Patent ID: 12185938

DETAILED DESCRIPTION

Embodiments described herein provide systems, methods, and devices for closing an opening in tissue. Embodiments can be configured to close an opening within a body lumen. For instance, in one embodiment, an apparatus for suturing a body lumen includes a flexible elongated member that has a proximal end, a distal end, a central passage and multiple needle lumens extending from the proximal end toward the distal end. The flexible elongated member further includes an elongated subsection spanning from the end of the needle lumens in the elongated member to a barrel portion that includes corresponding needle lumens on the proximal end of the elongated member. The elongated subsection provides sufficient space between the needles and the barrel portion to allow transapical insertion of the elongated member into a body lumen. The apparatus further includes multiple different needles disposed within and advanceable from the needle lumens in the flexible elongated member across the elongated subsection to corresponding needle lumens in the barrel portion. The apparatus also includes a handle disposed at the proximal end of the elongated member. The handle is operable to retract the needles through the needle lumens of the elongated member across the elongated subsection toward the handle at the proximal end.

In another embodiment, a method is provided for suturing an opening in a body lumen. The method includes providing a body lumen suturing device, where the body lumen suturing device includes a flexible elongated member that has a proximal end, a distal end, a central passage and multiple needle lumens extending from the proximal end toward the distal end. The flexible elongated member includes an elongated subsection spanning from the end of the needle lumens in the elongated member to a barrel portion that includes corresponding needle lumens on the proximal end of the elongated member. The elongated subsection provides sufficient space between the needles and the barrel portion to allow transapical insertion of the elongated member. The body lumen suturing device further includes needles disposed within and advanceable from the needle lumens in the flexible elongated member across the elongated subsection to corresponding needle lumens in the barrel portion, as well as a handle disposed at the proximal end of the elongated member, where the handle is operable to retract the needles through the needle lumens of the elongated member across the elongated subsection toward the handle at the proximal end.

In yet another embodiment, a body lumen suturing device includes a flexible elongated member having a proximal end, a distal end, a central passage and multiple needle lumens extending from the proximal end toward the distal end. The flexible elongated member further includes an elongated subsection spanning from the end of the needle lumens in the elongated member to a barrel portion that includes corresponding needle lumens on the proximal end of the elongated member. The elongated subsection provides sufficient space between the needles and the barrel portion to allow transapical insertion of the elongated member. The elongated member also includes a crimp ring configured to hold pledgets in place at the proximal end of the needle lumens in the elongated member. The device also includes needles disposed within and advanceable from the needle lumens in the flexible elongated member across the elongated subsection to corresponding needle lumens in the barrel portion, as well as one or more pledgets stored at the proximal end of the needle lumens in the elongated member. The pledgets include holes through which the sutures may be pulled. The device also includes a handle disposed at the proximal end of the elongated member, where the handle is operable to retract the needles through the needle lumens of the elongated member across the elongated subsection toward the handle at the proximal end.

As used herein, the term “distal” is generally defined as in the direction of the patient, or away from a user of a device, or in a downstream direction relative to a forward flow of blood. In the context of a medical device intervention with or through a vessel wall, “distal” herein refers to the interior or the lumen side of the vessel wall.

Conversely, “proximal” generally means away from the patient, or toward the user, or in an upstream direction relative to a forward flow of blood. In the context of a medical device intervention with or through a vessel wall, “proximal” herein refers to the exterior or outer side of the vessel wall.

Additionally, “oblong” is herein intended to mean oval, elliptical, or otherwise having a generally rounded shape that is not perfectly circular. In particular, the term describes the shape of a tubular graft end cut at an acute angle relative to the plane perpendicular to the tissue walls defining the graft.

The term “hemostasis” is herein used to mean the arrest of bleeding or substantially blocking flow of blood outwardly from a vessel lumen while the vessel lumen is pressurized or sustaining physiological blood flow. This amount of blockage or occlusion to flow is further defined such that the blood loss which is experienced is less than an amount which would affect procedural methods or outcomes according to a physician user of a device of ordinary skill in the art. In other words, “hemostasis” is not intended to mean only “total hemostasis” such that there is a total lack of blood loss. Rather, the term is used to also mean “procedural hemostasis” as a relative term in its use among physicians of ordinary skill.

Similarly, “occlusion,” “occlude,” “blockage,” “block . . . plugging”, “block,” or variations thereof are all terms which are herein intended to have a procedurally relevant definition in the context of their use. For instance, an aperture is “occluded” although there is some measurable flow therethrough, but that flow is so low such that the intended procedural benefit of occlusion is at least partially achieved. Certainly, such terms also properly include within their scope a “total effect” definition, as well.

The term “perfusion” is herein used to mean the flow of blood or other unit of perfusate (the fluid used for perfusion) per unit volume of tissue. Physiological perfusion refers to the amount of blood flow present when the body is functioning normally. For example, physiological perfusion usually prevents clinically significant ST elevations which is one of the most sensitive indicators of inadequate perfusion. Adequate perfusion refers to the amount of blood flow that avoids the clinical requirement of transfusing the patient or that is needed to prevent tissue necrosis distal to the aperture in the blood vessel.

The term “suturing” is herein intended to include the process of joining two surfaces or edges together with a fastener so as to close an aperture, opening, or wound or join tissues. The fastener is usually a suture such as a thread of material (either polymeric or natural), gut, wire or the like. The term fastener as used herein also includes clamps, studs, hasps, catches, hooks, rivets, staples, snaps, stitches, VELCRO, buttons, and other coupling members.

As shown inFIG.1, a tissue suturing device101may be provided to close openings in body tissues. The tissue suturing device101includes multiple different parts. These parts may be generally divided into three sections including a handle section192, a substantially rigid intermediate section191, and a flexible elongated section190. Each section may include different sub-parts that are each designed to provide an intended portion of functionality.

The handle section192of the tissue suturing device101includes a hand grip110and rotatable handle portion109R. The hand grip and rotatable handle portion allow a physician or other user to hold and manipulate the tissue suturing device101. For example, the physician can hold on to the hand grip110and the rotatable handle portion109R when inserting or withdrawing the tissue suturing device from a body lumen. The handle section192also includes an actuating member (i.e., handle109N) which is mechanically linked to the needles115(FIG.4A) in the elongated member113. When the handle109N is pulled, the mechanical link to the needles is actuated and the needles are drawn from the distal end113D of the elongated member toward the proximal end113P of the elongated member. As will be shown further in regard toFIGS.2and3, the handle109N is mechanically linked to a needle holder121which holds the needles within the sheath105. When the handle109N is pulled toward the user, the needle holder moves, along with the needles, through the sheath105and toward the handle.

The substantially rigid intermediate section191extends from the rotatable handle portion109R to the needle guide106. This intermediate section includes a barrel portion108which routes the needles115through the barrel and out toward the handle portion192. The needles115carry sutures112which are used to close openings in the tissue. The needles extend from the needle guide106through any intervening tissue toward the barrel portion108. The barrel portion108captures the needles and routes them through an opening (element124inFIG.2) toward the user. The substantially rigid intermediate section191also includes elongated subsection107which spans a tissue gap. This tissue gap comprises the tissue area through which the elongated subsection is inserted. The elongated subsection allows for the tissue suturing device101to be inserted transapically into the heart or into other bodily tissues. In some embodiments, the elongated subsection107may allow a user to insert the device transapically and perform a percutaneous closure of the left ventricle of the heart. This embodiment will be explained in greater detail below.

The flexible elongated portion190of the tissue suturing device101includes the needles115(shown inFIGS.2-4), a guidewire port for advancing the device along a guidewire114(shown inFIG.2) and a flexible outer sheath105. The flexible elongated portion190may be inserted entirely into the body lumen using the guidewire to advance the device. Once the tissue suturing device has been inserted into the vascular tissue, the guidewire can be removed by the operator. The sheath105of the elongated member113supports various internal structures including the needle holder121. The flexibility of the elongated portion allows the elongated portion to be inserted in a variety of different types and sizes of tissues, including into arteries (such as the femoral artery) and into the heart.

The needle holder121of the flexible elongated portion190may be configured to hold one or more needles within needle lumens119which are axially aligned and spaced about the interior of the elongated member113(as shown in the cross-sectional view ofFIG.5(which itself corresponds to cross-section5ofFIG.3)). The needle holder, upon actuation of the handle109, may be advanced up the needle shaft111toward the proximal end113P of the elongated member113. As the needle holder102is advanced, the needles115held by the needle holder are correspondingly advanced toward the needle shaft111in the handle109. The needles are withdrawn through the needle guide106toward the barrel portion108. As will be explained in greater detail with regard toFIG.7, the barrel portion108includes two semi-circular openings130that receive the needles115, even in cases where the needles are drawn through relatively large tissue gaps.

Thus, the flexible elongated portion190houses the needles115which will be drawn toward the handle109of the tissue suturing device101. The needles115are withdrawn along needle guide106and across the tissue gap covered by elongated subsection107toward the barrel portion108. While being advanced from the needle guide106to the barrel portion108, the needles may exhibit a tendency to deflect or travel away from the tissue suturing device101. For example, in cases where the tissue suturing device101is inserted transapically into the left ventricle of the heart, the tissue suturing device will be inserted through body tissue that is thicker and/or tougher than the body tissue typically involved in a femoral arteriotomy. For instance, the tissue gap in a transapical insertion may be 1-5 cm. In a femoral arteriotomy, a tissue suturing device is placed through skin and muscle tissue in the leg, and ultimately through the femoral artery. In a transapical insertion, the tissue suturing device is inserted near or through the ribcage toward the heart. This tissue near the ribcage and heart is often fibrous and tough, and may cause the needles to deflect and travel away from the tissue suturing device. Accordingly, larger, semi-circular openings130are provided in the barrel portion108to capture the needles115as they approach the handle109.

Thus, to compensate for the thicker, more fibrous tissue through which the tissue suturing device101will be inserted, a tissue suturing device with a substantially rigid elongated subsection107is provided. The elongated subsection107provides sufficient space between the needle guides106and the needle-receiving barrel portion108to allow transapical insertion of the device101. The needles115are drawn through the tissue and across the tissue gap provided by the elongated subsection107. The elongated subsection107is specifically designed to provide sufficient space between the needles115and the barrel portion108to allow transapical insertion of the elongated member113. This is shown in greater detail inFIGS.2-4. It should be noted that although the tissue suturing device is usable for transapical insertion into a heart ventricle, it will be appreciated that the tissue suturing device101can be readily adapted for use with punctures made to other hollow body organs and lumens. It may, however, be necessary to modify the dimensions and other particular aspects of the tissue suturing device to accommodate the different usage environments.

Referring now toFIGS.2and3, the tissue suturing device101is suitable for suturing and sealing of a percutaneous vascular puncture site (particularly those made transapically to the left ventricle of the heart). The tissue suturing device101has an elongated member113and the needle shaft111. The elongated member113includes a guide tip123of the needle guide106at its distal end. The guide tip123includes a plurality of guide channels125which receive the proximal ends of needles115. The needles115, as illustrated, comprise a sharpened tip section115A and an elongated shank portion122, but may also be manufactured as an integral piece. The shank portion122may be sufficiently long so that the needles may be pushed from their butt end by a needle holder121fixedly attached to the needle shaft111. By withdrawing the handle109N, the mechanically linked needle holder121is also withdrawn toward the user, carrying the needles115and pushing the needles through the intervening tissue. The needles may be withdrawn until they enter the barrel portion108and exit through the barrel opening124.

The elongated member113further includes a plurality of needle lumens119which are axially aligned and spaced about the periphery of the elongated member. As shown inFIGS.4B and5, the needles115are designed to enter the proximal ends of the lumens119as the needles are advanced proximally relative to the elongated member113. A flexible needle sheath (channel guide)105is attached to the guide tip123of the elongated member113. The central lumen of the needle sheath105receives a needle holder121attached to the distal end of the needle shaft111, as well as the needles115. The butts of the needles115are removably received within the needle holder121. The sheath105is designed to be sufficiently long to permit the needles to extend at least 5 cm beyond the distal end of elongated member113and into the barrel portion108.

Prior to use, the tissue suture device101will be in the configuration illustrated inFIGS.1and4A. That is, the needle shaft111will be distally positioned within the elongated member113and needle sheath105. In particular, the tips of needles115A will lie just at the guide tip123so that they may be easily advanced through the vascular tissue of the heart, as well as any surrounding tissue. That is, the tips of the needles115A will be generally retracted within the guide tip123. A length of suture112is attached to the proximal tips115A of opposed pairs of needles115, with the connecting suture being stored within side lumens126extending axially along the exterior of the needle sheath105.

As best observed inFIGS.4A,4B and5, the suture112extending between one pair of opposed needles is received in a first of the side lumens126, while the suture extending between the other pair of opposed needles is received in the second of the side lumens126. In some embodiments, the sutures112may be stored in the lumens119of the elongated member113(and thus eliminate the need for side lumens126). The use of side lumens126may simplify feeding of the suture as the needles115are withdrawn.

After the guide tip123has been passed through the puncture site to be sutured, the needles may then be drawn proximally forward through the tissue to be sutured by drawing proximally on handle109at the proximal end of needle shaft111. Methods described herein for suturing an opening in a body lumen will now be described in more detail with reference toFIGS.2-4.

The situation following an interventional or other vascular procedure, where the attending physician is satisfied that the puncture site may be sealed, is illustrated inFIG.2. The device101may then be introduced over a guidewire114, as illustrated inFIG.2. The needles115and sutures112mostly encased by flexible needle sheath105, will be fully advanced into the artery or ventricle FA past the puncture site A. The handle109N may then be partially withdrawn proximally to expose the needle lumens119(as shown inFIGS.1,4A and4B).

The handle109N will then be drawn proximally outward relative to the elongated member113, causing the needles115to pass out of the needle lumens119and through the superficial wall of the artery/ventricle FA, as illustrated inFIGS.2and4B. The handle109may continue to be drawn proximally (i.e., outward from the patient) in order to continue to pull the needle shaft111through the elongated member113. Such movement of the needle shaft111, in turn, continues to draw the needles115outward through the lumens119of the elongated member113until the tips of the needles are exposed.

As mentioned above, the needles115are drawn from out of needle lumens119and through any intervening tissue. The tissue may be thick and fibrous, as is the case when the tissue suturing device is inserted transapically into the heart. The device's elongated subsection107provides sufficient rigidity and stiffness for insertion through and placement in the thick and fibrous tissue. It is across this elongated subsection107and through this tissue that the needles115are withdrawn. In some cases, the needles115may deflect or drift while traveling through this tissue. Upon reaching the outer surface of the tissue, the needles may be guided into the semicircular openings of the barrel portion108. The needles will thus carry their attached sutures112through the tissue, across the elongated subsection107, and through the barrel portion108. The sutures can then be grasped by the user and drawn out until the sutures are available to the user. The elongated member113may then be withdrawn from the needle sheath105, leaving a portion of the needle sheath105still in the puncture site A to maintain hemostasis. The suture can then be tied and the knot pushed back down to the puncture site A. The knot will then only be tightened when the needle sheath is finally withdrawn from the puncture site A.

It can be seen that the guide tip123deflects the needles radially outward so that the pattern of four needles engages the arterial or ventrical wall in an approximately square pattern. These needles are then captured by the barrel portion108. As shown inFIG.7, the barrel portion captures the needles115traveling toward the handle109. The needles115enter the distal end of the barrel portion108through one of two semi-circular openings130(in some cases, there may be more or fewer openings, and the openings may be in shapes other than semi-circles). The outer surface at the proximal end of the barrel portion108includes a hole124connected to the semi-circular openings130through which the needles115are withdrawn. As such, the openings130direct the needles on a narrower trajectory toward the handle109of the suturing apparatus. The needles are drawn across the elongated subsection107in order to reach the barrel portion108. The elongated subsection107may be a predefined length, and may be specifically designed for the tissue though which the elongated member113is to be inserted.

For instance, as mentioned above, when the suturing device101is transapically inserted into the left ventricle of the heart, the elongated subsection107may comprise a specific length (e.g. within the range of 1-5 cm) for that type and/or thickness of tissue. Other types of insertion may necessitate use of a longer or shorter elongated subsection107. In some cases, the diameter of the barrel portion108may be proportional to the thickness of the tissue (i.e. the tissue gap). Thus, in cases where the tissue gap is longer (e.g. within the range of 4-5 cm) and the needles are more prone to drift, the barrel portion108may be larger. Conversely, in cases where the tissue gap is shorter (e.g. within the range of 1-2 cm) and the needles are less prone to drift, the barrel portion108may be smaller in diameter.

In specific cases where the body lumen suturing device is inserted into the left ventricle of the heart transapically, and implemented to suture an opening in the left ventricle of the heart, the elongated member113of the tissue suturing device101may be advanced through the body lumen opening so that the needle lumens119are entirely within the body lumen150. The elongated member113of tissue suturing device101may be advanced in this manner until it is substantially aligned with the interior wall of the body lumen. One or more pledgets116stored at the proximal end of the needle lumens119in the elongated member113may be placed between the needle ends and the interior wall of the body lumen (as shown inFIG.6C). The needles115A/115B and attached sutures114A/114B are withdrawn through holes118in the pledget(s)116. As such, the pledgets remain in contact with the interior wall of the body lumen150, protecting the interior wall from forces applied to the sutures. The handle109may then be actuated to withdraw the needles115carrying the sutures112along the needle lumens119, through the interior wall of the body lumen150, and out through the opening124of the barrel portion108. After the sutures are tied and the knots advanced back through the needle sheath105, the resulting pattern of tied suture will appear as inFIG.8when viewed towards adventitial surface of the body.

Turning now to another embodiment, the tissue suturing apparatus101may further be designed to implement pledgets. As used herein, a pledget may refer to an absorbent pad or other cloth- or cotton-like material for absorbing bodily fluids. In some cases, the pledgets may be fabricated using biocompatible and/or absorbable materials, and may be used accordingly in different applications. For instance, pledgets may be placed interior to or exterior to a body lumen. Accordingly, a pledget may be placed inside an arterial wall, outside an arterial wall, or elsewhere in the body. In embodiments where pledgets are used in ventricles of the heart, the pledgets may protect the inner ventricle from cutting of the tissue by knot advancement, tying or by other causes. The pledgets may be stored at the end of the proximal end of the needle lumens119. The sutures114A/114B may be routed through holes the pledgets. These holes are large enough not to restrict suture travel. The pledgets may be held in place by crimp ring134. These concepts will be explained below with regard toFIGS.6A-6D.

FIG.6Aillustrates a zoomed-in view of the proximal end of the needle lumens119, and the distal end of the elongated subsection107. Needles115A and115B are shown still within the sheath105of the elongated member113. Corresponding sutures114A and114B are attached to needles115A and115B. In some cases, the sutures may be of differing colors. For instance, suture114A may be colored green, while suture114B is colored white. The sutures may be drawn through a hole118in pledget116. The pledget may be held in place by crimp ring134which extends around the elongated member113.

As mentioned previously, the pledgets may be used both interior to and exterior to a vascular or arterial wall. Accordingly,FIG.6Billustrates an embodiment where the pledget116is placed on the interior side of a body lumen (e.g. tissue150). The sutures are threaded through the hole118in the pledget, and then through the tissue150as they are drawn toward the barrel portion108of the suturing apparatus. In this position, the pledget can alleviate bleeding in the vascular wall, and help to maintain hemostasis. Although shown with four needles115and two sutures, it should be noted that substantially any number of needles and/or sutures may be used in different scenarios. In some cases, it may be beneficial to have more or fewer needles and/or sutures. Accordingly, the suturing apparatus may be adapted (or remanufactured) to be used in these cases.

Thus, as shown inFIG.6C, the sutures114A/114B held by the needles115are threaded through the pledget116, which is located between the sutures and the interior wall of the body lumen150. In some cases, as shown inFIG.6D, a second, different pledget may be placed in addition to (or as an alternative to) the pledget placed on the interior side of the body lumen (pledget116B). Pledget116A may be placed on the outside of the body lumen, and may function to alleviate bleeding on the outer part of the vascular wall. The exterior pledget (116A) may, like the interior pledget116B, be threaded with sutures114A and114B. These sutures may be drawn through the pledget(s) and out through the puncture site (PS). Thus, inFIG.6D, the sutures114A/114B held by the needles115are threaded through the interior pledget116B within the body lumen. The sutures114A/114B are also threaded through the exterior pledget116A which is exterior to the body lumen150, such that the exterior pledget116A is located between the exterior wall of the body lumen and the barrel portion108of the device101. The pledgets116A are stored at the proximal end113P of the elongated member113, and are held in place by a another crimp ring similar to crimp ring134and are configured to hold the pledgets in place at the proximal end of the elongated member until they are withdrawn along with the sutures and the needles toward the barrel portion108.

FIGS.6E and6Fshow bottom and top views, respectively, of a pledget116with slits in various locations. The slits180may be placed on the outer edge of the pledget in order to allow a suture to be slid into place (as opposed to being threaded through a hole in the pledget). InFIG.6E, the pledget has two slits on opposite sides. Each slit180is shown as having two sutures through it. While two sutures are used in the Figures, it will be appreciated that substantially any number of sutures and/or slits may be used. The bottom view ofFIG.6Fillustrates that the sutures are slid through the slits and wrapped underneath the pledget. The ends of the sutures112A and112B come out of the top surface of the pledget, as illustrated in the top view ofFIG.6E. The pledget slits may be sewn or otherwise fastened shut, resulting in sewn edges181. The edges may be sewn after the sutures have been slid into place. The slits thus allow the sutures to be slid into place on the pledget, while the sewn edges prevent the sutures from coming out of place.

These slits and sewn edges may be configured in different arrangements, as shown inFIGS.6G-6J.FIG.6Hillustrates a bottom view of a pledget116that has crossing sutures112A and112B. The sutures may be slid into place using the respective slits180. As can be seen on the corresponding top view (FIG.6G), the sutures may extend out of the slits toward the user and/or toward the tissue suturing device. The sutures are held in place within the slits with the sewn edges181. As with the pledgets described above, the pledgets ofFIGS.6E-6Jcan be held in place in the tissue suturing device101using crimp ring134. Or, alternatively, the pledgets can be held in place by the sutures themselves. For example, if the sutures are crossed behind the suture as shown inFIG.6H, the pledget may be drawn up next to the tissue suturing device with the sutures holding the pledget in place. Another pattern for placing sutures in a pledget is shown inFIGS.61and6J. The sutures may be slid into place through slits180, and may be aligned next to each other vertically (see bottom viewFIG.6J). The top ends of the sutures112A and112B are then available for the user or device as shown in the top view ofFIG.6I.

Accordingly, methods, systems and apparatuses are provided for suturing body lumens. A predefined tissue gap may be implemented to provide mechanisms for inserting the suturing device transapically into the left ventricle of the heart. Moreover, pledgets may be positioned within the suturing device for implementation on the exterior and interior walls of the body lumen. The placement of these pledgets may reduce blood loss and may assist in maintaining hemostasis.

The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.