Patent ID: 12232721

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The term “distal” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, as in the direction of the patient, or away from a user of a device, or in a case of arterial deployment, in a direction of antegrade 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. In the context of a medical device intervention with or through an opening in tissue, “distal” herein refers to the interior side of the tissue.

The term “proximal” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, as away from the patient, or toward the user, or in a case of arterial deployment, in a direction of retrograde 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. In the context of a medical device intervention with or through an opening in tissue, “proximal” herein refers to the exterior side of the tissue.

The term “hemostasis” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, 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.

The term “suturing” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, 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, is a broad term and is used in its ordinary sense, including, without limitation, clamps, studs, hasps, catches, hooks, rivets, staples, snaps, stitches, VELCRO, buttons, and other coupling members.

The term “pre-close” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, the placement of the sutures in a blood vessel, e.g., femoral artery, before the arteriotomy is enlarged by an endovascular sheath.

One or more specific embodiments of the present disclosure will be described below. In an effort to provide a concise description of these embodiments, some features of an actual embodiment may be described in the specification. It should be appreciated that in the development of any such actual embodiment, as in any engineering or design project, numerous embodiment-specific decisions will be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which may vary from one embodiment to another. It should further be appreciated that such a development effort might be complex and time consuming, but would nevertheless be a routine undertaking of design, fabrication, and manufacture for those of ordinary skill having the benefit of this disclosure.

The present disclosure relates to methods, systems, and devices for closing an opening in tissue, such as closing an opening or puncture through a wall of a body lumen. In one example embodiment, a closure system of the present disclosure may allow an operator to quickly and efficiently achieve hemostasis of an opening while simultaneously providing the operator with a greater measure of control and flexibility in positioning and anchoring portions of the closure system than previously available. For example, the closure system may allow an operator to achieve a more intimate securement of a closure element in the tissue, such as tissue surrounding a body lumen opening. In a yet further embodiment, the closure system may be compatible with a wider range of tissue structures and tissue thicknesses, such as body lumen wall thicknesses, thereby considering the possibility of calcifications or scar tissue. In addition, the closure system can optionally be configured to advance into a body lumen opening over a guidewire. In addition, the closure system can be used to pre-close the tissue opening. Furthermore, the closure system may be compatible with a variety of sizes of body lumen openings and tissue tracts.

Referring now toFIG.1, a closure device10generally has a shaft12having a proximal end14and a distal end16. A proximal housing18supports a needle actuation handle20that is coupled to a plurality of needles22(FIG.3) that can be advanced to penetrate tissue and deploy anchored sutures. A flexible, atraumatic guidebody24, with an atraumatic tip26, extends from the distal end16of the shaft12. A lock member28is disposed between the proximal housing18and the needle actuation handle20to prevent inadvertent distal movement of the needle actuation handle20to deploy the plurality of needles22, the lock member28being tethered to the proximal housing18, such as to one of the finger grips19.FIG.1illustrates the closure device10with the lock member28in a first position preventing the inadvertent distal movement before actuation andFIG.2illustrates the lock member28in a second position so that movement of the needle actuation handle20in the direction of the arrows advances the plurality of needles22(FIG.3). A biasing member30is positioned relative to the needle actuation handle20, such as on a portion of the needle actuation handle20, to selectively maintain separation of the proximal housing18and the needle actuation handle20. The biasing member30provides resistance to needle actuation handle20movement toward the proximal housing18and so provides enhanced control to the user. Additionally, the biasing member30aids in retracting the needles22delivering the self-locating suture anchor120(FIG.8) of the suture. The anchor120will have an exposed portion so that when the user releases the needle actuation handle20, the biasing member30will retract the needles22back through the vessel wall causing the exposed portion of the anchor120(FIG.5) to engage with the vessel wall and pulled off the needle22as the needle22is retracted. Further details will be provided later.

As illustrated inFIGS.1and3, disposed at the distal end16of the shaft12are needle ports32a,32b(anterior needle port32aand posterior needle port32b) to accommodate the plurality of needles22and through which the needles22would extend to penetrate tissue. The needle ports32a,32bcommunicate with needle lumens34a,34b, illustrated in the cross-sectional view ofFIG.3, which extend from the proximal housing18to the needle ports32a,32b. The needles22can be advanced distally to and through the needle ports32a,32bto penetrate tissue and also proximally to retrieve the needles22.

The needle lumens34a,34bare positioned in a body36of the shaft12, the body36being covered with an outer sheath38. As illustrated inFIGS.3and4A, the needle lumens34a,34bare disposed on radially opposite sides of the body36with a guidewire lumen40and a marker lumen42being radially opposite each other at a location between the needle lumens34a,34b. Positioning the needle lumens34a,34bradially opposite each other positions the needles22on an anterior and posterior side of the shaft12, consistent with anterior and posterior positioning of the needles22relative to the opening through which the shaft12is advanced. It will be understood that the needle lumens34a,34b, the guidewire lumen40, and the marker lumen42and can be placed at other locations about the body36, such as to achieve different needle puncture patterns, accommodate different target tissue within the patient's anatomy, or to vary a delivery procedure to position the closure device10in proximity to a tissue opening.

FIGS.4B-4Dillustrate a number of alternate locations and forms for the needle lumens34a,34band the guidewire lumen40within the body36. For instance,FIG.4Billustrates a plurality of needle lumens34a,34bradially opposite each other on the anterior and posterior sides of the shaft12, with the guidewire lumen40radially spaced from the marker lumen42. The needle lumens34a,34band guidewire lumen40are lumens having generally circular cross-sections and are spaced from an outer periphery of the body36. In contrast, the marker lumen42is illustrated as a through hole, groove, recess, or channel formed in the outer periphery of the body36. That said, the marker lumen42can alternatively be a lumen having a generally cross-section and be spaced from the outer periphery of the body36. Additionally, and as illustrated inFIGS.4C-4D, the needle lumens34a,34band guidewire lumen40can also take the form of a through-hole, groove, recess, or channel similar to the marker lumen42ofFIGS.4A-4B

In addition to the illustrated alternate configurations, it will be understood that the needle lumens34a,34bcan be disposed beside each other on one side, either anterior or posterior. Similarly, the guidewire lumen40and the marker lumen42can be disposed beside each other on one side, either anterior or posterior. The needle lumens34a,34bneed not be separated by one or both of the guidewire lumen40and the marker lumen42in a circumferential direction about a longitudinal axis of the body32.

Generally, the spacing of the needle lumens34a,34bor the spacing of the guidewire lumen40and the marker lumen42need not be about 180°. Instead, the spacing can be between about 5° to about 175° apart, between about 10° to about 165° apart, between about 20° to about 155° apart, between about 45° to about 135° apart. Additionally, while the needle lumens34a,34b, the guidewire lumen40, and the marker lumen42can have a generally circular cross-section, alternate configurations are possible. For instance, the cross-sections of the lumens can be elliptical, oval, polygonal, non-circular, or combinations thereof.

The guidewire lumen40accommodates a guidewire46upon which the closure device10is advanced, whether by an over-the-wire or rapid exchange configuration. For instance, the guidewire lumen40can extend from an inlet port50at the atraumatic tip26to an exit port52positioned proximal the needle actuation handle20of the closure device10. Alternatively, the guidewire lumen40can be formed on a small section of the guidebody22or the shaft12, with both an input port50and an exit port52being formed in the guidebody22or the shaft12. In still another configuration, the inlet port50can be disposed closer to the inlet56of the bleed back passageway54, as shown in phantom inFIG.2, as inlet50a.

The marker lumen42forms part of a bleed back passageway54extending from the guidebody24to the proximal housing18. When an inlet port56of the bleed back passageway54enters a body lumen, such as a blood vessel, the pressure of the blood will cause blood to flow through inlet port56, along the passageway54, and exit from the outlet port58. Pulsating flow from the outlet port58indicates that the shaft12is appropriately positioned in the blood vessel. Instead of locating the inlet port56as illustrated inFIGS.1and2, the inlet port can be disposed closer to the needle ports32a,32b, as illustrated in phantom inFIG.1, as inlet ports56aand56b.

The needle lumens34a,34b, the guidewire lumen40, and the marker lumen42can be formed from one or more tubes provided in the shaft12, proximal housing18, and the guidebody24. For instance, as shown inFIGS.1,2, and5, at least a portion of the guidewire lumen40is formed by the guidewire tube60extending from a proximal end of the needle actuation handle20and a guidewire tube48disposed within the guidebody24, the guidewire tube60overlapping or being received within the guidewire tube48to form the guidewire lumen40.

At least a portion of the marker lumen42is formed by the marker tube62extending from the proximal housing18. Optionally, at least portions of the needle lumens34a,34b, the guidewire lumen40, and the marker lumen42can be formed integrally with the body36of the shaft12. For instance, the needle lumens34a,34band the guidewire lumen40can be formed as the body36is extruded or otherwise formed. The marker lumen42can be partially formed in the body36when extruded and closed upon sealing by connecting the outer sheath38to the body36. In still other configurations, the needle lumens34a,34band the guidewire lumen40can be formed in a similar manner to the marker lumen42, such as the needle lumens34a,34band the guidewire lumen40being partially formed by the body36and closed or sealed when the outer sheath38connects to the body36.

Turning toFIGS.5and6, the needles22and the needle actuation handle20form a needle assembly70that can be advanced into and retracted from the proximal housing18. This movement not only moves the needle actuation handle20but also a suture storage receptacle72, and optionally the guidewire tube60, that extend from and are mounted to the needle actuation handle20. When the needle assembly70is removed from the proximal housing18, a suture66is released from the suture storage receptacle72as the suture storage receptacle72is slid over the suture. Similarly, the guidewire tube60is slid over the guidewire46. Each length of suture66can be about 10.5 inches (26.7 cm) in length. Alternatively, the suture can have a length from about 10 inches (25.4 cm) to about 15 inches (38.1 cm) of working length from an engagement surface of the suture anchor120(FIG.5).

To aid with such movement, a body portion78of the needle actuation handle20can be slidably received within an interior80of the proximal housing18. With the plurality of the needles22being guided in their movement by the needle lumens34a,34b, the body portion78can simply slide within an opening82formed in the proximal housing18. However, if additional control to the movement is desired, the body portion78and a portion of the proximal housing18can be keyed together so that rotational movement of the body portion78relative to the proximal housing18, or vice versa, can be limited.

To further control movement of the needle actuation handle20into and away from the proximal using18in proximal-to-distal or distal-to-proximal directions, the biasing member30provides resistance to movement of the needle actuation handle20toward the proximal housing18and so provides enhanced control to the user. The biasing member30, such as a spring, is positioned on the body portion78between a handle portion76of the needle actuation handle20and a proximal end of the proximal housing18. As the biasing member30is compressed during proximal-to-distal movement of the handle portion76, the biasing member30resists the movement. This provides enhanced tactile feel to the user, so needle penetration is more controlled. The biasing member30can have a generally uniform cross-section and approximates an outer diameter of the body portion78. Alternatively, the biasing member30can have a configuration where it provides increased resistance as the proximal-to-distal translation of the handle portion76increases, i.e., the handle portion76moves closer to the proximal housing18. This can be achieved, when the biasing member30is a spring, through increasing a diameter of the wires from the spring, changing a cross-section of the spring, or other manners know by those skilled in the art. It will also be appreciated that other biasing members can be used and may be adjusted to provide variable resistance. For instance, the spring force of the biasing member30may be linear or non-linear. The biasing member30can have a higher density of coils at a distal end and lower density of coils at a proximal end allowing for an increase in resistive force as the handle portion76is advanced. This would reduce a needle speed of the needles22at an end of the stroke of the handle portion76as the vessel is pierced by the needles22. Additionally, detents (illustrated in phantom) could be provided at a proximal end and/or distal end of the body portion78to retain the biasing member30so it does not become disengaged from the body portion78.

In addition to the biasing member30controlling movement of the needle actuation handle20relative to the proximal handle18, the lock member28prevents the inadvertent distal movement before actuation. As illustrated inFIGS.6and7, the lock member28at least partially surrounds the biasing member30and the body portion78of the needle actuation handle30and receives lipped structures44, such as flanges or ledges, extending from the handle portion76and the proximal housing18. Those lipped structures44are received within complementary grooves96formed within a channel90having a curved surface92and generally planar surfaces94. The locking member28prevents the biased movement of the handle portion76relative to the proximal housing18under the force of the biasing member30as the lipped structures44slide into the grooves96as the locking member28is advanced transversely to a longitudinal axis of the proximal housing18and the needle actuation handle20. The lipped structures44can extend around the body portion78and the opening82of proximal housing18in a circumferential direction as a continuous lipped structure or can include one or more discrete spaced apart lipped structures.

While reference is made to including the lipped structures on the locking member28, it will be understood that the locking member can included other structures that capture or engage with the proximal hosing18and the needle actuation handle20. For instance, optionally, extending from the planar surfaces94are detents97that provide frictional engagement with one or both of the biasing member30and the body portion78of the needle actuation handle30.

An outer surface98of the locking member28includes grasping structures100, such as grooves, slots, or other texturing, to aid with grasping and manipulating the lock member28so a user can disengage the lock member28. While an outer surface98generally mirrors the shape of the curved surface92and the planar surfaces94, this need not be the case and the outer surface98can have a variety of other shapes or configurations. Additionally, while reference is made to including the grasping structures and detents, it will be understood that one or more of the outer surface98, the curved surface92, and generally planar surfaces94can include friction enhancing surfaces to aid with grasping by a user or being securely retained against the biasing member30and/or the body portion78.

Returning toFIG.5, with removal of the lock member28, the needle actuation handle20can move into and from the proximal handle18, thereby moving the needles22through the needle port32a,32bto puncture tissue. This movement advances a distal end110of each needle22and deploys a suture anchor120from each needle22, as illustrated inFIGS.8-10. The suture anchor120is partially retained within a lumen112of the needle22and partially extends through a slot114extending proximally from the distal end110. The suture66attached to each suture anchor120extends proximally within the lumen112of the needle22to which the suture anchor120is selective attached. The legs122of the suture anchor120bend proximally from a base124, with the legs122and the base124generally forming a T-shape. The legs122can rest, in one configuration, along an outer surface116of the needle22, when the needle22is disposed within the needle lumen34a,34b. The legs122remain in this orientation as the needle22is advanced from the needle port32a,32band through the tissue as a sharpened edge130of the distal end110. Once through the tissue, the legs122extend outwardly and away from the outer surface116, as illustrated inFIG.9, returning to the general T-shape configuration. When the needle actuation handle20is moved proximally, frictional engagement of the suture anchor120within the lumen112and slot114is overcome as the suture anchor120is brought into contact with the tissue so that the suture anchor120is deployed from the retracted needle22.

The suture anchor120illustrated inFIGS.8-10can be fabricated from polypropylene or another polymer. The legs122can be integrally formed with the base124that is subsequently bonded to the suture66. For instance, the base124can include an opening126providing access for the suture66into a lumen128. The suture66can be secured within the lumen128, such as through thermal welding, adhesives, crimping, mechanical affixation, or other attachment techniques. Alternatively, the suture66and base124can be heated to reflow to form a one-piece, optionally monolithic, suture anchor and suture structure. In still another configuration, the legs122, whether individually or as a bar-like member forming both legs122in the illustrated configuration, can be heated to reflow to form a one-piece, optionally monolithic, suture anchor and suture structure, without the base124. In this other configuration where the suture anchor120does not include the base124, the legs122can be secured to the suture66through thermal welding, adhesives, crimping, mechanical affixation, or other attachment techniques.

While reference is made to the legs122and the base124generally forming a T-shape, it will be understood that other orientations are possible. For instance, the legs122can form a V-shape, with the V-shape being open in the proximal direction and with or without the base124extending from an apex in the open form. In another configuration, the legs122can form a U-shape being open in the proximal direction and with or without the base124extending from the curved portion of the U-shape. In still another configuration, the suture66is tied to the suture anchor120, such as at an intermediate position of the legs122when no base124is included. The knot provides a mechanical connection between the suture66and the suture anchor120. To aid with maintaining the knot, it can be thermally set or can be headed to at least partially reflow.

Turning toFIG.11-21illustrated is one method for closing a tissue opening or puncture using the closure device of the present invention.FIG.11illustrates first steps of a method for closing a puncture150in a body wall152. The method can begin following positioning a guidewire46through the skin156along the tissue tract158through the puncture150in the body wall152and into the body lumen154, such as a vessel. With the guidewire46in place, the guidebody24is advanced over the guidewire46, as illustrated inFIG.11, until the guidebody24is within the body lumen154. The guidebody24is then retracted proximally until pulsating flow from the outlet port58indicates that the shaft12is appropriately positioned in the body lumen154, as illustrated inFIG.12.

Following positioning the shaft12within the body lumen154, the lock member28is disconnected from its engagement with the needle assembly70. More specifically, a user grasps the outer surface98and applies sufficient force to overcome the engagement between the detents96and the biasing member30and/or the body portion78. The lock member28remains attached to the finger grips19of the proximal handle18through the tether102, as illustrated inFIG.13, but no longer prevents inadvertent movement of the needle actuation handle20. Instead, the user can advance the needle actuation handle20to begin to advance the needles22from the needle ports32a,32bso that the legs122extend generally transversely or perpendicularly to the suture in a pre-deployed or partially deployed state. The needles22can then be advanced into and through the tissue, as illustrated inFIGS.14and15.

The legs122resiliently flex or deflect to extend proximally as the needle22penetrates and passes through the body wall152on opposite sides of the puncture150and into the body lumen154. Once in the body lumen154, as illustrated inFIG.16, the legs122extend outwardly from the needle22and the suture anchor120moves to the deployed state with the legs122. The legs122extend generally transversely or perpendicularly to the suture as the force on the legs122as they move through the tissue is released and the resiliency of the material forming the legs122allows the legs to transition to the deployed state. Alternatively, the legs122can be biased toward the deployed state, such as through forming the legs122with or including a biasing member in the legs formed of NITINOL or other shape memory or superelastic material. Alternatively, the legs122can be formed of Magnesium or some other biodegradable or bioabsorbable material.

As shown, the suture anchor120in the expanded state has a diameter or width greater than the width of the needle22or the opening in the body wall152formed by the needle22. This increased dimension prevents passage of the suture anchor120when the user pulls back on the needle actuation handle20and the legs122contact the body wall152, as illustrated inFIGS.17-19. Instead, following the initial contact with the body wall152, continued proximal movement of the needle actuation handle20overcomes frictional engagement between the suture anchor120and the slot114, walls of the needle22, and/or interior surface of the lumen112to release or allow detachment of the suture anchor120from the needle22.

Referring now toFIG.20, the needle assembly70is moved proximally through the shaft12and separated from the proximal handle18. This movement also draws the sutures66from within suture storage receptacle72leaving the sutures66extending from the suture anchor120through the shaft12and the proximal handle18, as illustrated inFIGS.20and21. Thereafter, the closure device10can be removed while leaving the guidewire46in place to retain access to the puncture150. The sutures66from each suture anchor120can be tied together to create hemostasis and then the ends of the sutures66can be cut following confirmation of hemostasis. This can be achieved directly by the clinician, surgeon, or the like, manually forming, advancing the knot to the puncture150, and then cutting the suture66. Alternatively, the clinician, surgeon, or the like can use a knot pusher and suture cutter, such as the suture trimmer disclosed in U.S. Pat. No. 8,211,123 entitled Suture Trimmer and the snared suture trimmer disclosed in U.S. Pat. No. 6,746,457 entitled Snared Suture Trimer, the disclosures of which are is incorporated here by this reference.

Instead of using a knot pusher and suture cutter, the present invention also contemplates use of a knot replacement device that holds sutures in a position to induce hemostasis without the sutures being tied into a knot. The knot replacement device uses a suture lock as a mechanical structure to prevent suture slippage following tensioning to cause hemostasis. This provides for a quick and efficient mechanism to retain the sutures to maintain hemostasis.

Referring now toFIGS.22-24there is shown an exemplary embodiment of a knot replacement device200in accordance with the present invention. The knot replacement device200comprises a shaft210having a proximal end212and distal end214, with a handle230disposed at the proximal end212of the shaft210. A suture lock250is disposed at the distal end214within an opening216communicating with a bore218of the shaft210. A cutting member260and an actuator member270are slidably disposed within the bore218of the shaft210, with the cutting member260selectively closing an aperture220in a wall222of the shaft. The cutting member260is adapted to cut the sutures66, while the actuator270can aid with deployment of the suture lock250from the shaft210.

Generally, the knot replacement device200in accordance with the present invention is suitable for use in remote procedures performed through percutaneous tissue punctures, such as vascular closures, laparoscopic and other minimally invasive procedures and the like. Thus, the shaft210of the knot replacement device200may be embodied in many lengths to accommodate the various procedures for which the device may be utilized. The diameter of the shaft210will be sufficiently small to facilitate the introduction through access sheaths, trocars, and the like, as well as punctures through the tissue of a patient's body, herein referred to as a “tissue tract,” and/or coated with lubricious coatings such, as hydrophilic or hydrophobic coatings. Typically, the diameter of the shaft210will range from about 4 French to about 10 French, more preferably the diameter of the shaft may range from about 6 French to about 8 French.

It shall be appreciated that although the knot replacement device200will be described as being utilized in minimally invasive procedures, it is contemplated that the knot replacement device200can be utilized for many open procedures that utilize sutures to close vessels or wounds.

The shaft210of the knot replacement device200in accordance with the present invention is preferably rigid, typically being formed from of a bio-compatible material such as metal or plastic. Suitable metals include stainless steel, gold plated metals, silver plated metals, platinum or platinum plated metals, or titanium. It shall be understood that other metals may be utilized if an appropriate bio-compatible coated was applied thereto. Suitable plastics include polycarbonate, polyvinyl chloride (PVC), nylon, or similar plastics. As will be described in greater detail below, the shaft210may be formed of more than one component. It is further contemplated that the shaft210may be constructed to provide a degree of flexibility which will enable the device to be utilized in a greater number of surgical procedures.

The housing230may be constructed of a bio-compatible material such as metal or plastic. Suitable metals include stainless steel, gold plated metals, silver plated metals, platinum or platinum plated metals, or titanium. It shall be understood that other metals may be utilized if an appropriate bio-compatible coated was applied thereto. Suitable plastics include polycarbonate, polyvinyl chloride (PVC), nylon, or similar plastics. In a preferred embodiment the housing is constructed of plastic.

In a preferred embodiment the suture lock250will be provided within the bore218at the distal end214of the shaft210. The suture lock250is preferably formed of a material that can firmly engage the sutures and prevent inadvertent slippage that would prevent hemostasis, while also being bio-compatible. For instance, the suture lock250is constructed from the following or compounds of the following: polylactic acid (PLA), polyglycolic acid (PGA), polyglactin, polyepsilon-caprolactone, polydioxanone (PDS), polyorthoester, and polyethylene oxide. A cross-section of the suture lock250can be rounded, elliptical, oval, polygonal, non-circular or non-rounded, or combinations thereof.

As illustrated inFIG.24, the suture lock250has an opening252extending through a proximal portion254and a distal portion256. The proximal portion254has a shape complementary to the opening216. For instance, in the illustrated configuration, the proximal portion254has a generally cylindrical form. In contrast, the distal portion256has a slightly convex or concave front face258. The suture lock250preferably has a diameter equal to or less than the diameter of the shaft210for one or both of the proximal portion254and the distal portion256. In some circumstances, however, a distal end of the suture lock250can have a larger diameter than the shaft210. The suture lock250will further include the opening252formed through an axis thereof and in communication with the opening216formed the shaft210. The opening252also is in communication with the aperture220in the wall222and has sufficient clearance so that the free ends and limbs of S and S′ of the suture66may be drawn through the opening252and the aperture220through the use of a suture snare290(FIGS.22-23). The free ends and limbs S and S′ of the suture66extend from the aperture220in the shaft210and enable the tensioning of the suture66, if needed.

The opening252can have a diameter that approximates and accommodates for any suture extrusion dimensional variation to assure interference when the suture is wrapped. The opening252can include one or more internal grooves259that extend from the proximal portion254to the distal portion256axially, non-axially, spirally, helically, or combinations thereof. The grooves259allow for excess suture to be wedged during lock advancement. The grooves259can have uniform or non-uniform depth along the groove's length. For instance, the non-uniformity can be gradual between the proximal portion254to the distal portion256or can be discontinuous, irregular, or intermittent along the groove's length. Alternate examples of the openings of the suture lock250are illustrated inFIGS.32-36.

The suture lock250may be retained within a bore218of the shaft210through the use of mechanical fasteners or suitable adhesives while being selectively released from the shaft220. As illustrated inFIG.24, the detents224can be formed on the shaft210to hold the suture lock250. Alternatively, the shaft210can be crimped or deformed to form the detents224either before or after the suture lock250is disposed within the opening216. The detents224provide some resistance to twisting or rotating of the suture lock250relative to the distal end214of the shaft210, in addition to limiting longitudinal movement. By so doing, the suture lock250does not inadvertently release from distal end engagement while the sutures66are twisted or braided together.

It will be understood that while reference is made to inclusion of detents, the shaft and suture lock can have various other configurations. For instance, the suture lock can include a circumferential groove or independent holes or apertures that cooperate with a detent. In still another configuration, the shaft can have a proximally tapering end that receives a proximal portion of the suture lock having sufficient pliability or deformability to being inserted through the opening into the tapering end and be retained therein until released.

With reference toFIGS.22-24, the cutting member260and the actuator270may be retained within the bore218of the shaft210coaxially, though it is contemplated that they may be retained in other manners, such as, side-by-side or offset. Both the cutting member260and the actuator270are slidably disposed within the bore218of the shaft210and can be actuated by a first lever240and second lever242extending from the handle230. The first lever240and second lever242are operatively associated with the cutting member260and the actuator member270.

As shown inFIG.25, the cutting member260comprises an elongated member262having a proximal end and a distal end264. A cutting edge266is formed within the cutting member260adjacent to the distal end264. The second lever242is coupled to the cutting member260adjacent to the proximal end. The lever242is further configured to engage a biasing member232, such as a spring, within the handle230, as shown inFIG.23.

The cutting member260may be constructed of a bio-compatible material, such that the material chosen is capable of having a sufficiently sharp cutting edge264formed therein. For example, surgical stainless steel may be utilized as well as titanium. Furthermore, it is contemplated that the cutting member260may include one or more elements coupled together. For example, the elongated member262of the cutting member260may be constructed of a bio-compatible material such as plastic and the sharp cutting edge264may be formed of metal, the cutting edge264being mounted to the elongated member262to form a single structure.

The actuator270may be constructed of a bio-compatible material such as metal or plastic. In a preferred embodiment the actuator270is constructed of a bio-compatible plastic. Additionally, the actuator270may be constructed of multiple pieces, wherein the actuator270and lever are assembled utilizing known methods of mechanical fastening or through the use of an adhesive. It is further contemplated that the actuator270and lever may be integrally formed or a one-piece construction, such as through the use of injection molding.

Referring now toFIGS.26-28there is shown a distal end of the knot replacement device200in accordance with the present invention in use. As shown, the sutures66have the two free ends, S and S,′ those two ends S and S′ having been pulled through the suture lock250by the suture snare290. For instance, following placing the two free ends S and S′ of the suture66within a distal end portion292of the suture snare290that has been disposed through the opening216, a housing294of the suture snare290is detached from the shaft210(FIG.23) and removed, thereby allowing a user to draw the distal end portion292, with the captured suture ends S and S′ through the opening216and the suture lock250. As the distal end portion292is drawn through opening218and from the aperture220, the free ends S and S′ are drawn through to extend from the shaft210.

With continued reference toFIGS.26-28, there is shown the distal end of the knot replacement device200in accordance with the present invention.FIG.26illustrates the actuator270retracted to receive the sutures66through manipulation of the first lever240proximally. When the first lever240is released, the biasing member232coupled to the proximal end of the actuator270, causes the actuator270to advance distally and partially closing the bore218adjacent the aperture220, as illustrated inFIG.27. A secondary biasing member236, such as a spring, distal a distal end of the first lever240limits distal movement of the actuator270until the suture lock250is to be deployed from the shaft210. The biasing force of the secondary biasing member236can be overcome through distal movement of the first lever240to distally advance the distal end of the actuator270against the proximal portion254to release it from, in one example, engagement with the detent224, or other rotational and/or longitudinal movement limiter.

As shown, the actuator270includes a groove272within which the sutures66can be disposed to protect the sutures66from inadvertent cutting by the edges of the aperture220. If the suture66were allowed to contact the edge of the aperture220, a nick or cut may be formed in the sutures66, this may lead to failure of the sutures66during tensioning and before the suture lock250can be placed appropriately. If the sutures were to fail the clinician, surgeon, or the like would be required to place additional sutures. Therefore, the actuator270prevents the suture from being cut or abraded by the edge of the aperture220which may lead to failure of the suture.

Referring now toFIG.28, there is shown a partial view of the distal end of the knot replacement device200in accordance with the present invention where the cutting member260has been actuated to cut the sutures. For instance, with the sutures66captured by the actuator270the knot replacement device200is rotated to tension the sutures and create hemostasis of the puncture. This also braids or twists the sutures66together. When the braided or twisted portion is drawing into a lumen256of the suture lock250, sufficient frictional contact with the sutures66occurs to prevent suture slippage and releasing of the tensions.

Upon actuation, the cutting edge264is advanced from a shielded position within the shaft210toward the sutures66through manipulating the lever242. The cutting member260is advanced from the shielded position by applying a force to the lever242, the lever242being coupled to the proximal end of the cutting member260. As described above, the cutting member260is actuated by pulling back on the lever242, thereby advancing the lever242towards the proximal end of the knot replacement device200and compressing a second biasing member234disposed within the handle230. As shown, the cutting member260includes the sharpened cutting edge266that cooperates with a distal end of the aperture to shear or cut the sutures66. As described above and illustrated inFIG.28, the cutting member260of the knot replacement device200moves relative to the shaft210.

Referring now toFIGS.29-32, there is shown a partial view of the distal end214of the knot replacement device200in accordance with the present invention disposed in various states of use associated with a method of the present invention.

Referring now toFIG.29, there is shown the distal end of the knot replacement device200with the actuator270disposed in a distally advanced position. Sutures66have been positioned in tissue as shown, wherein the two free ends S and S′ of the sutures66extend from the tissue. In this position the knot replacement device200is ready to receive the sutures66when the suture snare290(FIG.22) draws the two free ends S and S′ through the lumen256of the suture lock250and from the aperture220in the wall222, as illustrated inFIG.30.

Once the sutures66are positioned to extend through the aperture220, the force applied to the first lever240(FIG.22) is released, thereby allowing the actuator270to advance distally within the bore218of the shaft210. The distal end of the actuator270passes the distal end of the aperture220but remains proximal to the proximal portion254of the suture lock250, as illustrated inFIG.30.

With the sutures66locked in position through positioning of the actuator270, the knot replacement device200is rotated to twist or braid the sutures66together. This can include one or more full or partial rotations until the sutures66have a cross-sectional dimension that is sufficient to frictionally engage with the opening252. For instance, in one configuration the opening252has a diameter that receives two sutures and approximates and accommodates for any suture extrusion dimensional variation to assure interference when the suture is wrapped.

When sufficient twisting or braiding has occurred, an axial force is applied to the second lever242to distally advance the cutting member260to cut or sever the sutures66. Additionally, either simultaneously with, or following movement of the cutting member, the first lever240is moved distally, overcoming the biasing force of the secondary biasing member236, so that the distal end of the actuator270contacts the proximal portion254of the suture lock250. Continued distal movement, distally advances the suture lock250from the distal end215of the shaft210to overcome the engagement forces between the detent224and the suture lock250, for instance, as illustrated inFIG.32. The engagement force is less than the anchor suture attachment force, which is about 2 lbf. The engagement force, therefore, is about 0.5 to about 1.25 lbf.

Turning toFIGS.33-37, illustrated are different configurations of the suture lock according to the present invention. Like reference numerals are associated with like elements. Additionally, the disclosure of the suture lock250is applicable to the suture locks illustrated inFIGS.33-37. For instance, openings in the suture locks ofFIGS.33-37can have a diameter that approximates and accommodates for any suture extrusion dimensional variation to assure interference when the suture is wrapped. The openings can include internal grooves that extend from the proximal portion to the distal portion axially, non-axially, spirally, helically, or combinations thereof. The grooves allow for excess suture to be wedged during lock advancement. The grooves can have uniform or non-uniform depth along the groove's length, such as gradual or discontinuous, irregular, or intermittent depth non-uniformity between the proximal portion and the distal portion.

With reference toFIG.33, illustrated is a suture lock350ahaving an opening352a. The opening352aincludes one or more grooves359adisposed around the periphery of the opening352a. The grooves359ainclude a curved wall374aextending from an inner wall376aof the opening352ain a radial direction, the inner wall376aforming an inner periphery378aof the opening352aand the outer periphery of the curved wall374a, in the radial direction, forming an outer periphery380aof the opening352a.

FIG.34illustrates another suture lock350bhaving an opening352b. The opening352bincludes one or more grooves359bdisposed around the periphery of the opening352b. The grooves359bincludes a wall374bextending from an inner wall376bof the opening352bin the radial direction, the inner wall376bforming an inner periphery378bof the opening352band an apex of the wall374bforming an outer periphery380bof the opening352b.

FIG.35illustrates another suture lock350chaving an opening352c. The opening352cincludes one or more grooves359cdisposed around the periphery of the opening352c. The grooves359cincludes a curved wall374cextending radially inwardly from an outer wall376cof the opening352c, the innermost periphery of the curved wall374cforming an inner periphery378cof the opening352band the outer wall376cforming an outer periphery380cof the opening352c.

FIG.36illustrates another suture lock350dhaving an opening352d. The suture lock350dis similar to suture lock350a, however, the grooves359dhave differing depths in a radial direction and differing width in a circumferential direction.

FIG.37illustrates another suture lock350ehaving an opening352e. The suture lock350eis similar to suture lock350a, however, the opening352eis non-circular in that the opening352ehas a long axis382eand a short axis384esuch that the opening352eapproximate an oblong or rectangular shape with the grooves359e. While reference is made to approximating an oblong or rectangular shape, the opening can have other polygonal, elliptical, or other non-polygonal shapes so long as there is a long axis and a short axis, even if there is no symmetry about one or both of the long axis and the short axis.

It is understood that any of the structures and features of embodiments illustrated inFIGS.33-37can be combined into a single suture lock. Generally, each suture lock can include an opening and grooves, with such opening approximating any polygonal, elliptical, or other non-polygonal shape and such grooves having the same or different depths, widths, and shapes in the suture lock and being uniformly or non-uniformly distributed about the periphery of the suture lock.

The articles “a,” “an,” and “the” are intended to mean that there are one or more of the elements in the preceding descriptions. The terms “comprising,” “including,” and “having” are intended to be inclusive and mean that there may be additional elements other than the listed elements. Additionally, it should be understood that references to “one embodiment” or “an embodiment” of the present disclosure are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the recited features. Numbers, percentages, ratios, or other values stated herein are intended to include that value, and also other values that are “about” or “approximately” the stated value, as would be appreciated by one of ordinary skill in the art encompassed by embodiments of the present disclosure. A stated value should therefore be interpreted broadly enough to encompass values that are at least close enough to the stated value to perform a desired function or achieve a desired result. The stated values include at least the variation to be expected in a suitable manufacturing or production process, and may include values that are within 5%, within 1%, within 0.1%, or within 0.01% of a stated value.

A person having ordinary skill in the art should realize in view of the present disclosure that equivalent constructions do not depart from the spirit and scope of the present disclosure, and that various changes, substitutions, and alterations may be made to embodiments disclosed herein without departing from the spirit and scope of the present disclosure. Equivalent constructions, including functional “means-plus-function” clauses are intended to cover the structures described herein as performing the recited function, including both structural equivalents that operate in the same manner, and equivalent structures that provide the same function. It is the express intention of the applicant not to invoke means-plus-function or other functional claiming for any claim except for those in which the words ‘means for’ appear together with an associated function. Each addition, deletion, and modification to the embodiments that falls within the meaning and scope of the claims is to be embraced by the claims.

The terms “approximately,” “about,” and “substantially” as used herein represent an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, the terms “approximately,” “about,” and “substantially” may refer to an amount that is within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of a stated amount. Further, it should be understood that any directions or reference frames in the preceding description are merely relative directions or movements. For example, any references to “up” and “down” or “above” or “below” are merely descriptive of the relative position or movement of the related elements.

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, with it being understood that the scope of the present disclosure extends to rewriting any of the claims to depend from any other claim, to include multiple dependencies from any combination of other claims, and/or to combine multiple claims together. Additionally, elements described in relation to any embodiment depicted and/or described herein may be combinable with elements described in relation to any other embodiment depicted and/or described herein. Such also extends to the embodiments as described in the Summary section, as well as the Detailed Description section, including the drawings. The scope of the present disclosure also extends to inserting and/or removing any combination of features from any claim or described embodiment, for insertion into another claim or embodiment, or drafting of a new claim including any combination of such features from any other claim(s) or embodiments. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.