Abstract: A method of securing a medical article to the body of a patient is disclosed in which an anchoring device comprising an anchor and a retainer is used. The retainer is attached to an upper surface of the anchor and comprises a base, a cover and a post. The base is disposed on the upper surface of the anchor and the cover is connected to the base so as to move between an open and a closed position. When the cover is in the closed position, it lies above at least part of the base. The post is attached movably to either the base or the cover and is arranged so as to lie at least partially between the cover and the base when the cover is in the closed position. When securing a medical article, the cover is placed in the open position and the medical article placed onto the retainer. The cover may then be closed over the medical article and the anchoring device attached to the patient.

Abstract: Methods and apparatus are disclosed for making and using adjustable epidermal tissue ingrowth cuff and catheter assemblies for transcutaneous placement to provide periodic or continuous external access for medical purposes to an interior body region of a patent who requires such medical treatment over an extended period of time.

Abstract: A catheter retention assembly and method of use with a catheter. The assembly has a carrier system and a cuff positioning device with an in-growth cuff and a lumen having an inner wall adapted to be mounted on the outer surface of the catheter, and a carrier system with an inner surface and an outer surface in contact with the inner wall of the cuff positioning device. The carrier system holds the lumen in a first radial state. When the carrier system is removed, the lumen contracts to a second radial state, and the inner wall of the cuff positioning device provides sufficient surface adherence to the outer surface of the catheter, so as to maintain the position of the cuff positioning device relative to the catheter, and to allow for catheter exchange.

Abstract: The invention relates to a device for delivery of pigment epithelium derived factor (PEDF) to the eye utilizing encapsulated PEDF-secreting cells and related methods for the treatment and prevention of ophthalmic diseases and disorders.

Abstract: A break-way PEG tube uses a releasable connector between two tubing segments to facilitate release of a feeding portion of the PEG tube when pulled on to avoid accidental removal of a distal portion of the PEG tube from a patient's abdomen.

Abstract: A dual lumen catheter for insertion into a vein of a patient for use in hemodialysis treatments. An asymmetric dialysis catheter may have a tube containing at least an axial septum asymmetrically disposed within the tube, thereby defining a first and a second lumens, wherein said first lumen is larger in cross sectional area than said second lumen, and a single lumen catheter inserted through the first lumen.

Abstract: A percutaneous implant serves for implantation into an animal or a human body. The implant is of the kind that has an anchoring section, extending radially from a distal end of an interior section. The anchoring section comprises an inner anchoring ring extending from or integral with the interior section, an outer anchoring ring, and at least one connection member for connecting the inner anchoring ring with the outer anchoring ring. Since a first connection point between a first end of the at least one connection member and the inner anchoring ring is angularly offset from a second connection point between a second end of the connection member and the outer anchoring ring, the anchoring section constitutes a resilient spring means, which adapts to the movements of the body. The implant is especially designed for use without externalization of the vessel to be brought into communication with the exterior.

Abstract: A catheter assembly including an internal bolster. According to one embodiment, the catheter assembly includes a medical catheter preferably made of extruded silicone rubber. The catheter is shaped to include a cylindrical wall defining a primary longitudinal bore. A plurality of secondary longitudinal bores are provided in the cylindrical wall, the secondary bores being evenly spaced around the primary bore. The assembly also includes a plurality of identical resilient members collectively forming an anchor at a first end of the catheter. Each resilient member comprises a resilient wire and a protective jacket. Each wire is made of a shape-memory material and is reversibly transformable between a spiral shape, when at rest, and a straightened shape, when forcibly unfurled. One end of each wire is disposed within a secondary bore of the catheter, with the remainder of each wire extending out from the catheter.

Abstract: A self attaching injection port has integral moveable fasteners which are moveable from a undeployed state to a deployed state engaging tissue. The fasteners may be disposed radially or tangentially, and rotated to pierce the fascia. The fasteners may be rigid or elastically deformable.

Abstract: Device for securing a line such as a medical tube, a catheter, diagnostic wires etc., the device including a line retaining part and a base part, the line retaining part having at least one groove for accommodating a line, the groove being designed with flexible retaining means, the base part including fixing means, where the line retaining part and the base part are provided with complementary locking means.

Abstract: A catheter includes a catheter tube, internal and external retention bolsters and a retractable catheter tip. The retractable tip is in the form of a bolus which is extended to axial alignment with the tube for insertion. After insertion with a stylet or the like, removal of the stylet permits the tip to retract automatically and assume a position perpendicular to the axis with minimal protrusion into the corporeal space involved.

Abstract: An organ-fixing instrument and a gastric fistula catheter able to accomplish proper suturing reliably and through a simple procedure. An organ-fixing instrument 10 is structured by a transversely elastic, cylindrical sheath 12, and a body surface installation part 11 attached to the base part of the sheath 12. In the body surface installation part 11 there are provided a through-hole 13 communicating with the sheath 12 and a pair of needle through-holes 14, 15. The sheath 12 is structured by a web-shaped covering part 16 made from a resin, a plurality of reinforcing parts 17 provided at the base end portion of the covering part 16, and skeletal parts 18a, 18b provided at the tip portion of the covering part 16. A suturing thread catch 18 projected in an axial direction by compression in the axial direction is structured by the tip side portion of the covering part 16 and the skeletal parts 18a, 18b.

Abstract: A surgical fastening system for implantable devices is disclosed. The implantable device may contain a plurality of fasteners in pre-deployment position, may have a housing fitted over or around it which contains a plurality of fasteners in pre-deployment position, or may be a part of a two-part system into which it fits. Accordingly, the present invention also encompasses a deployment system or tool that optionally positions the implantable device, and which causes the fasteners to move into post-deployment position. The fasteners may be staples, metal loops, coils, springs or hooks formed of biocompatible materials, including shape memory alloys such as NiTi.

Abstract: A covering for delivering a substance or material to a surgical site is provided. The covering, with substance provided therein, may be referred to as a delivery system. Generally, the covering may be a single or multi-compartment structure capable of at least partially retaining a substance provided therein until the covering is placed at a surgical site. Upon placement, the covering may facilitate transfer of the substance or surrounding materials. For example, the substance may be released (actively or passively) to the surgical site. The covering may participate in, control, or otherwise adjust the release of the substance. In various embodiments, the covering is suitable for a variety of procedure specific uses. Implantation tools may be provided for placing the covering at a surgical site. Kits may be provided including variously sized or shaped coverings and one or more tools for use in placing the covering.

Abstract: An ostomy tube device comprises a hollow flexible tube with internal retention member, a tapered hollow cannula and a pull-loop member forming leading and rear pole loop when positioned through the tapered cannula. The hollow flexible tube folded over the rear pole loop and squeezed into the lumen of the tapered cannula provides a releasable attachment. An ostomy placement kit includes an ostomy tube device, an external retention member, a needle, a flexible guide wire, a wire-loop device and a tubular device for external retention member delivery. The flexible guide wire is passed through an endoscope into the hollow organ, is grasped with the wire-loop device, and is pulled through the abdominal wall. The ostomy tube device attached to guide wire is passed and positioned through the abdominal wall. Tapered cannula is pulled off the hollow flexible tube and the external retention member is positioned over using the tubular device.

Abstract: An insertion device and insertion set. The insertion device for inserting at least a portion of at least one piercing member of an insertion set through the skin of a patient includes a device housing, a carrier body and a driver. The carrier body is slidably received within the device housing for movement between an advanced position and a retracted position. The carrier body also includes a receiving structure to support the insertion set in a position with the at least one piercing member oriented for insertion through the skin of the patient at a predetermined or variable angle relative to the skin of the patient upon movement of the carrier body from the retracted position to the advanced position.

Abstract: An anchor deployment apparatus for deploying an anchor about a therapy delivery element includes an anchor receiving element having an elongate member having a distal opening and a lumen extending proximally in the elongate member from the distal opening. The lumen of the elongate member is configured to slidably receive at least a portion of a therapy delivery element. The anchor deployment tool further includes an anchor engagement element having (i) a body forming a channel in which the elongate member of the anchor receiving element is axially movable, and (ii) an engagement feature forming at least a part of the channel. The engagement feature is configured to engage the anchor when the anchor is disposed about the elongate member and the elongate member is moved distally relative to the engagement element, and to cause the anchor to move distally along the elongate member when the feature is engaged with the anchor and the elongate member is moved distally relative to the engagement element.

Abstract: Implantable access device for removal and/or return of fluids to a patient, comprising a casing attached to an internal conduit to be connected with a lumen of the patient; a connector attached at the casing and connected to an external conduit, and arranged for attachment of an extracorporeal lumen to the device; and an actuator unit within the casing to selectively allow or block the fluid communication between the internal conduit and the external conduit; the device further comprising a fixation unit integrated in or attached at the casing arranged for fixation of the device to a bone of the patient; wherein the fixation unit extends axially along the longitudinal axis of the device. The disclosed access device can be used for high volume removal and/or return of blood or other fluids from the patient.

Abstract: An internal bolster for use securing a medical device, such as a feeding tube, within a body of a patient is disclosed. In one embodiment, a feeding tube includes an internal bolster, comprising one or more bolster arms that each include a first end hingedly connected to a distal end of the medical device and a free second end. The bolster arms are selectively deployable between a first position wherein the bolster arms are substantially in-line with an axis of feeding tube, and a second position wherein the bolster arms are substantially deflected from the axis of the feeding tube to enable securement of the feeding tube within a stoma or other opening defined in the body. Various means for selectively moving the bolster arms between the first and second positions are disclosed. Related methods of use are also disclosed.

Abstract: A self attaching injection port has integral moveable fasteners which are moveable from a undeployed state to a deployed state engaging tissue. The fasteners may be disposed radially or tangentially, and rotated to pierce the fascia. The fasteners may be rigid or elastically deformable.

Abstract: An apparatus, device and method are provided to enable performing a treatment in a minimally invasive fashion in a pericardial space. The device includes a needle having a sensing means to detect substantially different bodily tissues to enable a practitioner to determine when the distal end of the needle is in the pericardial space; an anchoring means to secure the distal end of the needle inside or in proximity to the pericardial space; and a delivery means for delivering a guidewire to the pericardial space to perform the treatment.

Abstract: An attachment mechanism for a surgically implantable medical device includes one or more fasteners which may be simultaneously moved from an undeployed position to a deployed position by operation of an integral actuator. The attachment mechanism may be configured to be deactuated, and the fasteners simultaneously moved from a deployed position to an undeployed position, allowing removal or repositioning of the medical device. An applier includes a locator for detachably holding the implantable medical device, locating it at the desired position, and actuating the attachment mechanism. The applier is configured to undeploy the attachment mechanism the implantable medical device can be detached from the body tissue.

Abstract: The invention relates to a cap for use in neurosurgery. The cap may be applied to a bore hole in a patient's skull, allowing the entry and removal of neurosurgical instruments, whilst providing an openable seal over the bore hole.

Abstract: An apparatus for direct gastric feeding via a gastrostomy tract formed in a patient. The apparatus includes a tube, an internal bolster, an external bolster, and a force-generating device. The force-generating device may include a pair of automatically adjustable spring members on the external bolster. The spring members are responsive to changes in the length of the gastrostomy tract and eliminate the need for periodic adjustment or replacement of the apparatus.

Abstract: A cannula insertion device includes a housing defining an opening for receiving therethrough a cannula and further defining a channel, and a cannula forming a lumen, the cannula adapted for sliding movement within the housing from a retracted position to an extended position. When the cannula is in the retracted position, the lumen is located remotely from the channel and the channel is in fluidic communication with the opening. When the cannula is in the extended position, the lumen is in fluidic communication with the channel.

Abstract: The present invention provides devices and methods for safe, easy and cost effective means of placing and verifying proper placement of nasogastric and nasoenteric feeding tubes. Specifically, an integrated feeding device including a tube operable to deliver a nutritional and/or medicinal substance to the gastrointestinal tract, an optical system including a light source, flexible optical fibers or a camera, and a lens, and a steering system is disclosed. The components of the system, namely the optical system and the steering system, may be integrated into the tube.

Abstract: The present invention is a method for accessing the abdominal cavity of a patient in order to perform a medical procedure therein. In one embodiment the method includes the step of inserting a guide wire into the upper gastrointestinal tract, via a gastric opening in the gastric wall and an abdominal opening in the abdominal wall of the patient, the guide wire having a first end that extends from the mouth of the patient, and a second end that extends from the abdominal opening of the patient. The method further includes providing an access device in the form of an elongated sheath having a lumen therethrough, attaching the first end of the guide wire to the distal end of the elongated sheath, and pulling the second end of the guide wire to position the access device into the upper gastrointestinal tract, wherein the distal end of the access device extends into the abdominal cavity while the proximal end of the access device extends out of the mouth of the patient.

Abstract: Implantable infusion devices configured to improve fill and evacuation procedures.

Abstract: A suture bar for facilitating the securing of an implantable medical device in a body. The suture bar including a body member having a length disposed between a first and a second end, the body member being formed of a generally elongate tube that is piercable by a suture needle. The suture bar also including a first and second connector fixedly attached on the first and second end of the body member, the first and second connector operable to connect the implantable medical device to a pocket in a body.

Abstract: A subcutaneous needle conduit attaches directly to a blood vessel or other biological boundary structure. The subcutaneous needle conduit is tapered such that a proximal end is wider than a distal end. A body of the subcutaneous needle conduit guides the tip of a needle or other canula from the proximal end to the distal end. The subcutaneous needle conduit may be funnel-shaped. An elongated funnel shape may be used to selectively provide access to a plurality of desired access sites along an axis of a blood vessel. Other shapes, such as sluice-shaped, may also be used. The subcutaneous needle conduit may be located beneath the skin surface using, for example, tactile sensation, magnetism, metal detection, detection of a signal emitted from a minute transponder, detection of light emission, or through other detection methods.

Abstract: Embodiments provide a drug delivery cuff including a drug reservoir. In an embodiment, an integrated drug pump may be provided. A drug delivery cuff in accordance with an embodiment may be placed around any suitable vascular graft (e.g., ePTFE) or directly around any natural tissue conduit (e.g., perivascularly), at any position along the graft/conduit or overlapping a graft and conduit, either at the time of graft surgical placement or separate therefrom.

Abstract: An access port for subcutaneous implantation is disclosed. Such an access port may comprise a body for capturing a septum for repeatedly inserting a needle therethrough into a cavity defined within the body. Further, the access port may include at least one feature structured and configured for identification of the access port subsequent to subcutaneous implantation. Methods of identifying a subcutaneously implanted access port are also disclosed. For example, a subcutaneously implanted access port may be provided and at least one feature of the subcutaneously implanted access port may be perceived. Further, the subcutaneously implanted access port may be identified in response to perceiving the at least one feature. In one embodiment, an identification feature is included on a molded insert that is incorporated into the access port so as to be visible after implantation via x-ray imaging technology.

Abstract: The instant invention provides an inert DNA sequence having a length of between about 0.5 kb and about 5 kb, wherein said isolated inert DNA sequence does not contain an open reading frame and which is suitable for efficient packaging of expression cassettes comprising a nucleic sequence encoding a therapeutic agent into viral vectors, as well as methods of selecting such inert DNA sequences. The invention also provides DNA constructs and medical composition comprising such inert DNA sequences, and kits and medical systems for delivering such DNA constructs and/or compositions.

Abstract: Methods and apparatus are disclosed for making and using adjustable epidermal tissue ingrowth cuff and catheter assemblies for transcutaneous placement to provide periodic or continuous external access for medical purposes to an interior body region of a patent who requires such medical treatment over an extended period of time.

Abstract: A therapeutic device to release a therapeutic agent comprises a porous structure coupled to a container comprising a reservoir. The reservoir comprises a volume sized to release therapeutic amounts of the therapeutic agent for an extended time when coupled to the porous structure and implanted in the patient. The porous structure may comprise a first side coupled to the reservoir and a second side to couple to the patient to release the therapeutic agent. A plurality of interconnecting channels can extend from the first side to the second side so as to connect a first a plurality of openings on the first side with a second plurality of openings on the second side.

Abstract: A graft, for example, an arterio-venous shunt graft, is provided, which in a first aspect of the subject invention, is formed with longitudinal ribs. With fibrotic tissue ingrowth between the ribs, a composite rib/tissue layer is formed about the graft. The ribs provide counteracting lateral force against the embedded tissue to seal punctures formed therethrough during hemodialysis procedures. To provide additional surface area for puncturing, the graft may be formed with a truncated cross-section. With a second aspect of the invention, the graft is mounted onto a strip to prevent kinking, twisting or bending during an implantation procedure.

Abstract: A cannula assembly for directing blood from the heart of a patient and a minimally invasive method of implanting the same. The cannula assembly includes a flexible cannula body having a proximal end and a distal end with a receiving portion, and a transseptal tip having a distal end and a proximal end with an engaging portion. First and second anchors are coupled to the transseptal tip and configured to be deployed from a contracted state to an expanded state. The engaging portion of the transseptal tip is operable to removably engage the receiving portion of the flexible cannula body in vivo.

Abstract: The present invention comprises an implantable subcutaneous port for anchoring a transcutaneous treatment component. The implantable subcutaneous port comprises a body portion and one or more frangible lines formed within the body portion. The body portion is adapted for receiving the transcutaneous treatment component beneath the point of entry into the physiology of a patient and routing the transcutaneous treatment component. The body portion is produced from a deformable material and has an area footprint and defines a support wall through which the transcutaneous treatment component enters the body portion. Fracturing the one or more frangible lines formed within the body portion enables removal of the body portion from the physiology of a patient through a transcutaneous opening defining an area of less than thirty percent of the area footprint of the body portion.

Abstract: Some embodiments of a medical device anchor system includes an anchor sleeve and a catheter (or other medical instrument) to advance though a working channel of the anchor sleeve. The anchor sleeve may have a subcutaneous cuff device arranged along an outer surface. In such circumstances, the embedded cuff device can inhibit the migration of infection from outside the skin and into the blood stream.

Abstract: Apparatus and techniques to address problems associated with lead migration, patient movement or position, histological changes, neural plasticity or disease progression. Disclosed are techniques for implanting a lead having therapy delivery elements, such as electrodes or drug delivery ports, within a vertebral or cranial bone so as to maintain these elements in a fixed position relative to a desired treatment site. The therapy delivery elements may thereafter be adjusted in situ with a position control mechanism and/or a position controller to improve the desired treatment, such as electrical stimulation and/or drug infusion to a precise target. The therapy delivery elements may be positioned laterally in any direction relative to the targeted treatment site or toward or away from the targeted treatment site. A control system maybe provided for open- or closed-loop feedback control of the position of the therapy delivery elements as well as other aspects of the treatment therapy.

Abstract: An injection port applier is configured to engage an injection port that has integral fasteners that are movable from a non-deployed position to a deployed position. The applier comprises a shaft, a port engagement portion, and a handle. The port engagement portion is includes a fastener deployment member that is operable to move the fasteners to the deployed position. The handle comprises a first handle portion and a second handle portion. The second handle portion is movable distally relative to the first handle portion in order to actuate the fastener deployment member, to thereby move the fasteners to the deployed position. An elongate actuating member couples the second handle portion with the fastener deployment member. One part of the elongate actuating member translates longitudinally in response to the second handle being moved distally; while another part of the elongate actuating member rotates in response to the first portion translating.

Abstract: A medical apparatus and method of use for implanting a percutaneous catheter in a patient's body which catheter can be easily positioned, repositioned, and replaced. The apparatus includes an elongate sleeve comprising a wall surrounding an interior elongate passageway. The passageway extends from a sleeve proximal end to a sleeve distal end. The sleeve is intended to be percutaneously implanted through an incision in the patient's skin so that the sleeve distal end resides subcutaneously. The sleeve outer peripheral surface carries a layer of porous material intended to be placed just under the patient's outer skin layer in contact with the dermis to promote tissue ingrowth for anchoring the sleeve and forming an infection resistant barrier. The sleeve passageway is dimensioned to snugly accommodate the outer surface of catheter while permitting the catheter to slide relative to the sleeve.

Abstract: A system for attaching an access port to bodily tissue includes an access port assembly and including an access port having a generally central axis. The access port assembly further includes an attachment mechanism structured to enable the access port to be attached, for example, to an abdominal muscle of a patient. The system includes a safety cap which lies substantially flush against the anchor base to provide no space for movement of the anchors. The safety cap prevents the anchors from deploying prematurely.

Abstract: A method of repositioning an injection port comprises positioning the injection port at a first location in a patient's body and extending fasteners of the injection port to substantially secure the injection port at the first location. The fasteners are then retracted to substantially unsecure the injection port from the first location in the patient's body. The injection port is then moved to a second location in the patient's body. The fasteners are then re-extended to substantially secure the injection port at the second location in the patient's body. The injection port includes a port body. The fasteners are integral with the port body. The fasteners may be selectively extended and retracted relative to the port body. For instance, the fasteners may be pivoted relative to the port body to transition between extended and retracted positions. The extension and retraction of fasteners may be provided through a port applier.

Abstract: An injection port system comprises an injection port and an applier. The port comprises a body and a plurality of fasteners. The fasteners are integral with the body and are movable from a non-deployed position to a deployed position. The applier comprises a port engagement portion and an actuator. The port engagement portion is configured to selectively engage the port body to selectively retain the port relative to the applier. The actuator is operable to move the fasteners to the deployed position. The applier is also configured to disengage the port engagement portion from the port body to release the port from the applier when the actuator moves the fasteners to the deployed position. The actuator may release the port from the applier by moving a resilient member away from the port body as the actuator also moves the fasteners from the non-deployed position to the deployed position.

Abstract: A system and method for intracranial access is disclosed. In particular, a drill stop is shown providing a way to control the penetration of a drill bit as an access hole into the brain is being formed. Access to a desired location is achieved using a catheter guide device. Also disclosed is a mechanism by which multiple diagnostic and treatment devices can be placed at a desired location in brain tissue without the need for more than one access hole. A drainage catheter is disclosed with a mechanism to allow both drainage and to allow intracranial pressure measurement.

Abstract: An injection port comprises a body, a fluid reservoir, a septum, and a plurality of fasteners. The fluid reservoir is defined in part by the body and the septum. A needle may be inserted through the septum to reach the reservoir. The fasteners are integral with the body. The fasteners are simultaneously rotatable from a non-deployed position to a deployed position. The fasteners are retracted relative to the body when the fasteners are in the non-deployed position. The fasteners are extended relative to the body when the fasteners are in the deployed position. The fasteners are also simultaneously rotatable from the deployed position to the non-deployed position. The injection port may be coupled with a gastric band via a conduit. The conduit may provide fluid communication between an inflatable member of the gastric band and the reservoir of the injection port as part of a closed fluid circuit.

Abstract: A ventricular catheter includes an external ventricular drainage (EVD) catheter and has at least one conduit formed in the wall of the EVD catheter. The conduit opens at a side port of the wall at an angle to the EVD catheter. The side port is formed in the wall to allow a probe to be extended from the conduit at the angle into brain tissue that is not altered by the insertion of the EVD catheter. The ventricular catheter has an oval shape to minimize the total cross-sectional area while still allowing the necessary number of conduits.

Abstract: An implant with a surface structure on at least a portion of a surface of the implant, wherein the surface structure is selected to facilitate, improve and enhance ingrowth characteristics of the implant. A method of providing an implant with a selected surface structure is encompassed.

Abstract: Ports for accessing a vessels within a patient include passageways that can guide needles or other access devices directly into the vessels. The ports can be implanted subcutaneously within a patient. Some ports may be used in the creation and use of vascular access buttonholes.