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WO2015085107A1 - Fil et son procédé de fabrication - Google Patents

Fil et son procédé de fabrication Download PDF

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Publication number
WO2015085107A1
WO2015085107A1 PCT/US2014/068648 US2014068648W WO2015085107A1 WO 2015085107 A1 WO2015085107 A1 WO 2015085107A1 US 2014068648 W US2014068648 W US 2014068648W WO 2015085107 A1 WO2015085107 A1 WO 2015085107A1
Authority
WO
WIPO (PCT)
Prior art keywords
wire
aspect ratio
cross
section
flattening
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/US2014/068648
Other languages
English (en)
Inventor
Thomas R. MOLZ
Robert A. Kiefer
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.)
US BIODESIGN LLC
Original Assignee
US BIODESIGN 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 US BIODESIGN LLC filed Critical US BIODESIGN LLC
Publication of WO2015085107A1 publication Critical patent/WO2015085107A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2002/016—Filters implantable into blood vessels made from wire-like elements

Definitions

  • Braiding of fine wires is a common manufacturing process used to make certain medical devices, such as the braided occlusion device of PCT Pub. No. WO 2011/147784, filed May 23, 2011, which is incorporated by reference herein in its entirety, other braided vascular filters such as pulmonary embolism thrombectomy baskets or filters, braided tubing (incl uding reinforcement within the wall of an otherwise non-braided element (e.g. embedded or inside of catheter walls), or combinations thereof,
  • Figure 1 illustrates braided implantable device 1, such as a stent or vascular filter, having a low braid angle, such as 30°
  • Figure 2 illustrates a higher braid angle, such as 75°.
  • the braiding process imparts a large amount of cyclic bending stress into each of the wires.
  • the wire may be cycled as high as 300 times during manufacturing.
  • the higher braid angles impart significantly more cycles of stress into the wires during manufacturing, as compared to lower braid angles,
  • Wires partially flattened to have cross-sectional aspect ratios from about 1.05: 1 to about 3: 1, more narrowly from about 1.1 : 1 to about 2: 1 , yet more narrowly from about 1 , 1 : 1 to about 1.3:1, even more narrowly from about 1.1:1 to about 1.2: 1 are disclosed, Medical devices, such as those listed herein, and elements thereof can be made by braiding the wires,
  • An implantable medical device can have a vascular filter comprising a braided wire having a longitudinal axis.
  • a cross-section of the wire transverse to the longitudinal axis can have a first curved side diametrically opposite to a second curved side, and a first flat side diametric lly opposite to a second flat side.
  • the cross -section of the wire can have has an aspect ratio as disclosed herein.
  • An implantable raedicai device can have a braid comprising a wire.
  • the wire can ha ve a perpendicular transverse cross-section with an aspect ratio as disclosed herein.
  • the wire can have a first curved side diametrically opposite to a second curved side, and a first flat side diametrically opposite to a second flat side.
  • a method for making a vascular filter device is disclosed herein.
  • the method can include forming a wire having a longitudinal axis and a circular cross-section.
  • the method can further include flattening the wire.
  • Flattening can include flattening a top side and a bottom side of the wire.
  • Flattening can reduce the aspect ratio of the cross-section from 1:1 to the aspect ratios disclosed herein.
  • the method can further include winding the wire to form at least part of the filter device. Winding can include braiding the wire.
  • Figures 1 and 2 are illustrations of braided medical tubes having lower and higher braid angles, respectively.
  • Figures 3 is a cross-sectional view of a variation of an unfiattened wire, not the invention.
  • Figures 4 and 5 are cross- section views of variations of partially-flattened wires.
  • Figure 6 illustrates a fi nite element stress analysis of a variation of an unfiattened wire in a braid.
  • Figure 7 illustrates a finite element stress analysis of a variation of a partial!y- flattened wire in a braid.
  • Figure 8 i llustrates a variation of a method of making the partially- flattened wire.
  • Figure 3 illustrates that an unfiattened wire 2 having a circular cross-section transverse to the longitudinal axis of the wire can have a height 4 equal to the width 6.
  • the height 4 and width 6 of the unfiattened circular cross-section are equal to the diameter.
  • the aspect ratio of the unfiattened circular wire is 1 : 1 (i.e., ratio of height to width).
  • Figures 4 and 5 illustrate that the wire can have a partially flattened top and bottom (the orientation of the flattening is merely stated as top and bottom for explanatory purposes, but can be in any orientation with flattening occurring on diametrically opposite sides of the cross-section).
  • the diametrically opposite sides of the wire adjacent to the flattened top and bottom can remain curved with the same curvature of the pre-flattened wire, or the curvature can increase due to deformation of the wire.
  • the aspect ratio of the flattened wire can be 1.1 : 1 s as shown in Figure 4, and 1.2: 1 as show in Figure 5.
  • the width of the flattened wires can increase slightly compared to the original circular cross- section wire.
  • Figure 6 shows the amount of bending stress creating in wire during current art braiding of round wires (i.e., wires with circular cross-sections, such as shown in Figure 3).
  • Figure 7 shows the bending stress within the wires when a slightly flattened wire ⁇ such as those shown in Figures 4 or 5 - is used. This analysis shows a reduction in bending stress of 1 .3% compared to the bending stress of the unfiattened wire of Figure 6.
  • Radial force the partially flattened wire can increase from about 20% to about 100% over convention round wire. Wire coverage in a braid ranges increase from about 40% coverage to about 80% coverage with the partially flattened wire. Braid angles from 140 degrees max with round wire to as high as 170 degrees with slightly flattened wire.
  • a wire having a circular cross-section can be rolled between two metal rollers 10, as shown in Figure 8.
  • spacers can be placed between the rollers.
  • spacers ca support the bearings of the axles holding the rollers.
  • the spacers can space the axles 12 farther apart than during wire rolling performed under dimensions previously used in the art for manufacture of wire for medical devices,
  • the rollers 10 ca deliver the same amount, of pressure as the rollers 10 would deliver without the spacers, but the rollers 10 can be spaced apart so as to only flatten the wire 2 to the desired dimension.
  • the wire can have a pre-rolled height 4a that can be greater than a post-rolled height 4b.
  • the wire's cross section can provide the following possible exemplary advantages for the braiding of such fiber:
  • the partially flattened shape of the wire disclosed herein can allow for higher densities— higher braid angles and picks/inch.
  • Slightly flattened wire 2 can increase braid angles by as much as 30 degrees, and increase the density by as much as 60% coverage of the surface of a braid compared to the use of wire having a circular cross section .
  • Second moment of inertia is a propert of a geometric shape.
  • a second moment of inertia indicates how a shape resists bending.
  • the thinner the wire. the easier the wire is able to bend, but if the wire is too thin, the aspect ratio becomes too large to be useful.

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne des fils aplatis et des dispositifs fabriqués à partir de ceux-ci. L'invention concerne également des procédés d'utilisation desdits fils pour fabriquer lesdits dispositifs. Lesdits fils peuvent présenter des facteurs de forme de section transversale supérieurs à 1:1 et inférieurs à 3:1. Il est possible d'enrouler ou de tresser lesdits fils afin d'obtenir des dispositifs médicaux implantables, tels que des filtres vasculaires.
PCT/US2014/068648 2013-12-04 2014-12-04 Fil et son procédé de fabrication Ceased WO2015085107A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361911964P 2013-12-04 2013-12-04
US61/911,964 2013-12-04

Publications (1)

Publication Number Publication Date
WO2015085107A1 true WO2015085107A1 (fr) 2015-06-11

Family

ID=53274137

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2014/068648 Ceased WO2015085107A1 (fr) 2013-12-04 2014-12-04 Fil et son procédé de fabrication

Country Status (1)

Country Link
WO (1) WO2015085107A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6500203B1 (en) * 1997-01-23 2002-12-31 Boston Scientific Scimed, Inc. Process for making stent graft with braided polymeric sleeve
US20040049260A1 (en) * 2002-09-05 2004-03-11 Scimed Life Systems, Inc. Flat knitted stent and method of making the same
US20110166638A1 (en) * 2006-02-28 2011-07-07 C. R. Bard, Inc. Flexible stretch stent-graft
US20120022634A1 (en) * 2006-06-30 2012-01-26 Tyco Healthcare Group Lp Medical devices with amorphous metals and methods therefor
US20130226222A1 (en) * 2011-02-28 2013-08-29 Mitchell Donn Eggers Absorbable Vascular Filter

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6500203B1 (en) * 1997-01-23 2002-12-31 Boston Scientific Scimed, Inc. Process for making stent graft with braided polymeric sleeve
US20040049260A1 (en) * 2002-09-05 2004-03-11 Scimed Life Systems, Inc. Flat knitted stent and method of making the same
US20110166638A1 (en) * 2006-02-28 2011-07-07 C. R. Bard, Inc. Flexible stretch stent-graft
US20120022634A1 (en) * 2006-06-30 2012-01-26 Tyco Healthcare Group Lp Medical devices with amorphous metals and methods therefor
US20130226222A1 (en) * 2011-02-28 2013-08-29 Mitchell Donn Eggers Absorbable Vascular Filter

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