Abstract: The present invention provides for a drug delivery mechanism for use with a protection device. The protection device has an expandable filter. The drug delivery mechanism automatically delivers a drug to the filter without requiring the intervention of the operator of the protection device. The drug delivered to the filter facilitates continued filter patency during the medical procedure.

Abstract: A tissue opening occluder comprising first and second occluder portions, each occluder portion including a frame structure and an attachment structure to attach one portion to the other portion. The frames may be utilized to constrain the tissue between the two portions enough to restrict the significant passage of blood therethrough. The frame portions may be covered by a fabric suspended from a perimeter thereof. The occluder portions are conjoined at least one point on each portion.

Abstract: A tissue opening occluder comprising first and second occluder portions, each occluder portion including a frame structure and an attachment structure to attach one portion to the other portion. The frames may be utilized to constrain the tissue between the two portions enough to restrict the significant passage of blood therethrough. The frame portions may be covered by a fabric suspended from a perimeter thereof. The occluder portions are conjoined at least one point on each portion.

Abstract: A stentless support structure capable of being at least partly assembled in situ. The support structure comprises a braided tube that is very flexible and, when elongated, becomes very long and very small in diameter, thereby being capable of placement within a small diameter catheter. The support structure is preferably constructed of one or more thin strands of a super-elastic or shape memory material such as Nitinol. When released from the catheter, the support structure folds itself into a longitudinally compact configuration. The support structure thus gains significant strength as the number of folds increase. This radial strength obviates the need for a support stent. The support structure may include attachment points for a prosthetic valve.

Abstract: Implantable occlusion devices that include one or more flanges extending from a tubular body are disclosed. The flange or flanges may assist in retention of the device within a vessel, cavity, appendage, etc. At least one flange on the occlusion device may include a concave surface proximate one end of a body. Because of the shape of the flange, e.g., its concavity, the occlusion device may resist dislocation due to e.g., the forces generated within the left atrial appendage during atrial filbrillation.

Abstract: A collapsible medical device and associated methods of occluding an abnormal opening in, for example, a body organ, wherein the medical device is shaped from plural layers of a heat-treatable metal fabric. Each of the fabric layers is formed from a plurality of metal strands and the assembly is heat-treated within a mold in order to substantially set a desired shape of the device. By incorporating plural layers in the thus-formed medical device, the ability of the device to rapidly occlude an abnormal opening in a body organ is significantly improved.

Abstract: A system and method for sizing and imaging of cardiovascular defects generally are disclosed capable of producing model images or forms that mimic the shape of defects such as openings or breaches in cardiac septum walls, so that remedial devices of the correct size and shape can be administered to occlude defects. The system uses a three-dimensional open wire imaging structure which is flexible, easy to position and does not occlude blood flow and when expanded, can be measured in situ.

Abstract: A collapsible medical device and associated methods of occluding an abnormal opening in, for example, a body organ, wherein the medical device is shaped from plural layers of a heat-treatable metal fabric. Each of the fabric layers is formed from a plurality of metal strands and the assembly is heat-treated within a mold in order to substantially set a desired shape of the device. By incorporating plural layers in the thus-formed medical device, the ability of the device to rapidly occlude an abnormal opening in a body organ is significantly improved.

Abstract: A septal defect occluder is provided having first and second occluder panels. Each occluder panel includes a fabric support structure and fabric suspended therefrom. The occluder panels are conjoined at a plurality of discrete points which are located within an area bounded by each perimeter of the fabric support structures, as well as on the fabric, to thereby form a defect conforming region for the occluder. In an alternate embodiment, each occluder panel includes a cambered fabric support structure and fabric suspended from a perimeter thereof, the occluder panels being arranged in cooperative cambered opposition such that the perimeters of the cambered fabric support structures impart a clamping force upon tissue adjacent a tissue defect interposed there between when the occluder is deployed for tissue defect occlusion.

Abstract: The present invention provides for a drug delivery mechanism for use with a protection device. The protection device has an expandable filter. The drug delivery mechanism automatically delivers a drug to the filter without requiring the intervention of the operator of the protection device. The drug delivered to the filter facilitates continued filter patency during the medical procedure.

Abstract: A septal defect occluder is provided having first and second occluder panels. Each occluder panel includes a fabric support structure and fabric suspended therefrom. The occluder panels are conjoined at a plurality of discrete points which are located within an area bounded by each perimeter of the fabric support structures, as well as on the fabric, to thereby form a defect conforming region for the occluder. In an alternate embodiment, each occluder panel includes a cambered fabric support structure and fabric suspended from a perimeter thereof, the occluder panels being arranged in cooperative cambered opposition such that the perimeters of the cambered fabric support structures impart a clamping force upon tissue adjacent a tissue defect interposed there between when the occluder is deployed for tissue defect occlusion.

Abstract: A tissue opening occluder comprising first and second occluder portions, each occluder portion including a frame structure and an attachment structure to attach one portion to the other portion. The frames may be utilized to constrain the tissue between the two portions enough to restrict the significant passage of blood therethrough. The frame portions may be covered by a fabric suspended from a perimeter thereof. The occluder portions are conjoined at least one point on each portion.

Abstract: A septal defect occluder is provided having first and second occluder panels. Each occluder panel includes a fabric support structure and fabric suspended therefrom. The occluder panels are conjoined at a plurality of discrete points which are located within an area bounded by each perimeter of the fabric support structures, as well as on the fabric, to thereby form a defect conforming region for the occluder. In an alternate embodiment, each occluder panel includes a cambered fabric support structure and fabric suspended from a perimeter thereof, the occluder panels being arranged in cooperative cambered opposition such that the perimeters of the cambered fabric support structures impart a clamping force upon tissue adjacent a tissue defect interposed there between when the occluder is deployed for tissue defect occlusion.

Abstract: A septal defect occluder is provided having first and second occluder panels. Each occluder panel includes a fabric support structure and fabric suspended therefrom. The occluder panels are conjoined at a plurality of discrete points which are located within an area bounded by each perimeter of the fabric support structures, as well as on the fabric, to thereby form a defect conforming region for the occluder.

Abstract: The present invention provides a reliable, leak-resistant site for the introduction of blunt or sharp penetrators and includes an elastomeric septum through which multiple openings are formed in the axial direction. The septum is inserted within a housing having a passageway defining an axial direction. The present invention also includes a method of using the injection or sampling site along with a method of assembling the same.

Abstract: A free flow prevention system for preventing undesired free flow of fluid through IV tubing of the type used in an infusion pump. The system comprises a spring clip having a base and a spring arm defining a channel adapted to receive the IV tubing. The spring arm is resiliently biased to a closed position in which the IV tubing is squeezed by the spring clip to close the lumen to prevent fluid flow, and the spring arm is movable against the bias to an open position wherein the lumen of the IV tubing is allowed to open to allow flow. The system also includes a clip-opening pin in the infusion pump for moving the spring arm of the clip from its closed position to the open position.

Abstract: An IV injection site adapted to receive a blunt cannula. The injection site comprises a housing having a passageway extending inwardly from its outside end, and an elastomeric septum closely received in the passageway of the housing. The septum has a bore extending into the septum from the inside end of the septum but not through the septum, and a slit extending generally in the axial direction into the septum from the outside end of the septum to the bore. When a cannula is introduced through the slit of the septum, the elastomeric material of the septum is displaced into the bore of the septum to sealingly engage the cannula along the bore of the septum.

Abstract: A method of making an injection and sampling site adapted to receive a blunt cannula. The method comprises providing an elastomeric septum, and a housing adapted to receive that septum; making a slit in the elastomeric septum; inserting the elastomeric septum into the passageway of the housing; and swaging an outer annular ledge on the housing inwardly over the septum until a septum-engaging portion of the swaging tool applies a predetermined amount of force to the septum. Before the swaging step, a pin is inserted into the passageway of the housing against the inside end of the septum to inhibit deformation of the septum during swaging.

Abstract: An injection or sampling site adapted to receive a blunt cannula includes a housing having an outside end with a passageway extending inwardly from the outside end, the passageway defining an axial direction; and an elastomeric septum closely received in the passageway of the housing. There is a slit extending through the septum generally in the axial direction which is formed by a hole through the septum that is flattened against itself to seal against itself when the septum is assembled in the housing. Either the septum-receiving portion of the housing or the septum itself has a generally elliptical cross-section to preferentially compress the hole in the septum to form the slit.

Abstract: A method of making an injection and sampling site adapted to receive a blunt cannula. The method comprises providing an elastomeric septum, and a housing adapted to receive that septum; making a slit in the elastomeric septum; inserting the elastomeric septum into the passageway of the housing; and swaging an outer annular ledge on the housing inwardly over the septum until a septum-engaging portion of the swaging tool applies a predetermined amount of force to the septum. Before the swaging step, a pin is inserted into the passageway of the housing against the inside end of the septum to inhibit deformation of the septum during swaging.