Suturing device and method for sealing an opening in a blood vessel or other biological structure

A suturing device includes a handle, an elongated body, at least one suture snag, at least one pair of needles, and at least one suture pair. The suture snag is moveable between a deployed position in which two distal arm portions thereof radially extend away from the elongated body and a retracted position in which the two distal arm portions are disposed within the elongated body. The suture pair is slidingly disposed through the needle pair. The suturing device deploys the suture snag within a vessel adjacent to an arteriotomy, extends the needle pair through a vessel wall around the arteriotomy and through the deployed suture snag, extends the suture pair beyond the distal ends of the needle pair, and then utilizes the suture snag to capture the extended suture pair by retracting the suture snag to pull first or distal ends of the sutures back into the suturing device. An inflatable balloon or an expandable suture capture component may be alternatives to the suture snag for capturing the suture ends.

FIELD OF THE INVENTION

The present invention relates to medical suturing devices, and more particularly, to suturing devices for closing an opening in an arterial or other biological tissue wall that is not directly accessible to a user.

BACKGROUND OF THE INVENTION

Various cardiovascular procedures, such as angioplasty, stent placement and atherectomy, require gaining access to the vasculature. With reference toFIGS. 1 and 2, access to the vasculature of a patient100typically is through the femoral artery and is percutaneous, involving insertion of a needle (not shown), and in some cases a dilator (not shown), in the region of the groin to form a track104through subcutaneous tissue106and to puncture and create an arteriotomy VAin a vessel wall VWof the femoral artery. A guidewire GW is then advanced through the needle and into the femoral artery. The needle and dilator, if present, are then removed. A catheter or other interventional device102is then advanced over the guidewire GW, along the track104and into the femoral artery in order to perform the selected procedure.

The size of the puncture opening in the artery corresponds to the size of the catheter or interventional device used, and such devices may typically range in diameter from 5 French for a diagnostic procedure to 6-20 French for a therapeutic procedure. In some cases, medical suturing systems are utilized to “pre-close” the arteriotomy VAby positioning one or more stitches adjacent to interventional device102that result in hemostasis of the arteriotomy VAaround the interventional device102during the procedure. After the procedure is completed and the interventional device(s) are removed, the stitches positioned by the medical suturing system are utilized to fully close the arteriotomy VA.

In other cases, i.e., when the size of the arteriotomy is relatively small, such pre-closure is not required and a medical suturing system or other technique is utilized to close the arteriotomy after the interventional device(s) are removed. A number of other techniques are known to facilitate closure and healing of the arteriotomy. One technique includes application of pressure at the puncture site for a relatively extended length of time. More particularly, compression has traditionally been applied to the puncture site for at least 30-45 minutes for the wound to close naturally after removal of the catheter. Patients are required to remain lying down, essentially motionless and often with a heavy sandbag placed on their upper leg, for several hours to ensure that the bleeding has stopped. The recovery time from the medical procedure may be as little as half of an hour, but the recovery time from the wound can exceed twenty-four hours. Longer recovery times may result in increased expenses, increased patient discomfort, and greater the risk of complications. Other approaches to arteriotomy closure include a compression clamp device, a thrombotic or collagen plug, biological adhesives adapted to seal the arteriotomy, and/or stapling devices.

Medical suturing systems that have been proposed facilitate closure and healing of the arteriotomy and resolve some of the concerns associated with arteriotomy closure during and after vascular catheterization procedures. However, a need in the art still exists for a medical suturing system that consistently and reliably facilitates closure and healing of the arteriotomy.

BRIEF SUMMARY OF THE INVENTION

Embodiments hereof relate to a suturing device including a handle, an elongated body coupled to a distal end of the handle, and a shaft slidingly disposed within the handle and the elongated body. An inflatable balloon is mounted on a distal portion of the shalt, the inflatable balloon being operable to alternate between an inflated configuration in which the inflatable balloon is inflated and a deflated configuration in which the inflatable balloon is not inflated. The suturing device also includes at least one pair of needles moveable to a deployed position in which the at least one pair of needles distally extend from the distal end of the elongated body and into the inflatable balloon in the inflated configuration and a retracted position in which the at least one pair of needles is disposed within the elongated body. Each needle includes a distal end configured to penetrate through a vessel wall.

Embodiments hereof also relate to a suturing device for positioning a suture in situ, the suturing device including a handle, an elongated body coupled to a distal end of the handle, and a shaft slidingly disposed within the handle and the elongated body. The handle has a first actuation mechanism and a second actuation mechanism, wherein the second actuation mechanism includes a suture holder and a needle holder disposed within the handle. The shaft is moveable via the first actuation mechanism. An inflatable balloon is mounted on a distal portion of the shaft and the shaft is moveable via the first actuation mechanism, the inflatable balloon being operable to alternate between an inflated configuration in which the inflatable balloon is inflated and a deflated configuration in which the inflatable balloon is not inflated. The suturing device also includes a pair of needles extending through the handle and through the elongated body, each needle including a distal end configured to penetrate through a vessel wall. The pair of needles is coupled to the needle holder and wherein the second actuation mechanism moves the pair of needles to a deployed position in which the pair of needles distally extend away from the distal end of the elongated body and into the inflatable balloon in the inflated configuration and a retracted position in which the pair of needles is disposed within the elongated body. A pair of sutures is slidingly disposed through the pair of needles. The sutures are coupled to the suture holder when the needles are in their deployed position and are disengaged from the suture holder when the needles are in their retracted position and wherein the second actuation mechanism moves the pair of sutures relative to the pair of needles from a loaded position in which each first end of each suture is disposed within its respective needle to a deployed position in which each first end of each suture extends distally beyond the distal end of its respective needle.

Embodiments hereof also relate to a method of positioning a suture at an arteriotomy of a vessel wall of a vessel. A distal end of a suturing device is positioned through the arteriotomy, wherein the suturing device includes a handle, an elongated body coupled to a distal end of the handle, and a shaft slidingly disposed within the handle and the elongated body. An inflatable balloon is mounted on a distal portion of the shaft and is in a retracted configuration in which the balloon is disposed within the elongated body. The shaft of the suturing device is to position the inflatable balloon within the vessel. The balloon is inflated to a deployed configuration within the vessel, wherein the balloon radially expands and extends away from the elongated body. At least one pair of needles of the suturing device is distally extended from a loaded position in which the at least one pair of needles is disposed within the elongated body to a deployed position in which the at least one pair of needles distally extend from a distal end of the elongated body and penetrate through the vessel wall and through the inflated balloon. A suture is slidingly disposed through the lumen of each needle and each suture is concurrently carried with its respective needle during the step of distally extending the at least one pair of needles to the deployed position.

DETAILED DESCRIPTION OF THE INVENTION

Specific embodiments of the present invention are now described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements. The terms “distal” and “proximal” are used in the following description with respect to a position or direction relative to the treating clinician. “Distal” or “distally” are a position distant from or in a direction away from the clinician. “Proximal” and “proximally” are a position near or in a direction toward the clinician.

The following detailed description is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. Although the description of the invention is in the context of treatment of an arteriotomy, which is used herein to refer to an opening, cut, or incision of an artery, the invention may also be used in any other blood vessels or body passageways where it is deemed useful. For example, the device could be used to suture openings or incisions of other tissue such as a patent ductus arteriosus, a patent foramen ovale, a heart defect, a puncture wound, and the like. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description.

Suturing devices according to embodiments hereof use a pair of needle to position a pair of sutures beyond the boundaries or perimeter of an arteriotomy and then utilize a suture snag to capture the ends of the sutures and pull the suture ends back into the suturing device. The captured sutures are then tied together to form a single stitch. The suturing devices may be used to seal a blood vessel during and/or following an interventional catheterization procedure. As will be understood by one of ordinary skill in the art, the number of suture snags and needles may vary depending upon the number of sutures being positioned by the suturing device. For instance, one suture snag and one pair of needles are utilized for positioning one pair of sutures at an arteriotomy, whereby the suture pair is then tied together to form a single stitch, while two suture snags and two pairs of needles are utilized for positioning two pairs of sutures at an arteriotomy, whereby each suture pair is then tied together to form a total of two stitches. During delivery thereof, a first suture of a suture pair is housed within a first needle of a needle pair and a second suture of the suture pair is housed within a second needle of the needle pair. The first and second needles of the needle pair actuate or move together. Thus, a plurality of needles with a complementing number of suture snags may be incorporated into the device to accomplish the specific needs of the application. The embodiment ofFIGS. 3-13illustrate a suturing device for positioning two suture pairs for forming a total of two stitches at an arteriotomy while the embodiment ofFIGS. 14-15illustrate a suturing device for positioning one suture pair for forming a single stitch at an arteriotomy.

More particularly, a suturing device320for suturing arterial vessel walls and other biological tissue is shown inFIGS. 3-13. With initial reference toFIGS. 3,3A, and3B, suturing device320according to one embodiment includes first and second needle pairs356A,356B and first and second suture snags348A,348B for positioning and capturing respective ends of first and second suture pairs360A,360B beyond the boundaries of the arteriotomy. Suturing device320includes an inner or guidewire shaft340as well as suture pairs360A,360B extending proximally from a handle322and an elongated body324extending distally from handle322. Handle322includes first and second sliders or actuators366A,366B which are utilized to extend needle pairs356A,356B, respectively, and suture pairs360A,360B, respectively, as will be described in more detail herein, and third and fourth sliders or actuators368A,368B which are utilized to deploy suture snags348A,348B, respectively, as will be described in more detail herein. More particularly, first suture pair360A and first needle pair356A are independently deployed or controlled by first actuator366A of a first needle and suture pair actuation mechanism of handle322, and second suture pair360B and second needle pair356B are independently deployed or controlled by opposing second actuator366B of a second needle and suture pair actuation mechanism of handle322. As such, a user may choose to deploy only one needle pair within a vessel at a time, for example when the vessel is of a relatively smaller size, or may choose to deploy both needle pairs simultaneously. In addition, each actuator366A,366B and corresponding actuation mechanism is provided for the deployment of two components, i.e., a pair of needles and the respective suture pair held thereby, which is beneficial for ease of use.

Elongated body324includes an outer shaft326and a distal guiding component332which is disposed over and coupled to a distal portion of outer shaft326. Distal guiding component332may be coupled to outer shaft326by adhesive or a threaded connection, or may be unitary or integral with the outer shaft. A distal end of distal guiding component332defines the distal end of elongated body324. Each of the outer shaft and the distal guiding component are hollow tubular components and collectively define at least one continuous lumen328through elongated body324for housing two elongated transmission members370A,370B and inner shaft340, as shown in the sectional view ofFIG. 3B. As will be explained in more detail herein, transmission members370A,370B extend between third and fourth actuators368A,368B, respectively, and suture snags348A,348B, respectively, and function as actuation mechanisms for the suture snags because they interact with third and fourth actuators368A,368B, respectively, in the deployment and retraction of the suture snags. Inner shaft340extends through handle332to a tapered distal tip or nosecone346, which is coupled to a distal end portion345(shown inFIG. 4D) of inner shaft340. Inner shaft340and distal tip346may define a continuous lumen342for tracking suturing device320over a guidewire (not shown). As shown in the sectional view ofFIG. 3A, a hemostasis seal325is disposed with handle322around inner shaft340adjacent to a proximal end of outer shaft326.

Since suturing device320is utilized to place the sutures around the border or edge of an arteriotomy of a vessel, the components of the suturing device will be described while simultaneously describing a method of using the suturing device to position suture pairs360A,360B in situ with reference toFIGS. 4-13. Referring toFIG. 4, a side view of a distal end portion of suturing device320having suture pairs360A,360B loaded therein is shown being distally advanced over a guidewire GW towards an arteriotomy VAin the vessel wall VWof a vessel. In an embodiment, each suture of suture pairs360A,360B is a continuous strand or filament of material having a first end362A,362B, respectively (seeFIG. 4E) and a second end364A,364B, respectively (seeFIG. 3). Exemplary suture materials include but are not limited to a monofilament or plastic suture material, such as polypropylene. Suturing device320is in a delivery configuration, in which suture snags348A,348B are in a retracted position while needles pairs356A,356B and suture pairs360A,360B are in a loaded position.

More particularly, as shown in the sectional view ofFIG. 4E, two suture snags348A,348B in the collapsed or retracted position are located or housed in lumen328of elongated body324and are substantially parallel to a longitudinal axis of elongated body324. Suture snags348A,348B are disposed within distal guiding component332during delivery of suturing device320so that they do not catch on the vessel walls of the vasculature during insertion and removal of the suturing device. Suture snags348A,348B are deployed by third and fourth actuators368A,368B, respectively, on handle322that interact with respective suture snag actuation mechanisms within handle322comprised of transmission members370A,370B. Suture snags348A,348B are coupled to the actuators via transmission members370A,370B, respectively. With additional reference toFIG. 4Bwhich is a sectional view of handle322at actuators368A,368B andFIG. 4Fwhich is a perspective view of transmission member372B removed from the suturing device for illustrative purposes only, proximal ends372A,372B of transmission members370A,370B are located adjacent to actuators368A,368B, respectively, while distal ends374A,374B of transmission members370A,370B are attached or connected to suture snags348A,348B, respectively. In another embodiment hereof (not shown), transmission members370A,370B may be integrally formed with suture snags348A,348B.

Proximal ends372A,372B of transmission members370A,370B each include a recess or groove371A,371B, respectively, that form proximal surfaces375A,375B and distal surfaces373A,373B, respectively. When it is desired to deploy suture snag348A, actuator368A is slid forward or distally advanced such that a knob or boss369A thereof slides or moves within recess371A until it abuts against distal surface373A and pushes or distally advances transmission member370A, thereby also pushing or distally advancing suture snag348A. Similarly, when it is desired to deploy suture snag348B, actuator368B is slid forward or distally advanced such that a knob or boss369B thereof slides or moves within recess371B until it abuts against distal surface373B and pushes or distally advances transmission member370B, thereby also pushing or distally advancing suture snag348B. In the delivery configuration of the suturing device shown inFIGS. 4B and 4E, suture snags348A,348B are both in a retracted position with bosses369A,369B of actuators368A,368B, respectively, abutting against proximal surfaces375A,375B of recesses371A,371B of transmission members370A,370B, respectively. In addition, actuators368A,368B also abut against stops359A,359B, respectively, of a housing323of the handle322that project or protrude radially to limit proximal retraction of actuators368A,368B.

FIG. 4Ealso illustrates the loaded position of needles pairs356A,356B and suture pairs360A,360B. Each needle is a generally straight tubular shaft component or hypotube which defines a lumen357for slidingly receiving a suture and includes a distal end358configured to penetrate or pierce through the vessel wall. During delivery, a first suture of first suture pair360A has a distal length disposed within a first needle of needle pair356A and a second suture of first suture strand pair360A has a distal length disposed within a second needle of needle pair356A, wherein distal ends of the first and second sutures do not extend from the distal ends of their respective needles. Similarly, a first suture of second suture pair360B has a distal length disposed within a first needle of needle pair356B and a second suture of second suture pair360B has a distal length disposed within a second needle of needle pair356B, wherein distal ends of the first and second sutures do not extend from the distal ends of their respective needles. Each of the sutures of suture pairs360A,360B has a proximal length that extends proximally of handle322to be accessible to a clinician as described in more detail below. Outer shaft326and distal guiding component332collectively define or include a plurality of needle pathways or guides330for housing needle pairs356A,356B, which are slidingly disposed thereon or therein. With reference to the cross-sectional view ofFIG. 3B, needle guides330may be formed via channels or grooves formed on an exterior surface of outer shaft326that mate with a plurality of lumens formed through distal guiding component332. Alternatively, rather than channels or grooves formed on the outer surface thereof, outer shaft326may define individual lumens for housing each needle.

Needle pair356A and suture pair360A are deployed by actuator366A that interact with a first needle and suture actuation mechanism within handle322comprised of a suture holder376A, a needle holder378A, and a carriage380A. An identical second needle and suture actuation mechanism comprised of a needle holder378B, a suture holder376B, and a carriage380B within handle322is utilized to deploy needle pair356B and suture pair360B via interaction with actuator366B. InFIG. 4A, needle pairs356A,356B and suture pairs360A,360B are each in a loaded position, with suture pairs360A,360B disposed within their respective needle pair356A,356B. With reference toFIGS. 4A,4C, and4D, needle pair356A is coupled to needle holder378A and needle pair356B is coupled to needle holder378B. The needle pairs may be coupled to the respective needle holder via adhesive or other bonding mechanism. Similarly, when in the loaded position, suture pair360A is coupled to a suture holder376A which is formed of a resilient material such as silicone. As best shown in the sectional view ofFIG. 4G, in the loaded position of the needle pairs and the suture pairs, proximal ends331A of needle pair356A are located within a portion of longitudinal slits327A of suture holder376A, adjacent to a distal end329A of suture holder376A, but at this stage of deployment the needle pair365A does not extend through the suture holder. In order to couple each suture of suture pair360A to suture holder376A, each suture of suture pair360A extends proximally from a respective proximal end331A of needle pair356A and extends through a respective longitudinal slit327A of suture holder376A. When suture holder376A is distally advanced first with needle holder378A during deployment of needle pair365A and second decoupled from needle holder378A during deployment of suture pair360A, each suture of suture pair360A is essentially squeezed or held via an interference fit within its respective slit327A of suture holder376A and therefore is distally advanced or carried by suture holder376A. Suture pair360B is similarly coupled to a suture holder376B which is obscured from the views ofFIGS. 4A,4C, and4D but may be seen inFIG. 8D.

In the delivery configuration of the suturing device, suture holder376A and needle holder378A are both coupled to a shuttle or carriage380A of the actuation mechanism. As will be explained in more detail herein, actuator366A pushes or distally advances carriage380A in order to first extend or deploy needle pair356A (via needle holder378A coupled to carriage380A) from the suturing device while carrying suture pair360A loaded therein, and thereafter to extend or deploy suture pair360A (via suture holder376A which is also coupled to carriage380A) relative to and distal of needle pair356A. Similarly, in the delivery configuration of the suturing device, suture holder376B and needle holder378B are both coupled to a shuttle or carriage380B, and actuator366B pushes or distally advances carriage380B in order to extend or deploy first needle pair356B and then suture pair360B. Needle holder378A, suture holder376A, carriage380A, and actuator366A are mirror images of needle holder378B, suture holder376B, carriage380B, and actuator3668, respectively, and as such, interactions of the actuation mechanism of needle holder378A, suture holder376A, and carriage380A with actuator366A is described herein.

More particularly, carriage380A includes a first leg397A, a second leg399A, which extends substantially parallel but spaced apart from first leg397A, and a distal bridge379A, which extends between the distal ends of first and second legs397A,399A. Each leg397A,399A rides or slides along a track365of housing323of handle322. Track365projects radially inward from the housing of the handle, and carriage380A rides or slides along the track as it is distally advanced during extension of needle pair356A and/or suture pair360A as will be explained in more detail herein. Suture holder376A is positioned within a proximal portion of carriage380A, to be sandwiched between first and second legs397A,399A thereof, and is coupled to carriage380A via integrally formed protrusions396A of suture holder376A which extend into corresponding recesses394A of first and second legs397A,399A. Since suture holder376A is coupled to carriage380A, carriage380A essentially pulls or carries suture holder376A, and thus suture pair360A attached thereto, forward when carriage380A is distally advanced via actuator366A. Suture holder376A includes a longitudinal channel or groove381A (seeFIG. 4D) formed on an inner surface thereof for sliding or riding along inner shaft340A.

Needle holder378A includes a distal portion having claws or prongs382A, a U-shaped proximal portion384A, and an intermediate portion388A extending therebetween. Intermediate portion388A includes a pair of channels or grooves390A formed on an outer surface thereof for receiving respective needles of needle pair356A and also includes a channel or groove392A (seeFIG. 4D) formed on an inner surface thereof for sliding or riding along inner shaft340A. In a delivery configuration of the suturing device, needle holder378A is coupled to carriage380A via mating or bearing surfaces383A (seeFIG. 4D). As a result of the interference fit between needle holder378A and carriage380A at bearing surfaces383A, carriage380A pushes or carries needle holder378A, and thus needle pair356A attached thereto, forward, i.e., in a distal direction, when carriage380A is distally advanced via actuator366A.

Referring toFIG. 5, suturing device320is shown advanced to a position in which a distal portion thereof is positioned through a target arteriotomy VAsuch that distal tip346is disposed within a lumen of the vessel. Suturing device320is still in a delivery configuration, in which suture snags348A,348B are in a retracted position and needle pairs356A,356B and suture pairs360A,360B are in a loaded position as described above with respect toFIG. 4. Distal guiding component332includes a stepped or tapered region which creates an abutment surface334. The outer diameter of a proximal portion333of distal guiding component332, i.e., a portion which is proximal to abutment surface334, is greater than the outer diameter of a distal portion335of distal guiding component332, i.e., a portion which is distal to abutment surface334. For example, the outer diameter of proximal portion333of distal guiding component332may be between 15 and 20 French while the outer diameter of distal portion335of distal guiding component332may be between 8 and 12 French. As shown inFIG. 5, distal portion335of distal guiding component332is sized to protrude through the arteriotomy VAand extend into the lumen of the vessel, while proximal portion333of distal guiding component332is sized to abut against the outer surface of the vessel wall Vwand not protrude or extend through the arteriotomy VAand into the lumen of the vessel. When the user is advancing suturing device320to the arteriotomy VA, a resistance to further advancement is felt when abutment surface334contacts the vessel wall, thereby notifying the user that the suturing device is in place within the arteriotomy VAas desired.

Once the distal portion of distal guiding component332is positioned through the arteriotomy VAof the vessel to reside within the lumen of the vessel, suture snags348A,348B are deployed against the vessel wall Vwaround the arteriotomy VAof the vessel as shown inFIG. 6. For illustrative purposes, suture snag348A is shown inFIG. 6Cin a deployed configuration removed from the suturing device. Suture snag348B is identical to suture snag348A and thus only the structure of suture snag348A is described herein. Suture snag348A includes two arms350A,352A which are disposed at an angle of approximately 90 degrees relative to each other. “Approximately” as utilized herein includes a range of plus or minus ten degrees. The proximal ends of arms350A,352A are joined via a connector354A. Distal ends374A,374B of transmission members370A,370B may fit within a space or gap337between arms350A,352A to thereby couple transmission members370A,370B to suture snag348A, although other mechanisms for coupling the transmission members and the suture snags may be used. When suturing device320is being delivered, arms350A,352A are generally straight. However, in the deployed configuration shown inFIG. 6C, distal arm portions351A,353A of each arm350A,352A, respectively, curve or extend radially outward from a longitudinal axis of the suturing device because at least distal arm portions351A,353A are formed from a resilient material having a mechanical memory. Mechanical memory may be imparted by thermal treatment to achieve a spring temper in stainless steel, for example, or to set a shape memory in a susceptible metal alloy, such as nitinol, or a polymer, such as any of the polymers disclosed in U.S. Pat. Appl. Pub. No. 2004/0111111 to Lin, which is incorporated by reference herein in its entirety. Distal arm portions351A,353A of suture snag348A each include a thru-hole or aperture355there through. Aperture355is generally circular or elliptical but includes two radial extensions339of the aperture or hole that function to catch or grip the ends of the suture as will be described in more detail herein. As will be shown in an additional embodiment described herein, if a single needle pair and a single suture snag are included on a suturing device to deploy a single suture pair, the distal arm portions of the suture snag are circumferentially spaced at approximately 180 degrees from each other. However, when two suture snags are included on a suturing device such as suturing device320, the distal arm portions of each suture snag are circumferentially spaced approximately 90 degrees from each other.

Distal guiding component332includes four passageways or openings338formed at a distalmost end thereof which allow the distal arm portions of the two suture snags348A,348B to alternate between the retracted position during delivery in which each suture snag326is disposed within and is substantially parallel to elongated body324, as shown and described above with respect toFIGS. 4 and 5, and a second deployed position in which the distal arm portions of each suture snag348A,348B extend radially outward from openings338away from the elongated body, as shown inFIGS. 6,6A, and6B. With reference toFIG. 6Dwhich is a sectional view of handle322at actuators368A,368B, when it is desired to deploy suture snag348A, actuator368A is distally advanced such that boss369A thereof abuts against distal surface373A and pushes or distally advances transmission member370A, thereby also pushing or distally advancing distal arm portions351A,353A of suture snag348A out of two of the four openings338of distal guiding component332. Similarly, when it is desired to deploy suture snag348B, actuator368B is distally advanced such that boss369B thereof abuts against distal surface373B and pushes or distally advances transmission member370B, thereby also pushing or distally advancing distal arm portions351B,353B of suture snag348B out of the other two of the four openings338of distal guiding component332. It will be apparent to one of ordinary skill in the art that suture snags348A,348B may be deployed simultaneously or independently.FIGS. 6A and 6Billustrate both suture snags348A,348B deployed, whileFIG. 6Eillustrates only suture snag348A deployed. When each suture snag348A,348B is distally advanced via actuator368A,368B, respectively, distal arm portions351A,353A,351B,353B extend out of openings338formed at a distalmost end of distal guiding component332. The mechanical memory of each suture snag causes the distal arm portions351A,353A,351B,353B to assume their deployed configurations and radially extend. When deployed, distal arm portions351A,353A,351B,353B of suture snags348A,348B, respectively, lie adjacent to or against an inside surface of the vessel wall Vwwith respective apertures355thereof positioned radially outward of the arteriotomy VA.FIG. 6Dillustrates actuators368A,368B when both suture snags348A,348B are in a deployed position with bosses369A,369B of actuators368A,368B, respectively, abutting against distal surfaces373A,373B of recesses371A,371B of transmission members370A,370B, respectively. Proximal ends372A,372B of transmission members370A,370B, respectively, abut against stops377A,377B, respectively, of housing323of handle322which project radially inward to limit distal advancement of actuators368A,368B.

After suture snags348A,348B are deployed, needle pair356A and suture pair360A are distally advanced until the respective actuation mechanism has reached a needle deployment position wherein the needles pierce through the vessel wall Vwat points that are radially outward of the arteriotomy VAas shown inFIG. 7. In one embodiment, as shown inFIGS. 7 and 7A, only needle pair356A is first extended into a lumen of a vessel. Extending only one needle pair into the vessel at a time provides access to relatively smaller vessels. However, it will be understood that both needle pairs may alternatively be extended or deployed into the vessel wall at the same time. With additional reference to the perspective view ofFIG. 7A, needle pair356A is distally advanced out of distal ports336of distal guiding component332and is distally advanced through tissue around the arteriotomy of a vessel until distal ends358of the needles extend through apertures355of deployed suture snags348A,348B. Accordingly, in situ, needle pair356A creates incisions or pathways within tissue around the arteriotomy during deployment. Although not visible in the views ofFIGS. 7 and 7A, suture pair360A extending within and carried with needle pair356A is similarly distally advanced concurrently with needle pair356A. Notably, since needle pair356A is distally deployed out of the relatively larger proximal portion of distal guiding component332, the needles extend straight out of ports336to pierce through the vessel wall VWand do not need to bend or curve. As such, the amount of force or energy required to extend the needles is minimized. Further, since no bending is required, the needles may be formed from stainless steel for improved pushability. In an embodiment, the outer diameter of the needles ranges between 0.015 and 0.025 inches, but needles with other diameters may be used herewith.

In order to extend needle pair356A and suture pair360A to the position shown inFIG. 7, actuator366A on handle322is distally advanced until the actuation mechanism associated therewith reaches a needle deployment position. With reference toFIG. 7Bwhich is a cutaway view of handle322at actuator366A, a knob or boss367A (shown in phantom) of actuator366A is positioned proximal to and abuts against distal bridge379A of carriage380A. When actuator366A is pushed forward or distally advanced, boss367A pushes or distally advances carriage380A, thereby also distally advancing in unison both suture holder376A (and suture pair360A coupled thereto) and needle holder378A (and needle pair356A coupled thereto). Since suture holder376A is coupled to carriage380A via protrusions396A which mate with corresponding recesses394A as described above, carriage380A pulls or carries suture holder376A, and thus suture pair360A attached thereto, forward when carriage380A is distally advanced via actuator366A. In addition, since needle holder378A is coupled to carriage380A via an interference fit between bearing surfaces383A as described above, carriage380A pushes or carries needle holder378A, and thus needle pair356A attached thereto, forward when carriage380A is distally advanced via actuator366A. Needle holder378A is carried by or moves concurrently with carriage380A until U-shaped proximal portion384A of the needle holder abuts against a stop385A of housing323of handle322, such that the needle deployment position has been reached as shown inFIG. 7B. Needle holder378A, as well as needle pair356A attached thereto, cannot be distally advanced after U-shaped proximal portion384A of the needle holder abuts against stop385A. As such, at this point in the method of use, needle pair356A is in an extended deployed position while suture pair360A may be considered to be in a partially extended position or as remaining in a loaded position within needle pair356A.

First ends362A of suture pair360A are then deployed out of or beyond distal ends358of needle pair356A as shown inFIGS. 8 and 8A. In order to extend or deploy suture pair360A out of needle pair356A, actuator366A on handle322is further distally advanced until the actuation mechanism associated therewith reaches a suture deployment position. With reference toFIGS. 8B and 8Cwhich are cutaway and sectional views, respectively, of handle322at actuator366A, further distal advancement of actuator366A (shown in phantom inFIG. 8B) results in carriage380A disengaging or decoupling from needle holder378A so that carriage380A and suture holder376A may be further distally advanced. As previously explained, needle holder378A is prevented from further distal movement because U-shaped proximal portion384A of the needle holder abuts against stop385A of housing323of handle322. With additional reference back to the sectional view ofFIG. 7C, as carriage380A is further distally advanced via actuator366A, carriage380A overcomes the interference fit between bearing surfaces383A and thereby squeezes or compresses distal prongs382A of needle holder378A to allow the carriage to slidingly advance over the needle holder. Carriage380A, as well as suture holder376A and suture pair360A coupled thereto, are distally advanced via actuator366A until distal bridge379A of carriage380A abuts against a stop386A of housing323of handle322such that the suture deployment position has been reached. As such, suture pair360A is distally advanced relative to needle pair356A by continued movement of actuator366A. Although the distal advancement of actuator366A is described in two sequential method steps withinFIGS. 7 and 8, it will be understood by those of ordinary skill in the art that such steps are performed by a single user action, i.e., distal advancement of actuator366A.

Carriage380A rides or slides along track365of housing323of handle322as carriage380A is distally advanced towards stop386A. Track365includes a stop387A that projects radially inward from housing323of handle322. When carriage380A is distally advanced to the point that distal bridge379A abuts against stop386A, a proximalmost end or surface of carriage380A passes over stop387A such that the proximalmost end or surface of carriage380A is located distal to stop387A as shown in the sectional view ofFIG. 8D. Carriage380A may bow or arch as it passes or rides over stop387A, and then snap back to its flat or planar shape when the proximalmost end or surface of carriage380A is located distal to stop387A. Stop387A prevents retraction of carriage380A and suture holder376A coupled thereto, thereby locking the fully extended deployed position of suture pair360A.

After distal portions of suture pair360A are extended or deployed beyond needle pair356A, needle pair356A is retracted as shown inFIGS. 9 and 9A, thereby leaving only the suture ends extending through the vessel wall and through apertures355of deployed suture snag348A. With additional reference to the cutaway and sectional views ofFIGS. 9B and 9C, respectively, actuator366A is proximally retracted until boss367A thereof abuts against U-shaped proximal portion384A of needle holder378A and then actuator366A pushes or proximally retracts the needle holder, thereby also proximally retracting needle pair356A. Carriage380A and suture pair360A cannot be retracted since they are locked in their extended positions due to stop387A, as described above, and needle holder378A is free to move independently from and relative to carriage380A since it was previously decoupled therefrom. Needle holder378A and needle pair356A attached thereto are proximally retracted until U-shaped proximal portion384A of the needle holder abuts against suture holder376A, such that the actuation mechanism may be considered to have reached a needle retraction position as shown inFIGS. 9B and 9C. Once needle holder378A is in its needle retraction position, distal tips358of needle pair356A are retracted back into distal guiding component332.

In addition, when needle pair356A is in the retracted position shown inFIG. 9,9A,9B, and9C, needle pair356A extends through longitudinal slits327A of suture holder376A such that proximal ends331A of needle pair356A are located proximal to a proximal end321A of suture holder376A as best shown in the sectional view ofFIG. 9Dto envelop or surround suture pair360A such that suture pair360A is slidingly positioned through needle pair356A, and therefore is no longer coupled to suture holder376A. Stated another way, since suture pair360A is slidably disposed within needle pair356A for the entire length of suture holder376A, suture pair360A no longer contacts the suture holder and therefore is no longer squeezed or held via an interference fit within longitudinal slits327A of suture holder376A. Since needle pair356A extends through the length of suture holder376A, suture pair360A disengages from or decouples from suture holder376A.

As previously mentioned with respect toFIG. 7, it may be desirable to extend only a single needle pair at a time into a lumen of a vessel if the vessel is of a relatively smaller size. If only a single needle pair and corresponding suture pair has been deployed into the lumen of the vessel, the remaining needle pair368B and first ends362B of suture pair360B are subsequently extended into the lumen of the vessel via actuator366B as shown inFIG. 10by following the method steps described above with respect to actuator366A. Alternatively, suture pair360B may have been extended into the lumen of the vessel via actuator366B before or concurrently with suture pair360A.

After respective ends of suture pairs360A,360B all extend into the lumen of the vessel and both needle pairs356A,356B have been retracted into elongated body324of the suturing device, suture snags348A,348B are proximally retracted to thereby capture the four extended suture ends and pull them into suturing device320as shown inFIG. 11. In order to retract suture snags348A,348B, actuators368A,368B are proximally retracted until bosses369A,369B thereof abut against and push proximal surfaces375A,375B of recesses371A,371B of transmission members370A,370B. By pushing transmission members370A,370B, suture snags348A,348B are thereby pushed or retracted back through openings338and into distal guiding component332. Essentially, proximal ends372A,372B of transmission members370A,370B are returned to the position described above with respect toFIG. 4. Proximal ends372A,372B of transmission members370A,370B are proximally retracted until bosses369A,369B of actuators368A,368B, abut against stops359A,359B, respectively, of housing323of handle322that project radially inward to limit proximal retraction of actuators368A,368B. When the suture snags are retracted, suture pairs360A,360B extend out of ports336of distal guiding component332, through tissue around the arteriotomy via the pathways or incisions created by needle pairs356A,356B, and then the ends of suture pairs360A,360B are captured within distal portion335of distal guiding component332as shown inFIG. 11. When captured, the ends of suture pairs360A,360B are pushed into catches or grips339of apertures355(seeFIG. 6C) and therefore are tightly secured within apertures355of the suture snags.

Notably, other suturing devices known in the art utilize extendable needles to capture modified suture ends of a suture which have been delivered through an arteriotomy to a position within a vessel lumen. However, suturing device320positions ends of a suture through a vessel wall around an arteriotomy and then utilizes deployable suture snags to capture or catch the suture ends back into the suturing device. As such, suturing device320does not require modification of the suture ends for capture thereof. In addition, suturing device320improves consistency and reliability of capturing the suture ends.

At this point in the method of use, suturing device320having the captured suture ends therein is retracted until it is withdrawn from a patient so that a clinician gains access to second ends364A,364B of suture pairs360A,360B. More particularly, since suture pairs360A,360B are no longer coupled to suture holders376A,376B, respectively, and are instead slidingly positioned through retracted needle pairs356A,356B, suture pairs360A,360B slide through the needle pairs as the suturing device320(having first ends362A,362B captured therein) is retracted until second ends364A,364B of the suture pairs exit out of distal ends358of needle pairs356A,356B. The clinician then ties or forms at least one surgical knot363between the respective second ends of each suture pair, thereby forming a first elongated suture361A from suture pair360A and a second elongated suture361B from suture pair360B. In order to facilitate tying or forming the surgical knot between each pair of opposing suture ends, suture pair360A may be formed from a different color and/or may be a different length than suture pair360B so that the physician can easily identify the suture ends that are to be tied together. With reference toFIG. 12, which is a top view of vessel V having an arteriotomy VA, newly formed elongated sutures361A,361B extend through the vessel wall around the arteriotomy and the opposing ends thereof (originally first ends362A,362B of suture pairs360A,360B) are still captured within suturing device320. The clinician then pulls on or further proximally retracts suturing device320such that surgical knots363of elongated sutures361A,361B are positioned over the vessel wall and/or arteriotomy VAas shown inFIG. 12. The physician then cuts or severs elongated sutures361A,361B from suturing device320. The physician may then pull one end of each elongated suture until surgical knots are accessible, i.e. located outside of the patient. A slip knot (not shown) is then tied below each surgical knot363, and one end of each elongated suture361A,361B is pulled to move or slide each slip knot over the length of each elongated suture towards arteriotomy VA. Hemostasis occurs when each slip knot abuts against the inside of the vessel wall, thereby closing or substantially closing the arteriotomy VAwith a first stitch393A and a second stitch393B as shown inFIG. 13.FIG. 13illustrates arteriotomy VAclosed for illustrative purposes; however, if suturing device320is being utilized in a pre-closure technique, stitches393A,393B would seal the arteriotomy VAaround an interventional device inserted through the arteriotomy VAas would be understood by one of ordinary skill in the art. The method steps described above for forming two stitches from suture pairs360A,360B are merely exemplary. Other devices or methods known in the art may be utilized to form two stitches from suture pairs360A,360B after suturing device320has captured the suture ends and thereby positioned the suture pairs through the vessel wall around the arteriotomy as desired. For example, although the above method illustrates forming two essentially parallel stitches393A,393B as shown inFIG. 13, different combinations of sutures may be tied together for forming the stitches, such as opposing sutures located 180 degrees from each other, to thereby form two stitches that crisscross in an “X” configuration. Stated another way, the elongated sutures361A,361B need not be formed from sutures of the same suture pair. Sutures of suture pair360A may be tied to opposing sutures of suture pair360B.

In order to access smaller vessels, which have inherently smaller arteriotomies due to the relatively smaller diameters of the vessels themselves, it may be desirable to utilize a relatively smaller suturing device which delivers a single suture pair.FIGS. 14 and 15illustrate an embodiment in which a suturing device1420includes a single suture snag1448and a single needle pair1456for delivering a single suture pair1460.FIG. 14andFIG. 14Aare perspective views of a distal portion of suturing device1420. As shown, suturing device1420includes an elongated body1424including an outer shaft1426and a distal guiding component1432. Distal guiding component1432includes a distally tapered region that ends at an abutment surface1434, and distal guiding component1432is utilized for guiding needle pair1456towards deployed suture snag1448having radially expandable distal arm portions1451,1453. A first suture of suture pair1460is housed within a first needle of needle pair1456, and a second suture of suture pair1460is housed within a second needle of needle pair1456.FIG. 14Aillustrates first ends1462of suture pair1460housed within the distal ends of needle pair1456.

FIG. 15illustrates a sectional view of a handle1422of suturing device1420, which deploys a single suture snag1448as well as only a single needle pair1456and single suture pair1460.FIG. 15Ais an enlarged sectional view of actuator1468for deploying and retracting suture snag1448. As shown, similar to actuator368, actuator1468includes a knob or boss1469which slidingly operates within a recess or groove1471of a proximal end1472of a transmission member1470which extends to and couples with a proximal end of suture snag1448. Actuator1468distally advances or proximally retracts transmission member1470, thereby distally advancing or proximally retracting suture snag1448.FIGS. 15B,15C, and15D are views of actuator1466for extending and retracting needle pair1456, as well as for extending suture pair1460. As shown, similar to actuator366, actuator1466includes a knob or boss1467which operates to distally advance a shuttle or carriage1480. In the delivery configuration of the suturing device, a suture holder1476and a needle holder1478are both coupled to carriage1480. Carriage1480includes a first leg1497, a second leg1499, which extends substantially parallel but spaced apart from first leg1497, and a distal bridge1479which extends between the proximal ends of first and second legs1497,1499. Suture holder1476is positioned adjacent to and coupled to a distal portion of carriage1480, between first and second legs1497,1499thereof. Since suture holder1476is coupled to carriage1480, carriage1480essentially pulls or carries suture holder1476, and thus suture pair1460attached thereto, forward when carriage1480is distally advanced via actuator1466. Needle holder1478includes a distal portion having claws or prongs1482, which in this embodiment essentially clips or bosses to distal bridge1479of carriage1480. Needle holder1478also includes a U-shaped proximal portion1484A which includes a pair of channels or lumens1490formed there through for receiving needle pair1456and also includes a channel1492formed on an inner surface thereof for sliding or riding along inner shaft1440. In a delivery configuration of the suturing device, needle holder1478is coupled to carriage1480via mating or bearing surfaces1483formed between prongs1483of the needle holder and distal bridge1479of the carriage. As a result of the interference fit between needle holder1478and carriage1480at bearing surfaces1483, carriage1480pushes or carries needle holder1478, and thus needle pair1456attached thereto, forward when carriage1480is distally advanced via actuator1466until the needle holder abuts against a stop1485of a housing1423of handle1422. Needle holder1478, as well as needle pair1456attached thereto, cannot be distally advanced any further but continued distal advancement of actuator1466results in continued distal advancement of carriage1480, as well as suture holder1476and the ends of suture pair1460. As best shown inFIG. 15C, continued distal advancement of carriage1480results in carriage1480overcoming the interference fit between bearing surfaces1483and thereby spreading or pushing apart distal prongs1482of needle holder1478, thereby decoupling needle holder1478and carriage1480to allow the carriage to slidingly advance through or past the needle holder. As such, suture pair1460is distally advanced by continued movement of actuator1466while needle pair1456is not.

In another embodiment hereof, in order to access smaller vessels, the size or outer diameter of the elongated body of the suturing devices described herein may be minimized by designing the plurality of needles to bend when being extended out of the distal guiding component. In an embodiment shown inFIG. 16, a suturing device1620includes an elongated body1624having an outer shaft1626and a distal guiding component1632. Distal guiding component1632is utilized for guiding a needle pair1656towards deployed suture snag1648having radially extendable distal arm portions1651,1653. Only one suture snag is shown deployed inFIG. 16, and only one needle is shown for sake of clarity and illustration. In this embodiment, distal guiding component1632includes a plurality of side openings or ports1636in a wall thereof that each allow the needle associated therewith to be alternately extended and retracted therethrough. In a retracted position each needle is disposed within the elongated body and in an extended position each needle extends distally and radially outward from a longitudinal axis LAof elongated body1624. As will be understood by one of ordinary skill in the art, the number of ports1636formed through distal guiding component1632corresponds to the number of needles located within the elongated body of suturing device1620. When each needle pair1656is distally advanced, distal ends1658comes into contact with a curved deflection surface or edge formed within transverse port1636that operates to guide distal ends1658of each needle out of elongated body1624and causes each needle to bend radially outward at an acute angle relative to the longitudinal axis LAof elongated body1624. As distal end1658exits from transverse port1636, each needle gradually bends and assumes the extended position shown inFIG. 16in which each needle extends distally and outwardly from elongated body1624. In embodiment hereof, the angle ⊖ of the needle deflection may be in a range of between 5 and 25 degrees. When needle pair1656is retracted back into elongated body1624, they return to their original generally straight configurations since they are no longer in contact with the deflection surface of distal guiding component1632that caused the needles to bend radially outward in the extended position.

In another embodiment hereof, an inflatable balloon may be utilized as an alternative to suture snags for capturing the ends of the suture(s) beyond the boundaries of the arteriotomy. An inflatable balloon provides a relatively larger target area or zone for placement of the needles of the suturing device. In addition, an inflatable balloon may provide apposition to the inner vessel wall during the suturing procedure, thereby improving the structural integrity of the vessel wall for the needles to puncture or penetrate there through. More particularly, with initial reference toFIGS. 17 and 17A, suturing device1720includes first and second needle pairs1756A,1756B and an inflatable balloon1810(shown inFIG. 18) for positioning and capturing respective ends of first and second suture pairs1760A,17608beyond the boundaries of the arteriotomy. Suturing device1720includes a transmission shaft1770, as well as suture pairs1760A,1760B extending proximally from a handle1722and an elongated body1724extending distally from handle1722. Handle1722includes first and second sliders or actuators1766A,1766B (slider1766B is not shown on the view ofFIG. 17but is located on the handle similar to slider366B described above) which each interact with a suture holder, needle holder, and carriage (not shown inFIG. 17but disposed within handle1722) to extend needle pairs1756A,1756B, respectively, and suture pairs1760A,1760B, respectively, as described above with respect to actuators366A,366B. Handle1722also includes a third slider or actuator1768which is utilized to distally advance or extend inflatable balloon1810as will be described in more detail herein.

Similar to elongated body324described above, elongated body1724includes an outer shaft1726and a distal guiding component1732which is disposed over and coupled to a distal portion of outer shaft1726. Outer shaft1726and distal guiding component1732collectively define or include a plurality of needle pathways or guides1730for housing needle pairs1756A,1756B, which are slidingly disposed thereon or therein. With reference to the cross-sectional view ofFIG. 17A, needle guides1730may be formed via channels or grooves formed on an exterior surface of outer shaft1726that mate with a plurality of lumens formed through distal guiding component1732. Alternatively, rather than channels or grooves formed on the outer surface thereof, outer shaft1726may define individual lumens for housing each needle. Each of the outer shaft and the distal guiding component are hollow tubular components and collectively define at least one continuous lumen1728through elongated body1724for housing transmission shaft1770, as shown in the cross-sectional view ofFIG. 17A. Transmission shaft1770extends through handle1732to a tapered distal tip or nosecone1746, which is coupled to a distal end portion1745(shown inFIGS. 18-19) of transmission shaft1770.

A distal portion of transmission shaft1770is shown removed from suturing device1720for illustration purposes only inFIGS. 18 and 19. The distal portion of transmission shaft1770is positionable through an arteriotomy and includes inflatable balloon1810, which is shown in a deflated or delivery configuration inFIG. 18and in an expanded or inflated configuration inFIG. 19. As will be understood by those of ordinary skill in the art, transmission shaft1770and balloon1810collectively form a balloon catheter. A proximal end or neck1812and a distal end or neck1813of balloon1810is coupled to distal end portion1745of transmission shaft1770. Proximal and distal necks1812,1813of balloon1810may be joined to transmission shaft1770in any conventional manner known to one of skill in the art of balloon catheter construction, such as by laser welding, adhesives, heat fusing, or ultrasonic welding. Transmission shown1770is a tubular shaft formed by multi-lumen profile extrusion. Transmission shaft1770defines at least an inflation lumen1715and a guidewire lumen1742for tracking suturing device1720over a guidewire GW (shown inFIGS. 18-19). Inflation lumen1715extends the full length of transmission shaft1770to allow inflation fluid received through an inflation port of a hub1714(shown inFIG. 17) to be delivered to inflatable balloon1810. Inflation lumen1715is in fluid communication with an interior of balloon1810via a port or opening (not shown) of transmission shaft1770to allow inflation fluid, i.e., saline, to flow between the inflation lumen and the interior of the balloon. As would be understood by one of ordinary skill in the art of balloon catheter design, hub1714provides a luer hub or other type of fitting that may be connected to a source of inflation fluid and may be of another construction or configuration without departing from the scope of the present invention. In addition, hub1714includes a guidewire port (not shown) that communicates with lumen1742of transmission shaft1770for receiving a guidewire GW there through. Transmission shaft1770may be formed of a polymeric material, non-exhaustive examples of which include polyethylene, PEBA, polyamide and/or combinations thereof, either blended or co-extruded.

As shown inFIG. 17A, although not required, transmission shaft1770may also define further lumens in addition to inflation lumen1715and guidewire lumen1742. In the embodiment ofFIG. 17A, transmission shaft1770defines a gas egress lumen1711that provides a pathway for gas to exit as balloon1810is filled with inflation fluid via inflation lumen1715. Gas egress lumen1711is in fluid communication with an interior of balloon1810via a port or opening (not shown) of transmission shaft1770to allow gas or air to exit from the interior of the balloon into the gas egress lumen. More particularly, prior to inflation of balloon1810, gas or air may be present within inflation lumen1715. During balloon inflation, such gas gets pushed into the interior volume of balloon1810and creates a trapped gas or air bubble inside the balloon. Such gas bubbles may be released into the blood stream when needle pairs1756A,1756B are distally advanced or deployed into the balloon, as will be described in more detail herein. Although small amounts of gas or air can be introduced into the blood stream without patient injury, it is desired to minimize the amount of gas that can expel from the balloon after it is punctured by the needle(s). Thus, gas egress lumen1711provides a pathway for the gas to travel through during balloon inflation so that the trapped gas bubbles do not form within the interior of balloon1810.

As previously mentioned, third slider or actuator1768of handle1722is utilized to distally advance or extend inflatable balloon1810. Balloon1810in its deflated or delivery configuration is disposed or housed within distal guiding component1732during delivery of suturing device1720so that it does not catch on the vessel walls of the vasculature during insertion and removal of the suturing device. Balloon1810is deployed by third actuator1768on handle1722that interacts with transmission shaft1770, which extends from balloon1810and through handle1722. More particularly, third actuator1768is coupled to transmission shaft1770within handle1722so that when it is desired to distally advance balloon1810, actuator1768is slid forward or distally advanced to push or distally advance transmission shaft1770, thereby also pushing or distally advancing balloon1810coupled thereto. Thus, when it is desired to proximally retract balloon1810, actuator1768is slid backward or proximally retracted to pull or proximally retract transmission shaft1770, thereby also pulling or proximally retracting balloon1810.

In the construction ofFIG. 17A, transmission shown1770is a single shaft formed by multi-lumen profile extrusion and defines a plurality of lumens there-through. Other types of construction of the transmission shaft are also amendable to the invention, such as, without limitation thereto, dual concentric shafts. More particularly, as shown in the embodiment ofFIG. 17B, an inner shaft1740which defines a guidewire lumen1742B may extend within a transmission shaft1770B such that an annular inflation lumen1715B is defined between an inner surface of transmission shaft1770B and an outer surface of inner shaft1740. As will be understood by those of ordinary skill in the art, transmission shaft1770B, inner shaft1740, and a balloon (not shown) collectively form a balloon catheter having an over-the-wire (OTW) configuration with a proximal end or neck the balloon coupled to a distal end of transmission shaft1770B, and a distal end or neck of the balloon is coupled to a distal end portion of inner shaft1740. In this embodiment, transmission shaft1770B and inner shaft1740may be coupled together so that the concentric shafts as well as the balloon are distally advanced and proximally retracted as a single unit or assembly. The concentric shafts may be coupled together via one or more bonds (not shown) which are non-circumferential so as not to interfere with the flow of inflation fluid through inflation lumen1715B.

With reference to the cross-sectional view ofFIG. 19A, taken along line A-A ofFIG. 19, in one embodiment hereof, balloon1810is a single layer balloon defining a single compartment or interior volume. Balloon1810may be formed from any material that is relatively elastic and deformable, including a compliant or semi-compliant material. Balloon compliance can be defined as the change in balloon diameter and length as a function of inflation pressure. A high compliance balloon has a relatively large increase in diameter and length in response to an increase in inflation pressure, while a balloon having a relatively small increase in diameter and length in response to an increase in inflation pressure is said to be a low compliance balloon or a non-compliant balloon. Non-exhaustive examples of materials for balloon1810include polymers such as silicone, polyethylene, PEBA, polyethylene terephthalate (PET), polyamide, and polyurethane, copolymers or blends thereof. In one embodiment, balloon1810is a relatively compliant thermoplastic elastomer (TPE) material. The compliant material of balloon1810is self-sealing such that the insertion and removal of needles through the balloon material does not affect the operation, i.e., the inflation and deflation, of the balloon. Compliant or semi-compliant materials such as those listed above as non-exhaustive examples of materials for balloon1810exhibit self-sealing characteristics due to the compliant nature thereof. In general, the compliance of the material is directly related or proportional to the self-sealing ability of the material such that higher compliance materials result in more self-sealing characteristics.

In an embodiment hereof, balloon1810is pre-blown or pre-formed, i.e., formed by extruding material into a tube shape and then forming the tube into a balloon through a process known as blow molding as will be understood by those of ordinary skill in the art of catheter balloon manufacture. When inflated, pre-formed balloons expand to the predetermined expanded or inflated shape or diameter of the mold that was used in the blow molding process. In another embodiment hereof, balloon1810is not pre-formed but rather may be an extruded tubular component that freely expands and deflates back to a tubular configuration. As used herein, “freely expands” refers to uncontrolled expansion of the balloon rather than expansion to a predetermined expanded or inflated shape of the mold that was used in the blow molding process. The inflated or expanded configuration of a non pre-formed balloon is generally spherical and may be similar to that of a pre-formed balloon, however, such expansion is less controlled and the outer diameter thereof is less predictable. Such a non pre-formed balloon may be deflated via retraction or removal of the needles of the suturing device, and thus does not require a vacuum to cause deflation thereof. More particularly, when the needles of suturing device1720are proximally retracted as described in more detail herein, removal of the needles causes the non pre-formed balloon to deflate or revert back to its tubular deflated or delivery configuration due to the elastic nature of the balloon. As the non pre-formed balloon deflates, the inflation fluid, i.e., saline, leaks out of the holes formed by needle pairs1756A,1756B. Although a vacuum is not required to cause deflation of a non pre-formed balloon, it will be apparent to one of ordinary skill in the art that a vacuum may be applied to accelerate deflation of the balloon.

In embodiments hereof, the balloon may include dual or double layers of different materials and/or may include multiple compartments or chambers. For example, as illustrated inFIG. 20in another embodiment taken along line A-A ofFIG. 19, a balloon2010includes an outer layer2016and an inner layer2018. Outer layer2016is formed from a compliant or semi-compliant material that is self-sealing, such as those listed above with respect to balloon1810, while inner layer2018is formed from a non-compliant or low-compliant material such as but not limited to polyethylene terephthalate, or nylon-based non-compliant materials such as Grilamid™ or Vestamid™. Since non-compliant materials generally expand more predictably than compliant materials and have a higher tensile strength than compliant materials, the addition of non-compliant inner layer2018allows balloon2010to be pre-blown or pre-formed to a predetermined inflated or expanded diameter while compliant outer layer2016provides the self-sealing function.

Balloons having multiple compartments or chambers are illustrated inFIGS. 21-22, other embodiments taken along line A-A ofFIG. 19.FIG. 21illustrates a single layer balloon2110having four internal compartments2117A,2117B,2117C,2117D, collectively referred to as compartments2117. Four compartments2117correspond to the four needles of needle pairs1756A,1756B. Multiple compartments2117ensure that if any leakage of inflation fluid occurs when a needle pierces into its respective compartment, the leakage would be confined to a single chamber of the balloon and pressure may be maintained in the non-affected compartments. In addition, multiple compartments2117are beneficial when needle pairs1756A,1756B are deployed non-simultaneously because each compartment is individually inflatable as described in more detail herein and may be selectively inflated immediately prior to deployment of the corresponding needle pair. Balloon2110is formed from a compliant or semi-compliant material that is self-sealing, such as those listed above with respect to balloon1810.FIG. 22illustrates a dual layer balloon2210having four compartments2217A,2217B,2217C,2217D. Balloon2210includes an outer layer2216and an inner layer2218. Outer layer2216is formed from a compliant or semi-compliant material that is self-sealing, such as those listed above with respect to balloon1810, while inner layer2218is formed from a non-compliant or low-compliant material such as but not limited to polyethylene terephthalate. If the suturing device includes a balloon having multiple internal compartments, i.e., balloon2110or balloon2210, transmission shaft2370as shown inFIG. 23defines a plurality of individual inflation lumens2319A,2319B,2319C,2319D extending there-through rather than a single inflation lumen such that inflation and deflation of each individual compartment of the balloon may be separately and selectively controlled. Thus, each chamber or compartment of the balloon is independently inflatable.

FIGS. 24-32illustrate a method of using suturing device1720in order to position two sutures at an arteriotomy of a vessel wall of a vessel. Referring toFIG. 24, suturing device1720is shown advanced to a position in which a distal portion thereof is positioned through a target arteriotomy VAsuch that distal tip1746is disposed within a lumen of the vessel. Suturing device1720is in a delivery configuration, in which inflatable balloon1810is in a deflated configuration and disposed within the elongated body of the suturing device. In addition, needle pairs1756A,1756B and suture pairs1760A,1760B are in a loaded position described above with respect toFIGS. 4 and 17. Similar to distal guiding component332, distal guiding component1732includes a stepped or tapered region which creates an abutment surface1734. As shown inFIG. 24, a distal portion1735of distal guiding component1732is sized to protrude through the arteriotomy VAand extend into the lumen of the vessel, while a proximal portion1733of distal guiding component1732is sized to abut against the outer surface of the vessel wall VWand not protrude or extend through the arteriotomy VAand into the lumen of the vessel. When the user is advancing suturing device1720to the arteriotomy VA, a resistance to further advancement is felt when abutment surface1734contacts the vessel wall, thereby notifying the user that the suturing device is in place within the arteriotomy VAas desired.

Once the distal portion of distal guiding component1732is positioned through the arteriotomy VAof the vessel to reside within the lumen of the vessel, transmission shaft1770, and balloon1810coupled thereto are distally advanced such that balloon1810exits from a distalmost opening of distal guiding component1732and is positioned within the lumen of the vessel as shown inFIG. 25. While being distally advanced or extended into position, balloon1810remains in its deflated or delivery configuration. When it is desired to distally advance or extend balloon1810, actuator or slider1768of handle1722is distally advanced such that the actuator pushes or distally advances transmission shaft1770as described above.

Next, balloon1810is inflated within the lumen of the vessel to an inflated or expanded configuration as shown inFIG. 26. More particularly, a source of inflation fluid is connected to the inflation port of hub1714so that balloon1810may be inflated as is known to one of ordinary skill in the art. In an embodiment hereof, the inflation fluid may be saline. In another embodiment hereof, the inflation fluid may be a contrast fluid to assist in visualization of balloon1810in situ. When inflated, balloon1810radially expands and extends away from the elongated body of the suturing device. Balloon1810may lie against an inside surface of the vessel wall Vwor be slightly spaced apart from the vessel wall, with the balloon outer surface positioned radially outward of the arteriotomy VA. As such, balloon1810provides apposition to vessel wall Vwduring the suturing procedure, thereby improving the structural integrity of vessel wall when needle pairs1756A,1756B are distally advanced to penetrate through the vessel wall and through inflated balloon1810as described in more detail below.

After balloon1810is inflated, needle pair1756A and suture pair1760A are distally advanced or extended to a deployed position in which needle pair1756A and suture pair1760A distally extend from a distal end of the elongated body of the suturing device and penetrate through the vessel wall and through inflated balloon1810. More particularly, as shown inFIG. 27, needle pair1756A and suture pair1760A are distally advanced until the respective actuation mechanism has reached a needle deployment position wherein the needles pierce through the vessel wall Vwand extend into balloon1810. Accordingly, in situ, needle pair1756A creates incisions or pathways within tissue around the arteriotomy during deployment. In one embodiment, as shown inFIG. 27, only needle pair1756A is first extended into a lumen of a vessel although, as in the embodiment described above with respect toFIGS. 3-13, it will be understood that both needle pairs may alternatively be extended or deployed into the vessel wall at the same time. Although not visible in the view ofFIG. 27, suture pair1760A extending within and carried with needle pair1756A is similarly distally advanced concurrently with needle pair1756A. In order to extend needle pair1756A and suture pair1760A to the position shown inFIG. 27, actuator1766A on handle1722is distally advanced until the actuation mechanism associated therewith reaches a needle deployment position as described above with respect to actuator366A. As previously stated, balloon1810is formed from a compliant material that is self-sealing such that the material seals around the needles when the needles penetrate into the inflated balloon. Thus, the insertion and removal of needles through the balloon material does not affect the operation, i.e., the inflation and deflation, of the balloon.

First ends1762A of suture pair1760A are then deployed out of or beyond distal ends1758of needle pair1756A as shown inFIG. 28. In order to extend or deploy suture pair1760A out of needle pair1756A, actuator1766A on handle1722is further distally advanced until the actuation mechanism associated therewith reaches a suture deployment position as described with respect to actuator366A above. As such, suture pair1760A is distally advanced relative to needle pair1756A by continued movement of actuator1766A. Although the distal advancement of actuator1766A is described in two sequential method steps withinFIGS. 27 and 28, it will be understood by those of ordinary skill in the art that such steps are performed by a single user action, i.e., distal advancement of actuator1766A.

After distal portions of suture pair1760A are extended or deployed beyond needle pair1756A, needle pair1756A is retracted as shown inFIG. 29, thereby leaving only the suture ends extending through the vessel wall and within an interior volume of inflated balloon1810. Needle pair1756A is retracted and suture pair1760A remains extended or deployed via operation of actuator1766A, as described with respect to actuator366A above.

As previously mentioned with respect toFIG. 27, it may be desirable to extend only a single needle pair at a time into a lumen of a vessel if the vessel is of a relatively smaller size. If only a single needle pair and corresponding suture pair has been deployed into the lumen of the vessel, the remaining needle pair1768B and first ends1762B of suture pair1760B are subsequently extended into the lumen of the vessel via actuator1766B as shown inFIG. 30by following the method steps described above with respect to actuator1766A. Alternatively, suture pair1760B may have been extended into the lumen of the vessel via actuator17668before or concurrently with suture pair1760A.

After respective ends of suture pairs1760A,1760B all extend into the lumen of the vessel and both needle pairs1756A,1756B have been retracted into elongated body1724of the suturing device, balloon1810is deflated to thereby capture the four extended suture ends into the balloon as shown inFIG. 31. More particularly, in order to capture the extended suture ends, balloon1810deflates and holes formed by the retracted needle pairs compress over or around the sutures. In one embodiment hereof in which balloon1810is a pre-formed or pre-blown balloon, a vacuum (not shown) may be applied to hub1714in order to remove the inflation fluid from the interior of balloon1810and deflate balloon1810, to as would be understood by one of ordinary skill in the art. When the vacuum is applied and the balloon deflates, the suture ends are compacted, packed, or otherwise clamped within the compressed interior volume of the balloon. In another embodiment hereof in which balloon1810is not a pre-formed or pre-blown balloon, the use of a vacuum to deflate balloon1810may not be required as described in more detail above. If a vacuum is not applied to deflate the balloon, the inflation fluid leaks out of the holes formed by needle pairs1756A,1756B as the balloon reverts or returns to its deflated or delivery configuration.

Once balloon1810is deflated with the suture ends captured therein, transmission shaft1770and balloon1810are proximally retracted until balloon1810is positioned within distal guiding component1732and/or elongated body1724of the suturing device as shown inFIG. 32, thereby pulling the captured first ends of the sutures into the suturing device. In order to proximally retract deflated balloon1810, actuator or slider1768of handle1722is proximally retracted such that the actuator pulls or proximally retracts transmission shaft1770as described above. When balloon1810is disposed within the elongated body of the suturing device, suture pairs1760A,1760B extend out of ports1736of distal guiding component1732, through tissue around the arteriotomy VAvia the pathways or incisions created by needle pairs1756A,1756B, and then the ends of suture pairs1760A,1760B are captured within distal portion1735of distal guiding component1732as shown inFIG. 32. The friction between deflated balloon1810and the inner surface of the distal guiding component1732secures or locks the ends of the sutures within the distal guiding component. In addition, when transmission shaft1770is retracted, tapered distal tip or nosecone1746is adjacent to or abuts against the distalmost end of distal guiding component1732to operate as a plug or stop that tightly secures the ends of the sutures within the distal guiding component. At this point in the method of use, suturing device1720having the captured suture ends therein is retracted until it is withdrawn from a patient so that a clinician gains access to the second or non-captured suture ends in the same manner as described above with respect to suturing device320. Once a clinician has gained access to the second suture ends, at least one surgical knot may be tied or formed between the respective second ends of each suture pair to form two elongated sutures that may be manipulated to close or substantially close the arteriotomy VAin the same manner as described above with respect toFIGS. 12-13and suturing device320.

In another embodiment hereof, the suturing device may include an expandable suture capture or snare component as an alternative for capturing the ends of the suture(s) beyond the boundaries of the arteriotomy. An expandable suture capture or snare component provides a relatively larger target area or zone for placement of the needles of the suturing device and, if desired, may be configured to provide apposition to the inner vessel wall during the suturing procedure, thereby improving the structural integrity of the vessel wall for the needles to puncture or penetrate there through. For example, a suturing device3320having a distal guiding component3332of an elongated body3324, a transmission shaft3370, an inner shaft3340, and expandable suture capture component3308is illustrated inFIGS. 33-34, with expandable suture capture component3308in a delivery or compressed configuration inFIG. 33and in a deployed or expanded configuration inFIG. 34. Only a distal portion of suturing device3320is shown inFIGS. 33-34, but it will be understood that by those of ordinary skill in the art that transmission shaft3370, inner shaft3340, and expandable suture capture component3308may replace transmission shaft1770and inflatable balloon1810of suturing device1720. A proximal end3309of expandable suture capture component3308is coupled to a distal end3311of a transmission shaft3370. Proximal end3309of expandable suture capture component3308may be spot welded, laser welded or secured using a bonding sleeve or adhesive to transmission shaft3370as would be apparent to one skilled in the relevant art. Inner shaft3340having a tapered distal tip3346coupled to a distal end thereof extends through transmission shaft3370and expandable suture capture component3308.

Expandable suture capture component3308is formed from a self-expanding material meaning it has a mechanical memory to return to the expanded or deployed configuration ofFIG. 34. Mechanical memory may be imparted to expandable suture capture component3308by thermal treatment to achieve a spring temper in stainless steel, for example, or to set a shape memory in a susceptible metal alloy, such as Nitinol. In the delivery or compressed configuration, expandable suture capture component3308is a relatively straight cylindrical or tubular structure disposed within distal guiding component3332and/or elongated body3324. The delivery or compressed configuration provides expandable suture capture component3308with a minimized delivery profile such that suturing device3320may be advanced to the target site. When it is desired to deploy expandable suture capture component3308, expandable suture capture component3308is distally advanced until it is no longer disposed within distal guiding component3332and/or elongated body3324. Once expandable suture capture component3308is no longer constrained, it assumes the deployed or expanded configuration ofFIG. 34and radially expands and extends away from distal guiding component3332and/or elongated body3324. An expanded or deployed outer diameter of expandable suture capture component3308may vary according to application. In one embodiment, the expanded or deployed outer diameter of expandable suture capture component3308is predetermined to be smaller than an inner diameter of the target vessel, i.e., a diameter of the vessel lumen. In another embodiment, the expanded or deployed outer diameter of expandable suture capture component3308is predetermined to be equal to or slightly greater than the inner diameter of the target vessel. Stated another way, the expanded or deployed outer diameter of expandable suture capture component3308is predetermined to be over-sized with respect to the inner diameter of the target vessel such that when deployed, radially expandable suture capture component3308slightly over-expands the vessel and provides apposition to the inner vessel wall during the suturing procedure, thereby improving the structural integrity of the vessel wall for the needles to puncture or penetrate there through.

Expandable suture capture component3308includes a tubular braided or mesh structure3306that is expandable within a vessel at a treatment site of an arteriotomy. Open spaces3307in braided or mesh tubular structure3306allow blood or other fluid to flow there-through, such that the blood vessel is not blocked or occluded. In an embodiment, expandable suture capture component3308is a tubular braided structure constructed from a plurality of self-expanding metallic wires or filaments woven together to form a tubular or cylindrical structure. In another embodiment, expandable suture capture component3308may be constructed from a stamped metallic mesh of self-expanding material. In an embodiment hereof, the mesh pore size is 1000 microns. However, with respect to a minimum mesh pore size, the only requirement is that the mesh pore size may allow a needle to pass there-through. Similarly, with respect to a maximum pore size, the only requirement is that the mesh pore size captures a suture therein when collapsed. Thus, the mesh pore size can vary for example from 50 to 5000 microns. In addition to the size of open spaces3307or the mesh pore size, the flexibility and/or strength of expandable suture capture component3308may be tailored by controlling the diameter or thickness of the wire utilized in braided or mesh tubular structure3306or the thickness of the stamped metallic mesh, respectively. In general, smaller diameters and thicknesses result in a more flexible expandable suture capture component3308that conforms and bends to the native anatomy while larger diameters and thicknesses result in a stronger, stiffer expandable suture capture component3308that more precisely retains the expanded or deployed configuration in situ. In addition, pics per inch, or the number of winds in each braid per inch thereof, may be varied to tailor the characteristics of expandable suture capture component3308. In an embodiment hereof, increasing the height and decreasing the width of the number of winds in each braid may more effectively capture or snare the sutures extending therein when expandable suture capture component3308is collapsed as described in more detail herein. The deployed configuration of expandable suture capture component3308is cylindrical. However, the expandable suture capture component may have other deployed configurations that are operable to capture suture ends. For example,FIG. 35illustrates an expandable suture capture component3508having a cone-shaped deployed or expanded configuration andFIG. 36illustrates an expandable suture capture component3608having a disc-shaped deployed or expanded configuration. In addition,FIG. 36Aillustrates an expandable suture capture component3608A having a disc-shaped deployed or expanded configuration that is angled with respect to the longitudinal axis of the suturing device. More particularly, the suturing device may be introduced into a vessel having a vessel wall VW at an acute angle ⊖. In one embodiment, acute angle ⊖ is between 30 and 45 degrees but may range between 30 and 89 degrees. When deployed or expanded, disc-shaped expandable suture capture component3608A is angled with respect to the suturing device to compensate or accommodate for the angled introduction into the vessel and permit disc-shaped expandable suture capture component3608A to lie substantially flat against or parallel to the vessel wall VW of the vessel. As such, when deployed, a longitudinal axis LAMof disc-shaped expandable suture capture component3608A forms acute angle ⊖ with a longitudinal axis LADof the suturing device. Other deployed configurations are suitable for use herein, such as but not limited to a spherical or ellipsoidal deployed configuration.

FIGS. 37-38illustrate another embodiment of an expandable suture capture component for capturing the ends of the suture(s) beyond the boundaries of the arteriotomy. A suturing device3720having a distal guiding component3732of an elongated body3724, a transmission shaft3770, an inner shaft3740, and expandable suture capture component3708is illustrated inFIGS. 37-38, with expandable suture capture component3708in a delivery or compressed configuration inFIG. 37and in a deployed or expanded configuration inFIG. 38. Inner shaft3740having a tapered distal tip3746coupled to a distal end thereof extends through transmission shaft3770and expandable suture capture component3708.

Similar to expandable suture capture component3308, expandable suture capture component3708is formed from a self-expanding material meaning it has a mechanical memory to return to the expanded or deployed configuration ofFIG. 38. However, in this embodiment, expandable suture capture component3708includes a plurality of overlapping or overlaying loops3704. In the delivery or compressed configuration, loops3704of expandable suture capture component3708are compressed together and disposed within distal guiding component3732and/or elongated body3724. When it is desired to deploy expandable suture capture component3708, expandable suture capture component3708is distally advanced until it is no longer disposed within distal guiding component3732and/or elongated body3724. Once expandable suture capture component3708is no longer constrained, it assumes the deployed or expanded configuration ofFIG. 38and the plurality of loops3704radially expand and extend away from distal guiding component3732and/or elongated body3824.

The method for utilizing expandable suture capture components3308,3708for capturing the ends of the suture(s) beyond the boundaries of the arteriotomy is similar to the method for utilizing inflatable balloon1810described with respect toFIGS. 24-32. More particularly,FIGS. 39-45illustrate a method of using suturing device3320in order to position two sutures at an arteriotomy of a vessel wall of a vessel. Referring toFIG. 39, suturing device3320is shown advanced to a position in which a distal portion thereof is positioned through a target arteriotomy VAsuch that distal tip3346is disposed within a lumen of the vessel. Suturing device3320is in a delivery configuration, in which expandable suture capture component3308is in a delivery configuration and disposed within the elongated body of the suturing device. In addition, needle pairs3356A,3356B and suture pairs3360A,3360B are in a loaded position as described above with respect to previous embodiments. Similar to distal guiding component332, distal guiding component3332includes a stepped or tapered region which creates an abutment surface3334that contacts the vessel wall, thereby notifying the user that the suturing device is in place within the arteriotomy VAas desired.

Once the distal portion of distal guiding component3332is positioned through the arteriotomy VAof the vessel to reside within the lumen of the vessel, transmission shaft3370and expandable suture capture component3308coupled thereto are distally advanced or extended into the lumen of the vessel. When expandable suture capture component3308is released from distal guiding component3332, it self-expands to its deployed configuration in which the expandable suture capture component radially expands and extends away from the elongated body as shown inFIG. 40. Expanded suture capture component3308may lie against an inside surface of the vessel wall Vwor be slightly spaced apart from the vessel wall, with the component's outer surface positioned radially outward of the arteriotomy VA. As such, expandable suture capture component3308provides apposition to vessel wall Vwduring the suturing procedure, thereby improving the structural integrity of vessel wall when needle pairs3356A,3356B are distally advanced to penetrate through the vessel wall and through expanded suture capture component3308as described in more detail below.

After expandable suture capture component3308is deployed or expanded, needle pair3356A and suture pair3360A are distally advanced or extended to a deployed position in which needle pair3356A and suture pair3360A distally extend from a distal end of the elongated body of the suturing device and penetrate through the vessel wall and through expanded suture capture component3308. More particularly, as shown inFIG. 41, needle pair3356A and suture pair3360A are distally advanced until the respective actuation mechanism has reached a needle deployment position wherein the needles pierce through the vessel wall Vwand extend into the open spaces of the braided or mesh tubular structure of expanded suture capture component3308. Accordingly, in situ, needle pair3356A creates incisions or pathways within tissue around the arteriotomy during deployment. In one embodiment, as shown inFIG. 41, only needle pair3356A is first extended into a lumen of a vessel although, as in the embodiment described above with respect toFIGS. 3-13, it will be understood that both needle pairs may alternatively be extended or deployed into the vessel wall at the same time. However, in this embodiment, unlike previous embodiments described herein, non-simultaneous deployment of the needle pairs is not required to accommodate smaller vessel sizes since expandable suture capture component3308expands to its expanded or deployed configuration within the vessel lumen and accommodates a range of vessel sizes. Although not visible in the view ofFIG. 41, suture pair3360A extending within and carried with needle pair3356A is similarly distally advanced concurrently with needle pair3356A.

First ends3362A of suture pair3360A are then deployed out of or beyond distal ends3358of needle pair3356A as shown inFIG. 42. In order to extend or deploy suture pair3360A out of needle pair3356A, the actuator or slider associated therewith is further distally advanced until it reaches a suture deployment position as described with respect to actuator366A above. As such, suture pair3360A is distally advanced relative to needle pair3356A by continued movement of the actuator associated therewith.

After distal portions of suture pair3360A are extended or deployed beyond needle pair3356A, needle pair3356A is retracted as shown inFIG. 43, thereby leaving only the suture ends extending through the vessel wall and within an interior volume of expanded suture capture component3308. Needle pair3356A is retracted and suture pair3360A remains extended or deployed via operation of the actuator or slider associated therewith, as described with respect to actuator366A above.

As previously mentioned with respect toFIG. 41, it may be desirable to extend only a single needle pair at a time into a lumen of a vessel if the vessel is of a relatively smaller size. If only a single needle pair and corresponding suture pair has been deployed into the lumen of the vessel, the remaining needle pair3368B and first ends3362B of suture pair3360B are subsequently extended into the lumen of the vessel via the actuator or slider associated therewith as shown inFIG. 44by following the method steps described above for needle pair3368A and suture pair3360A. Alternatively, suture pair3360B may have been extended into the lumen of the vessel via the actuator or slider associated therewith before or concurrently with suture pair3360A.

After respective ends of suture pairs3360A,3360B all extend into the lumen of the vessel and both needle pairs3356A,3356B have been retracted into elongated body3324of the suturing device, transmission shaft3370and expandable suture capture component3308coupled thereto are proximally retracted back into distal guiding component3332and/or elongated body3324of the suturing device, thereby collapsing the expandable suture capture component to the compressed configuration and pulling the four extended suture ends into the elongated body of the suturing device as shown inFIG. 45. More particularly, in order to capture the extended suture ends, the suture ends are ensnared or trapped within the compressed interior volume of suture capture component3308when the suture capture component is pulled into the elongated body of the suturing device. When suture capture component3308is disposed within the elongated body of the suturing device, suture pairs3360A,3360B extend out of ports3336of distal guiding component3332, through tissue around the arteriotomy VAvia the pathways or incisions created by needle pairs3356A,3356B, and then the ends of suture pairs3360A,3360B are captured within distal guiding component3332. The friction between compressed suture capture component3308and the inner surface of the distal guiding component3332secures or anchors the ends of the sutures within the distal guiding component. In addition, tapered distal tip or nosecone3346is adjacent to or abuts against the distalmost end of distal guiding component3332to operate as a plug or stop that tightly secures the ends of the sutures within the distal guiding component. At this point in the method of use, suturing device3320having the captured suture ends therein is retracted until it is withdrawn from a patient so that a clinician gains access to the second or non-captured suture ends in the same manner as described above with respect to suturing device320. Once a clinician has gained access to the second suture ends, at least one surgical knot may be tied or formed between the respective second ends of each suture pair to form two elongated sutures that may be manipulated to close or substantially close the arteriotomy VAin the same manner as described above with respect toFIGS. 12-13and suturing device320.

The expandable suture capture components described herein self-expand to their deployed or expanded configurations upon release or exit from the suturing device. However, it will be understood by one of ordinary skill in the art that deployment or expansion of the expandable suture capture components may be accomplished via other mechanisms. For example, expandable suture capture components may be coupled to both the transmission shaft and the inner or guidewire shaft, and expansion thereof may be accomplished via relative motion between the shafts. More particularly, a transmission shaft4670, an inner shaft4640, and expandable suture capture component4608is illustrated inFIGS. 46-47, with expandable suture capture component4608in a delivery or collapsed configuration inFIG. 46and in a deployed or expanded configuration inFIG. 47. Only a distal portion of transmission shaft4670and inner shaft4640are shown inFIGS. 46-47, but it will be understood that by those of ordinary skill in the art that transmission shaft4670, inner shaft4640, and expandable suture capture component4608may replace transmission shaft3370, inner shaft3340, and expandable suture capture component3308of suturing device3320. A proximal end4609of expandable suture capture component4608is coupled to a distal end4611of transmission shaft4670. Inner shaft4640having a tapered distal tip4646coupled to a distal end thereof extends through transmission shaft4670and expandable suture capture component4608. A distal end4605of expandable suture capture component4608is coupled to inner shaft4640, proximal to tapered distal tip4646. Expandable suture capture component4608may be spot welded, laser welded or secured using a bonding sleeve or adhesive to transmission shaft4670and inner shaft4640as would be apparent to one skilled in the relevant art.

Expandable suture capture component4608is expanded and contracted by relative movement between inner shaft4640and transmission shaft4670. While inner shaft4640remains stationary or fixed, transmission shaft4670and expandable suture capture component4608coupled thereto are distally advanced over inner shaft4640. When transmission shaft4670is distally advanced, the attachment point or bond between expandable suture capture component4608and inner shaft4640remains fixed such that expandable suture capture component4608radially expands to the bulbous or spherical deployed configuration shown inFIG. 47. Similarly, when transmission shaft4670and expandable suture capture component4608coupled thereto are proximally retracted over inner shaft4640, expandable suture capture component4608collapses or straightens back to the delivery configuration ofFIG. 46. Although described with transmission shaft4670being movable relative to inner shaft4640to expand expandable suture capture component4608, it should be apparent to one of ordinary skill in the art that expandable suture capture component4608is expanded by shortening the distance between proximal and distal ends4609,4605thereof. Thus, in another embodiment, expandable suture capture component4608may be expanded by proximally retracting inner shaft4640while holding transmission shaft4670stationary. In addition, expandable suture capture component4608may be expanded by a combination of distally advancing transmission shaft4670and proximally retracting inner shaft4640.

When expansion of expandable suture capture component4608is accomplished via relative motion between the transmission shaft and inner shaft, the expandable suture capture component may be constructed from polymeric materials that are less traumatic than the metallic self-expanding materials that are utilized for expandable suture capture component3308. In addition, when expansion of expandable suture capture component4608is accomplished via relative motion between the transmission shaft and inner shaft, the outer expanded or deployed diameter of the expandable suture capture component may be selectively controlled or varied in situ. For example, expandable suture capture component4608may be expanded to be selectively over-sized with respect to the inner diameter of the target vessel such that when deployed, radially expandable suture capture component4608slightly over-expands the vessel and provides apposition to the inner vessel wall during the suturing procedure, thereby improving the structural integrity of the vessel wall for the needles to puncture or penetrate there through.

FIG. 48illustrates another embodiment of an expandable suture capture component4808having dual mesh layers4803A,4803B. More particularly, a transmission shaft4870, an inner shaft4840, and expandable suture capture component4808is illustrated inFIG. 48, with expandable suture capture component4808in a deployed or expanded configuration inFIG. 48. Only a distal portion of transmission shaft4870and inner shaft4840are shown inFIG. 48, but it will be understood that by those of ordinary skill in the art that transmission shaft4870, inner shaft4840, and expandable suture capture component4808may replace transmission shaft3370, inner shaft3340, and expandable suture capture component3308of suturing device3320. First or outer layer4803A of expandable suture capture component4808is coupled to a distal end4811of transmission shaft4870. Inner shaft4840extends through transmission shaft4870and second or inner layer4803B of expandable suture capture component4808is coupled to a distal end4845of inner shaft4840. Each layer4803A,4803B is formed from a self-expanding material, and each layer may be spot welded, laser welded or secured using a bonding sleeve or adhesive to transmission shaft4870and inner shaft4840as would be apparent to one skilled in the relevant art.

Transmission shaft4870and inner shaft4840are independently or separately controlled at a proximal end of the suturing device (not shown) and, as such, expansion or deployment of outer and inner layers4803A,4803B of expandable suture capture component4808are independently or separately controlled by operation of its respective shaft, i.e., operation of transmission shaft4870controls expansion or deployment of outer layer4803A coupled thereto and operation of inner shaft4840controls expansion or deployment of inner layer4803B coupled thereto. Independent control of each layer may allow a user to better secure the suture ends within expandable suture capture component4808. For example, after a suture is positioned through both layers of expandable suture capture component4808, a user may selectively contract inner layer4803B in order to bend the suture ends with respect to outer layer4803A, thereby improving retention of the suture end within expandable suture capture component4808. The deployed configuration of dual layer expandable suture capture component4808is exemplary and other deployed configurations may be utilized. For example,FIG. 48Aillustrates a dual layer expandable suture capture component4808A having an open-ended disc-shaped deployed or expanded configuration andFIG. 48Billustrates a dual layer expandable suture capture component4808B having an open-ended cone-shaped deployed or expanded configuration.