodiments provide a cannula device comprising a Y-configuration for bifurcating arterial flow between an anastomosis and the underlying artery. The devices, systems and methods herein can further provide simultaneous autoretroperfusion therapy to more than one area of an ischemic tissue.

Abstract: This invention provides a device for implantation directly into the spinal cord for the purpose of treating back pain. Electrodes on a backing that conforms directly to the spinal cord are installed as a source of electrical stimulation and pain relief. The electrode array is maintained on the spinal cord by way of a spring or support structure that is anchored to an anatomical structure outside the spinal cord but near the site of implantation. Suitable anchoring structures include the vertebrae and the dura. Secured in this fashion, the support structure maintains a gentle pressure of the electrode array against the spinal cord so as to stay in electrical contact but minimize injury or inflammation. The device may accommodate and buffer movement of the spinal cord both laterally and in a caudal-rostral fashion so that the electrode array remains in place.

Abstract: The present invention is directed to polyphenolic polymers formed from dihydroxybenzoic acid (DHB) derivatives or from resorcinol derivatives, monomers which form such polymers, blends of the polymers with drugs and/or additional polymers, as well as medical devices formed from, coated with, impregnated by or coverings made with any of the foregoing polymers (with or without drugs) or blends (with or without drugs).

Abstract: A peripheral nerve conduction diagnosis system that utilizes an electrostimulation device having dry elastomer electrodes and a distance measuring device that allow a user to move the electrostimulation device along the skin of a patient while in constant contact with the skin and measure the distance moved.

Abstract: This invention provides a new technology for management of back pain by stimulating the spinal cord in a manner that renders it refractory to transmission of deleterious or undesirable sensory input. The electrical stimulus comprises high frequency pulses in a regular or complex pattern or that are stochastically produced under microprocessor control. The stimulus is applied directly to the surface of the spinal cord from within the spinal canal, which provides important benefits over previous technology. The stimulus alleviates symptoms and signs of back pain, while minimizing the risk of side effects such as paresthesia, and potentially minimizing the effects on motor neuron transmission and proprioception.

Abstract: An implantable infusion device includes a positive pressure reservoir, a pump, a flow restrictor, and an outlet. The device includes a first fluid flow path from the reservoir to the outlet, where the pump is downstream of the reservoir, and the outlet is downstream of the pump. The device further includes a second fluid flow path from the reservoir to the outlet, where the flow restrictor is downstream of the reservoir, and the outlet is downstream of the restrictor. The device may also include one or more controllable, MRI-safe valves to select whether fluid is delivered via the first or second flow path.

Abstract: This invention provides a device for implantation directly into the spinal cord for the purpose of treating back pain. Electrodes on a backing that conforms directly to the spinal cord are installed as a source of electrical stimulation and pain relief. The electrode array is maintained on the spinal cord by way of a spring or support structure that is anchored to an anatomical structure outside the spinal cord but near the site of implantation. Suitable anchoring structures include the vertebrae and the dura. Secured in this fashion, the support structure maintains a gentle pressure of the electrode array against the spinal cord so as to stay in electrical contact but minimize injury or inflammation. The device may accommodate and buffer movement of the spinal cord both laterally and in a caudal-rostral fashion so that the electrode array remains in place.

Abstract: A septum for a port is provided, the septum having a top wall and a side wall. The side wall can include a pressure-activated valve element for regulating the flow of fluid across the valve. The curvature of the side wall and the geometry of the sidewall and the housing can be tailored to bias the valve element to open at different pressures during infusion and aspiration. The side wall can also include an extended portion that can function as a suture wing for securing the port within a port pocket.

Abstract: In one embodiment, an IDDC system utilizes an intelligent therapeutic agent delivery system comprised of one, but more likely an array of “cells” containing therapeutic agent(s) and/or diagnostic agents(s); an integrated bio-sensing system designed to sample and analyze biological materials using multiple sensors that include both hardware and software components. The software component involves biomedical signal processing to analyze complex liquid mixtures and a microcontrollers) acts as interface to the biosensors, to the therapeutic delivery elements, and to a communications system(s) for the purpose of controlling the amount of therapeutic agent to deliver and also to provide information in a useful form to interested parties on the progress of therapy and compliance thereto.

Abstract: The invention provides multi-chamber encapsulated cell therapy cartridge devices that are capable of delivering biologically active molecules as well as methods of using these devices.

Abstract: The perivascular leak repair system, and method of using the same, of the present invention provides a sealant reservoir 102 with a repair catheter 104 operably attached; a flow control device 106 disposed between the sealant reservoir 102 and the repair catheter 104, and the flow control device 106 responsive to a flow control signal 108; a heart phase detector 114 generating a diastole phase signal 112; an injection switch 122 generating a injection signal 120; and a flow controller 110 responsive to the diastole phase signal 112 and the injection signal 120, and generating the flow control signal 108. A method of sealing a perivascular leak comprises identifying the perivascular leak 140; inserting a repair catheter to the perivascular leak 142; injecting sealant at the perivascular leak 144; and removing the repair catheter 146. The sealant can be injected when the heart is in diastole to sweep the sealant into the perivascular leak.

Abstract: A medical microelectrode includes an elongate electrode body including a tip section, a main body section and, optionally, a coupling section. The tip section, the main body section and, optionally, the coupling section are embedded in a first electrode matrix element, which is substantially rigid, biocompatible and soluble or biodegradable in a body fluid. Additionally the microelectrode includes a dissolution retarding layer on the first electrode matrix element and/or a second electrode matrix element disposed between the first electrode matrix element and the electrode. Upon dissolution or biodegradation of the first electrode matrix element a drug comprised by the first electrode matrix element or the second electrode matrix element is released into the tissue. Also disclosed are bundles and arrays of the electrodes and their use.

Abstract: A method for evaluating dosing from an implanted infusion system that includes receiving input regarding the identity of a therapeutic agent into an external device. The method further includes displaying on the external device a predetermined set of symptoms associated with the therapeutic agent; receiving input into the external device regarding with which of the symptoms the patient presents; and determining whether the therapeutic agent is being delivered, or has been delivered, at an appropriate dose based on the input identity of the therapeutic agent and the input symptoms.

Abstract: The present invention relates to methods of treating and/or ameliorating the severity of inflammation and autoimmunity in the central nervous system (CNS). In one embodiment, the present invention provides a method of treating multiple sclerosis by administering a therapeutically effective dosage of nicotine, or a pharmaceutical equivalent, analog, derivative, or salt thereof.

Abstract: The invention pertains to an applicator (1) for inserting an implant, in particular a rod-like implant (2) containing an active substance, under the skin of a human or animal, comprising a housing (3), a cannula (6) extending from the housing (3), and a handle (15) for grasping and maneuvering the applicator (1) and the cannula (6) during insertion of an implant (2). In accordance with the invention, the handle (15) extends above at least part of the length of the cannula (6). Such a handle facilitates insertion of the cannula and/or accurate positioning of the implant.

Abstract: Methods for administering medication at or near an intervertebral spinal disc are provided. In various embodiments, a microporous uninflated balloon is inserted into a spinal disk and after insertion of the balloon into the disc space, a medication is inserted into the interior of the balloon. Due to both the pressure on the balloon from the spine and drug diffusion, the medication moves through the pores over time.

Abstract: A catheter assembly includes a catheter, including an inner member and a sheath, extending from a handle. The handle includes a housing, a braking assembly, a carriage and a carriage driver. The braking assembly comprises a braking element within the housing interior and a braking element rotator. The carriage comprises at least one carriage braking surface engaging the braking element. The carriage driver, such as a spring, biases the carriage towards the proximal end of the handle. The inner member has a proximal end secured to the housing. The sheath has a proximal end secured to the carriage. Rotating the braking element causes the carriage to move proximally as the carriage braking surface slides along the braking element. This causes the sheath to move proximally relative to the inner member.

Abstract: A drug delivery device includes a first portion, formed primarily from elastomeric material, and a closure portion, cooperating with an opening of the first portion so as to complete an inflatable drug reservoir. The closure portion extends into the first portion inwards from the opening, defining at least one region of overlap between the first portion and the closure portion. The first portion and the closure portion define an outlet flow path for releasing a drug from the drug reservoir, with at least part of the outlet flow path passing between the first portion and the closure portion in the region of overlap. The region of overlap is disposed so as to be acted upon by a pressure within the drug reservoir thereby changing a flow impedance of the outlet flow path to provide an at least partially pressure compensated flow regulating mechanism.

Abstract: A method for replenishing gas in a subcutaneously implanted medical device containing functional cells comprising: inserting at least one needle, adopted to penetrate the skin and connecting a subcutaneously implanted medical device; connecting the inserted at least one needle to a gas replenishing apparatus; extracting gas from a gas reservoir in the implanted device into the gas replenishing apparatus; sensing oxygen level in the extracted gas; calculating the amount of gas needed for replenishing oxygen in the reservoir based on the sensed oxygen level in the extracted gas; and supplying gas from a gas tank in the gas replenishing apparatus to the gas reservoir in the implanted device.

Abstract: An implantable pump includes a base plate and a can that are parts of the pump housing. The base plate bottom divides the housing into a first electronics chamber and a second chamber. A bellows mechanism is connected to the base plate and is disposed within the second chamber. The bellow mechanism has an expandable sidewall and a bottom plate. The bellow mechanism divides the second chamber into a medicament receiving portion and a non-medicament-receiving portion. The bellow mechanism has an intermediate plate disposed within the medicament-receiving portion. A coil is disposed in a recess on the lower surface of the base plate, and the coil is spaced from an internal wall of the recess. The amount of fluid remaining in the implantable pump can be monitored by energizing the coil. A primary magnetic field is generated by the energized coil.

Abstract: A one-time use device to deliver preservative-free follicle stimulating hormone (FSH) solution is disclosed. The device includes a needle covered by a sliding needle shield, which covers the needle in all modes of the device. The device can be placed into a ready-to-use position in four or fewer user steps. The device has a knob for setting a desired dose of FSH. The knob includes longitudinally spaced elements respectively corresponding to the lock position and the seven or fewer discrete dosing positions. The device locks after one use and cannot be reused thereafter.

Abstract: The present invention provides a system and a method for distending a body tissue cavity of a subject by continuous flow irrigation such that minimal or negligible fluid turbulence is present inside the cavity, such that any desired cavity pressure can be created and maintained for any desired outflow rate. The present invention also provides a method for accurately determining the rate of fluid loss, into the subject's body system, during any endoscopic procedure without utilizing any deficit weight or fluid volume calculation or flow rate sensor. The system and the methods of the present invention described above can be used in any endoscopic procedure requiring continuous flow irrigation few examples of such endoscopic procedures being hysteroscopic surgery, arthroscopic surgery, trans uretheral surgery, endoscopic surgery of the brain and endoscopic surgery of the spine.

Abstract: The perivascular leak repair system, and method of using the same, of the present invention provides a sealant reservoir with a repair catheter operably attached; a flow control device disposed between the sealant reservoir and the repair catheter, and the flow control device responsive to a flow control signal; a heart phase detector generating a diastole phase signal; an injection switch generating a injection signal; and a flow controller responsive to the diastole phase signal and the injection signal, and generating the flow control signal. A method of sealing a perivascular leak comprises identifying the perivascular leak; inserting a repair catheter to the perivascular leak; injecting sealant at the perivascular leak; and removing the repair catheter. The sealant can be injected when the heart is in diastole to sweep the sealant into the perivascular leak.

Abstract: A method for implanting an injection port within a patient. The method involves providing a port having a housing with a closed distal end, a open proximal end, a fluid reservoir therebetween, a needle penetrable septum attached to the housing about the opening, and at least one attachment mechanism mounted to the housing at a pivot point along an outer periphery of the housing. The attachment mechanism is an arcuate hook pivotable with respect to the housing, the arcuate hook having a length extending substantially at least 180° about the pivot point. The method further involves placing the distal end of the port adjacent tissue, and rotating the arcuate hook at least 180 degrees so that a free end of the hook extends into tissue and back out again.

Abstract: The invention provides systems for treating an obstructed biological conduit that include administering to the conduit an agent that can degrade extracellular matrix of obstructing tissue. Particular methods include delivery of an enzyme or a mixture of several enzymes to the area or region of obstruction wherein the enzyme(s) have the capability to degrade extracellular matrix components within the obstruction thereby restoring the normal flow of transported fluid through the conduit. The invention also includes prophylactically dilating a section of conduit to minimize the risk of obstruction formation.

Abstract: Devices and methods are provided for delivery of a positive inotropic agent to the heart of a patient in need thereof. An epicardial patch includes (i) a backing layer which is impermeable to the positive inotropic agent; and (ii) a drug release layer attached to the backing layer and including the positive inotropic agent and a polymeric membrane material. The polymeric membrane material provides controlled release of the positive inotropic agent to the epicardium to a region of the myocardium and in an amount effective to increase contractility. At least one of the backing layer or the drug release layer includes a tissue coupling portion for affixing the epicardial patch to an area of the epicardial surface. The epicardial patch is dimensioned and compliant to substantially avoid impeding myocardial functionality when affixed to the area of the epicardial surface.

Abstract: Drug infusion system capable of delivering a fluid medication to a patient and method for doing same is described. An implantable drug delivery device is capable of delivering the fluid medication at a programmable rate to the patient under control of an original programming cycle having a plurality of steps in a plurality of time slots beginning at a starting time. The programming cycle specifies the programmable rate for each of the plurality of steps. An external controller is capable of storing a program representative of the original programming cycle in the implantable drug delivery device at a programming time. The drug infusion system adjusts the implantable drug delivery device so that the original programming cycle will begin at a time during the original programming cycle adjusted for the programming time.

Abstract: Multiple reservoir implantable valve accumulator pump for the delivery of medication, and method of infusate delivery. The apparatus includes at least first and second infusate reservoirs in a common pressure chamber, each in fluid communication with a metering assembly. The metering assembly includes an accumulator that is preferably a fixed volume accumulator having an inlet and an outlet. A first valve is in fluid communication with the first infusate reservoir and an inlet of the accumulator, and a second valve is in fluid communication with the second infusate reservoir and an inlet of the accumulator. An outlet valve is in fluid communication with the outlet of the accumulator. The accumulator can be filled with infusate from the first and second infusate reservoirs sequentially, can be filled from the first infusate reservoir multiple times consecutively, the second infusate reservoir multiple times consecutively, or any combination or permutation thereof.

Abstract: Methods and systems for treating pleural disease comprising a providing a low dosage of a sclerosing agent over a period of time. Certain examples include catheter with a sclerosing agent that is inserted into the pleural space. The sclerosing agent is released in a sustained-release manner over a period of time to achieve diffuse pleurodesis of the pleural layers.

Abstract: A drug infusion system capable of delivering a fluid medication to a patient under direction of a medical professional continually at a basal rate and at an interval rate in each of a plurality of time slots over a specified period of time. The total dose of the fluid medication to be delivered to the patient over the period of time based on the basal rate and the interval rate for each of the plurality of time slots is determined, compared the total dose against a maximum dose. The basal rate is adjusted, if necessary, so that the total dose does not exceed the maximum dose.

Abstract: A method is provided for monitoring the status of a medical device implanted in a patient. The method includes the steps of implanting in a patient a medical device which comprises (i) a substrate in which two or more reservoirs are located, with each covered by a reservoir cap, (ii) a drug or sensor located in the reservoir, (iii) a power source and actuation electronics for disintegrating or permeabilizing the reservoir cap, and (iv) a telemetry system; and then using said telemetry system to wirelessly transmit to a remote controller data about the condition of the power source and/or data about which reservoirs have been or have yet to be activated to release the drug therefrom or to expose the sensor therein.

Abstract: A method for coating medication for a medical product is disclosed. A technique for coating gel in a viscous semisolid state is provided to facilitate coating of medication. Coating of medication on an article can be facilitated using gel, and coating of medication on an article such as an article made of silk and an article made of polypropylene can be further facilitated.

Abstract: A method is provided for suppressing or preventing pain in a patient. One step of the method includes positioning first and second electrodes, without penetrating the cranium, on or proximate to at least one of the sphenopalatine ganglia, the sphenopalatine nerves, or the vidian nerves on both sides of the patient's face. At least one of a medication solution, an analgesic, or an electrical signal is then applied to at least one of the sphenopalatine ganglia, the sphenopalatine nerves, or the vidian nerves through the first and second electrodes. Pain signal generation in, or transmission through, the at least one of the sphenopalatine ganglia, sphenopalatine nerves, or vidian nerves is disrupted on both sides of the patient's face.

Abstract: Methods and systems for treating pleural disease comprising a providing a low dosage of a sclerosing agent over a period of time. Certain examples include catheter with a sclerosing agent that is inserted into the pleural space. The sclerosing agent is released in a sustained-release manner over a period of time to achieve diffuse pleurodesis of the pleural layers.

Abstract: A port for implantation within a body, comprises a housing having proximal and distal surfaces and a side surface wherein, the proximal surface faces outward toward the skin, the distal surface faces inward away from the skin and the side surface extends between the proximal and distal surfaces. A first well formed within the housing includes a first opening in the proximal surface and a second well formed in the housing adjacent to the first well has a second opening formed in the proximal surface. First and second outlet openings formed on the side surface of the port are in fluid communication with the first and second wells, respectively, and are separated from one another by a distance substantially equal to a distance separating lumens of a dual lumen catheter to which the port is to be connected.

Abstract: Drug infusion system capable of delivering a fluid medication to a patient and method for doing same. An implantable drug delivery device is capable of delivering the fluid medication at a programmable rate to the patient under control of an original programming cycle having a plurality of steps in a plurality of time slots beginning at a starting time. The programming cycle specifies the programmable rate for each of the plurality of steps. An external controller is capable of storing a program representative of the original programming cycle in the implantable drug delivery device at a programming time. The drug infusion system adjusts the implantable drug delivery device so that the original programming cycle will begin at a time during the original programming cycle adjusted for the programming time.