Patent Description:
The present invention relates generally to surgical tools, and specifically to surgical suture fasteners.

The current standard of care treatment for heart valve disease is open-heart surgery, in which the valvular problem is corrected either by repair of the valve or replacement of the valve, with the use of therapeutic prostheses. These prostheses are held in position with respect to the cardiovascular tissue using sutures. These sutures are usually manually tied using hands or traditional knot pushers.

Recently, automated fastener devices have been developed. These devices exhibit safe, reliable and fast application, in combination with substantial time savings in cardioplegic arrest and cardiopulmonary bypass.

Cor-Knot® (LSI Solutions, Inc. , Victor, NY, USA) is an automated titanium fastener indicated in the approximation of soft tissue and prosthetic materials, used in conjunction with either <NUM>-<NUM> polyester or <NUM>-<NUM>/<NUM>-<NUM> polypropylene sutures.

<CIT> relates to systems and methods for anchoring an implant, and discloses a suture fastener as defined in the pre-amble of appended independent claim <NUM>.

<CIT> relates to apparatus and methods for tendon or ligament repair.

<CIT> relates to suture anchoring assemblies and methods of use.

<CIT> relates to an implant inserted without bone anchors for treatment of urge incontinence.

W) <NUM>/<NUM> relates to suture securement devices that replace the need to tie knots in sutures.

In accordance with the present invention, there is provided a suture fastener as defined in appended independent claim <NUM>. Embodiments of the present invention are defined in appended claims dependent on independent claim <NUM>. Methods of using the suture fastener are described as a way of better understanding the suture fastener and do not form part of the present invention.

The present disclosure provides a suture fastener system for fastening sutures in medical applications. The suture fastener system is typically used for automatic suture fastening for securing an implantable prosthesis to tissue of a patient, such as cardiac tissue, or for securing two or more cardiovascular tissues sutured together, e.g., for cardiac bypass surgery or anastomosis. The suture fastener system may be configured for use during open, minimally-invasive, percutaneous, laparoscopic, robotic, or other surgical procedures.

The surgical fastener system comprises a surgical fastener instrument and a suture fastener, typically a plurality of suture fasteners. The surgical fastener instrument typically comprises an outer delivery tube, which has a distal opening at a distal end of the outer delivery tube; an inner delivery shaft, which is disposed at least partially in the outer delivery tube; and a handle, which is coupled to a proximal portion of the outer delivery tube, and comprises a user control element arranged to rotate the inner delivery shaft with respect to the outer delivery tube.

The suture fastener is removably disposed in the outer delivery tube in an unlocked conical helical configuration. The surgical fastener instrument is arranged such that distal advancement of the inner delivery shaft, when one or more portions of the one or more sutures pass through respective portions of the suture fastener, transitions the suture fastener from the unlocked conical helical configuration to a locked planar spiral configuration, in which the one or more sutures are fixedly coupled to the suture fastener. The suture fastener can be fastened to the one or more sutures and any locations along the one or more sutures. This crimping of the suture fastener to the one or more sutures tightens the sutures and keeps them in place. This crimping of the suture fastener may replace standard suture knots, which are generally made manually by surgeons.

For some applications, the surgical fastener instrument is configured such that when the suture fastener is removably disposed in the outer delivery tube in the unlocked conical helical configuration, and the one or more sutures are disposed partially within the outer delivery tube, rotation of the inner delivery shaft rotates the suture fastener, thereby causing the one or more portions of the one or more sutures to pass through and become entangled in the respective portions of the suture fastener. This rotational technique for introducing the one or more sutures into the fastener obviates the need to hook the sutures or use a loop system to engage the sutures. The open shape of the suture fastener when in the unlocked conical helical configuration enables this rotational introduction technique.

The suture fastener may be used with many types of sutures, including monofilament sutures (e.g., comprising Prolete® Polypropylene Sutures (Ethicon US, LLC) of any diameter, because the suture fastener can apply sufficient friction to tightly grasp monofilament sutures between the turns of the planar spiral of the fastener.

If necessary, before the suture fastener has been crimped by the distal advancement of the inner delivery shaft, the one or more sutures can be released from the suture fastener by counter-rotation of the inner delivery shaft. This enables the repositioning of the surgical fastener instrument over the same one or more sutures in a different position or under different conditions (e.g., different tension). After the suture fastener has been crimped, the one or more sutures can be freed from the surgical fastener instrument by cutting the one or more sutures using (a) a scalpel in supra fastener position, (b) one or more blades of the surgical fastener instrument, which may be activated by a user control element of a handle of the surgical fastener instrument, without risking to damage the prosthesis to which the sutures are coupled, or (c) one or more blades defined by the suture fastener itself.

There is provided, in accordance with the present invention, a suture fastener for fastening one or more sutures, the suture fastener shaped so as to define:.

In one form of the suture fastener, the radially-inward portion is shaped so as to define a non-circular and non-spiral opening.

In one form of the suture fastener, a height of the suture fastener, when in the locked planar spiral configuration, is less than <NUM>.

In one form of the suture fastener, when the suture fastener is in the locked planar spiral configuration, a height of the suture fastener is less than <NUM>% of a greatest dimension of the suture fastener.

In one form of the suture fastener, an area of an upper surface of the radially-inward portion is between <NUM>% and <NUM>% of a total area of an upper surface of the suture fastener, including the radially-inward portion and the spiral portion.

In one form of the suture fastener, the suture fastener is shaped as a double helix in the unlocked conical helical configuration, and a double planar spiral in the locked planar spiral configuration.

In one form, the suture fastener further includes sterile packaging, in which the suture fastener is removably disposed.

<FIG> is a schematic illustration of a surgical fastener system <NUM> for fastening one or more sutures <NUM>, including a suture fastener in accordance with an application of the present invention. The one or more sutures <NUM> shown in <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> are typically not elements of surgical fastener system <NUM>.

Surgical fastener system <NUM> comprises a surgical fastener instrument <NUM> and a suture fastener <NUM>, typically a plurality of suture fasteners <NUM>. Surgical fastener instrument <NUM> comprises:.

Typically, user control element <NUM> is operated by the palm and fingers of the operator using wrist and finger movement, using little force. For some applications, handle <NUM> comprises a plurality of user control elements <NUM>, for controlling the different functions of surgical fastener instrument <NUM> during the several steps of its use, as described hereinabove with reference to <FIG>. For example, user control element <NUM> may be a first user control element <NUM>, and handle <NUM> may comprise a second user control element <NUM>, which is arranged to cause distal advancement of inner delivery shaft <NUM> (typically with respect to outer delivery tube <NUM>).

For some applications, user control element <NUM> is arranged to both rotate inner delivery shaft <NUM> with respect to outer delivery tube <NUM> and to cause the distal advancement of inner delivery shaft <NUM> (typically with respect to outer delivery tube <NUM>). Typically, user control element <NUM> is arranged to begin causing the distal advancement of inner delivery shaft <NUM> after beginning rotating of inner delivery shaft <NUM>. Optionally, user control element <NUM> is arranged to begin causing the distal advancement of inner delivery shaft <NUM> after completing rotating of inner delivery shaft <NUM>. Alternatively or additionally, user control element <NUM> may be arranged to cause the distal advancement of inner delivery shaft <NUM>, and thereafter cause one or more blades of surgical fastener instrument <NUM> to cut the one or more sutures <NUM>, such as described hereinbelow with reference to <FIG>, mutatis mutandis.

Suture fastener <NUM> is removably disposed in outer delivery tube <NUM> in an unlocked conical helical configuration <NUM> (which may be considered an uncrimped or open configuration), such as, for example, shown in <FIG>. Surgical fastener instrument <NUM> is arranged such that distal advancement of inner delivery shaft <NUM>, when one or more portions of the one or more sutures <NUM> pass through respective portions of suture fastener <NUM>, transitions suture fastener <NUM> from unlocked conical helical configuration <NUM> to a locked planar spiral configuration <NUM>, such as, for example, shown in <FIG>, by a distal portion of inner delivery shaft <NUM> pushing on a proximal portion of suture fastener <NUM>. In locked planar spiral configuration <NUM> (which may be considered a crimped configuration), the one or more sutures <NUM> are fixedly coupled to suture fastener <NUM> (as shown in <FIG> and <FIG>). This transitioning may be considered crimping suture fastener <NUM> to the one or more sutures <NUM>. (It is noted that surgical fastener instrument <NUM> is arranged such that the distal advancement of inner delivery shaft <NUM> transitions suture fastener <NUM> from unlocked conical helical configuration <NUM> to locked planar spiral configuration <NUM> even if no sutures <NUM> pass through suture fastener <NUM>, although surgical fastener instrument <NUM> is not intended to be used without at least one suture. ) As used in the present application, including in the claims, when suture fastener <NUM> is in the unlocked conical helical configuration <NUM>, suture fastener <NUM> is not necessarily entirely helical, and when suture fastener <NUM> is in the locked planar spiral configuration <NUM>, suture fastener <NUM> is not necessarily entirely planar spiral; for example, suture fastener <NUM> may be shaped so as define one or more non-helical portions, such as the radially-inward center portion described hereinbelow.

For some applications, a plurality of suture fasteners <NUM> are removably disposed in outer delivery tube <NUM> in unlocked conical helical configurations <NUM>, and surgical fastener instrument <NUM> is configured to deploy the suture fasteners one at a time (configuration not shown).

Reference is now made to <FIG>, which are schematic illustrations of suture fastener <NUM>, in accordance with an application of the present invention. In <FIG>, suture fastener <NUM> is shown in unlocked conical helical configuration <NUM>. In <FIG>, suture fastener <NUM> is shown in locked planar spiral configuration <NUM>.

The above-mentioned relatively low height H1, i.e., low profile (compared to known surgical fasteners) results in a relatively low offset of suture fastener <NUM> from the prosthesis (compared to known surgical fasteners), which may reduce the likelihood of damaging surround tissue or prosthesis components.

For some applications, the conical helices and planar spirals of suture fastener <NUM> have between <NUM> and <NUM> turns, such as two, three, or four turns.

For some applications, suture fastener <NUM> is configured to assume unlocked conical helical configuration <NUM> when in a resting state. For these applications, surgical fastener instrument <NUM> is arranged such that the distal advancement of inner delivery shaft <NUM> transitions suture fastener <NUM> from unlocked conical helical configuration <NUM> to locked planar spiral configuration <NUM> by axially plastically deforming suture fastener <NUM>. For these applications, suture fastener <NUM> typically comprises a metal such as titanium, tantalum, gold, silver, platinum-iridium, cobalt-chromium, or stainless steel.

Alternatively, for some applications, suture fastener <NUM> is configured to assume locked planar spiral configuration <NUM> when in a resting state, and surgical fastener instrument <NUM> is arranged to temporarily constrain suture fastener <NUM> in unlocked conical helical configuration <NUM>. For these applications, suture fastener <NUM> typically comprises a metal having a shape memory, such as a superelastic metal, e.g., Nitinol.

For some applications, suture fastener <NUM> is shaped so as to define a radially-inward portion <NUM> that is neither helical nor spiral, both when suture fastener <NUM> is in unlocked conical helical configuration <NUM> and when suture fastener <NUM> is in locked planar spiral configuration <NUM>. Radially-inward portion <NUM> is typically shaped so as to define a non-circular and non-spiral opening <NUM>, as shown in the figures. This shape of opening <NUM> may aid in engagement of suture fastener <NUM> by the distal end of inner delivery shaft <NUM>, which may be shaped, for example, like a conventional flat screwdriver head. In these applications, suture fastener <NUM> is shaped so as to define a spiral portion <NUM>, which is (a) conically helical when suture fastener <NUM> is in unlocked conical helical configuration <NUM> and (b) planar spiral when suture fastener is in planar spiral configuration <NUM>. Radially-inward portion <NUM> is disposed radially inward from spiral portion <NUM>, both when suture fastener <NUM> is in unlocked conical helical configuration <NUM> and when suture fastener <NUM> is in locked planar spiral configuration <NUM>.

For some applications, an area of an upper surface of radially-inward portion <NUM> is at least <NUM> mm2, no more than <NUM> mm2, and/or between <NUM> and <NUM> mm2. Alternatively or additionally, for some applications, a total area of an upper surface of suture fastener <NUM>, including radially-inward portion <NUM> and spiral portion <NUM>, is at least <NUM> mm2, no more than <NUM> mm2, and/or between <NUM> and <NUM> mm2. Further alternatively or additionally, for some applications, an area of an upper surface of radially-inward portion <NUM> is at least <NUM>% (e.g., at least <NUM>%), no more than <NUM>% (e.g., no more than <NUM>%, and/or between <NUM>% (e.g., <NUM>%) and <NUM>% (e.g., <NUM>%) of a total area of an upper surface of suture fastener <NUM>, including radially-inward portion <NUM> and spiral portion <NUM>. (In configurations in which radially-inward portion <NUM> is shaped so as to define opening <NUM>, the above-mentioned areas exclude the area of opening <NUM>.

Reference is now made to <FIG>, which are schematic illustrations of a suture fastener <NUM> in an unlocked conical helical configuration <NUM> and a locked planar spiral configuration <NUM>, respectively, in accordance with an application of the present invention. Other than as described below, suture fastener <NUM> is similar to suture fastener <NUM>, described hereinabove, and may implement any of the features thereof, and surgical fastener instrument <NUM> may be used to deploy suture fastener <NUM> in the same manner as suture fastener <NUM>.

Suture fastener <NUM> is shaped as a double conical helix in unlocked conical helical configuration <NUM>, and a double planar spiral in locked planar spiral configuration <NUM>. This double helical configuration allows the one or more suture <NUM> to remain entangled within the spiral space between the two helical arms of suture fastener <NUM> when in unlocked conical helical configuration <NUM>. The crimping of the helical arms in locked planar spiral configuration <NUM> strengthens the tightening of the one or more sutures <NUM> because of the friction created by the crimped structure, leaving the one or more sutures <NUM> in place. In addition, this double helical configuration may allow the securement of more sutures <NUM>, and access of the sutures <NUM> to suture fastener <NUM> from more than one specific direction, increasing the entanglement of the sutures <NUM> within at least one spiral during rotating of inner delivery shaft <NUM>, as described above. Suture fastener <NUM> may be deployed using the techniques described in the same manner as suture fastener <NUM>, mutatis mutandis.

Reference is now made to <FIG>, which are schematic illustrations of a suture fastener <NUM>, in accordance with an application of the present invention. Other than as described below, suture fastener <NUM> is similar to suture fastener <NUM>, and may implement any of the features thereof. Suture fastener <NUM> is shown in <FIG> in unlocked conical helical configuration <NUM>.

Suture fastener <NUM> is shaped so as to define one or more blades <NUM> (e.g., a single blade <NUM>, as shown), which are configured to cut the one or more sutures <NUM> upon rotation of suture fastener <NUM>, after crimping of the suture fastener. Typically, suture fastener <NUM> first engages with the one or more sutures <NUM> by rotation, and then the suture fastener is crimped using handle <NUM> of surgical fastener instrument <NUM>; subsequently, suture fastener <NUM> rotates a bit further to fully cut the one or more sutures <NUM>. For example, the one or more blades <NUM> (e.g., a single blade <NUM>, as shown) may be defined by a surface of spiral portion <NUM> that faces radially inward.

Reference is now made to <FIG>, which is a schematic illustration of a suture fastener <NUM>. Other than as described below, suture fastener <NUM> is similar to suture fastener <NUM>, and may implement any of the features thereof. Suture fastener <NUM> is shown in <FIG> in unlocked conical helical configuration <NUM>.

Suture fastener <NUM> is shaped so as to define one or more blades <NUM> (e.g., a single blade <NUM>, as shown), which are configured to cut the one or more sutures <NUM> upon directing of the one or more suture <NUM> against the one or more blades <NUM>, after crimping of the suture fastener. For example, the one or more blades <NUM> (e.g., a single blade <NUM>, as shown) may be defined by:.

Typically, suture fastener <NUM> first engages with the one or more sutures <NUM> by rotation, and then the suture fastener is crimped using handle <NUM> of surgical fastener instrument <NUM>; subsequently, the one or more sutures are tensioned and angled against the one or more blades <NUM> of the fastener <NUM> to fully cut the one or more sutures <NUM>, while leaving portions of the one or more sutures crimped to the suture fastener.

Reference is now made to <FIG> and <FIG>, which are schematic illustrations of the use of surgical fastener system <NUM> to fasten an annuloplasty ring <NUM> to the mitral valve during a surgical procedure. By way of example and not limitation, <FIG> and <FIG> show surgical fastener system <NUM> being used to fasten annuloplasty ring <NUM> to the mitral valve, as is known in the mitral valve repair art. In <FIG> and <FIG>, a plurality of suture fasteners <NUM> are shown after locking (crimping) in their locked planar spiral configurations <NUM>, and the last of suture fasteners <NUM> is shown during crimping using surgical fastener instrument <NUM>. Although the procedure is shown using suture fasteners <NUM>, the other suture fasteners described herein may alternatively be used.

Reference is now made to <FIG> and <FIG>, which are schematic illustrations of the use of surgical fastener system <NUM> to fasten a suture <NUM> used to perform anastomosis during another surgical procedure. By way of example and not limitation, <FIG> and <FIG> show surgical fastener system <NUM> being used to fasten a suture <NUM> used to perform anastomosis, as is known in the anastomosis surgical art. Although the procedure is shown using suture fastener <NUM>, the other suture fasteners described herein may alternatively be used.

<FIG> shows two blood vessels 200A and 200B to be anastomosed. For example, the two blood vessels may be two arteries (arterio-arterial anastomosis), two veins (veno-venous anastomosis), an artery and a vein (arterio-venous anastomosis), or a blood vessel and an artificial blood-carrying vessel, as is known in the anastomosis surgical art.

As shown in <FIG>, the two blood vessels 200A and 200B are sutured together using a suture <NUM>, as is known in the anastomosis surgical art.

As shown in <FIG>, surgical fastener system <NUM> is used to fasten two loose portions 62A and 62B of suture <NUM> together.

As shown in <FIG>, surgical fastener instrument <NUM> used to entangle the suture two portions 62A and 62B with suture fastener <NUM> and transition suture fastener <NUM> to locked planar spiral configuration <NUM>, and, optionally, to cut excess suture portions 62A and 62B, stabilizing suture <NUM> on the anastomosis. Alternatively, a separate, conventional surgical tool is used to cut the excess suture portions, as is known in the surgical art. If necessary, more than one suture fastener <NUM> may be used to fasten the suture ends together, if the surgeon believes it to be necessary.

Reference is now made to <FIG>, which are schematic illustrations of the use of surgical fastener system <NUM> to fasten a prosthetic aortic valve <NUM> during an aortic valve replacement (AVR) surgical procedure. The above-mentioned relatively low height H1, i.e., low profile (compared to known surgical fasteners) results in a relatively low offset of suture fastener <NUM> from the prosthesis (compared to known surgical fasteners), which may reduce the likelihood of damaging surround tissue or prosthesis components. Although the procedure is shown using suture fastener <NUM>, the other suture fasteners described herein may alternatively be used.

Although <FIG> show the use of a single suture <NUM> (i.e., mattress suturing), multiple sutures <NUM> may instead be used, as is known in the art (similar to the approach shown in <FIG>.

Surgical fastener system <NUM> may also be used to fasten any other surgical sutures for any other medical procedure, including, but not limited to, implantation of other valvular prostheses (such an rings, band, or prosthetic valves), including for the mitral, tricuspid, and aortic valves.

Reference is now made to <FIG>, which are schematic illustrations of the use of surgical fastener instrument <NUM> for crimping a single suture fastener <NUM>. Reference is also made to Figs. 6A-F, which are schematic illustrations of another use of surgical fastener instrument <NUM> for crimping a single suture fastener <NUM>.

In <FIG> and <FIG>, the one or more sutures <NUM> are shown prior to being fastened using suture fastener <NUM>. For example, as shown, the one or more sutures <NUM> may include exactly one suture <NUM>, which has two portions 62A and 62B, which are fastened together by suture fastener <NUM>. Alternatively, two or more sutures <NUM> are fastened together by suture fastener <NUM> (configuration not shown). Further alternatively, exactly one portion of exactly one suture <NUM> is fastened to suture fastener <NUM> (configuration not shown), for various applications. By way of example and not limitation, the one or more sutures <NUM> are shown fastening annuloplasty ring <NUM> to tissue <NUM> of the mitral valve.

In the use of surgical fastener instrument <NUM> shown in <FIG>, suture portions 62A and 62B are arranged on generally opposite sides of outer delivery tube <NUM>, while in the use of surgical fastener instrument <NUM> shown in <FIG>, suture portions 62A and 62B are arranged on generally the same side of outer delivery tube <NUM>.

For some applications, such as shown in <FIG> and <FIG>, outer delivery tube <NUM> is shaped so as to define one or more lateral openings <NUM> that extend to distal end <NUM>, and facilitate insertion of the one or more portions 62A and 62B of the one or more sutures <NUM> into outer delivery tube <NUM> and through the respective portions of suture fastener <NUM>.

For some applications, as shown in <FIG> and <FIG> and <FIG> and <FIG>, surgical fastener instrument <NUM> is configured such that when suture fastener <NUM> is removably disposed in outer delivery tube <NUM> in unlocked conical helical configuration <NUM>, and the one or more portions 62A and 62B of the one or more sutures <NUM> are disposed partially within outer delivery tube <NUM>, rotation of inner delivery shaft <NUM> rotates suture fastener <NUM>, thereby causing the one or more portions 62A and 62B of the one or more sutures <NUM> to pass through the respective portions of suture fastener <NUM>. Typically, the rotation causes the one or more portions 62A and 62B of the one or more sutures <NUM> to become entangled with the respective portions of suture fastener <NUM>. Generally, additional rotation of suture fastener <NUM> captures additional suture in the fastener, thereby increasing the tension in the one or more sutures. Controlling the amount of rotations thus allows the surgeon to achieve a desired level of tension in the one or more sutures, such as to avoid loose knots, on the one hand, and overtightening on the other hand.

As shown in <FIG> and <FIG>, after the one or more portions 62A and 62B of the one or more sutures <NUM> pass through the respective portions of suture fastener <NUM>, distal end <NUM> of outer delivery tube <NUM> is typically pressed tightly against the implant.

As shown in <FIG> and <FIG>, surgical fastener instrument <NUM> is arranged such that the distal advancement of inner delivery shaft <NUM> transitions suture fastener <NUM> from unlocked conical helical configuration <NUM> to locked planar spiral configuration <NUM> while suture fastener <NUM> is disposed entirely within outer delivery tube <NUM>. For some applications, surgical fastener instrument <NUM> is configured to rotate inner delivery shaft <NUM> during distal advancement of inner delivery shaft <NUM>, such as to facilitate the transition from unlocked conical helical configuration <NUM> to locked planar spiral configuration <NUM> illustrated between <FIG>. For some applications, as shown perhaps most clearly in <FIG>, <FIG>, and <FIG>, distal end <NUM> of outer delivery tube <NUM> is shaped so as to define one or more radially-inwardly-extending lips <NUM>, each of which extends partially around distal opening <NUM>, and which hold suture fastener <NUM> in outer delivery tube <NUM> during distal advancement of inner delivery shaft <NUM> to transition suture fastener <NUM> from unlocked conical helical configuration <NUM> to locked planar spiral configuration <NUM>. As a result, surgical fastener instrument <NUM> does not require a rigid counter-surface to operate properly, i.e., the instrument can operate against a flexible prosthesis. In addition, surgical fastener instrument <NUM> does not require the one or more sutures to be under high tension during crimping for optimal placement.

This crimping of suture fastener <NUM> to the one or more sutures <NUM> tightens the sutures and keeps them in place, maintaining tension in the sutures.

As shown in <FIG> and <FIG>, after the one or more portions 62A and 62B of the one or more sutures <NUM> have been fixedly fastened to suture fastener <NUM>, surgical fastener instrument <NUM>, including outer delivery tube <NUM> and inner delivery shaft <NUM>, is disengaged from suture fastener <NUM> and the one or more portions 62A and 62B of the one or more sutures <NUM>. For some applications, distal end <NUM> of outer delivery tube <NUM> is shaped to allow distal passage of suture fastener <NUM> out of distal opening <NUM> when suture fastener <NUM> is in locked planar spiral configuration <NUM>, as shown in <FIG> and <FIG>. For some applications, distal end <NUM> of outer delivery tube <NUM> is shaped to allow the distal release of suture fastener <NUM> out of distal opening <NUM> upon rotation of outer delivery tube <NUM> with respect to suture fastener <NUM> when suture fastener <NUM> is in locked planar spiral configuration <NUM>. This rotation generally aligns the greatest dimension D of suture fastener <NUM> (labeled in <FIG>) with lateral openings <NUM>, and the smallest dimension of suture fastener <NUM> with lips <NUM>, such that suture fastener <NUM> can pass out of distal opening <NUM>.

As mentioned above, in the use of surgical fastener instrument <NUM> shown in <FIG>, suture portions 62A and 62B are arranged on generally opposite sides of outer delivery tube <NUM>, while in the use of surgical fastener instrument <NUM> shown in <FIG>, suture portions 62A and 62B are arranged on generally the same side of outer delivery tube <NUM>. As a result, after use of surgical fastener instrument <NUM> as shown in <FIG>, suture portions 62A and 62B are arranged on generally opposite sides of suture fastener <NUM>, while after use of surgical fastener instrument <NUM> as shown in <FIG>, suture portions 62A and 62B are arranged on generally the same side of suture fastener <NUM>. Optionally, this arrangement allows both suture portions 62A and 62B to pass through an innermost turn of the spiral.

Of course, suture portions 62A and 62B may be arranged at other relative angular positions with respect to each other, such as offset at an angle of between <NUM> and <NUM> degrees about a center of suture fastener <NUM>, e.g., between <NUM> and <NUM> degrees, such as <NUM> degrees.

Reference is now made to <FIG>, which are schematic illustrations of a suture fastener <NUM>, not forming part of the present invention. In <FIG>, suture fastener <NUM> is shown in unlocked open configuration <NUM>. In <FIG>, suture fastener <NUM> is shown in locked closed configuration <NUM>. <FIG> also show a suture <NUM>, which is positioned within a central opening <NUM> of suture fastener <NUM>, such as by hooking or positioning manually. Suture <NUM> is typically not elements of the suture fastener or the surgical fastener system. Suture fastener <NUM> may implement any of the features of suture fastener <NUM> described hereinabove, mutatis mutandis, including, but not limited to, its resting state (e.g., in the unlocked open configuration), material properties, and plasticity.

As shown in <FIG>, when in unlocked open configuration <NUM>, suture fastener <NUM> is shaped so as to define a continuous loop <NUM> that is shaped so as to define central opening <NUM> surrounded by continuous loop <NUM>. Continuous loop <NUM> includes first and second crimping portions 256A and 256B, which are joined to each other at first and second joining portions 258A and 258B (such that the portions are arranged around continuous loop <NUM> in the following order: first crimping portion 256A, first joining portion 258A, second crimping portion 256B, second joining portion 258B). First and second crimping portions 256A and 256B are disposed at different first and second axial locations 260A and 260B, respectively, along a central longitudinal axis <NUM> defined by continuous loop <NUM> and passing through central opening <NUM>. When suture fastener <NUM> is disposed in an outer delivery tube of a surgical fastener instrument, central longitudinal axis <NUM> is also defined by the outer delivery tube.

It is noted that first and second crimping portions 256A and 256B are not merely arbitrary portions of a completely cylindrical piece of material. Instead, suture fastener <NUM> does not comprise any material at the circumferential location of first crimping portion 256A, other than at first axial location 260A, and suture fastener <NUM> does not comprise any material at the circumferential location of second crimping portion 256B, other than at second axial location 260B. By "circumferential location" it is meant the angular position around central longitudinal axis <NUM>.

For some applications, when suture fastener <NUM> is in unlocked open configuration <NUM>:.

For some applications, when suture fastener <NUM> is in unlocked open configuration <NUM>, each of first and second crimping portions 256A and 256B defines a portion of a cylinder, e.g., is generally half-cylindrical, such as shown in <FIG>.

For some applications, when suture fastener <NUM> is in unlocked open configuration <NUM>, the different first and second axial locations 260A and 260B at which first and second crimping portions 256A and 256B are respectively disposed do not axially overlap (as shown in <FIG>) or axially overlap by less than <NUM>. The phrase "axially overlap" means axially coincide, i.e., be disposed at some of the same axial positions along central longitudinal axis <NUM>.

For some applications, when suture fastener <NUM> is in unlocked open configuration <NUM>, an average distance D1 of first crimping portion 256A from central longitudinal axis <NUM> equals between <NUM>% and <NUM>%, e.g., between <NUM>% and <NUM>%, such as <NUM>%, of an average distance D2 of second crimping portion 256B from central longitudinal axis <NUM>.

For some applications, both when suture fastener <NUM> is in unlocked open configuration <NUM> and when suture fastener <NUM> is in locked closed configuration <NUM>, a height H3, measured along central longitudinal axis <NUM>, is at least <NUM> and/or less than <NUM>, e.g., less than <NUM>, such as less than <NUM>, such as less than <NUM>, e.g., less than <NUM>. Typically, the height H3 of suture fastener <NUM> when in unlocked open configuration <NUM> equals the height H3 of suture fastener <NUM> when in locked closed configuration <NUM>. Typically, respective heights of first and second crimping portions 256A and 256B equal each other and/or equal half of height H3.

As shown in <FIG>, when suture fastener <NUM> is in locked closed configuration <NUM>, a contact interface <NUM> between first and second crimping portions 256A and 256B creates friction that prevents sliding of the one or more sutures <NUM>, thereby fastening the suture portions or sutures together. For example, contact interface <NUM> may include a straight portion, or may be entirely straight. Typically, in order to transition suture fastener <NUM> from unlocked open configuration <NUM> to locked closed configuration <NUM>, a lateral crimping force is applied to at least one of first and second crimping portions 256A and 256B of suture fastener <NUM>, such as using a surgical fastener instrument similar to surgical fastener instrument <NUM>, described hereinabove. The lateral crimping force transitions suture fastener <NUM> from unlocked open configuration <NUM> to locked closed configuration <NUM>, in which the one or more sutures <NUM> are fixedly crimped and coupled to suture fastener <NUM>. Typically, the lateral crimping force is perpendicular to central longitudinal axis <NUM>.

For some applications, the lateral crimping force is applied to both first and second crimping portions 256A and 256B of suture fastener <NUM>. For other applications, the lateral crimping force is applied to only one of first and second crimping portions 256A and 256B, while the other crimping portion is held relatively stationary by the surgical fastener instrument, until the force applied to the one crimping portion transitions the suture fastener <NUM> to locked closed configuration <NUM>.

As shown in <FIG>, when the suture fastener <NUM> is unlocked open configuration, one or more sutures <NUM> are positioned within the central opening <NUM>. The positioning of the suture <NUM> is aided by means of standard surgical instruments (e.g. surgical forceps) or by positioning tools integrated within the delivery system. In some embodiment an hook is passed through the central lumen <NUM>, to engage the suture <NUM> in the distal groove of the hook at the opposite direction that the hook entrance into the central lumen <NUM>, that then is positioned within and across the opening <NUM> by retraction of the hook. In another embodiment a metallic suture loop is passes through the opening <NUM>, to open and expand its loop. The suture <NUM> is passes through this loop opening and is positioned through the central opening <NUM> by exiting the loop within the opening, then to free the suture <NUM> that will remain at the edge across the opening <NUM>. Once the suture <NUM> is positioned within the opening <NUM> the fastener is crimped and excessive suture is cut.

<FIG> are schematic illustrations of a surgical fastener system <NUM> for fastening one or more sutures <NUM>. The one or more sutures <NUM> shown in <FIG> are typically not elements of surgical fastener system <NUM>. Other than described below, surgical fastener system <NUM> is similar to surgical fastener system <NUM>, described hereinabove with reference to <FIG>, <FIG>, and <FIG>, and may implement any of the features thereof, mutatis mutandis. Although surgical fastener system <NUM> is described with reference to suture fasteners <NUM>, the system may alternatively deploy a plurality of the other suture fasteners described herein, mutatis mutandis.

Surgical fastener system <NUM> comprises a surgical fastener instrument <NUM> and a plurality of suture fasteners <NUM> (e.g., between <NUM> and <NUM> suture fasteners <NUM>. Surgical fastener instrument <NUM> comprises:.

A plurality of suture fasteners <NUM> are contained with outer delivery tube <NUM>, typically with inner delivery shaft <NUM> passing through suture fasteners <NUM>. Outer delivery tube <NUM> thus functions as a multiple-fastener cartridge, which enables the deployment of multiple suture fasteners <NUM> and allows for fast and quick application of surgical fastener instrument <NUM> on sutures <NUM> without requiring from the operator to manually reapply the surgical fastener instrument for the deployment of each suture fastener <NUM> separately.

Typically, user control element <NUM> is operated by the palm and fingers of the operator using wrist and finger movement, using little force. For some applications, handle <NUM> comprises a plurality of user control elements <NUM>, for controlling the different functions of surgical fastener instrument <NUM> during the several steps of its use, as described hereinbelow with reference to <FIG>. For example, user control element <NUM> may be a first user control element <NUM>, and handle <NUM> may comprise a second user control element <NUM>, which is arranged to cause distal advancement of inner delivery shaft <NUM> (typically with respect to outer delivery tube <NUM>).

For some applications, outer delivery tube <NUM> is shaped so as to define a plurality of tabs <NUM>, which are biased radially inward, and are configured to temporarily hold suture fasteners <NUM>, respectively, in place within the outer delivery tube until the fasteners are individually axially advanced and deployed.

For some applications, as shown in <FIG> and <FIG>, in order to advance a single suture fastener <NUM> at a time, surgical fastener instrument <NUM> is configured to cause inner delivery shaft <NUM> to move axially in order to engage each of suture fasteners <NUM> one at a time, beginning with the distal-most fastener and working proximally as each fastener is deployed. Optionally, this action is automated within surgical fastener instrument <NUM> using a spring and a knob, to avoid to activity work on inner delivery shaft <NUM> to free the previous fastener and connect to the next in the cartridge.

For some of these applications, in order to advance a single suture fastener <NUM> at a time, inner delivery shaft <NUM> is shaped so as to define two distal prongs <NUM>. When distal prongs <NUM> are disposed in a radially compressed configuration, such as shown in the three left-most figures in <FIG> and the left-most figure in <FIG>, the distal prongs can pass through the non-circular and non-spiral openings <NUM> of suture fasteners <NUM>. Once distal prongs <NUM> are inserted in the distal-most suture fastener <NUM> (i.e., the lowest suture fastener <NUM> in <FIG> and <FIG>), the distal prongs are radially expanded, such as by inserting an inner shaft <NUM>, and the distal prongs engage opening <NUM> of the distal-most suture fastener <NUM>. This distal-most suture fastener is rotated and axially compressed, such as described hereinabove regarding surgical fastener instrument <NUM> with reference to <FIG>. For some applications, the advancement and withdrawal of inner shaft <NUM> with respect to inner delivery shaft <NUM> is controlled by separate user control elements, e.g., respective concentric control elements, as shown, while for other applications, one or first or second user control elements <NUM> or <NUM> also controls the advancement and withdrawal of inner shaft <NUM> with respect to inner delivery shaft <NUM> (configuration not shown).

As shown in <FIG>, surgical fastener instrument <NUM> is used in the same manner as surgical fastener instrument <NUM>, described hereinabove with reference to <FIG>, for completing the locking and deployment of each suture fastener <NUM>, mutatis mutandis.

<FIG> are schematic illustrations of a surgical fastener system <NUM> for fastening one or more sutures <NUM>, in accordance with an application of the present invention. The one or more sutures <NUM> shown in <FIG> are typically not elements of surgical fastener system <NUM>. Other than described below, surgical fastener system <NUM> is similar to surgical fastener system <NUM>, described hereinabove with reference to <FIG>, and may implement any of the features thereof, mutatis mutandis. Surgical fastener system <NUM> comprises a surgical fastener instrument <NUM> and a plurality of suture fasteners <NUM> (e.g., between <NUM> and <NUM> suture fasteners <NUM>). Although surgical fastener system <NUM> is described with reference to suture fasteners <NUM>, the system may alternatively deploy a plurality of the other suture fasteners described herein, mutatis mutandis. Typically, rotation of inner delivery shaft <NUM> with respect to an outer delivery tube <NUM> of surgical instrument <NUM>, e.g., by <NUM> degrees, engage/disengages each suture fastener <NUM>. For some applications, the rotation of inner delivery shaft <NUM> is controlled by separate user control elements, as shown, while for other applications, one or first or second user control elements <NUM> or <NUM> also controls the rotation of inner delivery shaft <NUM> (configuration not shown).

Reference is now made to <FIG>, which is a schematic illustration of a surgical fastener system <NUM> for fastening one or more sutures <NUM>. The one or more sutures <NUM> are typically not elements of surgical fastener system <NUM>. Other than described below, surgical fastener system <NUM> is similar to surgical fastener system <NUM>, described hereinabove with reference to <FIG>, <FIG>, and <FIG>, and may implement any of the features thereof, and/or of surgical fastener system <NUM>, described hereinabove with reference to <FIG>, and/or of surgical fastener system <NUM>, described hereinabove with reference to <FIG>, mutatis mutandis. Although surgical fastener system <NUM> is described with reference to suture fasteners <NUM>, the system may alternatively deploy a plurality of the other suture fasteners described herein, mutatis mutandis.

A surgical fastener instrument <NUM> of surgical fastener system <NUM> further comprises one or more blades <NUM> (e.g., exactly one blade <NUM>), which are configured to cut the one or more sutures <NUM>. For some applications, surgical fastener system <NUM> further comprises a cutting shaft <NUM>, which is shaped so as to define the one or more blades <NUM>. For example, a distal portion of cutting shaft <NUM> may be shaped so as to define the one or more blades <NUM>; optionally the distal portion is shaped so as to define one or more scallops <NUM>, which are shaped so as to define the one or more blades <NUM>.

The rotation of cutting shaft <NUM> cuts the one or more sutures <NUM> by applying the cutting force of the one or more blades <NUM> against the one of more sutures <NUM>, which are held in position during the rotation by the boundary of lateral opening <NUM> of an outer delivery tube <NUM> of surgical fastener system <NUM>.

For some applications, handle <NUM> comprises a separate third user control element <NUM>, which is arranged to cause the rotation of cutting shaft <NUM>.

Claim 1:
A suture fastener (<NUM>, <NUM>, <NUM>) for fastening one or more sutures (<NUM>), the suture fastener (<NUM>, <NUM>, <NUM>) shaped so as to define:
a spiral portion (<NUM>); and
a radially-inward portion (<NUM>) that is disposed radially inward from the spiral portion (<NUM>),
wherein the suture fastener (<NUM>, <NUM>, <NUM>), when in a resting state, has an unlocked conical helical configuration (<NUM>, <NUM>), in which the spiral portion (<NUM>) is conically helical,
wherein the suture fastener (<NUM>, <NUM>, <NUM>) is configured, when one or more portions of the one or more sutures (<NUM>) pass through respective portions of the suture fastener (<NUM>, <NUM>, <NUM>), to transition from the unlocked conical helical configuration (<NUM>, <NUM>) to a planar spiral configuration, in which the spiral portion (<NUM>) is planar spiral and the one or more sutures (<NUM>) are coupled to the suture fastener (<NUM>, <NUM>, <NUM>),
wherein the radially-inward portion (<NUM>) is neither helical nor spiral, both when the suture fastener (<NUM>, <NUM>, <NUM>) is in the unlocked conical helical configuration (<NUM>, <NUM>) and when the suture fastener (<NUM>, <NUM>, <NUM>) is in the planar spiral configuration, and wherein
the planar spiral configuration is a locked planar spiral configuration (<NUM>, <NUM>),
characterised in that
the suture fastener (<NUM>, <NUM>, <NUM>) is configured to be axially plastically deformed, when the one or more portions of the one or more sutures (<NUM>) pass through the respective portions of the suture fastener (<NUM>, <NUM>, <NUM>), and to thereby transition from the unlocked conical helical configuration (<NUM>, <NUM>) to the locked planar spiral configuration (<NUM>, <NUM>), in which the spiral portion (<NUM>) is planar spiral and the one or more sutures (<NUM>) are fixedly coupled to the suture fastener (<NUM>, <NUM>, <NUM>).