CA2473451A1 - Vascular hole closure device - Google Patents

Vascular hole closure device Download PDF

Info

Publication number
CA2473451A1
CA2473451A1 CA002473451A CA2473451A CA2473451A1 CA 2473451 A1 CA2473451 A1 CA 2473451A1 CA 002473451 A CA002473451 A CA 002473451A CA 2473451 A CA2473451 A CA 2473451A CA 2473451 A1 CA2473451 A1 CA 2473451A1
Authority
CA
Canada
Prior art keywords
aperture
elongated member
legs
vessel
curved
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.)
Granted
Application number
CA002473451A
Other languages
French (fr)
Other versions
CA2473451C (en
Inventor
Peter W. J. Hinchliffe
James F. Mcguckin, Jr.
Richard T. Briganti
Walter H. Peters
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.)
Rex Medical LP
Original Assignee
Individual
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 US10/163,142 external-priority patent/US7341595B2/en
Application filed by Individual filed Critical Individual
Publication of CA2473451A1 publication Critical patent/CA2473451A1/en
Application granted granted Critical
Publication of CA2473451C publication Critical patent/CA2473451C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00637—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for sealing trocar wounds through abdominal wall
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646—Type of implements
    • A61B2017/00659—Type of implements located only on one side of the opening
    • 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

Abstract

A device for closing an aperture in a vessel wall comprising an elongated member positionable inside the vessel against an internal opening of the aperture and having a dimension exceeding a dimension of the internal opening of the aperture to prevent egress of fluid through the aperture, and at least two curved legs positionable outside the vessel to help retain the elongated member in position.

Claims (54)

WHAT IS CLAIMED IS:
1. A device for closing an aperture in a vessel wall, the aperture having an external opening in an external region of the vessel wall and an internal opening in an internal region of the vessel wall, the device comprising:
an elongated member having a longitudinal axis and positionable inside the vessel against the internal opening of the aperture, the elongated member having a dimension at least substantially equal to a dimension of the internal opening of the aperture to prevent egress of fluid through the aperture; and at least two curved legs positionable outside the vessel to help retain the elongated member in position.
2. The device of claim 1, wherein the at least two curved legs are wires composed of shape memory material.
3. The device of claim 1, further comprising a connecting member to couple the curved legs to the elongated member.
4. The device of claim 3, wherein the connecting member comprises a flexible wire having a first portion connected to the elongated member and a second portion connected to a retaining member for the curved legs.
5. The device of claim 4, wherein the retaining member is a collar which secures the curved legs therein.
6. The device of claim 1, further comprising a tube connected to the elongated member for moving the elongated member toward the internal opening of the aperture, the tube having a series of slots for flexibility and an opening to receive and retain the at least two curved legs.
7. The device of claim 1 wherein the elongated member has a first portion of a first width and a second portion of a second width greater than the first width.
8. The device of claim 7, wherein the elongated member is paddle-shaped so the first portion is at one end of the elongated member and a second portion is at an adjacent second end of the elongated member.
9. The device of claim 1, further comprising a retaining member for securing the curved legs, the retaining member coupled to the elongated member.
The device of claim 1, wherein the elongated member has first and second ends, a lengthwise dimension and a widthwise dimension, the lengthwise dimension exceeding the widthwise dimension, and the widthwise dimension having an enlarged dimension at a region between the first and second ends of the elongated member.
11. The device of claim 1, wherein the elongated member is composed of a resorbable material.
12. The device of claim 1, wherein the at least two legs comprise four discrete wire elements, wherein opposing wire elements are spaced approximately 180 degrees apart.
13. The device of claim 1, wherein the elongated member is biased to a position transverse to an axis extending from the external opening to the internal opening of the aperture.
14. An apparatus for closing an aperture in a vessel comprising:
a closure device having an aperture covering member and a at least one leg connected to the covering member, the covering member and the at least one leg being movable between an insertion position and a deployed position;
wherein in the insertion position the covering member is substantially parallel to a longitudinal axis of the aperture and in the deployed position the covering member is substantially perpendicular to the longitudinal axis of the aperture on a first side of the aperture, and the at least one leg in the insertion position is in a substantially straightened position and in the deployed position has a curved configuration to grasp tissue on a second side of the aperture.
15. The apparatus of claim 14, further comprising a connecting wire coupled to the covering member and connecting the at least one leg to the covering member.
16. The apparatus of claim 14, wherein the at least one curved leg is composed of wire elements which extend downwardly toward the vessel and inwardly toward the aperture in the deployed position.
17. The apparatus of claim 14, wherein the aperture covering member has an enlarged width portion.
18. An apparatus for closing an aperture in a vessel, the apparatus comprising a patching member and a retaining member, the patching member positioned inside the vessel in contact along a portion of the inner vessel wall and having a dimension at least substantially equal to a dimension of the aperture to cover the aperture and prevent blood flow through the aperture, the retaining member positioned outside the vessel wall and including a at least one gripping element which extends inwardly toward the aperture and directs tissue towards the aperture.
19. The apparatus of claim 18, wherein the at least one gripping element comprises a plurality of spaced apart curved legs composed of shape memory material.
20. The apparatus of claim 19, further comprising a flexible member connecting the patching member to the retaining member.
21. A system for closing an aperture in a vessel wall comprising:
a) a closure device having an aperture covering member and a retaining member, the aperture covering member positionable inside the vessel and dimensioned to cover an internal side of the aperture in the vessel wall, and the retaining member having a plurality of curved legs engaging tissue outside the vessel; and b) a delivery instrument for delivering the closure device, the delivery instrument having a holding member releasably engagable with the closure device to position the closure device and to release the closure device.
22. The system of claim 21, wherein the holding member comprises a slotted tube releasably positioned over a portion of the closure device.
23. The system of claim 22, wherein the slotted tube is positioned over a collar which retains the curved legs.
24. A system for closing an aperture in a vessel wall comprising:
a) a closure device having an aperture covering member and a retaining member, the aperture covering member positionable inside the vessel and dimensioned to cover an internal side of the aperture in the vessel wall, and the retaining member having a plurality of curved legs engaging tissue outside the vessel;
and b) a delivery instrument for delivering the closure device, the delivery instrument having an outer tube and a pusher slidably disposed within the outer tube, wherein the pusher engages the retaining member to advance the covering member from the outer tube.
25. The system of claim 24, wherein the delivery instrument is insertable through an introduces sheath such that a distal end of the outer tube remains proximal of a distal end of the introduces sheath.
26. The system of claim 25, wherein the delivery instrument is snap fitted onto an introduces sheath.
27. The system of claim 24, wherein the pusher has a plurality of longitudinal slots to receive the curved legs when in a straightened position within the delivery instrument.
28. The system of claim 27, further comprising a retention mechanism for retaining the pusher in an initial position and in an advanced position to deploy the retaining member.
29. The system of claim 24, wherein a portion of the outer tube has a diameter less than a lengthwise dimension of the aperture covering member so that the portion of the outer tube bulges outwardly when the covering member is positioned therein.
30. A method for closing an aperture in a vessel wall comprising:
providing a closure device having an elongated member and a plurality of retention legs;
deploying the elongated member in the vessel to cover a first internal side of the aperture; and deploying the retention legs outside the vessel wall, the legs assuming a curved configuration to grasp tissue on a second external side of the aperture.
31. The method of claim 30, wherein the step of deploying the elongated member comprises the step of actuating a pusher to advance the elongated member distally.
32. The method of claim 30, further comprising the steps of placing an introducer sheath through the aperture into the vessel and connecting a delivery instrument containing the closure device to the introducer sheath.
33. The device of claim 1, wherein the at least two curved legs are formed from a single element of metallic material.
34. The device of claim 33, wherein the at least two curved legs are composed of shape memory material.
35. The device of claim 34, wherein the metallic element is formed to separate at a first end into curved leg regions and further formed with a tab at a second end to couple the curved legs to the elongated member.
36. The device of claim 35, wherein the elongated member has a slot formed therein to receive the tab.
37. The device of claim 33, wherein the legs curve in a direction substantially parallel to the longitudinal axis of the elongated member.
38. The device of claim 33, wherein the legs curve in a direction substantially perpendicular to the longitudinal axis of the elongated member.
39. The device of claim 33, wherein the elongated member is oval shaped with a substantially uniform width between a first and second end portion.
40. The device of claim 33, wherein the elongated member is composed of a resorbable material.
41. The device of claim 33, wherein the elongated member has a first thickness at an end portion and second greater thickness at a central portion.
42. The device of claim 33, wherein the at least two legs comprises two legs positioned approximately 180 degrees apart.
43. The device of claim 1, wherein the legs curve in a direction substantially perpendicular to the longitudinal axis of the elongated member.
44. The device of claim 43, wherein the elongated member has a U-shaped channel with first and second openings to receive the legs.
45. The device of claim 43, wherein the elongated member has a first thickness at an end portion and second greater thickness at a central portion.
46. The device of claim 43, wherein the elongated member is oval shaped with a substantially uniform width between a first and second end portion.
47. The device of claim 43, wherein the elongated member is composed of a resorbable material.
48. The device of claim 47, wherein the at least two curved legs are composed of shape memory material.
49. The device of claim 43, wherein the at least two curved legs are composed of shape memory material.
50. The device of claim 43, wherein a portion of the curved legs extend beyond the widthwise dimension of the elongated member.
51. The device of claim 43, wherein the legs are connected to the elongated member at an acute angle.
52. The device of claim 1, wherein the at least two curved legs are connected to the elongated member at an acute angle and positionable outside the vessel to help retain the elongated member in position, the legs curved in different directions.
53. The device of claim 52, wherein the elongated member further comprises a channel to receive the curved legs.
54. The device of claim 52, wherein the elongated member has first and second openings and the legs are connected to the elongated member via the first and second openings.
CA2473451A 2002-02-06 2003-01-31 Vascular hole closure device Expired - Fee Related CA2473451C (en)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US35552602P 2002-02-06 2002-02-06
US60/355,526 2002-02-06
US10/163,142 US7341595B2 (en) 1999-09-13 2002-06-05 Vascular hole closure device
US10/163,142 2002-06-05
US10/345,533 US7267679B2 (en) 1999-09-13 2003-01-16 Vascular hole closure device
US10/345,533 2003-01-16
PCT/US2003/002934 WO2003065898A2 (en) 2002-02-06 2003-01-31 Vascular hole closure device

Publications (2)

Publication Number Publication Date
CA2473451A1 true CA2473451A1 (en) 2003-08-14
CA2473451C CA2473451C (en) 2012-03-27

Family

ID=27739051

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2473451A Expired - Fee Related CA2473451C (en) 2002-02-06 2003-01-31 Vascular hole closure device

Country Status (6)

Country Link
US (2) US7267679B2 (en)
EP (1) EP1480567B1 (en)
JP (1) JP4335690B2 (en)
AU (1) AU2003210767B2 (en)
CA (1) CA2473451C (en)
WO (1) WO2003065898A2 (en)

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US20070293880A1 (en) 2007-12-20
US7267679B2 (en) 2007-09-11
JP2005516659A (en) 2005-06-09
AU2003210767B2 (en) 2008-05-15
WO2003065898A3 (en) 2004-01-08
WO2003065898A2 (en) 2003-08-14
US20030144695A1 (en) 2003-07-31
CA2473451C (en) 2012-03-27
EP1480567A2 (en) 2004-12-01
EP1480567B1 (en) 2013-08-21
JP4335690B2 (en) 2009-09-30
AU2003210767A1 (en) 2003-09-02
US8128653B2 (en) 2012-03-06

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