|Publication number||USRE40913 E1|
|Application number||US 10/997,558|
|Publication date||Sep 8, 2009|
|Filing date||Nov 24, 2004|
|Priority date||Jun 1, 2000|
|Also published as||US6719749, US6881211, US20040075198|
|Publication number||10997558, 997558, US RE40913 E1, US RE40913E1, US-E1-RE40913, USRE40913 E1, USRE40913E1|
|Inventors||Timothy M. Schweikert, Anthony J. Madison, Donald A. Schon|
|Original Assignee||Medical Components, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (144), Non-Patent Citations (76), Referenced by (2), Classifications (14), Legal Events (3)|
|External Links: USPTO, USPTO Assignment, Espacenet|
Catheters for the introduction or removal of fluids may be located in various venous locations and cavities throughout the body for the introduction or removal of fluids. Such catheterization may be performed by using a single catheter having multiple lumens. A typical example of a multiple lumen catheter is a dual lumen catheter in which one lumen introduces fluids and one lumen removes fluids. Catheterization may also be performed by using separate, single lumen catheters inserted through two different incisions into an area to be catheterized. Such multiple catheter assemblies are known as Tesio catheters. Procedures are also known as described in U.S. Pat. No. 5,624,413 for inserting two wholly independent single lumen catheters into a vessel through a single insertion site.
Generally, to insert any catheter in a blood vessel, the vessel is identified by aspiration with a long hollow needle in accordance with the Seldinger technique. When blood enters a syringe attached to the needle, indicating that the vessel has been found, a thin guide wire is then introduced, typically through a syringe needle or other introducer device, into the interior of the vessel. The introducer device is then removed leaving the guide wire within the vessel. The guide wire projects beyond the surface of the skin.
At this point, several options are available to a physician for catheter placement. The simplest is to pass a catheter into the vessel directly over the guide wire. The guide wire is then removed leaving the catheter in position within the vessel. However, this technique is only possible in cases where the catheter is of a relatively small diameter, made of a stiff material and not significantly larger than the guide wire, for example, for insertion of small diameter dual lumen catheters. If the catheter to be inserted is significantly larger than the guide wire, a dilator device is first passed over the guide wire to enlarge the hole. The catheter is then passed over the guide wire, and the guide wire and dilator are removed.
In the case of an individual, single-lumen catheter typically used in multiple catheter assemblies (e.g., a Tesio catheter), a physician may use an introducer sheath. If a Tesio is used for hemodialysis, for example, each catheter is inserted in two separate veins, such as the femoral vein. Alternatively, each catheter may be inserted in two different locations of the same vein, such as the internal jugular vein as noted above. The introducer sheath is simply a large, stiff thin-walled tube, which serves as a temporary conduit for the permanent catheter which is being placed. Tearaway sheaths are also available which split apart for easier removal. The introducer sheath is positioned by placing a dilator device inside of the introducer and passing both the dilator and the introducer together into the vessel over a guide wire. The guide wire, left in the vessel after insertion as described above, and the dilator are then removed, leaving the thin-walled introducer sheath in place. The catheter is placed through the introducer sheath. Each of the catheters in the assembly is typically subcutaneously secured within the patient's body by a cuff located in a subcutaneous tunnel, or by otherwise externally affixing the catheter to the body.
The Tesio catheter may also be inserted, in accordance with the technique described in U.S. Pat. No. 5,624,413 as noted above, through a single insertion point using a sheath into the vessel. The Tesio, once inserted in the vessel, is then tunneled separately through the patient in two subcutaneous tunnels for securement of the external, proximal portions of the catheter.
The Tesio double catheter assembly, while comfortable for the patient, due to its soft durometer, and very effective for hemodialysis, typically requires multiple procedures and incisions for insertion and/or for tunneling, which increase the attendant risks of the catheterization procedure. Further, in the case of side-by-side placement of two catheter tubes through a single insertion site in a vessel, while minimizing the number of procedures, can present a potential for leakage between the catheter tubes at the point where the catheter tubes pass into the vessel.
However, Tesio catheter assemblies provide catheters which are capable of independent movement within the vessel. Such catheters present several advantages over unitary multi-lumen catheters formed of a single internally divided tube when in the vessel. Because the individual tubes of a Tesio double catheter assembly are independently movable at their fluid outlets, it is possible to provide fluid intake and/or return flow around the entire circumference of the distal ends of the catheter tubes. In addition, if one tube becomes blocked, or otherwise requires replacement, it can be removed independently of the other tube. Further, the softer durometer of such catheters, which are typically made of a silicone or a similar material, reduces the risk of vessel wall damage. The 360° circumferential flow provides a more stable tube within the vessel, which is less likely to be suctioned against the vessel wall due to a pressure differential, as occasionally occurs in the use of some side-by-side multi-lumen catheters.
U.S. Pat. No. 5,718,692, issued to Schon, et al., (“the Schon catheter”) describes a self-retaining double catheter system in which each catheter can be subcutaneously secured without the use of fabric tissue ingrowth cuffs or external suturing as a result of the placement of a retaining sleeve surrounding both individual catheters in a multiple catheter assembly to hold the catheters together at the location of the sleeve. The individual catheters are permanently linked in one portion by a hub for self-anchoring under the skin, as an alternative to requiring a fabric stabilizing cuff, such that such cuffs are optional. The distal ends are longitudinally prespaced by an appropriate distance to avoid recirculation. While this device requires only one incision, it requires two subcutaneous tunnels in order to facilitate the self-retaining feature. This catheter provides independently movable distal ends within the vessel and 360° circumferential flow in the manner of a standard Tesio. Further, since the retaining sleeve is located outside the vessel when in place to provide the self-retaining feature, at the point of entry into the vessel, the catheters are side-by-side in the manner of a standard Tesio catheter, and there still remains the potential risk of blood leakage between the catheters at the vessel site.
U.S. Pat. No. 5,947,953 discloses a splittable multiple catheter assembly that has a hub and at least two fully independent catheter tubes which are initially releasably joined together, for example, by a breakable membrane. A single subcutaneous tunnel may be used in inserting the catheter, and the catheter tubes are at least partially separated by splitting the catheter tubes prior to insertion into a vessel. As a result, the portions of the catheter within the vessel are capable of independently moving and having 360° circumferential flow from the distal portion of each tube. The catheter may be secured using standard securement means such as suturing, ingrowth or other available securement devices.
A further multiple catheter assembly is described in U.S. Pat. No. 5,776,111 for use in acute Tesio catheterizations. The assembly includes two independent single lumen catheters joined at a location by a generally flat disc that may be attached to the surface of a patient's skin to secure the assembly in an acute procedure. The distal ends are prespaced to avoid recirculation.
There is a need in the art for a multiple catheter assembly and a need for making such a catheter assembly which can provide the advantages of the above-mentioned multi-lumen catheters with respect to easy insertion through a single tunneling procedure and which prevents the potential risk of leakage at the site of vessel entry, but which can still provide the advantage of multiple catheter assemblies with respect to independent movement within a vessel and good flow properties.
The present invention provides a method of making a multilumen catheter assembly, comprising forming a unitary catheter tube to have a distal portion and a distal end portion terminating in a distal end, a proximal portion terminating in a proximal end, and a first lumen and a second lumen, each of the first lumen and the second lumen extending longitudinally through the unitary catheter tube; and splitting the unitary catheter tube longitudinally along the distal end portion of the unitary catheter tube to form a first distal end tube and a second distal end tube.
The invention further includes a method of making a multilumen catheter assembly, comprising arranging a first catheter having a distal end, a distal end portion and at least one first lumen extending longitudinally therethrough and a second catheter having a distal end, a distal end portion and at least one second lumen extending longitudinally therethrough such that the first catheter and the second catheter are substantially longitudinally parallel; and forming an outer layer around at least a portion of an exterior surface of the first catheter proximal to the distal end portion of the first catheter and around at least a portion of an exterior surface of the second catheter proximal to the distal end portion of the second catheter such that first catheter and the second catheter are fixed within the outer layer, the first lumen and the second lumen are generally parallel within the outer layer and the distal end portions of the first and second catheters extend outwardly and distally from the portions of the exterior surfaces of the first and second catheters which are within the outer layer and the distal end portions are capable of independent movement.
The invention also includes, in one embodiment, a method of making a multilumen catheter assembly which comprises forming a unitary catheter tube to have a distal portion and a distal end portion terminating in a distal end, a proximal portion terminating in a proximal end, and a first lumen and a second lumen, each of the first lumen and the second lumen extending longitudinally through the unitary catheter tube; forming a first distal end tube having a first passageway extending longitudinally therethrough and a second distal end tube having a second passageway extending longitudinally therethrough; and attaching the first and second distal end tubes to the distal end of the unitary catheter tube such that the first passageway in the first distal end tube is in communication with the first lumen of the unitary catheter tube and the second passageway in the second distal end tube is in communication with the second lumen in the unitary catheter tube.
A multilumen catheter assembly is included in the invention which comprises a unitary catheter having an exterior surface and a first lumen and a second lumen extending longitudinally therethrough, a distal end and a proximal end; and a first distal end tube defining a first longitudinally extending passageway and a second distal end tube defining a second longitudinally extending passageway, wherein the first and second distal end tubes extend distally from the distal end of the unitary catheter, the first passageway in the first distal end tube is in fluid communication with the first lumen, the second passageway in the second distal end tube is in fluid communication with the second lumen and the first and second distal end tubes are capable of independent movement with respect to each other.
The invention also encompasses a method for inserting a multilumen catheter assembly into an area of a body to be catheterized. The multilumen catheter assembly comprises a unitary catheter having an exterior surface and at least a first lumen and a second lumen extending longitudinally therethrough, a distal end and a proximal end; and at least a first distal end tube defining a first longitudinally extending passageway and a second distal end tube defining a second longitudinally extending passageway, wherein the first and second distal end tubes extend distally from the distal end of the unitary catheter, the first passageway in the first distal end tube is in fluid communication with the first lumen, the second passageway in the second distal end tube is in fluid communication with the second lumen and the first and second distal end tubes are capable of independent movement with respect to each other. The method comprises making an incision near the area to be catheterized; inserting the first and second distal end tubes through the incision and into the area to be catheterized until the first and second distal end tubes are fully within the area to be catheterized and a portion of the unitary catheter extends into the area to be catheterized; and securing the proximal end of the unitary catheter.
The foregoing summary, as well as the following detailed description of preferred embodiments of the invention, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there are shown in the drawings embodiments which are presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown. In the drawings, the same reference numerals are employed for designating the same elements throughout the several figures. In the drawings:
Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. The words “right,” “left,” “outwardly” and “inwardly” designate directions in the drawings to which reference is made. The words “proximal” and “distal” refer to directions away from and closer to, respectively, the insertion tips of the first and second catheters in the multiple catheter assembly according to the present invention. The terminology includes the words above specifically mentioned, derivatives thereof, and words of similar import.
The following describes preferred embodiments of the invention. However, it should be understood, based on this disclosure, that the invention is not limited by the preferred embodiments described herein. Referring now: to the drawings in detail, there are shown in
The multilumen catheter assembly 10 of the present invention can be adapted for use in various applications in which bodily fluids, medicaments or other solutions are introduced into and removed from the body such as perfusion, infusion, plasmapheresis, hemodialysis, chemotherapy, and the like. The catheter assembly 10 is particularly suitable for chronic hemodialysis and apheresis. The area to be catheterized is preferably a blood vessel such as an internal jugular vein, but may be any suitable area within the body. Other areas in which the catheter assembly may be used include, for example, other blood vessels, including the femoral and subclavian veins, any abscess cavity, post-operative cavity, the peritoneal cavity, and other areas of the body including intra-abdominal, sub-diaphragmatic and sub-hepatic areas. It should be understood by one of ordinary skill in the art from this disclosure that these areas are exemplary, and that the catheter assembly may be used to remove or introduce fluids in various areas to be catheterized.
The embodiment of the invention shown in
For the purposes of describing the preferred embodiment of the present invention, the device will be described with respect to the preferred application of hemodialysis, more specifically, for purifying blood flowing through the internal jugular vein 19. However, it will be understood by one skilled in the art based on this disclosure, that the assembly can be configured and adapted, by increasing or decreasing the size (diameter or length) and/or number of distal end tubes and/or lumens in the assembly, such that the assembly can be beneficially used for other medical applications in which fluids are introduced into and/or removed from the body.
Referring now to the embodiment of FIG. 1 and
Preferably, the first and second distal end tubes 26, 30 and/or the passageways 28, 32 through the end tubes and the first and second lumens 22, 23 have a generally circular cross section as shown in
It is further within the scope of the invention that the distal end tubes have varying diameters or distal end shapes as are known in the art or to be developed. For example, the distal end tubes may have a larger diameter proximate to the unitary catheter which transitions abruptly or gradually to a smaller diameter proximate to the distal ends of the tubes. Alternatively, a more tapered, conical or angled distal end may be provided for varying applications. However, blunt ends, preferably formed of soft durometer material are preferred for the catheter and distal ends to provide comfort to the patient and avoid vessel wall trauma and stenosis.
The first and second distal end tubes 26, 30 have respective first and second distal ends 26a and 30a. Preferably, as shown in
A fabric tissue ingrowth cuff 44 or other similar subcutaneous securement device is preferably provided on the unitary catheter 20, which can be used to allow subcutaneous tissue or other body tissue depending upon the application of the catheter assembly to grow into the cuff 44 to thereby secure the catheter, preferably in chronic catheterizations. However, it will be understood based on this disclosure that other securement methods and devices known or to be developed may be used with the assembly and in methods according to the present invention.
With reference to
The hub 24 is sealed, such as by bonding, adhering, heat molding or otherwise attaching the hub 24 to the distal ends 42, 43 of the extension tubes 38, 39 and proximal end 46 of the unitary catheter 20. In one embodiment of the invention, described in further detail below, the extension tubes 38, 39 are proximal portions of two separate catheters which are then coated with an outer layer, preferably by heat molding, to form the unitary catheter portion of the assembly. As such, the extension tubes 38, 39 are continuous with the unitary catheter 20 and the hub 24 can be simply molded or otherwise adhered around the end of the unitary catheter and around the proximally extending portions of the catheters within the outer layer.
The catheter assembly further preferably comprises connection devices for connecting the extension tubes 38, 39 to a hemodialysis unit. Any suitable connector may be used. Preferably, a detachable quick connect device is used such as that shown in FIG. 1. Such connector devices are known in the art and are commercially available on catheters available from Medical Components, Inc., Harleysville, Pa. As such they are described herein for convenience purposes, however, since other connectors may be used, while preferred, the connectors shown in
The connectors in
The connector may have a further, replaceable and detachable connection section including detachable tubes 52 which are preferably made of a more resilient and easily replaceable material than extension tubes 38, 39. While this is not necessary, it enables the use of softer durometer materials to be used for the extension tubes, but avoids possible damage to them from clamps or quick changes to connect to hemodialysis equipment. Clamps 56 may also be provided to stop flow or seal off tubes when not in use. Standard luer locks 58 or similar connectors may be provided on the proximal ends of the tubes 52 to connect to dialysis equipment.
The distal end tubes 26 and 30 extend from the unitary catheter 20 and are formed by splitting an initially formed unitary catheter tube and by grinding and polishing to yield smooth, round tubes as described below. The hub 24 attaches the extension tubes 38, 39 to the unitary catheter 20.
The first distal end tube 26 and the second distal end tube 30, the unitary catheter tube 20, the extension tubes 38, 39 and the hub are all preferably made of biocompatible plastics or elastomers, most preferably biocompatible elastomers.
Suitable biocompatible plastics may be selected from materials such as, for example, polyurethane, polyethylene, homopolymers and copolymers of vinyl acetate such as ethylene vinyl acetate copolymer, polyvinylchlorides, homopolymers and copolymers of acrylates such as polymethylmethacrylate, polyethylmethacrylate, polymethacarylate, ethylene glycol dimethacrylate, ethylene dimethacrylate and hydroxymethyl methacrylate, polyurethanes, polyvinylpyrrolidone, 2-pyrrolidone, polyacrylonitrile butadiene, polycarbonates, polyamides, fluoropolymers such as homopolymers and copolymers of polytetrafluoroethylene and polyvinyl fluoride, polystyrenes, homopolymers and copolymers of styrene acrylonitrile, cellulose acetate, homopolymers and copolymers of acrylonitrile butadiene styrene, polymethylpentene, polysulfones, polyesters, polyimides, polyisobutylene, polymethylstyrene and other similar compounds known to those skilled in the art. It should be understood that these possible biocompatible polymers are included above for exemplary purposes and should not be construed as limiting. If a biocompatible polymeric material is used to form the unitary catheter 20, distal end tubes 26, 30 and preferably the extension tubes 38, 39 it is most preferred that the polymeric material includes a polyurethane polymer or a polyolefin polymeric material having a preferably soft durometer, as specified below.
The extension tubes 38, 39 may be made separately from the unitary catheter and distal end tubes and formed of a material such as a polyurethane or a polyvinyl chloride polymer or elastomer. However, it is preferred that the extension tubes 38, 39 are formed of the same material as the unitary catheter and distal end tubes.
It is most preferred to use a biocompatible elastomer to form the unitary catheter, distal end tubes, hub and extension tubes. Suitable, preferred, biocompatible elastomers for use in forming the unitary catheter 20, distal end tubes 26, 30 and preferably the extension tubes 38, 39 include biocompatible elastomers such as medical grade silicone rubbers, polyvinyl chloride elastomers, polyolefin homopolymeric and copolymeric elastomers, urethane-based elastomers, and natural rubber or other synthetic rubbers. Preferably, the unitary catheter, distal end tubes and extension tubes are made of the elastomeric material such that they are flexible, durable, soft, and with respect to those portions inserted in the patient or tunneled, they are easily conformable to the shape of the area to be catheterized 12 and/or the subcutaneous area 16. Further, these materials help to minimize risk of harm to vessel walls.
If the catheter assembly 10 is used for hemodialysis applications, the unitary catheter 20, distal end tubes 26, 30 and preferably the extension tubes are most preferably formed of a soft silicone elastomer which has a hardness of from about 75-A to about 85-A on a Shore durometer scale. Suitable, preferred elastomers include silicone or polyurethane elastomers, and most preferably polyurethane elastomers, such as, for example, Pelletane® from Dow Corning, or as Tecothane®, Carbothane® or Tecoflex® available from Thermetics. The distal end tubes 26, 30 may also optionally be made such that they include 20% barium sulfate in the elastomer to provide radiopacity if desired. While it is preferred to have a Shore-A durometer hardness in the above Shore-A durometer range and a somewhat soft material, if a biocompatible elastomer is used, particularly for hemodialysis, it is also possible to make a device from an elastomer having a lower Shore-A durometer hardness outside this range, particularly one which is more rigid material if a particular application so requires, without departing from the spirit of the invention. It is also preferred that the hub is formed of an elastomeric material, and most preferably the same material as the remaining components of the assembly 10. However, the hub while preferably somewhat flexible, may also preferably be somewhat harder and more rigid, by about 5-10 points on the Shore-A durometer scale, than the unitary catheter, distal end tubes and extension tubes. It will be understood based on this disclosure that the softness or rigidity may be varied for different applications.
Most preferably, the unitary catheter 20 and distal end tubes 26, 30 are formed of Carbothane® of durometer of about 75-A, extension tubes 38, 39 of Carbothane® 75-A or 85-A and a Carbothane® hub of about 85-A durometer. Alternatively, a preferred combination may be formed of a Tecoflex® of durometer of about 80-A for the unitary catheter 20 and distal end tubes 26, 30, and a Pelletane® of durometer of about 80-A for the hub and/or extension tubes 38, 39. The additional components for attaching to dialysis or similar equipment including luers, connectors and the like are preferably formed of a polymeric and/or elastomeric material such as acetal, silicone 80-A or polyvinyl chloride. However, such connectors may be formed from any suitable material known or to be developed in the art for forming such connectors and/or adapters.
The invention further includes methods for making a multilumen catheter assembly such as the assembly of FIG. 1. The method will be illustrated with respect to FIG. 1 and
As shown in
After the unitary catheter tube and distal tubes are formed, the exterior surface 36 of the unitary catheter tube and the exterior surfaces 34, 40 of the distal end tubes are then ground and polished by radio frequency (RF) tipping to provide a smooth surface. This process involves using RF energy to re-heat the outer surface until there is some melting and to polish the surface. Further, the distal end tubes 26, 30 preferably undergo this procedure on a mandrel such that they may be re-shaped to have a generally circular transverse cross section both in the interior passageways 28, 32 and on the exterior surfaces 34, 40 as shown in
As an alternative to splitting the unitary catheter, after forming the unitary catheter tube 60, distal end tubing of lengths l1, l2 (which may be previously extruded or heat molded) may then be fused onto the unitary catheter tube 60. The two distal end tubes are formed such that they have respectively longitudinal passageways 28, 32 extending therethrough, and may also be formed to include a plurality of holes 33 either prior to attaching to the distal end of the unitary catheter tube or such holes may be formed after attaching to the unitary catheter tube 60. The formed distal end tubes are then attached by a suitable heat molding or other form of attachment such as an adhesive, ultrasonic welding or other methods known in the art, to the distal end of the unitary catheter tube such that the first passageway in the first distal end tube is in communication with the first lumen of the unitary catheter tube and the second passageway in the second distal end tube is in communication with the second lumen in the unitary catheter tube. Preferably heat fusing is used to attach the distal end tubes, and the fusing may be carried out using heat applied to the unitary catheter tube and distal end tubing lengths in a female cavity mold to thereby create a smooth fused portion where the tube 60, and end tube lengths meet. The resulting structure would be of the same basic appearance of the device of
The extension tubes 38, 39 may be provided either by extruding or molding them initially when forming the unitary catheter tube 60 using techniques similar to those used to form the distal end tubes as described above. However, it is more preferred to attach the extension tubes to the proximal end 46 of the unitary catheter tube using the technique illustrated in FIG. 7D. Metal rods 68 are used which are bent to provide a desired angle of separation for the proximity extending projections 45 of the hub 24 once formed. The angle may be varied within the scope of the invention, preferably from about 25° to about 50°, and more preferably about 36°. The metal rods are inserted through the extension tubes 38, 39 and through the lumens within the unitary catheter tube 60 as formed in the manner described above. The extension tubes are spaced from the proximal end 46 of the unitary catheter tube 60 a distance slightly less than the size of the hub mold such that when the hub is molded around the extension tubes and unitary catheter tube, the hub will overlap the tubes for a watertight seal. The assembled rods and tubes are then placed in a mold and the hub 24 molded around the tubes as shown in phantom lines in FIG. 7D. After forming the extension tubes 38, 39 in connection by the hub to the unitary catheter tube 60, the metal rods are removed, and the connector assembly shown in
In one embodiment of the method of the invention, as shown in
An outer layer 76 is formed around at least a portion 77 of the exterior surfaces 78, 80 of the first and second catheters 68, 70 which is proximal to the distal end portions 74, 75 of the catheters. The outer layer is preferably extruded around the two catheters. However, the arrangement of catheters and formation of the outer layer 76 may also be formed by extruding the two catheters simultaneously through dies while coextruding the outer layer 76 around the catheters 68, 70. However, the outer layer is coextruded only over a portion of the exterior surfaces of the catheters proximal to the distal end portions 74, 75. Once the outer layer is formed, sufficient heat molding capability may be applied to heat mold the first and second catheters together. The lumens are generally longitudinally parallel and the catheters are heat molded together, preferably in juxtaposed relation and fixed within the outer layer. The distal end portions of the catheters extend outwardly and distally from the portions of the exterior surfaces of the first and second catheters which are within the outer layer. Since the distal end portions are not connected, they are capable of independent movement. It is also within the scope of the invention to heat mold a fill material between the first and second catheters to ensure that a smooth, oval exterior surface is formed around the catheters once the outer layer is formed.
As with the method discussed above, extension tubes may be provided to the ends of the catheters if the outer layer is formed to extend to the proximal ends of the catheter tubes in the manner shown in
The multilumen catheter assembly is preferably used in hemodialysis and may be inserted as described below. Referring to again to
In an embodiment of one method of inserting a catheter according to the present invention as shown in
In another embodiment of the present invention method as shown in
Referring to FIGS. 1 and 4-6, each of the catheters 26, 30 is configured to have a suitable length and width useful for insertion into the internal jugular vein 19 as described. The distal end tubes 26, 30 are of different lengths as described above and their ends 26a and 30a are proximally and longitudinally spaced from each other by a sufficient distance which is the difference between 11 and 12 which substantially prevents recirculation of the purified blood and blood to be purified. The distance is preferably from about 3 to about 4 centimeters, however, it should be understood by one of ordinary skill in the art, based on this disclosure, that the ends can be flush with each other and the distance between the ends 26a, 30a can be varied for different applications of the multilumen catheter assembly 10. Since blood flows toward the atrium, the blood flow in the internal jugular vein 19 is in a downward direction in
During use of the multilumen catheter assembly 10 for hemodialysis, blood is preferably drawn out of the internal jugular vein 19 (i.e., the arterial flow) through the distal end 26a of the first distal end tube 26 (upstream catheter) and returned (i.e., the venous flow) through the distal end 30a of the second distal end tube 30 (downstream catheter). This flow direction may be reversed depending upon the desired flow rate and concerns associated with approaching the atrium during hemodialysis for the internal jugular vein. It should be understood by one of ordinary skill in the art, based on the this disclosure, that either direction of flow may be used provided that flow in both lumens for hemodialysis applications is in opposite directions. If flow is reversed to draw from near the atrium, higher flow rates for high flow rate dialysis devices of flow rates of about 450 cc/min may be achieved. The ability to use higher flow rates without collapse of the lumens, as in multiple lumen catheters, decreases the time necessary for a patient to undergo conventional dialysis treatments, a significant patient benefit.
Referring now to the acute catheterization procedure of
The distal end tubes 26, 30 are inserted into, and through, the sheath in juxtaposed relationship. The distal end tubes 26, 30 are inserted until they are properly positioned within the area 12, as shown in FIG. 4 and the unitary catheter 20 extends through the vessel entry site 112. The sheath is then removed in the conventional manner, leaving the distal end tubes 26, 30 in the area 12. As shown in
Next, the incision 110 is closed and the proximal portion 81 of the unitary catheter 20 is secured to an external surface 18 of the body 14 by fastening material 84, such as adhesive tape. The incision 110 may also be closed after securement. While not necessary in acute catheterization, tunneling and subcutaneous securement can be effected by use of a trocar as discussed below with respect to chronic catheterization. The luer locks 58 are connected in fluid communication to respective fluid inlets and outlets of a hemodialysis unit, or other fluid transfer equipment (not shown) and dialysis may now begin.
The chronic catheterization procedure is now described with respect to
Referring now to
To further ensure that the proximal portion 81 of the unitary catheter remains secured in the subcutaneous area 16 of the body 14, one or more anchoring members, such as a tissue ingrowth cuff 44 may be positioned around (i.e., circumferentially disposed on) the proximal portion 81 of the unitary catheter 20, such that the anchoring members will be situated in the subcutaneous area 16 after tunneling, as is well-known in the prior art.
The present invention provides the advantages of a Tesio or Schon multiple catheter assembly, in that is has two freely movable distal tips, while also providing the advantages of a single insertion method, and the ability to easily manipulate the proximal portion of the unitary catheter 20 and tunnel with only one tunneling procedure. The unitary catheter 20 has a smooth, generally convex exterior surface, which passes through the insertion site 112. With reference to
By having the unitary catheter 20, which has the smooth, generally curved surface, the vessel wall 19a can seal quite well around the surface particularly well with a ligature. Since there is a good seal at the insertion site 112, the risk of blood loss around the unitary catheter 20 is minimized.
The smooth, round distal end tubes 26 and 30 do not have any protuberances on their surfaces that would promote clotting. A rough external surface provides protuberances, which can be points where clotting can begin. The distal end tubes 26 and 30 have smooth, round exterior surfaces that float freely within the vessel 19, which do not provide a source of clot formation. The free-floating distal end tubes 26 and 30 provide the many advantages of an individual catheter tube, such as provided by a Tesio catheter, including no tendency to suction against an inside surface of the vessel wall 19a, which minimizes the tendency of stenosis. The multilumen catheter assembly 10 further has little tendency to kink, since the unitary catheter 20 has a good deal of support due to the thickness of its walls and cross-section and due to the smoothness of the separate catheter tubes.
It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the appended claims.
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|1||11.0 French Uldall Double Lumen Hemodialysis Catheter Tray, 2 pages, date unknown.|
|2||Amended Answer to Complaint, Counterclaim and Jury Demand against Medical Components, Inc. by Spire Biomedical, Inc., Spire Corporation. (Entered: Aug. 31, 2007).|
|3||Answer to Complaint Affirmative Defenses, Counterclaims, and Demand for Jury, Counterclaim Against Medical Components, Inc. by Arrow International, Inc. (Entered: Aug. 22, 2007).|
|4||Answer to Complaint together with Affirmative Defenses, Amended Counterclaims and Demand for Jury, Counterclaim, against Medical Components, Inc. by Arrow International, Inc. (Entered: Sep. 6, 2007).|
|5||Answer to Complaint, Counterclaim and Jury Demand against Medical Components, Inc. by Spire Biomedical, Inc., Spire Corporation. (Entered: Aug. 23, 2007).|
|6||Answer to Counterclaim by Medical Components, Inc. with Affirmative Defenses, Certificate to Service. (Entered: Sep. 19, 2007).|
|7||Anwser to Counterclaim by Medical Components, Inc. with Affirmative Defenses, Certificate of Service. (Entered: Sep. 19, 2007).|
|8||Arrow International, Inc.'s Answer to Complaint together with Affirmative Defenses, Second Amended Counterclaims, and Demand for Jury, Counterclaim against Medical Components, Inc. by Arrow International, Inc. (Entered: Jun. 26, 2008).|
|9||Arrow International, Inc.'s Initial Non-Infringement and Invalidity Contentions (Oct. 17, 2007).|
|10||Arrow International, Inc.'s Proposed Claim Terms and Construction Counterproposal (Nov. 12, 2007).|
|11||Arrow International, Inc's Request for Admission (Mar. 31, 2008).|
|12||Arrow's Response to Medcomp's First Set of Interrogatories to Arrow International, Inc. (Oct. 3, 2007).|
|13||Arrow's Second Supplemental Response to Medcomp's First Set of Interrogatories (Jul. 2, 2008).|
|14||*||B. Canaud, J.J. Beraud, H. Joyeux, C. Mion. "Internal Jugular Vein □□Cannulation with Two Silicone Rubber Catheters" Artificial Organs, 1986; □□10(5):397-403.|
|15||*||Brochure Entitled "Schon Cath" (One Dual Catheter) Permanent Access, 2 □□pages (Jul. 1996).|
|16||*||Brochure entitled, "The MedComp Tesio Catheter", MEDCOMP, Harleysville, PA, □□date unknown, 4 pages.|
|17||Claim Construction Order Signed by Honorable Paul S. Diamond on May 19, 2008. (Entered: May 20, 2008).|
|18||Clinical Instrument Corp. Swan-Ganz catheter FDA 510(k) database entry (Rec'd: Jun. 9, 1977; Approved: Dec. 20, 1977).|
|19||Complaint against Arrow International, Inc., filed by Medical Components, Inc. (Entered: Jul. 12, 2007).|
|20||Complaint against Spire Biomedical, Inc., Spire Corporation, filed by Medical Components, Inc. (Entered: Jul. 12, 2007).|
|21||Defendant Spire Biomedical, Inc. and Spire Corporation's Counterproposal of Claim Terms and Constructions (Nov. 9, 2007).|
|22||Defendant's Claim Construction Brief by Arrow International, Inc. (Entered: Jan. 31, 2008).|
|23||Deposition Transcript of Kevin Mauch, inventor of U.S. Pat. 6,117,117 (Feb. 26, 2008).|
|24||Deseret Polymer Research, Becton Dickinson Safedwel Plus catheter FDA 510(k) database entry (Rec'd: Oct. 9, 1991; Approved: Oct. 13, 1992).|
|25||Edwards Presep Oligon Oximetry Catheter FDA 510(k) Summary (Date Prepared: Jan. 10, 2006).|
|26||Edwards Presep Oximetry and PediaSat Oximetry Catheters FDA 510(k) Summary (Date Prepared: Dec. 21, 2005).|
|27||Expert Report of Howard Pearsall (Jul. 8, 2008).|
|28||*||F. Tesio, et al. "Double Catheterization of the Internal Jugular Vein for □□Hemodialysis: Indications, Techniques and Results" Artificial Organs, 1994; □□18(4):301-304.|
|29||Haskel, et al., "Management of Hemodialysis Catheters," Applied Radiology, Jul. 1999, pp. 14-24.|
|30||*||Hocken, A.G., "Percutaneous Femoral Vein Catheterization for Hemodialysis: □□A Single Needle Technique,"Clinical Nephrology,vol. 12, No. 2, 1979, pp. 93-94.|
|31||Kelly, et al., "A Change in Flushing Protocols of Central Venous Catheters," Oncology Nursing Forum, 1992, 19(4):599-605.|
|32||Mankus, et al., "The Duo Split Acute Hemodialysis Cathether: A Two-Limbed Acute Hemodialysis Catheter with Novel Technique for Insertion," ASAIO Journal, Mar./Apr. 2000, 46(2).|
|33||Medcomp Medical Components, Inc.'s Proposed Claim Terms and Constructions (Oct. 29, 2007).|
|34||Medcomp's Amended Initial Infringement Contentions to Arrow (Jan. 18, 2008).|
|35||Medcomp's Amended Response to Arrow's First Set of Interrogatories (Dec. 10, 2007).|
|36||Medcomp's First Supplemental Response to Arrow's First Set of Document Requests (Feb. 11, 2008).|
|37||Medcomp's First Supplemental Response to Arrow's First Set of Interrogatories (Feb. 11, 2008).|
|38||Medcomp's First Supplemental Response to Arrow's First Set of Interrogatories (Oct. 25, 2007).|
|39||Medcomp's Initial Non-Invalidity Contentions to Arrow (Nov. 5, 2007).|
|40||Medcomp's Response to Arrow's First Set of Document Requests (Oct. 1, 2007).|
|41||Medcomp's Response to Arrow's First Set of Interrogatories (Oct. 1, 2007).|
|42||Medcomp's Responses and Objections to Arrow's Requests for Admissions (Apr. 30, 2008).|
|43||Medcomp's Second Set of Interrogatories to Arrow (Feb. 8, 2008).|
|44||Medical Components, Inc.'s Amended Initial Non-Invalidity Contentions (Dec. 10, 2007).|
|45||Medical Components, Inc.'s Amended Response to Defendants' First Set of Interrogatories (Dec. 10, 2007).|
|46||Medical Components, Inc.'s Initial Infringement Contentions (Oct. 1, 2007).|
|47||Medical Components, Inc.'s Response to Defendants' First Request for Production of Documents (Oct. 29, 2007).|
|48||Medical Components, Inc.'s Response to Defendants' First Set of Interrogatories (Oct. 29, 2007).|
|49||Memorandum in Opposition re Motion for Partial Summary Judgment of Infringement filed Arrow International, Inc., Certificate of Service. Modified on May 13, 2008. (Entered: May 12, 2008).|
|50||Memorandum In Opposition to Plaintiff's Motion to Dismiss Arrow's Third Counterclaim by Arrow International, Inc. with Certificate of Service. Modified on Jul. 25, 2008 (Entered: Jul. 24, 2008).|
|51||Motion for Partial Summary Judgment of Infringement filed by Medical Components, Inc. Memorandum of Law, Certificate by Service. (Attachments: # 1 Text of Proposed Order, # 2 Memorandum of Law, # 3 Exhibit A, # 4 Exhibit B, # 5 Exhibit C, # 6 Exhibit D, # 7 Exhibit E, # 8 Exhibit F, # 9 Exhibit G, # 10 Exhibit H, # 11 Exhibit I, # 12 Exhibit J) (Entered: Apr. 11, 2008).|
|52||Motion for Summary Judgment filed by Arrow International, Inc. Memorandum, Declaration with Exhibits, Certificate of Service (Entered: Nov. 21, 2007).|
|53||Motion to Dismiss Defendant Arrow International, Inc.'s Third Counterclaim filed by Medical Components, Inc. Memorandum of Law, Certificate of Service. (Entered: Jul. 11, 2008).|
|54||Order that the Motion for Partial Summary Judgment is Denied. Signed by Honorable Paul S. Diamond on Jun. 30, 2008. Jul. 1, 2008 Entered and Copies E-Mailed. (Entered: Jul. 1, 2008).|
|55||Order that the Motion for Summary Judgment is Denied Without Prejudice, Signed by Honorable Paul S. Diamond on Jun. 25, 2008. Jun. 26, 2008 Entered and Copies E-Mailed. (Entered: Jun. 26, 2008).|
|56||Order that the Stipulation of Dismissal of all Claims is Entered and all Pending Claims and Counterclaims Asserted in this Action by and between Plaintiff and Counterclaim Defendant Medical Components, Inc. and Defendants and Counterclaim Plaintiffs Spire Biomedical, Inc. and Spire Corporation are Hereby Dismissed with Prejudice. Each Party to Bear its own cost. Signed by honorable Paul S. Diamond on Feb. 21, 2008.|
|57||Patel, et al., "Sheathless Technique of Ash Split-Cath Insertion," J. Vasc. Interv Radiol., 2001, 12:376-378.|
|58||Peter Steele and Hywel Davies, "The Swan-Ganz catheter in the cardiac laboratory," 35 British Heart Journal, 647-650 (1973).|
|59||Plaintiff Medical Components, Inc.'s Proposed Claim Terms and Construtions (Oct. 29, 2007).|
|60||Plaintiff's Claim Construciton Reply Brief by Medical Components, Inc., Certificate of Service. Modified on Mar. 6, 2008 (Entered: Feb. 29, 2008).|
|61||Reply to Response to Motion re Motion for Leave to File Second Amended Counterclaims filed by Arrow International, Inc. (Attachments: # 1 Exhibit B, # 2 Exhibit C, # 3 Exhibit D, # 4 Certificate of Service) (Entered: Jun. 23, 2008).|
|62||Reply to Response to Motion re Motion for Partial Summary Judgment of Intringement filed by Medical Components, Inc. Certificate of Service attached. (Entered: May 23, 2008).|
|63||Response in Opposition re Motion for Summary Judgment filed by Medical Components, Inc. (Attachments: # 1 Exhibits 1-7, # 2 Exhibits 8-15) (Entered: Dec. 10, 2007).|
|64||Response to Motion re Motion for Leave to File Second Amended Counterclaims filed by Medical Components, Inc. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C) (Entered: Jun. 13, 2008).|
|65||*||Sheet listing three references, dated 1999 (Cook Critical Care).|
|66||Stanco Medical, Inc. Swan-Ganz catheter FDA 510(k) database entry (Rec'd: Sep. 19, 1980; Approved: Nov. 20, 1980).|
|67||Statement Defendants' Responsive Claim Construction Brief by Spire Biomedical, Inc., Spire Corporation. (Entered: Jan. 31, 2008).|
|68||Stipulation of Dismissal with Prejudice by Medical Components, Inc., Spire Biomedical, Inc., Spire Corporation. (Entered: Feb. 20, 2008).|
|69||Uldall, et al., "A New Vascular Access Catheter for Hemodialysis," American Journal of Kidney Diseases, 1993, 21(3):270-277.|
|70||Uldall, P. Robert, "Temporary Vascular Access for Hemodialysis," Vascular Access For Hemodialysis, Dialysis Therapy 2nd Edition, 1993, pp. 5-10.|
|71||Vas-Cath Flexxicon 2 FDA 510(k) database entry (Rec'd: Sep. 17, 1991; Approved: Jul. 1, 1993).|
|72||Vas-Cath Flexxicon Adverse Event Report (Event Date: Jan. 20, 1998).|
|73||Vas-Cath Flexxicon Plus FDA 510(k) database entry (Rec'd: Apr. 22, 1988; Approved: Jun. 23, 1988).|
|74||Vas-Cath Flexxicon Plus FDA 510(k) database entry (Rec'd: Sep. 12, 1998; Approved: Feb. 9, 1990).|
|75||Vas-Cath Niagara 510(k) Summary (Date Prepared: Nov. 15, 1996).|
|76||Vas-Cath Niagara Adverse Event Report (First Marketed: Aug. 19, 1997).|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US8585950||Dec 28, 2009||Nov 19, 2013||Angiodynamics, Inc.||Multilumen catheters and method of manufacturing|
|US9656043||Dec 22, 2011||May 23, 2017||Cook Medical Technologies Llc||Multi-split-tipped catheter|
|U.S. Classification||604/544, 604/43, 604/28|
|International Classification||A61M27/00, A61M25/00|
|Cooperative Classification||A61M25/0068, A61M25/0009, A61M2025/0081, A61M25/007, A61M2025/0031, A61M25/0029, A61M25/008, A61M2025/0037|
|Oct 13, 2011||FPAY||Fee payment|
Year of fee payment: 8
|May 21, 2012||SULP||Surcharge for late payment|
|Sep 30, 2015||FPAY||Fee payment|
Year of fee payment: 12