Various surgical procedures entail the need for estimating a size of an enclosed bodily joint, and typically require the use of one or more instruments. For example, prior to implanting a device into an intervertebral disc space/joint, a sizing instrument is normally employed to first estimate the size of the disc space so that an appropriately sized implant can be selected. Sizing instruments for measuring a size of a spinal disc space typically include a distal end that approximates a size and shape of an implant to be inserted into the disc space. Often times, the sizing instrument is impacted into the disc space with a mallet or other tool. A sequential sizing method (i.e., smallest to largest) is typically used, with the sizes of distal ends of the sizing instrument graduating until a desired fit is achieved. The desired fit is determined by a user based upon tactile feel, for example by determining whether the fit of the sizer in the disc space “feels” not too loose and not too tight. Based upon this subjective “feel test,” a final sizer is selected as an indicator of an appropriate implant size for a particular patient. Similar techniques are employed for estimating or measuring the size of other bodily joints.
Unfortunately, tactile feel is subjective and varies from person-to-person. Such directions as snug, or not too tight, while generally appropriate, leave room for some individual error. While surgeons have become adept at the sizing method described above, ensuring proper sizing techniques is important. For example, when the surgeon inadvertently selects a sizer instrument that is much larger than the space being evaluated, excessive impaction might be used to drive the distal end of the sizer instrument into the intervertebral disc space (or other bodily joint). As a result, the adjacent vertebrae could be over-distracted, resulting not only in damage to vertebral body endplates (or other bodily tissue or structure), but also damaging soft tissue stabilizers, which can result in an increase in iatrogenic instability, for example.
Some aspects of the present disclosure relate to a sizing instrument for measuring a bodily joint having opposed, top and bottom surfaces, such as a disc space bounded by a top vertebra and a bottom vertebra. The sizing instrument includes a jaw assembly, a handle assembly, and an indicator portion. The jaw assembly includes an upper contact pad adapted to substantially rigidly engage the top surface, such as the top vertebra. The jaw assembly also includes a lower contact pad adapted to substantially rigidly engage the bottom surface, such as the bottom vertebra. The handle assembly is linked to the jaw assembly and is adapted to vary a distance between the upper contact pad and the lower contact pad. The indicator portion is associated with the handle assembly and is adapted to communicate the distance between the upper contact pad and the lower contact pad. The sizing instrument also optionally includes a biasing device in mechanical communication with the jaw assembly to bias the upper contact pad away from the lower contact pad, the biasing device adapted to provide a predetermined spring force for engaging the top and bottom surfaces of the bodily joint.
Other aspects of the present invention relate to a method of measuring a bodily joint of a human patient bounded by top and bottom surfaces, such as a disc space bounded by a top vertebra and a bottom vertebra. The method includes providing a sizing instrument including a jaw assembly, a handle assembly, and an indictor portion. The jaw assembly includes an upper contact pad and a lower contact pad. The handle assembly is in mechanical communication with the jaw assembly and is adapted to vary a distance between the upper contact pad and the lower contact pad. The indicator portion is adapted to communicate the distance between the upper contact pad and the lower contact pad. The method also includes collapsing the jaw assembly to bring the upper contact pad toward the lower contact pad such that the jaw assembly defines a minimized profile. The jaw assembly is inserted into the joint (e.g., disc space) and expanded against the top and bottom surfaces (e.g., top vertebra and the bottom vertebra) to substantially rigidly engage the surfaces. Following engagement, a height or other dimension of the bodily joint is obtained by a user via the indictor portion. The sizing instrument optionally includes a biasing device in mechanical communication with the jaw assembly to bias the upper contact pad away from the lower contact pad. A predetermined spring force of the biasing device is selected to reduce risk of over distraction of the bodily joint.
While some aspects of the invention have been described above, other related products and methods are also disclosed and provide additional advantages.
In some embodiments, the handle assembly 22 includes a lever arm 30, a grip arm 32, a biasing device 34, and the indicator portion 28. The lever arm 30 extends from a first end 36 to a second end 38. The lever arm 30 is adapted to be grasped by a user, for example incorporating ergonomic features or other features facilitating a comfortable secure hand hold on the lever arm 30, such as a loop 40 sized to receive a user's fingers. The grip arm 32 is also optionally substantially ergonomically shaped or otherwise adapted to facilitate grasping, for example with a palm of the user's hand. While the handle assembly 22 is shown as incorporating a looped, pistol-style configuration, a wide variety of other configurations are also acceptable, adapted to facilitate grasping/actuation by a user's hand.
The lever and grip arms 30, 32 are pivotably assembled to one another at a pivot point P. With this in mind, the biasing device 34 is configured to bias the lever arm 30 (and in particular the second end 38) away from (or alternatively toward) the grip arm 32, with the arms 30, 32 pivoting relative to one another at the pivot point P. The biasing device 34 is characterized by a spring force or a spring constant, and in some embodiments is a spring. In one embodiment, the spring force is pre-selected to bias the second end 38 of the lever arm 30 arm away from the grip arm 32 at a predetermined force. As described below, the handle assembly 22, and thus the biasing device 34, is mechanically linked to the jaw assembly 26 such that the spring force associated with the biasing device 34 is transferred to the jaw assembly 26. As such, the biasing device 34 can assume a variety of other forms and can be assembled as other locations along the instrument 20 (including locations other than the handle assembly 22) so long as a biasing force is applied to the jaw assembly 26.
In some embodiments, the indicator portion 28 of the handle assembly 22 includes a scale member 42 and a pointer 43. The scale member 42 can extend from the grip arm 32 and includes a plurality of graduated markings 44 or other indicia adapted to communicate a dimension, such as the overall separation distance (e.g., height) of the jaw assembly 26 as described below. The pointer 43 is formed by, or extends from, the second end 38 of the lever arm 30, and is configured to highlight an individual one of the graduated markings 44 when positioned in close proximity thereto. For example, the pointer 43 can be a gap defined in the second end 38. Regardless, the lever arm 30 is associated with the scale member 42 such that the second end 38 (or the pointer 43) travels over the graduated markings 44 as the lever arm 30 is actuated relative to the grip arm 32. To this end, a position of the pointer 43 relative to individual ones of the graduated markings 44 is correlated with a position of the jaw assembly 26 as described below.
The extension assembly 24 defines a length convenient for inserting the jaw assembly 26 into a bodily joint, for example a disc space, by a user otherwise grasping the instrument 20 at the lever and grip arms 30, 32. The extension assembly 24 includes, in some embodiments, a slider arm 46 and a base 48. The slider arm 46 is a substantially elongate body extending from a proximal end 50 to a distal end 52. The proximal end 50 is connected to the lever arm 30 such that the slider arm 30 moves with the rotation of the lever arm 30 about the pivot point P. Further, the slider arm 46 forms or includes a yoke 54 (best shown in
As reflected in
With reference to
The lower contact pad 58 can have a height on the order of 1-10 mm, for example 3 mm, and a width on the order of 3-15 mm, for example 8 mm, although other dimensions are contemplated. The lower contact pad 58 defines a substantially oval-shaped profile, forms a slot 68 sized to slidably receive the connector 62, and defines a lower contact surface 70. The lower contact pad 58 is adapted to forcibly, or otherwise substantially rigidly engage or contact bodily tissue during a sizing procedure (e.g., an endplate of a vertebra) with the lower contact surface 70. In this regard, the lower contact surface 70 is smooth and free of comers so as to minimize traumatic interaction with tissue. Further, a leading end 72 is curved and/or smooth, thus presenting an atraumatic surface for initial insertion into a bodily joint (or other bodily structure being measured). Additionally, the lower contact pad 58 is optionally substantially continuously formed with the base 48 of the extension assembly 24, extending distally from the distal end 56 of the base 48.
The upper contact pad 60 is optionally substantially U-shaped, defining a slot 76 with rounded edges and an upper contact surface 78. The upper contact pad 60 can have a height on the order of 1-10 mm, for example 3 mm, and a width on the order of 3-15 mm, for example 8 mm, although other dimensions are contemplated. As will be described subsequently in greater detail, the upper contact pad 60 is adapted to forcibly, or otherwise substantially rigidly, engage or otherwise contact bodily tissue during a sizing procedure (e.g., an endplate of a vertebra or other bodily joint surface) with the upper contact surface 78. Thus, the upper contact surface 78 is, similar to the lower contact surface 70, smooth and free of corners. Further, a leading end 79 of the upper contact pad 60 is curved and/or smooth for atraumatic insertion into a bodily joint.
In some embodiments, the connector 62 is generally triangular in shape defining a first corner 80 (shown partially obscured), a second corner 82 (shown partially obscured), and a third corner (hidden within the yoke 54). With the one configuration of
With reference to
The scale member 42 is secured to (or integrally formed with) the grip arm 32 and extends proximate the second end 38 of the lever arm 30. In particular, the scale member 42 extends such that the pointer 43 (in association with the second end 38 of the lever arm 30) is selectively aligned relative to respective ones of the graduated markings 44.
The slider arm 46 extends at least partially within the slot 57 (
With reference to
With additional reference to
With reference to
With the above construction, the jaw assembly 26 can define an overall minimized profile in the collapsed state or position for optimal insertion into a bodily joint, such as a disc space. In some embodiments, the minimized overall profile is substantially smaller than an implant (not shown) to be inserted into the bodily joint (e.g., disc space) following measurement. As such, insertion of the jaw assembly 26 into the bodily joint to be measured does not require a larger hole than that required for implant insertion.
With the above in mind, a method of adjusting the overall spacing or height H defined by the contact pads 58, 60 is described as follows. In the absence of an external user-supplied squeezing force, the biasing device 34 biases the second end 38 of the lever arm 30 away from the grip arm 32 (i.e., clockwise relative to the orientation of
With reference to
The method includes first accessing the disc space 90. In one embodiment, an anterior retro-peritoneal approach (ARPA) is used. An annular opening is created, forming a window in the annulus fibrosis (not shown) capable of receiving (or allowing passage of) the jaw assembly 26. Where the ARPA technique is used, a more centrally located anterior incision or window is optionally formed. In turn, where a posterior approach to the intervertebral disc 90 is used, the incision or window in the annulus fibrosis is at an offset from a posterior-anterior centerline of the disc space 90. A desired amount of the disc nucleus (not shown) is optionally removed, for example substantially the entire disc nucleus.
With additional reference to
Once the contacts pads 58, 60 are within the joint to be measured, the user then removes the squeezing force being applied to the handle assembly 22 (e.g., the user releases the lever arm 30 while still holding the grip arm 32). As referenced above, the biasing device 34 is in mechanical communication with the jaw assembly 26 via the extension assembly 24. In this manner, the biasing device 34 self-biases the lower and upper contact pads 58, 60 away from one another at a predetermined force until the pads 58, 60 contact or engage the top and bottom vertebrae 100, 102, respectively. In one embodiment, the predetermined force is selected to avoid overt distraction and/or trauma of the bodily joint being sized. For example, for intervertebral disc space sizing, the force constant of the biasing device 34 is selected such that a maximum expansion force exerted by the pads 58, 60 upon the vertebrae 100, 102 will not exceed 50N. For other applications (e.g., sizing of bodily joints other than a disc space), a greater (i.e., greater than 50 N) or lesser or maximum expansion force can be selected. In fact, in some embodiments, the predetermined force can be selected or adjusted to match the constraints or needs of a subsequently implanted input device. Regardless, the jaw assembly 26 expands until the top and bottom vertebrae 100, 102 are substantially rigidly engaged, with a distance between the upper and lower contact surfaces 70, 78 reflecting a height (or other dimension) of the bodily joint (e.g., height of the disc space 90). This measured dimension is indicated to the user at indicator portion 28. In particular, the user is able to take a reading for the joint dimension in question by reading the location of the second end 38/pointer 43 of the lever arm 30 on the graduated markings 44, for example. In this manner, the user is able to obtain a height measurement of the disc space 90 (or other joint dimension) at a controlled and predetermined force selected to avoid over distraction of the top and bottom vertebrae 100, 102. Where desired, the jaw assembly 26 can be partially retracted and maneuvered to other locations within the joint space and additional measurements obtained. The handle assembly 22 is then squeezed to fully collapse the jaw assembly 26, and the jaw assembly 26 is then retracted from the disc space 90.
According to the techniques described above, a center of the disc space 90 is optionally measured, for example by using the ARPA technique to have a more centrally located approach at the disc space 90 during insertion of the sizing instrument 20, rather than a measurement taken at an angular offset or a measurement taken at the annular margin. In one embodiment, by measuring the center of the disc space 90, the overall height H between the top and bottom contact surfaces 70, 78 is taken at a location of a properly positioned spinal implant (not shown). Where an approach is made into the disc space 90 at an angular offset in the vertical direction and/or at a lateral offset from the posterior-anterior centerline toward the annular margin, the overall height measured may not be as indicative of a height of the disc space 90 where an implant will be placed. For example, if the end plates 110, 112 are substantially concave then an overall height of the disc space 90 at the annular margin is potentially less than an overall height of the disc space 90 at a location in the disc space 90 where the implant is properly positioned. In sum, less desirable readings may be taken where an angle of approach is more vertical and/or laterally offset toward the annular margin. In at least this manner, the ARPA technique is particularly advantageous in some applications.
In one embodiment, the instrument 20 is used in connection with a procedure for implanting a spinal implant (not shown) into the disc space, it being understood that the instrument 20 and method in accordance with aspects of the present invention is equally applicable to other spine-related procedures (e.g., fusion and non-fusion surgical procedures) as well as procedures related to bodily joints apart from the spine. With this one embodiment, however, the jaw assembly 26 is adapted to be substantially smaller than a size and shape of the spinal implant (not shown) being inserted into the disc space 90. In particular, the lower and upper contact pads 58, 60 taken together are substantially smaller in size and shape (e.g., height and width) in comparison to the implant when the jaw assembly 26 is in the minimized overall profile state. However, various dimensions are contemplated, including the lower and upper contact pads 58, 60 being about the same size as, or larger than, the implant to be inserted. The spinal implant is optionally a prosthetic spinal disc nucleus (not shown), such as those available from Raymedica, LLC of Bloomington, Minn. The prosthetic disc nucleus includes an outer jacket (not shown) surrounding an expandable core (not shown) formed of a hydrogel material, which upon hydration, expands to, and is constrained by, the outer jacket. Exemplary hydrogel core implants in accordance with the present invention are described in U.S. Pat. Nos. 5,824,093 and 6,132,465, the teachings of which are incorporated herein by reference.
It should also be understood that the sizing instrument 20, and in particular the jaw assembly 26, is optionally adapted for sizing the disc space 90 for other spinal implants, including other types of hydrogel core implants or implants using springs or disc replacement devices or other mechanical means of supporting the disc space 90. Thus, the sizing instrument 20 is in no way limited to any one particular spinal implant configuration (can be used with fusion or non-fusion procedures), nor is it limited to use with disc space applications.
More particularly, the extension assembly 202 includes a slider arm 206 and a base 208. The slider arm 206 and the base 208 are connected at proximal ends (not shown) thereof to the handle assembly (not shown). Further, the slider arm 206 is slidably retained by the base 208 such that a distal segment 210 of the slider arm 206 is axially moveable relative to a distal segment 212 of the base 208. In this regard, each of the distal segments 210, 212 includes a shoulder 214, 216 that extends transversely relative to or from a corresponding intermediate segment 218, 220 respectively. With this arrangement, then, the distal segments 210, 212 locate the jaw assembly 204 so as to be offset from a centerline or axis of the intermediate segments 218, 220.
During use, the instrument 200 is employed to perform a bodily joint sizing procedure as previously described. In this regard, the offset arrangement of the jaw assembly 204 relative to the extension assembly 202 (and in particular the intermediate segments 214, 216) can facilitate desired positioning of the jaw assembly 204, including upper and lower contact pads 222, 224, while avoiding various anatomical structures of concern. For example, as shown in
In the foregoing Detailed Description, reference is made to the accompanying drawings which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. In this regard, directional terminology, such as “top,” “bottom,” “front,” “back,” “leading,” “trailing,” etc., is used with reference to the orientation of the Figure(s) being described. Because components of embodiments of the present invention can be positioned in a number of different orientations, the directional terminology is used for purposes of illustration and is in no way limiting. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. The foregoing detailed description, therefore, is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims.
The subject matter of this application is related to the subject matter of U.S. Provisional Application Ser. No. 60/786,975, filed Mar. 29, 2006 and entitled “Sizing Instrument for Bodily Joint Such as an Intervertebral Disc Space,” priority to which is claimed under 35 U.S.C. §119(e) and an entirety of which is incorporated herein by reference.
Number | Date | Country | |
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60786975 | Mar 2006 | US |