EP0862477A1 - Catheter de guidage a segment distal souple - Google Patents

Catheter de guidage a segment distal souple

Info

Publication number
EP0862477A1
EP0862477A1 EP96936150A EP96936150A EP0862477A1 EP 0862477 A1 EP0862477 A1 EP 0862477A1 EP 96936150 A EP96936150 A EP 96936150A EP 96936150 A EP96936150 A EP 96936150A EP 0862477 A1 EP0862477 A1 EP 0862477A1
Authority
EP
European Patent Office
Prior art keywords
ofthe
segment
catheter according
thermoplastic elastomer
elongated
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.)
Withdrawn
Application number
EP96936150A
Other languages
German (de)
English (en)
Inventor
David S. Brin
Stuart R. Macdonald
Albert H. Dunfee
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.)
Medtronic Inc
Original Assignee
Medtronic Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medtronic Inc filed Critical Medtronic Inc
Publication of EP0862477A1 publication Critical patent/EP0862477A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0054—Catheters; Hollow probes characterised by structural features with regions for increasing flexibility
    • 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
    • A61M25/0043—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
    • A61M25/0053—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid

Definitions

  • the present invention relates to catheters, and more particularly, to a catheter which exhibits differential flexibility along the length ofthe catheter.
  • a catheter can be used in PTCA procedures such as balloon angioplasty, atherectomy, stent implantation procedures, or radiology procedures.
  • PTCA percutaneous transluminal coronary angioplasty
  • This procedure can be used, for example, to reduce arterial build-up of cholesterol fats or atherosclerotic plaque.
  • a guidewire is steered through the vascular system to the lesion site of therapeutic interest.
  • a dilatation catheter is inserted over the guidewire and is tracked along the guidewire to the lesion where the catheter is inflated to dilate the lesion.
  • a guiding catheter acts as a support conduit for both the guidewire and the dilatation catheter.
  • the considerations in guiding catheter design include torsional stiffness, bending stiffness, and kink resistance.
  • United States patent number 5,254,107, issued to Soltesz discloses at column 2, lines 6-23, a catheter which "carries an embedded fibrous, tubular reinforcement member, with the catheter shaft defining a first section which comprises a first plastic material and a second section abutting the first section which comprises a second plastic material having different physical properties from the first plastic material.
  • the tubular reinforcement member comprises integral fibers that extend between, and are embedded in, the plastic of both the first and second sections ofthe catheter shaft.
  • the guiding catheter must possess the requisite torsional stiffness to facilitate the positioning and rotation ofthe catheter within the vasculature.
  • the catheter must be able to be aggressively manipulated in axial, compressive, bending, and torsional modes without kinking or buckling ofthe cross- section ofthe catheter.
  • the present invention relates to a guiding catheter which comprises an elongated shaft of a relatively high bending stiffness, a first elongated segment of a relatively intermediate bending stiffness, and a second elongated segment, of a relatively low bending stiffness.
  • a first junction comprising a plurality of tongue-in-groove interlocks is used to bond the elongated shaft to the first elongated segment and a second junction comprising a plurality of tongue-in-groove interlocks is used to bond the first elongated segment to the second elongated segment.
  • a soft tip is bonded to the distal end ofthe second elongated segment.
  • the invention in an alternative embodiment, relates to a guiding catheter which comprises an elongated shaft of a relatively high bending stiffiiess, and a first elongated segment of a relatively low bending stiffiiess.
  • a first junction comprising a plurality of tongue-in-groove interlocks is used to bond the elongated shaft to the first elongated segment.
  • a soft tip is bonded to the distal end ofthe first elongated segment.
  • Figure 1 depicts applicants' preferred embodiment of a guiding catheter
  • Figure 2 depicts a cross-sectional view of applicants' preferred embodiment of a guiding catheter along section line 2-2 of Figure 1;
  • Figure 3 depicts the preferred embodiment of applicants' guiding catheter in a cross-section along section line 3-3 in Figure 1;
  • Figure 4 depicts the preferred embodiment of applicants' guiding catheter in a cross-section along section line 4-4 in Figure 1;
  • Figure 5 depicts a plan view of applicants' alternative embodiment of a guiding catheter
  • Figure 6 depicts applicants' guiding catheter in a cross-section ofthe alternative embodiment along section line 6-6 in Figure 5.
  • the catheter is shown in the commonly-used "Amplatz" curve shape, the Amplatz shape being first suggested by pioneer interventionalist Dr. Kurt Amplatz.
  • the guiding catheter 10 preferably includes an inner lumen of 0.086 inches, an outer diameter of 0.104 inches, and a length of approximately 100 cm.
  • a first transition segment 12 is bonded to the elongated shaft 11 and to the first elongated segment 13.
  • the first elongated segment 13 is approximately 5 cm in length.
  • the first transition segment 12 is preferably comprised of a 63D PEBAX® which is injection molded or otherwise bonded by heat and pressure to the elongated shaft 11 and to the first elongated segment 13.
  • the first transition segment 12 is preferably of a unitary polymer construction, without any additional means for reinforcement.
  • the elongated shaft 11, the first transition segment 12 , and the first elongated segment 13 are connected to form the first junction 14. It is critical that the first junction 14 exhibit acceptable kink resistance. Acceptable kink resistance for a catheter with an outside diameter of 0.104 inches and an inside diameter of 0.086 inches is defined as 60 degrees to 80 degrees of angular deflection, as measured by the ASTM D684 testing method. To achieve acceptable flexural and torsional kink resistance, the geometry ofthe first junction 14 is selected so that a gradual stiffness transition is achieved across these respective structural elements.
  • the first junction 14 will be prone to flexural kinking at the first transition segment 12 unless the ratio ofthe length to the wall thickness ofthe first transition segment 12 is less than approximately 10.
  • the length ofthe first transition segment 12 must be less than 0.090 inches.
  • the first junction 14 will be prone to torsional kinking at the first transition segment unless the ratio ofthe circumference to the wall thickness ofthe first transition segment 12 is less than approximately 10.
  • the circumference ofthe first transition segment must be less than 0.090 inches.
  • the first transition segment 12 can have a length and a circumference of not greater than 0.090 inches without an additional means for reinforcement to prevent torsional kinking.
  • the first junction 14 is characterized by preferably four "tongue-in- groove" interlocks 15 between the elongated shaft 11 and the first elongated segment 13.
  • the interlocks 15 are spaced at 90 degree intervals about the circumference ofthe first junction 14.
  • the first transition segment 12 occupies the interstices ofthe interlocks 15 between the elongated shaft 11 and the first elongated segment 13 and has a "zigzag" shape about the circumference ofthe first junction 14.
  • the length ofthe first transition segment 12 is approximately 0.078 inches to achieve a gradual stiffiiess transition while allowing for acceptable flexural kink resistance across the first junction 14.
  • one to three tongue-in-groove interlocks 15 between the elongated shaft 11 and the first elongated segment 13 may be used. In the case of one tongue-in-groove interlock 15, a slight improvement in manufacturability is obtained over the 4 interlocks 15, but the one interlock is less torsionally and flexurally kink resistant.
  • the interlocks 15 are spaced at 180 degree intervals about the circumference ofthe first junction 14. Similarly, in the case of three interlocks 15, the interlocks 15 are spaced at 120 degree intervals about the circumference ofthe first junction 14.
  • a second transition segment 16 is bonded to the first elongated segment 13 and to the second elongated segment 17.
  • the second elongated segment 17 is approximately 2 cm in length.
  • the second transition segment 16, which is of unitary polymer construction, is preferably comprised of a 63D PEBAX® which is injection molded or otherwise bonded by heat and pressure to the first elongated segment 13 and to the second elongated segment 17.
  • the first elongated segment 13, the second transition segment 16, and the second elongated segment 17 are connected to form the second junction 18.
  • the geometry ofthe second junction 18 is selected so that a gradual durometer transition is achieved across these respective structural elements.
  • the second junction 18 is characterized by preferably four tongue-in-groove interlocks 15 between the first elongated segment 13 and the second elongated segment 17.
  • the geometric constraints applied to the first junction 14 and the first transition segment 12 apply to the second junction 18 and second transition segment 16, respectively.
  • the second transition segment 16 occupies the interstices ofthe interlocks 15 between the first elongated segment 13 and the second elongated segment 17.
  • a soft tip 19 is bonded using heat and pressure to the distal end ofthe second elongated segment 17.
  • Preferred materials for the soft tip 19 include the Shore durometer 40D grade of PEBAX®.
  • the elongated shaft 11 is constructed of a relatively stiff composite, and is preferably a heat and pressure lamination of a thermoplastic elastomeric inner tube 20 and a composite outer tube 21, the composite outer tube 21 consisting of a stainless steel wire braid 22 and a thermoplastic elastomeric outer tube 23.
  • the stainless steel wire braid 22 is preferably a 16 strand weave at a preferred density of 40-50 pixels per inch.
  • the stainless steel wire braid 22 acts as a means for reinforcement for the thermoplastic elastomeric outer tube 23 which increases flexural and torsional kink resistance ofthe composite outer tube 21.
  • the materials for the elongated shaft 11 are selected so that the desired bending stiffness and torsional stiffiiess is achieved.
  • thermoplastic elastomeric inner tube 20 and the thermoplastic elastomeric outer tube 23 are of compatible melt temperatures and melt viscosities.
  • thermoplastic elastomers which possess the desired flexural moduli and melt compatibility include the tradename PEBAX®, a polyether block amide copolymer obtainable from the Elf Atochem Corporation, Philadelphia, PA.
  • the preferred PEBAX® grades include the Shore durometer 70D grade for both the thermoplastic elastomeric inner tube 20 and the thermoplastic elastomeric outer tube 23.
  • the applicants' guiding catheter 10 is shown depicted in a cross-section ofthe preferred embodiment along section line 3-3 of Figure 1.
  • the first elongated segment 13 has a bending stiffiiess which is approximately 20 to 50 % less than the elongated shaft 11.
  • the first elongated segment 13 is preferably a heat and pressure lamination of a thermoplastic elastomeric inner tube 30 and a composite outer tube 31, the composite outer tube 31 consisting of a stainless steel wire braid 32 and a thermoplastic elastomeric outer tube 33.
  • the materials for first elongated segment 13 are selected so that the desired bending stiffiiess is achieved.
  • thermoplastic elastomeric inner tube 30 and the thermoplastic elastomeric outer tube 33 are of compatible melt temperatures and melt viscosities.
  • Preferred materials for the thermoplastic elastomeric inner tube 30 include the Shore durometer 70D grade of PEBAX® while the preferred materials for the thermoplastic elastomeric outer tube 33 include the Shore durometer 55D grade of PEBAX®.
  • Shore durometer 63D PEBAX® may be used for the thermoplastic elastomeric outer tube 33.
  • the applicants' guiding catheter 10 is shown depicted in a cross-section along section line 4-4 of Figure 1.
  • the second elongated segment 17 has a bending stiffness which is approximately 20 to 50 % less than the first elongated segment 13.
  • the second elongated segment 17 is preferably a heat and pressure lamination of a thermoplastic elastomeric inner tube 40 and a composite outer tube 41, the composite outer tube 41 consisting of a stainless steel wire braid 42 and a thermoplastic elastomeric outer tube 43.
  • the materials for second elongated segment 17 are selected so that the desired bending stiffness is achieved.
  • thermoplastic elastomeric inner tube 40 and the thermoplastic elastomeric outer tube 43 are of compatible melt temperatures and melt viscosities.
  • Preferred materials for the thermoplastic elastomeric inner tube 40 include the Shore durometer 70D grade of PEBAX® while the preferred materials for the thermoplastic elastomeric outer tube 43 include the Shore durometer 40D grade of PEBAX®.
  • a first transition segment 52 is bonded to the elongated shaft 51 and to the first elongated segment 53.
  • the first elongated segment 53 is approximately 2 cm in length.
  • the first transition segment 52 is of a unitary polymer construction and is preferably comprised of a 63D PEBAX® which is injection molded or otherwise bonded by heat and pressure to the elongated shaft 51 and to the first elongated segment 53.
  • the elongated shaft 51, the first transition segment 52, and the first elongated segment 53 are connected to form the first junction 54. It is critical that the first junction 54 exhibit acceptable kink resistance. Acceptable kink resistance for a catheter with a preferred outside diameter of 0.078 inches and an inside diameter of 0.064 inches is defined as 60 degrees to 80 degrees of angular deflection, as measured by the ASTM D684 testing method.
  • the geometry ofthe first junction 54 is selected so that a gradual durometer transition is achieved across these respective structural elements.
  • the first junction 54 is characterized by preferably four tongue-in-groove interlocks 55 between the elongated shaft 51 and the first elongated segment 53.
  • the first transition segment 52 occupies the interstices ofthe interlocks 55 between the elongated shaft 51 and the first elongated segment 53. Further, the first transition segment 52 is fused to both the elongated shaft 51 and to the first elongated segment 53.
  • a soft tip 56 is bonded to the distal end ofthe first elongated segment 53. Preferred materials for the soft tip 56 include the Shore durometer 40D grade of PEBAX®.
  • the applicants' guiding catheter 50 is shown depicted in a cross-section along section line 6-6 of Figure 5.
  • the first elongated segment 53 has a bending stiffness which is approximately 20 to 50 % less than the elongated shaft 51.
  • the first elongated segment 53 is preferably a heat and pressure lamination of a thermoplastic elastomeric inner tube 60 and a composite outer tube 61, the composite outer tube 61 consisting of a stainless steel wire braid 62 and a thermoplastic elastomeric outer tube 63.
  • the materials for first elongated segment 53 are selected so that the desired bending stiffiiess is achieved.
  • thermoplastic elastomeric inner tube 60 and the thermoplastic elastomeric outer tube 63 are of compatible melt temperatures and melt viscosities.
  • Preferred materials for the thermoplastic elastomeric inner tube 60 include the Shore durometer 70D grade of PEBAX® while the preferred materials for the thermoplastic elastomeric outer tube 63 include the Shore durometer 40D grade of PEBAX®.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention porte sur un cathéter de guidage à plusieurs couches s'utilisant dans le cadre de processus ACTP et présentant une rigidité en flexion variant progressivement sur sa longueur du fait de sa constitution en segments allongés dont la raideur décroît de l'extrémité proximale à l'extrémité distale. Lesdits segments sont de préférence reliés entre eux au niveau de chaque jonction par quatre assemblages à rainures et languettes. Lesdits assemblages sont fixés aux extrémités de segments de transition qui occupent les interstices entre les languettes et les rainures de chacun d'entre eux.
EP96936150A 1995-10-17 1996-10-02 Catheter de guidage a segment distal souple Withdrawn EP0862477A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US54399295A 1995-10-17 1995-10-17
US543992 1995-10-17
PCT/US1996/015845 WO1997014466A1 (fr) 1995-10-17 1996-10-02 Catheter de guidage a segment distal souple

Publications (1)

Publication Number Publication Date
EP0862477A1 true EP0862477A1 (fr) 1998-09-09

Family

ID=24170360

Family Applications (1)

Application Number Title Priority Date Filing Date
EP96936150A Withdrawn EP0862477A1 (fr) 1995-10-17 1996-10-02 Catheter de guidage a segment distal souple

Country Status (3)

Country Link
EP (1) EP0862477A1 (fr)
AU (1) AU7386996A (fr)
WO (1) WO1997014466A1 (fr)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6858024B1 (en) 1994-02-14 2005-02-22 Scimed Life Systems, Inc. Guide catheter having selected flexural modulus segments
US5911715A (en) * 1994-02-14 1999-06-15 Scimed Life Systems, Inc. Guide catheter having selected flexural modulus segments
US5938653A (en) * 1997-06-09 1999-08-17 Scimed Life Systems, Inc. Catheter having controlled flexibility and method of manufacture
US6022341A (en) 1997-10-03 2000-02-08 Medtronic, Inc. Catheter with multiple internal diameters
ATE392858T1 (de) 1998-03-31 2008-05-15 Medtronic Vascular Inc Katheter und systeme für einen perkutanen insitu arterio-venösen bypass
US6106510A (en) * 1998-05-28 2000-08-22 Medtronic, Inc. Extruded guide catheter shaft with bump extrusion soft distal segment
US6945970B2 (en) 2001-12-27 2005-09-20 Scimed Life Systems, Inc. Catheter incorporating a curable polymer layer to control flexibility and method of manufacture
US7828790B2 (en) 2004-12-03 2010-11-09 Boston Scientific Scimed, Inc. Selectively flexible catheter and method of use
US7718106B2 (en) * 2006-05-30 2010-05-18 Boston Scientific Scimed, Inc. Medical devices and related systems and methods
US9521990B2 (en) 2011-05-11 2016-12-20 Acist Medical Systems, Inc. Variable-stiffness imaging window and production method thereof
US10905851B2 (en) 2012-03-23 2021-02-02 Acist Medical Systems, Inc. Catheter sheath and methods thereof
JP2017503540A (ja) 2013-12-19 2017-02-02 アシスト・メディカル・システムズ，インコーポレイテッド カテーテルシースシステムおよび方法
KR102163659B1 (ko) * 2016-08-23 2020-10-08 아사히 인텍크 가부시키가이샤 접합 구조 및 그 접합 구조를 가지는 카테터
JP6965579B2 (ja) * 2017-05-26 2021-11-10 住友ベークライト株式会社 カテーテル
IL270695B2 (en) * 2017-05-26 2024-01-01 Sumitomo Bakelite Co catheter

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0383914B1 (fr) * 1987-10-02 1994-12-14 Terumo Kabushiki Kaisha Catheter
US5092848A (en) * 1988-10-13 1992-03-03 Deciutiis Vincent L Intravenous catheter with built-in cutting tip and method for making the same
CA2082315C (fr) * 1991-11-13 1997-03-18 Harold I. Pearsall Catheter
US5569218A (en) * 1994-02-14 1996-10-29 Scimed Life Systems, Inc. Elastic guide catheter transition element
US5533985A (en) * 1994-04-20 1996-07-09 Wang; James C. Tubing
US5509910A (en) * 1994-05-02 1996-04-23 Medtronic, Inc. Method of soft tip attachment for thin walled catheters

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO9714466A1 *

Also Published As

Publication number Publication date
WO1997014466A1 (fr) 1997-04-24
AU7386996A (en) 1997-05-07

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