U.S. patent application number 09/754606 was filed with the patent office on 2001-06-07 for hemostatic puncture closure system and method of use.
This patent application is currently assigned to Kensey Nash Corporation. Invention is credited to Evans, Douglas, Kensey, Kenneth, Nash, John.
Application Number | 20010003158 09/754606 |
Document ID | / |
Family ID | 27120940 |
Filed Date | 2001-06-07 |
United States Patent
Application |
20010003158 |
Kind Code |
A1 |
Kensey, Kenneth ; et
al. |
June 7, 2001 |
Hemostatic puncture closure system and method of use
Abstract
A system, a closure, and method of use for sealing a
percutaneous puncture in a blood vessel. The puncture includes an
opening in the vessel wall and a tract leading to the opening. The
system includes an introducer sheath and associated positioning
device, a hemostatic puncture closure, and a deployment instrument.
The positioning device enables the introducer sheath to be
positioned at a desired position within the vessel. The deployment
instrument includes a tubular carrier storing the closure. The
closure comprises a rigid, e.g., radio-opaque, anchor, a compressed
collagen plug, and a thin filament connecting the two in a
pulley-like arrangement. The instrument and introducer are used to
introduce the closure into the puncture, with the anchor located
within the artery and with the collagen plug within the puncture
tract. A locking member is provided to hold the closure in place at
its operative position, whereupon hemostasis occurs rapidly,
thereby sealing the puncture.
Inventors: |
Kensey, Kenneth; (Chester
Springs, PA) ; Nash, John; (Chester Springs, PA)
; Evans, Douglas; (Downingtown, PA) |
Correspondence
Address: |
CAESAR, RIVISE, BERNSTEIN,
COHEN & POKOTILOW, LTD.
12TH FLOOR, SEVEN PENN CENTER
1635 MARKET STREET
PHILADELPHIA
PA
19103-2212
US
|
Assignee: |
Kensey Nash Corporation
|
Family ID: |
27120940 |
Appl. No.: |
09/754606 |
Filed: |
January 4, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09754606 |
Jan 4, 2001 |
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09294154 |
Apr 19, 1999 |
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6179863 |
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09294154 |
Apr 19, 1999 |
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08992041 |
Dec 17, 1997 |
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5935147 |
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08992041 |
Dec 17, 1997 |
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08604205 |
Feb 21, 1996 |
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5707393 |
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08604205 |
Feb 21, 1996 |
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08426371 |
Apr 21, 1995 |
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08426371 |
Apr 21, 1995 |
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08154882 |
Nov 18, 1993 |
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5441517 |
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08154882 |
Nov 18, 1993 |
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07846322 |
Mar 5, 1992 |
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5282827 |
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07846322 |
Mar 5, 1992 |
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07789704 |
Nov 8, 1991 |
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5222974 |
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Current U.S.
Class: |
606/213 |
Current CPC
Class: |
Y10S 604/90 20130101;
A61B 2017/00672 20130101; A61B 2017/00654 20130101; A61B 90/03
20160201; A61B 17/0057 20130101; A61B 2017/00659 20130101; A61B
2017/00004 20130101; A61B 2017/00637 20130101; A61B 2090/032
20160201; A61B 2017/00898 20130101; F16G 11/108 20130101; A61B
90/39 20160201; A61B 2017/0496 20130101; A61B 2090/0811
20160201 |
Class at
Publication: |
606/213 |
International
Class: |
A61B 017/03 |
Claims
What is claimed is:
1. A closure device for sealing a percutaneous incision or puncture
formed in the body of a living being wherein the incision or
puncture comprises an opening in the wall of a vessel, duct, lumen,
or thin walled organ and a tract contiguous with the opening and
extending through tissue to the surface of the skin of the being,
the tract having an inner surface, said closure comprising: (a) a
filament arranged to be extended through the tract and the wall of
the vessel, duct, lumen, or hollow organ adjacent the opening in
the wall thereof so that a portion of said filament is within the
interior of the vessel, duct, lumen or hollow organ; and (b) a mass
of material adapted be inserted into the tract and movable along
said filament within the tract to a predetermined position without
entering into the vessel, duct, lumen or hollow organ and being
movable along said filament within the tract relative to said
portion of said filament located within the interior of said
vessel, duct, lumen or hollow organ, said mass of material in said
predetermined position extending proximally of the outer surface of
the wall of the vessel, duct, lumen, or hollow organ to engage the
inner surface of the tract along a substantial length of the tract
to fill a substantial portion of the tract, said mass of material
being coupled to the filament member within the tract and being
alterable within the tract to change to another state within the
tract after insertion therein to inhibit the flow of fluid from the
vessel, duct, lumen, or hollow organ through the tract.
2. The closure device of claim 1 wherein said mass of material
changes to said other state in response to conditions within the
tract.
3. The closure device of claim 2 wherein said mass of material
changes to said other state in response to fluid within the
tract.
4. The closure device of claim 2 wherein said mass of material
changes to said other state in response to blood within the
tract.
5. The closure device of claim 1 wherein said mass of material is
resorbable.
6. The closure device of claim 5 wherein said mass of material is
formed of collagen.
7. The closure device of claim 1 wherein said mass of material is
hemostatic.
8. The closure device of claim 1 wherein said mass of material is
alterable to another state in response to the application of a
tamping force thereto.
9. The closure device of claim 1 wherein said mass of material is
alterable to another state in response to conditions within the
tract.
10. The closure device of claim 9 wherein said mass of material is
alterable to said other state in response to fluid within the
tract.
11. The closure device of claim 9 wherein said mass of material is
alterable to said other state in response to blood within the
tract.
Description
[0001] This application is a Continuation of our earlier filed U.S.
patent application Ser. No. 08/992,041 filed on Dec. 17, 1997,
entitled Hemostatic Puncture Closure System and Method of Use,
which in turn is a Continuation of our earlier filed U.S. patent
application Ser. No. 08/604,205 filed on Feb. 21, 1996 entitled
Hemostatic Puncture Closure System and Method of Use, now U.S. Pat.
No. 5,707,393, which in turn is a Continuation of our earlier filed
U.S. patent application Ser. No. 08/426,371 filed on Apr. 21, 1995
entitled Hemostatic Puncture Closure System and Method of Use,
which in turn is a Continuation of our earlier filed U.S. patent
application Ser. No. 08/154,882 filed on Nov. 18, 1993, entitled
Radio-opaque Hemostatic Puncture Closure System and Delivery System
Therefore, now U.S. Pat. No. 5,441,517, which in turn is a
Continuation of our earlier filed U.S. patent application Ser. No.
07/846,322 filed on Mar. 5, 1992, entitled Hemostatic Puncture
Closure System and Method of Use, now U.S. Pat. No. 5,282,827,
which in turn is a Continuation-In-Part of our earlier filed U.S.
patent application Ser. No. 07/789,704, filed on Nov. 8, 1991,
entitled Hemostatic Puncture Closure System and Method of Use, now
U.S. Pat. No. 5,222,974, all of whose disclosures are incorporated
by reference herein and which are assigned to the same assignee as
this invention.
BACKGROUND OF THE INVENTION
[0002] In U.S. Pat. No. 5,021,059, which has been assigned to the
same assignee as this invention, there is disclosed a closure
device and method of use for sealing a small incision or puncture
in tissue separating one portion of the body of a living being from
another portion thereof, e.g., a percutaneous puncture in a artery,
to prevent the flow of a body fluid, e.g., blood, through the
puncture. The closure device is arranged to be used with (deployed
by) an instrument which comprises a carrier in the form of a
tubular member. The tubular member has a proximally located portion
and a distally located portion. The latter includes an open free
end arranged to be introduced through the incision or puncture. The
proximately located portion of the tubular member is arranged to be
located out of the body of the being when the distally located
portion is extended through the incision or puncture.
[0003] The closure device comprises three components, namely, an
anchor member, a sealing member, and a filament, e.g., suture. The
sealing member is formed of a hemostatic material, e.g., compressed
collagen foam. The anchor member includes a tissue engaging portion
configured to pass through the puncture in one direction but
resistant to passage therethrough in the opposite direction. The
sealing member includes a tissue engaging portion. The filament is
connected between the anchor member and the sealing member in a
pulley-like arrangement so that they may be moved relative to each
other by the application of a pulling force on the filament.
[0004] The instrument is arranged to expel the anchor member
through the puncture, e.g., into the artery, and to draw its tissue
engaging portion into engagement with the tissue contiguous with
the puncture. The filament extends through the instrument to a
point outside the body of the being and is arranged to be drawn in
the proximal direction, whereupon the portion of the filament
connecting the anchor member and the sealing member causes the
tissue engaging portion of the sealing member to move with respect
to said anchor member and into engagement with the tissue
contiguous with the puncture on the opposite side thereof from said
anchor member. This action causes the tissue engaging portion of
the sealing member to seal the puncture from the flow of fluid
therethrough.
[0005] The closure device and deploying instrument in that patent
leave something to be desired from the standpoints of effectiveness
and efficiency of use.
OBJECTS OF THE INVENTION
[0006] Accordingly, it is a general object of this invention to
provide a closure device and methods of use which overcomes the
disadvantages of the prior art.
[0007] It is a further object of this invention to provide a system
including a closure, a deploying instrument, and method of use for
quickly, easily, safely and effectively sealing a percutaneous
puncture in a blood vessel within the body of a living being from
another portion.
[0008] It is still a further object of this invention to provide
devices and methods for enabling one to radiographically image the
closure during its placement to seal a percutaneous incision or
puncture in a blood vessel and after such placement has been
accomplished.
SUMMARY OF THE INVENTION
[0009] These and other objects of this invention are achieved by
providing a closure for use in a system for sealing a percutaneous
incision or puncture in a blood vessel. The system basically
comprises carrier means, introducer means, and closure means. The
puncture comprises a tract extending through tissue overlying the
blood vessel. The closure means comprises anchoring means, sealing
means, and filament means. The filament means is connected between
the anchoring means and the sealing means. The introducer means
comprises a tubular member having a distal free end arranged to be
inserted into the puncture tract and through the puncture. The
carrier means is arranged to be inserted through the introducer
means to expel the anchoring means therefrom and to draw the
anchoring means into engagement with the distal free end of the
introducer means. The introducer means and the carrier means are
arranged to be moved together to draw the anchoring means into
engagement with the interior tissue of the blood vessel contiguous
with the puncture. The filament means is arranged to pull the
anchoring means and the sealing means relative to each other to
cause the sealing means to engage tissue contiguous with the
puncture outside of the vessel.
[0010] In accordance with one aspect of this invention the system
includes means and a method of use to enable one to readily
determine the location of the wall of the vessel or lumen by the
percutaneous introduction of such means into the vessel or lumen.
Such means can be used as a part of the system or method to seal
the puncture or incision in a vessel or lumen or may be used for
other purposes, e.g., it may be used for any application wherein it
is desirable to determine the location of a vessel or lumen wall
via a percutaneous incision or puncture.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] Other objects and many of the attendant advantages of this
invention will readily be appreciated as the same becomes better
understood by reference to the following detailed description when
considered in connection with the accompanying drawings
wherein:
[0012] FIG. 1 is a side elevational view, partially in section,
showing a deploying instrument and a closure device of the system
of the subject invention;
[0013] FIG. 2 is an enlarged top plan view of the closure device
shown in FIG. 1, with the sealing component shown in an
uncompressed state;
[0014] FIG. 3 is a top plan view, like that of FIG. 2, but showing
the sealing component in its compressed state ready for deployment
by the instrument of FIG. 1;
[0015] FIG. 4 is an enlarged top plan view of the anchor component
of the closure device;
[0016] FIG. 5 is an enlarged side elevational view of the anchor
component of closure device;
[0017] FIG. 6 is a greatly enlarged plan view showing the knot used
to effect the securement of a filament component of the closure
device to the sealing component thereof;
[0018] FIG. 7 is a top plan view of one embodiment of a introducer
sheath position indicating device forming a portion of the system
of this invention;
[0019] FIG. 8 is an enlarged sectional view taken along line 8-8 of
FIG. 7;
[0020] FIG. 9 is a front elevational view of a torsion spring used
with the deployment instrument;
[0021] FIG. 10 is a side elevational view of the spring shown in
FIG. 9;
[0022] FIG. 11 is an isometric view of the deployment instrument
shown in FIG. 1;
[0023] FIG. 12 is an illustration showing a preliminary step in the
positioning of a conventional introducer sheath through a
percutaneous puncture in an artery using the position indicating
device shown in FIG. 7;
[0024] FIG. 13 is an illustration similar to that of FIG. 12
showing desired position of the introducer sheath within the artery
as established by the use of the position indicating device shown
in FIG. 7;
[0025] FIG. 14 is an illustration showing the introduction of the
deployment instrument into the properly located introducer
sheath;
[0026] FIGS. 15-23 are illustrations, similar to FIGS. 11 and 12,
but showing the sequential steps in the use of the instrument to
deploy the closure device to seal the percutaneous puncture in the
artery;
[0027] FIG. 24 is an enlarged illustration showing the closure
device in place after it has sealed the percutaneous puncture in
the artery;
[0028] FIG. 25 is an isometric view of a position indicating clip
of the system of this invention;
[0029] FIG. 26 is an isometric view of a second embodiment of a
introducer sheath position indicating device forming a portion of
the system of this invention;
[0030] FIG. 27 is an illustration similar to that of FIG. 12
showing desired position of a conventional introducer sheath within
the artery as established by the use of the second embodiment of
the position indicating device shown in FIG. 26;
[0031] FIG. 28 is an isometric view of a third embodiment of a
introducer sheath position indicating device forming a portion of
the system of this invention;
[0032] FIG. 29 is an illustration similar to that of FIG. 12
showing desired position of a conventional introducer sheath within
the artery as established by the use of the third embodiment of the
position indicating device shown in FIG. 28;
[0033] FIG. 30 is an isometric view of a conventional dilator;
[0034] FIG. 31 is an isometric view of a modified introducer sheath
forming a position indicating device of the system of this
invention;
[0035] FIG. 32 is an enlarged sectional view taken along line 32-32
of FIG. 31;
[0036] FIG. 33 is an illustration similar to that of FIG. 12
showing desired position of the modified introducer sheath of FIG.
32 located within the artery;
[0037] FIG. 34 is an enlarged top plan view of an alternative
anchor component to that shown in FIG. 4;
[0038] FIG. 35 is an enlarged side elevational view of the
alternative anchor shown in FIG. 34;
[0039] FIG. 36 is an enlarged sectional view of an alternative
tamping means to that shown in FIG. 1;
[0040] FIG. 37 is an enlarged illustration similar to FIG. 23 but
showing the use of the alternative tamping means of FIG. 36;
and
[0041] FIG. 38 is an enlarged illustration similar to FIG. 24 but
showing the closure device in place after it has sealed the
percutaneous puncture in the artery using the alternative tamping
means.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0042] Referring now in greater detail to the various figures of
the drawings wherein like reference characters refer to like parts,
there is shown at 20 an instrument forming a portion of a system
for deploying a closure device 22 to seal a percutaneous puncture
24 within a blood vessel 26, e.g., the femoral artery, constructed
in accordance with this invention. The puncture 24 includes not
only the opening in the wall of the vessel but also the tract 24A,
i.e., the passageway in the tissue located between the vessel and
the skin of the being formed when the vessel is punctured.
[0043] The instrument 20 and closure device 22 have particular
utility when used in connection with intravascular procedures, such
as angiographic dye injection, cardiac catheterization, balloon
angioplasty and other types of recanalizing of atherosclerotic
arteries, etc. since the closure 22 is designed to cause immediate
hemostasis of the blood vessel, e.g., arterial, puncture. However,
it is to be understood that while the description of the preferred
embodiment instrument and closure contained herein is directed to
the closing off of percutaneous incisions or punctures in arteries,
they have much more wide-spread applications. Thus, the sealing of
a percutaneous opening in an artery shown herein is merely
exemplary.
[0044] Before describing the closure 22 and the instrument 20 for
inserting it to seal the opening, a brief description of a typical,
conventional, intravascular surgical procedure, e.g., catheter
instrumentation of an artery, utilizing a percutaneous opening will
be given to best appreciate the features of the invention. In such
a procedure a cannula of an instrument, such as an angiographic
needle (not shown), is inserted percutaneously through the skin
into the artery, such as the femoral artery, 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-guide wire is in
place the needle cannula is removed, leaving the guidewire in
place. An introducer sheath 28 (FIGS. 12 and 13) and an arterial
dilator (not shown) are then passed over the guidewire, through the
puncture or incision and into the artery. The guidewire and then
the dilator are removed leaving the introducer sheath in place. A
catheter, or other intravascular instrument (not shown) is then
inserted through the introducer sheath 28 and threaded down the
artery 26 to the desired intravascular location, e.g., the situs of
the atherosclerotic occlusion.
[0045] 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 manual,
digital pressure to the percutaneous puncture until hemostasis has
occurred. In particular, the current standard of care for puncture
hemostasis is to apply digital or mechanical pressure on the
puncture site for twenty minutes to an hour, depending on the
puncture size and the degree of hemolytic therapy. Obviously this
results in wasted time for the physicians and other catheter lab
personnel, and causes inconvenience and discomfort for the patient.
In addition serious complications arise from persistent bleeding
and hematom a formation in approximately five percent of the
patients.
[0046] In accordance with the method of this invention the
introducer sheath 28 is left in place within the artery (although
it is moved so that its distal end is at a desired position
therein, as will be described later). The deployment instrument 20
having the closure device 22 therein is inserted into the
introducer sheath. The closure device is then deployed (ejected)
and operated to immediately seal the arterial puncture site 24 and
plug the tract 24A. Moreover, as will be appreciated from the
description to follow the closure device 22 is designed to reduce
post-procedure puncture complications, cause minimal inflammatory
reaction and resorb completely within a relatively short period of
time, e.g., sixty to ninety days.
[0047] The details of the closure 22 and instrument 20 for
introducing it will be described in detail later. Suffice it for
now to briefly describe the closure and its method of deployment
and use. Thus, as will be seen later the closure has three basic
components, namely, a sealing member 30, an intraarterial anchor
member 32, and a positioning member 34. The sealing member is in
the form of an elongated rod-like plug, e.g., a hemostatic,
resorbable collagen sponge or foam. This member is arranged for
sealing the puncture. The anchor member 34 is an elongated, stiff,
low-profile, resorbable member which is arranged to be seated
inside the artery against the artery wall contiguous with the
puncture 24. The anchor member 32 is made of non-hemostatic
resorbable polymer similar to resorbable suture. The positioning
member 34 comprises a filament, e.g., a resorbable suture. The
suture connects the anchor member and the collagen plug (sealing
member) via a pulley-like arrangement which serves to move the
anchor and plug together, to sandwich and lock the artery wall
between the anchor and plug.
[0048] The closure device 22 is used after the interventional
procedure is finished. In particular, the physician inserts the
delivery or deployment instrument 20 containing the closure device
22 into the patients' introducer sheath 28. On insertion, the
anchor member 32 passes out of the distal end of the introducer
sheath and deploys into the artery lumen. The deployment instrument
20 is then withdrawn from the introducer sheath until resistance is
felt when the anchor member catches on the distal end thereof. Once
this occurs (and assuming that the anchor is in the correct
orientation when it catches on the end of the introducer sheath, as
will be described later) the deployment instrument and the
introducer sheath are then immediately withdrawn together. This
withdrawing action causes the anchor member 32 to engage (catch) on
the artery wall contiguous with the puncture. Continued withdrawal
of the instrument and introducer sheath causes the pulley-like
configuration of the filament to pull the collagen plug 30 toward
the anchor member 32, thereby depositing the plug in the puncture
tract 24A against the exterior of the artery contiguous with the
puncture. The pulling on the filament to bring the plug into
engagement with the puncture site also has the effect of deforming
the plug into a larger diameter body to aid in holding it in place.
Moreover, since the plug is formed of a compressed collagen it also
expands automatically in the presence of blood within the puncture
tract when deployed, thereby further contributing to the plug's
enlargement. The instrument 20 also includes a tamper (to be
described later) which is mounted on the suture and which is
slidable thereon. The deployment of the plug member also effects
the deployment of the tamper into the puncture tract proximally of
the plug member. The tamper is then used to gently compress and
lock the collagen plug on the outside of the artery.
[0049] The closure is now locked in place through the clotting of
the hemostatic collagen plug and by spring tension (to be described
later) on the filament 34 attached to the intraarterial anchor 32.
Thus the artery wall is sandwiched between the collagen plug 30 and
anchor 32. Within a few hours after deployment, the anchor 32 will
be coated with fibrin and thus attached firmly to the arterial
wall, thereby eliminating the possibility of distal embolization.
After approximately thirty days, only a small deposit of anchor
material will remain. In fact, resorption of all components will
have occurred after approximately sixty days.
[0050] The anchor member 32 is non-hemostatic and is sized to be
hemodynamically insignificant in comparison to the size of the
femoral artery. Thus, the resorbable anchor has an insignificant
hemodynamic effect on blood flow.
[0051] As will be appreciated by the description to follow
deployment of the closure device 22 by the instrument 20 is easy,
quick and reliable. Anchoring is repeatable, safe, and effective to
deploy the collagen plug. Hemostasis occurs almost instantaneously,
e.g., in 15 seconds or less, when the closure device is deployed
properly.
[0052] Referring now to FIGS. 2-5 the details of the closure device
22 will now be described. As can be seen in FIG. 2 the sealing
member or plug 30 comprises a cylindrical member formed of a
compressible, resorbable, collagen foam, such as that sold by
Collatec, Inc. of Plainsboro, N.J. The plug 30 is arranged to be
compressed from the large diameter configuration shown in FIG. 2 to
the small diameter, elongated configuration shown in FIG. 3. In the
configuration of FIG. 3 the diameter of the plug is very small,
e.g., 1.32 mm, and therefor suitable for disposition within the
instrument 20 as will be described later. The plug 30 includes an
annular recess 40 extending about its outer periphery adjacent its
proximal end. Three apertures 42, 44, and 46 extend through the
plug. In particular, the aperture 42 is located close to the recess
40 and diametrically through the centerline of the plug. The
aperture 46 is located close to the distal end of the plug and
extends transversely through the plug on one side of the
centerline. The aperture 44 is located between apertures 42 and 44
and extends transversely through the plug on the other side of the
centerline. These apertures serve as passageways through which the
filament 34 extends to connect the anchor member to the plug and
are spaced apart to preclude tearing of the plug.
[0053] The manner of connection of the plug to the anchor will be
described later Suffice it for now to state that the filament 34 of
the closure device 22 serves to couple the plug component to the
anchor component in an arrangement to effect the movement of the
plug component toward the anchor component, once the anchor
component is in its desired position in the artery at the puncture
or incision. In particular the coupling of the plug component to
the anchor component simulates a pulley to achieve a desired
mechanical advantage.
[0054] In accordance with a preferred embodiment of this invention
the filament is formed of resorbable, flexible, strong material,
e.g., a resorbable suture.
[0055] As can be seen in FIGS. 4 and 5 the anchor member 32
basically comprises a thin, narrow, strip or bar of material, such
as a resorbable lactide/glycolide polymer sold by Medisorb
Technologies International L.P. under the trade designation
MEDISORB. The strip is sufficiently rigid such that once it is in
position within the artery (as will be described later) it is
resistant to deformation to preclude it from bending to pass back
through the puncture through which it was first introduced. The
member 32 has a generally planar top surface 48, a generally planar
bottom surface 50 and a peripheral side surface 52. Each end of the
member 32 is rounded. The side surface 52 of the anchor member 32
tapers inward from its top surface to its bottom surface as shown
in FIG. 5 to facilitate the removal of the plug from the mold for
making it. A hemispherical projection 54 is located at the center
of the top surface 48. The hemispherical projection 54 includes a
longitudinally extending slot 56 disposed perpendicularly to the
top surface 48 of the member 32. The bottom 58 of the slot 56 is
arcuate (FIG. 5). A cylindrical opening 60 extends transversely
across the member 32 through the projection 54. A loop 62 of suture
material extends through the opening 60. The loop 62 is closed by a
knot 64. The portion of the loop 62 extending through the opening
60 overlies the bottom 58 of the slot and forms a "pin" about which
the filament 34 extends. In particular the filament 34 is threaded
through the slot 56, under the "pin" of the loop 60 and back out
the slot 56 on the other side thereof as shown clearly in FIG. 5 to
connect the plug member 30 to the anchor member 32.
[0056] In this regard the pulley-like connection between the anchor
member and the plug member is effected by threading the filament 34
from a remote point (which is located outside the deployment
instrument 20 when the closure device is in place in that
instrument) through the transverse aperture 42, down the plug to
the aperture 46, through that aperture to the opposite side of the
plug and from there to the anchor member where it is threaded
through the slot 56 and about the "pin" as described earlier. From
there the filament 34 extends back to the plug where it enters into
aperture 44, passes through the aperture to the opposite side of
the plug, where it terminates in a loop 66 extending around the
annular recess 40. The loop is secured by a knot 68, whose details
are shown in FIG. 6.
[0057] In FIGS. 34 and 35 there is shown an alternative anchor
member 32'. That anchor member is virtually identical to the anchor
member 32 except that member 32' includes means to enable it to be
imaged radiographically to facilitate the placement of the closure
at the desired situs within the patient's body. Thus, as can be
seen therein the alternative anchor member 32' includes a pair of
wells 32A in the top surface 48 adjacent the respective ends of the
anchor member. A plug or powder of a conventional radio-opaque
material, which is preferably biocompatible and which is
excretable, e.g., solid agents of sodium diatrizoate, iohexal,
etc., is located within each well 32A. A respective cover or cap
32B, preferably formed of a thin disk of a bioresorbable material,
e.g., PGA, is disposed over each well to seal the material within
the well. Each cover is secured to the top surface 48 of the anchor
32' by a seal line extending about the periphery of the well. That
seal line can be formed in various ways, e.g., by heat sealing.
[0058] Referring now to FIGS. 1 and 11 the details of the
deployment instrument 20 will now be described. As can be seen the
instrument basically comprises a carrier 100 in the form of an
elongated tube 102 formed of a somewhat flexible material, such as
polyethylene or polyvinyl chloride, so that the carrier may be
freely passed through the introducer sheath into an operative
position within the patient's artery, notwithstanding any curvature
of the introducer sleeve which may exist.
[0059] In accordance with a preferred embodiment of this invention
the outside diameter of the tubular carrier 100 is 8 French. The
distal end of the tube 102 includes a rigid, e.g., stainless steel,
sleeve or bypass tube 104 mounted thereon, to enable it to be
inserted through a conventional hemostasis valve 28A (FIGS. 12-14)
forming a portion of the introducer sheath 28, through the sheath,
and out the distal end thereof into the artery 26. The distal end
of the flexible tube 102 necks down into a generally
hemicylindrical configuration (See FIG. 1) which includes a
longitudinally extending slit (not shown) therein to enable it to
be fit within the bypass tube 104 without buckling.
[0060] As can be seen in FIG. 11, the closure device 22 is located
within the distal end of the tubular carrier 100. In particular the
anchor member 32 is disposed longitudinally within the bypass tube
104 laterally of the central longitudinal axis 106 of the carrier.
The plug member 30 is located within the tube 102 just behind
(proximally) of the anchor member and on the opposite side of the
central longitudinal axis. In fact the distal end of the plug
member overlies the proximal end of the anchor member. The bypass
tube 104 includes a reference detent 108 in its periphery located
diametrically opposite to the position of the anchor member. The
detent 108 serves as a visual guide to help the user orient the
instrument to a proper yaw angle with respect to the central
longitudinal axis for insertion within the introducer sheath as
will be described later.
[0061] As can be seen in FIGS. 1 and 11, the instrument 20 includes
a conventional luer fitting 110. The proximal end of the carrier
tube 102 extends into an opening in the fitting 110 and is secured
in place therein by any suitable means. Another conventional luer
fitting 112 is threadedly secured to the threaded distal end 114 of
the fitting 110. The fittings 110 and 112 together form a hollow
body through which the proximal end of the filament 34 extends. A
tensioning assembly is located within that body and basically
comprises a ball 116, a cup shaped ball seat 118, a compression
spring 120, and a spring seat 122. The spring seat is a disk-like
member located within an annular recess within the center of the
luer fitting 110. The ball seat includes a conical inner surface
124 having a central opening 126. The spring is a helical member
interposed between the spring seat 122 and the ball 116 to bias the
ball toward the conical surface 124 of the ball seat 118. The
proximally located portion of the filament 34 extends through the
space between the ball 116 and its seat. The amount of force
applied to the ball is established by a spacer sleeve 128 located
between the luer fittings 110 and 112. By appropriate selection of
the width of the sleeve 128 any desired preload can be applied to
the spring.
[0062] As will be appreciated by those skilled in the art the
tensioning assembly just described will tend to hold the filament
in place with respect thereto until the force applied to the
filament exceeds the preload force applied by the compression
spring, whereupon the filament will be freed to slide through the
instrument.
[0063] The carrier 100 also includes a tamping member 130. This
member is an elongated rod-like member formed of any suitable
material, e.g., polyethylene, and is disposed within the carrier
tube 102 immediately proximally of the plug 32. The tamping member
130 includes a central passageway 132 extending down its length
from its distal end 134 to its proximal end 136. The filament 34
portion extending from the anchor member 32 passes through the
passageway 132 in the tamping member and from there into the luer
fittings 110 and 112, past the tensioning assembly, and out through
the hole 126 at the proximal end of the instrument 20. A holding
sleeve or tag 138, e.g., a stainless steel tube, is crimped onto
the filament so that it engages the proximal end of the tamping
member 130 to hold that member in place. The tag 138 is arranged to
cooperate with a torsion spring 142 (FIGS. 9 and 10) to apply
tension onto the filament 34 after the closure device is in place
to enable the instrument 20 to be removed and the filament severed
(as will be described later).
[0064] As mentioned earlier the instrument 20 is arranged to be
inserted into a conventional introducer sheath 28 to effect the
deployment of the closure device 20. Before describing that
operation a brief description of the introducer sleeve and its
method of location with respect to the percutaneous puncture is in
order. As can be seen in FIGS. 12-14 the sheath 28 includes a body
portion in which a conventional hemostasis valve 28A is located and
a tubular portion 28B extending from the body. The tubular portion
28B terminates in an open distal or free end 28C. The body portion
of the sheath 28 includes a sideport 28D having a conventional
stopcock 28E located therein. The distal end of the body of the
sheath includes an annular groove 28F which is arranged to receive
a position indicator clip 150 forming a portion of the system of
this invention, for reasons to be described later.
[0065] Before the instrument can be inserted into the introducer
sheath 28, the sheath itself must be properly located within the
artery. This action is accomplished via a positioning device 200.
That device forms a portion of the system of this invention and is
shown in FIGS. 7 and 8. As can be seen the device 200 basically
comprises a conventional dilator whose outer periphery has been
modified to include a longitudinally extending flat 202. The device
200 is arranged to be fully inserted within the introducer sheath
28 like shown in FIG. 12. The insertion of the device 200 within
the introducer sheath 28 forms a passageway between the flatted
surface 202 of the device 200 and the interior surface of the
tubular portion 28B of the sheath disposed thereover. The length of
the flatted portion 202 is selected so that when the device 200 is
fully with the introducer sheath, and the distal end of the sheath
within the interior of the artery, the distal end of the flatted
surface extends just beyond the distal end 28C of the introducer
sheath to form a window 204 into which blood may flow, while the
proximal end of the surface 202 is in fluid communication with the
interior of the introducer body and the sideport 28D. Accordingly,
blood may flow into the window 204 through the passageway formed by
the flatted surface, into the sideport 28D and from there to the
stopcock 28E when the window 204 is within the interior of the
artery.
[0066] In order to correctly position the introducer sheath the
location of the artery wall must be established. This is
accomplished by inserting the device 200 within the introducer
sheath as just described and then opening the stopcock 28E to
observe the flow of blood therefrom. The blood will normally flow
out of the opened stopcock by virtue of the pressure differential
across the lumen wall. If however, there is insufficient pressure
to cause such a flow of blood some means (not shown) can be used to
create the desired differential pressure, e.g., suction can be
used. In any event once the flow of blood is observed the
introducer sheath with the device therein is then retracted (moved
proximally) until the blood flow through the stopcock just stops, a
position shown in FIG. 13. This indicates that the distal end 28C
of the introducer sheath has just left the artery lumen. The
introducer sheath with the device therein is then reinserted
approximately 10 mm into the puncture to ensure that the distal end
of introducer sheath is at the desired position within the artery.
Blood flow should be reestablished through the stopcock at this
time. Then the stopcock is closed. From this point the introducer
sheath must be kept fixed, i.e., it must not move axially relative
to the patient. To achieve that end the user of the system should
provide a continuous grasp on the introducer sheath, with the
patient's groin as a position reference. The position indicating
device 200 is then removed from the introducer sheath to ready the
introducer sheath for receipt of the deployment instrument 20
carrying the closure device 22 as will be described later.
[0067] In FIG. 26 there is shown a second embodiment of a
positioning device 300 for effecting the proper positioning of the
introducer sheath 28 within the artery. As can be seen the device
300 basically comprises a conventional obturator whose outer
periphery has been modified to include an annular recess 302
extending thereabout. Like the device 200, the device 300 is
arranged to be fully inserted within the introducer sheath 28 as
shown in FIG. 27. The insertion of the device 300 within the
introducer sheath 28 forms an annular passageway between the
annular recess 302 of the device 300 and the interior surface of
the tubular portion 28B of the sheath 28. A side opening or port
304 is provided in the sidewall 28B of the introducer sheath 28
closely adjacent its open distal end 28C.
[0068] The length of the annular recess 302 is selected so that
when the device 300 is fully with the introducer sheath 28, and the
port 304 in the distal end of the sheath is located within the
interior of the artery, the distal end of the annular recess 302
extends just beyond the port 304 while the proximal end of the
recess 302 is in fluid communication with the interior of the
introducer's sideport 28D.
[0069] The port 304 forms a window into which blood in the artery
may flow when the distal end 28C of the introducer is located
therein. In particular, blood may flow into the window 304 through
the annular passageway formed between the recess 302 and the inner
surface of the tubular portion 28A of the introducer, into the
sideport 28D and from there to the stopcock 28E when the window 304
is within the interior of the artery.
[0070] In FIG. 28 there is shown a third embodiment of a
positioning device 400 for effecting the proper positioning of the
introducer sheath 28 within the artery. As can be seen the device
400 basically comprises a conventional obturator having a
passageway 402 extending longitudinally down substantially the
length of the device. An entrance port 404 extends radially inward
into the device communicating with the distal end of the passageway
402, while an outlet port extends radially inward into the device
communicating with the proximal end of the passageway 402. Like the
devices 200 and 300, the device 400 is arranged to be fully
inserted within the introducer sheath 28 as shown in FIG. 29.
[0071] The length of the annular passageway 402 is selected so that
when the device 400 is fully with the introducer sheath 28 and the
distal end of the sheath is located within the interior of the
artery, the inlet port 404 of the passageway 402 extends just
beyond the free end of the sheath, while the outlet port 406 is in
fluid communication with the interior of the introducer's sideport
28D. The port 404 forms a window into which blood in the artery may
flow when the distal end 28C of the introducer is located
therein.
[0072] In FIG. 31 there is shown alternative embodiment 28' of an
introducer sheath. The sheath is similar to sheath 28 described
earlier except that its tubular portion 28B includes a second
passageway 502 (FIG. 31) extending therethrough. The passageway 502
serves as the passageway for blood to flow therethrough so that the
sheath 28', itself, can act as a positioning device for effecting
its proper positioning within the artery. As can be seen in FIG. 31
the passageway 502 extends longitudinally down the sheath 28'
within its wall and parallel to the central passageway 504 (the
central passageway receives the deployment instrument 20--to be
described later). The distal end of the passageway 502 includes a
radially extending port 506. The proximal end of the passageway 502
(not shown) is in fluid communication with the interior of the
introducer's sideport 28D. The introducer sheath 28' is arranged to
be used with a conventional obturator 600 (shown in FIG. 30).
[0073] The positioning of the introducer sheath 28 utilizing either
of the devices 300 or 400 or the positioning of the introducer
sheath 28' utilizing the obturator 600 is similar to that described
with reference to the device 200. Thus, after the introducer sheath
is positioned as described earlier the stopcock 28E is opened to
observe the flow of blood therefrom (thereby indicating that the
inlet port or window is within the artery). The introducer sheath
is then retracted (moved proximally) until the blood flow through
the stopcock just stops, thereby indicating that the distal end 28C
of the introducer sheath has just left the artery lumen. The
introducer sheath with the device therein is then reinserted
approximately 10 mm into the puncture to ensure that the distal end
of introducer sheath is at the desired position within the artery.
Blood flow should be reestablished through the stopcock at this
time. Then the stopcock is closed. From this point the introducer
sheath must be kept fixed (as described earlier) and the position
indicating device 300 or 400 (or the conventional obturator 600)
removed to ready the introducer sheath for receipt of the
deployment instrument 20 carrying the closure device 22 through the
central passageway in the particular introducer sheath (that
passageway is denoted by the reference number 504 in the embodiment
28').
[0074] The deployment of the closure will now be described with
reference to FIGS. 14-23 and is as follows: The reference detent
108 on the bypass tube is identified by the user and the bypass
tube grasped by the user and oriented so that the detent faces up
(away from the patient) as shown in FIG. 14. This ensures that the
anchor member is located towards the patient. The bypass tube is
then inserted into the sheath through the hemostasis valve 28A. The
rigid nature of the bypass tube facilitates the passage of the
carrier 100 through the hemostasis valve and also protects the
closure device from damage. The instrument is then pushed fully
down the introducer sheath so that a stop surface 110A on the front
(distal) luer fitting 110 (FIG. 11) engages the body of the
introducer sheath housing the hemostasis valve. At this time the
distal end of the carrier will be in the position shown in FIG. 16
and the anchor member 32 will be located in the artery 26 beyond
the distal end of the introducer sheath. The bypass tube 104
remains within the portion of the introducer sheath housing the
hemostasis valve 28A.
[0075] The position indicator clip 150 is then mounted onto the
annular recess 28F on the introducer sheath 28 as shown in FIG. 17.
As can be seen in FIG. 25 the clip 150 includes a linear section
150A from which a yoke 150B projects perpendicularly. The yoke 150B
includes a circular mouth 150C for receipt of the annular recess
28F of the introducer sheath. When mounted in place on the
introducer sheath the free end 150D of the indicator clip will
extend beyond the distal end of the instrument 20 (beyond the
tensioner assembly).
[0076] The system 20 is then operated to determine if the anchor
member 32 has been properly deployed. To that end the introducer
sheath is then held by the user to prevent axial movement and the
instrument 20 is carefully withdrawn from it. This action causes
the anchor member 32 to engage or catch on to the distal end of the
introducer. As the anchor member catches on the distal end of the
introducer, resistance will be felt by the user. This resistance
must be noted by the time the luer fitting 112 housing the
tensioner assembly reaches the free end 150D of the indicator clip
150 as shown in FIG. 18. If so, then the anchor member will have
caught on the distal end of the introducer at the location of its
hemispherical projection 54 (the desired occurrence).
[0077] If, however, no resistance is noted by the time that the
luer fitting 1 12 passes (extends proximally of) the free end of
the indicator clip, this will indicate that the anchor has
re-entered the introducer sheath, and that the anchor will not
catch onto the artery as required. Thus, if no resistance is felt
at this point, the instrument 20 must be reinserted within the
introducer sheath and the foregoing procedure retried, this time by
turning the instrument 20 about its axis 106 by 1/4turns to each
side before it is again withdrawn.
[0078] If the resistance is felt before the luer fitting reaches
the free end of the indicator clip this will indicate that one of
the curved ends of the anchor member has caught on the free end of
the introducer sheath, an undesired occurrence. Accordingly, the
instrument 20 must be withdrawn then reinserted within the
introducer sheath and the foregoing procedure retried, this time by
turning the instrument 20 about its axis 106 by 1/4turns to each
side before it is again withdrawn.
[0079] Once the anchor member has been properly deployed, as shown
in FIG. 18, the collagen plug is deployed. To that end the
introducer sheath 28 and the instrument 20 are held together and
withdrawn as a unit from the puncture, whilst swinging the unit
toward the vertical as shown in FIG. 19. This action causes the
anchor 32 to engage or catch onto the inner surface of the artery
26 contiguous with the puncture 24. The introducer sheath and the
instrument are pulled further outward as shown in FIG. 20. Inasmuch
as the anchor member is trapped against the interior of the artery
wall the continued retraction of the introducer sheath and
instrument causes the filament 34 to pull the collagen plug out of
the carrier tube 102 and into the puncture tract 24A. As the
introducer and instrument come out of the puncture tract,
continuous steady resistance will be felt as the tensioner assembly
described heretofore controls the force on the filament 34 during
the retraction procedure. Continued retraction of the introducer
and the instrument brings the tamping member 130 out of the free
end of the instrument.
[0080] Moreover the pulley arrangement of the filament 24
connecting the anchor member and the plug member ensures that
during the retraction of the introducer and the instrument the plug
member is moved into engagement with the exterior of the artery
wall contiguous with the puncture 24. In fact continued retraction
causes the filament to somewhat deform the plug, i.e., cause it to
deform radially outward. The existence of blood within the puncture
tract further contributes to the deformation of the plug member
since the collagen foam expands in the presence of blood.
[0081] The retraction procedure continues to pull the introducer
and instrument up the filament until the tag 138 is exposed as
shown in FIG. 22. At this point the anchor member and collagen plug
member have been deployed. At this time the collagen plug is tamped
by the tamping member 130. In particular the user quickly compacts
the collagen of the plug by gently tensioning the filament by
pulling on the introducer sheath and instrument in the proximal
direction with one hand. The tamping member is then manually slid
down the filament by the user's other hand so that it enters the
puncture tract 24A and engages the proximal end of the plug member
32. A few gentle compactions are adequate to achieve the desired
result, i.e., to assist the plug member 30 to conform to the artery
contiguous with the puncture and to assist to lock the plug in
place until hemostasis occurs (which happens very quickly, thereby
locking the closure in place). It should be noted that during the
tamping action care must be taken to maintain tension on the
filament 34 at a load greater than that used on the tamping member
130 to ensure that the tamping action doesn't propel the plug
member 30 into the interior of the artery.
[0082] After the tamping action is completed the torsion spring 142
is mounted on the filament 34 as shown in FIG. 23. This action is
necessary to maintain appropriate tension on the filament while the
instrument 20 is removed (the filament severed). In FIGS. 9 and 10
the torsion spring is shown. As can be seen therein the spring 142
includes a pair of legs 142A and 142B projecting outward from a
helical central section 142C. Each leg includes a slot 142D at its
free end. One of the slots is arranged to receive the filament 34
therein and to engage the tag 138. The other of the slots is
arranged to receive the filament 34 therein and to engage the
proximal end of the tamping member 130. The legs 142A and 142B are
biased by the intermediate section 142C so that when the spring is
mounted on the filament as just described they will bias the
tamping means towards the plug member 30 to hold it in place so
that the filament can be severed (as is necessary to remove the
instrument and the introducer from the closure device). Thus, once
the spring is in place the filament on the proximal side of the tag
138 is cut and the spring applies a light controlled pressure to
the collagen plug and anchor. The closure is left in this condition
without being disturbed for approximately 30 minutes. After that
time the spring 142 is removed and the filament is then severed at
the top of the tamping member 130. The tamping member 130 is then
removed and the remaining portion of the filament is taped to the
skin at 160 as shown in FIG. 24. The tape (not shown) should be
removed and the filament cut subcutaneously prior to the discharge
of the patient.
[0083] With the closure in final position as shown in FIG. 24 the
anchor member 32 (the only portion within the artery) does not take
up a substantial portion of the interior of the artery and thus
does not block off or otherwise impede the flow of blood
therethrough. Since the components of the closure are all formed of
resorbable materials the closure can be left in place within the
body until it is absorbed.
[0084] In FIG. 36 there is shown an alternative embodiment 700 of
tamping means constructed in accordance with this invention. The
tamping means 700 basically comprises an assembly of two
components, whereas the tamping means 130 described earlier is
composed of only a single component. Thus, as can be seen in FIG.
36 the assembly 700 comprises a first tubular component 702 and a
second tubular component 704. The component 702 includes a central
passageway 706 and is formed of any suitable material, e.g., the
same material as used to form the tamping component 130 described
earlier. The second component 704 also includes a central
passageway 708 extending therethrough.
[0085] The component 704 is mounted on the front or distal end of
the component 702. To that end the component 704 includes an
annular recess 710 about its periphery at the proximal end thereof.
This recess is arranged to receive the distal end 712 of the
component 702, with the two passageways 706 and 708 axially aligned
to enable the filament 34 to extend therethrough.
[0086] The component 704 is preferably formed of a compressed
collagen foam, e.g., the same type of material used for the sealing
portion or plug 30 of the closure. The distal end 714 of the
component 704 is arranged to engage the plug 30 to tamp it down in
the same manner as that accomplished by the distal end 134 of
tamping member 130. Once the tamping action is completed the
torsion spring 142 is mounted on the filament as shown in FIG. 37
so that it is located between the tag 138 and the proximal end of
the component 702 (in the same manner as described with respect to
tamping member 130 shown in FIG. 23). Thus, the filament on the
proximal side of the tag 138 can be cut, while the spring applies
light controlled pressure to the collagen plug 30 and anchor 32.
The closure is left in this condition in the same manner as
described earlier after which time the spring is removed and the
filament severed at the top (proximal end) of the tamping component
702. That component can then be removed, leaving the tamping
component 704 within the puncture tract as shown in FIG. 38. The
remaining (exteriorly extending) portion of the filament is taped
to the skin at 160 as also described earlier.
[0087] As should be appreciated by those skilled in the art the two
sections of the filament 34 between the anchor component 32 and the
plug component 30 effectively form a "pulley" arrangement to
increase the mechanical advantage of the force applied to the
filament to move the two components toward each other. Accordingly,
the closure can be properly seated without the application of a
high pulling force. The use of the biased ball and associated seat
between which the filament passes during the placing of the closure
ensures that irrespective of how hard the instrument and the
introducer are withdrawn from the puncture during the deployment
and seating of the closure, the amount of force applied to the
filament 34, and hence to the closure device, will not exceed a
predetermined maximum, e.g., one pound. This feature is of
considerable importance to ensure that the anchor portion of the
closure is not pulled through the opening (e.g., incision or
puncture) once it is in place.
[0088] As should also be appreciated from the foregoing, the
closure device, the instrument for deploying it, and their method
of use enables the ready, effective and efficient sealing of a
percutaneous puncture in an artery. Thus, it is expected that the
hemostatic puncture closure device 20 will be a significant
advancement in the fields of cardiology and radiology. The device
may allow continuance of anticoagulation post-procedure, more
aggressive use of thrombolytic agents and safer use of large bore
catheters. It should also reduce discomfort and complication rates
for patients; allow many in-patient procedures to be performed
safely on an out-patient basis; decrease the time and cost of
interventional procedures; and reduce exposure of hospital
personnel to human blood.
[0089] Without further elaboration the foregoing will so fully
illustrate our invention that others may, by applying current or
future knowledge, adopt the same for use under various conditions
of service.
* * * * *