Patent Grant
9675341
The present invention relates generally to filaments for surgical procedures, methods of manufacturing filaments for surgical procedures, and uses thereof.
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, and 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, the 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. No. 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 this produces 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.
The advantages of greater accuracy and time savings provided by self-retaining sutures may be more pronounced when surgical conditions are sub-optimal. In areas of armed conflict, natural disaster zones, sites of terrorist attack, and other emergency situations, wound closure (and other tissue approximation) may be more quickly, easily, and effectively accomplished with self-retaining sutures than with their conventional counterparts and thus could potentially save more lives. Obviating the need for knots would not only enable a first responder to more quickly close a wound, but would also allow a nurse, surgeon, or other medical trauma staff to more quickly remove the temporary or emergency closure in order to treat the trauma victim.
For example, to treat soldiers suffering traumatic injuries on a battlefield, a military medic must rapidly close external wounds and quickly transport the injured patient to the closest field hospital. Then, at the field hospital, the medical personnel must remove the sutures from the wound and begin surgery. The knotless wound closure made possible by self-retaining sutures provides a significant advantage for rapid closure in the field. Likewise, self-retaining sutures can be easily and quickly removed from tissue, by locating the transition segment of a bidirectional suture, severing it, and then pulling out the remaining suture segments by each segment's distal, or deployment, ends. (Similarly, in the case of a unidirectional suture, the anchor may be severed and the suture segment pulled out from the tissue by its deployment end.) Given the time constraints presented by the aftermath of battle, in which multiple trauma victims would be brought in for treatment at once, in sometimes sub-optimal surgical conditions, as well as the potentially complex nature of wounds sustained by those injured in combat, the rapid identification of the self-retaining suture's transition point in a wound closure can be difficult.
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 suture deployment end (which may be sharp enough to penetrate tissue itself or may have a needle attached to it) until the transition portion of the suture is reached; at the transition portion 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.
Given the advantages of self-retaining sutures, it is desired to provide improved self-retaining sutures and methods useful in emergency situations, for wound closure and tissue approximation in suboptimal surgical conditions, such as in areas of armed conflict and natural disaster.
In accordance with one aspect, the present invention provides bidirectional self-retaining sutures having grasp engagement elements to facilitate suture deployment and subsequent removal.
In accordance with another aspect, the present invention provides unidirectional self-retaining sutures having grasp engagement elements to facilitate suture deployment and subsequent removal.
In accordance with another aspect, the present invention provides multidirectional self-retaining sutures having grasp engagement elements to facilitate suture deployment and subsequent removal.
In accordance with another aspect, the present invention provides methods of deploying and subsequently removing self-retaining sutures having grasp engagement elements.
In accordance with another aspect, the present invention provides self-retaining sutures having detachable grasp engagement elements.
The following are exemplary embodiments of the present invention:
A removable bidirectional self-retaining suture, the suture comprising:
a. a first end, a second end, and a periphery;
b. a plurality of retainers, the retainers on a first portion of the suture between the first end of the suture and a first axial location on the suture for permitting movement of the suture through tissue in a direction of movement of the first end and preventing movement of the suture through tissue in a direction opposite the direction of movement of the first end, and the retainers on a second portion of the suture between the second end of the suture and a second axial location on the suture permitting movement of the suture through tissue in a direction of movement of the second end and preventing movement of the suture through tissue in a direction opposite the direction of movement of the second end; and
c. a grasp engagement element between the first and second axial locations.
The suture of embodiment 1, wherein the grasp engagement element comprises a loop.
The suture of embodiment 2, wherein the loop is discontinuous.
The suture of embodiment 1, wherein the grasp engagement element comprises a tab.
The suture of embodiment 1, wherein the grasp engagement element comprises a suture segment having a stop at each end thereof, for preventing entry of said suture segment into tissue.
The suture of embodiment 1, wherein the grasp engagement element is comprises a different colour than the rest of the suture.
The suture of embodiment 6, wherein the suture further comprises a frangible portion between the grasp engagement element and the first and second axial locations for facilitating removal of the grasp engagement element from the suture.
The suture of embodiment 6, wherein the grasp engagement element further comprises an enhanced gripping surface.
The suture of embodiment 1, wherein the grasp engagement element has a periphery greater than the periphery of the suture.
The suture of embodiment 9, wherein the suture further comprises a frangible portion between the grasp engagement element and the first and second axial locations for facilitating removal of the grasp engagement element from the suture.
The suture of embodiment 9, wherein the grasp engagement element further comprises an enhanced gripping surface.
The suture of embodiment 1, wherein the grasp engagement element further comprises an enhanced gripping surface.
The suture of embodiment 1, wherein the suture further comprises a frangible portion between the grasp engagement element and the first and second axial locations for facilitating removal of the grasp engagement element from the suture.
The suture of embodiment 1, further comprising a detachable connector connecting the grasp engagement element and the suture.
The suture of embodiment 1, wherein the grasp engagement element is at least in part flexible.
The suture of embodiment 1, wherein the grasp engagement element is at least in part rigid.
The suture of embodiment 1, wherein the grasp engagement element comprises a different material than the rest of the suture.
The suture of embodiment 2, wherein the configuration of the loop is selected from the class comprising circles, ellipses, and polygons.
A removable multidirectional self-retaining system comprising:
a. a grasp engagement element;
b. at least three suture segments, each suture segment having a plurality of retainers between a first end of the suture segment and a second end of the suture segment for permitting movement of the suture through tissue in a direction of movement of the first end and preventing movement of the suture segment through tissue in a direction opposite the direction of movement of the first end, and a second end of each suture segment being attached to the grasp engagement element.
The system of embodiment 19, wherein the grasp engagement element comprises a loop.
The system of embodiment 20, wherein the loop is discontinuous.
The system of embodiment 19, wherein the grasp engagement element comprises a tab.
The system of embodiment 19, wherein the grasp engagement element comprises a suture segment having a stop at each end thereof, for preventing entry of said suture segment into tissue.
The system of embodiment 20, wherein the loop is circular.
The system of embodiment 20, wherein the loop is elliptical.
The system of embodiment 20, wherein the loop is polygonal.
A method of emergency wound closure, comprising:
a. providing a bidirectional self-retaining suture having a plurality of retainers, the retainers on a first portion of the suture between a first end of the suture and a first axial location on the suture for permitting movement of the suture through tissue in a direction of movement of the first end and preventing movement of the suture through tissue in a direction opposite the direction of movement of the first end, and the retainers on a second portion of the suture between a second end of the suture and a second axial location on the suture permitting movement of the suture through tissue in a direction of movement of the second end and preventing movement of the suture through tissue in a direction opposite the direction of movement of the second end;
b. inserting the first end of the suture into tissue at a first insertion point between first and second ends of the wound;
c. drawing the first end of the suture towards the first end of the wound along a first deployment path through tissue on alternating sides of the wound to a first exit point;
d. inserting the second end of the suture into tissue at a second insertion point between the first and second ends of the wound, leaving a portion of the suture between the first and second insertion points;
e. drawing the second end of the suture towards the second end of the wound along a second deployment path through tissue on alternating sides of the wound to a second exit point; and,
f. severing the suture along the portion between the first and second insertion points for removal of the suture from the wound prior to provision of permanent treatment.
The method of embodiment 27, wherein the step of inserting the second end of the suture into tissue is performed before the step of drawing the first end of the suture towards the first end of the wound.
A method of emergency wound closure, comprising:
a. providing a unidirectional self-retaining suture, the suture having a plurality of retainers between a first and second end of the suture for permitting movement of the suture through tissue in a direction of movement of the first end and preventing movement of the suture through tissue in a direction opposite the direction of movement of the first end, and a grasp engagement element at the second end of the suture;
b. positioning the grasp engagement element at least in part outside the wound;
c. inserting the first end of the suture into tissue at an insertion point at the wound; and,
d. drawing the first end of the suture towards an end of the wound along a deployment path through tissue on alternating sides of the wound to an exit point outside the tissue.
The method of embodiment 29, wherein the unidirectional suture further comprises a frangible portion proximal to the grasp engagement element.
A method of emergency wound closure comprising:
a. providing a multidirectional self-retaining system, the system having a grasp engagement element and at least two suture segments, each suture segment having a plurality of retainers between a first end of the suture segment and a second end of the suture segment for permitting movement of the suture through tissue in a direction of movement of the first end and preventing movement of the suture segment through tissue in a direction opposite the direction of movement of the first end, and a second end of each suture segment being attached to the grasp engagement element;
b. positioning the grasp engagement element at least in part outside the wound;
c. inserting the first end of a first suture segment into tissue at a first insertion point at the wound;
d. drawing the first end of the first suture segment towards a first end of the wound along a first deployment path through tissue on alternating sides of the wound to a first exit point;
e. inserting the first end of a second suture segment into tissue at a second insertion point proximal to the first insertion point; and,
f. drawing the first end of the second suture segment towards a second end of the wound along a second deployment path through tissue on alternating sides of the wound to a second exit point.
The method of embodiment 31, wherein the self-retaining system comprises at least a third suture segment having a plurality of retainers between a first end of the suture segment and a second end of the suture segment for permitting movement of the suture through tissue in a direction of movement of the first end and preventing movement of the suture segment through tissue in a direction opposite the direction of movement of the first end, the second end of the third suture segment being attached to the grasp engagement element.
The method of embodiment 32, further comprising inserting the first end of the third suture segment into tissue at a third insertion point proximal to at least one of the first and second insertion points, and drawing the first end of the third suture segment towards a third end of the wound along a third deployment path through tissue on alternating sides of the wound to a third exit point.
The method of embodiment 312, wherein the grasp engagement element comprises a connection between the suture segments.
A method of achieving an emergency closure of a stellate wound having at least three tissue apexes, comprising:
a. providing a multidirectional self-retaining system, the system having a grasp engagement element and at least three suture segments, each suture segment having a plurality of retainers between a first end of the suture segment and a second end of the suture segment for permitting movement of the suture through tissue in a direction of movement of the first end and preventing movement of the suture segment through tissue in a direction opposite the direction of movement of the first end, and a second end of each suture segment being attached to the grasp engagement element;
b. positioning the grasp engagement element proximal to the tissue apexes;
c. inserting the first end of a first suture segment into a first tissue apex and drawing the first end of the first suture segment out of the tissue;
d. inserting the first end of a second suture segment into a second tissue apex and drawing the first end of the second suture segment out of the tissue; and,
e. inserting the first end of a third suture segment into tissue at a third tissue apex and drawing the first end of the third suture segment out of the tissue.
A method of removing an emergency self-retaining suture from tissue, the suture having a at least one self-retaining suture segment, the suture segment having a first end connected to grasp engagement element and a second end, the method comprising:
a. severing the grasp engagement element from the suture segment; and,
b. drawing the suture segment out of the tissue by its second end.
A package for holding a suture device having a grasp engagement element attached to at least one suture segment having a distal end, the package comprising
a. a base having at least one surface; and,
b. a segment holder for releasably securing the suture segment to the base; and,
c. a grasp engagement element holder for releasably securing the grasp engagement element to the base.
The package of embodiment 37, wherein the segment holder and grasp engagement element holder are positioned to segregate the segment and the grasp engagement element.
The package of embodiment 37, further comprising an additional segment holder.
The package of embodiment 39, wherein the additional segment holder is adapted to segregate an additional segment from the segment and the grasp engagement element.
The package of embodiment 37, wherein the grasp engagement element holder is adapted for contacting the device at or near the grasp engagement element while securing the grasp engagement element to the base.
The package of embodiment 37 or 38, wherein the segment holder is adapted for contacting the device at or near the segment distal end while securing the segment to the base.
The package of embodiment 37 or 38, wherein at least one holder comprises multiple sections.
The package of embodiment 37 or 38, wherein at least one holder is removable from the package.
The package of embodiment 37 or 38, further comprising a segment guide for positioning a portion of the at least one suture segment.
The package of embodiment 37, wherein the segment holder is a needle park.
The package of embodiment 37, further comprising an outer housing.
The package of embodiment 47, wherein the outer housing is adapted to hold at least one of a needle driver and a scissors.
A trauma kit comprising:
d. an outer housing;
e. a suture package containing a self-retaining suture having a grasp engagement element attached to at least one suture segment.
The kit of embodiment 49, further comprising at least one of a needle driver and scissors.
A removable bidirectional self-retaining suture, the suture comprising:
a. a suture body having a first end, a second end, and a periphery;
b. a plurality of retainers, the retainers on a first portion of the suture between the first end of the suture and a first axial location on the suture for permitting movement of the suture through tissue in a direction of movement of the first end and preventing movement of the suture through tissue in a direction opposite the direction of movement of the first end, and the retainers on a second portion of the suture between the second end of the suture and a second axial location on the suture permitting movement of the suture through tissue in a direction of movement of the second end and preventing movement of the suture through tissue in a direction opposite the direction of movement of the second end; and
c. a grasp engagement element between the first and second axial locations, the grasp engagement element having at least two apertures through which the suture body is threaded between the first and second axial locations.
The suture of embodiment 51, wherein at least one aperture of the grasp engagement element comprises a sharp edge.
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. In addition, the disclosures of all patents and patent applications referenced herein are incorporated by reference in their entirety.
Features of the invention, its nature and various advantages will be apparent from the accompanying drawings and the following detailed description of various embodiments.
Definitions of certain terms that may be used hereinafter include the following.
“Self-retaining system” refers to a self-retaining suture together with 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.
“Self-retaining suture” refers to a suture that comprises features on the suture filament for engaging tissue without the need for a knot or suture anchor.
“Tissue retainer” (or simply “retainer”) or “barb” refers to a physical feature of a suture filament which is adapted to mechanically engage tissue and resist movement of the suture in at least one axial directions, and preferably prevent such movement. 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 physician, 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 one embodiment, the emergency sutures described herein are prepared from one or more segments of filament that each comprise a plurality of cuts, that is, cuts have been made in the filament using a blade or a laser or other suitable cutting instrument, and those cuts create and provide for retainers that can fan out from the filament. Retainers formed in this way are advantageous because when the segment is pulled through tissue, the retainers can retract into the body of the filament and thus contribute little, and preferably no resistance to the movement of the suture segment through the tissue, during the time when the suture segment is being deployed into the wound or other area needing a suture. The cuts made in the filament are preferably not too deep, so as to minimize a reduction in the tensile strength of the filament caused by the presence of the cuts, where cut depths of less than about 5%, or less than about 10%, 15%, 20%, or 25% of the cross-sectional distance of the filament are provided in different optional embodiments of the invention, with 5-25% or 5-20% or 5-15% being ranges present in optional embodiments of the invention. The retainers created by cutting a filament will have a topside composed of the outer surface of the filament, and an underside formed by the cut and composed of the material that forms the inside of the filament. In various optional embodiments of the present invention, a particular cut may create a retainer having an underside that lies within a single plane, that is, the cut may be a single straight cut, or the cut may create a retainer having an underside that lies in two planes, that is, the cut may following a first trajectory for a first distance and then a second trajectory for a second distance. Retainers having undersides lying within two different planes may be advantageous where the first plane cuts into and toward the center of the filament, typically with some concomitant cutting along the longitudinal axis of the filament, effectively establishing a depth of cut, while the subsequent second plane travels along the longitudinal axis of the filament but with little or no movement toward the center of the filament, effectively establishing a retainer length. When filaments having a plurality of cuts are utilized to provide for segments comprising retainers, the underside of the retainer will join to the filament along a baseline, where this baseline may be straight or may be arcuate. An arcuate baseline may be advantageous in assisting the retainer to “fan out”. 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 certain other configurations, the tissue retainer may be configured or combined with other tissue retainers to resist motion of the suture filament in both directions. 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”.
“Transition segment” or “transition portion” 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 system.
“Suture thread” or refers to the filamentary body component of the suture. The suture thread may be a monofilament, or comprise 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. Polymer degradation may be characterized, for example, using gel permeation chromatography (GPC), which monitors the polymer molecular mass changes during erosion and breakdown. 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. 20020161168, 20040024169, and 20040116620. 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 of 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 and 11-0.
“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). The point of attachment of the suture to the needle is known as the swage.
“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 a 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.
Suturing needles are described, for example, in U.S. Pat. Nos. 6,322,581 and 6,214,030 (Mani, Inc., Japan); and U.S. Pat. No. 5,464,422 (W. L. Gore, Newark, Del.); and U.S. Pat. Nos. 5,941,899; 5,425,746; 5,306,288 and 5,156,615 (US Surgical Corp., Norwalk, Conn.); and U.S. Pat. No. 5,312,422 (Linvatec Corp., Largo, Fla.); and U.S. Pat. No. 7,063,716 (Tyco Healthcare, North Haven, Conn.). Other suturing needles are described, for example, in U.S. Pat. Nos. 6,129,741; 5,897,572; 5,676,675; and 5,693,072. 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.
“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.
“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.
“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.
Emergency Self-Retaining Sutures and Systems
In accordance with particular embodiments, the present invention provides emergency self-retaining sutures and systems which are unidirectional, bidirectional, multidirectional. The sutures and systems of the present invention include a grasp engagement element to facilitate removal of the emergency suture or system; in some embodiments, the grasp engagement element may be adapted to engage fingers, while in other embodiments it may be adapted to engage surgical tools (such as tweezers). It is also configured to be easily detectable, whether due to its size, shape, colour, texture, or any combination thereof. To remove an emergency suture or system of the present invention from a wound closure, the grasp engagement element may, in some embodiments, be grasped (again, by fingers or surgical tools) and severed from the rest of the suture and thus permit each self-retaining segment to be removed from the tissue in the direction it was originally deployed. In other embodiments, the grasp engagement element may be grasped and then each self-retaining segment severed from the grasp engagement element and from each other to facilitate the subsequent removal of the self-retaining segments. Grasp engagement elements may be provided with any number of configurations, including continuous loops (including circular and elliptical loops), polygons, handled loops, tabs, partial loops, and partial polygons. They include tissue stops at each end, to inhibit passage of the grasp engage element into the tissue. They may be rigid or flexible.
According to particular embodiments of the present invention, these emergency sutures and suture systems and/or sections thereof may be unmarked, marked or differentially-marked by one or more types of markers or combination of markers to facilitate the differentiation of the grasp engagement element from the rest of the device.
To serve the purpose of allowing the soldier or medical personnel to identify the grasp engagement element, any visible marking used should be readily recognized and distinguished by the soldier or medical personnel under the conditions in which the suture is to be used. For example, for a battlefield or field hospital, the marking of the grasp engagement element would desirably be readily visible to the naked eye in low light conditions.
The markers can be provided in various forms that may be identified and distinguished from one another. The markers may comprise distinguishable, patterns, shapes, lengths, colors sizes, directions and arrangements. The markers can include different colors such as red, green, orange, yellow, green, blue etc. Such colors may be used in a uniform density or varying density in which case the graduation of color density may be used to designate e.g. an orientation. The markers may be included along the entire length of the self-retaining suture system, at a number of discrete points, or only at the ends or transition section of the self-retaining suture. In some cases it may be desirable to use a color for markers that is uncommon in the operative environment. For example, it may be desirable to use green markers because green is not common in the human body.
The markers can be formed by various conventional methods. For example, the markers can be coated, sprayed, glued, dyed, stained, or otherwise affixed to the self-retaining suture systems or components thereof. Traditional colourant application processes include, without limitation, dipping, spraying (by, for example, an ink jet), painting, printing, applying and/or coating colourants on the suture section of interest. Critical fluid extraction (such as carbon oxide) may also be used to add colourant locally to all or part of the section desired to be marked. Alternatively, colourant(s) for the suture section of interest may be included in a portion of the suture material that is used to form the suture body, wherein that portion is in the section of interest of the manufactured suture.
Additionally, the colourant(s) employed for demarcating the suture section of interest may be included on a plastic biocompatible material which is applied on the suture at the section of interest. Such a layer may be absorbable, such as polyglycolide coating which has a colourant to mark the suture section of interest, or it may be a non-absorbable material, such silicone. The coloured material may be synthetic or may be derived from a natural source (whether the material be modified or unmodified), such as collagen.
Alternatively, the suture section of interest may be reverse-marked, such that where the suture body is already visibly coloured, the colourant may be absent from all or part of the suture section of interest such that at least a portion of the section of interest is optically distinguishable by the surgeon from the rest of the suture. Such a suture may manufactured by including a colourant-free portion of suture material in the suture section of interest area during the manufacture of the suture body (for example, by extrusion) or by removal of colourant from the suture section of interest after the suture body has been manufactured, whether before or after retainers have been formed on the suture body. Colourant may be removed locally by, for example, critical fluid extraction such as (e.g., carbon oxide). It is not necessary to remove all of the colourant from the section of interest of the suture as long as there is a difference detectable by a surgeon between the section of interest and the rest of the suture.
Another example of a reverse-marked suture is one that lacks a coloured layer that is present on the rest of the suture body. A plastic biocompatible material bearing a colourant may be applied on the other sections of the suture, and at least where the other sections border the section of interest. Examples of such materials are discussed above. As in the foregoing examples, demarcating the suture section of interest may be effected in the suture manufacturing process either before or after forming retainers.
Another example of a reverse-marked suture is one having a coaxial structure wherein each coaxial layer having a different colour, and a portion of the outermost layer(s) is removed to visually expose a layer below. For example, a dual-layer monofilament polypropylene suture can be produced with a white inner core (intercoaxial layer) with a blue outer coaxial layer, and portions of the outer layer can be removed to visually expose the white inner monofilament to mark the suture section of interest.
Yet another example of a reverse-marked suture is one in which an external coating is removed (or partially removed) from the suture in the suture section of interest, and where either the coating or base suture has a contrasting colour difference. This technique of removing (or partially removing) material in the suture section of interest may also create a tactile demarcation of the suture section of interest.
As described above, the grasp engagement element or detachment regions may be marked to enable that section to be identified and distinguished from other sections instead of, or in addition to, marking the suture filament itself. If such marking is present in a wavelength range other than the visible wavelength range, a detector would be used to located and image the non-visible marker so that field hospital personnel would have the use and benefit of this marker.
Bidirectional Emergency Sutures
Embodiments of bidirectional emergency sutures in accordance with the present invention are shown in
An embodiment of an emergency suture in accordance with the present invention illustrated in
Providing texture differences to all or part of the grasp engagement element 306 includes providing a plurality of areas of increased and/or decreased suture body diameter along the grasp engagement element 306. For example, a plurality of indentations, a plurality of relief configurations, and any combinations thereof may be provided in the section of interest, by methods including, without limitation, compression, cutting, coating, application of agents such as abrasives, polymerisers, acid etchants, base etchants, and so forth.
In
In yet another embodiment, as illustrated in
Grasp engagement element 806 is depicted in
Another use of an emergency bidirectional suture is illustrated in
Unidirectional Emergency Sutures
The sutures of the invention also include unidirectional embodiments, as in the example shown in
Multidirectional Emergency Suture Systems
Self-retaining suture systems may comprise more than two suture segments. A self-retaining suture system may have one, two or more suture segments including up to about ten suture segments or more, depending upon the application. For example, as shown in
Another embodiment of a multidirectional emergency suture system is illustrated in
Self-retaining systems having more than two suture segments are useful in applications where it is desirable to have a plurality of suture lines radiating from a common point. Such self-retaining suture systems are useful for example in closes, puncture wounds, stellate wounds and other non-linear wounds. Such wounds can be produced by blunt trauma, gunshots, explosions and the like and are quite difficult to close with regular suturing techniques.
Packaging of Emergency Self-Retaining Sutures
Sutures and systems described herein may be loaded into packaging adapted to prevent tangling of the suture segments, ends, and grasp engagement elements, and to provide easy removal of the suture or system from the package.
An embodiment of a package is shown in
In another embodiment shown in
The embodiment in
Materials
Suture threads described herein may be produced by any suitable method, including without limitation, injection molding, stamping, cutting, laser, extrusion, and so forth. With respect to cutting, polymeric thread or filaments may be manufactured or purchased for the suture body, and the retainers can be subsequently cut onto the suture body; the retainers may be hand-cut, laser-cut, or mechanically machine-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 of cut 210. Particular methods for cutting barbs on a filament are described in U.S. patent application Ser. No. 09/943,733 titled “Method Of Forming Barbs On A Suture And Apparatus For Performing Same” to Genova et al., and U.S. patent application Ser. No. 10/065,280 titled “Barbed Sutures” to Leung et al. both of which are incorporated herein by reference. The sutures 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.
Grasp engagement elements described herein may be produced by any suitable method, including without limitation, injection molding, stamping, cutting, laser, extrusion, and so forth. They may be integrally formed with the suture threads, or the threads and grasp engagement elements may be assembled after manufacture of each component. They may be manufactured from cloth, felt, mesh, plastic (both absorbable and non-absorbable), metallic, or other materials, and may be glued, knotted, crimped or otherwise attached to suture threads. In some embodiments, they may be manufactured from stainless steel or other radio-opaque materials. In some embodiments, they may configured to comfortably accommodate a typical adult finger; suitable diameter ranges may be 0.75″ to 1.5″, and between 1″ to 1.25″.
Packaging described herein may be made from any suitable material, such as a combination of paper and synthetic materials, or synthetic materials only, or paper only. Needle holders may be made of foam or other materials that may securely engage needles. The outer sleeves may be manufactured from any suitable materials, including materials permutable to sterilizing gas (such as ethylene dioxide) while preventing microorganism contamination, materials that are compatible with sterilisatoin by gamma radiation, materials that are moisture-resistant (such as foil), and any combinations thereof.
Additionally, sutures and systems described herein may be provided with compositions to promote healing and prevent undesirable effects such as scar formation, infection, pain, and so forth. This can be accomplished in a variety of manners, including for example: (a) by directly affixing to the suture a formulation (e.g., by either spraying the suture with a polymer/drug film, or by dipping the suture into a polymer/drug solution), (b) by coating the suture with a substance such as a hydrogel which will in turn absorb the composition, (c) by interweaving formulation-coated thread (or the polymer itself formed into a thread) into the suture structure in the case of multi-filamentary sutures, (d) by inserting the suture into a sleeve or mesh which is comprised of, or coated with, a formulation, or (e) constructing the suture itself with a composition. While compositions including analgesic agents, anti-infective agents, anti-scarring agents, lubricious agents, and anti-inflammatory agents may be generally useful in the emergency situations discussed herein, other such compositions may include without limitation anti-proliferative agents, anti-angiogenic agents, fibrosis-inducing agents, echogenic agents, cell cycle inhibitors, analgesics, and anti-microtubule agents. For example, a composition can be applied to the suture before the retainers are formed, so that when the retainers engage, the engaging surface is substantially free of the coating. In this way, tissue being sutured contacts a coated surface of the suture as the suture is introduced, but when the retainer engages, a non-coated surface of the retainer contacts the tissue. Alternatively, the suture may be coated after or during formation of retainers on the suture if, for example, a fully-coated rather than selectively-coated suture is desired. In yet another alternative, a suture may be selectively coated either during or after formation of retainers by exposing only selected portions of the suture to the coating. The particular purpose to which the suture is to be put or the composition may determine whether a fully-coated or selectively-coated suture is appropriate; for example, with lubricious coatings, it may be desirable to selectively coat the suture, leaving, for instance, the tissue-engaging surfaces of the sutures uncoated in order to prevent the tissue engagement function of those surfaces from being impaired. On the other hand, coatings such as those comprising such compounds as anti-infective agents may suitably be applied to the entire suture, while coatings such as those comprising fibrosing agents may suitably be applied to all or part of the suture (such as the tissue-engaging surfaces). Coatings may also include a plurality of compositions either together or on different portions of the suture, where the multiple compositions can be selected either for different purposes (such as combinations of analgesics, anti-infective and anti-scarring agents) or for their synergistic effects.
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 combinations of features, and 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 the national stage of international application number PCT/US2011/060069, filed Nov. 9, 2011, which is incorporated herein by reference in its entirety and which claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 61/411,918 filed Nov. 9, 2010, and U.S. Provisional Patent Application No. 61/412,389, filed Nov. 10, 2010, which provisional applications are incorporated herein by reference in their entireties.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/US2011/060069 | 11/9/2011 | WO | 00 | 5/1/2013 |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2012/064902 | 5/18/2012 | WO | A |
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| Number | Date | Country | |
|---|---|---|---|
| 20130226233 A1 | Aug 2013 | US |
| Number | Date | Country | |
|---|---|---|---|
| 61411918 | Nov 2010 | US | |
| 61412389 | Nov 2010 | US |
