construct for surgical repair

专利摘要:
Invention Patent SYSTEMS, DEVICES AND METHODS FOR ATTACHING TISSUE WITH THE USE OF A SUTURE THAT HAS ONE OR MORE PROTUBERANCES. The present invention relates to systems, devices and methods that are provided for attaching soft tissue to bone. An exemplary embodiment of a construct for surgical repair includes an anchor, a filament that has a loop formed at one end and a collapsible loop at the other end, and a suture that has a plurality of stationary protuberances formed at it. The suture is configured to be attached to the disconnected tissue and has its ends that pass through an opening in the loop. The loop can be collapsed around the suture so that at least one of the suture protuberances is proximal to the collapsed loop. The anchor can be arranged on the bone and on the filament attached to it. Consequently, collapsing the loop around the suture joins the tissue to the bone, and applying tension to a filament tensioning tip can collapse the collapsible loop to incrementally tighten and secure the tissue to the bone. Other exemplifying systems, devices and methods for use with soft tissue repair are also presented.
公开号:BR102013011238B1
申请号:R102013011238-0
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 invention relates to systems, devices and methods for attaching a soft tissue to a bone, and more particularly it relates to attaching a soft tissue using a suture that has one or more protuberances formed in it , while minimizing or eliminating the formation of knots to tension and secure the tissue. BACKGROUND
[0002] A common injury, specifically among athletes and elderly people, is the complete or partial disconnection of tendons, ligaments, or other soft tissues of the bone. Tissue shedding can occur during a fall, overexertion, or for a variety of other reasons. Surgical intervention is often necessary, particularly when the tissue is completely disconnected from its associated bone. Currently available devices for attaching tissues include screws, staples, suture anchors, and tacks. The devices currently available for elderly patients may be particularly insufficient due to soft and weak bones, leading to inadequate anchor suture fixation.
[0003] Arthroscopic knot tying is commonly practiced in rotator cuff procedures and shoulder instability. Typically, an anchor loaded with the suture is first attached to the bone. The suture is usually slidably attached to the anchor through a hole or around a column, so that a single suture length has two free ends. One end of the suture is passed through the soft tissue to be repaired 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 the loop is tightened, the soft tissue is brought to the bone through the anchor.
[0004] Surgeons typically tie the ends of the suture with the use of a sliding surgical knot like the Tennessee Slider or Duncan Loop. After advancing the knot distally to tighten the loop, several ends or other additional knots are tied in an effort to secure the new sliding knot location. Additional knots are required as a conventional sliding knot used in current repair constructs does not provide the necessary protection against loosening or slipping, specifically when tension is placed primarily on the ends of the loop. The generally accepted practice is to follow the sliding knot with at least three reverse ends in alternating columns of the suture.
[0005] Before one or more ties or other knots can be added to the sliding knot, however, there is a potential for the sliding knot to slip, that is, that the loop will widen as the fabric applies tension to the loop. This has been called "snare security" and can occur even in the hands of very experienced surgeons. Sometimes, even fully tied knots can slip. In addition to this "loop security" problem, conventional knots are typically of a general size that can be obstructive or intrusive, specifically in tight joints, which can damage cartilage or other tissues by abrasion with the knot.
[0006] Suture anchor systems with sliding and locking knots for repair of broken or damaged tissue include U.S. patent 6,767,037 issued to Wenstrom, Jr. Other suture anchor systems specifically suited for meniscal repair are presented in the US patent 7,390,332 attributed to Selvitelli et al. and are used in the OmniSpan ™ menis lime repair system, commercially available from DePuy Mitek Inc., 325 Paramount Drive, Raynham, Massachusetts 02767, USA. Threaded anchors usually require anchor fixation prior to suture operation, which can lead to challenges related to the connection between the suture and the tissue.
[0007] There are several suture implant systems that are said to be "free from knots", that is, that do not require a surgeon to tie a knot during surgery. Several of these systems control the tension in the tissue by the depth at which an anchor is forcibly inserted into the bone. US patents 5,782,864 and 7,381,213 issued to Lizardi have certain types of suture anchors that capture a fixed length loop of the suture. Knot-free anchor assemblies with adjustable loops that use an anchor element inserted into a sleeve are described by Thal in US patents 5,569,306 and 6,045,574 and in US patent application publication 2009/0138042. Other systems that have claws or other locking mechanisms include US patent 5,702,397 issued to Goble et al. and the publication of the North American patent application 2008/0091237 attributed to Schwartz et al. Currently, designs called "knot-free", however, generally suffer from inadequate anchor suture fixation and / or inadequate anchor to bone fixation, among other deficiencies.
[0008] Therefore, it is desirable to obtain systems, devices and methods for use in soft tissue repair that are robust, strong, and optimize "loop security", yet still minimize or eliminate the number and size of nodes to be used. be tied by a surgeon, particularly during arthroscopic repair procedures. SUMMARY
[0009] Systems, devices and methods are generally provided for attaching soft tissue to bone. In an exemplifying embodiment, a surgical repair construct includes an anchor, a filament that has a collapsible loop formed at one end of it, and a collapsible loop at a second end of it, and a suture that has a plurality of stationary protuberances formed in it in a spaced arrangement. The anchor may include a filament engagement feature and may be able to be attached to a bone. The filament and the suture are both capable of being passed through the soft tissue to be repaired. An opening in the loop of the filament can be configured to receive the suture so that the loop is slid in relation to the suture and collapsible around the suture. The collapsible loop of the filament can be coupled with the engagement feature of the anchor filament, and the loop can include a sliding knot with a tensioning tip extending from it. The tensioning tip can be effective for collapsing the collapsible loop regardless of the loop. In addition, the collapsible loop may be able to be tightened incrementally to secure the soft tissue to the bone.
[00010] The loop can have a variety of configurations and can be produced in several ways. In some embodiments, the loop can be configured by passing the end of the filament through an adjacent portion of the filament. The end end may include a protuberance that maintains the end end within the portion of the filament through which it is arranged. In some other embodiments, the loop can be configured by a second sliding knot that is effective in collapsing the loop. In still other embodiments, the loop may include a coaxial sliding neck that is effective in collapsing the loop. In addition, a flexible element can be removably positioned on a portion of the loop to prevent unintentional loop collapse, and when the loop includes a coaxial sliding neck, the flexible element can be removably disposed through it to immobilize the loop. coaxial sliding neck. The filament can be a cannulated surgical filament or a braided suture filament. Additionally, in embodiments that include a flexible element, the flexible element can be formed from a second filament. A thickness of the second filament can be in the range of about 25 gauge to about 40 gauge, while a thickness of the one or both filaments that form the collapsible loop and the collapsible loop can be in the range of about 20 gauge to about 34 gauge. The diameter of the suture protuberances can be in the range of about 0.5 millimeters to about 2 millimeters.
[00011] In an exemplary embodiment of a surgical repair method, the method includes passing a first end of a suture that has formed a plurality of stationary protuberances through and / or into the tissue. The first end of the suture can be passed through the tissue so that the first and second ends of the suture extend from the first side of the tissue. The suture can be arranged in the tissue so that at least one of the protuberances is disposed adjacent to at least one of the first and second sides of the tissue. In one embodiment, at least one lump is disposed adjacent to the first side of the tissue. The method may also include inserting an anchor into the bone close to the disconnected soft tissue. The anchor may have a filament engagement feature to which a filament is attached, and the filament may have a collapsible loop formed at one end and a collapsible loop at its second end, the collapsible loop being coupled to the filament engagement feature. The collapsible loop can include a sliding knot with a tensioning tip that extends therefrom, and the tensioning tip can be effective in collapsing the collapsible loop independent of the loop. The method may also include insertion of the first and second ends of the suture through an opening formed in the loop, sliding the loop distally towards the fabric and distally in addition to at least one protuberance arranged on the first side of the fabric, collapse of the loop at the around the first and second ends of the suture, and pulling the loop towards the anchor by shrinking the collapsible loop and, thus, placing the tissue in close proximity to the bone.
[00012] In some embodiments, the loop pulling step towards the anchor by shrinking the collapsible loop may include tensioning of the tensioning tip. In such embodiments, the loop can be incrementally advanced without loosening the filament. The suture can include at least four lumps. In some modalities, the loop can be positioned between at least one protuberance and the fabric, while in some other modalities the loop can be positioned between at least two protuberances and the fabric. Optionally, a flexible element can be arranged on a portion of the loop to prevent unintentional collapse. In such embodiments, the flexible element can be removed from the loop before the loop collapses. The methods provided here can be performed without creating a node. BRIEF DESCRIPTION OF THE DRAWINGS
[00013] The present invention will be fully understood from the following detailed description taken in conjunction with the attached drawings, where:
[00014] Figure 1 is a schematic view of an exemplary modality of a surgical repair construct disposed in a surgical site;
[00015] Figure 2 is a schematic view of an exemplary embodiment of a filament attached to an anchor for use as part of a surgical repair construct;
[00016] Figure 3 is a close view of a portion of the filament of Figure 2, illustrating the formation of a loop using the filament;
[00017] Figure 4 is a schematic view of a filament attached to an anchor of the surgical repair construct of Figure 1;
[00018] Figures 5A to 5D are sequential views of an exemplary modality for forming a loop from a filament in which the loop has a coaxial sliding neck;
[00019] Figure 6 is a schematic view of an exemplary embodiment of a loop formed from a filament, and a flexible element in which the loop has a coaxial sliding neck and the flexible element is arranged through the loop;
[00020] Figure 7A is a schematic view of another exemplary embodiment of a loop formed from a filament and a flexible element in which the loop has a coaxial sliding neck, this view illustrating how the flexible element can be arranged through the neck and loop;
[00021] Figure 7B is a schematic view of the loop and the flexible element of Figure 7A, illustrating the flexible element arranged through the neck and the loop;
[00022] Figure 8 is a schematic view of a suture of the surgical repair construct of Figure 1; and
[00023] Figures 9A to 9E are sequential views of an exemplary modality that uses the surgical repair construct of Figure 1 to attach tissue to a bone. DETAILED DESCRIPTION
[00024] Certain exemplary modalities will now be described to provide an overall understanding of the principles of structure, function, manufacture and use of the devices and methods presented in the present invention. One or more examples of such 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 characteristics illustrated or described in relation to an exemplary modality can be combined with the characteristics of other modalities. These modifications and variations are intended to be included within the scope of the present invention. In addition, in the present description, components of the similarly numbered modalities have, in general, similar characteristics, and therefore within a specific modality each characteristic of each similarly numbered component is not necessarily fully elaborated. In addition, to the extent that linear or circular dimensions are used in describing the systems, devices and methods presented, such dimensions are not intended to limit the types of formats that can be used in conjunction with such systems, devices and methods. One skilled in the art will recognize that an equivalent to such linear and circular dimensions can be easily determined for any geometric shape. The sizes and formats of the systems and devices, and the components thereof, 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 on which the systems and devices will be used, and the methods and procedures in which the systems and devices will be used.
[00025] The Figures presented here are not necessarily to scale. Furthermore, to the extent that arrows are used to describe a direction in which a component can be tensioned or pulled, these arrows are illustrative and are not intended to limit the direction in which the respective component can be moved. One skilled in the art will recognize other trajectories and directions for creating the desired effect. In addition, several terms can be used interchangeably throughout the description, but will be understood by one skilled in the art.
[00026] Soft tissue repair systems, devices and methods are generally provided with and generally involve the use of surgical filaments and sutures that are configured in a variety of ways to minimize and / or eliminate the formation of knots during a surgical procedure. . The systems and devices described here provide superior strength for use in a number of different surgical procedures, such as rotator cuff repair and instability procedures, and other types of tendon and tissue repair procedures. The systems and devices provided here also allow for both improved and new procedures for soft tissue repair. For example, the systems and devices provided here can be used to advance the tissue towards the bone in an incremental manner without loosening the construct. Reducing and / or eliminating loosening during advancement can prevent the size of the collapsible loop from increasing, and prevent the tissue from moving away from the bone and / or not being held tightly in place in relation to the bone due to loosening . In addition, the systems and devices allow a surgeon to secure a tissue site without a knot forming during the procedure.
[00027] As shown by an exemplary embodiment of a surgical repair construct 10 in Figure 1, the constructs of the present description generally include a filament 20 that forms a loop 50 at the first end 22 thereof and a collapsible loop 30 in a second end 24 thereof, a suture 70 having one or more stationary protuberances 72 formed therein, and an anchor 90 coupled to the collapsible loop 30, for example to an engagement feature 92 of anchor 90. In the illustrated embodiment, the anchor 90 is arranged on bone 100, suture 70 is passed through the soft tissue, for example a tendon 102, and loop 50 is slid in relation to suture 70 and collapsed around a portion of suture 70 to join bone 100 and tendon 102 through the surgical repair construct 10. As will be described in more detail below, loop 50 can start outside the body and be moved distally (for example, towards bone 100) so that it is distal in with respect to at least one of the protrusions 72. Loop 50 can subsequently be collapsed so that protrusions 72 prevent loop 50 from loosening in a proximal direction (for example, away from bone 100), which would allow the tissue to move away from the bone. Filament 20 may further include a sliding knot 36 at a first end 32 of loop 30, which can be moved distally towards a second end 34 of loop 30 to collapse a size of an aperture 38 formed by loop 30, applying thus a force to pull tendon 102 towards bone 100. A collapsible tail or tensioning tip 40 can extend from sliding knot 36 and can be operable to move sliding knot 36 towards the second end 34 in a manner similar to a ratchet or incremental, to attach tendon 102 to bone 100. The movement of loop 50, including collapse of loop 50, and the movement of collapsible loop 30, including tensioning the tensioning tip 40, can be independent each other's.
[00028] The filaments for use in a surgical repair construct can have a variety of configurations, some of which are described in more detail below. In general, the filaments have a portion for attaching a separate suture attached to the tissue, here illustrated as a loop, and a portion, here illustrated as a collapsible loop, which is attached to the bone and to which tension can be applied to move the tissue towards the bone. In operation, attaching the separate suture joins the tissue to the filament and collapsing the loop towards the bone moves the tissue towards the bone.
[00029] Figure 2 provides an exemplary embodiment of a 120 filament for use as part of a surgical repair construct. A first end 122 of filament 120 may include a loop 150 that is configured to be collapsed under tension, a second end 124 of filament 120 may include a collapsible loop 130 that is configured to be collapsed under tension, independent of loop 150, and a neck 123 that can extend between the first and second ends 122, 124. Filament 120 having both a loop 150 and a collapsible loop 130 can be called a loop assembly.
[00030] Loop 150 can be formed in a variety of ways known to those skilled in the art, some of which are discussed in greater detail below. In the illustrated embodiment, loop 150 is formed by passing a portion of filament 120 through itself. In addition, a protrusion 129 may be formed at a terminal end 128 of filament 120, adjacent to loop 150, to prevent pulling and resist fraying, particularly if filament 120 is a braided filament. The protuberance 129 may be preformed, or it may be formed by a surgeon, for example by forming a cap or other simple knot.
[00031] Figure 3 illustrates one of the several ways that loop 150 can be formed. As shown, an initial end 126 of filament 120 can be passed through an opening 127 of filament 120 to form a collapsible opening 152 of loop 150. Opening 127 can be preformed and collapsible, or alternatively, it can be part of the construct of filament 120, as an opening due to filament 120 being braided. The starting end 126 can be used to form the other portions of filament 120, including collapsible loop 130, a sliding knot 136, and a tensioning tip 140, which are described in more detail below, for example by forming loop 130 and the sliding knot 136 at the tensioning tip 140. In this arrangement, any tension applied to the neck 123, such as by pulling the tensioning tip 140, not only collapses the loop 150 to strangle the objects that pass through it, but also ties the portion of filament 120 through the opening 127 over itself. In other arrangements, a cap or other simple knot can be tied adjacent to the opening, and filament 120 can be looped through this simple knot.
[00032] Loop 130 can similarly be formed in a variety of ways known to those skilled in the art, some of which are discussed in greater detail below. In the embodiment illustrated in Figure 2, loop 130 has a first and second ends 132, 134, with a sliding knot 136 formed at the first end 132. As shown, the second end 134 can be slidably coupled to an anchor 190, for example example to a coupling characteristic 192 thereof, such as a saddle or column. At the same time that in the illustrated embodiment, the coupling characteristic 192 is located at a distal end 190d of anchor 190, it can be located anywhere in anchor 190 and this allows filament 120 to be slidably connected to anchor 190 .
[00033] Collapsible loop 130 can be expanded and collapsed as desired by sliding knot 136. Consequently, when loop 130 is coupled to the fabric, for example by having a suture arranged through loop 150 of filament 120 forming loop 130 , collapsing loop 130 creates a force that moves the fabric toward a desired location. As shown in Figure 2, as the sliding node 136 is moved towards the second end 134, the loop 130 is collapsed, and as the node 136 is moved away from the second end 134, the size of an opening 138 of the loop 130 increases . Sliding knot 136 can be formed in a variety of ways and using a variety of techniques well known to those skilled in the art. Non-limiting examples of the types of knots that can be used as the sliding loop knot include a sliding knot, a Tennessee Slider, a Duncan Loop, a gallows knot, and a loop that has a coaxial sliding neck. The type of node selected can affect the way in which loop 130 can be collapsed, and one skilled in the art will recognize how to collapse the loop based on the type of node used.
[00034] As shown in Figure 2, loop 130 can also be a collapsible tail or tensioning tip 140 that extends from sliding node 136. tensioning tip 140 can be an end end of a used filament tip 120 to form the sliding node 136 that completes the collapsible loop 130. The tensioning tip 140 can be operable to tension and collapse the loop 130 by moving the sliding node 136 towards the second end 134 of the loop. More particularly, applying tension to the tensioning tip 140 approximately in the direction A can cause the knot 136 to slide distally towards the second end 134. As a result, the sliding knot 136 can move in a manner similar to a ratchet or incrementally, so that the knot 136 moves towards the second end 134 with little or no loosening, which in turn minimizes or prevents the opening 138 of the collapsible loop 130 from increasing in size. When tension is not applied, the location of the sliding node 136 remains substantially fixed, and additional tensioning of the tensioning tip 140 can cause additional distal movement of the node 136 until either the tension is released or an obstruction prevents further distal movement of the node 136. The self-locking capabilities provided by this sliding knot 136 which results from the general formation of a surgical repair construct including filament 120 are beneficial, at least due to the ability to incrementally advance knot 136 with little or no loosening. . Even more in addition, in some embodiments, a second stationary tail or tail can also be formed and can be used, for example, to assist the passage of the filament through the fabric, providing additional resistance to repair, and / or in carrying out various procedures. surgical procedures, such as double-row procedures.
[00035] With reference to Figure 3, an example of the manufacturing steps of the loop assembly formed by filament 120 is as follows. The protrusion 129 can be formed at the end end 128 by tying a knot and a tail at an end end of the same can be trimmed. The starting end 126 can be looped and passed through itself in opening 127, in close proximity to hump 129, to form opening 152 in loop 150. Alternatively, a second cap can be tied in close proximity to hump 129, and the starting end 126 can be passed through the second cap to form the opening 152 in loop 150. A flexible element, such as a filament or suture (discussed in more detail below with respect to Figures 6, 7A and 7B), or other objects, including, but not limited to, a mandrel or slender pin, can be placed through loop 150 to maintain clearance. The sliding knot 136, like a sliding knot, can be tied in close proximity to the loop 150 and the filament 120 can be placed in sliding latch with an anchor latch characteristic. Sliding knot 136 can subsequently be coated or finished as desired, including in the ways described herein.
[00036] Figure 4 provides another exemplary embodiment of a 120 'filament for use as part of a surgical repair construct. Similar to filament 120, a first end 122 'of filament 120' may include a loop 150 'having an opening 152' that is configured to collapse under tension, a second end 124 'of filament 120' may include a collapsible loop 130 'which is configured to be collapsed under tension, independent of loop 150', and a neck 123 'which can extend between the first and second ends 122', 124 '. The filament 120 'which has both a loop 150' and a collapsible loop 130 'can be called a loop set.
[00037] Loop 150 'can be formed in a variety of ways known to those skilled in the art, some of which are discussed in greater detail below. In the illustrated embodiment, loop 150 'is formed by means of a sliding knot 156', as, by way of non-limiting examples, a sliding knot, a Tennessee Slider, a Duncan Loop, a gallows knot, and a loop that it has a coaxial sliding neck. Although the type of sliding knot affects the relative movement of knot 156 'and filament 120' relative to the direction, one or the other is moved to expand or collapse loop 150 ', as described here, except where otherwise indicated, a knot used to form a loop is movable away from the second end 124 'of filament 120', that is, away from the collapsible loop 130 ', to collapse the loop 150' and towards the second end 124 ', that is, towards the collapsible loop 130 ', to increase a loop size 150'. One skilled in the art would be able to adapt the teachings of the present invention based on the type of sliding knot used in conjunction with the 150 'loop.
[00038] Figures 5A to 5D illustrate one of the several ways in which the loop 150 'can be formed. As shown, loop 150 'is formed from a bifurcated suture filament that has a tubular portion 153' with a core removed from it to form a cannulated portion 154 ', and a first and second end points 156', 158 ' . As shown in Figure 5B, the end tips 156 ', 158' can be curled backwards towards the tubular portion 153 'to form a loop having an opening 152' that defines the loop 150 '. As shown in Figure 5C, a hole 160 'can be formed on one side of the tubular portion 153' and the end tips 156 ', 158' can be placed on the cannulated tubular portion 154 'through the hole 160'. The ends of the end tips 156 ', 158' can be fed through the cannulated portion 154 ', and as shown in Figure 5D, the end tips 156', 158 'can be pulled distally (direction B in Figure 5D) through the tubular portion 153 ', so that the tubular portion 153' is fed through itself and a coaxial sliding neck 155 'that can slide relative to the tubular portion 153' of the filament is formed. Consequently, the loop 150 'can be collapsed by tensioning the tips 156', 158 'and / or the coaxial sliding neck 155' in approximately the first direction B, and the loop 150 'can be expanded by applying a force to the yarn 150 'approximately in the second opposite C direction, which pulls the ends 156', 158 'and the coaxial sliding neck 155' towards the yarn 150 '. Passing the filament through itself to form a coaxial sliding neck allows the filament to have a low profile, which minimizes the amount of space that the construct occupies in the body and minimizes and / or eliminates the trauma associated with passage of the filament through the fabric.
[00039] Loop 130 'can similarly be formed in a variety of ways known to those skilled in the art, some of which are discussed in greater detail below. In the illustrated embodiment of Figure 4, loop 130 'has a first and second ends 132', 134 'with a sliding knot 136' formed at the first end 132 '. As shown, the second end 134 'can be slidably coupled to an anchor 190', for example to an engagement feature 192 'thereof, such as a saddle or column. While in the illustrated embodiment the engagement feature 192 'is located at a distal end 190d' of anchor 190 ', it can be located anywhere on anchor 190' and allows filament 120 'to be slidably connected to the anchor 190 '.
[00040] Collapsible loop 130 'can be expanded and collapsed, as desired, by sliding node 136', in a similar manner to that described in relation to sliding node 136 of loop 130. Additionally, as shown in Figure 4, loop 130 'may include a collapsible tail or tensioning tip 140' which extends from the sliding knot 136 'and may operate in a similar manner to that described in relation to tensioning tip 140. In this way, loop 130' of filament 120 ' it can move in a ratchet-like or incremental manner, so that node 136 'moves towards the second end 134' with little or no loosening, which in turn minimizes or prevents the opening of the collapsible loop 130 'increase in size. Even more in addition, in some embodiments, a second stationary tail or tail may also be formed and used in a manner similar to that described in relation to filament 120.
[00041] Filaments 120, 120 'can be of any suitable suture material such as a cannulated filament, a braided filament, and a mono filament. The type, size and strength of the filament may depend, at least in part, on other materials in the system, including the material (s) of any sutures attached to it, any obstructions through which the filament may pass, and the type of procedure in which it is used. In an exemplifying embodiment, the filament is formed from a # 0 filament (from about 26 gauge to about 27 gauge), such as an Orthocord ™ filament that is commercially available from DePuy Mitek, Inc, or a filament Ethibond ™ available from 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 # 4 filament (from about 21 gauge to about 22 gauge) and about a # 4-0 filament (from about 32 gauge to about 34 gauge) . Orthocord ™ # 2 filament can be useful as it has a braided configuration, which allows other components, including the filament itself and flexible elements as discussed below, to pass through subcomponents of the braid without causing damage to the filament. Filaments configured to allow a cannulated configuration, such as removing a core from it or having a preformed cannulated configuration, can also be used. 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 is ultra high molecular weight polyethylene, while the Ethi- bond ™ suture it is primarily high-strength polyester. The amount and type of bioabsorbable material, if any, used in the filaments of this description is primarily a case of surgeon's preference for the specific surgical procedure to be performed.
[00042] A length of the filament can be in the range of about 2 centimeters to about 60 centimeters, and in one embodiment it can be about 40 centimeters. Even more in addition, a diameter of the sliding knot of the loop will depend, at least in part, on the size of the filament used to form it, the type of sliding knot it is, and the type of procedure in which it will be used. In an exemplary embodiment, a diameter of the sliding knot of the loop can be in the range of about 0.5 millimeters to about 2 millimeters, and in one embodiment it can be about 1 millimeter. Similarly, if the loop is formed from a sliding knot, its diameter will also depend, at least in part, on the size of the filament used to form it, the type of sliding knot it is, and the type of procedure on which it will be used.
[00043] Although in the modalities described above the loop and the collapsible loop are formed from the same filament, in other modalities each component can be formed from a separate filament. Exemplary systems, devices and methods related to such configurations involving the formation of loops and loops from a single filament or more than one filament are described, at least, in U.S. Patent Application Serial No. 13 / 218,810, filed on August 26, 2011, and entitled "SURGICAL FILAMENT SNARE ASSEMBLIES", and in U.S. Patent Application Serial No. 13 / 465,288, filed on the same date, and entitled "Systems, Devices, and Methods for Securing Tissue "[Attorney Summary No. 22956-970 (MIT5183USNP)], the contents of which are incorporated herein in their entirety, by way of reference.
[00044] Due to the fact that the loop of the filament can either expand or contract, a flexible element, such as a suture pin, can be removably arranged along the neck to prevent unintentional movement of the loop. An exemplary embodiment of a flexible element 180 '' associated with a neck that slides coaxially 155 '' from a loop 150 '' of a filament 120 '' is shown in Figure 6. As shown, the flexible element 180 '' can extend along filament 120 '' to immobilize the neck that slides coaxially 155 '' with respect to a 154 '' portion of filament 150 '' through which it is passed. When the surgeon wants to collapse the loop, the flexible 180 '' element can be removed. The use of a flexible element of the type described here to prevent unintentional loop collapse in tissue repair procedures is advantageous, as it can prevent unintentional loop collapse during procedures, including in cases where the loop is passed through through obstructions, like a tissue.
[00045] In another embodiment, shown in Figures 7A and 7B, a flexible 180 '' 'element can immobilize a 150' '' loop of a filament and serve as a suture shuttle to guide the filament through the obstructions, like a tissue during the course of a procedure. As shown in Figure 7A, a first end 182 '' 'of flexible element 180' '' can be passed through the filament, including a cannulated portion 154 '' 'and a neck that slides coaxially 155' '' of the filament, so that a first portion of the flexible element 180 '' 'is arranged through the neck that slides coaxially 155' '', while a second end 184 '' 'of the flexible element 180' '' is passed through and is arranged in the loop 150 ' '' A 186 '' 'protuberance, for example a stationary knot that can be preformed or formed or modified during a procedure, can be arranged on flexible element 180' '' at a location between the first and second ends 182 ' '' 184 '' '. The protrusion 186 '' 'can serve to hold the flexible element 180' '' in an arrangement coupled with the filament, and as shown in Figure 7B, the protrusion 186 '' 'can be arranged inside the opening or loop 152' '' formed by the loop 150 '' ', which is contiguous to a loop surface, with a terminal portion 188' '' extending through and beyond loop 152 '' 'for use as a shuttle. Optionally, a needle, or similar tool or device, can be coupled to the 188 '' 'end portion to assist in passing the 120' '' filament through the fabric.
[00046] Other configurations in which a flexible element is used such as both a suture pin and a suture shuttle are also possible, depending, at least in part, on the configuration of the filament and the obstructions through which the filament will be passed, without deviate from the spirit of this description. For example, the flexible element 180 '' 'can be arranged through another portion of the neck that slides coaxially 155' '' or a different portion of the loop 150 '' '. A benefit of using a flexible element for both loop shape maintenance and filament conduction is that it can optimize filament maintenance by limiting the number of filaments used in a procedure. Additionally, such a construct allows a single action to remove both the pin and the hook from the filament, such as attaching the flexible 180 '' 'element between the stationary knot and the coaxially sliding neck 155' '' to uncouple the flexible element 180 '' 'of the filament. In still other embodiments, a flexible element can be used primarily for the purpose of conducting the filament and / or a flexible element can be used as a suture pin and a second flexible element can be used as a suture shuttle.
[00047] The flexible element (s) can be produced from a variety of materials, but in an exemplary embodiment it is a surgical filament that is separated from the filament that forms the loop and loop collapsible. In some modalities, the flexible element is formed using a surgical filament, such as a cannulated filament, a braided filament, and a mono filament. The type, size and strength of the filament may depend, at least in part, on the other materials in the system, including the filament material (s) through which it will pass, the obstructions through which the loop will pass, how the filament is being used (for example, as a suture pin, or a suture shuttle, or as a suture pin and suture shuttle set), and the type of procedure in which it is used. In an exemplifying embodiment, the flexible element is formed from a # 2-0 filament (about 28 gauge), such as an Orthocord ™ filament that is commercially available from DePuy Mitek, Inc., or an Ethiopian filament bond ™ available from Ethicon Inc. In general, the flexible element is relatively thin to minimize any trauma to the tissue through which it passes, and typically the flexible element is thinner than the filament through which it passes. In some embodiments, the flexible element can be between about a # 1 filament (from about 25 gauge to about 26 gauge) and about a # 6-0 filament (from about 38 gauge to about 40 gauge) ). A length of the flexible element can be in the range of about 1 centimeter to about 100 centimeters. In an embodiment in which the flexible element is only being used as a suture pin, it can be about 2 centimeters long. In a modality in which the flexible element is used as both a suture pin and a suture shuttle, it can be about 100 cm long.
[00048] Figure 8 illustrates an exemplary embodiment of a suture 70 for use as part of the surgical repair construct 10. The suture is, in general, a flexible element that has one or more stationary protuberances 72 formed therein. The protrusions 72 may have a spaced arrangement, may be preformed by the suture manufacturer, or alternatively, a surgeon may form one or more of the protrusions 72 before or during a surgical procedure. Different spaced arrangements can be used for different procedures, with the spaced relationship based, at least in parts, on the other components of the surgical repair construct 10, the tissue (s) that will be attached to the suture 70, and the type of procedure being performed. In the illustrated embodiment, there are four protrusions 72 approximately equidistant from each other, although any number of protrusions, including by way of non-limiting example six, in any form of spaced relationship may be used. The protrusions 72 can be used to assist in grasping the soft tissue for repair, to help prevent the collapsed loop 50 of filament 20 from loosening and to provide additional resistance to tissue attachment to bone.
[00049] The person skilled in the art will appreciate that protuberances 72 can be formed by placing a knot in suture 70, or by fixing another object to suture 70.
[00050] The suture can be produced from any suitable suture material, such as a cannulated filament, a braided filament, and a mono filament. The type, size and strength of the filament may depend, at least in part, on other materials in the system, including the material (s) of the filament to which it will be attached, the fabric (s) through which it will be attached. the suture will pass, and the type of procedure in which it is used. In an exemplary embodiment, the suture is formed from a # 2 filament (23 to 24 gauge), such as an Orthocord ™ filament that is commercially available from DePuy Mitek, Inc., or an Ethibond ™ filament available from to Ethicon, Inc. In general, the suture is relatively thin to minimize any trauma to the tissue through which it passes. In some embodiments, the suture may have a size between about a # 5 filament (about 20 gauge) and about a # 4-0 filament (from about 32 gauge to about 34 gauge). The length of the suture can be in the range of about 10 centimeters to about 120 centimeters, and in one embodiment the suture is about 90 centimeters long. Even more in addition, a diameter of the protrusions can be in the range of about 0.5 millimeters to about 2 millimeters, and in one embodiment the diameter of each of the protrusions is about 1 millimeter. In addition, a length of one space between each protrusion can be in the range of about 1 millimeter to about 10 millimeters, and in one embodiment the length of the space between each protrusion is about 5 millimeters. The diameters of the protuberances along a length of the suture and a length of a space between each of the protuberances can all be the same, or they can vary from protuberance to protuberance.
[00051] An exemplary method for performing a rotator cuff repair using the repair construct 10 illustrated in Figure 1 is illustrated schematically in Figures 9A to 9E. A surgical opening can be formed through the skin 104 and a cannula can be passed through it to create 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 9A to 9E for ease of illustration. Consequently, in that the Figures show components of the systems and devices that pass through the skin 104, these components would typically extend through the cannula, which itself is passed through the skin 104. Additionally, although the devices and methods described here are particularly useful for minimally invasive surgery, such as arthroscopic surgery, they can also be used in open surgical procedures.
[00052] As shown in Figure 9A, suture 70 can be passed through a tendon 102 disconnected from bone 100, so that at least one of the protuberances 72 is disposed adjacent to at least one side of the tendon 102. In the illustrated embodiment, two protuberances 72 are located proximal to tendon 102, while two protuberances 72 are arranged within tendon 102. Although not shown, it is understood that one or more protuberances may be formed on the distal side of tendon 102, rather than within the same. Suture 70 can be passed completely or partially through the tissue using various techniques known to those skilled in the art, including coupling a needle, or similar tool or device, to one of the terminal ends 74 of suture 70 to assist in the passage of the suture 70 through tendon 102. In an exemplary embodiment, one of the terminal ends 74 is passed through tendon 102 from a first (proximal) side of tendon 102 facing the opposite side of adjacent bone 100, and back through tissue from a second (distal) side of tendon 102 towards bone 100, so that the first and second ends 76, 78 of suture 70 extend from the first side of tendon 102, that is, proximal to the tendon 102. Suture 70 can be manipulated by a surgeon in relation to tendon 102 to expose as many lumps 72 as desired. Lumps 72 located proximal to and adjacent to tendon 102 can be used to help maintain a collapsed loop location 50, as well as to accommodate variations in tissue thickness and small size (that is, the distance between locations in the ends of the suture enter the tissue). In one embodiment, it is particularly useful to have at least two lumps fully exposed in close proximity to tendon 102. One skilled in the art will recognize that there are other ways in which suture 70 can be attached to or guided through tendon 102, including , as a non-limiting example, wrap suture 70 around tendon 102 so that at least one of the protuberances 72 is proximal to tendon 102. Additionally, the suture can be passed through the tissue (for example, tendon 102) through of a variety of techniques and guidelines known to those skilled in the art.
[00053] As shown in Figure 9B, anchor 90 can be fixed to bone 100 using common techniques, such as with a wrench to thread or hold anchor 90 in place. In the illustrated embodiment, the filament 20 is already coupled to the coupling characteristic 92, although in other embodiments the filament 20 can be slidably coupled to the anchor 90 after the anchor 90 is positioned in its desired location. As shown, filament 20 includes loop 50, collapsible loop 30, sliding knot 36, and collapsible tail or tensioning tip 40.
[00054] As shown in Figure 9C, the end ends 74 of the first and second ends 76, 78 of suture 70 can be passed through the opening 52 of loop 50, thus placing tendon 102 in a position to be coupled to filament 20 Loop 50 can then be advanced distally towards bone 100, for example by sliding loop 50 along suture 70, until loop 50 is distal to at least one of the protuberances 72 and proximal to the tendon 102. As shown in Figure 9D, loop 50 can be advanced distally with respect to the two protuberances 72, and is located approximately adjacent to tendon 102. In other embodiments, loop 50 can be advanced distally with respect to three or more protuberances 72. Various techniques known to those skilled in the art can be used to advance the loop 50 distally, including the use of a propelling tool or advancing it by hand.
[00055] After loop 50 has been advanced distally beyond at least one of the protrusions 72 and to its desired location, loop 50 can be collapsed or covered in a manner consistent with its loop type. Collapsing loop 50 around the suture joins tendon 102 to filament 20 and directs it to bone 100. In some embodiments, a flexible element may be arranged through loop 50 to prevent unintentional collapse of loop opening 52. In In such embodiments, the flexible element can be removed before the loop collapses or covers. Additionally, although in the illustrated modality the loop 50 is collapsed after being advanced distally beyond at least one of the protrusions 72, in other modalities the loop 50 can be at least partially collapsed before advancing it completely in the distal direction, as long as the opening 52 in loop 50 is still configured to allow at least one of the protrusions 72 to pass through it.
[00056] As shown in Figure 9E, tension can be applied to the tensioning tip 40 by pulling it approximately in a D direction, thus causing the sliding knot 36 to advance distally towards the bone 100 to decrease an opening size 38 of the collapsible loop 30, that is, shorten the collapsible loop 30. This movement also applies additional tension to the suture 70 because it is coupled to the filament 20, and in turn places the tendon 102 in proximity to the bone 100. The configuration of filament 20 in conjunction with suture 70 allows the node 36 to be advanced in an incremental, ratchet-like manner, when the tensioning tip 40 is pulled in the D direction, without the risk of reversing the progress of the node 36 as a result sliding backward, sometimes called recoil, loosening, or relaxation of the filament. Optionally, as shown, excess portions of the terminal ends 74 of suture 70 proximal to protrusions 72 can be trimmed and removed. Similarly, an excess portion of the tensioning tip 40 can also be trimmed and removed if desired. In embodiments in which the filament includes a stationary tail or terminal tip adjacent to the tensioning tip, excess portions of this tip can be trimmed and removed in a similar manner, if desired. Even further, optionally, one or more ends can be added to filament 20, for example at the tensioning tip 40, suture 70, or at the stationary endpoint if such a tip exists, to provide additional strength when filament 20 and the suture 70 were finally positioned to bring the fabric closer together. In addition to the optional finishes, no knots need to be formed during the course of the illustrated procedure.
[00057] The resistance to rupture resulting from the fixation formed can be in the range of about 50 Newtons to about 200 Newtons, without the formation of any finishes, and in one embodiment the resistance to rupture can be about 130 Newtons, without the formation of any finishes. The use of tailings typically increases the load capacity.
[00058] The procedure discussed with respect to Figures 9A to 9E is just one example of a procedure that can be performed in conjunction with the systems, devices and methods presented here. One skilled in the art will recognize numerous other ways in which the systems, devices and methods presented can be used in various other configurations and types of surgical procedures. For example, although filament 20 of Figures 9A to 9E is coupled to an anchor, in other embodiments, no anchor can be used and, instead, constructs for repairing the nature presented here can be coupled directly to the bone without an anchor. Alternatively, the nature repair constructs presented here can be used to put two or more fabrics together, passing a filament of a construction through a fabric, a suture that has one or more stationary protuberances formed in it over a second tissue, and the operation of the construct in a manner consistent with the teachings of the present invention. In addition, systems, devices and methods 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 tissue components. 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 U.S. Patent Application Serial No. 13 / 218,810, filed on August 26, 2011, and entitled "SURGICAL FILAMENT SNARE ASSEMBLIES", and in US patent application serial number 13 / 465,288, filed on the same date, and entitled "Systems, Devices, and Methods for Securing Tissue "[Attorney Summary No. 22956-970 (MIT5183USNP)], the contents of which were previously incorporated herein in their entirety, by way of reference.
[00059] The person skilled in the art will appreciate additional 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. By way of non-limiting example, although the embodiments described here include a loop formed at a first end of the filament, other components that have similar functionality can be associated with the first end of the filament, such as a clamp or similar element for attaching a portion of the suture. In addition, although the systems, devices and methods provided here are generally intended for surgical techniques, at least part 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 (12)
[0001]
1. Surgical repair construct, characterized by the fact that it comprises: an anchor (90, 190, 190 ’) capable of being fixed to the bone and which has a filament hitch characteristic (92, 192, 192’); a filament (20, 120, 120 ') capable of being passed through a soft tissue to be repaired and which has a collapsible loop (50, 150, 150') formed at its first end and a collapsible loop (30, 130, 130 ') at a second end of the same and coupled to the filament hitch feature, the collapsible loop (30, 130, 130') including a sliding knot (26, 136, 136 ') with a tensioning tip (40, 140, 140 ') which extends from it and is effective for collapsing the collapsible loop independent of the loop; and a suture (70) which has a plurality of stationary protuberances (72) formed thereon in a spaced arrangement, the suture (70) being able to pass through the soft tissue to be repaired, in which an opening (152, 152 ') of the loop is configured to receive the suture (70), the loop being slid in relation to the suture and collapsible around the suture, and in which the collapsible loop (30, 130, 130') is capable of being tightened incremental to attach the soft tissue to the bone.
[0002]
2. Construct according to claim 1, characterized by the fact that the loop (50, 150, 150 ') is configured by passing an end end (128) of the filament through an adjacent portion of the filament, the end end (128) having a protrusion (129) in it to maintain the terminal end (128) within the portion of the filament through which it is arranged.
[0003]
3. Construct according to claim 1, characterized by the fact that the loop (50, 150, 150 ’) is configured by a second sliding knot that is effective in collapsing the loop.
[0004]
4. Construct according to claim 1, characterized by the fact that the filament (20, 120, 120 ') comprises one of a cannulated surgical filament and a braided suture filament.
[0005]
5. Construct according to claim 1, characterized by the fact that it still comprises a flexible element (180 ’’ ’) positioned removably in a portion of the loop to prevent unintentional collapse thereof.
[0006]
6. Construct according to claim 5, characterized by the fact that the loop is configured by a filament that passes through itself to form a coaxial sliding neck (155 ’’ ’) that is effective in collapsing the loop.
[0007]
7. Construct according to claim 6, characterized in that the flexible element (180 '' '') is removably disposed through the coaxial sliding neck (155 '' '') to immobilize the coaxial sliding neck.
[0008]
8. Construct according to claim 5, characterized by the fact that the flexible element (180 ’’ ’) is formed from a second filament.
[0009]
9. Construct according to claim 8, characterized by the fact that the thickness of the second filament is in the range of 0.16 mm2 to 0.005 mm2 (from 25 gauge to 40 gauge).
[0010]
10. Construct according to claim 1, characterized by the fact that a thickness of the filament (20, 120, 120 ') is in the range of 0.52 mm2 to 0.02 mm2 (from 20 gauge to 34 gauge ).
[0011]
11. Construct according to claim 1, characterized by the fact that the thickness of the suture (70) is in the range 0.52 mm2 to 0.02 mm2 (from 20 gauge to 34 gauge).
[0012]
12. Construct, according to claim 1, characterized by the fact that the diameter of the protuberances (72) is in the range of 0.5 mm to 2 mm.

类似技术:

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公开号 | 公开日 | 专利标题

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BR102013011238B1|2021-02-02|construct for surgical repair

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AU2017258860B2|2019-04-04|Systems, devices, and methods for securing tissue

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AU2017258862B2|2019-03-07|Systems, devices, and methods for securing tissue

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US20190216457A1|2019-07-18|Surgical constructs and methods for securing tissue

同族专利:

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公开号 | 公开日

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EP2662031A1|2013-11-13|

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BR102013011238A2|2018-05-02|

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JP2013233433A|2013-11-21|

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CN103385742A|2013-11-13|

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CA2815757A1|2013-11-07|

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AU2019283953A1|2020-01-23|

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US9795373B2|2017-10-24|

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JP6113572B2|2017-04-12|

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法律状态:
2018-05-02| B03A| Publication of a patent application or of a certificate of addition of invention [chapter 3.1 patent gazette]|

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

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

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

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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:

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申请号 | 申请日 | 专利标题

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US13/465,362|2012-05-07|

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US13/465,362|US8894684B2|2012-05-07|2012-05-07|Systems, devices, and methods for securing tissue using a suture having one or more protrusions|

---