WO2013112938A1 - Constructions composites thermoplastiques reconfigurées - Google Patents

Constructions composites thermoplastiques reconfigurées Download PDF

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Publication number
WO2013112938A1
WO2013112938A1 PCT/US2013/023298 US2013023298W WO2013112938A1 WO 2013112938 A1 WO2013112938 A1 WO 2013112938A1 US 2013023298 W US2013023298 W US 2013023298W WO 2013112938 A1 WO2013112938 A1 WO 2013112938A1
Authority
WO
WIPO (PCT)
Prior art keywords
medical device
elements
reconfigured
consolidated
thermoplastic composite
Prior art date
Application number
PCT/US2013/023298
Other languages
English (en)
Inventor
Frank Paul BECKING
David Mayer DE ROTHSCHILD
Original Assignee
Smarter Planet Llc
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 Smarter Planet Llc filed Critical Smarter Planet Llc
Publication of WO2013112938A1 publication Critical patent/WO2013112938A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • 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
    • 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
    • B29C70/04—Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts comprising reinforcements only, e.g. self-reinforcing plastics
    • B29C70/28—Shaping operations therefor
    • B29C70/40—Shaping or impregnating by compression not applied
    • B29C70/42—Shaping or impregnating by compression not applied for producing articles of definite length, i.e. discrete articles
    • B29C70/46—Shaping or impregnating by compression not applied for producing articles of definite length, i.e. discrete articles using matched moulds, e.g. for deforming sheet moulding compounds [SMC] or prepregs
    • B29C70/465—Shaping or impregnating by compression not applied for producing articles of definite length, i.e. discrete articles using matched moulds, e.g. for deforming sheet moulding compounds [SMC] or prepregs and impregnating by melting a solid material, e.g. sheets, powders of fibres
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A61B2017/00871—Material properties shape memory effect polymeric
    • 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
    • B29C35/00—Heating, cooling or curing, e.g. crosslinking or vulcanising; Apparatus therefor
    • B29C35/02—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould
    • B29C35/0266—Local curing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2101/00—Use of unspecified macromolecular compounds as moulding material
    • B29K2101/12—Thermoplastic materials
    • 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

Definitions

  • the assignee hereof is in the business of developing products with fiber reinforced thermoplastic composites.
  • the USAi boat was built employing an srPET (self-reinforced polyester fiber) composite frame securing approximately 12,000 two- liter bottles for buoyancy.
  • the frame elements, together with the boat cabin, furniture, rudder and other structural features were all built from srPET.
  • the srPET material (e.g . , as supplied by Comfil, Inc.) comprises high melt (a high tenacity/reinforcement fiber component) and lower melt (a matrix material component) portions comingled with one another in tows woven into fabric.
  • high melt a high tenacity/reinforcement fiber component
  • lower melt a matrix material component
  • thermoplastic polymer composites may be employed in the construction of medical devices as previously unknown.
  • thermoplastics in composite form.
  • catheters are commonly manufactured with
  • thermoplastic PEBAX material fused with metal braid to form a reinforced catheter.
  • the PEBAX adheres the metal braid (often stainless steel or Nitinol), interior liner (often PTFE) and marker bands commonly employed in such construction.
  • thermoplastic composite constructs are described.
  • a woven, knitted or braided fabric comprising comingled thermoplastic fibers.
  • the fabric may comprise comingled srPET (i.e., a combination of high melt and low melt PET) another option is comingled PEEK and PET tow from which the fabric is made.
  • the material may comprise a combination of a polymer (e.g., PET, PEEK, nylon, polypropylene, polyethylene) fiber and metal (e.g., stainless steel, Nitinol) fine wire (e.g., from about 0.0008 to about 0.002 inch diameter round wire or ribbon with comparable cross-sectional area and/or bending modulus).
  • the material may be combined within each tow as comingled material.
  • the different materials may be in different/separate tows that are twisted together and woven, knitted or braided together.
  • separate-material tows may by be woven, knitted or braided in a pattern together (optionally spooled together or by other means).
  • Yet another option is coating the reinforcing fiber (metal or polymer) with the matrix material that will flow upon heating to consolidate a composite structure.
  • the material selected should be any material selected.
  • the starting "fabric” material is defined as a construct with a repeating or regular pattern holding tow in place.
  • a portion of the fabric is reconfigured/reorganized and formed into an different operative structure.
  • a braided tube of fabric is provided.
  • the freed fibers and the fabric can be consolidated in an intermediate step or transitional state of production.
  • the braided tube becomes a reinforced shaft and the unbraided fibers may be set into straight or curved beams. These beams can then be woven, knotted, crocheted, knitted or otherwise combined.
  • One such combination is in the form of a cage, basket or a temporary stent, examples of which are illustrated in: US Patent Publication Nos. 2009/0069828 and 2009/0299393 (Lazzarus Effect), USPN 5,916,235 (Target Therapeutics), USPNs 8,066,757; 8,070,791 or 8,088, 140 (Mind Frame) and US Patent Publication Nos. 2004/0068314 or 2008/0039930 (Johnson & Johnson) or as in the eV3 SOLITAIRE stent stentriever.
  • the structure is heated, causing the matrix material to flow and set its final shape upon cooling (i.e., it is heat set).
  • the aforementioned beams may be fully consolidated. Alternatively they may be consolidated in sections, with sections only partially consolidated or left unconsolidated. Such locations can serve as hinge points. When fully unconsolidated (i.e., as in essentially virgin/fiber state) the fibers can be run-through as "eyelets" or crossing-points. Selective consolidation can be accomplished with a patterned heated "iron", ultrasonic weld head(s) or otherwise.
  • a tubular form of fabric is provided.
  • This material may comprise braid, rolled weave or knitted material, for example.
  • a distal end of the device is reconfigured by passing pins or rods through the fabric, displacing fibers and rearranging their position but not cutting or punching through them. So-prepared, upon consolidation an infusion catheter can be produced. It will include composite walls that are, in fact, reinforced around the openings/ports in the device.
  • the tows may be consolidated as straight rods or "sticks". In another approach, they are consolidated as pre-shaped subcomponents.
  • pre-shaped or not they are then combined in a new configuration and then consolidated or simply bonded by heating and allowing matrix material therein to completely or selectively fuse/weld the elements together.
  • unshaped i.e., straight
  • the subcomponents are typically reshaped at the working end of the device and reset in shape.
  • the second consolidation may simply fuse/weld and finalize the construction.
  • the present invention includes such features as described above in any
  • aspects of the invention include methods of manufacture, the completed devices themselves and the devices in intermediate stages of manufacture. Still further, aspects of the present invention includes methods associated with and/or activities implicit to the use of the devices described.
  • Fig. 1 A illustrates a braided tube of thermoplastic composite material
  • Fig. 1 B shows the material in Fig. 1 A with one end reconfigured
  • Fig. 1 C shows tooling for use in consolidating the material in a second reconfigured state
  • Fig. 1 D shows a final medical device product so-consolidated.
  • Fig. 2 is a flow chart illustrating the process of medical device production according to Figs. 1 A-1 D.
  • Figs. 3A and 3B illustrates the working end of another medical device during and after production.
  • FIGS. 4A and 4B illustrate individual perform elements of consolidated tow.
  • Fig. 5 illustrates the Fig. 4A and/or 4B elements assembled and consolidated in a final medical device construction in the form of a guide wire.
  • Fig. 1 A illustrates a braided tube 10 of thermoplastic composite material. It includes interlaced tows 12 of thermoplastic composite material.
  • the braid may have any number of such "ends" often provided in common multiples of 32, 48, 64, 72, 96, 144, 192 or 288 corresponding to even and half-loads of carriers on a given braider.
  • Fig. 1 B shows the tube 100' in Fig. 1 A with one side reconfigured delacing the individual tows 102 to provide free tow ends 14.
  • Fig. 1 C shows tooling 20 for use in consolidating the material in a second reconfigured state.
  • a form 22 may be provided with grooves, slots 24 or pins (not shown) in which (or around which) to set the freed tows 14 in configuring the shape of a working end of a medical device.
  • the tows (alone or grouped with others) may be secured in place using adhesive (e.g. , 4014 LOCTITE), selective application of heat (e.g. , with an ultrasonic head or soldering iron) or slipped into spring-loaded locks (not shown, but otherwise resembling suture locks).
  • An inner lumen within the braid may be maintained by inserting a mandrel 24 therein.
  • the construct (braid, reconfigured tow and internal tooling) is set within a two-piece mold 26, 28.
  • Various of the tooling elements may comprise stainless steel, or silicone rubber - the latter to facilitate pressure by expansion upon heating and release upon device cooling and being set in final shape.
  • Fig. 1 D shows a medical device 30 so-formed. It includes an (optionally
  • Marker bands or sleeves 38 are optionally affixed on thermoplastic composite extension underlying the same. The affixation may be accomplished by local re-heating and flowing of matrix material within the composite tow, by adhesive, crimping or otherwise.
  • FIG. 2 is a flow chart 50 illustrating the process of medical device production according to Figs. 1 A-1 D and/or other options. Processing of such a device may occur by a direct path vertically down the flowchart or with optional "shortcuts" as indicated by
  • thermosetting comprises heating at least a portion of the material causing the thermoplastic polymer matrix material to flow (typically without also flowing the material used in any polymer reinforcement filaments/fibers) and then cooling the thermoplastic polymer to set the device in the reconfigured shape.
  • Figs. 3A and 3B illustrates the working end of another medical device during and after production.
  • a tube 60 of fabric 62 is provided. It is set over a mandrel 64 (shown exposed by cutaway of the thermoplastic composite fiber tube for illustration only) with a plurality of pins or rods 66 passing through the fabric
  • FIG. 3B provides an overview of an infusion catheter 70 so-constructed.
  • a proximal body 72 is imperforate up to hub 74.
  • a distal perfusion section 76 includes a plurality of holes or ports 78 therein provided as discussed above.
  • FIGS. 4A and 4B illustrate individual perform elements 80 of consolidated tow.
  • the preforms may be more complex as in "corkscrew" end shaped elements 84 as shown in Fig. 4B.
  • the elements in Fig. 4B may be produced substantially as described above, using a form around which to wind turns 86 and a cavity to receive elongate portions 88.
  • Another alternative is to reshape consolidated rods 82 into shaped elements
  • the members 82/84 can be combined for form a medical device - in this case in the form of a guidewire 90 as illustrated in Fig. 5.
  • the guidewire comprises multiple sections defining different flex zones as common in the art.
  • a fused (as indicated by stippling) proximal section 92 maximum stiffness is provided by the combination of linear element orientation and monolithic construction.
  • a more distal non/unfused section 94 greater flexibility is achieved since the elongate elements can flex independently.
  • a distal-most shaft section 96 the elements are arranged in a multi-filar helical cable arrangement.
  • the turns 86, 86', etc. may be fused together at a distal atraumatic tip 98 or at strategic and varied locations along their length. The same holds true for section 94 (so as to make it a partially-fused section irrespective of the discussion above).
  • a straight or tapered core member 100 (optionally taper-ground NiTi,
  • the core member may be a mandrel over which the members are place for heat setting. Radio Frequency (RF) energy applied to the core member may be used to cause the heating. If any such core member/mandrel is used, it may be replaced with a different core member engineered (e.g., by taper grinding as typical in guidewire construction) for the desired flex performance of the final device.
  • RF Radio Frequency
  • invention herein is not intended to limit the scope of the claims in any manner. Rather it should be recognized that the "invention” includes the many variations explicitly or implicitly described herein, including those variations that would be obvious to one of ordinary skill in the art upon reading the present specification. Further, it is not intended that any section or subsection of this specification (e.g., the Summary, Detailed Description, Abstract, Field of the

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Pulmonology (AREA)
  • Chemical & Material Sciences (AREA)
  • Composite Materials (AREA)
  • Mechanical Engineering (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Vascular Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Materials For Medical Uses (AREA)

Abstract

La présente invention concerne des techniques de construction ainsi que des produits finis produits par celles-ci. L'invention décrit des constructions composites thermoplastiques reconfigurées. Les techniques sont particulièrement utiles pour la production de dispositifs médicaux composites thermoplastiques présentant des caractéristiques et des avantages uniques.
PCT/US2013/023298 2012-01-27 2013-01-25 Constructions composites thermoplastiques reconfigurées WO2013112938A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201261591569P 2012-01-27 2012-01-27
US61/591,569 2012-01-27

Publications (1)

Publication Number Publication Date
WO2013112938A1 true WO2013112938A1 (fr) 2013-08-01

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2013/023298 WO2013112938A1 (fr) 2012-01-27 2013-01-25 Constructions composites thermoplastiques reconfigurées

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996026671A1 (fr) * 1995-02-28 1996-09-06 Boston Scientific Corporation Instruments en polymere permettant de transmettre un couple
US20070038290A1 (en) * 2005-08-15 2007-02-15 Bin Huang Fiber reinforced composite stents
US20080169582A1 (en) * 2006-10-23 2008-07-17 Vipul Bhupendra Dave Method and apparatus for making polymeric drug delivery devices having differing morphological structures
EP2343028A1 (fr) * 2004-12-22 2011-07-13 Gore Enterprise Holdings, Inc. Dispositifs implantables filamentaires

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996026671A1 (fr) * 1995-02-28 1996-09-06 Boston Scientific Corporation Instruments en polymere permettant de transmettre un couple
EP2343028A1 (fr) * 2004-12-22 2011-07-13 Gore Enterprise Holdings, Inc. Dispositifs implantables filamentaires
US20070038290A1 (en) * 2005-08-15 2007-02-15 Bin Huang Fiber reinforced composite stents
US20080169582A1 (en) * 2006-10-23 2008-07-17 Vipul Bhupendra Dave Method and apparatus for making polymeric drug delivery devices having differing morphological structures

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