Abstract: A medical article, such as a catheter, is secured with respect to a patient with a securement device. The securement device may include a retainer and anchor pad. Certain devices may further include, for example, straps, flaps, dressings, slots, and recesses for securing the medical article to the patient. The retainer may include a recess and/or a channel. At least one surface of the retainer may be coated with an adhesive. A support member may be coupled to the retainer. The support member may include a channel configured to receive a proximally extending portion of the medical article.

Abstract: A dressing for use in protectively covering and isolating a medical device placed on and/or through the skin surface of a patient is disclosed. Examples of such devices include infusion needles for accessing subcutaneously implanted access ports, catheters of various types and purposes, insulin infusion needles, etc. In one embodiment, a dressing for covering a medical device on a skin surface of a patient is disclosed and comprises a dressing portion that is configured to rest against a skin surface of a patient, with the dressing portion defining a hole, and a polymeric cover film that is at least indirectly attached to the dressing portion. The cover film includes a pliable domed portion aligned with the hole of the dressing portion. The pliable domed portion defines a cavity that is configured to receive therein the medical device when the dressing is placed on the skin of the patient.

Abstract: A safety needle assembly of an infusion set is disclosed. The needle assembly is configured to prevent fluid/vapor escape therefrom so as to reduce or prevent fluid exposure to a clinician using the needle assembly. In one embodiment, the needle assembly comprises a handle portion including a needle extending therefrom, the needle defining a lumen for passage of a fluid therethrough. The needle assembly also includes a safety assembly defining a needle hole through which the needle initially extends. The safety assembly is selectively and axially slidable along the needle in order to shield a distal tip of the needle and prevent user contact therewith. A fluid isolation component is included in the safety assembly for isolating fluid escape from the needle. In another embodiment, an interface pad is included on the bottom of the needle assembly and includes an antimicrobial and/or haemostatic agent to protect the needle insertion site.

Abstract: An insertion device to assist in accessing an access port that has been subcutaneously implanted in the body of a patient is disclosed. The implanted access port is accessed by a needle of a needle assembly, such as a needle-based infusion set. In one embodiment, the insertion device comprises a body that includes a stabilizing portion and a guide portion. The stabilizing portion stabilizes a position of the implanted access port when the body is placed on the skin of the patient atop the implanted access port. The guide portion guides a needle of the needle assembly along a predetermined path such that the needle transcutaneously pierces a septum of the implanted access port.

Abstract: A medical article, such as a catheter, is secured with respect to a patient with a securement device. The securement device may include a retainer and anchor pad. Certain devices may further include, for example, straps, flaps, dressings, slots, and recesses for securing the medical article to the patient. The retainer may include a recess and/or a channel. At least one surface of the retainer may be coated with an adhesive.

Abstract: A catheter and introducer needle assembly with a needle shield is provided. The needle shield includes a means for preventing unwanted distal movement of the needle once the needle has been withdrawn into the needle shield. The needle shield also includes a means for connecting the needle shield to the catheter hub until the sharp distal tip of the introducer needle has been withdrawn into the needle shield. Thus, when the distal end of the introducer needle extends from the distal portion of the needle shield, the needle shield is connected to the catheter hub and when the sharp distal end of the introducer needle is withdrawn into the needle shield, the needle shield is disconnected from the catheter hub. At that point, the sharp needle tip is secured within the needle shield.

Abstract: A guidance system for assisting with the insertion of a needle into a patient body is disclosed. The guidance system utilizes ultrasound imaging or other suitable imaging technology. In one embodiment, the guidance system comprises an imaging device including a probe for producing an image of an internal body portion target, such as a vessel. One or more sensors are included with the probe. The sensors sense a detectable characteristic related to the needle, such as a magnetic field of a magnet included with the needle. The system includes a processor that uses data relating to the sensed characteristic to determine a 3-D position of the needle. The system includes a display for depicting the position of the needle. A needle assembly including a hub, cannula, and magnetic element is also disclosed, wherein a magnetic axis of the magnetic element is configured to be coaxially aligned with the needle cannula.

Abstract: A medical device includes an antimicrobial layer. A method of depositing an antimicrobial agent on or in the body of a medical device includes inserting a high temperature resistant tube having multiple holes through its surface into a vascular access device and coating, or delivering an antimicrobial agent to, and interior surface of the device.

Abstract: A medical access device provides needleless access to patient fluid lines such as intravascular catheters. A retaining ring at the top end of the housing of the medical access device is molded around a septum that provides access for a tubular portion of a medical device such as a male luer taper of a syringe. Alternatively, the retaining ring may also be molded around the body or around both the body and the base of the housing. The molded retaining ring and septum are attached by mechanical attachment and/or chemical adhesion to minimize axial and rotational movement between the septum and the housing.

Abstract: A delivery device for inserting a plurality of T-fastener-equipped sutures into a body of a patient in a spaced-apart configuration for the purpose of securing the stomach wall against the abdominal wall, also known as gastropexy, is disclosed. The suture delivery device is configured to deliver multiple sutures using a single needle and without need for reloading, saving time and effort for the clinician and simplifying the suture placement process. In one embodiment, a T-fastener-equipped suture delivery device comprises a housing, a hollow needle extending from the housing, and a plurality of T-fastener-equipped sutures at least partially disposed within one of the needle and the housing. An ejection assembly for successively ejecting the T-fasteners from a distal end of the needle without reloading the delivery device is also included in the housing.

Abstract: A dilator system for insertion of a catheter or other elongate device into a body of a patient includes a catheter having a lumen that initially defines a first inner diameter. The catheter includes a swellable material that swells after insertion into the body. A dilator includes an elongate body that is initially disposed in the catheter lumen and a tapered head extending from a distal end of the catheter lumen. The dilator head defines an outer diameter that is larger than the first inner diameter of the catheter lumen. After insertion of the dilator head and a distal portion of the catheter into the body, the catheter swells such that the lumen defines a second inner diameter that is larger than the outer diameter of the dilator head. This enables the dilator to be proximally removed from the body via the catheter lumen defining the second diameter.

Abstract: A vascular access device may include a body and a layer of the body that communicates with a pathogenic environment to discourage adhesion of a pathogen to the layer and thus repress pathogenic activity. A method of repressing pathogenic activity in a vascular access device includes providing the device with a body, and coating the body with a layer that discourages adhesion of a pathogen to the layer.

Abstract: Infusion sets for insertion into an insertion site for preventing misalignment of the base and cap or fluid connector by providing one or more alignment features between each, and in alternative embodiments, provide one or more features to secure the cap or fluid connector to the base in anyone of a number of rotational positions and having release features to allow the cap or fluid connector to be rotatable with respect to the base portion of the infusion set, and yet easily removed and inserted. Further embodiments provide infusion sets wherein the user can easily see the insertion site of the catheter and the skin, to determine if infections have occurred at an earlier stage than was possible using prior art infusion sets and with substantially less difficulty.

Abstract: A deflation indicator system for visually indicating an inflation status of a balloon-type or other inflatable internal bolster of a medical device is disclosed. The indicator system enables an observer to ascertain from an external vantage point whether the internal bolster of the indwelling device is inflated. In one embodiment, the medical device comprises an elongate body defining a lumen, and an inflatable internal bolster for securing a portion of the medical device within the patient. A deflation indicator is also disclosed, including a flexible membrane in fluid communication with the internal bolster. The membrane is included in an external portion of the medical device. The membrane assumes a first concavely-shaped position when the internal bolster is deflated. Correspondingly, the membrane assumes a second convexly-shaped position when the internal bolster is inflated. The positions of the membrane are externally observable to indicate the inflation status of the internal bolster.

Abstract: A needle shield assembly with a needle having a distal tip and a static feature is provided. The needle shield assembly includes an adapter having an open distal terminus and an open proximal terminus to allow passage of the needle and a needle shield slidably associated with the adapter having an open distal end and an open proximal end where the open proximal end is sufficiently narrow to restrict proximal movement of the needle static feature causing the shield to move in a proximal direction when the needle is pulled proximally after the static feature has established contact with the needle shield proximal end. The assembly includes a canting plate having an unactivated first position and an activated second position that restricts needle movement. The canting plate is activated via a canting plate retention system in communication with the canting plate and responsive to proximal movement of the needle.

Abstract: A vascular access device for communicating with the vascular system of a patient may include a status indicator. The status indicator may detect and signal that a period of time has elapsed in relation to the use of the vascular access device.

Abstract: A catheter and introducer needle assembly with a needle shield is provided. The needle shield includes a means for preventing unwanted distal movement of the needle once the needle has been withdrawn into the needle shield. The needle shield also includes a means for connecting the needle shield to the catheter hub until the sharp distal tip of the introducer needle has been withdrawn into the needle shield. Thus, when the distal end of the introducer needle extends from the distal portion of the needle shield, the needle shield is connected to the catheter hub and when the sharp distal end of the introducer needle is withdrawn into the needle shield, the needle shield is disconnected from the catheter hub. At that point, the sharp needle tip is secured within the needle shield.

Abstract: A catheter and introducer needle assembly with a needle shield is provided. The needle shield includes a means for preventing unwanted distal movement of the needle once the needle has been withdrawn into the needle shield. The needle shield also includes a means for connecting the needle shield to the catheter hub until the sharp distal tip of the introducer needle has been withdrawn into the needle shield. Thus, when the distal end of the introducer needle extends from the distal portion of the needle shield, the needle shield is connected to the catheter hub and when the sharp distal end of the introducer needle is withdrawn into the needle shield, the needle shield is disconnected from the catheter hub. At that point, the sharp needle tip is secured within the needle shield.

Abstract: A vascular access device having a spring-biased septum is provided for preventing the leakage of blood during the placement and use of vascular catheters and similar devices. The structure of the device includes a housing with an internal channel. A spring-biased septum is placed securely within the channel such that it substantially blocks blood flow through the channel. The spring-biased septum includes an elastic plug having a pre-slit or pre-molded hole and a biasing element disposed about the elastic plug. A needle or other object may be withdrawn through the slit or hole, after which the biasing element forces the hole closed, preventing blood leakage.

Abstract: A catheter and introducer needle assembly with a needle shield is provided. The needle shield includes a means for preventing unwanted distal movement of the needle once the needle has been withdrawn into the needle shield. The needle shield also includes a means for connecting the needle shield to the catheter hub until the sharp distal tip of the introducer needle has been withdrawn into the needle shield. Thus, when the distal end of the introducer needle extends from the distal portion of the needle shield, the needle shield is connected to the catheter hub and when the sharp distal end of the introducer needle is withdrawn into the needle shield, the needle shield is disconnected from the catheter hub. At that point, the sharp needle tip is secured within the needle shield.