CA2634717A1 - Systems and methods for closing a vessel wound - Google Patents

Systems and methods for closing a vessel wound Download PDF

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Publication number
CA2634717A1
CA2634717A1 CA002634717A CA2634717A CA2634717A1 CA 2634717 A1 CA2634717 A1 CA 2634717A1 CA 002634717 A CA002634717 A CA 002634717A CA 2634717 A CA2634717 A CA 2634717A CA 2634717 A1 CA2634717 A1 CA 2634717A1
Authority
CA
Canada
Prior art keywords
anchor member
sealing member
suture
outer sheath
vessel
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
CA002634717A
Other languages
French (fr)
Other versions
CA2634717C (en
Inventor
David Szabo
David Gale
Paul Johnson
Valerie Scott
Ben Morris
Greg Furnish
Trevor Beckett
Michael J. Ii Trezza
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.)
Cordis Corp
Original Assignee
Cordis Corporation
David Szabo
David Gale
Paul Johnson
Valerie Scott
Ben Morris
Greg Furnish
Trevor Beckett
Michael J. Ii Trezza
Ethicon, 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
Application filed by Cordis Corporation, David Szabo, David Gale, Paul Johnson, Valerie Scott, Ben Morris, Greg Furnish, Trevor Beckett, Michael J. Ii Trezza, Ethicon, Inc. filed Critical Cordis Corporation
Publication of CA2634717A1 publication Critical patent/CA2634717A1/en
Application granted granted Critical
Publication of CA2634717C publication Critical patent/CA2634717C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A61B17/04—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
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0467—Instruments for cutting sutures
    • 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
    • A61B17/0487—Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • 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
    • 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
    • A61B2017/0404—Buttons
    • 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
    • A61B2017/0414—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having a suture-receiving opening, e.g. lateral opening
    • 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
    • A61B2017/0445—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors cannulated, e.g. with a longitudinal through-hole for passage of an instrument
    • 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
    • A61B2017/0446—Means for attaching and blocking the suture in the suture anchor
    • A61B2017/0448—Additional elements on or within the anchor
    • A61B2017/0451—Cams or wedges holding the suture by friction
    • 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
    • A61B2017/0464—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft 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
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166—Sutures
    • A61B2017/06176—Sutures with protrusions, e.g. barbs

Abstract

A vessel wound closure system (100) comprising: an introducer (110); an outer sheath (120) slidably disposed through the introducer (110) and having a proximal first position, a distal second position at, or beyond, a distal end of the introducer, and a partially withdrawn third postion; an inner sheath (130) slidably disposed through the outer sheath (120) and having a proximal first position, and a distal second position at, or beyond, a distal end of the outer sheath in the third position; a handle (140) associated with the outer sheath and the inner sheath; a plunger (150) extending through the handle (150); a sealing member (170) configured to deploy from a distal end of the outer sheath (120) when the outer sheath is in the third position; an anchor member (180) configured to deploy from a distal end of the inner sheath (130) by depression of the plunger (150); and a suture (160) connecting the sealing member (170) with the anchor member (180).

Claims (35)

1. A vessel wound closure system comprising:
an outer sheath;
a delivery rod slidably disposed within the outer sheath;
a guidewire slidably associated with the delivery rod;
a sealing member deployably housed within the delivery rod;
an anchor member deployably housed within the delivery rod;
a suture connecting the sealing member and the anchor member, whereby the outer sheath and delivery rod are configured such that at a first position the outer sheath prevents the sealing member, the suture, and the anchor member from deploying and at a second position, when the outer sheath and delivery rod have been moved relative to one another, the sealing member, the suture; and the anchor member are deployable.
2. The vessel wound closure system of claim 1, wherein the sealing member is an intravascular sealing member, and the anchor member is an extravascular anchor member.
3. The vessel wound closure system of claim 1, wherein the delivery rod further comprises an exterior channel and a tapered distal section through which the guidewire slides for locating the system within a target vessel.
4. The vessel wound closure system of claim 3, wherein the delivery rod further comprises a first recess in which the sealing member is oriented for deployment therefrom; a second recess in which the anchor member is oriented for deployment therefrom, and an open channel extending between the first recess and the second recess, in which open channel the suture connecting the sealing member and the anchor member is oriented for deployment therefrom.
5. The vessel wound closure system of claim 4, further comprising a tamping tool, at least a portion of which is disposed within the delivery rod.
6. The vessel wound closure system of claim 4, wherein the suture further comprises a connecting portion that connects the sealing member with the anchor member, and an accessible portion that extends proximally of the delivery rod for manipulation thereof by an operator, the connecting portion of the suture being oriented in the open channel of the delivery rod.
7. The vessel wound closure system of claim 6, wherein the anchor member further comprises at least one passageway through which some of the connecting portion of the suture extends.
8. The vessel wound closure system of claim 7, wherein the connecting portion of the suture further comprises one way barbs that pass through the at least one passageway of the anchor member to tighten and secure the anchor member in place relative to the sealing member.
9. The vessel wound closure system of claim 1, wherein the sealing member and the anchor member are comprised of bioresorbable material.
10. The vessel wound closure system of claim 1, wherein the sealing member is larger than the anchor member.
11. The vessel wound closure system of claim 10, wherein the sealing member is elliptical with a width less than an inner diameter of the delivery rod.
12. The vessel wound closure system of claim 10, wherein the sealing member is cylindrical with a diameter less than an inner diameter of the delivery rod.
13. The vessel wound closure system of claim 1, wherein the suture is comprised of bioresorbable material.
14. The vessel wound closure system of claim 5, further comprising a cutting element, at least a portion of which is disposed within the delivery rod.
15. A method of closing a vessel wound in a patient, comprising:
providing a delivery rod having a sealing member and anchor member therein connected by a suture;
inserting the delivery rod through an outer sheath and into the target vessel over a guidewire;
partially withdrawing the outer sheath to deploy the sealing member within the target vessel;
partially withdrawing the outer sheath and the delivery rod to orient the sealing member against an inner wall of the target vessel;
drawing the suture taught and maintaining the sealing member in place;
withdrawing the outer sheath further to deploy the anchor member outside the target vessel and the connecting suture through the vessel wound;
further drawing the suture to tighten the anchor member relative to the sealing member; and securing the suture in place to effect the seal of the vessel wound by the anchor member and the sealing member.
16. The method of claim 15, further comprising:
tamping or maintaining the anchor member in place against the outside surface of the target vessel as tightening of the anchor member and the sealing member occurs.
17. The method of claim 16, further comprising:
securing the suture in place with one way barbs provided on the suture that pass through the anchor member as tightening of the anchor member and the sealing member occurs.
18. The method of claim 17, further comprising:
cutting excess suture and removing the delivery rod, guidewire, outer sheath and the excess suture from the patient after tightening and securing has occurred.
19. A vessel wound closure system comprising:
an introducer;
an outer sheath slidably disposed through the introducer and having a proximal first position, a distal second position at, or beyond, a distal end of the introducer, and a partially withdrawn third postion;
an inner sheath slidably disposed through, the outer sheath and having a proximal first position, and a distal second position at, or beyond, a distal end of the outer sheath in the third position;
a handle associated with the outer sheath and the inner sheath;
a plunger extending through the handle;
a sealing member configured to deploy from a distal end of the outer sheath when the outer sheath is in the third position;
an anchor member configured to deploy from a distal end of the inner sheath by depression of the plunger; and a suture connecting the sealing member with the anchor member.
20. The vessel wound closure system of claim 19, further comprising a support rod associated with the plunger within the inner sheath.
21. The vessel wound closure system of claim 20, wherein the support rod further comprises a tamper at a distal end thereof, a recessed portion, and a cutting member.
22. The vessel wound closure system of claim 20, wherein the introducer further comprises a flared end and the outer sheath further comprises a hub, wherein the hub of the outer sheath is received within the flared end of the introducer when the outer sheath is in the proximal first position.
23. The vessel wound closure system of claim 19, wherein the inner sheath further comprises an angled exit port.
24. The vessel wound closure system of claim 19, wherein the sealing member is larger than the anchor member.
25. The vessel wound closure system of claim 19, wherein the suture is comprised of bioresorbable material attached to the sealing member and through the anchor member.
26. The vessel wound closure system of claim 19, wherein the suture further comprises a connecting portion between the sealing member and the anchor member, the connecting portion having one way barbs that pass through at least one passageway of the anchor member to tighten and secure the anchor member and the sealing member relative to one another.
27. The vessel wound closure system of claim 19, wherein the anchor member further comprises prongs that extravascularly penetrate the target vessel to secure the anchor member and the sealing member relative to one another to effect a seal of the vessel wound.
28. ,The vessel wound closure system of claim 19, wherein the anchor member further comprises an m-shaped member that extravascularly penetrates the target vessel to secure the anchor member and the sealing member relative to one another to effect a seat of the vessel wound.
29. A method of closing a vessel wound in a patient, comprising:
providing an introducer;
providing an assembly of an outer sheath, an inner sheath, a handle and a plunger;

providing a sealing member connected to an anchor member via a suture within the assembly;
inserting the outer sheath through the introducer from a proximal first postion, to a distal second position such that a distal end of the outer sheath is located at, or beyond, a distal end of the suture, and partially withdrawing the outer sheath proximally to a third position to deploy the sealing member within a target vessel;
moving the handle distally to locate the inner sheath from a proximal first position to a distal second position such that a distal end of the inner sheath is located at, or beyond, the distal end of the outer sheath in the third position;
partially retracting the assembly to orient the sealing member against the inner surface of the target vessel;
depressing the plunger to expel the anchor member from the inner sheath and dispose the anchor member extravascularly of the target vessel; and securing the anchor member and the sealing member relative to one another to maintain the seal.
30. The method of claim 29, further comprising providing a support rod connected to the plunger within the inner sheath, and tamping or maintaining the anchor member in place with a distal end of the support rod as the suture is pulled further to tighten the anchor member and the sealing member.
31. The method of claim 30, further comprising cutting excess suture material after tightening and securing of the anchor member and the sealing member has occurred.
32. The method of claim 29, wherein the securing is achieved by one way barbs provided on the connecting portion of the suture that pass through the anchor member as tightening occurs.
33. The method of claim 29, wherein the securing is achieved by prongs of the anchor member that extravascularly penetrate into the exterior surface of the target vessel as tightening occurs.
34. The method of claim 29, wherein the securing is achieved by an m-shaped anchor member that extravascularly penetrates into the exterior surface of the target vessel as tightening occurs.
35. The method of claim 29 further comprising providing a flared end in the introducer into which the outer sheath is received to determine the distal second position of the outer sheath at, or beyond, a distal end of the introducer and within the target vessel.
CA2634717A 2005-12-23 2006-12-14 Systems and methods for closing a vessel wound Expired - Fee Related CA2634717C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US11/317,478 US8267942B2 (en) 2005-12-23 2005-12-23 Systems and methods for closing a vessel wound
US11/317,478 2005-12-23
PCT/US2006/047667 WO2007078812A2 (en) 2005-12-23 2006-12-14 Systems for closing a vessel wound

Publications (2)

Publication Number Publication Date
CA2634717A1 true CA2634717A1 (en) 2007-07-12
CA2634717C CA2634717C (en) 2011-09-27

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Family Applications (1)

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CA2634717A Expired - Fee Related CA2634717C (en) 2005-12-23 2006-12-14 Systems and methods for closing a vessel wound

Country Status (10)

Country Link
US (2) US8267942B2 (en)
EP (2) EP1976438B1 (en)
JP (2) JP5138607B2 (en)
CN (2) CN101389276B (en)
AT (2) ATE469604T1 (en)
AU (1) AU2006333048B2 (en)
CA (1) CA2634717C (en)
DE (1) DE602006014732D1 (en)
MX (1) MX2008008345A (en)
WO (1) WO2007078812A2 (en)

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