Abstract: Catheter connectors, connection systems, and methods of use in which a catheter is attached to an offset connector such that the catheter is retained on the connector by compression between a tube located within the catheter and a collar fitted over the portion of the catheter containing the tube. The catheters used with the offset catheter connection systems may include an elastically compressible inner body that is surrounded by a reinforcing braid. After the offset connector tube is inserted into the lumen of the catheter, a collar may be advanced over the exterior of the catheter and the offset connecter tube contained therein.

Abstract: Sealing device for sealing externally debouching, natural or artificial body canals of animals or human beings, the device enabling liquid tight sealing against the inner wall of the bowel system of the animal or human being, the device further being made from a resilient material. The device is soft and resilient and may thus not trigger the analreflex, but is still able to provide a fluid-tight seal.

Abstract: Some embodiments of a medical anchor device include an elongate body coupled with deployable subcutaneous anchors to secure a catheter instrument (or other medical instrument) in place relative to a skin penetration point. In some circumstances, the elongate body may be in the form of catheter hub body, and the subcutaneous anchors can be deployed from the hub body by adjustment of a movable actuator. A locking member can interact with the actuator so as to retain the actuator in the deployed orientation during the medical procedure.

Abstract: A system for monitoring an implantable medical device. The system includes an implantable therapeutic substance delivery device for delivering a therapeutic substance, along with a temperature sensor and an indicator device. The delivery device includes a housing maintaining a reservoir for containing the therapeutic substance. Further, the delivery device includes a fill port assembly having a port chamber in fluid communication with the reservoir and including a septum fluidly sealing the chamber. The temperature sensor is associated with the fill port assembly. Finally, the indicator device is adapted to indicate presence of a needle within the port chamber based upon information from the temperature sensor.

Abstract: A laparoscopic port assembly includes a cannula unit including three cannulas each extending at an acute angle relative to a base. The cannulas are flexible for receiving respective angulated laparoscopic instruments. The cannula unit is rotatingly received in a port holder for rotation about a longitudinal axis of the holder, the holder being disposable in an opening in a patient's skin.

Abstract: A prostate immobilizer has a shaft with a fluid passageway extending therethrough, a balloon affixed over an end of the shaft such that the fluid passageway communicates with an interior of the balloon, a lumen extending within the shaft so as to have an end opening adjacent an end of the balloon, and a device for locking a position of the shaft. The device has a positioning member having a stem portion extending from a head portion, and a locking member having a locked position and an unlocked position. The locking member cooperates with the stem portion of the positioning member so as to fix a position on the shaft. A channel is formed in the head portion so as to receive the shaft therein.

Abstract: An anchored working channel includes an elongated shaft with a proximal end and a distal end, and at least one inflatable balloon positioned at the distal end of the elongated shaft and having an outer wall having an outer surface for contacting surrounding tissue, wherein the elongated shaft has a first lumen through which fluid is supplied to inflate the at least one inflatable balloon such that the balloon anchors the shaft to surrounding tissue, wherein the elongated shaft has a second lumen that accommodates at least one medical instrument and/or device inserted therein, and wherein the outer surface of the at least one inflatable balloon comprises a textured surface for preventing slippage of the outer surface on surrounding tissue.

Abstract: Syringe assemblies comprising a disinfecting reservoir collar to ensure adherence to aseptic techniques for use in flush procedures for vascular access devices (VAD's) are described. Also described are methods of disinfecting vascular access devices.

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

Abstract: An access port, wherein the access port may include a body having an exterior surface and a chamber defined therein, a bore defined in the body providing fluid communication between the chamber and the exterior surface, a needle in fluid communication with the chamber, a passage defined in the body providing communication between the chamber and the exterior surface, a seal secured within the passage, and an actuator in communication with the needle, configured to move the needle relative to the passage or move the passage relative to the needle.

Abstract: An injection site (12) for infusion of parenteral fluids has a pressure-actuated valve (20) and a split septum unit (24), which prevent reflux of blood into the assembly (10). The septum unit (24) includes a resilient split septum body (64) precompressed so that the septum body (64) is caused to protrude proximally (78) upon insertion of a cannula (16). Consequently, upon removal of the cannula (16), there is essentially no “drumming” or creation of friction-induced negative pressures sufficient to generate blood reflux. The preloaded septum body (64) also has its proximal surface (74) essentially flush and coplanar with the adjacent proximal end (66b) of the tubular septum holder (66) to enhance the cleanliness of the unit (24).

Abstract: An integrated vascular delivery system having a frame configured to receive a catheter insertable in a patient to deliver fluid at an insertion site. The frame includes a first hub, a second hub, and a pair of flexible lateral members extending between the hubs and including a tubular lateral member. The system also includes a fluidic channel that fluidically communicates with the catheter, wherein the fluidic channel passes through the tubular lateral member and at least one of the hubs, and includes a fixed turnabout portion in which fluid flows in a direction different from that within the catheter. The first and second hubs provide anchoring points on the patient distributed around the insertion site and on opposite ends of the catheter, thereby anchoring the frame to the patient and stabilizing the catheter. A method is provided for using an integrated vascular delivery system.

Abstract: An embodiment in accordance with the present invention provides an integrated syringe-device which can store a volume of fluid for infusion, can connect via an air-tight connector to another device (such as a luer connector), can flush fluid through the connector into the other device, and can deliver a cap that forms an air-tight closure to the device connector.

Abstract: Apparatus and methods for blocking needle tracts are disclosed. In some embodiments, the needle tracts are blocked by using a needle that includes an elongated shaft that defines an outer surface, and a polymer coating applied to the outer surface of the shaft, the coating being adapted to block the tract formed by insertion of the needle into an object.

Abstract: A syringe assembly including: (1) a syringe barrel defining a chamber; (2) a plunger mounted in the chamber and moveable with respect to the barrel; and (3) a cap assembly containing a cap and an absorbent material is removably attached to the plunger.

Abstract: An indwelling needle assembly includes a stylet having a sharp needlepoint at an end thereof, a stylet hub secured to a base end of the stylet, a hollow outer needle in which the stylet is inserted, an outer needle hub secured to a base end of the outer needle, an opening formed at the base end or at a side of the outer needle hub to communicate with the inner cavity of the outer needle, a seal fitted onto the outer needle hub and in which a hole or slit is provided for insertion of the stylet therein, the hole or slit being formed to become closed when the inserted stylet is extracted, an operating part installed on the outer needle hub to move the stylet and outer needle along the longitudinal direction when the stylet is inserted into the outer needle, and a movement suppresser for stopping or suppressing moving the stylet relative to the seal when the operating part is operated.

Abstract: A capsule configured for in vivo refilling of a thereapeutic agent. In certain embodiments, the capsule may contain methotrexate.

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: Device and method are provided for diagnosing and treating diseases and injuries to the spine by injecting drugs into the diseased or injured area. The device and method of the subject invention provide improvements to patient and operator safety, along with ease-of-use and convenience improvements over conventional techniques.

Abstract: An extractable device is used to insert a medicinal filling into a spinal disc. The device comprises a filling member and a flowable medicine. The filling member is made of a flexible and permeable wall and is provided with a holding portion and an injection port via which the flowable medicine is injected into the holding portion after the filling member is inserted into the spinal disc. The holding portion is provided with an opening which is releasably lashed by one end of one or more threads so as to make the opening leakproof. Upon completion of solidification of the flowable medicine in the holding portion of the filling member, other end of the thread is pulled to unlash the opening of the holding portion, thereby enabling the filling member to be extracted from the spinal disc so as to leave only the medicine in the spinal disc.

Abstract: Apparatus for the aspiration of a fluid from an individual, the apparatus comprising a port in fluid communication with the atmosphere; a catheter having a proximal end arranged to be inserted into the body of an individual and having a distal end; a one-way valve; and a fluid passage switch reversibly movable between a first position in which the distal end of the catheter is in fluid communication with the port and a second position in which the distal end of the catheter is in fluid communication with the one-way valve, the one-way valve being arranged to permit fluid flow there through in a direction from the distal end of the catheter. The apparatus may be used for both the aspiration of fluid from within the body and instillation of fluid into the body.

Abstract: A safety needle device and method of supplying fluid to a vascular access port is described. The device may include a base member, a handle member, and a compressible member positioned between the handle member and a compression plate. The compressible member is coupled to a proximal end of a needle. Following the delivery of fluid to a vascular access port, the needle is removed by moving the handle member away from the base member, which collapses the compressible member, flushing fluid into the vascular access port to substantially replace a volume of the needle.

Abstract: Method and apparatus for preventing air embolisms during surgical procedures which involves providing a fluid source in communication with an aperture extending into an anatomical cavity such that fluid may be delivered into the cavity when a condition of negative pressure exists in the cavity, thereby preventing the introduction of air into the cavity.

Abstract: Disclosed herein is a method of treating a patient, that includes providing a gastrointestinal sleeve device having an elongate tubular body, with a proximal opening and a distal opening; and positioning the gastrointestinal sleeve device in the patient's digestive tract such that the proximal opening of the tubular body is positioned at the native gastroesophageal junction to receive ingested food and liquids from the patient's esophagus and the distal opening of the tubular body is positioned in the patient's jejunum. The tubular body can then be attached near its proximal opening to the patient at the native gastroesophageal junction.

Abstract: A medical device for delivering material through tissue into a defined area of a patient may comprise: a material delivery element through which the material may flow out of a delivery end; the delivery end having an opening that can be inserted through a surface of the tissue; and a sealing system proximal to the delivery end that can extend away from the material delivery element along the surface of the tissue and apply pressure to the tissue after the material delivery element has been inserted through the surface of the tissue. A physical barrier may be provided on the material delivery device to reduce back flow loss of delivered material.

Abstract: A pain management kit for the administration of medication and a related method of use is disclosed. The pain management kit includes the primary medical supplies for performing a continuous nerve block procedure, preferably in a single, sterile container. Specifically, the kit may contain medical supplies to create a sterile field, perform a local anesthetic procedure and to perform a continuous nerve block procedure. Preferably, the contents of the kit are arranged in the general order of their use.

Abstract: An infiltration cannula and method of using the infiltration cannula during an infiltration procedure are disclosed herein. The infiltration cannula includes: a tubular needle and a hub. The tubular needle has a proximal end and a distal end. The tubular needle also has a plurality of apertures disposed in a pattern about the distal end. The apertures are configured to infiltrate fluid into the subcutaneous tissue of a patient. The hub is configured to be held by a person performing the infiltration procedure. The hub has a first end and an opposing second end. The first end is attached to the proximal end of the tubular needle and the second end includes a connector configured to connect to an input source for receiving the fluid to be infiltrated into the subcutaneous tissue of the patient. The fluid flows from the connector, through the hub and into the tubular needle.

Abstract: An access port, wherein the access port may include a body having an exterior surface and a chamber defined therein, a bore defined in the body providing fluid communication between the chamber and the exterior surface, a needle in fluid communication with the chamber, a passage defined in the body providing communication between the chamber and the exterior surface, a seal secured within the passage, and an actuator in communication with the needle, configured to move the needle relative to the passage or move the passage relative to the needle.

Abstract: The present invention is directed to a device for a portable convection enhanced delivery system that allows administering liquids to specific locations within the body, especially tissues and tumors also allowing outsubject treatment. The application system comprises a portable extracorporal pump with a fluid reservoir that is connected via an infusion system to an infusion catheter placeable to any tissue or tumor the fluid should be administered to by high flow microperfusion. The system enables administration of fluids of any kind by convection enhanced delivery also in out-patient treatment. The system can be used for delivering various drugs, proteins, protein toxins, antibodies for treatment or imaging, proteins in enzyme replacement therapy, growth factors and viruses or oligonucleotides in gene therapy etc. The application methods as well as the surgical method to implant this device are enclosed to this invention.

Abstract: An integrated vascular delivery system having a frame configured to receive a catheter insertable in a patient to deliver fluid at an insertion site. The frame includes a first hub, a second hub, and a pair of flexible lateral members extending between the hubs and including a tubular lateral member. The system also includes a fluidic channel that fluidically communicates with the catheter, wherein the fluidic channel passes through the tubular lateral member and at least one of the hubs, and includes a fixed turnabout portion in which fluid flows in a direction different from that within the catheter. The first and second hubs provide anchoring points on the patient distributed around the insertion site and on opposite ends of the catheter, thereby anchoring the frame to the patient and stabilizing the catheter. A method is provided for using an integrated vascular delivery system.

Abstract: A self-closing antiseptic plaster (1) for puncturing blood vessels, muscle tissue, tissue, skin, organs (biopsy) or bone marrow is puncturable by cannulas, needles or the like. It has a backing layer (2), a sealing layer (5) made of a material having an elastic restoring force and a skin adhesive layer (3) applied to the underside U of the backing layer (2), the sealing layer being applied to the backing layer (2) by means of an adhesive layer (4). The backing layer (2) is usually thin. The backing layer (2), the sealing layer (5), the adhesive layer (4) and the skin adhesive layer (3) are transparent or approximately transparent in the entire area or at least in a superimposed partial area. The backing layer (2) and the sealing layer (5) are made of thin and soft materials so that any puncture site is visible and/or palpable through the self-closing antiseptic plaster (1). The advantages include the fact that the antiseptic state at the puncture site is preserved before, during and after the puncturing.

Abstract: A surgical access device includes a housing; an access member extending distally from the housing and being dimensioned for positioning within tissue, and defining a longitudinal axis; and a seal assembly disposed within the housing. The seal assembly includes first and second seal components respectively having first and second seal members. Each of the first and second seal members defines a passage for passage of a surgical object in substantial sealed relation therewith. The first and second seal components are capable of relative rotation about the longitudinal axis between a first position, in which passages of the first and second seal members are in substantial alignment, and a second position where the passages of the first and second seal members are offset to inhibit the communication of fluid through the seal assembly.

Abstract: A catheter insertion sheath assembly (100) including a tubular sheath body (106) having a proximal end (102), a distal end (104), and a hollow passage (107) extending between the proximal end and the distal end. A handle portion (110,114) is disposed at the proximal end of the tubular sheath. A clamp (120;300;400) extends from the handle portion for releasably closing the sheath prior to insertion of a catheter thereinto and includes a relatively movable portion (130) or portions (310,310?;410,410?) that is or are movable between an open position and a closed position, wherein, when the clamp is in the open position, fluid may flow through the hollow passage between the proximal end and the distal end and when the clamp is in the closed position, fluid flow is restricted through the hollow passage between the proximal end and the distal end. A method includes inserting a catheter into the sheath upon the clamp's movable portion(s) being moved to an open position.

Abstract: A safety needle device and method of supplying fluid to a vascular access port is described. The device may include a base member, a handle member, and a compressible member positioned between the handle member and a compression plate. The compressible member is coupled to a proximal end of a needle. Following the delivery of fluid to a vascular access port, the needle is removed by moving the handle member away from the base member, which collapses the compressible member, flushing fluid into the vascular access port to substantially replace a volume of the needle.

Abstract: A venous port for withdrawal of fluid in which one or more extensions are provided which can selectively extend to remove impediments from an aperture of the port.

Abstract: Percutaneous apparatus for forming a bicuspid venous valve from autologous tissue are disclosed. A multilumen catheter is disclosed that includes a delivery shaft positioned on either side of the balloon. When the balloon is inflated within the vein at a treatment location where a bicuspid valve is to be created, the delivery shafts are pressed into the wall of the vein by the inflated balloon so that exit ports in the delivery shafts are at diametrically opposed locations. The delivery shafts may than be used to deliver puncture elements through the exit ports and into the vessel wall to gain access to a subintimal layer of the vein wall. In this manner, the inventive multilumen catheter aids in making properly positioned flaps of venous tissue for creating a bicuspid venous valve from autologous tissue.

Abstract: A device is provided for use with a medical implant for delivering an agent to a designated site of action in a body of a patient. The agent-delivery device comprises a body member adapted to be secured to the medical implant and an agent-delivery component associated with the body member. The agent-delivery component includes a therapeutic agent for treating the body of the patient. The agent-delivery component is configured to release the therapeutic agent after implantation in the body of the patient.

Abstract: Implantable drug delivery apparatuses and methods are described. An input port septum receives a therapeutic drug. An implantable delivery catheter holds a volume of the therapeutic drug and includes a proximal end in fluid communication with the input port septum, a distal end including an output septum for removing fluid from the catheter, and a drug permeable surface for diffusion of the therapeutic drug into nearby tissue.

Abstract: A device and method facilitates the forming of a skin fold during deployment of a cannula. The device may be a disposable infusion device and the method comprises adhering, to a skin surface, a base member having a port for receiving a cannula, forming a skin fold having skin surfaces sloping away from opposite sides of the base member, driving a cannula through the port of the base member while maintaining the skin fold, and releasing the skin fold. To facilitate the forming of the skin fold, the device comprises a base having a base surface and a flexible layer member. The flexible layer member has a first surface adjacent the base surface and a second surface adapted to be adhered to a patient's skin. The first surface has a first portion adhered to a portion of the base surface and a second portion adherable to the base surface.

Abstract: Apparatus for delivering therapeutic agents to the central nervous system of a subject is described. The apparatus comprises at least one intracranial catheter and a percutaneous access device. The percutaneous access device comprises a body having at least one extracorporeal surface and at least one subcutaneous surface, the body defining at least one port for connection to an implanted intracranial catheter. The port is accessible from the extracorporeal surface of the device, but is provided with a seal such as a rubber bung between the lumen of the port and the extracorporeal surface. The percutaneous access device may have more than two ports and/or a flange. A method of implanting the percutaneous access device is also described.

Abstract: A medical article securement device holds a medical article in position upon the body of a patient and can be used to inhibit lateral and longitudinal motion of the medical article. The securement device includes a retainer with a base and at least one post, and at least one cap. The cap is attached to the base of the retainer by a flexible connection, and can be placed into either a covered or uncovered configuration with respect to the post. The cap includes a recess which can receive a protrusion at the end of the post of the retainer. By placing the post through an appropriate opening in the medical article to be retained and then securing the medical article to the retainer by placing the cap into the covered position over the post, longitudinal and lateral motion of the medical article is inhibited.

Abstract: A vascular access catheter having a catheter hub assembly and a catheter shaft having a plurality of lumens is disclosed. The hub assembly has a body with an interior cavity and an exterior surface with a plurality of openings that are configured to receive the catheter shaft and a plurality of extension tubes, which are fluidly connected to lumens of the catheter shaft. A vascular access port having a housing, at least one reservoir and a self-sealing septum having an outer surface, is positioned partially therein the interior cavity of the body. A portion of the housing defines a reservoir outlet stem that is in fluid communication with the reservoir. At least a portion of the outer surface of the septum is defined therein a port opening that is defined therein the body and is circumferentially surrounded by portions of the exterior surface of the hub body.

Abstract: A rapid exchange-type catheter for aspiration of embolic debris from a blood vessel includes an elongate aspiration tube and a relatively short guidewire tube mounted beside a distalmost portion of the aspiration tube. A proximal portion of the guidewire tube defines a strain relief segment. In one embodiment, the strain relief segment is formed detached from the aspiration tube. In another embodiment, the strain relief segment is minimally attached to the aspiration tube and becomes detached from the aspiration tube when a sufficient transverse force is applied to urge the guidewire tube away from the aspiration tube.

Abstract: A power injection system comprises an introducer needle including a lumen extending therethrough to a non-coring distal tip and an anchoring device extendable laterally from the introducer needle distal tip, the anchoring device including a port contacting surface engaging one of an inner surface of the port and an inner surface of a septum to anchor the introducer needle within a subcutaneous port.

Abstract: A needle assembly including a positive flush mechanism for use with a vascular access port. The needle assembly is configured to supply fluid to the port and to provide a positive flush to overcome negative pressures in the port that can potentially occur during withdrawal of the needle from the port.

Abstract: In various embodiments, a needle is employed in refilling drug-delivery devices.

Abstract: An implantable prosthesis with at least one fenestration in a side wall of that prosthesis is disclosed. The fenestration provides an access port through which a medical device (such as a needle or a cannula) can be directed to enable access to the lumen of the blood vessel which the prosthesis is supporting.

Abstract: An access port assembly having an attachable catheter allows for inserting a guidewire into the catheter to aid in the placement of the integral catheter while still attached to the access port assembly. A method is described for placing an access port fixedly attached to a catheter into a patient using a guidewire inserted into the catheter.

Abstract: Implantable cardiac drug delivery systems. The systems are installed endocardially into a chamber in the heart, and are variously capable of delivering anti-arrhythmia agents into the heart wall, and into the epicardial space outside the heart, and into other chambers in the heart through the septa of the heart.

Abstract: A device for providing access to an implantable fluid transfer port, comprises a needle extending to a distal end insertable into body to enter a reservoir of a port implanted therein and an actuation member extending through a lumen of the needle from an actuator which remains external to a living body accessible to a user thereof in combination with an obturator coupled to a distal end of the actuation member, an outer diameter of the obturator substantially matching an inner diameter of the lumen of the needle so that, when retracted into the lumen, the obturator seals a distal opening thereof and an anchoring mechanism coupled to the actuation member proximally of the obturator, the anchoring mechanism being moved to an expanded state in which an outer diameter of the anchoring mechanism exceeds an outer diameter of the needle when moved out of the lumen of the needle.