Systems for intravascular procedures and methods of use

• US 6,017,352 A
• Filed: 01/16/1998
• Issued: 01/25/2000
• Est. Priority Date: 09/04/1997
• Status: Expired due to Term

• Current Assignee: Kensey Nash Corporation (DSM-Firmenich AG)
• Original Assignee: Kensey Nash Corporation (DSM-Firmenich AG)
• Inventors: Nash, John E., Evans, Douglas G.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): HO, TAN-UYEN THI
• Application Number:
  US09/008,266
• Time in Patent Office: 739 Days
• Field of Search: 606/153, 606/154, 606/151, 606/139, 606/152, 606/219, 623/1
• US Class Current: 606/153
• 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 17/06 Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials puncturing needles A61B17/34; hypodermic needles A61M5/32 ; sewing needles D05B85/00
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/12009 Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections Y-shaped blood vessel prostheses A61F2002/065
• CPC Class Codes: A61B 2017/12004 for haemostasis, for prevention of bleeding

Abstract

A system and method of use for effecting the bypass or other anastomosis of a portion of a native blood vessel, duct, lumen or other tubular organ within the body of a living being. The system includes a connector assembly and a deployment instrument for carrying the device to the desired position within the vessel, duct, lumen or tubular organ. The system includes a piercerdilator instrument to form an opening in the wall of the vessel, duct, lumen or tubular organ into which the connector assembly is deployed by the deployment instrument. The connector assembly is at least partially formed of a resorbable material and includes movable members for securing it to the tissue of the vessel, duct, lumen or tubular organ contiguous with the opening. Other components may be included in the device for expediting the anastomosis procedure, with or without the use of sutures. Moreover, the system can be used to bypass of at least two coronary arteries by a common connection with the aorta utilizing at least two bypass grafts and plural connectors for securement to the aorta and the coronary arteries.

Claims

1. A system for forming an anastomosis junction of a first vessel, duct, lumen or hollow organ to a native vessel, duct, lumen or hollow organ of a living being at an anastomosis site, the site having an opening formed in the native vessel, duct, lumen or hollow organ, said system comprising an anastomosis connector and a fluid exclusion device, said anastomosis connector being arranged for securement to the native vessel, duct, lumen or hollow organ and to the first vessel, duct, lumen hollow organ so that they are in fluid communication with each other, said fluid exclusion device being arranged for insertion within the body of the being to a location in close proximity to the anastomosis site and being arranged to operate to form an exclusion zone within the native vessel, duct, lumen or hollow organ contiguous with the opening in the wall of the native vessel, duct, lumen or hollow organ at the anastomosis site through which fluid is temporarily precluded from flowing to thereby facilitate the formation of the anastomosis junction, said anastomosis connector comprising a resorbable tubular member, said anastomosis connector being arranged to be inserted through the opening in the wall of the native vessel, duct, lumen or hollow organ into the exclusion zone, said tubular member having a first portion in communication with the exclusion zone and a second portion arranged to extend through the opening in the wall of the native vessel, duct, lumen or hollow organ to enable the first vessel, duct, lumen or hollow organ to be connected thereto to complete the anastomosis junction.

2. The system of claim 1 wherein said fluid exclusion device enables fluid to flow from a location in the native vessel, duct, lumen or hollow organ upstream of the anastomosis site to a location in the native vessel, duct, lumen or hollow organ downstream of the anastomosis site while said fluid exclusion device is precluding fluid from flowing in the exclusion zone.

3. The system of claim 1 wherein said fluid exclusion device is operative to temporarily preclude fluid from flowing through said exclusion zone to facilitate the formation of the anastomosis junction.

4. The system of claim 3 wherein said fluid exclusion device enables fluid to flow from a location in the native vessel, duct, lumen or hollow organ upstream of the anastomosis site to a location in the native vessel, duct, lumen or hollow organ downstream of the anastomosis site, while said fluid exclusion device is temporarily precluding fluid from flowing in the zone.

5. The system of claim 2 wherein said fluid exclusion device comprises an elongated member having a passageway extending at least partially therethrough, an upstream blocking member and a downstream blocking member, at least a portion of said passageway being arranged to be located within the interior of the native vessel, duct, lumen or hollow organ, said upstream blocking member being arranged to be expanded to engage the interior of the native vessel, duct, lumen or hollow organ upstream of the anastomosis site to block the flow of fluid therebeyond, said downstream blocking member being arranged to be expanded to engage the interior of the native vessel, duct, lumen or hollow organ downstream of the anastomosis site to block the flow of fluid therebeyond, said passageway enabling fluid to flow from a location within the native vessel, duct, lumen or hollow organ upstream of said upstream blocking member to a location within the native vessel, duct, lumen or hollow organ downstream of said downstream blocking member.

6. The system of claim 5 wherein each of said expandable blocking members comprises an inflatable balloon.

7. The system of claim 2 wherein said fluid exclusion device comprises an elongated member having a passageway extending at least partially therethrough, an upstream blocking member and a downstream blocking member, said passageway being arranged to be located within the interior of the native vessel, duct, lumen or hollow organ, said upstream blocking member being arranged to constrict the native vessel, duct, lumen or hollow organ upstream of the anastomosis site to block the flow of fluid therebeyond, said downstream blocking member being arranged to constrict the native vessel, duct, lumen or hollow organ downstream of the anastomosis site to block the flow of fluid therebeyond, said passageway enabling fluid to flow from a location within the native vessel, duct, lumen or hollow organ upstream of said upstream blocking member to a location within the native vessel, duct, lumen or hollow organ downstream of said downstream blocking member.

8. The system of claim 7 wherein said elongated member comprises an over-the-wire dilator.

9. The system of claim 1 wherein said fluid exclusion device comprises a member for collapsing at least a portion of the native vessel, duct, lumen or hollow organ upstream of the anastomosis site and a member for collapsing at least a portion of the native vessel, duct, lumen or hollow organ downstream of the anastomosis site.

10. The system of claim 1 wherein said fluid flow preclusion means comprises means for cross clamping the native vessel, duct, lumen or hollow organ contiguous with the anastomosis site.

11. The system of claim 1 additionally comprising a stabilizer for stabilizing said fluid exclusion device with respect to the native vessel, duct, lumen or hollow organ.

12. The system of claim 11 wherein said stabilizer is arranged to apply suction to the exterior of the vessel, duct, lumen or hollow organ.

13. The system of claim 1 wherein said anastomosis device additionally comprises a retraction member coupled to said tubular member, said anastomosis device being arranged to be inserted through the opening into the exclusion zone, said tubular member having a portion arranged to be retracted out of the zone through the opening by said retraction member to serve as a point at which the bypass graft is connected.

14. The system of claim 1 wherein said fluid exclusion device is arranged to divert the flow of fluid around the exclusion zone during the securement of the anastomosis device.