Patent Description:
Modem advances in minimally invasive cardiac surgery have enabled surgeons to perform surgical procedures which extend patient lives and improve patient quality of life while reducing post-operative pain, hospital stays, and post-operative limitations. Among such minimally invasive procedures, tricuspid valve repair is one of the more challenging procedures. In addition to the specialized medical knowledge and surgical skills needed to complete such a procedure, surgeons and their medical staff must also be very adept at suture management. It is desirable to have improved apparatuses which help surgical staff with suture management and maintaining appropriate suture tension. It would also be desirable to have improved apparatuses for suture management and tensioning which provide additional security and visual feedback to surgical staff during modern minimally invasive surgical procedures.

<CIT> discloses a line lock device for a sailboat. The line lock device comprises two cleats that are configured to hold a line. <CIT> discloses a device for securing prostheses such as a heart valve. The device comprises a coil spring that presses two halves together thereby fixing a suture positioned in between the halves. <CIT> discloses a device to retain a suture. The device comprises two clamps fixing a suture in between the two clamps. One clamp is fixed and the other clamp is biased by use of a spring towards the first clamp within a linear arrangement. <CIT> discloses a suture tensioning device as such. <CIT> discloses a surgical crimping instrument for crimping a suture fastener to one or more sutures. <CIT> discloses a plication assistance device including a tension gauge mechanism with an indicator for indicating the level of tension being applied to a suture.

The invention is set out by the appended claims. A device for tensioning suture for minimally invasive surgical procedures is disclosed. The device also includes a housing; a first cleat comprising a first gripping surface and wherein the first cleat is movably connected to the housing; a second cleat comprising a second gripping surface opposing the first gripping surface and wherein the second cleat is connected to the housing; wherein the second cleat and the first cleat are colinear with one another and are arranged within the same line; an actuator which is connected to the housing and wherein the actuator is in contact with the first cleat, wherein the actuator is movable between an unlocked position, a tensioned position, and a locked position and wherein the device is configured such that: a) the first cleat and the second cleat are not in contact, and suture passage through the device for holding suture is not restricted when the actuator is in the unlocked position, b) the first cleat and the second cleat are in partial contact, and suture passage through the device for holding suture is partially restricted when the actuator is in the tensioned position, and c) the first cleat and the second cleat are in full contact, and suture passage through the device for holding suture is fully restricted when the actuator is in the locked position; an indicator biasing element which is connected to the housing, wherein the indicator biasing element is configured to provide a visual indication about a tension on the suture and is configured to be colinear with the first cleat and the second cleat when the suture is under tension.

The device for tensioning suture also includes a housing having a plurality of suture channels; a cleat array which may include: a first cleat array portion movably connected to the housing, the first cleat array portion may include a plurality of first cleats, each first cleat may include a first gripping surface, and a plurality of spacer blocks interposed between each first cleat; and a second cleat array portion fixedly connected to the housing, the second cleat array portion may include a plurality of second cleats, each second cleat may include a second gripping surface, where each second cleat is colinear with each first cleat, and a plurality of spacer blocks interposed between each second cleat. The device for tensioning suture also includes a plurality of indicator biasing elements, each indicator biasing element connected to the housing and colinear with the first cleat and the second cleat and each indicator biasing element may include a suture channel; and an actuator connected to the housing and in contact with the first cleat array portion where the actuator is movable between an unlocked position, a tensioned position, and a locked position.

It will be appreciated that for purposes of clarity and where deemed appropriate, reference numerals have been repeated in the figures to indicate corresponding features, and that the various elements in the drawings have not necessarily been drawn to scale in order to better show the features.

<FIG> is a partial cross-sectional view of a suture tensioning device element of a suture tensioning device. The suture tensioning device element of <FIG> is constructed of a first or top cleat <NUM> and a second or bottom cleat <NUM>. The top cleat <NUM> has two top cleat holes <NUM> configured to fasten or hole the top cleat <NUM> to an external structure or assembly, and a top cleat cam recess <NUM> configured to accept a cam (not shown here but will be discussed later in further detail). The suture facing gripping surface 12A of the top cleat <NUM> also has several alternating surface recesses <NUM> and flat spots <NUM> configured to hold suture <NUM> with sufficient force when opposing or held in opposition to the bottom cleat <NUM>. The bottom cleat <NUM> has two bottom cleat holes <NUM> configured to fasten the bottom cleat <NUM> to an external structure or assembly. The suture facing gripping surface 22A of the bottom cleat <NUM> also has several alternating protrusions or surface teeth <NUM>, flat spots <NUM>, and surface recesses <NUM>, configured to hold suture <NUM> with sufficient force when opposing or held in opposition to the top cleat <NUM>. The top cleat <NUM> and the bottom cleat <NUM> are colinear with one another and are arranged such that they lie within the same line or linear arrangement. The asymmetric teeth on the bottom cleat <NUM> are oriented in an opposing direction relative to the direction that the suture would be tensioned during operation of a suture tensioning device having a cleat pair such as the one depicted herein. The top cleat <NUM> or bottom cleat <NUM> may have alternate arrangements of protrusions, surface recesses <NUM> and flat spots <NUM>, such as alternate numbers of surface recesses <NUM> and flat spots <NUM>, surface recesses <NUM> and flat spots <NUM> arranged in a pattern other than alternating, or composed of similar features having various symmetrical or asymmetrical sizes and shapes, including, but not limited to saw tooth, square, rounded, ramped, triangular, or inversions or combinations thereof. The top cleat may or may not have all the aforementioned features, and the second cleat may or may not have all of the aforementioned features. Asymmetric teeth may be oriented in the same direction as tensioned suture, or in an opposing direction to the direction of the tensioned suture in alternate embodiments. The aforementioned shapes and features may be protruding or recessed from a plane line formed by the suture facing surface and may be composed of one or more than one of the aforementioned shapes or characteristics. The first cleat or top cleat <NUM> and the second cleat or bottom cleat <NUM> are constructed of plates that may be made of metal, plastic, or other rigid materials capable of holding sufficient holding force on a suture in such a configuration. It should be understood that the term "suture," as used herein, is intended to cover any thread, cable, wire, filament, strand, line, yarn, gut, or similar structure, whether natural and/or synthetic, in monofilament, composite filament, or multifilament form (whether braided, woven, twisted, or otherwise held together), as well as equivalents, substitutions, combinations, and pluralities thereof for such materials and structures.

It should be noted that sufficient force refers to a minimum threshold level of force required to hold and tension suture between two opposing gripping surfaces configured in a locked position. Sufficient force may be dictated by a specific surgical procedural consideration, suture material property, or overall device configuration. Alternate suture materials or configurations may result in different actual values in terms of sufficient force required for holding and tensioning suture during minimally invasive surgical procedures. As an example, certain surgical procedures may require a holding force or tensioning force of at least <NUM> (<NUM> N) on a suture in order to pull one or more sutures simultaneously held in a tensioning device. The configuration or arrangement of a cleat pair may be modified in order to deliver this amount of holding force or tension. <FIG> is a top-left-front perspective view of the suture tensioning device element of <FIG>. Similar to the view in <FIG>, the suture <NUM> is shown held between the top cleat <NUM> and the bottom cleat <NUM>.

<FIG> are partial cross-sectional views of a suture tensioning device during operation. <FIG> illustrates a suture tensioning device <NUM> having a tensioning device body <NUM>, several support walls <NUM>, each of the support walls <NUM> having a suture channel <NUM> configured to pass suture <NUM> therethrough and a side wall <NUM>. The suture tensioning device <NUM> also has a device cover <NUM> which may or may not be removable. The device cover <NUM> has an opening <NUM> configured to allow visualization of the top portion <NUM> of an indicator biasing element <NUM> by the user. The indicator biasing element <NUM> also has a beam <NUM>. The indicator biasing element <NUM> is connected to the device body <NUM> via an element support <NUM>. The indicator biasing element <NUM> also has a biasing element suture channel <NUM> passing therethrough, which is configured to receive suture. The location of the biasing element suture channel <NUM> on the indicator biasing element <NUM> is such that when suture <NUM> passing through the channel <NUM> is under tension, the beam <NUM> of the indicator biasing element <NUM> is configured to flex, and the top portion <NUM> is lowered relative to its position shown in <FIG>. Thus, the indicator biasing element <NUM> is colinear with both the top cleat <NUM> and the bottom cleat <NUM>. The pair of the top cleat <NUM> and the bottom cleat <NUM> may also be referred to as a cleat pair.

The suture tensioning device <NUM> also has an actuator <NUM> coupled to an actuator mount <NUM>. A cam <NUM> is coupled to the actuator mount <NUM> which rotates when the actuator <NUM> is rotated. As the cam <NUM> is rotated through various positions, the cam <NUM> contacts the top cleat cam recess <NUM> of the top cleat <NUM>, moving the top cleat <NUM> into various vertical positions in relation to the bottom cleat <NUM>. Positioned between two support walls <NUM> is an alignment side plate <NUM> having two alignment side plate pin guides <NUM> attached to the top cleat <NUM> via two top cleat pins <NUM>. The two top cleat pins also attach a corresponding alignment side plate (not shown in this view) to an opposing side of the top cleat <NUM>. The top cleat <NUM> and its associated structure are movable within the device body <NUM> of the suture tensioning device <NUM>. The bottom cleat <NUM> is fixedly attached to the device body <NUM> via two bottom cleat pins <NUM>. The two bottom cleat pins <NUM> are passed through the alignment side plate pin guides <NUM> in the alignment side plate <NUM> for the purpose of vertically aligning the top cleat <NUM> and the bottom cleat <NUM> while the top cleat <NUM> is moved through its various positions. While the motion of the actuator brings the top cleat <NUM> closer to the bottom cleat <NUM>, the first cleat <NUM> and the second cleat <NUM> are not in contact and the suture passage through the various suture channels <NUM>, <NUM> in the suture tensioning device <NUM> is not restricted when the actuator <NUM> is in the unlocked position shown in <FIG>.

<FIG> illustrates a partial cross-section of the suture tensioning device <NUM> with the actuator <NUM> moved into a partial tensioned position. When the actuator <NUM> is rotated in movement direction <NUM> the cam <NUM> also moves into a position where a different point on the radius of the cam <NUM> is in contact with the top cleat cam recess <NUM>. This position of the movement direction <NUM> coordinates with a partially locked position. In this partially locked position, the suture is only under a partial amount of the total force that can be delivered by the suture tensioning device <NUM>. In this position of the top cleat <NUM> relative to the bottom cleat <NUM>, the suture is held within the suture tensioning device <NUM> and can be moved through the device, with some resistance. In this partial locked or tensioned position, the suture <NUM> can travel through the various suture channels <NUM>, <NUM> in the suture tensioning device <NUM>. <FIG> illustrates the suture tensioning device <NUM> in a partially locked position, where the first cleat <NUM> and the second cleat <NUM> are in partial contact and suture passage through the various suture channels <NUM>, <NUM> in the suture tensioning device <NUM> is partially restricted. If the device <NUM> or suture <NUM> are moved relative to one another, there will be some drag or friction on the movement due to the partially tensioned state of the top cleat <NUM> relative to the bottom cleat <NUM>.

<FIG> illustrates a partial cross-section of the suture tensioning device <NUM> with the actuator <NUM> moved into a fully locked position. When the actuator <NUM> is rotated in movement direction <NUM> the cam <NUM> also moves into a position where a different point on the radius of the cam <NUM> is in contact with the top cleat cam recess <NUM>. This position of the movement direction <NUM> coordinates with a fully locked position. In this fully locked position, the suture <NUM> is under the maximum amount of the total force that can be delivered by the suture tensioning device <NUM>. <FIG> illustrates the suture tensioning device <NUM> in a fully locked or locked position or configuration, such that the first cleat <NUM> and the second cleat <NUM> are in full contact and suture <NUM> passage through the various suture channels <NUM>, <NUM> in the suture tensioning device <NUM> is fully restricted when the actuator <NUM> is in the locked position.

<FIG> illustrates a partial cross-section of the suture tensioning device <NUM> with the actuator <NUM> in a fully locked position. Upon positioning and locking a suture <NUM> within the various suture channels <NUM>, <NUM> in the suture tensioning device <NUM>, visual confirmation of appropriate suture tension may be desirable. It is also desirable in some minimally invasive surgical procedures to tighten suture once it has been secured in a suture tensioning device <NUM> such as the one shown and described herein. As the suture tensioning device <NUM> is pulled in a direction <NUM>, the suture is pulled taut, and is held firmly between the locked first cleat <NUM> and bottom cleat <NUM>. Since the suture <NUM> is threaded through the suture channel <NUM> and the indicator biasing element suture channel <NUM>, the suture <NUM> is moved from a loose configuration to a straight configuration when tightened, as shown in <FIG>. The indicator biasing element <NUM> thus moves downward in direction <NUM>, moving the top portion <NUM> of the indicator biasing element <NUM> out of the opening <NUM> of the device cover <NUM>. This provides a visual indication to the operator that appropriate tension on the suture has been achieved within the suture tensioning device <NUM>. This visual effect is reversible and as tension on the device is relaxed, the indicator biasing element <NUM> will return to its original configuration and the top portion <NUM> of the indicator biasing element <NUM> returns to its original position in the opening <NUM> of the device cover <NUM>. The indicator biasing element <NUM> is designed and configured such that a threshold required level of tensioning force is on suture when locked. This amount of force needed for visual confirmation may be modified by utilizing alternate shapes materials or biasing element shapes. This may provide alternate levels of tensioning or visualization methods to indicate the appropriate tension on the suture has been achieved by locking the device. While the movement of the indicator biasing element <NUM> is shown as a means of tension visualization, other means known to those skilled in the art may also be used, such as color, letter, numeral, symbol, sound, or lighting effect.

<FIG> are top-left-front and top-left-rear perspective views, respectively, of an embodiment of a suture tensioning device capable of tensioning six sutures. A suture tensioning device <NUM> is illustrated having a body <NUM>, the body having two ergonomic gripping features <NUM>, an actuator <NUM> and a shaft recess <NUM>. The ergonomic gripping features <NUM> are configured such that they provide a comfortable hand position for holding and pulling multiple locked and tensioned sutures during a minimally invasive surgical procedure. The actuator <NUM> rotates a cam that engages in a cam recess in a top cleat such as those described in regard to <FIG>. The shaft recess <NUM> is configured such that it and locks onto the shaft of a crimping instrument. Above the shaft recess <NUM> are several external suture channels <NUM> for the purpose of directing and organizing multiple sutures. The suture tensioning device <NUM> has a cover <NUM> with a cover opening <NUM> whereby six indicator tops <NUM> are visible therethrough. This embodiment of a suture tensioning device <NUM> has the capacity to lock, tension and provide visual indication related to six separate sutures used in a minimally invasive surgical procedure. <FIG> further illustrates the location of several top cleat pin locations <NUM>, not shown in this view, and bottom cleat pin locations <NUM>, showing the relative locations of the various cleat pairs within the suture tensioning device <NUM>.

<FIG> is a top-left-front perspective view of the suture tensioning device of <FIG> with the cover removed. The suture tensioning device <NUM> is shown with a suture <NUM> threaded through the device <NUM> and exiting through one of the suture channels <NUM>. With the cover removed, several top cleats <NUM> are visible, with multiple spacers <NUM> placed in between the top cleats <NUM>. The cam <NUM> attached to the actuator <NUM> is shown resting in a cam recess formed by the top cleats <NUM> and spacers <NUM>. These spacer blocks <NUM> are interposed between each of the top cleats <NUM>.

<FIG> is a top-left-front perspective view of a cleat array of the suture tensioning device of <FIG>. A cleat array <NUM> is shown in <FIG>, which is constructed from several top cleats <NUM> and top cleat spacers <NUM>, interposed along the length of the top cleat array portion. The top cleat array portion is held together by two top cleat pins <NUM>. The individual components and the combined structure formed by the top cleats <NUM> and top cleat spacers <NUM> form an array cam recess <NUM> which receives a cam as described in previous embodiments herein. The cleat array <NUM> also contains several bottom cleats <NUM> interposed between several first bottom cleat spacers <NUM> and several second bottom cleat spacers <NUM>. The first bottom cleat spacer <NUM> has several relief recesses <NUM>, forming a bottom cleat array portion. The second bottom cleat spacers <NUM> also have several relief recesses <NUM> which are not shown in this view. The purpose of these relief recesses <NUM>, <NUM> are to allow for suture to expand from out of the space between the top cleat <NUM> and the bottom cleat <NUM> when in the locked position. In some suture materials, in particular, suture made from expanded polytetrafluoroethylene (ePTFE), the suture may expand in an outward direction when under compression forces such as those created by the locking mechanism of the top and bottom cleats. Suture of such a design or material may break under tension if spatial allowance for expansion of suture under pressure is not made. These spacers or spacer blocks may have alternate arrangements, shapes or configurations of relief recesses known to those skilled in the art. The bottom array portion is held together by two bottom cleat pins <NUM>. The top portion and bottom portion of the array are held within a side alignment plate <NUM>. A corresponding side alignment plate <NUM> would be part of the cleat array <NUM>, but this one is not shown for purposes of visibility. The two alignment plates receive the top cleat pins <NUM> and bottom cleat pins <NUM> and align the top cleats <NUM> with the bottom cleats <NUM>. While this embodiment shows the cleat array being constructed of several pieces attached together to form the cleat array <NUM>, other embodiments may have a top portion or a bottom portion or both composed of a single piece while having some or all of the features and structure of the illustrated embodiment. These array pieces may be molded, printed, or machined out of a plastic material, or machined, printed, or cast of a metal or metal alloy material. Other materials or methods of constructing cleat arrays as described will be known to those skilled in the art.

<FIG> are side views of different spacer elements of the cleat array of <FIG>. <FIG> is a side view of a first bottom cleat spacer <NUM> demonstrating the location of the pin holes <NUM> and spacer recesses <NUM> defined by the first bottom cleat spacer <NUM>. <FIG> is a side view of a second bottom cleat spacer <NUM> demonstrating the location of the pin holes <NUM> and spacer recesses <NUM> defined by the second bottom cleat spacer <NUM>. <FIG> is a side view of a top cleat spacer <NUM> demonstrating the location of the pin holes <NUM> and cam recess <NUM> defined by the top cleat spacer <NUM>.

<FIG> is a top-left-rear perspective view of an embodiment of a crimping instrument, with the suture tensioning device of <FIG> loaded onto the shaft. An embodiment of a crimping instrument <NUM>, having three shafts <NUM>, a shaft support <NUM>, and three crimping ends <NUM>, can fasten three mechanical knots simultaneously. The crimping instrument <NUM> has a housing <NUM> defining a handle <NUM>. The instrument <NUM> has an actuation lever <NUM> which simultaneously crimps the mechanical fasteners and cuts sutures when actuated. The suture tensioning device <NUM> is placed onto the instrument over the shafts <NUM>. The suture tensioning device <NUM> is slidably engaged along the shafts <NUM> by placing the shaft recess <NUM> over the shafts <NUM> and can be pulled in a direction towards <NUM> the operator for the purpose of tensioning suture threaded through one or more mechanical fasteners.

<FIG> is a top-left-rear perspective view of another embodiment of a crimping instrument, with the suture tensioning device of <FIG> loaded onto the shaft. Another embodiment of a crimping instrument <NUM>, having three shafts <NUM>, a shaft support <NUM>, and three crimping ends <NUM>, can fasten three mechanical knots simultaneously. The crimping instrument <NUM> has a housing <NUM> defining a handle <NUM>. The instrument <NUM> has an actuation lever <NUM> which simultaneously crimps the mechanical fasteners and cuts suture when actuated. The suture tensioning device <NUM> is placed onto the instrument over the shafts <NUM>. The suture tensioning device <NUM> is slidably engaged along the shafts <NUM> by placing the shaft recess <NUM> over the shafts <NUM> and can be pulled in a direction towards <NUM> the operator for the purpose of tensioning suture threaded through one or more mechanical fasteners. On top of the housing <NUM> there is a guide rail <NUM> having a plurality of ratchets <NUM> on either side of the guide rail <NUM>.

The instrument <NUM> also has a snare assembly or snare loader <NUM> having a target tray <NUM> and a target cover <NUM>. A snare <NUM> within the snare loader <NUM> is threaded through the suture tensioning device <NUM> and anchored within the snare puller <NUM> (the anchoring mechanism is not shown in this view, but may be in the form of a mechanical fastener, handle, snare target or other structure suitable for anchoring a snare to the snare puller <NUM>. The snare puller <NUM> has ergonomic grips <NUM> for simultaneously pulling multiple snares in a direction <NUM> and through the suture tensioning device <NUM>. Similar embodiments such as this may have multiple snares loaded into the snare loader <NUM> for snaring multiple sutures and threading them through the suture tensioning device <NUM>.

In a minimally invasive surgical procedure requiring multiple sutures that need to be tensioned prior to a mechanical fastening step, the snare <NUM> pulls the suture through the suture tensioning device <NUM>. Once multiple sutures are threaded through and locked within the suture tensioning device <NUM>, the suture tensioning device <NUM> may be disengaged from the ends <NUM> and placed and engaged onto the guide rail <NUM>. If the suture tensioning device <NUM> needs further tensioning or adjustment in direction <NUM>, the ratchets <NUM> engage corresponding features in the suture tensioning device <NUM> to prevent reverse motion relative to direction <NUM>. Other means or methods of retaining the suture tensioning device <NUM> after tensioning and pulling may be known to those skilled in the art.

Claim 1:
A device (<NUM>) for tensioning suture (<NUM>) for minimally invasive surgical procedures, comprising:
a housing (<NUM>);
a first cleat (<NUM>) comprising a first gripping surface (12A) and wherein the first cleat (<NUM>) is movably connected to the housing (<NUM>);
a second cleat (<NUM>) comprising a second gripping surface (22A) opposing the first gripping surface (12A) and wherein the second cleat (<NUM>) is connected to the housing (<NUM>);
wherein the second cleat (<NUM>) and the first cleat (<NUM>) are colinear with one another and are arranged within the same line;
an actuator (<NUM>) which is connected to the housing (<NUM>) and wherein the actuator (<NUM>) is in contact with the first cleat (<NUM>);
wherein the actuator (<NUM>) is movable between an unlocked position, a tensioned position, and a locked position and wherein the device (<NUM>) is configured such that:
a) the first cleat (<NUM>) and the second cleat (<NUM>) are not in contact, and suture passage through the device (<NUM>) for holding suture (<NUM>) is not restricted when the actuator (<NUM>) is in the unlocked position,
b) the first cleat (<NUM>) and the second cleat (<NUM>) are in partial contact, and suture passage through the device (<NUM>) for holding suture (<NUM>) is partially restricted when the actuator (<NUM>) is in the tensioned position, and
c) the first cleat (<NUM>) and the second cleat (<NUM>) are in full contact, and suture passage through the device (<NUM>) for holding suture (<NUM>) is fully restricted when the actuator (<NUM>) is in the locked position;
characterised by an indicator biasing element (<NUM>) which is connected to the housing (<NUM>);
wherein the indicator biasing element (<NUM>) is configured to provide a visual indication about a tension on the suture (<NUM>) and is further configured to be colinear with the first cleat (<NUM>) and the second cleat (<NUM>) when the suture (<NUM>) is under tension.