AU621548B2 - Creation of Inventions and Patents with Artificial Intelligence

AU621548B2 – Soft tip catheter
– Google Patents

AU621548B2 – Soft tip catheter
– Google Patents
Soft tip catheter

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Publication number
AU621548B2

AU621548B2
AU20674/88A
AU2067488A
AU621548B2
AU 621548 B2
AU621548 B2
AU 621548B2
AU 20674/88 A
AU20674/88 A
AU 20674/88A
AU 2067488 A
AU2067488 A
AU 2067488A
AU 621548 B2
AU621548 B2
AU 621548B2
Authority
AU
Australia
Prior art keywords
tip
catheter
distal end
jacket
core
Prior art date
1987-08-14
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.)

Ceased

Application number
AU20674/88A
Other versions

AU2067488A
(en

Inventor
Richard M. Demello
Robert J. Ham
Michael F. Lang
Gerry D. Ouellette
Andrea T. Slater
Frederick W. Trombley Iii
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)

CR Bard Inc

Original Assignee
CR Bard Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
1987-08-14
Filing date
1988-08-11
Publication date
1992-03-19

1988-08-11
Application filed by CR Bard Inc
filed
Critical
CR Bard Inc

1989-02-16
Publication of AU2067488A
publication
Critical
patent/AU2067488A/en

1992-03-19
Application granted
granted
Critical

1992-03-19
Publication of AU621548B2
publication
Critical
patent/AU621548B2/en

2008-08-11
Anticipated expiration
legal-status
Critical

Status
Ceased
legal-status
Critical
Current

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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

A61M25/0009—Making of catheters or other medical or surgical tubes

A61M25/001—Forming the tip of a catheter, e.g. bevelling process, join or taper

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

A61L29/04—Macromolecular materials

A61L29/041—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds

A—HUMAN NECESSITIES

A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE

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

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

A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips

A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure

A61M25/0069—Tip not integral with tube

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

A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips

A61M25/008—Strength or flexibility characteristics of the catheter tip

B—PERFORMING OPERATIONS; TRANSPORTING

B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL

B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING

B29C41/00—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor

B29C41/02—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor for making articles of definite length, i.e. discrete articles

B29C41/20—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor for making articles of definite length, i.e. discrete articles incorporating preformed parts or layers, e.g. moulding inserts or for coating articles

B—PERFORMING OPERATIONS; TRANSPORTING

B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL

B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING

B29C57/00—Shaping of tube ends, e.g. flanging, belling or closing; Apparatus therefor, e.g. collapsible mandrels

B—PERFORMING OPERATIONS; TRANSPORTING

B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL

B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING

B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor

B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure

B—PERFORMING OPERATIONS; TRANSPORTING

B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL

B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING

B29C66/00—General aspects of processes or apparatus for joining preformed parts

B29C66/01—General aspects dealing with the joint area or with the area to be joined

B29C66/05—Particular design of joint configurations

B29C66/10—Particular design of joint configurations particular design of the joint cross-sections

B29C66/11—Joint cross-sections comprising a single joint-segment, i.e. one of the parts to be joined comprising a single joint-segment in the joint cross-section

B29C66/114—Single butt joints

B29C66/1142—Single butt to butt joints

B—PERFORMING OPERATIONS; TRANSPORTING

B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL

B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING

B29C66/00—General aspects of processes or apparatus for joining preformed parts

B29C66/01—General aspects dealing with the joint area or with the area to be joined

B29C66/05—Particular design of joint configurations

B29C66/10—Particular design of joint configurations particular design of the joint cross-sections

B29C66/12—Joint cross-sections combining only two joint-segments; Tongue and groove joints; Tenon and mortise joints; Stepped joint cross-sections

B29C66/122—Joint cross-sections combining only two joint-segments, i.e. one of the parts to be joined comprising only two joint-segments in the joint cross-section

B29C66/1222—Joint cross-sections combining only two joint-segments, i.e. one of the parts to be joined comprising only two joint-segments in the joint cross-section comprising at least a lapped joint-segment

B—PERFORMING OPERATIONS; TRANSPORTING

B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL

B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING

B29C66/00—General aspects of processes or apparatus for joining preformed parts

B29C66/01—General aspects dealing with the joint area or with the area to be joined

B29C66/05—Particular design of joint configurations

B29C66/10—Particular design of joint configurations particular design of the joint cross-sections

B29C66/12—Joint cross-sections combining only two joint-segments; Tongue and groove joints; Tenon and mortise joints; Stepped joint cross-sections

B29C66/122—Joint cross-sections combining only two joint-segments, i.e. one of the parts to be joined comprising only two joint-segments in the joint cross-section

B29C66/1224—Joint cross-sections combining only two joint-segments, i.e. one of the parts to be joined comprising only two joint-segments in the joint cross-section comprising at least a butt joint-segment

B—PERFORMING OPERATIONS; TRANSPORTING

B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL

B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING

B29C66/00—General aspects of processes or apparatus for joining preformed parts

B29C66/50—General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles

B29C66/51—Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles

B29C66/53—Joining single elements to tubular articles, hollow articles or bars

B29C66/534—Joining single elements to open ends of tubular or hollow articles or to the ends of bars

B29C66/5344—Joining single elements to open ends of tubular or hollow articles or to the ends of bars said single elements being substantially annular, i.e. of finite length, e.g. joining flanges to tube ends

B—PERFORMING OPERATIONS; TRANSPORTING

B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL

B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING

B29C66/00—General aspects of processes or apparatus for joining preformed parts

B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material

B29C66/72—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined

B29C66/723—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered

B—PERFORMING OPERATIONS; TRANSPORTING

B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL

B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING

B29C70/00—Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts

B29C70/68—Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts by incorporating or moulding on preformed parts, e.g. inserts or layers, e.g. foam blocks

B29C70/74—Moulding material on a relatively small portion of the preformed part, e.g. outsert moulding

B29C70/76—Moulding on edges or extremities of the preformed part

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

A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips

A61M25/008—Strength or flexibility characteristics of the catheter tip

A61M2025/0081—Soft tip

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

A61M25/0009—Making of catheters or other medical or surgical tubes

A61M25/0012—Making of catheters or other medical or surgical tubes with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils

A—HUMAN NECESSITIES

A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE

A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR

A61M25/00—Catheters; Hollow probes

A61M25/0043—Catheters; Hollow probes characterised by structural features

A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids

A—HUMAN NECESSITIES

A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE

A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR

A61M25/00—Catheters; Hollow probes

A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters

A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning

A61M25/0108—Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers

B—PERFORMING OPERATIONS; TRANSPORTING

B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL

B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING

B29C2793/00—Shaping techniques involving a cutting or machining operation

B29C2793/0081—Shaping techniques involving a cutting or machining operation before shaping

B—PERFORMING OPERATIONS; TRANSPORTING

B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL

B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING

B29C41/00—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor

B29C41/14—Dipping a core

B—PERFORMING OPERATIONS; TRANSPORTING

B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL

B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING

B29C66/00—General aspects of processes or apparatus for joining preformed parts

B29C66/71—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the composition of the plastics material of the parts to be joined

B—PERFORMING OPERATIONS; TRANSPORTING

B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL

B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES

B29L2031/00—Other particular articles

B29L2031/753—Medical equipment; Accessories therefor

B29L2031/7542—Catheters

Description

T
‘I
A U s627I1A5 48 COMMONWEALTH OF PATENT ACT 1952 COMPLETE SPECI FICATION
(ORIGINAL)
FOR OFFICE USE Application Number: Lodged: Complete Specification Lodged: Accepted: Published: Priority: Related Art-: CLASS INT. CLASS 0 0 0 0 0o 000 C0 0 NAME OF APPLICANT: ADDRESS OF APPLICANT: C.R. BARD, INC.
731 Central Avenue Murray Hill New Jersey UNITED STATES OF AMERICA 07974 NAME(S) OF INVENTOR(S) RICHARD M. DeMELLO ROBERT J. HAM MICHAEL F. LANG GERRY D. OUELLETTE ANDREA T. SLATER FREDERICK W. TROMBLEY III ADDRESS FOR SERVICE: DAVIES COLLISON, Patent Attorneys I Little Collins Street, Melbourne, 3000.
‘I
1’ p COMPLETE SPECIFICATION FOR THE INVENTION ENTITLED: SOFT TIP CATHETER The following statemnent is a full description of this invention, including the best method of performing it known to us -1- B0410/7042 GLG/mc 8/14/87 9541B -la- SOFT TIP CATHETER
INTRODUCTION
a, This invention relates to catheters and more SVt particularly relates to guide catheters and their c 5 method of manufacture.
e Typical functions of a guide catheter are to e provide an access pathway for the delivery of a dilatation catheter to the coronary vasculature and on to act as a support for the dilatation catheter 10 during coronary angioplasty. To perform those o functions, the catheter must be capable of safely a o reaching the coronary ostium. Catheterization of 0 0 C the coronary arteries is a very delicate procedure which sometimes causes vascular trauma and/or creates embolisms with devastating consequences for the patient.
i The principal object of the present invention is “H to provide a qgdtA catheter with a soft tip so as to reduce the frequency of vascular complications.
S,0410/7042 GLG/mc 8/14/87 9541B PRIOR ART In U.S. patents Nos, 4,551,292 and 4,531,943 assigned to Angiomedics Corporation, a soft tip angiographic catheter and a method of manufacturing it are described. The angiographic catheter which is the subject matter of those patents has a soft Sdistal tip with a circumferential preferential fold line, which causes the tip to collapse in a predetermined fashion whenever the tip engages an obstruction. The circumferential preferential fold line is formed by a cylindrical wire having a protuberance of a predetermined shape, which is inserted into the distal end of the catheter body so as to expand the catheter material. The catheter material is heated with the cylindrical wire in S place to form the preferential fold line. This procedure provides the catheter with a bulbous tip at its distal end having a diameter which exceeds the diameter of the main tubular portion of the 0 C catheter. This construction has at least two disadvantages, namely, the enlarged tip makes it more difficult to insert the catheter into the blood vessel through the percutaneous introducer and it impedes blood flow around the catheter to the coronary arteries.
i i 4 1 SB0410/7042 GLG/mc 8/14/87 9541B ^i 3 Patent No. 4,636,346 dated January 13, 1987 and assigned to Cordis Corporation discloses a soft tipped guide catheter that includes a tubular body having an interior lubricious sheath, an intermediate, relatively stiff sheath and a flexible outer sheath, and a tip having an interior ,lubricious sheath and a flexible outer sheath made of the same material as the outer sheath of the tubular body. In one embodiment, the tip may 10 initially be formed as a separate member and then ‘affixed end to end to the tubular body by such cc techniques as heat, adhesive, etc. with the assistance of a shrink film. In another embodiment, i t the distal end of the body is ground down to remove j t 15 the intermediate and outer sheaths of the body, and the tip is slipped over the ground portion affixed Jl to it with the aid of heat, shrink film, adhesive, etc, In this form, the tip and tubular body share the same inner sheath, In a third embodiment, the tip is integrally extended with the inner and outer
C
V sheaths of the tubular body while the intermediate 0 c sheath is interrupted at the tip region, The tip softness in all these embodiments is essentially the same as the outer sheath of the body, and therefore the protection provided is limited. Furthermore, the tip material is not provided at its distal end with a substantial overlapping of the relatively B0410/7042 GLG/mc 8/14/87 9541B Sstiff core of the tubular body, and consequently the bonding of the tip to the body is not always effective.
In Cordis patent No. 4,596,563, a catheter with a flexible tip is described having a tubular body made up of a rigid inner sheath and a relatively flexible outer sheath. The flexible tip is formed by extending the outer sheath distally beyond the inner sheath. Like the ‘346 Cordis patent, supra, 10 the tip has the same hardness as the sheath or outer 9 t 1 I jacket of the tubular body.
o U.S. Patent No. 4,385,635 issued to Ruiz discloses an angiographic catheter having a main tubular body, an intermediate zone and a tip zone.
The main tubular body is reinforced with an inner ply of polyamide material which diminishes in I thickness through the intermediate zone to zero at the tip. As with the Cordis ‘563 patent, supra, the tip has the same softness as the jacket of the main tubular body portion.
i 2In the U.S. patent No. 4,563,181 assigned to Mallinckrodt, Inc., another soft tip intravascular catheter is shown wherein the tip made of a nylon blend is fused or welded at a butt-joint to the tubular body made of a different, stiffer nylon.
That type of connection, as mentioned above, is sometimes ineffective.
i Other U.S. patents showing catheters with soft tips are 4,464,176, 4,321,226, 4,282,876 and 3,890,976.
SUMMARY OF THE INVENTION The various embodiments of the invention have been designed to address some or all of the above disadvantages.
According to a first aspect of the invention there is provided a guide catheter comprising a main tubular body having a relatively hard wirebraided Teflon core and a polyurethane outer jacket, said body having proximal and distal ends, said distal end of the body having an end portion of reduced outer diameter, and a polyurethane tip having a proximal end overlapping the reduced diameter end portion of the body and extending distally beyond the distal end of the core, the material of the tip being softer than the material of the outer jacket.
According to a second aspect of the invention there is provided an intravascular catheter comprising a main tubular body having a relatively stiff core and a smooth outer jacket, said core extending distally beyond the end of the jacket, and a tip made of a material which is softer than the material of the jacket secured to and overlapping the distal end of the core and secured to the distal end of the jacket, said tip extending distally beyond the distal end of the core.
In a third aspect the invention provides an intravascular catheter comprising a main tubular body having distal and proximal ends, a step provided at the distal end of the body forming a section of reduced outer diameter extending to the distal end of the body, and a tip made of a material which is softer than the material of the body, secured to and overlapping the t911012wpftdisk45,20674.spe,5 r -6section of reduced diameter and secured to the step in the body, said tip extending distally beyond the end of the body and having an outer diameter equal to the diameter of the body immediately proximal to the step and having an inner diameter equal to the inner diameter of the body immediately distal to the step.
In accordance with the present invention, the soft tip catheter has no preferential fold line, and in a preferred embodiment its outer diameter at the tip does not exceed the outer diameter of the main body of the guide catheter. Rather, the catheter of this embodiment of the present invention has essentially a uniform outer diameter throughout its axial extent. Consequently, the tip of the catheter will pass through the introducer with the same facility as the main body of the catheter, and the catheter tip will not obstruct the blood flow around the catheter to the coronary arteries. Furthermore, if the inner diameter of the tip is not less than the inner diameter of the tubular body it will not interfere with insertion of the dilatation catheter through it.
In accordance with the preferred embodiment of the present invention, the main body of the guide catheter has a reduced outer diameter at its distal end, and a soft polyurethane tip is mounted on the end portion of reduced diameter. The soft tip overlaps the distal end for approximately two millimeters and extends distally approximately two millimeters beyond the main body. In the preferred embodiment, the tip is separately fabricated as a soft polyurethane tube and attached to the main body, and the tip is then shaped in a place as part of the assembly. The tip may be developed by repeated dipping of the distal end of the main body into a semi-viscous slurry of the soft polyurethane. The reduced diameter distal end of the main body may be placed in a female mold whose cavity has been machined to the desired tip configuration. Soft polyurethane is pLI injected into the cavity so as to mold the tip onto the 9110 fd 45,274.spe,6 0c~i 911oZwpfdisk452O674.spe,6
I
-7body of the catheter.
The preferred embodiment of the present invention is made up of a main body composed of a polyurethane outer jacket laminated onto a wire-braided teflon core.
Approximately two millimeters of the outer jacket at the distal end are stripped from the core, which forms a shoulder proximally of the end of the core, and a marker bank is placed about the core against the shoulder. A soft polyurethane tube is forced over the core and may abut against the shoulder at the distal end of the jacket and overlie the marker band. A stepped mandrel is then inserted into the distal end of the assembled soft polyurethane tube and relatively stiff core with the step in the mandrel abutting the distal end of the soft polyurethane tube. A tubular shrink film is next placed over the soft polyurethane tube and the distal end of the jacket and overlies the region where the two are to be bonded. The assembly is then heated for a time and temperature sufficient to cause the soft polyurethane tube to fill the gaps about the marker band and any other gaps which may exist at the bonding area and about the mandrel so that the inner diameter of the tube conforms to the mandrel surface. The mandrel and the shrink tube are thereafter removed, the outer diameter of the assembled guide catheter may be ground smooth and the assembly may be provided with an antithrombogenic coating. Finally, the tip may be ground again so as to remove any coating which covers approximately the last two millimeters of the tip so as to preserve its soft character. The substantial overlap of the tip material on the core assures the formation of a sound bond between the body and tip.
The invention further provides a method of making an intravascular catheter comprising the steps of providing a main tubular body having a wire-braided Score and softer outer jacket, 911012wpftdisk4,20674.spe,7 r- -7aremoving the jacket from the distal end of the body, providing a tubular tip of a material softer than the jacket and forcing its proximal end over the distal end of the body where the jacket has been removed and with the distal end of the tip extending distally beyond the distal end of the body, and securing the tubular tip in position.
Furthermore, the invention provides a method of making an intravascular catheter comprising the steps of providing a main tubular body with a step at its distal end to establish a distal section of reduced outer diameter, providing a tubular tip of a material softer than the body and having an outer diameter equal to inner diameter of the body immediately distal to the step and overlapping its proximal end onto the section of reduced diameter, a portion of the tubular tip extending beyond the distal end of the section of reduced diameter and securing the tip to the body in the overlapped position to thereby provide a catheter having a uniform inner and outer diameter throughout a distal end portion.
These and other objects and features of the present invention will be better understood and appreciated from the following detailed description i9 0 i: 91101L,upftdisk45,20674.spe,8 -0i 0 B0410/7042 GLG/mc 8/14/87 9541B 8 i of several embodiments thereof, selected for purposes of illustration and shown in the accompanying drawings, SBRIEF FIGURE DESCRIPTION cc c :C 5 FIG. 1 is a fragmentary view, partly in section showing the preferred embodiment of a guide catheter with a soft tip, constructed in accordance with this C C invention; and FIGS. 2A-2I are fragmentary cross-sectional views diagrammatically illustrating the sequence of steps for manufacturing the soft tip guide catheter of FIG. 1, in accordance with the present invention.
C C DETAILED DESCRIPTION C C The catheter shown in FIG, 1 includes an elongated tubular body 10 and a soft tip 12 bonded “c to In the region where the body 10 and tip 12 c^ are bonded together, a precious metal marker band 14 is provided which serves as a radiopaque identifier.
The tubular body 10 typically may be made up of a wire-braided Teflon core 16 and a polyurethane outer jacket 18 bonded together at their interface by an epoxy 20. (Teflon is a trademark of and is S11.41 p /\Ii I B0410/7042 GLG/mc 8/14/87 9541B -9available from E.I. duPont de Nemours Co., Inc.) This catheter body construction is well-known in the ineto. Tewr-rie lncrindustry and is not per se the subject of this jacket laminate is currently used in guide catheters sold by C.R. Bard, Inc., the assignee of this application. While that particular body construction is particularly suitable for use C C C C C with guide catheters because of its ability to transmit torque, its stiffness, and other CC characteristics, it should be understood that the catheter tubular body may be made of other materials and be uniform throughout its cross-section. The t CCT Durometer of the polyurethane jacket 18 in the 15 example given is approximately 55D while the much
C
softer polyurethane tip 12, on the other -hand, Q CC C Cpreferably has a Durometer of approximiately Radii are formed in the tip at the inner and outer diameters as suggested at 22 and 24 to further reduce the likelihood of vascular trauma as the catheter passes through the blood vessels.
J r Preferably, the catheter assembly is provided with an antithrombogenic coating as suggested at However, to preserve the softness of the tip, any coating which may have been applied to the last two millimeters of the tip at its distal end should be removed. In the tubular body described above, B0410/7042 GLG/mc 8/14/87 9541B 10 typically the various thicknesses of the layers may be approximately as follows: Teflon layer 17, .002″; epoxy 20, .0005″; urethane jacket 18, .012″ and coating 25, .0015″. Its length is approximately 40″. In one size guide catheter, the inner and outer diameters of the tubular body are t approximately .072 and .104 inch.
*The outer diameter of the guide catheter shown in FIG. 1 is uniform throughout its length. That c 10 is, the outer diameter of the tip 12 is essentially re C the same as the other diameter of the tubular body of the guide catheter. Consequently, it is no harder to introduce the tip 12 through an introducer c” (not shown) to insert the guide catheter into a patient’s blood vessel than it is to project the tubular body 10 through it, and when the guide ece catheter is in place in the vessel, the tip does not increase the impedence to blood flow about the catheter body.
C 0cc 20 In FIGS. 2A-2I, the method of making the C.,tt catheter shown in FIG. 1 is suggested. In FIG. 2A, the laminate composed of the polyurethane outer jacket 18 and the wire-braided Teflon core 16 is shown. The jacket has a Durometer reading of approximately 55D. The tubular body 10 of the guide catheter normally is approximately 40 inches in length and the wire braid about the Teflon layer 17 NLL4 i P J J
E
r 1 1 __1 B0410/7042 GLG/mc 8/14/87 9541B 11 terminates several inches from the distal end. As stated, the material is widely used in catheters for angioplasty, arteriography, etc. sold by C.R. Bard, Inc. It is ordinarily provided with a antithrombogenic coating 25 on the surface 26, and e the distal end 28 is capable of being formed into a variety of curved shapes by heating and then cooling Q 0 the material. The absence of the wire braid at the end facilitates the shaping of the curved end. The 10 body 10 is capable of monitoring intravascular pressures and may be used to deliver constrast agents for vessel opacification as well as for the delivery of balloon dilatation catheters used in angioplasty, 15 In FIG. 2B, at approximately two millimeters from the distal end 28, the catheter tubular body *a is shown skived at 10, which enables the section 32 of the polyurethane jacket 18 and the epoxy beyond the wire braid to be stripped from the core 16.
20 FIG. 2C illustrates the body 10 with the section 32 o.o removed. The removal of section 32 reduces the diameter of the body 10 at the distal end and forms a shoulder 34 at the distal end of the jacket 18 extending radially from the surface 36 of the core 16.
FIG. 2D shows the marker band 14 disposed on the surface 36 of the core 16 and abutting the shoulder B01/74 GLG/mc 8/14/87 9541B 12 34, The band 14 serves as a radiopaque identifier to assist the physician in placing the distal end of the catheter at the desired location within the patient’s blood vessel. Typically, the band may be made of a precious metal such as gold, platinum, etc. and have a wall thickness of approximately .002 and be approximately one millimeter in length.
*00After the marker band 14 is applied, a soft polyurethane tube 40 approximately four millimeters 10 long and from which the soft tip 12 is formed, is forced over the reduced diameter distal end of the main body 10 so that its proximal end 42 abuts against the shoulder 34. While this position is ~.illustrated in FIG. 2E, it is to be understood that 4:4: 4 15 the polyurethane tube 40 may be forced onto the distal end of the main body 10 with a slight gap @0 between the shoulder 34 and the proximal end of the tube to allow the polyurethane material of the tube to flow when the assembly is heated in a later step in the manufacture of the catheter. The tube extends approximately two millimeters beyond the distal end 44 of the core 16, and the proximal end 42 of the tube 40 overlaps the marker 14. In FIG.
2E, a gap 46 is suggested between inner surface of the tube 40 and the outer surface 36 of the core immediately adjacent the marker 14, As is evident from an inspection of FIG. 1, that gap is also B0410/7042 GLG/mc 8/14/87 9541B 13 filled during the heating step in the manufacture of the catheter.
FIG. 2F illustrates the next step in the manufacturing process wherein a mandrel 50 having a section 52 with an outer diameter which essentially matches the inner the diameter of the core 16 is inserted through the tube 40 and into the core 16 so as to extend proximally at least to and preferably beyond the shoulder 34, The mandrel also has an r 10 enlarged portion 56 and a shoulder 58. A radius is shown joining the surface 54 and the shoulder 58 of the mandrel section 52. The mandrel is inserted into the distal end of the main body 10 and tube until the shoulder 58 engages the distal end 62 of .15 the tube. The mandrel extends proximally beyond the bonding area between the tube 40 and the body H r’ After the mandrel is inserted as shown in FIG.
2F, a sleeve of shrink film 64 is placed over the polyurethane tube 40 and the distal end of the jacket 18 and overlaps the shoulder 34. With the sleeve of shrink film 64 in placed as shown in FIG.
ji 2G, the distal end of the assembly is heated to a temperature and for a time sufficient to cause the soft polyurethane tube 40 to fluw and fill the gap 46 along with any other gaps which may exist between it and the shoulder 34, outer surface 36 of the core 16, and the outer surface 54 of the mandrel 50. The Ii B0410/7042 GLG/mc 8/14/87 9541B 14 time and temperature is a function of the particular polyurethane used. With one material tested, the temperature was approximately 320° for a duration of approximately five minutes, The tube 40 as a result assumes the shape shown in FIG. 2H and includes the t’F radius 22 at the inner diameter of the tube 40 at Io the distal end 62. The film 64 as it shrinks under C t, the application of heat will somewhat compress the polyurethane and cause it to conform closely to the contours of the mandrel 50. After the assembly cools, the mandrel 50 may be removed and the shrink film 64 should be stripped from the assembly. The assembled body 10, tube 40 and marker 14 are then generally configured as illustrated in FIG, 2H.
Next, the distal end of the tube 40 at the outer diameter should be ground to form the radius 24 as shown in FIG. 21. The entire outer diameter of the assembly may then be ground to smooth the outer :ctI surface of the catheter throughout its length.
20 Thereafter, a coating of antithrombogenic material may be applied to the outer surface. The coating should be removed from the distal end of the tiD 12 for an axial distance of approximately two millimeters particularly if the coating increases the stiffness of the tip 12.
As suggested above, while the soft polyurethane tip in the preferred embodiment is applied as
I
B0410/7042 GLG/mc 8/14/87 9541B 15 a~, ;ooc o@ o Jo a f o 0 4 o a ooot iooo° ooo( 0 a ao o S6 0 S0o or 4o 0 0 0 S e oosc 00C o e 0 0 o 0 0 described by forcing a tube of the material over the stepped distal end of the main body of the catheter, the tip may be formed by other techniques. For example, the tip may be formed by applying 5 successive coatings of soft polyurethane over the stepped distal end of the tubular body 10 with the body prepared as illustrated in FIGS. 2A-2C. This may be accomplished by forming a slurry of polyurethane composed of approximately 12% by weight 10 of the polyurethane and 82% of a polyurethane solvent such as tetrahydrofurane (THF). With the solution at room temperature, the distal end of the body may be inserted to the depth of the shoulder 34 for a period of approximately one second and thereafter, be removed for a period of six to ten minutes to permit the slurry to partially dry. The rate at which the tip is removed from the slurry will determine the thickness of the application of the coating. The faster the tip is removed, the 20 thicker the layer of coating which will be applied to the main body. This dipping procedure may be repeated several times (seven times in a test conducted by applicants) so as to achieve sufficient thickness for the tip. Because the material applied in this fashion shrinks significantly during the first 24 hours, it may be desirable to build up a coating or tip thickness which exceeds the diameter L’ 7 B0410/7042 GLG/mc 8/14/87 9541B 16 of the main body. The finishing of the manufacture in accordance with this method includes forming radii at the inner and outer diameters of the tiD at the distal end.
In accordance with yet another method of manufacturing the soft tip guide catheter, the a. stepped distal end of the body prepared as shown in ,0 FIGS. 2A-2C may be inserted into a mold cavity and liquid soft polyurethane forced into the cavity.
The cavity of the mold should be machined to the desired tip configuration. After the distal end of the body is placed in position in the cavity, the soft polyurethane is injected into the cavity under heat and pressure, and the material fuses to the stepped end. This manufacturing technique results in a unified shaft-soft tip product. The radii at the inner and outer diameters of the tip may be formed during the molding step so as to eliminate an additional manufacturing operation.
20 In the foregoing description, the invention has been described in terms of a guide catheter having a laminated main body composed of a polyurethane outer jacket and a wire-braided Teflon core. It will be appreciated that the tubular body may be uniform throughout its cross-section, and may be made of a variety of different materials. It should also be j appreciated that the invention may be embodied in i i B0410/7042 GLG/mc 8/14/87 9541B 17 catheters of a variety of different sizes, and the invention will be beneficial in all those applications where vascular trauma or the creation of embolisms is of concern. In accordance with this invention, the last few Smillimeters of tip (two millimeters in the S, embodiment described)are very soft to form a bumper c C t< to protect the patient. The very soft region is C'Cj "confined to the tip so as not to interfere with placement of the catheter in the blood vessels or interfere with its ability to support the dilatation catheter. If the soft material extended back from St the tip over the curved end, the catheter would buckle or otherwise distort when being inserted into the system and would not support a dilatation Scatheter. It will also be appreciated that the scope of the invention is not confined to the specific c embodiments illustrated and described herein. 20 Rather, it is the intention of applicants that the scope of this invention be determined by the appended claims and their equivalents. I A N Claims (23) 1. A guide catheter comprising a main tubular body having a relatively hard wire- braided Teflon core and a polyurethane outer jacket, said body having proximal and distal ends, said distal end of the body having an end portion of reduced outer diameter, and a polyurethane tip having a proximal end overlapping the reduced diameter end portion of the body and extending distally beyond the distal end of the core, the material of the tip being softer than the material of the outer jacket. 2. A guide catheter as defined in claim 1 wherein the outer diameter of the end portion is reduced by the absence of the polyurethane outer jacket from the core. 3. A guide catheter as defined in claim 1 wherein the relatively soft polyurethane tip includes a plurality of layers deposited one on top of another. 4. A guide catheter as defined in claim 2 wherein the relatively soft polyurethane tip includes a plurality of layers deposited one on top of another. A guide catheter as defined in claim 1 wherein the relatively soft polyurethane tip is injection molded over the end portion of the body. 6. A guide catheter as defined in claim 2 wherein the relatively soft polyurethane tip is injection molded over the end portion of the body. 41 nl wiz9110lZwpftdsk45.20674.spe,18 S19- 7. A guide catheter as defined in any one of claim 1-6 wherein the tip overlaps the distal end of the body by approximately two millimeters. 8. A guide catheter as defined in any one of claims 1-7 wherein the tip extends distally approximately two millimeters beyond the distal end of the core. 9. An intravascular catheter comprising a main tubular body having a relatively stiff core and a smooth outer jacket, said core extending distally beyond the end of the jacket, and a tip made of a material which is softer than the material of the jacket secured to and overlapping the distal end of the core and secured to the distal end of the jacket, said tip extending distally beyond the distal end of the core. 10. A catheter as defined in claim 9 wherein a marker band is sandwiched between the tip and the core. 11. A catheter as defined in claim 9 or 10 wherein the core is made of a wire-braided material and the jacket and tip are made of polyurethane. 12. A catheter as defined in any one of claims 9-11 wherein the tip has a Durometer of approximately 13. A catheter as defined in claim 12 wherein the jacket has a Durometer of approximately 14. An intravascular catheter comprising a main tubular body having distal and proximal ends, a step provided at the distal end of the body forming a section of reduced outer diameter extending to the distal 911012wpftdisk45,20674.spe,19 end of the body, and a tip made of a material which is softer than the material of the body, secured to and overlapping the section of reduced diameter and secured to the step in the body, said tip extending distally beyond the end of the body and having an outer diameter equal to the diameter of the body immediately proximal to the step and having an inner diameter equal to the inner diameter of the body immediately distal the step. A catheter as defined in claim 14 wherein the tip has a Durometer in the order of 16. A catheter as defined in claim 14 or 15 wherein the tip overlaps the section of reduced outer diameter by approximately two millimeters. 17. A catheter as defined in any one of claims 14-16 wherein the tip extends distally approximately two millimeters beyond the end of the body. 18. A catheter as defined in any one of claims 14-17 wherein the outer diameter of the tip is substantially the same as that of the body. 19. A method of making an intravascular catheter comprising the steps of providing a main tubular body having a wire-braided core and softer outer jacket, removing the jacket from the distal end of the body, providing a tubular tip of a material softer than the jacket and forcing its proximal end over the distal end of the body where the jacket has been removed and with the distal end of the tip extending distally beyond i the distal end of the body, and securing the tubular tip in position. 0ol 91101Zwpftdisk45,20674.speO 7 7'E ,i 21 A method as defined in claim 19, and further providing a marker band and mounting the band on the core adjacent the distal end of the jacket and under the tubular tip. 21. A method as defined in claim 19 or 20 and further forming radii at the inner and outer diameters of the distal end of the tip after it is secured to the body. 22. A method as defined in any one of claims 19-21 and further applying an antithrombogenic coating to the catheter body and the tip proximally of approximately the last two millimeters of the tip. 23. A method as defined in claim 19 and further placing a heat shrink film over the proximal portion of the tubular tip and distal end of the jacket of the core, and heating the distal end of the assembly of body, tip, and shrink film to bond the tip to the core. 24. A method as defined in claim 23 and further providing a marker band and mounting the band on the core adjacent the distal end of the jacket and under the tubular tip. A method of making an intravascular catheter comprising the steps of providing a main tubular body with a step at its distal end to establish a distal section of reduced outer diameter, providing a tubular tip of a material softer than the body and having an outer diameter equal to the diameter of the body immediately proximal to the step and having an inner diameter equal to the inner diameter of the body immediately distal to the step and overlapping its proximal end onto the section of reduced diameter, a portion of the tubular tip extending beyond the distal 911012,wpftdisk4,20674.spe,2i -22- end of the section of reduced diameter and securing the tip to the body in the overlapped position to thereby provide a catheter having a uniform i inner and outer diameter throughout a distal end portion. 26. A catheter as defined in claim 20 wherein the tip has a Durometer in the order of 85A and overlaps the body by approximately two millimeters. j 10 27. An intravascular catheter substantially as Shereinbefore described with reference to the accompanying drawings. 28. A method of making an intravascular catheter substantially as hereinbefore described with reference to the accompanying drawings. Dated this 9th day of January, 1992 C.R. BARD, INC. By its Patent Attorneys DAVIES COLLISON CAVE }j4 920109,wpftdisk45,20674.spe,22 AU20674/88A 1987-08-14 1988-08-11 Soft tip catheter Ceased AU621548B2 (en) Applications Claiming Priority (2) Application Number Priority Date Filing Date Title US085392 1987-08-14 US07/085,392 US4863442A (en) 1987-08-14 1987-08-14 Soft tip catheter Publications (2) Publication Number Publication Date AU2067488A AU2067488A (en) 1989-02-16 AU621548B2 true AU621548B2 (en) 1992-03-19 Family ID=22191316 Family Applications (1) Application Number Title Priority Date Filing Date AU20674/88A Ceased AU621548B2 (en) 1987-08-14 1988-08-11 Soft tip catheter Country Status (4) Country Link US (1) US4863442A (en) EP (1) EP0303487A3 (en) JP (1) JPH072184B2 (en) AU (1) AU621548B2 (en) Families Citing this family (215) * Cited by examiner, † Cited by third party Publication number Priority date Publication date Assignee Title JPH01227766A (en) * 1988-03-04 1989-09-11 Yuichi Furukawa Catheter for angiography US5078702A (en) * 1988-03-25 1992-01-07 Baxter International Inc. 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