Surgical instruments and methods for selectively coupling to objects
The surgical instruments with grooved shafts and locked sleeves enable secure, disassemblable connections for surgical procedures, addressing the challenge of maintaining rigidity and cleanliness in surgical instruments.
Patent Information
- Application Number
- JP2023546478
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2021-02-02
- Filing Date
- 2022-02-02
- Publication Date
- 2026-01-27
- Estimated Expiration
- 2042-02-02
AI Technical Summary
Existing surgical instruments struggle to provide a selective, rigid connection with objects while allowing for easy disassembly for cleaning and sterilization, often failing due to play and tolerances at component interfaces.
The surgical instruments feature an elongate shaft with longitudinal and circumferential grooves, a sleeve with protrusions and locks, and a button mechanism that allows for constrained axial and rotational movement, enabling a rigid connection with modular receiver heads and other objects, while being disassemblable for cleaning.
The instruments provide a secure, rigid connection during surgical procedures and can be easily disassembled for cleaning and sterilization, ensuring effective use and hygiene in operating room environments.
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Abstract
Description
[Technical Field]
[0001] The present disclosure relates to instruments and methods for selectively coupling to objects, for example, surgical instruments that form a rigid connection with an object during a surgical procedure and can later be disassembled for cleaning, sterilization, and the like. [Background technology]
[0002] Various surgical procedures may require one or more instruments to selectively couple to another object for use during the procedure. For example, in minimally invasive procedures, various elongated instruments may be coupled to various implants, anchors, and other objects and utilized to pass the objects through the surgical site and manipulate them from a remote location. In some cases, such instruments may be required to apply significant forces to the objects coupled thereto, e.g., significant axial forces in tension or compression, as well as rotational forces in some cases. Furthermore, certain instruments may include multiple components that can be selectively moved relative to one another, such as components that rotate relative to one another to selectively lock onto the object, etc.
[0003] Furthermore, surgical instruments used in an operating room environment may be subject to cleaning requirements that necessitate designs that allow for disassembly for sterilization, etc. The need to utilize disassembly-enabled components may conflict with the requirement for the instrument to achieve a desired selective coupling with an object, such as forming a rigid connection with an implant to apply the forces described above, etc.
[0004] One example of this tension is seen during surgery when assembling a modular receiver head to a bone screw shank, although various other examples exist. Modular bone anchors can be desirable in surgical procedures because they allow the surgeon or other user to implant a screw shank without attaching the spinal fixation element (e.g., a rod) that will receive the head to the screw shank, thereby allowing the surgeon to better visualize the implantation site and use thinner instruments. Once the screw shank is implanted, an insertion instrument can be used to couple the modular receiver head to the screw shank. The instrument may require a selectively rigid connection to the modular receiver head so that the instrument can be utilized to apply significant forces during implantation and positioning of the bone anchor. However, a competing concern is that the insertion instrument also be easily cleaned / sterilized, which often means disassembling the instrument into various parts. This can include instrument components that can rotate relative to each other and lock in one or more positions, but are separable as needed. Conventional instruments configured for such use often fail to provide a sufficiently rigid connection to an object due to play and tolerances at the various interfaces between the instrument's components. Summary of the Invention [Problem to be solved by the invention]
[0005] Therefore, there is a need for improved instruments and methods that provide selective attachment to objects, such as selective rigid connections between instrument components, while allowing for disassembly for cleaning and sterilization. [Means for solving the problem]
[0006] The present disclosure provides examples of surgical instruments that address the above-mentioned challenges. For example, the embodiments described herein can provide a surgical instrument having multiple components that can be disassembled and moved relative to one another for configuration changes (e.g., coupling / detachment to various objects), while still providing a desired selective coupling (e.g., rigid connection) to another object. While the particular embodiments described herein are particularly adapted to couple with modular receiver heads used during spinal fixation procedures, the features of the disclosed embodiments can also be utilized with other types of instruments used in a variety of other surgical procedures.
[0007] In one aspect, a surgical instrument is disclosed that includes an elongate shaft having a longitudinal groove formed along a portion of the elongate shaft, a first partial circumferential groove intersecting a distal end of the longitudinal groove, and a second at least partial circumferential groove formed distal to the first partial circumferential groove. The instrument further includes a sleeve configured to be disposed over the elongate shaft, the sleeve including a protrusion extending from an inner wall of the sleeve configured to be received within the longitudinal groove of the elongate shaft to constrain movement of the sleeve relative to the shaft when the sleeve is disposed over the elongate shaft. The sleeve further includes a lock configured to cooperate with the second at least partial circumferential groove when the protrusion is disposed within the first partial circumferential groove to further selectively constrain both axial and rotational movement of the sleeve relative to the shaft.
[0008] The instruments and methods described herein can have many additional features and / or variations, all of which are within the scope of the present disclosure. For example, in some embodiments, the lock can include a button disposed within a recess in the sleeve and configured to translate radially relative to the sleeve and elongate shaft between a locked position and an unlocked position. The button can optionally be biased toward the locked position. In some embodiments, the button can include a throughbore configured to receive the elongate shaft.
[0009] In certain embodiments, the second at least partial circumferential groove can include a plurality of flat portions angularly offset from one another to define a plurality of rotational positions of the shaft relative to the sleeve. In some embodiments, for example, the plurality of flat portions can include a first flat portion and a second flat portion that define a first rotational position and a second rotational position of the shaft relative to the sleeve. The lock can optionally include a flat portion configured to abut one of the plurality of flat portions of the second at least partial circumferential groove to maintain the shaft in one of the plurality of rotational positions relative to the sleeve.
[0010] In some embodiments, the instrument can further include a handle configured to couple to a proximal portion of the elongate shaft to facilitate manipulation. Additionally, in certain embodiments, the sleeve and the elongate shaft can be configured to engage one or more objects therebetween to form a rigid connection with the one or more objects. For example, in some cases, the sleeve can further include a pair of arms that engage an object when positioned between the elongate shaft and the sleeve. The object can be any of a variety of objects utilized in various surgical procedures. For example, in some embodiments, the object can include one or more extension tabs on the receiver head.
[0011] In another aspect, a surgical instrument is disclosed that includes an elongate shaft having a longitudinal groove formed along a portion of the elongate shaft, a first partial circumferential groove intersecting a distal end of the longitudinal groove, and a second circumferential groove formed distal to the first partial circumferential groove. The instrument further includes a sleeve configured to be disposed over the elongate shaft and a pin configured to be received in a throughbore of the sleeve, the pin extending into an inner lumen of the sleeve and capable of being received in the longitudinal groove and the first partial circumferential groove of the elongate shaft to constrain relative movement between the sleeve and the elongate shaft when the sleeve is disposed over the elongate shaft. The instrument further includes a button received in a recess of the sleeve and configured to translate radially relative to the recess. The button includes a throughbore formed therein that is configured to receive the elongate shaft through the throughbore when the sleeve is disposed over the elongate shaft. Additionally, the button is disposed within the second circumferential groove of the elongate shaft and is configured to further restrict relative movement between the elongate shaft and the sleeve when the pin is received in the first partial circumferential groove of the elongate shaft.
[0012] As noted above, any of a variety of additional features and / or modifications are possible and within the scope of the present disclosure. For example, in some embodiments, the sleeve can further include a first partial circumferential protrusion and a second partial circumferential protrusion formed on the wall of the inner lumen of the sleeve. Also, in certain embodiments, the button can be biased radially outward relative to the sleeve.
[0013] In some embodiments, the second circumferential groove can include a plurality of flat portions angularly offset from one another to define a plurality of rotational positions of the shaft relative to the sleeve. For example, in some embodiments, the plurality of flat portions can include a first flat portion and a second flat portion that define a first rotational position and a second rotational position of the shaft relative to the sleeve. In some embodiments, the button can include a flat portion configured to abut one of the plurality of flat portions of the second circumferential groove to maintain the shaft in one of the plurality of rotational positions relative to the sleeve.
[0014] In some embodiments, the sleeve and elongate shaft can be configured to engage one or more objects therebetween to form a rigid connection with the one or more objects. Such objects can include, for example, opposing arms of a receiver head used in spinal fixation, but other objects utilized in different procedures are also possible.
[0015] In another aspect, a method for coupling an instrument to an object is disclosed, the method including advancing a sleeve over an elongate shaft such that a protrusion extending from an inner wall of the sleeve moves within a longitudinal groove formed in the elongate shaft. The method further includes positioning an object such that a portion of the object is disposed between the sleeve and the elongate shaft. The method also includes rotating the sleeve relative to the elongate shaft such that the protrusion moves within a partial circumferential groove formed in the elongate shaft that intersects a distal end of the longitudinal groove to prevent relative movement between the object and the instrument.
[0016] As with the aspects disclosed above, various additional steps and / or variations are possible and within the scope of the present disclosure. For example, in some embodiments, positioning the object can include contacting the object with a pair of arms extending from the sleeve.
[0017] In certain embodiments, the sleeve can be advanced over the elongate shaft to a position where the protrusion is disposed at an intersection of the longitudinal groove and the partial circumferential groove, and the sleeve lock can be disposed in a second at least partial circumferential groove formed in the elongate shaft distal to the partial circumferential groove. Furthermore, in some embodiments, the second at least partial circumferential groove includes a plurality of flats angularly offset from one another to define a plurality of rotational positions of the shaft relative to the sleeve, the lock including a flat configured to abut one of the plurality of flats of the second at least partial circumferential groove to maintain the shaft in one of the plurality of rotational positions relative to the sleeve, and rotating the sleeve relative to the elongate shaft can include rotating the sleeve between a first rotational position of the plurality of rotational positions and a second rotational position of the plurality of rotational positions. In other embodiments, the method can further include actuating the sleeve lock to move the lock from the second at least partial circumferential groove formed in the elongate shaft.
[0018] Any of the features or variations described above may be applied to any particular aspect or embodiment of the present disclosure in several different combinations, and without explicit mention of any particular combination, this is solely to avoid duplication in this summary or elsewhere in the present disclosure. [Brief explanation of the drawings]
[0019] The present invention will be more fully understood from the following detailed description when read in conjunction with the accompanying drawings, in which: [Figure 1] FIG. 1 illustrates a front perspective view of one embodiment of a modular implant inserter. [Figure 2] 2 is a side view of the modular implant inserter of FIG. 1 mated to a bone anchor and a handle. [Figure 3] FIG. 1 is a perspective view of a bone anchor assembly. [Figure 4] FIG. 10 is a perspective view of a modular receiver member of a bone anchor assembly having extension tabs. [Figure 5] FIG. 10 is a side view of another modular receiver member of a bone anchor assembly having extension tabs. [Figure 6] FIG. 2 is an exploded perspective view of the device of FIG. 1. [Figure 7] FIG. 2 is a detailed, partially transparent top view of the device of FIG. 1. [Figure 8A] FIG. 2 is a rear perspective view of the sleeve of the device of FIG. 1. [Figure 8B] FIG. 8B is a rear exploded view of the sleeve of FIG. 8A. [Figure 8C] FIG. 8B is a front perspective view of the sleeve of FIG. 8A. [Figure 9] FIG. 2 is a top view of the device of FIG. 1 in an unlocked position. [Figure 10] FIG. 2 is a cross-sectional side view of the device of FIG. 1 in an unlocked position. [Figure 11] FIG. 2 is a detailed cross-sectional side view of the device of FIG. 1 in an unlocked position. [Figure 12] FIG. 2 is a detailed cross-sectional view of the device of FIG. 1 in an unlocked position. [Figure 13] 6 is a top view of the device of FIG. 1 in a locked position coupled to a modular receiver member having an extension tab as shown in FIG. 5. [Figure 14] FIG. 14 is a top cross-sectional view of the device of FIG. 13. [Figure 15] FIG. 3 is a front perspective view of the handle of FIG. 2. [Figure 16] FIG. 17 is a front perspective view of the modular actuator of the handle of FIG. 16. [Figure 17] FIG. 18 is a cross-sectional side view of the modular actuator of FIG. 17 having an elongated shaft disposed therein. [Figure 18] FIG. 10 is a front perspective view of another embodiment of a modular implant inserter. [Figure 19] FIG. 19 is a front perspective view of the sleeve assembly of the device of FIG. 18. [Figure 20] 19 is a top view of the device of FIG. 18 in an unlocked configuration and positioned for coupling with a polyaxial bone anchor such as that shown in FIG. 3. [Figure 21] 19 is a top view of the elongate shaft and sleeve assembly of the device of FIG. 18 in a locked position coupled to a modular receiver member such as that shown in FIG. 3. [Figure 22] FIG. 22 is a top cross-sectional view of the assembly of FIG. 21. DETAILED DESCRIPTION OF THE INVENTION
[0020] Certain exemplary embodiments will now be described to provide a general understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments, and that the scope of the invention is defined only by the claims. Features illustrated or described in connection with one embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be within the scope of the present disclosure.
[0021] Instruments and methods are generally provided for assembly of modular implants. In particular, the instruments and methods disclosed herein enable the formation of rigid connections with implant components, such as bone anchors, to enable intraoperative assembly of the implant components. During assembly of the implant, the instrument can apply one or more forces to the implant components to secure the components together. For example, the instrument can rigidly connect to an implant component and manipulate it relative to other implant components to modularly assemble the implant. The instrument can include multiple components that can move independently relative to each other and the other implant components to lock the instrument in one or more positions. The components can be selectively disassembled so that one or more of the components can be cleaned and / or replaced.
[0022] Various devices and methods are disclosed herein. Some devices include spinal implants configured to be placed between adjacent vertebrae. Other devices include spinal fixation elements that can be configured to extend from one vertebra to one or more other vertebrae, even if the vertebrae are not adjacent. The disclosed methods include surgical techniques that allow implants to be placed through small incisions located laterally, anteriorly, or posterolaterally on the subject receiving treatment. Furthermore, in this disclosure, like-numbered components of embodiments generally have similar features, and therefore, each feature of like-numbered components within a particular embodiment has not necessarily been fully described. Furthermore, to the extent that linear or circular dimensions are used in describing the disclosed devices and methods, such dimensions are not intended to limit the types of shapes that can be used with such devices and methods. Equivalents to such linear and circular dimensions can be determined for any geometric shape. The size and shape of each device and its components may depend, at least, on the anatomy of the subject with whom the device is used and the size and shape of the components with which the device is used.
[0023] FIG. 1 illustrates one embodiment of an instrument 100 for connecting modular structures, e.g., implant components, to couple the structures to various devices. For example, instrument 100 can generally be used to assemble a modular spinal fixation element receiver member or head to a shank, e.g., a bone screw shank, during surgery and / or in situ. Instrument 100 can selectively form a rigid connection with an implant by engaging one or more implant components. As shown, instrument 100 can be attached to opposing arms or extension tabs of a modular component, e.g., a receiver member, to allow for the transfer of tension and compression forces during selective attachment of the modular component to another structure, thereby forming an implant.
[0024] The instrument 100 can include an assembly of an elongate shaft 102 and a sleeve or sleeve assembly 104. The instrument can further be coupled to a handle 106, as shown in FIG. 2. As shown in FIGS. 1 and 2, the elongate shaft 102 can be received within the sleeve 104, allowing selective independent movement therebetween. The configurations of the elongate shaft 102 and the sleeve 104 can be manipulated relative to one another to provide multiple configurations, e.g., unlocked and locked positions of the instrument 100, as described in further detail below. The instrument 100 can engage one or more modular components, e.g., receiver members, to allow these modular components to be assembled to form an implant. The handle 106 can be coupled to the elongate shaft 102 to facilitate manipulation of the instrument and / or movement of the instrument between its unlocked and locked positions.
[0025] 3-5 illustrate exemplary embodiments of modular components with which the instruments disclosed herein may be used. It will be understood that the illustrated modular components are examples, and that other modular components having additional or alternative features, both related and unrelated to implants used within a patient's body, may be used with the instruments disclosed herein.
[0026] The instrument 100 may be coupled to a bone anchor assembly 10. The illustrated bone anchor assembly 10 may include a receiver member or head 12 for receiving a spinal fixation element, such as a spinal rod (not shown), which is coupled to a bone shank 14 for implantation within a patient. The receiver member 12 may include a proximal end having a pair of spaced apart arms 16A, 16B defining a recess 18 therebetween, and a distal end having a distal end face defining an opening 22 (see FIG. 4 ) through which at least a portion of the bone shank 14 may extend. The bone shank 14 may be configured to engage bone and, in the illustrated embodiment, includes external threads for engaging bone.
[0027] The shape of the receiver member 12 may vary. For example, the receiver member 12 may be generally cylindrical with flat proximal and distal surfaces and rounded corners at least at the distal end. A pair of spaced-apart arms 16A, 16B may each extend from the distal end of the receiver member 12 to a free proximal end. The outer surface of each of the arms 16A, 16B may include features such as recesses, indentations, notches, protrusions, etc. to facilitate connection of the receiver member 12 to an instrument, such as an instrument of the type described herein. For example, the outer surface of each arm 16A, 16B may include an arcuate groove 19 at the arm's respective free end. Such grooves are described in more detail in U.S. Pat. No. 7,179,261, issued February 20, 2007, the disclosure of which is incorporated herein by reference.
[0028] The pair of spaced apart arms 16A, 16B can vary in size. For example, in some embodiments, the pair of spaced apart arms 16A, 16B can be designed for implantation within a patient's body (e.g., as shown in FIG. 3). In some embodiments, as shown in FIGS. 4 and 5, the receiver member 12 can include one or more extension tabs 20 extending proximally therefrom to operatively extend the length of the arms 16A, 16B, e.g., integrally formed with or coupled to one or more extension tabs 20. The length of these extension tabs 20 can vary, e.g., as shown in FIGS. 4 and 5, and can be used to aid in head positioning, reduction of a fixation rod, introduction of a rod-locking fixation element such as a set screw, etc.
[0029] In use, the instrument can be positioned such that one or more of the pair of spaced arms 16A, 16B of the receiver member 12 are received between the elongate shaft 102 and the sleeve 104 to dock the instrument 100 to the receiver member 12, for example, as shown in FIG. 2 . The sleeve 104 can be movable between an unlocked position and a locked position to lock the instrument 100 to the receiver member 12. For example, the sleeve 104 can be rotated or axially translated relative to the elongate shaft 102 to selectively prevent the pair of spaced arms 16A, 16B from separating from the instrument 100, thereby retaining the receiver member 12 to the instrument 100. The instrument can enable delivery of axial loads and transmission of tensile and compressive forces to the receiver member 12 to assemble the bone anchor assembly 10 by coupling the receiver member 12 to the bone anchor shank 14. After assembly, the instrument 100 can be separated from the bone anchor assembly 10 and the elongate shaft 102 and sleeve 104 can be disassembled for cleaning.
[0030] 6-15 illustrate the assembly of the elongate shaft 102 and sleeve 104 of the instrument 100, as well as its operation. The elongate shaft 102 may include a generally tubular body 108 having a central longitudinal axis A1 extending along the length L of the tubular body 108 from the proximal end 102p to the distal end 102d. The elongate shaft 102 may include an inner channel 110 (see FIG. 10) extending from the proximal end to the distal end along the central longitudinal axis A1 of the shaft 102, although in some embodiments, the elongate shaft 102 may have a solid core therethrough. The elongate shaft 102 may transmit force to an implant, such as the bone anchor assembly 10, fitted thereto.
[0031] The proximal end 102p of the elongate shaft 102 may be sized to be received within the sleeve 104. The proximal end 102 may include a tab 112 that may pass through a lumen of the sleeve 104 to advance the elongate shaft 102. As shown, the tab 112 may include an interface 114 that may couple the elongate shaft 102 to other components of the instrument 100, such as the handle 106. The interface may be keyed to be received within the handle 106 in one or more specific orientations.
[0032] The distal end 102d of the elongate shaft 102 can include a coupler 116. In some embodiments, the coupler 116 can be received between a pair of spaced apart arms 16A, 16B to apply a force to a receiver member 12 coupled to the instrument 100 and prevent unintentional rotation of the receiver member 12 relative to the instrument. The coupler 116 can be in the form of a block, as shown, but in some embodiments, the coupler 116 can be a tube, a pair of arms, or a spring configured to facilitate application of force and / or securing of an object to the instrument 100.
[0033] The tubular body 108 can include one or more sections having different diameters. For example, the elongate shaft 102 can include an intermediate portion 120 disposed between the proximal end 102p and the distal end 102d. As shown, the intermediate portion 120 can be a portion of the tubular body 108 that tapers toward one or more of the proximal end 102p and the distal end 102d. For example, the intermediate portion can taper toward the distal end 102d at the distal junction 122d and can taper toward the proximal end 102p at the proximal junction 122p. In other words, the diameter D of the tubular body 108 at the intermediate portion 120 can be larger than either the diameter Dp at the proximal end 102p or the diameter Dd at the distal end 102d, although in some embodiments, the tubular body 108 can include a uniform diameter extending therethrough. It will be understood that the diameters Dp, Dd of the proximal and distal ends 102p, 102d may be equal, although in some embodiments, Dp may be greater than Dd, or vice versa. Additionally, the diameter along a particular portion of the elongate shaft may be configured to substantially match the inner diameter between opposing arms 16A, 16B or extension tabs 20 to prevent radially inward bowing of the arms, which could result in inadvertent separation of the receiver member 12 from the instrument 100. For example, the diameter of the elongate shaft 102 is shown as being substantially similar to the inner diameter between arms 16A, 16B or extension tabs 20 at locations 1402 and 1404 in FIG. 14 .
[0034] 7 , the intermediate portion 120 can include one or more mating features 124 that engage the sleeve 104 to selectively lock the elongate shaft 102 relative to the sleeve 104. For example, the tubular body 108 can include a longitudinal groove 126 and a first partial circumferential groove 128 formed on a surface thereof. The longitudinal groove 126 and the first partial circumferential groove 128 can allow one or more portions of the sleeve 104 to engage with the elongate shaft 102 to couple the sleeve 104 thereto and guide relative movement between the two components. For example, in some embodiments, the grooves 126, 128 can receive one or more protrusions formed on the inner wall of the sleeve (e.g., pins that pass through through holes in the sidewall of the sleeve, as described in more detail below), which can guide the position of the sleeve 104 relative to the shaft 102, as described further below.
[0035] As shown, the longitudinal groove 126 can extend along the surface of the tubular body 108. For example, the longitudinal groove 126 can extend from the proximal portion of the elongate shaft 102 into the intermediate portion 120, although in some embodiments, the longitudinal groove 126 can be limited to the intermediate portion. As shown, the longitudinal groove 126 can be a substantially rectangular groove having a proximal end 126p and a distal end 126d, as shown in FIGS. 7 and 10, although other groove shapes or geometries can also be utilized. The distal end 126d of the longitudinal groove 102 can terminate in a first shoulder 130. The first shoulder 130 can be positioned along the tubular body 108 of the intermediate portion 120 to act as a stop against further distal advancement of the sleeve 104 relative to the shaft 102.
[0036] Although a single longitudinal groove is shown, in some embodiments, the tubular body 108 can have one or more additional longitudinal grooves, for example, parallel grooves formed around the circumference of the elongate shaft 102, allowing one or more additional features of the sleeve to extend through multiple grooves simultaneously, increasing the strength of the bond.
[0037] The first partial circumferential groove 128 may be offset from the longitudinal groove 126 along the tubular body 108 of the elongate shaft 102. As shown, the partial circumferential groove 128 may form a dogleg junction 129 with the radial groove 128 at the first shoulder 130 such that the groove forms an "L" or inverted "L" shape (see FIG. 7 ). The first partial circumferential groove 128 extends along the circumference of the elongate shaft 102 and may receive an object (e.g., a protrusion or pin on the sleeve 104) moving distally along the longitudinal groove 126 to the junction 129. Rotation of the elongate shaft 102 relative to an object located at the dogleg junction 129 may move the object moving distally along the longitudinal groove 126 into the first partial circumferential groove 128. Although a single partial circumferential groove 128 is shown, in some embodiments, for example, in embodiments employing multiple longitudinal grooves as described above, the tubular body 108 can have one or more other partial circumferential grooves formed therein. In such embodiments, the various longitudinal grooves can be appropriately spaced to avoid interference of their associated partial circumferential grooves, such as two opposing longitudinal grooves with non-intersecting partial circumferential grooves, or multiple partial circumferential grooves formed at longitudinally offset locations that connect with parallel longitudinal grooves of different lengths and receive protrusions or features formed on the sleeve 104 at different longitudinal locations.
[0038] The elongate shaft 102 may also include an additional at least partial circumferential groove 132 formed therein. As shown, the at least partial circumferential groove 132 may include a reduced diameter relative to the diameter D of the intermediate portion 120. The at least partial circumferential groove 132 may be formed between a first shoulder 130 and a second shoulder 134 formed along the tubular body 108 (see FIG. 7 ). The at least partial circumferential groove 132 may be configured to cooperate with one or more components of the instrument 100, such as the sleeve 104, to maintain the orientation of the instrument in one or more positions.
[0039] 8A-8C show the sleeve 104 of the instrument 100 in more detail. As described above, the sleeve 104 can receive a portion of the elongate shaft 102 therethrough. The sleeve 104 can include a generally cylindrical body 134 having a channel or lumen 138 extending therethrough. The channel 138 can extend along a central longitudinal axis A2 of the sleeve 104 from a proximal end 104p of the body 134 to a distal end 104d of the body. As shown, the central longitudinal axis A2 of the sleeve 104 can extend substantially parallel to the central longitudinal axis A1 of the elongate body. The channel or lumen 138 can define one or more diameters D1 through which an instrument, implant, or other object, such as, among other things, the elongate shaft 102, can be inserted. In some embodiments, the inner surface of the channel 138 can include features for cooperation with another component, such as the elongate shaft 102, or a portion of an implant component, such as the receiver head 12.
[0040] The body 134 of the sleeve 104 may include a distal mating portion 140 and a proximal engaging portion 142. The distal mating portion 140 and the engaging portion 142 may share a common channel or lumen 138 within the sleeve 104, although these sections may define different lumen diameters. For example, the length of the channel 138 extending through the proximal engaging portion 142 of the sleeve 104 may include a reduced diameter relative to the distal mating portion (see FIG. 10 ), which may be configured to receive the elongate shaft 104 therethrough. The distal mating portion 140 may include a portion having an enlarged diameter relative to the proximal engaging portion 142, allowing an implant component or portion thereof, such as the spaced arms 16A, 16B of the receiver member 12, to be received within the space between the sleeve 104 and the elongate shaft 102, as discussed below with respect to FIGS. 13 and 14 .
[0041] The distal mating portion 140 can include one or more features for mating the sleeve 104 to an implant component or other object disposed therein. For example, the features can be a pair of opposing protrusions or shelves 146A, 146B extending from an inner surface 148 of the mating portion 140 of the sleeve 104 into the channel 138 of the mating portion, as shown in FIGS. 13 and 14, features 146A, 146B can abut features formed on an implant component (e.g., extension tab 20 or arms 16A, 16B of receiver member 12), such as threads, lips, or other features, to prevent the component from retracting or moving distally relative to the distal end 104d of sleeve 104, although features 146A, 146B can also, in some embodiments (e.g., when features 146A, 146B are disposed in a valley between opposing protruding features formed on a component received within lumen 138 of sleeve 104), prevent proximal advancement of an object through channel 138 of sleeve 104. Additionally, arms 146A, 146B can cooperate with coupler 116 at the distal end of elongate shaft 102 and flange 131 configured to abut the top or proximally facing surface of extension tab 20 to fully restrain movement of receiver member 12 relative to instrument 100 when in the locked configuration. As shown, features 146A, 146B can be formed on diametrically opposed portions of inner surface 148, and as described further below, features 146A, 146B can cooperate with diametrically opposed surfaces of an object, such as opposed extension tabs 20 of receiver member 12. Features 146A, 146B can be secured to sleeve 104 such that they rotate in coordination with the sleeve. For example, in some embodiments, rotation and / or manipulation of the position of sleeve 104 can position features 146A, 146B to mate with an object placed within the lumen of the sleeve. While two opposed protrusions, ledges, or other features 146A, 146B are shown, mating portion 140 can include one or more additional features disposed around the circumference of the lumen.
[0042] As shown in FIG. 9, the proximal engaging portion 142 of the sleeve 104 can have an outer diameter De that is larger than the diameter Dm of the distal mating portion 140, although in some embodiments the diameter Dm of the distal mating portion 140 can be larger than the diameter of the proximal engaging portion De, or the diameter of the sleeve 104 can be uniform throughout.
[0043] The elongate shaft 102 can move relative to the sleeve 104 in one or more degrees of freedom. For example, as shown, the engagement portion 142 can be positioned over the at least partial circumferential groove 132 formed in the elongate shaft 102 to couple the sleeve thereto. FIG. 8B shows the sleeve 104, and in particular the engagement portion 142, in more detail. The engagement portion 142 can receive one or more link components 150 for interacting with the at least partial circumferential groove 132 of the elongate shaft 102. As shown, the link component 150 can include a button 152, a locating pin 154, and a guide pin 156. The link component 150 can be received in one or more recesses, through-holes, or bores formed in the engagement portion 142 to place the link component 150 in communication with the channel or lumen 138. For example, as shown, engagement portion 142 may include a recess 158 for receiving button 152 therein, a recess 160 for receiving guide pin 156 therethrough, and a recess 162 for receiving locating pin 154 therethrough, although in some embodiments, additional recesses may be formed in engagement portion 142 and / or distal mating portion 140. The interface between link component 150 disposed within engagement portion 142 and corresponding features of elongate shaft 102 to facilitate cooperation between elongate shaft 102 and sleeve 104 is described further below.
[0044] The button 152 can include a substantially rectangular body 153 having one or more channels 166 formed therein. As shown, the button 152 can be received in a corresponding recess 158 formed in the body 134 of the sleeve 104 for placement of the button therein. The button 152 can be received within the recess 158 to cooperate with one or more features of the elongate shaft 102 to enable the transmission of an axial force to any implant component held by the instrument 100. In some embodiments, the button 152 can be actuated to enable disassembly of the elongate shaft 102 from the sleeve 104, thereby disassembling the instrument for cleaning, sterilization, etc.
[0045] The button 152 can include a central channel 166 formed therein to allow the elongate shaft 102 to pass therethrough. As shown, the central channel 166 can define a longitudinal axis A3 extending through the width of the button that is substantially aligned with one or more of the central longitudinal axes A1, A2 of the elongate shaft 102 and the sleeve 104 to allow the elongate shaft 102 to extend therethrough. The central channel 166 can include at least one curved surface that can correspond to the shape of the elongate shaft 102 such that the central channel 166 forms a substantially negative shape of the elongate shaft 102 along at least a portion of the elongate shaft 102. In some embodiments, the central channel 166 can be at least partially circular, oval, rectangular, square, oval, or another shape configured to allow the elongate shaft 102 to pass therethrough.
[0046] The button 152 can include an additional recess formed in its body 153. For example, the button 152 can have a recess 168 formed in a lateral side thereof. As shown, the recess 168 can be formed in a surface substantially perpendicular to the central channel 166. In some embodiments, the recess 168 can be positioned such that an object placed therein does not communicate with the central channel 166, while in some embodiments, the recess can extend through the body 153 to communicate with the central channel 166. The recess 168 can be sized and shaped to receive one of the link components 150 therethrough, for example, the locating pin 154. The locating pin 154 can travel within the recess 168 to limit movement of the button 152 along an axis A4 that is substantially perpendicular to the central longitudinal axis A3 of the central channel 166.
[0047] The button 152 can engage the elongate shaft 102 via a biasing element (e.g., a coil spring) 170 disposed between the button 152 and the sleeve 104. For example, the button 152 can include a first recess 172 formed in a bottom surface thereof, as shown in FIG. 11 . The first recess 172 can be sized and shaped to receive the biasing element 170 therethrough. In some embodiments, the biasing element 170 can be disposed between the first recess 172 and a second recess 174 formed in the body 134 of the sleeve 104.
[0048] As described above, biasing element 170 can bias button 152 to move along axis A4, substantially perpendicular to axes A1, A2 of elongate shaft 102 and sleeve 104, respectively, between (i) a first position in which button 152 engages elongate shaft 102, locking the orientation of sleeve 104 relative to elongate shaft 102, and (ii) a second position in which button 152 disengages from elongate shaft 102, allowing sleeve 104 to translate and / or rotate in one or more degrees of freedom relative to elongate shaft 102. While a coil spring 170 is shown, various other biasing elements, such as leaf springs, wave springs, torsion springs, resilient compressible members, electromagnets, etc., can be used instead or in addition to depressing the button to rebound along axis A4.
[0049] The guide pin 156 may be received within a recess 160 formed on the engagement portion 142 to guide movement of the sleeve along the elongate shaft, as shown. The guide pin 156 may be a fixed pin that moves in coordination with the sleeve 104 relative to the elongate shaft 102, although in some embodiments, the guide pin may pivot and / or translate relative to the elongate shaft 102. In yet other embodiments, the guide pin may be integrally formed with the sleeve 104 as a protrusion extending from the inner wall of the lumen 38. The guide pin 156 may move within a longitudinal groove 126 formed in the elongate shaft 102. As shown, the guide pin 156 may extend through the engagement portion 142 into the channel or lumen 38 of the sleeve 104 to coordinate with the elongate shaft. When so positioned, guide pin 156 can align with one or more of longitudinal groove 126 and / or partial circumferential groove 128 of elongate shaft 102 to guide and limit translation and rotation of elongate shaft 102 relative to sleeve 104, for example, to allow movement of instrument 100 between locked and unlocked configurations. Recesses 158, 160 can be angularly aligned about longitudinal axis A2 such that the angular position of button 152 and guide pin 156 relative to elongate shaft 102 remains the same as instrument 100 moves between the unlocked and locked configurations.
[0050] The sleeve 104 and / or elongate body 102 may include one or more indicators 176 that indicate whether the instrument is in an unlocked or locked position or configuration. For example, as shown in FIGS. 8A-8C , the body 134 may include a label or image 176 that indicates the locked / unlocked state of the instrument 100. In some embodiments, the sleeve 104 may include a first image of a padlock in an unlocked or open position along with an image of an arrow pointing in a counterclockwise direction. The padlock in the unlocked position may indicate that the instrument 100 can be unlocked by rotating the sleeve in the direction of the arrow. The sleeve 104 may also include an arrow 176 on the distal mating portion 140, as shown. This arrow 176 may be aligned with an image of a padlock in an open or closed position along another portion of the instrument, such as the padlock in an open position on the elongate shaft 102 shown in FIG. 9 , to indicate that the instrument 100 is in the unlocked position. In some embodiments, the image on the elongate shaft 102 may be an image of a padlock in a closed position, which indicates that the instrument 100 is in a locked position when the arrow on the sleeve 104 aligns with the image. Alternatively or additionally, other text or images may be used, such as text labels reading "open" and "closed," other drawings, etc.
[0051] The instrument 100 may include additional indicators to communicate the position of the instrument 100. For example, the position of the button 152 relative to the longitudinal groove 126 can inform the user as to whether the instrument 100 is in the unlocked or locked position. As shown, when the button 152 is aligned with the longitudinal groove 126 of the elongate shaft 102, the instrument 100 is in the unlocked position, and when the button 152 is angularly offset from the longitudinal groove 126, the instrument 100 is in the locked position, or at least in transition toward the locked position. In some embodiments, the shape of the engagement portion 142 can also inform the user as to whether the instrument is in the unlocked or locked position. For example, as shown in FIGS. 9, 10, 13, and 14, the engagement portion 142 can have a substantially cylindrical shape with opposing scalloped or notched portions 200 that may be aligned with the longitudinal groove 126 in the unlocked configuration and angularly offset therefrom in the locked configuration.
[0052] In use, the elongate shaft 102 can be advanced proximally through the mating portion 140 and into the engagement portion 142 to assemble the device, as shown in FIG. 6 above. During assembly, the sleeve 104 can be positioned so that the guide pin 156 aligns with and contacts and / or engages the longitudinal groove 126. As the elongate shaft 102 continues to advance proximally through the sleeve 104, it passes through the central channel 166 of the button 152 and exits the proximal end 104p of the sleeve 104. During advancement, the guide pin 156 engages the proximal end 126p of the longitudinal groove 126 and slides distally therein. Elongate shaft 102 and / or sleeve 104 can continue to move relative to one another until guide pin 156 is positioned at distal end 126d of longitudinal groove 126 and button 152 engages recess 132 between first shoulder 130 and second shoulder 134. In this position, instrument 100 can engage receiver member 12 as shown in FIG. 5, as described further below.
[0053] 9-12 show the instrument 100 in an unlocked position, while FIGS. 13 and 14 show the instrument in a locked position while engaged with extension tabs 16A, 16B of a receiver member 12 similar to that shown in FIG. 5. Other than as indicated below, the steps of the described methods may be performed in various orders, and one or more steps may be omitted or added. Furthermore, for the sake of brevity, a detailed description of every sequence of steps is omitted herein. The instrument 100 may include adjustment mechanisms for docking, engaging, and disengaging the instrument from one or more implant components, as well as disassembling the instrument components. For example, the sleeve 104 may be rotated relative to the elongated body 102 to move the instrument 100 between (i) an unlocked position in which the instrument 100 freely engages the tabs of the receiver member, and (ii) a locked position in which the instrument 100 engages the tabs of the receiver member to form a rigid connection with the receiver member, allowing the transfer of tension and compression forces during assembly of the receiver head onto the bone screw shank. Assembly of the modular receiver member to the bone screw shank can occur pre-operatively, post-operatively, or intra-operatively to allow for rapid bone anchor assembly. The instrument is shown in each of the unlocked and locked positions and is described in more detail below.
[0054] 9-12 show the instrument 100 in an unlocked position, with the sleeve 104 oriented relative to the elongate shaft 102 so that the guide pin 156 is disposed within the longitudinal groove 126. As shown, the button 152 is disposed substantially perpendicular to the longitudinal groove 126, and the arrow 176 on the distal mating portion aligns with the padlock depicted on the elongate shaft 102 in the open position to clarify that the instrument 100 is in the unlocked position. In one embodiment, the elongate shaft distal coupler 116 can be pressed into the U-shaped seat of the receiver member 12 while the sleeve 104 is separated from the elongate shaft 102 or disposed along its proximal portion. The sleeve 104 can then be advanced distally along the elongate shaft 102 until the distal engagement portion 142, with its open distal end, slides over the proximal end of the receiver member extension tab 20. 10 , in the unlocked position, guide pin 156 seats within distal end 126 d of longitudinal groove 126 or within dogleg junction 129 between longitudinal groove 126 and radial groove 128. Furthermore, in the unlocked configuration, opposing inwardly projecting arms 146A, 146B formed on the inner surface of sleeve 104 can align with gaps formed between opposing extension tabs 20 of the receiver member, ensuring there is no interference between these components when sleeve 104 slides distally over the proximal ends of tabs 20. As described above, the adjustment mechanism of instrument 100 can enable sleeve 104 to be rotatable about axis A2 relative to elongate shaft 102 and moved between the unlocked and locked positions once the components are properly positioned relative to one another along longitudinal axis A2. For example, the sleeve 104 can be rotated in a clockwise direction when viewed from a proximal perspective to move the sleeve 104 from the unlocked position shown in FIG. 9 to the locked position shown in FIG. 13, although in other embodiments the direction of rotation can be reversed.Such rotation of the sleeve 104 relative to the elongate shaft 102 and receiver member 12 (held relative to the elongate shaft by the coupler 116) can allow the opposing arms 146A, 146B of the sleeve to cooperate with notches, grooves, protrusions, or other features formed on the outer surface of the extension tab 20 to help securely secure the receiver member 12 to the instrument 100. Additionally, a flange 131 formed on the elongate shaft 102 can abut the proximal face of the extension tab 20 to further limit relative movement between the receiver member 12 and the instrument 100.
[0055] 11 and 12 show in more detail the interface between the engagement portion 142 of the sleeve 104 and the elongate shaft 102 in the unlocked position. As shown, the button 152 can include a flange 178 formed on the body 153. In some embodiments, the flange 178 can extend from the body 153 and interface with one or more features of the instrument 100, such as the elongate shaft 102, the sleeve 104, etc. For example, as shown, the flange 178 of the button 152 interfaces with the first and second shoulders 130, 134 that define the recess 132 of the elongate shaft 102 to provide an axial stop that prevents further proximal and distal displacement of the elongate shaft relative to the sleeve. The interface between the flange 178 and the shoulders 130, 134 also allows for the transmission of axial forces to the implant when the instrument 100 is mated to the implant.
[0056] A biasing element 170 disposed within the first spring recess 172 biases the button 152 toward the axis A4 such that the flange 178 seats within the recess 132 of the elongate shaft 102. As described above, the recess 132, disposed between the first shoulder 130 and the second shoulder 134 along the length L of the elongate shaft 102, may include one or more flats 180, 181. The flats 180, 181 within the recess 132 may function as detents to provide a preferred orientation of the sleeve 104 in each of the unlocked and locked positions (e.g., the sleeve 104 preferentially moves to align the flat surface of the flange 178 with the nearest flat 180, 181 upon rotation). The flats 180, 181 may be positioned substantially perpendicular to one another such that their orientation aligns with the orientation of the sleeve 104 in the unlocked and locked positions to allow the flange 178 to engage one of the flats in each of the locked and unlocked positions. For example, as shown in FIG. 12 , the flange 178 of the button 152 engages the flat 181 along the elongate shaft 102 to help maintain the orientation of the sleeve in the unlocked position. In some embodiments, the elongate shaft includes first and second flats 180, 181 as shown, but can also include multiple flats, including any number of flats that can be utilized to provide any number of rotational stops or detents, as needed or desired.
[0057] When a rotational force is applied to the sleeve 104, the guide pin 156 moves out of the dogleg junction 129 connection between the longitudinal groove 126 and the partial circumferential groove 128 and becomes disposed within the partial circumferential groove 128. The guide pin 156 moves along the circumference of the elongated shaft 126 as it moves from the dogleg junction 129 into the partial circumferential groove 128 in the direction of rotation of the sleeve 104. Once inside the partial circumferential groove 126, the guide pin 156 can provide a rotational stop to lock the sleeve 104 relative to the elongated shaft 102 and position the instrument 100 in a locked position. For example, the guide pin 156 can ride in the partial circumferential groove 128 as the instrument is moved between the unlocked and locked positions while preventing over-rotation of the sleeve 104 relative to the elongated shaft 102. The sleeve 104 can be rotated approximately a quarter turn, or 90 degrees, from the unlocked position to the locked position, although in some embodiments, the instrument 100 can be in the locked position after a different angle of rotation, for example, from about 45 degrees to about 110 degrees in certain embodiments, although other values are possible. Further rotation of the sleeve 104 relative to the elongated shaft 102 is prevented by the guide pin 156 abutting the end of the partial circumferential groove 128 to resist such rotation. Once the required rotation is completed, the flange 178 of the button 152 can engage a flat 180 on the elongated shaft, which can help hold the sleeve 104 in the locked position. Furthermore, as soon as the user sufficiently rotates the sleeve 104 to move the flange away from the flat 181 and toward the flat 180, the interaction of the components and their complementary shapes urges the sleeve 104 to continue in the locked configuration, with the flat 180 abutting the flange 178 at a right angle.
[0058] 13 and 14 show the instrument 100 in a locked position. As shown, the sleeve 104 is positioned approximately a quarter turn relative to the elongated shaft 102 such that the arrow 176 on the engagement portion 142 is offset from the padlock icon on the shaft 102 and the button 152 is offset from the longitudinal groove 126. The receiver member 12 is positioned between the sleeve 104 and the elongated shaft 102 to allow the extension tabs 16A, 16B of the receiver member 12 to mate with the instrument 100. A guide pin 156 can be positioned within the partial circumferential groove 128 to act as a rotational stop and prevent over-rotation of the sleeve 104 relative to the shaft 102. 14, rotation of sleeve 104 to the locked configuration can position locking arms 146A, 146B of mating portion 140 along the surfaces of extension tabs 16A, 16B to prevent the tabs from backing out of mating portion 140, thereby rigidly securing receiver member 12 to instrument 100. Button 152 can remain aligned with recess 132 of shaft 102 located between shoulders 130, 134, such that forces applied to the shaft are transferred to the rigidly coupled receiver member 12.
[0059] The sleeve 104 and elongate shaft 102 can be disassembled for cleaning after use. For example, to disassemble the instrument, the sleeve 104 can be moved in the opposite direction, e.g., counterclockwise, as shown by the arrow and unlock indicator 202 in FIG. 8B, to return the instrument 100 from the locked position to the unlocked position. This movement rotates the arms 146A, 146B of the mating portion 140 out of engagement with the extension tabs 16A, 16B of the receiver member 12, allowing the receiver member to separate from the instrument 100. The rotation also rotates the guide pin 156 out of the partial circumferential groove 126, through the dogleg joint 129, and back to the distal end 126d of the longitudinal groove 126. In the unlocked position, the button 152 can be depressed against the biasing force of the biasing element 170, such that the flange 178 no longer engages either of the flats 180, 181 of the recess 132. As the button 152 is further depressed, the flange 178 moves out of the recess 132 until the flange 178 no longer engages with either of the first and second shoulders 130, 134 that define the recess 132. Once the button 152 is no longer engaged with the first and second shoulders 130, 134, any axial stops are released, allowing the elongate shaft 102 to translate relative to the sleeve 104. The elongate shaft 102 can be advanced out of the sleeve 104 for disassembly from the sleeve. While the elongate shaft 102 can be advanced distally from the engagement portion 142, in some embodiments, the shaft 102 can be advanced through the mating portion 140 to disassemble from the sleeve 104.
[0060] 15 illustrates a handle 106 of the instrument 100 that can be used with the elongate shaft and sleeve assembly described above. The handle 106 can be attached to the elongate shaft 102 and sleeve 104 assembly to facilitate manipulation of the instrument by a user. For example, the handle 106 can be used to apply an axial load to an instrument component. As shown, the handle 106 can include a handle body 182, a modular activator 184, and a cap 186. The handle 106 can receive the proximal end of the elongate shaft 102 therein to attach the handle 106 to the instrument 100.
[0061] 16 and 17 show the modular activator 184 of the handle 106 in more detail. As shown, the modular activator 184 can include a through hole 188 for receiving the elongate shaft 102 and a push button 190 for attaching and detaching the elongate shaft 102. The push button 190 can include a channel 192 that aligns with the through hole 188 and receives the elongate shaft 102. As shown, the push button 190 can be disposed within a recess 194 in the handle that extends substantially perpendicular to the through hole 188. A biasing member 196 can be disposed within the recess 194 to bias the push button 190 upward from the handle 106 (as viewed in FIG. 17 ), displacing the channel 192 of the button 190 from the through hole 188 and locking an object, such as the elongate shaft 102, disposed within the through hole 188. A screw 198 can retain the push button 190 within the modular activator 184.
[0062] In use, the elongate shaft 102 is received within the through-hole 188 of the activator 184 and can be advanced therethrough to attach the elongate shaft 102 to the handle 106. To receive the elongate shaft 102, the push button 190 can be depressed to align the channel 192 of the push button 190 with the through-hole 188, against the biasing force of the biasing member 196, allowing the elongate shaft 102 to extend through the through-hole. To remove the handle 106 from the elongate shaft 102 after use, the push button 190 can be depressed to align the channel 192 of the button with the through-hole 188, allowing translation of the elongate shaft 102 relative to the handle 106 from the through-hole 188. The handle 106 can then be used to attach another elongate shaft 102 or can be removed for cleaning. In other embodiments, the handle may have a different shape (e.g., a laterally extending "T" shape), or multiple handles may be provided to suit the needs of the procedure and / or user preferences.
[0063] 18-22 illustrate another embodiment of an instrument 200 that can be used in a modular assembly of surgical devices. The structure and function of the instrument can be substantially the same as those of the embodiments described above, and therefore, for the sake of brevity, a detailed description will not be given here.
[0064] The instrument 1800 can include a sleeve 1804 disposed on an elongate shaft 1802 that can be coupled to a handle 2006, as shown in FIG. 20 . The instrument can be used to mate with a multi-axial head of a receiver member, such as the receiver member 12 shown in FIGS. 3 and 4 . As mentioned above, the receiver member 12 can be without an extension tab 20, or in some embodiments, the extension tab 20 can be smaller than the extension tab 20 of the receiver member 12 of FIG. 5 . Thus, the instrument 1800 can be adapted to mate with a receiver member 12 that does not have an extension tab (e.g., as shown in FIG. 3 ) or has a shorter extension tab (e.g., as shown in FIG. 4 ) by including a sleeve 1804 having a mating portion 1840 with a length L that extends along the length of the elongate shaft toward the receiver member 12 to mate the sleeve 1804 with the receiver head 12 or the shorter extension tab 20.
[0065] As shown, the mating portion 1840 of the sleeve 1804 can taper to a coupling member 1843 configured to receive the polyaxial head of the receiver member 12 therein. The coupling member 1843 can include a pair of arms 1946A, 1946B that can be received in notches or other features formed on the surface of the receiver member 12 to assist in coupling the instrument 1800 to the receiver member, as shown in FIG. 22 . More specifically, as shown in FIG. 19 , the arms 1946A, 1946B can extend inward from the cylindrical surface of the coupling member 1843 and can extend around a partial circumference of the surface to allow a gap therebetween. The receiver head 12 can be inserted into the open distal end of the coupling member 1843 so that the opposing arms 16A, 16B or short extension tab 20 pass through the gap between the arms 1946A, 1946B. Additionally, the distal end 1881 of the elongate shaft 1802 can be configured to seat within a U-shaped opening formed between the opposing arms 16A, 16B of the receiver member 12. This can prevent unintentional rotation of the receiver member 12 relative to the elongate shaft 1802 and sleeve 1804. Similar to the instrument 100 described above, such insertion can occur while the instrument 1800 is in an unlocked configuration, ultimately reaching the configuration shown in FIG. 20 . While the proximal end of the receiver member is disposed within the open distal end of the coupling member 1843, the sleeve 1804 can be rotated relative to the elongate shaft 1802 and receiver member 12 to a locked configuration. This can rotate the arms 1946A, 1946B to engage slots, notches, or other features formed in the outer surfaces of the opposing arms 16A, 16B of the receiver member 12, as shown in FIGS. 21 and 22 . As seen in the cross-sectional view of FIG. 22, the receiver member 12 can be firmly and securely secured to the instrument 1800 in the locked configuration by opposing forces from the arms 1946A, 1946B, the distal end of the elongate shaft 1802, and a flange 1883 formed on the distal portion of the elongate shaft 1881 that abuts the upper surface of the receiver member 12.
[0066] Similar to the instrument 100 described above, the mating portion 1840 may include an arrow or other indicator 1876 disposed thereon to indicate that the instrument is in an unlocked position, pointing to a padlock or other indicator 1877 on the elongated shaft 1802 in an open position. As described above, the sleeve 1804 may be rotated to lock the instrument 1800 and mate the receiver member 12 thereto. Furthermore, to remove the instrument 1800 from the receiver member 12, the sleeve 1804 may be moved in the opposite direction to the unlocked position. Thus, a primary differentiator between the device 100 and the device 1800 may be the length L of the mating portion 1840, which may be extended to reach a receiver member 12 that does not have an extension tab or has a short extension tab, as compared to the short mating portion 140 of the sleeve 104 in the instrument 100. The engagement portion 1842 of the sleeve 1804 may function substantially similarly to the engagement portion 142 of the sleeve 104 of the instrument 100, for example, by utilizing a guide pin 1856 that rides within a longitudinal slot 1826 and a partial circumferential slot 1828 formed in the elongate shaft 1802, and a spring-loaded button 1852 having a central passage and a flat surface that can engage with at least a partial circumferential groove or recess in the elongate shaft having flats or other features for guiding the instrument between the locked and unlocked configurations.
[0067] The devices, systems, and methods disclosed herein can be used in minimally invasive and / or open surgery. As noted above, any of a variety of surgical procedures can be performed utilizing the surgical instruments described herein, including various orthopedic surgical procedures, such as knee surgery, spine surgery, shoulder surgery, hip surgery, and the like, as well as general modular combinations of implant components that may be applicable to a wide range of surgical procedures. Furthermore, while the devices and methods disclosed herein are generally described in the context of surgery on human patients, it will be understood that the methods and devices disclosed herein can be used in any of a variety of surgical procedures or non-surgical procedures with any human or animal subject.
[0068] It should be noted that any order of method steps depicted or suggested in the above description or the accompanying drawings should not be construed as limiting the disclosed methods to performing the steps in that order. Rather, the various steps of each of the methods disclosed herein can be performed in any of a variety of orders. Furthermore, the described methods are merely exemplary embodiments, and various other methods including additional or fewer steps are within the scope of the present disclosure.
[0069] The instruments, devices, and systems disclosed herein may be constructed from any of a variety of known materials. Exemplary materials include materials suitable for use in surgical applications, including, for example, metals such as stainless steel, titanium, nickel, cobalt chromium, or alloys and combinations thereof; polymers such as PEEK; ceramics; carbon fiber; and the like. Various components of the instruments disclosed herein can have varying degrees of stiffness or flexibility appropriate for their use. The size of the device can also vary widely depending on the intended use and the anatomy of the surgical site. Furthermore, certain components may be formed from different materials than other components. One or more components or portions of the instrument may be formed from a radiopaque material to facilitate visualization under fluoroscopy and other imaging techniques, or from a radiolucent material so as not to interfere with visualization of other structures. Exemplary radiolucent materials include carbon fiber and high-strength polymers.
[0070] The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular parts, and subsequent reassembly. Specifically, the device can be disassembled, and any number of particular parts or portions of the device can be selectively replaced or removed in any combination. Following cleaning and / or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Reconditioning of a device can utilize a variety of techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques, and the resulting reconditioned device, are all within the scope of the present disclosure.
[0071] The devices described herein can be processed before being used in a surgical procedure. First, new or used instruments can be obtained and, if necessary, cleaned. The instruments can then be sterilized. In one sterilization technique, the instruments can be placed in a closed and sealed container, such as a plastic bag or a TYVEK bag. The container and its contents can then be placed in a field of radiation that can penetrate the container, such as gamma rays, X-rays, or high-energy electrons. The radiation can kill bacteria on the instruments and within the container. The sterilized instruments can then be stored in the sterile container. The sealed container can keep the instruments sterile until opened in the medical facility. Other forms of sterilization known in the art are also possible, including beta or other radiation, ethylene oxide, steam, or a liquid bath (e.g., cold immersion). Depending on the materials used, the presence of electrical components, etc., certain forms of sterilization techniques may be more suitable for use with different parts of the device.
[0072] The above-described embodiments of the present disclosure are intended to be illustrative, and many variations and modifications are possible and are within the scope of the present disclosure. Accordingly, the present disclosure is not limited to what has been particularly shown and described. All publications and references cited herein are expressly incorporated by reference in their entirety.
[0073] [Embodiment] (1) A surgical instrument, an elongate shaft having a longitudinal groove formed along a portion of the elongate shaft, a first partial circumferential groove intersecting a distal end of the longitudinal groove, and a second at least partial circumferential groove formed distal to the first partial circumferential groove; a sleeve configured to be disposed over the elongate shaft, the sleeve including a protrusion extending from an inner wall of the sleeve configured to be received in the longitudinal groove of the elongate shaft to constrain movement of the sleeve relative to the shaft when the sleeve is disposed over the elongate shaft; the sleeve including a lock configured to mate with the second at least partial circumferential groove when the protrusion is disposed within the first partial circumferential groove to further selectively restrain both axial and rotational movement of the sleeve relative to the shaft. (2) The device of embodiment 1, wherein the lock includes a button disposed within a recess in the sleeve and configured to translate radially relative to the sleeve and elongate shaft between a locked position and an unlocked position. (3) The device of claim 2, wherein the button is biased toward the locked position. (4) The device of embodiment 2, wherein the button includes a through hole configured to receive the elongate shaft. (5) The instrument of embodiment 1, wherein the second at least partial circumferential groove includes a plurality of flat portions angularly offset from one another to define a plurality of rotational positions of the shaft relative to the sleeve.
[0074] (6) The device of embodiment 5, wherein the plurality of flat portions includes a first flat portion and a second flat portion that define a first rotational position and a second rotational position of the shaft relative to the sleeve. (7) The device of embodiment 5, wherein the lock includes a flat portion configured to abut one of the plurality of flat portions of the second at least partial circumferential groove to maintain the shaft in one of the plurality of rotational positions relative to the sleeve. (8) The instrument of embodiment 1, further comprising a handle configured to couple to a proximal portion of the elongate shaft to facilitate manipulation of the instrument. (9) The device of embodiment 1, wherein the sleeve and the elongate shaft are configured to engage one or more objects therebetween to form a rigid connection with the one or more objects. (10) The device of embodiment 9, wherein the sleeve further comprises a pair of arms that engage the object when positioned between the elongate shaft and the sleeve.
[0075] (11) The device of claim 10, wherein the object includes one or more extension tabs on the receiver head. (12) A surgical instrument, an elongate shaft having a longitudinal groove formed along a portion of the elongate shaft, a first partial circumferential groove intersecting a distal end of the longitudinal groove, and a second circumferential groove formed distal to the first partial circumferential groove; a sleeve configured to be disposed over the elongate shaft; a pin configured to be received within the throughbore of the sleeve, the pin extending into the inner lumen of the sleeve and capable of being received within the longitudinal groove and the first partial circumferential groove of the elongate shaft to constrain relative movement between the sleeve and the elongate shaft when the sleeve is disposed over the elongate shaft; and a button received within a recess of the sleeve and configured to translate radially relative to the recess, the button including a through hole formed therein, the through hole configured to receive the elongate shaft when the sleeve is positioned over the elongate shaft; the button is disposed within the second circumferential groove of the elongate shaft and is configured to further constrain relative movement between the elongate shaft and the sleeve when the pin is received in the first partial circumferential groove of the elongate shaft. (13) The device of embodiment 12, wherein the sleeve further includes a first partial circumferential protrusion and a second partial circumferential protrusion formed on a wall of the inner lumen of the sleeve. (14) The device of claim 12, wherein the button is biased radially outward relative to the sleeve. (15) The instrument of embodiment 12, wherein the second circumferential groove includes a plurality of flat portions angularly offset from one another to define a plurality of rotational positions of the shaft relative to the sleeve.
[0076] (16) The device of embodiment 15, wherein the plurality of flat portions includes a first flat portion and a second flat portion that define a first rotational position and a second rotational position of the shaft relative to the sleeve. (17) The device of claim 15, wherein the button includes a flat portion configured to abut one of the plurality of flat portions of the second circumferential groove to maintain the shaft in one of the plurality of rotational positions relative to the sleeve. (18) The device of embodiment 12, wherein the sleeve and the elongate shaft are configured to engage one or more objects therebetween to form a rigid connection with the one or more objects. (19) A method for coupling an instrument to an object, said method comprising: advancing a sleeve over the elongate shaft so that a protrusion extending from an inner wall of the sleeve moves within a longitudinal groove formed in the elongate shaft; positioning an object such that a portion of the object is disposed between the sleeve and the elongate shaft; rotating the sleeve relative to the elongate shaft so that the protrusion moves within a partial circumferential groove formed in the elongate shaft that intersects the distal end of the longitudinal groove to prevent relative movement between the object and the instrument; A method comprising: (20) The method of embodiment 19, wherein the sleeve is advanced on the elongate shaft to a position where the protrusion is positioned at the intersection of the longitudinal groove and the partial circumferential groove, and the sleeve lock is positioned in a second at least partial circumferential groove formed in the elongate shaft distal to the partial circumferential groove.
[0077] (21) The second at least partial circumferential groove includes a plurality of flat portions angularly offset from one another to define a plurality of rotational positions of the shaft relative to the sleeve; the lock includes a flat portion configured to abut one of the plurality of flat portions of the second at least partial circumferential groove to maintain the shaft in one of the plurality of rotational positions relative to the sleeve; 21. The method of claim 20, wherein rotating the sleeve relative to the elongated shaft includes rotating the sleeve between a first rotational position of the plurality of rotational positions and a second rotational position of the plurality of rotational positions. (22) The method of claim 20, further comprising actuating the lock of the sleeve to move the lock from the second at least partial circumferential groove formed in the elongate shaft. (23) The method of embodiment 19, wherein positioning the object includes contacting the object with a pair of arms extending from the sleeve.
Claims
1. 1. A surgical instrument comprising: an elongate shaft having a longitudinal groove formed along a portion of the elongate shaft, a first partial circumferential groove intersecting a distal end of the longitudinal groove, and a second at least partial circumferential groove formed distal to the first partial circumferential groove; a sleeve configured to be disposed over the elongate shaft, the sleeve including a protrusion extending from an inner wall of the sleeve configured to be received in the longitudinal groove of the elongate shaft to constrain movement of the sleeve relative to the elongate shaft when the sleeve is disposed over the elongate shaft; the sleeve including a lock configured to mate with the second at least partial circumferential groove when the protrusion is disposed within the first partial circumferential groove to further selectively restrain both axial and rotational movement of the sleeve relative to the elongate shaft.
2. The surgical instrument of claim 1 , wherein the lock includes a button disposed within a recess in the sleeve and configured to translate radially relative to the sleeve and elongate shaft between a locked position and an unlocked position.
3. The surgical instrument of claim 2 , wherein the button is biased toward the locked position.
4. The surgical instrument of claim 2 , wherein the button includes a throughbore configured to receive the elongate shaft.
5. The surgical instrument of claim 1 , wherein the second at least partial circumferential groove includes a plurality of flat portions angularly offset from one another to define a plurality of rotational positions of the elongate shaft relative to the sleeve.
6. The surgical instrument of claim 5 , wherein the plurality of flats includes first and second flats that define first and second rotational positions of the elongate shaft relative to the sleeve.
7. 6. The surgical instrument of claim 5, wherein the lock includes a flat portion configured to abut one of the plurality of flat portions of the second at least partial circumferential groove to maintain the elongate shaft in one of the plurality of rotational positions relative to the sleeve.
8. The surgical instrument of claim 1 , further comprising a handle configured to couple to a proximal portion of the elongate shaft to facilitate manipulation of the surgical instrument.
9. The surgical instrument of claim 1 , wherein the sleeve and the elongate shaft are configured to engage one or more objects therebetween to form a rigid connection with the one or more objects.
10. The surgical instrument of claim 9, wherein the sleeve further comprises a pair of arms that engage the object when disposed between the elongate shaft and the sleeve.
11. The surgical instrument of claim 10 , wherein the object includes one or more extension tabs on a receiver head.
12. A surgical instrument as described in claim 2, wherein the protrusion is defined by a pin configured to be received within a through hole of the sleeve, the pin extending within an inner lumen of the sleeve.
13. The surgical instrument of claim 12, wherein the sleeve further includes a first partial circumferential protrusion and a second partial circumferential protrusion formed on a wall of the inner lumen of the sleeve.
14. The surgical instrument of claim 12, wherein the button is biased radially outward relative to the sleeve.
15. The surgical instrument of claim 12, wherein the second at least partial circumferential groove includes a plurality of flat portions angularly offset from one another to define a plurality of rotational positions of the elongate shaft relative to the sleeve.
16. The surgical instrument of claim 15, wherein the plurality of flats includes first and second flats that define first and second rotational positions of the elongate shaft relative to the sleeve.
17. 16. The surgical instrument of claim 15, wherein the button includes a flat portion configured to abut one of the plurality of flat portions of the second at least partial circumferential groove to maintain the elongate shaft in one of the plurality of rotational positions relative to the sleeve.
18. The surgical instrument of claim 12, wherein the sleeve and the elongate shaft are configured to engage one or more objects therebetween to form a rigid connection with the one or more objects.
19. A surgical instrument as described in claim 4, wherein the second at least partial circumferential groove is a recess defined between a first shoulder and a second shoulder formed along the elongated shaft.
20. A surgical instrument as described in claim 19, wherein the button includes a flange defining a portion of the through hole, and when the flange engages the first shoulder or the second shoulder, it provides an axial stop that prevents proximal or distal displacement of the elongated shaft relative to the sleeve.
21. A surgical instrument as described in claim 8, wherein the handle is configured to be attached to the elongated shaft proximal to the longitudinal groove so that the position of the lock relative to the longitudinal groove is visible to the user.
Citation Information
Patent Citations
Spinal rod approximators
US20040147937A1
Quick-lock driver for a bone screw
US20150201987A1
Single action locking pedicle screwdriver
US20150359572A1