Bioabsorbable Sealant

• US 20030135236A1
• Filed: 03/27/2003
• Published: 07/17/2003
• Est. Priority Date: 12/07/2001
• Status: Active Grant

• Current Assignee: MEDgenesis Inc.
• Original Assignee: Bioseal LLC
• Inventors: Fisher, John S., Ahari, Frederick, Hronowski, Lucjan J.J.
• Granted Patent: US 7,001,410 B2
• Time in Patent Office: Days
• US Class Current: 606/213
• CPC Class Codes: A61B 17/0057 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 sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system

Abstract

Abstract of Disclosure

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 The needle is then withdrawn while the position of the pushing device is maintained. The pushing device is then withdrawn, leaving the plug in sealing relation to the opening.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

1. A method for sealing an opening made by any means in a mammalian

body, comprising the steps of:

forming an elongate suture of a preselected dehydrated material that expands in response to a predetermined stimulus;

adapting said elongate suture to be pulled by a needle so that said elongate suture is used to sew closed said opening;

dimensioning said elongate suture so that it has a diameter slightly less than a diameter of said needle, there being a clearance space about said elongate suture equal in diameter to said diameter of said needle less the diameter of said elongate suture;

applying said predetermined stimulus to said elongate suture until said elongate suture seals said clearance space;

whereby said elongate suture, when expanded, prevents flow of liquid or gaseous fluid through said clearance space.

2. The method of claim 1, wherein said predetermined stimulus is applied by natural moisture within said mammalian body.

3. The method of claim 1, wherein said preselected dehydrated material is formed of a bioabsorbable polymer.

4. The method of claim 3, wherein said bioabsorbable polymer is a bioabsorbable hydrogel material.

5. The method of claim 4, wherein said bioabsorbable hydrogel material is selected from the group consisting of polypeptides cross-linked with a compound selected from the group consisting of formaldehyde, glutaraldehyde, and dialdehydes.

6. The method of claim 3, further comprising the step of impregnating said bioabsorbable polymer with a therapeutic substance to provide therapy as said bioabsorbable polymer is bioabsorbed.

7. The method of claim 1, further comprising the step of impregnating said preselected dehydrated material with a contrasting agent to facilitate detection of said elongate suture by imaging means including imaging means selected from the group including magnetic resonance imaging, ultrasound, Doppler, and roentgenological means including x-ray, CT scan, mammography, and fluoroscopy.

8. A method for sealing an opening made by any means in a mammalian

body, comprising the steps of:

coating an elongate suture with a preselected dehydrated material that expands in response to a predetermined stimulus;

adapting said elongate suture to be pulled by a needle so that said elongate suture is used to sew closed said opening;

dimensioning said elongate suture so that it has a diameter slightly less than a diameter of said needle, there being a clearance space about said elongate suture equal in diameter to said diameter of said needle less the diameter of said elongate suture;

applying said predetermined stimulus to said preselected dehydrated material until said material seals said clearance space;

whereby said preselected dehydrated material, when expanded, prevents flow of liquid or gaseous fluid through said clearance space.

9. The method of claim 8, wherein said predetermined stimulus is applied by natural moisture within said mammalian body.

10. The method of claim 8, wherein said preselected dehydrated material is formed of a bioabsorbable polymer.

11. The method of claim 10, wherein said bioabsorbable polymer is a bioabsorbable hydrogel material.

12. The method of claim 11, wherein said bioabsorbable hydrogel material is selected from the group consisting of polypeptides cross-linked with a compound selected from the group consisting of formaldehyde, glutaraldehyde, and dialdehydes.

13. The method of claim 10, further comprising the step of impregnating said bioabsorbable polymer with a therapeutic substance to provide therapy as said bioabsorbable polymer is bioabsorbed.

14. The method of claim 8, further comprising the step of impregnating said preselected dehydrated coating with a contrasting agent to facilitate detection of said elongate suture by imaging means including imaging means selected from the group consisting of magnetic resonance imaging, ultrasound, Doppler, and roentgenological means including x-ray, CT scan, mammography, and fluoroscopy.