Some embodiments described herein relate generally to methods and apparatus for stabilizing bone, for example, stabilizing vertebrae by securing the articular processes of the vertebrae.
Traumatic, inflammatory, and degenerative disorders of the spine can lead to severe pain and loss of mobility. One source of back and spine pain is related to degeneration of the facets of the spine or facet arthritis. Bony contact or grinding of degenerated facet joint surfaces can play a role in some pain syndromes. While many technological advances have focused on the intervertebral disc and artificial replacement or repair of the intervertebral disc, relatively little advancement in facet repair has been made. Facet joint and disc degeneration frequently occur together.
The current standard of care to address the degenerative problems with the facet joints is to fuse the two adjacent vertebrae. By performing this surgical procedure, the relative motion between the two adjacent vertebrae is stopped, thus stopping motion of the facets and any potential pain generated as a result thereof. Procedures to fuse two adjacent vertebrae often involve fixation and/or stabilization of the two adjacent vertebrae until the two adjacent vertebrae fuse.
Injuries and/or surgical procedure on and/or effecting other bones can also result in the desire to fixate and/or stabilize a bone until the bone, or bone portions, can fuse, for example, to stabilize a sternum after heart surgery, to stabilize a rib after a break, etc. Current procedures to fixate and/or stabilize adjacent vertebrae and/or other bones, however, can be slow and/or complex.
Accordingly, a need exists for an apparatus and methods to better stabilize and/or fixate a bone.
In some embodiments, a method comprises forming a lumen in a first bone portion and forming a lumen in a second bone portion. The method further includes inserting a portion of a flexible fastening band through the lumen in the first bone portion and through the lumen in the second bone portion, and inserting the portion of the flexible fastening band into a fastener mechanism monolithically formed with the flexible fastening band. The method further includes advancing the portion of the flexible fastening band through the fastener mechanism until the first bone portion and the second bone portion are stabilized.
In some embodiments, a method comprises forming a lumen in a first bone portion and forming a lumen in a second bone portion. The method further includes inserting a portion of a flexible fastening band through the lumen in the first bone portion and through the lumen in the second bone portion, and inserting the portion of the flexible fastening band into a fastener mechanism monolithically formed with the flexible fastening band. The method further includes advancing the portion of the flexible fastening band through the fastener mechanism until the first bone portion and the second bone portion are stabilized.
In some embodiments, an apparatus includes a flexible elongate body and an anchor. The flexible elongate body includes a distal end portion, a body portion, and an attachment connection. The attachment connection receives the distal end portion of the flexible elongate body when the body portion is disposed in contact with a first bone portion and a second bone portion. The anchor receives a fastener configured to secure the flexible elongate body to the first bone portion via the anchor.
In some embodiments, a kit includes a flexible band and a fastener. The flexible band includes an interface portion configured to receive the fastener. The flexible band is configured to stabilize a first bone portion and a second bone portion. The fastener is configured to anchor the flexible band to the first bone portion such that the first bone portion, the second bone portion, and the flexible band are stabilized after being anchored.
As used in this specification, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, the term “a ratchet” is intended to mean a single ratchet or a combination of ratchets. As used in this specification, a substance can include any biologic and/or chemical substance, including, but not limited to, medicine, adhesives, etc. While exemplary references are made with respect to vertebra, in some embodiments another bone can be involved. While specific reference may be made to a specific vertebra, a subset of vertebrae, and/or a grouping of vertebrae, it is understood that any vertebra, subset, and/or grouping, or combination of vertebrae can be used.
The words “proximal” and “distal” generally refer to the direction closer to and away from, respectively, a center of a body. The embodiments described herein, however, can be arranged in any orientation relative to the center of the body. Thus, when discussing the embodiments described herein (specifically a flexible elongate body), the terms “proximal” and “distal” refer to a direction closer to and away from, respectively, an attachment connection or fastener mechanism, the position of which is visually presented with respect to specific embodiments in the attached figures.
As shown in
The orientation of the facet joints vary, depending on the level of the vertebral column. In the C1 and C2 vertebrae, for example the facet joints are parallel to the transverse plane.
In addition to guiding movement of the vertebrae, the facet joints also contribute to the load-bearing ability of the vertebral column. One study by King et al. Mechanism of Spinal Injury Due to Caudocephalad Acceleration, Orthop. Clin. North Am., 6:19 1975, found facet joint load-bearing as high as 30% in some positions of the vertebral column. The facet joints may also play a role in resisting shear stresses between the vertebrae. Over time, these forces acting on the facet joints can cause degeneration and arthritis.
In some embodiments described herein, a flexible elongate body can be anchored to a first vertebra via an anchor and can be used to stabilize and/or fixate a first vertebra to a second vertebra to reduce the pain, to reduce further degradation of a spine (e.g., a specific vertebra and/or a specific disc of a spine), and/or until the first vertebra and the second vertebra have fused.
The fastener mechanism 150 is configured to accept at least a portion of distal end portion 148 and/or the body portion 145, as further described herein. The fastener mechanism 150 is disposed at a proximal end of the band 140. In some embodiments, the fastener mechanism 150 defines a lumen (not shown in
The body portion 145 is a linear elongate that extends from a portion of the fastener mechanism 150. More specifically, the body portion 145 of the band 140 can be monolithically formed with the fastener mechanism 150 such that the body portion 145 is a linear elongate portion between the fastener mechanism 150 and the distal end portion 148. In other embodiments, the body portion 145 can be coupled to the fastener mechanism 150 in any suitable manner (e.g., coupled via an adhesive, a weld, a friction fit, a threaded fit, or the like). The body portion 145 can be any suitable configuration. For example, in some embodiments, the body portion 145 can have a cross-sectional shape that is polygonal (e.g., square, rectangular, trapezoidal, etc.) or oval (e.g., circular, elliptical, oblong, etc.). In some embodiments, the cross-sectional shape of the body portion 145 can be associated with one or more characteristics of the bone or bone portion against which the body portion 145 may contact. For example, while the body portion 145 can have a substantially square cross-sectional shape, a set of edges of the body portion 145 can be rounded, partially rounded, and/or otherwise shaped to compliment the shape of a bone or bone portion, and/or to reduce digging or grinding into the bone or bone portion. In this manner, use of band 140 may cause little or no damage to the bone or bone portions contacted by band 140.
In some embodiments, the body portion 145 can define a substantially uniform cross-sectional area along a longitudinal axis (e.g., a centerline) of the band 140. In other embodiments, the cross-sectional area of the body portion 145 can vary along the longitudinal axis (centerline) of the band 140. For example, in some embodiments, the body portion 145 can have a cross-sectional area that is substantially tapered (i.e., reduced) from a proximal end (e.g., adjacent the fastener mechanism 150) to a distal end (e.g., adjacent the distal end portion 148). In some embodiments, the cross-sectional area of the body portion 145 can be associated with the cross-sectional area of the lumen defined by the fastener mechanism 150 (the attachment connection 150 described above). In this manner, at least a portion of the body portion 145 can have a cross-sectional area that is sufficiently small such that the body portion 145 can be at least partially disposed within the lumen of the fastener mechanism 150.
The body portion 145 can be configured to include a gear rack (not shown in
The distal end portion 148 is configured to extend from the body portion 145 of the band 140. More specifically, the distal end portion 148 is disposed adjacent the distal end of the body portion 145 such that the body portion 145 is disposed between the distal end portion 148 and the fastener portion 150. In some embodiments, the distal end portion 148 can have a cross-sectional area that is substantially similar to the cross-sectional area of the body portion 145. In other embodiments, the distal end portion 148 can have a cross-sectional area that is substantially smaller than the cross-sectional area of the body portion 145. In such embodiments, the distal end portion 148 and the body portion 145 can collectively define a discontinuity defining a stepwise reduction in the cross-sectional area. In other embodiments, the body portion 145 and/or the distal end portion 148 can define a tapered portion such that the band 140 is tapered between smaller cross-sectional area of the distal end portion 148 and the larger cross-sectional area of the body portion 145.
While not shown in
The anchor 180 is configured to receive a fastener 185 to secure the band 140 to a bone portion. In some embodiments, the anchor 180 is monolithically formed with the band 140. For example, in some embodiments, the anchor 180 can be disposed on or within the body portion 145 and can define an aperture (not shown in
In some embodiments, the anchor 180 can be formed independently from the band 140 and can be at least partially disposed about the band 140 to secure the band 140 to the bone portion. For example, in some embodiments, the anchor 180 can define a second aperture configured to receive the distal end portion 148 of the band 140. In this manner, the anchor 180 can define a strap or loop configured to be slid into any suitable position along the distal end portion 148 and/or the body portion 145. In some embodiments, the anchor 180 can form a hook (e.g., a J-hook, an L-hook, etc.). In this manner, the anchor 180 can be configured to engage at least three sides of the band 140. In such embodiments, the anchor 180 can include an edge configured to engage a surface of the bone portion to retain the band 140 between the edge and the fastener 185 when the fastener 185 is disposed within the second aperture (e.g., defined by the anchor 180) and the bone portion, as described in further detail herein.
In use, the band 140 can be configured, for example, to stabilize a vertebra (e.g., a first vertebra) and/or a second vertebra by securing an articular process of the first vertebra to an articular process of a second vertebra. More specifically, the band 140 can be configured to stabilize the first vertebra and/or a second vertebra by securing an articular process of the first vertebra to an articular process of a second vertebra by securing a facet of the articular process of the first vertebra with a facet of the articular process of the second vertebra. For example, the band 140 can be placed into a suitable position relative to the first vertebra and/or the second vertebra, and the distal end portion 148 of the band can be inserted into the lumen of the fastener member 150 such that the body portion 145 substantially encircles at least a portion of the first vertebra and the second vertebra. Similarly stated, the distal end portion 148 can be inserted in to the lumen of the fastener mechanism 150 such that the band 140 forms a loop about the articular process of the first vertebra and the articular process of the second vertebra. In this manner, the distal end portion 148 and/or the body portion 145 can be advanced through the lumen of the fastener mechanism 150 such that the volume disposed within the loop formed by the band 140 is reduced. Thus, the band 140 exerts a compressive force on the articular process of the first vertebra and the articular process of the second process. While not shown in
With the band 140 at least partially tightened about the articular process of the first vertebra and the articular process of the second vertebra, the fastener 185 can be inserted into the anchor 180 and advanced into a portion of the articular process of the first vertebra and/or second vertebra. In some embodiments, the fastener 185 can be advanced through a pre-drilled hole of the articular process. In other embodiments, the fastener 185 can be configured to self-tap into the articular process (e.g., when the fastener is a self taping screw). In this manner, the anchor 180 can be affixed to the articular process of the first vertebra and/or the second vertebra such that the anchor 180 secures the band 140 to the first vertebra and/or the second vertebra. In this manner, the distal end portion 148 and/or the body portion 145 can be advanced through the lumen defined by the fastener mechanism 150 to stabilize and/or fixate the first vertebra to the second vertebra. Furthermore, by affixing the anchor 180 to the first vertebra and/or the second vertebra, the anchor 180 can substantially reduce slippage of the band 140 relative to the first vertebra and/or the second vertebra.
While not explicitly described above, in embodiments wherein the anchor 180 is independently formed, the anchor 180 can be disposed about the distal end portion 148 and/or the body portion 145 prior to inserting the distal end portion 148 into the lumen of the fastener member 150. While being described above as being partially tightened about the first vertebra and the second vertebra prior to affixing the anchor 180, in other embodiments, the anchor can be affixed to the first vertebra and/or the second vertebra prior to inserting the distal end portion 148 into the fastener mechanism 150. Conversely, in some embodiments, the band 140 can be tightened to a desired amount prior to the anchor 180 being affixed to the first vertebra and/or the second vertebra.
As shown in
The band 240 can be used in any suitable procedure to stabilize and/or fixate a first bone portion to a second bone portion. For example, in some embodiments, the band 240 can be disposed about an articular process of a first vertebra and an articular process of a second vertebra. In this manner, the distal end portion 248 and/or the body portion 245 can be positioned within the lumen 266 of the fastener mechanism 250 such that the band 240 forms a loop of suitable tightness about the first vertebra and the second vertebra. The band 240 can be used in conjunction with any suitable anchor configured to facilitate the stabilization and/or fixation of the first vertebra to the second vertebra and further configured to reduce potential slippage of the band 240 relative to the first vertebra and/or the second vertebra (as described in detail above with reference to
In some embodiments, the band 240 can be used in any procedure described in or similar to those in U.S. patent application Ser. No. 12/859,009; filed Aug. 18, 2010, and titled “Vertebral Facet Joint Drill and Method of Use” (referred to as “the '009 application”), the disclosure of which is incorporated herein by reference in its entirety. In some embodiments, the band 240 can be used in conjunction with a spacer such as those described in the '009 application. For example, the spacer can be implanted and deployed to restore the space between facets of a superior articular process of a first vertebra and an inferior articular process of an adjacent vertebra. The spacer can be implanted and deployed to help stabilize adjacent vertebrae with adhesives and/or to deliver a medication. For example, in some embodiments, the spacer can be at least temporarily maintained in a desired position via an adhesive while the band 240 is positioned relative to the first vertebra and/or second vertebra. In some embodiments, an adhesive can be used in conjunction with the band 240 to stabilize and/or fixate the first vertebra to the second vertebra.
In some embodiments, the spacer can be, for example, substantially disc shaped. In other embodiments, the spacer can be other shapes, e.g., square, elliptical, or any other shape. The spacer can include a first side and a second side. The first side and/or the second side can be, for example, convex, concave, or flat. Said another way, the first side of the spacer can be concave, convex, or flat, and the second side of the spacer can be concave, convex, or flat, for example, the first side can be concave and the second side concave, the first side can be concave and the second side convex, etc. The spacer can include the same materials as band 140. In some embodiments, the spacer can include substances configured to release medication and/or increase the stability of a vertebra and/or band 140. As discussed above, the substances can include a medicine(s) and/or an adhesive(s).
The fastener mechanism 350 defines a lumen 366 and includes a ratchet 362. The lumen 366 of the fastener mechanism 350 receives the distal end portion 348 of the band 340 such that the body portion 345 forms a loop that substantially encircles the process 16A of the first vertebra 4A and the process 16B of the second vertebra 4B. While not shown in FIGS. 9A-10B, the band 340 includes a gear rack that can be similar to or the same as the gear racks described above in the previous embodiments. In this manner, the ratchet 362 is configured to engage the gear rack of the band 340 to maintain the distal end portion 348 of the band 340 within the lumen 366 (as described in detail above).
The anchor 380 is configured to substantially surround a portion of the band 340 as shown in
The spacer 354 is disposed between the process 16A of the first vertebra 4A and the process 16B of the second vertebra 4B. The spacer 354 can be any suitable shape, size, or configuration. For example, as shown in
As shown in
While the anchor 380 is shown as being independently formed from the band 340, in other embodiments, an anchor can be monolithically formed with a band. For example,
As shown in
With the anchor portion 480 affixed to the process 16A via the fastener 485, movement of the band 440 in the anterior and/or posterior direction, relative to the process 16A is substantially limited. In addition, a spacer 454 can be disposed between the process 16A of the first vertebra 4A and the process 16B of the second vertebra 4B prior to tightening the band 440 about the process 16A of the first vertebra 4A and the process 16B of the second vertebra 4B. For example, in some embodiments, the spacer 454 can be disposed between the process 16A of the first vertebra 4A and the process 16B of the second vertebra 4B after advancing the fastener 485 into the process 16A and prior to advancing the distal end portion 448 of the band 440 through the lumen 466. In other embodiments, the spacer 454 can be disposed between the process 16A of the first vertebra 4A and the process 16B of the second vertebra 4B prior to the insertion of the fastener 454 in the process 16A and prior to the insertion of the distal end portion 448 into the lumen 466. In still other embodiments, the spacer 454 can be disposed between the process 16A of the first vertebra 4A and the process 16B of the second vertebra 4B after the fastener 485 is advanced into the process 16A and after the band 440 is partially tightened. The spacer 454 can be similar to the spacer 354 described above with reference to
While the anchor portion 480 is shown in
The anchor portion 580 is monolithically formed with the band 540. More specifically, the anchor portion 580 can be a lateral protrusion extending from a side of the band 540. For example, in some embodiments, the anchor portion 580 can extend substantially perpendicularly from a side of the band 540. In other embodiments, the anchor portion 580 can extend from the side of the band 540 at any suitable angular orientation (i.e., an angular orientation other than the perpendicular orientation (e.g., other than 90 degrees)). The anchor portion 580 can be substantially annular such that the anchor portion 580 defines an aperture 582. The aperture 582 can receive a fastener 585 (
As shown in
With the anchor portion 580 affixed to the process 16A via the fastener 585, movement of the band 540 in the anterior and/or posterior direction, relative to the process 16A is substantially limited. In addition, a spacer 554 can be disposed between the process 16A of the first vertebra 4A and the process 16B of the second vertebra 4B. The spacer 554 can be similar to the spacer 554 described above with reference to
While the anchor portion 580 is shown extending from a particular side of the band 540 in
Referring now to
The method 790 includes advancing a portion of the flexible band through an attachment connection until the first bone portion and the second bone portion are stabilized, at 794. The attachment portion can be substantially similar to the attachment portion (e.g., the fastener mechanism) 340 described herein. The advancing of the portion of the band through the attachment connection can be such that, for example, the band tightens about the first bone portion and about the second bone portion to move the first bone portion from a first orientation relative to the second bone portion to a second orientation relative to the second bone portion. Moreover, the second orientation of the first bone portion relative to the second bone portion can correspond to a stabilized orientation of the first bone portion and the second bone portion. In some embodiments, the first bone portion and the second bone portion can be a portion of a first vertebra and a portion of a second vertebra, respectively. For example, in some embodiments, the first bone portion and the second bone portion can be a spinous articular process of a first vertebra and a spinous articular process of a second vertebra, respectively. In other embodiments, the first bone portion and the second bone portion can be a transverse articular process of a first vertebra and a transverse articular process of a second vertebra, respectively.
In some embodiments, a spacer can be optionally disposed between the first bone portion and the second bone portion to facilitate the stabilization. For example, in some embodiments, the spacer can define a channel configured to receive a portion of the flexible band, thereby limiting or reducing slippage of the flexible band relative to the first bone portion and/or the second bone portion. In some embodiments, a spacer can define a desired distance between the first bone portion and the second bone portion.
The method further includes advancing a portion of the fastener through an aperture and into the first bone portion until the flexible band is secured to the first bone portion, at 796. In some embodiments, the fastener can be advanced through a pre-drilled hole in the first bone portion. In other embodiments, the fastener can be a self-taping fastener such as, for example, a self-taping screw. In this manner, the fastener can substantially limit slippage of the flexible band relative to the first bone portion and or the second bone portion.
Any of the embodiments, described above can be packaged independently or in any suitable combination. For example, in some embodiments, a kit can include at least flexible elongate body (e.g., a band) and a fastener. The band can include an interface portion configured to receive the fastener. For example, the band can be similar to or the same as the band 440 described above with reference to
In some embodiments, the kit can include a spacer and/or implant. For example, in some embodiments, the kit can include a spacer that is similar to or the same as the spacer 354 described above with reference to
While various embodiments have been described above, it should be understood that they have been presented by way of example only, not limitation, and various changes in form and details may be made. For example, while the embodiments are illustrated here as being disposed about a spinous articular process of a first vertebra and a spinous articular process of a second vertebra, in other embodiments, a flexible elongate body (e.g., a band) can be disposed about another portion of one or more vertebra. For example, in some embodiments, a flexible elongate body can be dispose about a transverse articular process of a first vertebra and a transverse articular process of a second vertebra. In such embodiments, the band can be tightened about the vertebrae to offset or correct misalignment of a portion of the spine (e.g., scoliosis, or the like).
While the descriptions given are with reference to stabilizing vertebra, another bone(s) such as for example, a sternum and/or a rib(s) could be stabilized using the flexible fastening bands described herein. In another example, a flexible fastening band can be used to stabilize and/or fixate an intramedullary (IM) rod or nail. For example, the flexible fastening band can be used at different longitudinal locations along an IM rod or nail, and used to couple adjacent bone portions to the IM rod or nail. In such situations, a given flexible fastening band can fix a first bone portion, the IM rod or nail, and a second bone portion, all of which are positioned between the distal portion and the attachment connection of the flexible fastening band. In yet another example, a flexible fastening band can be used to stabilize and/or fixate a bone fragment. While various embodiments have been described above with regard to natural bone spaces, (e.g., the space between an inferior articulate process and a superior articulate process), in other embodiments, the bone spacing can be man-made (e.g., sternum split during a heart procedure), and/or due to an injury (e.g., broken bone).
Where methods described above indicate certain events occurring in certain order, the ordering of certain events can be modified. Additionally, certain of the events can be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. For example, while the method 790 described above includes advancing a portion of the band into the attachment connection prior to advancing the fastener, in some embodiments, the fastener can be at least partially advanced into a bone portion prior to the portion of the band being advanced through the attachment portion. In some embodiments, at least a portion of the advancing of the fastener into the bone portion and at least a portion of the advancing of the portion of the band into the attachment connection can be done concurrently (e.g., simultaneously or alternatively in relatively small increments).
By way of another example, in some embodiments, a spacer (e.g., the spacer 454 described above with reference to
Any portion of the apparatus and/or methods described herein may be combined in any combination, except mutually exclusive combinations. The embodiments described herein can include various combinations and/or sub-combinations of the functions, components and/or features of the different embodiments described.
This application is a divisional application of U.S. patent application Ser. No. 13/804,407, filed Mar. 14, 2013. This application is related to U.S. patent application Ser. No. 29/448,946 entitled “Flexible Elongate Member with a Portion to Receive a Bone Anchor,” filed on Mar. 14, 2013.
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Number | Date | Country | |
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20180085149 A1 | Mar 2018 | US |
Number | Date | Country | |
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Parent | 13804407 | Mar 2013 | US |
Child | 15784577 | US |