Abstract: A novel high tensile strength semi-absorbable composite suture with minimized non-absorbable mass. The suture has a core made from a bioabsorbable polymer. The core is covered by a braided sheath. The braided sheath is made from an absorbable yarn and a bioabsorbable yarn. The bioabsorbable yarn is made from a least one filament of a bioabsorbable polymer. The nonabsorbable yarn is made from at least one filament of ultra high molecular weight polyethylene.

Abstract: A method of preparing a substantially planar microdevice comprising a plurality of reservoirs is provided. In general, the method comprises forming a plurality of microdevices comprising a plurality of reservoirs from a planar layer of a biocompatible polymer. The method also comprises depositing one or more bioactive agents into the reservoirs. The microdevice is configured to attach to a target tissue and release the bioactive agent in close proximity to the tissue.

Abstract: A securement system (100) includes a device which permits a portion of a catheter or similar medical article to be easily anchored to a patient, desirably without the use of tape or needles and suture. A securement system for an elongated medical article comprises an anchor pad (110) and a retainer (120) mounted upon the anchor pad. The retainer (120) includes a channel (130) that has at least one abutment surface (160) corresponding to a contact surface on the medical article and a groove (210) configured to receive a spline (40) of the medical article. The medical article is placed into the channel (130). The medical article is secured within the channel by retaining at least one spline (40) and contact surface on the medical article.

Abstract: An anchor deployment apparatus for deploying an anchor about a therapy delivery element, such as a lead or a catheter, includes an anchor receiving element having an elongate member defining a lumen. The lumen is configured to slidably receive at least a portion of the therapy delivery element. The anchor is disposable about the elongate member. The deployment apparatus further includes an anchor engagement apparatus having an anchor engagement feature and a channel in which the elongate member of the anchor receiving element is moveable. The engagement feature is configured to engage the anchor when the anchor is disposed about the elongate member, 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 proximally relative to the engagement element.

Abstract: An embodiment in accordance with the present invention provides an implanted catheter and an external device that the patient uses to inject a therapeutic into the implanted tube. The implanted catheter can be equipped with a fixation mechanism that secures the catheter in place and eases physician insertion and removal. The fixation mechanism can include shape memory arms having silicone tips or can be a second catheter branch configured to hold the device in the user's sinus cavity. The catheter can also include numerous exit holes to prevent obstruction and deliver the therapeutic. An interface between the implanted catheter and the external device is incorporated, to ensure a reliable seal for medication passage. A method and device for delivery of the catheter to the correct position can also be included.

Abstract: Some embodiments of a medical device anchor system include an anchor device that receives a catheter (or other medical instrument) and secures the catheter in place relative to a skin penetration point. In some embodiments, the anchor device can secure the catheter in an operative position relative to the skin without the use of sutures or skin tapes. In particular embodiments, the anchor device can be adjusted to a folded condition so that subcutaneous anchors are partially rotated prior to removal from the skin penetration point.

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: 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: Some embodiments of a medical device anchor system include an anchor device that receives a catheter (or other medical instrument) and secures the catheter in place relative to a skin penetration point. In some embodiments, the anchor device can secure the catheter in an operative position relative to the skin without the use of sutures or skin tapes. In particular embodiments, the anchor device can be adjusted to a folded condition so that subcutaneous anchors are partially rotated prior to removal from the skin penetration point.

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: An implantable flow connector for fluidically coupling a source tissue-enclosed body space with a destination element, comprising: a conduit having a lumen terminating at an orifice at a first end of the conduit implantable in the source body space through an opening formed in a tissue wall of the source body space, and a second end of the conduit implantable in the destination element through an opening in a surface of the destination element; and a circumferential flange, radially extending from the conduit proximate the conduit first end, configured to be implanted in the source body space adjacent an opening in the tissue wall of the source body space such that the conduit extends through the opening, the flange comprising one or more circumferentially adjacent sections at least one of which has a rigidity that decreases in a radially-increasing direction.

Abstract: An infusion set comprises a base member (60), an introducer cap (64), and an infusion cap (54). The base member (60) preferably comprises a soft cannula (52) extending from a lower side (118) of the base member (60), and a port (62) on an upper side (92) thereof. The port (62) is configured to be in fluid communication with the cannula (52). The port (62) also comprises a septum (130) adapted to seal the port (62) against unwanted fluid flow. The introducer cap (64) is adapted to be mounted to the base member (60) and has a needle (66) adapted to extend through the septum (130) and said soft cannula (52) in an assembled position. The infusion cap (54) comprises a lumen (160) adapted to receive an elongate flexible tube (162). The infusion cap (54) also comprises a hard cannula (170) adapted to be inserted through the septum (130) and to place said soft cannula (52) in fluid communication with said lumen (160).

Abstract: Some embodiments of a medical device anchor system include an anchor device that secures a medical instrument (such as a catheter or the like) in place relative to a skin penetration point using subcutaneous anchors. In some implementations, the anchor device can be installed using a technique in which the subcutaneous anchors undergo relatively little or no flexing when being inserted through the skin into the subcutaneous region between the skin and underlying muscle tissue which may be occupied by fatty tissue.

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 tissue anchor system includes a plurality of elongated members pivotally coupled by a pivot member and at least one coupler coupled to at least one of the elongated members between a pivot point and an end of the elongated member which coupler is operable to secure the elongated members in a configuration that securely couples the tissue anchor to tissue.

Abstract: A fistula catheter which allows a supply tube to be easily connected to a body-external fixing member positioned on the body surface side, and which is only slightly invasive for a patient is provided. The fistula catheter 10 includes a tube body 11 which is inserted into a fistula formed in the abdominal wall and the wall of the alimentary canal; a body-external fixing part 12 which is linked to one end of the tube body 11 and positioned on the abdominal wall surface side of the fistula; and a body-internal fixing part 13 which is linked to the other end of the tube body 11 and positioned inside the wall of the alimentary canal. The body-internal fixing part 13, and the fistula catheter has a flow path allowing fluid to flow through the body-external and body-internal fixing members. The body-external fixing part 12 includes a flexible tube 1 and is connected substantially at right-angles to the axial direction of the tube body 11.

Abstract: A device and method for creating a connection with the left ventricle of a heart are provided. A seal member capable of moving between a folded position and an open position is attached to the end of a conduit. An introducer capable of moving between a first and second position allows for the expansion of the seal member into an open position. A clamp component is positioned outside of the heart to provide an axial clamping force with the wall of the heart so that a seal is created between the seal member and the wall of the heart.

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

Abstract: A cannula for preventing spraying of liquid is disclosed. The cannula includes a support tube partially inserted into a human body to guide a surgical instrument to an inside of the human body and a handle integrally formed with the support tube to allow the surgical instrument to be in and out of the human body, wherein the handle further includes a plurality of seal plates coupled to an inside thereof to prevent spraying of liquid onto an operator by an internal pressure of the human body and an outlet formed at a side surface thereof to reduce an internal pressure of the handle to atmospheric pressure.

Abstract: An artificial blood has a trunk portion with both ends connected to blood vessels, and access branch portions and a shunt branch portion branched from the trunk portion. The access branch portions are disposed with a solid column-shaped access port that plugs these branch portions. The access port has a solid center portion and a tube-shaped peripheral portion disposed to surround the center portion. The peripheral portion is harder than the center portion and prevents the needle from deviating from the inside of the center portion. This enables a puncture to be easily made in a therapy in which a puncture is highly frequently made in a blood vessel.

Abstract: An external bolster having a main body, a curved portion and a hinge. The bolster also includes a base fixably attached to the main body, the base including a spoke configured to allow air through the base and a cap removably attached to the main body at the hinge, wherein the cap is configured to position a tube along the curved portion of the main body when the cap is in a closed position.

Abstract: The present disclosure is directed to an implantable repository including a housing comprising at least one bioactive agent and at least one attachment member coupled to the housing, the at least one attachment member configured to couple the implantable repository to at least one of a medical device and a tissue surface.

Abstract: Implant devices for intravesical administration and local drug delivery. The device has a body which includes a hollow tube formed of a biocompatible material; at least one reservoir in the tube which contains a drug; and one or more apertures through which the drug can be released. The device is configured for minimally invasive insertion into a body cavity, such as the bladder. The hollow tube may be elastomeric to permit the device to be elastically deformed from its initial shape into an elongated shape for passage through a catheter, where following such passage the device can return to or toward its initial shape to facilitate retention of the device in the body cavity. The body may have a narrow, elongated shape effective to permit insertion of the drug delivery device through a catheter without necessarily deforming the body, yet include flexible projections which effect retention within the body cavity.

Abstract: Devices and methods for delivering drugs and other therapeutic or diagnostic substances to desired locations within the bodies of human or non-human animal subjects. An implantable delivery device comprising a reservoir is initially attached to a deliver catheter or delivery tool and is introduced into the body and positioned at a desired site. A therapeutic or diagnostic substance is then introduced into the reservoir and the delivery catheter or deliver tool is then removed, leaving the implantable delivery device implanted within the body. The substance is then delivered from the reservoir at a rate that causes the desire diagnostic or therapeutic effect. Also provided are substance eluting stents that elute substance from a selected surface of the stent (e.g., the outer surface) but not from another surface of the stent (e.g., the inner surface).

Abstract: An implantable percutaneous fluid delivery device is described that includes a subcutaneous base portion having one or more ports for supplying fluid to one or more implanted catheter devices and a percutaneous portion including an extracorporeal surface. The one or more ports of the subcutaneous base portion are accessible from the extracorporeal surface of the percutaneous portion. The subcutaneous base portion is at least partially insertable into a complementary recess formed in a bone, the subcutaneous base portion including one or more features for gripping the internal surface of such a complementary recess thereby directly anchoring the subcutaneous base portion to the bone. The device may be used to route fluid to neurosurgical catheters optionally via a router unit.

Abstract: A lead anchor includes a core housing defining a cavity; a swivel anchor disposed in the cavity and having a tubular portion and a locking portion; at least two locking members; and at least two sleeves with a portion of each of the sleeves and each of the locking members disposed within the cavity at a periphery of the cavity. The tubular portion is adapted to receive an external tool to rotate the swivel anchor within the cavity. The lead anchor has an unlocked configuration, in which the swivel anchor can rotate within the cavity of the core housing without compressing the sleeves, and a locked configuration, in which opposing ends of the locking portion of the swivel anchor each lie between one of the sleeves and one of the locking members and compress the sleeves and any lead disposed within the sleeves to hold that lead in place.

Abstract: A fistula catheter in which an intracorporeal fixing part comprises an inner balloon and an outer balloon is disclosed, whereby it is possible to prevent removal from the fistula by means of the inner balloon, even if the outer balloon deflates.

Abstract: A device for delivering a substance in situ in a body comprising at least one permeable expandable container having a first dimension and a second dimension and having contained therein the substance to be delivered; and at least one expandable particle comprising a swellable material contained within the container and capable of expanding when contacted with a fluid; whereby when the device is positioned in situ, bodily fluid permeates the container causing the at least one expandable particle contained therein to swell and the container to expand from the first dimension to the second dimension so that the device remains in situ for a period of time sufficient to achieve the desired delivery of the substance is provided.

Abstract: Intrauterine fetal growth restriction (IUGR) is an affliction of a disparaging spectrum, placental insufficiency being the major inciting pathology. The resultant fetal hypoglycemia is alleviated by intravenous hypertonic D-glucose 25-50% maternal supplements, by improving the Vmax of placental transfer for D-glucose, in accordance with Michaelis-Menten model of substrate transfer. Fetal normoglycemia so restored in turn surprisingly improves fetal hypoxia, hypercapnia, hyperlacticemia, acidosis, hypertriglyceridemia, oliguria/hydromnios, and the fetal nutrient/mineral/vitamin acquisition. The list being phenomenal can only convince an inquiring reader by a biochemical sojourn into the aquatic world of the fetus, herein described. Maternal carbohydrate-predominant IUGR diet with maximal amounts of vitamin/mineral supplements are highly beneficial.

Abstract: An implant for insertion into a punctum of a patient comprises a body. The body has a distal end, a proximal end, and an axis therebetween. The distal end of the body is insertable distally through the punctum into the canalicular lumen. The body comprises a therapeutic agent included within an agent matrix drug core. Exposure of the agent matrix to the tear fluid effects an effective therapeutic agent release into the tear fluid over a sustained period. The body has a sheath disposed over the agent matrix to inhibit release of the agent away from the proximal end. The body also has an outer surface configured to engage luminal wall tissues so as to inhibit expulsion when disposed therein. In specific embodiments, the agent matrix comprises a non-bioabsorbable polymer, for example silicone in a non-homogenous mixture with the agent.

Abstract: Some embodiments of a medical device anchor system include an anchor device that secures a medical instrument (such as a catheter or the like) in place relative to a skin penetration point using subcutaneous anchors. In some implementations, the medical instrument can be coupled to the anchor device using a snap-lock cap mechanism.

Abstract: A biocompatible implantable bone anchor is provided that has a threaded first portion that engages and anchors into a bone. The implant also has a neck region extending from the first portion adapted to promote autologous cell growth thereon at an interface of the bone and one or more epidermal or gum layers, the neck region having a plurality of channels extending about the neck region. The neck region is configured to mechanically engage at least one of an abutment, dental restoration, or osseous device attachment. An in situ bone anchor cell growth assembly includes the bone anchor and a manifold encompassing the neck portion so as to form a seal therebetween and a route of fluid communication between a manifold inlet and at least one of said plurality of channels. A process for growing autologous cells on a neck region of a bone anchor is provided.

Abstract: The subcutaneously implantable vascular access port has two parts including a body and a wing. The body supports a chamber covered by a septum, with a septum held in place over the chamber by a collar. The chamber is coupleable to a vascular structure, such as through tubing extending from the body, for delivery of medical preparations. The body is preferably elongate in form. The wing is configured to be adjustable in width. In one embodiment the wing rotates relative to the body and has an elongate form similar to that of the body. When the wing is rotated it extends laterally from the body and enhances a stability of the body. In another embodiment, the wing is provided as a deformable wing which can expand laterally out of side openings of a cavern in the body into which the deformable wing is inserted.

Abstract: An anchor sleeve for securing a therapy delivery element, such as a stimulation lead or catheter, within a living body, that includes an inner sleeve with pre-formed locations of weakness that facilitate localized deformation. The anchor includes a deformable outer sleeve with a primary lumen extending along an axis. The outer surface of the outer sleeve includes a plurality of suture grooves oriented generally concentric to the axis. The inner sleeve includes a plurality of beams connected at deflection regions arranged around a secondary lumen. The inner sleeve is located in the primary lumen adjacent to the suture grooves so that the secondary lumen is generally concentric with the primary lumen. A plurality of locations of weakness are preformed in each of the beams to facilitate localized deformation in response to a radially inward force applied around the suture grooves by a suture material.

Abstract: An external end device for permanent catheters includes a container that houses two taps being provided with knobs and having, at one hand, a first connector for the connection to the catheters and, at the other hand, second connectors projecting from the container for the connection to an external equipment. The first connector is connected to the catheter by a coupling exiting the container and externally holding a subcutaneous cuff designed to be positioned in the subcutaneous tissue of the patient's body. The second connectors are provided with caps surrounded by the disposable absorbent material being received in the closure lid and having spaces for housing the caps for protecting them externally from a bacterial attack by the antiseptic substance by which it is impregnated. Further an implantation method of the device in a patient is 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: A surgically implantable injection port has a tissue in-growth promoting surface associated with a fluid conduit that is coupled to the injection port. The injection port includes a housing, a fluid reservoir defined in part by the housing, a needle penetrable septum, a fluid conduit in communication with the reservoir, and a tissue in-growth promoting surface coupled to the fluid conduit. The tissue in-growth promoting surface may be provided by surgical mesh wrapped around the conduit or through which the conduit is threaded. The injection port and the fluid conduit may be used as part of a gastric band system or some other type of system.

Abstract: A catheter configured with an elongate tube and a diffuser is disclosed. The diffuser may be configured to facilitate high flow rates through the catheter and to resist blockage of openings disposed within the body. Further, the catheter may be comprised of flexible materials to facilitate delivery into and removal from the body. In some embodiments the diffuser may be generally disc shaped.

Abstract: An anchoring system provides secure attachment between a portion of a medical article and a body of a patient. The anchoring system comprises a securement device and a first fitting attached to the medical article, the first fitting having a first configuration. Embodiments of the anchoring system also comprise a second fitting attached to the medical article. The second fitting has a second configuration that differs from the first. The securement device includes a mounting surface for attaching the securement device to the patient's body and a receiving area. The receiving area is oriented so as to face away from the patient's body, and includes retainer mechanisms that are capable of engaging one or both of the first and second fittings, which have different configurations.

Abstract: Disclosed is a catheter assembly that includes a catheter, a sheath on the catheter, a sleeve on the sheath and a tissue ingrowth cuff affixed to the sleeve. The sleeve and sheath are movable along the length of the catheter with the sheath being removable from between the sleeve and the catheter. When the sheath is removed, the sleeve becomes substantially fixed in position on the catheter. The sheath may have a comparatively low coefficient of friction against the catheter while the sleeve may have a comparatively high coefficient of friction against the catheter.

Abstract: Embodiments of the disclosed positioning systems can include a catheter assembly having a catheter with an external surface and an outer diameter, and a movable cuff assembly engaged around the circumference of the catheter. An exemplary movable cuff assembly includes a sleeve, a tissue ingrowth cuff affixed to the sleeve, and a clamp affixed to the sleeve, where when the first clamp is engaged, the movable cuff assembly is substantially fixed in position on the external surface of the catheter and wherein when the first clamp is disengaged, the movable cuff assembly is slidably movable over the external surface of the catheter.

Abstract: Anchors for securing a medical device relative to a burr hole, wherein the anchors may accommodate most any implantation trajectory through the burr hole. Such anchors may further secure the device along any such trajectory without imparting undesirable biasing forces that may shift the device from its intended implanted location. In some embodiments, the anchor is configured with a cup-shaped retention member through which the medical device passes. The retention member may receive a volume of curable material therein to provide strain relief to the medical device.

Abstract: A stepped catheter comprising a distal portion of smaller diameter than a proximal portion, wherein the distal portion defines a flow aperture configured to deliver fluid passing through the catheter from the proximal portion to the flow aperture. The catheter may include a flow restrictor located within a lumen of the catheter at or near the flow aperture. A filter element may also be included and located within the lumen of the catheter at a location upstream of the flow restrictor.

Abstract: Anchors for securing a medical device relative to a body portal, wherein the anchors may accommodate most any implantation trajectory through the portal. Such anchors may further secure the device along any such trajectory without imparting undesirable biasing forces that may shift the device from its intended implanted location. In some embodiments, the anchor is configured as a burr hole anchor including a spherical member contained in a socket of the anchor wherein the socket may be collapsed to lock the spherical member along a particular trajectory.

Abstract: Anchors for securing a medical device relative to a body portal, wherein the anchors may accommodate most any implantation trajectory through the portal. Such anchors may further secure the device along any such trajectory without imparting undesirable biasing forces that may shift the device from its intended implanted location. In some embodiments, the anchor is configured as a burr hole anchor including a spherical member contained in a socket of the anchor such that orientation of the spherical member is permitted about three mutually perpendicular axes.

Abstract: Some embodiments of an anchor device may include bendable anchor mechanism that is deployable in a subcutaneous layer to releasably secure the anchor device to a patient's body. Certain embodiments of the anchor mechanism may include one or more barbs that flexibly bend in response to an insertion or removal force. As such, the anchor mechanism may be inserted into a subcutaneous layer, and removed from the subcutaneous layer, without the need for a separate actuation device to extend or retract the barbs.

Abstract: An implantable percutaneous fluid delivery device is described that includes a subcutaneous base portion having one or more ports for supplying fluid to one or more implanted catheter devices and a percutaneous portion including an extracorporeal surface. The one or more ports of the subcutaneous base portion are accessible from the extracorporeal surface of the percutaneous portion. The subcutaneous base portion is at least partially insertable into a complementary recess formed in a bone, the subcutaneous base portion including one or more features for gripping the internal surface of such a complementary recess thereby directly anchoring the subcutaneous base portion to the bone. The device may be used to route fluid to neurosurgical catheters optionally via a router unit.

Abstract: A subcutaneous, venous catheter is provided in conjunction with a method of installation in hemodialysis treatments. The catheter has an implantable hub attached to a first end of the primary lumen. An anchoring back plate is pivottably secured to the catheter hub and surgically anchored to underlying musculature. Once the device is implanted, the hub can be arcuately translated underneath the skin by applying gentle pressure to either side of the hub. To reduce fluid stagnation within and around the lumen, a series of piezo-electric elements are integrated therein. A vibration processor is electrically connected to the piezo-electric elements such that the initiation of electrical current by the vibration processor results in contraction of the piezo-electric elements. Expansion and contraction of these elements propagates low-energy acoustic waves through the lumen, agitating liquid contained therein and improving flow of same through the catheter lumen.

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 surgical apparatus for positioning within a tissue tract accessing an underlying body cavity includes a seal anchor member including leading portion, a trailing portion, and an intermediate portion disposed between the leading and trailing portions. The leading portion of the seal anchor member is configured and adapted to ease insertion of the seal anchor member into the tissue tract. Subsequent to insertion of the seal anchor member, the leading portion of the seal anchor member is also configured and adapted to facilitate securing and/or anchoring of the seal anchor member within the tissue tract.