CA2083593A1 - Catheter guidewire device having a covering of fluoropolymer tape - Google Patents
Catheter guidewire device having a covering of fluoropolymer tapeInfo
- Publication number
- CA2083593A1 CA2083593A1 CA002083593A CA2083593A CA2083593A1 CA 2083593 A1 CA2083593 A1 CA 2083593A1 CA 002083593 A CA002083593 A CA 002083593A CA 2083593 A CA2083593 A CA 2083593A CA 2083593 A1 CA2083593 A1 CA 2083593A1
- Authority
- CA
- Canada
- Prior art keywords
- tape
- guidewire
- wire
- fluoropolymer
- covering
- 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.)
- Abandoned
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
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
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- 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
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B10/06—Biopsy forceps, e.g. with cup-shaped jaws
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
- A61B17/22012—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
- A61B2017/22014—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire
- A61B2017/22015—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire with details of the transmission member
-
- 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
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09058—Basic structures of guide wires
- A61M2025/09083—Basic structures of guide wires having a coil around a core
- A61M2025/09091—Basic structures of guide wires having a coil around a core where a sheath surrounds the coil at the distal part
Abstract
A catheter guidewire having a covering of a fluoropolymer tape.
The tape may be applied either helically or longitudinally to the outer surface of the guidewire or to the surface of the wire from which the guidewire is made. Such a covering is inert, lubricious, flexible, will not flake, and can be applied as an extremely thin coating. Additionally, such a covering allows the guidewire to tolerate the application of greater force before uncoiling and wire breakage occurs. Other catheter guidewire devices having fluoropolymer tape coverings are also described.
The tape may be applied either helically or longitudinally to the outer surface of the guidewire or to the surface of the wire from which the guidewire is made. Such a covering is inert, lubricious, flexible, will not flake, and can be applied as an extremely thin coating. Additionally, such a covering allows the guidewire to tolerate the application of greater force before uncoiling and wire breakage occurs. Other catheter guidewire devices having fluoropolymer tape coverings are also described.
Description
WO 91/15251 PCI`/US91/01770 -1- 2 a ~ 3 TITLE OF THE INVENTION
A Catheter Guidewire Device Having a Covering of Fluoropolymer Tape FIELD OF THE INVENTION
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This invention relates to the field of catheter guidewires and -catheter guidewire devices.
BACKGROUND OF THE INVENTION
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Guidewires are used for directing catheters to precise locations within passageways of living bodies. These passageways are often of small inside diameter (as small as 0.020 inch), incorporate many branches and present tortuous, curved paths. The ideal guidewire must be break-resistant, flexible, kink-resistant, have a smooth and lubricious surface, have a minimal outside diameter, provide good torque characteristics and offer good column strength to allow the guidewire to be pushed through complex passageways like the vascular system.
A guidewire is typically inserted into a gu;ding catheter which was previously placed into the vascular system through a cannula device and pushed through the vascular system to the desired location by routing through the appropriate branches. Careful manipulation of the guidewire past the d;stal end of the guiding catheter is required while view;ng the passage of the guidewire radiographically. After the distal t;p of the guidewire is in the desired position, a catheter ; is inserted over the gu;dewire and moved along the length of the guidewire to the des;red posit;on.
; 25 Guidewires typically take the form of a tightly wound springwhich is constructed of very fine wire tightly wrapped into a :
hel;cally wound coil spring in which adjacent turns typically contact each other. Guidewires are generally available as small as 0.014 inch outside diameter formed from round-section w;re of diameter as small ; 30 as 0.002 inches. Wires of essentially square and rectangular cross-section have been used as well, as have round wires with their outer :
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surface ground flat in order that the guidewire may present a flat ` surface to the tissue walls.
In use, breakage of the helically wound guidewire is known to `i occur on occasion, resulting in the separation and loss of the distal -end of the guidewire. Surgical intervention is often required to retrieve the lost end. It is common practice to employ a safety wire oriented along the axis of the guidewire to prevent the loss of a ~!' broken distal guidewire portion. This is accomplished by suitably attaching (welding, brazing, etc.) the tip of the safety wire to the ; 10 tip of the guidewire. The use of safety wires has reduced the frequency of breakage and loss of the distal end, but has not eliminated it, apparently due to breakage of the safety wire or its attachment to the guidewire during the same trauma responsible for the breakage of the guidewire.
Some guidewires do not use a safety wire within the distal end portion of the device so that the device tip may be as flexible as possible. It is this distal end portion that is most commonly broken and lost.
Breakage of these devices generally appears to follow the same pattern. In attempting to pass the guidewire around a sharp bend or through an obstructed passageway, the tip of the device becomes trapped. The operator generally attempts to free the device with rotary, extension (compression) and traction (tensile) forces. The applicat;on of an excessive traction force results in uncoiling of the ; 25 guidewire. If this traction force is then relieved momentarily, the uncoiled length of guidewire tries to recover at least some of its previously coiled form. The application of a rotary force to the partly uncoiled wire appears to result in tangling of the wire as the ;~ uncoiled wire loops or crosses over itself in one or more places.
Continued application of rotary and/or traction forces causes kinking ; of the tangled wire, which quickly results in breakage of the wire at the location of a kink.
Uncoiling is herein meant to mean extension of the coil spring m beyond its elastic limit.
; 35 Guidewires have béen available for some time with plasticcoatings, most frequently of polytetrafluoroethylene (hereinafter ` PTFE). This is done so as to present a smooth, lubricious and inert ,. . .
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;, WO 91/15251 PCI~US91/01770 2~3~.~3 surface to the vessel wall. Such coatings have been applied to the outer surface of the guidewire coil and have also been applied to the circumferential surface of the wire before winding the wire into a coil so that the entire circumference of the wire surface is coated.
While previous PTFE coated guidewires have provided improved guidewire performance, these previous coatings still have significant shortcomings. PTFE coatings have typically been applied by either dip-coating the wire in a liquid dispersion of PTFE or by covering with PTFE heat-shrink tubing. Either method may be used to coat the circumferential surface of the wire before winding into a guidewire or ; to coat the outer surface of the already wound guidewire. Dip-coatings may be applied more thinly than heat-shrink tubing, however, such dip-coatings are prone to flaking during manipulation of the guidewire. Such flaking presents an undesirable risk of contamination to the patient. Heat-shrink coatings generally are not vulnerable to -flaking, however, the use of such coatings results in a guidewire of increased outside diameter due to the increased thickness of the heat-shrink coating. Additionally, heat shrink tubing covering the distal end of small diameter guidewires significantly restricts flexibility.
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~ 20 SUMMARY OF THE INVENTION
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A catheter guidewire is disclosed having a covering of a fluoropolymer tape. The tape can be applied either helically around the outer surface of the wound guidewire, or longitudinally around the outer surface of the wound guidewire, as in a cigarette wrap. ;
Addltionally, the tape can be applied around the circumferential surface of the wire comprising the guidewire before the wire is wound into the coiled form of the guidewire. It can also be applied around ` the circumferent;al surface of the axially oriented safety wire.
The use of a tape is advantageous for several reasons. A coating of fluoropolymer tape offers the same fundamental advantages of previous PTFE coatings, i.e., a lubricious and inert surface is presented to the living tissue. Additionally, the tape can be applied ` as an extrernely thin covering, for example, about 0.0005 inches total thickness. Such a coating only minimally increases the outside diameter of the guidewire. ~he thin tape covering is not subject to ... ~ .. . ... . . ... . . .
: WO 91/15251 PCI/US91/01770 :; 208~93 -4_ flaking problems as are previous guidewire coatings applied in liquid form. It therefore offers the integrity of heat-shrink coverings in a previously unavailable extremely thin form. The tape covering also increases the ability of a guidewire tip to withstand rotary and , 5 traction forces without becoming uncoiled, thus reducing the likelihood of breakage.
Additionally, in cases where the circumferential surface of the wire is tape-wrapped prior to winding the wire into the form of a guidewire, the tape-wrapped covering on the wire makes it more difficult to break such a guidewire that has been uncoiled by excessive traction forces. While the uncoiled guidewire is still liable to tangling, it does not break so easily. This is apparently because the lubricious surface of the tape-wrapped wire prevents it from binding on itself during the tangling process, so that the subsequent application of rotary or traction forces does not produce a kink in the wire that quickly results in wire breakage.
~he fluoropolymer tape coating can be a porous fluoropolymer.
; Porous tape coatings can be impregnated with other materials such as anticoagulants and lubricants and can be used to carry those other , 20 materials into body cavities.
Other types of catheter guidewire devices can also benefit from fluoropolymer tape-wrapping.
` BRIEF DESCRIPTION OF THE DRAWINGS
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Figure 1 shows a longitudinal section of a tape-wrapped guidewire wherein the tape has been helically wrapped around the outer surface of the previously wound guidewire.
Figure 2 shows a cross section of a tape-wrapped guidewire wherein the tape has been longitudinally wrapped around the outer surface of the previously wound guidewire in the fashion of a cigarette wrap, the edges of the tape being overlapped.
Figure 3 shows a cross section of a tape-wrapped guidewire wherein the tape has been longitudinally wrapped around the previously wound guidewire in the fashion of a cigarette wrap, the edges of the tape being abutted.
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_5~ ' 20~3~3 Figure 4 shows a partially uncoiled guidewire wherein the tape is shown inhibiting further uncoiling of the guidewire.
Figure 5 shows a longitudinal section of a tape-wrapped guidewire wherein the tape has been wrapped around the circumferential surface of the wire comprising the guidewire before the guidewire is wound into the form of a coiled ~pring.
Figure 6 shows a longitudinal section of a tape-wrapped guidewire wherein a first tape-wrapped covering has been applied to -the circumferential surface of the ~ire before winding the wire into the form of a guidewire, and a second tape-wrapped covering has been applied to the guidewire outer surface after the wire has been wound into the form of a guidewire.
Figure 7 shows a guidewire having an axially-oriented safety wire -wherein the circumferential surface of the safety wire has been given a tape-wrapped covering.
Figure 8 shows a cross-section of a die that may be used in the appl;cation of tape to flexible guidewires.
Figure 9 shows a longitudinal section of an ultrasound drive shaft having a fluoropolymer tape-wrapped covering. ;
Figure 10 shows the tape-wrapping method used to manufacture the catheter guidewire of Example 3 having a tape-wrapped covering applied to the wire before winding the wire into ;I the co;led form of the guidewire.
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;I DETAILED DESCRIPTION OF THE INVENTION
.,i This invention comprises a catheter guidewire having a tape-wrapped covering of a fluoropolymeric tape. Such a tape would preferably be either fluorinated ethylene propylene (hereinafter FEP) or PTFE. The PTFE tape may be of a porous form. A preferred material . is expanded, porous PTFE having a microstructure of nodes interconnected by fibrils, manufactured as taught by U. S. Patent 3,962,153, hereby incorporated by reference.
Other useful fluoropolymer materials include tapes cut from films of perfluoroalkoxy resin (PFA), polychlorotrifluoroethylene (PCTFE), , ethylene-chlorotrifluoroethylene copolymer (ECTFE), ethylene-.. ~ .9 . , .
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tetrafluoroethylene copolymer (ETFE), polyvinylidene fluoride (PVDF), and polyvinyl fluoride (PVF).
"Tape" herein describes a thin and narrow strip of material of relatively long length, that when used as a covering material is capable of covering a useful length, for example, the length of a guidewire, preferably without the necessity of adding a second tape to augment the length of the first. Devices such as guidewires having a tape-wrapped covering may be identified by exposed edges of the covering tape material or by helical appearance of the covering tape material. Devices having coverings of dip-coated materials or of heat-shrink tubing materials will not have such exposed edges or helical appearances. Microscopy may be necessary to view these characteristics.
Tape-wrapped coverings may be applied to guidewires as extremely thin coverings. Fluoropolymer films are available of thinness approaching 0.0005 inch. These thin films may be cut into tapes to create the present invention. Tension applied to nonporous tape during the process of wrapping the guidewire can be such that the tape stretches during wrapping to provide a still thinner covering. The mechanical integrity of these fluoropolymer tapes is such that the finished guidewire covering, even in extremely thin form, is not ~ subject to breaking up and flaking as are previous liquid-applied i fluoropolymer thin coatings. While previous heat-shrink tubing coatings do not have the flaking problems of liquid-applied coatings, the heat-shrink coatings have not been previously available in extremely thin form. Thinness is desirable to minimize the outside diameter and maximize the flexibility of the finished guidewire.
As shown in Figure 1, in one embodiment the tape 11 is wrapped ~ helically around the outer surface of a previously wound guidewire 12.
; 30 Such a helically-wound covering of fluoropolymer tape is practical regardless of the cross sectional form of the wire comprising the guidèwire.
The tape 11 may also be longitudinally applied to the outer surface 12 of a previously wound guidewire in the manner of a cigarette wrap so that the tape seam line is parallel to the guidewire axis. The seam may consist of either overlapped 20 or abutted 30 tape , . . ,:.
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WO 91/lS251 PCT/US91/01770 -7- ' " ' 2~83~3 edges as shown respectively by the tape-wrapped guidewire cross-sections of Figures 2 and 3.
Tape-wrapped guidewire outer surface coverings are capable of -increasing the amount of force that the guidewire may withstand before uncoiling of the guidewire occurs. Figure 4 shows how the tape-wrapped covering 11 absorbs some part of an uncoiling force F. As :
` breakage of the guidewire may result from uncoiling, breakage can be forestalled by application of a tape-wrapped outer surface covering to a guidewire.
In a further embodiment of this invention, the tape may be applied to the circumferential surface of the wire comprising the guidewire befare winding the wire into the coil-spring form of the guidewire. As shown by Figure 5, the wire coils 51 of the guidewire -are completely surrounded or encapsulated by the tape 11. The tape may be applied around the circumferential surface of the wire in either helical or cigarette wrap fashion.
An additional embodiment of this invention is shown in Figure 6 which shows a longitudinal section of a tape-wrapped guidewire wherein a first tape-wrapped covering 61 has been applied to the circumferential surface of the wire 51 before winding the wire into the form of a guidewire, and a second tape-wrapped covering 62 has been applied after the wire 51 has been wound into the form of a guidewire.
As shown by Figure 7, in a further embodiment of this invention, the axially-oriented safety wire 71 within the interior 72 of the guidewire 70 can also be provided with a thin and lubricious tape-wrapped fluoropolymer coating 73 without risk of flaking af the coating.
The following are some of the factors that may influence the ~ 30 handling characteristics of the tape-wrapped guidewire: the type of `; fluoropolymer and porosity (if any), the pitch of the helically wound wrap, the width and thickness of the tape used, the number of layers - applied (taken at any cross section) and the direction of the wraprelative to the direction of the winding of the guidewire. In general, ;
tapes may be applied in coverings so thin as to have little effect on the handling af the guidewire.
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.~. ' WO 91/15251 PCr/US91/01771) 2083~93 -8-Preferred fluoropolymers for use as the tape material are FEP and PTFE. These materials are highly inert and can be expected to cause no adverse tissue reaction. They are highly lubricious, reducing the -~ friction of the guidewire surface and easing its passage along vessel walls.
The most preferred fluoropolymer tape is porous PTFE. Such a material is porous, expanded PTFE having a microstructure of nodes interconnected by fibrils. The manufacture of this material is described in U.S. Patent 3,962,153. That patent describes the lo manufacture of a porous, expanded PTFE film that, when slit into a narrow tape, is suitable for use as the tape-wrapped guidewire covering of this invention. The porous, expanded PTFE tape-wrapped covering is most preferred because in addition to being inert and lubricious, it has a greater tensile strength and flexibility than non-porous fluoropolymer tapes. This allows the use of even thinner tape coverings having adequate mechanical integrity to avoid damage , and flaking during guidewire use.
The tape may be applied with equipment presently used for tape-wrapping applications such as, for example, insulating electrical wires and cables.
Figure 8 descrlbes in cross section a die 80 that is useful in the application of tape to flexible guidewires where the flexibility of the guidewire causes difficulty in tape application. The die 80 consists of a cyl~nder 81, preferably of a lubricious plastic such as Delrin~ or PTFE, having a through-hole 82 along the axis of the cylinder, the through-hole being of diameter adequate to provide a ' slight clearance 83 beyond the diameter of the guidewire 12 after tape ;
wrapping. The purpose of the through-hole is to serve as a guide to :
! the rotating guidewire. The length of this cylinder should be adequate to support the guidewire in order to prevent any tendency to , twist or kink during wrapping. The die has a section 84 cut away in order to provide an access slot 85 into the through-hole of the die.
This slot 85 allows tape 11 to pay off of a spool 86 and feed onto the ;
rotating guidewire 12 as the guidewire is simultaneously fed axially within the through-hole 82 of the die 80. The slot is preferably of the minimum width necessary to allow the tape to feed freely onto the rotating guidewire. A slot of minimum width offers the least possible ~ ., :.
2 ~ 3 interruption of the internal surface of the through-hole that serves to guide the rotating guidewire. Figure ~ shows a ninety degree angular sectisn 84 cut away to provide the access slot-85; the angle of the cut away section 84 is relatively unimportant.
After the application of the tape-wrapped covering to the - ;
guidewire, the assembly is preferably heated above the melt point of the fluoropolymer. This heat treating process thermally bonds adjacent surfaces of the tape together, i.e., bonds overlapping or abutting tape surfaces, thereby preventing the tape edges from coming loose and producing a bonded-together flexible covering.
In the case of wire that is tape-wrapped prior to winding into a guidewire, the heat treating process can be performed before the winding process to prevent bonding together the coated surfaces of adjacent windings. Alternatively, the heat treating process may be performed after the winding process if it is desired to bond together the coated surfaces of adjacent windings.
In the case of wire that has a first tape-wrapping applied to the circumferential surface of the wire prior to winding the wire into a guidewire and a second tape-wrapping applied to the outer surface of the guidewire after winding the wire into a guidewire, it is possible to produce a guidewire with good handling properties by heat treating this guidewire only once, after the second tape-wrapping is applied.
Because the heat-treating process bonds the tape edges to the adjacent underlying or overlying tape surface, the tape-wrapped outer covering of the guldewire can be water-tight, and therefore is capable of preventiing the passage of water and similar fluids between the exterior and iinterior surfaces of the guidewire. This characteristic helps prevent contamlnation of the guidewire by biological materials exterior to the guidewire surface. It also means that the interior of the guidewire may be used in the fashion of a catheter to convey i fluids from one end of the guidewire to the other, that is, with adequate interior cross sectional area the guidewire of the present invention may be used as a catheter.
Heat-treated porous PTFE tape-wrapped coverings can also be water-tight. The hydrophobic characteristic of PTFE, combined with a small enough maximum pore size can prevent the passage of many types of fluids (for example, water) through the porous PTFE tape-wrapped .. . .
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WO 91/15251 PCl/US91/01770 : 2a~3~`3 -lo-outer surface covering. Porous PTFE has the further advantage of being gas permeable and may therefore allow the guidewire of the present invention to be used for the injection or withdrawal of gases.
; Heat treating times and temperatures may be determined ; 5 experimentally by those skilled in the art of processing ; fluoropolymers.
It is possible to increase the maximum pore size of porous PTFE
with the application of additional heat. Heat can be applied to the distal end of a guidewire for a longer time or at a greater temperature than required by the previous heat-treating process in order to locally increase the permeability of the porous PTFE tape-wrapped covering to the point that it will allow the passage of liquids. If the spacing between adjacent windings of the guidewire distal end is increased so that they are not in contact, the guidewire can be used as a catheter for the iniection or extraction of fluids through the permeable distal end covering. This technique can also be ; used to provide a valve at the distal end for turning off the flow of liquids as taught by U.S. Patent 3,841,308.
An additional advantage of tape-wrapped coverings of porous PTFE
is that the void spaces within the structure of the tape can be impregnated with other materials in order to carry those other materials into body cavities with the guidewire. These other materials are herein considered generically as chemicals and may include coagulant or anticoagulant agents, contrast medium, antibiotic or antimicrobial agents, various time-release drugs and lubricants.
Tape-wrapped fluoropolymer coverings can also be applied to other comparable catheter guidewire devices. For example, biopsy sample ' retrieval cables are made similarly to catheter guidewires. These devices are also comprised of a wire wound into a coil, generally of `
slightly larger outside coil diameter than the coiled wire of catheter guidewires. In addition, they incorporate one or more axially oriented control wires within the lumen of the coiled wire, the ~ ~-control wires intended to activate a cutting mechanism at the distal end of the device that is used to retrieve a tissue sample from a desired location within a living body. The flexibility and maneuverability requirements of biopsy sample retrieval cables are '' . ~; ,:
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WO 91/152~1 PCI/US91/01770 O~i.,3 ; similar to those for catheter guidewires; therefore they also canbenefit from the application o~ tape-wrapped fluoropolymer coatings.
As shown by Figure 9, ultrasound driveshafts (also known as ultrasound torque sha-Fts) are likewise devices of the same type of construction as catheter guidewires, that is, they are typically made of small gauge wire, usually of stainless steel, that has been wound into the form of a coil. Most typically, they are comprised of a first helically wound coil of wire 91 that is concentrically surrounded by a second helically wound coil of wire 92. The two coils are typically wound in opposite directions (that is, one was wound in a clockwise direction while the other was wound counter-clockwise).
Therefore, when a rotary force is applied to such an ultrasound driveshaft in either a clockwise or counterclockwise direction, the driveshaft is not subject to uncoiling. These driveshafts may be tape-wrapped with lubricious fluoropolymer tapes 11 in the same manner as catheter guidewires. The benefits of tape-wrapped ultrasound driveshaft coverings include having a thin, lubricious surface that allows smoother rotation and therefore more constant angular velocity of the driveshaft in order to provide a stable ultrasound image.
, 20 EXAMPLE 1 ., A catheter guidewire of 0.003 inch diameter stainless steel wire and having an outside diameter of 0.014 inches of the wound coil was tape-wrapped with an outer surface covering of porous PTFE tape, applied by the following process. First, a tape was cut from a roll of microporous expanded PTFE film manufactured according to the teachings of U.S. Patent 3,962,153. This tape was aboùt 0~0005 inch thick, 0.125 inch wide, and of less than about 1.0 g/cc density. A
length of this tape was wound onto a small spool. Next, a cylindrical Delrin die was constructed as shown by Figure 8, having a bored hole of 0.025 inch diameter and a 0.005 inch wide access slot into the ~ bored hole. The access slot was provided by cutting a ninety degree `~ angular section from the cylindrical die, so that the corner of the section formed the slot. The spool of film was set up adjacent to the cylindrical die to enable the spool to pay tape through the access slot of the die as shown by Figure 8. The distal end of the guidewire `
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,, ' . WO 91/15251 PCI/US91/01770 2083~93 -12-was inserted into the through-hole of the die and allowed to protrude from the other end of the hole. ~he end of the porous PTFE tape was pulled from the spool and wound several times around the distal end of the guidewire. The distal end of the guidewire was then pulled back into the bore of the through-hole (toward the proximal end) so that the tape fed through the access slot as shown by Figure 8. The proximal end of the guidewire was gripped in a traversing chuck mechanism and rotated at about 330 RPM while being fed axially through the through-hole of the die by the traverse mechanism at a rate of about 2 inches per minute. A drag mechanism was used to resist rotation of the tape spool, thereby applying about 2 ounces of tension to the tape as it paid off of the tape spool and onto the surface of the rotating guidewire. The payoff angle, that is, the angle between the longitudinal axis of the guidewire and the centerline of the tape as it pays from the spool to the guidewire, was set so that the tape ; would feed from the spool without wrinkling onto the outer surface of the rotating and traversing guidewire. The tape-wrapped guidewire was ' then heat treated in an oven set at 380C for about 60 seconds in order to thermally bond adjacent tape layers together. After heat -treating, the ends of the film were trimmed off even with the ends of the guidewire using a razor blade. The tape-wrapped guidewire -~ appeared to be only slightly less flexible than the same guidewire '~ before tape-wrapping. The tape-wrapped covering showed no indication of flaking after repeated bending of the guidewire.
Tension was applied to a short length of this tape-wrapped gu~dewire to determine the amount of force necessary to cause the wire to uncoil. This was done by placing the ends of this length into the `~ grips of an Instron tester with a grip separation of 1.2 inches and crosshead speed of 2 inches per minute. A force of 0.6 pounds was required to cause extension and failure of the tape-wrapped covering and subsequent uncoiling of the tape-wrapped guidewire. The same test was applied to another sample of the same type of guidewire that had not been tape-wrapped; a force of less than 0.1 pounds was required to cause uncoiling.
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WO ~1/15251 PCl/US91/01770 2~83~93 .
;' A second guidewire of the same type as used in Example 1 was tape-wrapped and tested with the method and equipment described in Example 1. A non-porous tape of FEP (from Norton Performance Plastics, Wayne, N.J.) was used to wrap the outer surface of this : guidewire. The guidewire was rotated at about 100 rpm while being fed axially along its longitudinal axis at 2 feet per minute. A tension of about 2 ounces was applied to the tape dur;ng wrapping. The wrapped guidewire was then heat treated in an oven set at 380C for a period of twenty seconds. After heat treating and cooling, the FEP
tape-wrapped guidewire was subjectively examined for flexibility and poss;ble flaking of the coating. This sample was not as flexible as the porous PTFE tape-wrapped guidewire of Example 1, however, it was ;
felt to still have good flexibility and was deemed suitable for practical use. This sample also showed no evidence of flaking of the coating after repeated flexing. When tested for the amount of force required to cause uncoiling of the wire, it was found that .3 pounds was necessary.
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, ` EXAMPLE 3 , .
A stainless steel wire of 0.002" diameter was wrapped with the same porous expanded PTFE tape as used in Example 1. The wire was wrapped using standard tape-wrapping equipment for insulating small ~ gauge electrical wires. As shown by Figure 10, a spool 101 of this ; tape 11 was rotated around the wire 102 at 600 rpm while the wire was 25 fed at a rate of 0.492 inches per minute along its axis (around which the spool of tape was being rotated). The spool was able to rotate about its own axis, although drag was applied to this rotation to provide tension to the tape as it paid off of the spool on its way to wrap around the wire. The tape-wrapped guidewire was then heat 30 treated for 15 seconds in an oven set at 380C and subsequently coiled into the form of a guidewire of 0.014 inch outside diameter. For ;
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comparison, an uncovered 0.002 stainless wire was also coiled into the form of a guidewire of the same dimensions. 8ending and flexing of . .
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. ' .; i . . . . ~ . . . :, . . . ,. . - . - -WO 91/1S2SI PCl'/US91/01770 ~o83~3 _14_ both samples revealed no apparent differences in the bending and handling characteristlcs of the two guidewires. Repeated bending of the tape-wrapped guidewire produced no evidence of flaking of the tape-wrapped covering.
Both samples were subsequently pulled in tension and rotated in order to simulate in vivo stresses. These forces were increased until uncoiling of the guidewires occurred. In both samples, the further application of traction and rotational forces caused looping and tangling of the uncoiled portion of the wire. Further tractional force caused the tangled wire to form a sharp kink which was followed by sudden breakage of the uncoated wire at the site of the kink.
; Conversely, the wrapped wire with the lubricious surface also tangled after uncoiling but no kinks were produced. It appeared that kinking did not occur because the lubricious tape-wrapped wire surface prevented the tangled wire from binding and gripping itself to produce a kink that would result in breakage. Instead, the tangled, tape-` wrapped wire simply untangled and straightened out on the application ~ -of additional tension. Because kinking was avoided, the tensile strength of the wire was not compromised and the wire was not so ; 20 easily broken.
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EXAMPLE 4 :
An additional guidewire of the same type as described in Example 3 was produced from the same materials and by the same method except that the heat treating step was not performed after the tape-wrapped wire was wound into the form of a guidewire. An additional outer tape-wrapped covering was then applied with the same tape and method described in Example 1. After application of the second tape-wrapped covering, the guidewire was heat treated for 60 seconds in an oven set at 380C. After removal from the oven and cooling to room ;
temperature, this guidewire was subjected to repeated bending and `
flexing in order to compare its handling with another comparative guidewire made from the same wire wound to the same dimenslons but not having any tape-wrapped coverings. It was found that the comparative guidewire was slightly more flexible but the tape-wrapped guidewire ''.,'''' .~ -,.
W O 91/15251 PCT/~ 3 still exhibited good flexibility and was therefore deemed suitable for functional use as a catheter guidewire.
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A Catheter Guidewire Device Having a Covering of Fluoropolymer Tape FIELD OF THE INVENTION
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This invention relates to the field of catheter guidewires and -catheter guidewire devices.
BACKGROUND OF THE INVENTION
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Guidewires are used for directing catheters to precise locations within passageways of living bodies. These passageways are often of small inside diameter (as small as 0.020 inch), incorporate many branches and present tortuous, curved paths. The ideal guidewire must be break-resistant, flexible, kink-resistant, have a smooth and lubricious surface, have a minimal outside diameter, provide good torque characteristics and offer good column strength to allow the guidewire to be pushed through complex passageways like the vascular system.
A guidewire is typically inserted into a gu;ding catheter which was previously placed into the vascular system through a cannula device and pushed through the vascular system to the desired location by routing through the appropriate branches. Careful manipulation of the guidewire past the d;stal end of the guiding catheter is required while view;ng the passage of the guidewire radiographically. After the distal t;p of the guidewire is in the desired position, a catheter ; is inserted over the gu;dewire and moved along the length of the guidewire to the des;red posit;on.
; 25 Guidewires typically take the form of a tightly wound springwhich is constructed of very fine wire tightly wrapped into a :
hel;cally wound coil spring in which adjacent turns typically contact each other. Guidewires are generally available as small as 0.014 inch outside diameter formed from round-section w;re of diameter as small ; 30 as 0.002 inches. Wires of essentially square and rectangular cross-section have been used as well, as have round wires with their outer :
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surface ground flat in order that the guidewire may present a flat ` surface to the tissue walls.
In use, breakage of the helically wound guidewire is known to `i occur on occasion, resulting in the separation and loss of the distal -end of the guidewire. Surgical intervention is often required to retrieve the lost end. It is common practice to employ a safety wire oriented along the axis of the guidewire to prevent the loss of a ~!' broken distal guidewire portion. This is accomplished by suitably attaching (welding, brazing, etc.) the tip of the safety wire to the ; 10 tip of the guidewire. The use of safety wires has reduced the frequency of breakage and loss of the distal end, but has not eliminated it, apparently due to breakage of the safety wire or its attachment to the guidewire during the same trauma responsible for the breakage of the guidewire.
Some guidewires do not use a safety wire within the distal end portion of the device so that the device tip may be as flexible as possible. It is this distal end portion that is most commonly broken and lost.
Breakage of these devices generally appears to follow the same pattern. In attempting to pass the guidewire around a sharp bend or through an obstructed passageway, the tip of the device becomes trapped. The operator generally attempts to free the device with rotary, extension (compression) and traction (tensile) forces. The applicat;on of an excessive traction force results in uncoiling of the ; 25 guidewire. If this traction force is then relieved momentarily, the uncoiled length of guidewire tries to recover at least some of its previously coiled form. The application of a rotary force to the partly uncoiled wire appears to result in tangling of the wire as the ;~ uncoiled wire loops or crosses over itself in one or more places.
Continued application of rotary and/or traction forces causes kinking ; of the tangled wire, which quickly results in breakage of the wire at the location of a kink.
Uncoiling is herein meant to mean extension of the coil spring m beyond its elastic limit.
; 35 Guidewires have béen available for some time with plasticcoatings, most frequently of polytetrafluoroethylene (hereinafter ` PTFE). This is done so as to present a smooth, lubricious and inert ,. . .
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;, WO 91/15251 PCI~US91/01770 2~3~.~3 surface to the vessel wall. Such coatings have been applied to the outer surface of the guidewire coil and have also been applied to the circumferential surface of the wire before winding the wire into a coil so that the entire circumference of the wire surface is coated.
While previous PTFE coated guidewires have provided improved guidewire performance, these previous coatings still have significant shortcomings. PTFE coatings have typically been applied by either dip-coating the wire in a liquid dispersion of PTFE or by covering with PTFE heat-shrink tubing. Either method may be used to coat the circumferential surface of the wire before winding into a guidewire or ; to coat the outer surface of the already wound guidewire. Dip-coatings may be applied more thinly than heat-shrink tubing, however, such dip-coatings are prone to flaking during manipulation of the guidewire. Such flaking presents an undesirable risk of contamination to the patient. Heat-shrink coatings generally are not vulnerable to -flaking, however, the use of such coatings results in a guidewire of increased outside diameter due to the increased thickness of the heat-shrink coating. Additionally, heat shrink tubing covering the distal end of small diameter guidewires significantly restricts flexibility.
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~ 20 SUMMARY OF THE INVENTION
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A catheter guidewire is disclosed having a covering of a fluoropolymer tape. The tape can be applied either helically around the outer surface of the wound guidewire, or longitudinally around the outer surface of the wound guidewire, as in a cigarette wrap. ;
Addltionally, the tape can be applied around the circumferential surface of the wire comprising the guidewire before the wire is wound into the coiled form of the guidewire. It can also be applied around ` the circumferent;al surface of the axially oriented safety wire.
The use of a tape is advantageous for several reasons. A coating of fluoropolymer tape offers the same fundamental advantages of previous PTFE coatings, i.e., a lubricious and inert surface is presented to the living tissue. Additionally, the tape can be applied ` as an extrernely thin covering, for example, about 0.0005 inches total thickness. Such a coating only minimally increases the outside diameter of the guidewire. ~he thin tape covering is not subject to ... ~ .. . ... . . ... . . .
: WO 91/15251 PCI/US91/01770 :; 208~93 -4_ flaking problems as are previous guidewire coatings applied in liquid form. It therefore offers the integrity of heat-shrink coverings in a previously unavailable extremely thin form. The tape covering also increases the ability of a guidewire tip to withstand rotary and , 5 traction forces without becoming uncoiled, thus reducing the likelihood of breakage.
Additionally, in cases where the circumferential surface of the wire is tape-wrapped prior to winding the wire into the form of a guidewire, the tape-wrapped covering on the wire makes it more difficult to break such a guidewire that has been uncoiled by excessive traction forces. While the uncoiled guidewire is still liable to tangling, it does not break so easily. This is apparently because the lubricious surface of the tape-wrapped wire prevents it from binding on itself during the tangling process, so that the subsequent application of rotary or traction forces does not produce a kink in the wire that quickly results in wire breakage.
~he fluoropolymer tape coating can be a porous fluoropolymer.
; Porous tape coatings can be impregnated with other materials such as anticoagulants and lubricants and can be used to carry those other , 20 materials into body cavities.
Other types of catheter guidewire devices can also benefit from fluoropolymer tape-wrapping.
` BRIEF DESCRIPTION OF THE DRAWINGS
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Figure 1 shows a longitudinal section of a tape-wrapped guidewire wherein the tape has been helically wrapped around the outer surface of the previously wound guidewire.
Figure 2 shows a cross section of a tape-wrapped guidewire wherein the tape has been longitudinally wrapped around the outer surface of the previously wound guidewire in the fashion of a cigarette wrap, the edges of the tape being overlapped.
Figure 3 shows a cross section of a tape-wrapped guidewire wherein the tape has been longitudinally wrapped around the previously wound guidewire in the fashion of a cigarette wrap, the edges of the tape being abutted.
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_5~ ' 20~3~3 Figure 4 shows a partially uncoiled guidewire wherein the tape is shown inhibiting further uncoiling of the guidewire.
Figure 5 shows a longitudinal section of a tape-wrapped guidewire wherein the tape has been wrapped around the circumferential surface of the wire comprising the guidewire before the guidewire is wound into the form of a coiled ~pring.
Figure 6 shows a longitudinal section of a tape-wrapped guidewire wherein a first tape-wrapped covering has been applied to -the circumferential surface of the ~ire before winding the wire into the form of a guidewire, and a second tape-wrapped covering has been applied to the guidewire outer surface after the wire has been wound into the form of a guidewire.
Figure 7 shows a guidewire having an axially-oriented safety wire -wherein the circumferential surface of the safety wire has been given a tape-wrapped covering.
Figure 8 shows a cross-section of a die that may be used in the appl;cation of tape to flexible guidewires.
Figure 9 shows a longitudinal section of an ultrasound drive shaft having a fluoropolymer tape-wrapped covering. ;
Figure 10 shows the tape-wrapping method used to manufacture the catheter guidewire of Example 3 having a tape-wrapped covering applied to the wire before winding the wire into ;I the co;led form of the guidewire.
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;I DETAILED DESCRIPTION OF THE INVENTION
.,i This invention comprises a catheter guidewire having a tape-wrapped covering of a fluoropolymeric tape. Such a tape would preferably be either fluorinated ethylene propylene (hereinafter FEP) or PTFE. The PTFE tape may be of a porous form. A preferred material . is expanded, porous PTFE having a microstructure of nodes interconnected by fibrils, manufactured as taught by U. S. Patent 3,962,153, hereby incorporated by reference.
Other useful fluoropolymer materials include tapes cut from films of perfluoroalkoxy resin (PFA), polychlorotrifluoroethylene (PCTFE), , ethylene-chlorotrifluoroethylene copolymer (ECTFE), ethylene-.. ~ .9 . , .
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tetrafluoroethylene copolymer (ETFE), polyvinylidene fluoride (PVDF), and polyvinyl fluoride (PVF).
"Tape" herein describes a thin and narrow strip of material of relatively long length, that when used as a covering material is capable of covering a useful length, for example, the length of a guidewire, preferably without the necessity of adding a second tape to augment the length of the first. Devices such as guidewires having a tape-wrapped covering may be identified by exposed edges of the covering tape material or by helical appearance of the covering tape material. Devices having coverings of dip-coated materials or of heat-shrink tubing materials will not have such exposed edges or helical appearances. Microscopy may be necessary to view these characteristics.
Tape-wrapped coverings may be applied to guidewires as extremely thin coverings. Fluoropolymer films are available of thinness approaching 0.0005 inch. These thin films may be cut into tapes to create the present invention. Tension applied to nonporous tape during the process of wrapping the guidewire can be such that the tape stretches during wrapping to provide a still thinner covering. The mechanical integrity of these fluoropolymer tapes is such that the finished guidewire covering, even in extremely thin form, is not ~ subject to breaking up and flaking as are previous liquid-applied i fluoropolymer thin coatings. While previous heat-shrink tubing coatings do not have the flaking problems of liquid-applied coatings, the heat-shrink coatings have not been previously available in extremely thin form. Thinness is desirable to minimize the outside diameter and maximize the flexibility of the finished guidewire.
As shown in Figure 1, in one embodiment the tape 11 is wrapped ~ helically around the outer surface of a previously wound guidewire 12.
; 30 Such a helically-wound covering of fluoropolymer tape is practical regardless of the cross sectional form of the wire comprising the guidèwire.
The tape 11 may also be longitudinally applied to the outer surface 12 of a previously wound guidewire in the manner of a cigarette wrap so that the tape seam line is parallel to the guidewire axis. The seam may consist of either overlapped 20 or abutted 30 tape , . . ,:.
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WO 91/lS251 PCT/US91/01770 -7- ' " ' 2~83~3 edges as shown respectively by the tape-wrapped guidewire cross-sections of Figures 2 and 3.
Tape-wrapped guidewire outer surface coverings are capable of -increasing the amount of force that the guidewire may withstand before uncoiling of the guidewire occurs. Figure 4 shows how the tape-wrapped covering 11 absorbs some part of an uncoiling force F. As :
` breakage of the guidewire may result from uncoiling, breakage can be forestalled by application of a tape-wrapped outer surface covering to a guidewire.
In a further embodiment of this invention, the tape may be applied to the circumferential surface of the wire comprising the guidewire befare winding the wire into the coil-spring form of the guidewire. As shown by Figure 5, the wire coils 51 of the guidewire -are completely surrounded or encapsulated by the tape 11. The tape may be applied around the circumferential surface of the wire in either helical or cigarette wrap fashion.
An additional embodiment of this invention is shown in Figure 6 which shows a longitudinal section of a tape-wrapped guidewire wherein a first tape-wrapped covering 61 has been applied to the circumferential surface of the wire 51 before winding the wire into the form of a guidewire, and a second tape-wrapped covering 62 has been applied after the wire 51 has been wound into the form of a guidewire.
As shown by Figure 7, in a further embodiment of this invention, the axially-oriented safety wire 71 within the interior 72 of the guidewire 70 can also be provided with a thin and lubricious tape-wrapped fluoropolymer coating 73 without risk of flaking af the coating.
The following are some of the factors that may influence the ~ 30 handling characteristics of the tape-wrapped guidewire: the type of `; fluoropolymer and porosity (if any), the pitch of the helically wound wrap, the width and thickness of the tape used, the number of layers - applied (taken at any cross section) and the direction of the wraprelative to the direction of the winding of the guidewire. In general, ;
tapes may be applied in coverings so thin as to have little effect on the handling af the guidewire.
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.~. ' WO 91/15251 PCr/US91/01771) 2083~93 -8-Preferred fluoropolymers for use as the tape material are FEP and PTFE. These materials are highly inert and can be expected to cause no adverse tissue reaction. They are highly lubricious, reducing the -~ friction of the guidewire surface and easing its passage along vessel walls.
The most preferred fluoropolymer tape is porous PTFE. Such a material is porous, expanded PTFE having a microstructure of nodes interconnected by fibrils. The manufacture of this material is described in U.S. Patent 3,962,153. That patent describes the lo manufacture of a porous, expanded PTFE film that, when slit into a narrow tape, is suitable for use as the tape-wrapped guidewire covering of this invention. The porous, expanded PTFE tape-wrapped covering is most preferred because in addition to being inert and lubricious, it has a greater tensile strength and flexibility than non-porous fluoropolymer tapes. This allows the use of even thinner tape coverings having adequate mechanical integrity to avoid damage , and flaking during guidewire use.
The tape may be applied with equipment presently used for tape-wrapping applications such as, for example, insulating electrical wires and cables.
Figure 8 descrlbes in cross section a die 80 that is useful in the application of tape to flexible guidewires where the flexibility of the guidewire causes difficulty in tape application. The die 80 consists of a cyl~nder 81, preferably of a lubricious plastic such as Delrin~ or PTFE, having a through-hole 82 along the axis of the cylinder, the through-hole being of diameter adequate to provide a ' slight clearance 83 beyond the diameter of the guidewire 12 after tape ;
wrapping. The purpose of the through-hole is to serve as a guide to :
! the rotating guidewire. The length of this cylinder should be adequate to support the guidewire in order to prevent any tendency to , twist or kink during wrapping. The die has a section 84 cut away in order to provide an access slot 85 into the through-hole of the die.
This slot 85 allows tape 11 to pay off of a spool 86 and feed onto the ;
rotating guidewire 12 as the guidewire is simultaneously fed axially within the through-hole 82 of the die 80. The slot is preferably of the minimum width necessary to allow the tape to feed freely onto the rotating guidewire. A slot of minimum width offers the least possible ~ ., :.
2 ~ 3 interruption of the internal surface of the through-hole that serves to guide the rotating guidewire. Figure ~ shows a ninety degree angular sectisn 84 cut away to provide the access slot-85; the angle of the cut away section 84 is relatively unimportant.
After the application of the tape-wrapped covering to the - ;
guidewire, the assembly is preferably heated above the melt point of the fluoropolymer. This heat treating process thermally bonds adjacent surfaces of the tape together, i.e., bonds overlapping or abutting tape surfaces, thereby preventing the tape edges from coming loose and producing a bonded-together flexible covering.
In the case of wire that is tape-wrapped prior to winding into a guidewire, the heat treating process can be performed before the winding process to prevent bonding together the coated surfaces of adjacent windings. Alternatively, the heat treating process may be performed after the winding process if it is desired to bond together the coated surfaces of adjacent windings.
In the case of wire that has a first tape-wrapping applied to the circumferential surface of the wire prior to winding the wire into a guidewire and a second tape-wrapping applied to the outer surface of the guidewire after winding the wire into a guidewire, it is possible to produce a guidewire with good handling properties by heat treating this guidewire only once, after the second tape-wrapping is applied.
Because the heat-treating process bonds the tape edges to the adjacent underlying or overlying tape surface, the tape-wrapped outer covering of the guldewire can be water-tight, and therefore is capable of preventiing the passage of water and similar fluids between the exterior and iinterior surfaces of the guidewire. This characteristic helps prevent contamlnation of the guidewire by biological materials exterior to the guidewire surface. It also means that the interior of the guidewire may be used in the fashion of a catheter to convey i fluids from one end of the guidewire to the other, that is, with adequate interior cross sectional area the guidewire of the present invention may be used as a catheter.
Heat-treated porous PTFE tape-wrapped coverings can also be water-tight. The hydrophobic characteristic of PTFE, combined with a small enough maximum pore size can prevent the passage of many types of fluids (for example, water) through the porous PTFE tape-wrapped .. . .
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WO 91/15251 PCl/US91/01770 : 2a~3~`3 -lo-outer surface covering. Porous PTFE has the further advantage of being gas permeable and may therefore allow the guidewire of the present invention to be used for the injection or withdrawal of gases.
; Heat treating times and temperatures may be determined ; 5 experimentally by those skilled in the art of processing ; fluoropolymers.
It is possible to increase the maximum pore size of porous PTFE
with the application of additional heat. Heat can be applied to the distal end of a guidewire for a longer time or at a greater temperature than required by the previous heat-treating process in order to locally increase the permeability of the porous PTFE tape-wrapped covering to the point that it will allow the passage of liquids. If the spacing between adjacent windings of the guidewire distal end is increased so that they are not in contact, the guidewire can be used as a catheter for the iniection or extraction of fluids through the permeable distal end covering. This technique can also be ; used to provide a valve at the distal end for turning off the flow of liquids as taught by U.S. Patent 3,841,308.
An additional advantage of tape-wrapped coverings of porous PTFE
is that the void spaces within the structure of the tape can be impregnated with other materials in order to carry those other materials into body cavities with the guidewire. These other materials are herein considered generically as chemicals and may include coagulant or anticoagulant agents, contrast medium, antibiotic or antimicrobial agents, various time-release drugs and lubricants.
Tape-wrapped fluoropolymer coverings can also be applied to other comparable catheter guidewire devices. For example, biopsy sample ' retrieval cables are made similarly to catheter guidewires. These devices are also comprised of a wire wound into a coil, generally of `
slightly larger outside coil diameter than the coiled wire of catheter guidewires. In addition, they incorporate one or more axially oriented control wires within the lumen of the coiled wire, the ~ ~-control wires intended to activate a cutting mechanism at the distal end of the device that is used to retrieve a tissue sample from a desired location within a living body. The flexibility and maneuverability requirements of biopsy sample retrieval cables are '' . ~; ,:
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WO 91/152~1 PCI/US91/01770 O~i.,3 ; similar to those for catheter guidewires; therefore they also canbenefit from the application o~ tape-wrapped fluoropolymer coatings.
As shown by Figure 9, ultrasound driveshafts (also known as ultrasound torque sha-Fts) are likewise devices of the same type of construction as catheter guidewires, that is, they are typically made of small gauge wire, usually of stainless steel, that has been wound into the form of a coil. Most typically, they are comprised of a first helically wound coil of wire 91 that is concentrically surrounded by a second helically wound coil of wire 92. The two coils are typically wound in opposite directions (that is, one was wound in a clockwise direction while the other was wound counter-clockwise).
Therefore, when a rotary force is applied to such an ultrasound driveshaft in either a clockwise or counterclockwise direction, the driveshaft is not subject to uncoiling. These driveshafts may be tape-wrapped with lubricious fluoropolymer tapes 11 in the same manner as catheter guidewires. The benefits of tape-wrapped ultrasound driveshaft coverings include having a thin, lubricious surface that allows smoother rotation and therefore more constant angular velocity of the driveshaft in order to provide a stable ultrasound image.
, 20 EXAMPLE 1 ., A catheter guidewire of 0.003 inch diameter stainless steel wire and having an outside diameter of 0.014 inches of the wound coil was tape-wrapped with an outer surface covering of porous PTFE tape, applied by the following process. First, a tape was cut from a roll of microporous expanded PTFE film manufactured according to the teachings of U.S. Patent 3,962,153. This tape was aboùt 0~0005 inch thick, 0.125 inch wide, and of less than about 1.0 g/cc density. A
length of this tape was wound onto a small spool. Next, a cylindrical Delrin die was constructed as shown by Figure 8, having a bored hole of 0.025 inch diameter and a 0.005 inch wide access slot into the ~ bored hole. The access slot was provided by cutting a ninety degree `~ angular section from the cylindrical die, so that the corner of the section formed the slot. The spool of film was set up adjacent to the cylindrical die to enable the spool to pay tape through the access slot of the die as shown by Figure 8. The distal end of the guidewire `
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,, ' . WO 91/15251 PCI/US91/01770 2083~93 -12-was inserted into the through-hole of the die and allowed to protrude from the other end of the hole. ~he end of the porous PTFE tape was pulled from the spool and wound several times around the distal end of the guidewire. The distal end of the guidewire was then pulled back into the bore of the through-hole (toward the proximal end) so that the tape fed through the access slot as shown by Figure 8. The proximal end of the guidewire was gripped in a traversing chuck mechanism and rotated at about 330 RPM while being fed axially through the through-hole of the die by the traverse mechanism at a rate of about 2 inches per minute. A drag mechanism was used to resist rotation of the tape spool, thereby applying about 2 ounces of tension to the tape as it paid off of the tape spool and onto the surface of the rotating guidewire. The payoff angle, that is, the angle between the longitudinal axis of the guidewire and the centerline of the tape as it pays from the spool to the guidewire, was set so that the tape ; would feed from the spool without wrinkling onto the outer surface of the rotating and traversing guidewire. The tape-wrapped guidewire was ' then heat treated in an oven set at 380C for about 60 seconds in order to thermally bond adjacent tape layers together. After heat -treating, the ends of the film were trimmed off even with the ends of the guidewire using a razor blade. The tape-wrapped guidewire -~ appeared to be only slightly less flexible than the same guidewire '~ before tape-wrapping. The tape-wrapped covering showed no indication of flaking after repeated bending of the guidewire.
Tension was applied to a short length of this tape-wrapped gu~dewire to determine the amount of force necessary to cause the wire to uncoil. This was done by placing the ends of this length into the `~ grips of an Instron tester with a grip separation of 1.2 inches and crosshead speed of 2 inches per minute. A force of 0.6 pounds was required to cause extension and failure of the tape-wrapped covering and subsequent uncoiling of the tape-wrapped guidewire. The same test was applied to another sample of the same type of guidewire that had not been tape-wrapped; a force of less than 0.1 pounds was required to cause uncoiling.
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;' A second guidewire of the same type as used in Example 1 was tape-wrapped and tested with the method and equipment described in Example 1. A non-porous tape of FEP (from Norton Performance Plastics, Wayne, N.J.) was used to wrap the outer surface of this : guidewire. The guidewire was rotated at about 100 rpm while being fed axially along its longitudinal axis at 2 feet per minute. A tension of about 2 ounces was applied to the tape dur;ng wrapping. The wrapped guidewire was then heat treated in an oven set at 380C for a period of twenty seconds. After heat treating and cooling, the FEP
tape-wrapped guidewire was subjectively examined for flexibility and poss;ble flaking of the coating. This sample was not as flexible as the porous PTFE tape-wrapped guidewire of Example 1, however, it was ;
felt to still have good flexibility and was deemed suitable for practical use. This sample also showed no evidence of flaking of the coating after repeated flexing. When tested for the amount of force required to cause uncoiling of the wire, it was found that .3 pounds was necessary.
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, ` EXAMPLE 3 , .
A stainless steel wire of 0.002" diameter was wrapped with the same porous expanded PTFE tape as used in Example 1. The wire was wrapped using standard tape-wrapping equipment for insulating small ~ gauge electrical wires. As shown by Figure 10, a spool 101 of this ; tape 11 was rotated around the wire 102 at 600 rpm while the wire was 25 fed at a rate of 0.492 inches per minute along its axis (around which the spool of tape was being rotated). The spool was able to rotate about its own axis, although drag was applied to this rotation to provide tension to the tape as it paid off of the spool on its way to wrap around the wire. The tape-wrapped guidewire was then heat 30 treated for 15 seconds in an oven set at 380C and subsequently coiled into the form of a guidewire of 0.014 inch outside diameter. For ;
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comparison, an uncovered 0.002 stainless wire was also coiled into the form of a guidewire of the same dimensions. 8ending and flexing of . .
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. ' .; i . . . . ~ . . . :, . . . ,. . - . - -WO 91/1S2SI PCl'/US91/01770 ~o83~3 _14_ both samples revealed no apparent differences in the bending and handling characteristlcs of the two guidewires. Repeated bending of the tape-wrapped guidewire produced no evidence of flaking of the tape-wrapped covering.
Both samples were subsequently pulled in tension and rotated in order to simulate in vivo stresses. These forces were increased until uncoiling of the guidewires occurred. In both samples, the further application of traction and rotational forces caused looping and tangling of the uncoiled portion of the wire. Further tractional force caused the tangled wire to form a sharp kink which was followed by sudden breakage of the uncoated wire at the site of the kink.
; Conversely, the wrapped wire with the lubricious surface also tangled after uncoiling but no kinks were produced. It appeared that kinking did not occur because the lubricious tape-wrapped wire surface prevented the tangled wire from binding and gripping itself to produce a kink that would result in breakage. Instead, the tangled, tape-` wrapped wire simply untangled and straightened out on the application ~ -of additional tension. Because kinking was avoided, the tensile strength of the wire was not compromised and the wire was not so ; 20 easily broken.
; : :.. .
EXAMPLE 4 :
An additional guidewire of the same type as described in Example 3 was produced from the same materials and by the same method except that the heat treating step was not performed after the tape-wrapped wire was wound into the form of a guidewire. An additional outer tape-wrapped covering was then applied with the same tape and method described in Example 1. After application of the second tape-wrapped covering, the guidewire was heat treated for 60 seconds in an oven set at 380C. After removal from the oven and cooling to room ;
temperature, this guidewire was subjected to repeated bending and `
flexing in order to compare its handling with another comparative guidewire made from the same wire wound to the same dimenslons but not having any tape-wrapped coverings. It was found that the comparative guidewire was slightly more flexible but the tape-wrapped guidewire ''.,'''' .~ -,.
W O 91/15251 PCT/~ 3 still exhibited good flexibility and was therefore deemed suitable for functional use as a catheter guidewire.
, .
.:..
'-~ ' ' '.
..
'`, '' '' ';.
.' , ' .
' . ....
., .; :.; .
,' :.
,'', . ~ .
Claims (24)
1. A catheter guidewire device comprising at least one length of helically wound wire having a covering of a fluoropolymer tape.
2. A catheter guidewire device according to claim 1 wherein the fluoropolymer tape is fluorinated ethylene propylene.
3. A catheter guidewire device according to claim 1 wherein the fluoropolymer tape is polytetrafluoroethylene.
4. A catheter guidewire device according to claim 3 wherein the fluoropolymer tape is porous polytetrafluoroethylene.
5. A catheter guidewire device according to claim 4 wherein the porous polytetrafluoroethylene tape is impregnated with a chemical.
6. A catheter guidewire device according to claim 1 wherein the guidewire has an outer surface and the fluoropolymer tape is helically wrapped around the guidewire outer surface.
7. A catheter guidewire device according to claim 1 wherein the guidewire has an outer surface and the fluoropolymer tape is longitudinally wrapped around the guidewire outer surface in the fashion of a cigarette wrap.
8. A catheter guidewire device according to claim 1 wherein the wire has a circumferential surface and the tape is wrapped around the wire circumferential surface prior to the wire being helically wound to form the guidewire.
9. A catheter guidewire device according to claim 8 wherein the guidewire has an outer surface and has an additional fluoropolymer covering applied around the guidewire outer surface.
10. A catheter guidewire device comprising a length of helically wound wire and an axially oriented safety wire within the helically wound wire, said safety wire having a covering of fluoropolymer tape.
11. A catheter guidewire device according to claim 1 that is a biopsy sample retrieval cable.
12. A catheter guidewire device according to claim 1 that is an ultrasound driveshaft.
13. A catheter guidewire device according to claim 1 wherein said covering is water-tight.
14. A catheter guidewire device comprising a helically wound wire having a covering of a fluoropolymer tape wherein said tape has edges and said edges are oriented helically around said helically wound wire.
15. A catheter guidewire device comprising a helically wound wire having a longitudinal axis and having a covering of a fluoropolymer tape wherein said tape has edges and said edges are oriented longitudinally and parallel to the longitudinal axis of said helically wound wire.
16. The process comprising tape-wrapping a catheter guidewire device with a fluoropolymer tape.
17. The process of claim 16 wherein the tape is helically wrapped around the guidewire device.
18. The process of claim 16 wherein the tape is longitudinally wrapped around the guidewire device in the fashion of a cigarette wrap.
19. The process of claim 16 further comprising heat treating the tape-wrapped catheter guidewire device to melt-bond said tape.
20. The process of claim 16 wherein the fluoropolymer tape is fluorinated ethylene propylene.
21. The process of claim 16 wherein the fluoropolymer tape is polytetrafluoroethylene.
22. The process of claim 21 wherein the polytetrafluoroethylene tape is porous polytetrafluoroethylene.
23. The process comprising tape-wrapping a fluoropolymer tape around a wire and helically winding said wire to form a catheter guidewire device.
24. The process of claim 23 further comprising tape-wrapping a fluoropolymer tape around said catheter guidewire device.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US503,189 | 1990-04-02 | ||
US07/503,189 US5107852A (en) | 1990-04-02 | 1990-04-02 | Catheter guidewire device having a covering of fluoropolymer tape |
Publications (1)
Publication Number | Publication Date |
---|---|
CA2083593A1 true CA2083593A1 (en) | 1991-10-03 |
Family
ID=24001082
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002083593A Abandoned CA2083593A1 (en) | 1990-04-02 | 1991-03-15 | Catheter guidewire device having a covering of fluoropolymer tape |
Country Status (4)
Country | Link |
---|---|
US (1) | US5107852A (en) |
EP (1) | EP0523088A1 (en) |
CA (1) | CA2083593A1 (en) |
WO (1) | WO1991015251A1 (en) |
Families Citing this family (92)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DK146790D0 (en) * | 1990-06-15 | 1990-06-15 | Meadox Surgimed As | PROCEDURE FOR THE PREPARATION OF A FERTILIZER COATING COATING AND MEDICAL INSTRUMENT WITH COATING COATING |
CA2073750C (en) * | 1991-07-18 | 1996-11-12 | Toshiaki Yutori | Catheter guide wire and catheter |
CA2117088A1 (en) * | 1991-09-05 | 1993-03-18 | David R. Holmes | Flexible tubular device for use in medical applications |
US5290230A (en) * | 1992-05-11 | 1994-03-01 | Advanced Cardiovascular Systems, Inc. | Intraluminal catheter with a composite shaft |
JPH0767895A (en) * | 1993-06-25 | 1995-03-14 | Sumitomo Electric Ind Ltd | Antimicrobial artificial blood vessel and suture yarn for antimicrobial operation |
US6025044A (en) | 1993-08-18 | 2000-02-15 | W. L. Gore & Associates, Inc. | Thin-wall polytetrafluoroethylene tube |
US6027779A (en) * | 1993-08-18 | 2000-02-22 | W. L. Gore & Associates, Inc. | Thin-wall polytetrafluoroethylene tube |
US5735892A (en) * | 1993-08-18 | 1998-04-07 | W. L. Gore & Associates, Inc. | Intraluminal stent graft |
CA2169549C (en) * | 1993-08-18 | 2000-07-11 | James D. Lewis | A tubular intraluminal graft |
US6159565A (en) * | 1993-08-18 | 2000-12-12 | W. L. Gore & Associates, Inc. | Thin-wall intraluminal graft |
US5405338A (en) * | 1993-08-19 | 1995-04-11 | Cordis Corporation | Helically wound catheters |
US5404887A (en) * | 1993-11-04 | 1995-04-11 | Scimed Life Systems, Inc. | Guide wire having an unsmooth exterior surface |
US5454795A (en) * | 1994-06-27 | 1995-10-03 | Target Therapeutics, Inc. | Kink-free spiral-wound catheter |
US5622184A (en) * | 1994-11-29 | 1997-04-22 | Applied Medical Resources Corporation | Guidewire and method of manufacture |
US6231600B1 (en) | 1995-02-22 | 2001-05-15 | Scimed Life Systems, Inc. | Stents with hybrid coating for medical devices |
US5702754A (en) * | 1995-02-22 | 1997-12-30 | Meadox Medicals, Inc. | Method of providing a substrate with a hydrophilic coating and substrates, particularly medical devices, provided with such coatings |
US6558798B2 (en) | 1995-02-22 | 2003-05-06 | Scimed Life Systems, Inc. | Hydrophilic coating and substrates coated therewith having enhanced durability and lubricity |
US6468649B1 (en) | 1995-02-22 | 2002-10-22 | Scimed Life Systems, Inc. | Antimicrobial adhesion surface |
US5724989A (en) * | 1995-06-20 | 1998-03-10 | The Microspring Company, Inc. | Radiopaque medical devices |
US5722424A (en) * | 1995-09-29 | 1998-03-03 | Target Therapeutics, Inc. | Multi-coating stainless steel guidewire |
US5830155A (en) * | 1995-10-27 | 1998-11-03 | Cordis Corporation | Guidewire assembly |
US5883319A (en) * | 1995-11-22 | 1999-03-16 | W.L. Gore & Associates, Inc. | Strings for musical instruments |
US5907113A (en) * | 1995-11-22 | 1999-05-25 | W. L. Gore & Associates, Inc. | Strings for musical instruments |
US6852075B1 (en) * | 1996-02-20 | 2005-02-08 | Cardiothoracic Systems, Inc. | Surgical devices for imposing a negative pressure to stabilize cardiac tissue during surgery |
DE19648246A1 (en) * | 1996-11-21 | 1998-05-28 | Daum Gmbh | Vena cava catheter device for use with nuclear spin equipment |
US6258080B1 (en) | 1997-07-01 | 2001-07-10 | Target Therapeutics, Inc. | Kink-free spiral-wound catheter |
US6824550B1 (en) | 2000-04-06 | 2004-11-30 | Norbon Medical, Inc. | Guidewire for crossing occlusions or stenosis |
US9254143B2 (en) | 1998-02-25 | 2016-02-09 | Revascular Therapeutics, Inc. | Guidewire for crossing occlusions or stenoses having a shapeable distal end |
US6746422B1 (en) | 2000-08-23 | 2004-06-08 | Norborn Medical, Inc. | Steerable support system with external ribs/slots that taper |
US6059767A (en) * | 1998-02-25 | 2000-05-09 | Norborn Medical, Inc. | Steerable unitary infusion catheter/guide wire incorporating detachable infusion port assembly |
US6139511A (en) * | 1998-06-29 | 2000-10-31 | Advanced Cardiovascular Systems, Inc. | Guidewire with variable coil configuration |
US7018401B1 (en) | 1999-02-01 | 2006-03-28 | Board Of Regents, The University Of Texas System | Woven intravascular devices and methods for making the same and apparatus for delivery of the same |
US6258121B1 (en) | 1999-07-02 | 2001-07-10 | Scimed Life Systems, Inc. | Stent coating |
US6203534B1 (en) | 1999-08-10 | 2001-03-20 | Biosense Webster, Inc. | Catheter with protective covering |
US7381198B2 (en) | 2000-08-23 | 2008-06-03 | Revascular Therapeutics, Inc. | Steerable distal support system |
WO2002015958A2 (en) | 2000-08-24 | 2002-02-28 | Corazon Technologies, Inc. | Fluid delivery systems for delivering fluids to multi-lumen catheters |
US6652574B1 (en) | 2000-09-28 | 2003-11-25 | Vascular Concepts Holdings Limited | Product and process for manufacturing a wire stent coated with a biocompatible fluoropolymer |
US7097624B2 (en) * | 2000-10-05 | 2006-08-29 | Scimed Life Systems, Inc. | Multi-layer and multi-section coils for guide wire |
US6669652B2 (en) * | 2000-12-21 | 2003-12-30 | Advanced Cardiovascular Systems, Inc. | Guidewire with tapered distal coil |
US7201940B1 (en) | 2001-06-12 | 2007-04-10 | Advanced Cardiovascular Systems, Inc. | Method and apparatus for thermal spray processing of medical devices |
US7247313B2 (en) | 2001-06-27 | 2007-07-24 | Advanced Cardiovascular Systems, Inc. | Polyacrylates coatings for implantable medical devices |
US20030073961A1 (en) * | 2001-09-28 | 2003-04-17 | Happ Dorrie M. | Medical device containing light-protected therapeutic agent and a method for fabricating thereof |
US6765136B2 (en) * | 2002-01-16 | 2004-07-20 | Gibson Guitar Corp. | Hydrophobic polymer string treatment |
US7217426B1 (en) | 2002-06-21 | 2007-05-15 | Advanced Cardiovascular Systems, Inc. | Coatings containing polycationic peptides for cardiovascular therapy |
US7005137B1 (en) | 2002-06-21 | 2006-02-28 | Advanceed Cardiovascular Systems, Inc. | Coating for implantable medical devices |
US7396539B1 (en) | 2002-06-21 | 2008-07-08 | Advanced Cardiovascular Systems, Inc. | Stent coatings with engineered drug release rate |
US7491233B1 (en) | 2002-07-19 | 2009-02-17 | Advanced Cardiovascular Systems Inc. | Purified polymers for coatings of implantable medical devices |
US20040063805A1 (en) * | 2002-09-19 | 2004-04-01 | Pacetti Stephen D. | Coatings for implantable medical devices and methods for fabrication thereof |
JP3822549B2 (en) * | 2002-09-26 | 2006-09-20 | 富士通株式会社 | Wiring board |
US9433745B2 (en) * | 2003-01-17 | 2016-09-06 | W.L. Gore & Associates, Inc. | Puncturing tool for puncturing catheter shafts |
US7625337B2 (en) * | 2003-01-17 | 2009-12-01 | Gore Enterprise Holdings, Inc. | Catheter assembly |
US8016752B2 (en) * | 2003-01-17 | 2011-09-13 | Gore Enterprise Holdings, Inc. | Puncturable catheter |
US8791171B2 (en) * | 2003-05-01 | 2014-07-29 | Abbott Cardiovascular Systems Inc. | Biodegradable coatings for implantable medical devices |
US7563454B1 (en) | 2003-05-01 | 2009-07-21 | Advanced Cardiovascular Systems, Inc. | Coatings for implantable medical devices |
US7641621B2 (en) * | 2003-08-25 | 2010-01-05 | Boston Scientific Scimed, Inc. | Elongated intra-lumenal medical device |
US8613712B1 (en) * | 2003-09-16 | 2013-12-24 | Abbott Cardiovascular Systems Inc. | Textured polymer coated guide wire and method of manufacture |
US7217876B2 (en) * | 2003-11-14 | 2007-05-15 | Gore Enterprise Holdings, Inc. | Strings for musical instruments |
JP4699391B2 (en) | 2004-01-09 | 2011-06-08 | コラゾン テクノロジーズ インコーポレーティッド | Multi-lumen catheter and method of use |
US7244443B2 (en) | 2004-08-31 | 2007-07-17 | Advanced Cardiovascular Systems, Inc. | Polymers of fluorinated monomers and hydrophilic monomers |
US20060047224A1 (en) * | 2004-09-01 | 2006-03-02 | Ryan Grandfield | Polymer coated guide wire |
US7666217B2 (en) * | 2004-10-29 | 2010-02-23 | Boston Scientific Scimed, Inc. | Implantable medical endoprosthesis delivery systems and related components |
DE102005007596A1 (en) * | 2005-02-18 | 2006-08-24 | Breeze Medical, Inc., Boca Raton | Coating, manufacturing method and method for applying a coating to a medical instrument and medical instrument |
US7828832B2 (en) * | 2005-04-18 | 2010-11-09 | Medtronic Vascular, Inc. | Intravascular deployment device with improved deployment capability |
US9101949B2 (en) * | 2005-08-04 | 2015-08-11 | Eilaz Babaev | Ultrasonic atomization and/or seperation system |
US20070031611A1 (en) * | 2005-08-04 | 2007-02-08 | Babaev Eilaz P | Ultrasound medical stent coating method and device |
US7896539B2 (en) * | 2005-08-16 | 2011-03-01 | Bacoustics, Llc | Ultrasound apparatus and methods for mixing liquids and coating stents |
US7972361B2 (en) * | 2006-06-19 | 2011-07-05 | Cardia, Inc. | Occlusion device with flexible spring connector |
US9028859B2 (en) | 2006-07-07 | 2015-05-12 | Advanced Cardiovascular Systems, Inc. | Phase-separated block copolymer coatings for implantable medical devices |
CA2667318C (en) | 2006-10-22 | 2016-09-13 | Idev Technologies, Inc. | Methods for securing strand ends and the resulting devices |
KR101659197B1 (en) | 2006-10-22 | 2016-09-22 | 이데브 테크놀로지스, 아이엔씨. | Devices and methods for stent advancement |
US20080142616A1 (en) * | 2006-12-15 | 2008-06-19 | Bacoustics Llc | Method of Producing a Directed Spray |
US8221860B2 (en) * | 2007-05-04 | 2012-07-17 | Personics Holdings Inc. | Earguard sealing system I: multi-chamber systems |
US7780095B2 (en) | 2007-07-13 | 2010-08-24 | Bacoustics, Llc | Ultrasound pumping apparatus |
US7753285B2 (en) | 2007-07-13 | 2010-07-13 | Bacoustics, Llc | Echoing ultrasound atomization and/or mixing system |
US7811623B2 (en) * | 2007-12-21 | 2010-10-12 | Innovatech, Llc | Marked precoated medical device and method of manufacturing same |
US8048471B2 (en) * | 2007-12-21 | 2011-11-01 | Innovatech, Llc | Marked precoated medical device and method of manufacturing same |
US8231927B2 (en) * | 2007-12-21 | 2012-07-31 | Innovatech, Llc | Marked precoated medical device and method of manufacturing same |
US8231926B2 (en) | 2007-12-21 | 2012-07-31 | Innovatech, Llc | Marked precoated medical device and method of manufacturing same |
US7714217B2 (en) | 2007-12-21 | 2010-05-11 | Innovatech, Llc | Marked precoated strings and method of manufacturing same |
US7871414B2 (en) * | 2007-12-28 | 2011-01-18 | Wilson-Cook Medical Inc. | Loop tip wire guide with outer sleeve |
US8657821B2 (en) | 2008-11-14 | 2014-02-25 | Revascular Therapeutics Inc. | Method and system for reversibly controlled drilling of luminal occlusions |
US8162891B2 (en) * | 2008-11-26 | 2012-04-24 | Revascular Therapeutics, Inc. | Delivery and exchange catheter for storing guidewire |
US20110008600A1 (en) * | 2008-12-29 | 2011-01-13 | Walsh Edward D | Chemical barrier lamination and method |
JP5411533B2 (en) * | 2009-03-09 | 2014-02-12 | テルモ株式会社 | Guide wire |
US9023095B2 (en) | 2010-05-27 | 2015-05-05 | Idev Technologies, Inc. | Stent delivery system with pusher assembly |
BR112012032039B1 (en) | 2010-06-14 | 2020-12-15 | Maquet Cardiovascular Llc | CIRURGICAL INSTRUMENTS |
US8900652B1 (en) | 2011-03-14 | 2014-12-02 | Innovatech, Llc | Marked fluoropolymer surfaces and method of manufacturing same |
EP3408093B1 (en) | 2016-01-28 | 2023-08-02 | Rogers Corporation | Fluoropolymer composite film wrapped wires and cables |
CN108064179B (en) * | 2016-09-05 | 2020-10-30 | 朝日英达科株式会社 | Guide wire |
CA3095450A1 (en) * | 2018-04-05 | 2019-10-10 | Royal Melbourne Institute Of Technology | Multi surface acoustic nebuliser |
US11504503B2 (en) * | 2019-04-05 | 2022-11-22 | Becton, Dickinson And Company | Vascular access instrument having a fluid permeable structure, and related devices and methods |
US20230135237A1 (en) * | 2021-04-16 | 2023-05-04 | Bard Peripheral Vascular, Inc. | Strength-adjustable guidewire |
Family Cites Families (17)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3223564A (en) * | 1962-01-22 | 1965-12-14 | Tensolite Insulated Wire Co In | Manufacture of polytetrafluoroethylene insulated wires |
US3711917A (en) * | 1969-08-18 | 1973-01-23 | North American Rockwell | Coated spring |
US3962153A (en) * | 1970-05-21 | 1976-06-08 | W. L. Gore & Associates, Inc. | Very highly stretched polytetrafluoroethylene and process therefor |
US3757768A (en) * | 1972-04-07 | 1973-09-11 | Medical Evaluation Devices And | Manipulable spring guide-catheter and tube for intravenous feeding |
US3922378A (en) * | 1972-08-04 | 1975-11-25 | Medical Evaluation Devices & I | Fluorinated hydrocarbon coating method |
US3841308A (en) * | 1973-10-15 | 1974-10-15 | Medical Evaluation Devices & I | Distally valved catheter device |
US4003369A (en) * | 1975-04-22 | 1977-01-18 | Medrad, Inc. | Angiographic guidewire with safety core wire |
US3973556A (en) * | 1975-06-20 | 1976-08-10 | Lake Region Manufacturing Company, Inc. | Smoothened coil spring wire guide |
US4534363A (en) * | 1982-04-29 | 1985-08-13 | Cordis Corporation | Coating for angiographic guidewire |
US4479835A (en) * | 1982-06-01 | 1984-10-30 | Automation Industries, Inc. | Apparatus and method for forming wire reinforced helically fabricated tubing |
US4536179A (en) * | 1982-09-24 | 1985-08-20 | University Of Minnesota | Implantable catheters with non-adherent contacting polymer surfaces |
US4456017A (en) * | 1982-11-22 | 1984-06-26 | Cordis Corporation | Coil spring guide with deflectable tip |
US4548206A (en) * | 1983-07-21 | 1985-10-22 | Cook, Incorporated | Catheter wire guide with movable mandril |
FR2582504A1 (en) * | 1985-06-04 | 1986-12-05 | Schintgen Jean Marie | IMPROVEMENTS ON BIOPSY CLAMPS |
SE450104B (en) * | 1985-10-18 | 1987-06-09 | Spirac Engineering Ab | DEVICE FOR COMPRESSING MATERIAL AND REDUCING ITS LIQUID CONTENT |
US4721117A (en) * | 1986-04-25 | 1988-01-26 | Advanced Cardiovascular Systems, Inc. | Torsionally stabilized guide wire with outer jacket |
US4676249A (en) * | 1986-05-19 | 1987-06-30 | Cordis Corporation | Multi-mode guidewire |
-
1990
- 1990-04-02 US US07/503,189 patent/US5107852A/en not_active Expired - Lifetime
-
1991
- 1991-03-15 CA CA002083593A patent/CA2083593A1/en not_active Abandoned
- 1991-03-15 EP EP91906664A patent/EP0523088A1/en not_active Ceased
- 1991-03-15 WO PCT/US1991/001770 patent/WO1991015251A1/en not_active Application Discontinuation
Also Published As
Publication number | Publication date |
---|---|
WO1991015251A1 (en) | 1991-10-17 |
EP0523088A1 (en) | 1993-01-20 |
US5107852A (en) | 1992-04-28 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
EEER | Examination request | ||
FZDE | Discontinued |