Devices and methods for interconnecting vessels

Abstract

The present invention provides implantable devices and associated methods for interconnecting human vessels in a side-to-side or an end-to-side arrangement rapidly, safely and in a minimally invasive manner. The devices comprises at least a first segment, a second component, and a flow opening between the at least one segment and the second component when operatively used. The first segment is flexible and has physical and mechanical properties which allow it to be easily inserted into a vessel, to conformably seal with the inside wall of the vessel and to be resistant to dislodging from the vessel. The second component may comprise a second segment having the same or a similar configuration as the first segment or may be a tubular member which extends from the first segment. The first and second segments are flexible for easy insertion into an incision made within the side of each vessel. Upon release from a constricted state, each flexible segment subsequently conforms to the interior walls of a vessel to provide a sealing contact along the contact surface of the segment inserted within. The tubular member is configured to be inserted into a transected end of a vessel. The flow opening provides fluid interconnectivity between the vessels connected by the implanted devices. The devices are configured so as to: (1) not impede flow inside a vessel; (2) prevent leakage from the incisions within the vessels; and (3) apposition the vessels toward each other allowing the vessels to heal together so that flow in one vessel may flow to the other.

What is claimed is:  
     
         1 . A device for performing an anastomosis wherein the device is implantable to a site within a conduit of a subject through an artificially-made opening in the conduit, said device comprising: 
 at least one permanently implantable flexible member comprising an opening therein for providing a pathway for the transport of substances between the conduit and another conduit of the subject, the at least one flexible member adapted to conform to and seal with an inner surface of the conduit and further adapted to utilize the internal conduit pressure exerted thereon to form a substantially fluid-tight seal with the inner surface of the conduit whereby substances within the conduit are prevented from leaking from the artificial opening under normal physiological conditions.    
     
     
         2 . The device of  claim 1  wherein the at least one flexible member comprises a first surface and a second surface, wherein the first surface is adapted to be in contact with the substances within the conduit and the second surface is adapted to readily conform to and seal with an inner surface of the conduit upon delivery of the flexible member within the conduit wherein the substantially fluid-tight seal is formed between the second surface and the inner surface of the conduit.  
     
     
         3 . The device of  claim 1  wherein the flexible member forms the substantially fluid-tight seal without compressing, tensioning or puncturing the conduit wall.  
     
     
         4 . The device of  claim 1  wherein wherein the conduit is a blood vessel.  
     
     
         5 . The device of  claim 4  wherein the blood vessel is an artery or a vein.  
     
     
         6 . A device for performing an anastomosis wherein the device is implantable to a site within a vessel of a subject through an artificially-made opening in the vessel, comprising: 
 a first segment having a configuration and comprised of a compliant material whereby the first segment is constrictable to a size sufficient to fit through the artificial opening and is expandable to be securely and permanently self-retained within the vessel upon implantation.    
     
     
         7 . The device of  claim 6  wherein the compliant material readily conforms to and seals with an inner surface of the vessel upon deployment within the vessel to form a substantially fluid-tight seal with an inner surface of the conduit.  
     
     
         8 . The device of  claim 6  wherein the first segment comprises a vessel-contacting surface and a lumen-facing surface, wherein, upon implantation of the first segment, the vessel-contacting surface is adapted to readily conform to and seal with the inner surface of the conduit and wherein the lumen-facing surface is adapted to utilize the internal conduit pressure exerted thereon to form a substantially fluid-tight seal between the vessel-contacting surface and an inner surface of the conduit.  
     
     
         9 . The device of  claim 6  wherein the segment comprises a thin membrane having a contact surface area.  
     
     
         10 . The device of  claim 9  wherein the thin membrane has a generally planar configuration in an expanded state.  
     
     
         11 . The device of  claim 6  wherein the thin membrane has a generally curved configuration in an expanded state.  
     
     
         12 . The device of claims  9  wherein the thin membrane has at least a partially cylindrical configuration when in a constricted state.  
     
     
         13 . The device of  claim 12  wherein the thin membrane has a cylindrical configuration when in a constricted state.  
     
     
         14 . The device of  claim 9  wherein the thin membrane has a rectangular shape.  
     
     
         15 . The device of claims  9  wherein the thin membrane has a circular shape.  
     
     
         16 . The device of  claim 9  wherein the thin membrane has an elliptical shape.  
     
     
         17 . The device of  claim 9  wherein the thin membrane has a cylindrical configuration when in an expanded state.  
     
     
         18 . The device of  claim 9  wherein the surface area of the thin membrane is at least about 40 mm 2 .  
     
     
         19 . The device of  claim 18  wherein the surface area of the thin membrane is at least about 70 mm 2 .  
     
     
         20 . The device of  claim 19  wherein the surface area of the thin membrane is at least about 90 mm 2 .  
     
     
         21 . The device of  claim 20  wherein the surface area of the thin membrane is no greater than about 450 mm 2  for vascular applications.  
     
     
         22 . The device of  claim 9  wherein the thickness of the thin membrane is in the range from about 100×10 −3  to 380×10 −3  mm.  
     
     
         23 . The device of  claim 22  wherein the thickness of the thin membrane is in the range from about 150×10 −3 to 350×10 −3  mm.  
     
     
         24 . The device of  claim 23  wherein the thickness of the thin membrane is in the range from about 250×10 −3  to 300×10 −3  mm.  
     
     
         25 . The device of  claim 9  wherein the thin membrane comprises an elastomer.  
     
     
         26 . The device of  claim 8  comprising a biocompatible material.  
     
     
         27 . The device of  claim 26  comprising a biodegradable or bioresorbable material.  
     
     
         28 . The device of  claim 26  wherein at least a portion of the first segment comprises a metal.  
     
     
         29 . The device of  claim 28  wherein the metal comprises stainless steel, vitalium, titanium or nitinol.  
     
     
         30 . The device of  claim 29  wherein the metal is in the form of a wire mesh.  
     
     
         31 . The device of  claim 26  comprising PTFE or Dacron.  
     
     
         32 . The device of  claim 26  comprising a polymer material.  
     
     
         33 . The device of  claim 32  wherein the polymer is an elastomer.  
     
     
         34 . The device of  claim 33  wherein the elastomer comprises polysiloxane or polyurtheane.  
     
     
         35 . The device of  claim 32  wherein the elastomer has a durometer ranging from about 80 Shore A to 55 Shore D.  
     
     
         36 . The device of  claim 26  comprising a bioprosthetic material.  
     
     
         37 . The device of  claim 36  wherein the bioprosthetic material is fabricated from autologous, allogenic or xenogenic tissue.  
     
     
         38 . The device of  claim 8  wherein the first segment comprises a reinforcement portion.  
     
     
         39 . The device of  claim 38  wherein the reinforcement portion comprises a surface area which extends radially outward from the center of the first segment.  
     
     
         40 . The device of  claim 39  wherein the reinforcement portion comprises a an annular, rectangular or petaled configuration.  
     
     
         41 . The device of  claim 8  further comprising a second segment for implantation into a second vessel.  
     
     
         42 . The device of  claim 41  wherein the second segment comprises the same configuration and material as the first segment.  
     
     
         43 . The device of  claim 41  wherein the second segment comprises a different configuration and/or a different material as the first segment.  
     
     
         44 . The device of  claim 41  wherein the first and second segments are in fluid communication with each other.  
     
     
         45 . The device of  claim 44  further comprising a flow opening between the first and second segments.  
     
     
         46 . The device of  claim 45  wherein the flow opening comprises a flow channel extending between the first and second segments.  
     
     
         47 . The device of  claim 41  wherein the first and second segments are in a unitary configuration.  
     
     
         48 . The device of  claim 41  comprised of two pieces, a first piece comprising the first segment and a second piece comprising the second segment.  
     
     
         49 . The device of  claim 48  further comprising a securement member for securing the two pieces in a sealed engagement thereby forming a fluid-tight channel between first and second segments.  
     
     
         50 . The device of  claim 8  further comprising a tubular member extending radially from the first segment for implantation into a graft vessel.  
     
     
         51 . The device of  claim 50  wherein the tubular member is comprised of the same material as the first segment.  
     
     
         52 . The device of  claim 50  wherein the tubular member is comprised of a material different from the first segment.  
     
     
         53 . The device of  claim 41  wherein the first segment and the tubular member are in fluid communication with each other.  
     
     
         54 . The device of  claim 53  further comprising a flow opening between the first and second segments.  
     
     
         55 . The device of  claim 50  wherein the first and second segments are in a unitary configuration.  
     
     
         56 . The device of  claim 50  comprised of two pieces, a first piece comprising the first segment and a second piece comprising the tubular member.  
     
     
         57 . The device of  claim 48  further comprising a securement member for securing the two pieces in a sealed engagement thereby forming a fluid-tight channel between the first segment and the tubular member.  
     
     
         58 . The device of  claim 50  wherein the tubular member has an outer diameter that approximates the inner diameter of the graft vessel.  
     
     
         59 . The device of  claim 58  wherein the tubular member has a length in the range from about 10 to 20 mm.  
     
     
         60 . The device of  claim 59  wherein the tubular member extends substantially perpendicular to the first segment.  
     
     
         61 . The device of  claim 59  wherein the tubular member extends at an angle from the first segment.  
     
     
         62 . The device of  claim 61  wherein the angle is in the range from about 1° to 90°.  
     
     
         63 . The device of  claim 62  wherein the angle is in the range from about 5° to 90°.  
     
     
         64 . The device of  claim 63  wherein the angle is in the range from about 20° to 90°0.  
     
     
         65 . The device of  claim 50  wherein the tubular member is straight along its entire length.  
     
     
         66 . The device of  claim 50  wherein the tubular member comprises a bend along its length wherein the bend defines an angle in the range from about 90° to 179°.  
     
     
         67 . A method of interconnecting conduits in a patient using a flexible anastomosis device having a first member connecting to a second member along a periphery of an opening in the first member and the second member, comprising the steps of: 
 bending a flexible first member of the flexible anastomosis device to a reduced size, the first member having a flexible surface which conforms to an inner surface of a first conduit of a patient;    inserting the bent first member into an opening of the first vessel, wherein upon being inserted into the first conduit, the bent first member expands conforming to the inner surface of the first conduit; and    inserting the second member into an opening of the second conduit.    
     
     
         68 . The method of  claim 67 , further comprising securing the second conduit to the second member.  
     
     
         69 . The method of  claim 68 , wherein the step of securing comprises applying an adhesive between a surface of the second member and a surface of the second conduit.  
     
     
         70 . The method of  claim 68 , wherein the step of securing comprises using a securement member to secure the second conduit to the second member.  
     
     
         71 . The method of  claim 67 , wherein the first member and the second member are each inserted manually by a surgeon using only the surgeon's hands.  
     
     
         72 . A method of interconnecting vessels in a patient, comprising the steps of: 
 inserting a first member of a flexible device by bending the first member and moving it into an opening in a first vessel wherein the first member is configured to an inner circumference of the first vessel and narrows to a flow opening leading to a second member of the device; and    inserting the second member by moving it into an opening in a second vessel wherein the second member is configured to an inner circumference of the second vessel, thereby connecting the first vessel and the second vessel via the flow opening between the first member and the second member.    
     
     
         73 . A kit for forming an anastomosis between vessels, said kit comprising: 
 at least one device according to any of  claims 1  to  66 ; and    a means for appropriately sizing the at least one device to ensure a proper fit within the vessel into which the at least one device is to be inserted.    
     
     
         74 . The kit of  claim 73  wherein the means for appropriately sizing comprises a tool for trimming a first segment of the device.  
     
     
         75 . The kit of  claim 73  further comprising a means for measuring the diameter of the vessel.  
     
     
         76 . The kit of  claim 73  further comprising a means for inserting the first segment into the vessel.  
     
     
         77 . A kit for forming an anastomosis between vessels, said kit comprising: 
 two or more device according to any of  claims 1  to  66  wherein the devices have different configurations and sizes.    
     
     
         78 . The kit of  claim 77  further comprising a means for measuring the diameter of the vessel.