US5290310A — Hemostatic implant introducer

Claim 1

Independent Claim 335 words

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.

Claim 2

Dependent Claim 335 words

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.

Claim 3

Dependent Claim 57 words

The surgical delivery instrument as in claim 1 wherein said housing comprises: (a) a generally cylindrical tube having a wall surface defining a longitudinal bore with a longitudinal slot formed through said wall surface into said bore; (b) said slide disposed in said bore; and (c) finger-engageable means connected to said slide and extending through said slot.

Claim 4

Dependent Claim 16 words

The surgical delivery instrument as in claim 1 wherein said inner tubular member is generally rigid.

Claim 5

Dependent Claim 24 words

The surgical delivery instrument as in claim 1 wherein said mass is sized to prevent entry into said blood vessel through said penetration site.

Claim 6

Dependent Claim 32 words

The surgical delivery instrument as in claim 1 and further including an additional mass of said hemostatic material initially adapted to surround said tubular body adjacently positioned relative to said annular mass.

Claim 7

Dependent Claim 18 words

The surgical delivery instrument as in claims 1 or 5 wherein said hemostatic material is a resorbable collagen.

Claim 8

Dependent Claim 18 words

The surgical delivery instrument as in claims 1 or 5 wherein said hemostatic material is a resorbable gelatin.

Claim 9

Dependent Claim 18 words

The surgical delivery instrument as in claim 1 or 5 wherein said hemostatic material is a resorbable lactide/glycoside.

Claim 10

Dependent Claim 317 words

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 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.

Claim 11

Dependent Claim 317 words

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 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.

Claim 12

Dependent Claim 14 words

The instrument as in claim 9 wherein said hemostatic material is a dried collagen.

Claim 13

Dependent Claim 14 words

The instrument as in claim 9 wherein said hemostatic material is a resorbable gelatin.

Claim 14

Dependent Claim 15 words

The instrument as in claim 9 wherein said hemostatic material is a resorbable polyglycolic acid.

Claim 15

Dependent Claim 56 words

The instrument as in claim 9 wherein said housing comprises: (a) a cylindrical tube having a wall surface defining a longitudinal bore with a longitudinal slot formed through said wall surface into said bore; (b) said slidable member disposed in said bore; and (c) finger-engageable means connected to said slidable member and extending through said slot.

Claim 16

Dependent Claim 30 words

The instrument as in claim 9 wherein said pusher is sufficiently rigid to resist longitudinal deformation when pushed against said mass sufficiently hard to displace said mass from said lumen.

Claim 17

Dependent Claim 21 words

The instrument as in claim 9 wherein said mass is sized to prevent passage through said incision in said vessel wall.

Claim 18

Dependent Claim 15 words

The instrument as in claim 15 wherein said mass has a rounded distal edge surface.

Claim 19

Dependent Claim 27 words

The instrument as in claim 16 wherein said distal end of said tubular sheath is shaped to conform to said rounded distal edge surface of said mass.

Claim 20

Dependent Claim 16 words

The instrument as in claim 17 wherein said distal end of said tubular sheath is distensible.

Claim 21

Dependent Claim 15 words

The instrument as in claim 15 wherein said mass has a blunt distal edge surface.

Claim 22

Dependent Claim 15 words

The instrument as in claim 9 wherein said mass has a bullet-shaped distal edge surface.

Claim 23

Dependent Claim 16 words

The instrument as in claim 15 wherein said mass has a generally beveled distal edge surface.

Claim 24

Dependent Claim 18 words

An instrument as in claim 15 wherein said mass assumes a mushroom shape when exposed to body fluids.

Claim 25

Dependent Claim 25 words

The instrument as in claim 9 and further including a stop formed in said housing for limiting movement of said pusher in the distal direction.

Claim 26

Dependent Claim 31 words

The instrument as in claim 9 wherein said outer tubular sheath is provided with means on an exterior surface for inhibiting dislodgement from a wound in which said sheath is inserted.

Claim 27

Dependent Claim 34 words

The instrument as in claim 9 wherein said housing means includes means for facilitating attachment of said housing to a patient's body to prevent unwanted movement of said instrument relative to the patient's body.

Claim 28

Dependent Claim 251 words

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 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.

Claim 29

Dependent Claim 251 words

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 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.

Claim 30

Dependent Claim 286 words

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 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.

Claim 31

Dependent Claim 286 words

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 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.

Claim 32

Dependent Claim 66 words

The instrument as in claim 27 wherein said housing further includes first and second finger grippable segments, the first being joined to said pusher and the second being joined to said sheath member, and said releasable locking means comprises a pin extending between said first and second segments and a hole extending through one of said first and second segments for selectively receiving said pin therethrough.

Claim 33

Dependent Claim 259 words

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 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.

Claim 34

Dependent Claim 259 words

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 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.

Claim 35

Independent Claim 187 words

A method for performing a catheterization procedure comprising the steps of: (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.

Claim 36

Independent Claim 187 words

A method for performing a catheterization procedure comprising the steps of: (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.

Claim 37

Dependent Claim 42 words

The method as in claim 30 wherein said step of advancing said tubular body includes: (a) passing a guidewire through said hollow needle-like instrument; (b) removing said hollow, needle-like instrument from said guidewire; and (c) advancing said tubular body over said guidewire.

Claim 38

Dependent Claim 33 words

The method as in claim 31 and further including the step of passing a dilator over said guidewire following removal of said hollow needle-like instrument and prior to advancing of said tubular body.

Claim 39

Independent Claim 200 words

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 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.

Claim 40

Independent Claim 200 words

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 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.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	1997-02-28	1997-08-30	1998-03-01	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2001-02-28	2001-08-30	2002-03-01	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2005-02-28	2005-08-30	2006-03-01	$7700.00	Window Closed / Lapsed

Hemostatic implant introducer

Abstract

Inventors

Bibliographic Details

Claims Analysis

References Cited (Backward Citations)

USPTO Annuity & Maintenance Windows

Assigned Categories & Tags

Assign Category Tag