Device for sealing percutaneous puncture in a vessel

Abstract

A device and method for sealing a puncture or incision formed percutaneously in tissue separating two internal portions of the body of a living being, e.g., a puncture or incision in an artery, in the gall bladder, in the liver, in the heart, etc. The device comprises plug means having a holding portion which is adapted to engage portions of the tissue adjacent the puncture or incision to hold the plug means in place and a sealing portion formed of a foam material and extending through the puncture or incision to engage the tissue contiguous therewith to seal the puncture or incision from the flow of body fluid therethrough. In the preferred embodiment, the closure or plug means is formed of a biodegradable material.

What is claimed is: 
     
       1. A closure device for sealing a puncture or incision formed percutaneously in tissue separating two internal portions of the body of a living being, .Iadd.said tissue having an inside and an outside portion, said puncture or incision including a first portion extending through said tissue from said inside portion to said outside portion and a second portion extending from said first portion of said puncture or incision to the surface of said skin, .Iaddend.said device comprising plug means arranged for placement at a predetermined position within the body of said being and having a first holding portion and a second sealing portion .[.adapted.]..Iadd., said first holding portion being preformed in a predetermined shape and being orientable into a first orientation to enable it to be extended in a first direction through said incision or puncture and thereafter orientable into a second and different orientation without changing from said predetermined shape so that it can be retracted in a second direction opposite to said first direction .Iaddend.to .[.engage.]. .Iadd.a position contiguous with the inside .Iaddend.portions of the tissue adjacent said puncture or incision .Iadd.without being pulled through said puncture or incision .Iaddend.to hold said plug means in place.Iadd., said second sealing portion being configured for location within said second portion of said puncture or incision, and being .Iaddend.formed of an expandable material which expands automatically in response to the ambient surroundings when in said .[.predetermined position and extending through said.]. .Iadd.second portion of .Iaddend.said puncture or incision to engage .[.the.]. tissue contiguous therewith to seal said puncture or incision from the flow of a body fluid therethrough .[.between said two internal portions.].. 
     
     
       2. The device of claim 1, wherein said expandable material comprises a collagen foam. 
     
     
       3. The device of claim 1, wherein said expandable material comprises a gelatinous foam. 
     
     
       4. The device of claim 1 wherein said tissue comprises .Iadd.the wall of .Iaddend.a blood vessel and wherein said second sealing portion .Iadd.is shaped to .Iaddend.extend.[.s fully.]. through said .Iadd.second portion of said .Iaddend.puncture or incision .[.in the wall of said blood vessel.]. to a point adjacent the skin of the being. 
     
     
       5. The device of claim 4 wherein said expandable material comprises a collagen foam. 
     
     
       6. The device of claim 4 wherein said expandable material comprises a gelatinous foam. .[.7. The device of claim 1 wherein said tissue comprises the gall bladder and wherein said second sealing portion extends fully through said puncture or incision in the wall of said gall bladder and into a cooperating puncture or incision in the liver of said being..]. .[.8. The device of claim 7, wherein said expandable material comprises a collagen foam..]. .[.9. The device of claim 7, wherein expandable material comprises a gelatinous foam..]. .[.10. The device of claim 1 wherein said tissue comprises the liver of said being and wherein said second sealing portion extends substantially into said puncture or incision in said liver..]. .[.11. The device of claim 10 wherein said expandable material comprises a collagen foam..]. .[.12. The device of claim 10 wherein said expandable material comprises a gelatinous foam..]. .[.13. The device of claim 1 wherein said tissue is the heart of said being and wherein said second sealing portion extends through said incision or puncture in said heart to a point closely adjacent the skin of said being..]. .[.14. The device of claim 13 wherein said expandable material comprises a collagen foam..]. .[.15. The device of claim 13 wherein said expandable material 
     
     
        comprises a gelatinous foam..]. 16. The device of claim 1 additionally 
     
     
        comprising retraction means. 17. The device of claim 16 wherein said retraction means comprises a filament secured to said holding portion. 
     
     
            The device of claim 17 wherein said holding portion toggles with 
     
     
        respect to the sealing portion. 19. The device of claim 18 wherein said filament and said .[.toggle.]. .Iadd.holding portion .Iaddend.are each formed of a biodegradable material. .[.20. The device of claim 1 wherein said tissue is a lung of said being and wherein said second sealing portion extends through said incision or puncture into said lung to a point closely adjacent the skin of said being..]. .[.21. The device of claim 20 wherein said expandable material comprises a collagen foam..]. .[.22. The device of claim 20 wherein said expandable material comprises a 
     
     
        gelatinous foam..]. 23. The method of sealing a small puncture or incision formed percutaneously in tissue separating two internal portions of the body of a living being by the use of plug means.Iadd., said tissue having an inside portion and an outside portion, said puncture or incision including a first portion extending through said tissue from said inside portion to said outside portion and a second portion extending from said first portion of said puncture or incision to the surface of said skin, said plug means .Iaddend.comprising a first holding portion and a second sealing portion.Iadd., said first holding portion being preformed in a predetermined shape, said second sealing portion being .Iaddend.formed of an expandable material which expands automatically in response to the ambient surroundings when in the body of said being, said method comprising .Iadd.orienting said first holding portion into a first orientation without changing said predetermined shape, inserting said first holding portion while in said first orientation .Iaddend..[.inserting said plug means.]. percutaneously into said puncture or incision .Iadd.in a first direction, orienting said first holding portion into a second orientation without changing said predetermined shape and retracting said first holding portion while in said second orientation in a second, opposite direction to said first direction .Iaddend.so that said first holding portion .[.engages.]. .Iadd.is pulled into a position contiguous with inside .Iaddend.portions of said tissue .Iadd.adjacent said puncture or incision and without being pulled through said puncture or incision .Iaddend.to hold said plug means in place and with said second sealing portion extending through said puncture or incision .[.expanding.]. .Iadd.so that said sealing portion is located within said second portion of said puncture or incision, whereupon said second portion expands automatically to engage .[.the.]. tissue contiguous therewith to seal said puncture or incision from the flow of a body fluid 
     
     
        therethrough .[.between said two internal portions.]..  24. The method of claim 23 wherein said tissue comprises .Iadd.the wall of .Iaddend.a blood vessel and wherein said second sealing portion is .[.arranged.]. .Iadd.shaped .Iaddend.so that its extends .[.fully.]. through said .Iadd.second portion of said .Iaddend.puncture or incision .[.in the wall 
     
     
        of said blood vessel.]. to a point adjacent the skin of the being. 25. The method of claim 24 wherein said expandable material comporises of a 
     
     
        collagen foam. 26. The method of claim 24 wherein said expandable material 
     
     
        comprises a gelatinous foam. 27. The method of sealing a small puncture or incision formed percutaneously in the gall bladder by use of plug means comprising a first holding portion and a second sealing portion formed of an expandable material, said method comprising inserting said plug means percutaneously into said puncture or incision so that said first holding portion engages portion of said gall bladder to hold said plug means in place and with said second sealing portion extending fully through said puncture or incision in the wall of said gall bladder and into a cooperating puncture or incision in the liver of said being to seal said 
     
     
        puncture or incision from the flow of a body fluid therethrough. 28. The method of claim 27 wherein said expandable material comprises a collagen 
     
     
        foam. 29. The method of claim 27 wherein said expandable material 
     
     
        comprises a gelatinous foam. 30. The method of claim 27 wherein said second sealing portion automatically expands in response to the ambient surroundings when in the body of said being in said puncture or incision. 
     
     
         1. The method of sealing a small puncture or incision formed percutaneously in the liver of a living being by the use of plug means comprising a first holding portion and a second sealing portion formed of an expandable material, said method comprising inserting said plug means percutaneously into said puncture or incision so that said first holding portion engages portions of said liver to hold said plug means in place and with said second sealing portion extending substantially into said puncture or incision in said liver to engage the tissue contiguous therewith to seal said puncture or incision from the flow of body fluid 
     
     
        therethrough. 32. The method of claim 31 wherein said expandable material 
     
     
        comprises a collagen foam. 33. The method of claim 31 wherein said 
     
     
        expandable material comprises a gelatinous foam. 34. The method of claim 31 wherein said second sealing portion automatically expands in response to the ambient surroundings when in the body of said being in said 
     
     
        puncture or incision. 35. The method of sealing a small puncture or incision formed percutaneously in the heart of a living being by use of plug means comprising a first holding portion and a second sealing portion formed of an expandable material, said method comprising inserting said plug means percutaneously into said puncture or incision so that first holding portion engages portions of said heart to hold said plug means in place and with said second sealing portion extending through said incision or puncture in said heart to a point closely adjacent the skin of said being and engaging the tissue contiguous therewith to said seal puncture 
     
     
        or incision from the flow of body fluid therethrough. 36. The method of 
     
     
        claim 35 wherein said expandable material comprises a collagen foam. 37. The method of claim 37 wherein said expandable material comprises a 
     
     
        gelatinous foam. 38. The method of claim 35 wherein said second sealing portion automatically expands in response to the ambient surroundings when 
     
     
        in the body of said being in said puncture or incision. 39. The method of sealing a small puncture or incision formed percutaneously in a lung of a living being by the use of plug means comprising a first holding portion and a second sealing portion formed of an expandable material, said method comprising inserting said plug means percutaneously into said puncture or incision so that said first holding portion engages portion of said lung to hold said plug means in place and with said second sealing portion extending fully through said puncture or incision in said lung to a point closely adjacent the skin of said being to engage the tissue contiguous therewith to seal said puncture or incision from the flow of a body fluid 
     
     
        therethrough. 40. The method of claim 39 wherein said expandable material 
     
     
        comprises a collagen foam. 41. The method of claim 39 wherein said 
     
     
        expandable material comprises a gelatinous foam. 42. The method of claim 39 wherein said second sealing portion automatically expands in response to the ambient surroundings when in the body of said being in said 
     
     
        puncture or incision. .Iadd.43.  A method of sealing a small puncture or incision formed percutaneously in a blood vessel of the body of a living being by use of a plug means comprising first and second portions, said first portion being positioned distally of said second portion in use, at least one of said portions being formed of an expandable material, a flexible retraction means being operatively connected to said first portion of the plug means and extending beyond the being's skin after the plug means has been inserted percutaneously into said puncture or incision, said method comprising the steps of: inserting said plug means percutaneously into said puncture or incision; maneuvering said flexible retraction means from a location beyond the being's skin for adjusting the plug means after it has been inserted so that said plug means is in an orientation wherein said first portion is located within said blood vessel to act as a stop to prevent retraction of said plug means out of said puncture or incision and wherein said second portion engages a portion of the being's body located between the exterior surface of the blood vessel and the surface of the being's skin, said first and second portions cooperating for sealing said puncture or incision from the flow of blood passing through said blood vessel. .Iaddend. .Iadd.44. The method of claim 43, including the step of forming said second portion of said expandable material for expanding into engagement with portions of the being's body located between the exterior surface of the blood vessel and the surface 
     
     
        of the being's skin. .Iaddend. .Iadd.45.  The method of claim 44 wherein said expansion of said second portion occurs automatically in response to 
     
     
        the presence of blood. .Iaddend. .Iadd.46.  The method of claim 44 wherein said second portion promotes hemostasis and aids in holding said plug means in position for sealing the puncture or incision. .Iaddend. 
     
     
        .Iadd.     The method of claim 43, including the step of forming said first and second portions of said plug means of materials which are absorbable within the body after a period of time sufficient for permitting effective closure of said incision or puncture. .Iaddend. 
     
     
        .Iadd.8.  The method of claim 47, including the step of selecting the materials of said first and second portions of said plug means for causing said second portion to be absorbed within the body in a shorter period of 
     
     
        time than said first portion. .Iaddend. .Iadd.49.  The method of claim 48 including the steps of forming said first portion and second portion of 
     
     
        different materials. .Iaddend. .Iadd.50.  The method of claim 43, including the step of forming said plug means and flexible retraction means of a material which is absorbable within the body after a period of time sufficient for permitting effective closure of said incision or puncture. .Iaddend. .Iadd.51. The method of claim 43, including the steps of performing said first portion, prior to use of the plug means, in a configuration for permitting insertion of the first portion through the puncture or incision of the blood vessel to a position within said blood vessel when the first portion is in a first orientation relative to said second portion, and for permitting the first portion to bridge the puncture or incision within said blood vessel when said first portion is in a second orientation relative to said second portion for preventing the plug means from being pulled out of the blood vessel during the step of employing the retraction means to assist in locating the plug means for sealing the puncture or incision, and arranging said preformed first portion distally of said second portion in use for permitting said first portion to be positioned in the first orientation when the first portion is being inserted into the blood vessel through the puncture or incision, and then to be toggled relative to said second portion into said second 
     
     
        orientation when in the interior of the blood vessel. .Iaddend. .Iadd.52. The method of claim 51 including the step of forming said second portion of said expandable material for expanding into engagement with internal body tissue after said first portion has been inserted into the interior of the blood vessel, said second portion being arranged relative to said first portion for aiding in toggling said first portion into said second orientation upon expansion of said second portion. .Iaddend. .Iadd.53. The method of claim 52 wherein said expansion of said second portion occurs 
     
     
        automatically in response to the presence of blood. .Iaddend. .Iadd.54. The method of claim 43 wherein said second portion promotes hemostatis and aids in holding said plug means in position for sealing the puncture or 
     
     
        incision. .Iaddend. .Iadd.55.  The method of claim 43 including the step of operatively connecting the flexible retraction means to the first portion by connecting the retraction means to the first portion and in a 
     
     
        location extending along said second portion. .Iaddend. .Iadd.56.  The method of claim 55 including the step of positioning the retraction means 
     
     
        through the second portion. .Iaddend. .Iadd.57.  A plug device for sealing a small puncture or incision formed percutaneously in a wall of a blood vessel of a living being, said device comprising a plug including a first portion and a second portion, said first portion being positioned distally of said second portion in use, and said device further including a flexible retraction means operatively coupled to the plug for extending beyond the being's skin after the plug has been inserted percutaneously into said puncture or incision in the wall of the blood vessel, one of said first and second portions of said plug being formed of an expandable material, said plug being configured to be inserted percutaneously into said puncture or incision such that retraction of said retraction means causes said first portion of said plug to move to a position within said blood vessel to act as a stop to prevent the retraction of said plug out of said puncture and said second portion of said plug being in engagement with internal tissue portions of the being's body located between the exterior surface of the wall of said blood vessel and the surface of the being's skin when said plug is positioned in said puncture or incision, said second portion of said plug being movable into engagement with said internal tissue portions for aiding in holding said plug in a position for sealing said puncture or incision from the flow of blood therethrough. .Iaddend. .Iadd.58. The plug device of claim 57 wherein said second portion of the plug is formed of an expandable material and is expanded into engagement with said internal tissue portions to retain said plug in said position for sealing said puncture or incision from the flow of blood 
     
     
        therethrough. .Iaddend. .Iadd.59.  The plug device of claim 58 wherein said second portion of the plug comprises a material which expands automatically in response to the presence of blood. .Iaddend. .Iadd.60. The plug device of claim 59 wherein said second portion of the plug comprises a material which promotes hemostatis and aids in holding said plug device in said position. .Iaddend. .Iadd.61. The plug device of claim 58 wherein said second portion of the plug comprises a material which promotes hemostatis and aids in holding said plug device in said position. .Iaddend. .Iadd.62. The plug device of claim 57 wherein said first portion of said plug is configured to be positioned along the inner surface of the blood vessel to obstruct the flow of blood into the puncture or incision 
     
     
        from the blood vessel. .Iaddend. .Iadd.63.  The plug device of claim 57 wherein the flexible retraction means is directly connected to the first portion of the plug and extends along the second portion of the plug. .Iaddend. .Iadd.64. The plug device of claim 63 wherein the flexible retraction means extends along the second portion of the plug by extending through the second portion. .Iaddend. .Iadd.65. The plug device of claim 57 wherein said first and second portions of said plug are formed of materials which are absorbable within the body after a period of time sufficient for permitting effective closure of said incision or puncture. .Iaddend. .Iadd.66. The plug device of claim 65 wherein the second portion of the plug is absorbed within the body in a shorter period of time then 
     
     
        said first portion. .Iaddend. .Iadd.67.  The plug device of claim 66 wherein said first portion and said second portion of the plug are 
     
     
        constructed of different materials. .Iaddend. .Iadd.68.  The plug device of claim 57 wherein said first portion of the plug is preformed in a configuration for permitting insertion of the first portion through the puncture or incision of the blood vessel to a position within said blood vessel when the first portion is in a first orientation relative to the second portion of the plug, and for permitting said first portion to bridge the puncture or incision within said blood vessel when said first portion is in a second orientation relative to said second portion for preventing the plug from being pulled out of the blood vessel, said preformed first portion being located distally of the second portion in use of the plug device for permitting the first portion to be positioned in the first orientation when the first portion is inserted into the blood vessel through the puncture or incision and then to be toggled relative to said second portion into said second orientation when in the interior of the blood vessel. .Iaddend. .Iadd.69. The plug device of claim 68 wherein the second portion of the plug is formed of an expandable material, said expandable material being positioned relative to the first portion for causing movement of the first portion into the second orientation upon expansion of the second portion. .Iaddend. .Iadd.70. The plug device of claim 69 wherein the second portion of the plug comprises a material which expands automatically in response to the presence of blood. .Iaddend.