Source: https://patents.google.com/patent/EP2037982B1/en
Timestamp: 2019-07-17 18:57:05
Document Index: 171997716

Matched Legal Cases: ['art 110', 'art 120', 'art 110', 'arts 110', 'art 120', 'art 120', 'art 110', 'art 110', 'art 110', 'art 410', 'art 410', 'arts 410', 'arts 410', 'art 410']

EP2037982B1 - Indwelling catheter with anti-clotting features - Google Patents
US 2005/277862 A1 describes splitable-tip catheters with bioresorbable adhesive to provide spatial separation of distal tip elements during use. Such an arrangement can be used in hemodialysis applications where it is desirable to separate blood extraction and return lumens. The adhesive facilitates insertion of the distal end of the catheter as an assembly, while the bioresorbable nature of the adhesive allows the tip elements to separate in vivo.
As an alternative to the separate catheter for the standard flow-through dialysis system, a single-bodied catheter with two separate lumens can be used for dialysis access. In this arrangement, the tip of the arterial lumen is placed 3-4 cm above the tip of the venous lumen. Like the standard flow-through arrangement, this arrangement also prevents mixture of cleansed blood with blood entering the arterial lumen. As yet another alternative, dialysis can also be performed by using a single catheter with a single lumens. In this case, the dialysis machine delivers a quantity of untreated blood and then returns treated blood in alternating cycles.
The present invention provides a catheter comprising:
a first lumen part and a second lumen part extending along a longitudinal axis in side-by-side relation, said first and second lumen parts forming a proximal portion and a distal portion of the catheter, wherein at least a distal segment of said proximal portion extends along said longitudinal axis and said first and second lumen parts separate from one another at a bifurcation between said distal and proximal portions, wherein said first lumen part extends distally from said bifurcation and includes a first bend so that said first lumen part is concavely curved toward said longitudinal axis on a first side of said longitudinal axis and said second lumen part extends distally from said bifurcation and includes a second bend so that said second lumen part is concavely curved toward said longitudinal axis on a second side of said longitudinal axis, and said first lumen part is curved so that a distal end thereof is located on said second side of said longitudinal axis.
These and ether aspects are further discussed below.
The catheter can be made from any suitable bio-compatible material, including silicone, polyurethane, polyurethane-polycarbonate copolymer, or any other plastic or polymer material. The catheter can also include an antibacterial coating. The catheter can also be treated with an anti-infection agent, such as methylene blue, for example. The catheter can be of any suitable size for placement in a vessel structure, including sizes ranging from 2.667 mm to 5 mm (8 to 15 French). Other sizes are also contemplated. The outer wall surface of the catheter or of the lumen parts forming the catheter can be cylindrical, D-shaped, double D-shaped, or split, for example. The lumen parts can also include a single lumen or multiple lumens extending within the wall of the lumen part. Multiple lumen parts can be fixed to one another along the length of the catheter. In one embodiment, lumen parts are fixed along a substantial portion of the length to a bifurcation in the lumen parts that is fixed in location between a proximal and distal portion of the catheter. In another embodiment, the lumen parts are splittable to vary the location of the bifurcation along the length of the catheter.
Catheter 100 includes a distal end portion 112 extending distally from bifurcation 106 along axial length L. Length L can be about 6 centimeters, or other suitable length. Distal end portion 112 has a non-linear profile along longitudinal axis 104. In the illustrated embodiment, distal portion 112 forms a double bend configuration to make it less likely that the distal end portion 112 can be encased in a fibrous sheath formed by the patient's body. For example, Lumen part 110 forms a first portion 116 that extends from bifurcation 106 along a bend defined by a radius R1. Lumen part 120 forms a first portion 126 that extends from bifurcation 106 along a bend that is defined by radius R2. Radius R1 and radius R2 arc located on the side of the respective lumen part 110, 120 away from longitudinal axis 104 so that the lumen parts 110, 120 separate and diverge distally away from longitudinal axis 104 and form a convex relationship toward longitudinal axis 104. Radius R1 and radius R2 can be the same, or can differ from one another.
In yet another embodiment shown in Fig. 9, a catheter 100' is similar to catheter 100 except for the distal tip of the arterial lumen part 120'. Distal tip 124' is arranged so that the distal opening is oriented in the direction of flow in the vascular structure. Accordingly the distal tip 124' includes a distal end wall 125' that is obliquely oriented to the wall 140 of lumen part 120'. The acutely angled side 127' of distal end wall 125' is positioned toward lumen part 110, and is attached to lumen part 110 to maintain the distal opening oriented in the direction of the fluid flow and away from the vessel wall. The attachment arrangement also prevents the distal opening of distal tip 124' from being obstructed by the wall 130 of lumen part 110 in the vascular structure.
In addition, catheter 400 includes end caps 430,440 associated with each respective lumen part 410, 420. End caps 430, 440 are movable relative to the distal end of lumen part 410, 420 from an open position, as shown in Fig. 11, to a closed position by manipulating the actuating members 450. The port 416 can be opened by deforming catheter 400 from its closed position by displacing end cap 430, 440 distally from its closed position to the open position. In the open position, cap 430, 440 is spaced from distal end 422, resulting in a change of length of catheter 400, so that port 416 is open to permit fluid passage from or into lumen 421. End caps 430, 440 are coupled to lumen parts 410,420 with one or more actuating members 450 that extend between lumen parts 410, 420 and end caps 430, 440. Actuating members 450 are in the form of an actuating wire in wall 418 at or adjacent the junction of the linear portion 419 and the rounded, convex portion 423. Each actuating member 450 is positioned in a lumen 451 formed in wall 418 along the length of the respective lumen part 410, 420. Such a lumen 451 for receiving the respective actuating member 450 could be formed by a flat wire coil of stainless steel or shape memory material. Actuating members 450 can also be made from stainless steel, shape memory material, or any suitable material. Actuating members 450 and one or more other actuating members or non-movable stiffening elements can be located at other locations about wall 418.
While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character. For example, for any embodiment catheter actuating mechanisms are contemplated that include micro-motors or other automatic or mechanical systems for opening and closing the fluid flow ports. All changes and modifications that come within the scope of the invention as defined by the claims are desired to be protected.
A catheter (100; 200; 300; 400), comprising:
a first lumen part (110; 210; 310; 410) and a second lumen part (120; 220; 320; 420) extending along a longitudinal axis (104; 204; 306) in side-by-side relation, said first and second lumen parts forming a proximal portion (102; 202; 302; 402) and a distal portion (112; 212; 312) of the catheter, wherein at least a distal segment (362) of said proximal portion extends along said longitudinal axis and said first and second lumen parts separate from one another at a bifurcation (106; 206) between said distal and proximal portions, wherein said first lumen part extends distally from said bifurcation and includes a first bend so that said first lumen part is concavely curved toward said longitudinal axis on a first side of said longitudinal axis and said second lumen part extends distally from said bifurcation and includes a second bend so that said second lumen part is concavely curved toward said longitudinal axis on a second side of said longitudinal axis, and characterised in that said first lumen part is curved so that a distal end (114; 214) thereof is located on said second side of said longitudinal axis.
The catheter of claim 1, wherein said first lumen part and said second lumen part each include a D-shaped wall (130; 140) along said proximal and distal portions, each of said D-shaped walls defining a central passage (132; 142) extending along said respective lumen part.
The catheter of claim 2, wherein said first and second lumen parts each include a pair of elongated stiffening elements (150a; 150b; 152a; 152b) in said wall, said elongated stiffening elements extending along said proximal and distal portions of the catheter.
The catheter of claim 3, wherein said first and second lumen parts each define a distally opening port in the distal end thereof, and further comprising a cap (430; 440) at said distal end of each of said first and second lumen parts, wherein said stiffening elements are coupled to a respective one of said caps and are movable in said wall of said respective lumen part to move said respective cap from an open position spaced from said distal end of said respective lumen part to a closed position engaged to said distal end of said respective lumen part to close said passage thereof.
The catheter of claim 4, wherein said stiffening elements of each of said first and second lumen parts are coupled with an actuator (450) adjacent a proximal end of said first and second lumen parts, said actuator being operable to selectively move each of said caps between said open and closed positions.
The catheter of claim 1, wherein said second lumen part is curved so that a distal end (124; 224) there of located on said first side of said longitudinal axis.
The catheter of claim 1, wherein said first lumen part has a length along said longitudinal axis that is greater than a length of said second lumen part along said longitudinal axis so that the distal end of said first lumen part is spaced distally of a distal end of said second lumen part along said longitudinal axis.
The catheter of claim 1, wherein said proximal portion (302) of said first and second lumen parts (310; 320) include a proximal segment (364) extending along a second longitudinal axis (304) and a bend (360) connecting said proximal segment and said distal segment (362), wherein said longitudinal axes form an angle of about 30 degrees.
The catheter of claim 1, wherein said proximal portion (402) of said first and second lumen parts (410; 420) include a proximal segment extending along a second longitudinal axis and a bend connecting said proximal segment and said distal segment, wherein said longitudinal axes are parallel to one another.
The catheter of claim 1, wherein:
said first lumen part forms a third bend at said bifurcation and said first bend is distal of said third bend, said first and third bends forming a reverse compound curve along said first lumen part: and
The catheter of claim 1, wherein at least one of said first and second lumen parts includes a distal tip and said distal tip includes a proximal part with a first wall thickness and at least one stiffening element extending in said first wall thickness, said at least one stiffening element terminating in said proximal part and said distal tip including a distal part and said wall thickness tapers distally from said proximal part along said distal part to a distal end of said distal tip.
The catheter of claim 1, wherein said first lumen part extends distally beyond a distal tip of said second lumen part, and said distal tip of said second lumen part includes a distal end wall obliquely oriented to a wall of said second lumen part at said distal tip, wherein said distal tip of said second lumen part is secured to a wall of said first lumen part.
EP2037982B1 true EP2037982B1 (en) 2012-12-12