WO2009120871A2 - Triple lumen catheter - Google Patents

Triple lumen catheter Download PDF

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Publication number
WO2009120871A2
WO2009120871A2 PCT/US2009/038414 US2009038414W WO2009120871A2 WO 2009120871 A2 WO2009120871 A2 WO 2009120871A2 US 2009038414 W US2009038414 W US 2009038414W WO 2009120871 A2 WO2009120871 A2 WO 2009120871A2
Authority
WO
WIPO (PCT)
Prior art keywords
lumen
catheter
septa
body portion
wall
Prior art date
Application number
PCT/US2009/038414
Other languages
French (fr)
Other versions
WO2009120871A3 (en
Inventor
Kenneth Chesnin
Original Assignee
Medical Components, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medical Components, Inc. filed Critical Medical Components, Inc.
Priority to ES09724674.8T priority Critical patent/ES2683894T3/en
Priority to EP09724674.8A priority patent/EP2257332B1/en
Publication of WO2009120871A2 publication Critical patent/WO2009120871A2/en
Publication of WO2009120871A3 publication Critical patent/WO2009120871A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • A61M25/0032Multi-lumen catheters with stationary elements characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • A61M2025/0035Multi-lumen catheters with stationary elements characterized by a variable lumen cross-section by means of a resilient flexible septum or outer wall
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • A61M2025/0037Multi-lumen catheters with stationary elements characterized by lumina being arranged side-by-side
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter

Definitions

  • This invention relates to catheters that are inserted into a patient's body for diagnostic or therapeutic purposes.
  • the invention specially relates to multiple- lumen intravenous eatheters that are suitable, as one of the intended applications, for pressurized injection of diagnostic and therapeutic agents.
  • TIVAS Totally Implantable Venous Aceess System
  • PICC Peripherally Inserted Central Catheter
  • a TIVAS usually consists of a reservoir compartment (the portal) that has a silicone bubble for needle insertion (the septum), with an attached plastic tube (the catheter).
  • the device is surgically inserted under the skin in the upper chest or in the ami, and the eatheter is inserted into a vein,
  • a PICC is inserted in a peripheral vein, such as the cephalic vein, basilic vein, or braehial vein and then advanced through increasingly larger veins, toward the heart until the tip rests in the distal superior vena cava or cavo-atrial junction.
  • the proximal end of the PICC remains outside of the body.
  • Central venous eatheter is also referred to as a chest catheter or a Hickman line.
  • the distal end of the catheter enters the jugular vein and advances into the superior vena cava.
  • the proximal end of the catheter tunnels under the skin and exits on the chest wall.
  • a stainless steel wire guide wire
  • Angiography is a medical imaging technique in whieh an X-ray picture is taken to visualize the inner opening of blood filled structures, including arteries, veins and the heart ehambers.
  • Computed tomography (CT) technique can also be used to generate detailed three dimensional images.
  • CT computed tomography
  • a radio-contrast agent is added to the blood to make angiography visualization possible, A large amount of contrast agent infused in a short period of time is usually necessary for successfully obtaining images with good contrast.
  • Power injection equipment is routinely employed with central venous access eathetcrs to achieve the required rate of delivery.
  • Clinical injection rates can go as high as SmIVscc, Other medical procedures, such as in the treatment of dehydration and sepsis, may also require infusion of large amounts of fluid through a central venous line.
  • PICC insertion is less traumatic compared to a central venous catheter.
  • Multiple- lumen catheters have the distinct advantage of enabling multiple diagnostic and therapeutic access through a single placement procedure.
  • Some patients undergoing imaging examinations may already have a PICC placed for other purposes. Insertion of a traditional central venous eatheter solely for the purpose of imaging examination ean be traumatie for the patients and eumbersome for the medieal staff.
  • Existing multiple-lumen PICCs may be used for power injection of diagnostie and therapeutic agents.
  • the internal lumens of existing multiple-lumen PICC are generally configured as represented in FIGs, IA and I B.
  • the lumens 110 are formed by three septa 120 arranged radially, extending from the outer wall 130 of the eatheter to the eenter of the catheter. Angular corners are formed at the interseetion between the septa 120, and between eaeh of the septum 120 and the outer wall 130 of the eatheter.
  • one of the lumens must be used to thread the guide wire.
  • FIG, IB depicts the cross section of another example of a multiple-lumen catheter having three lumens with circular cross sections. A larger lumen 140 is formed on one side of the catheter, with two smaller lumens 150 on the other side.
  • the larger lumen 140 which lacks any angular corners, is naturally suited to be used with the guide wire for advancement of the PICC,
  • the diameter of the larger lumen 140 is relatively small compared to the usable space within the body of the catheter, As can be seen when viewing the FIG. IB embodiment, the use of space is not very efficient.
  • the small diameter of the larger lumen 140 also restricts the maximum flow rate achievable through this lumen. High pressure resulting from the required flow rate for power injection would reaeh unsafe levels that may cause catheter rupture.
  • the struetural weak point of the larger lumen is its outer wall 160, In the event of a catheter rupture, the outer wall 160 of the larger lumen 140 is the likely plaee to breach. Fluid in the larger lumen 140 may eseape into the surrounding tissue, and eause eomplieations.
  • a PICC with the FIG. 1 B configuration is generally not suitable for power injeetion.
  • a praetitioner may have to increase the diameter of the inner lumen by increasing the overall diameter of the PICC.
  • the multiple-lumen PICCs that are eurrently available on the market are generally of large diameters, typieally 6 Fr or larger.
  • the relatively large size of the existing multiple-lumen PICC is not an ideal solution, beeause it would make PICC placement more diffieult and diminish the advantage of PICCs over eentral venous lines.
  • a multiple-lumen PICC eapable of use for power injection of diagnostic and therapeutic agents while still having a traditional outer dimension and being configured (without small angular eorners) for easy insertion over a guide wire.
  • a triple lumen power injection PICC with an outer diameter of 5 Fr or less.
  • the present invention presents a multi-lumen intravenous catheter comprising an elongated body portion having an outer wall extending longitudinally between proximal and distal ends, wherein two septa extend longitudinally through the elongated body portion, the septa and the outer wall define a eentral lumen and two side lumens, the central lumen has a generally oblong shape in cross section and is positioned between the two side lumens, and each of the septa are configured to flex when the central lumen is under pressure, whereby a cross seetional area of the central lumen resultantly increases to increase flow capacity through the central lumen; and a plurality of extension tubes, eaeh having a first end and a second end, extending generally longitudinally away from the proximal end of the body portion, wherein the first ends of the extension tubes connect to the proximal end of the body portion, the central lumen and the two side lumens eaeh form a fluid tight connection to a respective extension tube.
  • the present invention multi-lumen catheter may further comprise a plurality of eonnectors, wherein a conneetor is located at a seeond end of each of the extension tubes,
  • the eentral lumen has a rounded top and bottom inner surface
  • the central lumen has a generally stadium shape.
  • the eentral lumen having generally concave side surfaces and rounded top and bottom surfaces at normal atmospheric pressure, and generally convex side surfaces when under pressure.
  • a radius of eurvature of an inner surface of each of the side lumens is in all locations equal to or greater than a radius of curvature of an outer wall of a guide wire used for insertion of the multi-lumen eatheter.
  • a minimal thickness of the outer wall that bounds the central lumen maybe larger than a thickness of each of the septa.
  • the outer wall is more rupture resistant than either of the septa, Eaeh of the septa is configured to have less mechanical strength under catheter pressure than the outer wall, whereby catheter rupture will occur in one or both of the septa prior to in the outer wall.
  • Each of the septa ls configured to fail under catheter pressure before failure of the outer wall.
  • the sum of the cross sectional areas of the two side lumens is less than the cross sectional area of the central lumen. In another embodiment of the present invention, the sum of the cross sectional areas of the two side lumens does not equal the eross seetional area of the central lumen.
  • the side lumen is of generally "D” shape. In another embodiment of the present invention, the side lumen is of generally "C” shape. In yet another embodiment of the present invention, the side lumen is of generally cireular shape. In a further embodiment of the present invention, the side lumen is of generally elliptical shape.
  • the present invention also provides a multi-lumen intravenous eatheter comprising an elongated body portion including an outer wall extending longitudinally along and forming the elongated body portion between proximal and distal ends, and two septa extending longitudinally along, through, and forming the elongated body portion, wherein the two septa and the outer wall define a central lumen and two side lumens, the central lumen has an inner surface defining a generally stadium shape of the central lumen; and a radius of eurvature of the inner surfaee of the central lumen is, in all locations, equal to or greater than a radius of curvature of an outer surfaee of a guide wire used for insertion of the multi-lumen catheter.
  • the present invention also provides a multi-lumen intravenous catheter comprising an elongated body portion ineluding an outer wall extending longitudinally along and forming the elongated body portion between proximal and distal ends, and two septa extending longitudinally along, through, and forming the elongated body portion, wherein the two septa and the outer wall define a central lumen and two side lumens, and each of the septa is configured to fail under catheter pressure before failure of the outer wall.
  • the present invention further provides a multi-lumen intravenous catheter comprising an elongated body portion including an outer wall extending longitudinally along and forming the elongated body portion between proximal and distal ends, and two septa extending longitudinally along, through, and forming the elongated body portion, wherein the two septa and the outer wall define a eentral lumen and two side lumens, and eaeh of the septa is configured to have less mechanical strength under eatheter pressure than the outer wail, whereby catheter rupture will oceur in one or both of the septa prior to in the outer wall.
  • the present invention also provides a multi-lumen intravenous catheter comprising an elongated body portion including an outer wall extending longitudinally along and forming the elongated body portion between proximal and distal ends, and two flexible septa extending longitudinally along, through, and forming the elongated body portion, wherein the two septa and the outer wall define a central lumen and two side lumens, and the central lumen having generally concave side surfaces and rounded top and bottom surfaces at normal atmospheric pressure, and generally convex side surfaees when under pressure,
  • the present invention also provides a multi-lumen intravenous catheter comprising an elongated body portion including an outer wall extending longitudinally along and forming the elongated body portion between proximal and distal ends, and at least two septa extending longitudinally along, through, and forming the elongated body portion, wherein the at least two septa and the outer wall define a central lumen and at least two side lumens, wherein the eentral lumen is located essentially at the center of the catheter body, and at least one of the side lumen is located on a first side of the central lumen and at least one side lumen is located on a second side of the central lumen, septa arc configured to flex when the central lumen is under pressure, whereby a cross sectional area of the eentral lumen resultantly increases to increase flow capacity through the central lumen.
  • FIG. IA and FIG. IB arc schematie cross section views of existing, prior art triple lumen catheters
  • FIG. 2 is a diagrammatic side view of one embodiment of a multiple-lumen catheter
  • FIG. 3 is a sehematic cross section view of the body portion of one embodiment of the present invention multiple lumen catheter
  • FIG. 4 is a schematic eross section view of the body portion of a second embodiment of the present invention multiple lumen catheter
  • FIG. 6 is a schematic cross section view of the body portion of a third embodiment of the present invention multiple lumen catheter.
  • FIG. 6 is a schematic cross seetion view of the body portion of a fourth embodiment of the present invention multiple lumen catheter.
  • FIG. 2 depicts a representative multiple-lumen catheter 200 employing the present invention lumen configuration.
  • the catheter comprises an elongated body portion 220. In the distal end, the body portion 220 connects to a tip structure 210.
  • the internal space of the body portion 220 is divided into several lumens.
  • Each of the lumens has an opening in the tip structure 210. In the embodiment shown in FIG. 2, each of the lumens opens at the same point of the tip strueture 210.
  • openings of each of the lumens may be placed at different locations along the tip structure 210, thereby minimizing mixing ond the possibility of adverse reactions when incompatible drugs or therapeutic agents are delivered at the some time through separate lumens of the catheter.
  • the proximal end 230 of the body portion 220 of the eatheter connects to o plurality of extension tubes 231 232 233, Each of the internal lumen forms a fluid tight eonneetion to an extension tube 231 232 233, In some embodiments of the present invention more than one lumen can be connected to a single extension tube.
  • Each of the extension tube 231 232 233 further may conneet to a eonnector of a type commonly used in emanatal applications 241 242 243, such as Luer-Lock type conneeters, whieh provides easy linkage to other emanatal instruments or devices.
  • Connectors for the present invention multiple-lumen catheter may be manufactured separately from the catheter, and are attached during insertion of the catheter assembly.
  • Clamps 251 252 253 may be placed on the extension tubes to stop fluid flow when the catheter is not in use,
  • FIG. 3 shows a cross section view of the catheter body of one embodiment of the present invention.
  • Two septa 304 divide the internal spaee of the body portion 220 into three lumens 302 303.
  • the lumens are arranged in a side-by-side configuration.
  • the eentral lumen 303 is defined by the two septa
  • the eentral lumen 303 has a generally stadium shape in cross section, In the embodiment shown in FIG. 3, the eentral lumen 303 is formed by septa with essentially planar side surfaees 306, and rounded top and bottom surfaces 305, In other embodiments, the central lumen 303 may have a cross section of an elongated eirele, an ellipse, or other shapes that efficiently utilizes the internal space of the catheter. In the embodiment shown in FIG, 3, the side lumens 302 have a crescent or "D" shape in cross seetion.
  • the side lumens 302 ean have cireular, elliptical, "C" shaped, or other suitable cross sections.
  • the shape of the cross sections of the central lumen 303 and side lumens 302 is chosen so that it provides optimal utilization of the internal space of the body portion 220 of the catheter.
  • the rounded top and bottom surface 305 of the central lumen 303 and the outer surfaee 307 of the catheter body portion 220 forms the outer wall 301 of the catheter body portion 220.
  • the rounded top and bottom interior surface of the central lumen 305 conneets smoothly to the side surfaees 306.
  • the inner surface 305 306 of the central lumen 303 is free from any sharp corners.
  • the smooth inner surface 305 306 of the eentral lumen 303 is optimal for catheter placement along a guide wire.
  • the radius of curvature of the inner surface 305 is chosen to minimize the possibility that any corner within the central lumen 303 can catch the guide wire and hinder the advance of the catheter 200 along the guide wire. For example, if a guide wire of 0,018 in. diameter is intended, the radius of curvature for any eorner in the central lumen 303 would preferably be equal to or larger than 0.009 in.
  • the radius of curvature within the eentral lumen 303 (and/or within the side lumens 302) is in all locations (i.e., at all points along the inner wall of the central lumen 303 and/or the side lumens 302) equal to or greater than the radius of curvature of the outer wall (or outer perimeter surface) of an associated guide wire.
  • FIG. 4 shows a cross seetion view of a second embodiment of the present invention.
  • the two side lumens 402 are of a generally circular shape.
  • the central lumen 403 is of a "dog bone" shape.
  • the top and bottom interior surfaces 405 of the eentral lumen of the embodiment shown in FIG. 4 connect smoothly to the side surfaees 406.
  • the entire interior surface 405 406 of the central lumen 403 is free of sharp corners.
  • the septa 404 between the two side lumens 402 and the central lumen 403 protrude into the central lumen 403 at normal atmospheric pressure, i.e., the septa 404 are of generally concave shape.
  • the septa 404 When under pressure, such as during power injection procedure, the septa 404 are capable of deforming and may be pushed outward.
  • the side lumens 402, as a eonsequence, may have reduced size under pressure.
  • the septa 404 may adopt convex shape under pressure.
  • the potential to deform and expand the diameter of the eentral lumen 403 provides the present invention excellent flow performance when the overall exterior diameter is of a small size.
  • the outer wall 401 of the catheter ean be made thieker at the top and bottom of the central lumen than the septa 404, This configuration would help to provide stronger mechanical strength to the exterior wall of the catheter body 220,
  • FIG. 5 shows a cross section view of catheter body of a third embodiment of the present invention
  • the central lumen 503 is of a "hour glass" shape.
  • the two side lumens 502 are of irregular elliptical shape having the interior surface 508 following the general shape of the side surfaces 506 of the central lumen 506.
  • the septa 504 between the two side lumens 502 and the central lumen 503 protrude into the eentral lumen 503 under normal atmospheric pressure, i,e, the septa 504 are of generally concave shape. When under pressure, such as during power injection procedure, the septa 504 are capable of deforming and may be pushed outward.
  • the septa 504 would adopt convex shape under pressure, Similarly, the outer wall 501 of the catheter can be made thieker at the top and bottom of the central lumen than the septa 504. This configuration would help to provide stronger mcehanieal strength to the exterior wall of the eatheter body 220.
  • FIG. 6 shows a cross section view of the catheter body of a fourth embodiment of the present invention, In this particular embodiment, instead of one side lumen on one side of the central lumen 603, two smaller side lumens 608 609 are formed.
  • This lumen configuration can be adapted to all embodiments of the present invention, whieh include, but are not limited to, the embodiments disclosed in F(Gs. 3, 4, and 5.
  • a guide wire is preferably traversed through one of the respective side lumens 402 502 602 when used to advanee the catheter.
  • the radius of curvature within the side lumen 402 502 602 is in all locations (i.e., at all points along the inner wall of the side lumen 402 502 602) equal to or greater than the radius of curvature of the outer wall (or outer perimeter surfaee) of an associated guide wire.
  • the eentral lumen of the present invention 303 403 503 603, has ⁇ large cross section (or cross-sectional area) relative to the available space (or eross-sectional area) within the body portion 220 of the catheter. Because the flow rate is proportional to the fourth power of the radius of a tube, even a small increase in the cross section of the central lumen 303 403 503 603 greatly increases the flow rate achievable though the tube when all other parameters are constant, The present invention optimizes space utilization within the body portion 220 of the catheter, allowing the body portion 220 to have a relatively thick outer wall 301. This increases the mechanical strength of the body portion 220, and in turn allows a higher pressure rating for the catheter 200. When the catheter 200 is under pressure, each of the septa 304 404 504 604 may flex outward, resultantly increasing the cross section of the central lumen 303 403 503 603, and thereby further facilitating fluid flow.
  • the septa 304 404 504 604 of the present invention is designed to have less mechanical strength than the outer wall 301 401 501 601 of the eatheter body portion 220, In another aspect, the septa 304 404 504 604 are of a thickness less than the minimal thickness of the outer wall 301 401 501 601. In still another aspeet, the rupture characteristics of the septa 304 404 504 604 and the outer wall 301 401 501 601 are optimized by modifying both the thiekness and the shape.
  • the configuration of the present invention central lumen 303 403 503 603 provides high flow rate and fail safe protection under pressure. It is, therefore, suited for power injection of diagnostic or therapeutic agents.
  • the eatheter of the present invention ean be safely used at a flow rate of 5 ce/sec at 300 psi.
  • the configuration of the lumens also provide added benefits such as kink resistance and flexibility.
  • the lumens of the present invention eatheter are intended to be used independently to deliver drugs, therapeutic or diagnostic agents.
  • the dimensions of the lumens are not necessarily eonstraincd in relation to one another.
  • the cross sectional area of the central lumen 304 404 504 604 may or may not be equal to the sum of the cross sectional areas of the side lumens 302 402 502 602 608 609.
  • the sum of the cross seetional areas of the two side lumens 302 402 502 602 608 609 is greater than the cross sectional area of the central lumen 303 403 503 603.
  • the sum of the cross seetional areas of the two side lumens 302 402 502 602 is less than the eross seetional area of the eentral lumen 303 403 503 603,
  • the present invention eatheter ean be manufactured to various sizes suitable for PICC application.
  • the unique lumen configuration of the present invention makes it possible to manufacture triple lumen PICC with small outer diameters such as French size 5 or 6.
  • the catheters of the present invention can be made from existing thermal plasties presently used for intravenous eatheters, such as silicone and polyurethane or other tissue compatible polymers.
  • the body portion of the catheter of the present invention ean be manufactured using existing molding or extrusion manufacturing processes. Placement of the eatheters of the present invention also does not require any special modification to present medical procedures.

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Abstract

A multi-lumen catheter comprising a longitudinally extending elongated body portion, with at least two septa extending longitudinally there through the entire body portion, defining a central lumen and two side lumens. The central lumen is of oblong shape in cross section, and is positioned between the side lumens. The septa that form the central lumen are configured to be capable of fixing outwards when the central lumen is under pressure, such as when used in procedures that require power injection, whereby a cross sectional area of the central lumen resultantly increases to increase flow capacity through the central lumen. In some embodiments, the central lumen has α defining inner surface such that a radius of curvature of the central lumen inner surface is, in all locations, equal to or greater than a radius of curvature of an outer surface of a guide wire used for insertion of the multi-lumen catheter. The septa are each configured to fail under pressure before failure of the outer wall.

Description

TRIPLE LUMEN CATHETER
RELATED APPLICATION
[0001] This application claims priority to U.S, Provisional Application No. 61/039,655, filed on March 26, 2008, which is herein incorporated by reference.
FIELD OF THE INVENTION
[0002] This invention relates to catheters that are inserted into a patient's body for diagnostic or therapeutic purposes. The invention specially relates to multiple- lumen intravenous eatheters that are suitable, as one of the intended applications, for pressurized injection of diagnostic and therapeutic agents.
BACKGROUND OF THE INVENTION
[0003] Infusion of drugs, medications, or other diagnostic and therapeutie agents into the vascular system of a patient is a task routinely required by modern medicine. Placement of eentral venous access deviees is a common occurrence in hospitals for these purposes, They are essentially used to give intra venous medieations, obtain venous samples of blood and obtain measurements of central venous pressure. Three of the most eommonly used deviees are the Totally Implantable Venous Aceess System (TIVAS), the Peripherally Inserted Central Catheter (PICC), and the Central Venous Catheter, A TIVAS usually consists of a reservoir compartment (the portal) that has a silicone bubble for needle insertion (the septum), with an attached plastic tube (the catheter). The device is surgically inserted under the skin in the upper chest or in the ami, and the eatheter is inserted into a vein, A PICC is inserted in a peripheral vein, such as the cephalic vein, basilic vein, or braehial vein and then advanced through increasingly larger veins, toward the heart until the tip rests in the distal superior vena cava or cavo-atrial junction. The proximal end of the PICC remains outside of the body. Central venous eatheter is also referred to as a chest catheter or a Hickman line. The distal end of the catheter enters the jugular vein and advances into the superior vena cava. The proximal end of the catheter tunnels under the skin and exits on the chest wall. When inserting a PICC or Hickman line, a stainless steel wire (guide wire) is used to guide the flexible catheter through the vasculature to its intended site of placement.
[0004] Angiography is a medical imaging technique in whieh an X-ray picture is taken to visualize the inner opening of blood filled structures, including arteries, veins and the heart ehambers. Computed tomography (CT) technique can also be used to generate detailed three dimensional images. Because blood has the same radiodensity as the surrounding tissues, a radio-contrast agent is added to the blood to make angiography visualization possible, A large amount of contrast agent infused in a short period of time is usually necessary for successfully obtaining images with good contrast. Power injection equipment is routinely employed with central venous access eathetcrs to achieve the required rate of delivery. Clinical injection rates can go as high as SmIVscc, Other medical procedures, such as in the treatment of dehydration and sepsis, may also require infusion of large amounts of fluid through a central venous line. [0005] PICC insertion is less traumatic compared to a central venous catheter. Multiple- lumen catheters have the distinct advantage of enabling multiple diagnostic and therapeutic access through a single placement procedure. Some patients undergoing imaging examinations may already have a PICC placed for other purposes. Insertion of a traditional central venous eatheter solely for the purpose of imaging examination ean be traumatie for the patients and eumbersome for the medieal staff.
[0006] Existing multiple-lumen PICCs may be used for power injection of diagnostie and therapeutic agents. The internal lumens of existing multiple-lumen PICC are generally configured as represented in FIGs, IA and I B. In the PICC depieted in FIG, IA, the lumens 110 are formed by three septa 120 arranged radially, extending from the outer wall 130 of the eatheter to the eenter of the catheter. Angular corners are formed at the interseetion between the septa 120, and between eaeh of the septum 120 and the outer wall 130 of the eatheter. During the placement of a PICC, one of the lumens must be used to thread the guide wire. The angular corners in the catheter lumens have a tendency to eatch the guide wire, and make PICC placement difficult. The radially arranged lumens 1 10 in FIG, IA also do not perform well under pressure. The angular corners of the lumens are prone to rupture under pressure. [0007] FIG, IB depicts the cross section of another example of a multiple-lumen catheter having three lumens with circular cross sections. A larger lumen 140 is formed on one side of the catheter, with two smaller lumens 150 on the other side. The larger lumen 140, which lacks any angular corners, is naturally suited to be used with the guide wire for advancement of the PICC, However, the diameter of the larger lumen 140 is relatively small compared to the usable space within the body of the catheter, As can be seen when viewing the FIG. IB embodiment, the use of space is not very efficient. The small diameter of the larger lumen 140 also restricts the maximum flow rate achievable through this lumen. High pressure resulting from the required flow rate for power injection would reaeh unsafe levels that may cause catheter rupture. Further, the struetural weak point of the larger lumen is its outer wall 160, In the event of a catheter rupture, the outer wall 160 of the larger lumen 140 is the likely plaee to breach. Fluid in the larger lumen 140 may eseape into the surrounding tissue, and eause eomplieations. For the foregoing reasons, a PICC with the FIG. 1 B configuration is generally not suitable for power injeetion.
[0008] To increase the pressure rating for the multiple-lumen PICCs with the aforementioned existing lumen configurations, a praetitioner may have to increase the diameter of the inner lumen by increasing the overall diameter of the PICC. The multiple-lumen PICCs that are eurrently available on the market are generally of large diameters, typieally 6 Fr or larger. The relatively large size of the existing multiple-lumen PICC is not an ideal solution, beeause it would make PICC placement more diffieult and diminish the advantage of PICCs over eentral venous lines. Accordingly, it would be desirable to have a multiple-lumen PICC eapable of use for power injection of diagnostic and therapeutic agents, while still having a traditional outer dimension and being configured (without small angular eorners) for easy insertion over a guide wire. Particularly it would be desirable to have a triple lumen power injection PICC with an outer diameter of 5 Fr or less. Additionally, it would be desirable to have a multiple-lumen PICC that is fail safe. In ease of a lumen rupture when the catheter is used under pressure, the integrity of the exterior wall is retained.
SUMMARY OF THE INVENTION
[0009] The present invention presents a multi-lumen intravenous catheter comprising an elongated body portion having an outer wall extending longitudinally between proximal and distal ends, wherein two septa extend longitudinally through the elongated body portion, the septa and the outer wall define a eentral lumen and two side lumens, the central lumen has a generally oblong shape in cross section and is positioned between the two side lumens, and each of the septa are configured to flex when the central lumen is under pressure, whereby a cross seetional area of the central lumen resultantly increases to increase flow capacity through the central lumen; and a plurality of extension tubes, eaeh having a first end and a second end, extending generally longitudinally away from the proximal end of the body portion, wherein the first ends of the extension tubes connect to the proximal end of the body portion, the central lumen and the two side lumens eaeh form a fluid tight connection to a respective extension tube.
[0010] The present invention multi-lumen catheter may further comprise a plurality of eonnectors, wherein a conneetor is located at a seeond end of each of the extension tubes,
[0011] In one aspect of the present invention, the eentral lumen has a rounded top and bottom inner surface,
[0012] In one embodiment of the present invention, the central lumen has a generally stadium shape.
[0013] In another embodiment of the present invention, the eentral lumen having generally concave side surfaces and rounded top and bottom surfaces at normal atmospheric pressure, and generally convex side surfaces when under pressure.
[0014] In one embodiment of the present invention, a radius of eurvature of an inner surface of each of the side lumens is in all locations equal to or greater than a radius of curvature of an outer wall of a guide wire used for insertion of the multi-lumen eatheter.
[0015] In one embodiment of the present invention, a minimal thickness of the outer wall that bounds the central lumen maybe larger than a thickness of each of the septa. The outer wall is more rupture resistant than either of the septa, Eaeh of the septa is configured to have less mechanical strength under catheter pressure than the outer wall, whereby catheter rupture will occur in one or both of the septa prior to in the outer wall. Each of the septa ls configured to fail under catheter pressure before failure of the outer wall.
[0016] In one embodiment of the present invention, the sum of the cross sectional areas of the two side lumens is less than the cross sectional area of the central lumen. In another embodiment of the present invention, the sum of the cross sectional areas of the two side lumens does not equal the eross seetional area of the central lumen.
[0017] In one embodiment of the present invention, the side lumen is of generally "D" shape. In another embodiment of the present invention, the side lumen is of generally "C" shape. In yet another embodiment of the present invention, the side lumen is of generally cireular shape. In a further embodiment of the present invention, the side lumen is of generally elliptical shape.
[0018] The present invention also provides a multi-lumen intravenous eatheter comprising an elongated body portion including an outer wall extending longitudinally along and forming the elongated body portion between proximal and distal ends, and two septa extending longitudinally along, through, and forming the elongated body portion, wherein the two septa and the outer wall define a central lumen and two side lumens, the central lumen has an inner surface defining a generally stadium shape of the central lumen; and a radius of eurvature of the inner surfaee of the central lumen is, in all locations, equal to or greater than a radius of curvature of an outer surfaee of a guide wire used for insertion of the multi-lumen catheter.
[0019] Additionally, the present invention also provides a multi-lumen intravenous catheter comprising an elongated body portion ineluding an outer wall extending longitudinally along and forming the elongated body portion between proximal and distal ends, and two septa extending longitudinally along, through, and forming the elongated body portion, wherein the two septa and the outer wall define a central lumen and two side lumens, and each of the septa is configured to fail under catheter pressure before failure of the outer wall.
[0020] The present invention further provides a multi-lumen intravenous catheter comprising an elongated body portion including an outer wall extending longitudinally along and forming the elongated body portion between proximal and distal ends, and two septa extending longitudinally along, through, and forming the elongated body portion, wherein the two septa and the outer wall define a eentral lumen and two side lumens, and eaeh of the septa is configured to have less mechanical strength under eatheter pressure than the outer wail, whereby catheter rupture will oceur in one or both of the septa prior to in the outer wall.
[0021] The present invention also provides a multi-lumen intravenous catheter comprising an elongated body portion including an outer wall extending longitudinally along and forming the elongated body portion between proximal and distal ends, and two flexible septa extending longitudinally along, through, and forming the elongated body portion, wherein the two septa and the outer wall define a central lumen and two side lumens, and the central lumen having generally concave side surfaces and rounded top and bottom surfaces at normal atmospheric pressure, and generally convex side surfaees when under pressure,
[0022] Finally, The present invention also provides a multi-lumen intravenous catheter comprising an elongated body portion including an outer wall extending longitudinally along and forming the elongated body portion between proximal and distal ends, and at least two septa extending longitudinally along, through, and forming the elongated body portion, wherein the at least two septa and the outer wall define a central lumen and at least two side lumens, wherein the eentral lumen is located essentially at the center of the catheter body, and at least one of the side lumen is located on a first side of the central lumen and at least one side lumen is located on a second side of the central lumen, septa arc configured to flex when the central lumen is under pressure, whereby a cross sectional area of the eentral lumen resultantly increases to increase flow capacity through the central lumen.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] FIG. IA and FIG. IB arc schematie cross section views of existing, prior art triple lumen catheters;
[0024] FIG. 2 is a diagrammatic side view of one embodiment of a multiple-lumen catheter;
[0025] FIG. 3 is a sehematic cross section view of the body portion of one embodiment of the present invention multiple lumen catheter,
[0026] FIG. 4 is a schematic eross section view of the body portion of a second embodiment of the present invention multiple lumen catheter,
[0027] FIG. 6 is a schematic cross section view of the body portion of a third embodiment of the present invention multiple lumen catheter, and
[0028] FIG. 6 is a schematic cross seetion view of the body portion of a fourth embodiment of the present invention multiple lumen catheter.
DETAILED DESCRIPTION OF THE INVENTION
[0029] The advantages of the present invention will be apparent to those skilled in the art from the following specification. Aecordingly, it will be recognized by those skilled in the art that ehanges or modifications may be made to the below-deseribed embodiments without departing from the broad inventive concepts of the invention. It should therefore be understood that this invention is not limited to the particular embodiments described herein, but is intended to include all ehanges and modifications that are within the scope and spirit of the invention. The words "proximal" and "distal" refer to directions away from and closer to the insertion tip, respectively, of a eatheter of the present invention.
[0030] FIG. 2 depicts a representative multiple-lumen catheter 200 employing the present invention lumen configuration. The catheter comprises an elongated body portion 220. In the distal end, the body portion 220 connects to a tip structure 210. The internal space of the body portion 220 is divided into several lumens. Each of the lumens has an opening in the tip structure 210. In the embodiment shown in FIG. 2, each of the lumens opens at the same point of the tip strueture 210. In other embodiments of the present invention, openings of each of the lumens may be placed at different locations along the tip structure 210, thereby minimizing mixing ond the possibility of adverse reactions when incompatible drugs or therapeutic agents are delivered at the some time through separate lumens of the catheter. Other tip structure well know in the art can also be used with the present invention. The proximal end 230 of the body portion 220 of the eatheter connects to o plurality of extension tubes 231 232 233, Each of the internal lumen forms a fluid tight eonneetion to an extension tube 231 232 233, In some embodiments of the present invention more than one lumen can be connected to a single extension tube. Each of the extension tube 231 232 233 further may conneet to a eonnector of a type commonly used in medieal applications 241 242 243, such as Luer-Lock type conneeters, whieh provides easy linkage to other medieal instruments or devices. Connectors for the present invention multiple-lumen catheter may be manufactured separately from the catheter, and are attached during insertion of the catheter assembly. Clamps 251 252 253 may be placed on the extension tubes to stop fluid flow when the catheter is not in use,
[0031] The pressure generated by injeetion of fluid though a rigid tube ean be described by Poiseυille's Law, whieh states that: Q = (πr4ΔP)/(η8L), The rate of flow through a rigid tube (Q) is proportional to the fourth power of the radius of the tube (r) and the difference in pressure at the two ends of the tube (ΔP), and is inversely related to the viseosity of the fluid (η) and the length of the tube (L). The body portion 220 of eatheter is usually made of material that is flexible, such as silicone or polyurethane or other tissue compatible polymers. Although not direetly applicable, Poiseuilie's Law provides important guidance to approximate fluid flow characteristics within a multiple-lumen eatheter where the walls may flex and expand slightly under pressure.
[0032] FIG. 3 shows a cross section view of the catheter body of one embodiment of the present invention. Two septa 304 divide the internal spaee of the body portion 220 into three lumens 302 303. The lumens are arranged in a side-by-side configuration. The eentral lumen
303 is located essentially in the center of the eatheter body, and the two side lumens 302 are loeated on eaeh side of the eentral lumen 303. The eentral lumen 303 is defined by the two septa
304 and the outer wall 301 of the eatheter, and is positioned between the two side lumens 302. The eentral lumen 303 has a generally stadium shape in cross section, In the embodiment shown in FIG. 3, the eentral lumen 303 is formed by septa with essentially planar side surfaees 306, and rounded top and bottom surfaces 305, In other embodiments, the central lumen 303 may have a cross section of an elongated eirele, an ellipse, or other shapes that efficiently utilizes the internal space of the catheter. In the embodiment shown in FIG, 3, the side lumens 302 have a crescent or "D" shape in cross seetion. In other embodiments, the side lumens 302 ean have cireular, elliptical, "C" shaped, or other suitable cross sections. The shape of the cross sections of the central lumen 303 and side lumens 302 is chosen so that it provides optimal utilization of the internal space of the body portion 220 of the catheter. The rounded top and bottom surface 305 of the central lumen 303 and the outer surfaee 307 of the catheter body portion 220 forms the outer wall 301 of the catheter body portion 220.
10033] The rounded top and bottom interior surface of the central lumen 305 conneets smoothly to the side surfaees 306. The inner surface 305 306 of the central lumen 303 is free from any sharp corners. The smooth inner surface 305 306 of the eentral lumen 303 is optimal for catheter placement along a guide wire. The radius of curvature of the inner surface 305 is chosen to minimize the possibility that any corner within the central lumen 303 can catch the guide wire and hinder the advance of the catheter 200 along the guide wire. For example, if a guide wire of 0,018 in. diameter is intended, the radius of curvature for any eorner in the central lumen 303 would preferably be equal to or larger than 0.009 in. Accordingly, in one aspect of the invention, the radius of curvature within the eentral lumen 303 (and/or within the side lumens 302) is in all locations (i.e., at all points along the inner wall of the central lumen 303 and/or the side lumens 302) equal to or greater than the radius of curvature of the outer wall (or outer perimeter surface) of an associated guide wire.
[0034] FIG. 4 shows a cross seetion view of a second embodiment of the present invention. In this particular embodiment, the two side lumens 402 are of a generally circular shape. And the central lumen 403 is of a "dog bone" shape. The top and bottom interior surfaces 405 of the eentral lumen of the embodiment shown in FIG. 4 connect smoothly to the side surfaees 406. The entire interior surface 405 406 of the central lumen 403 is free of sharp corners. The septa 404 between the two side lumens 402 and the central lumen 403 protrude into the central lumen 403 at normal atmospheric pressure, i.e., the septa 404 are of generally concave shape. When under pressure, such as during power injection procedure, the septa 404 are capable of deforming and may be pushed outward. The side lumens 402, as a eonsequence, may have reduced size under pressure. Thus, the septa 404 may adopt convex shape under pressure. The potential to deform and expand the diameter of the eentral lumen 403 provides the present invention excellent flow performance when the overall exterior diameter is of a small size. The outer wall 401 of the catheter ean be made thieker at the top and bottom of the central lumen than the septa 404, This configuration would help to provide stronger mechanical strength to the exterior wall of the catheter body 220,
[0035] FIG. 5 shows a cross section view of catheter body of a third embodiment of the present invention, In this particular embodiment, the central lumen 503 is of a "hour glass" shape. The two side lumens 502 are of irregular elliptical shape having the interior surface 508 following the general shape of the side surfaces 506 of the central lumen 506. Similar to the embodiment shown in FIG, 4, the septa 504 between the two side lumens 502 and the central lumen 503 protrude into the eentral lumen 503 under normal atmospheric pressure, i,e,, the septa 504 are of generally concave shape. When under pressure, such as during power injection procedure, the septa 504 are capable of deforming and may be pushed outward. Thus, the septa 504 would adopt convex shape under pressure, Similarly, the outer wall 501 of the catheter can be made thieker at the top and bottom of the central lumen than the septa 504. This configuration would help to provide stronger mcehanieal strength to the exterior wall of the eatheter body 220.
[0036] FIG. 6 shows a cross section view of the catheter body of a fourth embodiment of the present invention, In this particular embodiment, instead of one side lumen on one side of the central lumen 603, two smaller side lumens 608 609 are formed. This lumen configuration can be adapted to all embodiments of the present invention, whieh include, but are not limited to, the embodiments disclosed in F(Gs. 3, 4, and 5.
[0037] For the lumen configurations shown in FIG. 4, 5, and 6, a guide wire is preferably traversed through one of the respective side lumens 402 502 602 when used to advanee the catheter. The radius of curvature within the side lumen 402 502 602 is in all locations (i.e., at all points along the inner wall of the side lumen 402 502 602) equal to or greater than the radius of curvature of the outer wall (or outer perimeter surfaee) of an associated guide wire. [0038] The eentral lumen of the present invention 303 403 503 603, has α large cross section (or cross-sectional area) relative to the available space (or eross-sectional area) within the body portion 220 of the catheter. Because the flow rate is proportional to the fourth power of the radius of a tube, even a small increase in the cross section of the central lumen 303 403 503 603 greatly increases the flow rate achievable though the tube when all other parameters are constant, The present invention optimizes space utilization within the body portion 220 of the catheter, allowing the body portion 220 to have a relatively thick outer wall 301. This increases the mechanical strength of the body portion 220, and in turn allows a higher pressure rating for the catheter 200. When the catheter 200 is under pressure, each of the septa 304 404 504 604 may flex outward, resultantly increasing the cross section of the central lumen 303 403 503 603, and thereby further facilitating fluid flow.
[0039] One shortcoming of existing multiple lumen eatheter designs is that the exterior wall of the respective eatheter tends to rupture first (relative to other catheter walls) when under pressure. In one aspect of the invention, the septa 304 404 504 604 of the present invention is designed to have less mechanical strength than the outer wall 301 401 501 601 of the eatheter body portion 220, In another aspect, the septa 304 404 504 604 are of a thickness less than the minimal thickness of the outer wall 301 401 501 601. In still another aspeet, the rupture characteristics of the septa 304 404 504 604 and the outer wall 301 401 501 601 are optimized by modifying both the thiekness and the shape. This provides a fail-safe meehanism. In the event of catheter malfunction, such as a blockage, one or both of the septa 304 404 504 604 would be first to rupture (relative to the outer wall 301 40! 501 601). When a septum 304 404 504 604 breaeh occurs, the fluid within the central lumen 303 403 503 603 would therefore leak into a side lumen 302 402 502 602 608 609, Accordingly, the integrity of the body portion 220 of the catheter 200 is retained. This configuration effectively protects against extravastation of the fluid within the central lumen 303 403 503 603 in the event of a septa 304 404 504 604 breach. [0040] The configuration of the present invention central lumen 303 403 503 603 provides high flow rate and fail safe protection under pressure. It is, therefore, suited for power injection of diagnostic or therapeutic agents. The eatheter of the present invention ean be safely used at a flow rate of 5 ce/sec at 300 psi. The configuration of the lumens also provide added benefits such as kink resistance and flexibility.
[0041] The lumens of the present invention eatheter are intended to be used independently to deliver drugs, therapeutic or diagnostic agents. The dimensions of the lumens are not necessarily eonstraincd in relation to one another. The cross sectional area of the central lumen 304 404 504 604 may or may not be equal to the sum of the cross sectional areas of the side lumens 302 402 502 602 608 609. In one embodiment of the present invention, the sum of the cross seetional areas of the two side lumens 302 402 502 602 608 609 is greater than the cross sectional area of the central lumen 303 403 503 603. In another embodiment, the sum of the cross seetional areas of the two side lumens 302 402 502 602 is less than the eross seetional area of the eentral lumen 303 403 503 603,
[0042] The present invention eatheter ean be manufactured to various sizes suitable for PICC application. The unique lumen configuration of the present invention makes it possible to manufacture triple lumen PICC with small outer diameters such as French size 5 or 6. The catheters of the present invention can be made from existing thermal plasties presently used for intravenous eatheters, such as silicone and polyurethane or other tissue compatible polymers. The body portion of the catheter of the present invention ean be manufactured using existing molding or extrusion manufacturing processes. Placement of the eatheters of the present invention also does not require any special modification to present medical procedures.

Claims

I claim:
1 , A multi-lumen intravenous catheter comprising: an elongated body portion having an outer wall extending longitudinally between proximal and distal ends, wherein: two septa extend longitudinally through the elongated body portion, wherein the septa and the outer wall define a centra) lumen and two side lumens, the eentral lumen has a generally oblong shape in cross section and is positioned between the two side lumens, and each of the septa are configured to flex when the central lumen is under pressure, whereby a cross sectional area of the central lumen resultantly increases to increase flow capacity through the eentral lumen; and a plurality of extension tubes, each having a first end and a second end, extending generally longitudinally away from the proximal end of the body portion, wherein the first ends of the extension tubes connect to the proximal end of the body portion, the central lumen and the two side lumens each form a fluid tight connection to a respective extension tube.
2, The multi-lumen catheter of claim 1, further comprising: a plurality of eonneetors, wherein a conneetor is located at a sceond end of eaeh of the extension tubes.
3, The multi-lumen catheter of claim 1, wherein the central lumen has a rounded top and bottom inner surface.
4. The multi-lumen catheter of claim I3 wherein the eentral lumen has a generally stadium shape.
5. The multi-lumen catheter of elaim 1, wherein the central lumen having generally concave side surfaces and rounded top and bottom surfaces at normal atmospherie pressure, and generally convex side surfaces when under pressure,
6. The multi-lumen catheter of elaim 1, wherein a radius of curvature of an inner surfaee of eaeh of the side lumens is in all locations equal to or greater than a radius of curvature of an outer wall of a guide wire used for insertion of the multi-lumen catheter.
7. The multi-lumen catheter of claim 1 , wherein a minimal thiekness of the outer wall is larger than a thickness of each of the septa.
8. The multi-lumen catheter of claim 1, wherein the outer wall is more rupture resistant than either of the septa.
9. The multi-lumen catheter of claim 1, wherein each of the septa is configured to have less mechanical strength under catheter pressure than the outer wall, whereby catheter rupture will occur in one or both of the septa prior to in the outer wall.
10. The multi-lumen catheter of claim 1, wherein each of the septa is configured to fail under catheter pressure before failure of the outer wall.
11. The multi-lumen catheter of claim \, wherein the sum of the cross sectional areas of the two side lumens is less than the cross seetional area of the central lumen.
12. The multi-lumen catheter of claim 1, wherein the sum of the cross sectional areas of the two side lumens docs not equal the cross sectional area of the central lumen.
13. The multi-lumen catheter of claim I , wherein the side lumen is of generally "D" shape.
14. The multi-lumen catheter of claim 1, wherein the side lumen is of generally "C" shape.
15. The multi-lumen eatheter of elaim 1, wherein the side lumen is of generally circular shape.
16. The multi-lumen catheter of elaim 1, wherein the side lumen is of generally elliptical shape.
17. A multi-lumen intravenous catheter comprising an elongated body portion including: an outer wall extending longitudinally along and forming the elongated body portion between proximal and distal ends; and two septa extending longitudinally along, through, and forming the elongated body portion, wherein; the two septa and the outer wall define a central lumen and two side lumens; the central lumen has an inner surface defining α generally stadium shape of the eentral lumen; and a radius of curvature of the inner surface of the eentral lumen is, in all locations, equal to or greater than a radius of curvature of an outer surfaee of a guide wire used for insertion of the multi-lumen catheter.
18. A multi-lumen intravenous catheter comprising an elongated body portion including: an outer wall extending longitudinally along and forming the elongated body portion between proximal and distal ends; and two septa extending longitudinally along, through, and forming the elongated body portion, wherein: the two septa and the outer wall define a central lumen and two side lumens; and each of the septa is configured to fail under catheter pressure before failure of the outer wall,
19. A multi-lumen intravenous catheter comprising an elongated body portion including: an outer wall extending longitudinally along and forming the elongated body portion between proximal and distal ends; and two septa extending longitudinally along, through, and forming the elongated body portion, wherein; the two septa and the outer wall define a central lumen and two side lumens; and each of the septa is configured to have less mechanical strength under catheter pressure than the outer wall, whereby catheter rupture will oecur in one or both of the septa prior to in the outer wall.
20. A multi-lumen intravenous eatheter comprising an elongated body portion ineluding: an outer wall extending longitudinally along and forming the elongated body portion between proximal and distal ends; and two flexible septa extending longitudinally along, through, and forming the elongated body portion, wherein: the two septa and the outer wall define a ecntral lumen and two side lumens; and the central lumen having generally concave side surfaces and rounded top and bottom surfaces at normal atmospheric pressure, and generally convex side surfaces when under pressure.
21. The multi-lumen eatheter of claim 20, wherein a minimal thiekness of the outer wall is larger than a thickness of eaeh of the septa.
22. The multi-lumen eatheter of claim 20, wherein the outer wall is more rupture resistant than either of the septa.
23. The multi-lumen catheter of claim 20, wherein each of the septa is configured to have less mechanical strength under catheter pressure than the outer wall, whereby catheter rupture will oecυr in one or both of the septa prior to in the outer wall.
24. The multi-lumen catheter of claim 20, wherein each of the septa is configured to fail under catheter pressure before failure of the outer wall.
25. The multi-lumen catheter of claim 20, wherein the sum of the cross sectional areas of the two side lumens is less than the eross seetional area of the eentral lumen,
26. The multi-lumen eatheter of claim 20, wherein the sum of the eross seetional areas of the two side lumens is greater than the eross sectional area of the central lumen.
27. The multi-lumen eatheter of claim 20, wherein the side lumen is of generally "D" shape,
28. The multi-lumen eatheter of claim 20, wherein the side lumen is of generally "C" shape.
29. The multi-lumen eatheter of claim 20, wherein the side lumen is of generally eircular shape,
30. The multi-lumen catheter of claim 20, wherein the side lumen is of generally elliptical shape,
31 . The multi-lumen catheter of claim 20, wherein a radius of curvature of the inner surface of at least one of the side lumen is, in all locations, equal to or greater than a radius of curvature of an outer surface of a guide wire used for insertion of the multi-lumen eatheter,
32. A multi-lumen intravenous catheter comprising: an elongated body portion as described in claim 20; and a plurality of extension tubes, eaeh having a first end and a second end, extending generally longitudinally away from the proximal end of the body portion, wherein the first ends of the extension tubes eonπeet to the proximal end of the body portion, the eentral lumen and the two side lumens eaeh form a fluid tight eonneetion to a respective extension tube,
33. The multi-lumen catheter of elaim 32, farther comprising: a plurality of eonneetors, wherein a eonneetor is loeated at a second end of eaeh of the extension tubes.
34. A multi-lumen intravenous catheter eomprising an elongated body portion including: an outer wall extending longitudinally along and forming the elongated body portion between proximal and distal ends; and at least two septa extending longitudinally along, through, and forming the elongated body portion, wherein: the at least two septa and the outer wall define a eentral lumen and at least two side lumens, wherein the central lumen is located essentially at the center of the eatheter body, and at least one of the side lumen is located on a first side of the eentral lumen and at least one side lumen is located on a second side of the central lumen, wherein; the septa that define the eentral lumen are configured to flex when the central lumen is under pressure, whereby a cross sectional area of the eentral lumen rcsultantly increases to increase flow capacity through the central lumen.
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US10555772B2 (en) 2015-11-23 2020-02-11 Ra Medical Systems, Inc. Laser ablation catheters having expanded distal tip windows for efficient tissue ablation
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US8440122B2 (en) 2005-06-30 2013-05-14 Abbott Vascular Inc. Introducer sheath and methods of making
US9889275B2 (en) 2006-06-28 2018-02-13 Abbott Laboratories Expandable introducer sheath to preserve guidewire access
US11690979B2 (en) 2006-06-28 2023-07-04 Abbott Laboratories Expandable introducer sheath to preserve guidewire access
US8801744B2 (en) 2006-06-28 2014-08-12 Abbott Laboratories Expandable introducer sheath to preserve guidewire access
US9597063B2 (en) 2006-06-28 2017-03-21 Abbott Laboratories Expandable introducer sheath to preserve guidewire access
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US11123458B2 (en) 2011-10-14 2021-09-21 Ra Medical Systems, Inc. Small flexible liquid core catheter for laser ablation in body lumens and methods for use
US11241519B2 (en) 2011-10-14 2022-02-08 Ra Medical Sysiems, Inc. Small flexible liquid core catheter for laser ablation in body lumens and methods for use
US10245417B2 (en) 2013-10-16 2019-04-02 Ra Medical Systems, Inc. Package for extended shelf life of liquid core catheters
US10322266B2 (en) 2013-10-16 2019-06-18 Ra Medical Systems, Inc. Methods and devices for treatment of stenosis of arteriovenous fistula shunts
US10384038B2 (en) 2013-10-16 2019-08-20 Ra Medical Systems, Inc. Methods and devices for treatment of stenosis of arteriovenous fistula shunts
US9962527B2 (en) 2013-10-16 2018-05-08 Ra Medical Systems, Inc. Methods and devices for treatment of stenosis of arteriovenous fistula shunts
US11020570B2 (en) 2013-10-16 2021-06-01 Ra Medical Systems, Inc. Methods and devices for treatment of stenosis of arteriovenous fistula shunts
US11730929B2 (en) 2013-10-16 2023-08-22 Ra Medical Systems, Inc. Methods and devices for treatment of stenosis of arteriovenous fistula shunts
WO2017042074A1 (en) * 2015-09-07 2017-03-16 Raumedic Ag Tube
US10544887B2 (en) 2015-09-07 2020-01-28 Raumedic Ag Tube
US10555772B2 (en) 2015-11-23 2020-02-11 Ra Medical Systems, Inc. Laser ablation catheters having expanded distal tip windows for efficient tissue ablation
US11284941B2 (en) 2015-11-23 2022-03-29 Ra Medical Systems, Inc. Laser ablation catheters having expanded distal tip windows for efficient tissue ablation
US11147616B2 (en) 2018-03-22 2021-10-19 Ra Medical Systems, Inc. Liquid filled ablation catheter with overjacket

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EP2257332B1 (en) 2018-07-04
WO2009120871A3 (en) 2009-12-30
US20090247868A1 (en) 2009-10-01
EP3078394A1 (en) 2016-10-12
EP2257332A2 (en) 2010-12-08
EP2257332A4 (en) 2013-06-05
ES2683894T3 (en) 2018-09-28
US9314586B2 (en) 2016-04-19

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