Apparatus and method for positive closure of an internal tissue membrane opening

The invention provides a device having two components: a needle advancing apparatus slidable longitudinally along a catheter to advance needles into a tissue membrane, such as a blood vessel wall, around an opening in the membrane; and, a suture retrieval assembly insertable through the catheter beyond a distal side of the tissue membrane. The needle advancing apparatus advances suture through the tissue wall. The suture retrieval assembly grabs the suture on the distal side of the tissue membrane for extraction thereof through the opening in the tissue membrane. A method for suturing a membrane beneath the patient's skin is also disclosed.

BACKGROUND OF THE INVENTION 
The present invention relates generally to an apparatus and method for 
closure, such as by suturing, of tissue membrane openings. The present 
invention has particular application in the closure of openings in blood 
vessel walls after catheterization procedures in the cardiovascular system 
have been performed. 
A wide variety of techniques have been employed to provide nonsurgical, 
less invasive procedures in a medical patient. These include laparoscopy, 
arthroscopy, and various other techniques in which surgical and/or 
medicational procedures are performed via tubes, such as catheters, rather 
than full-scale "cut down" surgery. One such technique is the Seldinger 
technique involving the placement of guide wires and catheters in the 
cardiovascular system of the patient. Although such nonsurgical procedures 
typically greatly enhance the recovery time of the patient when compared 
to more conventional cut down surgery, nevertheless, openings formed in 
tissue membranes, such as arterial walls, take time to heal. 
Prior methods and devices typically involve placement of collagen external 
to the puncture wound with or without the placement of a polylactide 
member internal to the puncture wound such as in the lumen of the blood 
vessel. Potential problems with this approach involve the increase in 
thrombosis that has been observed to follow placement of a permanent 
intravascular device, the known effects of collagen to activate platelets 
and consequently induce thrombosis, and the occurrence of a systemic 
autoimmune inflammatory response following implants of bulk collagen. 
By way of background, other suturing and stitching devices and methods are 
disclosed in the following U.S. Pat. Nos. 5,037,433 to Wilk et al., 
4,957,498 to Caspari et al., 4,836,205 to Barrett, 4,437,465 to Nomoto et 
al., and 4,898,155 to Ovil et al.. 
The present invention provides a suture-based method of closure which 
circumvents the need for placement of any large piece, such as a stent, 
within the blood vessel, avoiding attendant risks of thrombosis. 
Additionally, use of collagens can be avoided, reducing the risk of 
thrombosis or of an inflammatory autoimmune reaction. The present 
invention provides these advantages while being usable in the context of 
noninvasive techniques, such as laparoscopy, cardiovascular procedures, or 
other procedures avoiding conventional cut down surgery, thereby providing 
the benefits without the necessity for direct visualization of the opening 
in the tissue which is to be closed. Additionally, the present invention 
provides substantially reduced healing times for medical patients, 
reducing patient discomfort and risk and also reducing hospital and 
personnel costs associated with prolonged healing.

SUMMARY OF THE INVENTION 
According to one embodiment, the present invention provides a nonsurgical 
method for closure of an opening in a tissue membrane beneath the skin of 
a patient. The method includes the steps of providing a tubular member 
having a lumen therein beneath the skin of the patient and in close 
proximity to and preferably protruding through the opening; inserting a 
retrieval assembly through the lumen and past the opening to a location on 
a distal side of the tissue membrane; advancing needle means for passing 
sutures through the tissue membrane at separate suture locations around 
the opening; grabbing the sutures with the retrieval assembly on the 
distal side of the tissue membrane; retrieving the sutures through the 
opening by withdrawing the retrieval assembly out through the opening; 
and, drawing together the suture location with the sutures. 
According to another embodiment, the present invention provides an 
apparatus for passing sutures through a tissue membrane located beneath 
the skin of a patient around an opening in the tissue membrane. The 
apparatus includes a tubular body having a side wall defining a lumen 
therein. The tubular body allows introduction of material into the patient 
through the lumen beyond the tissue membrane. The apparatus further 
includes an array of at least two needles disposed around the tubular body 
which carry a respective length of suture. The array of needles is 
advanceable through the tissue to a distal side thereof to provide sutures 
at separate suture locations in the tissue membrane around the opening. 
According to another embodiment, the present invention provides an 
apparatus for retrieving sutures, alone or in combination with the 
previously described apparatus, comprising a retrieval assembly having an 
elongated portion having a first end. The first end includes at least one 
flexible bow having a distal end, a proximal end, and a central portion 
therebetween. The apparatus further includes a tension member attached to 
the distal end of the bow member. The tension member and the proximal end 
of the bow are selectively movable with respect to each other to urge the 
distal end and the proximal end towards each other and apart from each 
other, causing the central portion of the bow to deflect outwardly away 
from the tension member to receive sutures, and to deflect inwardly toward 
the tension member in a collapsed position to secure sutures at the first 
end. The first end in the collapsed position is sized to be withdrawn 
through a catheter lumen. 
One object of the present invention is to provide an improved apparatus and 
method for positive closure of a subcutaneous tissue membrane opening. 
Another object of the present invention is to provide closure of tissue 
membrane openings, such as punctures in blood vessels. 
Another object of the present invention is to reduce the need for the use 
of collagens and/or intravascular devices, such as stents, for closure of 
puncture wounds. 
A further object of the present invention is to reduce the clotting time 
and the healing time required for a puncture wound in a tissue membrane. 
These and other objects and advantages of the present invention will be 
apparent from the written description and drawing figures herein. 
DESCRIPTION OF THE PREFERRED EMBODIMENT 
For the purposes of promoting an understanding of the principles of the 
invention, reference will now be made to the embodiment illustrated in the 
drawings and specific language will be used to describe the same. It will 
nevertheless be understood that no limitation of the scope of the 
invention is thereby intended, such alterations and further modifications 
in the illustrated device and method, and such further applications of the 
principles of the invention as illustrated therein being contemplated as 
would normally occur to one skilled in the art to which the invention 
relates. 
The present invention provides for the closure of openings in tissue 
membranes beneath the skin of a medical patient. The invention is useful, 
for example, to close the opening in the wall of a blood vessel caused by 
catheterization procedures. The invention is advantageous in that it 
allows closure of such openings without the need to surgically cut open 
the patient to visualize the closure procedure. In addition to closure of 
openings in blood vessels, the invention is useful for closing a variety 
of openings in various tissue membranes beneath the skin of a patient. 
Regarding the terminology herein, "distal" means toward the patient and 
away from the operator (doctor), and conversely "proximal" means toward 
the operator and away from the patient. 
The general procedure of the invention begins with the placement of a 
catheter through the opening in the tissue membrane. A retrieval device is 
inserted through the catheter and beyond the opening to the distal side of 
the membrane. The distal end of the retrieval device is expanded and 
pulled tightly against the inside surface of the tissue membrane. 
Thereafter, one or more needles carrying sutures are inserted through the 
tissue membrane around the opening. The retrieval device grabs the sutures 
on the distal side of the membrane. The retrieval device is then 
contracted and removed through the catheter, pulling the sutures with it. 
Thereafter, knots are formed in the sutures to draw the opening closed for 
healing. The preferred embodiment of the present invention has two primary 
components, retrieval assembly 51 (see FIG. 16) and needle advancing 
apparatus 50 (see FIG. 15a). Collectively, these form the suturing device 
52. 
Referring to FIGS. 1-13 and FIGS. 14a-14f, a representative illustration of 
the present inventive method is illustrated for positive closure of 
opening 99 in tissue membrane 43 of blood vessel 42. The blood vessel is 
located beneath the skin 40 of a medical patient, and is accessed through 
opening 41 in the skin. Note that the side wall of blood vessel 42 is 
illustrated partially cut away to facilitate illustration of the method, 
it being understood that ordinarily the method is performed only with 
opening 99 in tissue membrane 43. Tissue membrane 43 has a proximal side 
or surface 44 on the outside thereof and an opposite distal side or 
surface 45 on the inside thereof as illustrated. While the present 
invention is illustrated for repairing blood vessel 42, it is to be 
understood that the present invention may have applicability in positive 
closure of openings in other tissue membranes in a medical patient which 
are located beneath the surface of the skin. Such openings may include 
openings caused by medical procedures, such as laparoscopy, angiography, 
and others, as well as openings caused by traumatic wounds, including 
puncture wounds. 
FIG. 1 illustrates blood vessel 42 having a sheath 56, such as a catheter, 
passing through opening 41 and opening 99 and into the interior lumen of 
the blood vessel, beyond distal side 45. Sheath 56 includes a side wall 
defining one or more lumens therein as is well known. Sheath 56 typically 
may be initially placed in blood vessel 42 to facilitate introduction of 
material into the blood vessel, such as guide wires, catheters, scopes, 
dilators, inflatable balloons, or any other medical appliance, as well as 
introduction and/or removal of fluids such as blood, medication, and/or 
contrast media. In one application, the present inventive method is 
typically employed after such techniques and/or procedures, referred to 
herein generally as catheterization procedures, are completed and such 
medical devices have been removed from sheath 56. 
Needle advancing apparatus 50 is illustrated in FIG. 1 disposed around the 
outside of the side wall of sheath 56, and slideable longitudinally along 
the length thereof. Apparatus 50 is described in greater detail below. 
Apparatus 50 includes a tubular member 62 having a side wall defining a 
lumen therein with an array of needles disposed around sheath 56 protected 
by a needle guard 55. The needles each have respective lengths of sutures 
attached thereto. 
The distal end 53 of retrieval assembly 51 is inserted (FIG. 2) into the 
proximal end of the lumen of sheath 56. Retrieval device 51 is fully 
inserted into sheath 56 (FIG. 3) to position the distal end 53 beyond the 
distal end of sheath 56 and on the distal side of the membrane 43. The 
distal end of the retrieval assembly is initially in a collapsed state, 
being sized with a cross-sectional dimension to allow insertion and 
withdrawal of distal end 53 through the lumen of sheath 56. 
Distal end 53 is then expanded within blood vessel 42 (FIG. 4) on the 
distal side of membrane 43. The expanded state in this embodiment is 
formed by a plurality of bows, such as bow member 54, which are bulged 
outwardly. In this particular embodiment the configuration is analogous to 
an expandable bolt used to anchor fixtures to a building wall. The 
mechanics of this expansion are described more fully below, but generally 
are caused by manipulating two handle members at the proximal end of 
retrieval assembly 51, namely by rotational release of spring-loaded 
and/or screw threaded handles, such as movement of handle 75 with respect 
to handle 73 as shown by the arrow. The distal end preferably includes an 
expandable outer member and an inner member which rotates within the outer 
member. 
Distal end 53 is expanded and urged against the distal side 45 of the 
tissue membrane (FIG. 5). Such urging is preferably accomplished by 
pulling on handle 73, which is connected to distal end 53, in the 
direction of the arrow. By urging the distal end against the distal side 
of the tissue (e.g., against the inside of the blood vessel) the blood 
vessel is distended somewhat and held relatively stationary to facilitate 
insertion of the suture carrying needles through the tissue membrane. A 
hemostasis seal member, such as boot 631 (see FIGS. 4 and 5) described 
further below, seals opening 99 against outflow of fluid such as blood 
during the procedure. 
Needle advancing apparatus 50 is advanced forwardly along sheath 56 towards 
opening 99. It is slid far enough forward (i.e., distally) so that needle 
guard 55 passes through opening 41 in the skin, with the distal edge of 
the needle guard near opening 99 in the blood vessel (see FIG. 6). In this 
position, the needle guard is poised to be withdrawn, exposing the needles 
in close proximity to opening 99. 
The needle guard 55 is then withdrawn (FIG. 7) by sliding it along tube 
member 62 (which surrounds sheath 56) to expose the suturing needles, such 
as needle 57. In the illustrated embodiment, apparatus 50 includes four 
such needles arrayed equidistantly around sheath 56 for insertion into the 
tissue membrane around opening 99. The needles are initially in a compact 
mode. 
The needles, such as needle 57, are then moved radially outwardly (FIG. 8) 
(not to scale) away from their relatively radially compact position 
illustrated in FIG. 7. The manner of deployment in the preferred 
embodiment is described further below, but generally is caused by ninety 
degree rotation of a suture magazine 60 with respect to tubular member 62 
as shown by the arrow. The needles are arranged as a cranking mechanism 
which, in response to rotation of magazine 60, causes the needles to move 
radially outward. In this way, the needles are better radially spaced to 
allow insertion in the tissue membrane around the circumference of opening 
99. It is to be understood that this crank mechanism is only one approach, 
and other approaches of radially deploying the needles may be utilized, 
such as spring biased needles which spring outwardly. 
The needles, such as needle 57, are then advanced through the tissue 
membrane (see FIG. 9). This is caused by forward (i.e. distal) movement of 
apparatus 50 along sheath 56. The needles are advanced through the tissue 
membrane at various suture locations caused by the puncturing action of 
the needles. The needles carry suture or other suitable surgical closure 
materials. In the preferred embodiment, each needle is a solid stylet with 
an eyelet near its distal tip carrying a doubled-back length of suture 58 
(see FIG. 15b). Accordingly, four lengths of suture, each doubled back, 
are simultaneously advanced through the tissue membrane from proximal side 
43 to distal side 45. The sutures carried by the needles are preferably 
stored in four independent magazine compartments within suture magazine 
60. Not only is the suture advanced beyond distal wall 45 of the blood 
vessel, but furthermore, the needles and their respective sutures are 
inserted interstitially between the suture grabbing elements of distal end 
53 of the retrieval device 51. 
Handle member 73 is attached to the proximal end of retrieval assembly 51 
and is rotated with respect to handle 71. This causes rotation of distal 
end 53 as shown by the arrows (FIG. 10). This rotating, in the preferred 
embodiment, grabs the sutures carried by the needles. This grabbing action 
along with the rotation may cause a suture to be pulled out of the 
magazine compartments (shown partially cutaway) in magazine chamber 60 as 
it is being drawn into the distal end of the retrieval assembly. A variety 
of mechanisms, rotational and nonrotational, may be used for this grabbing 
feature, it being understood that the embodiment illustrated and the 
embodiments described later are merely exemplary. It should be further 
noted that the grabbing action occurs beyond opening and occurs on the 
distal side 45 of the blood vessel wall. 
Distal end 53 of the retrieval assembly is then collapsed to allow 
withdrawal through the lumen of sheath 56 (see FIG. 11). Such collapsing 
may be accomplished by a variety of mechanisms. In the preferred 
embodiment this is done by longitudinal movement of handle 75 towards 
handle 73 as illustrated by the arrow in FIG. 11, collapsing the bows of 
distal end 53 into a cross-sectionally compact mode. In this mode, the 
sutures remain held by distal end 53. 
FIG. 12 illustrates retrieval assembly 51 completely withdrawn from 
apparatus 50. Such withdrawal is accomplished by pulling the retrieval 
assembly, including elongated tube member 63 and distal end 53, out of the 
lumen of sheath 56. Since the sutures, such as suture 58, are still 
connected to distal end 53, the withdrawal pulls the sutures out of 
magazine 60 distally through the suture locations in the tissue membrane. 
The sutures are thereby doubled back and pulled outwardly through the 
lumen of sheath 56. 
Apparatus 50 is thereafter withdrawn from opening 99 and opening 41 in the 
patient, carrying the sutures outwardly through opening 41. FIG. 13 
illustrates needle guard 55 advanced forwardly, covering the tips of the 
needles. Such movement of needle guard 55 forwardly is done prior to 
withdrawal of apparatus 50 and after the needles are retracted into a 
radially compact mode in a manner inverse to the steps described in 
connection with FIGS. 6 and 7. Thereafter, apparatus 50 is removed 
entirely with the sutures being separated (by cutting or otherwise) so 
that what remains are four lengths of suture (each doubled back) threaded 
through a respective four suture locations around opening 99 in the blood 
vessel. 
The foregoing method has been described with the simultaneous advancing of 
four needles and sutures through the tissue membrane. However, it is to be 
understood that the present procedure may be done with more or less 
needles and sutures and/or be done with sequential advancing of needles 
and suture through the tissue membrane. The foregoing method is 
advantageous in that it may be performed "blind" inside of a patient 
beneath the surface of the skin of the patient, without the necessity for 
endoscopic or other viewing. The present invention may also be performed 
with the assistance of endoscopic equipment in appropriate circumstances. 
However, such threading operation through opening 41 in the skin without a 
full cut-down opening of the skin to access and view the opening in the 
blood vessel or other membrane is extremely advantageous and does not 
require endoscopic viewing. 
FIGS. 14a through 14f illustrate one example of a technique to position the 
sutures as illustrated in FIG. 13 across opening 99 to positively draw the 
opening closed for healing. In FIGS. 14a-14f, only two (rather than four) 
sutures are illustrated for purposes of drawing clarity and simplicity, it 
being understood that the same technique may be repeated for the other 
sutures. FIG. 14a illustrates suture 58a and suture 58b which are typical 
surgical sutures (sterilized) which will eventually dissolve in the 
patient after the wound is healed. Suture 58a is doubled back to form loop 
59a at one end with free ends 61a and 62a at the opposite end. Suture 58a 
is threaded downwardly through suture location 157a from the proximal side 
of the tissue membrane to the distal side of the tissue membrane, and is 
doubled back out through opening 99 in blood vessel 42. Similarly, suture 
58b is doubled back, forming loop 59b and free ends 61b and 62b. Suture 
58b is threaded through suture location 157b. 
Free end 61a is pulled through (see the bold arrow in FIG. 14b) suture 
location 157a and outwardly through openings 99 and 41 so that the suture 
is no longer doubled back. Then, distal end 61a is inserted through (see 
the bold arrow in FIG. 14c) loop 59b of the opposite suture 58b. Pulling 
(see the bold arrows) on both of free ends 61b and 62b (FIG. 14d) causes 
loop 59b to be drawn downwardly, pulling suture 58a downwardly with it. 
Continued pulling on free ends 61b and 62b pulls loop 59b upwardly through 
suture location 157b (FIG. 14e), pulling suture 58a upwardly through 
suture location 157b. 
FIG. 14f illustrates suture 58a passing through the tissue membrane at 
suture locations 157a and 157b, spanning diametrically across opening 99. 
Thereafter, suture 58a is drawn tight, such as by advancing or by 
"throwing" a suturing knot (e.g. an overhand knot) across opening 99, and 
positively drawing it closed. Such knot techniques and knot throwing may 
be accomplished with the aid of a pusher to advance the suturing knot 
downwardly towards opening 99. 
It is to be understood that the foregoing threading illustrated in FIGS. 
14a-14b is merely exemplary, and other techniques may be used, including 
techniques to provide a suture circumferentially around opening 99 in a 
purse string configuration. After opening 99 is drawn closed, opening 41 
is closed in the conventional manner and the patient is allowed to heal. 
FIGS. 15a-17d illustrate in greater detail the needle advancing apparatus 
50 and the retrieval assembly 51 previously described. Sheath 56 forms a 
central core of apparatus 50. Sheath 56 comprises a side wall defining a 
central lumen 56a passing all the way through assembly 50. Although as 
illustrated sheath 56 has a single lumen, it is contemplated that the 
present invention may be utilized with a multi-lumen sheath and/or device 
having endoscopic capabilities. Sheath 56 has housing 56d forming a 
chamber therein mounted at its proximal end. Housing 56d has a seal 56b 
also known as a valve body, mounted therein. This seal may be a variety of 
designs, but preferably is an elastomeric gasket body, such as silicone 
rubber, having slits and/or other collapsible openings 56b therein to 
allow selective insertion and removal of medical instruments, such as 
guide wires, catheters and other such devices, while maintaining a fluid 
tight seal therearound. In this way, blood or other bodily fluid is 
prevented from leaking out, and unwanted air is prevented from entering 
into the body. 
Housing 56d further has a side port (optional) 56e which ordinarily will 
have a stop-cock or other closure mechanism (not shown). In this way, 
catheter 56 may act as a hemostasis cannula to remain indwelling in the 
blood vessel 42 throughout the prior medical procedure. 
Apparatus 50 further includes a tubular member 62 surrounding sheath 56 and 
providing a housing for holding the four needles, such as needle 57. 
Needle 57 is shown in isolation in FIG. 15b and includes needle tip 57a at 
its distal end, a proximal portion 57b, and a central portion 57c 
therebetween. Central portion 57c defines a longitudinal axis of rotation. 
Proximal portion 57b is connected to the central portion by crank portion 
57e. Similarly, the needle tip is eccentric to the axis defined by central 
portion 57c since it is connected to the central portion by crank portion 
57d. As illustrated in FIG. 15a, needle 57 is mounted with the central 
portion 57c rotationally movable within tubular member 62, and with 
proximal portion 57b mounted in thread magazine 60. Thread magazine 60 is 
rotationally movable over a ninety degree arc with respect to tubular 
member 62, and such movement causes a cranking action of needle 57 ranging 
from fully compact to fully deployed, optionally with locks in each 
position. Such cranking action causes rotation of the central portion 57c 
which, in turn, causes cranking or swinging of crank portion 57d and 
needle tip 57a inwardly and outwardly with respect to sheath 56. In this 
way, with needle guard 55 withdrawn as illustrated in FIG. 15a, needle tip 
57a, along with the needle tips of the other three needles, is cranked to 
swing radially inwardly and outwardly with respect to sheath 56 to allow 
positioning of the needles for insertion through the tissue membrane 
around the hole. Such cranking action is illustrated comparatively between 
FIG. 17a and FIG. 17c, and between FIGS. 17b and 17d. FIG. 15c illustrates 
a cross sectional view, looking distally, through apparatus 50 and 
assembly 51 with the needles in a compact mode. 
Suture 58 is housed in suture chamber 65 within suture magazine 60. In FIG. 
15a, the remaining suture magazines are shown empty for illustration 
purposes, it being understood that in operation each carries suture for 
its respective needle. Suture chamber 65 includes a pair of suture 
openings 66 through which the suture is pulled as the suture is advanced 
through the tissue membrane of the patient. The suture passes between 
sheath 56 and tubular member 62 and is carried through an eyelet at the 
tip of its respective needle. Alternative needle constructions may also be 
used, such as a hollow needle cannula carrying suture downwardly through 
the center of the cannula and doubled back on the outside of the cannula 
away from the cutting edge. 
The needle assembly and member 62, along with the needle magazine 60, may 
be modified to allow placement around sheath 56 even after sheath 56 is in 
place in the patient, as an option to the illustrated version in which 
tubular member 62 is positioned around sheath 56 prior to insertion of 
sheath 56. For example, member 62 may be longitudinally split and provided 
as two mating parts, such as a clam shell, around the outside of sheath 56 
(not shown). 
FIG. 16a illustrates a partially cutaway side view of retrieval assembly 
51. Retrieval assembly 51 has a handle assembly on the proximal side 
thereof opposite of distal member 53, with elongated tubular member 63 
therebetween. Elongated tubular member 63 may comprise a catheter having a 
wire or other tension member 80 disposed in its central lumen. Distal end 
53 has a plurality of inner bows and outer bows such as bow 54. These bows 
are formed in one embodiment by slits in the wall of tubular member 63a 
(outer bow) and slits in the wall of tubular member 63b (inner bows). Each 
bow has a distal end 53d, a proximal end 53p, and a central portion 53c 
therebetween. Tension member 80 is attached to the distal end 53d by 
connection 80a. As illustrated, each inner bow may have serrations along 
its inside edge. When tension member 80 is pulled towards the proximal end 
of assembly 51, it draws the distal ends of the bows toward the proximal 
ends of the bows, causing the central portions to bulge outwardly in a 
radial direction. Such bulging is illustrated by comparing FIG. 17c (end 
53 in a contracted position) with FIG. 17a (end 53 in an expanded 
position). In the expanded position, serrations on the inner bows are 
exposed to help grab the sutures. 
Movement of tension member 80 with respect to elongated tubular body 63 may 
be accomplished in a variety of ways, one of which is illustrated in FIG. 
16a. Specifically, handle 75 is moved longitudinally with respect to 
handle 71 and handle 73 to cause such relative movement. Handle 75 is 
mounted and slidable longitudinally within handle 73. Handle 75 is urged 
axially away from handle 73 by compression spring 77. Handle 75 is 
connected to tension member 80, whereas handle 73 is connected to 
elongated member 63b. Pin 76a secured to handle 75 is slidable within 
z-shaped slot 76b in handle 73. In this way, relative movement between the 
handles is at a predetermined and controlled distance with a positive 
locking feature. Furthermore, handle 73 is rotatable within handle 71. 
Specifically, handle 73 includes a circumferential groove 72b which rides 
around radially inward detent 72a, allowing radial rotation but not 
allowing axial movement between handles 73 and 71. Such rotation is 
further controlled and limited by pin 74a abutting stop member 74b. The 
rotational position of distal end 53 is thereby limited and is indexed at 
a known position. By maintaining handle 71 stationary the outer bows of 
tubular member 63a (affixed thereto) are maintained stationary; whereas 
rotation of handle 73 within handle 71 cause the inner bows of tubular 
member 63b to rotate inside of the stationary, outer bows. The rotating 
inner bows have serrations which grab the suture while the outer bows 
remain stationary to shield surrounding tissue from abrasion or other 
damage. 
Through visual indexing markings, or actual physical forced alignment, the 
relative axial position between the bows of distal end 53 of retrieval 
assembly 51 may be predetermined with respect to the needles 57 of 
assembly 50. As a result, when the needles are advanced through the tissue 
membrane, the operator may ensure that the bows are placed to allow 
interstitial insertion of the needles between the outer bows. It is 
contemplated that this indexing mechanism may be facilitated by providing 
apparatus 50 in a sterilized kit with retrieval assembly 51. For example, 
tubular member 63 and sheath may be modified as illustrated in FIG. 15d 
with tubular member 763 having a longitudinal outer rib 763R which slides 
in a corresponding longitudinal inner groove in sheath 756. A mating 
interaction may be provided between retrieval assembly 51 and apparatus 
50, such as by mating interaction between the distal end of handle 71 and 
housing 56d to maintain alignment of the needles and the bows. 
FIGS. 16b and 16c illustrate an alternative embodiment of the retrieval 
assembly of the present invention. The structure noted by reference 
characters are similar to those used in connection with FIG. 16a except 
that a "1" or "2" is set forth in the hundredths digit of the 
corresponding reference character. For example, the handle 175 as in FIG. 
16b and 16c is analogous to handle 75 in FIG. 16a. The retrieval assembly 
has three key components, handle 171, handle 173 and handle 175. Handle 
171 is affixed to tubular member 63a; handle 173 is affixed to tubular 
member 263b; and, handle 175 is affixed to tension member 80. 
Handle 175 moves rearwardly (proximally) with respect to handle 171, 
thereby causing tension member 80 to be pulled in tension rearwardly 
(proximally) with respect to tubular member 63a. Such rearward movement is 
actuated by withdrawing pin 276a from recess 276b, such as by radially 
inward movement of the lever to which pin 276a is attached. Such 
withdrawal of the pin from the recess causes handle 175 to move rearwardly 
due to the forces acted upon by it by compression spring 177b. Pin 176a of 
handle 175 rides in longitudinal slot 176b of handle 171 to maintain 
alignment and to restrict relative travel distance. Tension is thereby 
exerted on tension member 80, causing the distal end of the retrieval 
assembly to expand as described in connection with FIG. 16a. Movement of 
handle 175 forward causes the distal end to collapse to allow passage 
through sheath 56. 
Handle 173 is first advanced and then rotated. Handle 173 is longitudinally 
movable with respect to handle 171, thereby causing longitudinal movement 
of tubular member 263b with respect to tubular member 63a. Handle 173 may 
be advanced forwardly (distally) with pin 172a riding in longitudinal slot 
172c overcoming the bias of compression spring 177a causing extension of 
tubular member 263b. Handle 173 is rotatable with respect to handle 171, 
causing tubular member 263b to rotate with respect to tubular member 63a. 
Rotation occurs with pin 172a riding in circumferential groove 172b. 
Rotation of handle 173 and the resulting rotation of tubular member 263b 
causes rotation of the snagging mechanism within the bows of the distal 
end of the retrieval assembly. Longitudinal withdrawal of tubular member 
263b causes withdrawal of the snagging mechanism at the distal end of the 
assembly, such as described further in connection with FIGS. 19 and 20 
below. 
FIGS. 17a-17d provide schematic comparisons of the moving parts of the 
present invention in different positions. For example, FIG. 17a and FIG. 
17b show needle guard 55 retracted or withdrawn, with needles 57 in a 
radially expanded mode and with distal end 53 of the retrieval assembly 
like wise in an expanded mode. Needle guard 55 includes handle 55a 
attached thereto to facilitate manual sliding along the outside of tubular 
member 62. Conversely, FIG. 17c and FIG. 17d illustrate needle guard 55 
advanced in a sheathed position with the needles 57 in a radially 
retracted position and with a distal end 53 of the retrieval assembly 
likewise in a contracted position. Comparison between FIGS. 17b and 17d 
illustrates the cranking action of cranking portion 57e of the needles. 
Note further that these two figures illustrate sutures in dual coils in 
all four chambers of the suture magazine. 
FIG. 18 shows distal end 153 with outer bow 153a and inner serrated bow 
154. Serrated bow 154 is formed from slits in flexible tubular member 63b 
having at least one serrated edge along each bow, as illustrated. Serrated 
bow 154 deflects outwardly similarly to the action of bow 153a when 
tension member 80 is pulled proximally with respect to elongated member 
63a. In such expanded state, end 153 comprises four inner bows within four 
outer bows. The inner bows rotate as previously described with respect to 
the stationary outer bows. A sealing member, such as elastomeric boot 631, 
preferably is provided at the proximal base of the outer bows. This seal 
631 functions to seal the opening which is being closed during the 
procedure so fluid, such as blood, is prevented from flowing out. Seal 631 
expands as the bows are expanded sufficiently to seal the opening. 
Referring to FIG. 19, an alternative embodiment of the distal end of the 
retrieval device is shown as distal end 253, with one of the bows 
partially cutaway for drawing clarity. The bows, such as 253a, are formed 
from slits in elongated tube 63a which surrounds tension member 80. Bow 
253a includes distal end 253d, proximal end 253p and central portion 253c. 
Two serrated members, such as serrated member 254, are rigidly attached to 
a collar 263b, which is an end of tubular member 263b described in 
connection with FIG. 16b above, and which is mounted over tension member 
80. Rotation of the collar/tubular member 263b and serrated member 254 
within fixed distal end 253 causes snagging and grabbing of sutures which 
are attached to the needles (previously described) positioned 
interstitially between the bows. Seal 631 is provided and functions as 
described above. Pulling on tension member 80 and its end piece 80a cause 
the bows to expand. Collar 263b may be a portion of an elongated tube 
which is axially movable to retract serrated members 254 within the outer 
bows as described with FIG. 16b. 
As a further alternative, FIG. 20 illustrates distal end 353 with bow 353a 
surrounding prong 354. As illustrated, other prongs (shown in phantom 
lines) are mounted over tension member 80 to grab and snag suture. Note 
that optionally, instead of a boot 631 providing a seal, the bow 
configuration is altered to provide a frustoconical sealing surface around 
the base of the outer bows. As with the device of FIG. 19, tubular member 
263b may be rotated and retracted to withdraw prongs 354 into a collapsed 
state. 
FIG. 21 illustrates yet another embodiment, in which distal end 453 
includes a plurality of bows, such as bow 453a, formed in an outer sheath 
63a. Sheath 63a is mounted around elongated member 463a which in turn is 
mounted around tension member 80. Inside the outer bows is a second set of 
bows, such as bow 454. These inner bows 454 may be of a hook fabric 
material, such as Velcro.RTM. material. Such hook material may be used in 
connection with multi-filament and/or monofilament suture material which 
acts as nap material to snag on the hook material of bow 454 as bows 454 
are rotated within the outer bows. A seal may optionally be added. 
As stated, other approaches to grasping the suture material on the distal 
side of the membrane to be closed may be provided. FIG. 22 illustrates 
distal end 553 with a membrane 554 of an elastomeric material, such as 
latex rubber, stretched around the outside of the expandable bows of 
member 63a and/or as part of a balloon. It has been found that when the 
interstitial needles penetrate through such latex rubber with the suture, 
the suture remains in place in the latex, even upon removal of the 
needles. A rotational inner member is typically not required, although 
optionally may be provided. Membrane 554 also acts as a hemostasis seal. 
While the invention has been illustrated and described in detail in the 
drawings and foregoing description, the same is to be considered as 
illustrative and not restrictive in character, it being understood that 
only the preferred embodiment has been shown and described and that all 
changes and modifications that come within the spirit of the invention are 
desired to be protected.