WO2003049598B1 - Bioabsorbable sealant - Google Patents

Bioabsorbable sealant

Info

Publication number
WO2003049598B1
WO2003049598B1 PCT/US2002/039169 US0239169W WO03049598B1 WO 2003049598 B1 WO2003049598 B1 WO 2003049598B1 US 0239169 W US0239169 W US 0239169W WO 03049598 B1 WO03049598 B1 WO 03049598B1
Authority
WO
WIPO (PCT)
Prior art keywords
plug
dehydrated
bioabsorbable
lumen
opening
Prior art date
Application number
PCT/US2002/039169
Other languages
French (fr)
Other versions
WO2003049598A2 (en
WO2003049598A3 (en
Inventor
John S Fisher
Frederick Ahari
Lucjan J J Hronowski
Original Assignee
Biopsy Sciences Llc
John S Fisher
Frederick Ahari
Lucjan J J Hronowski
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 Biopsy Sciences Llc, John S Fisher, Frederick Ahari, Lucjan J J Hronowski filed Critical Biopsy Sciences Llc
Priority to EP02797219A priority Critical patent/EP1450725A4/en
Priority to AU2002362087A priority patent/AU2002362087A1/en
Priority to JP2003550651A priority patent/JP4471342B2/en
Priority to CA002469001A priority patent/CA2469001C/en
Publication of WO2003049598A2 publication Critical patent/WO2003049598A2/en
Publication of WO2003049598A3 publication Critical patent/WO2003049598A3/en
Publication of WO2003049598B1 publication Critical patent/WO2003049598B1/en

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
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0644—Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • 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
    • 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
    • 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
    • A61B2017/00575—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 closure at remote site, e.g. closing atrial septum defects
    • 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
    • A61B2017/00575—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 closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00601—Implements entirely comprised between the two sides of the opening

Abstract

Openings in a mammalian body made by any medical procedure or non-medical event are sealed with a bioabsorbable plug or sewn with a bioabsorbable suture. In one exemplary embodiment, the plug in dehydrated, unexpanded condition is pushed by a pushing device through the lumen of a needle until a first part of the plug is external to the opening and a second part is internal to the opening. The needle is then withdrawn while the position of the pushing device is maintained. The pushing device is then withdrawn, leaving the plug in sealing relation to the opening. The body's moisture causes the plug to expand to complete the sealing of the opening, or the expansion may be caused by exposure to air, light, or other stimulant. The opening may be formed in soft tissue, internal organs, or hard tissue. The plug seals the flow of liquid or gaseous biological fluids.

Claims

AMENDED CLAIMS[received by the International Bureau on 19 December 2003 (19.12.03); original claims 1-69 replaced by amended claims 1-10]
1. An apparatus for sealing an opening made by any means in a mammalian body, comprising: a plug formed of a dehydrated, bioabsorbable hydrogel polymer that expands in response to moisture that is naturally present in said mammalian body; said dehydrated plug being sized to fit within said opening prior to application of said moisture to said dehydrated plug; and said dehydrated plug expanding upon application of said moisture thereto until said plug seals said opening; whereby said plug, when expanded, prevents flow of liquid or gaseous fluid through said opening; and whereby said plug is gradually bioabsorbed as said opening is healed by natural processes.
2. The apparatus of claim 1, wherein said dehydrated plug has a solid, cylindrical configuration prior to application of said moisture thereto so that said dehydrated plug is adapted to fit into a lumen of a needle to facilitate introduction of said dehydrated plug into said opening.
3. The apparatus of claim 1, further comprising: said dehydrated plug adapted to be slideably disposed in a lumen of said needle; plug displacement means adapted to abuttingly engage and slidingly displace said dehydrated plug within said lumen to a preselected location near a distal end of said lumen; whereby withdrawal of said needle coupled with maintaining said plug displacement means at said preselected location during said withdrawal results in placement of said dehydrated plug at said preselected location; and whereby withdrawal of said plug displacement means does not cause displacement of said dehydrated plug.
4. A method for promoting angiogenesis in a mammalian heart, comprising the steps of: forming a bore in a heart that penetrates the epicardium and extends into the myocardium but which does not penetrate the endocardium; introducing growth factor means into said bore;
34 providing a bioabsorbable plug formed of a dehydrated, bioabsorbable hydrogel polymer that expands in response to moisture that is naturally present in said mammalian heart; plugging said bore by inserting said bioabsorbable plug into said bore; applying said moisture to said bioabsorbable plug so that said bioabsorbable plug expands and seals said growth factor means within said bore.
5. A method for promoting angiogenesis in a mammalian heart, comprising the steps of: forming a bore in a heart that penetrates the endocardium and extends into the myocardium but which does not penetrate the epicardium; introducing a therapeutic substance into said bore, said therapeutic substance being selected from a group of therapeutic substances consisting of growth factor, stem cells, gene therapy drugs, anti-cancer drugs, and other preselected drugs; providing a bioabsorbable plug formed of a dehydrated, bioabsorbable hydrogel polymer that expands in response to moisture naturally present in said mammalian heart; plugging said bore by inserting said bioabsorbable plug into said bore; applying said moisture to said bioabsorbable plug so that said bioabsorbable plug expands and seals said growth factor means within said bore.
6. A method for preventing the loss of spinal fluid from the thecal sac, comprising the steps of: forming an opening at a preselected site in the thecal sac by a biopsy needle introduced to the preselected site through a coaxial needle; withdrawing the biopsy needle and coaxial needle from said preselected site after said opening has been formed; introducing a delivery catheter to the preselected site; providing a dehydrated, bioabsorbable plug formed of a hydrogel polymer that expands in response to moisture naturally present within said thecal sac; pushing said dehydrated, bioabsorbable plug from a lumen of said delivery catheter into said opening; withdrawing the delivery catheter from said preselected site; whereby said bioabsorbable plug expands upon being hydrated by natural fluids present at the preselected site, said expansion serving to hold said plug in place and further serving to prevent leakage of spinal fluid from said opening.
35
7. A method for sealing an incision in an artery, comprising the steps of: inserting a guide wire through said incision; placing a lumen of an introducer sheath in receiving relation to said guide wire so that a leading end of said introducer sheath is guided to said incision by said guide wire; positioning said leading end of said introducer sheath into abutting and surrounding relation to said incision; providing a dehydrated, bioabsorbable tube formed of a hydrogel polymer that expands in response to moisture naturally present within said artery; pushing said dehydrated, bioabsorbable tube from a lumen of said introducer sheath so that a leading end of said dehydrated, bioabsorbable tube is disposed in abutting and surrounding relation to said incision; withdrawing said guide wire and said introducer sheath from said artery; providing a delivery catheter having an external diameter less than an internal diameter of said dehydrated, bioabsorbable tube and positioning a leading end of said delivery catheter in a lumen of said dehydrated, bioabsorbable tube; providing a dehydrated, bioabsorbable plug formed of a hydrogel polymer that expands in response to moisture naturally present in said artery; positioning said dehydrated, bioabsorbable plug in a lumen of said delivery catheter; pushing said dehydrated, bioabsorbable plug from said lumen of said delivery catheter into a lumen of said dehydrated, bioabsorbable tube; and withdrawing said delivery catheter; whereby said dehydrated, bioabsorbable plug expands within the lumen of said dehydrated, bioabsorbable tube when contacted by natural moisture within the blood flowing through said artery; and whereby said dehydrated, bioabsorbable tube expands when contacted by said natural moisture within said blood and by natural moisture within tissue that surrounds said artery.
8. A method for sealing a puncture opening of the type made by a needle in a mammalian body, comprising the steps of: providing a plug formed of a dehydrated, bioabsorbable hydrogel polymer that expands in response to moisture naturally present in said mammalian body; slidingly disposing the plug in a lumen of said needle; pre-hydrating said plug by introducing a liquid-fluid solution into said lumen of said needle before displacing said plug from said lumen; slidingly displacing said plug within said lumen to a preselected location near a distal end of said lumen; withdrawing said needle while maintaining said plug at said preselected location; whereby said pre-hydrated plug expands to fill said puncture opening in less time than a plug that is not pre-hydrated.
9. A method of plugging an opening in an animal or human body with a plug, comprising the steps of: closing said opening by plugging said opening with a plug material made by crosslinking a preselected compound from the group consisting of polyhydroxyalkyl methylacrylates, polyacrylamide, polymethacrylamide, polyN-vinyl-2-pyrrolidone, anionic and cationic hydrogels, polyvinyl alcohol, polyethylene glycol, diacrylate and derivatives from copolymers composed of poly(ethylene oxide)-poly(propylene oxide)-poly(ethylene oxide) and poly ropylene oxide)-poly(ethylene oxide)- poly(propylene oxide) blocks with agents selected from the group consisting of ethylene glycol dimethacrylate and methylene-bis-acrylamide, and reacting the resulting non-biodegradable synthetic hydrogels with at least one monomer selected from the group of monomers consisting of glycolide, lactide, e-caprolactone, p- dioxanone and trimethylene carbonate.
10. A method for filling a cavity in a mammalian body, comprising the steps of: depositing at least one dehydrated, bioabsorbable plug into said cavity; said bioabsorbable plug being formed of a dehydrated, bioabsorbable hydrogel polymer that expands upon contact with moisture naturally present within said mammalian body; whereby said cavity is filled when said at least one bioabsorbable plug expands.
37
PCT/US2002/039169 2001-12-07 2002-12-06 Bioabsorbable sealant WO2003049598A2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
EP02797219A EP1450725A4 (en) 2001-12-07 2002-12-06 Bioabsorbable sealant
AU2002362087A AU2002362087A1 (en) 2001-12-07 2002-12-06 Bioabsorbable sealant
JP2003550651A JP4471342B2 (en) 2001-12-07 2002-12-06 Bioabsorbable sealing material
CA002469001A CA2469001C (en) 2001-12-07 2002-12-06 Bioabsorbable sealant

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/683,282 2001-12-07
US09/683,282 US6592608B2 (en) 2001-12-07 2001-12-07 Bioabsorbable sealant

Publications (3)

Publication Number Publication Date
WO2003049598A2 WO2003049598A2 (en) 2003-06-19
WO2003049598A3 WO2003049598A3 (en) 2004-04-29
WO2003049598B1 true WO2003049598B1 (en) 2004-05-27

Family

ID=24743342

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2002/039169 WO2003049598A2 (en) 2001-12-07 2002-12-06 Bioabsorbable sealant

Country Status (6)

Country Link
US (10) US6592608B2 (en)
EP (1) EP1450725A4 (en)
JP (1) JP4471342B2 (en)
AU (1) AU2002362087A1 (en)
CA (1) CA2469001C (en)
WO (1) WO2003049598A2 (en)

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