Hemostatic vessel puncture closure system utilizing a plug located within the puncture tract spaced from the vessel, and method of use

A system, a closure, and method for sealing a percutaneous puncture in a blood vessel. The puncture includes a tract leading to it from the skin of the being. The system includes an introducer sheath, a positioning device, a hemostatic puncture closure, and a deployment instrument. The positioning device positions the introducer sheath at a desired position within the vessel. The deployment instrument includes a tubular carrier having a distal end storing the closure. The carrier is extended via an introducer sheath through the tract and puncture into the blood vessel. The closure comprises a rigid anchor, a spacer member, a compressed collagen plug, and a thin filament connecting them in a pulley-like arrangement. The anchor has a centrally located domed projection. The carrier ejects the anchor through the introducer and puncture and then draws it against the free end of the introducer. The instrument and introducer are then withdrawn together to pull the anchor against the tissue contiguous with the puncture inside the artery and so that the domed portion of the anchor extends through the puncture. Further withdrawal draws the plug and spacer out of the carrier into the puncture tract, whereupon the spacer engages the domed portion of the anchor to prevent the plug from entering the puncture. A tensioning device limits the force applied to the filament. The carrier also includes a tamper which is used to mechanically deform the plug within the tract. Hemostasis occurs rapidly and the plug seals the tract.

BACKGROUND OF THE INVENTION 
In U.S. Pat. No. 5,021,059, which has also 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 an 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. The closure device comprises 
three components, namely, an anchor member, a sealing member, and a 
filament, e.g., suture. 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 is formed of a hemostatic material, such as compressed collagen 
foam, and has 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. 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 causes the tissue engaging portion of the sealing member to move 
with respect to the anchor member, thereby drawing the anchor member and 
sealing member together. This action causes the tissue engagement portion 
of the sealing member to seal the puncture from the flow of fluid 
therethrough. The closure device and deploying instrument in that patent 
have left something to be desired from the standpoints of effectiveness 
and efficiency of use. The inventions of the two foregoing applications of 
which this application is a Continuation-In-Part, were designed to improve 
upon the invention of U.S. Pat. No. 5,021,059. 
In particular, in copending U.S. patent application Ser. No. 07/846,322, 
filed on Mar. 5, 1992, entitled Hemostatic Puncture Closure System and 
Method of Use, there is disclosed an claimed an improved system for 
sealing a percutaneous puncture in a blood vessel of a living being, with 
the puncture comprising a opening in the wall of the blood vessel and a 
tract contiguous with that opening and extending through tissue overlying 
the blood vessel. That system basically comprises carrier means, 
introducer means, and closure means. The closure means comprises anchoring 
means, sealing means, and filament means, with the filament means coupling 
the anchoring means and the sealing means. The introducer means comprises 
a tubular member having a distal free end insertable into the puncture 
tract and through the opening in the blood vessel wall. 
The carrier means is insertable through the introducer means and includes 
means to expel the anchoring means therefrom. Moreover, the carrier means 
is retractable with respect to the introducer means after the anchoring 
means has been expelled from the carrier means, so that when it is 
retracted it draws the anchoring means into engagement with the distal 
free end of the introducer means. 
The introducer means and the carrier means are coupled for movement 
together to draw the anchoring means which is now in engagement with the 
distal end of the introducer means into engagement with the interior 
tissue of the vessel generally adjacent the opening in the wall thereof. 
The filament means is operative to move the anchoring means and the sealing 
means relative to each other to cause the sealing means to engage tissue 
generally adjacent the puncture outside of the vessel. 
While the closure and deployment system of the aforementioned patent 
applications are suitable for their intended purposes, they still may 
leave something to be desired from one or more of the following 
standpoints: simplicity of construction; ease of deployment and operation; 
and safety. 
OBJECTS OF THE INVENTION 
Accordingly, it is a general object of this invention to provide a device 
and methods of use which overcomes the disadvantages of the prior art. 
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 of the body. 
It is still a further object of this invention to provide a closure 
utilizing sealing means in the puncture tract but spaced from the opening 
in the wall of the blood vessel to ensure that if any portion of the 
sealing means should break off it will not enter into the blood vessel. 
It is yet a further object of this invention to provide a closure deploying 
instrument which is simple in construction. 
SUMMARY OF THE INVENTION 
These and other objects of this invention are achieved by providing a 
system for sealing a percutaneous incision or puncture in a blood vessel. 
The system comprises carrier means, introducer means, and closure means. 
The puncture comprises a tract extending through tissue overlying the 
blood vessel. In the preferred embodiment, the closure device comprises 
four components, namely, an anchor member, a sealing member, a spacer 
member, and a filament, e.g., suture. 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 is formed of a hemostatic material, such as compressed 
collagen foam. The spacer member is mounted upon the suture, and is 
slidable thereon, and is positioned between the anchor member and the 
sealing member. The filament member is connected between the anchor member 
and the sealing member in a pulley-like arrangement so that the members 
may be moved relative to each other by the application of a pulling force 
on the filament. 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 sealing member to move with respect to said anchor 
member and into engagement with the spacer member thereby drawing the 
anchor member, spacer member and sealing member together. This action 
causes the sealing member to seal the puncture from the flow of fluid 
therethrough. 
The presence of the spacer member prohibits the sealing member from 
contacting the arterial wall and thereby possibly entering into the artery 
where a portion could conceivably break off and flow distally or cause the 
creation of an embolism.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
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. 
As shown clearly in FIGS. 16 and 17, 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 10 located between the vessel and the skin of the 
being formed when the vessel is punctured. The instrument 20 and closure 
device 22 have particular utility when used in connection with 
intravascular procedures, such as angiographic dye injection, cardiac 
catheterizations, 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. 
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 guidewire 202 (FIG. 16) is then 
passed through the cannula into the artery to the desired depth (i.e., a 
longitudinal position therealong). Once the guidewire is in place the 
needle cannula is removed, leaving the guidewire in place. An introducer 
sheath 28 (FIGS. 16 and 17) 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. 
Once the intravascular procedure (e.g., angioplasty) has been completed, 
the catheter is removed. Thereafter, the sheath is removed and the 
physician or other trained person applies manual or 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 hematoma formation in approximately five percent of the patients. 
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. 
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 four basic components, namely, a sealing member 30, an 
intraarterial anchor member 32, a spacer member 36, and a positioning 
member 34. The sealing member is in the form of an elongated rod-like 
plug, e.g., a hemostatic resorbable material such as a collagen sponge or 
foam. This member is arranged for sealing the puncture tract 24A. The 
anchor member 32 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 in the artery's wall. The anchor member 32 
is made of non-hemostatic resorbable material e.g., a resorbable polymer 
similar to a resorbable suture. The position member comprises a flexible 
filament, e.g., a resorbable suture. 
The spacer member 36 of FIGS. 8 and 9 comprises a cylindrical member with a 
single longitudinally oriented lumen 36A extending the length thereof. The 
lumen 36A is arranged to receive therethrough the suture 34 so that it is 
slidable thereon. The spacer member 36' is similar in construction to 36 
except that it includes a pair of longitudinally extending lumens 36'A and 
36'B through which the suture 34 extends. Both spacer members 36 and 36' 
are made of a resorbable material, e.g., a resorbable polymer or gelatin. 
One or more additives such as a radiopaque material or hemostatic agent or 
antibacterial agent can be blended into or coated upon the spacer member. 
As mentioned earlier, the positioning member 34 comprises a filament, e.g., 
a resorbable suture. The suture connects the anchor member 32 and the 
sealing member 30 (collagen plug) via a pulley-like arrangement with the 
spacer member 36 or 36' located therebetween. Accordingly, when the 
positioning member is pulled in the proximal direction (as will be 
described later), this action serves to move the anchor member and plug 
member together to cause the anchor member to engage the interior surface 
of the artery contiguous with the puncture, with the spacer member 
engaging a portion of the anchor member through the puncture, but not 
engaging the exterior of the artery wall, and with the sealing member 
engaging the proximal (top) end of the spacer member so that the sealing 
member is within the puncture tract but remote from the opening in the 
artery wall. 
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 patient's 
introducer sheath 28. On insertion, the anchor member 32 passes out of the 
distal end of the introducer sheath 28C so that it is deployed within 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 20 and the 
introducer sheath 28 are then immediately withdrawn together. This 
withdrawing action causes the anchor member 32 to engage (catch) on the 
artery wall 26 contiguous with the puncture in the wall. Continued 
withdrawal of the instrument and introducer sheath causes the pulley-like 
configuration of the filament 34 to pull the collagen plug 30 and spacer 
member 36 toward the anchor member 32, thereby depositing the plug in the 
puncture tract 24A at the exterior of the artery contiguous with the 
puncture. Neither the spacer member nor the sealing member engage the 
arterial wall. In this regard the spacer member contacts a dome portion 54 
(to be described later) of the anchor member 32 which extends from the 
interior of the artery through the opening in the artery wall (See FIG. 
27). Thus, the spacer member 36 serves to prohibit the sealing member 30 
from being pulled into the arterial puncture. The pulling on the filament 
34, to bring the spacer and plug into engagement with the anchor dome 54, 
also has the effect of deforming the plug into a larger diameter body to 
aid in holding it in place within the puncture tract 24A as shown in FIGS. 
24-27 and which will be described later. Moreover, since the plug 30 is 
formed of compressed collagen or other hydrophilic material it also 
expands automatically in the presence of blood within the puncture tract 
24A when deployed, thereby further contributing to the plug's enlargement. 
The instrument 20 also includes a tamper 130 (to be described later) which 
is mounted on the suture 34 and which is slidable thereon. The deployment 
of the plug member 20 also effects the deployment of the tamper 130 into 
the puncture tract 24A proximally of the plug member. The tamper is then 
used to gently compress and lock the collagen plug on the suture filament 
within the puncture tract but outside of the artery. The closure 22 is now 
locked in place through the clotting of the hemostatic collagen plug and 
by spring tension provided by means (to be described later) on the 
filament 34 attached to the intraarterial 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. 
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 30 has an insignificant hemodynamic effect on blood 
flow. 
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. 
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 Colla-Tec, 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 center- line. 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 32 to the plug member 30 and are spaced apart to preclude tearing 
of the plug. 
The manner of connection of the plug member to the anchor member 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. 
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 in the artery through which it was first introduced. 
The member 32 has a generally planar top surface 48, a radially contoured 
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 
slightly from its top surface 48 to its bottom surface 50 as shown in FIG. 
5 to facilitate the removal of the plug from the mold for making it. A 
hemispherical dome-like projection 54 is located at the center of the top 
surface 48. The top surface of the projection 54 is slightly flatted at 
54A (FIG. 5). 
A cylindrical opening 60 extends transversely across the member 32 through 
the projection 54. In particular the filament 34 is threaded through the 
cylindrical opening 60 as shown clearly in FIG. 5 to connect the plug 
member 30 to the anchor member 32. 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 in a chamber (to be 
described later) in the proximal portion of the deployment 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 spacer member 36' where it is threaded through the longitudinal 
opening 36'A in the spacer member 36' and from there to the anchor member 
where it is threaded through the opening 60 as described earlier. From 
there the filament 34 extends through the opening 36'B in the spacer 
member 36' and then 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. In the 
alternate embodiment 36 of the spacer having the single central lumen 36A 
the filament 34 extends through that lumen going to the anchor member and 
returning from the anchor member. 
Both embodiments 36 and 36' of the spacer are formed of a resorbable 
material, such as the polymer MEDISORB as described previously. Each 
component can also include means to enable the component to be imaged 
radiographically to facilitate the placement of the closure at the desired 
situs within the patient's body or to monitor the resorption of the 
closure. One configuration of the spacer member 36 can contain a plug or 
powder of a conventional radiopaque material, which is preferably 
biocompatible and which is excretable, e.g., solid agents of sodium 
diatrizoate, iohexal, etc. 
Referring now to FIGS. 1 and 15 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, polyurethane, or TEFLON, 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. In accordance with a 
preferred embodiment of this invention the outside diameter of the tubular 
carrier 100 is 8 French. The distal end 102 of the tubular carrier 100 
includes a rigid, e.g., stainless steel or polycarbonate, sleeve or bypass 
tube 104 mounted thereon, to enable the distal end 102 of the carrier 100 
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 through the puncture tract 24A and the puncture or 
incision 24 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. 
As can be seen in FIGS. 1 and 12, the closure device 22 is located 
partially within the distal end of the tubular carrier 102. In particular 
the anchor member 32 is disposed outside the distal end of the carrier 102 
longitudinally within the bypass tube 104 and laterally of the central 
longitudinal axis 106 of the carrier. The spacer member 36 is located 
within the tube 102 just behind (proximally) of the anchor member. The 
plug member 30 is located within the tube 102 just behind (proximally) of 
the spacer member 36. The bypass tube 104 includes a reference indicator 
or mark 108 in its periphery located diametrically opposite to the 
position of the anchor member. The mark 108 serves as a visual guide to 
help the user orient the instrument 20 to a proper yaw angle with respect 
to its central longitudinal axis for insertion within the introducer 
sheath 28 as will be described later. 
As can be seen in FIGS. 1 and 15, the proximal end of the instrument 20 
includes a housing assembly 170 comprising a cover or cap member 112 
serving as a handle, a tensioner support frame 110 having a recess 148 for 
a supply of filament 34, and a tensioner assembly 126. The proximal end of 
the tubular carrier 102 is secured to the distal end of the housing 
assembly 170. In particular, the proximal end of the carrier 102 is flared 
at 100A and is located within a corresponding shaped opening 174 in a 
capture member 122. The member 122 is an integrally molded member 
comprising a pair of sections 122A and 122B secured together by a living 
hinge 122C. The section 122A and 122B are arranged to be snap fit together 
as shown in FIG. 1. As can be seen section 122A includes the heretofore 
identified opening 176. The proximal end of the opening 176 is flared to 
receive the outwardly flared end 100A of the carrier tube 102. The section 
122B includes a conical central portion 178 which is configured to fit 
closely within the flared end 100A of the carrier tube when the section 
122B is snap fit to section 122A. A central passageway 180 is located 
within the conical portion 178 and communicates with the interior of the 
carrier tube 102 to enable the filament 34 to pass therethrough from the 
tension assembly 126. 
As will be appreciated by those skilled in the art, the use of the capture 
member 122 facilitates the assembly of the deployment instrument by 
enabling the carrier tube to be quickly and easily connected to the 
housing/handle 170 without the need for any adhesive. 
The capture member 122 is mounted within the cover 112 by the frame member 
110. This member is an integral unit, also molded of a suitable plastic, 
and serves to mount the tensioner assembly and a supply of the filament 
within the cover. The cover is also molded of a suitable plastic material. 
The cover or cap member 112 is a hollow member which is snapped onto the 
frame 110. The tensioner frame 110 has two prongs 140 which extend 
longitudinally on opposite sides of the housing and are directed distally. 
These prongs will be described later. Suffice it for now to state that 
each prong has a widened portion 146 which is arranged to cooperate with 
and engage a portion of the introducer to effect the proper placement of 
the deployment instrument 20 as will also be described later. 
The tensioning assembly 126 is located within the cover 112 and basically 
comprises a ball 116 and a compression leaf spring 120. The leaf spring 
120 is a generally U-shaped member whose open end is located towards the 
distal end of the frame 110. The spring is held in place via a pin 118 on 
the frame 110. 
The ball 116 is located between the free ends of two legs or leaves 120A 
and 120B of the spring 120 in a conical recess 128 located in the free end 
of the leaf 120B. The proximally located portion of the filament 34 
extends through the space between the ball 116 and the conical recess 128 
in the spring 124. The amount of force applied to the ball is established 
by the spring force of the leaf spring 120. By appropriate selection of 
the spring, any desired preload can be applied to the filament. As can be 
seen clearly in FIG. 30, a small indentation or seat 114 extends in the 
conical recess 128 for approximately 120.degree. of the periphery of the 
recess. This seat 114 provides a track for the filament 34 to pass 
therethrough. The seat's width is quite small, e.g., 0.003 inch (0.76 mm), 
but sufficiently large so that the filament 34 will not be crushed by the 
pressure applied to it from the spring loaded ball 116. In particular, the 
filament (suture) 34 cannot be crushed completely flat by the ball member 
116 but will be deformed slightly to a predetermined finite thickness. In 
this regard, as will be appreciated by those skilled in the art, suture 
material and other polymers tend to deform when loaded by a force over an 
extended period of time. Such deformation can reduce the strength 
characteristics of the material. The seat 114 in the conical recess 128 
limits the degree to which the ball 116 can deform the suture 34. Thus, 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. 
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 
through the proximal end of the carrier tube into the tensioner frame 110, 
through the tensioner assembly 126, and out through the seat 114 in the 
recess in the spring 124 into an annular storage space or recess 148 in 
the tensioner assembly 126. In particular, the space 148 is located within 
the frame 110 which supports the tensioner assembly. The suture filament 
is preferably stored as a coil inside the annular recess 148. However, if 
desired, the filament can be stored in any other compact and freely 
extendable manner, e.g., as a fan-fold configuration like a fire-hose. A 
disk or cap member 144 holds the filament in the recess 148. The annular 
recess is of a dimension such that a coil of the filament 34 ranging from 
approximately 1 inch (2.54 cm) to 5 inches (12.7 cm) in length and one 
suture diameter in height can be neatly stored therein. 
A holding sleeve or tag 138, e.g., a stainless steel tube, is crimped onto 
the filament 34 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. 10 and 11) to apply tension onto the 
filament 34 after the closure 22 is in place to enable the instrument 20 
to be removed and the filament 34 severed (as will be described later). 
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 sheath and its method of location with respect to the 
percutaneous puncture is in order. As can be seen in FIGS. 16-17 the 
sheath 28 includes a body portion or hub 28A in which a conventional 
hemostasis valve is located and a tubular portion 28B extending from the 
body. The tubular portion 28B terminates in an open distal or free end 
28C. 
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 is shown in FIG. 7. 
As can be seen the device 200 basically comprises a conventional dilator 
which has been modified to include two additional holes, namely, an 
entrance hole or port 204 and an exit hole or port 206. The device 200 is 
arranged to be fully inserted within the introducer sheath 28 like shown 
in FIG. 16. The holes 204 and 206 in the device 200 are connected by a 
hollow internal passageway or lumen (not shown) which extends along the 
length of the device. The location of the entrance port 204 is selected so 
that when the device 200 is fully with the introducer sheath, and the 
distal end of the sheath is within the interior of the artery, the 
entrance port 204 extends just beyond the distal end 28C of the introducer 
sheath to form a window into which blood may flow. The outlet port 206 is 
located on the proximal end of the surface 202 and is in fluid 
communication with the entrance port 204 via the internal lumen. 
Accordingly, blood may flow into the window 204 through the internal lumen 
of device 200 and out the exit port 206 as shown by the exemplary droplets 
12 in FIG. 16. 
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 observing 
the flow of blood 12 from the outlet port 206 of the device 200. The blood 
will normally flow out of the outlet port 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 outlet port just stops, a position shown in FIG. 17. 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 outlet port at this time. 
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. 
The deployment of the closure will now be described with reference to FIGS. 
18-26 and is as follows: The reference mark 108 on the bypass tube 104 is 
identified by the user and the bypass tube grasped by the user and 
oriented so that the mark 108 faces up (away from the patient) as shown in 
FIG. 18. This ensures that the anchor member 32 is located towards the 
patient. 
The bypass tube 104 is then inserted into the sheath 28 through the 
hemostasis valve 28A. The rigid nature of the bypass tube facilitates the 
passage of the flexible carrier tube 102 through the hemostasis valve and 
protects the closure 22 from damage and from potential contamination from 
non-sterile materials. The instrument 20 is then pushed fully down the 
introducer sheath so that a stop surface 110A (FIG. 18) on the front 
(distal end) of the tensioner frame 110 (FIGS. 19 and 20) engages the hub 
28A of the introducer sheath which houses the hemostasis valve. At this 
time the distal end of the carrier tube 102 will be in the position shown 
in FIG. 20 and the anchor member 32 will be located in the artery 26 
beyond the distal end 28C of the introducer sheath 28. The bypass tube 104 
remains within the hemostasis valve 28A of the introducer. 
As can be seen in FIG. 1 and 15, each of the thin rectangular extension 
prongs 140 includes an intermediate widened section 146 located 
approximately halfway along the length thereof. The extension prongs serve 
as a means for measuring the distance which the instrument should be 
removed from the introducer 28 while testing for deployment of the anchor 
member 32, as will be described hereinafter. The system 20 is then 
operated to determine if the anchor member 32 has been properly deployed. 
To that end the introducer sheath 28 is held by the user to prevent axial 
movement and the deployment instrument 20 is carefully withdrawn from it. 
This action causes the anchor member 32 to engage or "catch on" to the 
distal end 28C 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 indicators (widened portion) 146 
of the extension prongs pass the proximal edge of the hub 28A of the 
introducer as shown in FIG. 21. 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). If, however, no 
resistance is noted by the time that the widened portion 146 of the 
indicator prongs 140 pass (extends proximally of) the proximal end of the 
introducer hub, this will indicate that the anchor member 32 has 
re-entered the introducer sheath, and that the anchor member will not 
catch onto the artery as required. Thus, if no resistance is felt at this 
point, the deployment instrument 20 must be reinserted within the 
introducer sheath 28 and the foregoing procedure retried, this time by 
turning the instrument 20 about its central longitudinal axis by 
approximately 1/4 turn to each side before it is again withdrawn. 
If the resistance is felt before the indicator portions 146 on the 
extension prongs 140 reach the distal end of the introducer hub this will 
indicate that one of the curved ends of the anchor member 32 has caught on 
the free end 28C of the introducer sheath, an undesirable occurrence. 
Accordingly, the instrument 20 must be reinserted within the introducer 
sheath 28 and the foregoing procedure retried, this time by turning the 
instrument 20 about its longitudinal axis by approximately 1/4 turns to 
each side before it is again withdrawn. 
Once the anchor member has been properly deployed, as shown in FIG. 21, the 
collagen plug 30 and spacer 36' are deployed next. To that end a light 
force is applied perpendicularly to the middle of each extension prong, in 
effect pinching the flexible prongs together as shown in a side view of 
the instrument in FIG. 22. As the force is applied the extension prongs 
will flex slightly until they contact the cap or hub portion 28A of the 
introducer 28. As shown in FIGS. 1 and 15 the inner surface of the 
extension prongs contain a series of parallel ridges 150. These ridges 
engage a series of annular recesses 152 which encircle the outer diameter 
of the introducer hub 28A. The surface geometry of the inner surface of 
the extension prongs and of the outer surface of the introducer hub are 
defined such that when the extension prongs are pinched together onto the 
hub, the ridges on the prongs enter the recesses on the hub. By grasping 
the extension prongs in such a manner, the instrument 20 and the 
introducer sheath 28 can be moved together as a single unit. In 
particular, while maintaining light transverse pressure upon the extension 
prongs, the instrument is steadily withdrawn as a unit from the puncture 
whilst swinging the instrument toward the vertical as shown in FIGS. 23 
and 24. This action causes the anchor 32 to engage or catch onto the inner 
surface of the artery 26 contiguous with the puncture 24. 
The continued retraction of the introducer sheath and the deployment 
instrument causes the filament 34 to pull the collagen plug 30 and the 
spacer 36' out of the carrier tube 102 and into the puncture tract 24A as 
shown clearly in FIG. 23. As the introducer and instrument come out of the 
puncture tract, as shown in FIG. 24, 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. 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 30 and spacer member 36' are moved so that the spacer member 
engages the dome portion 54 of the anchor member 32 which extends through 
the puncture 24, and with the plug member 30 seated on the dome portion 54 
spaced from the artery wall. In fact, continued retraction causes the 
filament 34 to somewhat deform the plug 30, i.e., causing it to deform 
radially outward. 
The existence of blood within the puncture tract 24A further contributes to 
the deformation of the plug member 30 since the collagen foam expands in 
the presence of blood. The retraction procedure continues to pull the 
introducer sleeve and deployment instrument up the filament until the tag 
138 is exposed, as shown in FIG. 25. At this point the anchor member 32 
and collagen plug member 30 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 30. A few gentle compactions 
are adequate to achieve the desired result, i.e., to assist the plug 
member 30 in spreading out and conforming to the tract, thereby assisting 
in holding the plug in place until hemostasis occurs (which happens very 
quickly, thereby locking the closure in place). 
As can be clearly seen in FIG. 27 when the closure 22 is in place the 
spacer member 36' (or member 36--if that spacer is used in lieu of 36') 
holds the collagen plug 30 away from the puncture 28 in the artery wall. 
In particular, the spacer 36' rests on top of the dome portion 54 of the 
anchor where that portion extends through the puncture 28, and does not 
contact the exterior of the artery wall. The plug 30 rests on top of the 
spacer 36' and is thus within the tract 28A below the surface of the skin 
but spaced from the puncture. The action of the spacer ensures that no 
portion of the collagen plug 30 will enter the artery (where it could 
conceivably break off and flow distally). 
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 spacer member 36 and plug member 30 into the interior of the artery. 
After the tamping action is completed a torsion spring 142, which is shown 
in FIGS. 13 and 14, and whose details will be described hereinafter, is 
mounted on the filament 34 as shown in FIG. 26. This action is necessary 
to maintain appropriate tension on the filament while the instrument 20 is 
removed (the filament severed) . 
In FIGS. 13 and 14 the torsion spring 142 is shown. As can be seen therein 
the spring 142 is a leaf spring which includes a pair of legs 142A and 
142B projecting outward from a central section 142C. A portion of the each 
leg contains several rectangular shaped slots where material is removed 
and remaining material is bent upward, i.e., to form respective louvers 
96. The louvers can be of any variety of shapes. These protrusions from 
the spring surface make the spring easy to grasp and handle and also serve 
to reduce the weight of the spring. Each spring leg includes a slot 142D 
(FIG. 14) 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 ends of each leg of the spring are shaped in 
a manner such that it is unlikely that the spring will be inadvertently 
dislocated from the suture. 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 cut subcutaneously 
prior to the discharge of the patient. With the closure in final position 
as shown in FIG. 27 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. 
Preferably the spacer 36' (or 36) includes some resorbable radio-opaque 
means therein. This enables one to radiographically image the site of the 
closure to determine when the closure has been absorbed by the body, 
whereupon a new percutaneous incision or puncture can be made at that 
site, if desired. 
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 plug and anchor 
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 located in between the leaf spring 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. 
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 or 
other blood vessel, duct or lumen. 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. 
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.