CA2048002C - Reinforced multiple lumen catheter - Google Patents
Reinforced multiple lumen catheterInfo
- Publication number
- CA2048002C CA2048002C CA002048002A CA2048002A CA2048002C CA 2048002 C CA2048002 C CA 2048002C CA 002048002 A CA002048002 A CA 002048002A CA 2048002 A CA2048002 A CA 2048002A CA 2048002 C CA2048002 C CA 2048002C
- Authority
- CA
- Canada
- Prior art keywords
- interior
- filament
- catheter
- sheath
- interior element
- Prior art date
- Legal status (The legal status 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 status listed.)
- Expired - Fee Related
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M25/003—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
- A61M2025/0031—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
Abstract
Disclosed is a flexible, reinforced, multiple lumen catheter. This catheter includes an elongated, flexible, tubular element extending about a central axis, and including embedded therein at least one filament extending in a helical path about the central axis. The inner surface of the tubular element defines an interior region . The catheter also includes an elongated divider element having elongated lateral edges. These edges are integral with, and extending from, portions of the inner surface of the tubular element. At least two lumens are defined in the interior region of the tubular element on opposing sides of the divider element. Also disclosed is a method for assembling the flexible, reinforced, multiple lumen catheter.
Description
~ 2~ 2 RFTN~OR('~n M~L~IPLE LUMFN ~AT~T~'I'FR
Back~round of the Invention This invention relates to accessing body fluids for diagnostic and therapeutic purposes, and in particular, to a catheter for venous vascular access. More specifically, this invention relates to a reinforced dual lumen catheter for h ~ l ysis or apheresis procedures requiring bidirectional blood f low.
Extracorporeal treatment of blood requires that the vascular system of a subject be directly accessed, and that the blood be removed and then returned to the subject after removal of various _ -~ts or toxins, or after addition of oxygen. Extracorporeal treatments include apheresis, or the collection of blood cells, the removal of a specific blood cell type from the blood, or plasma exchange, and hemodialysis, or the removal of various chemical substances from the blood including ingested or injected drugs, or toxins created during normal body metabolism, the presence of which is most often due to renal impairment.
Traditionally, such extracorporeal treatments involve the tapping of the vascular system via a f irst needle attached to a f irst catheter . The blood is then circulated through a treatment device, and then returned to the vascular system via a second catheter and needle. This technique requires that the needles be spaced a sufficient distance apart so that treated blood will not reenter the output needle for additional treatment. Adequate needle spacing is also required to prevent collapse of the accessed vein. The problem of vascular collapse becomes compounded if the treatment is one which must be repeated and the vein or f istula becomes weakened with repeated punctures .
Another method of performing extracorporeal blood treatment includes the use of a single needle and catheter a~ 3ting bidirectional flow through which the blood is removed and returned. See, for example, the simple double lumen cather disclosed by Mahurkar in U. S . Patent No.
.~
Back~round of the Invention This invention relates to accessing body fluids for diagnostic and therapeutic purposes, and in particular, to a catheter for venous vascular access. More specifically, this invention relates to a reinforced dual lumen catheter for h ~ l ysis or apheresis procedures requiring bidirectional blood f low.
Extracorporeal treatment of blood requires that the vascular system of a subject be directly accessed, and that the blood be removed and then returned to the subject after removal of various _ -~ts or toxins, or after addition of oxygen. Extracorporeal treatments include apheresis, or the collection of blood cells, the removal of a specific blood cell type from the blood, or plasma exchange, and hemodialysis, or the removal of various chemical substances from the blood including ingested or injected drugs, or toxins created during normal body metabolism, the presence of which is most often due to renal impairment.
Traditionally, such extracorporeal treatments involve the tapping of the vascular system via a f irst needle attached to a f irst catheter . The blood is then circulated through a treatment device, and then returned to the vascular system via a second catheter and needle. This technique requires that the needles be spaced a sufficient distance apart so that treated blood will not reenter the output needle for additional treatment. Adequate needle spacing is also required to prevent collapse of the accessed vein. The problem of vascular collapse becomes compounded if the treatment is one which must be repeated and the vein or f istula becomes weakened with repeated punctures .
Another method of performing extracorporeal blood treatment includes the use of a single needle and catheter a~ 3ting bidirectional flow through which the blood is removed and returned. See, for example, the simple double lumen cather disclosed by Mahurkar in U. S . Patent No.
.~
2~8~
4, 808 ,155; a double lumen needle and cannula also disclosed by Mahurkar in U.S. Patent No. 4,134,402; a dual thAnnP~
hypodermic needle disclosed by Grumarud in U. S . Patent No .
4,203,436; and a h 'i~lysis catheter with two circular lumens arranged side by side disclosed by Uthmann in U. S .
Patent No. 4,385,631. This method m;n;m;Z~ insertion trauma and reduces potential for clotting. However, this method may not be of use to all patients as f low rates within the needle are limited. In addition, prerequisite to this technique is an intermittent occlusion machine capable of cyclical operation.
A common problem encountered in the extracorporeal treatment of blood is collapse of the catheter due to decreased pressure within the catheter, and subsequent w~kPn;n~ of the catheter walls. Single lumen catheters and tubes have long been reinforced to reduced collapse. See, for example, U.S. Patent No. 419,926 granted to Chapman in 1890, and U.S. Patent No. 2,211,975 granted to Hendrickson in 1937; and more recently U.S. Patent Nos. 4,832,681, 4,737,153, and 4,639,252.
Hence there is a long felt need for a vascular access catheter which will not collapse, which accomodates dual flow therethrough with a sufficient flow rate, and the use of which causes minimal clotting and recycling of treated blood.
Accordingly, it is an object of the present invention to provide an improved catheter allowing for plural flow therein .
It is another object of the invention to provide a reinforced multiple lumen catheter which will not collapse.
Yet another object of the invention is to provide a method of fabricating a reinforced, multiple lumen catheter.
Summarv Of The Invention Brief ly, the present invention is directed to a multiple lumen catheter for blood treatment. It has been discovered that a flexible, multiple lumen catheter which is reinforced will not collapse, and has a reduced potential to 2~8~2 .
form clots within the tube. Neither does this catheter lend itself to leakage at the point of insertion in the body. In addition, this multiple lumen catheter has a reduced potential to recycle blood while providing a high f low rate 5 of blood therethrough.
The catheter includes an elongated, flexible, tubular element extending about a central axis, and whose inner surface defines an interior region. Preferably, this tubular element is _ --od of a material selected from the 10 group consisting of natural rubber, synthetic rubber and thermoplastics. In some ~mho~;r-nts of the invention, the tubular element includes silicone or a thermal plastic selected from the group consisting of polyurethane and polyvinylchloride. A preferred synthetic rubber is butyl 15 styrene.
~ r h~ Pd in the tubular element is a f ilament extending in a helical path about the central axis. In preferred aspects of the invention, the filament is, ---d of a metal such as surgical grade st~inl~e~ steel, titanium, or 20 a plastic such as polyester or polyamide.
The catheter also includes an elongated divider element having elongated lateral edges which are integral with, and extend from, portions of the inner surface of the tubular element. In this way, at least two lumens are defined in 25 the interior region on opposing sides of the divider element .
In one form, the divider element is substantially rectangular, and thus def ines two distinct lumens . In alternative embodiments, the divider element has a 30 substantially Y-shaped cross-section, thereby defining three lumens in the interior region. Similarly, the divider element may be X or star-shaped, thereby defining four or more lumens in the interior region.
In one Pmhofli nt of the invention, the tubular element 35 ~n~ c two concentric components. The first is an elongated, flexible, tubular sheath having a substantially circular cross-section and an inner diameter substantially 8~
equal to D. The second ~_ Ant is an elongated, flexible, tubular interior element having an outer surface, an interior surface, and a substantially circular cross-section, all ~1 i cpos-cl concentrically within the f irst 5 ~ ~ t. The outer surface of the second cn-~rAn~nt has a diameter equal to D1 and the interior surface has a diameter equal to d, where D1 is less than D, and d is less than Dl.
In this configuration, the interior surface of the interior element forms the inner surface of the tubular element. The 10 tubular element further includes a f ilament wound about the outer surface of the tubular interior element. A flexible bonding material is disposed in the region between the outer surface of the interior element and the inner surface of the sheath .
Another ~nho~; r -nt of the invention is a method of assembling the reinforced, multiple lumen catheter. This method includes extruding a f irst material to establish an elongated, flexible, tubular sheath extending along a central axis. Also extruded is a second material which establishes a flexible, multiple lumen interior element extending along a central axis. An axial stretching force is applied to stretch the interior element in the direction of the central axis, whereby the outer diameter of the interior element is reduced to be less than D1. The stretched interior element is then drawn through the interior of at least one filament. The filament is formed in the shape of a helix having an inner ~li; Pr substantially equal to D1. The stretching force is then removed from the interior element. At this point, the interior element and the helical filament are in intimate contact, thereby establishing a filament-wound, multiple lumen interior element. The exterior of this element is coated with an adhesive. The sheath is then positioned over the adhesive coated element and the adhesive is then cured.
In preferred aspects of the invention, the adhesive ; n~ the same material of which the tubular element is formed. The method may further include the step of shaping 2~9~
the distal end of the catheter to produce a formed tip. In addition, the step of dividing a proximal end of the catheter to establish at least a f irst tubular portion ; n~ ; n~ one of the lumens and a second tubular portion 5 1nclll~1in~ the other of the lumens, may be provided. In yet another Pmho~li nt of the method of the invention, the sheath may be PYr~nrled by exposing it to freon before the sheath is positioned over the adhesive-coated, f ilament-wound catheter .
Brief DescriQtior~ of the Drawinqs The foregoing and other objects of this invention, the various features thereof, as well as the invention itself, may be more fully understood from the following description, wl~en read together with the ~r~c~rr:~nying drawings in which:
FIG. 1 is a perspective view of a flexible, reinforced, dual-lumen catheter having a bifurcated proximal external portion terminating in luer lock connections useful for insertion into a hemodialysis or apheresis device;
FIG. 2 is a partially cut away view of a portion of the catheter of FIG. 1 showing a wire reinforcement;
FIG. 3 is a cross-sectional view along lines 3-3 of FIG. 1;
FIG. 4 is a cross-sectional view of a tri-lumen catheter; and FIG. 5 is a partially cut-away view of a portion of another prhQrl;r -nt of the invention.
Detailed Descri~tion of the Invention FIGs. 1-3 refer to various views of a reinforced, flexible, dual lumen catheter 100. FIG. 1 shows a perspective view of catheter 100 including tubular element 10 extending about central axis A, and having inner surface 12 def ining an interior region . In the illustrated r~ ir--lt, element 10 includes an outer cylindrial sheath 46 concentrically positioned over an inner, generally cylindrical element 47. In alternative embodiments, element 10 may be an integral one-piece element.
2~
A substantially rectangular divider element 18 has elongated lateral edges intergral with, and extending from, portions of the inner surface 12 of tubular element 10.
Divider element 18 def ines lumens 14 and 16 in the interior region on opposing side~ of divider element 18. In this : ~ -;r--,t, proximal portion 22 of tubular element 10 bifurcates into extension tubes 32 and 34, and terminates in two female threaded luer lock connectors 42 and 44.
Extension tubes 32 and 34 are equipped with clamp closures 52 and 54, respectively, and removable gum injection ports 62 and 64. Clamp closures 52 and 54 may be color coded or otherwise labelled to distinguish venous (return) flow from arterial (outflow).
Tubular element 10 is cnrros~l of a material selected from the group consisting of natural rubber, synthetic rubber and thermoplastics. For exampIe, silicone or a thermal plastic selected from the group consisting of polyurethane and polyvinylchloride are useful. A preferred synthetic rubber is butyl styrene.
FIG. 2 is a partially cut away view of a portion of catheter 100 of FIG. l showing wire reinforcement filament 36 ~mh~ l in tubular element lO and extending in a helical path about central axis A. Filament 36 may be ~ ' of a metal, such as surgical grade stainless steel or titanium, or a plastic, such as polyester or polyamide.
The divider element 18 is shown in FIG. 3 as substantially ribbon-shaped or rectangular, whereby two lumens, 14 and 16, are defined in the interior region.
Alternatively, the divider element 48 within multiple lumen catheter 200 shown in FIG. 4 has a Y-shaped cross-section, thereby defining lumens 102, 103, and 104. This divider element may be ~ - sed of the same material as the tubular element .
In another form of the invention shown in FIG. 5, dual lumen catheter lO0 includes sheath 300 having a substantially circular cross-section and an inner surface 301 with an inner diameter substantially equal to D. Within 8~
sheath 300 lies interior tubular element 302 having outer surface 304 and interior surface 320. Outer surface 304 has a diameter equal to D1 whereas inner surface 320 has a r equal to d, where d is less than Dl. A filament 5 336 is wound in a helical path around outer surface 304. A
flexible bonding material (not shown) is disposed in region 308 between outer surface 304 and inner surface 301.
The multiple lumen catheter of FIGS. 1-3 can be a6sembled as follows. A first material is extruded to 10 establish the tubular sheath 46. A second material is also extruded to establish the interior element 47. An axial stretching force is then applied to stretch the interior element 47 in the direction of the central axis A, whereby the outer diameter of the interior element is reduced to be 15 less than Dl, the nominal ~or "at rest") diameter of the outer surface of the interior element 47. The stretched interior element 47 is then drawn through the interior of at least one filament 36 formed in the shape of a helix. This helical f ilament has an inner diameter substantially equal 20 to Dl. The exterior of the filament-wound interior element is then coated with an adhesive and the sheath 4 6 is positioned over it. The stretching force on element 47 is then removed. Upon removal of the stretching force from the interior element, the interior element and the filament have 25 intimate contact, thereby establishing a filament-wound, multiple lumen interior element. Useful adhesives include, for example, polyurethane and butyl styrene. Upon curing the adhesive, a multiple lumen, filament-wound catheter 10 is formed. Alternatively, tlle stretching force may be 30 removed just after the filament is wound, and prior to said the positioning step, the sheath may be ~--r~n~ by exposing it to freon, permitting easy placement of that sheath over the f ilament wound interior element.
A formed tip may be produced at the distal end of the 35 catheter. In addition, the proximal end of the catheter may be divided into separated tubular portions each ; n~ ; ng a single lumen.
-8- ~ 2 The invention may be embodied in other specific forms without departing from the Gpirit and scope thereof. The pre6ent c.rhQ,lir Ls are therefore to be considered in all aspects as illustrative and not resptrictive, the scope of 5 the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.
4, 808 ,155; a double lumen needle and cannula also disclosed by Mahurkar in U.S. Patent No. 4,134,402; a dual thAnnP~
hypodermic needle disclosed by Grumarud in U. S . Patent No .
4,203,436; and a h 'i~lysis catheter with two circular lumens arranged side by side disclosed by Uthmann in U. S .
Patent No. 4,385,631. This method m;n;m;Z~ insertion trauma and reduces potential for clotting. However, this method may not be of use to all patients as f low rates within the needle are limited. In addition, prerequisite to this technique is an intermittent occlusion machine capable of cyclical operation.
A common problem encountered in the extracorporeal treatment of blood is collapse of the catheter due to decreased pressure within the catheter, and subsequent w~kPn;n~ of the catheter walls. Single lumen catheters and tubes have long been reinforced to reduced collapse. See, for example, U.S. Patent No. 419,926 granted to Chapman in 1890, and U.S. Patent No. 2,211,975 granted to Hendrickson in 1937; and more recently U.S. Patent Nos. 4,832,681, 4,737,153, and 4,639,252.
Hence there is a long felt need for a vascular access catheter which will not collapse, which accomodates dual flow therethrough with a sufficient flow rate, and the use of which causes minimal clotting and recycling of treated blood.
Accordingly, it is an object of the present invention to provide an improved catheter allowing for plural flow therein .
It is another object of the invention to provide a reinforced multiple lumen catheter which will not collapse.
Yet another object of the invention is to provide a method of fabricating a reinforced, multiple lumen catheter.
Summarv Of The Invention Brief ly, the present invention is directed to a multiple lumen catheter for blood treatment. It has been discovered that a flexible, multiple lumen catheter which is reinforced will not collapse, and has a reduced potential to 2~8~2 .
form clots within the tube. Neither does this catheter lend itself to leakage at the point of insertion in the body. In addition, this multiple lumen catheter has a reduced potential to recycle blood while providing a high f low rate 5 of blood therethrough.
The catheter includes an elongated, flexible, tubular element extending about a central axis, and whose inner surface defines an interior region. Preferably, this tubular element is _ --od of a material selected from the 10 group consisting of natural rubber, synthetic rubber and thermoplastics. In some ~mho~;r-nts of the invention, the tubular element includes silicone or a thermal plastic selected from the group consisting of polyurethane and polyvinylchloride. A preferred synthetic rubber is butyl 15 styrene.
~ r h~ Pd in the tubular element is a f ilament extending in a helical path about the central axis. In preferred aspects of the invention, the filament is, ---d of a metal such as surgical grade st~inl~e~ steel, titanium, or 20 a plastic such as polyester or polyamide.
The catheter also includes an elongated divider element having elongated lateral edges which are integral with, and extend from, portions of the inner surface of the tubular element. In this way, at least two lumens are defined in 25 the interior region on opposing sides of the divider element .
In one form, the divider element is substantially rectangular, and thus def ines two distinct lumens . In alternative embodiments, the divider element has a 30 substantially Y-shaped cross-section, thereby defining three lumens in the interior region. Similarly, the divider element may be X or star-shaped, thereby defining four or more lumens in the interior region.
In one Pmhofli nt of the invention, the tubular element 35 ~n~ c two concentric components. The first is an elongated, flexible, tubular sheath having a substantially circular cross-section and an inner diameter substantially 8~
equal to D. The second ~_ Ant is an elongated, flexible, tubular interior element having an outer surface, an interior surface, and a substantially circular cross-section, all ~1 i cpos-cl concentrically within the f irst 5 ~ ~ t. The outer surface of the second cn-~rAn~nt has a diameter equal to D1 and the interior surface has a diameter equal to d, where D1 is less than D, and d is less than Dl.
In this configuration, the interior surface of the interior element forms the inner surface of the tubular element. The 10 tubular element further includes a f ilament wound about the outer surface of the tubular interior element. A flexible bonding material is disposed in the region between the outer surface of the interior element and the inner surface of the sheath .
Another ~nho~; r -nt of the invention is a method of assembling the reinforced, multiple lumen catheter. This method includes extruding a f irst material to establish an elongated, flexible, tubular sheath extending along a central axis. Also extruded is a second material which establishes a flexible, multiple lumen interior element extending along a central axis. An axial stretching force is applied to stretch the interior element in the direction of the central axis, whereby the outer diameter of the interior element is reduced to be less than D1. The stretched interior element is then drawn through the interior of at least one filament. The filament is formed in the shape of a helix having an inner ~li; Pr substantially equal to D1. The stretching force is then removed from the interior element. At this point, the interior element and the helical filament are in intimate contact, thereby establishing a filament-wound, multiple lumen interior element. The exterior of this element is coated with an adhesive. The sheath is then positioned over the adhesive coated element and the adhesive is then cured.
In preferred aspects of the invention, the adhesive ; n~ the same material of which the tubular element is formed. The method may further include the step of shaping 2~9~
the distal end of the catheter to produce a formed tip. In addition, the step of dividing a proximal end of the catheter to establish at least a f irst tubular portion ; n~ ; n~ one of the lumens and a second tubular portion 5 1nclll~1in~ the other of the lumens, may be provided. In yet another Pmho~li nt of the method of the invention, the sheath may be PYr~nrled by exposing it to freon before the sheath is positioned over the adhesive-coated, f ilament-wound catheter .
Brief DescriQtior~ of the Drawinqs The foregoing and other objects of this invention, the various features thereof, as well as the invention itself, may be more fully understood from the following description, wl~en read together with the ~r~c~rr:~nying drawings in which:
FIG. 1 is a perspective view of a flexible, reinforced, dual-lumen catheter having a bifurcated proximal external portion terminating in luer lock connections useful for insertion into a hemodialysis or apheresis device;
FIG. 2 is a partially cut away view of a portion of the catheter of FIG. 1 showing a wire reinforcement;
FIG. 3 is a cross-sectional view along lines 3-3 of FIG. 1;
FIG. 4 is a cross-sectional view of a tri-lumen catheter; and FIG. 5 is a partially cut-away view of a portion of another prhQrl;r -nt of the invention.
Detailed Descri~tion of the Invention FIGs. 1-3 refer to various views of a reinforced, flexible, dual lumen catheter 100. FIG. 1 shows a perspective view of catheter 100 including tubular element 10 extending about central axis A, and having inner surface 12 def ining an interior region . In the illustrated r~ ir--lt, element 10 includes an outer cylindrial sheath 46 concentrically positioned over an inner, generally cylindrical element 47. In alternative embodiments, element 10 may be an integral one-piece element.
2~
A substantially rectangular divider element 18 has elongated lateral edges intergral with, and extending from, portions of the inner surface 12 of tubular element 10.
Divider element 18 def ines lumens 14 and 16 in the interior region on opposing side~ of divider element 18. In this : ~ -;r--,t, proximal portion 22 of tubular element 10 bifurcates into extension tubes 32 and 34, and terminates in two female threaded luer lock connectors 42 and 44.
Extension tubes 32 and 34 are equipped with clamp closures 52 and 54, respectively, and removable gum injection ports 62 and 64. Clamp closures 52 and 54 may be color coded or otherwise labelled to distinguish venous (return) flow from arterial (outflow).
Tubular element 10 is cnrros~l of a material selected from the group consisting of natural rubber, synthetic rubber and thermoplastics. For exampIe, silicone or a thermal plastic selected from the group consisting of polyurethane and polyvinylchloride are useful. A preferred synthetic rubber is butyl styrene.
FIG. 2 is a partially cut away view of a portion of catheter 100 of FIG. l showing wire reinforcement filament 36 ~mh~ l in tubular element lO and extending in a helical path about central axis A. Filament 36 may be ~ ' of a metal, such as surgical grade stainless steel or titanium, or a plastic, such as polyester or polyamide.
The divider element 18 is shown in FIG. 3 as substantially ribbon-shaped or rectangular, whereby two lumens, 14 and 16, are defined in the interior region.
Alternatively, the divider element 48 within multiple lumen catheter 200 shown in FIG. 4 has a Y-shaped cross-section, thereby defining lumens 102, 103, and 104. This divider element may be ~ - sed of the same material as the tubular element .
In another form of the invention shown in FIG. 5, dual lumen catheter lO0 includes sheath 300 having a substantially circular cross-section and an inner surface 301 with an inner diameter substantially equal to D. Within 8~
sheath 300 lies interior tubular element 302 having outer surface 304 and interior surface 320. Outer surface 304 has a diameter equal to D1 whereas inner surface 320 has a r equal to d, where d is less than Dl. A filament 5 336 is wound in a helical path around outer surface 304. A
flexible bonding material (not shown) is disposed in region 308 between outer surface 304 and inner surface 301.
The multiple lumen catheter of FIGS. 1-3 can be a6sembled as follows. A first material is extruded to 10 establish the tubular sheath 46. A second material is also extruded to establish the interior element 47. An axial stretching force is then applied to stretch the interior element 47 in the direction of the central axis A, whereby the outer diameter of the interior element is reduced to be 15 less than Dl, the nominal ~or "at rest") diameter of the outer surface of the interior element 47. The stretched interior element 47 is then drawn through the interior of at least one filament 36 formed in the shape of a helix. This helical f ilament has an inner diameter substantially equal 20 to Dl. The exterior of the filament-wound interior element is then coated with an adhesive and the sheath 4 6 is positioned over it. The stretching force on element 47 is then removed. Upon removal of the stretching force from the interior element, the interior element and the filament have 25 intimate contact, thereby establishing a filament-wound, multiple lumen interior element. Useful adhesives include, for example, polyurethane and butyl styrene. Upon curing the adhesive, a multiple lumen, filament-wound catheter 10 is formed. Alternatively, tlle stretching force may be 30 removed just after the filament is wound, and prior to said the positioning step, the sheath may be ~--r~n~ by exposing it to freon, permitting easy placement of that sheath over the f ilament wound interior element.
A formed tip may be produced at the distal end of the 35 catheter. In addition, the proximal end of the catheter may be divided into separated tubular portions each ; n~ ; ng a single lumen.
-8- ~ 2 The invention may be embodied in other specific forms without departing from the Gpirit and scope thereof. The pre6ent c.rhQ,lir Ls are therefore to be considered in all aspects as illustrative and not resptrictive, the scope of 5 the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.
Claims (30)
1. A multiple lumen catheter comprising:
an elongated, flexible, tubular element extending about a central axis and including embedded therein at least one filament extending in a helical path about said central axis, with said tubular element having an inner surface defining an interior region; and an elongated divider element having elongated lateral edges, with the lateral edges being integral with and extending from portions of said inner surface of said tubular element, and with at least two lumens being defined in said interior region on opposing sides of said divider element;
wherein said tubular element further comprises:
an elongated, flexible, tubular sheath having a substantially circular cross-section and an inner diameter substantially equal to D;
an elongated, flexible interior element having an outer surface, an interior surface, and a substantially circular cross-section, said outer surface having a diameter equal to D1 and said interior surface having a diameter equal to d, wherein D1 is less than D and d is less than D1, and wherein the interior surface of said interior element forms said inner surface of said tubular element;
said filament being wound about said outer surface of said tubular element; and a flexible bonding material disposed in the region between the outer surface of said interior element and the inner surface of said sheath.
an elongated, flexible, tubular element extending about a central axis and including embedded therein at least one filament extending in a helical path about said central axis, with said tubular element having an inner surface defining an interior region; and an elongated divider element having elongated lateral edges, with the lateral edges being integral with and extending from portions of said inner surface of said tubular element, and with at least two lumens being defined in said interior region on opposing sides of said divider element;
wherein said tubular element further comprises:
an elongated, flexible, tubular sheath having a substantially circular cross-section and an inner diameter substantially equal to D;
an elongated, flexible interior element having an outer surface, an interior surface, and a substantially circular cross-section, said outer surface having a diameter equal to D1 and said interior surface having a diameter equal to d, wherein D1 is less than D and d is less than D1, and wherein the interior surface of said interior element forms said inner surface of said tubular element;
said filament being wound about said outer surface of said tubular element; and a flexible bonding material disposed in the region between the outer surface of said interior element and the inner surface of said sheath.
2. The catheter of claim 1 wherein said divider element is substantially rectangular, whereby two lumens are defined in said interior regions.
3. The catheter of claim 1 wherein said divider element has a substantially Y-shaped cross-section, whereby three lumens are defined in said interior region.
4 . The catheter of claim 1 wherein said filament comprises a material selected from the group consisting of metal and plastic.
5. The catheter of claim 4 wherein said metallic filament comprises surgical grade stainless steel.
6. The catheter of claim 4 wherein said metallic filament comprises titanium.
7. The catheter of claim 4 wherein said plastic filament comprises polyester.
8. The catheter of claim 4 wherein said plastic filament comprises polyamide.
9. The catheter of claim 1 wherein said tubular element comprises a material selected from the group consisting of natural rubber, synthetic rubber, and thermoplastics.
10. The catheter of claim 9 wherein said tubular element comprises silicone.
11. The catheter of claim 9 wherein said tubular element comprises a thermoplastic selected from the group consisting of polyurethane and polyvinylchloride.
12. The catheter of claim 9 wherein said tubular element comprises the synthetic rubber, butyl styrene.
13. A method of assembling a multiple lumen, filament-wound catheter comprising the steps of:
(a) extruding a first material to establish an elongated, flexible, tubular sheath extending along a central axis, said sheath having a substantially circular cross-section with an inner diameter substantially equal to D:
(b) extruding a second material to establish a flexible, multiple lumen interior element extending along a central axis and having a substantially circular cross-section with an outer diameter D1 where D1 is less than D, said interior element including at least two interior lumens extending along its length;
(c) applying an axial stretching force to stretch said interior element in the direction of said central axis, whereby the outer diameter of said interior element is reduced to be less than D1;
(d) drawing said stretched interior element through the interior of at least one filament formed in the shape of a helix, said helix having an inner diameter substantially equal to D1;
(e) removing said stretching force from said interior element, whereby said interior element and said helical filament are in intimate contact, thereby establishing a filament-wound, multiple lumen interior element;
(f) coating the exterior of said filament-wound interior element with an adhesive;
(g) positioning said sheath over said adhesive-coated, filament-wound interior element; and (h) curing said adhesive, thereby forming a multiple lumen, filament-wound catheter.
(a) extruding a first material to establish an elongated, flexible, tubular sheath extending along a central axis, said sheath having a substantially circular cross-section with an inner diameter substantially equal to D:
(b) extruding a second material to establish a flexible, multiple lumen interior element extending along a central axis and having a substantially circular cross-section with an outer diameter D1 where D1 is less than D, said interior element including at least two interior lumens extending along its length;
(c) applying an axial stretching force to stretch said interior element in the direction of said central axis, whereby the outer diameter of said interior element is reduced to be less than D1;
(d) drawing said stretched interior element through the interior of at least one filament formed in the shape of a helix, said helix having an inner diameter substantially equal to D1;
(e) removing said stretching force from said interior element, whereby said interior element and said helical filament are in intimate contact, thereby establishing a filament-wound, multiple lumen interior element;
(f) coating the exterior of said filament-wound interior element with an adhesive;
(g) positioning said sheath over said adhesive-coated, filament-wound interior element; and (h) curing said adhesive, thereby forming a multiple lumen, filament-wound catheter.
14. The method of claim 13 wherein said extruding steps include extruding said sheath and said interior element, said sheath and said interior element comprising a material selected from the group consisting of natural rubber, synthetic rubber, and thermoplastics.
15. The method of claim 14 wherein said extruding steps include extruding said sheath and said interior element, said sheath and and interior element comprising silicone .
16. The method of claim 14 wherein said extruding steps include extruding said sheath and said interior element, said sheath and said interior element comprising polyurethane.
17. The method of claim 14 wherein said extruding steps include extruding said sheath and said interior element, said sheath and said interior element comprising butyl styrene.
18. The method of claim 14 wherein said extruding steps include extruding said sheath and said interior element, said sheath and said interior element comprising polyvinylchloride.
19. The method of claim 13 wherein said coating step further comprises coating the exterior of said filament-wound interior element with a silicone adhesive.
20. The method of claim 13 wherein said coating step further comprises coating the exterior of said filament-wound interior element with a polyurethane adhesive.
21. The method of claim 13 wherein said coating step further comprises coating the exterior of said filament-wound interior element with a butyl styrene adhesive.
22. The method of claim 13 wherein said coating step further comprises coating the exterior of said filament-wound interior element with a polyvinylchloride adhesive.
23. The method of claim 13 wherein said drawing step includes drawing said stretched interior element through at least one helical filament comprising a metal.
24. The method of claim 13 wherein said drawing step includes drawing said stretched interior element through at least one helical filament comprising a surgical grade stainless steel.
25. The method of claim 13 wherein said drawing step includes drawing said stretched element through a helical filament comprising titanium.
26. The method of claim 13 wherein said drawing step includes drawing said stretched element through a helical filament comprising polyester.
27. The method of claim 13 wherein said drawing step includes drawing said stretched element through a helical filament comprising polyamide.
28. The method of claim 13 further including the further step of shaping the distal end of said catheter to produce a formed tip.
29. The method of claim 13 further including the step of dividing a proximal end of said catheter to establish at least a first tubular portion including one of said lumens and a second tubular portion including the other of said lumens.
30. The method of claim 13 comprising, prior to said step (g), the further step of expanding sheath by exposing said sheath to freon.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US595,028 | 1990-10-10 | ||
| US07/595,028 US5190520A (en) | 1990-10-10 | 1990-10-10 | Reinforced multiple lumen catheter |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2048002A1 CA2048002A1 (en) | 1992-04-11 |
| CA2048002C true CA2048002C (en) | 1996-08-06 |
Family
ID=24381417
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002048002A Expired - Fee Related CA2048002C (en) | 1990-10-10 | 1991-07-26 | Reinforced multiple lumen catheter |
Country Status (2)
| Country | Link |
|---|---|
| US (1) | US5190520A (en) |
| CA (1) | CA2048002C (en) |
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Also Published As
| Publication number | Publication date |
|---|---|
| CA2048002A1 (en) | 1992-04-11 |
| US5190520A (en) | 1993-03-02 |
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