Method of making an enhanced flexibility neurovascular catheter

• US 10,183,146 B2
• Filed: 02/27/2017
• Issued: 01/22/2019
• Est. Priority Date: 02/24/2016
• Status: Active Grant

• Current Assignee: Imperative Care, Inc., Incept LLC
• Original Assignee: Incept LLC
• Inventors: Yang, Yi, Khosravi, Fred, Young, Lisa M.
• Primary Examiner(s): Wollschlager, Jeffrey M
• Application Number:
  US15/443,877
• Publication Number:
  US 20170239441A1
• Time in Patent Office: 694 Days
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12168 having a mesh structure A61B17/1214 takes precedence
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 17/2202 the ultrasound transducer being inside patient's body at the distal end of the catheter
• CPC Class Codes: A61B 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• CPC Class Codes: A61B 17/3203 Fluid jet cutting instruments
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00734 battery operated
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid
• CPC Class Codes: A61B 2017/00955 thermoplastic
• CPC Class Codes: A61B 2017/22025 applying a shock wave A61B2017/22091 takes precedence
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/22038 : with a guide wire
• CPC Class Codes: A61B 2017/22062 : to be filled with liquid
• CPC Class Codes: A61B 2017/22067 : Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22079 : with suction of debris
• CPC Class Codes: A61B 2017/22084 : stone- or thrombus-dissolving
• CPC Class Codes: A61B 2017/320733 : with a flexible cutting or scraping element, e.g. with a whip-like distal filament member
• CPC Class Codes: A61B 2017/320775 : Morcellators, impeller or propeller like means
• CPC Class Codes: A61B 2217/005 : with suction drainage system
• CPC Class Codes: A61B 6/481 : involving the use of contrast agents
• CPC Class Codes: A61B 6/501 : for diagnosis of the head, e.g. neuroimaging or craniography
• CPC Class Codes: A61F 2/95 : Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2007/126 : for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/12 : Devices for heating or cooling internal body cavities
• CPC Class Codes: A61L 2400/10 : Materials for lubricating medical devices
• CPC Class Codes: A61L 2400/16 : Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 29/02 : Inorganic materials
• CPC Class Codes: A61L 29/041 : obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/06 : obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/14 : Materials characterised by their function or physical properties , e.g. lubricating compositions
• CPC Class Codes: A61M 1/32 : Oxygenators without membranes
• CPC Class Codes: A61M 1/743 : by changing the cross-section of the line, e.g. flow regulating valves A61M1/7413 takes precedence
• CPC Class Codes: A61M 1/80 : Suction pumps A61M1/64, A61M1/71, A61M60/00 take precedence
• CPC Class Codes: A61M 1/84 : Drainage tubes; Aspiration tips for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32
• CPC Class Codes: A61M 2025/0002 : with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/0004 : having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0046 : Coatings for improving slidability
• CPC Class Codes: A61M 2025/0058 : having an electroactive polymer material, e.g. for steering purposes, for control of flexibility, for locking, for opening or closing
• CPC Class Codes: A61M 2025/0059 : having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking
• CPC Class Codes: A61M 2025/0079 : Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
• CPC Class Codes: A61M 2025/0096 : being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/0175 : having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61M 2039/062 : used with a catheter
• CPC Class Codes: A61M 2205/0216 : Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
• CPC Class Codes: A61M 2205/0266 : Shape memory materials
• CPC Class Codes: A61M 2205/3344 : Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2210/12 : Blood circulatory system
• CPC Class Codes: A61M 25/0009 : Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0012 : with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
• CPC Class Codes: A61M 25/0023 : by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0045 : multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/005 : with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0052 : Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
• CPC Class Codes: A61M 25/0053 : having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61M 25/007 : Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0074 : Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/008 : Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/0082 : Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0097 : characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/01 : Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0102 : Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/0108 : using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0662 : Guide tubes
• CPC Class Codes: A61M 25/09 : Guide wires
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1027 : Making of balloon catheters
• CPC Class Codes: A61M 31/005 : for contrast media
• CPC Class Codes: A61M 39/06 : Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
• CPC Class Codes: A61M 5/007 : for contrast media
• CPC Class Codes: B29C 41/02 : for making articles of definite length, i.e. discrete articles
• CPC Class Codes: B29C 41/14 : Dipping a core B29C41/10 takes precedence
• CPC Class Codes: B29C 41/22 : Making multilayered or multicoloured articles
• CPC Class Codes: B29C 41/42 : Removing articles from moulds, cores or other substrates B29C33/444 and B29C37/0017 take precedence
• CPC Class Codes: B29C 63/18 : using tubular layers or sheathings B29C63/26 and B29C63/38 take precedence; placing tubular labels around rigid containers B65C3/065
• CPC Class Codes: B29C 63/20 : using pressure difference, e.g. vacuum
• CPC Class Codes: B29C 63/22 : using layers or sheathings having a shape adapted to the shape of the article B29C63/26 and B29C63/38 take precedence
• CPC Class Codes: B29C 66/52 : Joining tubular articles, bars or profiled elements
• CPC Class Codes: B29C 66/522 : Joining tubular articles B29C66/53241 takes precedence
• CPC Class Codes: B29C 66/5221 : for forming coaxial connections, i.e. the tubular articles to be joined forming a zero angle relative to each other
• CPC Class Codes: B29K 2027/18 : PTFE, i.e. polytetrafluorethene , e.g. ePTFE, i.e. expanded polytetrafluorethene
• CPC Class Codes: B29K 2075/00 : Use of PU, i.e. polyureas or polyurethanes or derivatives thereof, as moulding material
• CPC Class Codes: B29L 2031/7542 : Catheters

Abstract

A method of making a high flexibility distal zone on a neurovascular catheter is provided. The method includes the steps of dip coating a removable mandrel to form a tubular inner layer on the mandrel, coating the tubular inner layer with a soft tie layer, applying a helical coil to the outside of the tie layer, positioning a plurality of tubular segments on the helical coil, heating the tubular segments to form the high flexibility distal zone on the neurovascular catheter; and removing the mandrel. The plurality of segments have durometers that decrease in a distal direction. The flexural load profile of the catheter as a function of catheter length is configured to provide enhanced distal flexibility while maintaining high backup support.

Claims

1. A method of making a flexible distal zone on a neurovascular catheter, having an elongate tubular body with a distal end, comprising the steps of:

dip coating a removable mandrel to form a tubular inner layer on the mandrel;

coating the tubular inner layer with a tie layer;

applying a helical coil to the outside of the tie layer;

positioning a plurality of tubular segments over the helical coil, the plurality of segments having durometers that decrease in a distal direction, wherein the plurality of tubular segments form a proximal section having a proximal end and a distal end and a durometer equal to or greater than 65D at all points along a length from the proximal end to the distal end of the proximal section, a distal section having a proximal end and a distal end and a durometer equal to or less than 35D at all points along a length extending from the proximal end to the distal end of the distal section, and a transition section extending from the distal end of the proximal section to the proximal end of the distal section, the transition section comprising at least two tubular segments and having a durometer less than 65D and greater than 35D at all points along a length extending from the distal end of the proximal section to the proximal end of the distal section, the transition section being shorter in length than the proximal section and shorter in length than the distal section;

heating the tubular segments to form the flexible distal zone on the neurovascular catheter; and

removing the mandrel.

2. The method as in claim 1, wherein removing the mandrel step includes axially elongating the mandrel.

3. The method as in claim 1, comprising positioning at least seven segments on the helical coil.

4. The method as in claim 1, comprising positioning at least nine segments on the helical coil.

5. The method as in claim 1, wherein the tubular inner layer comprises PTFE.

6. The method as in claim 1, wherein the tie layer comprises polyurethane.

7. The method as in claim 6, wherein the tie layer has a wall thickness of no more than about 0.005 inches.

8. The method as in claim 6, wherein the tie layer extends along at least the most distal 20 cm of the neurovascular catheter.

9. The method as in claim 1, wherein the coil comprises a shape memory material.

10. The method as in claim 9, wherein the coil comprises Nitinol.

11. The method as in claim 10, wherein the Nitinol comprises an Austenite state at body temperature.

12. The method as in claim 1, further comprising positioning at least one axially extending tensile strength enhancing filament over the tie layer and extending proximally along the catheter to less than about 40 cm from the distal end.

13. The method as in claim 12, wherein the filament extends along at least about the most distal 15 cm of the length of the catheter.

14. The method as in claim 12, wherein the filament extends along at least about the most distal 20 cm of the length of the catheter.

15. The method as in claim 12, wherein the filament comprises multiple fibers.

16. The method as in claim 1, wherein the transition section comprises at least three tubular segments.

17. The method as in claim 1, wherein the distal section is at least about twice as long as the transition section.