Abstract: A device for delivering a drug depot into a patient via a cannula is provided. The device includes a housing with a coupling mechanism. A drug cartridge is positioned within the housing and includes a cartridge depot channel having an occluding device that includes a ramp and a plateau. The occluding device occludes the cartridge depot channel to prevent the drug depot from moving beyond the occluding device without force applied to the drug depot sufficient to deflect the occluding device an amount to allow the drug depot to move beyond the occluding device. The drug cartridge includes an alignment boss with an end channel coaxial with the cartridge depot channel. A push rod is slidably receivable in the housing and the drug cartridge to move the drug depot beyond the occluding device, into the cartridge depot channel, through the cannula and into the patient.

Abstract: Cardiomyopathy may be treated by distributing space-occupying agent within the myocardium in a pattern about one or more chambers of the heart, such that the space-modifying agent integrates into and thickens at least part of the cardiac wall about the chamber so as globally to reduce wall stress and stabilize or even reduce chamber size. Some patterns also cause a beneficial global reshaping of the chamber. These changes occur quickly and are sustainable, and have a rapid and sustainable therapeutic effect on cardiac function. Over time the relief of wall stress reduces oxygen consumption and promotes healing. Moreover, various long-term therapeutic effects may be realized depending on the properties of the space-occupying agent, including combinations with other therapeutic materials. Specific cardiac conditions treatable by these systems and methods include, for example, dilated cardiomyopathy (with or without overt aneurismal formations), congestive heart failure, and ventricular arrhythmias.

Abstract: A temporary implantable medical electrical lead includes a conductor extending along a proximal, extracorporeal length and a distal, subcutaneous length of the lead. Electrically isolated first and second wire filars of the conductor are wound to form an elongate lumen of the lead. First and second electrodes are mounted directly onto the conductor, along the subcutaneous length, and each is directly coupled to the corresponding filar. A fixation member is attached to a tubular member, which is conformed to an outer surface of the conductor so as to only cover the conductor along the subcutaneous length, leaving the outer surface exposed along a portion thereof, adjacent to the extracorporeal length. When the lead is implanted, the fixation member holds the subcutaneous length in a relatively fixed location, and fluid communication exists between the outer surface of the conductor and the lumen of the lead.

Abstract: A dual-chambered drug delivery device (301) includes a first chamber (342) in which medicament is stored and a second chamber (331) in fluid communication with the first chamber (342). A medicament dose is transferred to the second chamber (331) from the first chamber (342) prior to injecting the medicament dose. A needle (363) communicates with the second chamber (331) for injecting the medicament dose into an injection site.

Abstract: The present patent application relates to delivery devices, methods, and systems of delivering at least one medicament from a reservoir using an automatic delivery device. Such an automatic delivery device system may comprise a dose injecting mechanism and a dispense interface, such as a needle module. The dose injecting mechanism comprises a triggering mechanism. An activating member, such as a needle guard of the needle module, can be used to initiate the triggering mechanism to enable the device to administer the set dose. The single dispense interface may comprise a medicated module containing at least one dose of a secondary medicament. The dose injecting mechanism may comprise a dose setting mechanism.

Abstract: A discharge device for discharging a product from a tube having a delivery outlet and a deformable wall. The discharge device according to the invention comprises a housing with a chamber that has a chamber opening and in which the tube is accommodated. A movable stopper is arranged inside the tube and is placed at the end opposite the delivery outlet and closes this end of the tube. An advancing member can be connected to the stopper and is displaceable inside the tube in the direction of the delivery outlet for discharging the fluid product from the tube.

Abstract: Embodiments of the invention provide needle guides that facilitate direct penile injection of drug therapies.

Abstract: An engagement catheter for use with a vacuum source for engaging a tissue. An embodiment of the engagement catheter includes a first lumen extending between a proximal end and a distal end, a skirt operatively connected to the distal end, the skirt having a distal end with a circumference larger than the outer circumference of the engagement catheter, a suction port located at or near the distal end of the engagement catheter, the suction port configured to allow the distal end of the skirt to removably engage a surface of a bodily tissue, and a vacuum port located at the proximal end of the engagement catheter and capable of operative connection to a vacuum source, wherein when a vacuum source is operatively attached to the vacuum port, the skirt is capable of forming a reversible seal with the surface of the bodily tissue.

Abstract: An injector for delivering an injectate into the myocardium of the heart may be implemented as a catheter or a handheld unit. The injector includes a body, a stabilizer secured to a distal end of the body, and a needle that may be controllably advanced from the distal end of the body. The stabilizer stabilizes the distal end of the body relative to the myocardium while the heart beats. An enlarged region disposed along the needle prevents the needle from being advanced into the myocardium beyond a desired penetration depth. To make an injection, the physician brings the distal end of the body in proximity to the myocardium, actuates the stabilizer to stabilize the distal end relative to the myocardium, and advances the needle into the myocardium. Advancement of the needle is impeded by the enlarged region, thereby placing the needle tip at the desired penetration depth for the injection.

Abstract: A device (10) for at least partially inserting a needle (16) into the body of a patient is disclosed. The device (10) comprises a connector adapted for attachment to a needle (16), and a guard member (18) having a guide surface adapted to rest against a surface of the skin. The connector is adapted to set an attached needle (16) with a fixed position relative to the guard member (18), such that movement of the guide surface along the surface of the skin at least partially inserts the needle (16) into the body.

Abstract: A fluid delivery device includes an array of needles, each in fluid communication with a respective reservoir. Respective actuators are coupled so as to be operable to drive fluid from the reservoirs via needle ports. Each needle can have a plurality of ports, and the ports can be arranged to deliver a substantially equal amount of fluid at any given location along its length. A driver is coupled to the actuators to selectively control the rate, volume, and direction of flow of fluid through the needles. The device can simultaneously deliver a plurality of fluid agents along respective axes in solid tissue in vivo. If thereafter resected, the tissue can be sectioned for evaluation of an effect of each agent on the tissue, and based on the evaluation, candidate agents selected or deselected for clinical trials or therapy, and subjects selected or deselected for clinical trials or therapeutic treatment.

Abstract: Antibiotics are administered in a surgical site subcutaneously via a small or stab incision in the surgical field. Transcutaneous ultrasonic vibrations are applied across the surgical field, which is then opened in the usual manner, to thereby provide a surgical field which contains a vastly higher and more effective level of antibiotic. At the same time the underlying tissue is hydrated.

Abstract: The present embodiments relate to methods and systems for identifying areas of a subject's skin that lack sufficient volume. In some embodiments, this can be used to direct the administration of filler compositions or the application of techniques that increase the volume or firmness of the area. In some embodiments, the methods and systems provide for improved aesthetic benefit as well as suitability for instruction and training. In some embodiments, the methods are especially useful in the administration of dermal fillers to a subject.

Abstract: The present embodiments relate to methods and systems for identifying areas of a subject's skin that lack sufficient volume. In some embodiments, this can be used to direct the administration of filler compositions or the application of techniques that increase the volume or firmness of the area. In some embodiments, the methods and systems provide for improved aesthetic benefit as well as suitability for instruction and training. In some embodiments, the methods are especially useful in the administration of dermal fillers to a subject.

Abstract: An infiltration cannula and method of using the infiltration cannula during a tumescent infiltration procedure are disclosed herein. The infiltration cannula may have an outwardly flaring hub which may be wedged into an adit of a patient to minimize leakage of fluid being infiltrated into the patient. Also, the infiltration cannula may be utilized to hydrate a dehydrated patient by a medically untrained person. The infiltration cannula may also be used to deliver an antibiotic/vasoconstrictive drug solution to minimize surgical site infections.

Abstract: The present invention provides a multi-directional needle assembly for injecting substance into at least one injection site of a patient's body, comprising: a. an elongated member having a distal end; said distal end having a plurality of openings disposed therein; b. a plurality of needles disposable at least partially within said elongated member, adapted to be reconfigured from a FOLDED configuration to a DEPLOYED configuration; said FOLDED configuration being characterized by the position of said needles within said elongated member; said DEPLOYED configuration being characterized by the protrusion of said needles out of said openings; the disposition of said openings is provided according to a predetermined scattering pattern such that (i) at least two separated areas within said distal end are provided for injection of said substance into at least two different injection locations at said injection site; and, (ii) a DEAD AREA between said two separated areas is obtained.

Abstract: Devices and systems for injecting fluids and/or other materials into a targeted anatomical location, in particular, a joint or intra-articular space, include a handpiece assembly having a needle extending from its distal end, a fluid delivery module comprising a cassette and a fluid transfer device. A conduit is generally configured to place the fluid delivery module in fluid communication with the handpiece assembly. Medicaments, formulations and/or other fluids or materials contained within vials that are secured to a cassette or other portion of the fluid delivery module can be selectively delivered into an anatomy through a needle located at the distal end of the handpiece assembly. In some embodiments, ultrasound or other imaging technologies can be used to locate a joint or other targeted anatomical location.

Abstract: Multichannel systems for engaging a bodily tissue and methods of using the same. In at least one embodiment of an exemplary multichannel system for engaging a tissue of the present disclosure, the system comprises an engagement catheter comprising a proximal end, a distal end, and defining a first lumen and second lumen extending between the proximal end and the distal end, an inducer sheath having a proximal portion and a distal portion, and defining a lumen extending therethrough, the inducer sheath configured for insertion into the second lumen of the engagement catheter, and a dilator defining a first channel and a second channel extending therethrough and a tapered tip at the distal end of the dilator, the dilator sized and shaped for inserted into the lumen of the inducer sheath.

Abstract: The present invention provides improved methods for ID delivery of drugs and other substances to humans or animals. The methods employ small gauge needles, especially microneedles, placed in the intradermal space to deliver the substance to the intradermal space as a bolus or by infusion. It has been discovered that the placement of the needle outlet within the skin and the exposed height of the needle outlet are critical for efficacious delivery of active substances via small gauge needles to prevent leakage of the substance out of the skin and to improve absorption within the intradermal space. The pharmacokinetics of hormone drugs delivered according to the methods of the invention have been found to be very similar to the pharmacokinetics of conventional SC delivery, indicating that ID administration according to the methods of the invention is likely to produce a similar clinical result (i.e., similar efficacy) with the advantage of reduction or elimination of pain for the patient.

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

Abstract: A reinforcement region is formed within the myocardium by introducing a delivery device through a vessel wall to a treatment site within a myocardium. A biomaterial is then delivered to the treatment site as the delivery device is withdrawn from the treatment site to form the reinforcement regions. Formation of the reinforcement region may further include introducing a delivery device through a vessel wall to a region within a myocardium such that the delivery device is positioned within the myocardium substantially parallel to a wall of the myocardium. A biomaterial may be delivered into a space formed within the region by the delivery device. The reinforcement region may be formed around an infarct tissue region of a myocardium to reinforce the damaged tissue.

Abstract: A method includes inserting a distal end portion of a needle of a medical injector into a skin of a body. An energy source operatively coupled to the medical injector is actuated such that a dermal filler is conveyed from the medical injector into the skin through the distal end portion of the needle. The distal end portion of the needle is moved within the skin during the actuating.

Abstract: A method for transferring a macromolecular complex to muscle cells by exsanguinating a region of the subject's microvasculature and delivering the complex to this region under high hydrostatic pressure. A balloon catheter having a balloon that extends substantially the full length of the cannula that is inserted into the subject is provided for use in the systemic delivery of macromolecular complex.

Abstract: Apparatus and methods for injecting biological agents into tissue. Devices are provided having elongate shafts and distal injection heads for transversely driving needles into tissue and injecting medical agents into the tissue through the needles. A longitudinal force directed along the shaft can be translated to a needle driving force transverse to the shaft. Some devices provide controllably variable needle penetration depth. Devices include mechanical needle drivers utilizing four link pantographs, rack and pinions, and drive yokes for driving a first needle bearing body toward a second tissue contacting body. Other devices include inflatable members for driving and retracting needles. Still other devices include magnets for biasing the needles in extended and/or retracted positions. The invention includes minimally invasive methods for epicardially injecting cardiocyte precursor cells into infarct myocardial tissue.

Abstract: Apparatus for administering certain nerve blocks includes a sheath constructed from a flexible ultrasound echogenic material, a more rigid introducer/dilator for introducing the sheath into the patient, and an ultrasound echogenic catheter for inserting through the sheath once the distal end of the sheath is in place adjacent the nerve(s) to be blocked and the introducer/dilator has been withdrawn. The catheter has provisions at its proximal end for connecting to a source of local anesthetic. Methods for use of this apparatus are also described.

Abstract: The present invention includes methods, systems, devices, and apparatus relating to minimizing source-sink mismatch associated with the application of a biological pacemaker in cardiac tissue. Stable and robust pacemaker activity is achieved by the application of the biological pacemaker at more than one site, in a linear pattern.

Abstract: A method and device are herein described to treat a target region of tissue, using at least one energy delivery device coupled to a power source and positioned in a treatment position so as to irreversibly electroporate tissue to ablate a target region, and introduce regenerative materials into a treated region.

Abstract: Methods are described for using compositions containing platelet-rich plasma for the treatment of acute or chronic dysfunction of cardiac muscle. The method may employ a kit which includes a platelet-rich plasma composition and a pH adjusting agent and a catheter or syringe for delivery of the platelet-rich plasma composition to dysfunctional cardiac muscle. The kit may also include a syringe for withdrawing blood from a patient and a centrifuge device means to obtain platelet-rich plasma.

Abstract: Devices and methods are provided for delivering a drug depot at or near the spinal column of a patient. In various embodiments, the drug depot comprises a drug cartridge containing drug pellets for delivery at or near the spinal column of a patient.

Abstract: Methods and apparatus for the reproducible, consistent and efficacious delivery of a therapeutic agent to a patient. The invention comprises means for the controlled administration of the therapeutic agent through an orifice to the patient, a plurality of penetrating electrodes arranged with a predetermined spatial relationship relative to the orifice, and means for generating an electrical signal operatively connected to the electrodes.

Abstract: A method for accelerating subcutaneous absorption of a fluid or drug into the systemic circulation of a specific targeted tissue. A first drug operative to produce local capillary vasodilatation and/or increase the rate of bulk flow of solution through the interstitial space is mixed with a fluid. The fluid may contain a crystalloid solution or a dilute solution of a pharmacologic drug required for a routine or emergency therapeutic treatment for a patient. The first drug is substantially non-toxic to the patient. The fluid mixed with the first drug is then delivered subcutaneously or into deeper tissues of the patient, by use of a hyperdermic needle or infiltration cannula. As the capillaries are dilated, the fluid is efficiently absorbed and circulated systemically.

Abstract: A method for accelerating subcutaneous absorption of a fluid or drug into the systemic circulation of a specific targeted tissue. A first drug operative to produce local capillary vasodilatation and/or increase the rate of bulk flow of solution through the interstitial space is mixed with a fluid. The fluid may contain a crystalloid solution or a dilute solution of a pharmacologic drug required for a routine or emergency therapeutic treatment for a patient. The first drug is substantially non-toxic to the patient. The fluid mixed with the first drug is then delivered subcutaneously or into deeper tissues of the patient, by use of a hyperdermic needle or infiltration cannula. As the capillaries are dilated, the fluid is efficiently absorbed and circulated systemically.

Abstract: A method with apparatus for performing surgery using plasma is described. In one exemplary embodiment, the apparatus includes a radiofrequency signal generator, a conditioning network coupled to the radiofrequency signal generator, and a catheter coupled to the conditioning network, the catheter including at least one electrode, such that the conditioning network conditions radiofrequency energy produced by the radiofrequency signal generator to create plasma at the at least one electrode of the catheter. Such novel plasma ablation system provides the capability to create high precision ablation with minimal damage to adjacent structures in numerous types of matter while employing multiple operation platforms including catheter based plasma application.

Abstract: Devices, systems, and methods for accessing tissue, including the internal and external tissues of the heart, are disclosed. At least some of the embodiments disclosed herein provide access to the external surface of the heart through the pericardial space for localized delivery of leads to the heart tissue. At least some of the embodiments disclosed herein provide access to the pericardial space for removal of accumulated fluid. In addition, various disclosed embodiments provide devices, systems, and methods for engaging a tissue, for removing fluid from a space within a body, and for the delivery of substances to a targeted site for therapeutic purposes.

Abstract: Methods of treating functional disorders of the bladder in mammalian females are disclosed. A therapeutic compound is delivered directly into the trigone of the bladder. The therapeutic may be delivered to the trigone through the vaginal wall. A device for delivering the therapeutic compound is also disclosed. The device may be an array of microneedles connected to a reservoir.

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.

Abstract: A method is disclosed for delivering molecules such as pharmaceutical drugs and nucleic acids into skeletal muscle in vivo. The molecule is first injected into the muscle at one or multiple sites. Immediately or shortly after injection, electrodes are placed flanking the injection site and a specific amount of electrical current is passed through the muscle. The electrical current makes the muscle permeable, thus allowing the molecule to enter the cell. In the case where nucleic acid is injected, the efficiency of transfer permits expression of protein encoded by the nucleic acid in an amount that exhibits systemic biological activity and which generates a robust immune response.

Abstract: Drug depot delivery devices and methods are provided for delivering one or more drug depots in close proximity to the nerve of a patient with or without repositioning the cannula. The device includes an electronic monitor for detecting the proximity of the tip of the cannula to a nerve. In some embodiments, a method of delivering a drug depot is provided by detecting the nerve and delivering the drug depot near the nerve.

Abstract: A medical device is provided. The device includes a cannula with a lumen defined therethrough and an upper portion, a right side portion, a bottom portion, and a left side portion each substantially equally spaced from their respective neighboring portion around the circumferential surface of the cannula. The cannula additionally includes a plurality of apertures disposed through the distal end portion to provide communication from the lumen and a visually perceptible indicator that is configured to allow the cannula to be positioned at an appropriate rotational position within the patient.

Abstract: Medical tubing (T), such as a guidewire, a stent, a catheter or a hollow needle, made of a kinked rigid-rod polyarylene exhibiting a outstanding characteristics including high torqueability, high pushability and high flexibility and which can be easily thin-wall extruded under especially harsh conditions.

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

Abstract: A needle assisted jet injector and method for jet injecting medicament are disclosed. In one embodiment of the injector, the needle is retractably located within an injector nozzle assembly. Upon activation of the force generating source, a portion of the needle extends past the nozzle assembly and penetrates the outer layer of skin to deliver the medicament via jet injection to a deeper region. After activation, the needle retracts back into the nozzle assembly. In another embodiment, the needle is fixed to the end of the nozzle assembly. In both embodiments, the length of the portion of the needle that penetrates the skin is less than 5 mm.

Abstract: The present embodiments relate to methods and systems for identifying areas of a subject's skin that lack sufficient volume. In some embodiments, this can be used to direct the administration of filler compositions or the application of techniques that increase the volume or firmness of the area. In some embodiments, the methods and systems provide for improved aesthetic benefit as well as suitability for instruction and training. In some embodiments, the methods are especially useful in the administration of dermal fillers to a subject.

Abstract: Drug depot delivery devices and methods for delivering a drug depot to a site beneath the skin of a patient are provided. In various embodiments, a device for delivering a drug depot to a site beneath the skin of a patient is provided, the device comprising: a cannula capable of insertion to the site beneath the skin of the patient and having an opening for passage of the drug depot; a drug cartridge comprising at least two chambers, wherein each chamber is configured to store and release a drug depot into the cannula when the cannula is aligned with a first chamber and the plunger. In some embodiments, the drug depot delivery device and methods provide slide-a-dose technology for delivering the drug depot to the target tissue site.

Abstract: Drug depot delivery devices and methods for delivering a drug depot to a site beneath the skin of a patient are provided. In various embodiments, a device for delivering a drug depot to a site beneath the skin of patient is provided, the device comprising: a cannula capable of insertion to the site beneath the skin of the patient and having an opening for passage of the drug depot; a drug cartridge comprising at least two chambers, wherein each chamber is configured to store and release a drug depot into the cannula when the cannula is aligned with a first chamber and the plunger. In some embodiments, the drug depot delivery device and methods provide dial-a-dose technology for delivering the drug depot to the target tissue site.

Abstract: Devices, systems, and methods for accessing the internal and external tissues of the heart are disclosed. At least some of the embodiments disclosed herein provide access to the external surface of the heart through the pericardial space for localized delivery of substances to the heart tissue. In addition, various disclosed embodiments provide access to the internal surface of the heart for aspiration and delivery of substances to a targeted region without disturbing or interfering with nearby structures or surfaces.

Abstract: An injector apparatus and associated methods for safely and repeatedly delivering an injectate at a predefined depth into the myocardium of the heart may be catheter-based or implemented in a handheld unit for use in open chest procedures. The injector includes a body, a stabilizer secured to a distal end of the body for stabilizing the distal end of the body relative to the myocardium, and a needle that may be controllably advanced from the distal end of the body into the myocardium. The stabilizer employs any suitable technique for stabilizing the distal end of the catheter body relative to the myocardium while the heart is beating. An enlarged region disposed along the needle functions as a stop to prevent the needle from being advanced into the myocardium beyond a desired penetration depth.

Abstract: An assembly for treating subcutaneous tissues using acoustic waves in the range of low acoustic pressure ultrasound waves is disclosed. The assembly comprises an acoustic wave generator and transducer for the generation and transmission of unfocused acoustic waves, a source of microbubble solution and solution injection members for percutaneously injecting the solution at a treatment area between 1 mm and 5 mm below the dermis. The assembly is useful for treatment of subcutaneous abnormalities including cellulite, lipomas and tumors.

Abstract: Some aspects of the present disclosure relate to methods for treating a tissue by forming a low-swelling biodegradable hydrogel in situ adherent to the tissue. In embodiments the hydrogel exhibits negative swelling, i.e., shrinking. Such treatments may be utilized to in cosmetic or reconstructive surgery, in sphincter augmentation, treating nerve inflammation, and the like.

Abstract: A needle assisted jet injector and method for jet injecting medicament are disclosed. In one embodiment of the injector, the needle is retractably located within an injector nozzle assembly. Upon activation of the force generating source, a portion of the needle extends past the nozzle assembly and penetrates the outer layer of skin to deliver the medicament via jet injection to a deeper region. After activation, the needle retracts back into the nozzle assembly. In another embodiment, the needle is fixed to the end of the nozzle assembly. In both embodiments, the length of the portion of the needle that penetrates the skin is less than 5 mm.