U.S. patent number RE34,866 [Application Number 07/816,518] was granted by the patent office on 1995-02-21 for device for sealing percutaneous puncture in a vessel.
This patent grant is currently assigned to Kensey Nash Corporation. Invention is credited to Harold E. Clupper, Kenneth Kensey.
United States Patent |
RE34,866 |
Kensey , et al. |
* February 21, 1995 |
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.
Inventors: |
Kensey; Kenneth (Chester
Springs, PA), Clupper; Harold E. (West Chester, PA) |
Assignee: |
Kensey Nash Corporation (Exton,
PA)
|
[*] Notice: |
The portion of the term of this patent
subsequent to January 2, 2007 has been disclaimed. |
Family
ID: |
26687154 |
Appl.
No.: |
07/816,518 |
Filed: |
December 31, 1991 |
Related U.S. Patent Documents
|
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
15267 |
Feb 17, 1987 |
4744364 |
|
|
Reissue of: |
194641 |
May 16, 1988 |
04890612 |
Jan 2, 1990 |
|
|
Current U.S.
Class: |
606/213 |
Current CPC
Class: |
A61B
17/0057 (20130101); A61B 2017/00004 (20130101); A61B
2017/00637 (20130101); A61B 2017/00654 (20130101); A61B
2017/00659 (20130101); A61F 2/04 (20130101); A61F
2/06 (20130101); A61F 2002/30062 (20130101); A61F
2002/30075 (20130101); A61F 2210/0004 (20130101); A61F
2210/0061 (20130101) |
Current International
Class: |
A61F
2/24 (20060101); A61B 17/00 (20060101); A61F
2/00 (20060101); A61F 2/02 (20060101); A61F
2/06 (20060101); A61F 2/04 (20060101); A61B
017/04 () |
Field of
Search: |
;604/15,60,51,285,288
;128/831,843,865,887,897,898,899 ;600/32 ;623/1,11
;606/213-218,228-233 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Lewis; Ralph A.
Attorney, Agent or Firm: Caesar, Rivise, Bernstein, Cohen
& Pokotilow, Ltd.
Parent Case Text
This invention relates generally to medical devices and more
particularly to devices for sealing percutaneously formed punctures
or incisions and is continuation-in-part of my copending U.S.
patent application Ser. No. 07/015,267 filed on Feb. 17, 1987, now
U.S. Pat. No. 4,744,364, entitled Device For Sealing Percutaneous
Puncture In A Vessel, assigned to the same assignee as this
invention and whose disclosure is incorporated by reference herein.
Claims
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.
Description
BACKGROUND OF THE INVENTION
As will be appreciated by those skilled in the art various surgical
procedures are now being carried out intravascularly or
intralumenally. For example in the treatment of vascular disease,
such as atherosclerosis, it is a common practice to invade the
artery to insert an instrument, e.g., a balloon or other type of
catheter to carry out the procedure within the artery. Such
procedures usually involve the percutaneous puncture of the artery
so that in introducer sheath can be inserted into the artery and
thereafter the instrument, e.g., catheter, itself can be inserted
through the sheath to the operative position within the artery.
Such procedures unavoidably present the problem of stopping the
bleeding at the percutaneous puncture after the procedure has been
completed and after the instrument (and any introducer sheaths used
therewith) have been removed. At present such bleeding is stopped
by the application of direct digital pressure over the puncture
site by a trained physician or other suitably trained medical
personnel. Such direct pressure has to be applied for a
sufficiently long time for hemostasis to occurs that the opening is
effectively closed against further bleeding. In the case of
punctures into femoral or superficial femoral arteries the pressure
may have to be applied for as long as forth-five minutes for
hemostasis to occur. Not only is this direct digital pressure
application procedure wasteful of time by highly skilled medical
professionals, the procedure results in a substantial reduction, if
not virtual arrest, of the flow of blood through the vessel. Since
thrombosis is one of the major calamities that can occur in the
immediate post operative period, any reduction in blood flow, such
as caused by the application of digital pressure, is
undesirable.
Applicator devices have been disclosed in the patent literature for
inserting an absorbent plug or member into the vagina. Such devices
basically comprises a tubular element adapted to be inserted into
the vagina and having a plug of absorbent material located therein.
The device also includes a plunger to push the plug out of the
tubular element into the vagina. The plug also includes a thread or
string attached to it to enable the plug to be retrieved from the
vagina. Examples of such devices are shown in U.S. Pat. Nos.
1,191,736 (Roberson) and 1,794,221 (Washburn et al.).
While such devices are suitable for their intended purposes, there
is no suggestion of their use, nor are they suitable for insertion
into an opening in the wall of a blood vessel or other bodily lumen
or duct to seal that opening.
The patent literature also includes devices for closing an opening
in a blood vessel using sutures, see U.S. Pat. No. 4,587,909
(Gillis). Other means and techniques for closing a wound are
disclosed in U.S. Pat. No. 4,606,337 (Zimmermann et al.).
None of the prior art teaches the use of simple means for effecting
the closure of an opening, e.g., puncture, in the wall of a blood
vessel, duct or lumen, by plugging the opening and without
requiring sutures or the application of digital pressure.
A need also exists for devices and methods of sealing
percutaneously formed punctures or incisions in other body tissues
such as in the gall bladder, the liver, the heart, the lung,
etc.
OBJECTS OF THE INVENTION
Accordingly, it is a general object of the instant invention to
provide a device and methods of use which overcome the
disadvantages of the prior art.
It is further object of the invention to provide a device and
methods of use that is effective for closing off a puncture or
other opening in a blood vessel, duct or lumen without the need for
the application of digital pressure thereto and without resulting
in any substantial reduction of blood flow through the vessel.
It is still a further object of the instant invention to provide an
instrument which is simple in construction and whose method of use
entails the ready insertion into a blood vessel, duct or lumen to
position a closure therein for hemostatically sealing the puncture
and without substantially blocking the flow of fluid through the
vessel, duct or lumen.
It is yet a further object of the invention to provide a device and
method of use for sealing percutaneously formed punctures or
incisions in tissue separating two portions of the body of a living
being from the flow of a body fluid therebetween.
SUMMARY OF THE INVENTION
These and other objects of the instant invention are achieved by
providing 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, such as punctures or incisions in blood
vessels, ducts or lumens, gall bladders, livers, hearts, etc. The
device comprises a tubular body having an outlet at the distal end
thereof and which is adapted to be inserted through the puncture or
incision to expel a closure therefrom. The closure comprises a
first holding portion adapted to engage portions of the tissue
adjacent the puncture or incision to hold the closure in place and
a second sealing portion formed of a foam material which is adapted
to extend through the puncture or incision to engage the tissue
contiguous with the puncture or incision to seal it from the flow
of a body fluid therethrough between the two body portions.
BRIEF DESCRIPTION OF THE DRAWING
FIG. 1 is a side elevational view partially in section showing a
portion of one device constructed in accordance with this invention
about to be inserted into a conventional sheath extending through a
percutaneous puncture into an artery;
FIG. 2 is a side elevational view of the device 20 in place in the
sheath;
FIG. 3 is a side elevational view of the device 20 during the
expulsion of its puncture sealing closure into the artery;
FIG. 4 is a side elevational view of the artery showing the sealing
closure in place to close off the percutaneous puncture;
FIG. 5 is a reduced plan view of the device 20 of the subject
invention;
FIG. 6 is a side elevational view of the device shown in FIG. 1 but
including an alternative embodiment of the closure;
FIG. 7 is a sectional view taken along line 7--7 of FIG. 6;
FIG. 8 is a side elevational view of the embodiment of the device
shown in FIG. 6 during the expulsion of its puncture sealing
closure into an artery;
FIG. 9 is a side elevational view similar to that of FIG. 8 but
showing the puncture sealing device in place within the puncture in
the artery;
FIG. 10 is a sectional view taken along line 10--10 of FIG. 9;
FIG. 11 is a sectional view through the body of the being showing
the sealing of a percutaneous incision or puncture in the gall
bladder and liver; and
FIG. 12 is a sectional view through the body of the being showing
the sealing of a wound in the lung and heart.
DESCRIPTION OF THE PREFERRED EMBODIMENT OF THE INVENTION
Referring now in greater detail to the various figures of the
drawing wherein like reference characters refer to like parts,
there is shown generally at 20 in FIG. 1 an instrument for
effecting the closure of a puncture or other opening in a blood
vessel, duct or lumen in a living being. The device 20 thus has
particular utility when used in connection with intravascular
procedures, such as angiographic dye injection, balloon angioplasty
and other types of recanalization of atherosclerotic arteries,
in-situ valvulectomy, etc. However, it should be appreciated that
the device 20 can be used to hemostatically close a puncture or
other opening in othe types of duct or lumens within the body.
Thus, it is to be understood that while the description of the
invention as contained herein is directed to closing off
percutaneous punctures in arteries, the device 20 has much more
wide-spread applications.
Before describing the instrument 20 itself a brief description of a
typical, conventional, intravascular surgical procedure, e.g.,
catheter instrumentation of an artery, utilizing a percutaneous
incision or puncture will be given to best appreciate the features
of the device 20. In such a procedure a cannula of an instrument,
such as an angiogrpahic needle (not shown), is inserted
percutaneously through the skin into the artery, such as the
femoral artery 24 at the situs for the instrument's insertion. The
needle cannula is held in place and the flexible end of a
mini-guidewire (not shown) is then passed through the cannula into
the artery to the desired depth (i.e., longitudinal position
therealong). Once the mini-guidewire is in place the needle cannula
is removed leaving the guidewire in place. A conventional
introducer sheath 26 and an arterial dilator (not shown) are then
passed over the guidewire through the puncture 28 and into the
artery 24. The guidewire and then the dilator are removed leaving
the sheath 26 in place. The catheter (not shown) or other
intravascular instrument (not shown) is then inserted through the
introducer sheath 24 and threaded down the artery to the desired
intravascular location, e.g., the situs of an atherosclerotic
occlusion. Once the intravascular procedure (e.g., angioplasty) has
been completed the catheter is removed. Thereafter the sheath is
removed and the surgeon or other trained person applies digital
pressure to the percutaneous puncture until hemostasis has
occurred.
The device 20 effects the hemostatic closure of a percutaneous or
other type of puncture, incision or opening in an artery or other
body duct or lumen without necessitating the application of
pressure thereto. Thus, once the catheter or other intravascular
instrument has been removed but with the sheath 26 left in place,
the device 20 of the subject invention is inserted through the
sheath 26 into the artery 24 and operated to expel a closure member
30 (to be described later) into the artery. The closure is arranged
to be drawn back into the puncture 28 to seal it. The sheath is
removed and the closure left in place. Due to its construction the
closure is ultimately absorbed by the surrounding tissue.
As can be seen in FIG. 1 the device 20 basically comprises a
tubular body 32 having an outlet 34 at its distal end, the
heretofore identified closure member 30 having a retraction
filament 36 connected thereto, and pusher means 38. The tubular
body is an elongate member preferably constructed of a sufficiently
small outside diameter, e.g., 8 F (French), and somewhat flexible
material, such as polyethylene or polyvinylchloride, to enable it
to be inserted through the introducer sheath 26 into the artery 24,
with the tubular body's outlet 34 within the artery distally of the
puncture 28.
The closure member 30 is an expandable member which, when
contracted or compressed is sufficiently compact to fit within the
interior of the tubular body 30, but when unconstrained by the
tubular body it expands to an enlarged configuration (See FIGS. 3
and 4) suitable for closing off the puncture 28 in the artery.
Thus, closure member 30 is formed by a resilient, hemostatic
material, which is preferably biodegradable, so that it need not be
removed after placement. One particular effective material is a
porous hemostatic absorbable gelatin sold by Johnson & Johnson,
Inc. under the name Gelfoam.
The pusher means 38 basically comprises an elongated, cylindrical
rod-like member, having a distal end 40. The pusher is also formed
of a relatively flexible material, such as polyethylene or
polyvinylchloride and is disposed within the interior of tubular
body 32. The outside diameter of the pusher is slightly less than
the inside diameter of the tubular body portion to enable the
pusher to be manually moved (slid) down the longitudinal axis of
the body portion 28, to push or force the closure 30 out of the
outlet 34. Thus the pusher is arranged to be moved from a retracted
position, like that shown in FIG. 2 to an extended position like
that shown in FIG. 3 wherein its distal end 40 is located close to
the outlet 34 of the body 32. When the pusher is moved to the
extended position its distal end forces the closure member 30 out
of the outlet 34.
The heretofore identified retraction filament 36 constitutes an
elongated thread, preferably formed of a long, yet very thin,
biodegradable material, such as an absorbable suture, and is
fixedly secured to the proximal side 42 of the closure member 30 at
the middle thereof. When the closure is in position within the
tubular body the thread 36 extends down the length of the tubular
body 32 between it and the pusher 38 so that the proximal end of
the thread is located outside the device 20.
The thread 36 being long and thin does not interfere with the
operation of the pusher expelling the closure member 32 out of
outlet 34. Thus, during the expulsion of the closure into the
artery the thread 36 slides down the tubular member with the
closure. The thread 36 is sufficiently long that a substantial
length extends outside of the proximal end of the device 20 even
after the closure is in the artery.
In order to effecuate the movement of the pusher from the retracted
to the extended position the tubular body includes a collar 44
having a flanged projection 46 arranged to be grasped by the
fingers of the user of the device 20. In addition the proximal end
48 of the pusher 38 includes an enlarged cap 50 arranged to be
engaged by the user's thumb. Thus, to effect the ejection of the
closure member 30 all the user of the device 20 merely has to do is
to grasp the projection 46 with his/her fingers while applying
pressure to the cap 50 with his/her thumb. This action forces the
pusher down the tubular body to the extended position.
As can be seen in FIGS. 3 and 4, when the closure member 30 is in
its unconstrained state (such as when it is ejected into the
artery) it assumes a configuration having an enlarged head portion
52 and an anchor portion 54. The head portion is of generally
disk-like shape of relatively large diameter, e.g., 6-9 mm, yet
relatively thin, e.g. 1-2mm. The head portion includes the rear
(proximal) surface 42 and a front (distal) surface 56. The anchor
portion 54 consists of a small diameter, e.g., 2-3 mm, hub-like
projection from the proximal surface 50 at approximately the center
thereof. The distal end of the retraction thread 36 is fixedly
secured to the anchor portion 54. The resilient nature of the
closure enables the enlarged head portion 52 to conform to the
surface 58 of the interior of the artery 24 contiguous with the
puncture 28 so that its proximal surface 42 intimately engages the
artery surface 58 while the hub-like anchor portion 54 extends
somewhat into the puncture 28 to hemostatically seal the puncture
when the closure is pulled into place, as will be described
hereinafter.
Thus, as shown in FIG. 3, after the tubular body 32 of device 20
has been inserted into the sheath 26 so that its outlet 34 is
within the artery, the sheath 26 is withdrawn. The pusher is then
extended or pushed down the tubular body as described heretofore so
that its distal end portion 40 forces the closure 30 out of outlet
34. Once the closure 30 is outside the confines of the tubular body
32 it expands or enlarges to its disk-shaped configuration. After
the closure is pushed out of the tubular member by the pusher, the
tubular body is itself withdrawn from the puncture 28 in the artery
and moved completely outside the body of the patient. This action
leaves the closure 30 within the artery and with the retraction
filament extending through the puncture 28 so that a substantially
portion of the filament is outside the patient's body. The filament
is then pulled by its proximal end to cause the closure to move
toward the puncture 28, until its anchor portion 42 is somewhat
within the puncture and its engagement surface 50 is in intimate
engagement with the interior of the artery wall contiguous with the
puncture. This action hemostatically seals the puncture. In order
to hold the closure in place the thread 34 is held taut and is
secured in position on the patients skin, such as by use of a strip
of conventional tape 60. Alternatively, some other gripping means
(not shown) can be used to slide down the filament into contact
with the skin while together gripping the filament tightly to
prevent it from slipping.
By virtue of the fact that the head portion 52 of the closure is
thin and conforms to the interior surface of the artery, it does
not block off or otherwise impede the flow of blood through the
artery.
It should be noted at this juncture that the closure can be of any
suitable shape and need not be of the disk-like shape shown herein,
so long as once it is pulled into position at the situs of the
puncture it serves to hemostatically seal that puncture without
appreciably blocking the passageway. Moreover, in order to minimize
the risks of thrombosis in the artery the front (distal) face 56 of
the closure 30, which is exposed to the flow of blood through the
artery, may be coated with a non-thrombogenic material. This
feature serves to minimize the risk of thrombosis forming in the
artery. The thrombogenic material used can comprise a waxy coating,
such as coconut oil, on the closure's front surface 56.
As mentioned earlier the closure and its retraction filament are
each preferably formed of an absorbable (e.g., biodegradable)
material. This feature enables the closure to be left in place
after hemostatis has occurred since it will be absorbed by the
bodily tissues thereafter. Accordingly, the closure does not have
to be removed after having served its purpose.
In order to accellerate hemostasis the nature forming the closures
of the invention may include conventional clotting agents, such as
tissue throboplastin.
In FIG. 6 there is shown an alternative embodiment of the closure
utilized in a device 20 for sealing a percutaneous puncture or
incision. The alternative embodiment of the closure is designated
by the reference numeral 100 and basically comprises three
components, namely, a holding member .[.102.]. .Iadd.106.Iaddend.,
a suture or filament 104, and a sealing member .[.106.].
.Iadd.102.Iaddend.. The holding member is an elongated body
constructed like a toggle and is preferably formed of a
biodegradable, thermoplastic polymer, such as polyglactide. This
material will degrade within the body within a short period of
time, e.g., approximately 45 days. The toggle is molded onto the
distal end of the filament 104 which is slightly bulbous to hold
the toggle in place thereon. The filament is also preferably formed
of polyglactide (e.g., it will degrade within the body in
approximately 90 days). The filament is quite flexible so that the
toggle can pivot to various orientations with respect to it.
Disposed promixally behind the toggle is the sealing member
.[.106.]. .Iadd.102 .Iaddend.. That member basically comprises a
cylindrical plug preferably formed of a compressed foam which is
highly absorbent and which, when disposed within the body, swells
in excess of its compressed diameter, e.g., swells to twice its
compressed diameter. The plug is preferably formed of gelatin or
collagen foam so that it also degrades quickly within the body,
e.g., in approximately ten days or so. The filament extends fully
through the plug.
The closure 100 is located within the device 20 adjacent the outlet
34 of the tubular portion 32 thereof. In particular, the foam plug
or sealing portion 102 is located immediately adjacent the free end
40 of the plunger 38, with the toggle or holding portion 106
located at the distal end of the portion 102. The toggle is
oriented so that its longitudinal axis is parallel to the
longitudinal axis of the device 20. When so disposed the toggle
compresses a portion of the distal end of the plug portion. The
filament 104 extends backward from the toggle portion through the
plug portion and through a central passageway in the plunger 38 to
a point outside the device 20. The closure is introduced into the
artery, or into a puncture or incision in any body tissue, such as
the liver (FIG. 11), gall bladder (FIG. 11), lung (FIG. 12), heart
(FIG. 12), etc., until the insertion device's outlet 34 is in the
desired position.
In the case of the sealing of an artery, the outlet 34 of the
device is positioned so that it is within the artery (See FIG. 8)
and just slightly beyond the introducer sleeve 26. This placement
is controlled by stops (not shown) on the device 25. The plunger 38
is then operated as described earlier to expel the closure 100.
Once the closure is expelled, the device 20 is held in this
position for a short period of time, e.g., 15 to 60 seconds, to
allow the foam at the tip of the closure, i.e., the distal end of
portion 102, to swell. This action effectively tips the toggle. The
insertion device 20 is then removed in a similar manner as
described earlier and the closure's filament 104 then retracted,
that is, pulled in the direction of arrow 108 in FIG. 8. This
action pulls the closure's plug portion 102 back through the
puncture or incision 28 in the artery wall until its toggle portion
106 engages the inner surface of the arterial wall to stop further
retraction. As the toggle comes into engagement with the arterial
wall, it effects the compression of the distal end portion 110 of
the plug portion 102. Moreover, the proximal end portion of the
plug 102 extends into the puncture or incision in the subcutaneous
tissue 22A to a point closely adjacent the skin 22. These actions
effectively seal the puncture or incision from the passage of blood
therethrough.
It should be noted that the engagement of the toggle with the inner
surface of the artery wall can either be direct or indirect, the
latter being through the interposed deformed distal end portion of
the plug 102. In either event, the toggle serves to act as a stop
precluding the closure 100 from being pulled out of sealing
engagement with the puncture or incision 28.
In lieu of the use of the toggle/foam plug closure 100, one can
utilize an alternative closure 200. The closure 200 basically
comprises a preformed foam plug having an enlarged distal end
portion 106 (See FIGS. 11 and 12) serving as the heretofore
described holding member, a proximally located rod-like portion 102
(See FIGS. 11 and 12) serving as the heretofore described sealing
member and a retraction filament 104 secured thereto. The closure
200 is preferably formed of a dense collagen foam with long
collagen fiber reinforcement so that it has a high expansion ratio
(wet-to-dry) and good mechanical wet strength.
The closure 200, like closures 30 and 100 is held within the
tubular portion 32 of the insertion device 20 in a compressed state
and with its holding portion 106 located immediately adjacent the
outlet 34. For sealing punctures or incisions in arteries the
device 20 is introduced into the artery in the manner as described
heretofore. The pusher member 38 then pushes the foam closure out
of the outlet, whereupon the holding portion 206 swells upon
contact with the blood in the artery. The insertion device 20 is
then removed so that the closure 200, now swollen, hangs up at the
puncture or incision 28 within the arterial wall, i.e., the
enlarged holding member portion 206 engages the inner surface of
the arterial wall and the sealing portion 102 extends fully through
the puncture or incision into the subcutaneous tissue 22A. The
retraction of the filament fully seats the closure in place so that
the sealing portion extends fully through the puncture or incision
in the artery wall and with its proximal end located within the
subcutaneous tissue closely adjacent the skin.
The advantage of the preformed foam closure as just described over
the toggle/plug closure 100 is that it is considerably simpler in
construction, assembly and cost.
As mentioned earlier, it is frequently desirable to be able to seal
a puncture or incision in body organs or tissue other than blood
vessels. For example, in cases where percutaneous transhepatic
punctures are made into the gall bladder for purposes of
introducing chemicals or mechanical instruments, there exists a
very real risk of bile leakage into the peritoneum via the liver
puncture site, thereby resulting in a dangerous possibility of
peritonitis. The closures 30, 100 and 200, as described heretofore,
can be utilized to seal such percutaneous punctures or incisions to
eliminate the risks of bile leakage. For example, as shown in FIG.
11 an insertion device 20 with a closure 100 to 200 disposed
therein is introduced through the puncture or incision 28 in the
right lobe of the liver and through the puncture or incision in the
gall bladder so that the devices outlet 34 extends just beyond its
introducer sheath 26. The plunger 38 is then pressed to eject the
closure so that the holding portion 106 thereof is located within
the gall bladder and in engagement with the inner surface thereof,
while the sealing portion 102 extends through the puncture or
incision in the gall bladder and into the puncture or incision in
the liver. Alternatively, the closure 100/200 may be left in the
incision or puncture 28 in the liver alone, if that makes best
sense from a medical/surgical standpoint.
The subject invention is also useful for effecting the sealing of
percutaneous incisions or punctures in the heart, such as could
result from a wound. In this connection, as shown in FIG. 12, a
wound penetrating the left lung and left ventricle may be sealed by
introducing the insertion device 20 with a closure 100/200 therein
through the wound, through the puncture in the lung, and into the
puncture in the left ventricle. The closure 100/200 is then ejected
so that its holding portion 106 is located within the ventricle,
while its sealing portion 102 extends through the puncture in the
left ventricle wall and through the puncture in the left lung. In
such applications, it is preferred that the closure member 100/200
be configured so that its sealing portion 102 is of a substantial
length to extend not only through the puncture in the left
ventricle, but also the puncture in the lung and through the wound
in the skin to some exterior point closely adjacent the skin. Thus,
the closure 100/200 acts as a tamponade.
As should be appreciated by those skilled in the art, the device
and methods of this invention as well as the closure device
mentioned in my copending U.S. patent application, can be utilized
to seal a percutaneous incision or puncture in any body tissue or
organ to prevent the flow of fluid through that puncture or
incision from one body portion to another.
Without further elaboration the foregoing will so fully illustrate
by invention that other may, by applying current or future
knowledge, adopt the same for use under various conditions of
service.
* * * * *