Abstract: The present invention provides a method for enhancing the immunogenicity using a microneedle device capable of enhancing the immunogenicity of an influenza vaccine. According to the method for enhancing the immunogenicity using the present microneedle device, a microneedle device having microneedles made of polylactic acid, coated with an influenza vaccine composed of an antigen having type A strain (H1N1), type A strain (H3N2), and type B strain as active ingredients is brought into direct contact with the skin so as to transcutaneously administer the aforementioned influenza vaccine. After the transcutaneous administration, lauryl alcohol is applied to the site of the skin where the microneedle device has been brought into direct contact.

Abstract: A method of treating a fracture includes creating an access path to a fracture site in a bone and inserting a guidewire through the access path into the fracture site is provided. The method includes the steps of positioning a cannulated drill bit having a distal end including helical flutes configured for drilling through bone over the guidewire into the fracture site, and advancing the drill bit to create a passageway in the bone configured to receive a screw. Positioning a cannulated inflatable bone tamp over the guidewire and inflating the inflatable bone tamp to compress at least a portion of the bone in or near the fracture site so as to create a void. Delivering a bone void filler into the void through the access path to fill the void. Systems and kits are disclosed.

Abstract: A device and method for placing jejunal tube device through stomach and into small intestine with spring mechanism that is curled to diameter that is similar small bowel diameter, wherein the spring mechanism can be straightened during placement with a stiffening apparatus. The stiffening apparatus is guided by a forceps, and includes a retractable wire for use in attachment to the forceps. A c-plug is provided for centering jejunal tube during the placement procedure and to facilitate insufflation, the c-plug being split about midline to facilitate removal of the c-plug after tube placement.

Abstract: Injection systems powered, controlled and network-enabled by a mobile device, and methods for powering and controlling an injection system using a mobile device, are disclosed. An injection device includes a fluid container having a fluid container exit port, an injection driving element adapted to displace fluid from the fluid container through the fluid container exit port, and a connection module connected to the injection driving element, connectable to a mobile device, and adapted to receive electrical power or injection input data from the mobile device.

Abstract: A device for delivering a drug comprising an elongate hollow body having a first longitudinal end and a second longitudinal end. The hollow body includes a radially outer peripheral wall, which surrounds a radially inner, and elongate hollow space. The peripheral wall of the hollow body has at least one drug outlet opening between the two longitudinal ends.

Abstract: An agent injection device is provided that is capable of injecting an agent to a known predetermined tissue depth. An injection member has an elongate injection shaft with an outlet port configured to dispense an agent at a controllable time. A controllable driver is coupled to the elongate injection shaft and is configured to drive the injection member into target tissue. A velocity control system is in communication with the controllable driver and is configured to control the velocity of the elongate injection shaft.

Abstract: The invention inter alia relates to a dispense interface for an ejection device. The dispense interface comprises at least two inlets, at least one outlet and a part having multiple portions; wherein the multiple portions are connected by living hinges such that the multiple portions are foldable towards each other; wherein the multiple portions are configured to form a fluid channel arrangement between functional surfaces of the multiple portions facing each other when the multiple portions are folded towards each other; wherein at least two functional surfaces of the functional surfaces are inclined to each other when the multiple portions are folded towards each other; and wherein the fluid channel arrangement is configured to provide fluid communication between the at least two inlets and the at least one outlet.

Abstract: Methods for maintaining patency in a bronchus of a patient are presented. A catheter is positioned within the bronchus. A target region of one or more of a bronchial wall, submucosa, media, and adventitia is punctured at or adjacent a location of a debulked bronchial carcinoma with an injection needle disposed on a distal end of the catheter. Such puncturing is achieved by expanding a balloon disposed on the distal end of the catheter. The balloon is comprised of at least two materials of different elastic modulus, which allows for a flexible but relatively non-distensible, unfolding component of the balloon as well as an elastomeric, inflatable component of the balloon. Through the injection needle, an amount of cytotoxic, cytostatic, or anti-neoplastic agent is delivered to the target region. The delivered amount is effective to limit by a therapeutically beneficial amount recurrent bronchial occlusion due to recurrence of the bronchial carcinoma.

Abstract: Methods and devices are provided for activating brown adipose tissue (BAT) with cooling. Generally, the methods and devices can activate BAT to increase thermogenesis, e.g., increase heat production in the patient, which over time can lead to weight loss and/or improved metabolic function. In one embodiment, a medical device is provided that activates BAT by cooling tissue having a high density of cold sensitive thermoreceptors and/or by cooling BAT depots directly, thereby increasing thermogenesis in the BAT and inducing weight loss and/or improved metabolic function through energy expenditure.

Abstract: An endoluminal stent transit device. The endoluminal stent transit device includes a wire having a distal end and a proximal end, and a guide element attached to the wire at the distal end, which is movable between a first position and a second position. The guide element in the first position is in a contracted configuration while located within a lumen of a catheter and has a first diameter smaller than the catheter, and in the second position is in an expanded configuration while located outside of the lumen of the catheter and has a second diameter larger than the catheter.

Abstract: Methods and devices are provided for reducing a diabetic patient's foreign body immune response, including infusion site-loss and/or occlusion. Such foreign body responses are associated with the treatment of the diabetic patient where the treatment requires subcutaneous implantation of a foreign body, such as a cannula or catheter. In certain embodiments of the invention, a response-inhibiting agent is administered to a patient at the site of cannula/catheter insertion, thereby facilitating delivery of insulin to the diabetic patient and mitigating site-loss and/or occlusion over a period of time.

Abstract: The disclosure describes a method for improving cerebrospinal fluid flow and improving functions of the blood-cerebrospinal fluid barrier by restoring its capacity to filter toxins into cerebrospinal fluid. In some examples, the method includes accessing a cisterna magna space and withdrawing a volume of cerebrospinal fluid from the cisterna magna space. After withdrawal, the same volume of cerebrospinal fluid is infused back into the cisterna magna space to exert pressure, which is transmitted as kinetic energy to the membrane of the blood-CSF barrier. This re-establishes the membrane with a proper electrochemical potential difference such that normal filtration mechanisms resumes with ongoing CSF production.

Abstract: Delivery devices and methods related thereto may be used in humans for spinal delivery of cells, drugs or vectors. The patient population may include patients with spinal traumatic injury, amyotrophic lateral sclerosis, multiple sclerosis, spinal ischemia and any other spinal neurodegenerative disorders which will require spinal cell, vector or drug delivery. Unlike conventional methods which require multiple injection sites to make multiple, localized substrate deliveries, the delivery devices and methods of the present invention may allow for multiple substrate delivery locations with homogeneous substrate delivery with a single injection site.

Abstract: A skin insertion mechanism of a needle fixedly positioned in a needle holder with connective means to an injection or analysis system has a skin attachment plate coated with an adhesive layer and a spacer mechanism keeping in the ready-to-use position the skin attachment plate spaced away from the needle support covering the needle. Subcutaneous insertion of the needle is effected by attachment with the adhesive layer to the skin and releasing the spacer mechanism by applying a pre-set trigger point pressure against the skin.

Abstract: The invention inter alia relates to a dispense interface for an ejection device. The dispense interface comprises at least two inlets, at least one outlet and a part having a body portion and a cover portion; wherein the body portion and the cover portion are connected by a living hinge such that the body portion and the cover portion are foldable towards each other; wherein the body portion and the cover portion are configured to form a fluid channel arrangement between surfaces of the body portion and the cover portion facing each other when the body portion and the cover portion are folded towards each other; wherein the living hinge is arranged next to the facing surfaces; and wherein the fluid channel arrangement is configured to provide fluid communication between the at least two inlets and the at least one outlet.

Abstract: Methods and apparatus for employing an adhesive strap about a medical connection for improving connection integrity for greater safety and reliability and a cross contamination barrier for medical syringes is disclosed. Also, a shielding tube for a medical syringe which acts as a barrier against cross contamination across a syringe plunger is disclosed. The tube comprises a pattern of raised ribs inside to protect against potentially tube tearing edges of an associated plunger rod assembly and to provide a skid resistant surface when disposed about flanges of the syringe.

Abstract: The present invention provides devices for creating an external percutaneous fluidic connections. In one embodiment, a needle is configured for extending through an endoscope. The needle includes a distal sharp tip and a lumen extending therethrough. The needle extends out of the endoscope within a body cavity to create an incision through a patient's skin. A safety cap is attached over the distal sharp tip without occluding the needle lumen. A wire is inserted through the needle lumen such that it extends from outside the body at the incision, through the body, and outside the body at the patient's mouth. After removing the needle and the endoscope from the body, a PEG device is coupled to the wire at the patient's mouth, and the PEG device is delivered through the upper GI tract and out through the incision.

Abstract: Devices, systems and methods are provided for accessing a target location in the body of a patient, particularly within the epidural space. A system includes a sheath and a sheath support supporting the sheath to reduce or avoid kinking. The sheath support closely fits within the sheath while maintaining free sliding therein. The sheath support has a non-compliant outer diameter maintaining the inner diameter of the sheath and preventing the sheath walls from collapsing into a kink, particularly during low radius bends that may occur during delivery. The sheath support may include a distal tip configured to resist retraction into the sheath until a threshold force is reached which causes the distal tip to at least partially retract into the lumen of the sheath. Likewise, the distal tip may be fully retractable through the sheath so that the sheath support is removable from the proximal end of the sheath.

Abstract: Epidural catheters include a tubular member and at least one bend indicator located proximate a distal end of the tubular member to provide a reference point for a user to bend the catheter. Catheter assemblies may include such catheters. Methods of inserting an epidural catheter having a bent distal end into a patient include bending a catheter at a location proximate at least one bend indicator formed proximate a distal end of the catheter and inserting at least a portion of the catheter into a patient. Methods of making an epidural catheter include forming a tubular member having a proximal end and a distal end and forming at least one bend indicator on the catheter proximate the distal end of the tubular member to provide a reference point for a user to bend the catheter.

Abstract: The present disclosure describes anti-needle stick safety mechanism that is passively activated during the normal course of giving an injection. In one embodiment, the device includes a spring member coupled at a proximal end to a needle member and at a distal end to a needle cover. The passive activation of the device is triggered when the needle is inserted to a minimum depth into the patient's tissue to unleash the force of a compressed spring to urge a needle cover towards the distal end of the needle. As the needle is withdrawn from the tissue, the needle cover advances to the end of the needle and as it partially clears the end of the needle, it adopts an orientation that prevents the needle tip from re-emerging from the needle cover.

Abstract: The present invention relates to drive mechanisms suitable for use in drug delivery devices, in particular pen-type injectors, wherein a number of pre-set doses of medicinal product can be administered. In particular, the present invention relates to such drug delivery devices where a user may activate the drug delivery device.

Abstract: A method for repairing a bone includes attaching a bone plate to the bone. The bone plate includes an upper surface, a bone-contacting surface, and at least one hole extending between the upper surface and the bone-contacting surface. The method also includes inserting at least a portion of a delivery device into the at least one hole. The delivery device includes at least one of an osteobiologic material, a graft material and a pharmacological substance. The method further includes injecting the at least one of the osteobiologic material, the graft material and the pharmacological substance into the bone and through the at least one hole.

Abstract: An inserter and methods of using embodiments of the inserter are described. The inserter includes a housing having a cannula assembly and an insertion mechanism. Two buttons are located on the inserter and are concomitantly actionable for actuation of the insertion mechanism, wherein the insertion mechanism is configured to place a cannula assembly in a well that is disposed on the cradle. The inserter also includes a first parts and second part, whereby the first part includes a handle and the second part comprises the entire insertion mechanism, whereby the first and second part are connected via an indentation.

Abstract: A system (10, 200) and corresponding method for introducing a drug delivery device (18, 218) through at least part of a biological barrier starts with the drug delivery device (18, 218) deployed within a channel of a hollow needle (12, 212). The hollow needle is inserted into the biological barrier and the drug delivery device is pushed forward by a suitable plunger. The drug delivery device is preferably anchored to the biological barrier through a radially expanding retention arrangement (36, 36?, 36a), and is preferably filled with a liquid drug after deployment via a filling needle (24, 222) extending within the channel of the hollow needle (12, 212).

Abstract: Method for detecting an end-of-dose condition in a pressurized system, comprising the steps of (a) providing a system having a fluid-filled variable volume reservoir comprising an elastically deformable portion and an outlet, pressurizing means, and means for detecting a property of the elastically deformable portion which varies with the internal pressure in the reservoir, (b) pressurizing the reservoir to expel a desired amount of fluid by applying a force, thereby deforming the elastically deformable portion, (c) measuring, after the actuating step, a property related to the elastically deformable portion as it regains its initial configuration, (d) comparing a value for the measured property with one or more threshold values, and (e) providing a user with an indication when a given threshold value has been reached, and/or when a given threshold value has not been reached within a given period of time.

Abstract: A system by which resource information relating to an insertable medical device, such as an intravascular catheter, can be identified by its source so as to be accessed by a practitioner, caregiver, or patient, is disclosed. In particular, a resource information key is included at a predetermined key location on or proximate to the medical device, wherein the key indicates the source of the resource information. In one example embodiment, therefore, an insertable medical device for establishing intravascular access to a patient, such as a peripherally inserted central catheter (“PICC”), is disclosed and comprises: an internal portion, and a portion external to the patient that includes a resource information key indicating a website where a user can acquire resource information relating to the medical device. In other embodiments indicia are provided as quick response (“QR”) codes, and as various markings to indicate compatibility of the medical device with ethanol.

Abstract: In one example, a device includes a telemetry module configured to retrieve graphics processing data from a device that is not configured to perform a rendering process using the graphics processing data and that is associated with delivering therapy to a therapy target of a patient, and a control unit configured to apply the graphics processing data while performing the rendering process to generate an image of an anatomical feature of the patient, wherein the anatomical feature comprises the therapy target for an implantable medical device, and to cause a display unit of a user interface to display the image, wherein the image of the anatomical feature is specific to the patient. The graphics processing data may include a list of vertices or a transform to be applied to a non-patient-specific anatomical atlas. The data may also include a location of a therapy element of the implantable medical device.

Abstract: A method of treating blood withdrawn from patient including: simultaneously withdrawing blood and infusing withdrawn blood from and to the patient by flowing the withdrawn blood through an extracorporeal dialysis circuit including a dialyzer having a semi-permeable dialysis membrane and a dialysate side adjacent the membrane; feeding a dialysate containing 1 to 5 mM total calcium and 2 to 8 mM citrate to the dialysate side of the dialyzer, and introducing an anticoagulation fluid including at least 8 mM citrate into the

Abstract: The invention includes a universal transvalvular insertion tool for providing a passage through a multiplicity of differently designed hemostatically valved introducers, each having a valve within a valved body coupled to a cardiac introducer. The tool includes a longitudinally rigid sheath having a lumen and for insertion through the valve of any one of the multiplicity of differently designed hemostatically valved introducers to provide a substantially obstruction free path for delivery of a lead or vascular device through the valve and valved body to the introducer, the sheath having a length selected to extend through the valve without substantial deformation of the lumen of the sheath. A mechanism is provided for separating the rigid sheath to allow removal from the lead or device without removal of the transvalvular insertion tool over either end of the lead or vascular device.

Abstract: Devices, kits, assemblies systems and methods for transferring fluid to or from a subject include an elongate guide cannula having opposing proximal and distal ends with an open axially extending lumen. The proximal end includes a connector. The devices also include an elongate needle having opposing proximal and distal ends, the needle having a connector that is configured to attach to the guide cannula connector and is attached to or attachable to a length of flexible tubing, wherein the elongate needle is configured to be slidably inserted into the guide cannula lumen so that the distal end of the needle extends out of the distal end of the distal end of the guide cannula a suitable distance.

Abstract: Drug delivery devices, medicaments, and methods are provided for the intraperitoneal treatment of ovarian cancer. An implantable device for drug delivery includes an elongated, flexible device having a housing defining a reservoir that contains a drug in solid or semi-solid form, and configured to be wholly deployed within the peritoneal cavity of a patient and continuously release a therapeutically effective amount of the drug over a period of at least 24 hours. A medicament includes cisplatin for administration into the peritoneal cavity of a patient continuously over a treatment period of at least 24 hours. A method of drug delivery includes implanting within the peritoneal cavity of a patient an elongated, flexible device having a reservoir containing a drug, solubilizing the drug at least in part with peritoneal fluid, and releasing an effective amount of the solubilized drug from the reservoir continuously for a period of at least 24 hours.

Abstract: A safety syringe may define a variable fluid chamber and detached needle assembly. The variable fluid chamber may be hermetically sealed off from the environment or ambient air until the needle assembly is attached to a syringe body of the safety syringe. A proximal end of the variable fluid chamber is sealed off from the environment via a seal between a piston and syringe body. The distal end of the variable fluid chamber may be sealed off from the environment via a barrier covering the distal end of the syringe body. The barrier may be punctured to allow fluid to through tberethrough at or about the same time when the needle assembly is attached to the distal end portion of the syringe body.

Abstract: Disclosed herein are methods of delivering implants to a target organ with an implant administration device, where the implant administration device includes a polymer retainer. Methods of making polymer retainers and methods of securing an implant within an implant administration device using a polymer retainer are also disclosed herein.

Abstract: The present invention provides a disposable sleeve for covering an instrument. The present invention also provides an instrument embedded in a sleeve. Also provided are a method of covering an instrument with a sleeve, a method of performing a medical procedure, a method of performing sonotubometry, a method of injecting steroids to prevent scarring, and a method of filtering cavities by using the sleeve and instrument combination.

Abstract: Described herein is an apparatus to insert an implantable therapeutic device into a patient. The apparatus includes a proximal handle (210) and a distal placement portion (220) coupled to the proximal handle and configured to hold the implantable therapeutic device. The distal placement portion includes a first side (222) having a first engagement structure (251) at a distal end of the first side, the first engagement structure configured to surround at least a first portion of a proximal end region of the implantable therapeutic device. The distal placement portion includes a second, opposite side (224) having a second engagement structure (253) at a distal end of the second side, the second engagement structure configured to surround at least a second, opposite portion of the proximal end region of the implantable therapeutic device.

Abstract: A connector clip for medical sensors, including a first main body having two main tip contacts in electrical contact with electrical wires connectable to an instrument and a second main body mounted on the first main body and movable with respect to the first main body between an open position and a closed position. Two auxiliary tip contacts and an electric/electronic circuit provided with two connecting leads each electrically connected to one of the two auxiliary tip contacts are positioned in first or second main body. When a disposable sensor tab is correctly located and clamped each of two contacts is in contact with one of the main tip contacts and one of the auxiliary tip contacts and the electric circuit is connected in parallel with an electrical circuit defined by the sensor.

Abstract: An auto-injector apparatus and associated methods utilizing specific dimensions and parameters of use for the auto-injector are provided for achieving increased effectiveness of the auto-injector device in delivering medicament into the patient's body, and in dispersion of the medicament from the initial injection site into the surrounding bodily tissues.

Abstract: One possible embodiment of the invention could be a hypodermic needle that rotatably connects to a shield comprising a hypodermic needle denoted into a distal needle portion and a proximal needle portion, the distal needle portion's injection aperture continuously connected to the proximal needle portion's connection aperture; a shield that comprises at least a skin pad portion, the proximal needle portion being rotatably held within a portion of the shield in a manner that allows the distal needle portion to be moved between an operative position, wherein the distal needle portion descends downward and away from a bottom of the skin pad portion to hold the needle tip away from the skin pad portion to a stored position that has the needle tip of the distal needle portion placed proximate to the skin pad portion.

Abstract: An injection device is provided for delivering a liquid medicament. The injection device includes a housing with a first chamber for storing a supply of the medicament. The first and second chambers are coupled within the housing. The second chamber is in fluid communication with the first chamber. The injection device also includes an outlet port for dispensing the medicament outside the housing. The outlet port is coupled to the housing and in fluid communication with one of said first and second chambers.

Abstract: Ambulatory infusion pumps, pump assemblies, and baseplate assemblies, including cartridges, baseplates, cannulas, inserters, and related components and batteries therefor, as well as component combinations and related methods.

Abstract: Transdermal drug delivery patch devices are described in which microneedle array insertion or application forces are decoupled or separated from drug delivery actuation or application forces. Dual-reservoir devices are described in detail for such purposes as are associated methods of use in various examples.

Abstract: Administration devices for supplying an injectable or infusible product into an organism include a reservoir for storing the product, a supply device for supplying the product from the reservoir into the organism, a controller to control operation of the administration device, a button communicatively coupled to the controller to initiate at least one action of the administration device and a touch sensor that generates an activation signal, wherein the touch sensor is incorporated into the button or is disposed in the vicinity of the button and is communicatively coupled to the button and/or the controller.

Abstract: A syringe having an integral ampule is disclosed. The syringe includes a barrel defining a reservoir configured to store a fluid and a plunger defining an inner cavity. The plunger includes an ampule within the inner cavity, where the ampule seals the fluid. The plunger also includes a cap at a proximal end of the plunger that is configured to move distally relative to the plunger, and a first one-way valve at the distal end of the plunger. The distal movement of the cap relative to the plunger causes an opening within the ampule. A method of injecting a fluid within a patient using a syringe having an integral ampule is also disclosed.

Abstract: Described is a syringe housing at least one removable carpule containing at least two injectable solutions and having a mixing chamber for mixing two injectable solutions during administration of the solutions, and methods of using the syringe.

Abstract: The present inventors have shown that electroporation with calcium ions are efficient on cutaneous and subcutaneous nodules. In particular the present inventors here disclose that a solution comprising calcium ions (Ca2+) with a concentration of at least 0.1 M is extremely useful in a method of treating a neoplasm, such as cancer with means for causing transient permeabilisation of the cell membranes of at least part of the neoplasm before, during and/or after administration of said solution, wherein said solution is administered with a ratio of 0.2 to 0.8 of the volume of said part of the neoplasm.

Abstract: Delivery devices, systems and methods are provided for inserting an implant into an eye. The delivery or inserter devices or systems can be used to dispose or implant an ocular stent or implant, such as a shunt, in communication with the suprachoroidal space, uveal scleral outflow pathway, uveoscleral outflow path or supraciliary space of the eye. The implant can drain fluid from an anterior chamber of the eye to a physiologic outflow path of the eye, such as, the suprachoroidal space, uveal scleral outflow pathway, uveoscleral outflow path or supraciliary space. Alternatively, or in addition, the implant can elute a drug or therapeutic agent. The delivery or inserter devices or systems can be used in conjunction with other ocular surgery, for example, but not limited to, cataract surgery through a preformed corneal incision, or independently with the inserter configured to make a corneal incision.

Abstract: Vial dosing systems and methods are disclosed. A vial dosing device includes a connecting body coupleable to a vial, a cannulated plunger having a proximal end coupled to the connecting body, a dose chamber adapted to slidably receive a distal end of the cannulated plunger and to expel medicament through a distal end of the dose chamber, and a plunger tip check valve coupled to the cannulated plunger and adapted for fluid flow from the cannulated plunger through the plunger tip check valve into the dose chamber.

Abstract: A portable handheld fluid-medicine-injection device for individual users, has a medicine vial has a substantially rectangular cross section that reduces a thickness profile of the device and a dispense mechanism coupled with the vial, the dispense mechanism has an inject push rod inside a threaded cylinder that reduces a length profile of the device. The device has a needle with a needle mount/dismount mechanism coupled with the medicine vial and a needle storage mechanism that stores the needle when not in use and replenishes the needle for reuse.

Abstract: Methods are disclosed herein for delivering a medicament to a fetus. The method includes administering the medicament from an injector configured to deliver the medicament across an amniotic membrane to amniotic fluid of the fetus. The method includes administering the medicament from a transmembrane patch placed at an amniotic membrane configured to deliver the medicament across the amniotic membrane to amniotic fluid of the fetus.

Abstract: A shielded pen needle assembly is provided in which the hub extends distally beyond an outer sleeve of the assembly.