Hemostatic implant introducer
First Claim
1. A surgical delivery instrument for delivering a hemostatic substance subcutaneously against a penetration site in a wall of a blood vessel in the course of a surgical procedure in which an incision is made through the blood vessel and a tubular body with an exterior wall is passed through said incision into said blood vessel, comprising:
- (a) an outer tubular sheath member having a proximal end, a distal end and a lumen extending therebetween, the diameter of said lumen being of a predetermined size greater than that of said tubular body and adapted to allow said tubular body to pass coaxially therethrough;
(b) a housing affixed to said proximal end of said outer sheath member;
(c) an annular mass of a hemostatic material, said mass having a proximal and a distal edge surface and initially being contained within said outer tubular sheath member proximate said distal end thereof so as to be isolated from exposure to body fluids and adapted to coaxially surround and slide longitudinally relative to the exterior wall of said tubular body upon insertion of said tubular sheath into said incision;
(d) an inner tubular member reciprocally movable relative to said outer tubular sheath member and within said lumen of said outer tubular sheath member, said inner tubular member being concentrically disposed relative to said outer tubular sheath member and having a wall thickness for engaging said proximal edge surface of said mass as said inner tubular member is moved relative to said outer tubular sheath; and
(e) a reciprocally movable slide mounted in said housing and operatively coupled to said inner tubular member for imparting relative movement in the longitudinal direction of said inner tubular member and said outer tubular sheath for exposing said mass to body fluids exterior of said lumen with said distal edge surface of said annular mass against the exterior wall of said blood vessel at said penetration site and with no portion of said hemostatic mass or said surgical delivery instrument entering into said blood vessel.
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0 Petitions
Accused Products
Abstract
A puncture seal device for stemming the flow of blood from a punctured blood vessel has an elongated outer sheath affixed to a generally tubular housing where the housing contains a manually actuable slide which is affixed to a rigid tubular pusher member coaxially disposed within the outer sheath. Also contained within the outer sheath in longitudinal alignment with the pusher and distally thereof is a ring-shaped plug of a hemostatic material. The assembly thus far described may be fitted over a tubular introducer or the body of a catheter and then advanced therealong until the distal end of the outer sheath is proximate a bleeding blood vessel. By actuating the pusher member, the hemostatic plug surrounding the introducer or catheter is ejected from the distal end of the outer sheath and held in abutting relationship to the bleeding blood vessel.
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Citations
33 Claims
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1. A surgical delivery instrument for delivering a hemostatic substance subcutaneously against a penetration site in a wall of a blood vessel in the course of a surgical procedure in which an incision is made through the blood vessel and a tubular body with an exterior wall is passed through said incision into said blood vessel, comprising:
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(a) an outer tubular sheath member having a proximal end, a distal end and a lumen extending therebetween, the diameter of said lumen being of a predetermined size greater than that of said tubular body and adapted to allow said tubular body to pass coaxially therethrough; (b) a housing affixed to said proximal end of said outer sheath member; (c) an annular mass of a hemostatic material, said mass having a proximal and a distal edge surface and initially being contained within said outer tubular sheath member proximate said distal end thereof so as to be isolated from exposure to body fluids and adapted to coaxially surround and slide longitudinally relative to the exterior wall of said tubular body upon insertion of said tubular sheath into said incision; (d) an inner tubular member reciprocally movable relative to said outer tubular sheath member and within said lumen of said outer tubular sheath member, said inner tubular member being concentrically disposed relative to said outer tubular sheath member and having a wall thickness for engaging said proximal edge surface of said mass as said inner tubular member is moved relative to said outer tubular sheath; and (e) a reciprocally movable slide mounted in said housing and operatively coupled to said inner tubular member for imparting relative movement in the longitudinal direction of said inner tubular member and said outer tubular sheath for exposing said mass to body fluids exterior of said lumen with said distal edge surface of said annular mass against the exterior wall of said blood vessel at said penetration site and with no portion of said hemostatic mass or said surgical delivery instrument entering into said blood vessel. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A surgical delivery instrument for delivering a hemostatic substance subcutaneously against a wound opening in a wall of a blood vessel during the course of a catheterization, laparoscopic or endoscopic procedure in which an incision is made through the skin and into said blood vessel wall, comprising:
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(a) a first tubular member having a distal end adapted to be received into said incision; (b) an outer tubular sheath member having a proximal end, a distal end and a wall surface defining a lumen extending between said proximal and distal ends of said outer tubular sheath, said lumen being of a size which allows said first tubular member to be coaxially received therein and said distal end of said outer tubular sheath having a generally closed but extensible tip when said tip is subjected to an axially directed force; (c) a housing affixed to said proximal end of said sheath member; (d) an annular shaped mass formed from a hemostatic material and having a proximal edge surface and a distal edge surface, said mass being initially disposed within said sheath member in coaxial surrounding relation relative to said first tubular member and isolated from exposure to body fluids by said sheath member; (e) a tubular pusher reciprocally movable relative to and within said lumen of said outer tubular sheath member, said pusher being concentrically disposed relative to said outer tubular sheath member and having a wall thickness for engaging said proximal edge surface of said mass; (f) a reciprocally slidable member operatively coupled between said housing and said pusher for imparting longitudinal movement to said pusher for ejecting said mass outward from said lumen through said extensible tip of said sheath member along said first tubular member and against the exterior wall of said blood vessel at the site of said incision and with no portion of said mass and said outer tubular sheath entering said blood vessel. - View Dependent Claims (10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25)
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26. A surgical delivery instrument for delivering a hemostatic substance subcutaneously against a wound opening in a wall of a blood vessel during the course of a catheterization, laparoscopic or endoscopic procedure in which an incision is made through the skin and into said blood vessel wall, comprising:
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(a) a first tubular member having a distal end adapted to be received into said incision; (b) an outer tubular sheath member having a proximal end, a distal end and a wall surface defining a lumen extending between said proximal and distal ends of said outer tubular sheath, said lumen being of a size which allows said first tubular member to be coaxially received therein, said sheath member having a housing supporting a thumb slide affixed to said proximal end thereof; (c) an annular-shaped mass formed from a hemostatic material and sized to prevent entry into said blood vessel through said incision and having a proximal edge surface and a distal edge surface, said mass being initially disposed within said sheath in coaxially surrounding relation relative to said first tubular member and isolated from exposure to body fluids by said sheath; and (d) plunger means coaxially surrounding said first tubular member and operatively coupled to said thumb slide for ejecting said mass outward from said lumen at said distal end of said sheath along said first tubular member and against the exterior wall of said blood vessel at the site of said incision, said mass assuming a frusto-conical shape when exposed to body fluids.
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27. A surgical delivery instrument for delivering a hemostatic substance subcutaneously against a wound opening in a wall of a blood vessel during the course of a catheterization, laparoscopic or endoscopic procedure in which an incision is made through the skin and into said blood vessel wall, comprising:
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(a) a first tubular member having a distal end adapted to be received into said incision; (b) an outer tubular sheath member having a proximal end, a distal end and a wall surface defining a lumen extending between said proximal and distal ends of said outer tubular sheath, said lumen being of a size which allows said first tubular member to be coaxially received therein, said sheath member having a housing affixed to said proximal end, said housing including a reciprocally slidable member; (c) an annular shaped mass formed from a hemostatic material and having a proximal edge surface and a distal edge surface, said mass being initially disposed within said sheath in coaxial surrounding relation relative to said first tubular member; (d) a tubular pusher reciprocally moveable relative to and within said lumen of said outer tubular sheath member, said tubular pusher being operatively coupled to said reciprocally slidable member in said housing, said pusher being concentrically disposed relative to said outer tubular sheath member and having a wall thickness for engaging said proximal edge surface of said mass for ejecting said mass outward from said lumen at said distal end of said sheath along said first tubular member and against said exterior wall of said blood vessel at the site of said incision upon displacement of said reciprocally slidable member; and (e) a releasible locking means disposed on said housing for preventing inadvertent deployment of said plug. - View Dependent Claims (28)
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29. A surgical delivery instrument for delivering a hemostatic substance subcutaneously against a wound opening in a wall of a blood vessel during the course of a catheterization, laparoscopic or endoscopic procedure in which an incision is made through the skin and into said blood vessel wall, comprising:
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(a) a first tubular member having a distal end adapted to be received into said incision; (b) an outer tubular sheath member having a proximal end, a distal end and a wall surface defining a lumen extending between said proximal and distal ends of said outer tubular sheath, said lumen being of a size which allows said first tubular member to be coaxially received therein, said sheath member having a housing affixed to said proximal end, said housing including a reciprocally slidable member; (c) an annular shaped mass formed from a hemostatic material and having a proximal edge surface and a distal edge surface, said mass being initially disposed within said sheath in coaxial surrounding relation relative to said first tubular member; (d) a tubular pusher reciprocally moveable relative to and within said lumen of said outer tubular sheath member, said pusher being concentrically disposed relative to said outer tubular sheath member and having a wall thickness for engaging said proximal edge surface of said mass for ejecting said mass outward from said lumen at said distal end of said sheath along said first tubular member and against said exterior wall of said blood vessel at the site of said incision; and (e) means for releasibly locking said housing to said pusher.
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30. A method for performing a catheterization procedure comprising the steps of:
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(a) using a hollow needle-like instrument to penetrate a selected blood vessel; (b) advancing a tubular body into the opening created by said hollow needle-like instrument until a distal end of said tubular body enter said blood vessel, said tubular body being coaxially disposed within a puncture sealing device and having a longitudinally displaceable mass of a hemostatic material coaxially surrounding the exterior of said tubular body and contained within a rigid protective sheath member of said puncture sealing device; (c) passing a catheter through said tubular body into said blood vessel; (d) subsequently removing said catheter from said blood vessel and said tubular body; (e) using said puncture sealing device to slide said mass of hemostatic material along the exterior of said tubular body until said mass is ejected from said protective sheath member in a position abutting said blood vessel; and (f) removing said tubular body and said puncture sealing device, leaving said mass of hemostatic material in place with no portion of said mass or said puncture sealing device in said blood vessel. - View Dependent Claims (31, 32)
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33. A method for effecting hemostasis of a bleeding blood vessel during the course of a surgical procedure comprising the steps of:
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(a) providing a puncture seal device having an elongated tubular outer sheath coaxially surrounding a tubular pusher member and a mass of hemostatic material disposed distally and coaxially of said pusher member, said tubular pusher member and said mass coaxially surrounding a dilator, said dilator and said outer sheath having corresponding fiducial marks on a surface thereof for providing a visual indication of depth of penetration; (b) surgically creating an opening through the skin and through a selected underlying blood vessel; (c) advancing said puncture seal device into said opening until a tactile response indicates that said dilator is engaging said blood vessel; (d) noting the depth of penetration of said dilator by observing said fiducial markings thereon at the point of the engagement; (e) performing the surgical procedure; (f) advancing said puncture seal device until the depth of penetration of said outer sheath reflected by said fiducial marks thereon corresponds to the noted depth of penetration of said dilator and (g) releasing said mass of hemostatic material against the exterior of said blood vessel at the opening therein.
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Specification