WO2003088869A2 - Dispositif médical - Google Patents

Dispositif médical Download PDF

Info

Publication number
WO2003088869A2
WO2003088869A2 PCT/IE2003/000055 IE0300055W WO03088869A2 WO 2003088869 A2 WO2003088869 A2 WO 2003088869A2 IE 0300055 W IE0300055 W IE 0300055W WO 03088869 A2 WO03088869 A2 WO 03088869A2
Authority
WO
WIPO (PCT)
Prior art keywords
support
filter
radiopaque
wire
vasculature
Prior art date
Application number
PCT/IE2003/000055
Other languages
English (en)
Other versions
WO2003088869A3 (fr
Inventor
Eamon Brady
David Vale
Original Assignee
Salviac 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 Salviac Limited filed Critical Salviac Limited
Priority to AU2003262374A priority Critical patent/AU2003262374A1/en
Publication of WO2003088869A2 publication Critical patent/WO2003088869A2/fr
Publication of WO2003088869A3 publication Critical patent/WO2003088869A3/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
    • 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
    • A61F2/0108—Both ends closed, i.e. legs gathered at both ends

Definitions

  • This invention relates to a medical device for transport through a body passageway and deployment in a body, in particular it relates to an intravascular medical device, such as an embolic protection filter.
  • This invention is aimed at overcoming at least some of the problems associates with known medical devices, and in particular at improving trackability.
  • a medical device having a collapsed configuration for transport through a body passageway, and an expanded configuration for deployment in a body;
  • the medical device comprising a support movable from the collapsed configuration to the expanded configuration to support the medical device in the expanded configuration; at least part of the support being of a multifilament wire construction.
  • each filament bends independently of the other filaments.
  • the overall force required to bend the support is a summation of the forces required to bend each filament. Because the force required to bend a wire is proportional to the fourth power of the diameter of the wire, the overall force required to bend the multifilament support is much less than the force which would be required to bend a single wire with the same overall diameter as the multifilament support.
  • the medical device of the invention achieves enhanced trackability during transport through even tortuous body passageways, while ensuring the medical device is moved by the support from the collapsed configuration to the expanded configuration upon deployment in the body.
  • the multifilament wire construction also provides the medical device with greater deformability in the expanded configuration. This enables the medical device to adapt to the particular characteristics of the body passageway in which it is deployed.
  • At least one filament is wound around at least one other filament.
  • the bending stress induced in the filament is reduced.
  • at least some of the filaments are braided together.
  • At least one filament is of a radiopaque material.
  • the radiopaque nature of the filament provides visualisation of the medical device during transport through and deployment in a body.
  • the radiopaque filament is ideally located substantially along the neutral axis of bending of the support.
  • At least one ilament may comprise a radiopaque core embedded within the filament.
  • the support comprises a jacket around the filaments.
  • the jacket helps to maintain the structure of the multifilament wire construction intact and ensure the filaments move in a co-ordinated manner.
  • the filaments are embedded within the jacket.
  • the jacket is at least partially of a radiopaque material.
  • the jacket may be at least partially of a polymeric material.
  • the support is of the multifilament wire construction at a point of high curvature in the expanded support.
  • the device is preferably an intravascular medical device for transport through a vasculature and deployment in a vasculature.
  • the device is an embolic protection filter.
  • the filter has an inlet end and an outlet end, the inlet end having one or more inlet openings sized to allow blood and embolic material enter the filter, and the outlet end having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embolic material within the filter.
  • the filter comprises a filter body supported by the support, and the inlet openings and the outlet openings are provided in the filter body to retain undesired embolic material within the filter body.
  • the filaments may define a mesh.
  • the inlet openings and the outlet openings are provided by openings through the mesh.
  • the support extends proximally of the inlet end.
  • the support comprises a tether.
  • the invention provides an embolic protection filter having a collapsed configuration for transport through a vasculature, and an expanded configuration for deployment in the vasculature, the filter comprising a support movable from the collapsed configuration to the expanded configuration, at least portion of the support being of a multifilament wire construction and at least one of the filaments is radiopaque.
  • Fig. 1 is a side view of a medical device according to the invention.
  • Fig. 2 is a perspective view of a support of the device of Fig. 1;
  • Fig. 3 is a perspective view of the support of Fig. 2 in use;
  • Figs. 4 to 6 are perspective views of supports of other medical devices according to the invention.
  • Fig. 7 is a perspective view of the support of Fig. 6 in use.
  • Figs. 8 to 12 are perspective views of supports of further medical devices according to the invention.
  • the medical device is an embolic protection filter 1 which has a collapsed configuration for transport through a vasculature, and an expanded configuration (Fig. 1) for deployment in a vasculature to filter undesired embolic material from the bloodstream flowing through the vasculature.
  • embolic protection filter 1 which has a collapsed configuration for transport through a vasculature, and an expanded configuration (Fig. 1) for deployment in a vasculature to filter undesired embolic material from the bloodstream flowing through the vasculature.
  • the filter 1 comprises a filter body 2 supported by a filter support 3.
  • the filter support 3 is a filter support 3.
  • the proximal end 9 of the filter support 3 is fixed to the inner tube 8, and the distal end 10 of the filter support 3 is fixed to a sleeve 11 which is slidable over the inner tube 8, so that the filter 1 is movable from the collapsed configuration to the expanded configuration to support the filter body 2 in the expanded configuration, as illustrated in Fig. 1.
  • the support 3 is of a multifilament wire construction.
  • the support 3 comprises seven Nitinol wires 21 wound in a spiral around a single radiopaque wire 22, the radiopaque wire 22 being located substantially along the axis of bending of the support 3.
  • the support 3 has the multifilament wire construction along the entire length of the support 3 in this instance.
  • each wire 21, 22 bends independently of the other wires.
  • the force required to bend the multifilament support 3 is minimised, and thus the filter 1 achieves enhanced trackability during transport through a tortuous vasculature, such as in coronary applications.
  • Nitinol wires 21 are wound in a spiral around the radiopaque wire 22, this configuration acts to decrease the bending stresses induced in each wire 21, 22 upon bending (Fig. 3).
  • the radiopaque wire 22 provides visualisation for a clinician during transport of the filter 1 through a vasculature and deployment of the filter 1 in the vasculature. Because the radiopaque wire 22 is located along the neutral axis of the support 3, the forces required to plastically deform the radiopaque wire 22 as the support 3 moves from the collapsed configuration to the expanded configuration, upon deployment of the filter 1, are minimised. In this way the dampening effect of the radiopaque material is minimised.
  • the filter body 2 has an inlet end 4 and an outlet end 5.
  • the inlet end 4 has one or more, and in this case two, large inlet openings 6 which are sized to allow blood and embolic material enter the filter body 2.
  • the outlet end 5 has a plurality of small outlet openings 7 which are sized to allow through passage of blood but to retain undesired embolic material within the filter body 2. In this way, the filter 1 captures and safely retains any undesired embolic material in the blood stream within the filter body 2 while facilitating continued flow of blood through the vascular system, which could otherwise have potentially catastrophic results.
  • the filter body 2 is supported by the filter support 3 so as to maximise the internal volume of the filter body 2 to capture and safely retain as much embolic material as possible.
  • the filter body 2 may be of an oriented polymeric material, as described in
  • the inner tube 8 has a guidewire lumen 12 therethrough for passing the filter 1 over a guidewire.
  • a guidewire is introduced into and advanced through a vasculature until the guidewire crossed a desired treatment location.
  • a delivery catheter is then used to deliver the embolic protection filter 1 through the vasculature over the guidewire, the filter 1 being housed within a distal pod of the delivery catheter in the collapsed configuration.
  • the filter 1 may, in one case, be loaded into a delivery catheter as described in International patent applications Nos. PCT/IE01/00052 and PCT/IE01/00053, the relevant contents of which are incorporated herein by reference.
  • the pod When the distal pod has been advanced to a desired site distal to the treatment location, the pod is moved proximally relative to an inner pusher to deploy the filter 1 out of the pod into the expanded configuration, as described in further detail in
  • An interventional procedure is then carried out at the treatment location.
  • a range of procedures are possible such as a stenting procedure using a self-expanding stent, a balloon angioplasty procedure, a balloon-expandable stenting procedure, an atherectomy procedure, a lysis.
  • Any embolic material generated during the interventional procedure is captured and safely retained in the deployed filter 1.
  • a retrieval catheter is introduced into the vasculature, and advanced through the vasculature until the treatment location has been crossed.
  • the filter 1 is then collapsed and retrieved into the retrieval catheter and with it the captured embolic material.
  • Fig. 4 illustrates a support 30 of another embolic protection filter according to the invention.
  • the support 30 comprises two radiopaque wires 31 around which are wound in a spiral a plurality of Nitinol wires 32.
  • a support 35 of a further embolic protection filter according to the invention is illustrated in Fig. 5.
  • the Nitinol wires 36 and the radiopaque wire 37 are braided together to form the multifilament wire support 35.
  • a support 40 of another embolic protection filter according to the invention.
  • the support comprises a single radiopaque wire 42 which extends substantially longitudinally, and a single Nitinol wire 41 which is wrapped around the radiopaque wire 42 in a coil.
  • the bending stress induced in the Nitinol wire 41 upon bending is substantially less than the bending stresses induced in a solid wire bent through the same angle.
  • a support 45 of another embolic protection filter is illustrated in Fig. 8.
  • a single Nitinol wire 47 extends substantially longitudinally, and a single radiopaque wire 46 is wrapped around the Nitinol wire 47 in a coil.
  • Fig. 9 illustrated part of a support 50 of another embolic protection filter according to the invention.
  • the support 50 is of a multifilament wire construction, and comprises two or more Nitinol wires 51.
  • the support 50 does not have any radiopaque wire filaments, instead radiopacity is achieved by a radiopaque core 52 embedded within at least one of the Nitinol wires 51.
  • the radiopaque core 52 is located substantially along the neutral axis of the Nitinol wire 51, and thus the force required to plastically deform the radiopaque core 52 during movement of the support 50 from the collapsed configuration to the expanded configuration is minimised, and the dampening effect of the radiopaque material is minimised.
  • Any suitable radiopaque material may be used for the radiopaque wire(s) 22, 31, 37, 42, 46 or the radiopaque core 52, such as gold, platinum, platinum iridium.
  • the support wire(s) 21, 32, 41, 47, 51 may be of any suitable superelastic material, or alternatively of a high strength material, such as stainless steel.
  • FIG. 10 there is illustrated a support 60 of another embolic protection filter according to the invention, which is similar to the support 3 of Figs. 1 to 3.
  • the support 60 comprises a jacket 63 of a polymeric material around the multifilament wires 61, 62.
  • the Nitinol wires 61 and the radiopaque wire 62 are embedded within the polymeric jacket 63.
  • a variety of manufacturing procedures, such as overmoulding, heat-shrinking, dipping, spraying, painting, depositing may be used to fabricate the wires 61, 67 embedded within the jacket 63.
  • the jacket 63 acts to maintain the structure of the multifilament wire construction intact, and ensures that the wires 61, 62 move in a co-ordinated manner.
  • Fig. 11 illustrates a support 70 of another embolic protection filter according to the invention, which is similar to the support 60 of Fig. 10.
  • the support 70 comprises five Nitinol wires 71 wound together in a spiral without any radiopaque wire filaments.
  • a radiopaque filter such as tungsten, bismuth subcarbonate, barium sulphate, may be loaded into the polymeric jacket 72 to achieve visualisation.
  • a jacket may be used with any of support structures described previously with reference to Figs. 1 to 9.
  • Fig. 12 illustrates a support 80 of a further embolic protection filter, which is similar to the support 35 of Fig. 5.
  • the Nitinol wires 82 and the radiopaque wire 81 are braided together and embedded in the polymeric jacket 83.
  • the multifilament wire construction may extend only partially along the support.
  • the support may only be of multifilament wire construction at point(s) which experience high curvature when the filter is in the expanded configuration.
  • the embolic protection filter comprises a filter support only without a separate filter body.
  • the wire filaments of the filter support define a mesh, and the inlet openings of the filter and the outlet openings of the filter are provided by openings through the filament mesh.
  • the filter captures and safely retains any undesired embolic material in the blood stream within the filter while facilitating continued flow of blood through the vascular system. Emboli are thus prevented from flowing downstream through the vascular system.
  • the multifilament support may extend proximally of the inlet end of the embolic protection filter in the form of a tether arm.
  • the tether facilitates greater control of the filter position in the vasculature, in particular during deployment of the filter.
  • the tether may be attached to the guidewire or may extend proximally through the vasculature for external control of the filter by the clinician.

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  • 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)
  • Surgical Instruments (AREA)

Abstract

La présente invention a trait un filtre de protection embolique dont au moins une partie du support (3) est une structure de fils multifilaments. Le support (3) comprend des fils de nitinol (21) enroulés en spirale autour d'un fil unique radio-opaque (22), le fil radio-opaque (22) étant disposé sensiblement selon l'axe de courbure du support (3). Lors de la flexion du support (3), par exemple lors d'un mouvement du support (3) vers une configuration expansée, chaque fil (21, 22) fléchît indépendamment des autres fils. Ainsi, la force requise pour la flexion du support (3) est minimisée, et donc le filtre (1) réalise une traçabilité améliorée lors de son transport à travers une vasculature sinueuse, tel que dans des applications coronaires. Etant donné que les fils de nitinol (21) sont enroulés en spirale autour du fil radio-opaque (22), cette configuration agit pour réduire les contraintes de flexion induites dans chaque fil (21, 22) lors d'une flexion. Le fil radio-opaque (22) fournit au clinicien une visualisation lors du transport du filtre (1) à travers une vasculature et du déploiement du filtre (1) dans la vasculature. Etant donné que le fil radio-opaque (22) est situé selon l'axe neutre du support (3), les forces requises pour la déformation plastique du fil radio-opaque (22) lors du mouvement du support (3) à partir d'une configuration d'affaissement vers une configuration expansée, lors du déploiement du filtre (1), sont minimisées. Ainsi l'effet amortisseur du matériau radio-opaque est minimisé.
PCT/IE2003/000055 2002-04-19 2003-04-15 Dispositif médical WO2003088869A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2003262374A AU2003262374A1 (en) 2002-04-19 2003-04-15 A medical device

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US37364002P 2002-04-19 2002-04-19
US60/373,640 2002-04-19

Publications (2)

Publication Number Publication Date
WO2003088869A2 true WO2003088869A2 (fr) 2003-10-30
WO2003088869A3 WO2003088869A3 (fr) 2004-03-25

Family

ID=29251053

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IE2003/000055 WO2003088869A2 (fr) 2002-04-19 2003-04-15 Dispositif médical

Country Status (2)

Country Link
AU (1) AU2003262374A1 (fr)
WO (1) WO2003088869A2 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE29880158U1 (de) 1997-11-07 2000-11-30 Salviac Ltd Embolieschutzgerät

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001060598A2 (fr) 2000-02-18 2001-08-23 Saes Getters S.P.A. Enveloppe sous vide d"isolation thermique et procede de fabrication
WO2002061336A1 (fr) 2001-02-01 2002-08-08 Sit La Precisa S.P.A. Melangeur air-gaz ameliore
WO2002062495A1 (fr) 2001-02-07 2002-08-15 Idrabel Italia S.R.L. Procede biotechnologique de regeneration d'hydrocarbures contenus dans des depots et des boues, a l'aide d'agents tensioactifs biologiques

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6361545B1 (en) * 1997-09-26 2002-03-26 Cardeon Corporation Perfusion filter catheter
US6602271B2 (en) * 2000-05-24 2003-08-05 Medtronic Ave, Inc. Collapsible blood filter with optimal braid geometry
US6866677B2 (en) * 2001-04-03 2005-03-15 Medtronic Ave, Inc. Temporary intraluminal filter guidewire and methods of use

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001060598A2 (fr) 2000-02-18 2001-08-23 Saes Getters S.P.A. Enveloppe sous vide d"isolation thermique et procede de fabrication
WO2002061336A1 (fr) 2001-02-01 2002-08-08 Sit La Precisa S.P.A. Melangeur air-gaz ameliore
WO2002062495A1 (fr) 2001-02-07 2002-08-15 Idrabel Italia S.R.L. Procede biotechnologique de regeneration d'hydrocarbures contenus dans des depots et des boues, a l'aide d'agents tensioactifs biologiques

Also Published As

Publication number Publication date
AU2003262374A1 (en) 2003-11-03
WO2003088869A3 (fr) 2004-03-25
AU2003262374A8 (en) 2003-11-03

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