Patent Application
20130238021
The present invention relates generally to self-retaining sutures and sutures having a high density of retainers and apparatus and methods for manufacturing such self-retaining sutures and sutures.
Wound closure devices such as sutures, staples and tacks have been widely used in superficial and deep surgical procedures in humans and animals for closing wounds, repairing traumatic injuries or defects, joining tissues together (bringing severed tissues into approximation, closing an anatomical space, affixing single or multiple tissue layers together, creating an anastomosis between two hollow/luminal structures, adjoining tissues, attaching or reattaching tissues to their proper anatomical location), attaching foreign elements to tissues (affixing medical implants, devices, prostheses and other functional or supportive devices), and for repositioning tissues to new anatomical locations (repairs, tissue elevations, tissue grafting and related procedures) to name but a few examples.
Sutures are often used as wound closure devices. Sutures typically consist of a filamentous suture thread attached to a needle with a sharp point. Suture threads can be made from a wide variety of materials including bioabsorbable (i.e., that break down completely in the body over time), or non-absorbable (permanent; non-degradable) materials. Absorbable sutures have been found to be particularly useful in situations where suture removal might jeopardize the repair or where the natural healing process renders the support provided by the suture material unnecessary after wound healing has been completed; as in, for example, completing an uncomplicated skin closure. Non-degradable (non-absorbable) sutures are used in wounds where healing may be expected to be protracted or where the suture material is needed to provide physical support to the wound for long periods of time; as in, for example, deep tissue repairs, high tension wounds, many orthopedic repairs and some types of surgical anastomosis. Also, a wide variety of surgical needles are available; the shape and size of the needle body and the configuration of the needle tip is typically selected based upon the needs of the particular application.
To use an ordinary suture, a suture needle is advanced through the desired tissue on one side of the wound and then through the adjacent side of the wound. The suture is then formed into a “loop” which is completed by tying a knot in the suture to hold the wound closed. Knot tying takes time and causes a range of complications, including, but not limited to (i) spitting, a condition where the suture, usually a knot, pushes through the skin after a subcutaneous closure), (ii) infection (bacteria are often able to attach and grow in the spaces created by a knot), (iii) bulk/mass (a significant amount of suture material left in a wound is the portion that comprises the knot), (iv) slippage (knots can slip or come untied), and (v) irritation (knots serve as a bulk “foreign body” in a wound). Suture loops associated with knot tying may lead to ischemia (knots can create tension points that can strangulate tissue and limit blood flow to the region) and increased risk of dehiscence or rupture at the surgical wound. Knot tying is also labor intensive and can comprise a significant percentage of the time spent closing a surgical wound. Additional operative procedure time is not only bad for the patient (complication rates rise with time spent under anesthesia), but it also adds to the overall cost of the operation (many surgical procedures are estimated to cost between $15 and $30 per minute of operating time).
Self-retaining sutures (including barbed sutures) differ from conventional sutures in that self-retaining sutures possess numerous tissue retainers (such as barbs) which anchor the self-retaining suture into the tissue following deployment and resist movement of the suture in a direction opposite to that in which the retainers face, thereby eliminating the need to tie knots to affix adjacent tissues together (a “knotless” closure). Knotless tissue-approximating devices having barbs have been previously described in, for example, U.S. Pat. No. 5,374,268, disclosing armed anchors having barb-like projections, while suture assemblies having barbed lateral members have been described in U.S. Pat. Nos. 5,584,859 and 6,264,675. Sutures having a plurality of barbs positioned along a greater portion of the suture are described in U.S. Pat. No. 5,931,855, which discloses a unidirectional barbed suture, and U.S. Pat. No. 6,241,747, which discloses a bidirectional barbed suture. Methods and apparatus for forming barbs on sutures have been described in, for example, U.S. Pat. Nos. 6,848,152. Self-retaining systems for wound closure also result in better approximation of the wound edges, evenly distribute the tension along the length of the wound (reducing areas of tension that can break or lead to ischemia), decrease the bulk of suture material remaining in the wound (by eliminating knots) and reduce spitting (the extrusion of suture material—typically knots—through the surface of the skin). All of these features are thought to reduce scarring, improve cosmesis, and increase wound strength relative to wound closures using plain sutures or staples. Thus, self-retaining sutures, because such sutures avoid knot tying, allow patients to experience an improved clinical outcome, and also save time and costs associated with extended surgeries and follow-up treatments. It is noted that all patents, patent applications and patent publications identified throughout are incorporated herein by reference in their entirety.
The ability of self-retaining sutures to anchor and hold tissues in place even in the absence of tension applied to the suture by a knot is a feature that also provides superiority over plain sutures. When closing a wound that is under tension, this advantage manifests itself in several ways: (i) self-retaining sutures have a multiplicity of retainers which can dissipate tension along the entire length of the suture (providing hundreds of “anchor” points that produce a superior cosmetic result and lessens the chance that the suture will “slip” or pull through) as opposed to knotted interrupted sutures which concentrate the tension at discrete points; (ii) complicated wound geometries can be closed (circles, arcs, jagged edges) in a uniform manner with more precision and accuracy than can be achieved with interrupted sutures; (iii) self-retaining sutures eliminate the need for a “third hand” which is often required for maintaining tension across the wound during traditional suturing and knot tying (to prevent “slippage” when tension is momentarily released during tying); (iv) self-retaining sutures are superior in procedures where knot tying is technically difficult, such as in deep wounds or laparoscopic/endoscopic procedures; and (v) self-retaining sutures can be used to approximate and hold the wound prior to definitive closure. As a result, self-retaining sutures provide easier handling in anatomically tight or deep places (such as the pelvis, abdomen and thorax) and make it easier to approximate tissues in laparoscopic/endoscopic and minimally invasive procedures; all without having to secure the closure via a knot. Greater accuracy allows self-retaining sutures to be used for more complex closures (such as those with diameter mismatches, larger defects or purse string suturing) than can be accomplished with plain sutures.
A self-retaining suture may be unidirectional, having one or more retainers oriented in one direction along the length of the suture thread; or bidirectional, typically having one or more retainers oriented in one direction along a portion of the thread, followed by one or more retainers oriented in another (often opposite) direction over a different portion of the thread (as described with barbed retainers in U.S. Pat. Nos. 5,931,855 and. 6,241,747). Although any number of sequential or intermittent configurations of retainers are possible, a common form of bidirectional self-retaining suture involves a needle at one end of a suture thread which has barbs having tips projecting “away” from the needle until the transition point (often the midpoint) of the suture is reached; at the transition point the configuration of barbs reverses itself about 180° (such that the barbs are now facing in the opposite direction) along the remaining length of the suture thread before attaching to a second needle at the opposite end (with the result that the barbs on this portion of the suture also have tips projecting “away” from the nearest needle). Projecting “away” from the needle means that the tip of the barb is further away from the needle and the portion of suture comprising the barb may be pulled more easily through tissue in the direction of the needle than in the opposite direction. Put another way, the barbs on both “halves” of a typical bidirectional self-retaining suture have tips that point towards the middle, with a transition segment (lacking barbs) interspersed between them, and with a needle attached to either end.
It is desirable in some applications to provide self-retaining sutures having profiles, materials and diameters upon which it is difficult to provide retainers. Thus, it is desirable to provide improved self-retaining sutures which have enhanced ability to anchor into the surrounding tissue, enhanced tissue holding capabilities, enhanced maximum load, and enhanced clinical performance.
It is particularly desirable to provide improved self-retaining sutures of small diameter which have enhanced ability to anchor into the surrounding tissue, enhanced tissue holding capabilities, enhanced maximum load, and enhanced clinical performance.
The present invention provides improved self-retaining sutures which have enhanced ability to anchor into the surrounding tissue, enhanced tissue holding capabilities, enhanced maximum load, and enhanced clinical performance.
The present invention further provides improved self-retaining sutures of small diameter which have enhanced ability to anchor into the surrounding tissue, enhanced tissue holding capabilities, enhanced maximum load, and enhanced clinical performance.
The present invention still further provides apparatus and methods for manufacturing improved self-retaining sutures of small diameter.
The present invention yet further provides clinical methods and procedures enabled by such improved self-retaining sutures of small diameter.
For example, in one embodiment the present invention provides a self-retaining suture comprising: a suture thread with a plurality of retainers distributed along the suture thread; wherein the plurality of retainers is distributed at a density of about at least 100 retainers per inch along a length of the suture thread; and wherein the plurality of retainers is distributed in a pattern selected from: a quadra-helix pattern; a double-helix pattern; and a single helix pattern. In this and other embodiments provided herein, the suture may optionally be further characterized by one, or any two or more not-inconsistent combinations of the following features, which are exemplary of features disclosed herein and therefore are non-limiting: the pattern has a pitch (P) and the retainers have a length (L) and wherein P<2 L; the density of retainers is about at least 200 retainers per inch along a length of the suture thread; the density of retainers is about at least 400 retainers per inch along a length of the suture thread; the density of retainers is about at least 800 retainers per inch along a length of the suture thread; the density of retainers is about at least 1200 retainers per inch along a length of the suture thread; the plurality of retainers is distributed in a double-helix pattern having one retainer per repeating unit of the pattern; the plurality of retainers is distributed in a double-helix pattern having at least two retainers per repeating unit of the pattern; the plurality of retainers is distributed in a quadra-helix pattern having at least four retainers per repeating unit of the pattern; the suture thread is of a size in the range of 4-0 to 12-0; the suture thread is no larger than size 4-0; the suture thread is no larger than size 6-0; the suture thread is no larger than 8-0; the retainers comprise a portion of the suture thread deformed by a mechanical process into a shape adapted to engage tissue; the retainers comprise a portion of the suture thread having a cut which partially separates a portion of the suture thread into a shape adapted to engage tissue; the retainers comprise a portion of the suture thread from which a portion of material has been removed to partially separate a portion of the suture thread into a shape adapted to engage tissue; the retainers are formed using a sapphire blade; each retainer has a length (L) and the suture thread has a diameter (SD) and wherein L>0.6SD; the retainers are characterized by an aspect ratio and the aspect ratio of the retainers is greater than 2.5; the aspect ratio of the retainers is greater than 3; the aspect ratio of the retainers is greater than 3.5; the aspect ratio of the retainers is greater than 3.5 but no greater than 6; the aspect ratio of the retainers is greater than 4; the aspect ratio of the retainers is greater than 5; the aspect ratio of the retainers is greater than 4 but no greater than 6; the aspect ratio of the retainers is greater than 5 but no greater than 7; the suture is characterized by the number of retainers per suture diameter in axial length of suture, for instance the number is greater than 1 and less than 5; the number of retainers per suture diameter in axial length of suture is greater than 3; the number of retainers per suture diameter in axial length of suture is greater than 3 and less than 5; the number of retainers per suture diameter in axial length of suture is greater than 4; the sum of the lengths of the retainers in an inch of suture is greater than 1 inch; the sum of the lengths of the retainers in an inch of suture is greater than 1 inch and less than 4 inches; the sum of the lengths of the retainers in an inch of suture is greater than 2 inches and less than 4 inches; the sum of the lengths of the retainers in an inch of suture is greater than 3 inches and less than 4 inches; the sum of the lengths of the retainers in an inch of suture is greater than 3 inches; the suture thread is a monofilament suture into which the retainers are cut; the suture thread is a polypropylene suture into which the retainers are cut; the suture thread is a drawn polymeric fiber suture into which the retainers are cut; the suture has a needle at each end; the suture has a needle at one end and an anchor at one end; and/or the suture has a needle at one end and an anchor at one end, wherein the anchor is an anchor selected from: a loop, a tack, a staple, a clip, a pledget, and a short barbed segment of suture without a needle.
In another embodiment, the present invention provides a self-retaining suture comprising: a suture thread; a plurality of retainers distributed along the suture thread; wherein the suture thread has a suture diameter (SD) no greater than about 300 μm; wherein the retainers have a cut depth (C) between 5% and 35% of the suture diameter (SD); wherein the retainers have a retainer length (L) greater than 50% of the suture diameter (SD); and wherein the retainers are distributed at a density greater than 2 retainers per suture diameters (SD) in length of suture thread. In this and other embodiments provided herein, the suture may optionally be further characterized by one, or any two or more not-inconsistent combinations of the following features, which are exemplary of features disclosed herein and therefore are non-limiting: the plurality of retainers is distributed at a density greater than 2 retainers per retainer length (L) of suture thread; the retainers are distributed at a density greater than 2.5 retainers per retainer length (L) of suture thread; the retainers are distributed at a density greater than 3 retainers per retainer length (L) of suture thread; the retainer length (L) is between 500% and 800% of the cut depth (C); the suture thread has a suture diameter (SD) no greater than about 100 μm; and the suture thread has a suture diameter (SD) no greater than about 50 μm; the suture thread has a suture diameter (SD) less than about 100 μm and the retainers have a length greater than 50 μm and the retainers are distributed at a density of at least 4 retainers per 100 μm of suture thread; the suture thread has a suture diameter SD less than about 60 μm and the retainers have a length greater than 25 μm and the retainers are distributed at a density of at least 4 retainers per 60 μm of suture thread; the retainers are characterized by an aspect ratio and the aspect ratio of the retainers is greater than 2.5; the aspect ratio of the retainers is greater than 3; the aspect ratio of the retainers is greater than 3.5; the aspect ratio of the retainers is greater than 3.5 but no greater than 6; the aspect ratio of the retainers is greater than 4; the aspect ratio of the retainers is greater than 5; the aspect ratio of the retainers is greater than 4 but no greater than 6; the aspect ratio of the retainers is greater than 5 but no greater than 7; the suture is characterized by the number of retainers per suture diameter in axial length of suture, for instance the number is greater than 1 and less than 5; the number of retainers per suture diameter in axial length of suture is greater than 3; the number of retainers per suture diameter in axial length of suture is greater than 3 and less than 5; the number of retainers per suture diameter in axial length of suture is greater than 4; the sum of the lengths of the retainers in an inch of suture is greater than 1 inch; the sum of the lengths of the retainers in an inch of suture is greater than 1 inch and less than 4 inches; the sum of the lengths of the retainers in an inch of suture is greater than 2 inches and less than 4 inches; the sum of the lengths of the retainers in an inch of suture is greater than 3 inches and less than 4 inches; the sum of the lengths of the retainers in an inch of suture is greater than 3 inches; the suture thread is a monofilament suture into which the retainers are cut; the suture thread is a polypropylene suture into which the retainers are cut; the suture thread is a drawn polymeric fiber suture into which the retainers are cut; the suture has a needle at each end; the suture has a needle at one end and an anchor at one end; and/or the suture has a needle at one end and an anchor at one end, wherein the anchor is an anchor selected from: a loop, a tack, a staple, a clip, a pledget, and a short barbed segment of suture without a needle.
In a further embodiment of the present invention, there is provided a self-retaining suture comprising a suture thread and a plurality of retainers distributed along the suture thread wherein: the suture thread has a suture diameter (SD) no greater than 300 μm; the retainers have a retainer length L greater than 20% of the suture diameter (SD); and the retainers are distributed at a density greater than 200 retainers per inch. In this and other embodiments provided herein, the suture may optionally be further characterized by one, or any two or more not-inconsistent combinations of the following features, which are exemplary of features disclosed herein and therefore are non-limiting: the retainers are distributed at a density of between 200 retainers per inch and 1,600 retainers per inch; the retainers are distributed at a density greater than 400 retainers per inch; the retainers are distributed at a density greater than 800 retainers per inch; the retainers are distributed at a density greater than 1200 retainers per inch; the suture thread has a suture diameter (SD) smaller than 100 μm; the suture thread has a suture diameter (SD) smaller than 100 μm and the self-retaining suture has at least 500 retainers within a one inch length of the suture thread; the suture thread has a suture diameter (SD) no greater than 50 μm and the self-retaining suture has at least 800 retainers within a one inch length of the suture thread; the retainers are characterized by an aspect ratio and the aspect ratio of the retainers is greater than 2.5; the aspect ratio of the retainers is greater than 3; the aspect ratio of the retainers is greater than 3.5; the aspect ratio of the retainers is greater than 3.5 but no greater than 6; the aspect ratio of the retainers is greater than 4; the aspect ratio of the retainers is greater than 5; the aspect ratio of the retainers is greater than 4 but no greater than 6; the aspect ratio of the retainers is greater than 5 but no greater than 7; the suture is characterized by the number of retainers per suture diameter in axial length of suture, for instance the number is greater than 1 and less than 5; the number of retainers per suture diameter in axial length of suture is greater than 3; the number of retainers per suture diameter in axial length of suture is greater than 3 and less than 5; the number of retainers per suture diameter in axial length of suture is greater than 4; the sum of the lengths of the retainers in an inch of suture is greater than 1 inch; the sum of the lengths of the retainers in an inch of suture is greater than 1 inch and less than 4 inches; the sum of the lengths of the retainers in an inch of suture is greater than 2 inches and less than 4 inches; the sum of the lengths of the retainers in an inch of suture is greater than 3 inches and less than 4 inches; the sum of the lengths of the retainers in an inch of suture is greater than 3 inches; the suture thread is a monofilament suture into which the retainers are cut; the suture thread is a polypropylene suture into which the retainers are cut; the suture thread is a drawn polymeric fiber suture into which the retainers are cut; the suture has a needle at each end; the suture has a needle at one end and an anchor at one end; and/or the suture has a needle at one end and an anchor at one end, wherein the anchor is an anchor selected from: a loop, a tack, a staple, a clip, a pledget, and a short barbed segment of suture without a needle.
Another embodiment of the present invention provides a self-retaining medical device comprising: a suture having a diameter less than about 350 μm and greater than about 250 μm; the suture having a longitudinal axis; a plurality of retainers, each retainer being formed by an angled cut into a section of the suture; each retainer having a retainer length measured along said axis wherein the retainer length is greater than about 300 μm and less than about 500 μm; the retainers being distributed in pairs, each pair comprising a first retainer and a second retainer; wherein the second retainer of each pair is positioned at substantially the same position along the axis and substantially 180 degrees around said axis from the first retainer of each pair; wherein for each pair of retainers there is at least one adjacent pair of retainers; wherein each pair of retainers is displaced by a pitch length along the axis and substantially 90 degrees around said axis relative to the adjacent pair of retainers; and wherein the pitch length is no less than about 300 μm and no greater than about 550 μm. In this and other embodiments provided herein, the suture may optionally be further characterized by one, or any two or more not-inconsistent combinations of the following features, which are exemplary of features disclosed herein and therefore are non-limiting: the retainer length is at least about 400 μm; the retainer length is at least about 400 μm and the pitch length is no greater than about 500 μm; the retainer length is at least about 400 μm and the pitch length is no less than about 400 μm; the pitch length is no more than 100 μm greater than the retainer length; wherein the retainer length is about 420 μm; the pitch length is about 500 μm; the retainer length is about 420 μm and the pitch length is about 500 μm; the retainers are characterized by an aspect ratio and the aspect ratio of the retainers is greater than 2.5; the aspect ratio of the retainers is greater than 3; the aspect ratio of the retainers is greater than 3.5; the aspect ratio of the retainers is greater than 3.5 but no greater than 6; the aspect ratio of the retainers is greater than 4; the aspect ratio of the retainers is greater than 5; the aspect ratio of the retainers is greater than 4 but no greater than 6; the aspect ratio of the retainers is greater than 5 but no greater than 7; the suture is characterized by the number of retainers per suture diameter in axial length of suture, for instance the number is greater than 1 and less than 5; the number of retainers per suture diameter in axial length of suture is greater than 3; the number of retainers per suture diameter in axial length of suture is greater than 3 and less than 5; the number of retainers per suture diameter in axial length of suture is greater than 4; the sum of the lengths of the retainers in an inch of suture is greater than 1 inch; the sum of the lengths of the retainers in an inch of suture is greater than 1 inch and less than 4 inches; the sum of the lengths of the retainers in an inch of suture is greater than 2 inches and less than 4 inches; the sum of the lengths of the retainers in an inch of suture is greater than 3 inches and less than 4 inches; the sum of the lengths of the retainers in an inch of suture is greater than 3 inches; the suture thread is a monofilament suture into which the retainers are cut; the suture thread is a polypropylene suture into which the retainers are cut; the suture thread is a drawn polymeric fiber suture into which the retainers are cut; the suture has a needle at each end; the suture has a needle at one end and an anchor at one end; the suture has a needle at one end and an anchor at one end, wherein the anchor is an anchor selected from: a loop, a tack, a staple, a clip, a pledget, and a short barbed segment of suture without a needle; and/or the suture is a polypropylene monofilament of USP 2-0.
In yet another embodiment, the present invention provides a self-retaining medical device comprising: a suture having a suture diameter and a longitudinal axis; a plurality of retainers, each retainer being formed by an angled cut into a section of the suture; each retainer having a retainer length greater than one suture diameter measured along said axis; the retainers being distributed in pairs, each pair comprising a first retainer and a second retainer at substantially the same position along the axis but on the opposite side of the suture; wherein for each pair of retainers there is at least one adjacent pair of retainers; and wherein the retainers of each pair of retainers are displaced by a pitch length less than two suture diameters along the axis and substantially 90 degrees around said axis relative to the retainers of the adjacent pair of retainers. In this and other embodiments provided herein, the suture may optionally be further characterized by one, or any two or more not-inconsistent combinations of the following features, which are exemplary of features disclosed herein and therefore are non-limiting: the retainers are distributed at a retainer density no less than about 100 retainers per inch; the combined lengths of retainers within an inch of suture is greater than an inch; the combined lengths of retainers within an inch of suture is greater than 1.5 inches; the pitch length is no more than 1.5 suture diameters; the pitch length is no more than 100 μm greater than the retainer length; the pitch length is no more than 120% of the retainer length; the suture is size USP 2-0; the suture diameter is less than 350 μm; the retainer length is at least about 400 μm; the suture diameter is less than about 350 μm, the retainer length is at least about 400 μm and the pitch length is no greater than about 500 μm; the suture diameter is less than about 350 μm and the retainer length is about 420 μm; the suture diameter is less than about 350 μm and the pitch length is about 500 μm; the suture diameter is less than about 350 μm, the retainer length is about 420 μm and the pitch length is about 500 μm; the retainers are characterized by an aspect ratio and the aspect ratio of the retainers is greater than 2.5; the aspect ratio of the retainers is greater than 3; the aspect ratio of the retainers is greater than 3.5; the aspect ratio of the retainers is greater than 3.5 but no greater than 6; the aspect ratio of the retainers is greater than 4; the aspect ratio of the retainers is greater than 5; the aspect ratio of the retainers is greater than 4 but no greater than 6; the aspect ratio of the retainers is greater than 5 but no greater than 7; the suture is characterized by the number of retainers per suture diameter in axial length of suture, for instance the number is greater than 1 and less than 5; the number of retainers per suture diameter in axial length of suture is greater than 3; the number of retainers per suture diameter in axial length of suture is greater than 3 and less than 5; the number of retainers per suture diameter in axial length of suture is greater than 4; the sum of the lengths of the retainers in an inch of suture is greater than 1 inch; the sum of the lengths of the retainers in an inch of suture is greater than 1 inch and less than 4 inches; the sum of the lengths of the retainers in an inch of suture is greater than 2 inches and less than 4 inches; the sum of the lengths of the retainers in an inch of suture is greater than 3 inches and less than 4 inches; the sum of the lengths of the retainers in an inch of suture is greater than 3 inches; the suture thread is a monofilament suture into which the retainers are cut; the suture thread is a polypropylene suture into which the retainers are cut; the suture thread is a drawn polymeric fiber suture into which the retainers are cut; the suture has a needle at each end; the suture has a needle at one end and an anchor at one end; the suture has a needle at one end and an anchor at one end, wherein the anchor is an anchor selected from: a loop, a tack, a staple, a clip, a pledget, and a short barbed segment of suture without a needle; and/or the suture is a polypropylene monofilament of USP 2-0.
As a further embodiment, the present invention provides a self-retaining medical device comprising: a USP 2-0 polypropylene monofilament suture having a longitudinal axis; a plurality of retainers, each retainer being formed by an angled cut into a section of the suture; each retainer having a retainer length greater than 400 μm measured along said axis; the retainers being distributed in pairs, each pair comprising a first retainer and a second retainer at substantially the same position along the axis but on the opposite side of the suture; wherein for each pair of retainers there is at least one adjacent pair of retainers; and wherein the retainers of each pair of retainers are displaced by a pitch length no greater than about 550 μm along the axis and substantially 90 degrees around said axis relative to the retainers of the adjacent pair of retainers. In this and other embodiments provided herein, the suture may optionally be further characterized by one, or any two or more not-inconsistent combinations of the following features, which are exemplary of features disclosed herein and therefore are non-limiting: the suture diameter is less than about 350 μm, the retainer length is about 420 μm and the pitch length is about 500 μm; the retainers are characterized by an aspect ratio and the aspect ratio of the retainers is greater than 2.5; the aspect ratio of the retainers is greater than 3; the aspect ratio of the retainers is greater than 3.5; the aspect ratio of the retainers is greater than 3.5 but no greater than 6; the aspect ratio of the retainers is greater than 4; the aspect ratio of the retainers is greater than 5; the aspect ratio of the retainers is greater than 4 but no greater than 6; the aspect ratio of the retainers is greater than 5 but no greater than 7; the suture is characterized by the number of retainers per suture diameter in axial length of suture, for instance the number is greater than 1 and less than 5; the number of retainers per suture diameter in axial length of suture is greater than 3; the number of retainers per suture diameter in axial length of suture is greater than 3 and less than 5; the number of retainers per suture diameter in axial length of suture is greater than 4; the sum of the lengths of the retainers in an inch of suture is greater than 1 inch; the sum of the lengths of the retainers in an inch of suture is greater than 1 inch and less than 4 inches; the sum of the lengths of the retainers in an inch of suture is greater than 2 inches and less than 4 inches; the sum of the lengths of the retainers in an inch of suture is greater than 3 inches and less than 4 inches; the sum of the lengths of the retainers in an inch of suture is greater than 3 inches; the suture thread is a monofilament suture into which the retainers are cut; the suture thread is a polypropylene suture into which the retainers are cut; the suture thread is a drawn polymeric fiber suture into which the retainers are cut; the suture has a needle at each end; the suture has a needle at one end and an anchor at one end; and/or the suture has a needle at one end and an anchor at one end, wherein the anchor is an anchor selected from: a loop, a tack, a staple, a clip, a pledget, and a short barbed segment of suture without a needle.
The present invention also provides devices for forming a retainer on a suture or equivalent. For example, in one embodiment, the present invention provides a device adapted to form a retainer on a suture having a suture diameter (SD) wherein the device comprises: an anvil adapted to support a suture; said anvil including a gap aligned with the suture and adapted for receiving at least a part of the suture; a spring adapted to hold the suture against said anvil and within said gap; and a cutting blade adapted to cut a retainer in a suture when the spring holds the suture against said anvil and within said gap. In this and other embodiments provided herein, the device may optionally be further characterized by one, or any two or more not-inconsistent combinations of the following features, which are exemplary of features disclosed herein and therefore are non-limiting: said gap is adjustable; said anvil includes a step which precludes contact between the suture and the anvil beyond the step; said step is located at an adjustable distance (D) from the spring; said step is located within two sutures diameters (SD) of the spring; said gap is adapted to receive a retainer that has been previously formed in said suture by said cutting blade; the gap has a width smaller than the suture diameter (SD) and greater than half the suture diameter (SD); the cutting blade passes within one suture diameter (SD) of the retainer when cutting a retainer; the cutting blade passes within one suture diameter (SD) of the step when cutting a retainer; the anvil has a surface for supporting the suture adjacent the gap and wherein the surface is curved; said anvil includes a first circular anvil segment and a second circular anvil segment and said gap is located between said first circular anvil segment and said second circular anvil segment; said cutting blade is adapted to be urged about across a longitudinal axis of a suture; the anvil includes a relief that communicates with said gap and is positioned after said cutting blade and adapted to receive retainers so that said retainers are not compressed by said anvil; said spring has a trailing edge and said relief defines a step, and wherein a proximity of the step to the trailing edge is adapted to allow for the creation of retainers at high density by providing support of the suture adjacent a cutting region associated with the blade while preventing interference between already formed retainers and said anvil; said anvil has a relief that defines a step that is located on the opposite side of the cutting blade from the spring and wherein, a distance between the cutting blade and said step is adapted for defining the density of retainer that can be formed; said anvil has a relief that defines a step and wherein the distance between the spring and the step is adjustable in order to adjust a density of retainers that can be created by said device on a suture; said anvil is rotatable and said anvil can be rotated to adjust the distance between the spring and the step; said anvil has a relief that defines a step and wherein the distance between the spring and the step is less than two suture diameters (SD); said anvil has a relief that defines a step; and wherein said cutting blade is adapted to cut a retainer on the suture thread between the spring and the step; said anvil has a relief that defines a step and wherein said cutting blade is adapted to cut a retainer on the suture thread between the spring and the step and wherein said cutting blade is adapted to cut a retainer on the suture thread at a distance from the step less than a pitch of the self-retaining suture; said gap is adapted to prevent already formed retainers from being crushed; said cutting blade is mounted in order to have two degrees of linear freedom of adjustment and two degrees of rotational freedom of adjustment relative to a suture; and the device further comprises a chuck adapted for holding suture, and/or wherein said chuck includes at least one degree of rotational freedom and one degree of linear freedom.
In another embodiment, the present invention provides a device adapted to form a plurality of retainers in a surgical filament comprising: an anvil adapted to support the surgical filament; said anvil including a gap aligned with the surgical filament adapted for receiving a portion of the surgical filament; a compressor adapted to push the suture against said anvil such that a portion of the surgical filament is received in the gap; and a retainer formation device adapted to form a retainer in the surgical filament adjacent the compressor. In this and other embodiments provided herein, the device may optionally be further characterized by one, or any two or more not-inconsistent combinations of the following features, which are exemplary of features disclosed herein and therefore are non-limiting: said gap is adjustable; said anvil includes a step which precludes contact between the surgical filament and the anvil beyond the step; said step is located at an adjustable distance (D) from the compressor; said step is located within two surgical filaments diameters (SD) of the compressor; said gap is adapted to receive a retainer that has been previously formed in said surgical filament by said retainer formation device; said gap has a width smaller than the surgical filament diameter (SD) and greater than half the surgical filament diameter (SD); the retainer formation device passes within one surgical filament diameter (SD) of the retainer when forming a retainer; the retainer formation device passes within one surgical filament diameter (SD) of the step when forming a retainer; the anvil has a surface for supporting the surgical filament adjacent the gap and wherein the surface is curved; said anvil includes a first circular anvil segment and a second circular anvil segment and said gap is located between said first circular anvil segment and said second circular anvil segment; said retainer formation device is adapted to be urged about across a longitudinal axis of a surgical filament; the anvil includes a relief that communicates with said gap and is positioned after said retainer formation device and adapted to receive retainers so that said retainers are not compressed by said anvil; said compressor is a spring which has a trailing edge and said relief defines a step, and wherein a proximity of the step to the trailing edge is adapted to allow for the creation of retainers at high density by providing support of the surgical filament adjacent a cutting region associated with the blade while preventing interference between already formed retainers and said anvil; said anvil has a relief that defines a step that is located on the opposite side of the retainer formation device from the compressor and wherein, a distance between the retainer formation device and said step is adapted for defining the density of retainer that can be formed; said anvil has a relief that defines a step and wherein the distance between the compressor and the step is adjustable in order to adjust a density of retainers that can be created by said device on a surgical filament; said anvil is rotatable and said anvil can be rotated to adjust the distance between the compressor and the step; said anvil has a relief that defines a step and wherein the distance between the compressor and the step is less than two surgical filament diameters (SD); said anvil has a relief that defines a step; and wherein said cutting blade is adapted to cut a retainer on the surgical filament thread between the compressor and the step; said anvil has a relief that defines a step; and wherein said cutting blade is adapted to cut a retainer on the surgical filament thread between the compressor and the step and wherein said retainer formation device is adapted to form a retainer on the surgical filament thread at a distance from the step less than a pitch of the self-retaining surgical filament; said gap is adapted to prevent already formed retainers from being crushed; said retainer formation device is mounted in order to have two degrees of linear freedom of adjustment and two degrees of rotational freedom of adjustment relative to a surgical filament; said device further comprising a chuck adapted for holding surgical filament, wherein said chuck includes at least one degree of rotational freedom and one degree of linear freedom; and/or the retainer formation device is a sapphire blade.
In another embodiment directed to a device, the present invention provides for a device adapted to form a plurality of retainers along a suture, the retainers being spaced at a pitch (P) along the suture, and the suture having a suture diameter (SD), the device comprising: an anvil adapted to support the suture; a compressor adapted to push the suture against said anvil; a step in the anvil adapted to distance the anvil from the suture; a retainer formation device adapted to form a retainer in a suture at a position between the compressor and the step; and wherein said retainer formation device is positioned so as to form a retainer at a distance from the step which is less than the pitch (P). In this and other embodiments provided herein, the device may optionally be further characterized by one, or any two or more not-inconsistent combinations of the following features, which are exemplary of features disclosed herein and therefore are non-limiting: the device is adapted to form a plurality of retainers along a suture having a suture diameter (SD) less than about 300 μm, the retainers being spaced at a pitch (P) less than about 500 μm along the suture, wherein said retainer formation device is positioned so as to from a retainer at a distance from the step which is less than about 500 μm; said compressor contacts the suture to push the suture against the anvil within 1000 μm from the step along the suture; the device is adapted to form a plurality of retainers along a suture having a suture diameter (SD) less than about 100 μm, the retainers being spaced at a pitch (P) less than about 100 μm along the suture, wherein said retainer formation device is positioned so as to form a retainer at a distance from the step which is less than about 100 μm; said compressor contacts the suture to push the suture against the anvil within 200 μm from the step along the suture; the device is adapted to form a plurality of retainers along a suture having a suture diameter (SD) less than about 50 μm, the retainers being spaced at a pitch (P) less than about 70 μm along the suture, wherein said retainer formation device is positioned so as to form a retainer at a distance from the step which is less than about 70 μm; said retainer formation device is positioned so as to form a retainer at an adjustable distance from the step; said compressor contacts the suture to push the suture against the anvil within 140 μm from the step along the suture; the anvil comprises a channel aligned with the suture and extending from the step towards the compressor, wherein the channel has a width less than the diameter of the suture and a depth sufficient to prevent interference with a previously-formed retainer located on an opposite side of the suture from a retainer currently being formed; the channel is at least as long as the pitch (P) of the suture and the width of the channel is optionally adjustable; an/or the anvil comprises a first anvil component and a second anvil component and wherein the channel comprises a gap between the first anvil component and the second anvil component adjacent the step, where the gap is optionally adjustable.
In one more embodiment directed to an exemplary device of the present invention, there is provided a device adapted to form a plurality of retainers along a surgical filament having a diameter SD, wherein the device comprises: a compressor, a blade, and an anvil; the anvil comprising a support surface adapted for supporting the suture; the support surface comprising a channel aligned with a longitudinal axis of the suture; the channel having a width W greater than 0.5SD and less than 0.9SD; the support surface having a step which intersects the channel; the compressor being positioned to push the suture against the support surface of the anvil within a distance L of the step, where L<4SD; and the blade being configured to cut a retainer in the surgical filament at a position between the compressor and the step. In this and other embodiments provided herein, the device may optionally be further characterized by one, or any two or more not-inconsistent combinations of the following features, which are exemplary of features disclosed herein and therefore are non-limiting: the device is adapted to form a plurality of retainers along a surgical filament having a diameter no greater than about 500 μm; the device is adapted to form a plurality of retainers along a surgical filament having a diameter SD no greater than about 300 μm; the device is adapted to form a plurality of retainers along a surgical filament having a diameter SD no greater than about 100 μm; the device is adapted to form a plurality of retainers along a surgical filament having a diameter SD no greater than about 50 μm; the density of retainers is about at least 1600 retainers per inch along a length of the suture thread; the retainers are distributed at a density of between 200 retainers per inch and 1,600 retainers per inch; and/or the retainers are characterized by an aspect ratio and the aspect ratio of the retainers is greater than 2.5; the aspect ratio of the retainers is greater than 3; the aspect ratio of the retainers is greater than 3.5; the aspect ratio of the retainers is greater than 3.5 but no greater than 6; the aspect ratio of the retainers is greater than 4; the aspect ratio of the retainers is greater than 5; the aspect ratio of the retainers is greater than 4 but no greater than 6; the aspect ratio of the retainers is greater than 5 but no greater than 7.
In addition to sutures and the like, and devices for preparing sutures and the like, the present invention provides methods for creating such sutures and the like. For example, in one embodiment the present invention provides a method for creating a plurality of retainers on a suture thread having a longitudinal axis and a suture diameter (SD) wherein the method comprises: (a) securing the suture thread to a support; (b) operating a cutting blade to move along a cutting axis substantially perpendicular to the longitudinal axis of the suture thread to cut a retainer of length L in the suture thread; (c) releasing the suture thread from the support; (d) rotating the suture thread around the longitudinal axis of the suture thread; (e) repeating steps (a), (b) and (c) at least once; (f) subsequent to step (e), releasing the suture thread from the support and advancing the suture thread a distance P along its longitudinal axis relative to the cutting blade; and (g) repeating steps (a) through (f) at least ten times. In this and other embodiments provided herein, the method may optionally be further characterized by one, or any two or more not-inconsistent combinations of the following features, which are exemplary of features disclosed herein and therefore are non-limiting: L is greater than 20% of SD and less than 200% of SD; P is less than 500 μm; P is less than about 100 μm; P is less than about 70 μm; P is no greater than 2 L; P is no greater than 1.5 L; P is no greater than 1.2 L; the retainers are characterized by an aspect ratio and the aspect ratio of the retainers is greater than 2.5; the aspect ratio of the retainers is greater than 3; the aspect ratio of the retainers is greater than 3.5; the aspect ratio of the retainers is greater than 3.5 but no greater than 6; the aspect ratio of the retainers is greater than 4; the aspect ratio of the retainers is greater than 5; the aspect ratio of the retainers is greater than 4 but no greater than 6; the aspect ratio of the retainers is greater than 5 but no greater than 7; step (e) comprises repeating steps (a), (b) and (c) at least three times prior to step (f); the support comprises an anvil having a channel aligned with the suture and smaller in width than the suture diameter (SD) and wherein step (a) comprises approximating the anvil to a compressor to trap the suture between the compressor and the anvil with a segment of the suture thread received within the channel and thereby secure the suture thread to the support; and/or the support comprises an anvil having a channel aligned with the suture and smaller in width than the suture diameter (SD) and wherein step (a) comprises approximating the anvil to a spring to trap the suture between the compressor and the spring with a segment of the suture thread received within the channel and thereby secure the suture thread to the support.
The details of one or more embodiments are set forth in the description below. Other features, objects and advantages will be apparent from the description, the drawings, and the claims.
Features of the invention, and the nature and various advantages thereof will be apparent from the accompanying drawings and the following detailed description of various embodiments of the invention.
o shows an enlarged view of suture of
Definitions of certain terms that may be used hereinafter include the following.
“Self-retaining suture” refers to a surgical suture that includes features on the suture thread for engaging tissue without the need for a knot or suture anchor. A “self-retaining suture” may also include devices for deploying the suture into tissue. Such deployment devices include, without limitation, suture needles and other deployment devices as well as sufficiently rigid and sharp ends on the suture itself to penetrate tissue.
“Tissue retainer” (or simply “retainer”) or “barb” refers to a physical feature of a suture thread which is adapted to mechanically engage tissue and resist movement of the suture in at least one axial directions. By way of example only, tissue retainer or retainers can include hooks, projections, barbs, darts, extensions, bulges, anchors, protuberances, spurs, bumps, points, cogs, tissue engagers, traction devices, surface roughness, surface irregularities, surface defects, edges, facets and the like. In certain configurations, tissue retainers are adapted to engage tissue to resist movement of the suture in a direction other than the direction in which the suture is deployed into the tissue by the surgeon, by being oriented to substantially face the deployment direction. In some embodiments the retainers lie flat when pulled in the deployment direction and open or “fan out” when pulled in a direction contrary to the deployment direction. As the tissue-penetrating end of each retainer faces away from the deployment direction when moving through tissue during deployment, the tissue retainers should not catch or grab tissue during this phase. Once the self-retaining suture has been deployed, a force exerted in another direction (often substantially opposite to the deployment direction) causes the retainers to be displaced from the deployment position (i.e. resting substantially along the suture body), forces the retainer ends to open (or “fan out”) from the suture body in a manner that catches and penetrates into the surrounding tissue, and results in tissue being caught between the retainer and the suture body; thereby “anchoring” or affixing the self-retaining suture in place. In certain other embodiments, the tissue retainers may be configured to permit motion of the suture in one direction and resist movement of the suture in another direction without fanning out or deploying. In each of the sutures and retainers of the present invention, in one optional embodiment, the retainers may be characterized as a plurality of barbs extending from the periphery of the body and tapering from a broad base to a narrow tip. In addition, or also optionally, the retainers may be characterized as a plurality of barbs that yield toward the suture body during movement of the suture through the tissue in the desired direction of movement of the suture through the tissue, and the barbs resist movement of the suture through the tissue in a direction opposite the desired direction of movement of the suture. Typically, a needle will be located at an end of the suture, and the barbs will yield toward the suture body as the suture is pulled through tissue in the direction that the needle is moving. In certain other configurations, the tissue retainer may be configured or combined with other tissue retainers to resist motion of the suture in either direction. Typically, a suture having such retainers is deployed through a device such as a cannula which prevents contact between the retainers and the tissue until the suture is in the desired location.
“Retainer configurations” refers to configurations of tissue retainers and can include features such as size, shape, flexibility, surface characteristics, and so forth. These are sometimes also referred to as “barb configurations”.
“Retainer distribution” and “retainer pattern” refers to the arrangement of retainers along and around a suture thread and can include features such as density and orientation.
“Bidirectional suture” refers to a self-retaining suture having retainers oriented in one direction at one end and retainers oriented in the other direction at the other end. A bidirectional suture is typically armed with a needle at each end of the suture thread. A bidirectional suture may have a transition segment.
“Transition segment” refers to a retainer-free (barb-free) portion of a bidirectional suture located between a first set of retainers (barbs) oriented in one direction and a second set of retainers (barbs) oriented in another direction. The transition segment can be at about the midpoint of the self-retaining suture, or closer to one end of the self-retaining suture to form an asymmetrical self-retaining suture.
“Suture thread” refers to the filamentary body component of a suture or suture. The suture thread may be a monofilament, or contain multiple filaments as in a braided suture. The suture thread may be made of any suitable biocompatible material, and may be further treated with any suitable biocompatible material, whether to enhance the sutures' strength, resilience, longevity, or other qualities, or to equip the sutures to fulfill additional functions besides joining tissues together, repositioning tissues, or attaching foreign elements to tissues.
“Monofilament suture” refers to a suture comprising a monofilamentary suture thread.
“Braided suture” refers to a suture comprising a multifilamentary suture thread. The filaments in such suture threads are typically braided, twisted, or woven together.
“Degradable suture” (also referred to as “biodegradable suture” or “absorbable suture”) refers to a suture which, after introduction into a tissue is broken down and absorbed by the body. Typically, the degradation process is at least partially mediated by, or performed in, a biological system. “Degradation” refers to a chain scission process by which a polymer chain is cleaved into oligomers and monomers. Chain scission may occur through various mechanisms, including, for example, by chemical reaction (e.g., hydrolysis, oxidation/reduction, enzymatic mechanisms or a combination of these) or by a thermal or photolytic process. Degradable suture material may include polymers such as polyglycolic acid, copolymers of glycolide and lactide, copolymers of trimethylene carbonate and glycolide with diethylene glycol (e.g., MAXON™, Tyco Healthcare Group), terpolymer composed of glycolide, trimethylene carbonate, and dioxanone (e.g., BIOSYN™ [glycolide (60%), trimethylene carbonate (26%), and dioxanone (14%)], Tyco Healthcare Group), copolymers of glycolide, caprolactone, trimethylene carbonate, and lactide (e.g., CAPROSYN™, Tyco Healthcare Group). A dissolvable suture can also include partially deacetylated polyvinyl alcohol. Polymers suitable for use in degradable sutures can be linear polymers, branched polymers or multi-axial polymers. Examples of multi-axial polymers used in sutures are described in U.S. Patent Application Publication Nos. 2002/0161168, 2004/0024169, and 2004/0116620. Sutures made from degradable suture material lose tensile strength as the material degrades. Degradable sutures can be in either a braided multifilament form or a monofilament form.
“Non-degradable suture” (also referred to as “non-absorbable suture”) refers to a suture comprising material that is not degraded by chain scission such as chemical reaction processes (e.g., hydrolysis, oxidation/reduction, enzymatic mechanisms or a combination or these) or by a thermal or photolytic process. Non-degradable suture material includes polyamide (also known as nylon, such as nylon 6 and nylon 6.6), polyester (e.g., polyethylene terephthlate), polytetrafluoroethylene (e.g., expanded polytetrafluoroethylene), polyether-ester such as polybutester (block copolymer of butylene terephthalate and polytetra methylene ether glycol), polyurethane, metal alloys, metal (e.g., stainless steel wire), polypropylene, polyethelene, silk, and cotton. Sutures made of non-degradable suture material are suitable for applications in which the suture is meant to remain permanently or is meant to be physically removed from the body.
“Suture diameter” refers to the diameter of the body of the suture. It is to be understood that a variety of suture lengths may be used with the sutures described herein and that while the term “diameter” is often associated with a circular periphery, it is to be understood herein to indicate a cross-sectional dimension associated with a periphery of any shape. Suture sizing is based upon diameter. United States Pharmacopeia (“USP”) designation of suture size runs from 0 to 7 in the larger range and 1-0 to 11-0 in the smaller range; in the smaller range, the higher the value preceding the hyphenated zero, the smaller the suture diameter. The actual diameter of a suture will depend on the suture material, so that, by way of example, a suture of size 5-0 and made of collagen will have a diameter of 0.15 mm, while sutures having the same USP size designation but made of a synthetic absorbable material or a non-absorbable material will each have a diameter of 0.1 mm. The selection of suture size for a particular purpose depends upon factors such as the nature of the tissue to be sutured and the importance of cosmetic concerns; while smaller sutures may be more easily manipulated through tight surgical sites and are associated with less scarring, the tensile strength of a suture manufactured from a given material tends to decrease with decreasing size. It is to be understood that the sutures and methods of manufacturing sutures disclosed herein are suited to a variety of diameters, including without limitation 7, 6, 5, 4, 3, 2, 1, 0, 1-0, 2-0, 3-0, 4-0, 5-0, 6-0, 7-0, 8-0, 9-0, 10-0, 11-0 and 12-0.
“Suture deployment end” refers to an end of the suture to be deployed into tissue; one or both ends of the suture may be suture deployment ends. The suture deployment end may be attached to a deployment device such as a suture needle, or may be sufficiently sharp and rigid to penetrate tissue on its own.
“Needle attachment” refers to the attachment of a needle to a suture requiring same for deployment into tissue, and can include methods such as crimping, swaging, using adhesives, and so forth. The suture thread is attached to the suture needle using methods such as crimping, swaging and adhesives. Attachment of sutures and surgical needles is described in U.S. Pat. Nos. 3,981,307, 5,084,063, 5,102,418, 5,123,911, 5,500,991, 5,722,991, 6,012,216, and 6,163,948, and U.S. Patent Application Publication No. US 2004/0088003) all of which are incorporated herein by reference. The point of attachment of the suture to the needle is known as the swage. “Armed suture” refers to a suture having a suture needle on at least one suture deployment end.
“Suture needle” refers to needles used to deploy sutures into tissue, which come in many different shapes, forms and compositions. There are two main types of needles, traumatic needles and atraumatic needles. Traumatic needles have channels or drilled ends (that is, holes or eyes) and are supplied separate from the suture thread and are threaded on site. Atraumatic needles are eyeless and are attached to the suture at the factory by swaging or other methods whereby the suture material is inserted into a channel at the blunt end of the needle which is then deformed to a final shape to hold the suture and needle together. As such, atraumatic needles do not require extra time on site for threading and the suture end at the needle attachment site is generally smaller than the needle body. In the traumatic needle the thread comes out of the needle's hole on both sides and often the suture rips the tissues to a certain extent as it passes through. Most modern sutures are swaged atraumatic needles. Atraumatic needles may be permanently swaged to the suture or may be designed to come off the suture with a sharp straight tug. These “pop-offs” are commonly used for interrupted sutures, where each suture is only passed once and then tied. For barbed sutures that are uninterrupted, these atraumatic needles are preferred.
Suture needles may also be classified according to the geometry of the tip or point of the needle. For example, needles may be (i) “tapered” whereby the needle body is round and tapers smoothly to a point; (ii) “cutting” whereby the needle body is triangular and has sharpened cutting edge on the inside; (iii) “reverse cutting” whereby the cutting edge is on the outside; (iv) “trocar point” or “taper cut” whereby the needle body is round and tapered, but ends in a small triangular cutting point; (v) “blunt” points for sewing friable tissues; (vi) “side cutting” or “spatula points” whereby the needle is flat on top and bottom with a cutting edge along the front to one side (these are typically used for eye surgery).
Suture needles may also be of several shapes including, (i) straight, (ii) half curved or ski, (iii) ¼ circle, (iv) ⅜ circle, (v) ½ circle, (vi) ⅝ circle, (v) and compound curve. The sutures described herein may be deployed with a variety of needle types (including without limitation curved, straight, long, short, micro, and so forth), needle cutting surfaces (including without limitation, cutting, tapered, and so forth), and needle attachment techniques (including without limitation, drilled end, crimped, and so forth). Moreover, the sutures described herein may themselves include sufficiently rigid and sharp ends so as to dispense with the requirement for deployment needles altogether. Suturing needles are described, for example, in U.S. Pat. Nos. 6,322,581; 6,214,030; 5,464,422; 5,941,899; 5,425,746; 5,306,288; 5,156,615; 5,312,422; 7,063,716; 6,129,741; 5,897,572; 5,676,675; and 5,693,072 all of which are incorporated herein by reference.
“Needle diameter” refers to the diameter of a suture deployment needle at the widest point of that needle. While the term “diameter” is often associated with a circular periphery, it is to be understood herein to indicate a cross-sectional dimension associated with a periphery of any shape. In preferred embodiments of self-retaining suture, the needle diameter is less than the maximum diameter/cross-sectional dimension of the retainers on the suture.
“Wound closure” refers to a surgical procedure for closing of a wound. An injury, especially one in which the skin or another external or internal surface is cut, torn, pierced, or otherwise broken is known as a wound. A wound commonly occurs when the integrity of any tissue is compromised (e.g., skin breaks or burns, muscle tears, or bone fractures). A wound may be caused by an act, such as a puncture, fall, or surgical procedure; by an infectious disease; or by an underlying medical condition. Surgical wound closure facilitates the biological event of healing by joining, or closely approximating, the edges of those wounds where the tissue has been torn, cut, or otherwise separated. Surgical wound closure directly apposes or approximates the tissue layers, which serves to minimize the volume new tissue formation required to bridge the gap between the two edges of the wound. Closure can serve both functional and aesthetic purposes. These purposes include elimination of dead space by approximating the subcutaneous tissues, minimization of scar formation by careful epidermal alignment, and avoidance of a depressed scar by precise eversion of skin edges.
“Tissue elevation procedure” refers to a surgical procedure for repositioning tissue from a lower elevation to a higher elevation (i.e. moving the tissue in a direction opposite to the direction of gravity). The retaining ligaments of the face support facial soft tissue in the normal anatomic position. However, with age, gravitational effects and loss of tissue volume effect downward migration of tissue, and fat descends into the plane between the superficial and deep facial fascia, thus allowing facial tissue to sag. Face-lift procedures are designed to lift these sagging tissues, and are one example of a more general class of medical procedure known as a tissue elevation procedure. More generally, a tissue elevation procedure reverses the appearance change that results from effects of aging and gravity over time, and other temporal effects that cause tissue to sag, such as genetic effects. It should be noted that tissue can also be repositioned without elevation; in some procedures tissues are repositioned laterally (away from the midline), medially (towards the midline) or inferiorly (lowered) in order to restore symmetry (i.e. repositioned such that the left and right sides of the body “match”).
“Medical device” or “implant” refers to any object placed in the body for the purpose of restoring physiological function, reducing/alleviating symptoms associated with disease, and/or repairing and/or replacing damaged or diseased organs and tissues. While normally composed of biologically compatible synthetic materials (e.g., medical-grade stainless steel, titanium and other metals or polymers such as polyurethane, silicon, PLA, PLGA and other materials) that are exogenous, some medical devices and implants include materials derived from animals (e.g., “xenografts” such as whole animal organs; animal tissues such as heart valves; naturally occurring or chemically-modified molecules such as collagen, hyaluronic acid, proteins, carbohydrates and others), human donors (e.g., “allografts” such as whole organs; tissues such as bone grafts, skin grafts and others), or from the patients themselves (e.g., “autografts” such as saphenous vein grafts, skin grafts, tendon/ligament/muscle transplants). Medical devices that can be used in procedures in conjunction with the present invention include, but are not restricted to, orthopedic implants (artificial joints, ligaments and tendons; screws, plates, and other implantable hardware), dental implants, intravascular implants (arterial and venous vascular bypass grafts, hemodialysis access grafts; both autologous and synthetic), skin grafts (autologous, synthetic), tubes, drains, implantable tissue bulking agents, pumps, shunts, sealants, surgical meshes (e.g., hernia repair meshes, tissue scaffolds), fistula treatments, spinal implants (e.g., artificial intervertebral discs, spinal fusion devices, etc.) and the like.
As discussed above, the present invention provides self-retaining sutures and apparatus and methods for manufacturing self-retaining sutures and methods of using self-retaining sutures in surgical procedures.
Although a bidirectional self-retaining suture 100 is illustrated, the present invention includes self-retaining sutures of a wide variety of suture thread, retainer and needle configurations as described above. In alternative embodiments, for example, a self-retaining suture is provided with an anchor on one end of the suture. The anchor can take the form of a loop, bar, hook, pledget or other structural feature which allows the end of the suture to be fixed to tissue and/or prevents the end of the suture from being drawn through tissue. The anchor can be formed by manipulation of the suture material (e.g. a loop) or can be formed separately and secured to the suture material (e.g. a pledget). Likewise the configuration of each of needles 110 and 112 can be any of the range of different surgical needles developed for use in different applications. Needles 110 and 112 may have the same configuration or different configurations.
Self-retaining sutures of the present invention may be made by cutting retainers 130 into the surface of a suture thread 120. In specific embodiments, polymeric thread or filaments may be manufactured for the suture body, and the retainers can be subsequently cut or formed on the suture body. The retainers 130 can be cut mechanically using a blade. During cutting either the blade or the suture thread may be moved, or both may be moved, to control the size, shape and depth of cut. The parameters of the cut control the shape of the resulting retainer 130.
As shown in
Cutting assembly 300, chuck assemblies 215a, 215b, and actuators 230a, 230b are under the control of a computer system 240. Computer system 240 coordinates the operation of the cutting assembly 300, chuck assemblies 215a, 215b, and actuators 230a, 230b so that the cutting assembly 300 cuts retainers at the desired locations on the suture thread 202. After suture thread 202 is mounted to chuck assemblies 215a, 215b, the chuck assemblies 215a, 215b translate and rotate suture thread 202 stepwise relative to retainer-forming head 212 under control of computer system 240. At selected positions of suture thread 202, computer system 240, activates retainer-forming head 212 of cutting assembly 300 to form a retainer on suture thread 202. The process is repeated stepwise until, for example, suture thread 202 is a bidirectional self-retaining suture having a first region 242 having a plurality of retainers oriented in a first direction; a second region 246 having a plurality of retainers oriented in a second direction; and a transition region 244 having no retainers and positioned between the first region 242 and the second region 246.
In step 254, the chuck assemblies 215a, 215b index the suture thread 202 to a desired position relative to the cutting assembly 300 by translating the suture thread 202 relative to the table 210 and cutting assembly.
In step 256, the chuck assemblies 215a, 215b rotate the suture thread 202 to a desired angle relative to its starting position.
In step 258, the cutting assembly 300 cuts a retainer on the suture thread.
In step 260, if further retainers are to be cut at this position along the suture thread 202, the process returns to step 256 in order to rotate the suture thread to a new angle. For example, the suture thread can be rotated once by 180 degrees if two retainers are to be formed at the same position along the length of the suture thread. Alternatively, the suture thread can be rotated three times by 90 degrees each if four retainers are to be formed at the same position along the length of the suture thread. If no further retainers are to be cut at this position along the suture thread 202, the process continues to step 262.
In step 262, if no more retainers need to be cut on the suture thread, the self-retaining suture is complete (step 264). However, further if retainers are to be cut at a different position on the suture thread, the process returns to step 254 for actuators 230a, 230b to move chuck assemblies 215a, 215b to index the suture thread 202 to a new position relative to the cutting assembly 300. The actuators 230a, 230b move chuck assemblies 215a, 215b along tracks 220a, 220b to translate the suture thread 202 along its longitudinal axis. For example, suture thread 202 is translated by a distance equal to the desired axial distance between retainers which is, in some distribution patterns, equal to the pitch (See
Returning to step 256, the chuck assemblies 215a, 215b rotate the suture thread about its longitudinal axis to create the desired spirality angle between the first retainer (set of retainers) and the second retainer (set of retainers). For example, the spirality angle can be 45 degrees in a quadra-helix pattern as shown, for example in
Base assembly 302 comprises a pneumatic actuator 322 for raising and lowering anvil assembly 304 relative to base assembly 302. (See arrow 323 of
Anvil assembly 304 includes an anvil 340 adapted to support a suture thread during cutting of retainers (as further described below). Anvil 340 is mounted beneath anvil plate 342. Anvil plate 342 has an anvil aperture 344 through which a portion of anvil 340 protrudes. Anvil plate 342 also has a column aperture 345 (see
Blade assembly 306 comprises a blade frame 360. A blade slide 364 is mounted to blade frame 360 such that blade slide 364 can slide relative to blade frame 360. Adjustable stops 369 on blade frame 360 are used to control the range of movement of blade slide 364 relative to blade frame 360. A blade actuator 362 is mounted to blade frame 360. The blade actuator can include, for example, an electric motor. Operation of blade actuator 362 cause blade slide 364 to slide relative to blade frame 360. (See arrow 363 of
Spring assembly 308, comprises spring arm 380 which is connected at one end by hinge 309 to base assembly 302. At the other end of spring arm 380 is spring 382 which is secured in place by spring mount 384. A spring-arm adjuster 386 is mounted through spring arm 380 and at its lowest point contacts column 324 of base assembly 302. Spring-arm adjuster 386 can be used to adjust the height of spring mount 384 above anvil 340.
Anvil gap 352 is one of the features of retainer cutting machine 200 which enable the creation of high density self-retaining sutures. A previously cut retainer can be positioned within gap 352 and thereby avoid interference with anvil 340 during cutting of a new retainer even though the previously cut retainer is not clear of anvil 340 (by, for example being positioned over relief 354). Thus, the presence of anvil gap 352 allows, in some embodiments, for the creation of two or four retainers at which substantially the same axial position along the suture. The presence of anvil gap 352 also allows, in some embodiments, for the creation of two or four retainers which are axially displaced from each other by distances less than the length of a retainer. To put it another way, the presence of relief 354 allows for creation of retainers in double-helix and quadra-helix distribution patterns where the helices are in-phase or out of phase by less than a retainer length (see examples below).
As shown in
Relief 354 is one of the features of retainer cutting machine 200 which enable the creation of high density self-retaining sutures. The previously cut retainers are positioned over the relief 354 and thereby avoid interference with anvil 340 during cutting of new retainers. The presence of relief 354 thus allows the cutting of retainers in very close proximity to retainers that have previously been cut. To put it another way, the presence of relief 354 allows for a small retainer pitch—the distance measured axially along the suture between one retainer of a pattern and the adjacent retainer in the pattern measured between identical points of the retainer (i.e. tip to tip or base to base). For example, the position of relief 354 can be adjusted to enable creation of retainers at a retainer pitch which is less than two retainer lengths, less than 1.5 retainer lengths, less than 1.2 retainer lengths and, in some cases, approximately equal to the retainer length.
Referring again to
As best shown in
Referring again to
The cutting stage angle 394 affects the shape and elevation of the retainers cut by blade 370. The cutting stage angle 394 determines the movement path 376 of the blade 370 as it passes through suture thread 202. As shown in
Two DOF linear stage 410 allows for adjustment of the position of the blade 440 relative to the anvil 340 and thus the suture thread 202. A first, linear stage 411 allows for adjustment of the height of the blade above the anvil. The height of the blade above the anvil and thus can be used to control the depth of cut. A second, the linear stage 412 allows for adjustment of the position of the blade along the axis of the suture thread. The second, linear stage 412 allows for adjustment of the relative positions of the path of the blade and the spring (see
Two DOF rotary stage 420 can be used to allow for adjustment of the orientation of the blade 440 relative to the movement axis of blade arm 366 and the suture thread 202. A first rotary stage 421 allows for adjustment of the angle of the blade relative to the suture thread 202 in the plane of the anvil 340 not shown. The first rotary stage 421 adjusts the angle of the cut into the suture thread 202. This rotary stage can therefore be used to adjust the cutting blade angle.
The second rotary stage 422 allows for adjustment of the orientation of the blade relative to the movement axis of the blade arm 366. That is, the second rotary stage 422 allows for adjustment of the blade orientation relative to the direction of cutting. This second rotary stage 422 allows the blade orientation to compensate for any cutting stage angle 394 (not shown but see
The linear or rotary stages of the cutting head are in some embodiments manually controlled. For example, where the same shape retainers will be formed at all positions along a suture thread it is only necessary to set these parameters before commencement of the retainer cutting. Thereafter, so long as there is no drift, the parameters need not be changed. In alternative embodiments, the linear and rotary stages of the cutting head are controlled by actuators such as piezo-electric actuators, servomotors ultrasonic motors and the like. Computer control of the linear and rotary stages allows for adjustment of the retainer cutting parameters at different positions along a suture thread. Thus, for example, the cut depth can be greater at some positions along a suture thread than at other positions. Also, computer control of the linear and rotary stages can also allow the computer system to adjust the position and/or orientation of the blade in response to drift in the parameters over time, caused for example by temperature changes of wear in the blade. Piezo-electric linear stages are readily available with uni-directional repeatability of 0.05 μm and encoder resolutions of 5 nm.
In a preferred embodiment, the blade 440 is a sapphire blade. Sapphire has a hardness of 9.0 Mohs. Sapphire blades are ceramic blades typically having an edge radius one or two magnitude lower than an edge radius of a steel blade thus allowing the accurate cutting of retainers on suture threads of size USP 2-0, 4-0, 6-0, 8-0, 9-0, 10-0, 11-0, 12-0 and smaller. Further, sapphire blades generally maintain their mechanical characteristics over the temperature ranges desirable for cutting polymer and co-polymer materials. Maintaining mechanical characteristics (i.e., geometry of a cut produced) can be desired where the retainers are extremely small and therefore sensitive to small changes. Further, sapphire blades are more abrasion resistant than, for example, typical steel blades, providing more repeatable results over long term use. Further, sapphire blades can be sharpened more effectively than steel blades. In alternative embodiments, the blade 440 may be metal, mineral or ceramic blades which are hard coated, mineral coated, ceramic coated and/or carbon coated blades. For example, synthetic diamond/black diamond blades are commercially available for use in ophthalmic applications. For example, the blades may have: carbon coating, diamond coating, diamond-like coating, nano-ceramic coating, ceramic coating, sapphire coating and/or yttriated zirconia coating or a ceramic material having the desired sharpness and durability or other hardened blades or hard coated blades.
In some embodiments, the blade 440 is temperature controlled to optimize formation and elevation of retainers. To control the temperature of the blade, the blade is or otherwise placed in conductive communication with a temperature-controlled copper plate. The copper plate can effectively heat or cool the blade to the desired temperature through conduction. The copper plate is temperature controlled utilizing a solid state or liquid heat transport system and a closed-loop temperature controller. The temperature of the blade can thus be tightly controlled to a desired temperature range to provide satisfactory retainer formation.
In alternative embodiments, a sapphire or diamond blade can be straight, angled or curved and may have be hemispherical, parabolic, or any other shape of cutting edge suitable for cutting the retainer.
Additionally, the blade or other cutting device can be mounted to an ultrasound generator\vibration generator in order to facilitate cutting. In some embodiments, for example, vibrational energy at a frequency within the ranges, 1 to 100 kHz, 10 to 90 kHz, and 15 to 50 kHz is applied by a horn to a converter configured to support the blade or other cutting tool.
The spring is used to develop holding force on the suture to hold it in place during cutting. The holding force should be selected to secure the suture without unduly deforming the suture. If the holding force selected is too high, the suture thread will be pushed into the gap of the anvil. If the holding force is too low, the suture thread will move during retainer formation and the quality of the retainers will be impaired. A holding force of less than 1 Newton is sufficient to hold a suture in place. In a preferred embodiment, a holding force of approximately 0.1N is sufficient for holding a 2-0 suture during retainer formation. For smaller diameter sutures, spring 382 is made of thinner stainless steel stock 0.030 mm in thickness. The thinner steel stock facilitates application of a lower holding force to the smaller diameter sutures. The amount of force applied by the spring is determined by the spring constant of the spring and the deflection of the tip of the spring when pushed into contact with the suture. As previously discussed the deflection of the spring is adjustable using the spring-arm adjuster 386 (See
Referring again to
Rotary stage 604 is mounted on the upper surface of carriage 621. Rotary stage 604 includes a shaft 640 mounted through a bushing 642. Chuck 606 is mounted on one end of shaft 640. A gear 646 is mounted on the other end of shaft 640. Gear 646 is driven by gear 648 attached to a high precision stepper motor 650. Operation of stepper motor 650 rotates gears 648, 646 and shaft 640 in a precisely controllable manner thereby turning chuck 606 as shown by arrow 609.
Referring first to
In the embodiment of
Referring now to
In the embodiment of
Referring now to
In the embodiment of
Referring first to
The retainer shapes described in
Referring now to
In the embodiment of
A plurality of self-retaining sutures have been made on the apparatus described above. The sutures have been formed on a range of stock suture threads with different retainer configurations and distributions. In some cases, the tissue holding strength of the retainers has been assessed to evaluate the function of retainer shape and bar distribution. Factors such as retainer length and plow angle had the most effect on retainer retention performance in addition to retainer density for a particular diameter of suture. Note however, that the optimum retainer length and distribution can differ dependent upon the tissue in which the suture is used and the manner in which the suture is to be deployed.
Although not all of these examples have been made, the cutting apparatus previously described is capable of creating retainers on suture threads of USP 8-0 (50 μm nominal diameter) as well as suture threads of USP 9-0 (30 μm nominal diameter), USP 10-0 (20 μm nominal diameter), USP 11-0 (10 μm nominal diameter) and USP 12-0 (9 μm or less nominal diameter). For example, a self-retaining suture can be made by cutting retainers in a quadra-helix pattern into a polypropylene suture thread of USP 9-0 (30 μm nominal diameter) using a sapphire blade by setting the cutting parameters: depth of cut 4 μm, retainer length 30 μm and pitch 40 μm, thereby creating retainers at a density of 2540 retainers per inch. For example, a self-retaining suture can be made by cutting retainers in a quadra-helix pattern into a polypropylene suture thread of USP 10-0 (20 μm nominal diameter) using a sapphire blade by setting the cutting parameters: depth of cut 3 μm, retainer length 20 μm and pitch 30 μm, thereby creating retainers at a density of 3386 retainers per inch. For example, a self-retaining suture can be made by cutting retainers in a quadra-helix pattern into a polypropylene suture thread of USP 11-0 (15 μm nominal diameter) using a sapphire blade by setting the cutting parameters: depth of cut 2 μm, retainer length 10 μm and pitch 25 μm, thereby creating retainers at a density of 4064 retainers per inch. For example, a self-retaining suture can be made by cutting retainers in a quadra-helix pattern into a polypropylene suture thread of USP 12-0 (9 μm nominal diameter) using a sapphire blade by setting the cutting parameters: depth of cut 2 μm, retainer length 5 μm and pitch 20 μm, thereby creating retainers at a density of 6350 retainers per inch. Note that by increasing the pitch for each of the above examples, the retainer density can be reduced from between 6350 and 200 retainers per inch depending upon the distribution pattern and retainer length. However, as illustrated by the barb configuration testing, a lower pitch relative to the barb length is preferred. For example, in preferred embodiments, the pitch is less than two times the barb length. More preferably the pitch is less than 1.5 times the barb length. Even more preferably the pitch is less than about 1.2 times the barb length.
Tissue-holding strength testing was conducted in order to evaluate and compare the performance of self-retaining sutures made with different retainers and retainer distributions. Tissue-holding strength testing was conducted in a range of different tissues.
Standardized tissue samples were prepared from swine tissue. The tissues were prepared to present a fixed thickness of tissue to be engaged by the suture. For anisotropic tissues, care was taken to prepare the sample such that the tissue was oriented in the same way from sample to sample. The following tissue samples were prepared: meniscus (10 mm); bladder wall (3 mm); uterine wall (3 mm); soft palate (10 mm); vaginal cuff (2.5 mm); and joint capsule (1.5 mm).
To analyze tissue-holding strength, a sample suture 920 was inserted downwards into standardized sample tissue 940 using a straight needle or a small diameter hypotube crimped to the leading end of the suture. After insertion of the sample suture 920, the needle and protruding suture was severed. The tissue sample 940 was then secured to the base 902 of the TA.XTplus Texture Analyzer 900 using a clamp 904. The trailing end 922 of the suture was secured to the moving arm 906 of the TA.XTplus Texture Analyzer 900 using a pneumatic grip 908 operated by a foot pedal (not shown). Note that the retainers 924 of the sample suture 920 are oriented to resist movement through tissue in the direction of travel 950 of the moving arm 906. The TA.XTplus Texture Analyzer 900 was then operated to drive moving arm 906 in the direction 950 at a constant velocity until the sample suture 920 was pulled out of the sample tissue 940. The Texture Exponent software was utilized to capture load cell data from the TA.XTplus Texture Analyzer 900 thereby measuring the force needed to pull the sample suture 920 from the sample tissue 940 and overcome the tissue retention by the retainers 924. The analysis was repeated for multiple samples of each suture in order to account for variability between samples. Minitab 15 was then used for statistical analysis of the results. The tissue holding strength of commercially available self-retaining sutures—Quill™ Polypropylene 2-0 was also tested.
The results of the analysis are shown in
Suture threads described herein may be produced by any suitable method, including without limitation, injection molding, stamping, cutting, extrusion, and so forth. In preferred embodiments, the suture threads are drawn polymeric monofilaments having a high strength to diameter ratio. Polymeric suture threads/filaments may be manufactured or purchased for the suture body, and the retainers can be subsequently cut onto the suture body. The suture threads/filaments can be biodegradable of non-degradable as desired for a particular application. The retainers can be mechanically-cut using blades, cutting wheels, grinding wheels, and so forth. During cutting, either the cutting device or the suture thread may be moved relative to the other, or both may be moved, to control the size, shape and depth.
Self-retaining sutures made according to the apparatus and methods described herein described herein may be used in open, endoscopic and robotic surgery. Self-retaining sutures made according to the apparatus and methods described herein described herein may also be used in microsurgical procedures that are performed under a surgical microscope (and thus may be referred to as “self-retaining sutures”) including, for example, microsurgery, vascular microsurgery, nerve repair, cosmetic and reconstructive surgery, urogenital microsurgery, and other microsurgery. Such surgical procedures include, but are not limited to, reattachment and repair of peripheral nerves, spinal microsurgery, vascular microsurgery, microsurgery of the hand, various plastic microsurgical procedures (e.g., facial reconstruction), microsurgery of the male or female reproductive systems, and various types of reconstructive microsurgery. Microsurgical reconstruction is used for complex reconstructive surgery problems when other options such as primary closure, healing by secondary intention, skin grafting, local flap transfer, and distant flap transfer are not adequate. Self-retaining sutures have a very small caliber, often as small as USP 9-0 or USP 10-0, and may have an attached needle of corresponding size. The sutures may be degradable or non-degradable. Self-retaining sutures as described herein may be used in similarly small caliber ranges for ophthalmic surgical procedures and thus may be referred to as “ophthalmic self-retaining sutures”. Such procedures include but are not limited to keratoplasty, cataract, and vitreous retinal microsurgical procedures. Ophthalmic self-retaining sutures may be degradable or non-degradable, and have an attached needle of correspondingly-small caliber.
The features of the self-retaining sutures described above can be combined to create a variety of sutures, in particular, the various retainer distribution patterns, retainer shapes, retainer densities can be selected from those described and combined in a multitude of ways without departing from the scope of the present invention. Such self-retaining suture thread can be incorporated into unidirectional or bidirectional sutures as desired for a particular application. Such suture thread can be combined with one or more needles and anchors to create a product suitable for a particular application. Additionally, aspects of the suture cutting apparatus can be selected or combined to create suture cutting apparatus without departing from the scope of the invention. Various modifications, omissions, and additions may be made to the disclosed embodiments without materially departing from the novel teachings and advantages of the invention, particularly in light of the foregoing teachings.
Although the present invention has been shown and described in detail with regard to only a few exemplary embodiments of the invention, it should be understood by those skilled in the art that it is not intended to limit the invention to the specific embodiments disclosed. Various modifications, omissions, and additions may be made to the disclosed embodiments without materially departing from the novel teachings and advantages of the invention, particularly in light of the foregoing teachings. Accordingly, it is intended to cover all such modifications, omissions, additions, and equivalents as may be included within the spirit and scope of the invention as defined by the following claims.
This application is a National Stage application under 35 U.S.C. 371 of PCT/US2011/034660, filed on Apr. 29, 2011, which claims priority from U.S. Provisional Application Ser. No. 61/329,436, filed on Apr. 29, 2010.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/US2011/034660 | 4/29/2011 | WO | 00 | 2/7/2013 |
| Number | Date | Country | |
|---|---|---|---|
| 61329436 | Apr 2010 | US |
