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WO1998031287A1 - Obturateur hemostatique bioabsorbable - Google Patents

Obturateur hemostatique bioabsorbable Download PDF

Info

Publication number
WO1998031287A1
WO1998031287A1 PCT/US1998/001189 US9801189W WO9831287A1 WO 1998031287 A1 WO1998031287 A1 WO 1998031287A1 US 9801189 W US9801189 W US 9801189W WO 9831287 A1 WO9831287 A1 WO 9831287A1
Authority
WO
WIPO (PCT)
Prior art keywords
closure device
puncture
blood vessel
patient
access sheath
Prior art date
Application number
PCT/US1998/001189
Other languages
English (en)
Inventor
Bradley D. Huss
Original Assignee
Tyco Group S.A.R.L.
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 Tyco Group S.A.R.L. filed Critical Tyco Group S.A.R.L.
Priority to EP98902674A priority Critical patent/EP0961580A4/fr
Priority to JP53469798A priority patent/JP2002515797A/ja
Priority to AU59274/98A priority patent/AU5927498A/en
Priority to CA002278243A priority patent/CA2278243C/fr
Publication of WO1998031287A1 publication Critical patent/WO1998031287A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • A61B2017/00004—(bio)absorbable, (bio)resorbable or resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • 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
    • A61B2017/00654—Type of implements entirely comprised between the two sides of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • 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
    • A61B2017/00672—Locating means therefor, e.g. bleed back lumen

Definitions

  • One form of the present invention preferably includes a sealing assembly consisting of a vessel closure device including an elongate bioabsorbable rod member having an anchor member on the distal end thereof.
  • the anchor member is preferably prestressed to extend laterally from the distal end of the rod member after insertion while being sufficiently flexible to be aligned with the lengthwise dimension of the rod member during insertion of the closure device into the incision.
  • the rod member also preferably includes a collagen tube extending along a portion thereof, locking groove and a retainment ring which is slidable lengthwise along the rod member.
  • the collagen tube of the closure device includes a distal end which is preferably sized and slightly blunt shaped so that the distal end of the collagen tube is reliably positioned proxi ally of the outer surface of the blood vessel and extends generally along the distal portion of the incision or puncture so that the collagen tube will not enter into the blood vessel. Additionally, the wall of the blood vessel is sandwiched between the anchor member and collagen tube.
  • One function of the anchor member is to allow for the convenient and reliable positioning of the rod member and collagen tube in the incision or puncture and therefore, the size and shape of the anchor member is chosen to minimize any disruption in the flow of fluid past the incision and to be absorbed in the body of the patient within a relatively short period of time.
  • Figure 1 is a side view, partially in cross section, showing the closure device and extension rod of the present invention
  • Figure 2 is a partial side view showing the access sheath and bypass member of the present invention
  • Figure 11 is a side view showing the extension rod of Figure 1;
  • Figure 12 is a side view showing the push rod of the present invention;
  • the sealing assembly 16 has particular utility when used in connection with intravascular procedures, such as angiographic dye injection, stents, cardiac catheterization, balloon angioplasty and other types of recanalizing of atherosclerotic arteries, etc. because the closure device 18 is designed to cause immediate hemostasis of the tissue and blood vessel of the patient. It is contemplated that the sealing assembly 16 of the present invention may be used with nearly any catheterization or other medical procedure wherein it is desirable to seal an incision or puncture to prevent the loss of the patient's body fluid therethrough, including laparoscopic or similar procedures.
  • closure device 8 of the present invention may be used with nearly any catheterization or other medical procedure or introduction device wherein it is desirable to reliably locate the lumen of a blood vessel, duct or target organ of a patient's body to prevent the loss of the patient's body fluid therethrough, including laparoscopic, cardioscopic, endoscopic, intracardiac or similar procedures.
  • a preferred form of the present invention consists of the sealing assembly 16 which generally includes the access or procedure sheath 20, the closure device 18 and related components such as the push rod 36, extension rod 34 and bypass member 42 as described below.
  • the closure device 18 of the present invention includes a generally elongate and preferably cylindrical rod-shaped member .22. which is constructed of a porous, biodegradable material such as a polymerized polylactic acid, or polyglycolic acid matrix or similar bioabsorbable materials may also be used.
  • the distal end 24. of the rod member includes the anchor member 26 as described in further detail below.
  • the present invention also preferably includes a tubular collagen member . 28 .
  • the collagen member 28 is preferably shaped as an elongate tubular member which is formed of a non-allergenic hemostatic resorbable material such as a collagen sponge or foam material.
  • the retainment ring 30 is preferably a relatively small member which is slidably positioned along the rod member 22 proximally of the collagen member 28 and is preferably formed of a molded resorbable polymeric material such as a lactide/glactide copolymer.
  • the outer diameter of the retainment ring 30 is preferably greater than the outer diameter of the extension rod 34 to enable the push rod 36 to move the retainment ring 30 distally along the rod member 22 as described below.
  • the closure device 18 is then moved distally in the access sheath and partially deployed (ejected) from the distal end of the access sheath 20 by moving the extension rod 34 distally with respect to the access sheath 20 while holding the access sheath 20 fixed relative to the skin surface 12 of the patient.
  • the anchor member 26 and a portion of the rod member 22 are passed out of the distal end of the access sheath 20 and deployed into the artery lumen.
  • the anchor member 26 passes from the distal end of the access sheath 20
  • the orientation of the anchor member 26 is changed with respect to the lengthwise dimension of the rod member 22 as the proximal end of the anchor member 26 passes beyond the distal end of the access sheath.
  • the anchor member 26 pivots to extend laterally from the distal end 24 of the rod member 22 as a result of the anchor member's preferred bias towards the lateral orientation.
  • the anchor member 26 basically comprises a thin, narrow strip or bar of resorbable material such as a resorbable lactide/glycolide polymer sold by Medisorb Technologies International L.P. under the trade designation MEDISORB.
  • the strip is sufficiently rigid such that once it is in position with the artery it is resistant to deformation to preclude it from bending to pass back through the puncture tract 14 through which it was first introduced.
  • the anchor member 26 preferably has a generally planar top surface, a generally planar bottom surface and a centrally located surface which is pivotally connected the distal end 24 of the rod member 22. Each end of the anchor member 26 is preferably rounded.
  • the centrally located surface of the anchor member 26 preferably includes a hemispherical projection which is located at the center of the top surface.
  • the hemispherical projection preferably includes one or more reinforcing sutures 32 extending therethrough and a longitudinally extending slot disposed perpendicularly to the top surface of the anchor member 26 having the sutures molded therein.
  • the overall shape of the anchor member 26 is chosen so as to allow the anchor member 26 to initially pass through the wall of the blood vessel and into the blood vessel while preventing the retraction therethrough and without significantly obstructing the flow of blood through the blood vessel.
  • the biased and laterally extending connection between the anchor member 26 and the rod member 22 is preferably effected during the molding of the rod member 22 and anchor member 26 and is preferably further reinforced by the use of the relatively stiff suture 32.
  • the bypass member 42 may also include a further reference detent (not shown) in its periphery located diametrically opposite to the desired position of the anchor member 26 to serve as a visual guide to help the user orient the closure device 18 to a proper yaw angle with respect to the central longitudinal axis of the closure device 18 for insertion within the access sheath 20 as will be described later.
  • a further reference detent (not shown) in its periphery located diametrically opposite to the desired position of the anchor member 26 to serve as a visual guide to help the user orient the closure device 18 to a proper yaw angle with respect to the central longitudinal axis of the closure device 18 for insertion within the access sheath 20 as will be described later.
  • the access sheath 20 preferably includes a conventional luer fitting side port on the proximal end thereof.
  • the bypass member 42 is preferably a funnel shaped member which is sized to extend into the opening in the luer fitting and is secured in place therein by any suitable means, including frictional contact, to maintain the hemostatic valve on the proximal end of the access sheath 20 open during the procedure.
  • the positioning of the access sheath 20 in the artery may be accomplished utilizing an artery locator device or an obturator which identify the location of the artery wall by the flow of blood or by physical contact with the wall of the blood vessel.
  • the depth of the puncture may be physically measured and then the access sheath 20 may be moved to the appropriate measured depth in the puncture using various markings on the access sheath and/or by using selected access sheaths having specified lengths.
  • a stopcock may be opened to observe the flow of blood therefrom (thereby indicating that the inlet port or window is within the artery) .
  • the closure device 18 must be reinserted within the access sheath 20 and the foregoing procedure retried, this time by turning the closure device 18 about its axis by one-quarter turns to either side before it is again withdrawn relative to the access sheath 20.
  • the push rod 36 and retainment ring 30 are manually slid down the rod member 22 by the user so that the retainment ring 30 is moved distally in the puncture tract 14 until the retainment ring 30 engages the locking member 38 as indicated to the user by the colored band 50 reaching the proximal end of the push rod 36.
  • This movement of the retainment member 30 moves the collagen member 28 distally to the desired location in the puncture tract 14.
  • a gentle distal movement is adequate to achieve the desired result; i.e., to assist the distal end portion of the collagen member 28 to conform to the outside of the blood vessel contiguous with the puncture and to assist to lock the collagen member 28 and anchor member 26 in place until hemostasis occurs (which happens very quickly, thereby further locking the closure device in place) .
  • the closure device of the present invention enables the ready, effective and efficient sealing of a percutaneous puncture in an blood vessel.
  • the closure device 18 may allow for the continuance of anticoagulation post-procedure, more aggressive use of thrombolytic agents and safer use of large bore catheters. It should also reduce discomfort and complication rates for patients, allow many in-patient procedures to be performed safely on an out-patient basis, decrease the time and cost of interventional procedures and reduce exposure of hospital personnel to human blood.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
  • Materials For Medical Uses (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

L'invention porte sur un dispositif (18) et un procédé d'obturation d'une incision ou d'une perforation chez un patient par insertion d'un obturateur dans l'incision ou la perforation jusqu'à ce que l'élément d'ancrage de l'obturateur se place le long de la paroi du vaisseau sanguin (10) ou de l'organe cible touchant la perforation de manière à ce que l'obturateur n'obstrue pas significativement le courant de fluide traversant le vaisseau sanguin ou l'organe cible, puis par mise en place d'un élément de collagène (28) le long de la surface extérieure du vaisseau sanguin ou de l'organe cible. Le positionnement précis de l'obturateur dans l'incision ou la perforation se fait à l'aide d'un élément d'ancrage (26) faisant de préférence partie intégrante d'une tige (22) et conçu pour se placer le long de la paroi intérieure du vaisseau sanguin ou de l'organe cible du patient, ladite tige s'étendant à travers la perforation et recevant l'élément extensible de collagène par-dessus.
PCT/US1998/001189 1997-01-21 1998-01-20 Obturateur hemostatique bioabsorbable WO1998031287A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
EP98902674A EP0961580A4 (fr) 1997-01-21 1998-01-20 Obturateur hemostatique bioabsorbable
JP53469798A JP2002515797A (ja) 1997-01-21 1998-01-20 生体吸収性の止血用シール組立体
AU59274/98A AU5927498A (en) 1997-01-21 1998-01-20 Bioabsorbable hemostatic sealing assembly
CA002278243A CA2278243C (fr) 1997-01-21 1998-01-20 Obturateur hemostatique bioabsorbable

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US3588297P 1997-01-21 1997-01-21
US60/035,882 1997-01-21

Publications (1)

Publication Number Publication Date
WO1998031287A1 true WO1998031287A1 (fr) 1998-07-23

Family

ID=21885346

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1998/001189 WO1998031287A1 (fr) 1997-01-21 1998-01-20 Obturateur hemostatique bioabsorbable

Country Status (5)

Country Link
EP (1) EP0961580A4 (fr)
JP (1) JP2002515797A (fr)
AU (1) AU5927498A (fr)
CA (1) CA2278243C (fr)
WO (1) WO1998031287A1 (fr)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002054958A1 (fr) 2001-01-11 2002-07-18 Bio-Seal Tech Inc. Dispositif et procede permettant de colmater une perforation dans un vaisseau sanguin
WO2004041122A2 (fr) 2002-11-04 2004-05-21 Sub-Q, Inc. Appareil et procede pouvant empecher les pertes sanguines
WO2005002451A1 (fr) * 2003-07-03 2005-01-13 Radi Medical Systems Ab Dispositif de suture de plaie
EP1671592A1 (fr) * 2004-12-16 2006-06-21 Radi Medical Systems Ab Dispositif de scellement médical
WO2009012257A3 (fr) * 2007-07-17 2009-03-26 Vercure Medical Llc Procédé et appareil de maintien d'accès
US8105352B2 (en) 2004-12-16 2012-01-31 Radi Medical Systems Ab Medical sealing device
EP2019631A4 (fr) * 2006-05-23 2013-03-13 St Jude Med Puerto Rico Bv Appareils d'obturation de ponction, bouchons d'obturation, et procédés associés
US8802124B2 (en) 2002-05-08 2014-08-12 Radi Medical Systems Ab Erodible vessel sealing device without chemical or biological degradation
US10149670B2 (en) 2004-11-05 2018-12-11 Access Closure, Inc. Apparatus and methods for sealing a vascular puncture

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005051176A2 (fr) * 2003-11-25 2005-06-09 Boston Scientific Limited Manchon de pression hemostatique
US8292918B2 (en) 2009-02-20 2012-10-23 Boston Scientific Scimed, Inc. Composite plug for arteriotomy closure and method of use
EP3256051B1 (fr) * 2015-02-10 2022-11-16 Teleflex Life Sciences Limited Dispositif de fermeture permettant d'obturer une ouverture percutanée dans un vaisseau

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4744364A (en) 1987-02-17 1988-05-17 Intravascular Surgical Instruments, Inc. Device for sealing percutaneous puncture in a vessel
US4829994A (en) 1987-05-27 1989-05-16 Kurth Paul A Femoral compression device for post-catheterization hemostasis
US4852568A (en) 1987-02-17 1989-08-01 Kensey Nash Corporation Method and apparatus for sealing an opening in tissue of a living being
US4890612A (en) 1987-02-17 1990-01-02 Kensey Nash Corporation Device for sealing percutaneous puncture in a vessel
US4929246A (en) 1988-10-27 1990-05-29 C. R. Bard, Inc. Method for closing and sealing an artery after removing a catheter
US5108421A (en) 1990-10-01 1992-04-28 Quinton Instrument Company Insertion assembly and method of inserting a vessel plug into the body of a patient
US5391183A (en) 1990-09-21 1995-02-21 Datascope Investment Corp Device and method sealing puncture wounds
US5411520A (en) 1991-11-08 1995-05-02 Kensey Nash Corporation Hemostatic vessel puncture closure system utilizing a plug located within the puncture tract spaced from the vessel, and method of use
US5496332A (en) * 1994-10-20 1996-03-05 Cordis Corporation Wound closure apparatus and method for its use
US5531759A (en) * 1994-04-29 1996-07-02 Kensey Nash Corporation System for closing a percutaneous puncture formed by a trocar to prevent tissue at the puncture from herniating

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5342393A (en) * 1992-08-27 1994-08-30 Duke University Method and device for vascular repair
AU7099994A (en) * 1993-06-04 1995-01-03 Kensey Nash Corporation Hemostatic vessel puncture closure with filament lock

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4744364A (en) 1987-02-17 1988-05-17 Intravascular Surgical Instruments, Inc. Device for sealing percutaneous puncture in a vessel
US4852568A (en) 1987-02-17 1989-08-01 Kensey Nash Corporation Method and apparatus for sealing an opening in tissue of a living being
US4890612A (en) 1987-02-17 1990-01-02 Kensey Nash Corporation Device for sealing percutaneous puncture in a vessel
US4829994A (en) 1987-05-27 1989-05-16 Kurth Paul A Femoral compression device for post-catheterization hemostasis
US4929246A (en) 1988-10-27 1990-05-29 C. R. Bard, Inc. Method for closing and sealing an artery after removing a catheter
US5391183A (en) 1990-09-21 1995-02-21 Datascope Investment Corp Device and method sealing puncture wounds
US5437631A (en) * 1990-09-21 1995-08-01 Datascope Investment Corp. Percutaneous introducer set and method for sealing puncture wounds
US5108421A (en) 1990-10-01 1992-04-28 Quinton Instrument Company Insertion assembly and method of inserting a vessel plug into the body of a patient
US5411520A (en) 1991-11-08 1995-05-02 Kensey Nash Corporation Hemostatic vessel puncture closure system utilizing a plug located within the puncture tract spaced from the vessel, and method of use
US5531759A (en) * 1994-04-29 1996-07-02 Kensey Nash Corporation System for closing a percutaneous puncture formed by a trocar to prevent tissue at the puncture from herniating
US5496332A (en) * 1994-10-20 1996-03-05 Cordis Corporation Wound closure apparatus and method for its use

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP0961580A4 *

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002054958A1 (fr) 2001-01-11 2002-07-18 Bio-Seal Tech Inc. Dispositif et procede permettant de colmater une perforation dans un vaisseau sanguin
US8802124B2 (en) 2002-05-08 2014-08-12 Radi Medical Systems Ab Erodible vessel sealing device without chemical or biological degradation
WO2004041122A2 (fr) 2002-11-04 2004-05-21 Sub-Q, Inc. Appareil et procede pouvant empecher les pertes sanguines
EP1572004A4 (fr) * 2002-11-04 2009-07-01 Sub Q Inc Appareil et procede pouvant empecher les pertes sanguines
WO2005002451A1 (fr) * 2003-07-03 2005-01-13 Radi Medical Systems Ab Dispositif de suture de plaie
US10149670B2 (en) 2004-11-05 2018-12-11 Access Closure, Inc. Apparatus and methods for sealing a vascular puncture
EP1671592A1 (fr) * 2004-12-16 2006-06-21 Radi Medical Systems Ab Dispositif de scellement médical
US8105352B2 (en) 2004-12-16 2012-01-31 Radi Medical Systems Ab Medical sealing device
EP2019631A4 (fr) * 2006-05-23 2013-03-13 St Jude Med Puerto Rico Bv Appareils d'obturation de ponction, bouchons d'obturation, et procédés associés
EP3162295A3 (fr) * 2006-05-23 2017-08-02 Terumo Puerto Rico L.L.C. Appareils de fermeture de ponction et tampons d'obturation
WO2009012257A3 (fr) * 2007-07-17 2009-03-26 Vercure Medical Llc Procédé et appareil de maintien d'accès

Also Published As

Publication number Publication date
CA2278243C (fr) 2006-06-13
EP0961580A1 (fr) 1999-12-08
JP2002515797A (ja) 2002-05-28
CA2278243A1 (fr) 1998-07-23
EP0961580A4 (fr) 2000-04-12
AU5927498A (en) 1998-08-07

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