Abstract: An insertion device for taking samples within a body. The insertion device includes a trigger housing, an outer sheath assembly, a sampling device, and a resilient member. The trigger housing includes an interior channel in which the resilient member is disposed to urge the outer sheath assembly away from a proximal end of the trigger housing. The outer sheath assembly is disposed within the interior channel of the trigger housing. The outer sheath assembly includes a body and an outer sheath attached to a distal end of the body. The sampling device is removably disposed within the outer sheath assembly and the trigger housing. The sampling device may be a removable biopsy needle assembly which is used to cock the insertion device. The removable biopsy needle assembly may be removed from the insertion device and be replaced by a needle assembly for fine needle aspiration.

Abstract: A guide wire advancer (102) for advancing a guide wire (107) into a patient and including a body having a longitudinal axis. The body includes a first portion (110) adapted to allow a user to advance a guide wire along the longitudinal axis using a finger and a thumb, and a second portion (108) connected to the first portion. The second portion (108) is adapted to allow a user to advance a guide wire (107) along the longitudinal axis using only one finger or the thumb to bias the guide wire against a platform (164) of the second portion when advancing the guide wire (107). Multiple methods of advancing a guide wire using the advancer are also disclosed.

Abstract: A filter assembly including a first body section having a first through passage with a seat defined about the through passage and including a first membrane-engaging surface and a central platform with the central platform extending about the first through passage. A second body section has a second through passage and defines a second membrane-engaging surface and a recess about the second through passage. A filter membrane is disposed within the filter membrane seat and the first and second body sections are secured to one another with a central portion of the filter membrane received within the recess and supported on the platform surface in a first plane and traversing the through passages and a peripheral portion of the filter membrane secured between the first and second membrane-engaging surfaces in a second plane spaced from the first plane.

Abstract: An inflatable gastric band incorporates a fluid channel within an outer surface of the band and an inflatable bladder on a stomach-facing side of the band. The gastric band attaches to a double lumen catheter, which communicates with a dual infusion port. One lumen communicates with the fluid channel and one port, while the other lumen communicates with the inflatable bladder and a second port. Injection of fluid into one chamber of the infusion port expands inflatable bladder, allowing adjustment to the diameter of the stoma. Injection of drugs or therapeutic agents into the second chamber allows the infusion of drugs or agents directly into the abdominal cavity of a gastric band recipient. The inflatable bladder can be continuous or segmented. A segmented bladder reduces pinching and/or folding of the inner surface of the gastric band during expansion/contraction, thereby lessening stomach pinching and/or irritation.

Abstract: A clamp guard for securing to flexible tubing such as catheters and their extension tubes and about a clamp therealong for housing the clamp at least when the clamp is in a tubing-clamping state, to prevent inadvertent contact of the clamp by a foreign body and undesirable unclamping of the clamp. The clamp guard is removable from around the clamp when desired.

Abstract: A tearaway introducer sheath assembly (10) for use in implantation of a catheter into a patient, having an elongated polytetrafluoroethylene sheath tube (12) and a proximal polyethylene hub component (16). The hub comprises two halves (22) insert molded about the sheath tube proximal end and joined to each other by frangible webs (28) enabling manual splitting. At least one pair of opposed holes (42) is formed through the tube proximal end portion 44, and a polyethylene liner (46) is inserted into the tube's proximal end portion. The polyethylene flows into the at least one pair of holes (42) to fuse with the liner, establishing a pair of physical joints (50?) integrally joining the liner (46) to a respective hub half (22). Upon manual splitting of the hub halves, the sheath tube easily splits along its length as a result of a property of the polytetrafluoroethylene material.

Abstract: A vascular guidewire introducer device (10) having a needle (52), a bulb (16), and a valve subassembly (100) through which a guidewire (14) is insertable for vascular guidewire insertion into a blood vessel (12) of a patient. The valve subassembly (100) includes a proximal fitting (102), a proximal cap (106), and a valve arrangement (104) disposed within a valve seat (118) defined by one of the fitting and the cap. The valve arrangement includes distal and proximal disc-shaped valve members (122,126) having centered slits (124,128) therethrough, and a spacer (130) disposed between the valve members. A method is disclosed for precisely centering the slits of the valve members during assembly and for retaining the valve members in their precisely centered positions in the valve seat. The valve arrangement permits use with a wide range of guidewire diameters.

Abstract: A tearaway sheath assembly (100) having a splittable sheath tube (102) a splittable hub (110), a split valve (150,250) and a split cap (180). The valve (150,250) has a slit (158,258) at least partially across the transverse distal section (154) such that transverse distal section may be displaced laterally during insertion through the slit (158,258), of a dilator (200) or a catheter. The valve (150,250) is formed in two separate halves (152A,152B;252) that are fused or adhered to each other to form a sealed weak bond (154) that is easily broken during splitting of the sheath; each valve half is mechanically affixed in a proximal valve-receiving recess (130) of the hub such as by anchor posts (136) extending through apertures (166A,166B) in ears (164A,164B) of each valve half. A two-part cap (180) is affixed to the hub proximal end (120) and traps the valve between itself and the hub.

Abstract: Catheter assembly (100) having at least one lumen (150 or 160) and joined to hub (106). While the lumen inner diameter(s) remain constant from distal end (144) of the catheter (140) to proximal end (142), the outer catheter diameter increases proximate the hub (106) providing increased resistance to kinking during connection and disconnection from medical apparatus. The increased proximal catheter diameter preferably is sufficiently large to plug the proximal end of an introducer sheath through which the catheter is inserted during patient placement, to plug the proximal sheath end and minimize blood aspiration therethrough, and later serves to fill the vascular insertion upon complete catheter insertion after removal of the introducer sheath again to minimize blood aspiration through the vascular incision. The catheter may have two lumens (150,160) or more, joined to respective extension tubes in hub (106). The two lumens may each have a respective inner diameter of between about 0.020 in and 0.025 in.

Abstract: A vascular guidewire introducer device (10) having a needle (52), a bulb (16), and a valve subassembly (100) through which a guidewire (14) is insertable for vascular guidewire insertion into a blood vessel (12) of a patient. The valve subassembly (100) includes a proximal fitting (102), a proximal cap (106), and a valve arrangement (104) disposed within a valve seat (118) defined by one of the fitting and the cap. The valve arrangement includes distal and proximal disc-shaped valve members (122,126) having centered slits (124,128) therethrough, and a spacer (130) disposed between the valve members. A method is disclosed for precisely centering the slits of the valve members during assembly and for retaining the valve members in their precisely centered positions in the valve seat. The valve arrangement permits use with a wide range of guidewire diameters.

Abstract: A method of maintaining a locking fluid in an implanted catheter including positioning a catheter assembly in a patient, the catheter assembly including a first lumen having a closed first distal end and a first proximal end, and a second lumen having a closed second distal end and a second proximal end and injecting the locking fluid into the first and second proximal ends at a low pressure such that the locking fluid enters each lumen without opening the respective closed distal end. A method of withdrawing the locking fluid is also provided.

Abstract: A catheter assembly (10) having an outer catheter (12) and an inner catheter (14) extending coaxially through the outer catheter, and a hub (16). The inner catheter (14) is axially movable within and with respect to the outer catheter (14) by use of an actuator assembly (130) such that the catheter assembly has an opened condition permitting fluid communication with vasculature of a patient, and a closed condition preventing fluid communication with the vasculature of the patient. The opened condition permits the intended use of the catheter assembly such as for hemodialysis of the patient. In the closed condition, locking solution may be maintained in the catheter assembly and later removed therefrom, with essentially no locking solution leaving the catheter assembly or entering the patient. The actuator assembly (130) is secured to a proximal end portion (128) of the inner catheter (14) as it protrudes proximally from the hub (16), where it is accessible to the practitioner.

Abstract: A tunneler (100,800) having a shaft (102,802) with an advancement end (106) and a connection end portion (104,804) having a lumen insertion tip (108,806) that may define a locating pin. At least one lumen-gripping section (120,818) is defined on the connection end portion spaced from the lumen insertion tip (108,806), and may be a barb section having at least one discrete barb (120), or an array of barbs (124), each with a sharp lumen-biting edge and a tapered lead-in surface (128) extending from the sharp edge toward the locating pin. Also, the lumen-gripping section (818) may be an annulus having a rounded lumen-engaging surface, or may be a circumferential array of nubs having rounded lumen-engaging surfaces. The connection end portion may have a plurality of axially spaced lumen-gripping sections (220,230;818) that may have the same diameters or different maximum dimensions for use with a range of sizes of catheter lumens.

Abstract: A venous access port assembly having a base, a peripheral surface, and a septum. The base defines an interior reservoir. The peripheral surface includes integrally molded X-ray discernable indicia identifying that the assembly is rated for power injection. The X-ray discernable indicia may extend through a height of the peripheral surface from a top surface to a bottom surface thereof. According to one aspect, the peripheral surface may be formed from X-ray discernable material, and the X-ray discernable indicia may be formed from the X-ray discernable material, or they may be formed by voids in the X-ray discernable material. According to another aspect, the peripheral surface may be formed from a radiotransparent or radiolucent material and applied with a radiopaque agent, and the X-ray discernable indicia may be one or more voids in the radiopaque agent or may be portions of the peripheral surface applied with the radiopaque agent.

Abstract: A venous access port assembly having a housing base, a flange, and a septum. The housing base defines an interior reservoir. The flange includes integrally molded X-ray discernable indicia identifying that the assembly is rated for power injection. The X-ray discernable indicia may extend through a height of the flange from a top surface to a bottom surface of the flange. According to one aspect, the flange may be formed from X-ray discernable material, and the X-ray discernable indicia may be formed from the X-ray discernable material of the flange, or they may be formed by voids in the X-ray discernable material. According to another aspect, the flange may be formed from a radiotransparent or radiolucent material and applied with a radiopaque agent, and the X-ray discernable indicia may be one or more voids in the radiopaque agent or may be portions of the flange applied with the radiopaque agent.

Abstract: A multilumen catheter assembly including an elongated body having a proximal end and a distal end and a first lumen having a sidewall extending between the proximal end and the distal end, a first distal opening disposed at the distal end, and a first guide wire opening disposed proximally of the distal end and co-planar with the sidewall. The assembly also includes a second lumen connected to the sidewall and extending from the proximal end toward the distal end, proximally of the distal end. The second lumen includes a second opening extending obliquely away from the sidewall distally toward the first distal opening and a second guide wire opening disposed proximally of the second opening and in a plane generally parallel to the sidewall. A method of inserting the catheter into a vessel is also disclosed.

Abstract: A tearaway sheath assembly (100) having a splittable sheath tube (102) a splittable hub (110), a splittable valve (150) and a split cap (180). The valve (150) is of the elongated duckbill type and having a slit (158) almost completely across the distal end wall (154) such that two diverging sides (156) of the distal valve portion may be moved apart during insertion therethrough of a dilator or a catheter. A two-part cap (180) is affixed to the hub proximal end (120) and traps a seating flange (168) of the valve between itself and a seating groove (136) of the hub. Pairs of opposed gaps (184,122) of the cap (180) and the hub (110) are aligned with frangible sections or seams (108) of the sheath tube (102) and frangible sections (172) and slits (166) of the valve, facilitating splitting of the assembly (100) when desired by the practitioner to peel it away from the inserted catheter.

Abstract: A tearaway sheath assembly (100) having a splittable sheath tube (102) a splittable hub (110), a split valve (150,250) and a split cap (180). The valve (150,250) has a slit (158,258) at least partially across the transverse distal section (154) such that transverse distal section may be displaced laterally during insertion through the slit (158,258), of a dilator (200) or a catheter. The valve (150,250) is formed in two separate halves (152A,152B;252) that are fused or adhered to each other to form a sealed weak bond (154) that is easily broken during splitting of the sheath; each valve half is mechanically affixed in a proximal valve-receiving recess (130) of the hub such as by anchor posts (136) extending through apertures (166A,166B) in ears (164A,164B) of each valve half. A two-part cap (180) is affixed to the hub proximal end (120) and traps the valve between itself and the hub.

Abstract: A clamp assembly (10,110) for flexible tubing (100), having a housing (12,112) and a clamp (14,114) slidable within the housing between first and second positions, to occlude the tubing when the clamp is in the second position. Both the clamp and the housing include tubing-engaging ribs (30,60;130,160) to compress the tubing when the clamp is moved from its first or open position to its second or occluding position, with the tubing-engaging ribs being axially offset to force the tubing (100) into a tortuous path causing occlusion thereof. A pair of latch arms (62) extend forwardly from the clamp to follow respective channels (32) formed into housing side walls (20,22), with latch arm free ends (64) extending beyond the end of the housing to become latchingly engaged therewith when the clamp is moved into its occluding position, and also to be exposed to be manually engaged for delatching when desired.

Abstract: A venous access port assembly having a housing base with a discharge port, a septum and a cap. An interior reservoir is defined by a well in the housing base and a bottom of the septum, and a passageway extends from the reservoir through the discharge port. The housing base includes a base flange having integrally molded therein indicia identifying an attribute of the assembly. The indicia could be formed of base flange material, or could be formed by voids in the base flange material. If of plastic material, the molded indicia could be applied with a radiopaque agent, thereby allowing the indicia (“CT”) to appear on an X-ray of the patient in a manner informing a practitioner of a particular attribute of the assembly.