Multi-axis receiver with tether
By designing a multi-axis receiver, the problem that the existing spinal fixation device requires additional equipment is solved, and simpler operation and better stability are achieved, which is suitable for spinal fixation devices.
Patent Information
- Application Number
- CN202480014379.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2023-02-22
- Filing Date
- 2024-02-21
- Publication Date
- 2025-10-03
AI Technical Summary
Existing spinal fixation devices require additional anchoring equipment, which increases the space occupied by the structure and the complexity of the surgeon's operation. In addition, most of them are single-axis structures and lack adjustability.
A multi-axial receiver was designed with a U-shaped cavity and a lower cavity that can be coupled to a bone screw and fixed with a tether through a clamp and a threaded member, providing multiple passages and slotted openings to stabilize the spine and reduce the use of additional equipment.
The invention simplifies surgical operation, reduces the space occupied by the structure, provides better adjustability and stability, and improves the flexibility of the spinal fixation device.
Smart Images
Figure CN120751996A_ABST
Abstract
Description
Technical Field
[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 486,285, filed on February 22, 2023, which is incorporated herein by reference in its entirety.
[0002] The present technology as a whole relates to implants that can be used in spinal fixation surgical procedures. More specifically, the disclosure herein can relate to implants and implant systems having holes for passing tethers, ligatures, and / or artificial ligament strips to further stabilize and support the implant and the patient's anatomy. The disclosed implants can be multi-axial receivers that can pop out onto bone anchors, bone screws, pedicle screws, or cortical screws. Additionally, various implants can have at least one hole for passing a tether through and a fixture for securing the tether to the implant. Background Art
[0003] There are a variety of structures and methods for treating one or more degenerative, deformed or damaged vertebral stages of a patient's spine with the aid of internal spinal fixation. Typically, this involves the attachment of a spinal implant system to provide a construct attached to two or more adjacent vertebrae to support and stabilize the vertebrae, thereby allowing them to fuse together in a fixed relationship relative to each other. Spinal fusion constructs typically include a bone screw and a longitudinal support member or rod attached to the bone screw, and the bone screw and the longitudinal support member or rod together can fix the position of the adjacent vertebrae to which they are attached.
[0004] The related art teaches various anchoring devices that attach to constructs and allow the surgeon to secure tethers and / or ligament strips to the construct. However, these specialized anchoring devices require the surgeon to add one or more additional devices to the construct. These additional devices increase the space occupied by the construct, requiring additional manipulation by the surgeon and requiring consideration. Furthermore, these constructs are typically uniaxial, have a relatively high height, occupy additional space along the shaft, and therefore do not provide the surgeon with sufficient adjustability.
[0005] The term "tether" is generally used to refer to a type of fiber rope that a surgeon can use to perform various procedures used together with the disclosed implant embodiment. Typically, these structures can be flexible elongated structures that make them bend easily (applying relatively little force), but also have strong resistance to longitudinal stretching by considerable pulling force. For example, these structures have relatively high tensile strength and relatively low compressive strength. Summary of the Invention
[0006] The present disclosure generally relates to receivers, such as multi-axial receivers, for performing surgical procedures on a patient's spine. Various multi-axial receivers may have at least one aperture for receiving a tether therein, and the tether may be wrapped around various portions of a vertebra (pedicle, lamina, spinous process, etc.) to further stabilize the patient's spine.
[0007] In one aspect, the present disclosure provides a multi-axis receiver comprising a body having a U-shaped cavity configured to receive a longitudinal rod therein and a lower cavity configured to couple to a bone screw. In various embodiments, the body may extend in a first direction along a longitudinal axis and in a transverse direction along a transverse axis. In various embodiments, the body may include a first arm portion and a second arm portion, the first and second arm portions together defining the U-shaped cavity, the first arm portion including a first passageway having a first hole extending in the transverse direction and a first slotted opening exposing the first passageway in the first direction, and the second arm portion including a second passageway having a second hole extending through the second passageway in the transverse direction and a second slotted opening exposing the second passageway. The first and second passageways may each be configured to receive at least one tether therein. In various embodiments, a clamp for securing the at least one tether may be provided, and the clamp may include a first protrusion and a second protrusion opposite the first protrusion. The receiver may further include a first threaded member configured to be disposed in the U-shaped cavity such that a proximal portion of the first threaded member extends above the top surface of the first arm portion and the top surface of the second arm portion in the first direction. The receiver may further include a second threaded member configured to engage with the first threaded member such that the second threaded member is movable in the first direction to urge the clamp into a tightened position in which the first protrusion extends into the first slotted opening and the second protrusion extends into the second slotted opening.
[0008] In another aspect, the present disclosure provides a multi-axial receiver and tether adapter assembly. The multi-axial receiver may include a body having a U-shaped cavity and a lower cavity, the U-shaped cavity being configured to receive a longitudinal rod therein, the lower cavity being configured to couple to a bone screw, and the body being extendable in a first direction along a longitudinal axis and in a transverse direction along a transverse axis. In various embodiments, the body may include a first arm portion and a second arm portion, the first arm portion and the second arm portion together defining the U-shaped cavity. In various embodiments, the receiver may include a clamp assembly comprising an upper clamp portion configured to mate with a lower clamp portion. The lower clamp portion may include a first passageway and a second passageway, the first passageway having a first hole extending in the transverse direction and a first slotted opening exposing the first passageway in the first direction, the second passageway having a second hole extending through the second passageway in the transverse direction and a second slotted opening exposing the second passageway in the first direction. For example, the first passageway can be configured to receive at least one tether therein, and the second passageway can be configured to receive the at least one tether therein. In various embodiments, for example, the upper clamp portion can include a first protrusion and a second protrusion disposed opposite the first protrusion. In various embodiments, the first threaded member can be configured to be disposed in the U-shaped cavity such that a proximal portion of the first threaded member extends above a top surface of the first arm portion and a top surface of the second arm portion in the first direction. In various embodiments, the second threaded member can be configured to engage with the first threaded member such that the second threaded member can move in the first direction, thereby pushing the clamp into a tightened position in which the first protrusion extends into the first slotted opening and the second protrusion extends into the second slotted opening.
[0009] In another aspect, the present disclosure provides a multi-axis receiver and tether adapter assembly. The multi-axis receiver may include a body having a U-shaped cavity and a lower cavity, the U-shaped cavity being configured to receive a longitudinal rod therein, the lower cavity being configured to couple to a bone screw, and the body being extendable in a first direction along a longitudinal axis and in a transverse direction along a transverse axis. The body may include a first arm portion and a second arm portion, the first arm portion and the second arm portion together defining the U-shaped cavity. In various embodiments, the receiver may include a clamp assembly comprising an upper clamp portion configured to mate with a lower clamp portion. In various embodiments, the lower clamp portion may include a passageway having a first hole extending in the transverse direction and a slotted opening exposing the passageway in the first direction. In various embodiments, for example, the upper clamp portion may include a protrusion having a size and shape corresponding to the size and shape of the slotted opening. In various embodiments, the first threaded member can be configured to be disposed in the U-shaped cavity such that a proximal portion of the first threaded member extends in the first direction above the top surface of the first arm portion and the top surface of the second arm portion. In various embodiments, the second threaded member can be configured to engage with the first threaded member such that the second threaded member can move in the first direction, thereby urging the clamp into a tightened position in which the first protrusion extends into the first slotted opening and the second protrusion extends into the second slotted opening.
[0010] The details of one or more aspects of the present disclosure are set forth in the following drawings and the description. Other features, objects, and advantages of the technology described in this disclosure will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS
[0011] Figure 1 is a perspective view of a first multi-axis receiver embodiment.
[0012] Figure 2 yes Figure 1 Side view of a multi-axis receiver embodiment.
[0013] Figure 3 yes Figure 1 A first exploded parts view of a multi-axis receiver embodiment of FIG.
[0014] Figure 4 yes Figure 1 A second exploded parts view of a multi-axis receiver embodiment of FIG.
[0015] Figure 5 is a perspective view of a second multi-axis receiver embodiment.
[0016] Figure 6 yes Figure 5 Side view of a multi-axis receiver embodiment.
[0017] Figure 7 yes Figure 5 A first exploded parts view of a multi-axis receiver embodiment of FIG.
[0018] Figure 8 yes Figure 5 A second exploded parts view of a multi-axis receiver embodiment of FIG.
[0019] Figure 9 yes Figure 5 An exploded parts view of selected components of an embodiment of a multi-axis receiver from a top-down perspective.
[0020] Figure 10 yes Figure 9 A perspective view of the assembled parts of the components shown in FIG.
[0021] Figure 11 is a perspective view of a third multi-axis receiver embodiment.
[0022] Figure 12 yes Figure 11 Side view of a multi-axis receiver embodiment.
[0023] Figure 13 yes Figure 11 A first exploded parts view of a multi-axis receiver embodiment of FIG.
[0024] Figure 14 yes Figure 11 A second exploded parts view of a multi-axis receiver embodiment of the embodiment from a side perspective.
[0025] Figure 15 yes Figure 11 An exploded parts view of selected components of an embodiment of a multi-axis receiver from a top-down perspective.
[0026] Figure 16 yes Figure 15 A perspective view of the assembled parts of the components shown in FIG. DETAILED DESCRIPTION
[0027] Embodiments of the present disclosure generally relate to, for example, a spinal stabilization system including a receiver, such as, for example, a multi-axial receiver, having a means for passing a tether through the multi-axial receiver and a securing means for securing the tether relative to the multi-axial receiver. Embodiments of apparatus and methods are described below with reference to the accompanying drawings.
[0028] The following discussion omits or only briefly describes certain components, features and functionality associated with medical implants, installation tools and related surgical techniques, which are obvious to those of ordinary skill in the art. It should be noted that various embodiments are described in detail with reference to the accompanying drawings, wherein similar reference numerals represent similar parts and components in several views, where possible. Reference to various embodiments does not limit the scope of the appended claims, as these embodiments are examples of the inventive concepts described herein. Additionally, any examples set forth in this specification are intended to be non-restrictive and set forth some embodiments of the many possible embodiments applicable to the appended claims. Moreover, unless the context or other statements clearly indicate otherwise, the specific features described herein may be used in combination with the features of the other descriptions in each of the various possible combinations and arrangements.
[0029] As used herein, terms such as "same," "equal," "planar," "coplanar," "parallel," and "perpendicular" are intended to encompass identical meanings, while also encompassing variations that may occur, for example, due to manufacturing processes or assembly or installation methods. The term "substantially" may be used herein to emphasize this meaning, particularly when the embodiments being described have the same or nearly the same functionality or characteristics, unless the context or other statements clearly indicate otherwise. The terms "upper" and "lower" may be used to describe the spatial relationship of one component relative to another component when viewed from a normal angle.
[0030] refer to Figures 1 to 16 , various multi-axis receivers 100, 101, and 102 for use with tethers are disclosed. The components of the disclosed embodiments can be made of bio-acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics, and bone materials and / or composites thereof. For example, the components can be made, individually or collectively, of materials such as stainless steel alloys, commercially pure titanium, titanium alloys, grade 5 titanium, superelastic titanium alloys, cobalt-chromium alloys, superelastic metal alloys (e.g., Nitinol), superelastic metals such as GUM, and the like. ), ceramics and their composites, such as calcium phosphate (e.g., SKELITE TM), thermoplastics such as polyaryletherketone (PAEK) (including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK)), carbon-PEEK composites, PEEK-BaSO4 polymer rubber, polyethylene terephthalate (PET), fabrics, silicones, polyurethanes, silicone-polyurethane copolymers, polymer rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermosetting elastomers, elastomer composites, rigid polymers (including polyphenylene, polyamide, polyimide, polyether amide), imide, polyethylene, epoxy resin), composites of metal and calcium-based ceramics, composites of PEEK and calcium-based ceramics, composites of PEEK and resorbable polymers, fully resorbable materials (such as, for example, calcium-based ceramics such as calcium phosphate, tricalcium phosphate (TCP), hydroxyapatite (HA)-TCP, calcium sulfate), or other resorbable polymers such as polyaetide, polyglycolide, polytyrosine carbonate, polycaprolactone, polyacetic acid or polylactide, and combinations thereof.
[0031] Figures 1 to 4 A first multi-axis receiver 100 is shown, Figures 5 to 10 A second multi-axis receiver 101 is shown, Figures 11 to 16 A third multi-axis receiver 102 is shown.
[0032] Overall reference Figures 1 to 4 , a first multi-axis receiver 100 is disclosed. Figure 1 is a perspective view of the multi-axis receiver 100, Figure 2 is a side view of the multi-axis receiver, Figure 3 is an exploded view of a multi-axis receiver, and Figure 4 1 is a partially exploded view of the parts. In various embodiments, the receiver 100 may include a body 1 having a lower cavity 19 for coupling with the head of a bone screw 50 that allows the receiver to be oriented at various angles. The receiver 100 may include a U-shaped cavity 41 for receiving the longitudinal rod 40 therein. Figure 2 In a side view of the body 1, the body 1 may extend in a vertical direction (X-axis) along a longitudinal axis and extend in a first horizontal direction (Y-axis) and a second horizontal direction (Z-axis) along a transverse axis. In some embodiments, the vertical direction may be referred to as a first direction, and the horizontal direction may be referred to as a transverse direction substantially perpendicular to the first direction.
[0033] In the disclosed embodiment, the body 1 can include a first arm portion 2 and a second arm portion 3 that together define a U-shaped cavity 41. In an exemplary embodiment, the U-shaped cavity 41 can include a thread profile 25 on each side of the U-shaped cavity for mating with a first threaded member 20 that secures the longitudinal rod 40 from above, as will be understood by one of ordinary skill in the art. In this embodiment, the first threaded member 20 is a set screw that can be configured to be disposed within the U-shaped cavity 41 of the body 1 such that a distal portion of the first threaded member 20 directly contacts the longitudinal rod 40 and a proximal portion of the first threaded member 20 extends vertically above a top surface of the first arm portion 2 and a top surface of the second arm portion 3.
[0034] As in Figure 2 The best seen in Figures 7 and 8 and Figures 13 and 14 In the illustrated embodiment, the first arm portion 2 and the second arm portion 3 are relatively wide when compared to the non-extended receiver body 1. For example, the first arm portion 2 may include an extended and / or widened arm portion wide enough to accommodate a first passageway 6 having a first aperture extending horizontally. Similarly, the second arm portion 3 may include an extended and / or widened arm portion wide enough to accommodate a second passageway 7 having a second aperture extending horizontally. In this embodiment, the first passageway 6 and the second passageway 7 extend in parallel, offset directions on opposite sides of the U-shaped cavity 41. In the exemplary embodiment, the first arm portion 2 includes a first slotted opening 4 vertically exposing the first passageway 6 from above, and the second arm portion 3 includes a second slotted opening 5 vertically exposing the second passageway 7 from above. In various embodiments, the first passageway 6 and the second passageway 7 are each configured to receive at least one tether therein. For example, the first passageway 6 may receive a first tether therein, and the second passageway 7 may receive a second tether therein. In some embodiments, the surgeon may utilize a single tether and pass it a first time through the first passage 6 and then a second time through the second passage 7 (or vice versa). Thereafter, the surgeon may secure the tether relative to the body 1 via the securing clamp 10, as will be explained in further detail below.
[0035] In various embodiments, the receiver 100 may include a clamp 10 having a central hole 11, a first protrusion 12, and a second protrusion 14 disposed opposite the first protrusion 12. Figure 4, the first protrusion 12 and the second protrusion 14 can be shaped like a rectangular block that includes a smooth bottom surface 13 or a high friction bottom surface 16 that can allow the corresponding type of protrusion to grip the tether passing through the first passage 6 and the second passage 7. As used herein, "high friction" surface is used in its broadest sense to include any texture or feature that can increase the coefficient of friction, such as teeth, spikes, chamfered teeth, dimples, shot peening, etc., to help secure the tether. For example, Figure 1 As shown, the clamp 10 can be positioned above the body 1 so that the first protrusion 12 extends from above into the first passage 6 and the second protrusion 14 extends from above into the second passage 7. For example, the size and shape of the first protrusion and the second protrusion can correspond to the size and shape of the first groove 4 and the second groove 5 (which communicate with the first passage 6 and the second passage 7 from above).
[0036] refer to Figure 2 and Figure 3 , the central hole 11 of the clamp 10 can be configured to permit the proximal portion of the first threaded member 20 to extend therethrough, such that the proximal portion of the first threaded member 20 is exposed and can be secured to the second threaded member 30. In various embodiments, the second threaded member 30 is a nut that can be configured to engage with the proximal portion of the first threaded member 20 such that when the second threaded member 30 is rotated in a first direction, the second threaded member 30 can move in a vertical direction along a corresponding length of the first threaded member 20.
[0037] In an alternative embodiment, the first threaded member 20 can be a bolt having an external thread pattern that is configured to threadably engage the internal thread pattern 25 of the first and second arm portions 2, 3 (not shown). For example, the bolt can have a hollow central bore with a corresponding thread pattern configured to receive a set screw. The set screw can be rotated so that it travels in a linear direction toward the longitudinal rod 40. In this manner, a bolt having a corresponding set screw for threading into the inner portion of the bolt can also be used to position the clamp 10 in a tightened position.
[0038] In this embodiment, the first threaded member 20 is a multi-diameter breakaway set screw comprising a breakaway portion 21, a first diameter thread pattern 23, and a second diameter thread pattern 24. For example, the first diameter thread pattern 23 corresponds to the smaller outer diameter of the set screw, and the second diameter thread pattern 24 corresponds to the larger outer diameter of the set screw. In the installed position, where the first threaded member 20 directly contacts the longitudinal rod 40, the proximal portion of the first threaded member 20 (including the breakaway portion 21 and the first diameter thread pattern 23) can extend above the upper surface of the clamp 10. In this manner, the internal thread pattern 31 of the second threaded member 30 can engage with the first diameter thread pattern 23 of the first threaded member 20. Therefore, when the second threaded member 30 is rotated, it is vertically advanced downward, thereby forcing the clamp 10 into a secured position, in which the first and second protrusions 12, 14 secure a tether threaded through either or both of the first and second passageways 6, 7. The breakaway portion 21 can then be sheared off using any suitable tool to reduce the height of the receiver 100.
[0039] As in Figure 4 As best seen in the drawings, the main body 1 may include a valley 8 on the bottom support surface of the first passage 6 and / or the second passage 7. In various embodiments, the valley 8 may form a gap space between the bottom surface of the first protrusion 12 and the second protrusion 14 and the support surface of the first passage 6 and the second passage 7. The valley 8 may have the advantage of providing pressure relief for the tether so that the tether is not damaged or cut due to over-tightening when the clamp 10 is secured in the fully tightened position. In an example embodiment, the longitudinal rod 40 may be oriented in a horizontal direction in a direction substantially parallel to the direction of extension of the first passage 6 and the second passage 7. However, in other embodiments, the main body 1 may be contoured in such a manner that the longitudinal rod 40 is offset and / or oriented at an angle relative to the direction of extension of the first passage 6 and / or the second passage 7 (not shown).
[0040] In one installation method, the first step of installation may include initially securing the body 1 to the bone screw 50 and thereafter securing the longitudinal rod 40 within the U-shaped cavity 41 by tightening the first threaded member 20. Once the body 1 and longitudinal rod 40 are secured in place, the surgeon may thread a tether through either or both of the passageways 6 and 7 of the body 1. For example, the surgeon may thread the tether through the first passageway 6 and wrap the tether around the spinous process of the vertebra, and then return the tether through the second passageway 7. Thereafter, the surgeon may secure the tether relative to the body 1 by rotating the second threaded member 30 along the first diametrical thread pattern 23 of the first threaded member 20, such that the first and second protrusions 12 and 14 will press downwardly onto the tether from above by passing through the first and second slotted openings 4 and 5. It should be understood that this example is non-limiting, and other tether installation methods and paths are contemplated. For example, it should be understood that in some embodiments, the surgeon may thread the tether through a hole in the body 1 before securing the body 1 to the bone screw 50 and / or longitudinal rod 40. In summary, embodiments according to the principles herein provide the surgeon with the ability to perform different installation sequences, eg, the tether may be passed before, after, or even simultaneously with securing the body 1 to the bone screw 50 .
[0041] Overall reference Figures 5 to 10 , a second multi-axis receiver 101 for receiving a tether is disclosed. The second multi-axis receiver 101 may include the same, similar, and / or substantially the same features and functionality as described above with respect to receiver 101. Therefore, the same numbering of parts will be maintained where practical, and repetitive descriptions will be omitted or only briefly described.
[0042] This embodiment may differ in that arm portions 2 and 3 do not have extensions for accommodating a tether receiving passageway. Instead, in this embodiment, a tether receiving adapter assembly is used with a standard-width multi-axis receiver. As used herein, a standard-width multi-axis receiver is used to describe a receiver in which the outer width of the receiver, as measured through first arm portion 2 and second arm portion 3, remains substantially constant. In other words, a first distance measured horizontally from a central vertical axis bisecting the receiver into two equal halves to an outer side surface of the first arm portion is equal to a second distance measured horizontally from the central vertical axis to a side surface of the second arm portion.
[0043] Figure 5 is a perspective view of a second multi-axis receiver embodiment 101, and Figure 6 is a side view of a second multi-axis receiver embodiment 101. Figure 7 and Figure 8 is an exploded parts view of a second multi-axis receiver embodiment 101 . Figure 9is an exploded parts view of a tether adapter assembly, which in this embodiment is a two-part clamp assembly 60 . Figure 10 yes Figure 9 A perspective view of the assembled parts of the components shown in FIG.
[0044] The receiver 101 may include a body 1 having a U-shaped cavity 41 configured to receive a longitudinal rod 40 therein. The body 1 may include a first arm portion 2 and a second arm portion 3, the first arm portion and the second arm portion together defining the U-shaped body 1. The U-shaped cavity 41 may include a thread profile 25 to receive a first threaded member 20 therein, thereby securing the longitudinal rod 40 beneath the U-shaped cavity.
[0045] As in Figure 7 As best seen in FIG, first threaded member 20 can be a multi-diameter set screw including a first thread pattern 23 and a second thread pattern 24. In this example, a small diameter portion corresponding to first thread pattern 23 can extend above the uppermost surfaces of first and second arm portions 2, 4. In this manner, first thread pattern 23 can engage with internal thread pattern 31 of second threaded member 30, similar to as explained above. A large diameter portion corresponding to second thread pattern 24 can be threadedly connected to thread profile 25 on the interior of first and second arm portions 2, 3. In this manner, the bottommost surface of first threaded member 20, corresponding to the large diameter portion, can directly contact longitudinal rod 40.
[0046] In this embodiment, the receiver 101 has a tether adapter assembly that includes a two-part clamp assembly 60 having an upper clamp portion 63 and a lower clamp portion 64. The upper clamp portion 63 can be configured to mate and / or engage with the lower clamp portion 64, as will be explained in further detail below. In an example embodiment, the lower clamp portion 64 may include a first passage 61 and a second passage 62 disposed on opposite sides of the center hole 11. The lower clamp portion 64 may also include slotted openings 4, 5 on either side of the center hole 11 that expose the first passage 61 and the second passage 62, respectively, from above. The upper clamp portion 63 may include a first protrusion 12 and a second protrusion 14 on either side of the center hole 11. Similar to as explained above, these protrusions 12, 14 may have a size and shape that generally corresponds to the size and shape of the slotted openings 4, 5. As in Figure 7, the upper clamp portion 63 may include a groove 32 that is slightly larger than the central hole 11 and is configured to allow the second threaded member 30 to rest in the groove. In this manner, as the second threaded member 30 rotates around the first thread pattern 23 of the first threaded member 20, the bottom surface of the second threaded member 30 slides along the groove 32. This can have the advantage of helping to center the second threaded member 30 and the first threaded member 20 and reducing the vertical height of the receiver 101.
[0047] refer to Figure 9 and Figure 10 , the receiver 101 has a two-part clamp assembly 60 in which the central hole 11 has a specific size and shape corresponding to an ovoid rectangle so that the two-part clamp assembly 60 can slide on the body 1 of the receiver 101 (see Figure 10 ). For example, in a top-down perspective, the size and shape of the central hole 11 corresponds to the size and shape of the main body 1 measured between the first arm portion 2 and the second arm portion 3. Figure 9 As shown, the central apertures 11 of the lower clamp portion 64 and the upper clamp portion 63 each resemble a rectangle with curved side surfaces. For example, the central apertures 11 of the lower clamp portion 64 and the upper clamp portion 63 each include a corresponding pair of curved surfaces 26 and a corresponding pair of substantially straight surfaces 29. The curved surfaces 26 have a geometry corresponding in length and curvature to the outermost surfaces 27 of the first and second arm portions 2, 3. Similarly, the substantially straight surfaces 29 have a length corresponding to the distance between the first and second arm portions 2, 3. This configuration has the advantage of allowing the surgeon to use a multi-axis receiver body 1 of a standard width. This configuration also prevents the two-part clamp assembly 60 from rotating during tightening of the second threaded member 30. For example, the two-part clamp assembly 60 can fit tightly around the body 1, preventing or inhibiting twisting or rotation of the two-part clamp assembly 60 relative to the body 1.
[0048] refer to Figure 7 and Figure 8, the lower clamp portion 64 may include a concave-convex profile 18 on its bottom surface that is shaped as a semicircle. In this example, the concave-convex profile 18 has a size and shape that generally corresponds to the curvature of the exposed surface of the longitudinal rod 40 (e.g., along a corresponding arc segment of the longitudinal rod 40). In this way, the surgeon can slide the lower clamp portion 64 over the body 1 and allow it to rest on top of the longitudinal rod 40. Thereafter, the surgeon can slide the upper clamp portion 63 over the body 1 before passing the tether through either or both of the first and second passageways 61, 62. Once the two-part clamp assembly 60 is slid over the body 1, the proximal portion of the first threaded member 20 can extend above the top surfaces of the first and second arm portions 2, 3, and the top surface of the two-part clamp assembly 60. Similar to what was explained above with respect to receiver 100, receiver 101 can include a second threaded member 30 having an internal thread pattern 31 configured to engage a proximal portion of the first threaded member 20 that extends above the top surface of the two-part clamp assembly 60. For example, the internal thread pattern 31 can have a pitch that corresponds to the pitch of the first diametrical thread pattern 23. In this manner, once the second diametrical thread pattern 24 of the first threaded member 20 is engaged with the body 1 and the longitudinal rod 40 beneath the first threaded member is properly captured, the surgeon can begin tightening the second threaded member 30 to lock the two-part clamp assembly 60 in place relative to the body 1. For example, when the second threaded member 30 is rotated in a first direction, the second threaded member 30 moves downward in a vertical direction, thereby urging the upper clamp portion 63 downward toward the lower clamp portion 64 into a locked configuration in which the protrusions 12 and 14 can extend from above through the slotted openings 4, 5 into the passageways 61, 62 to secure a tether extending through either or both of the first passageway 61 and / or the second passageway 62. Conversely, when the two-part clamp assembly 60 has not yet been tightened via the second threaded member 30, the tether is allowed to freely pass through either passageway 61, 62.
[0049] Overall reference Figures 11 to 16 , a third multi-axial receiver 102 for receiving a tether is disclosed. The third multi-axial receiver 102 may include the same, similar and / or substantially the same features and functionality as explained above with respect to receivers 100 and 101. Therefore, the same numbering of parts will be maintained where feasible, and repetitive descriptions will be omitted or only briefly described. Multi-axial receiver 102 may be similar to receiver 101 in that, in this embodiment, a tether receiving adapter assembly is used with a multi-axial receiver of a standard width. Multi-axial receiver 102 may differ from receiver 101 in that the multi-axial receiver includes only a single tether receiving passageway 61 (see Figure 11 and Figure 14 ).
[0050] Figure 11 is a perspective view of the multi-axis receiver 102, and Figure 12 is a side view of the multi-axis receiver 102. Figures 13 and 14 is an exploded parts view of the multi-axis receiver 102 . Figure 15 is a top-down exploded parts view of a tether adapter assembly, which in this embodiment is a curved, two-part clamp assembly 70 of reduced width. Figure 16 yes Figure 15 A perspective view of the assembled parts of the components shown in FIG.
[0051] Overall reference Figures 11 to 16 , the multi-axial receiver 102 may include a body 1 having a U-shaped cavity 41 configured to receive a longitudinal rod 40. Similar to the first receiver 100 and the second receiver 101, the body 1 may include a lower cavity 19 configured to couple to the head of a bone screw 50. For example, as in Figure 13 , which shows that the receiver 102 (and any of the other receivers disclosed herein) can include a saddle and / or crown 43 for supporting the longitudinal rod 40 and any number of washers, annular rings 44, c-rings 45, etc. to facilitate coupling of the polyaxial receiver 102 to the bone screw 50 (see Figure 12 ). For example, each of the annular ring 44, C-ring 45, etc. can be disposed in a corresponding annular groove (not shown) of the lower receiving cavity 19. In this manner, as will be understood by one of ordinary skill in the art, the multi-axial receiver 102 can be popped onto the head of the bone screw 50 simply by pressing down on the receiver 102.
[0052] Overall reference Figures 13 and 14 , the receiver 102 may include a first threaded member 20 configured to be disposed within the U-shaped cavity 41 such that a distal portion of the first threaded member 20 may directly contact the longitudinal rod 40 and a proximal portion of the first threaded member 20 may extend vertically above the top surface of the first arm portion 2 and the top surface of the second arm portion 3. The receiver 102 may include a two-part, curved clamp assembly 70 of reduced width having an upper clamp portion 73 configured to mate with a lower clamp portion 74. Similar to as explained above, the upper clamp portion 73 and the lower clamp portion 74 may each slide around the first arm portion 2 and the second arm portion 3 of the body 1.
[0053] Similar to embodiment 101, the lower clamp portion 74 may include a concave-convex profile 18 on its bottom surface that is shaped to resemble a semicircle. In various embodiments, the lower clamp portion 74 may include a single passage 61 having a first hole that extends in a horizontal direction for receiving a tether therein. The lower clamp portion 74 may also include a slotted opening 75 that exposes the passage 61 in a vertical direction. In this embodiment, the lower clamp portion 74 includes a curved side surface 77 on a side surface opposite the passage 61. Additionally, the upper clamp portion 36 includes a corresponding curved side surface 78. In various embodiments, the upper clamp portion 73 may include a protrusion 12 disposed opposite the curved side surface 78. The protrusion 12 may have a size and shape corresponding to the size and shape of the slotted opening 75 (see Figure 13 ).
[0054] Similar to receiver 101, receiver 102 includes a second threaded member 30 having an internal thread pattern 31 configured to engage the proximal portion of first threaded member 20 extending above the top surface of curved two-part clamp assembly 70. For example, internal thread pattern 31 may have a pitch corresponding to the pitch of first thread pattern 23. In this manner, once second thread pattern 24 of first threaded member 20 is engaged with body 1 and longitudinal rod 40 beneath the first threaded member is in a tightened position, the surgeon can begin tightening second threaded member 30 to lock curved two-part clamp assembly 70 in position relative to body 1. For example, when second threaded member 30 is rotated in a first direction, second threaded member 30 moves downward in a vertical direction, thereby forcing upper clamp portion 73 downward toward lower clamp portion 74 into a locked configuration in which protrusion 12 can extend from above into passageway 61 to secure a tether extending through first passageway 61. In contrast, when the two-part clamp 70 has not been tightened via the second threaded member 30 , the tether is allowed to freely pass through the passage 61 .
[0055] like Figures 15 and 16 As depicted, the receiver 102 has a curved two-part clamp assembly 70 in which the central hole 11 has a specific size and shape corresponding to an oval rectangle so that the two-part clamp assembly 70 can slide over the body 1 of the receiver (see Figure 16 ). For example, in a top-down perspective, the size and shape of the central hole 11 corresponds to the size and shape of the main body 1 measured between the first arm portion 2 and the second arm portion 3. Figure 15As shown, the central apertures 11 of the lower clamp portion 74 and the upper clamp portion 73 each resemble a rectangle with curved side surfaces. For example, the central apertures 11 of the lower clamp portion 74 and the upper clamp portion 73 each include a corresponding pair of curved surfaces 26 and a corresponding pair of substantially straight surfaces 29. The curved surface 26 has a geometry corresponding in length and curvature to the outermost surfaces 27 of the first and second arm portions 2, 3. Similarly, the substantially straight surface 29 has a length corresponding to the distance between the first and second arm portions 2, 3. This configuration has the advantage of allowing the surgeon to use a multi-axis receiver body 1 of a standard width. This configuration also prevents the curved two-part clamp assembly 70 from rotating during tightening of the second threaded member 30. For example, the two-part clamp 70 can fit tightly around the body 1, preventing and / or inhibiting twisting or rotation of the two-part clamp 70 relative to the body 1, the first and second arm portions 2, 3.
[0056] This embodiment may have additional advantages in selected surgical applications due to the reduced width of the curved two-part clamp assembly 70 relative to the two-part clamp assembly 60 of the receiver 101. For example, the curved side surfaces 77, 78 more closely approximate the curved side surface 27 of the first arm portion 2. In this manner, the width of the curved two-part clamp assembly 70 may be reduced to provide additional clearance.
[0057] It should be understood that the various aspects disclosed herein may be combined in combinations different from those specifically presented in the description and drawings. For example, unless the context clearly indicates otherwise, features, functionality, and components from one embodiment may be combined with another embodiment, and vice versa. Similarly, unless the context clearly indicates otherwise, features, functionality, and components may be omitted. It should also be understood that, depending on the example, certain actions or events of any of the processes or methods described herein may be performed in a different order, may be added, combined, or omitted entirely (e.g., not all described actions or events may be required to perform these techniques).
[0058] Unless otherwise specifically defined herein, all terms should be given their broadest possible interpretation, including the meaning implicit from the description and the meaning understood by those skilled in the art and / or the meaning as defined in dictionaries, treatises, etc. It must also be noted that, unless otherwise specified, the singular forms "a / an(s)" and "the" used in the description and the appended claims include plural referents, and the terms "comprises" and / or "comprising" when used in this description specify the presence of stated features, elements and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components and / or groups thereof.
[0059] What is claimed is
[0060] 1. A multi-axis receiver, comprising:
[0061] a body having a U-shaped cavity configured to receive a longitudinal rod therein and a lower cavity configured to couple to a bone screw, the body extending in a first direction along a longitudinal axis and extending in a transverse direction along a transverse axis;
[0062] a first arm portion and a second arm portion, the first arm portion and the second arm portion together defining the U-shaped cavity, the first arm portion including a first passageway having a first hole extending in the lateral direction and a first slotted opening exposing the first passageway in the first direction, the second arm portion including a second passageway having a second hole extending through the second passageway in the lateral direction and a second slotted opening exposing the second passageway in the first direction, the first passageway and the second passageway each being configured to receive at least one tether therein;
[0063] a clamp comprising a first protrusion and a second protrusion opposite to the first protrusion;
[0064] a first threaded member configured to be disposed in the U-shaped cavity such that a proximal portion of the first threaded member extends above a top surface of the first arm portion and a top surface of the second arm portion in the first direction; and
[0065] A second threaded member is configured to engage with the first threaded member so that the second threaded member can move in the first direction to urge the clamp into a tightened position, in which the first protrusion extends into the first slotted opening and the second protrusion extends into the second slotted opening.
[0066] 2. The multi-axis receiver of claim 1, wherein:
[0067] the first threaded member is a set screw configured to be disposed in the U-shaped cavity such that a distal portion of the set screw directly contacts the longitudinal rod and a proximal portion of the set screw extends through the central cavity of the clamp in the first direction and over a top surface of the first arm portion and a top surface of the second arm portion, and
[0068] The second threaded member is a nut configured to engage the proximal portion of the set screw.
[0069] 3. A multi-axis receiver according to claim 2, wherein the set screw is a multi-diameter set screw, the multi-diameter set screw having a first major diameter and a second major diameter, the first major diameter defining a first thread pattern corresponding to the thread pattern of the U-shaped cavity, and the second major diameter defining a second thread pattern corresponding to the internal thread pattern of the nut.
[0070] 4. The multi-axis receiver of claim 3, wherein the set screw includes a breakaway portion.
[0071] 5. The multi-axis receiver of claim 1, wherein:
[0072] the first hole includes a valley extending in the lateral direction such that in the tightened position a gap space exists between a bottom surface of the first passage and a bottom surface of the first protrusion, and
[0073] The clearance space is configured to reduce the likelihood of the at least one tether being cut in the tightened position.
[0074] 6. The multi-axis receiver of claim 1, wherein the first protrusion is shaped like a rectangular block, and the second protrusion is shaped like a rectangular block.
[0075] 7. The multi-axis receiver of claim 6, wherein the bottom surface of the first protrusion and the bottom surface of the second protrusion each comprise a high friction surface configured to grip the at least one tether.
[0076] 8. The multi-axis receiver of claim 1, wherein:
[0077] The first arm portion includes a first extension portion, and the second arm portion includes a second extension portion opposite to the first extension portion, the first extension portion protruding away from the U-shaped cavity in the transverse direction, and the second extension portion extending away from the U-shaped cavity in the transverse direction, and
[0078] The first passage extends through the first extension portion, and the second passage extends through the second extension portion.
[0079] 9. A multi-axis receiver and tether adapter assembly, the multi-axis receiver and tether adapter assembly comprising:
[0080] a body having a U-shaped cavity configured to receive a longitudinal rod therein and a lower cavity configured to couple to a bone screw, the body extending in a first direction along a longitudinal axis and in a transverse direction along a transverse axis, the body including a first arm portion and a second arm portion, the first arm portion and the second arm portion together defining the U-shaped cavity;
[0081] a clamp assembly comprising an upper clamp portion configured to mate with a lower clamp portion;
[0082] the lower clamp portion including a first passageway and a second passageway, the first passageway having a first hole extending in the lateral direction and a first slotted opening exposing the first passageway in the first direction, the second passageway having a second hole extending through the second passageway in the lateral direction and a second slotted opening exposing the second passageway in the first direction, the first passageway being configured to receive at least one tether therein, and the second passageway being configured to receive the at least one tether therein;
[0083] The upper clamp portion includes a first protrusion and a second protrusion disposed opposite to the first protrusion;
[0084] a first threaded member configured to be disposed in the U-shaped cavity such that a proximal portion of the first threaded member extends above a top surface of the first arm portion and a top surface of the second arm portion in the first direction; and
[0085] A second threaded member is configured to engage with the first threaded member so that the second threaded member can move in the first direction to urge the clamp into a tightened position in which the first protrusion extends into the first slotted opening and the second protrusion extends into the second slotted opening.
[0086] 10. The multi-axis receiver of claim 9, wherein:
[0087] the first threaded member is a set screw configured to be disposed in the U-shaped cavity such that a distal portion of the set screw directly contacts the longitudinal rod and a proximal portion of the set screw extends above a top surface of the first arm portion and a top surface of the second arm portion in the first direction, and
[0088] The second threaded member is a nut configured to engage the proximal portion of the set screw extending above the top surface of the clamp assembly so that when the nut is rotated in the first direction, the nut can move in the first direction, thereby urging the clamp assembly into the tightened position.
[0089] 11. The multi-axis receiver of claim 9, wherein in a cross-sectional view, the first hole has a circular shape such that in the tightened position, there is a gap space between a bottom surface of the first passage and a bottom surface of the first protrusion, and
[0090] Wherein the clearance space is configured to reduce the likelihood of the at least one tether being cut in the tightened position.
[0091] 12. The multi-axis receiver of claim 9, wherein a bottom surface of the first protrusion and a bottom surface of the second protrusion each comprise a high friction surface configured to grip the at least one tether.
[0092] 13. The multi-axis receiver of claim 9, wherein:
[0093] The upper clamp portion includes a first central hole, and the lower clamp portion includes a second central hole, and
[0094] The second central hole is configured to surround upper regions of the first arm portion and the second arm portion.
[0095] 14. The multi-axis receiver of claim 9, wherein the longitudinal axis extends in the first direction through a centerline of the body, the centerline bisecting the body into substantially symmetrical halves, and
[0096] wherein a first distance measured in the transverse direction from the longitudinal axis to an exposed side surface of the first arm portion is equal to a second distance measured in the transverse direction from the longitudinal axis to an exposed side surface of the second arm portion.
[0097] 15. A multi-axis receiver and tether adapter assembly, the multi-axis receiver and tether adapter assembly comprising:
[0098] a body having a U-shaped cavity configured to receive a longitudinal rod therein and a lower cavity configured to couple to a bone screw, the body extending in a first direction along a longitudinal axis and in a transverse direction along a transverse axis, the body including a first arm portion and a second arm portion, the first arm portion and the second arm portion together defining the U-shaped cavity;
[0099] a clamp assembly comprising an upper clamp portion configured to mate with a lower clamp portion;
[0100] The lower clamp portion includes a passage having a first hole extending in the transverse direction and a slotted opening exposing the passage in the first direction;
[0101] the upper clamp portion including a protrusion having a size and shape corresponding to the size and shape of the slotted opening; and
[0102] a first threaded member configured to be disposed in the U-shaped cavity such that a proximal portion of the first threaded member extends above a top surface of the first arm portion and a top surface of the second arm portion in the first direction;
[0103] A second threaded member is configured to engage with the first threaded member so that the second threaded member can move in the first direction to urge the clamp into a tightened position in which the first protrusion extends into the first slotted opening and the second protrusion extends into the second slotted opening.
[0104] 16. The multi-axis receiver of claim 15, wherein:
[0105] the first threaded member is a set screw configured to be disposed in the U-shaped cavity such that a distal portion of the set screw directly contacts the longitudinal rod and a proximal portion of the set screw extends above a top surface of the first arm portion and a top surface of the second arm portion in the first direction, and
[0106] The second threaded member is a nut configured to engage the proximal portion of the set screw extending above the top surface of the clamp assembly so that when the nut is rotated in the first direction, the nut can move in the first direction, thereby urging the clamp assembly into the tightened position.
[0107] 17. The multi-axis receiver of claim 15, wherein in a cross-sectional view, the first hole has a circular shape such that in the tightened position, there is a gap space between a bottom surface of the passage and a bottom surface of the protrusion, and
[0108] The clearance space is configured to reduce the likelihood of the tether being cut in the tightened position.
[0109] 18. The multi-axis receiver of claim 15, wherein a bottom surface of the protrusion comprises a high friction surface configured to grip the tether.
[0110] 19. The multi-axis receiver of claim 15, wherein:
[0111] The upper clamp portion includes a first central hole, and the lower clamp portion includes a second central hole, and
[0112] The second central hole is configured to surround upper regions of the first arm portion and the second arm portion.
[0113] 20. The multi-axis receiver of claim 15, wherein the longitudinal axis extends in the first direction through a centerline of the body, the centerline bisecting the body into substantially symmetrical halves, and
[0114] wherein a first distance measured in the transverse direction from the longitudinal axis to an exposed side surface of the first arm portion is equal to a second distance measured in the transverse direction from the longitudinal axis to an exposed side surface of the second arm portion.
Claims
1. A multi-axis receiver (100), comprising: a body (1) having a U-shaped cavity (41) configured to receive a longitudinal rod (40) therein and a lower cavity (19) configured to couple to a bone screw (50), the body extending in a first direction along a longitudinal axis and extending in a transverse direction along a transverse axis; a first arm portion (2) and a second arm portion (3), the first arm portion and the second arm portion together defining the U-shaped cavity, the first arm portion including a first passageway (6), the first passageway having a first hole extending in the transverse direction and a first slotted opening (4) exposing the first passageway in the first direction, the second arm portion including a second passageway (7), the second passageway having a second hole extending through the second passageway in the transverse direction and a second slotted opening (5) exposing the second passageway in the first direction, the first passageway and the second passageway each being configured to receive at least one tether therein; A clamp (10), comprising a first protrusion (12) and a second protrusion (14) arranged opposite to the first protrusion, a first threaded member (20) configured to be disposed in the U-shaped cavity (41) such that a proximal portion of the first threaded member extends above a top surface of the first arm portion and a top surface of the second arm portion in the first direction, and a second threaded member (30) configured to engage with the first threaded member so that the second threaded member can move in the first direction to urge the clamp into a tightened position in which the first protrusion extends into the first slotted opening and the second protrusion extends into the second slotted opening.
2. The multi-axis receiver of claim 1 , wherein: the first threaded member is a set screw configured to be disposed in the U-shaped cavity such that a distal portion of the set screw directly contacts the longitudinal rod and a proximal portion of the set screw extends through the central cavity of the clamp in the first direction and over a top surface of the first arm portion and a top surface of the second arm portion, and The second threaded member is a nut configured to engage the proximal portion of the set screw.
3. The multi-axis receiver according to any one of claims 1 to 2, wherein: In the open position, the at least one tether is allowed to selectively pass through any of: the first passageway, the second passageway, and both the first passageway and the second passageway, and In the tightened position, the first protrusion extends into the first slotted opening and the second protrusion extends into the second slotted opening, thereby securing the at least one tether passing through the first passageway and / or the second passageway.
4. The multi-axis receiver of any one of claims 1 to 3, wherein the first hole comprises a circular channel extending in the lateral direction such that in the tightened position, a gap space exists between a bottom surface of the first passage and a bottom surface of the first protrusion.
5. The multi-axis receiver of claim 4, wherein the clearance space is configured to reduce the likelihood of the at least one tether being cut in the tightened position. 6 . The multi-axis receiver according to claim 1 , wherein the first protrusion is shaped like a rectangular block, and the second protrusion is shaped like a rectangular block.
7. The multi-axis receiver of any one of claims 1 to 6, wherein the bottom surface of the first protrusion and the bottom surface of the second protrusion each include a high friction surface (16) configured to clamp the at least one tether.
8. The multi-axis receiver of claim 6, wherein the high friction surface comprises teeth.
9. The multi-axis receiver of any one of claims 1 to 6, wherein the bottom surface of the first protrusion and the bottom surface of the second protrusion each comprise a smooth surface (13) configured to clamp the at least one tether.
10. The multi-axis receiver according to any one of claims 1 to 9, wherein the first arm portion includes a first extension portion, and the second arm portion includes a second extension portion opposite to the first extension portion, the first extension portion protruding away from the U-shaped cavity in the transverse direction, and the second extension portion extending away from the U-shaped cavity in the transverse direction.
11. The multi-axis receiver of claim 10, wherein the first passage extends through the first extension portion and the second passage extends through the second extension portion.
12. A multi-axis receiver according to any one of claims 2 to 11, wherein the set screw is a multi-diameter set screw, the multi-diameter set screw having a first major diameter, the first major diameter defining a first thread pattern (24), the first thread pattern corresponding to the thread pattern (25) of the U-shaped cavity.
13. The multi-axis receiver of any one of claims 2 to 12, wherein the set screw further comprises a second major diameter, the second major diameter defining a second thread pattern (23), the second thread pattern corresponding to the internal thread pattern (31) of the nut.
14. The multi-axis receiver according to any one of claims 2 to 13, wherein the set screw comprises a break-away portion (21).
15. The multi-axis receiver according to any one of claims 2 to 14, wherein the clamp comprises a recess (32) having a size and shape corresponding to the size and shape of the nut.