Hemostatic implant introducer

• US 5,324,306 A
• Filed: 05/28/1993
• Issued: 06/28/1994
• Est. Priority Date: 10/30/1991
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Howmedica Inc.
• Inventors: Makower, Joshua, Vidal, Claude A., LeMott, Steven R., Banks, Thomas F., Wells, Rodney E.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): DAWSON, GLENN K
• Application Number:
  US08/068,199
• Time in Patent Office: 396 Days
• Field of Search: 128/887, 128/8, 604/1, 604/11, 604/14, 604/15, 604/18, 604/21, 604/48, 604/52, 604/53, 604/57, 604/59, 604/63, 604/104, 604/117, 604/158, 604/160, 604/161, 604/171, 604/174, 604/264, 604/285, 604/278 , 604/309, 604/368, 604/60, 604/61, 606/1, 606/108, 606/151, 606/154, 606/213
• 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 17/2909 Handles
• CPC Class Codes: A61B 2017/00469 for insertion of instruments, e.g. guide wire, optical fibre
• CPC Class Codes: A61B 2017/2923 Toothed members, e.g. rack and pinion
• CPC Class Codes: Y10S 128/08 Collagen

Abstract

A puncture seal device for stemming the flow of blood from a punctured blood vessel includes 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.

Claims

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 tubular outer sheath member, said housing including a tubular handle;

(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.

2. 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 tubular outer sheath member, said housing including a tubular handle having a wall surface defining a longitudinal bore with an arcuate slot formed through said wall surface and communicating with said bore and with a manually rotatable gear journaled in said arcuate slot;

(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) reciprocally movable slide mounted in said housing and including a gear rack affixed to said inner tubular member operatively coupled to said gear 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.

3. 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 tubular sheath member, said housing including a tubular handle, said tubular handle having a wall surface defining a longitudinal bore and an arcuate slot formed through said wall surface to communicate with said bore;

(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 partially contained in said longitudinal bore of said tubular handle, 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;

(e) a reciprocally movable slide mounted in said housing and including a stop member affixed to said inner tubular member with a spring means disposed within said handle and cooperating with said inner tubular member for applying a distally directed force 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 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; and

(f) trigger means disposed on said handle for selectively releasing said force.

4. 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 including a tubular handle affixed to said proximal end of said tubular 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, said outer tubular sheath member, said mass, said inner tubular member, said housing and said slide each including a longitudinal slot aligned with one another for receiving said tubular body therein, said slide being 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.

5. 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:

(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 beveled distal end and a wall surface defining a lumen extending between said proximal and distal ends, said lumen being of a size which allows said first tubular member to be coaxially received therein;

(c) a housing affixed to said proximal end of said outer tubular sheath member;

(d) an annular shaped mass formed from a hemostatic material and having a proximal edge surface and a distal edge surface conforming to said beveled distal end of said tubular sheath member, said mass being sized to prevent entry through said incision into said blood vessel and initially disposed within said sheath in coaxial surrounding relation relative to said first tubular member and isolated from exposure to body fluids by said sheath;

(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 tubular pusher for imparting longitudinal movement to said tubular pusher for ejecting said mass outward from said lumen at said distal end of said outer tubular sheath member along said first tubular member with said beveled distal edge surface against the exterior wall of said blood vessel at the site of said incision and with no portion of said mass entering said blood vessel.

6. 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:

(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, said lumen being of a size which allows said first tubular member to be coaxially received therein;

(c) said outer tubular sheath member having a cylindrical hub affixed to said proximal end thereof and there being a longitudinal slot formed through said wall surface of said outer tubular sheath member proximate said proximal end thereof;

(d) a knob journaled for rotation about said cylindrical hub, said knob including a helical groove on a portion of an exterior surface thereof;

(e) 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 and isolated from exposure to body fluids by said sheath; and

(f) a tubular pusher reciprocally movable relative to and within said lumen of said outer tubular sheath member, said tubular pusher having a finger grip member coupled to it through said longitudinal slot, said finger grip further including a follower member engaging said helical groove, said tubular 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, imparting longitudinal movement to said tubular pusher for ejecting said mass outward from said lumen at said distal end of said sheath along said first tubular member and against an exterior portion of said wall of said blood vessel at the site of said incision when said knob is first rotated so that said follower member clears said helical groove and is then pulled longitudinally in a proximal direction while said finger grip member is held stationary.

7. A surgical instrument for delivering a hemostatic substance subcutaneously against a wound opening in a wall of a blood vessel during the course of a catheterization or endoscopic procedure in which an incision is made through the skin and into said blood vessel wall, comprising:

(a) a tubular outer sheath member having a proximal end, an open distal end and a lumen extending therebetween;

(b) an inner tubular hub affixed to said proximal end of said tubular outer sheath member;

(c) a tubular pusher coaxially disposed within said lumen of said tubular outer sheath member and of a length less than that of said tubular outer sheath member;

(d) an annular mass of hemostatic material disposed between a distal end of said pusher and said distal end of said tubular sheath;

(e) an outer tubular hub secured to said tubular pusher by a coupling passing radially through said outer sheath; and

(f) a knob rotatably supported on said inner hub and having screw threads engaging said outer hub for imparting translational movement to said inner hub relative to said outer hub upon rotation of said knob.

8. The surgical instrument as in claim 7 wherein said rotatable knob includes an externally threaded tubular shank, the threads engaging a helical groove formed in said tubular outer hub.

9. The surgical instrument as in claim 8 wherein said tubular inner hub includes an annular flange cooperating with an annular shoulder formed on said rotatable knob.

10. The surgical instrument as in claim 7 wherein said outer tubular hub is coupled to said tubular pusher by at least one pin extending radially through said tubular outer sheath.

11. A method for effecting hemostasis of a bleeding blood vessel during the course of a surgical procedure comprising the steps of:

(a) providing a puncture seal device having an elongated tubular outer sheath with a distal end and a longitudinal slot extending the length thereof, said tubular outer sheath surrounding a tubular pusher member and a mass of hemostatic material disposed distally and coaxially of said tubular pusher member within said tubular outer sheath, said tubular pusher member and said mass each also having a slot formed longitudinally therein, the slots in said pusher member and in said mass being in longitudinal alignment with said longitudinal slot in said tubular outer sheath;

(b) providing a tubular body having a distal end and a working lumen extending the length thereof;

(c) positioning the distal end of said tubular body adjacent said bleeding blood vessel;

(d) coupling said puncture seal device to said tubular body by inserting said tubular body into said aligned slots;

(e) advancing said puncture seal device in the distal direction along said tubular body until the distal end of said tubular outer sheath is closely proximate said bleeding vessel; and

(f) advancing said tubular pusher member relative to said tubular outer sheath to force said mass out of said tubular outer sheath and into contact with the bleeding blood vessel.