Abstract: An intravenous catheter anchoring assembly is disclosed and includes a patient-contacting membrane, a platform, and a retaining strap for securing a catheter or tubing of an administration set to a patient. The strap is attached to the platform with adjustable pull-tabs that permit a variety of catheter shapes and sizes to be secured. The strap is also elastomeric so that the strap is stretchable and thereby grabs the secured catheter. The strap and platform further define a plurality of passageways that permit the catheter to be secured in a plurality of non-aligned directions.

Abstract: A fistula catheter which can be inserted and withdrawn without the use of a replacement tool such as a syringe or an extension tool and a fistula catheter that is sparingly invasive for the fistula are disclosed. The fistula catheter can have a substantially cylindrical catheter part; a rod-like bumper part; a guide part provided with a flexible peripheral wall which is bent in such a way that it can overlap the outer peripheral surface of the catheter part and the outer peripheral surface of the bumper part, wherein a catheter insertion opening into which the catheter part can be inserted is formed in said peripheral wall; a flexible first connecting part for connecting the catheter part and the bumper part in such a way as to extend in the axial direction; and a flexible second connecting part for connecting the bumper part and the guide part in such a way as to extend in the axial direction.

Abstract: Devices and methods provide accurate targeting, placement, and/or stabilization of an electrode or other instrument(s) into the brain or other body organ, such as to treat severe tremor or other neurological disorders. Targeting is performed using any form of image-guidance, including real-time MRI, CT, or frameless surgical navigation systems.

Abstract: Disclosed is a drug infusion system comprising a drug infusion device having a reservoir, a window for viewing the contents of the reservoir, a cannula arranged to be deployed beneath the skin of a patient, and an actuator configured to be manually actuated to drive a medicament from the reservoir to the cannula. The system also has a cannula cover and a needle handle that holds a needle for insertion into the patient. The cannula cover and needle handle are detachably attached to the drug infusion device, and each is attachable to the other. The device further comprises a septum and a septum pincher to seal the device. The device also comprises a pumping mechanism, part of which are a last-dose lock-out mechanism and an occlusion detection mechanism, both of which operate on the same actuator.

Abstract: An appliance which removably stores a portion of a catheter and an adapter, where the indwelling portion of catheter is still inside the body tissue of a patient. The appliance has an aperture that permits connection of a vacuum source such as hospital suction. When the appliance containing the catheter is held against the portion of the body including the indwelling site of the catheter, the vacuum source is applied, having a tendency to hold the appliance in place against the body. An orthopedic cast can be fabricated around the appliance, after which time the vacuum can be deactivated and the appliance can be removed, revealing a channel formed in the orthopedic cast. Through the channel, the distal portion of the catheter and the adapter can be accessed, facilitating continued post-operative anesthesia, easy visual inspection for signs of infection or dislodgment of the catheter and permitting easy removal when needed.

Abstract: A retainer comprises a first member and a second member. The first member can define at least a portion of a channel. The channel can have a longitudinal axis and be configured to receive at least a portion of a medical article. The second member can be moveable with respect to the first member, between locked and unlocked positions. The second member can contact the portion of the medical article received by the channel at least when in the locked position so as to inhibit longitudinal movement of the medical article relative to the retainer.

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: A method and apparatus are disclosed for a stabilization device for maintaining a position of a medical device relative to a body surface of a patient. The stabilization device comprises a support portion that defines a groove for receiving the medical device. The groove is structured to allow for positioning of the medical device at a plurality of angles relative to the body surface of the patient. The groove has opposing wall portions for securing the medical device.

Abstract: An infusion site retainer configured to maintain tubing coupled to an infusion port includes a base configured to be secured to a patient and comprises a patient surface opposite a first surface. At least one trench is formed in the base to couple the tubing to the base.

Abstract: The present invention is a protective sleeve for containing medical lines, comprising: (a) a foldable sleeve comprising first and second side panels, and adapted to be opened and closed along its longitudinal axis so as to form a conduit for medical lines, at least one of the panels being transparent, the foldable sleeve adapted to be reversibly opened along its longitudinal axis, and having releasable closures to maintain the foldable sleeve in a folded closed position; and (b) a plurality of rigid members incorporated into the sleeve and along the longitudinal axis.

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: An intravenous catheter system having a retractable needle system and a body system is disclosed. The retractable needle system includes a housing, a needle, a docking feature, and an optional anti-shearing mechanism. The body system includes a body, at least one hub, a catheter connector, at least one plug, a plug recoil mechanism, a locking mechanism, a flash chamber, and a flash window.

Abstract: Measurement of a patient's leak point pressure in the bladder can be taken by a processor in communication with a pressure catheter in the bladder. When leakage occurs pressure data points can be recorded. In some embodiments, the peak pressure can be determined based on pressure data points measured during a set time just before receiving a clinician input indicative that leakage has occurred.

Abstract: A lock for an outpatient's peripherally inserted central catheter (PICC) line limits access to the catheter by patients seeking to abuse injectable narcotics. The lock has two plastic housing halves which slide together, and which define an interior enclosure which receives the catheter line injection port. The housing halves have overlying flanges, through which a fastener extends to secure the device in a closed configuration. The fastener interacts with the flanges in such a way that it cannot be removed without distorting the device and giving evidence of tampering. A zippered sleeve may be provided which surrounds the line leading to the injection port and which has a pull tab which may be engaged within the housing to further prevent access to the line directly.

Abstract: A portable device (2) for providing a vacuum for medical vacuum treatment of wounds on the body of a person or of an animal has a holding or carrying device (10) with two connecting sections (12, 14) on the housing, which are disposed on the housing part (4) for connection to two connecting sections of a holding or carrying strap on the strap, wherein the holding or carrying strap comprises a third strap-side connecting section, which is spaced apart from the opposing ends of the holding or carrying strap and from the first and second strap-side connecting sections disposed there, and arranged between these ends, for connection to one of the connecting sections on the housing and/or to a strap-side connecting section disposed at the end.

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: 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: A medical tube securing device including: (a) an anchor that can be attached to the skin of a patient, wherein at least one opening extends through the anchor and is shaped and sized to receive a medical tube; (b) a first padding layer having a first side and a second side, wherein the first side of the first padding layer is joined to the anchor and has at least one opening that extends through the first side and the second side of the first padding layer; (c) at least one clasp joined to the second side of the first padding layer, wherein the clasp receives and holds in place a portion of the medical tube; and (d) a second padding layer. A method of securing a medical tube is also disclosed.

Abstract: A medical article securement device holds a medical article such as a catheter hub or a connector fitting in position upon the body of a patient and inhibits movement of the medical article relative to the patient. The medical article includes an elongated body, a pair of outwardly extending wings, and a port. The securement device includes a retainer and at least one anchor pad. The retainer forms a channel into which at least a portion of the medical article is secured. The retainer includes at least one abutment that abuts against a contact point or surface on the port. The anchor pad includes an adhesive layer that is attached to both an epidural layer of a patient and at least a portion of the pair of wings.

Abstract: Medical device designs for enteral nutrition that inhibit the relative motion of one device member to another device member are herein disclosed. The gastric and/or intestinal feeding tube shaft is disposed of teeth, furrows, ridges, indentions, tabs, or corrugations that operate with an external retaining member. Alternative embodiments utilize an external retaining member with a collet fitting that applies pressure against the gastric and/or intestinal feeding tube shaft. The assemblies prevent the relative motion of the internal retention member relative to the external retaining member and assist in maintaining the internal retention member against the gastric wall.

Abstract: A gel pad for use with a retainer for securing a medical article. The gel pad is formed from a soft, tacky elastomer. A first surface of the gel pad is placed in contact with a patient's skin. A second surface that faces in an opposite direction away from the first surface receives the retainer. The retainer has a channel configured to retain at least a portion of the medical article. In some embodiments, a securement member is employed to affix the retainer relative to the patient. A securement system including the gel pad and retainer is further disclosed along with a method of securing a medical article to a patient.

Abstract: A slotted catheter securement device adapted for securing a catheter extending generally perpendicularly from skin of a patient, having a base member and a securing member co-planarly oriented, the securing member being joined to the base member non-coextensively, an interior opening, a slot passing through the base member and the securing member in communication with the interior opening; the securing member having a first bridging member and a second bridging member non-coextensively joined to the base member, a securing adhesive layer positioned on at least one of the first and second bridging members, the first bridging member having an attached end and a free end, the second bridging member having two attached ends, whereby the first and second bridging members fold away from the base member to adhere to each other and to the catheter disposed therebetween.

Abstract: A securement device includes a retainer having at least one retention member extending into a channel of the retainer. The retention member is coupled to the retainer and includes a distal end. The distal end is movable relative to the retainer. The retention member can extend from the body and/or supports of the retainer on opposite sides of the channel axis. In some embodiments, a first set of retention members extends from a first support and a second set of retention members extends from the other support. The first set and the second set of retention members can be staggered laterally along the channel axis such that the lateral sides of the retainer are asymmetric which allow the same retainer to secure medical article having different shapes and sizes. The retainer may further include one or more abutment features or pills configured to contact the medical article.

Abstract: A system for securing a medical device such as a catheter or other medical article having various shapes or sizes in place on a patient includes a securing device. The securing device may optionally include a retainer having one or more receiving areas and one or more retention arms adjacent to the receiving areas. The securing device may also include a retention strap having a latching element that is removably connectable to a retention arm to securely hold a catheter in place. The retainer may optionally be connected to a base which may optionally be connected to an adhesive pad for easy attachment of the securing device to a patient.

Abstract: A catheter anchoring system, apparatus and method for securing a catheter to a patient's skin, having two flexible side members and a cross-member therebetween to which a retaining assembly is mounted. The retaining assembly may hold a catheter hub at an angle for patient comfort. Gripping tabs secure to each retaining assembly side are gripped while advancing a cannula guide needle into the patient's vein and while attaching the catheter hub to a medical accessory, such as intravenous (I.V.) tubing, for increased patient comfort, reduction of the risk in contamination and patient infection, and to more easily and quickly start an I.V.

Abstract: A surgical cannula system. The surgical cannula system includes a cannula having a proximal end, a distal end, and a lumen extending therebetween. A tissue attachment ring, being configured to be coupled to a biological tissue, includes a lumen extending therethrough. A locking mechanism has a first locking state, in which the cannula is configured to move with respect to the tissue attachment ring, and a second locking state, in which movement of the cannula with respect to the tissue attachment ring is resisted.

Abstract: An apparatus for sealing, securing and adjusting the length of a flexible tube is disclosed. The apparatus has a housing and an anchor. The housing has a sealing section, middle section and a opposing end. The housing has an outer surface and an inner lumen. The housing has at least one pair of abutted surfaces which define a slit from said outer surface to said lumen. The anchor has a base and a grip. The grip extends upwardly from the base. The grip is configured to engage the middle section of the housing. A method for using an apparatus for sealing, securing and adjusting the length of a flexible tube is also disclosed.

Abstract: An antimicrobial medical dressing provides a combination of antimicrobial agents in various concentrations that protect against microorganisms, absorb exudates, and promote healing. The antimicrobial agents may include compositions of ethanol, hydrogen peroxide, and/or ethylenediaminetetraacetic acid.

Abstract: An arthroscopic inflow and outflow sheath providing an improved inflow and outflow system reducing the diameter of a continuous flow system while eliminating the need for a third portal during arthroscopy. The improved arthroscopic inflow and outflow sheath comprises an elongated atraumatic sheath having an inner surface, outer surface, proximal end, and distal end. The atraumatic sheath further comprises plurality of ribs or webs extending from the inner surface of the sheath and designed to contact an outer surface of the arthroscope creating outer lumens facilitating the inflow and outflow of fluid to a surgical site. The atraumatic sheath further comprises a ridge to prevent the sheath from being easily removed from a surgical site.

Abstract: Anchors for securing a therapy device such as a therapy catheter relative to a burr hole, and systems and methods for using the same. Anchors in accordance with embodiments of the present disclosure may include a connector for securing the therapy catheter to a delivery catheter, wherein the connector is independently and removably attachable to the anchor. The connector may secure the therapy catheter relative to the burr hole and isolate forces that may otherwise tend to disrupt the placement of the therapy catheter.

Abstract: Some embodiments of a medical device anchor system include an anchor device, a tether, and an adapter for securing a medical instrument (such as a catheter or the like) in place relative to a skin penetration point using subcutaneous anchors.

Abstract: The present invention relates to devices and related methods for treating fistulas such as anal or recto-vaginal fistulas, in particular by the use of a seton to secure a tissue growth promoter such as a growth factor and/or fibrin. The various devices are particularly suitable for positioning tissue growth promoters securely within a fistula. Thus, one device comprises a seton and a tissue growth promoter. Further related aspects of the invention included devices comprising an enclosure provided in between portions of a seton, devices comprising a seton and a plurality of holes for enabling the device to be sutured to tissue, devices comprising a probe and a seton that are releasably connectable end-to-end, devices comprising an attachment device to secure the ends of a seton, and devices comprising a fistula plug adapted to be secured to a section.

Abstract: Included are embodiments of an infusion set for administering a liquid. One embodiment includes an infusion head to be placed on the tissue of a patient, a coupler for connecting the infusion head to an administering device, and a cannula that is configured for connection to the infusion head. Some embodiments include a display device for displaying an application period of at least a portion of the liquid administered using the infusion set.

Abstract: A bowel management system includes a waste collection catheter having at least two distinct sections. The first section is patient proximal when disposed in the patient's rectum and has durometer hardness in the range of about 50A to about 90A. The second catheter section is connected to the first section and has durometer hardness in the range of about 5A to about 49A. A selectively collapsible, substantially spherical retention balloon is attached coaxially and exterior of the first catheter section such that the proximal-most end of the retention balloon is coincident to the proximal-most end of the first section of the waste collection catheter, the substantially spherical retention balloon having an inflated size so as to be sufficiently large enough to retain the patient proximal end of the catheter in the patient's rectum without being so large as to trigger a defecatory response in the patient.

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: Intravesical devices are provided that are wholly deployable within the bladder of a patient in need of treatment and are well tolerated by the patient. The device may include an elastic body having a retention shape having (i) dimensions that provide intravesical mobility and that prevent voiding of the medical device through the urethra, and (ii) dimensions, buoyancy, or both, that exclude the medical device from entering the orifices of the ureters. The elastic body may exert a maximum acting force less than 1N when compressed to a shape with a maximum dimension in any dimension of 3 cm. The device may include a drug for controlled release within the bladder, for treatment of the bladder or a regional tissue. Methods of treatment are also provided that include selecting a patient in need of treatment in the bladder where tolerability of the treatment is a primary concern.

Abstract: In one aspect of the present disclosure, a surgical access apparatus is disclosed for positioning within an incision in tissue that includes an elongated seal member configured to removably receive at least one surgical object, and a deployment member. In another aspect of the present disclosure, a surgical access apparatus is disclosed for positioning within an incision in tissue that includes a housing configured to removably receive at least one surgical object, an elongated member, and at least one filament. A method of percutaneously accessing an underlying surgical work site using a surgical apparatus is also disclosed.

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: The present application relates to a molecular exchange device (1) for use with an analysis and control apparatus and a method of manufacturing a molecular exchange device.

Abstract: In accordance with aspects of the present invention, an applicator assembly suitable for application of a catheter patch about an insertion site of a percutaneous device includes a body having a distal end, a proximal end, and laterally extending right and left side gripping members, a pull tab member attached toward the proximal end of the body, and a release tab connected to the pull tab member, wherein the release tab is positioned toward the distal end of the body so that a lower surface of the release tab abuts an upper surface of the body. The release tab may have a securing mechanism for securing a catheter patch to a lower surface of the body toward the distal end of the body. A method of applying a catheter patch about an insertion site of a percutaneous device using an applicator assembly is provided.

Abstract: A multilayered wound dressing which is two-dimensional and has a peripheral edge is provided that includes at least one hydrophobic antimicrobial layer, at least one absorbent layer which includes a water-containing hydrogel, and a covering layer. Starting from the edge of the wound dressing, at least one incision is formed, which partially separates the wound dressing.

Abstract: An integrated vascular delivery system and method of use, the system including: a frame having a catheter hub that provides a first anchoring point on the patient and receives a catheter insertable in the patient to transfer fluid at an insertion site, a stabilization hub that provides a second anchoring point on the patient, at least one lateral member extending between the catheter and stabilization hubs, and a fluidic channel. The frame operates in a folded configuration in which the hubs are coupleable and an unfolded configuration in which the anchoring points are distributed around the insertion site to anchor the frame to the patient, thereby stabilizing the catheter. In some embodiments, the system further includes a septum that helps prevent fluid leakage from the catheter hub, or a needle shield that covers the distal end of a needle used during catheter insertion.

Abstract: A catheter fixture 11 for fixing a tubular catheter 1 to skin of a patient is provided with a plate shaped fixture main body 21, a fixing member 41 that is configured separately from the fixture main body, and a pivot connecting shaft 45. The plate shaped fixture main body 21 includes a retention part 22 where a catheter retaining groove 25 is formed, and a pair of winged pieces 23a and 23b. The pivot connecting shaft 45 both connects the fixture main body 21 and the fixing member 41 and acts as the pivot access C1 of the fixing member 41. The fixing member 41 has a pivoting action along a horizontal plane direction of the fixture main body 21 centrally around the pivot connecting shaft 45. When doing so, the catheter retaining groove 25 is covered by the fixing member 41 thereby fixing the catheter 1.

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: Apparatus for use in surgery comprises a sleeve (1) having an entry opening (4) at an outer end and an exit opening (5) at an inner end to access a patient's body. Exit sealing means (10) are provided for sealing the exit opening (5) to a body. Entry sealing means (20) are provided for sealing the outer entry against an arm passing therethrough to create a controlled environment within the sleeve. A valve (101) comprises an outer ring (105,106) and a sealing sleeve (107) of flexible material mounted to the ring (105,106) and extending into the opening defined by the ring to terminate in a substantially centrally disposed inlet opening (108).

Abstract: Fluid delivery apparatus is described for the delivery of fluids to regions of the body, especially for delivery to regions of the brain. The apparatus includes a first length of implantable tubing having a first end and a first fluid connector portion attached to the first end of the first length of implantable tubing. The first fluid connector portion is releaseably connectable to a complementary second fluid connector portion. An implantable housing is also provided for enclosing and protecting the first fluid connector portion. The implantable housing is openable to provide access to the first fluid connector portion. For example, the housing may have a hinged lid or cover portion. A corresponding method is also described.

Abstract: An apparatus and method for guiding a needle in conjunction with a biopsy using a medical imaging device, where a non-reusable needle guide, which is relatively inexpensive which grasps the sheathed bracket firm, and holds the same in a set position based upon a bullet-nose lock.

Abstract: The present invention provides devices for creating an external percutaneous fluidic connections. In one embodiment, the device includes a first tube defining a longitudinal axis, and a first bolster supporting the first tube, a second tube, and a second bolster supporting the second tube. The first and second bolsters are magnetically attractable, and promote airflow to the skin.

Abstract: A medical article securement device 100 holds a medical article 300 such as a catheter hub or a connector fitting in position upon the body of a patient and inhibits movement of the medical article relative to the patient. The medical article 300 includes an elongated body 430, a pair of outwardly extending wings 301(a), 301(b), and a port 305. The securement device 100 includes a retainer 120 and at least one anchor pad 110. The retainer 120 forms a channel 140 into which at least a portion of the medical article 300 is secured. The retainer 120 includes at least one abutment that abuts against a contact point or surface on the port 305. The anchor pad 110 includes an adhesive layer that is attached to both an epidural layer of a patient and at least a portion of the pair of wings 301(a), 301(b).

Abstract: An apparatus and corresponding method for providing convection enhanced delivery of bioactive agent to a tissue site. The apparatus involves the use of semipermeable membranes, typically in the form of one or more hollow fibers, together with a source and conduit of solution containing the bioactive agent to be delivered. The use of hollow fiber technology provides an optimal combination of features, including delivery kinetics and distribution, as compared to conventional (e.g., standard needle) type delivery devices.