WO2003082124A1 - Suture anchor system and associated method - Google Patents
Suture anchor system and associated method Download PDFInfo
- Publication number
- WO2003082124A1 WO2003082124A1 PCT/US2003/004367 US0304367W WO03082124A1 WO 2003082124 A1 WO2003082124 A1 WO 2003082124A1 US 0304367 W US0304367 W US 0304367W WO 03082124 A1 WO03082124 A1 WO 03082124A1
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- WO
- WIPO (PCT)
- Prior art keywords
- suture anchor
- insertion tool
- bore
- suture
- ofthe
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00867—Material properties shape memory effect
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0409—Instruments for applying suture anchors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0414—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having a suture-receiving opening, e.g. lateral opening
Definitions
- the present invention relates to a suture anchor for securing a suture to a bone and, more particularly, to a suture anchor system configured so as to allow an axial seating force to be applied to an insertion tool engaged with a suture anchor, so as to seat the suture anchor within a bore in the bone, before the insertion tool can be separated from the suture anchor by the exertion of an axial separation force no less than the seating force.
- Suture anchors are known in the art as providing a convenient and effective mechanism for securing bodily tissue to an adjacent bone structure in a human body such as, for example, where a ruptured tendon must be reattached to the conesponding bone.
- the suture anchor is generally inserted into a bore formed in the bone so as to provide an attachment point for securing a suture to the bone, wherein the suture is then used to secure the adjacent bodily tissue to the bone.
- the wedge-type suture anchor has shown good promise in practical applications. Examples of such wedge-type suture anchors may be found in U.S. Patent Nos.
- U.S. Patent Nos. 5,540,718, 5,626,612, 5,782,863, 5,871,503, 5,879,372, 6,146,408, and 6,306,158 to Bartlett U.S. Patent No. 5,683,418 to Luscombe et al, and U.S. Patent No. 5,961,538 to Pedlick et al. are incorporated in their entirety herein by reference.
- a wedge-type anchor having an engaged suture is first engaged with an insertion tool and introduced into a bore drilled into the bone at a location on the bone where the bodily tissue must be affixed.
- the suture anchor generally includes a first gripping portion, such as a sharp edge or a point, and is designed to rotate as it enters the bore or is in the process of being withdrawn therefrom. As the suture anchor rotates, the first gripping portion bites or penetrates the wall of the bore and causes further rotation ofthe anchor.
- a second gripping portion is typically provided at the opposite end of the suture anchor.
- the second gripping portion penetrates into the wall ofthe bore generally opposite the first gripping portion as the suture anchor is rotated, thereby wedging the suture anchor within the bore.
- the suture anchor When the suture anchor has rotated about the first gripping portion, as much as the second gripping portion will allow with respect to the bone structure surrounding the bore, the suture anchor is in a seated position where it is anchored in the bore and ready to have adjacent bodily tissue attached thereto.
- Bones generally include a number of trabeculae disposed throughout. The spacing ofthe trabeculae within the intermedulary canal of the bone is often a good indicator ofthe density ofthe bone. Cortical bone is solid bone without visible interstitial spaces and is typical ofthe midshafts, or diaphyseal regions, of long bones.
- Metaphyseal and epiphyseal bone which is the bone around the joints at the opposing ends of the long bones, has a variable amount of cortical shells with a deeper trabecular structure, wherein the amount of cortical shells may vary greatly.
- Dense bone typically has small and closely spaced trabeculae, resulting in a hard and strong bone.
- less dense or osteoporotic bone has larger and more widely spaced trabeculae, typically resulting in a softer and generally weaker bone.
- This less dense bone generally comprises a cancellous bone region about the intermedulary canal.
- a typical bone structure thus typically includes a cortical layer atop cancellous layer where the proportion of both types of bone may vary.
- suture anchors must be able to function as intended when used in all types of bone structure. Where suture anchors are implanted into dense bone structures, well-defined strong gripping edges are required for the suture anchor to securely engage the bore in the bone. However, where the suture anchor is implanted into less dense bone, a large surface area engaging the bone is prefe ⁇ ed in order to distribute and reduce the stresses on the relatively weak bone.
- wedge-type suture anchors generally depend on the rotation ofthe suture anchor within the bore in order to allow the gripping edges to interact with the wall ofthe bore to secure the suture anchor in place. Accordingly, the suture anchor must often be inserted into the bore in a particular orientation, which must be maintained in order to prevent the gripping edges ofthe suture anchor from engaging the wall ofthe bore until the suture anchor has been inserted to the proper depth. However, the suture anchor, once inserted to the desired depth in the bore, must then be properly seated by rotating the suture anchor such that the gripping edges engage the wall ofthe bore to optimally secure the suture anchor in the bone.
- an insertion tool is used for implanting the suture anchor in the bore, wherein the insertion tool is configured to have a frangible portion at or near the interface ofthe insertion tool and the suture anchor.
- the frangible portion is further configured to break or separate from the suture anchor after implantation thereof in the bore.
- the frangible portion ofthe insertion tool may limit the orientation at which the suture anchor may be introduced to and inserted into the bore without fracturing the frangible portion. Such limited mobility may also cause the gripping edges ofthe suture anchor to engage the wall ofthe bore before the proper implantation depth has been attained. Accordingly, the limited mobility ofthe insertion tool having a frangible portion may not facilitate rotation ofthe suture anchor and may render it difficult to attain a seated position for the suture anchor before breakage ofthe frangible portion. Where a seated position has not been attained, a tensile force on the suture engaged with the suture anchor may undesirably be required in addition to or in the alternative to a tensile force on the insertion tool.
- the application of a tensile force on the suture to seat the suture anchor may not be desirable for several reasons. For example, since the seating force for the suture anchor is applied by an individual, it would be very difficult to achieve the desired seating force, much less a consistent seating force, between applications.
- the location ofthe bore in the suture anchor through which the suture is looped may not be appropriately located on the suture anchor to allow a tensile force on the suture to provide any rotational force for seating the suture anchor. As such, the suture anchor may not be properly seated if the seating force is insufficient and the suture anchor may thus not provide the necessary securing force for securing the adjacent tissue to the bone.
- the suture may be broken or pulled out of the suture bore, or the suture anchor broken or pulled out ofthe bore, if the seating force is exceeded. Accordingly, in these instances, the implantation procedure may have to be performed again and at a different site, using a new suture anchor. Still further, it may also be difficult to design and manufacture a suture anchor having the necessary mechanical properties for implantation according to this procedure.
- Luscombe et al. '418 patent, the Pedlick et al. '538 patent, and the Bartlett '718, '612, '863, '503, '372, '408, and ' 158 patents each describe a discrete flexible metallic insertion tool comprised of, for example, a shape memory material, which engages a bore in the anchor in a friction fit.
- Such flexible insertion tools may be beneficial in maintaining the suture anchor in a desired orientation upon insertion thereof into the bore, as well as for facilitating the manipulation or rotation ofthe suture anchor toward a seated position.
- the insertion tool since the insertion tool is only engaged with the suture anchor via a friction fit and thus may be easily separated therefrom, a tensile force directly on the suture engaged with the suture anchor may be required in order for the suture anchor to attain a seated position.
- the suture may be held against or secured to the insertion tool to maintain the insertion tool in engagement with the suture anchor such that the necessary tensile force can then be applied on the insertion tool to seat the suture anchor. Accordingly, in either instance, the tensile seating force is undesirably applied to the suture anchor via the suture.
- the Pedlick et al. '538 patent describes a threaded connection between the suture anchor and a flexible insertion tool.
- threaded components may be difficult and time-consuming to form on both the suture anchor and the insertion tool.
- the suture anchor may undesirably rotate about the axis ofthe insertion tool during the suture anchor seating process, thus making it difficult to rotate the suture anchor toward the seated position within the bore.
- a seating force applied on the insertion tool may strip the threads in the suture anchor or cause other damage thereto. If, in these instances, the suture anchor is not properly seated, the stripped threads would prohibit the insertion tool from being re-engaged with the suture anchor so as to further apply a seating force and thus the undesirable application ofthe seating force directly to the suture may be the only remaining option.
- a suture anchor system having the desirable suture anchor implantation characteristics of a flexible insertion tool comprised of a shape memory material, while allowing a predetermined seating force to be applied on the suture anchor before the insertion tool is removed from the suture anchor following insertion thereof in the bore.
- Such a system would desirably provide predetermined and consistent seating characteristics ofthe suture anchor in the bone.
- a suture anchor system configured so as to facilitate implantation of a suture anchor within a bore formed in a bone so as to secure a suture to the bone.
- a suture anchor having a suture operably engaged therewith and an insertion tool having a tip and defining a first axis.
- the insertion tool is discrete with respect to the suture anchor and is capable of implanting the suture anchor within the bore such that the suture anchor is secured in the bone.
- the tip is engagable with the suture anchor and is configured to cooperate therewith so as to prevent the suture anchor from rotating about the first axis.
- the insertion tool is configured with respect to the suture anchor such that a rotational force exerted on the insertion tool rotates the suture anchor about a second axis disposed perpendicularly with respect to the first axis.
- a predetermined axial seating force is then applied to the insertion tool, outwardly ofthe bore, to seat the suture anchor in the bore.
- the insertion tool is further configured so as to require an axial separation force to be applied thereto so as to separate the insertion tool from the suture anchor, wherein the separation force is no less than the seating force.
- Another advantageous aspect ofthe present invention comprises a method of implanting a suture anchor in a bore in a bone, wherein the suture anchor has a suture operably engaged therewith, so as to secure the suture to the bone.
- the suture anchor is first inserted into the bore with a discrete insertion tool having a tip and defining a first axis.
- the tip is engaged with the suture anchor and cooperates therewith to prevent the suture anchor from rotating about the first axis.
- a rotational force is then exerted on the insertion tool so as to rotate the suture anchor about a second axis perpendicularly disposed with respect to the first axis.
- An axial seating force is also exerted on the insertion tool, outwardly ofthe bore, so as to seat the suture anchor in the bore.
- the insertion tool is then separated from the suture anchor by exerting an axial separation force on the insertion tool, wherein the separation force is no less than the seating force.
- embodiments ofthe present invention provide a suture anchor system having the desirable suture anchor implantation characteristics of a flexible insertion tool comprised of a shape memory material, while allowing a predetermined seating force to be applied on the suture anchor, by the insertion tool engaged therewith, before the insertion tool is removed from the suture anchor following insertion thereof in the bore, thereby providing predetermined and consistent seating characteristics of the suture anchor in the bone. Accordingly, embodiments ofthe present invention provide significant advantages as detailed herein.
- FIG. 1 is a perspective view of a suture anchor system according to one embodiment ofthe present invention illustrating a separator extension having a frangible portion.
- FIG. IA is a perspective view of a suture anchor system according to one embodiment ofthe present invention illustrating an example of a retaining mechanism between the insertion tool and the separator extension.
- FIG. IB is a perspective view of an alternate embodiment of a suture anchor system according to the present invention illustrating a separator extension having a tiered bore.
- FIG. 2 is a perspective view of another alternate embodiment of a suture anchor system according to the present invention illustrating a tether securing the insertion tool to the suture anchor.
- FIGS. 3-10 illustrate a cross-sectional sequence ofthe insertion of a suture anchor, as shown in FIG. 2, into a bore in a bone in accordance with one embodiment ofthe present invention.
- FIG. 10A is a cross-sectional view of a suture anchor, as shown in FIG. 1, being anchored within a bore in a bone in accordance with one embodiment ofthe present invention.
- FIG. 11 is a cross-sectional view of bodily tissue being attached to the bone by a suture anchored within the bone by a suture anchor in accordance with one embodiment ofthe present invention.
- FIG. 1 discloses one embodiment of a suture anchor system according to the present invention, the system being configured to allow a predetermined seating force to be applied on the suture anchor 10, by an insertion tool 50 engaged therewith, before the insertion tool 50 is removed from the suture anchor 10 following insertion thereof in the bore.
- a suture anchor 10 is described in, for example, U.S. Patent No. 6,306,158 to Bartlett, and generally comprises a quadrilaterally shaped body 12 having a maximum length surface 14, a leading edge 16, a separator surface 18, an upper width surface 20, a lower width surface 22, a trailing edge 24, and a suture bore 26.
- the maximum length surface 14 and the separator surface 18 intersect at an acute angle to form the leading edge 16.
- the maximum length surface 14 intersects with the lower width surface 22 at an acute angle to form the trailing edge 24.
- the separator surface 18 and the lower width surface 22 are further connected by the upper width surface 20, dispose generally opposite the maximum length surface 14 and comprising an arcuate portion 20a and a substantially linear portion 20b.
- the body 12 further defines a transverse suture bore 26 therethrough and through which a suture 28 extends.
- the leading edge 16 may be wide in order to distribute the anchoring stress over a greater surface area, as well as provide a more robust suture anchor 10.
- the separator surface 18 is generally a flat surface and has a separator extension 30 extending therefrom.
- the separator extension 30 extends from the separator surface 18 at a predetermined inserter angle, with respect to the maximum length surface 14, wherein the inserter angle is configured such that the insertion tool 50 is capable of simultaneously urging the maximum length surface 14 into the bore and against the wall ofthe bore when the suture anchor 10 is first inserted therein.
- the separator extension 30 includes a frangible portion 30a in proximity with the separator surface 18, wherein the frangible portion 30a is configured to have a predetermined tensile breaking strength.
- the frangible portion 30a is configured with respect to, for example, shape, dimensions, and other factors, such that a tensile force of at least a predetermined magnitude may be applied on the separator extension 30 before breakage ofthe frangible portion 30a and separation of the separator extension 30 from the suture anchor 10 occurs.
- the separator extension 30 is configured so as to engage at least a portion ofthe tip 52 of the insertion tool 50 such that the separator extension 30 is secured to the tip 52, and the tip 52 extends into the body 12 ofthe suture anchor 10, for reasons which are further discussed below.
- the tip 52/separator extension 30 interface is configured so as to be capable of withstanding a tensile force greater than the predetermined breaking strength ofthe frangible portion 30a.
- the tip 52 and the separator extension 30 may be configured to be separably engaged while having the necessary properties as discussed herein.
- the frangible portion 30a is configured to have a breaking strength no less than the predetermined required seating force ofthe suture anchor 10.
- the tip 52, the separator extension 30, and/or the body 12 are preferably configured to cooperate such that the separator extension 30 and body 12 are prevented from rotating about the axis ofthe tip 52.
- the tip 52 may have a generally square cross-section configured to engage a correspondingly square bore 31 defined by the separator extension 30 and the body 12.
- the tip 52 may be retained in the bore 31 through, for instance, a mechanical connection, adhesive, or other suitable mechanism, which may, in some instances, be combined with a friction fit configuration.
- a mechanism for retaining the tip 52 within the bore 31 is shown in FIG. IA, wherein a first portion ofthe mechanism 40a engaged with the tip 52 cooperates with a second portion ofthe mechanism 40b engaged with the bore 31 when the tip 52 is inserted into the bore 31 to thereby retain the tip 52 in response to a tensile force exerted on the tip 52 outwardly ofthe bore 31.
- the separator extension 30 may not necessarily extend entirely about the tip 52 as shown in FIG. 1, but may only engage, for example, one, two, or three ofthe sides of a square tip 52, wherein the tip 52/separator extension 30 interface is appropriately configured to accomplish the securing ofthe tip 52 to the separator extension as discussed herein.
- the body 12 will define the bore 31 for receiving the tip 52 if not readily apparent in the configuration ofthe separator extension 30.
- the separator extension 30 may define a tiered bore 31 for receiving a co ⁇ espondingly shaped tip 52.
- the larger tier 31a ofthe bore 31 may extend only into the separator extension 30, while the smaller tier 31b ofthe bore 31 may extend through the separator extension 30 and the frangible portion 30a and into the body 12 ofthe suture anchor 10.
- the larger portion ofthe tip 52 may be secured to the larger tier 31a through, for instance, a mechanical connection, adhesive, or other suitable mechanism, while the smaller portion ofthe tip 52 is not secured in the smaller tier 31b. Accordingly, the smaller portion ofthe tip 52 essentially reinforces the frangible portion 30a for withstanding the stresses experienced during the rotation ofthe suture anchor 10 toward a seated position by the insertion tool 50. However, when the axial seating force is applied to the insertion tool 50 to seat the suture anchor 10, the tip 52 is only secured to the separator extension about the larger tier 31a and thus the frangible portion 30a will break at the predetermined breaking strength and allow the insertion tool 50 to be separated from the suture anchor 10.
- a suture anchor 10 is preferably biocompatible and, in some instances, is comprised of a bioabsorbable material, such as polylactic acid, polydioxanone, polyglycolic acid, and similar materials or blends thereof. Such materials should preferably be recognized by the appropriate regulatory authority as being suitable for use in humans. Additionally, it is desirable that the material strengthen the bone into which the anchor is inserted.
- the suture anchor may also be comprised of cortical bone, where the bone may further be autologous or autogenous bone. More generally, the suture anchor may be comprised of a suitable biocompatible polymer, biocompatible metal, or other biocompatible material (see, e.g., U.S. Patent Nos.
- suture anchors 10 as described herein may be formed by many different processes such as, for example, casting, machining, molding, or the like, as will be appreciated by one skilled in the art.
- the suture anchor 10 is similar to that shown in FIG. 1, with the exceptions that the body 12 includes an inserter bore surface 70 defining an inserter bore 72 extending into the body 12.
- the inserter bore 72 is preferably located in the inserter bore surface 70 in the vicinity where the inserter bore surface 70 meets the arcuate portion 20a ofthe upper width surface 20.
- the inserter bore 72 extends into the body 12 towards the maximum length surface 14, wherein the obtuse angle between the inserter bore surface 70 and the maximum length surface 14 defines an inserter angle.
- the inserter bore 72 is configured to receive the tip 52 ofthe insertion tool 50 for implanting the suture anchor 10 within the bone.
- the inserter bore 72 and the tip 52 have conesponding non-circular lateral cross-sections, such as generally square cross- sections having beveled or radiused corners, so as to prevent rotation ofthe suture anchor 10 about the axis ofthe tip 52.
- the tip 52 ofthe insertion tool 50 and the inserter bore 72 may have any conesponding shapes or configurations which minimize rotation ofthe suture anchor 10 about the axis ofthe tip 52.
- the suture anchor 10 may further define a tether bore 74 having a tether 76 extending therethrough.
- the tether 76 and the insertion tool 50 are configured such that the tether 76 is capable of engaging the insertion tool 50 so as to secure the tip 52 ofthe insertion tool 50 in engagement with the inserter bore 72 via the tether bore 74. In some instances, however, the tether 76 may secure the insertion tool to the suture anchor 10 via the suture bore 26. In either instance, the tether 76 may form a loop through the tether bore 74/suture bore 26 and about the insertion tool 50, wherein the loop may be terminated with an appropriate knot 78 or other connector. Such a tether 76 may comprise, for example, a suture or other suitable material capable of securing the suture anchor 10 to the insertion tool 50 and providing the necessary separation force.
- the tether 76 and/or the knot 78 may be configured so as to break at a predetermined separation force exerted on the insertion tool 50, wherein the separation force is no less than the required seating force for seating the suture anchor 10 in the bore, as detailed further herein.
- the tip 52 ofthe insertion tool 50 is comprised of a material having elastic properties and, more preferably, superelastic properties, such as, for example, a shape memory material.
- the elastic or superelastic properties ofthe material should be such that the tip 52 is not substantially permanently deformed during insertion and implantation ofthe suture anchor 10, thereby allowing the tip 52 to substantially return to an initial configuration, namely the configuration ofthe tip 52 as it is initially inserted into the inserter bore 72.
- At least the tip 52 ofthe insertion tool 50 is comprised of a nickel-titanium alloy, such as is commercially available under the names NITINOLTM by Raychem, TINELTM by Raychem, or SENTINOLTM by GAC International Inc..
- a nickel-titanium alloy such as is commercially available under the names NITINOLTM by Raychem, TINELTM by Raychem, or SENTINOLTM by GAC International Inc.
- shape memory alloys having superelastic properties are well known in the art; however, any other shape retaining material sufficient for properly implanting the suture anchor 10 ofthe present invention in a bore in a bone may be used.
- the use of a shape memory material and the shape ofthe tip 52 which minimizes rotation ofthe suture anchor 10 about the tip 52 engaged therewith further allows a smaller sized tip 52 to be used to effectively implant the suture anchor 10 within a bone.
- a smaller sized tip 52 further allows a smaller suture anchor 10 to be used in situations where such is necessary or desired
- the suture anchor 10 may include a suture 28 engaged therewith through the suture bore 26.
- the suture bore 26 may vary in size and is preferably rounded or beveled around the openings in the body 12 in order to avoid abrasion ofthe suture 28.
- the inserter bore 72 is generally disposed intermediate the leading edge 16 and the suture bore 26. As described further herein, the inserter bore 72 cooperates with the insertion tool 50 to introduce the suture anchor 10 into a bore in a bone. As the suture anchor 10 is introduced into the bore, the maximum length surface 14 lies flush with the wall ofthe bore, with the insertion tool 50 imparting a force component sufficient to urge the maximum length surface 14 against the wall.
- the upper width surface 20 and, more specifically, the arcuate portion 20a, is thus disposed adjacent to the wall ofthe bore diametrically opposite the maximum length surface 14.
- an axial separation force is then exerted on the insertion tool 50, outwardly ofthe bore, such that the separation force acts on the suture anchor to rotate the suture anchor 10 into a seated position in the bore.
- the suture anchor 10 generally requires a certain seating force to be exerted thereon to rotate the suture anchor 10 within the bore in the bone until a seated position is attained, wherein the seated position is up to about ninety degrees from the orientation in which the suture anchor 10 was initially inserted into the bore and the degree of rotation depends, at least in part, on the structure ofthe bone into which the suture anchor 10 is implanted.
- the tether 76 and/or the knot 78 are preferably configured to have a breaking strength, otherwise refened to herein as the separation force required to separate the insertion tool 50 from the suture anchor 10, of no less than the seating force for the suture anchor 10.
- the separation force may be slightly greater than the seating force, but less than the pullout strength ofthe suture anchor 10 itself, such that the suture anchor 10 can be checked for proper seating by repeated applications ofthe seating force before the tether 76 is broken and the insertion tool 50 removed from the suture anchor 10.
- FIGS. 3-10 illustrate a method of implanting a suture anchor 10 within a bore in a bone according to one embodiment ofthe present invention using an embodiment of a suture anchor system as illustrated in FIG. 2.
- a bore is first drilled in the bone using a boring bit 54.
- the bore generally passes through an outer layer of dense bone (cortical layer) and into an inner layer of a less dense or osteoporotic bone (cancellous layer) further therein.
- the boring bit 54 is removed.
- the inserter bore 72 of a suture anchor 10 is then engaged with the tip 52 ofthe insertion tool 50, the suture anchor 10 including a suture 28 threaded through the suture bore 26.
- the suture anchor 10 is secured to the tip 52 or other portion ofthe insertion tool 50 by a tether 76 extending through the tether bore 74 to the insertion tool 50.
- the suture anchor 10 is then introduced into the bore such that the maximum length surface 14 is engaged with the wall ofthe bore.
- the insertion tool 50 is in its original configuration (substantially straight), with the tip 52 inserted in the inserter bore 72 and angled with respect to the axis ofthe bore. Further, as shown, the diameter ofthe bore roughly conesponds to the maximum width ofthe suture anchor 10.
- the maximum length surface 14 is preferably contacting the wall ofthe bore, while the point defining the maximum width of suture anchor 10 is at least within close proximity to the wall ofthe bore diametrically opposite the maximum length surface 14.
- a force directed inwardly with respect to the bore is then exerted on the insertion tool 50 such that the suture anchor 10 is urged into the bore.
- the force causes the insertion tool 50 to bend such that distal end ofthe tip 52 remains in the inserter bore 72, but the portion ofthe tip 52 outside ofthe suture anchor 10 bends or deforms to conform to the wall ofthe bore.
- FIG. 6 shows the suture anchor 10 after further force has been exerted on the insertion tool 50 inwardly with respect to the bore.
- the arcuate portion 20a is urged against the wall ofthe ofthe bore, wherein engagement with the wall proceeds along the arcuate portion 20a to the linear portion 20b and then to the lower width surface 22 as the suture anchor 10 rotates.
- the suture anchor 10 generally begins to rotate about the point where the leading edge 16 engages the wall ofthe bore.
- the rotation ofthe suture anchor 10 may continue until the tip 52 ofthe insertion tool 50 has returned to its original shape such that the insertion tool 50 rests against the wall at the entrance to the bore.
- suture anchor 10 has been illustrated in this embodiment of a method of implantation as interacting with a bone structure having a cancellous layer underlying a cortical layer, such as that found, for example, in the "rotator cuff area ofthe human shoulder (also known as the greater tuberosity ofthe humerus).
- a suture anchor 10 according to embodiments ofthe present invention may also be used in areas of dense bone, predominantly comprised of a cortical layer with an underlying cancellous layer having a relatively high density, such as, for example, at the "cup" or glenoid area ofthe shoulder. Note, however, that the density ofthe cancellous layer may vary greatly.
- a suture anchor 10 may tend not to rotate as freely or extensively within a cortical bone layer as within a cancellous layer
- a suture anchor 10 includes features further described herein which render the suture anchor 10 generally adapted for application to both dense cortical bone and less dense cancellous bone structures.
- further rotation ofthe suture anchor 10 may be obtained by exerting a rotational force on the insertion tool 50 so as to move the insertion tool 50 to the diametrically opposite side ofthe bore.
- the rotational force exerted on the insertion tool 50 causes the leading edge 16 to bite or penetrate further into the wall of the bore and the suture anchor 10 to rotate about the leading edge 16.
- the rotation ofthe insertion tool 50 causes the suture anchor 10 to rotate about an axis perpendicular to the axis ofthe insertion tool 50. Accordingly, at the wall on the opposite side ofthe bore, the trailing edge 24 begins to penetrate into the wall ofthe bore.
- the rotation ofthe insertion tool 50 may also be accompanied by an axial force exerted on the insertion tool 50 outwardly ofthe bore. In either event, at this point, the insertion tool 50 is in contact with the wall on generally the opposite side ofthe bore from which the insertion tool 50 initially entered the bore.
- the suture anchor 10 may not necessarily be in a seated position. Accordingly, an axial seating/separation force is then applied to the insertion tool 50, outwardly ofthe bore, so as to seat the suture anchor 10, as shown in FIG. 9.
- the tether 76 and/or the knot 78 are preferably configured to have a breaking strength, otherwise refened to herein as the separation force required to separate the insertion tool 50 from the suture anchor 10, of no less than the seating force for the suture anchor 10.
- the separation force may be slightly greater than the seating force, but less than the pullout strength ofthe suture anchor 10 itself, such that the suture anchor 10 can be checked for proper seating by repeated applications ofthe seating force before the tether 76 is broken and the insertion tool 50 removed from the suture anchor 10.
- FIG. 10A further illustrates the removal ofthe insertion tool 50, from a suture anchor 10 as shown in FIG. 1, wherein a force at least as great as the required breaking strength ofthe frangible portion 30a is applied to the insertion tool 50 outwardly ofthe bore. Accordingly, the separator extension 30 is broken and separated from the suture anchor 10 at the frangible portion 30a when the force on the insertion tool 50 exceeds the breaking strength.
- embodiments ofthe present invention provide a suture anchor system having the desirable suture anchor implantation characteristics of a flexible insertion tool comprised of a shape memory material, while allowing a predetermined seating force to be applied on the suture anchor, by the insertion tool engaged therewith, before the insertion tool is removed from the suture anchor following insertion thereof in the bore, thereby providing predetermined and consistent seating characteristics of the suture anchor in the bone.
Abstract
Description
Claims
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU2003211031A AU2003211031C1 (en) | 2002-03-25 | 2003-02-13 | Suture anchor system and associated method |
DE60326942T DE60326942D1 (en) | 2002-03-25 | 2003-02-13 | SEAM ANCHOR SYSTEM |
CA002479436A CA2479436C (en) | 2002-03-25 | 2003-02-13 | Suture anchor system and associated method |
EP03745514A EP1487351B1 (en) | 2002-03-25 | 2003-02-13 | Suture anchor system |
JP2003579671A JP4184979B2 (en) | 2002-03-25 | 2003-02-13 | Suture anchor system |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/105,807 | 2002-03-25 | ||
US10/105,807 US6843799B2 (en) | 2002-03-25 | 2002-03-25 | Suture anchor system and associated method |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2003082124A1 true WO2003082124A1 (en) | 2003-10-09 |
Family
ID=28040863
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2003/004367 WO2003082124A1 (en) | 2002-03-25 | 2003-02-13 | Suture anchor system and associated method |
Country Status (8)
Country | Link |
---|---|
US (1) | US6843799B2 (en) |
EP (2) | EP2055239B1 (en) |
JP (1) | JP4184979B2 (en) |
AT (2) | ATE543440T1 (en) |
AU (1) | AU2003211031C1 (en) |
CA (1) | CA2479436C (en) |
DE (1) | DE60326942D1 (en) |
WO (1) | WO2003082124A1 (en) |
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US8128698B2 (en) | 1999-10-20 | 2012-03-06 | Anulex Technologies, Inc. | Method and apparatus for the treatment of the intervertebral disc annulus |
US7615076B2 (en) | 1999-10-20 | 2009-11-10 | Anulex Technologies, Inc. | Method and apparatus for the treatment of the intervertebral disc annulus |
US7004970B2 (en) | 1999-10-20 | 2006-02-28 | Anulex Technologies, Inc. | Methods and devices for spinal disc annulus reconstruction and repair |
WO2004012601A2 (en) * | 2002-08-01 | 2004-02-12 | Abbott Laboratories Vascular Enterprises, Limited | Apparatus for sealing punctures in blood vessels |
US7320701B2 (en) * | 2003-06-02 | 2008-01-22 | Linvatec Corporation | Push-in suture anchor, insertion tool, and method for inserting a push-in suture anchor |
US20050090827A1 (en) * | 2003-10-28 | 2005-04-28 | Tewodros Gedebou | Comprehensive tissue attachment system |
US20050096696A1 (en) * | 2003-11-04 | 2005-05-05 | Forsberg Andrew T. | Arteriotomy closure device with anti-roll anchor |
GB0329654D0 (en) * | 2003-12-23 | 2004-01-28 | Smith & Nephew | Tunable segmented polyacetal |
FR2871361B1 (en) * | 2004-06-15 | 2006-09-29 | Analytic Biosurgical Solutions | SURGICAL ANCHORING DEVICE |
US20060229671A1 (en) * | 2005-04-08 | 2006-10-12 | Musculoskeletal Transplant Foundation | Suture anchor and suture anchor installation tool |
CA2679365C (en) * | 2006-11-30 | 2016-05-03 | Smith & Nephew, Inc. | Fiber reinforced composite material |
US20080177288A1 (en) * | 2007-01-19 | 2008-07-24 | Carlson Mark A | Remote Suturing Device |
WO2008129245A1 (en) | 2007-04-18 | 2008-10-30 | Smith & Nephew Plc | Expansion moulding of shape memory polymers |
AU2008243035B2 (en) | 2007-04-19 | 2013-09-12 | Smith & Nephew, Inc. | Graft fixation |
WO2008131197A1 (en) | 2007-04-19 | 2008-10-30 | Smith & Nephew, Inc. | Multi-modal shape memory polymers |
EP2923664B1 (en) | 2007-10-17 | 2019-01-02 | ARO Medical ApS | Systems and apparatuses for torsional stabilisation |
US8163022B2 (en) | 2008-10-14 | 2012-04-24 | Anulex Technologies, Inc. | Method and apparatus for the treatment of the intervertebral disc annulus |
US9717581B2 (en) * | 2009-02-05 | 2017-08-01 | Coloplast A/S | Incontinence treatment device including a system of anchors |
US8226685B2 (en) * | 2009-08-25 | 2012-07-24 | Redline Orthopedic Innovations, Llc | Suture anchor and method of use |
US8652153B2 (en) | 2010-01-11 | 2014-02-18 | Anulex Technologies, Inc. | Intervertebral disc annulus repair system and bone anchor delivery tool |
US8425611B2 (en) | 2010-10-26 | 2013-04-23 | Warsaw Orthopedic, Inc. | Expandable orthopedic implant system and method |
US9204959B2 (en) * | 2012-02-02 | 2015-12-08 | Smith & Nephew, Inc. | Implantable biologic holder |
EP2948068A4 (en) | 2013-01-28 | 2016-09-28 | Cartiva Inc | Systems and methods for orthopedic repair |
US9737294B2 (en) | 2013-01-28 | 2017-08-22 | Cartiva, Inc. | Method and system for orthopedic repair |
EP3348231B1 (en) | 2017-01-16 | 2022-05-11 | Coloplast A/S | Sacrocolpopexy support |
WO2020096861A1 (en) * | 2018-11-08 | 2020-05-14 | Edwards Lifesciences Corporation | Percutaneous anchoring for treatment of heart failure with reduced ejection fraction |
US11389154B1 (en) | 2021-04-08 | 2022-07-19 | Integrity Orthopaedics, Inc. | Knotless micro suture anchor array for high density anatomical attachment of soft tissue to bone |
US11382613B1 (en) | 2021-04-08 | 2022-07-12 | Integrity Orthopaedics, Inc. | Methods for transtendinous implantation of knotless micro suture anchors and anchor arrays |
US11375992B1 (en) | 2021-04-08 | 2022-07-05 | Integrity Orthopaedics, Inc. | Cartridge device for suture anchor and suture management during implantation of a micro suture anchor array |
US11375995B1 (en) | 2021-04-08 | 2022-07-05 | Integrity Orthopaedics, Inc. | Locking suture construct for tensioned suture to suture stitches in anchor arrays for attaching soft tissue to bone |
US11382611B1 (en) | 2021-04-08 | 2022-07-12 | Integrity Orthopaedics, Inc. | Knotless micro-suture anchors and anchor arrays for anatomical attachment of soft tissue to bone |
Citations (3)
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US5540718A (en) * | 1993-09-20 | 1996-07-30 | Bartlett; Edwin C. | Apparatus and method for anchoring sutures |
US5961538A (en) * | 1996-04-10 | 1999-10-05 | Mitek Surgical Products, Inc. | Wedge shaped suture anchor and method of implantation |
US6306158B1 (en) * | 1999-03-02 | 2001-10-23 | Edwin C. Bartlett | Suture anchor and associated method of implantation |
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-
2002
- 2002-03-25 US US10/105,807 patent/US6843799B2/en not_active Expired - Lifetime
-
2003
- 2003-02-13 JP JP2003579671A patent/JP4184979B2/en not_active Expired - Lifetime
- 2003-02-13 WO PCT/US2003/004367 patent/WO2003082124A1/en active Application Filing
- 2003-02-13 DE DE60326942T patent/DE60326942D1/en not_active Expired - Lifetime
- 2003-02-13 AT AT09001728T patent/ATE543440T1/en active
- 2003-02-13 EP EP09001728A patent/EP2055239B1/en not_active Expired - Lifetime
- 2003-02-13 EP EP03745514A patent/EP1487351B1/en not_active Expired - Lifetime
- 2003-02-13 AU AU2003211031A patent/AU2003211031C1/en not_active Expired
- 2003-02-13 CA CA002479436A patent/CA2479436C/en not_active Expired - Fee Related
- 2003-02-13 AT AT03745514T patent/ATE427071T1/en not_active IP Right Cessation
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
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US5540718A (en) * | 1993-09-20 | 1996-07-30 | Bartlett; Edwin C. | Apparatus and method for anchoring sutures |
US5961538A (en) * | 1996-04-10 | 1999-10-05 | Mitek Surgical Products, Inc. | Wedge shaped suture anchor and method of implantation |
US6306158B1 (en) * | 1999-03-02 | 2001-10-23 | Edwin C. Bartlett | Suture anchor and associated method of implantation |
Also Published As
Publication number | Publication date |
---|---|
EP2055239A1 (en) | 2009-05-06 |
AU2003211031A1 (en) | 2003-10-13 |
JP4184979B2 (en) | 2008-11-19 |
EP2055239B1 (en) | 2012-02-01 |
CA2479436C (en) | 2008-01-08 |
AU2003211031C1 (en) | 2008-10-09 |
EP1487351A1 (en) | 2004-12-22 |
US6843799B2 (en) | 2005-01-18 |
EP1487351B1 (en) | 2009-04-01 |
AU2003211031B2 (en) | 2008-04-03 |
ATE543440T1 (en) | 2012-02-15 |
CA2479436A1 (en) | 2003-10-09 |
ATE427071T1 (en) | 2009-04-15 |
US20030181946A1 (en) | 2003-09-25 |
JP2005521462A (en) | 2005-07-21 |
DE60326942D1 (en) | 2009-05-14 |
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