CA2127257C - Lubricious catheters - Google Patents
Lubricious catheters Download PDFInfo
- Publication number
- CA2127257C CA2127257C CA002127257A CA2127257A CA2127257C CA 2127257 C CA2127257 C CA 2127257C CA 002127257 A CA002127257 A CA 002127257A CA 2127257 A CA2127257 A CA 2127257A CA 2127257 C CA2127257 C CA 2127257C
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- Prior art keywords
- catheter
- segment
- polymer
- distal
- polymeric
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/08—Materials for coatings
- A61L29/085—Macromolecular materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
-
- 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
- A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
-
- 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
- A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
- A61M2025/0046—Coatings for improving slidability
Abstract
This invention is in the general field of surgical instruments. It relates specifically to catheters which may be used in cardiovascular and endovascular procedures to deliver diagnostic, therapeutic, or vaso-occlusive agents to a target site within a human or animal body which is accessible by a system of natural passageways within that body. The catheters are coated in such a way that they are exceptionally slippery and the coating is very durable. The invention also relates to methods of coating the catheters and to methods of applying lubricious coatings.
Description
r 1 k -~-LUBRICIO~Ta CATHETER
Field of the Invention This invention is in the general field of ' surgical instruments. It relates specifically to catheters which may be used in cardiovascular and _ endovascular procedures to deliver diagnostic, therapeutic, or vaso-occlusive agents or devices to a target site within a human or animal body which is accessible by a system of natural passageways within that body. The catheters are coated in such a way that they are exceptionally slippery and the coating is very durable. The invention also relates to methods for coating the catheters and to methods for applying lubricious coatings.
Backcxrourid O~ the nv~ant; nn Catheters are increasingly used to deliver diagnostic or therapeutic agents and devices to internal target sites that can be accessed through the circulatory or other system. There are a number of general approaches for placing catheters within vessels in the body to reach target sites that are difficult to access. In one technique, a torqueable~
guidewire is introduced into the vasculature and, using radiography to monitor its advance through the body~s passageways, is rotated to allow the guidewire~s bent guide tip to follow a chosen route (when a choice of pathways is found) and advanced .towards the target site. At chosen intervals during the guidewire~s advancement, the catheter is slid along the guidewire until the distal end of the catheter approaches. the distal end of the guidewire.
This procedure is repeated until the distal end of the f 1
Field of the Invention This invention is in the general field of ' surgical instruments. It relates specifically to catheters which may be used in cardiovascular and _ endovascular procedures to deliver diagnostic, therapeutic, or vaso-occlusive agents or devices to a target site within a human or animal body which is accessible by a system of natural passageways within that body. The catheters are coated in such a way that they are exceptionally slippery and the coating is very durable. The invention also relates to methods for coating the catheters and to methods for applying lubricious coatings.
Backcxrourid O~ the nv~ant; nn Catheters are increasingly used to deliver diagnostic or therapeutic agents and devices to internal target sites that can be accessed through the circulatory or other system. There are a number of general approaches for placing catheters within vessels in the body to reach target sites that are difficult to access. In one technique, a torqueable~
guidewire is introduced into the vasculature and, using radiography to monitor its advance through the body~s passageways, is rotated to allow the guidewire~s bent guide tip to follow a chosen route (when a choice of pathways is found) and advanced .towards the target site. At chosen intervals during the guidewire~s advancement, the catheter is slid along the guidewire until the distal end of the catheter approaches. the distal end of the guidewire.
This procedure is repeated until the distal end of the f 1
-2-catheter is positioned at the target site. An example of this technique is described in U.S. Patent No.
4,884,579. This is a widely accepted and respected method for approaching target~sites in complicated area of the vasculature. It, however, has the drawback of being somewhat time-consuming due to the necessity of rotating and advancing the guidewire and catheter through the vasculature.
A second technique for advancing a catheter to a target site is to use the blood flow as the motive force in placing the distal end of the catheter at the desired target site. Such methods often employ a highly flexible catheter having an inflatable, but pre-punctured balloon at its distal end. In use, the balloon is partially inflated, and carried by blood flow into the target site. During placement, the balloon is continually inflated to replenish fluid leaking from the balloon. This technique, too, has drawbacks including the fact that at least the distal portion of the catheter is so floppy that it cannot be pushed without buckling. Instead the catheter must be advanced using injected fluid to inflate the balloon to propel the catheter to the target site.
Additionally, there is a risk of rupture of a vessel by a balloon that has been overinflated.
In order to address some of the above described problems, another approach has involved the use of flexible catheters having extremely flexible distal portions which can be directed to a target site using the blood flowing to that site as the motive force but without the use of balloons on the distal catheter tip. These flow-directed catheters have the advantage of being quite fast in that they are able to access remote portions of the body very quickly. They carry the obvious limitation that the catheter distal tip can only go where the blood flow is the highest.
Furthermore, the catheters often are limited in the size of the '~load'~ carried to the selected site. Said another way, balloon-less flow-directed catheters may fe""'~~.., "212727
4,884,579. This is a widely accepted and respected method for approaching target~sites in complicated area of the vasculature. It, however, has the drawback of being somewhat time-consuming due to the necessity of rotating and advancing the guidewire and catheter through the vasculature.
A second technique for advancing a catheter to a target site is to use the blood flow as the motive force in placing the distal end of the catheter at the desired target site. Such methods often employ a highly flexible catheter having an inflatable, but pre-punctured balloon at its distal end. In use, the balloon is partially inflated, and carried by blood flow into the target site. During placement, the balloon is continually inflated to replenish fluid leaking from the balloon. This technique, too, has drawbacks including the fact that at least the distal portion of the catheter is so floppy that it cannot be pushed without buckling. Instead the catheter must be advanced using injected fluid to inflate the balloon to propel the catheter to the target site.
Additionally, there is a risk of rupture of a vessel by a balloon that has been overinflated.
In order to address some of the above described problems, another approach has involved the use of flexible catheters having extremely flexible distal portions which can be directed to a target site using the blood flowing to that site as the motive force but without the use of balloons on the distal catheter tip. These flow-directed catheters have the advantage of being quite fast in that they are able to access remote portions of the body very quickly. They carry the obvious limitation that the catheter distal tip can only go where the blood flow is the highest.
Furthermore, the catheters often are limited in the size of the '~load'~ carried to the selected site. Said another way, balloon-less flow-directed catheters may fe""'~~.., "212727
-3-be a marginal choice if a larger embolic coil or large diameter particle is to be delivered to the select site. One aspect of this invention involves the coating of catheters such as these to~further improve their access rate.
on the other hand, over-the-wire catheters having variable stiffness, although quite strong and able to deliver embolic coils and large diameter particles through their large lumen, are comparatively quite slow in time of access. Friction with the interior of the guide catheter or the vessel path considerably slows the procedure time. However, the over-the-wire catheters can be directed to portions of the vasculature inaccessible to the flow-directed catheter. Lowering the resistance of the over-the-wire catheter to improve its lubricity and allow improved access time to remote body sites forms a further aspect of this invention.
This invention is generically a coated catheter having portions of differing flexibility which is suitable for the delivery of diagnostic, therapeutic, or vaso-occlusive agents or devices to potentially remote portions of the vascular system or other systems of open lumen within the body. The - coating is significantly slipperier than other known coatings and is very durable.
This invention also includes a method of coating catheters using lubricious hydrophilic polymers and a method for producing a thin layer of such polymers on polymeric substrates.
The invention also includes a method for placing the catheter at the target site and a method for delivering diagnostic, therapeutic, or vaso-occlusive agents or devices to the target site.
' Summary of the Invention This invention is a coated catheter for placement within a tortuous, small vessel pathway and a method for delivery of an agent or device to a 2127~,~7
on the other hand, over-the-wire catheters having variable stiffness, although quite strong and able to deliver embolic coils and large diameter particles through their large lumen, are comparatively quite slow in time of access. Friction with the interior of the guide catheter or the vessel path considerably slows the procedure time. However, the over-the-wire catheters can be directed to portions of the vasculature inaccessible to the flow-directed catheter. Lowering the resistance of the over-the-wire catheter to improve its lubricity and allow improved access time to remote body sites forms a further aspect of this invention.
This invention is generically a coated catheter having portions of differing flexibility which is suitable for the delivery of diagnostic, therapeutic, or vaso-occlusive agents or devices to potentially remote portions of the vascular system or other systems of open lumen within the body. The - coating is significantly slipperier than other known coatings and is very durable.
This invention also includes a method of coating catheters using lubricious hydrophilic polymers and a method for producing a thin layer of such polymers on polymeric substrates.
The invention also includes a method for placing the catheter at the target site and a method for delivering diagnostic, therapeutic, or vaso-occlusive agents or devices to the target site.
' Summary of the Invention This invention is a coated catheter for placement within a tortuous, small vessel pathway and a method for delivery of an agent or device to a 2127~,~7
-4-target site. The coating is very slippery and quite durable. The catheter may be directed to the target site either by means of the blood flow to that site or by the use of a guidewire. The catheter has an elongate tubular body having proximal and distal ends and a lumen extending between the ends through which the diagnostic, therapeutic, or vaso-occlusive agent or device is delivered. Where appropriate, the lumen may be used for passage of a guidewire.
1o The elongate tubular body typically is formed of (a) a relatively stiff and, perhaps, tapered proximal segment, (b) a relatively flexible distal segment, and (c) a transition or intermediate section between the proximal and distal segments that is less flexible than the distal segment but more flexible than the proximal segment. At least the distal segment and, desirably, the transition segment'of the catheter is treated with a lubricious, polymeric material. If so desired , all but the portion of the 2o proximal section actually handled by the physician during final manipulation may be coated with the lubricious polymers.
The catheter bodies are coated with hydrophilic polymeric materials by a method involving application of the polymer from a dilute polymer or oligomer solution followed by simultaneous solvent removal and curing of the applied precursor. Multiple coatings of the polymeric material are contemplated.
Brief DescrS~ption of the Drawings FIG. 1 is a diagram that shows an infusion catheter constructed according to a preferred -embodiment of the present invention.
FIG. 2 is a diagram that shows the distal end on one embodiment of a flow-directed infusion catheter of the present invention in which the distal end is formed in an "S" shaped configuration.
1o The elongate tubular body typically is formed of (a) a relatively stiff and, perhaps, tapered proximal segment, (b) a relatively flexible distal segment, and (c) a transition or intermediate section between the proximal and distal segments that is less flexible than the distal segment but more flexible than the proximal segment. At least the distal segment and, desirably, the transition segment'of the catheter is treated with a lubricious, polymeric material. If so desired , all but the portion of the 2o proximal section actually handled by the physician during final manipulation may be coated with the lubricious polymers.
The catheter bodies are coated with hydrophilic polymeric materials by a method involving application of the polymer from a dilute polymer or oligomer solution followed by simultaneous solvent removal and curing of the applied precursor. Multiple coatings of the polymeric material are contemplated.
Brief DescrS~ption of the Drawings FIG. 1 is a diagram that shows an infusion catheter constructed according to a preferred -embodiment of the present invention.
FIG. 2 is a diagram that shows the distal end on one embodiment of a flow-directed infusion catheter of the present invention in which the distal end is formed in an "S" shaped configuration.
-5-FIG. 3 is a diagram showing a flow-directed infusion catheter, stylet, and guiding catheter assembly.
FIG. 4 is a side view of a typical catheter assembly according-to this invention adapted for use with a guidewire.
Descriot~on of the Invention This invention is a catheter, optionally including a guidewire, having discrete sections of varying flexibility. In each variation of the invention, the catheter has a relatively stiff proximal section and a less stiff mid portion. For devices intended for use as flow-directed catheters, the distal end section is quite flexible; far devices intended for use with guidewires, the distal end section need not be quite as flexible since it need only follow the path of the guidewire without substantial disturbance of that pre-determined path.
At least the distal portion of the catheter is coated with a polymeric material to increase its lubricity and to minimize the potential for trauma as it moves through the body lumen: The~mid or transition section of the catheter may also be coated with the polymeric material. The proximal.section may also be coated although most desirably a small proximal end portion is left uncoated for increased control.
Particularly suitable as coatings in the catheter assembly of this invention are polymers or oligomers of monomers selected from ethylene oxide; 2-vinyl pyridine; N-vinylpyrrolidone; polyethylene glycol acrylates such as mono-alkoxy polyethylene glycol mono(meth) acrylates, including mono-methoxy triethylene glycol mono (meth) acrylate, mono-methoxy tetraethylene glycol mono (meth) acrylate, polyethylene glycol mono (meth) acrylate; other hydrophilic acrylates such as 2-hydroxyethylmethacrylate, glycerylmethacrylate;
r 21 ~~~~
acrylic acid and its salts; acrylamide and acrylonitrile; acrylamidomethylpropane sulfonic acid and its salts, cellulose, cellulose derivatives such as methyl cellulose ethyl cellulose, carboxymethyl cellulose, cyanoethyl cellulose, cellulose acetate, polysaccharides such as amylose, pectin, amylopectin, alginic acid, and cross-linked heparin. These monomers may be formed into homopolymers or block or -random copolymers. The use of oligomers of these monomers in coating the catheter for further polymerization is also an alternative. Preferred monomers include ethylene oxide; 2-vinyl pyridine; N-vinylpyrrolidone and acrylic acid and its salts;
acrylamide and acrylonitrile each polymerized (with or without substantial crosslinking) into homopolymers, or into random or block copolymers.
Additionally, hydrophobic monomers may be included in the coating polymeric material in an amount up to about 30% by weight of the resulting copolymer so long as the hydrophilic nature of the resulting copolymer is not substantially compromised.
Suitable monomers include ethylene, propylene, styrene, styrene derivatives, alkylmethacrylates, vinylchloride, vinylidenechloride, methacrylonitrile, and vinyl acetate. Preferred, because of their propensity for ease of linkage to the typical polymeric catheter substrates, are ethylene, propylene, styrene, and styrene derivatives.
Polymers or oligomers applied using the procedure described below are activated or functionalized with photoactive or radiation-active groups to permit reaction of the~polymers or oligomers with the underlying polymeric surface. Suitable activation groups include benzophenone, thioxanthone, I and the like; acetophenone and its derivatives t _2127257 where R' is H, Rz is OH, R' is Ph; or R' is H, Rs is an alkoxy group including -OCH3, -OC2H3, R' is Ph; or R' = R= = an alkoxy group, R' is Ph; or R' = R= _ an alkoxy group, R' is H; or R' = Rz = C1, R' is H or C1.
Other known activators are suitable.
The polymeric coating may then be linked with the substrate using known and appropriate techniques selected on the basis of the chosen activators, e.g., by ultraviolet light, heat, or ionizing radiation. Crosslinking with the listed polymers or oligomers may be accomplished by use of peroxides or azo compounds such as acetyl peroxide, cumyl peroxide, propionyl peroxide, benzoyl peroxide, or the like. A polyfunctional monomer such as-divinylbenzene, ethylene glycol dimethacrylate', trimethylolpropane, pentaerythritol di- (or tri- or tetra-) methacrylate, diethylene glycol, or polyethylene glycol dimethacrylate, and similar multifunctional monomers capable of linking the polymers and oligomers discussed above is also appropriate for this invention.
The polymeric coating may be applied to the catheter body or other polymeric substrate by any of a variety of methods, e.g., by spraying a solution or suspension of the polymers or of oligomers of the monomers onto the catheter or by dipping the catheter into the solution or suspension (after sealing the open ends, if so desired). Initiators may be included in the solution or applied in a separate step. The catheter may be sequentially or simultaneously dried to remove solvent after application of the polymer or oligomer to the polymeric body and crosslinked.
The solution or suspension should be very dilute since only a very thin layer of polymer is to be applied. We have found that an amount of oligomer or polymer in a solvent of between 0.25% and 5.0%
(wt), preferred is 0.5 to 2.0% (wt), is excellent for - ~1272~°~
_$_ thin and complete coverage of the resulting polymer.
Preferred solvents for this procedure when using the preferred polymers and procedure are Water, low molecular weight alcohols, and ethers; especially methanol, propanol, isopropanol, ethanol, and their mixtures. Other water miscible solvents, e.g., tetrahydrofuran, methylene dichloride, methyTethylketone, dimethylacetate, ethyl acetate, etc., are suitable for the listed polymers and must be chosen according to the characteristics of the polymer; they should be polar because. of the hydrophilic nature of the polymers and oligomers but, because of the reactivity of the terminal groups of those materials, known quenching effects caused by oxygen, hydroxyl groups and the like must be recognized by the user of this process when choosing polymers and solvent systems.
Particularly preferred as a coating for the catheter bodies discussed below are physical mi~ttures of homo-oligomers of at least one of polyethylene oxide; poly 2-vinyl pyridine; polyvinylpyrrolidone, polyacrylic acid, polyacrylamide, and polyacrylonitrile. The catheter bodies or substrates are preferably sprayed or dipped, dried, and - irradiated to produce a polymerized and crosslinked~
polymeric skin of the noted oligomers.
The lubricious hydrophilic-coating is preferably produced using generally simultaneous solvent removal and crosslinking operations. The coating is applied at a rate allowing psheeting" of the solution, e.g., formation of a visibly smooth layer without "runs". In a dipping operation for most polymeric substrates noted below, the optimum coating rates are found at a'linear removal rate between 0.25 and 2.0 inches/sec, preferably 0.5 and 1.0 inches/seu.
The solvent evaporation operations may be conducted using a heating chamber suitable for maintaining the surface at a temperature between 25°C
and the glass transition temperature (Ts) of the °
~I27~~7 underlying substrate. Preferred temperatures are 50°C
to 125°C. Most preferred for the noted and preferred solvent systems is the range of 75° to 110°C.
Ultraviolet light sources may be used to crosslink the polymer precursors onto the substrate.
Movement through an irradiation chamber having an ultraviolet light source at 90-375nm (preferably 300-350nm) having an irradiation density of 50-300 mW/cm2 (preferably 150-250 mW/cm2) for a period of three to seven seconds is desired. Passage of a catheter through the chamber at a rate of 0.25 to 2.0 _ inches/second~(0.5 to 1.0 inches/second) in a chamber having three to nine inches length is suitable. When using ionizing radiation, a radiation density of 1 to 100 kRads/cm2 (preferably 20 to 50 kRads/cm2) may be applied to the solution or suspension on the polymeric substrate. ' Exceptional durability of the resulting coating is produced by repetition of the dipping/solvent removal/irradiation steps up to five times. Preferred are two to four repetitions.
. FIG. 1 shows an infusion catheter (100) constructed according to one embodiment of the invention. The catheter (100) has an elongate tubular body (102) with proximal (104) and distal (106) ends and an open inner lumen (108) extending between the ends. The elongate tubular body (102) has three segments; a relatively flexible and strong distal segment (120), a relatively stiff tapered proximal segment (122) and a transition section or segment (124) between the proximal and distal segments that is less flexible than the distal segment (120) but more flexible than the proximal segment (122).
The elongate tubular body (102) has a strong distal segment (120) which is desirably relatively flexible such that the catheter can easily navigate a tortuous vessel pathway. By "relatively flexible" is meant that a force of about 1x10' pounds corresponds to a deflection of the material that is 10° from horizontal, or only about 5x10' pounds of force to deflect the material about 80° from horizontal. By "relatively strong" is meant that the material has a burst pressure of greater than 195 psi, more preferably, the burst pressure is between about 195 and 220 psi.
The flexible distal segment (120) has an open end which allows for the infusion of diagnostic, therapeutic, or vaso-occlusive agents into the target site. When the catheter is a flow-directed infusion catheter, the flexible distal segment (120) preferably is made of a polymer that is springy and biologically compatible such as low density polyethylene, polyurethane, a block copolymer of polyamide, polyvinyl chloride, or silicone or blends of the above.
The flexible distal segment (120) may carry one or more radiopaque bands (130j or may be doped with a radiopaque material such as barium sulfate, bismuth trioxide, bismuth carbonate, tungsten, tantalum or the like so that the location of the distal region of the catheter within the vessel may be visualized radiographically. The distal segment (120j typically makes up between about 5 and 25~ of the total length of the tubular member and is. between about 5 and 40 cm long, preferably between about 10 and 20 cm long. The inner diameter of the distal segment (120) may be between about 0.25 and 0.50 mm, more preferably between about 0.25 and 0.35 mm. The outer diameter of the distal segment may be between about 0.50 and~0.80 mm, more preferably between about 0.60 and 0.70 mm. The wall thickness of the distal segment 120 is between about 0.1 and 0.3 mm.
The proximal segment (122) of the elongate tubular body (102j, when used as a flow-directed infusion catheter, is relatively stiff such that it can be easily pushed thus eliminating the need for guidewire support. The proximal segment (122) may be made of a polymeric or metallic material that is _ _ 21275 l relatively stiff and biologically compatible such as high density polyethylene, polypropylene, Nylon, polyurethane, polyimides, polyvinyl chloride, polysulfones, polyfluorocarbons, polyethylene terephthalate, their mixtures, copolymers; or polyester elastomers or a braided shaft (a polymer outer core with a metallic mesh inner core). The proximal segment (122) may comprise a tapered proximal section (134) for attachment to the proximal. end fitting (150j and a distal section (132). The proximal section (134j of proximal segment (122) may make up between about 60% and 80% of the total length of the tubular member (102) and typically is between about 90 and 130 cm long, preferably between about 100 and 120 cm long. The largest inner diameter of the proximal section (134), measured at the proximal end (104) of the tubular member 102, is often between about 0.40 and 0.60 mm, more preferably between about 0.45 and 0.55 mm. The outer diameter of the proximal section (134) at the proximal end (104) of the tubular member (102) is between about 0.8 and 1.2 mm. The wall thickness of the proximal section (134) of proximal segment (122j is between about 0.1 and 0.4 mm, more preferably between about 0.2 and 0.3 mm.
The distal section (132) of proximal segment (122j makes up between 10 and 20% of the total length of the tubular body (102) and is between about 20 and 40 cm long, preferably between about 20 and 30 cm long. The inner diameter of the distal section (132j of proximal segment (122) may be between about 0.20 and 0.50 mm, more preferably between about 0.25 and 0.35 mm. The outer diameter of the distal section (132) of proximal segment (122j is between about 0.60 and 0.90 mm, more preferably between about 0.60 and . 0.70 mm. The wall thickness of the distal section (134) of proximal segment (122) is typically between about 0.1 and 0.3 mm.
The transition section (124) of the elongate . tubular body (102) is less stiff than the proximal segment (122) but more stiff than the distal segment (120). A suitable material that is biologically compatible is a polymer such as polyurethane, a block copolymer of~polyamide, polyvinyl chloride or silicone with greater durometer reading (i.e. that is stiffer) than the flexible distal segment (120). The transition section (124) may be radiopaque and thus observable in the event that the catheter becomes lodged in a particular portion of the vasculature or buckles. The polymeric material may be doped with a radiopaque material such as barium sulfate, bismuth carbonate, bismuth trioxide, tungsten, tantalum or the like. The transition section (124) may make up between about 10 and 20% of the total length of the tubular member (102) and is between about 20 and 40 cm long, preferably between about 25 and 35 cm long. The transition section (124) may be of constant diameter or may be tapered. The inner diameter of the transition section (124) may be between about 0.20 and 0.50 mm, more preferably between about 0.20 and 0.35 mm. The outer diameter of the transition section (124) may be between about 0.50 and 0.90 mm, more preferably between about 0.60 and 0.70 mm. The wall thickness of the transition section (124) may be between about 0.1 and 0.3 mm.
The proximal segment (122), transition section (124), and distal segment (120) are joined at junctions (140) and (142), respectively. The junctions may be formed by flaring, overlapping, and heat fusing the materials of the proximal segment (122) and transition section (124) and the transition section (124) and distal segment (120). Other methods for forming the junction, e.g., heat welding, solvent welding, etc. are also suitable. The distal segment (120), transition section (124) and distal section (132) of proximal segment (122) may all have approximately the same outside diameter or the transition section (124) and the distal section (132) of the proximal segment (i22) may be tapered.
A standard proximal end fitting (150) is attached to the proximal end (134) of the proximal segment (122) often by heat fusion with reinforcing tubing.
~ FIG. 2 shows an embodiment of the distal segment (120) of the catheter where the tip (160) of the catheter is pre-shaped by heating with steam so that the distal end (106) points towards the wail of the vessel rather than in the direction of blood flow to increase the ease of manipulation through the tortuous vessel pathway. The particular embodiment shown is an-"S" shape, but the tip may be any shape that allows for access to the particular vasculature being treated. One additional shape is~that of a hockey stick. In this way, if the catheter becomes lodged against the vessel wall, the infusion of liquid through the catheter propels the distal end (106) of the catheter away from the vessel wall. Since the stiff proximal segment (122j is pushed, the distal segment (120) will be carried by the blood flood to the target site.
The catheter described above is us8ful in delivering diagnostic, therapeutic, or verso-occlusive agents and devices to deep tissue, usually without ~ need for a guidewire.
FIG. 3 shows a catheter assembly (200j for . placing the infusion catheter (100j at the target site. An appropriate guiding catheter (202j is inserted into the vasculature using standard placement techniques. A rotating hemostatic valve (204) may be utilized by connection to the guiding catheter luer adapter (206). The guiding catheter (202) is ,.
continuously flushed with saline. The thumb-screw of the valve (204) is opened and the infusion cat~';eter (100) is inserted through the rotating hemostatic ' valve (204). Optionally, as shown in FIG. 3, a Teflon coated stainless steel stylet (208) is first inserted into the flow-directed infusion catheter (100) in order to prevent kinking of the infusion ,_ _217257 catheter (100) within the valve (204). The distal end (106) of the infusion catheter (100) is advanced proximal to the tip of the guiding catheter (202).
The stylet (208) is then removed from the infusion catheter (100). Once the stylet (208) is removed, the infusion catheter (100) is pushed out of the guiding catheter {202). The flow-directed infusion catheter (100) is gently guided by the flow of blood in the vasculature to the target site. Optionally, gentle pushing and pulling and injection of saline or contrast medium through the catheter lumen {108) may aid in the placement of the catheter at the target site.
Once at the target site, the desired agent is injected. Such agents may include radiopaque agents for viewing blood vessel anatomy and blood flow characteristics in the target region, vaso-occlusive agents which can be used to produce small-artery vaso-occlusion in the tissue region supplied by the target 2o vessel, and pharmacological agents, such as anti-tumor drugs or sclerosing agents such as alcohols, which are effective against identified disease states at the target site. Vaso-occlusive agents useful in the treatment of arteriovenous malformations include polymers that are activated in the presence of polar solvents such as water and include materials such as n-butylcyanoacryiate. Other types of vaso-occlusive agents useful in the treatment of arteriovenous malformations include polymer solutions that coagulate by diffusion of the solvent when in contact with blood. Polyvinyl acetate dissolved in dimethylsulfoxide is one such agent. Alternatively, vaso-occlusive coils may be injected into the infusion catheter and delivered to a target site to occlude the blood flow at that site.
Figure 4 shows a variation of the invention in which the catheter is guided to its intended site by the use of a guidewire rather than through the use of blood flow. As with the device described above, ,, the catheter assembly (400) includes an elongate member (402) having a proximal end (404) and a distal end (406j and an inner lumen which extends between those two ends. The elongate-tubular body (402) has three segments; a relatively flexible distal segment (408), a relatively stiff proximal segment (410) and a transition section or middle segment (412j (separated at junction (414) from the proximal segment) between the proximal and distal segments that is less flexible than the distal segment (408) but more flexible than the proximal segment (410). Found within the lumen of the catheter assembly is guidewire (414) often having a bent tip (416) to allow ease of passage through the vasculature. Typically, such a catheter will have a small radiopaque band (418) of gold, platinum, palladium, or the like to permit monitoring of the catheter tip's position in relation to the tip of the guidewire or, when the guidewire is not in the catheter, to the vasculature itself. A standard proximal end fitting (420) may attached to the proximal end (404) of the proximal segment (410) often by heat fusion with reinforcing tubing. As is described in U.S. Pat. No. 4,739,768, to Engelson, the variation of flexibility may be introduced into the catheter assembly by use of sections of discrete coaxial tubing, e.g., by use of an inner stiff tuba of polypropylene or high density polyethylene covered by a flexible tube of low density polyethylene or silicone in the proximal section (410) with the inner tubing junction found at (410). A thinner wall inner tubing of the same polymer as found in the proximal section (410) may be used as the inner tubing in middle section (412j to provide decreased stiffness in the middle section (412j. In such an instance, the outer coaxial layer could be of the same composition and dimensions from proximal end (404) to distal end (406). Other methods of varying the stiffness to provide for strength at the proxinbal end, extreme flexibility at the distal end to allow conformance to the contortions of the guidewire through multiple flexions, and a middle section of strength sufficient to transmit pressure and torque from proximal end to distal end without buckling or compression. The various sections (particularly the inner section] may be tapered to provide variable stiffness through at the section or throughout the catheter.
EXAMPLE
Two sets of catheters were made, one according to the invention and one with a silicone coating, for comparison of the resulting slipperiness and durability of the coating. The catheters had three discrete sections: A proximal section of low-density polyethylene laminated over polypropylene tubing (having 0.022" I.D. and 0.039" O.D.j of 115 cm.
length, a transition section of low density polyethylene laminated over polypropylene tubing (having 0.022" I.D. and 0.036" O.D.j of I5 cm., and a distal section of low density polyethylene of 20 cm.
The low density polyethylene outer covering was a single piece covering throughout the length of the catheters.
The inventive catheter coating was~produced using the following procedure:
aj catheters were dipped into a dilute polymeric solution of XX%
polyvinylpyrrolidone and XX%
polyacrylamide (each having photoactive groups] in a solution of isopropanol and water, and removed from the solution at a rate of 0.7 "/sec., bj the coating was dried using . heated air at 100°C, cj the coated catheter was exposed to ultraviolet light (100 mW/cm2j for seven seconds to bond the coating to the catheter 2~ 2751 substrate and to crossiink the polymers in the solution, and d) steps aj, b), and c) were repeated three times.
' The comparative silicone catheter coating was applied using the following procedure:
a) catheters were dipped into a silicone solution of 1.5 ml Dow-Corning I~X 4-4159, 160 ml Freon, and 40 ml isopropanol.
b) -the coating was cured at 60°C, c) the catheters were then coated with a silicone fluid solution (15 ml Dow 360 in 160 ml Freon), and d) the catheters were then air-dried for 30 minutes.
The catheters were separately introduced into a USCI Angiographic Systems Berenstein J-tip guiding catheter in a test rig allowing measurement of the force needed to push and to pull the catheters through the guiding catheter. Each of the catheters was tested through 20 pulls and pushes of 2. inches pushed and pulled at a rate of 1 inch/minute. In this way both absolute force needed to introduce the catheter may be recorded as well as the magnitude of all deterioration in the slipperiness. The .
measurements were taken for both the midsection and for the distal sections of the two catheters.
TAB
MIDSECTION Force lin lbs.) Pull. No. Comparative ~ Invention 1 0.044 0.025 20 0.054 0.025 DISTAL sECTION
Pull. No. Comparative Invent:
1 0.023 0.013 0.027 0.013 It is apparent that the force needed to move the inventive catheter through the guiding catheter 15 was only about half of that needed to move the comparative device. Additionally, the amount of force needed to move the comparative catheter increased substantially during the repetitive testing indicating that the coating was failing. In contrast, the' 2o inventive coating did not degrade during the test.
Although preferred embodiments of the invention have been described herein, it will be recognized that a variety of changes and modifications can be made without departing from spirit of the invention as found in the claims which follow.
FIG. 4 is a side view of a typical catheter assembly according-to this invention adapted for use with a guidewire.
Descriot~on of the Invention This invention is a catheter, optionally including a guidewire, having discrete sections of varying flexibility. In each variation of the invention, the catheter has a relatively stiff proximal section and a less stiff mid portion. For devices intended for use as flow-directed catheters, the distal end section is quite flexible; far devices intended for use with guidewires, the distal end section need not be quite as flexible since it need only follow the path of the guidewire without substantial disturbance of that pre-determined path.
At least the distal portion of the catheter is coated with a polymeric material to increase its lubricity and to minimize the potential for trauma as it moves through the body lumen: The~mid or transition section of the catheter may also be coated with the polymeric material. The proximal.section may also be coated although most desirably a small proximal end portion is left uncoated for increased control.
Particularly suitable as coatings in the catheter assembly of this invention are polymers or oligomers of monomers selected from ethylene oxide; 2-vinyl pyridine; N-vinylpyrrolidone; polyethylene glycol acrylates such as mono-alkoxy polyethylene glycol mono(meth) acrylates, including mono-methoxy triethylene glycol mono (meth) acrylate, mono-methoxy tetraethylene glycol mono (meth) acrylate, polyethylene glycol mono (meth) acrylate; other hydrophilic acrylates such as 2-hydroxyethylmethacrylate, glycerylmethacrylate;
r 21 ~~~~
acrylic acid and its salts; acrylamide and acrylonitrile; acrylamidomethylpropane sulfonic acid and its salts, cellulose, cellulose derivatives such as methyl cellulose ethyl cellulose, carboxymethyl cellulose, cyanoethyl cellulose, cellulose acetate, polysaccharides such as amylose, pectin, amylopectin, alginic acid, and cross-linked heparin. These monomers may be formed into homopolymers or block or -random copolymers. The use of oligomers of these monomers in coating the catheter for further polymerization is also an alternative. Preferred monomers include ethylene oxide; 2-vinyl pyridine; N-vinylpyrrolidone and acrylic acid and its salts;
acrylamide and acrylonitrile each polymerized (with or without substantial crosslinking) into homopolymers, or into random or block copolymers.
Additionally, hydrophobic monomers may be included in the coating polymeric material in an amount up to about 30% by weight of the resulting copolymer so long as the hydrophilic nature of the resulting copolymer is not substantially compromised.
Suitable monomers include ethylene, propylene, styrene, styrene derivatives, alkylmethacrylates, vinylchloride, vinylidenechloride, methacrylonitrile, and vinyl acetate. Preferred, because of their propensity for ease of linkage to the typical polymeric catheter substrates, are ethylene, propylene, styrene, and styrene derivatives.
Polymers or oligomers applied using the procedure described below are activated or functionalized with photoactive or radiation-active groups to permit reaction of the~polymers or oligomers with the underlying polymeric surface. Suitable activation groups include benzophenone, thioxanthone, I and the like; acetophenone and its derivatives t _2127257 where R' is H, Rz is OH, R' is Ph; or R' is H, Rs is an alkoxy group including -OCH3, -OC2H3, R' is Ph; or R' = R= = an alkoxy group, R' is Ph; or R' = R= _ an alkoxy group, R' is H; or R' = Rz = C1, R' is H or C1.
Other known activators are suitable.
The polymeric coating may then be linked with the substrate using known and appropriate techniques selected on the basis of the chosen activators, e.g., by ultraviolet light, heat, or ionizing radiation. Crosslinking with the listed polymers or oligomers may be accomplished by use of peroxides or azo compounds such as acetyl peroxide, cumyl peroxide, propionyl peroxide, benzoyl peroxide, or the like. A polyfunctional monomer such as-divinylbenzene, ethylene glycol dimethacrylate', trimethylolpropane, pentaerythritol di- (or tri- or tetra-) methacrylate, diethylene glycol, or polyethylene glycol dimethacrylate, and similar multifunctional monomers capable of linking the polymers and oligomers discussed above is also appropriate for this invention.
The polymeric coating may be applied to the catheter body or other polymeric substrate by any of a variety of methods, e.g., by spraying a solution or suspension of the polymers or of oligomers of the monomers onto the catheter or by dipping the catheter into the solution or suspension (after sealing the open ends, if so desired). Initiators may be included in the solution or applied in a separate step. The catheter may be sequentially or simultaneously dried to remove solvent after application of the polymer or oligomer to the polymeric body and crosslinked.
The solution or suspension should be very dilute since only a very thin layer of polymer is to be applied. We have found that an amount of oligomer or polymer in a solvent of between 0.25% and 5.0%
(wt), preferred is 0.5 to 2.0% (wt), is excellent for - ~1272~°~
_$_ thin and complete coverage of the resulting polymer.
Preferred solvents for this procedure when using the preferred polymers and procedure are Water, low molecular weight alcohols, and ethers; especially methanol, propanol, isopropanol, ethanol, and their mixtures. Other water miscible solvents, e.g., tetrahydrofuran, methylene dichloride, methyTethylketone, dimethylacetate, ethyl acetate, etc., are suitable for the listed polymers and must be chosen according to the characteristics of the polymer; they should be polar because. of the hydrophilic nature of the polymers and oligomers but, because of the reactivity of the terminal groups of those materials, known quenching effects caused by oxygen, hydroxyl groups and the like must be recognized by the user of this process when choosing polymers and solvent systems.
Particularly preferred as a coating for the catheter bodies discussed below are physical mi~ttures of homo-oligomers of at least one of polyethylene oxide; poly 2-vinyl pyridine; polyvinylpyrrolidone, polyacrylic acid, polyacrylamide, and polyacrylonitrile. The catheter bodies or substrates are preferably sprayed or dipped, dried, and - irradiated to produce a polymerized and crosslinked~
polymeric skin of the noted oligomers.
The lubricious hydrophilic-coating is preferably produced using generally simultaneous solvent removal and crosslinking operations. The coating is applied at a rate allowing psheeting" of the solution, e.g., formation of a visibly smooth layer without "runs". In a dipping operation for most polymeric substrates noted below, the optimum coating rates are found at a'linear removal rate between 0.25 and 2.0 inches/sec, preferably 0.5 and 1.0 inches/seu.
The solvent evaporation operations may be conducted using a heating chamber suitable for maintaining the surface at a temperature between 25°C
and the glass transition temperature (Ts) of the °
~I27~~7 underlying substrate. Preferred temperatures are 50°C
to 125°C. Most preferred for the noted and preferred solvent systems is the range of 75° to 110°C.
Ultraviolet light sources may be used to crosslink the polymer precursors onto the substrate.
Movement through an irradiation chamber having an ultraviolet light source at 90-375nm (preferably 300-350nm) having an irradiation density of 50-300 mW/cm2 (preferably 150-250 mW/cm2) for a period of three to seven seconds is desired. Passage of a catheter through the chamber at a rate of 0.25 to 2.0 _ inches/second~(0.5 to 1.0 inches/second) in a chamber having three to nine inches length is suitable. When using ionizing radiation, a radiation density of 1 to 100 kRads/cm2 (preferably 20 to 50 kRads/cm2) may be applied to the solution or suspension on the polymeric substrate. ' Exceptional durability of the resulting coating is produced by repetition of the dipping/solvent removal/irradiation steps up to five times. Preferred are two to four repetitions.
. FIG. 1 shows an infusion catheter (100) constructed according to one embodiment of the invention. The catheter (100) has an elongate tubular body (102) with proximal (104) and distal (106) ends and an open inner lumen (108) extending between the ends. The elongate tubular body (102) has three segments; a relatively flexible and strong distal segment (120), a relatively stiff tapered proximal segment (122) and a transition section or segment (124) between the proximal and distal segments that is less flexible than the distal segment (120) but more flexible than the proximal segment (122).
The elongate tubular body (102) has a strong distal segment (120) which is desirably relatively flexible such that the catheter can easily navigate a tortuous vessel pathway. By "relatively flexible" is meant that a force of about 1x10' pounds corresponds to a deflection of the material that is 10° from horizontal, or only about 5x10' pounds of force to deflect the material about 80° from horizontal. By "relatively strong" is meant that the material has a burst pressure of greater than 195 psi, more preferably, the burst pressure is between about 195 and 220 psi.
The flexible distal segment (120) has an open end which allows for the infusion of diagnostic, therapeutic, or vaso-occlusive agents into the target site. When the catheter is a flow-directed infusion catheter, the flexible distal segment (120) preferably is made of a polymer that is springy and biologically compatible such as low density polyethylene, polyurethane, a block copolymer of polyamide, polyvinyl chloride, or silicone or blends of the above.
The flexible distal segment (120) may carry one or more radiopaque bands (130j or may be doped with a radiopaque material such as barium sulfate, bismuth trioxide, bismuth carbonate, tungsten, tantalum or the like so that the location of the distal region of the catheter within the vessel may be visualized radiographically. The distal segment (120j typically makes up between about 5 and 25~ of the total length of the tubular member and is. between about 5 and 40 cm long, preferably between about 10 and 20 cm long. The inner diameter of the distal segment (120) may be between about 0.25 and 0.50 mm, more preferably between about 0.25 and 0.35 mm. The outer diameter of the distal segment may be between about 0.50 and~0.80 mm, more preferably between about 0.60 and 0.70 mm. The wall thickness of the distal segment 120 is between about 0.1 and 0.3 mm.
The proximal segment (122) of the elongate tubular body (102j, when used as a flow-directed infusion catheter, is relatively stiff such that it can be easily pushed thus eliminating the need for guidewire support. The proximal segment (122) may be made of a polymeric or metallic material that is _ _ 21275 l relatively stiff and biologically compatible such as high density polyethylene, polypropylene, Nylon, polyurethane, polyimides, polyvinyl chloride, polysulfones, polyfluorocarbons, polyethylene terephthalate, their mixtures, copolymers; or polyester elastomers or a braided shaft (a polymer outer core with a metallic mesh inner core). The proximal segment (122) may comprise a tapered proximal section (134) for attachment to the proximal. end fitting (150j and a distal section (132). The proximal section (134j of proximal segment (122) may make up between about 60% and 80% of the total length of the tubular member (102) and typically is between about 90 and 130 cm long, preferably between about 100 and 120 cm long. The largest inner diameter of the proximal section (134), measured at the proximal end (104) of the tubular member 102, is often between about 0.40 and 0.60 mm, more preferably between about 0.45 and 0.55 mm. The outer diameter of the proximal section (134) at the proximal end (104) of the tubular member (102) is between about 0.8 and 1.2 mm. The wall thickness of the proximal section (134) of proximal segment (122j is between about 0.1 and 0.4 mm, more preferably between about 0.2 and 0.3 mm.
The distal section (132) of proximal segment (122j makes up between 10 and 20% of the total length of the tubular body (102) and is between about 20 and 40 cm long, preferably between about 20 and 30 cm long. The inner diameter of the distal section (132j of proximal segment (122) may be between about 0.20 and 0.50 mm, more preferably between about 0.25 and 0.35 mm. The outer diameter of the distal section (132) of proximal segment (122j is between about 0.60 and 0.90 mm, more preferably between about 0.60 and . 0.70 mm. The wall thickness of the distal section (134) of proximal segment (122) is typically between about 0.1 and 0.3 mm.
The transition section (124) of the elongate . tubular body (102) is less stiff than the proximal segment (122) but more stiff than the distal segment (120). A suitable material that is biologically compatible is a polymer such as polyurethane, a block copolymer of~polyamide, polyvinyl chloride or silicone with greater durometer reading (i.e. that is stiffer) than the flexible distal segment (120). The transition section (124) may be radiopaque and thus observable in the event that the catheter becomes lodged in a particular portion of the vasculature or buckles. The polymeric material may be doped with a radiopaque material such as barium sulfate, bismuth carbonate, bismuth trioxide, tungsten, tantalum or the like. The transition section (124) may make up between about 10 and 20% of the total length of the tubular member (102) and is between about 20 and 40 cm long, preferably between about 25 and 35 cm long. The transition section (124) may be of constant diameter or may be tapered. The inner diameter of the transition section (124) may be between about 0.20 and 0.50 mm, more preferably between about 0.20 and 0.35 mm. The outer diameter of the transition section (124) may be between about 0.50 and 0.90 mm, more preferably between about 0.60 and 0.70 mm. The wall thickness of the transition section (124) may be between about 0.1 and 0.3 mm.
The proximal segment (122), transition section (124), and distal segment (120) are joined at junctions (140) and (142), respectively. The junctions may be formed by flaring, overlapping, and heat fusing the materials of the proximal segment (122) and transition section (124) and the transition section (124) and distal segment (120). Other methods for forming the junction, e.g., heat welding, solvent welding, etc. are also suitable. The distal segment (120), transition section (124) and distal section (132) of proximal segment (122) may all have approximately the same outside diameter or the transition section (124) and the distal section (132) of the proximal segment (i22) may be tapered.
A standard proximal end fitting (150) is attached to the proximal end (134) of the proximal segment (122) often by heat fusion with reinforcing tubing.
~ FIG. 2 shows an embodiment of the distal segment (120) of the catheter where the tip (160) of the catheter is pre-shaped by heating with steam so that the distal end (106) points towards the wail of the vessel rather than in the direction of blood flow to increase the ease of manipulation through the tortuous vessel pathway. The particular embodiment shown is an-"S" shape, but the tip may be any shape that allows for access to the particular vasculature being treated. One additional shape is~that of a hockey stick. In this way, if the catheter becomes lodged against the vessel wall, the infusion of liquid through the catheter propels the distal end (106) of the catheter away from the vessel wall. Since the stiff proximal segment (122j is pushed, the distal segment (120) will be carried by the blood flood to the target site.
The catheter described above is us8ful in delivering diagnostic, therapeutic, or verso-occlusive agents and devices to deep tissue, usually without ~ need for a guidewire.
FIG. 3 shows a catheter assembly (200j for . placing the infusion catheter (100j at the target site. An appropriate guiding catheter (202j is inserted into the vasculature using standard placement techniques. A rotating hemostatic valve (204) may be utilized by connection to the guiding catheter luer adapter (206). The guiding catheter (202) is ,.
continuously flushed with saline. The thumb-screw of the valve (204) is opened and the infusion cat~';eter (100) is inserted through the rotating hemostatic ' valve (204). Optionally, as shown in FIG. 3, a Teflon coated stainless steel stylet (208) is first inserted into the flow-directed infusion catheter (100) in order to prevent kinking of the infusion ,_ _217257 catheter (100) within the valve (204). The distal end (106) of the infusion catheter (100) is advanced proximal to the tip of the guiding catheter (202).
The stylet (208) is then removed from the infusion catheter (100). Once the stylet (208) is removed, the infusion catheter (100) is pushed out of the guiding catheter {202). The flow-directed infusion catheter (100) is gently guided by the flow of blood in the vasculature to the target site. Optionally, gentle pushing and pulling and injection of saline or contrast medium through the catheter lumen {108) may aid in the placement of the catheter at the target site.
Once at the target site, the desired agent is injected. Such agents may include radiopaque agents for viewing blood vessel anatomy and blood flow characteristics in the target region, vaso-occlusive agents which can be used to produce small-artery vaso-occlusion in the tissue region supplied by the target 2o vessel, and pharmacological agents, such as anti-tumor drugs or sclerosing agents such as alcohols, which are effective against identified disease states at the target site. Vaso-occlusive agents useful in the treatment of arteriovenous malformations include polymers that are activated in the presence of polar solvents such as water and include materials such as n-butylcyanoacryiate. Other types of vaso-occlusive agents useful in the treatment of arteriovenous malformations include polymer solutions that coagulate by diffusion of the solvent when in contact with blood. Polyvinyl acetate dissolved in dimethylsulfoxide is one such agent. Alternatively, vaso-occlusive coils may be injected into the infusion catheter and delivered to a target site to occlude the blood flow at that site.
Figure 4 shows a variation of the invention in which the catheter is guided to its intended site by the use of a guidewire rather than through the use of blood flow. As with the device described above, ,, the catheter assembly (400) includes an elongate member (402) having a proximal end (404) and a distal end (406j and an inner lumen which extends between those two ends. The elongate-tubular body (402) has three segments; a relatively flexible distal segment (408), a relatively stiff proximal segment (410) and a transition section or middle segment (412j (separated at junction (414) from the proximal segment) between the proximal and distal segments that is less flexible than the distal segment (408) but more flexible than the proximal segment (410). Found within the lumen of the catheter assembly is guidewire (414) often having a bent tip (416) to allow ease of passage through the vasculature. Typically, such a catheter will have a small radiopaque band (418) of gold, platinum, palladium, or the like to permit monitoring of the catheter tip's position in relation to the tip of the guidewire or, when the guidewire is not in the catheter, to the vasculature itself. A standard proximal end fitting (420) may attached to the proximal end (404) of the proximal segment (410) often by heat fusion with reinforcing tubing. As is described in U.S. Pat. No. 4,739,768, to Engelson, the variation of flexibility may be introduced into the catheter assembly by use of sections of discrete coaxial tubing, e.g., by use of an inner stiff tuba of polypropylene or high density polyethylene covered by a flexible tube of low density polyethylene or silicone in the proximal section (410) with the inner tubing junction found at (410). A thinner wall inner tubing of the same polymer as found in the proximal section (410) may be used as the inner tubing in middle section (412j to provide decreased stiffness in the middle section (412j. In such an instance, the outer coaxial layer could be of the same composition and dimensions from proximal end (404) to distal end (406). Other methods of varying the stiffness to provide for strength at the proxinbal end, extreme flexibility at the distal end to allow conformance to the contortions of the guidewire through multiple flexions, and a middle section of strength sufficient to transmit pressure and torque from proximal end to distal end without buckling or compression. The various sections (particularly the inner section] may be tapered to provide variable stiffness through at the section or throughout the catheter.
EXAMPLE
Two sets of catheters were made, one according to the invention and one with a silicone coating, for comparison of the resulting slipperiness and durability of the coating. The catheters had three discrete sections: A proximal section of low-density polyethylene laminated over polypropylene tubing (having 0.022" I.D. and 0.039" O.D.j of 115 cm.
length, a transition section of low density polyethylene laminated over polypropylene tubing (having 0.022" I.D. and 0.036" O.D.j of I5 cm., and a distal section of low density polyethylene of 20 cm.
The low density polyethylene outer covering was a single piece covering throughout the length of the catheters.
The inventive catheter coating was~produced using the following procedure:
aj catheters were dipped into a dilute polymeric solution of XX%
polyvinylpyrrolidone and XX%
polyacrylamide (each having photoactive groups] in a solution of isopropanol and water, and removed from the solution at a rate of 0.7 "/sec., bj the coating was dried using . heated air at 100°C, cj the coated catheter was exposed to ultraviolet light (100 mW/cm2j for seven seconds to bond the coating to the catheter 2~ 2751 substrate and to crossiink the polymers in the solution, and d) steps aj, b), and c) were repeated three times.
' The comparative silicone catheter coating was applied using the following procedure:
a) catheters were dipped into a silicone solution of 1.5 ml Dow-Corning I~X 4-4159, 160 ml Freon, and 40 ml isopropanol.
b) -the coating was cured at 60°C, c) the catheters were then coated with a silicone fluid solution (15 ml Dow 360 in 160 ml Freon), and d) the catheters were then air-dried for 30 minutes.
The catheters were separately introduced into a USCI Angiographic Systems Berenstein J-tip guiding catheter in a test rig allowing measurement of the force needed to push and to pull the catheters through the guiding catheter. Each of the catheters was tested through 20 pulls and pushes of 2. inches pushed and pulled at a rate of 1 inch/minute. In this way both absolute force needed to introduce the catheter may be recorded as well as the magnitude of all deterioration in the slipperiness. The .
measurements were taken for both the midsection and for the distal sections of the two catheters.
TAB
MIDSECTION Force lin lbs.) Pull. No. Comparative ~ Invention 1 0.044 0.025 20 0.054 0.025 DISTAL sECTION
Pull. No. Comparative Invent:
1 0.023 0.013 0.027 0.013 It is apparent that the force needed to move the inventive catheter through the guiding catheter 15 was only about half of that needed to move the comparative device. Additionally, the amount of force needed to move the comparative catheter increased substantially during the repetitive testing indicating that the coating was failing. In contrast, the' 2o inventive coating did not degrade during the test.
Although preferred embodiments of the invention have been described herein, it will be recognized that a variety of changes and modifications can be made without departing from spirit of the invention as found in the claims which follow.
Claims (68)
1. A catheter assembly, said catheter comprising an elongate tubular member having proximal and distal ends and an inner lumen extending between these ends, said member comprising:
(a) a relatively stiff proximal segment;
(b) a relatively flexible distal segment; and (c) at least one transition segment between said proximal and said distal segments where said at least one transition segment is less flexible than the distal segment but more flexible than the proximal segment, which at least the distal segment has been coated with a lubricious coating which coating is a polymer or oligomer comprising monomers of mono-alkoxy polyethylene glycol mono(meth)acrylates and which is chemically linked to the distal segment.
(a) a relatively stiff proximal segment;
(b) a relatively flexible distal segment; and (c) at least one transition segment between said proximal and said distal segments where said at least one transition segment is less flexible than the distal segment but more flexible than the proximal segment, which at least the distal segment has been coated with a lubricious coating which coating is a polymer or oligomer comprising monomers of mono-alkoxy polyethylene glycol mono(meth)acrylates and which is chemically linked to the distal segment.
2. The catheter of claim 1 where the distal and the transition segments are coated with a lubricious coating.
3. The catheter of claim 2 where at least a portion of the proximal segment is coated with a lubricious coating.
4. The catheter of claim 1 wherein the distal segment has a burst pressure of at least about 195 psi.
5. The catheter of claim 4 wherein the burst pressure of the distal segment is between about 195 and 220 psi.
6. The catheter of claim 4 wherein the distal segment is made of a material allowing that distal.
segment to deflect 1° per 10 -5 pounds of force applied horizontally to that segment.
segment to deflect 1° per 10 -5 pounds of force applied horizontally to that segment.
7. The catheter of claim 4 wherein the composition of the proximal segment is selected from the group consisting of polyethylene, polypropylene, nylon, polyvinyl chloride, polyethylene terephthalate or other polyester elastomer or of a polymer outer core with a metallic mesh inner core and laminates thereof.
8. The catheter of claim 4 wherein the distal segment is made of a polymeric material selected from the group consisting of polyethylene, polypropylene, polyurethane, a block copolymer of polyamide, polyvinyl chloride, silicone and blends thereof.
9. The catheter of claim 4 wherein the coating of the distal segment is doped with a radio-opaque material selected from the group cons fisting of barium sulfate, bismuth trioxide, bismuth carbonate, tungsten, and tantalum.
10. The catheter of claim 1 wherein the transition section is made of a polymeric material selected from the group consisting of polyethylene, polypropylene, polyurethane, a block copolymer of polyamide, polyvinyl chloride, and silicone, and laminates thereof.
11. The catheter of claim 9 wherein the coating of the at least one transition segment is doped with a radio-opaque material selected from the group consisting of barium sulfate, bismuth trioxide, bismuth carbonate, tungsten, and tantalum.
12. The catheter of claim 1 wherein the distal segment is in an S-shaped or hockey stick-shaped configuration.
13, A method for producing a thin hydrophilic polymer coating on a polymeric substrate comprising the steps of:
a.) applying a dilute solution or suspension of a solvent and a polymer or oligomer to a selected polymeric substrate to form a sheet comprising said solvent and polymer or oligomer, b.) simultaneously removing solvent from the sheet by heating the substrate and crosslinking the polymer or oligomer to the substrate by applying a radiation source to the polymer or oligomer.
a.) applying a dilute solution or suspension of a solvent and a polymer or oligomer to a selected polymeric substrate to form a sheet comprising said solvent and polymer or oligomer, b.) simultaneously removing solvent from the sheet by heating the substrate and crosslinking the polymer or oligomer to the substrate by applying a radiation source to the polymer or oligomer.
14. The method of claim 13 additionally comprising the steps of sequentially repeating steps a.) and b.) up to four times.
15. The method of claim 13 where the dilute solution or suspension comprises a solvent selected from ethers, alcohols, water, and mixtures.
16. The method of claim 14 where the dilute solution or suspension comprises a solvent selected from methanol, ethanol, isopropanol, water, and mixtures.
17. The method of claim 13 where the dilute solution or suspension contains 0.25% to 5.0% (wt) of polymer precursor.
18. The method of claim 17 where the dilute solution ar suspension contains 0.250 to 2.0% (wt) of polymer precursor.
19. The method of claim 17 where the dilute solution or suspension contains polymers or oligomers of monomers selected from ethylene oxide; 2-vinyl pyridine; N-vinyl pyrrolidone; polyethylene glycol acrylates;
hydrophilic acrylates;
acrylamide and acrylonitrile; acrlylamidomethylpropane sulfonic acid and its salts; cellulose, cellulose derivatives, methyl cellulose, ethyl cellulose, carboxymethyl cellulose, cyanoethyl cellulose, cellulose acetate, polysaccharides.
hydrophilic acrylates;
acrylamide and acrylonitrile; acrlylamidomethylpropane sulfonic acid and its salts; cellulose, cellulose derivatives, methyl cellulose, ethyl cellulose, carboxymethyl cellulose, cyanoethyl cellulose, cellulose acetate, polysaccharides.
20. The method of claim 19, wherein the polyethyleneglycol acrylates are selected from the group of monoalkoxypolyethyleneglycolmono(meth) acrylate, monomethoxytriethyleneglycolmono(meth) acrylate, monomethoxytetraethyleneglycolmono(meth) acrylate, and polyethylenglycolmono(meth) acrylate.
21. The method of claim 19, wherein hydrophilic acrylates are selected from the group of 2-hydroxyethylmethylacrylate, glycerylmethylacrylate, acrylic acid and its salts.
22. The method of claim 19, wherein polysaccharides are selected from the group of amylose, pectin, amylopectin, alginic acid, and cross-linked heparin.
-22a-
-22a-
23. The method of claim 13 where the temperature of the solvent removal step is between 25°
C and the glass transition temperature of the polymeric substrate.
C and the glass transition temperature of the polymeric substrate.
24. The method of claim 23 where the temperature of the solvent removal step is between 50°
C and 125° C.
C and 125° C.
25. The method of claim 24 where the temperature of the solvent removal step is between 75°
C and 110° C.
C and 110° C.
26. The method of claim 13 where the crosslinking step comprises the application of ultraviolet light at a radiation density of 100 to 300 mW/cm2 to the polymeric substrate.
27. The method of claim 26 where the crosslinking step comprises the application of ultraviolet light at a radiation density of 150 to 250 mW/cm2 to the polymeric substrate.
28. The method of claim 27 additionally comprising the steps of sequentially repeating steps a.) and b.) up to four times.
29. The method of claim 13 where the crosslinking step comprises the application of ionizing radiation at a radiation density of 1 to 100 kRads/cm2 to the polymer or oligomer on the polymeric substrate.
30. The method of claim 29 where the crosslinking step comprises the application of ionizing radiation at a radiation density of 10 to 50 kRads/cm2 to the polymer or oligomer on the polymeric substrate.
31. The method of claim 29 additionally comprising the steps of sequentially repeating steps a.) and b.) up to four times.
32. A method for coating at least a portion of a polymeric catheter body substrate with a hydrophilic polymer layer comprising the steps of:
a.) applying a dilute solvent solution or suspension of a polymer or oligomer to the polymeric catheter body substrate to form a sheet comprising said solvent and polymer or oligomer, b.) simultaneously removing solvent from the sheet by heating the polymeric catheter body substrate and crosslinking the polymer or oligomer to the substrate by applying a radiation source to the polymer or oligomer.
a.) applying a dilute solvent solution or suspension of a polymer or oligomer to the polymeric catheter body substrate to form a sheet comprising said solvent and polymer or oligomer, b.) simultaneously removing solvent from the sheet by heating the polymeric catheter body substrate and crosslinking the polymer or oligomer to the substrate by applying a radiation source to the polymer or oligomer.
33. The method of claim 32 additionally comprising the steps of sequentially repeating steps a.) and b.) up to four times.
34. The method of claim 32 where the solvent solution or suspension comprises a solvent selected from ethers, alcohols, water, and mixtures.
35. The method of claim 34 where the solvent solution or suspension comprises a solvent selected from methanol, ethanol, isopropanol, water, and mixtures.
36. The method of claim 35 where the solvent solution or suspension contains 0.25 to 5.0%
(wt) of polymer or oligomer.
(wt) of polymer or oligomer.
37. The method of claim 36 where the solvent solution or suspension contains 0.25 to 2.0%
(wt) of polymer or oligomer.
(wt) of polymer or oligomer.
38. The method of claim 35 where the solvent solution or suspension contains polymers or oligomers of monomers selected form ethylene oxide; 2-vinyl pyridine; N-vinyl pyrrolidone; polyethylene glycol acrylates;
hydrophilic acrylates;
acrylamide and acrylonitrile; acrlylamidomethylpropane sulfonic acid and its salts; cellulose, cellulose derivatives, methyl cellulose, ethyl cellulose, carboxymethyl cellulose, cyanoethyl cellulose, cellulose acetate, polysaccharides.
-24a-
hydrophilic acrylates;
acrylamide and acrylonitrile; acrlylamidomethylpropane sulfonic acid and its salts; cellulose, cellulose derivatives, methyl cellulose, ethyl cellulose, carboxymethyl cellulose, cyanoethyl cellulose, cellulose acetate, polysaccharides.
-24a-
39. The method of claim 38, wherein polyethylene glycol acrylates are selected from the group of mono-alkoxypolyethyleneglycolmono(meth)acrylate, monomethoxytriethyleneglycolmono(meth) acrylate, monomethoxytetraethyleneglycolmono(meth) acrylate, and polyethyleneglycolmono(meth) acrylate.
40. The method of claim 38, wherein hydrophilic acrylates are selected from the group of 2-hydroxyethylmethylacrylate, glycerylmethylacrylate, acrylic acid and its salts
41. The method of claim 38, wherein polysaccharides are selected from the group of amylose, pectin, amylopectin, alginic acid, and cross-linked heparin.
42. The method of claim 32 where the temperature of the solvent removal step is between 25°
C and the glass transition temperature of the polymeric catheter body substrate.
C and the glass transition temperature of the polymeric catheter body substrate.
43. The method of claim 42 where the temperature of the solvent removal step is between 50°
C arid 125° C.
C arid 125° C.
44. The method of claim 43 where the temperature of the solvent removal step is between 75°
C and 110° C.
C and 110° C.
45. The method of claim 32 where the crosslinking step comprises the application of ultraviolet light at a radiation density of 100 to 300 mW/cm2 to the polymeric catheter body substrate.
46. The method of claim 45 where the crosslinking step comprises the application of ultraviolet light at a radiation density of 150 to 250 mW/cm2 to the polymeric catheter body substrate.
47. The method of claim 46 additionally comprising the steps of sequentially repeating steps a.) and b.) up to four times.
48. The method of claim 32 where the crosslinking step comprises the application of ionizing radiation at a radiation density of 1 to 100 kRads/cm2 to the polymeric catheter body substrate.
49. The method of claim 48 where the crosslinking step comprises the application of ionizing radiation at a radiation density of 10 to 50 kRads/cm2 to the polymeric catheter body substrate.
-26-~
-26-~
50. The method of claim 49 additionally comprising the steps of sequentially repeating steps a.) and b.) up to four times.
51. The catheter of claim 1 in which the mono-alkoxy polyethylene glycol mono(meth)acrylates are selected from mono-methoxy triethylene glycol mono(meth)acrylate, mono-methoxy tetraethylene glycol mono(meth)acrylate, and polyethylene glycol mono(meth)acrylate.
52. A catheter assembly, said catheter comprising an elongate tubular member having proximal and distal ends and an inner lumen extending between these ends, said member comprising:
(a) a relatively stiff proximal segment;
(b) a relatively flexible distal segment; and (c) a transition segment between said proximal and said distal segments that is less flexible than the distal segment but more flexible than the proximal segment, which at least the distal segment has been coated with a lubricious coating comprising a polymer or oligomer comprising monomers of mono-alkoxy polyethylene glycol mono(methyacrylates.
(a) a relatively stiff proximal segment;
(b) a relatively flexible distal segment; and (c) a transition segment between said proximal and said distal segments that is less flexible than the distal segment but more flexible than the proximal segment, which at least the distal segment has been coated with a lubricious coating comprising a polymer or oligomer comprising monomers of mono-alkoxy polyethylene glycol mono(methyacrylates.
53. The catheter of claim 52 where the distal and the transition segments are coated with said lubricious coating.
54. The catheter of claim 53 where at least a portion of the proximal segment is coated with said lubricious coating.
55. The catheter of claim 52 in which the lubricious coating additionally comprises a polymer or oligomer comprising monomers selected from at least one of ethylene oxide; 2-vinyl pyridine; N-vinylpyrrolidone; polyethylene glycol acrylates, 2-hydroxyethylmethacrylate, glycerylmethacrylate; acrylic acid and its salts, acrylamide and acrylonitrile;
acrylamidomethylpropane sulfonic acid and its salts;
cellulose, cellulose derivatives, and polysaccharides.
acrylamidomethylpropane sulfonic acid and its salts;
cellulose, cellulose derivatives, and polysaccharides.
56. The catheter of claim 52 wherein the distal segment has a burst pressure of at least about 195 psi.
57. The catheter of claim 52 wherein the burst pressure of the distal segment is between about 195 and 220 psi.
58. The catheter of claim 57 wherein the distal segment is made of a material allowing that distal segment to deflect 1° per 10 -5 pounds of force of force applied horizontally to that segment.
59. The catheter of claim 52 wherein the proximal segment is made of a polymeric material selected from the group consisting of polyethylene, polypropylene, nylon, polyvinyl chloride, polyethylene terephthalate or other polyester elastomer and laminates thereof.
60. The catheter of claim 52 wherein the distal segment is made of a polymeric material selected from the group consisting of polyethylene, polypropylene, polyurethane, a block copolymer of polyamide, polyvinyl chloride, silicone and blends thereof.
61. The catheter of claim 52 wherein the coating of the distal segment is doped with a metallic material selected from the group consisting of barium sulfate, bismuth trioxide, bismuth carbonate, tungsten, and tantalum.
62. The catheter of claim 52 wherein the transition segment is made of a polymeric material selected from the group consisting of polyethylene, polypropylene, polyurethane, a block copolymer of polyamide, polyvinyl chloride, and silicone, and laminates thereof.
63. The catheter of claim 62 wherein the polymeric material of the transition segment is doped with a radio-opaque material selected from the group consisting of barium sulfate, bismuth trioxide, bismuth carbonate, tungsten, and tantalum.
64. The catheter of claim 55 in which the monomers of cellulose derivatives are selected from methyl cellulose ethyl cellulose, carboxymethyl cellulose, cyanoethyl cellulose, and cellulose acetate.
65. The catheter of claim 55 in which the monomers of polysaccharides are selected from amylose, pectin, amylopectin, alginic acid, and crosslinked heparin.
66. The catheter of claim 52 in which the mono-alkoxy polyethylene glycol mono(meth)acrylates are selected from mono-methoxy triethylene glycol mono(meth)acrylate, mono-methoxy tetraethylene glycol mono(meth)acrylate, and polyethylene glycol mono (meth) acrylate.
The catheter of claim 4 wherein the composition of the proximal segment is a polymer outer core with a metallic mesh inner core.
68. The catheter of claim 52 wherein the composition of the proximal segment is a polymer outer core with a metallic mesh inner core.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/060,401 | 1993-05-12 | ||
| US08/060,401 US5531715A (en) | 1993-05-12 | 1993-05-12 | Lubricious catheters |
| PCT/US1994/005343 WO1994026336A1 (en) | 1993-05-12 | 1994-05-12 | Lubricious catheters |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2127257A1 CA2127257A1 (en) | 1994-11-13 |
| CA2127257C true CA2127257C (en) | 2002-04-23 |
Family
ID=22029228
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002127257A Expired - Fee Related CA2127257C (en) | 1993-05-12 | 1994-05-12 | Lubricious catheters |
Country Status (10)
| Country | Link |
|---|---|
| US (4) | US5531715A (en) |
| EP (1) | EP0693948B1 (en) |
| JP (1) | JP2705852B2 (en) |
| AT (1) | ATE168568T1 (en) |
| AU (1) | AU680911B2 (en) |
| CA (1) | CA2127257C (en) |
| DE (1) | DE69411903T2 (en) |
| IL (1) | IL109637A0 (en) |
| TW (1) | TW275586B (en) |
| WO (1) | WO1994026336A1 (en) |
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-
1993
- 1993-05-12 US US08/060,401 patent/US5531715A/en not_active Expired - Lifetime
-
1994
- 1994-05-12 DE DE69411903T patent/DE69411903T2/en not_active Expired - Lifetime
- 1994-05-12 AU AU68328/94A patent/AU680911B2/en not_active Ceased
- 1994-05-12 AT AT94916763T patent/ATE168568T1/en not_active IP Right Cessation
- 1994-05-12 EP EP94916763A patent/EP0693948B1/en not_active Expired - Lifetime
- 1994-05-12 JP JP6515507A patent/JP2705852B2/en not_active Expired - Fee Related
- 1994-05-12 WO PCT/US1994/005343 patent/WO1994026336A1/en active IP Right Grant
- 1994-05-12 IL IL10963794A patent/IL109637A0/en unknown
- 1994-05-12 CA CA002127257A patent/CA2127257C/en not_active Expired - Fee Related
- 1994-05-16 TW TW083104410A patent/TW275586B/zh active
-
1996
- 1996-02-14 US US08/601,186 patent/US6221061B1/en not_active Expired - Lifetime
- 1996-02-21 US US08/604,500 patent/US5789018A/en not_active Expired - Lifetime
-
2001
- 2001-02-28 US US09/796,776 patent/US6706025B2/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| DE69411903D1 (en) | 1998-08-27 |
| DE69411903T2 (en) | 1999-04-01 |
| US5531715A (en) | 1996-07-02 |
| ATE168568T1 (en) | 1998-08-15 |
| IL109637A0 (en) | 1994-08-26 |
| AU6832894A (en) | 1994-12-12 |
| JP2705852B2 (en) | 1998-01-28 |
| US20010011165A1 (en) | 2001-08-02 |
| US6706025B2 (en) | 2004-03-16 |
| AU680911B2 (en) | 1997-08-14 |
| EP0693948A1 (en) | 1996-01-31 |
| WO1994026336A1 (en) | 1994-11-24 |
| CA2127257A1 (en) | 1994-11-13 |
| EP0693948A4 (en) | 1995-12-07 |
| US6221061B1 (en) | 2001-04-24 |
| US5789018A (en) | 1998-08-04 |
| JPH07504599A (en) | 1995-05-25 |
| TW275586B (en) | 1996-05-11 |
| EP0693948B1 (en) | 1998-07-22 |
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| EEER | Examination request | ||
| MKLA | Lapsed |
Effective date: 20140513 |