Wound closure apparatus and method for its use

A wound closure apparatus and a method for its use are described. The apparatus includes a trilumen tubular member dimensioned to be positioned within a blood vessel through a conventional catheter sheath introducer. A mesh assembly extends longitudinally through the center lumen of the tubular member to position an expandable mesh portion within the vessel. The expandable mesh portion can be configured between a collapsed condition and an expanded condition by the attending surgeon or other medical personnel. Sutures are deposited into the blood vessel by a pair of medical needles inserted through the vessel wall adjacent the wound so that the leading ends of the sutures are deposited directly into the expandable mesh portion and are captured therein. The leading ends of the sutures can be withdrawn from the vessel through the center lumen of the trilumen body and pulled outside of the wound area where the surgeon can tie the ends thereof to close and seal the vessel wound.

The invention relates to a surgical instrument and a method for its use. 
More specifically, the invention relates to a surgical method and a 
related device for suturing a puncture or surgical incision in a blood 
vessel within the body of a living patient. The device and method of the 
present invention include a means for inserting suture material through 
the tissue wall adjacent the incision or puncture as well as additional 
means for withdrawing the suture material back out through the puncture so 
that the ends of the suture can be tied and the wound or incision thereby 
closed. 
BACKGROUND OF THE INVENTION 
Some medical procedures require surgical access into the vascular system 
through an artery or other vessel using, for example, a conventional 
catheter sheath introducer or dilator for the insertion of certain 
instruments for both therapeutic and diagnostic procedures. Medical 
Instruments such as guide wires, catheters, balloon angioplasty devices or 
the like are typically inserted into the vascular system through a sheath 
introducer positioned with its distal end extending through a vessel wall. 
Once the device gains access into the vascular system, it can be advanced 
to the area requiring a specific medical procedure. The conventional 
sheath introducer typically has a relatively large outer, diameter, 
resulting in a correspondingly large wound within the wall of the vessel 
which must be closed and sealed after the procedure is completed. 
It is generally desirable to prevent further bleeding from the blood vessel 
by sealing the wound as quickly as possible. One common technique to 
prevent further bleeding is through the application of continuous pressure 
on the wound until the patient's blood clots sufficiently to seal the 
vessel. One problem with this common technique, however, is that the 
application of pressure often requires the dedication of an hour or more 
of time by the attending medical personnel. Even with such dedicated 
medical attention, a hematoma can still occur if the patient moves during 
the clotting process. As a result of these problems, patients can be 
required to stay at least one night in a hospital for rest and 
observation. The additional hospital stay is an inconvenience for the 
patient which also increases the cost associated with the particular 
medical procedure. 
Other instruments for closing surgical wounds and the like are known. These 
devices typically insert a plug-like object or a clotting agent within the 
wound area to seal the vessel. The plug or clotting agent can be 
positioned either within the vessel or outside of the vessel and in close 
proximity to the outer vessel wall. Various types of plugs have been 
proposed. For example, collagen plugs are common and are typically 
designed to be placed outside of the vessel and near the opening within 
the vessel wall. Somewhat more elaborate plugs have also been proposed for 
placement directly within the vessel, with the plug secured against the 
inner vessel wall or lumen by an external suture extending into the wound 
and attached to the plug. Still other devices accomplish the placement of 
a clotting agent within the wound area, dispensing a foam, powder or gel 
within the wound from the distal end of an application device. 
A basic shortcoming of the aforementioned instruments is that their use 
often requires or results in the deposition of plugs or clotting agents 
within the vessel. This can be unintentional but, even in those instances 
where the deposition of a plug is to be outside of the vessel, the 
attending physician may encounter positioning problems so that the plug 
inadvertently protrudes at least partially into the vessel. Alternatively, 
the plug may slip into the vessel during the healing process due to the 
application of external pressure on the wound. In turn, these plugs or 
clotting agents can partially occlude the flow of blood through the vessel 
at the site of the original wound, possibly leading to complications such 
as thrombosis or stenosis. It would be desirable, therefore, to provide an 
apparatus which avoided the problems and shortcomings of the prior art 
techniques and devices for closing wounds or incisions within blood vessel 
in a living patient. Although sutures are very effective generally in 
closing and sealing surgical wounds, the art has failed to provide an 
instrument and a method for its use which utilize sutures to close a wound 
or incision within a vessel. Accordingly, it would be desirable to provide 
such an apparatus and method which would facilitate the proper placement 
of sutures within a vascular wound to allow the surgeon or attending 
medical personnel to quickly and efficiently close and seal such a wound. 
Most preferably, it is desirable to provide such an apparatus and method 
which can be used in conjunction with existing medical equipment such as 
conventional catheter sheath introducers, for example. 
Accordingly, it is a general object of the present invention to provide a 
wound closure apparatus and a method for closing vascular wounds, 
including surgical wounds. 
It is a further object of the invention to provide a wound closure 
apparatus and a method for its use which facilitate the proper placement 
of sutures for the closure of vascular wounds. 
It is still another object of the invention to provide a wound closure 
apparatus and a method for its use which can be used with conventional 
medical equipment such as a catheter sheath introducer, for example. 
BRIEF DESCRIPTION OF THE INVENTION 
The wound closure apparatus of the present invention overcomes the 
shortcomings of the prior art and achieves the aforementioned objectives 
by providing a device including a trilumen tubular member dimensioned to 
be positioned within a catheter sheath introducer. The tubular member is 
provided with a center lumen extending from its proximal end to its distal 
end. A mesh assembly is configured to extend through the center lumen of 
the tubular member and includes an expandable mesh portion constructed of 
a set of flexible filaments which are capable of being configured between 
an expanded condition and a collapsed condition. A leading coil is affixed 
to the distal end of the expandable portion to provide the attending 
physician with a means for sensing when the expandable mesh portion is 
properly positioned within a blood vessel. The mesh assembly also includes 
a shaft which, when the assembly is within the center lumar of the tubular 
member, is of sufficient length to extend from at least the proximal end 
of the tubular member through the center lumen and to the expandable 
portion. The stem member includes an outer sheath and an inner control 
cord extending axially through the outer sheath. The control cord is 
axially slidably moveable within the sheath and is affixed to one end of 
the expandable portion to provide a means to configure the expandable 
portion between its expanded condition and its collapsed condition. 
The trilumen tubular body also includes first and second side lumens 
positioned generally parallel to the aforementioned center lumen and 
extending longitudinally along opposing sides thereof. The side lumens are 
each dimensioned to slidably receive a needle or other piercing element 
and to thereby deliver a pair of sutures within the vessel being treated. 
In the arrangement of parts described herein, the needles or piercing 
elements are aligned to puncture the vessel wall on opposing sides 
adjacent the wound to thereby deliver sutures into the vessel through the 
vessel wall. The expandable mesh, when configured in its expanded 
condition, is constructed to trap the distal ends of each of the sutures 
ejected from the needles into the vessel. The mesh and the sutures trapped 
therein can then be withdrawn from the vessel through the center lumen and 
pulled outside of the patient's body. Accordingly, the suture material 
will then extend through the vessel wall on either side of the original 
wound, into the vessel and back out through the original wound where the 
surgeon can tie the ends of the suture material into a suitable knot for 
closing and sealing the punctured vessel. 
Those skilled in the art will more fully appreciate the scope of the 
present invention as well as the structural details of its preferred 
embodiment upon further consideration of the remainder of the disclosure 
including the detailed description of the preferred embodiment and the 
appended claims.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
The present invention provides a novel wound closure instrument as well as 
a method for the use of the instrument. The disclosed instrument is a 
useful surgical tool for applying sutures to a wound within a vessel 
following a procedure such as an angioplasty, for example, where the 
vessel has been surgically opened to insert a balloon catheter and the 
like. The apparatus of the invention can be inserted into the vessel 
through a conventional catheter sheath introducer and is constructed to 
allow the surgeon to insert a pair of sutures through the vessel wall on 
adjacent sides of the wound. A mesh assembly is provided to capture the 
free ends of the sutures within the vessel to allow the attending 
physician to then withdraw the captured sutures from the vessel back 
through the wound and outside of the patient's body where they can then be 
appropriately tied to close and seal the wound. 
In discussing the structural features of the preferred embodiment of the 
present invention, reference is now made to the various figures wherein 
the structural elements are identified with reference numerals, all of 
which are discussed herein. Referring now to the Figures, a wound closure 
apparatus 10 is provided and, in FIG. 1, the component parts and their 
interrelationship is illustrated. The instrument 10 includes an elongate 
tubular member 12 having three separate lumens extending from the proximal 
end 14 to the distal end 16 thereof. An elongate mesh assembly 18 is 
provided and is dimensioned to fit within and extend axially through the 
center lumen 40 (e.g. FIG. 2) of the tubular member 12. The assembly 18 
includes an elongate tubular outer sheath 26 having an inner lumen to 
receive a control cord 28 which extends through the sheath 26 and is 
axially slidable therein. A first hub or cap 30 is provided at the 
proximal end of the outer sheath 26 and a second hub or cap 32 is provided 
at the proximal end of the control cored 28. Both of the hubs or caps 30 
and 32 include gripping surfaces thereon. The caps 30 and 32 provide a 
manually operable means for the control and operation of the mesh assembly 
18, as is discussed herein. The control cord 28 extends from the proximal 
end 20 of the mesh assembly 18 and through the outer sheath 26 to the 
distal end 22 where the cord 28 is affixed to the expandable mesh portion 
34. 
The expandable mesh portion 34 is preferably composed of flexible filaments 
which are anchored at their respective ends along first and second collars 
37 and 39, respectively. The first collar 37 is preferably affixed to the 
surface of the outer sheath 26 at the distal end thereof. The second 
collar 39 is affixed to the distal end of the control cord 28. By the 
selective axial movement of the control cord 28 within the outer sheath 
26, the expandable mesh portion 34 can be configured in a collapsed 
condition where the filaments are extended to substantially their maximum 
longitudinal extent (FIGS. 1 and 2), and an expanded condition where 
collars 37 and 39 are brought into close proximity to bend the filaments 
and bow the mesh portion 34 (FIG. 3). The mesh 34 is configured between 
these two conditions by the relative movement of the control cord 28 
within the outer sheath 26 with the mesh 34 being constructed to assure 
the aforementioned collapsed condition as a preferred configuration. 
The tubular member 12 includes first and second side lumens 42 and 44, 
respectively (e.g. FIG. 2) which are disposed parallel to and on either 
side of the center lumen 40. The center lumen 40 as well as the first and 
second side lumens 42 and 44 extend from the proximal end 14 of the 
tubular member 12 to the distal end 16 thereof. The center lumen 40 is 
dimensioned to receive the mesh assembly therein with the expandable mesh 
portion 34 in its collapsed condition. The first side lumen 42 and the 
second side lumen 44 are dimensioned to slidably receive a piercing member 
such as first and second needles 46 and 48. The two needles 46 and 48 are 
both hollow and are of a sufficient gauge to receive sutures 66 and 68 
therein. 
Plungers 74 and 76 are provided to push the sutures through the lumen of 
the needles 46 and 48. The plungers 74 and 76 may be, in fact, a cannula, 
a solid wire or other rod-like member suitable for advancing the sutures 
66 and 68 through the first and second needles 46 and 48, respectively. 
Each of the plungers 74 and 76 are provided at one end thereof with caps 
78 and 80 to allow the user of the apparatus 10 to hold and manipulate the 
plungers 74 and 76. The caps 78 and 80 also serve as stops to limit the 
extent to which the plungers 74 and 76 can be longitudinally advanced 
within the lumens of the needles 46 and 48. Preferably, the plungers are 
of sufficient length to span the length of the needles 46 and 48 to push 
the sutures just past the pointed ends 54 and 56 and into the expanded 
mesh portion 34. The guide tips 70 and 72 on the sutures 66 and 68 are 
optional to allow the sutures to be more easily advanced through the 
needles 46 and 48 by the sliding action of the plungers 74 and 76. Of 
course, those skilled in the art will appreciate that a knot or other 
comparable structure or device will operate as functional and structural 
equivalents to the guide tips 70 and 72. 
The basic structure of the apparatus 10 of the present invention has been 
discussed and described above. Accordingly, its operation will now be 
described with reference to the structural members already identified. 
Referring generally to FIGS. 2-5, the basic operation of the apparatus 10 
is illustrated in its various stages of use. The apparatus 10 is inserted 
into a wound within the vessel wall 60 of the vessel 58 by use of a 
conventional catheter sheath introducer (CSI) 38 as shown in FIG. 2. As is 
known by those skilled in the art, the CSI 38 is used to facilitate the 
insertion of a variety of instruments for diagnostic and therapeutic use 
within the vascular system. 
Initially, the CSI is inserted within the wound in the vessel wall 60. The 
tubular member 12 is then inserted within the CSI to protrude into the 
vessel 58 at the distal end 16 thereof. The CSI 38 is then withdrawn over 
the tubular member and the mesh assembly 18 is inserted into the center 
lumen 40 to position the expandable mesh portion 34 within the vessel 58. 
The leading coil 36 provides a means for alerting the attending physician 
that the expandable mesh portion 34 is positioned within the vessel 58. 
The leading coil 36, when the mesh assembly is within the vessel 58, will 
abut the vessel lumen 62 thereby creating a resistance against the further 
advancement of the mesh assembly 18. 
Once the expandable mesh portion is properly positioned within the vessel 
58, as shown in FIG. 2 for example, the trilumen tubular member 12 can be 
partially withdrawn so that its distal end 16 is retracted from the wound 
and repositioned adjacent to the outer vessel wall 60 without protruding 
into the wound. At this stage of operation, the expandable portion 34 of 
the mesh assembly 18 is in its unexpanded or collapsed condition wherein 
the individual filaments of the mesh portion 34 are in their fully 
extended state with the first and second collars 37 and 39 at the greatest 
possible distance from each other within the structure of the instrument 
10. 
As shown in FIG. 3, when the distal end 16 of the tubular member 12 is 
positioned outside of the vessel wall 60, the expandable mesh portion 34 
can be reconfigured to its expanded condition by axially sliding the 
control cord within the outer sheath 26 of the mesh assembly 18 to pull 
the second collar 39 toward the first collar 37. The caps 30 and 32 are 
provided with gripping surfaces to allow the attending physician or other 
medical personnel to configure the expandable portion 34 by pulling the 
cap 32 affixed to the control cord 28 axially away from the cap 30 affixed 
to the outer sheath 26. When the expandable portion 34 is configured in 
its expanded condition, as shown in FIG. 3 the ends of the fibers thereof 
are in close proximity to one another and the member 34 expands to a width 
equal to or greater than the cross-sectional diameter of the tubular 
member 12. When the expandable portion 34 is fully expanded, the first and 
second collars 37 and 39 are positioned substantially adjacent one another 
and the fibers of the expandable portion 34 assumes a configuration where 
at least a portion of the expanded fibers are substantially perpendicular 
to the longitudinal axis of the control cord 28. 
Once the expandable mesh portion 34 is in its expanded condition, the 
relative position of the mesh assembly is adjusted to position the mesh 
portion 34 adjacent the wound so that the fibers of the mesh portion 34 
are at least partially in contact with the inner lumen 62 of the vessel 
wall 60. Proper positioning of the expandable mesh 34 can be accomplished 
by retracting the outer sheath using the gripping surface on the cap 30. 
As those skilled in the art will appreciate, the relative positioning of 
the caps 30 and 32 must be maintained during this step to maintain the 
mesh 34 in its expanded condition. The mesh assembly 18 is axially 
adjusted by advancing the mesh portion 34 toward the distal end 16 of the 
tubular member 12 until the operator experiences resistance to any further 
movement caused by the expanded mesh 34 when it abuts the lumen 62 of the 
vessel wall 60. 
Referring generally to FIGS. 3 and 4, the first and second needles 46 and 
48 are next advanced through the first and second side lumens 42 and 44, 
respectively. The pointed ends 54 and 56 on the needles 46 and 48 are 
advanced through the wall 60 of the vessel 58 to protrude therethrough and 
into the vessel 58 on adjacent sides of the original wound. The needles 46 
and 48 are provided with wing members 50 and 52, respectively, at the 
proximal ends thereof and the needles are advanced to their fullest extent 
into the side lumens 42 and 44. When the tubular member 12 is properly 
positioned, the needles are of sufficient length to penetrate the vessel 
wall 60 substantially as shown in FIG. 4 to advance the points 54 and 56 
into the mesh 34. It should be noted that the orientation of the needle 
points 54 and 56 is preferably such that the openings of the needles are 
oriented inwardly to open toward the center lumen 40. The wings 50 and 52 
provide gripping surfaces and are preferably oriented on the needles 46 
and 48 so that the outward orientation of the wings 50 and 52, as shown in 
FIG. 3, when the needles are disposed within the side lumens 42 and 44 
will serve as an indicator that the needle points 54 and 56 are oriented 
in a preferred manner. 
With the needles 46 and 48 fully inserted within the side lumens 42 and 44, 
sutures 66 and 68 can be advanced through the needles from the proximal 
ends thereof to the points 54 and 56 to deposit the leading ends of the 
sutures 66 and 68 within the expanded mesh member 34. To facilitate the 
advancement of the suture 66 and 68 through the needle lumens, plungers 74 
and 76 may be provided. Preferably the plungers 74 and 76 are each of 
sufficient length to travel the full longitudinal extent of the needles. 
Cap members 78 and 70 are provided at the proximal ends of the plungers 74 
and 76 to operate as stop members when the plungers are fully advanced 
within the lumen of the needles 46 and 48. 
The ends of the sutures 66 and 68 can be provided with guide tips 70 and 
72, substantially as shown in FIG. 1, for example. Alternatively, the ends 
of the sutures can be knotted to provide a means by which the ends of the 
sutures 66 and 68 can be easily pushed along the length of the needle 
lumen by the plungers 74 and 76. With the plungers 74 and 76 fully 
advanced within the needles 46 and 48, the ends of the sutures 66 and 68 
are deposited near or within the mesh portion 34 in its expanded 
condition. The sutures can be further secured within the fibers of the 
mesh portion by rotating the entire mesh assembly 18, including the mesh 
portion 34 around the longitudinal axis thereof. 
With the leading ends of sutures 66 and 68 advanced through the needles and 
captured within the expanded mesh portion 34, the mesh portion 34 can then 
be reconfigured to its collapsed orientation by advancing the control cord 
28 axially within the outer sheath 26 so that the hub 32 is advanced 
toward the hub 30 and the first and second collars 37 and 39 are again 
positioned at their greatest distance from each other. Once the expandable 
mesh portion 34 is reconfigured, it may then be withdrawn from the vessel 
58 through the wound and back through the center lumen 40 of the tubular 
member 12. With the distal ends of the sutures 66 and 68 trapped within 
the expandable mesh portion 34, the aforementioned withdrawal of the mesh 
34 through the center lumen further advances the suture material 66 and 68 
through the needles 46 and 48 and back up through the center lumen, 
substantially as shown in FIG. 5. In this manner, the suture material is 
threaded first through the vessel wall 60 adjacent the original wound and 
into the vessel 58, from which it is pulled back up through the original 
wound and outside the body of the patient. 
With the suture material advanced as described herein, the tubular member 
12 and the needles 46 and 48 can be withdrawn from the patient. FIG. 6, 
for example, illustrates a final stage of the process of the present 
invention with the tubular member 12 so withdrawn. At this stage, the ends 
of the sutures 66 and 68 can be detached by cutting, for example, from the 
needle tips 54 and 56. When the tubular member 12 is fully withdrawn from 
the wound, the portions of the sutures 66 and 68 extending through the 
center lumen 40 can also be detached therefrom to provide the attending 
physician or medical personnel with a set of sutures which are properly 
positioned within the wound and which may then be used in a known matter 
to close and seal the vessel wall 60. 
It will be appreciated that the relative positioning between the mesh 
portion 34 and the needle points 54 and 56 is not limited to the preferred 
positioning described above. Where the needle points 54 and 56 are not 
directly positioned within the expanded mesh portion 34, the sutures can 
still be captured within the mesh portion 34 by the rotation thereof about 
the longitudinal axis of the mesh assembly 18. Preferably, the filaments 
within the expandable mesh portion 34 are twisted somewhat in their 
orientation between the first collar 37 and the second collar 39 so that 
each of the filaments spans a twisted path between the first collar 37 and 
the second collar 39. Although other configurations are within the scope 
of the invention, the aforementioned configuration for these filaments is 
at least one preferred way to provide a structure which will efficiently 
and easily capture the ends of the sutures inserted into the vessel 
through the needles 46 and 48. 
Regarding materials, the tubular member is preferably manufactured of a 
suitable biocompatable polymeric material such as a polyurethane, for 
example. The mesh assembly 18 can be made from a variety of suitable 
materials. The outer sheath, for example can be made using stainless steel 
tubing or a suitably rigid polymeric material. The control core 28, 
similarly can be manufactured from a polymeric material or a stainless 
steel wire, for example. The caps 30 and 32 are of standard construction, 
typically made from a polymeric material such as a polyurethane, 
polycarbonate, nylon or polyurethane, for example. The expandable mesh 
portion is preferably made of resilient wire fibers which can withstand 
being configured between the aforementioned expanded configuration and the 
collapsed configuration without breaking or other substantial damage. The 
leading coil 36, likewise, is manufactured using a metallic coil member 
which is resilient and pliable to provide a means for determining the 
proper positioning of the mesh assembly within a blood vessel and without 
damaging the lumen of the blood vessel when the coil 36 makes contact 
therewith. Each of the needles 46 and 48 are preferably standard hollow 
point medical needles which are commercially available. The plungers 74 
and 76 can be manufactured of any suitable polymeric or metallic material. 
The plunger 74 and 76 can be a cannula or can be a solid member including 
a wire, for example. 
While a preferred embodiment of the present invention has been discussed 
and described herein those skilled in the art will understand that changes 
to the structure of the described apparatus and the method for its use can 
be made without departing from the true spirit and scope of the present 
invention as defined in the following claims.