Source: https://patents.google.com/patent/US9358002B2/en
Timestamp: 2019-05-26 21:23:25
Document Index: 661829755

Matched Legal Cases: ['Application No. 60', 'Application No. 09250460', 'Application No. 09251035', 'Application No. 07254341', 'Application No. 07254703', 'Application No. 2011']

US9358002B2 - Anchoring device - Google Patents
US9358002B2
US9358002B2 US12/783,947 US78394710A US9358002B2 US 9358002 B2 US9358002 B2 US 9358002B2 US 78394710 A US78394710 A US 78394710A US 9358002 B2 US9358002 B2 US 9358002B2
US12/783,947
US20100274283A1 (en
2008-04-01 Priority to US4130208P priority Critical
2009-01-29 Priority to US12/362,002 priority patent/US20090248070A1/en
2009-04-01 Priority to US12/416,421 priority patent/US8932327B2/en
2010-05-20 Application filed by Covidien LP filed Critical Covidien LP
2010-05-20 Priority to US12/783,947 priority patent/US9358002B2/en
2010-07-07 Assigned to TYCO HEALTHCARE GROUP LP reassignment TYCO HEALTHCARE GROUP LP ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: KIRSCH, DAVID, KOSA, TIMOTHY D., MAIORINO, NICHOLAS, PRIMAVERA, MICHAEL
2010-10-28 Publication of US20100274283A1 publication Critical patent/US20100274283A1/en
2016-06-07 Publication of US9358002B2 publication Critical patent/US9358002B2/en
An anchoring device includes an elongate body having a proximal portion and a distal portion. The proximal portion of the elongate body terminates in a free end and the distal portion forms a loop. The loop includes a proximal portion and a distal portion. and further includes a plurality of anchors disposed along a surface thereof. The plurality of anchors are oriented toward the proximal portion of the elongate body to limit movement of the loop through tissue. A pledget is disposed adjacent the proximal portion of the loop. Methods for securing anchoring devices of the present disclosure are also disclosed.
This application is a continuation in part of U.S. patent application Ser. No. 12/416,421 filed Apr. 1, 2009, which is a continuation in part of U.S. patent application Ser. No. 12/362,002 filed Jan. 29, 2009, which claims the benefit of and priority to U.S. Provisional Patent Application 61/041,302 filed Apr. 1, 2008, the disclosure of which is hereby incorporated by reference herein.
The present disclosure relates generally to the field of surgical devices, and more particularly to anchoring devices, such as sutures, which include a loop having barbs disposed along a surface.
The present disclosure provides medical devices, as well as methods for making and using same. In embodiments, a medical device of the present disclosure may include an elongate body having a proximal portion and a distal portion, the proximal portion of the elongate body terminating in a free end; the distal portion of the elongate body forming a loop; the loop including a first plurality of anchors disposed along a surface of the loop; and, a pledget disposed adjacent the proximal portion of the loop.
Methods of the present disclosure may include, in embodiments, methods for securing tissue, which include providing a suture having a proximal portion, an elongate body, and a distal portion, the distal portion of the suture terminating in a loop and at least a portion of the loop including a plurality of barbs, the suture including a pledget disposed about the elongate body adjacent a proximal portion of the loop; inserting the proximal portion of the suture into tissue at a penetration point; advancing the suture through the tissue such that the elongate body is pulled through the penetration point to the pledget; and, securing the suture in the tissue.
In other embodiments, methods of the present disclosure include providing a medical device as described herein, inserting a proximal portion of the medical device into tissue, pulling the elongate body through tissue, and advancing the proximal portion of the elongate body through tissue such that the pledget limits movement of the proximal portion of the loop through the tissue.
FIG. 4A is a side view illustrating an alternate embodiment of an anchoring suture including barbs;
FIG. 4B is a plan view of a portion of a barbed medical device having shape memory polymer barbs in a permanent configuration in accordance with an embodiment of the present disclosure;
FIG. 4C is a plan view of a portion of a barbed medical device having shape memory polymer barbs in a temporary configuration in accordance with an embodiment of the present disclosure;
FIG. 5 is an enlarged side view showing an alternate embodiment of an anchoring suture having a compound barb;
FIG. 9A is a plan view of the anchoring suture of FIG. 4A in tissue with portions of tissue removed;
FIG. 9B is a side view of the anchoring suture of FIG. 4A in tissue with portions of tissue removed;
FIG. 10A is a side view of an alternate embodiment anchoring suture in tissue with portions of tissue removed;
FIG. 10B is an enlarged view of the area of detail designated in FIG. 10A;
FIG. 11A is a plan view of the anchoring suture of FIG. 8C in a first position in tissue, with portions of tissue removed;
FIG. 11B is a plan view of the anchoring suture of FIG. 8C in a second position in tissue, with portions of tissue removed;
FIG. 12A shows a perspective view, partially in cross-section, of a suture filling a needle penetration point; and,
FIG. 12B shows a perspective view, partially in cross-section, of an anchoring suture of the present disclosure filling a needle penetration point.
The present disclosure is directed to an anchoring device and in certain preferred embodiments, a suture, herein referred to as an anchoring suture. The anchoring sutures of certain embodiments of the present disclosure have an elongate body, which connects to a needle at a proximal end thereof, and a distal end of the elongate body forms an anchoring loop. The anchoring loop further includes a plurality of barbs (tissue engaging barbs). Medical devices of the present disclosure include sutures formed from fibers, filaments, and yarns.
Anchoring devices, including anchoring sutures and pledgets of the present disclosure may be absorbable or non-absorbable. It should be understood that combinations of filaments made from different materials (e.g., natural and synthetic, or bioabsorbable and non-bioabsorbable materials) may be used to make the present anchoring suture.
Suitable synthetic absorbable materials include polymers such as those made from lactide, glycolide, caprolactone, valerolactone, carbonates (e.g., trimethylene carbonate, tetramethylene carbonate), dioxanones (e.g., 1,4-dioxanone), 1-dioxepanones (e.g., 1,4-dioxepan-2-one and 1,5-dioxepan-2-one), ethylene glycol, ethylene oxide, esteramides, γ-hydroxyvalerate, β-hydroxypropionate, alpha-hydroxy acid, hydroxybuterates, orthoesters, hydroxy alkanoates, tyrosine carbonates, polyimide carbonates, polyimino carbonates such as poly (bisphenol A-iminocarbonate) and poly (hydroquinone-iminocarbonate), and polymer drugs (e.g., polydiflunisol, polyaspirin, and protein therapeutics), and the like, and copolymers and combinations thereof. Suitable natural absorbable polymers include collagen, cellulose, gut, combinations thereof and the like. In embodiments, glycolide and lactide based polyesters, including copolymers of lactide and glycolide may be used.
Suitable non-absorbable materials which may be used to form the anchoring sutures disclosed herein include non-absorbable natural materials such as cotton, silk, and rubber. Suitable non-absorbable synthetic materials include monomers and polymers derived from materials such as nylons, polyolefins such as polypropylene and polyethylene, (including ultra high molecular weight polyethylene (UHMWPE)), polyamides, polyesters such as poly ethylene terephthalate (PET), polyaryletherketone, polyvinylidene difluoride (PVDF), acrylic, polyamides, aramids, fluoropolymers, polybutesters, silicones, and polymer blends, copolymers thereof, combinations with degradable polymers, and the like. Polypropylene can also be utilized to form the suture. The polypropylene can be isotactic polypropylene or a mixture of isotactic and syndiotactic or atactic polypropylene, combinations thereof, and the like. Additionally, non-absorbable synthetic and natural polymers and monomers may be combined with each other and may also be combined with various absorbable polymers and monomers to create fibers and filaments for the present anchored device.
In embodiments, suitable materials which may be utilized to form the anchoring devices in accordance with the present disclosure include homopolymers, copolymers, and/or blends possessing glycolic acid, lactic acid, glycolide, lactide, dioxanone, trimethylene carbonate, caprolactone, and various combinations of the foregoing. For example, in some embodiments, a copolymer of glycolide and trimethylene carbonate may be utilized. Methods for forming such copolymers are within the purview of those skilled in the art and include, for example, the methods disclosed in U.S. Pat. Nos. 4,300,565 and 5,324,307, the entire disclosures of each or which are incorporated by reference herein. Suitable copolymers of glycolide and trimethylene carbonate may possess glycolide in amounts from about 60% to about 75% by weight of the copolymer, in embodiments, from about 65% to about 70% by weight of the copolymer, with the trimethylene carbonate being present in amounts from about 25% to about 40% by weight of the copolymer, in embodiments, from about 30% to about 35% by weight of the copolymer.
In embodiments, suitable materials for forming anchoring devices according to the present disclosure include copolymers of glycolide, dioxanone, and trimethylene carbonate. Such materials may include, for example, copolymers possessing glycolide in amounts from about 55% to about 65% by weight of the copolymer, in embodiments, from about 58% to about 62% by weight of the copolymer, in some embodiments, about 60% by weight of the copolymer; dioxanone in amounts from about 10% to about 18% by weight of the copolymer, in embodiments, from about 12% to about 16% by weight of the copolymer, in some embodiments about 14% by weight of the copolymer; and trimethylene carbonate in amounts from about 17% to about 35% by weight of the copolymer, in embodiments, from about 22% to about 30% by weight of the copolymer, in some embodiments, about 26% by weight of the copolymer.
Other suitable materials including a copolymer of glycolide, lactide, trimethylene carbonate, and ε-caprolactone may be utilized to form anchoring devices in accordance with the present disclosure. Such materials may include, for example, a random copolymer possessing caprolactone in amounts from about 14% to about 20% by weight of the copolymer, in embodiments, from about 16% to about 18% by weight of the copolymer, in some embodiments, about 17% by weight of the copolymer; lactide in amounts from about 4% to about 10% by weight of the copolymer, in embodiments, from about 6% to about 8% by weight of the copolymer, in some embodiments about 7% by weight of the copolymer; trimethylene carbonate in amounts from about 4% to about 10% by weight of the copolymer, in embodiments from about 6% to about 8% by weight of the copolymer, in some embodiments about 7% by weight of the copolymer; and glycolide in amounts from about 60% to about 78% by weight of the copolymer, in embodiments, from about 66% to about 72% by weight of the copolymer, in some embodiments about 69% by weight of the copolymer.
In certain embodiments, anchoring devices, including anchoring sutures and pledgets, may, in whole or in part (e.g. barbs) may be constructed using shape memory polymers. The present disclosure provides anchoring devices, including anchoring sutures and pledgets, formed of shape memory polymeric materials which are capable of adopting a shape in vivo suitable for adhering tissue or affixing a surgical device, such as a mesh, to tissue. Shape memory polymeric materials utilized to form an anchoring device of the present disclosure possess a permanent shape and a temporary shape. In embodiments, the temporary shape is of a configuration which enhances the ability for the surgeon to introduce an anchoring device into a patient's body. The permanent shape, which is assumed in vivo upon application of energy, such as heat or light, is of a configuration which enhances the retention of the anchoring device in tissue and/or adhesion of the anchoring device to tissue.
Shape memory polymers are a class of polymers that, when formed into an object such as an anchoring device, can be temporarily deformed by mechanical force and then caused to revert back to an original shape when stimulated by energy. Shape memory polymers exhibit shape memory properties by virtue of at least two phase separated microdomains in their microstructure. The first domain is composed of hard, covalently cross-linked or otherwise chain motion-limiting structures, which act as barbs to retain the object's original shape. The second domain is a switchable soft structure, which can be deformed and then fixed to obtain a secondary or temporary shape.
In the case of heat stimulated shape memory polymers, a transition temperature (TTrans) exists at which the shape change occurs during heating. The shape memory polymers can thus be tailored by altering material properties at the molecular level and by varying processing parameters. An object's primary shape may be formed with heat and pressure at a temperature at which the soft domains are flexible and the hard domains are not fully formed. The object may then be cooled so that the hard domains are more fully formed and the soft domains become rigid. The secondary or temporary shape can be formed by mechanically deforming the object, which is most readily accomplished at a temperature approaching or above TTrans. Mechanical stresses introduced into the object are then locked into place by cooling the object to temperatures below TTrans, so that the soft segments solidify to a rigid state. Once the object is heated to T>TTrans, the soft segments soften and relax back to their original configuration and the object returns to its primary or original shape, sometimes referred to herein as its permanent shape. The temperature at which a shape memory material reverts to its permanent shape may be referred to, in embodiments, as its permanent temperature (Tperm).
Polymers possessing shape memory properties which may be used to construct anchoring devices disclosed herein include, for example, synthetic materials, natural materials (e.g., biological) and combinations thereof, which may be biodegradable and/or non-biodegradable. As used herein, the term “biodegradable” includes both bioabsorbable and bioresorbable materials. By biodegradable, it is meant that the materials decompose or lose structural integrity under body conditions (e.g., enzymatic degradation, hydrolysis), or are broken down (physically or chemically) under physiologic conditions in the body (e.g., dissolution) such that the degradation products are excretable or absorbable by the body.
Suitable non-degradable materials possessing shape memory properties which may be utilized to form an anchoring device include, but are not limited to, polyolefins such as polyethylene (including ultra high molecular weight polyethylene) and polypropylene including atactic, isotactic, syndiotactic, and blends thereof; polyethylene glycols; polyethylene oxides; ultra high molecular weight polyethylene; copolymers of polyethylene and polypropylene; polyisobutylene and ethylene-alpha olefin copolymers; fluorinated polyolefins such as fluoroethylenes, fluoropropylenes, fluoroPEGs, and polytetrafluoroethylene; polyamides such as nylon, Nylon 6, Nylon 6,6, Nylon 6,10, Nylon 11, Nylon 12, and polycaprolactam; polyamines; polyimines; polyesters such as polyethylene terephthalate, polyethylene naphthalate, polytrimethylene terephthalate, and polybutylene terephthalate; polyethers; polytetramethylene ether glycol; polybutesters, including copolymers of butylene terephthalate and polytetramethylene ether glycol; 1,4-butanediol; polyurethanes; acrylic polymers; methacrylics; vinyl halide polymers and copolymers such as polyvinyl chloride; polyvinyl alcohols; polyvinyl ethers such as polyvinyl methyl ether; polyvinylidene halides such as polyvinylidene fluoride and polyvinylidene chloride; polychlorofluoroethylene; polyacrylonitrile; polyaryletherketones; polyvinyl ketones; polyvinyl aromatics such as polystyrene; polyvinyl esters such as polyvinyl acetate; copolymers of vinyl monomers with each other and olefins such as ethylene-methyl methacrylate copolymers; acrylonitrile-styrene copolymers; acrylonitrile, butadiene and styrene (ABS) resins; ethylene-vinyl acetate copolymers; alkyd resins; polycarbonates; polyoxymethylenes; polyphosphazine; polyimides; epoxy resins; aramids; rayon; rayon-triacetate; spandex; silicones; and copolymers and combinations thereof. Additionally, non-biodegradable polymers and monomers may be combined with each other.
Suitable bioabsorbable polymers possessing shape memory properties which may be utilized to form an anchoring device include, but are not limited to, aliphatic polyesters; polyamides; polyamines; polyalkylene oxalates; poly(anhydrides); polyamidoesters; copoly(ether-esters); poly(carbonates) including tyrosine derived carbonates; poly(hydroxyalkanoates) such as poly(hydroxybutyric acid), poly(hydroxyvaleric acid), and poly(hydroxybutyrate); polyimide carbonates; poly(imino carbonates) such as poly (bisphenol A-iminocarbonate and the like); polyorthoesters; polyoxaesters including those containing amine groups; polyphosphazenes; poly (propylene fumarates); polyurethanes; polymer drugs such as polydiflunisol, polyaspirin, and protein therapeutics; biologically modified (e.g., protein, peptide) bioabsorbable polymers; and copolymers, block copolymers, homopolymers, blends, and combinations thereof.
Suitable aliphatic polyesters which may be utilized to form an anchoring device include, but are not limited to, homopolymers and copolymers of lactide (including lactic acid, D-,L- and meso lactide); glycolide (including glycolic acid); epsilon-caprolactone; p-dioxanone (1,4-dioxan-2-one); trimethylene carbonate (1,3-dioxan-2-one); alkyl derivatives of trimethylene carbonate; Δ-valerolactone; β-butyrolactone; γ-butyrolactone; ε-decalactone; hydroxybutyrate; hydroxyvalerate; 1,4-dioxepan-2-one (including its dimer 1,5,8,12-tetraoxacyclotetradecane-7,14-dione); 1,5-dioxepan-2-one; 6,6-dimethyl-1,4-dioxan-2-one; 2,5-diketomorpholine; pivalolactone; α,α diethylpropiolactone; ethylene carbonate; ethylene oxalate; 3-methyl-1,4-dioxane-2,5-dione; 3,3-diethyl-1,4-dioxan-2,5-dione; 6,8-dioxabicycloctane-7-one; and polymer blends and copolymers thereof.
Other suitable biodegradable polymers which may be utilized to form an anchoring device include, but are not limited to, poly(amino acids) including proteins such as collagen (I, II and III) elastin, fibrin, fibrinogen, silk, and albumin; peptides including sequences for laminin and fibronectin (RGD); polysaccharides such as hyaluronic acid (HA), dextran, alginate, chitin, chitosan, and cellulose; glycosaminoglycan; gut; and combinations thereof. Collagen as used herein includes natural collagen such as animal derived collagen, gelatinized collagen, or synthetic collagen such as human or bacterial recombinant collagen.
In embodiments, combinations of both degradable and non-degradable materials, including those having shape memory characteristics, may be utilized to form an anchoring device.
In embodiments, the shape memory polymer may be a copolymer of two components with different thermal characteristics, such as oligo (epsilon-caprolactone) dimethacrylates and butyl acrylates, including poly(epsilon-caprolactone) dimethacrylate-poly (n-butyl acrylate), or a diol ester and an ether-ester diol such as oligo (epsilon caprolactone) diol/oligo (p-dioxanone) diol copolymers. These multi-block oligo (epsilon-caprolactone) diol/oligo (p-dioxanone) diol copolymers possess two block segments: a “hard” segment and a “switching” segment linked together in linear chains. Such materials are disclosed, for example, in Lendlein, “Shape Memory Polymers-Biodegradable Sutures,” Materials World, Vol. 10, no. 7, pp. 29-30 (July 2002), the entire disclosure of which is incorporated by reference herein.
In other embodiments, blends of bioabsorbable materials may be utilized to form anchoring devices including, but not limited to, urethanes blended with lactic acid and/or glycolic acid, homopolymers thereof or copolymers thereof, and acrylates blended with caprolactones such as polycaprolactone dimethacrylate poly(butyl acrylate) blends, and combinations thereof.
Tg (TTrans)
Composition (mol %) Soft Domain Hard Domain [° C.]
85% Poly (L-lactide) Amorphous
80% Poly (L-lactide) Amorphous
It is envisioned that TTrans may be tailored by changing block segment molar ratios, polymer molecular weight, and time allowed for hard segment formation. In embodiments, TTrans may be tailored by blending various amounts of low molecular weight oligomers of the soft segment domain copolymer. Such oligomers may act as plasticizers to cause a downward shift in TTrans.
Additionally, the copolymers forming the anchoring devices of the present disclosure may include emulsifying agents, solubilizing agents, wetting agents, taste modifying agents, plasticizers, active agents, water soluble inert fillers, preservatives, buffering agents, coloring agents, and stabilizers. Addition of a plasticizer to the formulation can improve flexibility. The plasticizer or mixture of plasticizers may be polyethylene glycol, glycerol, sorbitol, sucrose, corn syrup, fructose, dioctyl-sodium sulfosuccinate, triethyl citrate, tributyl citrate, 1,2-propylenglycol, mono-, di- or triacetates of glycerol, or natural gums.
In some embodiments, crystalline degradable salts or minerals may be added to the block copolymer compositions to create polymer composites which may improve shape memory properties. An example of such a composite using polylactide homopolymer and crystalline hydroxyapatite is described in Zheng et al., “Shape memory properties of poly (D,L-lactide/hydroxyapatite composites,” Biomaterials, 27 (2002) 4288-4295, the entire disclosure of which are incorporated by reference herein.
Other shape memory materials, including shape memory metals and metal alloys such as Nitinol, may also be used to form the anchoring devices, including anchoring sutures and pledgets, of the present disclosure.
In embodiments, a molding process may be utilized to produce the anchoring devices of the present disclosure. Plastic molding methods are within the purview of those skilled in the art and include, but are not limited to, melt molding, solution molding, and the like. Injection molding, extrusion molding, compression molding and other methods can also be used as the melt molding technique. Once placed in the mold with the proper dimensions and configuration, the polymeric material used to form the anchoring device may be heated to a suitable temperature, referred to as the permanent temperature (Tperm) which may, in embodiments, be the melting temperature of the shape memory polymeric material utilized to form the anchoring device. Heating of the anchoring device may be at suitable temperatures including, for example, from about 40° C. to about 180° C., in embodiments from about 80° C. to about 150° C., for a period of time of from about 2 minutes to about 60 minutes, in embodiments from about 15 minutes to about 20 minutes, to obtain the permanent shape and dimensions.
The temperature for deformation treatment of the anchoring member molded with a previously memorized shape is one that makes possible ready deformation without producing cracks and should not exceed the temperature adopted for the shape memorization (e.g., Tperm). Deformation treatment at a temperature exceeding that for the original shape memorization may cause the object to memorize/program a new deformed shape.
After the anchoring device with the desired shape has been formed, the anchoring device may be deformed above Ttrans obtain an alternate, temporary shape.
Suitable temperatures for deformation will vary depending on the shape memory polymer utilized, but generally may be above the transition temperature of the polymer (Ttrans), but below the Tperm. In embodiments, the shape memory polymer may be cooled from its Tperm to a lower temperature which remains above the Ttrans and deformed, in embodiments by hand and/or mechanical means. In other embodiments, the anchoring device may be deformed at room temperature (about 20° C. to about 25° C.) to obtain its temporary shape, although the temperature may differ depending upon the particular polymer employed. The anchoring device may then be cooled to a temperature below the Ttrans of the material utilized to form the anchoring device at which time the anchoring device of the present disclosure is ready for use. As the Ttrans is usually greater than room temperature, in embodiments cooling to room temperature may be sufficient to lock in the temporary shape.
There are no particular limitations on the manner in which the deformation can be achieved. Deformation can be achieved either by hand or by means of a suitable device selected to provide the desired temporary configuration to the anchoring device.
In order to keep the shape of the anchoring device in its temporary shape, the shape memory anchoring device of the present disclosure should be stored at a temperature which will not cause a transition to the primary shape. In embodiments, the shape memory anchoring device may be stored in a refrigerator.
The anchoring devices thus prepared recover their primary shape upon application of energy, such as on heating, either by placement in a patient's body, or the addition of exogenous heat at a prescribed temperature, in embodiments above the Ttrans of the shape memory polymer utilized. As the anchoring devices of the present disclosure are utilized in a living body, heating with body heat (about 37° C.) is possible. In such a case, the temperature for shape programming should be as low as possible and the recovery of the primary (memorized) shape may occur fairly slowly. In embodiments, recovery of the permanent shape may occur from about 1 second to about 5 seconds after insertion into tissue.
However, in some embodiments a higher shape memory temperature may be desirable in order to make the shape recover at a slightly higher temperature than body temperature. Thus, in some cases, releasing the anchoring device from deformation to recover the primary shape can be achieved by heating. On heating at a temperature of from about 30° C. to about 50° C., in embodiments from about 37° C. to about 43° C., the temporary shape may be released and the primary shape recovered. The higher the temperature for heating, the shorter the time for recovery of the primary shape. The means for this heating is not limited. Heating can be accomplished by using a gas or liquid heating medium, heating devices, ultrasonic waves, electrical induction, and the like. Examples of liquid heating media include physiological saline solution, alcohol, combinations thereof, and the like. Of course, in an application involving a living body, care may be taken to utilize a heating temperature which will not cause burns. When a liquid heating medium is used, physiological saline solution or alcohol may be desirable.
Similarly, in other embodiments, electrically active polymers, also known as electroactive polymers, which can alter their configuration upon application of electricity, may be utilized to fashion anchoring devices, including anchoring sutures and pledgets, in accordance with the present disclosure. Suitable examples of electroactive polymers include poly(aniline), substituted poly(aniline)s, polycarbazoles, substituted polycarbazoles, polyindoles, poly(pyrrole)s, substituted poly(pyrrole)s, poly(thiophene)s, substituted poly(thiophene)s, poly(acetylene)s, poly(ethylene dioxythiophene)s, poly(ethylenedioxypyrrole)s, poly(p-phenylene vinylene)s, and the like, or combinations including at least one of the foregoing electroactive polymers. Blends or copolymers or composites of the foregoing electroactive polymers may also be used.
Similar to the change in shape which a shape memory material may undergo upon the application of energy, such as heat, in embodiments an electroactive polymer may undergo a change in shape upon the application of electricity from a low voltage electrical source (such as a battery). Suitable amounts of electricity which may be applied to effect such change will vary with the electroactive polymer utilized, but can be from about 5 volts to about 30 volts, in embodiments from about 10 volts to about 20 volts. The application of electricity will result in the anchoring device constructed of the electroactive polymer changing its shape into an anchoring configuration.
In embodiments, the anchoring suture and the pledget may be made of materials having the same or similar degradation rates, i.e., they will each degrade in about the same period of time, in embodiments from about 0 days to about 180 days after placement in a patient. More specifically the anchoring suture and pledget may both include homopolymers, copolymers, and/or blends possessing glycolic acid, lactic acid, glycolide, lactide, dioxanone, trimethylene carbonate, caprolactone, and various combinations of the foregoing. For example, in some embodiments, a copolymer of glycolide and trimethylene carbonate may be utilized. Suitable copolymers of glycolide and trimethylene carbonate may possess glycolide in amounts from about 60% to about 75% by weight of the copolymer, in embodiments, from about 65% to about 70% by weight of the copolymer, with the trimethylene carbonate being present in amounts from about 25% to about 40% by weight of the copolymer, in embodiments, from about 30% to about 35% by weight of the copolymer. In embodiments, anchoring sutures and/or pledgets made of these copolymers may provide effective wound support for about 6 weeks, and absorbing in about 180 days.
In another embodiment, the anchoring suture and pledget may both include copolymers of glycolide, dioxanone, and trimethylene carbonate. Such materials may include, for example, copolymers possessing glycolide in amounts from about 55% to about 65% by weight of the copolymer, in embodiments, from about 58% to about 62% by weight of the copolymer, in some embodiments, about 60% by weight of the copolymer; dioxanone in amounts from about 10% to about 18% by weight of the copolymer, in embodiments, from about 12% to about 16% by weight of the copolymer, in some embodiments about 14% by weight of the copolymer; and trimethylene carbonate in amounts from about 17% to about 35% by weight of the copolymer, in embodiments, from about 22% to about 30% by weight of the copolymer, in some embodiments, about 26% by weight of the copolymer. In embodiments, anchoring sutures and/or pledgets made of these copolymers may provide effective wound support for about 3 weeks, and absorbing, sometimes referred to herein as “losing structural integrity,” from about 90 days to about 110 days after placement in a patient.
The anchoring suture and pledget should have about the same or similar wound support. Thus, in other embodiments, the anchoring suture and pledget may include different materials or have different degradation times, as long as the wound support provided by each component is similar.
In embodiments, two or more of the elongate body, pledget and barbs may lose strength and/or structural integrity in about the same period of time, in embodiments from about 1 day to about 6 weeks.
In embodiments, sutures of the present disclosure may possess a core/sheath configuration. Fibers may possess a core/sheath configuration, yarns may possess a core/sheath configuration, or both. Any material described herein, including the shape memory materials described above, may be utilized to form the core, the sheath, or both.
Bioactive agents, sometimes referred to herein as therapeutic agents, which may be added to anchoring devices in accordance with the present disclosure include, but are not limited to, drugs, amino acids, peptides, polypeptides, proteins, polysaccharides, muteins, immunoglobulins, antibodies, cytokines (e.g., lymphokines, monokines, chemokines), blood clotting factors, hemopoietic factors, interleukins (1 through 18), interferons (β-IFN, α-IFN and γ-IFN), erythropoietin, nucleases, tumor necrosis factor, colony stimulating factors (e.g., GCSF, GM-CSF, MCSF), insulin, anti-tumor agents and tumor suppressors, blood proteins, fibrin, thrombin, fibrinogen, synthetic thrombin, synthetic fibrin, synthetic fibrinogen, gonadotropins (e.g., FSH, LH, CG, etc.), hormones and hormone analogs (e.g., growth hormone, luteinizing hormone releasing factor), vaccines (e.g., tumoral, bacterial and viral antigens); somatostatin; antigens; blood coagulation factors; growth factors (e.g., nerve growth factor, insulin-like growth factor); bone morphogenic proteins, TGF-B, protein inhibitors, protein antagonists, and protein agonists; nucleic acids, such as antisense molecules, DNA, RNA, RNAi; oligonucleotides; polynucleotides; cells, viruses, and ribozymes.
Methods for combining these therapeutic agents with compositions of the present disclosure are within the purview of those skilled in the art and include, but are not limited to mixing, blending, dipping, spraying, wicking, solvent evaporating and the like.
Various compositions and materials may also be applied to the anchoring sutures and/or pledgets or included in the filaments or fibers to improve mechanical properties such as handling and knot strength or to deliver medicinal agents. Suitable coating materials include any materials conventionally applied to sutures. For example, suitable materials include fatty acid esters which may be combined with the metal salt of a fatty acid in the coating composition. Such esters include, for example, calcium stearate, stearoyl lactylate esters, palmityl lactylate esters, oleyl lactylate esters such as calcium, magnesium, aluminum, barium, or zinc stearoyl lactylate, calcium, magnesium, aluminum, barium, or zinc palmityl lactylate; calcium, magnesium, aluminum, barium, or zinc oleyl lactylate; with calcium stearate and calcium stearoyl-2-lactylate (such as the calcium stearoyl-2-lactylate commercially available under the trade name VERV from American Ingredients Co., Kansas City, Mo.) being preferred. When desirable, the fatty acid ester may be combined with a solvent. Suitable solvents include polar and non-polar solvents including but not limited to alcohols (e.g., methanol, ethanol, propanol), chlorinated hydrocarbons (such as methylene chloride, chloroform, 1,2-dichloro-ethane), and aliphatic hydrocarbons such as hexane, heptene, ethyl acetate.
Adjuncts to making loops, such as adhesives and glues, may also be employed in the anchoring suture. In some embodiments (FIGS. 1A, 1B), the distal portion of suture may be folded and fixed to elongate body using adhesives and glues. In alternate embodiments, as shown in FIGS. 2A and 2B, loop portion may initially be a separate component which connects to an elongate body and optionally glued in place. It should be understood that embodiments and methods described in FIGS. 1 and 2 can be used to create any of the anchoring suture embodiments described herein (FIGS. 3-6). Suitable materials such as absorbable and nonabsorbable materials include, but not limited to cyanoacrylates, isocyanates, polyurethanes, polyamines, polyamides, polyacrylates, polymethacrylates, silicones, carbonates, and other synthetic monomers and polymers and combinations thereof.
The anchoring loop further includes barbs disposed along a surface. Barbs can be created on the anchoring suture using any technique, including but not limited to lasers, molding, knives, blades, stamping, and other cutting means within the purview of those skilled in the art. Ultrasonic energy can also be used to create barbs or barbs as described in U.S. Patent Application No. 60/994,173 filed on Sep. 17, 2007 entitled “Method of Forming Barbs on a Suture” the entire disclosures of which are incorporated by reference herein.
In some embodiments, anchoring sutures of the present disclosure include loops which are integral to an elongate body, as shown in FIGS. 1 and 3. Sutures with integral loops may be defined as having one structure or component in which the elongate body is continuous with the loop. For example, FIG. 1 shows an elongate body 10 in which the distal end is folded or “looped” to create a loop 14 (FIG. 1B) at the distal end of the medical device. The suture as shown in FIGS. 1 and 2 further includes transition area 16 and barbs which will be described in further detail below. An anchoring suture may also contain an integral loop as shown in FIG. 3, wherein the loop portion may be molded. In alternate embodiments, such as FIG. 2, anchoring sutures may comprise two components which are fixed or fitted together in a fashion as to create the anchoring suture. For example, the elongate body 10 may include a female component while the loop 14 may include a male component and the two components may be fitted together to create a final product. One skilled in the art can envision other manufacturing processes in which to create integral loops and medical devices with integral and non-integral loops.
Another embodiment of the anchoring suture of the present disclosure is shown in FIG. 3 and is designated generally by reference numeral 2. Suture 2 has an elongate body 10, a proximal portion of elongate body 10 terminating in a free end 11, and a distal portion of the elongate body 10 which forms, transitions into, or terminates in a loop 14. As shown in FIG. 3, the free end 11 further comprises a needle 12. The elongate body 10 has a diameter “x” and, in preferred embodiments, the elongate body 10 is generally elliptical in transverse cross-section. The distal end of elongate body 10 extends into a loop 14, bifurcating at transition area 16 (FIGS. 3 and 3A). Loop 14 includes two branches 14 a and 14 b, which may be identical in shape and cross-sectional area, to both each other and elongate body 10. In preferred embodiments, sections 14 a and 14 b are generally elliptical in shape and cross-sectional area, although other shapes are envisioned such as circular, oval, square, and rectangular. In the embodiment shown in FIG. 3, the loop 14 may be integral with the elongate body 10 of the suture 2. In alternate embodiments, the loop 14 may be a separate component prior to assembly (FIGS. 1 and 2), and during assembly the loop 14 may be attached to the elongate body 10. The loop 14 has a generally arcuate surface, and each branch (14 a and 14 b) has an independent diameter “y”, of which 14 a and 14 b may be of similar or different diameters. The loop may be of any shape including circular, oval, polygonal.
Furthermore, anchoring suture of FIG. 3 includes a first plurality of barbs 18 disposed along a surface of the loop 14. Barbs 18 a are disposed along surface of branch 14 a and barbs 18 b are disposed along branch 14 b. Additionally, segment 14 c is used to designate a loop segment in which barbs are absent. In the illustrated embodiment, barbs 18 are located adjacent transition area 16 of elongate body 10 and anchoring loop 14. Furthermore, the first plurality of barbs 18 is oriented such that movement of the anchoring loop 14 towards the proximal end is limited. As shown in FIG. 3, barbs 18 are oriented towards transition area 16 to prevent movement of anchoring loop 14 through tissue. In embodiments shown, barbs 18 are integral to the anchoring loop 14.
It will be understood that FIG. 4A is a generally similar to FIG. 3 and therefore all numerals and descriptions which are the same in FIG. 3 are designated with the prime mark and have some differences. FIG. 4A shows an alternate embodiment of an anchoring suture 2′ in which a second plurality of barbs 22 is disposed along the elongate body 10′. The second plurality of barbs 22 extends in the second direction which is different from a first direction of the first plurality of barbs. In the embodiment shown, the first plurality of barbs 18′ are disposed along a loop surface and extend in the first direction, generally towards transition area 16′ of the anchoring suture 2′. The second plurality of barbs 22 extend in a second direction, towards the loop 14′, with respect to longitudinal axis A of the elongate body 10.
In embodiments, the first set of barbs 18′ and/or second plurality of barbs 22 may be made of shape memory polymers. As depicted in FIG. 4B, barb 22 extends outwardly and away from elongate body 10′ thereby forming an barb angle 23 a between barb 22 and elongate body 10′ of anchoring suture 2′. The suture may then be deformed into a temporary shape, as illustrated in FIG. 4C, in which the barbs 22 are pressed against the elongate body 10′ and the barb angles 23 b are smaller than the barb barbs 23 a of the permanent shape, e.g., closed. As illustrated in FIG. 4C, in the temporary shape, barbs 22 are substantially parallel to the longitudinal axis of the elongate body 10′ of suture 2′ to from barb angle 23 b. Upon placement in the tissue the barbs 22 may extend away from the elongate body 10′ back to their permanent shape as depicted in FIG. 4B.
In the alternate embodiment shown in FIG. 5, anchoring suture 30 includes a compound barb 26 having an inner surface 30 including a first angle α, disposed at a first orientation relative to a longitudinal axis “A′” of the elongate body and a second angle (3 having a second inner surface 32, disposed at a second orientation relative to a longitudinal axis b of the elongate body. The anchoring suture may optionally include a third orientation (not shown). In the embodiment shown, the first, second and third orientations are each disposed at different angles with respect to the longitudinal axis. In some embodiments, the anchoring suture may include a staggered arrangement of large or small barbs. In other embodiments, an anchoring suture may have a random configuration of both large and small barbs. It will be understood that the embodiment shown in FIG. 5 is generally similar to FIGS. 3 and 4A, but has a different geometry for the barbs. In alternate embodiments, the above-mentioned compound barb geometry may also be present on the anchoring loop (not shown).
The surface area of the plurality of barbs can also vary. For example, fuller-tipped barbs can be made of varying sizes designed for specific surgical applications. When joining fat and relatively soft tissues, larger barbs may be desired, whereas smaller barbs may be more suitable for collagen-dense tissues. In some embodiments (FIG. 4A), a combination of large and small barbs within the same structure may be beneficial, for example when a fiber is used in tissue repair with differing layer structures. Use of the combination of large and small barbs with the same fiber wherein barb sizes are customized for each tissue layer will ensure maximum holding properties.
Another embodiment of an anchoring device is shown in FIG. 6. The anchoring device 40 includes a needle 42 at a proximal end 41 of the device. The device bifurcates at a transition area 45, and a distal portion of the device terminates in an anchoring loop 49. The anchoring loop 49 includes two branches 46 a and 46 b at a proximal end 47 of the anchoring loop 49. The anchoring loop 49 has a generally arcuate surface, branches 46 a and 46 b may have similar or different diameters. In the illustrated embodiment, a first plurality of barbs 48 are located adjacent the transition area 45. Furthermore, the first plurality of barbs 48 is oriented such that movement of the anchoring loop 49 in tissue, in a direction towards the distal end 43 of the device, is limited. As illustrated in FIG. 6, the device may have an elongate body 44 that is shorter in longitudinal length as compared to the anchoring loop 49. The two branches of the loop may be advanced through a single needle penetration point and pulled through tissue; the method of which will be described in detail later.
The pledget may be integral with, for example co-formed, or separate from the suture. If the pledget is separate from the suture, the pledget may be placed over the needle and elongate body prior to use.
Tissue may be sutured by inserting proximal portion of an anchoring suture into tissue at a first section and advancing the proximal portion of the suture through a second section of the tissue, and exiting tissue at an exit point. The suture is pulled through the exit point until the first plurality of barbs on the anchoring loop engages tissue and resists movement in direction of needle advancement, thus preventing further advancement of anchoring loop through tissue. The proximal portion of the suture may optionally be inserted through the segment of the loop remaining outside the body tissue for enhanced fixation. FIGS. 9A and 9B show the embodiment of FIG. 4A, where an unbarbed loop segment 14 c′ remains exterior to the wound site (or external to skin in dermal closure) due to the barbs 18 a′ and 18 b″ and lack of barbs on segment 14 c*. It should be understood that all embodiments described herein can be used in a similar fashion. Upon exit of tissue, needle and proximal end of suture may be passed through segment of loop which remains exterior to wound site to secure suture in place. User may then continue suturing wound, entering and exiting tissue until wound site is closed (or implant attached).
In one embodiment, tissue may be sutured by inserting the proximal portion of an anchoring suture into tissue at a first section and advancing the proximal portion of the suture through a second section of the tissue, and exiting tissue at an exit point. The suture is pulled through the exit point until the pledget engages tissue and the barbed portion of the loop resists movement of the pledget in direction of needle advancement, thus preventing further advancement of the pledget and anchoring loop through tissue. The pledget may broaden the anchoring capability of the suture by distributing the stress placed on the suture across a broader area and thereby enhancing suture capability in situations where the suture is likely to be exposed to a high level of tension. The proximal portion of the suture may optionally be inserted through the segment of the loop remaining outside the body tissue for enhanced fixation. FIG. 10A illustrates the suture of FIG. 4A, where a pledget 20 is positioned at the distal end of elongate portion 10 and adjacent the proximal end of loop 14. FIG. 10B illustrates an enlarged section of the loop 14 and pledget 20. (The loop is still present, to start a running stitch without tying a knot at the end; the pledget anchors the suture at the distal end to prevent pull through and stabilize the distal end.)
FIGS. 11A and 11B illustrate the embodiment of FIG. 8C in tissue. Tissue may be secured in a similar manner as described above, by inserting a proximal portion of the anchoring device into tissue at a first section and advancing the proximal portion of the anchoring device, including a proximal portion of the loop, through a second section of the tissue, and exiting tissue at an exit point. In the embodiments described in FIGS. 6, 7, 8A, 8B, and 8C once the needle is advanced through tissue, the remainder of the suture follows including the two branches of the loop. More specifically, the two branches of the loop are advanced through a needle penetration point (or points through which the needle and elongate body have passed). FIG. 11A illustrates a first position of the embodiment of an anchoring device as described in FIG. 8C. As illustrated, proximal portion of suture 70 and proximal portion 71 of loop 72, including two branches 72 a and 72 b, are advanced through tissue. Both branches 72 a and 72 b are advanced through needle penetration points (74 a, 74 b, 74 c, and 74 d), the barbs engage tissue and suture holding force is increased. FIG. 11B shows the embodiment of FIG. 8C in a second position. Once the anchoring suture has been further advanced through tissue, the pledget 67 prevents any further movement of the distal loop portion through tissue. It should be understood that other embodiments of end effectors and shown and described would function in a manner similar to the embodiment described with respect to FIGS. 11A and 11B. It should also be understood that anchoring sutures without end effectors may also be inserted and advanced through tissue in a similar manner.
FIG. 12A shows the prior art in which an oversized needle 80 penetrates tissue, and leaves a tissue penetration point (82 a and 82 b) that a single suture strand 84 may not fill. FIG. 12B shows one embodiment of the current disclosure in which an oversized needle 90 penetrates tissue and the two branches (94 a and 94 b) of the anchoring device 94 can better fill the needle penetration point 92. The two branches of the loop in combination with the barbs allow an increase in tissue holding strength which may be desirable in certain applications.
Anchoring devices, including anchoring sutures of the present disclosure may be employed in medical devices, drug delivery devices and cell growth substrates. Examples of suitable medical devices and/or surgical devices employing the anchoring sutures may include, but are not limited to meshes, wound dressings, bandages, drug delivery devices, anastomosis rings, stents, grafts, catheter systems, soft tissue repair and augmentation devices, scaffolds, buttresses, lap bands, tapes, barbs, ribbons, orthopedic devices, tissue engineering scaffolds, various cell growth substrates, and other implantable devices. In some embodiments, devices of the present disclosure may be knitted or woven with other fibers, either absorbable or non-absorbable, to form surgical devices. The anchoring devices and/or sutures also can be made into meshes or non-woven materials to form fabrics, such as matted fabrics and felts.
Additionally, anchoring devices of the present disclosure may be packaged using materials known to those within the purview of those skilled in the art, including foil and various plastics (e.g. polyethylene), which may provide a moisture barrier. Once the anchoring device is constructed, it can be sterilized by any means within the purview of those skilled in the art including but not limited to ethylene oxide, electron beam (e-beam), gamma irradiation, autoclaving, and the like.
Distal end of MAXON™ suture is folded towards elongate body to create a loop, and suture (loop) is then placed in an ultrasonic welding apparatus, where loop is welded closed. Suture is then affixed to an ultrasonic cutting apparatus to create barbs. Elongate body and anchoring loop of anchoring suture is cut via ultrasonic blades at various angles. A 3 mm polyester disc having a central opening is then advanced over the needle and elongate body of the suture and placed in abutment with the proximal portion of the loop.
1. A method for securing tissue comprising:
providing a suture including:
an elongate body having a proximal portion and a distal portion, the proximal portion of the elongate body terminating in a free end and the distal portion of the elongate body forming a loop, the loop including a proximal portion and a distal portion, and a first plurality of anchors disposed along a surface of the loop, the anchors being oriented toward the proximal portion of the elongate body to limit movement of the loop through tissue; and
a pledget including a separate device which is placed over the elongate body adjacent the proximal portion of the loop;
inserting the proximal portion of the suture into tissue at a penetration point;
advancing the suture through the tissue such that the elongate body is pulled through the penetration point to the pledget; and
pulling the suture through tissue until movement of the loop through tissue is limited by a pledget.
4. The method according to claim 1, wherein the passage of the elongate body through the penetration point to the pledget increases the holding force of the suture in tissue.
5. The method according to claim 1, wherein the pledget limits movement of at least a portion of the loop through tissue such that a segment of the loop remains outside the body tissue.
6. The method according to claim 1, wherein the pledget engages tissue to prevent movement of the loop in a proximal direction.
7. The method according to claim 1, wherein the pledget is disposed about the elongate body in abutment with a proximal portion of the loop.
a pledget including a separate device which is placed over the elongate body adjacent the proximal portion of the loop.
9. The medical device of claim 8, wherein the pledget is a disc configured and dimensioned to limit movement of a proximal segment of the loop in a proximal direction through tissue.
10. The medical device of claim 9, wherein the pledget is about 3 mm in diameter.
11. The medical device of claim 8, wherein the pledget is integral with the proximal portion of the loop.
12. The medical device of claim 8, wherein the pledget limits movement of at least a portion of the loop through tissue such that a segment of the loop remains outside a body tissue.
13. The medical device of claim 8, wherein the pledget engages tissue to prevent movement of the loop in a proximal direction.
14. The medical device of claim 8, further comprising a needle secured to the free end of the proximal portion of the elongate body.
15. The medical device of claim 8, wherein the pledget is disposed in abutment with the proximal portion of the loop.
16. A method for securing tissue, the method comprising the steps of
providing the medical device of claim 8, inserting a proximal portion of the medical device into tissue, pulling the elongate body through tissue, and, advancing the proximal portion of the elongate body through tissue such that the pledget limits movement of the proximal portion of the loop through the tissue.
17. The medical device of claim 8, wherein the first plurality of anchors is disposed on the proximal portion of the loop, and the distal portion of the loop is free of anchors.
an elongate body having a proximal portion and a distal portion, the proximal portion of the elongate body terminating in a free end and the distal portion of the elongate body forming a loop, the loop including a proximal portion and a distal portion, and a first plurality of anchors disposed along a surface of the loop at the proximal portion of the loop, and the distal portion of the loop is free of anchors, the anchors being oriented toward the proximal portion of the elongate body to limit movement of the loop through tissue; and
a pledget disposed adjacent the proximal portion of the loop.
19. The medical device of claim 18, wherein the pledget is a disc configured and dimensioned to limit movement of a proximal segment of the loop in a proximal direction through tissue.
20. The medical device of claim 19, wherein the pledget is about 3 mm in diameter.
21. The medical device of claim 18, wherein the pledget is integral with the proximal portion of the loop.
22. The medical device of claim 18, wherein the pledget is a separate device which is placed over the elongate body adjacent the proximal portion of the loop.
23. The medical device of claim 18, wherein the pledget limits movement of at least a portion of the loop through tissue such that a segment of the loop remains outside a body tissue.
24. The medical device of claim 18, wherein the pledget engages tissue to prevent movement of the loop in a proximal direction.
25. The medical device of claim 18, further comprising a needle secured to the free end of the proximal portion of the elongate body.
26. The medical device of claim 18, wherein the pledget is disposed in abutment with the proximal portion of the loop.
27. A method for securing tissue, the method comprising the steps of providing the medical device of claim 18, inserting a proximal portion of the medical device into tissue, pulling the elongate body through tissue, and,
advancing the proximal portion of the elongate body through tissue such that the pledget limits movement of the proximal portion of the loop through the tissue.
US12/783,947 2008-04-01 2010-05-20 Anchoring device Active 2032-06-27 US9358002B2 (en)
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US12/362,002 US20090248070A1 (en) 2008-04-01 2009-01-29 Anchoring Suture
US12/416,421 US8932327B2 (en) 2008-04-01 2009-04-01 Anchoring device
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CA2736390A CA2736390A1 (en) 2010-05-20 2011-04-04 Anchoring device
AU2011201607A AU2011201607A1 (en) 2010-05-20 2011-04-08 Anchoring device
JP2011103867A JP2011240134A (en) 2010-05-20 2011-05-06 Anchoring device
EP11250537.5A EP2387956B1 (en) 2010-05-20 2011-05-19 Anchoring device
US15/162,725 US10058326B2 (en) 2008-04-01 2016-05-24 Anchoring device
US12/416,421 Continuation-In-Part US8932327B2 (en) 2008-04-01 2009-04-01 Anchoring device
US15/162,725 Continuation US10058326B2 (en) 2008-04-01 2016-05-24 Anchoring device
US20100274283A1 US20100274283A1 (en) 2010-10-28
US9358002B2 true US9358002B2 (en) 2016-06-07
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US15/162,725 Active US10058326B2 (en) 2008-04-01 2016-05-24 Anchoring device
US (2) US9358002B2 (en)
EP (1) EP2387956B1 (en)
JP (1) JP2011240134A (en)
AU (1) AU2011201607A1 (en)
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Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:KIRSCH, DAVID;PRIMAVERA, MICHAEL;KOSA, TIMOTHY D.;AND OTHERS;REEL/FRAME:024642/0265