Patent Description:
Embodiments of the present invention relate to suturing devices, Some embodiments relate to suturing devices for suturing an anatomic structure, such as a heart.

Health practitioners frequently use sutures to close various openings such as cuts, punctures, and incisions in various places in the human body. Generally, sutures are convenient to use and function properly to hold openings in biological tissue closed thereby aiding in blood clotting, healing, and prevention of scarring.

There are some circumstances under which it is not feasible to use conventional sutures and suturing methods to close an opening. Additionally, there are some circumstances under which the use of conventional sutures and suturing methods require invasive procedures that subject a patient to risk of infection, delays in recovery, increases in pain, and other complications. From document <CIT>, a suturing device according to the preamble of claim <NUM> is known.

The present invention concerns a suturing device for suturing an opening in a heart wall, as defined in the independent claim <NUM>. Embodiments of suturing devices used to suture closed openings into a biological structure while maintaining or substantially maintaining haemostasis are described herein. The suturing devices and methods, wherein the methods do not form embodiments of the present invention, can also be used to place sutures prior to a surgical procedure and to prepare access for the procedure while maintaining or substantially maintaining haemostasis. The placed sutures can then be used to tighten an opening while any devices or tools are withdrawn, closing the opening while the final device or tool leaves the opening such that the opening is never without a device or tool inside it during the course of the procedure.

In the embodiments described herein, the disclosed devices are used to place sutures to close an opening into a heart, although they are not limited to applications within a heart. The heart can be accessed through a sternotomy or limited thoracotomy, or alternatively the device can pass through a trocar or other element into the thoracic cavity and then be led toward the opening in the heart, typically by following a guide wire. In some embodiments, the opening is a puncture made at or near the apex of the heart. The puncture can also be made at other areas of the heart. In some embodiments, suturing devices and methods disclosed herein can be used to minimize the collection of fluid between the heart and the pericardial sac that surrounds the heart.

The above-mentioned and other features disclosed herein are described below with reference to the drawings of specific embodiments. The illustrated embodiments are intended for illustration, but not limitatior. An embodiment of the invention is illustrated in <FIG>, while the devices of <FIG> do not represent embodiments of the present invention. The drawings contain the following figures:.

Embodiments of suturing devices used to suture closed openings into a biological structure while maintaining or substantially maintaining haemostasis are described herein. The suturing devices and methods can also be used to place sutures prior to a surgical procedure and to prepare access for the procedure while maintaining or substantially maintaining haemostasis. The placed sutures can then be used to tighten an opening while any devices or tools are withdrawn, closing the opening while the final device or tool leaves the opening such that the opening is never without a device or tool inside it during the course of the procedure.

In the embodiments described herein, the disclosed devices are used to place sutures to close an opening into a heart, although they are not limited to applications within a heart. In some embodiments, the opening is a puncture made at or near the apex of the heart. The puncture can also be made at other areas of the heart. The heart can be accessed through a sternotomy or limited thoracotomy, or alternatively the device can pass through a trocar or other element into the thoracic cavity and then be led toward the puncture in the heart, typically by following a guide wire.

A heart is surrounded by a pericardial sac (or pericardium), and in order to puncture into the heart the pericardium must also be punctured or cut and moved out of the way. Accessing the heart in this manner presents a risk that blood may leak through the opening and collect between the pericardium and the heart wall. This blood can put pressure against the heart and in some cases can cause a cardiac tamponade. In some embodiments described herein, the device can be used to limit the risk of blood collecting between the pericardium and the heart wall. This can be achieved by creating a space outside of the heart where blood can collect without running between the pericardium and the heart, and by creating a flow path from the space and into the device. In some embodiments, a negative pressure can be used to draw blood from the space and into the device.

In some embodiments described herein, the device can be used to limit the risk of blood collecting between the pericardium and the heart wall by suturing the opening closed with sutures that pass through the heart wall but not through the pericardium. The pericardium can thereby remain loose around the heart wall, blood can more easily drain out, and the pericardium can be sutured closed after blood has drained out.

In some embodiments, the suturing devices can be used to close or reduce a variety of other tissue openings, lumens, hollow organs or natural or surgically created passageways in the body. In some embodiments, the suturing devices can be used to suture prosthetics, synthetic materials, or implantable devices in the body. For example, the devices can be used to suture a pledget within the body.

Further details of suturing devices and methods that may be used to suture an opening in a heart can be found in <CIT>.

<FIG> and <FIG> illustrate perspective views of one embodiment of a suturing device <NUM>. <FIG> is an embodiment of the entire device, and <FIG> illustrates a section of a distal assembly <NUM> of the device. The device can be used to insert sutures through the outer wall of a heart in anticipation of a surgical procedure within the heart, while maintaining haemostasis. The device has a proximal and a distal end. At the distal end, the device can have a guide wire lumen <NUM>, which can allow the device to follow a guide wire to a desired position. At the proximal end, the suturing device can comprise one or more handles <NUM> with various mechanisms that can be used to control the elements of the distal assembly. Further details regarding handles and associated components, including actuator rods, are provided in <CIT>.

The device can comprise an elongate body <NUM> which can include a plurality of suture arms <NUM>. The suture arms <NUM> can move from a retracted position, as illustrated, in which the suture arms are at least partially within the elongate body <NUM>, to an extended position, described and illustrated below in which the suture arms extend outward from the elongate body. The suture arms can also be positioned at varying angles from each other around the circumference of the elongate body. The illustrated embodiment has four suture arms <NUM> spaced <NUM> degrees apart. In some embodiments, there may be more suture arms spaced varying degrees apart. In some embodiments, there may be just one suture arm, which can be rotated about an opening in the heart to place multiple sutures around the opening. For purposes of closing the opening, it can be desirable to have an even number of suture arms, such as <NUM>, <NUM>, <NUM>, or <NUM>, each suture arm part of a pair with another suture arm spaced <NUM> degrees apart around the circumference of the elongate body. In some embodiments, the device can also have an odd number of suture arms. If just a single suture arm is used to position multiple sutures around the opening, the sutures can be positioned in pairs spaced <NUM> degrees apart around the opening.

The suture arms <NUM> can comprise one or more suture mounts or clasps <NUM> at a distal end. The suture clasps <NUM> can be adapted to releasably retain a suture portion <NUM>. In some embodiments, the suture clasps can releasably retain a suture portion <NUM> while the suture arms <NUM> are in the retracted position and in the extended position. In some embodiments, as illustrated, the suture clasps may not retain a suture portion until the suture arms move toward the extended position. In some embodiments, a suture end may be retained in the suture clasps. In some embodiments, the suture clasps may retain a portion of suture that is not the suture end.

When the device is assembled, it can be pre-loaded with a first sheath <NUM> (for example an <NUM> french sheath) that surrounds at least a portion of the elongate body and a second sheath <NUM> surrounding at least a portion of the first sheath <NUM>. In some embodiments, as illustrated, a distal end of the first sheath <NUM> can extend to a position just proximal to the suture arms, thereby allowing the suture arms to move into the extended position or into the retracted position. The suture portions <NUM> can run outside of the first sheath <NUM> and through the second sheath <NUM> to a position proximal to at least the second sheath <NUM>. The second sheath can help confine the suture portions such that they do not get tangled or otherwise interfere with a procedure, described below. In some embodiments, the second sheath <NUM> is shorter than first sheath <NUM>. In some embodiments, the second sheath <NUM> can be a peel-away sheath that can be removed from around the first sheath and around the suturing device.

The device can also include suture catch mechanisms (referred to herein as needles), described below, that can retrieve sections of suture from the suture clasps <NUM>. In some embodiments, the device can include one or more needle exit channels <NUM>, from which the needles can exit an interior of the elongate body <NUM> in order to reach the suture clasps <NUM>. In some embodiments, there can be an equal number of needle exit channels <NUM> as there are suture arms <NUM>, and the needle exit channels can be configured to align with a corresponding suture arm.

<FIG> and <FIG> illustrate the suture arms <NUM> in more detail. <FIG> is a perspective view of a portion of the device with certain external components not illustrated in order to improve visibility. The device can have a suture arm driver <NUM>, to which the suture arms <NUM> can rotatably attach at a first end thereof. The suture arms can be free at a second end opposite the first end, allowing the second end to swing outward such that the arms can move from the retracted position to the extended position, or to swing inward such that the arms can move from the extended position to the retracted position.

As illustrated, the suture arms <NUM> can rotate about a proximal end of the suture arm. In some embodiments, the suture arms can slide or move in other ways from the retracted to the extended position, or from the extended to the retracted position. In the illustrated embodiment, as the suture arms <NUM> rotate from the extended to the retracted position, the suture clasps <NUM> will move toward a distal end of the suturing device. In some embodiments, the suture arms can be configured such that the suture clasp moves distally as the arms rotate from the retracted to the extended position. In some embodiments, the suture arms can rotate about a distal end of the suture arm.

In some embodiments, as illustrated in <FIG>, the suture arm driver <NUM> can translate along a central shaft <NUM>. As it translates it can move the suture arms <NUM> with it. In some embodiments, the suture arm driver can translate far enough such that the suture arms can contact a section <NUM> of the elongate body <NUM>, as illustrated. In some embodiments, the section <NUM> of the elongate body contacted by the suture arms can be angled. The ends of the suture arms opposite the suture arm driver can also have an angled surface <NUM>, and as the suture arm driver moves farther toward the section <NUM> the suture arms <NUM> will be pushed outward toward the extended position. To move the arms from the extended position to the retracted position, the suture arm driver <NUM> can translate along the central shaft <NUM> in the opposite direction, and the suture arms <NUM> can return to the retracted position.

<FIG> is a perspective view of a section of the distal assembly <NUM> with certain external components not illustrated in order to improve visibility. <FIG> illustrates one embodiment of the suture arms <NUM> in an extended position. In some embodiments, the suture arms <NUM> can be generally straight. In some embodiments, the suture arms <NUM> can extend from the elongate body at approximately <NUM> degrees. In some embodiments, the suture arms can extend from the elongate body at an angle less than <NUM> degrees or greater than <NUM> degrees. In some embodiments, the suture arms can have angled or curved segments, and can extend from the elongate body at a first angle and have other sections at other angles relative to the elongate body. In some embodiments, the suture clasps <NUM> can be on a section of the suture arms that is at an angle relative to the elongate body that is different from the first angle.

With continued reference to <FIG> and <FIG>, in some embodiments the suture arms <NUM> can each have a bumper <NUM>. The bumpers can be positioned such that they provide clearance for the suture arms to rotate to or from the extended position. Preferably, the bumpers <NUM> have a curved surface, but in some embodiments they can have flat sections. In some embodiments, the suture clasps <NUM> can have a beveled or tapered section <NUM> that is configured to receive a needle. The taper can help guide the needles into the suture clasps and toward a suture portion within a clasp. This can be beneficial if a needle has prolapsed slightly or otherwise deviated from a preferred alignment, such as an alignment with the center of a suture clasp <NUM>.

<FIG> is a perspective view of a section of the distal assembly <NUM> with certain external components not illustrated or made transparent in order to improve visibility. <FIG> illustrates two needles <NUM> instead of four for clarity, but as discussed above, in various embodiments the device can have a different number of needles. The needles are preferably located distal to the suture arms <NUM> and preferably point proximally toward the suture arms. In some embodiments, the needles can be located proximal to the suture arms and point distally toward the suture arms. The needles <NUM> can attach to a needle drive tube <NUM>, which can be positioned around the central shaft <NUM> and which can translate along the central shaft. In some embodiments, as illustrated, a collar <NUM> can be used to lock the needles <NUM> to the needle drive tube <NUM>.

<FIG> illustrates a cross sectional view of one embodiment where a collar <NUM> is used to lock the needles <NUM> to the needle drive tube <NUM>. The needles <NUM> can have a notch <NUM> adjacent one end, and the needle drive tube <NUM> can have a corresponding protrusion that can slot into the notch. The collar <NUM> can surround both the needles and the needle drive tube, locking them into their respective positions. In some embodiments, as illustrated, the needle drive tube <NUM> can be narrower where it receives the collar than in other locations of the needle drive tube. This can help seat the collar so that it does not slide further along the needle drive tube. In some embodiments, the needles can attach to the needle drive tube without a collar. Also visible in <FIG> is the central shaft <NUM> with a guide wire lumen <NUM>.

Returning to <FIG>, when the needles <NUM> and needle drive tube <NUM> translate along the central shaft <NUM>, they can also translate relative to an outer body <NUM>. In some embodiments, the outer body <NUM> can have channels <NUM> that can guide the needles within the outer body. The channels can help direct the needles and can also provide a measure of support to the needles to prevent them from prolapsing or buckling. In some embodiments, each needle can fit entirely within a respective channel. In some embodiments, each needle can fit partially or at least partially within a respective channel. Also visible in <FIG> is a distal sleeve <NUM>. present in some embodiments, which can help channel a guide wire into the central shaft <NUM>.

The needle drive tube <NUM> can move the needles toward or away from the suture arms <NUM>. As the drive tube moves the needles toward the suture arms <NUM> the needles will eventually reach the needle exit channels <NUM> (visible in <FIG>). The needle exit channels can be angled to direct the needles toward the suture arms <NUM>, and specifically the suture clasps <NUM>.

<FIG> is a transparent view of a portion of the distal assembly <NUM> when the needle drive tube (not visible in this figure) has moved the needles <NUM> through the needle exit channels <NUM> and out of the distal assembly. Only one needle is illustrated in <FIG> so that the shape of the needle exit channels <NUM> can be more easily seen, but the illustrated embodiment would have four needles. <FIG> illustrates a sectional view of the distal assembly <NUM>, taken along the line <NUM>-<NUM> visible in <FIG>. As illustrated in <FIG>, in some embodiments the needle exit channels <NUM> can extend radially outward along a line that passes through the longitudinal axis of the distal assembly. When a needle <NUM> is in a deployed position passing into a corresponding suture arm <NUM> and suture mount <NUM>, at least the portion of the needle external to the distal assembly can form a plane with the corresponding suture arm <NUM>. In some embodiments, the longitudinal axis of the distal assembly can lie on the plane formed by the needle and the corresponding suture arm. In some embodiments, the plane formed by at least the portion of the needle <NUM> external to the distal assembly <NUM> and the corresponding suture arm <NUM> can be parallel to and offset from the longitudinal axis of the distal assembly. In some embodiments, the longitudinal axis of the distal assembly can be angled relative to the plane formed by the needle and the corresponding suture arm.

<FIG> illustrates a cross-sectional view, similar to the view of <FIG>, of one embodiment of a distal assembly <NUM> with needle exit channels <NUM> that do not extend radially outward along a line that passes through the longitudinal axis of the distal assembly. Rather, the exit channels <NUM> can each have a longitudinal axis that is offset from a longitudinal axis of the distal assembly <NUM>. This arrangement can be used with embodiments in which the longitudinal axis of the distal assembly is either parallel to and offset from the plane formed by a needle and corresponding suture arm, as described above, or is angled relative to the plane.

<FIG> and <FIG> illustrate one embodiment in which the longitudinal axis of the distal assembly is angled relative to the plane formed by at least the portion of a needle <NUM> external to the distal assembly <NUM> and the corresponding suture arm <NUM>. <FIG> is a perspective view of a section of the distal assembly with various components removed for visibility. <FIG> is a top view of the section shown in <FIG>. As illustrated, the needle exit channels <NUM> can be arranged as in <FIG>, and the suture arms <NUM> can extend radially outward along a line passing through the longitudinal axis of the distal assembly. As illustrated in <FIG>, the needle exit channels <NUM> are spaced or offset from a plane defined by an extended suture arm and the longitudinal axis of the distal assembly, so that the needle <NUM> extends at an angle to this plane and intersects the plane at suture mount <NUM>. As above, in some embodiments the suture arms can be symmetrically spaced about the distal assembly <NUM>. In embodiments with four suture arms, as illustrated, they can be spaced <NUM> degrees apart from each other when extended.

In some embodiments, the suture arms can each have a longitudinal axis offset from the longitudinal axis of the distal assembly. In some embodiments, the offset for the suture arms can be the same as the offset for the needles, and the plane formed by a needle and corresponding suture arm can be parallel to and offset from the longitudinal axis of the distal assembly. In some embodiments, the needle exit channels can be arranged as in <FIG>, the suture arms can each have a longitudinal axis offset from the longitudinal axis of the distal assembly, and the longitudinal axis of the distal assembly can be angled relative to the plane formed by a needle and corresponding suture arm.

In some embodiments, the needles <NUM> can attach to a mounting plate <NUM> positioned around a central shaft <NUM> of the distal assembly. The mounting plate can have one or more cutouts <NUM>. In some embodiments, each needle can have a notch, as described above, and the needles can be positioned such that a notch interfaces with a cutout <NUM>. This can at least partially lock the needles in place, allowing relative movement between each needle and the mounting plate only along the length of the cutout in which the needle is positioned. In some embodiments, a retaining ring or collar <NUM> can be positioned around the plate to lock the needles into position within the cutouts. In some embodiments, cutouts can be sized to substantially prevent any needle movement.

<FIG> illustrates the needles <NUM> in a deployed position in which a distal tip of each needle is within a suture mount <NUM>. The mounting plate <NUM> can be configured to move along the length of the distal assembly, moving the needles with it. For example, the mounting plate can move away from the suture arms <NUM>, pulling the needles <NUM> with it. In some embodiments, moving away from the suture arms can be in the distal direction. In some embodiments, moving away from the suture arms can be in the proximal direction. When the mounting plate moves far enough, the needles can move to a retracted position in which they are entirely or substantially within the elongate body.

In some embodiments, needles <NUM> can have different configurations that can help prevent prolapse or buckling. For example, as illustrated in <FIG>, in some embodiments a needle <NUM> can include a first, proximal section <NUM> with a first diameter and a second, distal section <NUM> with a second diameter. In some embodiments, the second diameter can be sized for insertion into a suture clasp to receive a suture end. In some embodiments, the first diameter can be greater than the second diameter. The greater first diameter can help improve resistance of the needle to prolapse, buckling, or any other undesired movements. In some embodiments, the needle can transition from the first section to the second section between a needle exit channel <NUM> and a suture clasp <NUM>.

The suturing device can have a guide wire lumen, not illustrated, that can allow the suturing device to follow a guide wire <NUM> into a position within the heart. In a typical procedure, a hollow needle (delivered, for example, through a trocar into the thoracic cavity) can be used to puncture an opening at or near the apex of the heart and to feed a guide wire through the opening and into the heart. The suturing device can then follow the guide wire into the opening and into the heart. The suturing device can have a tapered end at the distal end of the elongate body <NUM>, as illustrated in <FIG>, and the taper can be configured such that the device is capable of following the guide wire through the opening formed by the needle, widening the opening as the device is advanced further into the heart. The device can then be used to place a plurality of sutures through the tissue of the heart near the opening, while maintaining or nearly maintaining haemostasis, as described below. The device can then be removed, leaving the sutures in place and the first sheath within the opening in the heart, thereby allowing other devices to be inserted through the sheath to perform a desired procedure within the heart. The sutures can then be used to tighten the opening closed after the desired procedure has been performed and while the sheath and/or device is being removed.

<FIG> illustrate one method of using the suturing device <NUM> to place sutures through tissue near an opening in the heart and to position a sheath through the opening to allow for entry of other devices, while maintaining or nearly maintaining haemostasis. As discussed above, the device <NUM> can follow a guide wire <NUM> through a puncture in or near the apex of a heart, the tapered end of the device widening the opening in the heart wall <NUM>, as the device enters further into the heart. The suture arms <NUM> can be moved into an extended position, as illustrated in <FIG>, which is a view of the device of <FIG> as it enters a heart. <FIG> show a cross sectional view of the heart, and only show the two arms <NUM> of the device that lie in the illustrated planes. Although the method illustrated in <FIG> can be performed with a device having only the two illustrated arms, the description of the method will be with reference to the device of <FIG>, which has four arms. Each suture arm <NUM> holds a separate suture <NUM>, so there are a total of four separate sutures when the device is positioned as in <FIG>.

With the suture arms in the extended position, the device can be further advanced into the heart until the suture arms press against tissue of the heart, as illustrated in <FIG>. Once in position at the base of the heart, needles <NUM> can fire and extend from a distal end of the elongate body <NUM>, through tissue of the heart, and into the suture clasps <NUM>, as illustrated in <FIG>. In some embodiments, the device can have a needle <NUM> that corresponds to each suture arm, a needle that corresponds to multiple suture arms, or multiple needles that correspond to a single suture arm. The needles can engage the sutures <NUM>, releasably positioned in the suture clasp, such that when the needles retract back into the elongate body they draw a portion of suture with them, as illustrated in <FIG>. In some embodiments, the needles can fire simultaneously, and in some embodiments they can fire sequentially.

Once the needles have fired and drawn sutures through tissue of the heart, the device can be withdrawn slightly from the heart in order to allow the suture arms to return to a retracted position, as illustrated in <FIG>. In embodiments where the distal ends of the suture arms move proximally as the suture arms rotate from an extended to a retracted position, it may not be necessary to withdraw the device prior to retracting the suture arms. Once the suture arms have been retracted, as illustrated in <FIG>, the sutures <NUM> will run from within the device, through the tissue of the heart, and to a proximal end of the device while passing beneath the second sheath <NUM> but over the first sheath <NUM>, as illustrated in <FIG>. The first sheath <NUM> can then be moved into the opening in the heart while the elongate body <NUM> is withdrawn, as illustrated in <FIG>. In some embodiments, the sheath can fully pass into the opening before the elongate body has begun to be withdrawn. In some embodiments, the elongate body can begin to be withdrawn before the sheath has entered the opening of the heart. Regardless of the order in which the motions occur, in order to maintain haemostasis either the sheath or the elongate body are preferably at least partially within the opening of the heart during the procedure. In <FIG>, the sheath has begun to be advanced into the opening of the heart while the elongate body has begun to be withdrawn.

In <FIG>, the first sheath <NUM> has been fully advanced into the opening of the heart and the elongate body has been withdrawn. The first sheath <NUM> can have a hemostatic valve (not illustrated) that can prevent extraneous bleed back, and in some embodiments the valve can be at a proximal end of the first sheath <NUM>. The suture ends that were within the elongate body now pass through the first sheath <NUM> and run to a proximal position outside of the patient where they can be manipulated, as illustrated in <FIG>. From the proximal position of those suture ends, the sutures run through the sheath and into the heart, through tissue of the heart, and back to the proximal position while remaining outside of the first sheath <NUM> and inside of the second sheath <NUM>. The second sheath <NUM> has been illustrated wider than in previous figures in order to improve visibility of sutures <NUM> running between the first and second sheaths. In some embodiments, the second sheath <NUM> can be wider or narrower in order to have a looser or tighter fit around the first sheath <NUM>, and the first sheath can be wider or narrower in order to have a looser or tighter fit around the elongate body.

In <FIG>, the second sheath <NUM> has been removed from around the first sheath <NUM> (e.g. by peeling it off), and the portions of the sutures <NUM> within the first sheath <NUM> are illustrated. <FIG> also illustrates the proximal end of the first sheath <NUM>, which can be extending through a trocar <NUM> positioned through the chest wall <NUM>. Each suture <NUM> has a free end at the proximal position outside of the patient that passes through the first sheath <NUM>, into the heart, through tissue of the heart, and back to the proximal position while remaining outside of the first sheath <NUM>. <FIG> only illustrates two separate sutures <NUM>, but the illustrated embodiment has two more sutures <NUM> (for a total of four) that pass through heart tissue in a plane substantially perpendicular to the illustrated plane. Thus, there are four suture ends that pass through the first sheath <NUM> and four suture ends that pass outside of the first sheath <NUM>. The four separate sutures arc shown schematically in <FIG>, discussed further below. The guide wire <NUM> also passes through the first sheath <NUM>, but it is not shown within the first sheath in <FIG> for the sake of clarity.

Suture ends that pass through the first sheath <NUM> can be secured together with a knot or other device. Further details regarding a device for joining sutures are provided in <CIT>. In some embodiments, suture ends that pass through the first sheath <NUM> can be secured together in pairs, each pair having suture ends that had been releasably attached to arms <NUM> spaced <NUM> degrees about the circumference of the elongate body <NUM> of the device <NUM>. By then pulling on one or more of the remaining free suture ends, the joined suture <NUM> can be pulled through the first sheath <NUM> and into the heart, as illustrated in <FIG> only shows one suture, but when the two pairs of suture ends that pass through the first sheath <NUM> have been secured together and pulled into the heart, a second suture would pass through the heart in the plane substantially perpendicular to the illustrated cross section.

In some embodiments, the point where a pair of suture ends has been joined together can be passed through the tissue of the heart and outside of the heart by pulling on one of the remaining free suture ends. In some embodiments, prior to joining the two suture ends that pass through the first sheath, a pledget can be slidably attached to a suture end, such as by threading a suture end through a hole in the pledget. After the two suture ends that pass through the first sheath have been secured together, the joined suture can be pulled through the tissue of the heart by one of the remaining free ends until the pledget contacts an inner surface of the heart wall, where it may remain. In some embodiments, prior to or after joining the two suture ends within the sheath, a pledget can be attached to a free suture end that passes outside of the first sheath <NUM>. With the two suture ends within the first sheath joined, the opposite free suture end can be pulled until the pledget contacts an outer surface of the heart, where it may remain.

<FIG> illustrate various methods and embodiments of closing an opening within a heart, including the use and placement of pledgets. The methods and embodiments described herein can also be used to close openings in other biological structures. Thus, although the ends of sutures are variously referred to herein as passing through or outside of the first sheath, such descriptions can also refer respectively to suture ends that pass through or outside of an opening in a heart or other biological structure.

In some embodiments, it can be useful to use a threader <NUM> to attach a pledget to a suture. <FIG> illustrates one embodiment of a threader, which can have a handle <NUM> and a section extending from the handle <NUM> to form a collapsible loop <NUM> at one end. In some embodiments, the loop can be made of wire. The loop <NUM> can be fed through a pledget <NUM>, as illustrated. Also as illustrated, the loop can be fed through the pledget in two locations, though in some embodiments it can be fed through only one or more than two locations. A free end of suture can then be fed through the loop and the loop can be pulled back through the pledget, bringing the suture with it. <FIG> illustrates a single suture <NUM> pulled through a pledget <NUM> in two locations. This can be done by arranging the threader and pledget as illustrated in <FIG>, or by using a threader to feed a suture through a first end of the pledget and then using the threader to feed the suture through the second end of the pledget.

In some embodiments, a threader <NUM> can have a first collapsible loop <NUM> and a second collapsible loop <NUM>, as illustrated in <FIG>. In some embodiments, each loop can be passed through separate locations of a pledget <NUM>, as illustrated. A separate suture can be fed through each loop and then pulled through the pledget, leading to the arrangement of <FIG>. In some embodiments, the arrangement of <FIG> can be achieved by using a threader with a single loop to separately pull a different suture through each end of the pledget. In some embodiments, a threader can have more than two collapsible loops.

<FIG> illustrates a schematic of a perspective view of a portion of a heart in which a suturing device has inserted four separate sutures through the tissue of the heart wall <NUM>. In some embodiments, this can be done with a suturing device that has four arms. As discussed above, a sheath, such as the first sheath <NUM>, can be positioned at least partially within the opening in the heart. A length of suture corresponding to each arm of the device can pass from outside of the heart, through tissue of the heart, and then through the sheath. For example, as illustrated, a first suture <NUM>, a second suture <NUM>, a third suture <NUM>, and a fourth suture <NUM> pass through the tissue of the heart. Each suture has a first end <NUM>', <NUM>', <NUM>', <NUM>' that passes through the sheath <NUM> and a respective second end <NUM>", <NUM>", <NUM>", <NUM>" that runs outside of the sheath. Pledgets can then be attached to various suture ends according to any method described above.

<FIG> and <FIG> illustrate two ways in which pledgets (internal pledgets) can be attached to the first suture ends, each way yielding a different result when the pledgets are then pulled into the heart. <FIG> illustrates an embodiment where adjacent suture ends that run through the sheath <NUM> are fed through opposite ends of the same pledget <NUM>. Thus, for example, the first end <NUM>' of the first suture <NUM> can be fed through a first end of a pledget <NUM> while the first end <NUM>' of the third suture <NUM> can be fed through a second end of the pledget <NUM>. Similarly, the first end <NUM>' of the second suture <NUM> can be fed through a first end of a second pledget <NUM> while the first end <NUM>' of the fourth suture <NUM> can be fed through a second end of the second pledget <NUM>.

<FIG> illustrates an embodiment where opposite suture ends that run through the sheath <NUM> are fed through opposite ends of the same pledget <NUM>. Thus, for example, the first end <NUM>' of the first suture <NUM> can be fed through a first end of a pledget <NUM> while the first end <NUM>' of the second suture <NUM> can be fed through a second end of the pledget <NUM>. Similarly, the first end <NUM>' of the third suture <NUM> can be fed through a first end of a second pledget <NUM> while the first end <NUM>' of the fourth suture <NUM> can be fed through a second end of the second pledget <NUM>. In some embodiments, other arrangements of attaching suture ends to pledgets can be employed.

Once the sutures have been fed through the pledgets, opposing suture sections that pass through the first sheath can be secured together and pulled into the heart, as discussed with respect to <FIG>. For example, suture ends <NUM>' and <NUM>' can be secured together to form a single suture, as can suture ends <NUM>' and <NUM>'. One or more of the suture ends <NUM>", <NUM>", <NUM>", <NUM>", which run outside of the sheath <NUM>, can then be pulled until the pledgets are brought into the interior of the heart. After a procedure is performed within the heart and the sutures are tightened to close the opening in the heart, the pledgets <NUM> will form different arrangements depending on how they were originally placed on the sutures.

<FIG> illustrate a schematic view from inside of the heart of two different pledget placements once the opening in the heart has been tightened. <FIG> correspond to the pledget placement of <FIG> and <FIG>, respectively. As can be seen, placing the pledgets according to the embodiment of <FIG> yields two adjacent pledgets <NUM>. In some embodiments, the pledgets can partially overlap. The arrangement of <FIG> yields pledgets that cross each other, as illustrated in <FIG>.

In some embodiments, one or more pledgets (external pledgets) can be placed on the second suture ends <NUM>", <NUM>", <NUM>", <NUM>", which run outside of the sheath <NUM>. The same placement techniques described above can be used. For example, suture ends that are located across from each other can be fed through opposite ends of a single pledget. In such embodiments, where four or more separate suture strands are used the pledgets can cross each other. Similarly, where adjacent suture ends are fed through opposite ends of a single pledget, the pledgets can be adjacent to each other.

The external pledgets are preferably placed on the sutures after the internal pledgets are placed on the first suture ends <NUM>', <NUM>', <NUM>', <NUM>'. In some embodiments, however, the external pledgets can be placed before the internal pledgets are placed. In some embodiments, the external pledgets can be placed even if no internal pledgets are placed. Once external pledgets are placed on the lengths of suture, they can be moved to a position adjacent heart tissue through a variety of methods. In some embodiments, external pledgets can be moved adjacent heart tissue by pulling a respective first suture end <NUM>', <NUM>', <NUM>', <NUM>' before first suture ends are secured together. In some embodiments, external pledgets can be moved adjacent heart tissue by sliding a sheath, catheter, or other cannulated instrument over the one or more suture ends passing through a pledget and pushing the pledget until it is at a desired location adjacent the heart. In some embodiments, a knot placement device, discussed below, can be used to push an external pledget or pledgets adjacent the heart.

In some embodiments the device can have more than four suture arms. In some embodiments, there can be more or fewer than four separate sutures with more or fewer than four suture end portions that pass through the first sheath <NUM> and more or fewer than four suture end portions that remain outside of the first sheath <NUM>. It can be desirable to secure together suture end portions that were previously attached to suture arms that were approximately <NUM> degrees apart around the circumference of the elongate body, or suture end portions that are spaced approximately <NUM> degrees apart around an opening in a heart, as discussed above. When more than two pairs of suture end portions that pass through the first sheath are thus joined and pulled into the heart as illustrated in <FIG>, the result will be a first length of suture as illustrated in <FIG> and two or more lengths of suture similar to the first length but rotated about an axis of the opening in the heart wall.

Determining which of the sutures running within the sheath are approximately <NUM> degrees apart can be done by pulling on the sutures to mechanically see which sutures runs through which point. In some embodiments, different colored sutures can be used to more easily determine which suture ends are approximately <NUM> degrees apart. For example, in an embodiment with four suture arms, the suture end attached to a first suture arm can be a first color and the suture end attached to a second suture arm <NUM> degrees about the circumference of the elongate body from the first suture arm can also be of the first color. A third suture end attached to a third arm can be of a second color, and a fourth suture end attached to a fourth arm <NUM> degrees about the circumference of the elongate body from the third arm can be of the second color, as well. Then, when the four suture ends run through the first sheath, the two ends of the first color can be secured together and the two ends of the second color can be secured together.

Once the suture ends that pass through the first sheath <NUM> have been appropriately secured and pulled into the heart, as illustrated in <FIG>, a suturing or other surgical device can be inserted through the first sheath <NUM> and into the interior of the heart. In some embodiments, prior to inserting a device into the heart, it may be desirable to replace the first sheath with a different sheath. This can be done by standard procedures known in the art, and can also be done while maintaining a sheath within the opening of the heart to thereby maintain haemostasis. For example, an obturator may be slid over the first sheath <NUM>. The sheath <NUM> can then be removed, and a larger sheath may be delivered over the obturator.

Once the desired procedure has been performed, the sheath can be withdrawn while tightening the sutures to close the opening around the sheath as the sheath is withdrawn. In some embodiments, a tapered sheath can be inserted prior to closing the opening, which can make it easier to close the opening tightly around the sheath as the sheath is withdrawn from the heart. In some embodiments, a knot delivery device, such as the device mentioned above and described in <CIT> can be pre-loaded with the two or more of the end portions of sutures <NUM> and delivered into the thoracic cavity alongside the sheath, making it easier to maintain a tightening pressure as the sheath is withdrawn. The opening in the heart can then be closed by applying or tying a knot to the suture ends or by other known methods.

<FIG> illustrates an embodiment of a device <NUM> that can be used to limit or prevent blood or other fluid from collecting between the heart and the pericardial sac that surrounds the heart. Many aspects of the device can function substantially the same as aspects of the device described with respect to <FIG>, even if not specifically illustrated or described with reference to the embodiment of <FIG>. For example, the embodiment illustrated in <FIG> can be used with a sheath or sheaths as discussed above to place sutures through the wall of the heart and allow for performance of a procedure within the heart while maintaining or substantially maintaining haemostasis. Unless discussed otherwise, components can be considered to have substantially the same function and operate in substantially the same manner as similarly labeled components described with respect to <FIG>.

The distal end <NUM> of the device can have a first section <NUM> and a second section <NUM>, as illustrated in <FIG>. The device can also have one or more openings or holes <NUM> positioned at a distal end of the second section. The one or more openings or holes can connect to one or more lumens that run through the proximal end of the device. In some embodiments, the lumen(s) can connect to a source of negative pressure, a stopcock, a syringe, or any other device or receptacle. In some embodiments, each of the one or more openings connects to a corresponding lumen. In some embodiments, some of the one or more openings connect to the same lumen.

The first and second sections are separated by a distally facing surface <NUM>, which can be formed from a step, notch, chamfer, bevel, or other geometry between the first and second sections whereby the second section has a larger outer dimension than the first section. In some embodiments, the second section <NUM> has a cross sectional area immediately adjacent the surface <NUM> that is greater than a cross sectional area of the first section <NUM> immediately adjacent the surface <NUM>. As illustrated, the surface <NUM> is formed from a step between the first and second sections. The surface <NUM> can be at varying angles relative to the first and second sections such that in some embodiments the surface <NUM> is only partially distally facing, but the surface is configured such that when the first section <NUM> of the device enters an opening in the outer wall of a heart that is smaller than the second section <NUM>, the surface <NUM> will press against the outer surface of the heart to block further entry of the device rather than expanding the opening to allow the second section <NUM> to enter the opening.

This mechanism can be seen in <FIG>, which illustrates the device after it has been inserted into the heart. In some embodiments a sheath (e.g. first sheath <NUM>) can be delivered into the heart first and then pulled back before the device is inserted into the heart. The surface <NUM> has pressed against the outer wall of the heart, compressing it inward to form a gap or space <NUM>. Blood that makes it out of the heart and into the space <NUM> can drain through the holes <NUM>, either through gravity or some form of negative pressure applied to the lumen(s) that connect to the holes <NUM>. Consequently, blood is much less likely to end up between the pericardium <NUM> and the heart wall <NUM>.

As illustrated, the arms <NUM> of the device are extended and pressing against the pericardium <NUM> and wall of the heart <NUM>. The arms extend from the device at less than a <NUM> degree angle, but in some embodiments the arms can extend from the device at <NUM> degrees. As described above, the arms can releasably retain suture portions (not shown), and the device can comprise needles that can fire through the heart wall <NUM> and the pericardium <NUM> to capture the suture portions, and then drawn them back through the tissue and into the device.

In some embodiments, it may be desired to have the sutures pass only through tissue of the heart wall, but not through the pericardium <NUM>. The pericardium can then be left open as a drain, it can be separately sutured shut, or a drainage device can be installed near or within an opening in the pericardium and it can be sutured later. <FIG> and <FIG> illustrate one method of using the device of <FIG> to pass sutures through tissue of the heart but not the pericardium.

As illustrated in <FIG>, the device can be inserted while the arms <NUM> remain in a retracted position until the distal ends of the arms reach a point between the pericardium <NUM> and an external surface of the heart wall <NUM>. In some embodiments a sheath (e.g. first sheath <NUM>) can be delivered into the heart first and then pulled back before the device is inserted into the heart. As illustrated, when the device has been inserted the surface <NUM> has begun to compress the heart wall when the distal ends of the arms are between the pericardium and the external surface of the heart wall. In some embodiments, the arms can reach that position before the surface contacts the heart wall.

Once the arms are in position they can rotate to the extended position, catching the pericardium and drawing it outward, as illustrated in <FIG>. In some embodiments, the arms can have a hook, sharp edge, notch, or other structure on an outer surface of the arms that can engage with the pericardium and make it easier to draw the pericardium outward. Once the arms have been extended to a desired position, the device can be advanced farther into the heart until the arms are against the heart wall <NUM>. From that position, any of the procedures discussed with reference to <FIG> can be used.

Furthermore, the particular features, structures or characteristics of any embodiment described above may be combined in any suitable manner, as would be apparent to one of ordinary skill in the art from this disclosure, in one or more embodiments.

Claim 1:
A suturing device (<NUM>) for suturing an opening in a heart wall, comprising:
an elongate body (<NUM>) comprising a proximal end and a distal end, a first section at the distal end, a second section proximal to the first section, and a distally facing body surface between the first and second sections, wherein the second section has a larger outer dimension than the first section;
a plurality of arms (<NUM>) near the distal end in the second section, wherein each arm is configured to move between a first position wherein the arm is retracted within the elongate body, and a second position wherein the arm has a free end extending away from the elongate body, each arm comprising at least one suture mount at the free end and configured to releasably retain a suture portion;
a plurality of needles (<NUM>), each needle configured to move between a retracted position in which the needle is within the elongate body to a deployed position in which a distal point of the needle extends out of the elongate body and into a suture mount;
the device further comprising at least one lumen (<NUM>) within the elongate body and being characterized by one or more openings (<NUM>) at an external surface of a distal end of the second section, the one or more openings connecting to the at least one lumen;
wherein the distally facing body surface is configured to press against an external surface of a heart when the first section is advanced into the opening in the heart,
wherein a proximal end of the at least one lumen is adapted to connect to a source of negative pressure.