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WO2006003451A2 - Procede pour former une structure tubulaire - Google Patents

Procede pour former une structure tubulaire Download PDF

Info

Publication number
WO2006003451A2
WO2006003451A2 PCT/GB2005/002648 GB2005002648W WO2006003451A2 WO 2006003451 A2 WO2006003451 A2 WO 2006003451A2 GB 2005002648 W GB2005002648 W GB 2005002648W WO 2006003451 A2 WO2006003451 A2 WO 2006003451A2
Authority
WO
WIPO (PCT)
Prior art keywords
former
mould
tubular structure
fluid
channel
Prior art date
Application number
PCT/GB2005/002648
Other languages
English (en)
Other versions
WO2006003451A3 (fr
Inventor
Anthony Walter Anson
Original Assignee
Anson Medical Limited
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 Anson Medical Limited filed Critical Anson Medical Limited
Publication of WO2006003451A2 publication Critical patent/WO2006003451A2/fr
Publication of WO2006003451A3 publication Critical patent/WO2006003451A3/fr

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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having an inflatable pocket filled with fluid, e.g. liquid or gas

Definitions

  • the present invention relates to an expandable medical device and to a method of forming a tubular structure for use in such a device, hi particular it relates to a method whereby tubular structures may be produced using a material in a liquid form that can be caused to change to a solid by a chemical reaction.
  • the liquid material is injected into a separable, closed cavity mould having internal channels conforming to a desired geometry. Within the internal pathways resides a removable core for forming a lumen.
  • the injected liquid may be converted to a solid by means of a chemical reaction between two or more component chemicals.
  • Reaction injection moulding also well known in the art, uses a similar principle except that a catalysing and/or exothermic reaction causes solidification of the liquid. This has the advantage of not having to heat the liquid media before it is poured into a closed cavity mould.
  • a suitable receptacle contains metal, which has been heated sufficiently to form a liquid. Said liquid is then poured into a mould and allowed to cool and solidify.
  • the mould commonly made of particular sand and binding resins
  • the mould is configured to resist the effects of high temperatures, which may be more than 2000 degrees Celsius, depending upon the type of metal used.
  • Metal die-casting also well known in the art, and uses a closed cavity mould in a similar fashion to plastic injection moulding.
  • the injectable media is in the form of a metal with a relatively low melting point such as zinc-based and aluminium alloys.
  • a method for forming a tubular structure comprising the steps of: (a) providing a mould cavity having at least one removable former therein,
  • tubular structures are made of a settable media that in one form is liquid and in its other form is set, due to a chemical reaction upon mixing two or more components.
  • a liquid media is poured or injected into a mould, having two or more separable parts.
  • the internal geometry of the mould is arranged to accommodate a removable component.
  • This removable component is preferably a low melting point metal alloy.
  • Said alloy can be arranged, depending upon its elemental composition, to have a melting point of 28 degrees Celsius to several hundred degrees Celsius. In this case, ideally the low melting point alloy has a melting point within the range 30 to 120 degrees Celsius.
  • a removable component made of said low melting point alloy is arranged to have dimensions which are generally smaller than the internal dimension of the closed-cavity mould within which it resides.
  • a settable media is now injected into the mould, it will fill the voids between the mould and removable component.
  • a catalysing or polymerising reaction now takes place, causing the injected media to solidify.
  • the mould assembly is now heated to a temperature at, or slightly above the melting point of the alloy insert.
  • the alloy is then poured out of the mould in its liquid form.
  • the separable mould is now disassembled, facilitating removal of the moulded part.
  • Such a moulding process may be applied advantageously to the manufacture of simple or complex tubular forms. For example, if a round, hollow tube with a series of round, hollow attachments arranged to be in-line and perpendicular to the axis of the structure, is required. If the main tube is required to be 25mm outside diameter and the attachment tubes 20mm diameter, both tube forms having a 2mm wall thickness. A two-part separable mould is then manufactured, having half of the form of the required structure in one half of the mould; a mirror form of the required geometry is generated in the other half-mould.
  • Another separable mould is then manufactured to make a low melting point alloy core.
  • the diametral outer dimension of the core is 21mm for the larger "parent" tube and 16mm for the manifolded attachment tubes.
  • Low melting point alloy is then heated to change to a liquid form.
  • a hypodermic syringe of suitable capacity can be used to scavenge the liquid metal.
  • the syringe is then used to inject the alloy into the closed cavity. If a syringe is used for this, a Luer-type injection port is positioned appropriately to connect the internal volume of the mould.
  • the metal alloy can be caused to flow using a hydrostatically derived pressure differential between the internal volume of the mould and the alloy. If a container, for the liquid metal is suspended above the mould and suitable pipes or tubes connect the liquid metal container to the mould, liquid metal will then flow into said mould, internal volume due to hydrostatic pressure.
  • a liquid polymer is now injected into the mould assembly, surrounding the voids between low melting point alloy core and mould cavity. If the moulding is made from a two, or multi-part silicone elastomer, a reduction in the time taken to effect polymerisation may be gained by heating the mould. However, the elevated curing temperature must be below the softening or melting point of the low melting point alloy.
  • the low melting point alloy is melted out of the mould, the mould is then disassembled and the cast artefact removed.
  • the low melting point alloy can comprise any other material capable of being a liquid at one temperature, a solid at another temperature.
  • An example of one such material is wax.
  • a body formed of at least one flexible material said body being convertible from a collapsed condition in which it is of a size to be inserted into the lumen into an expanded condition in which the body is fixed relative to the lumen,
  • inlet means communicating with said at least one inner channel to enable a rigidifying material to be introduced into said inner channel so that, in use, at least said region of said body can be rigidified Whereby to maintain the body in its expanded condition.
  • the at least one inner channel is preferably formed by means of a method as described above.
  • the at least one inner channel is employed in an expandable device as disclosed in WO 99/00073 (in the name of the present applicant), the contents of which are incorporated herein by reference.
  • the liquid inflating media is preferably selected so that it is capable of changing to a solid by polymerisation or catalysation.
  • the inflated device now becomes a structure capable of resisting radial and longitudinal deformations.
  • Both WO 99/00073 and US 6395019 disclose inflatable devices for use in vascular repair or maintenance in the human or other mammalian species, particularly using endo vascular techniques.
  • a separable inner tubular structure could be advantageously employed as a means to transport the injected media within the cavities resident inside the inflatable devices. This would give additional security against potential leakage of said injectable media.
  • a graft as described in the two cited patents has a limitation regarding ultimate inflation pressures. These limitations are determined by strength of material, geometry and manufacturing techniques. If the inflatable cavities were lined with a tubular structure whose geometry was similar to the cavities' geometry, increased inflation pressures can be realised.
  • a tubular graft being constructed of a material capable of expanding or stretching within an elastic limit
  • an advantage can be gained by allowing a nominally sized graft (when fully inflated), to cover an increased diametral size range as the inflation pressure and consequent inflation forces can be increased.
  • Grafts for the treatment of aneurysmal disease are invariably sized against the patient directly, from X- ray or ultrasound derived images, in the case of endovascular treatment.
  • One of the side arms can be everted inside the main body of the device; this allows what appears to be a single tube, to be inserted into an artery through a small incision.
  • the everted side-arm can now be reverted to produce a prominent extension from the artery.
  • An artery or suitable graft can now be affixed about the extension, forming the side- anastomosis.
  • the "Y" shaped tube is formed within a split-mould having a removable core.
  • a polymer in liquid form is injected into the mould assembly.
  • the polymer now sets to form a solid, conforming to a "Y" shaped tubular structure.
  • the removable core preferably a low melting point alloy is heated to form a liquid that can be poured out of the mould.
  • the split mould is then taken apart and the moulding removed.
  • a low melting point alloy as described, is to act as a removable core in a moulding process to produce interconnected tubular structures.
  • the low melting point alloy can be substituted by one of many commonly available metals or suitable polymers.
  • Metals such as stainless steels, brass alloys aluminium and titanium in elemental or alloy forms and polymers such as PTFE, nylons, polycarbonate, acrylics, polysulphone, PEEK, PVC could all be used to form a core in tubular structures.
  • a preferred metal or polymer having a nominally round or polygonal cross-section is machined to length and to closely mate with an essentially gap-less contact at one or both ends of the material.
  • the example of a bifurcated anastomosis device would require two round sections of the core former material to connect at an acute angle and to have a means of maintaining the spatial relationship between core element and moulding.
  • the two core forming elements consist of two straight members: one member has flat plain ends, the second member has one plain end face, the opposite end is machined with a profile that mimics the cross- section of member one. This profiled end when offered-up to member one, should be in intimate contact with half the circumference of member one. This intimate contact prevents or reduces the potential of a viscous pre-cured settable media perfusing into any gaps existing between the connected parts.
  • a split, two-part mould has a fabricated metal core placed within its mould cavity.
  • the mould halves are furnished with registrations to ensure precise placement of the core assembly.
  • the two mould halves are clamped together with the core assembly constrained within.
  • a settable resin is now injected into the mould cavity expelling air and surrounding the core.
  • the resin now sets to a solid and the mould halves are separated.
  • Each part of the core assembly is withdrawn and the moulding removed.
  • Certain settable resins will have an adhesive effect, making removal of the core element difficult.
  • a release agent or other lubricious material can be employed on the mould cavity and core assembly. Examples of such release agents are silicon oils, PTFE, waxes and a range of lubricating-type oils and greases. Other lubricious agents are diamond-like carbon or PTFE.
  • FIG.l Example of interconnected tubular structure to be inserted within an inflatable tubular vascular graft.
  • FIG. 1 A tubular structure in the form of bifurcated graft.
  • Fig 4 A low melting point alloy removable core to make a bifurcated graft.
  • Fig.5 Tubular structure comprised of circular and straight parts.
  • Fig.6 A cast, low melting point alloy form used to generate the lumen of an interconnected tubular structure as shown in Fig 1.

Landscapes

  • Health & Medical Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (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)
  • Materials For Medical Uses (AREA)

Abstract

Un procédé pour former une structure tubulaire consiste à former une cavité de moule possédant au moins un élément formateur amovible; à ajouter un fluide dursissable à la cavité de moule autour de l'élément formateur amovible; à permettre au liquide de durcir; et à retirer l'élément formateur de manière à laisser la structure tubulaire formée à partir dudit fluide durci. La structure tubulaire peut être employée en tant que canal interne dans un dispositif médical extensible.
PCT/GB2005/002648 2004-07-06 2005-07-06 Procede pour former une structure tubulaire WO2006003451A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0415152.8 2004-07-06
GB0415152A GB0415152D0 (en) 2004-07-06 2004-07-06 Interconnected tubular structures

Publications (2)

Publication Number Publication Date
WO2006003451A2 true WO2006003451A2 (fr) 2006-01-12
WO2006003451A3 WO2006003451A3 (fr) 2006-04-27

Family

ID=32865531

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2005/002648 WO2006003451A2 (fr) 2004-07-06 2005-07-06 Procede pour former une structure tubulaire

Country Status (2)

Country Link
GB (1) GB0415152D0 (fr)
WO (1) WO2006003451A2 (fr)

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5411550A (en) * 1991-09-16 1995-05-02 Atrium Medical Corporation Implantable prosthetic device for the delivery of a bioactive material
US5871537A (en) * 1996-02-13 1999-02-16 Scimed Life Systems, Inc. Endovascular apparatus
GB9713624D0 (en) * 1997-06-28 1997-09-03 Anson Medical Ltd Expandable device
WO2000048530A1 (fr) * 1999-02-16 2000-08-24 Talison Research, Inc. Greffon vasculaire multicouche et multifonction
US6312462B1 (en) * 1999-09-22 2001-11-06 Impra, Inc. Prosthesis for abdominal aortic aneurysm repair
US6926735B2 (en) * 2002-12-23 2005-08-09 Scimed Life Systems, Inc. Multi-lumen vascular grafts having improved self-sealing properties
US7803178B2 (en) * 2004-01-30 2010-09-28 Trivascular, Inc. Inflatable porous implants and methods for drug delivery

Also Published As

Publication number Publication date
WO2006003451A3 (fr) 2006-04-27
GB0415152D0 (en) 2004-08-11

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