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WO2023192800A1 - Revêtement polymère amélioré pour cathéter - Google Patents

Revêtement polymère amélioré pour cathéter Download PDF

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Publication number
WO2023192800A1
WO2023192800A1 PCT/US2023/064891 US2023064891W WO2023192800A1 WO 2023192800 A1 WO2023192800 A1 WO 2023192800A1 US 2023064891 W US2023064891 W US 2023064891W WO 2023192800 A1 WO2023192800 A1 WO 2023192800A1
Authority
WO
WIPO (PCT)
Prior art keywords
polymer tube
tubular body
polymer
hypotube
distal
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.)
Ceased
Application number
PCT/US2023/064891
Other languages
English (en)
Inventor
Cormac O’KEEFFE
Chloe BOWEN
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.)
Stryker European Operations Ltd
Stryker Corp
Original Assignee
Stryker European Operations Ltd
Stryker Corp
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 Stryker European Operations Ltd, Stryker Corp filed Critical Stryker European Operations Ltd
Publication of WO2023192800A1 publication Critical patent/WO2023192800A1/fr
Anticipated expiration legal-status Critical
Ceased 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
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A61M25/0051—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids made from fenestrated or weakened tubing layer
    • 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
    • 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
    • A61M25/0013—Weakening parts of a catheter tubing, e.g. by making cuts in the tube or reducing thickness of a layer at one point to adjust the 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
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0057—Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
    • 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

  • ePTFE expanded PTFE
  • ePTFE expanded PTFE
  • FIG. 2009/0048657A1 An example of using ePTFE for producing tubular structures is described in U.S. Patent Publication No. 2009/0048657A1.
  • the resulting properties of ePTFE provide lower distal stiffness, while retaining stretch resistance, thereby enhancing distal navigability of catheters.
  • manufacturing liners composed of ePTFE can be prohibitively expensive.
  • an intravascular catheter comprises an elongate tubular body with a proximal end, a distal end, and a tubular body lumen extending between the proximal end and the distal end of the tubular body.
  • the tubular body is a hypotube structure.
  • the hypotube structure may have a hypotube pattern of apertures and solid elements disposed on the distal end of the hypotube structure.
  • the intravascular catheter further comprises an outer polymer jacket disposed on an exterior surface of the tubular body.
  • the tubular body is an outer polymer jacket.
  • the intravascular catheter further comprises a tie layer attaching the inner polymer liner to the tubular body.
  • an intravascular catheter comprises an elongate tubular body with a proximal end, a distal end, and a tubular body lumen extending between the proximal end and the distal end of the tubular body.
  • the tubular body is a hypotube structure.
  • the hypotube structure may have a hypotube pattern of apertures and solid elements disposed on the distal end of the hypotube structure.
  • the intravascular catheter further comprises an outer polymer jacket disposed on an exterior surface of the tubular body.
  • the tubular body is an outer polymer jacket.
  • the intravascular catheter further comprises a tie layer attaching the inner polymer liner to the tubular body.
  • a method of manufacturing an intravascular catheter comprises providing an elongate tubular body with a proximal end, a distal end, and a tubular body lumen extending between the proximal end and the distal end of the tubular body.
  • the tubular body is a hypotube structure.
  • the hypotube structure may have a hypotube pattern of apertures and solid elements disposed on the distal end of the hypotube structure.
  • the method further comprises providing a polymer tube having a proximal section, a distal section, and a tube lumen extending through the polymer tube.
  • the proximal section and distal section of the polymer tube are composed of polytetrafluoroethylene (PTFE).
  • providing the polymer tube comprises selecting a PTFE resin and extruding the polymer tube from the PTFE resin.
  • the method further comprises affixing the polymer tube within the tubular body lumen. Affixing the polymer tube within the tubular body lumen may comprise radially expanding the polymer tube within the tubular body lumen. If the tubular body is a hypotube structure, the polymer tube may be affixed within the tubular body lumen, such that the distal section of the polymer tube spans the hypotube pattern.
  • One method further comprises affixing an outer polymer jacket on an exterior surface of the hypotube structure.
  • the elongate tubular body is an outer polymer jacket.
  • a method of manufacturing an intravascular catheter comprises providing an elongate tubular body with a proximal end, a distal end, and a tubular body lumen extending between the proximal end and the distal end of the tubular body.
  • the tubular body is a hypotube structure.
  • the hypotube structure may have a hypotube pattern of apertures and solid elements disposed on the distal end of the hypotube structure.
  • the method further comprises providing a polymer tube having a proximal section, a distal section, and a tube lumen extending through the polymer tube.
  • the proximal section and distal section of the polymer tube are composed of polytetrafluoroethylene (PTFE).
  • providing the polymer tube comprises selecting a PTFE resin and extruding the polymer tube from the PTFE resin.
  • the method further comprises affixing the polymer tube within the tubular body lumen. Affixing the polymer tube within the tubular body lumen may comprise radially expanding the polymer tube within the tubular body lumen. If the tubular body is a hypotube structure, the polymer tube may be affixed within the tubular body lumen, such that the distal section of the polymer tube spans the hypotube pattern.
  • FIG. 2 is a profile view of one embodiment of an intravascular catheter, particularly showing a distal end of the intravascular catheter in a straight geometry;
  • Fig. 4 is a profile view of the distal end of one embodiment of a hypotube structure used in the intravascular catheter of Fig. 2;
  • FIG. 5 is a perspective view of the distal end of the hypotube structure of Fig. 4;
  • Fig. 6 is a cross-sectional view of the distal end of one embodiment of a catheter body of the intravascular catheter of Fig. 2;
  • Fig. 7 is a longitudinal-sectional view of the distal end of the catheter body of Fig. 6, particularly showing one embodiment of a tie layer;
  • Fig. 8 is a perspective view of the distal end of another embodiment of a hypotube structure used in the catheter body of Fig. 6;
  • Fig. 9 is a perspective view of one embodiment of an inner polymer liner used in the catheter body of Fig. 6;
  • Fig. 10 is a longitudinal-sectional view of the distal end of the catheter body of Fig. 6, particularly showing another embodiment of a tie layer;
  • Fig. 12 is a perspective view of one tubular body used to make the hypotube structure in accordance with the flow diagram of Fig. 11 ;
  • Fig. 13 is a perspective view of a pattern of apertures and solid elements formed on the distal end of the tubular body of Fig. 12 to create a hypotube structure;
  • FIG. 15 is a perspective view of the polymer tube of Fig. 14, particularly showing the treatment of the distal section of the polymer tube in accordance with the flow diagram of Fig. 11 ;
  • FIG. 16 is a perspective view of the treated polymer tube of Fig. 15, particularly showing removal of the end of the distal section of the polymer tube in accordance with the flow diagram of Fig. 11 ;
  • Fig. 17 is a perspective view of the polymer tube of Fig. 16 disposed in the inner lumen of the hypotube structure of Fig. 13 in accordance with the flow diagram of Fig. 11 ;
  • Fig. 18 is a perspective view of the polymer tube intermittently attached to the hypotube structure via a plurality of discrete adhesion regions in accordance with the flow diagram of Fig. 11 ;
  • Fig. 19 is a plan view of one embodiment of a microporous structure of fibrils and nodes within the distal section of the treated polymer tube of Fig. 15;
  • Figs. 20A and 20B are plan views of alternative embodiments of microporous structures of fibrils within the distal section of the treated polymer tube of Fig. 15
  • the intravascular catheter 10 generally comprises an elongated catheter body 18 topologically divided between a proximal catheter body section 20 and a distal catheter body section 22, an inner catheter lumen 24 extending within the catheter body 18 from the proximal catheter body section 20 to the distal catheter body section 22, and a proximal catheter hub 26 affixed to the proximal catheter body section 20.
  • the catheter body 18 may optionally comprise an intermediate catheter body section (not shown) that may gradually transition the relatively high bending stiffness of the proximal catheter body section 20 to the relatively low bending stiffness of the distal catheter body section 22.
  • a distal tip 28 of the distal catheter body section 22 may be rounded to minimize the chance of traumatic piercing of body tissue.
  • the intravascular catheter 12 comprises a distal port 30 at the distal tip 28 in communication with the inner catheter lumen 24 and from which the vaso-occlusive device 16 is deployed.
  • the flexural stiffness of the proximal section 58 of the polymer tube 54 is greater than the flexural stiffness of the distal section 60 of the polymer tube 54.
  • the decreased flexural stiffness of the distal section 60 of the polymer tube 54 improves the navigability of the catheter body 18 through the vasculature of the patient.
  • the polymer tube 54 has a seamless design or structure, meaning that the proximal section 58 and distal section 60 of the polymer tube 54, when solid, are not joined together via bonding, but rather are formed together as a single component.
  • the proximal section 58 and distal section 60 of the polymer tube 54 are formed without any joints therebetween, e.g., as a single piece in an extrusion process or dip coating/case film process.
  • the seamless polymer tube 54 may be composed of other base materials (e.g., fluoropolymer, perfluoroalkyoxy, alkane (PFA), fluorinated ethylene polyethylene (FEP), polyethylene (PE), as long as the flexural stiffness/density of the proximal section 58 is greater than the flexural stiffness/density of the distal section 60 of the polymer tube 54.
  • the flexural stiffness/density is uniform along the length of the proximal section 58 of the polymer tube 54, and the flexural stiffness/density is uniform along the length of the distal section 60 of the polymer tube 54.
  • the tubular body 54 is unreinforced (meaning that there are no metallic elements disposed within the wall of the tubular body 54 that function to increase the radial strength of the tubular body 54), thereby minimizing any bending stiffness imparted by the inner polymer liner 40 onto the distal catheter body section 22 (see Fig. 3).
  • 3) may be reduced through selective application (or removal) of material that forms the tie layer 42, so that a certain distal length of the inner polymer liner 40 is not continuously attached to the hypotube structure 12. In this manner, the navigability of the catheter body 18 through the vasculature of the patient may be improved.
  • the method 100 initially comprises providing a tubular body 202 having a proximal end 204, a distal end 206, and a lumen 208 extending between the proximal end 204 and the distal end 206 (see Fig. 12) (step 102), and forming a pattern 210 of apertures 212 (e.g., slots) and solid elements 214 (e.g., struts) on the distal end 206 of the tubular body 202, e.g., by laser cutting, saw cutting (e.g., diamond grit embedded semiconductor dicing blade), etching, waterjet cutting, or electrical discharge machining, among other methods) (see Fig. 13) (step 104), thereby creating the hypotube structure 200.
  • apertures 212 e.g., slots
  • solid elements 214 e.g., struts
  • the method 100 further comprises providing a “green” polymer tube 216 having a proximal section 218, a distal section 220, and a lumen 222 (see Fig. 14) (step 106).
  • the method 100 may comprise selecting a polymeric resin for the green polymer tube 216, molding the selected polymeric resin under high pressure to form a billet, which may be cylindrical, extruding the green polymer tube 216 from the billet, and then sintering the green polymer tube 216.
  • the density of the green polymer tube 216 may be controlled by selecting the size of resin particles used in the extrusion process and/or pressure applied during the extrusion process.
  • the green polymer tube 216 initially has a uniform polymer composition having uniform mechanical properties (e.g., uniform flexural stiffness and uniform density), although in alternative embodiments, the green polymer tube 216 may initially have a non-uniform composition and/or have non-uniform mechanical properties (e.g., different densities along the length of the green polymer tube 216) as long as the average density and/or flexural stiffness of the distal section 220 of the processed polymer tube 216’ is less than that of the proximal section 220 of the processed polymer tube 216’.
  • uniform mechanical properties e.g., uniform flexural stiffness and uniform density
  • the green polymer tube 216 may initially have a non-uniform composition and/or have non-uniform mechanical properties (e.g., different densities along the length of the green polymer tube 216) as long as the average density and/or flexural stiffness of the distal section 220 of the processed polymer tube 216’ is less than that of the prox
  • the flexural stiffness/density of the distal section 220 of the green polymer tube 216 is modified by expanding the distal section 220 of the green polymer tube 216 beyond the elastic limit of the material therein under an elevated temperature (e.g., in the range of 500°F-700°F, such as 650°F).
  • the proximal section 218 of the green polymer tube 216 may be affixed within a mandrel (not shown) as the distal section 220 of the green polymer tube 216 is expanded.
  • the distal section 220 of the green polymer tube 216 may be expanded longitudinally (stretched), radially, or both, the latter of which may be referred to as bi-axial.
  • the distal section 220 of the green polymer tube 216 is stretched at a controlled speed and ratio (e.g., 1 :4).
  • the distal section 220 of the green polymer tube 216 will be transformed into a microporous structure 68 of fibrils 70 and nodes 72 to form the distal section 220 of the processed polymer tube 216’, as illustrated in Fig. 19, whereas the proximal section 218 of the processed polymer tube 216’ will have no such microporous structure.
  • the size of a fibril 70 is in the range of 0.05 pm to 0.5 pm in diameter.
  • the surfaces of the fibrils 70 and nodes 72 define numerous interconnecting pores 74 that extend completely through the wall of the processed polymer tube 216’. The average size of the pores 74 is sufficient to be deemed microporous.
  • the proximal section 218 of the processed polymer tube 216 will be less dense, and will have less flexural stiffness, than that of the distal section 218 of the processed polymer tube 216.
  • the proximal section 218 of the processed polymer tube 216’ may be 2.1 grams/cm 3
  • the distal section 220 of the processed polymer tube 216’ may be in the range of 0.1-1 .0 grams/cm 3 .
  • the method 100 further comprises disposing the processed polymer tube 216’ within the lumen 206 of the hypotube structure 200 (see Fig. 17) (step 112).
  • the method further comprises expanding the processed polymer tube 216’ within the lumen 206 of the hypotube structure 200, thereby decreasing the wall thickness of the processed polymer tube 216’, as well as creating continuous intimate contact between the exterior of the processed polymer tube 216’ and the interior of the hypotube structure 200 (step 114).
  • the processed polymer tube 216’ serves as an inner polymer liner to the hypotube structure 200.
  • the method 100 comprises affixing a proximal catheter hub 220 to the proximal end 204 of the hypotube structure 200 (not shown) (step 120).

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  • 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

Un cathéter intravasculaire comprend un corps tubulaire allongé ayant une extrémité proximale, une extrémité distale et une lumière de corps tubulaire s'étendant entre l'extrémité proximale et l'extrémité distale du corps tubulaire. Le cathéter intravasculaire comprend en outre un revêtement polymère interne disposé à l'intérieur de la lumière de corps tubulaire, le revêtement polymère interne ayant un tube polymère sans raccord allongé avec une section proximale composée de polytétrafluoroéthylène (PTFE) et une section distale composée de polytétrafluoroéthylène expansé (ePTFE), et une lumière de revêtement s'étendant à travers le tube polymère.
PCT/US2023/064891 2022-03-29 2023-03-23 Revêtement polymère amélioré pour cathéter Ceased WO2023192800A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202263324758P 2022-03-29 2022-03-29
US63/324,758 2022-03-29

Publications (1)

Publication Number Publication Date
WO2023192800A1 true WO2023192800A1 (fr) 2023-10-05

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PCT/US2023/064891 Ceased WO2023192800A1 (fr) 2022-03-29 2023-03-23 Revêtement polymère amélioré pour cathéter

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Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030105453A1 (en) * 2001-05-03 2003-06-05 Stewart Mark T. Porous medical catheter and methods of manufacture
US6622367B1 (en) 1998-02-03 2003-09-23 Salient Interventional Systems, Inc. Intravascular device and method of manufacture and use
US20090048657A1 (en) 2007-08-15 2009-02-19 Boston Scientific Scimed, Inc. Preferentially varying-density ePTFE structure
US20180304040A1 (en) * 2017-04-20 2018-10-25 Covidien Lp Catheter including an inner liner with a flexible distal section
US20190269491A1 (en) * 2018-03-01 2019-09-05 Covidien Lp Catheter including an expandable member
US20200206458A1 (en) * 2017-12-15 2020-07-02 Perfuze Limited Catheters and devices and systems incorporating such catheters
US20200230359A1 (en) * 2019-01-21 2020-07-23 Transit Scientific, LLC Hypotube catheters
WO2021025814A1 (fr) 2019-08-07 2021-02-11 Zeus Industrial Products, Inc. Cathéter comprenant un revêtement en ptfe
US10953193B2 (en) 2013-07-16 2021-03-23 Covidien Lp Microcatheter with modified PTFE liner

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6622367B1 (en) 1998-02-03 2003-09-23 Salient Interventional Systems, Inc. Intravascular device and method of manufacture and use
US20030105453A1 (en) * 2001-05-03 2003-06-05 Stewart Mark T. Porous medical catheter and methods of manufacture
US20090048657A1 (en) 2007-08-15 2009-02-19 Boston Scientific Scimed, Inc. Preferentially varying-density ePTFE structure
US10953193B2 (en) 2013-07-16 2021-03-23 Covidien Lp Microcatheter with modified PTFE liner
US20180304040A1 (en) * 2017-04-20 2018-10-25 Covidien Lp Catheter including an inner liner with a flexible distal section
US20200129733A1 (en) 2017-04-20 2020-04-30 Covidien Lp Catheter including an inner liner with a flexible distal section
US20200206458A1 (en) * 2017-12-15 2020-07-02 Perfuze Limited Catheters and devices and systems incorporating such catheters
US20190269491A1 (en) * 2018-03-01 2019-09-05 Covidien Lp Catheter including an expandable member
US20200230359A1 (en) * 2019-01-21 2020-07-23 Transit Scientific, LLC Hypotube catheters
WO2021025814A1 (fr) 2019-08-07 2021-02-11 Zeus Industrial Products, Inc. Cathéter comprenant un revêtement en ptfe

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