巴西专利BR102013011972B1 surgical device for soft tissue repair

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专利摘要:
SYSTEMS, DEVICES, AND METHODS FOR ATTACHING FABRIC WITH THE USE OF HANDLE AND SOFT ANCHOR SETS. The present invention relates to systems, devices, and methods that are provided for attaching soft tissue to bone. An exemplary embodiment of a surgical soft tissue repair device includes a loop assembly attached to a soft anchor in which the soft anchor has a first non-tensioned configuration that can be used to insert the anchor into the bone, and a second anchoring configuration which can be used to fix the anchor to the bone. The handle set can be configured to activate the anchor from the first configuration to the second configuration, and it can also be used to engage and approximate the tissue by pulling the tissue closer to the anchor fixed on the bone. The handle set can be used in conjunction with numerous different anchor configurations and other exemplary systems, devices and methods for use with soft tissue repair, are also presented.
公开号:BR102013011972B1
申请号:R102013011972-5
申请日:2013-05-07
公开日:2021-02-02
发明作者:Mehmet Sengun
申请人:Depuy Mitek, Llc；
IPC主号:

专利说明:

FIELD OF THE INVENTION
[0001] The present description refers to systems, devices and methods for attaching soft tissue to bone, and is particularly concerned with attaching soft tissue by minimizing or eliminating the creation of knots to tension and secure the tissue. BACKGROUND
[0002] A common injury, specifically among athletes and elderly people, is the complete or partial separation of tendons, ligaments or other soft tissues, from the bone. Tissue separation can occur during a fall, overexertion, or for a number of other reasons. Surgical intervention is often necessary, particularly when the tissue is completely separated from its associated bone. Currently available devices for fixing the tissue include screws, staples, suture anchors and tacks. The devices currently available for older patients may be particularly insufficient because of soft and weak bones, which leads to inadequate anchor-anchor fixation.
[0003] Arthroscopic knot tying is commonly practiced in shoulder rotator cuff procedures and in instabilities. Typically, an anchor loaded with suture is attached first to the bone. Normally, the suture is slidably attached to the anchor by means of an eyelet or around a column, so that a single suture length has two free members. A suture member is passed through the soft tissue to be repaired, such as a tendon or lip. The two ends of the suture are then tied together, thus capturing the soft tissue in a loop with the anchor. When tightening the loop, the soft tissue is brought closer to the bone through the anchor.
[0004] Typically, surgeons tie the ends of the suture with the use of a surgical slipknot, such as the Tennessee Slider or Duncan Loop. After advancing the knot distally to tighten the loop, a series of additional half-ties or other knots are tied in an effort to secure the new slip knot location. Additional nodes are required because a conventional sliding knot used in today's repair constructs does not provide the necessary protection against loosening or slipping, specifically when tension is applied, especially on the loop members. The generally accepted practice is to follow the slip knot with at least three reverse half-ties in alternating columns of the suture.
[0005] However, before one or more half-ties or another knot can be added to the sliding knot, there is a potential for the sliding knot to slide, that is, for the loop to widen as the fabric puts tension on the loop. This has been called "loop security" and can occur even in the hands of very experienced surgeons. Sometimes, even fully knotted knots can slip. In addition to this "loop security" problem, conventional knots typically have a general size that can be obstructive or invasive, specifically in tight joints, which can damage cartilage or other tissue by abrasion with the knot.
[0006] Suture anchor systems with sliding knots and blocking knots for repairing damaged or broken tissues include US Patent No. 6,767,037, granted to Wenstrom, Jr. Other suture anchor systems specifically adapted for meniscus repair are presented in US patent No. 7,390,332, granted to Selvitelli et al. and are used in the OmniSpan ™ meniscus repair system commercially available from DePuy Mitek Inc., 325 Paramount Drive, Raynham, Massachusetts, USA 02767. Screw anchors usually require anchor fixation prior to the operation sutures, which can take to challenges related to the connection between the suture and the tissue.
[0007] There are numerous suture implant systems that declare themselves to be "without a knot", that is, they do not require a surgeon to tie the knot during surgery. Many of these systems control the tension on the tissue by means of the depth to which an anchor is placed in the bone. US patents Nos. 5,782,864 and 7,381,213, granted to Lizardi, show certain types of suture anchors that capture a fixed-length suture loop. Knotless anchor assemblies with adjustable loop that use an anchor element inserted into a sleeve are described by Thal in US Patent Nos. 5,569,306 and 6,045,574 and in US Patent Application Publication No. 2009/0138042. Other systems that have clamps or other locking mechanisms include US patent No. 5,702,397, Goble et al. and US patent application publication No. 2008/0091237, by Schwartz et al. However, the so-called "no-knot" designs generally have inadequate suture-anchor fixation and / or inadequate anchor-bone fixation, among other deficiencies.
[0008] Therefore, it is desirable to obtain systems, devices and methods to use in the repair of soft tissue that are robust and strong, and that still minimize or eliminate the number and size of the knots to be tied by a surgeon, particularly during arthroscopic repair procedures. It is also desirable to provide systems, devices and methods that minimize the number of components that a system needs to attach an anchor to the bone and bring the tissue closer to that bone. There is also a need for suture anchors and methods of positioning such anchors that minimize the surgical trauma associated with the implantation of an anchor of a certain size. SUMMARY
[0009] Systems, devices and methods are provided, in general, for attaching soft tissue to bone. In an exemplary embodiment, a surgical soft tissue repair device includes a loop assembly attached to a soft anchor. The soft anchor can be formed of a flexible construct with a plurality of openings formed. The anchor can be configured to have a first configuration not subjected to tension, for example to insert the anchor in a bone, and a second anchoring configuration to fix the anchor to the bone. The anchor can have a first length and a first diameter in the first configuration and a second length that is less than the first length and a second diameter that is greater than the first diameter. The handle assembly may have a retractable handle at one end and at least one elongated filament that extends therefrom. The filament includes a terminal end that is opposite the retractable handle and the filament can pass through the openings in the soft anchor to couple the handle assembly to the soft anchor, so that the soft anchor is in an intermediate position in the elongated filament, between the handle and the end end. It is possible to configure the soft anchor and the handle so that the soft anchor is re-configurable from its first configuration not subjected to tension until its second anchoring configuration, by applying tension to the filament.
[00010] In some embodiments, the soft anchor may be a suture provided with a cannula with a central lumen. In addition, a plurality of openings may include a first opening in a distal portion of the soft anchor and a second opening in a proximal portion of the soft anchor, with each of the two openings being in communication with the central lumen. In a non-limiting configuration, the filament can pass to the second opening through the lumen and exit through the first opening. In some embodiments, the first and second openings may be the same size as the soft anchor.
[00011] In some other embodiments, the soft anchor may include a plurality of transverse holes that extend through it along the length of the soft anchor. In such an embodiment, the anchor can be provided with a cannula or not with a cannula. The plurality of openings can include opposed paired openings and each opposed paired opening can communicate with one of the transverse holes. In a non-limiting configuration, the anchor can include at least four transverse holes and the filament can pass, back and forth, through each transverse hole through the opposite paired openings.
[00012] In still other modalities, the soft anchor can be a crochet suture anchor and the filament extends through the defined openings between members of the crochet suture anchor filament along their length.
[00013] In its anchoring configuration, the soft anchor can have a diameter that is at least about 20% larger than its diameter in the configuration not subjected to tension. The loop assembly may be formed of a double filament loop so that the filament has first and second filament members. A removable flexible sleeve can be included as part of the device for removably encapsulating at least a portion of the filament.
[00014] In another exemplary embodiment, a surgical soft tissue repair device includes an anchor, a loop assembly and a connection filament attached to the loop assembly and effective for connecting the loop assembly to the anchor. The anchor can be configured to be attached to the bone, and can have at least one hole extending through it. The handle assembly may have a retractable handle at one end and at least one elongated filament extending therefrom, with the filament having an end that is opposite the retractable handle. The connecting filament can be arranged in the hole or on one side of the hole distal to the handle assembly, and can be configured so that it is attached to the anchor, such that the anchor is positioned at an intermediate location in the elongated filament between the retractable handle. and the end.
[00015] An exemplary embodiment of a surgical repair method includes the insertion of a flexible anchor into a hole in a bone at a location close to the separate soft tissue. The anchor can have first and second configurations, with the first configuration having a first length and a first diameter and the second configuration having a second length which is less than the first length and a second diameter which is greater than the first diameter. The anchor can be coupled to a loop assembly that passes through at least a portion of the anchor, with the loop assembly having a retractable loop at one end of the anchor and at least one elongated filament extending from it. The elongated filament may have an end that is opposite the retractable handle. The method may also include tensioning the filament to move the anchor from the first configuration to the second configuration to secure the anchor with respect to the bone, passing at least the loop or end of the elongated filament through at least a portion of the separated tissue, inserting the end of the filament through the loop, retracting the loop around the filament and sliding the closed loop towards the soft tissue to apply tension to the filament between the anchor and the tissue, placing the tissue close to the bone.
[00016] The first and second configurations can be defined by the second length being at least about 50% smaller than the first length. The first and second configurations can also be defined so that the second diameter is at least about 20% larger than the first diameter. In some embodiments, the flexible anchor may be an anchor provided with a cannula with a lumen extending through it. Such an anchor can include a first opening at its proximal end and a second opening at its distal end, with the first and second openings being in communication with the lumen. In some embodiments, the flexible anchor may have a plurality or more pluralities of holes extending transversely through it along the length of the flexible anchor. BRIEF DESCRIPTION OF THE DRAWINGS
[00017] This invention will be better understood from the detailed description below taken in conjunction with the accompanying drawings, in which: Figure 1 is a schematic view of an exemplary embodiment of a handle assembly for use as part of a safety device. surgical soft tissue repair; Figure 2A is a schematic view of a loop assembly having a sliding knot formed there with first and second filament members extending to a second end; Figures 2B and 2C are sequential views of the loop assembly of Figure 2A with the first and second filament members passed through the sliding knot to form a loop or a tight sliding knot; Figures 3A-3D are viewed in sequence from another exemplary embodiment to form a loop assembly having a loop at a first end and first and second filament members extending to a second end; Figure 4 is a schematic view of an exemplary embodiment of a soft tissue surgical repair device that includes a handle assembly of Figure 1 and an anchor embodiment; The figures. 5A-5H are seen in sequence of an exemplary embodiment for using the surgical tissue repair device of figure 4 to attach tissue to the bone; Figure 6 is a schematic view of another exemplary embodiment of a soft tissue surgical repair device that includes the handle assembly of Figure 1 and another embodiment of an anchor; Figures 7A-7H are seen in sequence of an exemplary embodiment for using the soft tissue surgical repair device of Figure 6 to attach tissue to the bone; Figure 8 is a schematic view of yet another exemplary embodiment of a soft tissue surgical repair device that includes the handle assembly of Figure 1 and yet another embodiment of an anchor; Figures 9A-9H are seen in sequence of an exemplary embodiment for using the soft tissue surgical repair device of Figure 8 to attach tissue to the bone; Figure 10 is a schematic view of another exemplary embodiment of a soft tissue surgical repair device that includes the handle assembly of Figure 1 and another embodiment of an anchor; and Figures 11A-11J are seen in sequence of an exemplary embodiment for using the soft tissue surgical repair device of Figure 10 to attach tissue to the bone. DETAILED DESCRIPTION
[00018] Certain exemplary modalities will now be described to provide a general understanding of the principles of structure, function, manufacture and use of the devices and methods of the present invention presented. One or more examples of these modalities are illustrated in the attached drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are exemplary non-limiting embodiments and that the scope of the present invention is defined only by the claims. The features illustrated or described in conjunction with an exemplary embodiment can be combined with the features of other embodiments. Such modifications and variations are designed to be included within the scope of the present invention. Furthermore, in the present description, components of the similarly numbered modalities generally have similar characteristics. In addition, to the extent that linear or circular dimensions are used in describing the systems, devices and methods presented, such dimensions are not designed to limit the types of formats that can be used in conjunction with such systems, devices and methods. A person skilled in the art will recognize that an equivalent to such linear and circular dimensions can easily be determined for any geometric shape. Sizes and formats of the systems and devices, and the components thereof, may depend at least on the anatomy of the individual in which the systems and devices will be used, the size and shape of the components with which the systems and devices will be used and the methods and procedures in which the systems and devices will be used.
[00019] The figures presented here are not necessarily to scale. In addition, to the extent that arrows are used to describe a direction of movement, these arrows are illustrative and in no way limit the direction in which the respective component can or should be moved. Someone who is well versed in the technique will recognize other ways and directions to create the desired result. In addition, countless terms can be used interchangeably throughout the description, but will be understood by someone who is well versed in the technique. As a non-limiting example, the terms suture and filament can be used interchangeably.
[00020] Soft tissue repair systems, devices and methods are generally provided and they generally involve the use of surgical filaments that are configured in a variety of ways to minimize and / or eliminate the knot tying during a procedure surgical. The systems and devices presented here provide superior strength for use in a number of different surgical procedures, such as instability and rotator cuff repair procedures and other types of tendon and tissue repair procedures. The systems, devices and methods presented here also allow constructs to be used to repair tissues made entirely of flexible elements, thereby minimizing or eliminating the trauma that can result from the use of tougher materials for tissue repair. The systems and devices provided here also allow procedures, both improved and new, for soft tissue repair. For example, the systems and devices provided here can be used both to attach an anchor to the bone and to pull the tissue towards the bone for attachment to the bone.
[00021] Figure 1 illustrates an exemplary embodiment of a handle set 20 for use in conjunction with numerous different soft anchor configurations, in which some non-limiting examples are provided and discussed below with respect to figures 411J. As shown in figure 1, the handle assembly 20 can be flexible in general, can include a handle 30 formed at a first end 22 and can have a terminal end 24 opposite the first end 22, with an intermediate portion extending between them. The end end 24 can be configured to pass through an opening 32 in the handle to create a construct capable of undergoing tension such that the handle assembly can pull two or more objects, such as tissue and bone, closer to each other, as described in more detail below. Additionally, in modalities in which the handle set 20 is coupled to an anchor having both a non-tensioned configuration for insertion and an anchoring configuration for positioning the anchor in the bone, the handle set 20 can be used to activate the transition of the anchor from its non-tensioned configuration to its anchoring configuration, also as described in more detail below.
[00022] Optionally, a flexible sleeve 50 can be provided to encapsulate at least a portion of the assembly 20. As shown in figure 1, the sleeve encapsulates a portion of the assembly 20 starting at the end end 24 and extending towards the first end 22. In other embodiments, the glove may extend more proximally than the terminal end 24. Such a configuration can assist a surgeon in pulling the handle assembly 20 through a portion of the body by providing extra length to which he or she can hold on. Preferably, when the assembly 20 is implanted, the glove 50 can extend out of a body, as well as out of a cannula positioned in the body, such that the glove 50 can be easily removed. Sleeve 50 may have a generally cylindrical configuration and may be flexible to allow it to flex, as shown in the various embodiments provided herein. Glove 50 can be useful when passing assembly 20 through obstructions such as an anchor and / or fabric, for a number of reasons. The glove 50 can be configured to have a more even surface, which is better configured to pass through a soft anchor and fabric, thereby reducing the possibility of wearing out the soft anchor or causing trauma to the fabric. In addition, due to the fact that the glove 50 can encapsulate a plurality of filament members, the glove 50 can facilitate the handling of the filaments by keeping the filaments within the closed glove 50. The glove 50 can be removable and thus can be removed at any time during the procedure, or at the completion of the procedure.
[00023] Figures 2A-2C illustrate an exemplary method of forming a loop assembly. As shown in figure 2A, the handle assembly 120 may be a filament having a sliding knot 160 and sliding knot members 164, 166. Sliding knot 160 defines a central opening 162 and secondary openings 161 and 163 formed from a half-lashing plus an additional length of the member 166 through the central opening 162. A flexible sleeve 150 is shown in dashed line, as it optionally encapsulates a portion of the members 164 and 166 in certain constructions, as described in more detail below.
[00024] Figures 2B and 2C more particularly illustrate the formation of a sliding loop or loop knot 130 in an improved sliding loop or loop assembly 120, having an opening 132. The extremities of the limbs of free filaments 134 and 136 of the filament are passed through the central opening 162, as represented by arrows 137 and 139 in figure 2B, which pulls the sliding knot members 134 and 136 through it. Then, the sliding knot 160 is tightened, as shown in figure 2C, to form a sliding knot for handle 130. Alternatively, if a glove 150, as shown in figure 2A, or a glove 150 ', as shown in figure 2C, is not used, or if such a glove is removed after being passed through the fabric to be tensioned, then one or both of the free members 134, 136 can be passed through one or both of the openings 161, 163.
[00025] The joining of at least free filament members improves the management of the suture and reduces the possibility of the suture entangling or damage by instruments, especially when passed through a cannula. For example, a surgeon or other user only needs to hold and pass a glove 150 through the sliding knot 160 to thereby manipulate the free filament members 134, 136 as a unit in itself.
[00026] Figures 3A-3D illustrate another exemplary method of forming a handle assembly 220 having a handle 230 and a coaxial sliding neck 235 for use in a surgical repair construct. In this exemplary embodiment, loop 230 is formed from a bifurcation suture filament having a tubular portion 237, the core being removed from there to form a portion provided with cannula 239 and first and second terminal members 234, 236. As shown in In figure 3B, the end members 234, 236 can be twisted backwards towards the tubular portion 237 to form a loop that has an opening 232 that defines the handle 230. As shown in figure 3C, a hole 260 can be formed on one side of the tubular portion 237 and end members 234, 236 can be placed in the tubular portion provided with cannula 239 through orifice 260. The ends of end members 234, 236 can be fed through the portion provided with cannula 239, and, as shown in In figure 3D, the end members 234, 236 can be pulled distally (direction A in figure 3D) through the tubular portion 237, so that the tubular portion 237 is fed through itself. Consequently, the handle 230 can be retracted by tensioning the members 234, 236 and / or coaxial sliding neck 235 in approximately a first direction A and the handle 230 can be expanded by applying force to the handle 230 approximately. in a second opposite direction B, which pulls the members 234, 236 towards the handle 230. Passing the filament through itself to form a coaxial sliding neck allows the filament to have a low profile that minimizes the amount of space that the construct occupies on the body and that minimizes and / or eliminates the trauma associated with the passage of the filament through the tissue.
[00027] Someone skilled in the art will recognize numerous other ways in which a handle for use in handle assemblies, can be created and used in conjunction with the teachings of the present invention. For example, several different sliding nodes can be used to form loops, including, but not limited to, a Buntline node (Buntline Hitch), a Tennessee Slider (Tennessee Slider), a Duncan Loop (Duncan Loop), a Sliding Node Hangman's Noose and a coaxial sliding neck. To the extent that the sliding knot used to form a loop affects the operation of the loop, for example, whether a member is pulled through a knot to change the position of the knot or whether a knot is slid along a member to changing the position of the knot, a person skilled in the art is able to adapt these types of knots for use with the teachings of the present invention without departing from the spirit of the present description. As described here, except where otherwise noted, a knot used to form a handle can be moved away from the end of the handle assembly to retract the handle and towards the end of the handle to increase the size of the handle.
[00028] Handle sets 20, 120, 220 can be produced from any suitable flexible material, for example, a filament, including a cannula filament, a braided filament and a monofilament. The type, size and strength of the flexible material may depend, at least in part, on the type of anchor with which it is used, on any obstruction through which the handle assembly can pass, and on the type of procedure in which it is used. it is used. In an exemplary embodiment, the flexible material is a # 2 filament (caliber about 23 to caliber about 24), such as an Orthocord ™ filament, which is commercially available from DePuy Mitek, Inc or Ethibond ™ filament, available from to Ethicon, Inc. In general, the filament is relatively thin to minimize any trauma to the tissue through which it passes. In some embodiments, the filament may have a size between about a # 5 filament (about 20 gauge to about 21 gauge) and about a # 5-0 filament (about 35 gauge to about 35 gauge) 38). Orthocord ™ # 2 filament can be useful because it has a twisted configuration, which allows other components, including the filament itself, to pass through subcomponents of the entanglement without causing damage to the filament. Configured filaments can also be used to allow for a cannula-like configuration, such as by removing the core from the cannula or having a configuration with a pre-formed cannula. The Orthocord ™ suture is approximately fifty-five to sixty-five percent polydioxanone PDS ™, which is bioabsorbable, and the remaining thirty-five to forty-five percent, ultra high molecular weight polyethylene, while the Ethibond ™ suture is mainly high-strength polyester. The amount and type of bioabsorbable material used, if used, in the filaments of this description, is mainly a matter of preference of the surgeon for the specific surgical procedure to be performed. In addition, a length of filaments used to form the handle assemblies 20, 120, 220 can be in the range of about 15 centimeters to about 125 centimeters, and in one embodiment, it can be about 60 centimeters.
[00029] In embodiments that include a flexible glove, such as those shown in figures 1, 2A and 2C, the glove 50, 150, 150 'can be produced from a wide variety of flexible bio-compatible materials, including a polymer or a flexible filament. In one embodiment, the glove is produced from a polymeric material. In another embodiment, the glove is a flexible filament, such as a braided suture, for example, Ethibond ™ # 0 filament or Orthocord ™ # 2 filament, which is typically braided to sixty weft threads by 2.54 centimeters. For use as a glove, a looser braid of approximately thirty to forty weft threads per 2.54 centimeters is preferred, more preferably about 36 weft threads per 2.54 centimeters. If the glove material is formed around a core, preferably that core is removed to facilitate the insertion of the filament members, which can themselves be formed from a typical suture, such as Orthocord ™ # 0 or suture # 2 braided to sixty weft threads by 2.54 centimeters. Additional convenience can be provided by perceptible indicators on the glove, such as markings, colors, diameters, interlacing or different design patterns, or other visual or tactile marking areas, especially if multiple fixings or fabric anchors are used.
[00030] The length and diameter of the glove 50, 150, 150 'may depend, at least in part, on the size and configuration of the components of the device with which it is used, the obstructions through which the glove can pass and the surgical procedure in which it is used. In any case, the glove is typically of a size such that it can automatically pass through the fabric. In embodiments in which the glove is a filament, the size of the glove can be in the range of about a # 5 filament (from about 20 gauge to about 21 gauge) to about a # 2-0 filament (about caliber 28), and in one embodiment, the size can be about a # 0 filament (from about 26 gauge to about 27 gauge). A person skilled in the art will recognize comparable diameters that can be used in the event that the glove is produced from a polymeric material or other material that is not filament. The glove can have a length in the range of about 10 centimeters to about 60 centimeters, and in one embodiment, it has a length of about 40 centimeters.
[00031] A person skilled in the art will recognize that the configurations in figures 1-3D are only a few options for forming the handle sets. In the illustrated mode, the handle set is produced from a single filament. In other embodiments, however, multiple filaments can be used, for example, with the use of a filament to create a component that includes a handle, such as a handle connection and another filament to form a retractable loop in place of a terminal end ( for example, endpoint 24 shown in figure 1), as described in more detail in US patent application serial number 13 / 465,288 filed simultaneously thereto, and entitled "Systems, Devices, and Me-thods for Securing Tissue" [ Attorney Summary n ° 22956-970 (MIT5183USNP)], the contents of which are hereby incorporated by reference. Other exemplary modalities of loop sets that can be used in conjunction with the teachings of the present invention are described at least in US patent application serial number 13 / 218,810 filed on August 26, 2011 and entitled "SURGICAL FILAMENT SNARE ASSEMBLIES" , the content of which is also incorporated into the present invention by reference.
[00032] The modalities of soft tissue surgical repair devices described here, generally attach a set of handles to a soft anchor. In general, soft anchors are flexible in nature and can be formed from a flexible filament or from a polymeric material in the form, for example, of a glove. Such soft anchors, which are typically non-metallic, may include one or more openings to allow at least a portion of the handle assembly to pass through and / or through the anchor. Soft anchors can have an unaltered or non-tensioned configuration that can be used for positioning at the surgical site and an anchoring configuration that can be used to secure the anchor after positioning at the surgical site. The manipulation of soft anchors can be effective in making the transition from anchors from the first unstressed configuration to the second anchoring configuration. The transition from a soft anchor from one configuration to another typically changes the dimensions (for example, the length and / or the diameter) of the anchor. As, in a non-limiting example, in some types of repair device, the diameter of a soft anchor, in its anchoring configuration (that is, its second diameter) can be in the range of about 10% greater than about 80 % greater than the diameter in the unstressed configuration (ie, its first diameter). In one embodiment, the second diameter can be about 20% larger than the first diameter of the soft anchor. Similarly, by way of an additional non-limiting example, in some types of repair device, a length of a soft anchor in its anchoring configuration (ie, its second length) may be in the range of about 20% minus about 80% less than a length of the soft anchor in its unstressed configuration (ie, its first length). In one embodiment, the second length can be about 50% less than the first length.
[00033] Figure 4 illustrates an exemplary embodiment of a soft tissue surgical repair device 310 in which the handle assembly 20 of Figure 1 is coupled to a modality of a soft anchor 312. As shown, anchor 312 can be a suture provided with cannula 314 which has a central lumen 316 disposed through it. The handle assembly 20 can pass through at least a portion of the central lumen 316 to couple the handle assembly 20 to anchor 312 so that anchor 312 is at an intermediate location in the handle assembly 20 (i.e., in a location between the first end 22 and the end end 24). More particularly, suture 312 may include a plurality of openings 318, 319 formed therein to accommodate the coupling to the loop assembly and the anchor's actuation from the non-tensioned anchoring configuration. In the illustrated embodiment, two openings are present close to the opposite ends of anchor 312 to pass the handle assembly, in and out of the central lumen 316. Those skilled in the art will appreciate that the openings 318, 319 can be located in numerous different locations. In the illustrated embodiment, the first opening 318 is formed next to a proximal portion 312p of anchor 312 and the second opening 319 is formed next to a proximal portion 312d of anchor 312. As shown, the first and second openings 318, 319 face the front, but if the suture provided with cannula 314 has been extended to an approximately straight line, it can be said that the openings 318, 319 are located on the same side as the soft anchor 312.
[00034] As noted above, when positioned on the bone, anchor 312 is able to move between a first unstressed configuration and a second anchoring configuration. The placement of the soft anchor 312 in the bone, as will be explained below, causes the anchor to be laterally constricted within a hole that is formed in the bone. When tension is applied to the handle assembly, which is attached to the soft anchor, the soft anchor deforms. This deformation causes the dimensions of the anchor to change. As the diameter of the positioned anchor increases within the hole in which it is positioned, as explained above, the length decreases. The effect of increasing the diameter is to create a frictional engagement of the soft anchor within the orifice and / or fixation of portions of the anchor to the bone (particularly spongy bone tissue), thereby fixing the anchor to the bone and allowing the tissue to be attached to the joint handle is secured in a desired position.
[00035] Anchor 312 can be produced from a variety of materials in a variety of ways. In an exemplary embodiment, anchor 312 is formed using a surgical filament, such as a cannula filament or a braided filament. Alternatively, anchor 312 can be produced from a polymeric material in the form of a flexible sleeve. The type, size and strength of the materials used to form the soft anchor 312 may depend, at least in part, on the other materials that make up the handle assembly, the type of fabric on which it will be positioned and the type of procedure with which it will be used for. In an exemplary embodiment, the anchor is formed from a # 2 filament (about 23 gauge to about 24 gauge), such as an Orthocord ™ filament that is commercially available from DePuy Mitek, Inc. or an Ethibond ™ filament that it is commercially available from Ethicon, Inc., Route 22 West, Somerville, NJ, USA, 08876. The cores of these filaments can be removed to form the cannula configuration. The Orthocord ™ suture is approximately fifty-five to sixty-five percent PDS ™ poly dioxanone, which is bioabsorbable, and the remaining thirty-five to forty-five percent, ultra high molecular weight polyethylene, while the Ethibond suture ™ is mainly high-strength polyester. The amount and type of bioabsorbable material used, if used, in the filaments of this description, is mainly a matter of preference of the surgeon for the specific surgical procedure to be performed.
[00036] An anchor length when it is in an approximately linear configuration, unfolded and not positioned, can be in the range of about 8 mm to about 50 mm, and in one embodiment, it can be about 20 mm. Additionally, an anchor length when it is positioned and in its unstressed configuration (figure 5A, described below) can be in the range of about 4 mm to about 25 mm, and in one embodiment, it can be about 10 mm and a diameter of the soft anchor positioned in such a configuration (i.e., a folded configuration) can be in the range of about 0.5 mm to about 5 mm, and in one embodiment, it can be about 1 mm. In addition, an anchor length when it is positioned and in its anchoring configuration (figure 5B, described below) can be in the range of about 2 mm to about 25 mm, and in one embodiment, it can be about 5 mm and a diameter in such a configuration can be in the range of about 1 mm to about 10 mm, and in one embodiment, it can be about 2 mm.
[00037] A person skilled in the art will recognize a variety of other constructions than the device 310, the handle assembly 20 (discussed above) and anchor 312 can have without departing from the spirit of the present description. By means of non-limiting examples, the loop assembly 20 can be attached to anchor 312 in locations other than those illustrated, it can pass in and out of the suture provided with cannula 314 any number of times, suture 314 can have a twisted configuration , and openings 318, 319 to allow the handle assembly that passes inside the central lumen 316 to be relocated to other portions of anchor 312. A person skilled in the art will recognize that the way in which the handle assembly 20 is passed through anchor 312 it can affect the look and performance of the second anchoring configuration. Other anchors to which the handle assembly 20 can be attached and operated in a similar manner to the modes provided in the present invention are described at least in US Patent No. 7,658,751, Stone et al., The content of which is incorporated by way of reference in the present invention.
[00038] Figures 5A-5H illustrate an exemplary method for performing a tissue repair using the repair construct illustrated in figure 4. A surgical opening can be formed through the skin 1000 and a cannula can be passed through it to access a surgical repair site in a manner well known to those skilled in the art. Although cannulas are often used to define a channel through which the procedure can be performed, the cannula is not shown in figures 5A-5H for clarity of illustration. Consequently, to the extent that the figures show components of the systems and devices that pass through the skin 1000, these components typically extend through the cannula which itself is passed through the skin 1000. Additionally, although the devices and methods here described are particularly useful for minimally invasive surgery, such as arthroscopic surgery, they can also be used in open surgical procedures.
[00039] As shown in figure 5A, the handle assembly 20 can be attached to anchor 312 by passing the end end 24 through opening 318, through central lumen 316, and exiting through the other opening 319, such that anchor 312 it is located in an intermediate location of the handle assembly 20 with the handle 30 extending from the first side of the anchor 312 and the end end 24 extending from the other. An orifice 1002 can be formed in a bone 1001 and the device 310 shown in figure 4 can be inserted into the orifice. In the positioned, unstressed configuration shown in figure 5A, the anchor is essentially folded in half to assume a U-shaped shape. Alternatively, the anchor can be delivered in an unfolded configuration, for example, approximately straight.
[00040] The person skilled in the art will appreciate numerous different techniques that can be used to place the 310 device in the orifice. As a non-limiting example, anchor 312 can be attached to a distal end of a stretched wire or other similar tool or device to position anchor 312 within orifice 1002. The wire may have one or more forks at its distal end thus forming a fork, and anchor 312 can be rolled up using one or more forks such that anchor 312 remains in its unstressed configuration during insertion. Alternatively, the wire may have a single fork at its distal end such that the fork pierces through the anchor, similarly to a skewer. In other embodiments, the wire may include one or more angled cuts on one side of the wire near its distal end, and anchor 312 may be suspended in one or more of one or more angled cuts. Additionally, by means of a non-limiting example, anchor 312 may be located in a device or tool similar to the device 590 described below with respect to figure 9A and placed in orifice 1002, in a similar manner. By way of a final non-limiting example, anchor 312 may include a fish tail, such as fish tail 617 described below with reference to figures 10 and 11A-11J and inserted into bone 1001 in a similar manner.
[00041] As shown in figure 5B, after the anchor is positioned, tension can be applied to the handle assembly 20 in approximately a C direction, which, in turn, can activate anchor 312 to move from its non-configurable configuration. tensioned to your anchoring configuration. This tension causes deformation of anchor 312 and it substantially clumps together with a larger diameter in the anchoring configuration. In the illustrated embodiment, the agglomerated anchoring configuration is substantially W-shaped for illustrative purposes, but a person skilled in the art will recognize numerous different configurations that anchor 312 may have in the anchoring configuration. In this configuration, anchor 312 engages and pushes the walls of orifice 1002, penetrating spongy bone tissue in some embodiments such that anchor 312 can be substantially fixed with respect to orifice 1002. Although the overall shape of the anchor in the anchoring configuration depends, at least in part, the way in which the handle assembly 20 is attached to anchor 312, as shown, the diameter of the anchor in the second anchoring configuration increases compared to the diameter in the unstressed configuration, while the length of the anchor in the configuration anchorage decreases compared to the length of the un-tensioned configuration.
[00042] As described here, the meeting of the anchor, such as anchor 312 and anchors 412, 512, 612 described below, with the orifice 1002 walls, can be initiated only by the friction between the anchor and the walls and additionally aided by varying bone density, which usually increases in one direction from the distal end of orifice 1002 to the proximal end. The process of transforming the shape can also be initiated by introducing a retention device against the anchor and applying tension on the loop against the retention device.
[00043] As shown in figure 5C, the end end 24 of the handle assembly 20 can be passed in and through at least a portion of tendon 1003 separated from bone 1001. Optionally, a needle or tool or similar device can be coupled to the terminal end 24 to assist in passing the loop assembly 20 through the tendon 1003. Similarly, other shuttle techniques known to a person skilled in the art can also be used to pass the loop assembly through the tendon.
[00044] As shown in figures 5D and 5E, a portion of the end end 24 can be passed through the opening 32 of the handle 30 and the handle 30 can be retracted or adjusted in a manner consistent with its type of handle. Thus, in the illustrated embodiment, the handle 30 can be retracted by moving the knot that forms the handle 30 away from the terminal end 24.
[00045] As shown in figure 5F, tension can be applied to the end end 24 by pulling approximately in a D direction, thus causing the retractable handle 30 to slide distally towards the tendon 1003, like a zipper, until the handle 30 is adjacent to tendon 1003. This, in turn, can cause tendon 1003 to move in the direction of the bone and contact the bone 1001. Alternatively, tension can be applied to the end end 24 before the handle 30 is adjusted and after loop 30 is in a position adjacent to tendon 1003, or some combination of the two actions can be used, such as partially adjusting loop 30 before aligning it in the direction of tendon 1003. As shown in figure 5F, in modalities that include glove 50, as the handle is slid distally towards the tendon, glove 50 can move proximally, out of the body. Glove 50, if included, can be removed at any time, as shown in figure 5G for example. The final tensioning can be carried out by applying tension to the terminal end 24, or to the sleeve 50 if it remains associated with the handle set.
[00046] As shown in figure 5H, one or more half-lashings can be formed in proximity to the closed loop for incremental or ratchet-type tensioning and / or to maintain a closed loop location. After a first half-lashing is formed, the loop assembly 20 can be additionally tensioned in an incremental or ratchet type, applying tension to the loop assembly 20. The addition of a second half-lashing or more half-lashings can lock the location of the closed handle. Then, the excess filament can be cut and removed to complete the procedure. Other techniques known to those skilled in the art can be used to maintain the location of the closed loop and thus the fabric nearby.
[00047] Figure 6 illustrates another exemplary embodiment of a soft tissue surgical repair device 410 in which the handle assembly 20 of figure 1 is coupled to a soft anchor 412. As shown, anchor 412 may be in the form of suture 414, or another flexible element such as a polymeric sleeve, which has a plurality of openings 416 formed there with a plurality of holes 418 extending through anchor 412 along a length thereof. The soft anchor 412 can be equipped with a cannula or not. As illustrated, the handle assembly 20 can enter and leave anchor 412 through openings 416 and pass through anchor 412 through holes 418 to couple handle assembly 20 to anchor 412, such that anchor 412 is in an intermediate location on the handle assembly 20. Openings 416 and holes 418 can be in a number of different configurations. In the illustrated embodiment, there are twelve openings 416 and six holes 418, with at least some of the holes 418 extending transversely between two openings 416. As shown, each opening 416 has a complementary opening through the other side of anchor 412 and a hole 418 if extends between the opposed paired openings 416. Furthermore, as shown, the handle assembly 20 can be passed through anchor 412 symmetrically, and thus the opposed paired openings 416, which have a hole 418 extending between them, can have a opposite counterpart of paired openings 416 and orifice 418 extending between them. When positioned, anchor 412 is able to move between an unstressed configuration and an anchoring configuration.
[00048] Anchor 412 can be produced from a variety of materials, but in an exemplary embodiment, anchor 412 is formed using a surgical filament, such as a cannula filament, a braided filament or a monofilament. Alternatively, anchor 412 can be produced from a polymeric material in the form of a flexible sleeve. The type, size and strength of the filament may depend, at least in part, on the other materials that make up the handle assembly, the type of fabric on which it will be positioned and the type of procedure with which it will be used. In an exemplary embodiment, the anchor is formed from a # 2 filament (about 23 gauge to about 24 gauge), such as an Orthocord ™ filament that is commercially available from DePuy Mitek, Inc. or an Ethibond ™ filament that is commercially available from Ethicon, Inc.
[00049] An anchor length when it is in an approximately linear configuration, unfolded and not positioned, can be in the range of about 8 mm to about 50 mm, and in one embodiment, it can be about 20 mm. Additionally, an anchor length when it is positioned and in its unstressed configuration (figure 7A, described below) can be in the range of about 4 mm to about 25 mm, and in one embodiment, it can be about 10 mm and a diameter of the soft anchor positioned in such a configuration (i.e., a folded configuration) can be in the range of about 0.5 mm to about 5 mm, and in one embodiment it can be about 1 mm. In addition, an anchor length when it is positioned and in its anchoring configuration (figure 7B, described below) can be in the range of about 2 mm to about 10 mm, and in one embodiment, it can be about 5 mm and a diameter in such a configuration can be in the range of about 1 mm to about 10 mm, and in one embodiment, it can be about 2 mm.
[00050] A person skilled in the art will recognize a variety of other constructs than device 410, handle assembly 20 (discussed above) and anchor 412 can have without departing from the spirit of the present description. As a non-limiting example, any number of openings and orifices and configurations thereof can be used, although in some embodiments the number of orifices may be in the range of about 2 orifices to about 10 orifices, and in one embodiment there may be 4 holes, while in another mode, there can be 6 holes. Additionally, anchor 412 can be configured to allow the handle assembly 20 to pass through any portion thereof, including an asymmetric, non-transverse manner, depending, at least in part, on other components of the device 410 and the second configuration of desired anchoring, among other factors. A person skilled in the art will recognize that the manner in which the handle assembly 20 is passed through anchor 412 can affect the look and performance of the anchoring configuration. Other anchors with which the handle assembly 20 can be coupled and operated in a manner similar to the modes provided in the present invention are described at least in [INSERT US PATENT OR PATENT APPLICATION INFORMATION FOR Y-KNOT], the content of which is incorporated as reference in the present invention.
[00051] Figures 7A-7H illustrate an exemplary method for performing a tissue repair using the repair construct illustrated in figure 6. A surgical opening can be formed through the skin 1000 and a cannula can be passed through it to access a surgical repair site according to well-known techniques. Similar to figures 5A-5H, although cannulas are often used to define a channel through which the procedure can be performed, the cannula is not shown in figures 7A-7H for clarity of the illustration. Consequently, to the extent that the figures show components of the systems and devices that pass through the skin 1000, these components typically extend through the cannula which itself is passed through the skin 1000.
[00052] As shown in figure 7A, the handle assembly 20 can be attached to anchor 412 by passing the end end 24 through the openings 416 and the holes 418 formed there, such that anchor 412 is located in an intermediate location in the handle assembly 20, with handle 30 extending from one first side of anchor 412 and end end 24 extending from the other. An orifice 1002 can be formed in a bone 1001 and the device 410 shown in figure 6 can be inserted into the orifice, for example in a folded configuration as shown, or in an unfolded configuration, for example, approximately straight. Numerous different techniques can be used to place the device 410 in the orifice, including techniques known to those skilled in the art, those described above with respect to anchor 312 and those that will be described below with respect to figures 9A, 10, and 11A-11J. As a non-limiting example, a device having a plurality of forks can be used to insert anchor 412 so that the forks maintain anchor 412 in its first unstressed configuration during insertion.
[00053] As shown in figure 7B, after the anchor is positioned, tension can be applied to the handle assembly 20 in approximately one direction E, which, in turn, can activate anchor 412 to move from its non-configurable configuration. tensioned to your anchoring configuration. This tension causes deformation of anchor 412 and it substantially agglomerates with a larger diameter in the anchoring configuration. In the illustrated embodiment, the agglomerated anchoring configuration is substantially spherical or like a closed fist for illustrative purposes, but a person skilled in the art will recognize numerous different configurations that anchor 412 can have in the anchoring configuration. In this configuration, anchor 412 engages and imposes the walls of hole 1002, in its anchoring configuration, penetrating the spongy bone tissue in some modalities such that anchor 412 can be substantially fixed in relation to hole 1002. Although the general shape of the anchor in the anchor configuration it depends, at least in part, on the way in which the handle assembly 20 is coupled to the anchor 412, as shown, the diameter of the anchor in the second anchor configuration increases compared to the diameter in the un-tensioned configuration , while the length of the anchor in the anchoring configuration decreases compared to the length of the unstressed configuration.
[00054] The device 410 can then be operated in a similar manner to that described with reference to figures 5C-5H. In this way, at least a portion of the terminal end 24 can be passed through at least a portion of the tendon 1003 and through the opening 32 in the handle 30 and the handle 30 can be closed or adjusted, for example by moving the knot that forms the handle 30 away from the end end 24. The handle 30 can be slid distally in the direction of the tendon 1003 by applying tension in approximately one direction F, which can result in the handle 30 being in a position adjacent to the tendon 1003 and tendon 1003 moves towards bone 1001. Final tensioning and removal of glove 50, if used, may occur and one or more half-ties may be formed near closed loop 30 to allow for incremental or type tensioning turnstile and / or maintain a location of the turnstile. Then, the excess filament can be cut and removed to complete the procedure.
[00055] Figure 8 illustrates yet another exemplary embodiment of a soft tissue surgical repair device 510 in which the loop assembly 20 of figure 1 is attached to anchor 512. As shown, anchor 512 can be a crochet suture 514 which has a plurality of openings 516 defined between the members of the filament along a length thereof. The loop assembly 20 can be woven back and forth through suture 514 any number of times to couple loop assembly 20 to anchor 512 so that anchor 512 is at an intermediate location on loop assembly 20. In the modality illustrated, the loop assembly is passed through suture 514 at a proximal end 514p of suture 514 and is passed back and forth through suture 514 five times more, each time more distal from the next, before being looped back from a distal end 514d to the proximal end 514p and being passed through suture 514 one last time at the proximal end 514p.
[00056] Anchor 512 can be produced from a variety of materials, but in an exemplary embodiment, anchor 512 is formed using a surgical filament, such as a cannula filament, a braided filament or a monofilament. The type, size and strength of the filament may depend, at least in part, on the other materials that make up the handle assembly, the type of fabric on which it will be positioned and the type of procedure with which it will be used. In an exemplary embodiment, the anchor is formed from a # 2 filament (about 23 gauge to about 24 gauge), such as an Orthocord ™ filament that is commercially available from DePuy Mitek, Inc. or an Ethibond ™ filament that is commercially available from Ethicon, Inc.
[00057] The length of anchor 512 when it is positioned on the bone and in its unstressed configuration (figure 9A, described below) can be in the range of about 5 mm to about 50 mm, and in one embodiment it can be about 25 mm. The diameter of anchor 512 in such a configuration can be in the range of about 0.5 mm to about 5 mm, and in one embodiment it can be about 1 mm. When anchor 512 is positioned and in its anchoring configuration (figure 9B, described below), its length can be in the range of about 2 mm to about 10 mm, and in one embodiment it can be about 5 mm. The diameter of the anchor positioned 512 in its anchoring configuration can be in the range of about 1 mm to about 10 mm, and in one embodiment it can be about 2 mm.
[00058] A person skilled in the art will recognize a variety of other constructs than the 510 device, the handle assembly 20 (discussed above) and the anchor 512 can have without departing from the spirit of the present description. As a non-limiting example, the handle assembly 20 can be passed through anchor 514 any number of times at any number of locations and not necessarily in a consecutive order downstream or upstream. A person skilled in the art will also recognize that the way in which the handle assembly 20 is passed through anchor 512 can affect the look and performance of the second anchoring configuration. Other anchors to which the handle assembly 20 can be attached and operated in a manner similar to the modes provided in this description, are described at least in US patent application publication No. 2011/0022083 filed on July 24, 2009, and titled "METHODS AND DEVICES FOR REPAIRING AND ANCHORING DAMAGED TISSUE", the content of which is incorporated by reference in the present invention.
[00059] Figures 9A-9H illustrate an exemplary method for performing a tissue repair using the repair construct shown in figure 8. A surgical opening can be formed through the skin 1000 and a cannula can be passed through the same to access a surgical repair site according to well-known techniques. Similar to figures 5A-5H, although cannulas are often used to define a channel through which the procedure can be performed, the cannula is not shown in figures 9A-9H, for clarity of the illustration. Consequently, to the extent that the figures show components of the systems and devices that pass through the skin 1000, these components typically extend through the cannula which itself is passed through the skin 1000.
[00060] As shown in figure 9A, the handle assembly 20 can be attached to anchor 512 in a similar manner to that described above with respect to figure 8. This construction is such that anchor 512 is located in an intermediate location of the assembly of handle 20 with handle 30 extending from one first side of anchor 512 and end end 24 extending from the other. An orifice 1002 can be formed in a bone 1001 and the device 510 shown in figure 8 can be inserted into the orifice. Several different techniques can be used to place the 510 device in the orifice, including techniques known to those skilled in the art. As a non-limiting example, an insertion device 590 having a body 592 defining a cavity 594 therein and a piston 596 disposed within the cavity 594, can be inserted at a distal end 1002d of the orifice 1002 such that the anchor 512 is located distally within orifice 1002, as shown in figure 9A. The device 590 may also include one or more features for handling the handle assembly 30, including, by way of non-limiting example, a central lumen 598 in the piston 596 for receiving the handle assembly 20. The body 592 can be removed while piston 596 is left stationary to hold anchor 512 in place, and then, after frame 592 is removed, piston 596 can be removed, thus leaving anchor 512 arranged in orifice 1002. Such a configuration allows unintended movement anchor 512 is minimized or eliminated, thus reducing the possibility of premature positioning in the second anchoring configuration. In an alternative embodiment, device 590 can be located adjacent to a proximal end 1002p of orifice 1002 and piston 596 can be activated to move anchor 512 from device 590 into orifice 1002. In addition, options delivery methods discussed above with respect to anchors 312, 412, can also be used with anchor 512, as well as other techniques known to those skilled in the art.
[00061] With reference to figure 9B, when anchor 512 is arranged in hole 1002, tension can be applied to the handle assembly 20 in approximately one direction G. With the anchor constricted inside hole 1002, this force activates anchor 512 such that it transitions from its non-tensioned configuration to its anchoring configuration. This tension causes deformation of anchor 512 and it substantially agglomerates, having a larger diameter in the anchoring configuration. In the illustrated embodiment, the agglomerated anchoring configuration is substantially spherical or like a closed fist for illustrative purposes, but a person skilled in the art will recognize numerous different configurations that anchor 512 can have in the anchoring configuration. In this configuration, anchor 512 engages and imposes the walls of hole 1002, penetrating the spongy bone tissue in some modalities, such that anchor 512 can be substantially fixed in relation to hole 1002. Although the general shape of the anchor in the anchoring configuration depends , at least in part of the way in which the handle assembly 20 is attached to anchor 512, as shown, the diameter of the anchor positioned at 512, in the anchoring configuration, increases compared to the diameter of the anchor in the unstressed configuration , while the length of the anchor positioned in the anchoring configuration decreases compared to the diameter of the anchor in the unstressed configuration.
[00062] As described above, the impact of the anchor on the wall of the orifice 1002 can be initiated only by the friction between the anchor and the walls and is additionally aided by the variation of bone density and, moreover, the process of transformation of the shape can also be initiated by introducing a retention device against the anchor and applying tension to the loop against the retention device. In some embodiments, piston 596 can serve as the holding device. For example, after the body 592 is retracted, piston 596 can be held in place and the handle assembly 20 can be tensioned against piston 596, thereby causing anchor 512 to move into the anchoring configuration. The piston 596 can then be removed from the surgical site. In such embodiments, the lumen 598 of piston 596 may be small enough so as not to accommodate the handle assembly 20 and anchor 512 together.
[00063] Following the positioning of anchor 512 from its first unstressed configuration to its second anchoring configuration, device 510 can be operated in a similar manner to that described with reference to figures 5C-5H. In this way, at least a portion of the terminal end 24 can be passed through at least a portion of the tendon 1003 and through the opening 32 in the handle 30 and the handle 30 can be closed or adjusted, for example by moving the knot that forms the handle 30 away from the end end 24. The handle 30 can be slid distally in the direction of the tendon 1003 by applying tension in approximately an H direction, which can result in the handle 30 being in a position adjacent to the tendon 1003 and the tendon 1003 move in the direction of the bone 1001. Final tensioning and removal of the glove 50, if used, may occur and one or more half-ties may be formed near the closed loop 30 to allow for incremental tensioning or ratchet type and / or maintain a location of the same. Then, the excess filament can be cut and removed to complete the procedure.
[00064] Figure 10 illustrates yet another exemplary embodiment of a soft tissue surgical repair device 610 in which the handle assembly 20 of figure 1 is coupled to soft anchor 612. As shown, anchor 612 has a similar nature to anchor 512 and thus can include the same features discussed above with respect to anchor 512. Consequently, it can be a crochet suture 614 that has a plurality of openings 616 defined between the filament members along a length of the same , with the loop assembly being woven back and forth by suture 614 in a similar manner to that described above, such that anchor 612 is at an intermediate location in loop assembly 20. Anchor 612 includes a fish tail 617 in a distal end 614d of suture 614. Fish tail 617 can be used to assist in the insertion of anchor 612 into a surgical site, as discussed in more detail below. In particular, the fish tail 617 can assist in navigating the device through and around obstructions and various non-linear paths in the body. As shown, a needle 619 or other similar tool or device can optionally be attached to suture 612 to assist in passing fish tail 617 through obstructions, such as skin and tissue.
[00065] The materials and dimensions of the device 610 may similarly be similar to those discussed above with respect to the device 510, with the fish tail 617 being part of suture 614. The length of the fish tail 617 may depend, at the at least in part, the dimensions of the rest of the 614 suture, other components with which it is being used and the type of procedure with which it is being used. The fish tail 617 can have a length in the range of about 5 centimeters to about 100 centimeters, and in one embodiment a length of the fish tail is about 40 centimeters. A person skilled in the art will recognize a variety of other constructions that the device 610, the handle assembly 20 (discussed above) and anchor 612 can have without departing from the spirit of the present description. In addition, a person skilled in the art will recognize that a fish tail similar to fish tail 617 can be incorporated into several other anchor modalities, including, but not limited to, anchors 312, 412, and 512 provided in present invention. The use of the fish tail to position such anchors occurs in a manner similar to the manner described below with respect to figures 11A-11J.
[00066] Figures 11A-11J illustrate an exemplary method for performing a tissue repair using the repair construct illustrated in figure 10. A surgical opening can be formed through the skin 1000 and a cannula can be passed through it to access a surgical repair site according to well-known techniques. Similar to figures 5A-5H, although cannulas are often used to define a channel through which the procedure can be performed, the cannula is not shown in figures 11A-11J, for clarity of the illustration. Consequently, to the extent that the figures show components of the systems and devices that pass through the skin 1000, these components typically extend through the cannula which itself is passed through the skin 1000.
[00067] As shown in figure 11A, the handle assembly 20 can be attached to anchor 612 in the same way as that described above with respect to figure 9A. The insertion of the device 610, however, may be different because of the fish tail 617. In an exemplary embodiment for inserting the device 610 in a surgical site, an orifice 1002 is formed entirely through bone 1001 and the fish tail 617 is used as a means of displacement to place anchor 612 in the desired location. In the illustrated embodiment, fish tail 617 passes through an upper layer of skin 1000, through hole 1002, and exits through a lower layer of skin 1000. As shown in figure 11B, tension can be applied to fish tail 617 approximately in a J direction to pull anchor 612 through hole 1002 to the desired location. The handle assembly 20 can be used to counterbalance the force applied by the fish tail 617 by releasing a force in a direction approximately opposite the J direction to assist in the placement of the device 610. Although in the illustrated embodiment the fish tail 617 extends through of the lower layer of skin 1000, in other modalities it may remain in the body, but be only distal to the orifice 1002, which allows tension to be applied to help the displacement of anchor 612 to the desired location.
[00068] The device 610 can then be used in a manner similar to that described with reference to figures 9B-9H. In this way, tension can be applied to the handle assembly 20 in approximately a K direction to move the anchor from its non-tensioned configuration to its anchoring configuration. This tension causes deformation of anchor 612 and it substantially agglomerates with a larger diameter in the anchoring configuration. Again, in the illustrated embodiment, the agglomerated anchoring configuration is substantially spherical or like a closed fist for illustrative purposes, but a person skilled in the art will recognize numerous different configurations that anchor 612 can have in the anchoring configuration. When anchor 612 is positioned and in its anchoring configuration, it typically resides in a position distal to hole 1002, on the side of the hole in a position adjacent to the lower layer of fabric. At least a portion of the end end 24 can be passed through at least a portion of the tendon 1003 and through the opening 32 in the handle 30 and the handle 30 can be closed or adjusted for example by moving the knot that forms the handle 30 to away from terminal end 24. Handle 30 can be slid distally in the direction of tendon 1003 by applying tension in approximately an L direction, which can result in handle 30 being in a position adjacent to tendon 1003 and tendon 1003 if move in the direction of bone 1001. Final tensioning and removal of glove 50, if used, can occur and one or more half-lashings can be formed near closed loop 30 to allow for incremental or ratchet and / or tensioning maintain a location of the same. Then, the excess filament can be cut and removed to complete the procedure. Fish tail 617 can also be cut and removed. Although removal of fish tail 617 is illustrated in figure 11D, such removal can occur at any time after anchor 612 is moved to its desired location.
[00069] A person skilled in the art will recognize numerous different modifications that can be made to the soft anchor procedures discussed in the present invention, without departing from the spirit of the invention. By way of a non-limiting example, although the embodiments of the present invention illustrate the loop assembly 20 passing through the fabric in one location, in other embodiments, it can pass through two or more locations and / or two or more fabrics. By another non-limiting example, the loop assembly 20 can be coupled to the fabric using a variety of techniques, for example by wrapping a portion of the loop assembly 20 around the fabric. By another non-limiting example, a loop 30 may be passed through the fabric instead of or in addition to passing the end end 24 through the fabric. A pin or other fastening element can be placed through any coaxial sliding neck of the handle to prevent unintentional retraction in such a mode, or it can be included in any type of handle set, as an extra precaution. In addition, a person skilled in the art will recognize that the order of at least a few steps of the method provided here can be changed without departing from the spirit of the present description.
[00070] Additionally, the procedures discussed with respect to figures 4-11G are just some forms of procedures that can be performed in conjunction with the systems, devices and methods presented in the present invention. A person skilled in the art will recognize countless other ways in which the systems, devices and methods presented can be used in several other configurations and types of surgical procedures. For example, the systems, devices and methods presented in the present invention can be easily adapted to be used in conjunction with three or more components, such as multiple tissues and a bone or three or more soft tissues. Some non-limiting examples of other systems, devices, assemblies, constructs and surgical procedures with which the present systems, devices and methods can be used are described in US patent application serial number 13 / 218,810 filed on August 26, 2011 , and entitled "SURGICAL FILAMENT SNARE ASSEMBLIES", and in US Patent Application Serial No. 13 / 465,288 filed simultaneously thereto, and entitled "Systems, Devices, and Methods for Securing Tissue" [Attorney Summary No. 22956-970 (MIT5183USNP)] whose content was previously incorporated by reference to the present invention.
[00071] The person skilled in the art will appreciate other features and advantages of the invention based on the modalities described above. Consequently, the invention should not be limited by what has been particularly shown and described, except as indicated by the appended claims. In addition, although the systems, devices and methods provided in the present invention are generally directed to surgical techniques, at least some of the systems, devices and methods can be used in applications outside the surgical field. All publications and references cited herein are hereby expressly incorporated, by reference, in their entirety.

权利要求:
Claims (10)
[0001]
1. Surgical device for soft tissue repair, comprising: a soft anchor (312, 412, 612) configured to be fixed on the bone and formed of a flexible construct with a plurality of openings (318, 319, 416, 516) formed there, in which the soft anchor (312, 412, 612) has an unstressed configuration with a first length and a first diameter; and a loop assembly (20, 120, 220) having a first end (22) and at least one elongated filament extending therefrom, the elongated filament having an end end (24) opposite the first end (22), the set of handle being attached to the soft anchor (312, 412, 612) by the filament that passes through the plurality of openings (318, 319, 416, 516) so that the soft anchor (312, 412, 612) is in an intermediate location in the elongated filament between the first end (22) and the end end (24), where the soft anchor (312, 412, 612) and the handle assembly (20, 120, 220) are configured so that the soft anchor ( 312, 412, 612) can be configured again from the non-tensioned configuration for an anchoring configuration by applying tension to the filament, the soft anchor (312, 412, 612) having, in the anchoring configuration, a second length that is less than the first length and a second diameter which is greater than the prime the first diameter, characterized by the fact that the handle assembly comprises a retractable handle (30, 130, 230) at the first end (22), wherein a portion of the end end (24) is configured to pass through an opening (32 ) on the retractable handle (30, 130, 230) and the retractable handle is configured to be folded around the end portion of the terminal (24) and where the handle assembly is formed by a double filament loop, of so that the filament has first and second filament members (134, 136, 234, 236).
[0002]
2. Device according to claim 1, characterized by the fact that the soft anchor is a suture provided with a cannula (314) with a central lumen (316).
[0003]
Device according to claim 2, characterized in that a plurality of openings includes a first opening (318, 319) in a distal portion of the soft anchor and a second opening (318, 319) in a proximal portion of the soft anchor, in which the first and second openings communicate with the central lumen (316).
[0004]
4. Device according to claim 3, characterized by the fact that the filament passes into the second opening (318, 319), through the lumen (316), and out of the first opening (318, 319).
[0005]
5. Device according to claim 3, characterized by the fact that the first and second openings (318, 319) are on the same side as the soft anchor (312).
[0006]
6. Device according to claim 1, characterized in that the soft anchor includes a plurality of transverse holes (418) extending through it along the length of the soft anchor, and a plurality of openings (416) includes opposite paired openings with each opposite paired opening communicating with one of the transverse holes (418).
[0007]
7. Device according to claim 6, characterized in that the soft anchor includes at least four transverse holes (418) and the filament passes in and out of each transverse hole (418) through the opposite paired openings ( 416).
[0008]
8. Device according to claim 1, characterized by the fact that the soft anchor is a crochet suture anchor (514) and the filament extends through the openings (516) defined between filament members of the anchor of crochet suture along their length.
[0009]
9. Device, according to claim 1, characterized by the fact that the soft anchor, in its anchoring configuration, has a diameter that is at least 20% larger than the diameter in the non-tensioned configuration.
[0010]
10. Device according to claim 1, characterized by the fact that it still comprises a flexible sleeve (50, 150) that removably encapsulates at least a portion of the filament.

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同族专利:

公开号 | 公开日

US20160296222A1|2016-10-13|

EP2662030A1|2013-11-13|

BR102013011972A2|2015-10-13|

AU2013205726A1|2013-11-21|

JP2013233435A|2013-11-21|

CN103385741A|2013-11-13|

EP2662030B1|2017-03-01|

AU2013205726B2|2017-12-07|

CA2815758A1|2013-11-07|

US9345567B2|2016-05-24|

US10271833B2|2019-04-30|

US20190223857A1|2019-07-25|

US20130296934A1|2013-11-07|

CN103385741B|2018-06-26|

JP6279228B2|2018-02-14|

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法律状态:
2015-10-13| B03A| Publication of a patent application or of a certificate of addition of invention [chapter 3.1 patent gazette]|

2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

2019-11-19| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

2020-12-01| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

2021-02-02| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 07/05/2013, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

申请号 | 申请日 | 专利标题

US13/465,376|US9345567B2|2012-05-07|2012-05-07|Systems, devices, and methods for securing tissue using snare assemblies and soft anchors|

US13/465,376|2012-05-07|

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