Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
  • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
  • A61M1/3621—Extra-corporeal blood circuits
  • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
  • A61M1/3659—Cannulae pertaining to extracorporeal circulation
  • A61M1/3661—Cannulae pertaining to extracorporeal circulation for haemodialysis
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0097—Catheters; Hollow probes characterised by the hub
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
  • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
  • A61M25/0026—Multi-lumen catheters with stationary elements
  • A61M25/003—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
  • A61M2025/0031—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
  • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
  • A61M25/0026—Multi-lumen catheters with stationary elements
  • A61M2025/0037—Multi-lumen catheters with stationary elements characterized by lumina being arranged side-by-side
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M2025/0188—Introducing, guiding, advancing, emplacing or holding catheters having slitted or breakaway lumens
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
  • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
  • A61M25/0026—Multi-lumen catheters with stationary elements
  • A61M25/0029—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
  • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
  • A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked

Definitions

• the present invention relates generally to medical instrumentation and more specifically to a multi-lumen catheter including y-shaped distal and proximal ends, and including selectively
• Catheters generally, are hollow, flexible tubes for insertion into a body cavity, duct, or
• Dialysis treatment provides for blood to be
• catheters are used to allow passage of a patient's blood into and out of the patient's
• the catheter tips, both in-flow and out-
• double lumen catheters e.g., U.S. Pat. No. 4,895,561
• double lumen catheters typically do not permit optimal catheter tip placement. Due to differences among patients, optimal tip position varies from
• Non-optimal tip position may significantly lower flow values, resulting in less
• a subcutaneous tunnel is made from a first end, which is near the area to
• the catheter tube is then routed forwardly into the through the subcutaneous tunnel from the second end to the first end so that the catheter tips extend
• a sheath is inserted trough the first end of the tunnel and into the area to be catheterized, and the catheter tips are
• the estimated catheter tube length and subsequent forward tunneling may result in less than optimal tip placement.
• the catheter can be reversed tunneled and trimmed to a desired length. Thereafter, the hub assembly is attached. Deficiencies, however, exist in this method of catheterization as well.
• This method requires two separate venous insertions, namely, two tunnels and two of each accessory instrument used for the procedure.
• catheter includes a selectively attachable hub assembly that allows the catheter tip to be positioned accurately within a patient's vein prior to subcutaneous tunneling.
• the distal end of the catheter tube is selectively attachable to the hub assembly. Accordingly, after the tips of the
• the other end of the catheter may be reverse
• a subcutaneous tunnel is then formed having a first end at the incision and a second end exiting the skin at a point remote from the first end of the tunnel, generally as the caudal direction.
• dilator is inserted into the tunnel, which is partially dilated so as to accommodate a tissue in- growth stabilizing cuff.
• the distal end of the catheter tube is routed through the subcutaneous
• a selectively attachable hub assembly is connected to the lumens at the distal tip of the catheter tube for subsequent connection of the catheter to a fluid exchange device, such as a
• the separable hub assembly creates the need to connect the hub • to a distal end of a multi-lumen catheter tube, thereby adding an additional step to the catheter
• the hub-catheter connection provides an additional connection which may leak or separate from the
• attachable hub assembly is a relatively complex part, which makes it difficult to manufacture and, therefore, use of the hub assembly increases the cost of the catheter itself.
• a multi-lumen catheter is provided for use in hemodialysis and the like.
• the multi-lumen catheter includes an elongated, central, multi-lumen tube portion having a distal end and a
• the central tube portion has a substantially cylindrical outer shape and is internally segmented into a plurality of lumens.
• a distal branch portion includes a plurality of
• Each distal extension tube has a proximal first end and a distal second end. The proximal first end of each distal extension tube is connected to the distal
• a proximal branch portion includes a plurality of single-lumen proximal extension tubes. Each proximal
• extension tube has a distal first end and a proximal second end. The distal first end of each
• proximal extension tube is comiected to the proximal end of the central tube portion such that the single lumen of each distal extension tube is in fluid communication with one of the plurality of lumens of the central tube portion.
• a plurality of selectively attachable connector hubs are provided, each connector hub being configured to be selectively attachable to the distal second end of one of the distal extension and being configured for selective connection to a fluid exchange device.
• Each lumen of the central tube portion and the lumens of the distal and proximal extension tubes in fluid communication therewith define a flow path through the catheter.
• An in-growth stabilizing cuff may be affixed to an outer portion of the central tube portion.
• the multi-lumen catheter may include a central tube portion having two lumens.
• the distal branch portion includes two distal extension tubes
• the proximal branch portion includes two proximal extension tubes.
• the catheter may be arranged such that the plurality of single-lumen distal extension tubes of the distal branch portion converge to form a distal multi-lumen connecting portion which connects to the distal end of the central tube portion, and the plurality of single-lumen proximal extension tubes comprising the proximal branch portion converge to form a proximal multi-lumen connecting portion which connects to the proximal end of the central tube portion.
• the central tube portion, the distal extension tubes, and the proximal extension tubes may be comprised of a fusible material, and the distal extension tubes and proximal extension tubes may be respectively fused to the distal and proximal ends of the central tube portion.
• the distal extension tubes may have a substantially cylindrical outer shape near their distal second ends, and the proximal multi-lumen connecting portion may also have substantially cylindrical outer shape.
• the proximal extension tubes may have a substantially D-shaped cross-section over at least a portion of their length. Also, the proximal extension tubes may be substantially parallel to each other in a free state, and the proximal second ends of the distal extension tubes may be
• the multi-lumen catheter may further include a plurality of connector hubs for connecting
• Each connector hub may configured to be connected to
• Each of the proximal extension tubes may include a tube wall, and each of the proximal extension tubes may include at least one opening extending
• an external portion of at least one of the distal extension tubes may include indicia which indicates a discrete flow path through the catheter.
• the two proximal extension tubes have longitudinal axes which intersect at an included angle in a free state, the included angle being in a range from about 10 degrees to about
• a y-shaped catheter junction for a multi-lumen catheter is also provided.
• the y-shaped junction includes a dual-lumen trunk, having a substantially cylindrical outer wall, a first end, a
• a first single-lumen extension tube is connected to the first end of the trunk, such that the single lumen of the first single-lumen extension tube is
• a second single-lumen extension tube is in fluid communication with the first lumen of the trunk.
• the y-shaped trunk is connected to the first end of the trunk such that the single lumen of the second single-lumen extension tube is in fluid communication with the second lumen of the trunk.
• junction is arranged such that the first lumen of the trunk and the first extension tube define a first flow path, and the second lumen of the trunk and the second extension tube define a second
• the y-shaped catheter junction may also be arranged such that the first and second
• extension tubes have longitudinal axes which intersect at an included angle near the first end of the trunk in a free state, the included angle being in a range from about 10 degrees to about 30 degrees.
• a method of forming a multi-lumen catheter is also disclosed.
• the method includes
• each extension tube is in fluid communication with one of the lumens of the length of
• the length of multi-lumen tubing may include two lumens, and the first and
• second pluralities of extension tubes may form substantially y-shaped junctions on each end of the length of multi-lumen tubing.
• the method of forming a multi-lumen catheter may include first forming a y-shaped
• the process may include providing a first length of single-lumen tubing to form
• a distal arterial extension tube providing a second length of single-lumen tubing to form a distal venal extension tube, providing a first length of multi-lumen tubing comprising at least an
• arterial lumen and a venal lumen and having a distal end and a proximal end, attaching an end of
• distal arterial extension tube is in fluid communication with the arterial lumen of the first length of multi-lumen tubing, and attaching an end of the distal venal extension tube to the distal
• the proximal end of the first length of multi-lumen tubing such that the distal venal extension tube is in fluid communication with the venal lumen of the first length of multi-lumen tubing.
• a second length of multi-lumen tubing having a distal end and a proximal end is
• the tubing includes an arterial lumen and a venal lumen.
• the connecting end of the first length of multi-lumen tubing is connected to the distal end of the second length of multi-
• the venal extension tube of the distal junction is in fluid communication with the venal lumen of the second length of multi-lumen tubing.
• a y-shaped proximal junction is also formed. This process includes providing a third
• lumen tubing which includes at least an arterial lumen and a venal lumen, and has a distal end and a proximal end. An end of the proximal arterial extension tube is attached to
• proximal arterial extension tube is in fluid communication with the arterial lumen of the third length of multi-lumen tubing.
• an end of the proximal venal extension tube is attached to the distal end of the third length of multi-lumen tubing such that the proximal venal extension tube is in fluid communication
• the attachment end of the third length of multi-lumen tubing is attached to the proximal end of the second length of multi-lumen tubing, such that the arterial extension tube of the proximal junction is in fluid communication with the arterial lumen of the second length of
• the method may also include forming at least one opening in a wall of the proximal venal extension tube, and forming at least one opening in a wall of the arterial proximal extension tube.
• the steps of attaching extension tubes and lengths of multi-lumen tubing together or to each other may include heat welding or similar fusing techniques.
• the longitudinal axes of the distal arterial extension tube and distal venal extension tube may be arranged to intersect at an included angle in a free state in a range from about 10 degrees to about 30 degrees.
• a method for surgically implanting a double-y shaped multi-lumen catheter into a patient is also provided.
• the method is suited for implanting a multi-lumen catheter having a an elongated, central, multi-lumen tube portion, a proximal end portion including a single-lumen proximal venal extension tube and a single-lumen proximal arterial extension tube each having a proximal tip, and a distal end portion including a single-lumen distal venal extension tube and a single-lumen distal arterial extension tube each having a distal end.
• the method includes making an incision in the skin of the patient, and inserting the proximal tips of the proximal venal and arterial extension tubes through the incision and placing the proximal tips in the patient.
• a subcutaneous tunnel is formed having a first end proximate to the incision and a second end remote from the first end of the tunnel.
• the distal venal and arterial extension tubes and at least a portion of the central tube portion are guided through the subcutaneous tunnel such that at least the distal ends of the distal venal and arterial extension tubes extend outwardly from the tunne] through the second end of the tum el.
• At least a portion of the distal end portion of the catheter i secured lo the patient such as by sutures or any other suitable means.
• the method may further include dilating at
• Dilation of the tunnel may be accomplished by sliding a sheath dilator along the shaft of a trocar longitudinally positioned
• the catheter implanting method may further include respectively connecting the distal arterial and venal extension tubes to arterial and venal legs of a fluid exchange device.
• Connecting the distal arterial and venal extension tubes may include connecting the distal arterial
• proximal venal and arterial extension tubes into a patient may include placing the proximal tip of
• the venal extension tube into a vein in the patient, and placing the proximal tip of the arterial
• extension tube into an artery in the patient.
• Figure 1 is a perspective view of a double y-shaped multi-lumen catheter
• Figure 2 is a cross-sectional view of a distal portion of the multi-lumen catheter of Figure
• Figure 3 is a partially exploded detail perspective view of a distal portion of the multi- lumen catheter of Figure 1;
• Figure 4 is a partially exploded detail perspective view of a proximal portion of the multi- lumen catheter of Figure 1;
• Figure 5 is a cross-sectional view of a proximal portion of the multi-lumen catheter of
• Figures 6A-6D illustrate a procedure for tunneling a multi-lumen catheter like that of Figure 1 in a patient
• Figure 7 is a partial sectional view of a sheath dilator engaged along a trocar to dilate a portion of a subcutaneous tunnel in a patient;
• Figures 8A-8C are views of a connection between a distal end of the catheter and a trocar for guiding the catheter through a subcutaneous tunnel.
• proximal refers to those portions of a catheter and those portions of components of the
• distal refers to those portions of a catheter and those portions of components
• Figure 1 shows a double-Y shaped multi-lumen catheter 10 according to the present invention.
• the catheter 10 includes a proximal end 34 for insertion into a patient, and a distal end 34 for insertion into a patient.
• catheter 10 includes an elongated, central, multi-lumen tube portion 12, a plurality of proximal
• the central tube portion 12 includes an arterial lumen 5 and a venal lumen 6.
• the catheter 10 includes a proximal venal extension tube 14
• venal extension tube 18 in fluid communication with the venal lumen 6, and a proximal arterial extension tube 16 and a distal arterial extension tube in fluid communication
• the catheter 10 may include a stabilizing cuff 15 affixed to an outer
• the cuff 15 is longitudinally positioned on the central tube portion 12 such that the cuff 15 will be finally
• FIG. 1 A construction for the distal end 36 of the multi-lumen catheter 10 is shown in Figures 1-
• a distal multi-lumen trunk may be connected to a distal end 12d of the central tube portion 12 by a distal multi-lumen trunk
• the multiple lumens of the distal trunk 30 correspond in number to the multiple lumens of
• the distal trunk 30 includes a venal distal trunk lumen 48, and an arterial distal trunk lumen 47 as shown in Figure 2. As shown in Figure 3, the proximal ends 18p, 20p of the
• distal extension tubes 18, 20 are connected to the distal end 30d of the distal trunk, thereby
• the proximal end 3 Op of the distal trunk 30 is
• the proximal end 30p of the distal trunk 30 is substantially cylindrical in shape, and is substantially equal in outer diameter to the outer
• the distal extension tubes are arranged such that an included angle " ⁇ " exists between the longitudinal axes of the tubes 18, 20 in a free state.
• ⁇ an included angle
• the angle " ⁇ " ranges from about 10 degrees to about 30 degrees.
• extension tubes 18, 20 can be arranged, however, so that the angle " ⁇ " is any desired angle.
• venal distal trunk lumen 48 is in fluid communication with the venal lumen 6 of the central tube portion 12 and the single lumen of the distal venal extension tube 18. Similarly, the arterial distal trunk lumen 47 is in fluid communication with the arterial lumen 5 of the and the single
• distal extension tubes 18, 20 maybe connected directly
• the distal end of the central tube portion 12d, and/or the distal trunk 30 are sealably fused
• interconnecting lumens of the components is established and maintained and no leakage occurs at the connections.
• the catheter 10 also includes selectively attachable connector
• the connector hubs 72, 74 are selectively attachable so that the connector hubs
• the coimector hubs 72, 74 are configured for
• the venal connector hub 74 is selectively attachable to the distal portion 18d of the distal venal extension tube 18, and the
• arterial connector hub 72 is selectively attachable to the distal portion 20d of the distal arterial
• the selectively attachable hubs 72, 74 are connectable with mating compression fittings 58, 60.
• the compression fittings may include cannulae 66, 68 and threaded male portions 62, 64 that matingly engage the distal extension tubes 18, 20 and the connector hubs 72, 74 as shown in Figure 2.
• the hubs When fully engaged, the hubs
• the luer-type fittings 50, 52 may then be connected to corresponding connector tubes 54, 56.
• the luer-type fittings 50, 52 may then be connected to corresponding connector tubes 54, 56.
• luer-type fittings 50, 52 may include quarter-turn type threads for leak-tight engagement with matching quarter-turn fittings on the venal and arterial legs of a fluid exchange device 200.
• the connector hubs 72, 74 can be selectively attached to the
• distal ends 18d, 20d of the distal extension tubes 18, 20 This arrangement permits the distal end 36 of the catheter 10 to be subcutaneously reverse tunneled in a patient as described more fully below without interference from the hubs 72, 74. After the distal end of the catheter 10 is
• the hubs 72, 74 can be backfit over the distal ends of distal extension tubes 18, 20 as shown for hub 72 in Figure 3.
• the compression sleeves 70 can then be placed over the distal
• the catheter 10 can then be connected to a fluid exchange device 200.
• FIG. 1 A construction for the proximal end 34 of the catheter 10 is shown in Figures 1, 4, and 5.
• the distal ends 14d, 16d of the proximal extension tubes 14,16 maybe connected to a proximal end 12p of the central tube portion 12 by a proximal multi-lumen trunk 32.
• proximal trunk 32 correspond in number to the multiple lumens of the central tube portion 12 and to the number of proximal extension tubes 14, 16.
• the proximal trunk 32 includes a venal proximal trunk lumen 31, and an arterial proximal trunk lumen 33 as shown in Figure 5.
• the distal ends 14d, 16d of the proximal extension tubes 14, 16 are connected to the proximal end 32p of the proximal trunk 32, thereby forming a substantially Y-shaped junction.
• the distal end 32d of the proximal trunk 32 is connected to the proximal end 12p of the central tube portion 12 as shown in Figure 5, thereby forming a substantially Y-shaped proximal end 34 on the catheter 10.
• the distal end 32d of the proximal trunk 32 is substantially cylindrical in shape, and is substantially equal in outer diameter to the outer diameter of the central tube portion 12, thereby providing a smooth transition at the juncture between the proximal trunk 32 and the central tube portion 12.
• the proximal extension tubes are arranged such that an included angle " ⁇ " exists between the longitudinal axes of the tubes 14, 16 in a free state.
• the angle " " is about 5 degrees in a rest position or free state.
• the distal extension tubes 18, 20 can be arranged, however, so that the angle " ⁇ " is any desired angle.
• the venal proximal trunk lumen 31 is in fluid communication with the venal lumen 6 of the central tube portion 12 and the single lumen of the proximal venal extension tube 14.
• the arterial proximal trunk lumen 33 is in fluid communication with the arterial lumen 5 of the central tube portion 12 and the single lumen of the proximal arterial extension tube 16.
• the proximal extension tubes 14, 16 may be connected directly to the proximal end 12p of the central tube portion 12 rather than to an interconnecting proximal trunk 32 (not shown), h either arrangement, the mating end portions of the proximal extension tubes 14, 16, the proximal end of the central tube portion 12p, and/or the proximal trunk 32 are sealably fused together, such as by heat welding or the like, such that the fluid cornmunication between the interconnected lumens of the components is established and
• the proximal arterial extension tube 16 is preferably
• extension tube 16 may be about 4 cm shorter in length than the proximal venal extension tube 14.
• the proximal venal extension tube 14 may include an end opening 43 in or near its proximal tip 14p.
• tube 14 may also include one or more transverse openings 42 in its tube wall 40. Similarly, as
• proximal arterial extension tube 16 may include an end opening 47 in
• the proximal arterial extension tube 16 may also include one or
• transverse openings 46 in its tube wall 44.
• the openings 42, 43, 46, and 47 facilitate fluid flow into or out from the proximal extension tubes 14, 16.
• the hubs 72 and 74 are selectively attachable and detachable from the distal end 36 of the
• FIGS 6A-6D A method of installing a catheter 10 in a patient is illustrated in Figures 6A-6D. As shown in Figure 6A, an incision 100 is made
• proximal tips 14p, 16p of catheter 10 are inserted through the
• incision 100 and are placed at desired locations within the patient using conventional techniques,
• a trocar 120 or other suitable instrument is used to form a subcutaneous tunnel 102 having a first end 104, which is preferably coincident with the incision 100, and an
• distal end 36 extends out from the tunnel 102 at its second end 106.
• the distal ends 18d, 20d of the distal extension tubes 18, 20 are attached to a connector 300.
• the 300 may include a first tip 302 and a second tip 304 as shown.
• the tips 302, 304 are insertable into the lumens at the distal ends 18d, 20d of the distal extension tubes 18, 20.
• the tips 302, 304 are insertable into the lumens at the distal ends 18d, 20d of the distal extension tubes 18, 20.
• the tips 302, 304 are insertable into the lumens at the distal ends 18d, 20d of the distal extension tubes 18, 20.
• the tips 302, 304 are respectively engaged in the distal
• the connector 300 holds the distal extension tubes 18, 20 in close arrangement as shown so that the distal extension tubes 18, 20 can be simultaneously subcutaneously tunneled in a patient as described below.
• the distal end of the connector 300d preferably includes a bore 306 which is configured to attachably receive an insertion tip 308 of the trocar 120.
• the bore 306 may include threads 310 which can be engaged with mating threads
• the bore 306 may include a collar portion 314 which snaps into a groove 309 on the insertion tip 308 of the trocar 120 as shown in
• the connector 300 can be disengaged from the distal extension tubes 18, 20.
• the sheath 320 may be used as shown in Figure 8B.
• the sheath 320 is placed over at least a portion of the
• the distal end 320d of the sheath 320 is tapered as shown.
• the sheath 320 and the distal portions of the catheter 10 can be drawn together through the tunnel 102 with the trocar 120.
• the sheath 320 is removed from the catheter 10 once the distal portions of the catheter 10 have been drawn through the tunnel 102.
• the distal end 36 of the catheter 10 is drawn from the second end
• the incision 100 and the second end 104 of the tunnel are suitably treated and
• An outer portion of the central tube portion 12 may include a tissue in-growth stabilizing cuff 15, as shown in Figure 1, for stabilizing the inserted catheter 10 in the patient.
• a portion 130 of tunnel 102 may be dilated to enlarge the width of the tunnel 102 to receive the cuff 15 as the catheter 10 is
• the dilated portion 130 of the tunnel is preferably dilated by sliding a sheath dilator 200 over an end 42 and shaft 4i of the trocar 120 when the trocar 120 is positioned in the subcutaneous tunnel 102 as shown in Figure 6A.
• sheath dilator 200 preferably includes a hollow bore 208, a tapered leading end 206. a substantially cylindrical portion 204, and a handle 202. The sheath dilator 200 is inserted through the first end 104 of the tunnel 102 and into the tunnel 102 until the tip 206 has been
• the sheath dilator 200 is
• the catheter 10 is connected to a fluid exchange device 200.
• the fluid exchange device 200 As shown in Figure 6D, the catheter 10 is connected to a fluid exchange device 200.
• distal end 18d of the distal venal extension tube 18 is selectively attached to a venal leg 224 of
• arterial extension tube 20 is selectively attached to an arterial leg 222 of the fluid exchange device 200 by connector hub 72.
• indicia 26 and 28 may be included on
• the indicia 26, 28 may be markings, colors, or any other distinctive indicator.
• invention also includes multi-lumen catheters including three or more lumens as required. It

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• Vascular Medicine (AREA)
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• Biophysics (AREA)
• Urology & Nephrology (AREA)
• Cardiology (AREA)
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• 2003
  • 2003-08-28 AU AU2003265836A patent/AU2003265836B2/en not_active Ceased
  • 2003-08-28 CA CA2497133A patent/CA2497133C/en not_active Expired - Lifetime
  • 2003-08-28 JP JP2004531904A patent/JP2005537064A/ja active Pending
  • 2003-08-28 CN CNA038241951A patent/CN1780657A/zh active Pending
  • 2003-08-28 MX MXPA05002272A patent/MXPA05002272A/es unknown
  • 2003-08-28 WO PCT/US2003/027078 patent/WO2004020019A2/en not_active Ceased
  • 2003-08-28 EP EP03791935.4A patent/EP1542759B1/en not_active Expired - Lifetime

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