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WO2012061368A1 - Matériaux composites résistant aux perforations - Google Patents

Matériaux composites résistant aux perforations Download PDF

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Publication number
WO2012061368A1
WO2012061368A1 PCT/US2011/058761 US2011058761W WO2012061368A1 WO 2012061368 A1 WO2012061368 A1 WO 2012061368A1 US 2011058761 W US2011058761 W US 2011058761W WO 2012061368 A1 WO2012061368 A1 WO 2012061368A1
Authority
WO
WIPO (PCT)
Prior art keywords
puncture resistant
assembly
resistant members
guard
composite
Prior art date
Application number
PCT/US2011/058761
Other languages
English (en)
Inventor
Nicholas J. Manesis
Kaustubh S. Chitre
Dustin B. Leslie
Nikhil S. Trilokekar
Original Assignee
Allergan, 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
Priority claimed from PCT/US2011/023467 external-priority patent/WO2011097292A1/fr
Priority claimed from US13/105,715 external-priority patent/US8636797B2/en
Priority claimed from US13/178,392 external-priority patent/US20110306827A1/en
Application filed by Allergan, Inc. filed Critical Allergan, Inc.
Priority to EP11785210.3A priority Critical patent/EP2635236A1/fr
Priority to AU2011323515A priority patent/AU2011323515A1/en
Priority to CA2816526A priority patent/CA2816526A1/fr
Publication of WO2012061368A1 publication Critical patent/WO2012061368A1/fr

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B3/00—Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar shape; Layered products comprising a layer having particular features of form
    • B32B3/02—Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar shape; Layered products comprising a layer having particular features of form characterised by features of form at particular places, e.g. in edge regions
    • B32B3/08—Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar shape; Layered products comprising a layer having particular features of form characterised by features of form at particular places, e.g. in edge regions characterised by added members at particular parts
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B25/00—Layered products comprising a layer of natural or synthetic rubber
    • B32B25/04—Layered products comprising a layer of natural or synthetic rubber comprising rubber as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B25/00—Layered products comprising a layer of natural or synthetic rubber
    • B32B25/20—Layered products comprising a layer of natural or synthetic rubber comprising silicone rubber
    • A—HUMAN NECESSITIES
    • A41—WEARING APPAREL
    • A41D—OUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
    • A41D19/00—Gloves
    • A41D19/015—Protective gloves
    • A41D19/01505—Protective gloves resistant to mechanical aggressions, e.g. cutting. piercing
    • A—HUMAN NECESSITIES
    • A41—WEARING APPAREL
    • A41D—OUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
    • A41D31/00—Materials specially adapted for outerwear
    • A41D31/04—Materials specially adapted for outerwear characterised by special function or use
    • A41D31/24—Resistant to mechanical stress, e.g. pierce-proof
    • A41D31/245—Resistant to mechanical stress, e.g. pierce-proof using layered materials
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/12—Mammary prostheses
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2274/00—Thermoplastic elastomer material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/50—Properties of the layers or laminate having particular mechanical properties
    • B32B2307/58—Cuttability
    • B32B2307/581—Resistant to cut
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2571/00—Protective equipment
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2571/00—Protective equipment
    • B32B2571/02—Protective equipment defensive, e.g. armour plates or anti-ballistic clothing

Definitions

  • the present invention generally relates to puncture resistant materials and more specifically relates to puncture resistant materials, including implantable puncture resistant materials .
  • Puncture resistant or puncture proof materials and fabrics for protection of the human body are well known. Puncture resistant materials are used for form protective armor, gloves, helmets, boots, and shields.
  • the present invention provides assemblies, for example, puncture resistant assemblies and methods of making the same.
  • puncture resistant assemblies are provided which are useful as components of surgical implants, for example, but not limited to, needle guards as components of inflatable implants that are accessed with a needle and syringe.
  • Such implants for which the present materials are useful include inflatable tissue expanders.
  • Other implants that can benefit from the present invention include fluid access ports which include a fluid reservoir and needle penetratable septum.
  • puncture resistant or puncture proof assemblies of the invention can be highly beneficial, for example, as a means for preventing a needle tip from penetrating other areas of the device that are not intended to be punctured.
  • Other beneficial uses for the present assemblies will become more apparent upon reading the present specification, and are considered to be included within the scope of the invention.
  • puncture resistant assemblies are provided which are flexible and/or formable into desired configurations.
  • puncture resistant assemblies are provided which are both flexible and resilient.
  • Some of the present assemblies have the characteristic of shape memory, such that after being rolled or folded, they can resume an original shape or configuration.
  • This aspect of the invention is particularly, but certainly not exclusively, useful for application in a surgical environment, in which the assembly may be in the form of a puncture proof material is rolled or folded into a narrow configuration, thereby enabling insertion thereof through a relatively small incision.
  • some of the assemblies of the invention are structured to be able to automatically resume an original, pre-deformed shape, for example, automatically, once the material is at the desired implantation site.
  • a puncture resistant assembly which generally comprises a first composite guard, a second composite guard, and an intermediate layer securing the first and second composite guards together and/or containing the first and second composite guards.
  • Each of the first and second composite guards generally comprises an arrangement of puncture resistant elements or members, and a flexible substrate on which the members are secured and positioned, generally in a spaced-apart relationship .
  • the members may be in the form of domes or plates.
  • the members have a hardness effective to resist penetration, puncture or breakage upon forceful contact with a sharp surface, for example, a tip of a needle, an edge of a cutting implement such cL S cL SCSlpel or knife, or the like.
  • the members may be made of any suitable material, such as a hard moldable substance, for example, a high durometer elastomer, polymer or rubber. Other suitable materials include metals, ceramics, and alloys thereof.
  • the flexible substrate on which the members are disposed may comprise a fabric, mesh, film, elastomer, or other material .
  • the first composite guard and the second composite guard are disposed with respect to one another such that the arrangement of members of the first composite guard is offset or misaligned with respect to the arrangement of members of the second composite guard.
  • a third composite guard is provided. The third composite guard may be positioned with respect to the first and second composite guards such that the members of the third composite guard are misaligned with the members of at least one of the first and second composite guards.
  • the misaligned or overlapping members of the adjacent composite guards provide a puncture resistant, or puncture proof, area while not significantly sacrificing flexibility of the assembly as a whole. That is, the composite guards may be arranged such that there are no significant gaps between individual puncture resistant members. It can be appreciated that depending upon the use of the final assembly, there may be some gaps between members so long as the gaps are sufficiently narrow to resist or prevent penetration by the type of instrument that the assembly is intended to be protected against puncture from.
  • the puncture resistant members of the composite guards may provide a area of protection that substantially entirely covers a first side of the needle guard assembly.
  • the assembly may further comprise a intermediate layer, for example, an elastomer, securing together the first and second composite guards such that the members maintain their offset relationship.
  • the intermediate layer may be located between adjacent composite guards and may be bonded thereto.
  • the intermediate layer seals the flexible composite members together and encapsulates the composite guards.
  • the intermediate layer may be an fluid tight barrier containing the two or more layered composite guards.
  • the intermediate layer exhibits a springiness and resiliency or provides a shape memory characteristic to the assembly.
  • the method may comprise the step of providing an intermediate layer between the composite guards. In some embodiments, the method may comprise the step of encasing or encapsulating the composite guards in a fluid tight seal .
  • an inflatable implantable device which includes a puncture resistant assembly as described herein.
  • Figure 2 is an exploded view of the prosthesis shown in Fig. 1 in order to illustrate certain components of the puncture resistant assembly
  • Figure 3 is a top view of a composite guard which is a component of the puncture resistant assembly shown in Fig. 1;
  • Figure 5 is a cross-sectional view of the composite guard taken along line 5-5 of Figure 4;
  • Figure 6 is a cross-sectional view, similar to the view shown in Figure 5, of an alternative composite guard in accordance with certain aspects of the invention.
  • Figure 6a is a cross-sectional view, similar to the view shown in Figure 5, of yet another composite guard in accordance with certain aspects of the invention.
  • the present invention provides puncture resistant assemblies.
  • the assemblies are useful, for example, in the prevention of needle puncture in any number of devices which would beneficially include such a puncture resistant assembly as described herein.
  • the assemblies of the invention may be useful components of an implantable device, such as an inflatable prosthesis, a fluid access port, or any number of devices that is implanted in a body and which is accessed by a needle but which requires a portion to function as a needle stop.
  • an implantable device such as an inflatable prosthesis, a fluid access port, or any number of devices that is implanted in a body and which is accessed by a needle but which requires a portion to function as a needle stop.
  • the materials can be used, for example, as a needle stop of an inflatable tissue expander.
  • assemblies of the invention include, but are not limited to, personal items and effects such as gloves, garments and equipment.
  • Such items include garments for use in the medical industry, such as gloves for surgical use.
  • Other uses include garments and equipment for sports and outdoors enthusiasts, for example, people engaged in fishing, hunting, and similar activities in which a puncture resistant material would be beneficial.
  • Other uses include uniforms for protecting a wearer from industrial injuries in factories, on construction sites, in solid waste handling facilities, and in other such hazardous environments.
  • Device 10 is expanded or inflated by insertion of a needle 13 (Figure 1) through bladder which form a fillable portion 12 and introduction of fluid into cavity 12a.
  • Portion 12 may include an access port (not shown) with a needle penetratable septum, or may be made partially or entirely of a puncturable, but self sealing material. Suitable self sealing materials are described in U.S. Provisional Patent Application No. 61/301,910, filed on February 10, 2010 and in U.S. Patent Application No. 12/543,795, filed on August 19, 2009, the entire specifications of which are incorporated herein by this reference.
  • the device can be equipped with assembly 14.
  • the assembly 14 generally comprises a first composite guard 16 and a second composite guard 18.
  • the assembly further includes a third composite guard 20.
  • only two composite guards or more than three composite guards are provided.
  • An intermediate layer 24 is provided between adjacent guards, for example, between guard 16 and guard 18, and likewise between guard 18 and guard 20.
  • Each of composite guards 16, 18, 20 includes a plurality of, for example, an arrangement, array, or pattern of, puncture resistant members 30, and a flexible substrate 32 having a first side on which the puncture resistant members 30 are disposed in a generally spaced apart fashion.
  • the first composite guard 16 and the second composite guard 18 are positioned such that the arrangement of puncture resistant members 30 of the second composite guard 18 are misaligned with the arrangement of puncture resistant members 30 of the first composite guard 16.
  • the second composite guard 18 and the third composite guard 20 may be positioned such that the arrangement of puncture resistant members of the third composite guard 20 are misaligned with the arrangement of puncture resistant members of at least one of the first composite guard 16 and the second composite guard 18.
  • the composite guards 16, 18, 20 are arranged relative to one another such that there are no straight line open spaces, or substantial gaps, between members 30 to allow a needle or sharp implement to penetrate entirely through the assembly 14.
  • the assembly 14 as a whole may be quite flexible in that the substrate 32 on which the spaced apart 30 members are disposed is supple, flexible and/or bendable .
  • the intermediate layer 24 may comprise a flexible, connecting material which is effective to couple or bond the first composite guard 16 with the second composite guard 18, and the second composite guard 18 with the third composite guard 20. As shown in Fig. 2, the intermediate layer 24 is positioned between the arrangement of puncture resistant members 30 of the first layer 16 and the flexible substrate 32 of the second layer 18, and another intermediate layer 24 is positioned between the arrangement of puncture resistant members 30 of the second layer 18 and the flexible substrate 32 of the third layer 20.
  • the composite guards 16, 18, 20 may be identical to one another, and for the sake of simplicity, only the first composite guard 16 will now be described, with the understanding that, in the shown embodiment, what is described for the first composite guard 16 is also applicable to second composite guard 18 and third composite guard 20.
  • the members 30 may be any suitable shape.
  • the members 30 are somewhat dome shaped with rounded surfaces.
  • members 30a may be planar as illustrated in Fig. 6.
  • the members 30b may include both rounded surface and planar or flat surfaces, such as the members 30b which are dome shaped with a flat upper surface, as illustrated in Fig. 6a.
  • the members 30 have a thickness of between about 0.1 mm and about 1.0 mm, for example, a thickness of between about 0.2 mm and about 0.5 mm for example, between about 0.1 mm and about 1.0 mm.
  • the members 30 have a spacing D of between about 0.2 mm and about 0.5 mm.
  • the members 30 have a diameter of between about 0.5 mm and about 2.0 mm, for example, a diameter of about 1.5mm.
  • the guard 16 includes between about 50 and about 1000 members per square inch (psi) , for example, about 400 psi.
  • the guard 16 include about
  • the members 30 are made of a suitable puncture resistant material, such as an epoxy, polymer, rubber, cermamic or metal, or suitable combination or alloy thereof.
  • suitable materials include polyethylene (PE) , polypropylene (PP) , polyurethane (PU) , polyethylene terephthalate (PET) , piolycarbonate (PC) , Polyisoprene (PI), thermoplastic urethanes and thermoplastic polyurethanes (TPU) , high durometer silicones, acrylonitrile butadiene styrene (ABS) etc.
  • the members 30 are made of material selected from acetal, nylon, and polycarbonate.
  • the members 330 are made of a metal, for example, stainless steel, aluminum, titanium, or other metal .
  • the flexible substrate 32 may comprise a mesh, film, fabric, elastomer, or other suitable material.
  • the intermediate layer 24 may be a polymer, for example, an elastomeric polymer, for example, a silicone elastomer, for example, a low durometer silicone rubber.
  • the assembly 14 has a resiliency or a shape memory such that it will restore from a folded or rolled configuration to an original, different configuration.
  • the original configuration may be a generally flat or planar configuration. This may be provided by using a suitable intermediate layer material, such as a silicone elastomer that has a shape memory characteristic.
  • Assembly of the guard assembly 14 may be accomplished as follows and as shown in Figures 7-9.
  • guard 16 generally comprising members 30 and substrate 32, is made by any suitable method, including stencil printing, for example, using equipment and processes used in surface mount technology/PCB fabrication. Other processes that can be used to make the guard 16 include micro-dot dispensing and printing, laser etching. Other suitable methods will be known to those of skill in the art.
  • intermediate layer 24 may be formed as follows.
  • a suitable material for example, a sheet of uncured silicone, is placed on one side of the guard 16, for example, on the side having members 30 and substrate 32.
  • the sheet is then subjected to curing conditions to cause the sheet to adhere to the members 30, forming intermediate layer 24 thereon. In the presently described example embodiment, this step is done three times, with three separate guards 16, 18, 20, to form the components 16', 18' and 20' of assembly 14. (See Figure 8a) .
  • the assembly 14 is then placed in an oven or otherwise subjected to further curing conditions to seal the assembly components together such as shown in Fig. 9.

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  • Prostheses (AREA)

Abstract

L'invention concerne un ensemble pare-aiguille comprenant une première protection composite (16) et une deuxième protection composite (18) comprenant chacune un agencement d'éléments résistant aux perforations sur un substrat souple. La première protection composite et la deuxième protection composite sont positionnées de telle façon que l'agencement d'éléments résistant aux perforations de la deuxième protection composite soit désaligné par rapport à l'agencement d'éléments résistant aux perforations de la première protection composite. L'ensemble comprend en outre une couche intermédiaire disposée entre la première protection composite et la deuxième protection composite et reliant celles-ci.
PCT/US2011/058761 2010-11-02 2011-11-01 Matériaux composites résistant aux perforations WO2012061368A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP11785210.3A EP2635236A1 (fr) 2010-11-02 2011-11-01 Matériaux composites résistant aux perforations
AU2011323515A AU2011323515A1 (en) 2010-11-02 2011-11-01 Puncture resistant composite materials
CA2816526A CA2816526A1 (fr) 2010-11-02 2011-11-01 Materiaux composites resistant aux perforations

Applications Claiming Priority (12)

Application Number Priority Date Filing Date Title
US40944010P 2010-11-02 2010-11-02
US40944910P 2010-11-02 2010-11-02
US61/409,449 2010-11-02
US61/409,440 2010-11-02
PCT/US2011/023467 WO2011097292A1 (fr) 2010-02-05 2011-02-02 Prothèses gonflables et procédés de fabrication de celles-ci
USPCT/US2011/023467 2011-02-02
US13/021,523 2011-02-04
US13/021,523 US20110288639A1 (en) 2010-02-05 2011-02-04 Inflatable prostheses and methods of making same
US13/105,715 US8636797B2 (en) 2010-02-05 2011-05-11 Inflatable prostheses and methods of making same
US13/105,715 2011-05-11
US13/178,392 US20110306827A1 (en) 2010-02-05 2011-07-07 Needle guard to protect access port tubing
US13/178,392 2011-07-07

Publications (1)

Publication Number Publication Date
WO2012061368A1 true WO2012061368A1 (fr) 2012-05-10

Family

ID=44999915

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2011/058761 WO2012061368A1 (fr) 2010-11-02 2011-11-01 Matériaux composites résistant aux perforations

Country Status (4)

Country Link
EP (1) EP2635236A1 (fr)
AU (1) AU2011323515A1 (fr)
CA (1) CA2816526A1 (fr)
WO (1) WO2012061368A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014042940A1 (fr) * 2012-09-12 2014-03-20 Allergan, Inc. Prothèses gonflables et leurs procédés de fabrication
US9387068B2 (en) 2008-08-20 2016-07-12 Allergan, Inc. Self-sealing shell for inflatable prostheses
US9416908B2 (en) 2014-02-26 2016-08-16 James Richard CHAMPLONE Deployable plug system

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9016321B1 (en) 2014-02-26 2015-04-28 Jim Champlone Deployable culvert plug system

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1992020519A1 (fr) * 1991-05-24 1992-11-26 Allied-Signal Inc. Composites souples comprenant des panneaux rigides pouvant se plier et articles fabriques avec ces derniers
US20010052141A1 (en) * 2000-03-15 2001-12-20 Andersen Lars P. Protective garment material
WO2002010667A2 (fr) * 2000-07-06 2002-02-07 Higher Dimension Medical, Inc. Tissu souple resistant a la penetration et son procede de fabrication
WO2003057462A1 (fr) * 2001-12-31 2003-07-17 Higher Dimension Medical, Inc. Tissu resistant a la penetration pourvu d'ensembles de plaques de protection a multiples couches et procede de fabrication
WO2003059617A2 (fr) * 2002-01-11 2003-07-24 Higher Dimension Medical, Inc. Materiau polymere a structure resistante et procede de fabrication
GB2392077A (en) * 2002-02-15 2004-02-25 Safety Distrib Ltd Clothing resistant to penetration by needles

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1992020519A1 (fr) * 1991-05-24 1992-11-26 Allied-Signal Inc. Composites souples comprenant des panneaux rigides pouvant se plier et articles fabriques avec ces derniers
US20010052141A1 (en) * 2000-03-15 2001-12-20 Andersen Lars P. Protective garment material
WO2002010667A2 (fr) * 2000-07-06 2002-02-07 Higher Dimension Medical, Inc. Tissu souple resistant a la penetration et son procede de fabrication
WO2003057462A1 (fr) * 2001-12-31 2003-07-17 Higher Dimension Medical, Inc. Tissu resistant a la penetration pourvu d'ensembles de plaques de protection a multiples couches et procede de fabrication
WO2003059617A2 (fr) * 2002-01-11 2003-07-24 Higher Dimension Medical, Inc. Materiau polymere a structure resistante et procede de fabrication
GB2392077A (en) * 2002-02-15 2004-02-25 Safety Distrib Ltd Clothing resistant to penetration by needles

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9387068B2 (en) 2008-08-20 2016-07-12 Allergan, Inc. Self-sealing shell for inflatable prostheses
US9630366B2 (en) 2008-08-20 2017-04-25 Allergan, Inc. Self-sealing shell for inflatable prostheses
WO2014042940A1 (fr) * 2012-09-12 2014-03-20 Allergan, Inc. Prothèses gonflables et leurs procédés de fabrication
US9416908B2 (en) 2014-02-26 2016-08-16 James Richard CHAMPLONE Deployable plug system

Also Published As

Publication number Publication date
AU2011323515A1 (en) 2013-06-13
CA2816526A1 (fr) 2012-05-10
EP2635236A1 (fr) 2013-09-11

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