DRILLING DEPTH AND CONTROL APPARATUS AND METHODS FOR USING THE SAME
20230117196 · 2023-04-20
Assignee
Inventors
- George Frey (Englewood, CO, US)
- Caleb Voelkel (West Glover, VT, US)
- Adam Jensen (Golden, CO, US)
- Sean Starkman (Centennial, CO, US)
Cpc classification
A61B17/1615
HUMAN NECESSITIES
A61B17/16
HUMAN NECESSITIES
A61B2090/033
HUMAN NECESSITIES
A61B17/17
HUMAN NECESSITIES
International classification
Abstract
This disclosure relates to drill guides and depth control apparatus for use with a variety of customized or standardized surgical instruments. In embodiments, the apparatus comprises at least a body portion and a collar portion, one or more of which are configured to be coupled to a cutting instrument, such as a drill bit, in a specified location and manner to prevent unwanted movement. In embodiments, the assembly of the body and collar portions may be incrementally adjusted to alter the desired depth of the cutting instrument. Methods for using the foregoing apparatus are also disclosed herein.
Claims
1. An apparatus configurable to contact and be secured to an instrument, the apparatus comprising: a body comprising at least a first portion and a second portion, the first portion having a smaller radial dimension than the second portion, the body further comprising a bore passing through the longitudinal axis of the body for receiving at least a certain length of the instrument, wherein the bore comprises at least one surface configured to engage at least a portion of the instrument; and a collar comprising a bore passing through its longitudinal axis and selectively engageable with the body by placement of the first portion of the body in the bore of the collar, the collar selectively positionable about the body to include both a first position, wherein the at least one surface does not engage the instrument, and a second position, wherein the at least one surface does engage the instrument.
2. The apparatus of claim 1 wherein the at least one surface configured to engage at least one portion of the instrument is a frictional engagement.
3. The apparatus of claim 1, wherein the instrument comprises a substantially cylindrical shaft.
4. The apparatus of claim 3, wherein the instrument comprises a substantially smooth shaft.
5. The apparatus of claim 3, wherein the instrument comprises a linear groove running substantially the entire length of the shaft.
6. The apparatus of claim 3, wherein the instrument comprises a plurality of circumferential slots along the length of the shaft.
7. The apparatus of claim 3, wherein the instrument comprises both a linear groove running substantially the entire length of the shaft and a plurality of circumferential slots along the length of the shaft.
8. The apparatus of claim 1 wherein the instrument is a drill bit, a bur, a tap, a probe, a reamer, or an implant.
9. The apparatus of claim 1 wherein a specified translation of the apparatus relative to the instrument relates to a specified depth the instrument may be inserted into a tube or guide.
10. The apparatus of claim 1 wherein the collar further comprises a plurality of indicia, including a first indicia representing a locked position of the apparatus and a second indicia representing an unlocked position of the apparatus.
11. The apparatus of claim 1 wherein the body further comprises a marker for visually identifying the position of the collar relative to the body.
12. The apparatus of claim 1 wherein the body or the collar further comprises surface features for improving the placement of a user's finger and manipulation of the body or the collar.
13. The apparatus of claim 1 wherein the body and collar are formed of a stainless steel, a titanium alloy, an aluminum alloy, a chromium alloy, a metal alloy, a PEEK material, a carbon fiber, an ABS plastic, a polyurethane, a polyethylene, a photo-polymer, a resin, a fiber-encased resinous material, a rubber material, a latex material, a synthetic rubber, a synthetic material, a polymer, or a natural material.
14. An assembly, comprising: a depth stop configurable to contact and be secured to the cutting instrument, a cutting instrument, comprising a body with at least one groove formed to interface with the depth stop; the depth stop comprising a body with at least a first portion and a second portion, the first portion having a smaller radial dimension than the second portion; the depth stop further comprising a collar with a bore passing through its longitudinal axis and selectively engageable with the body by placement of the first portion of the body in the bore of the collar, the bore comprising at least one expanded section having a radial dimension greater than the remainder of the bore and further comprising at least one detent that is selectively engageable with the cutting instrument; wherein the at least one detent of the body further comprises at least one tab configured to be displaced radially when the collar is rotated from a first position to a second position, the displacement of the tab increases contact of the at least one detent with the cutting instrument; wherein the depth of the surgical instrument assembly is adjustable such that the first position of the collar allows for unrestricted movement between the depth stop and the cutting instrument and the second position of the collar restricts movement of the depth stop and the with the instrument.
15. The assembly of claim 14 wherein the depth stop further comprises at least one projection, wherein the at least one projection is configured to contact the at least one groove of the cutting instrument.
16. The assembly of claim 15 wherein the at least one projection is formed along the bore of the body and is arranged in a substantially helical shape.
17. The assembly of claim 15 wherein the at least one projection is formed along the bore of the body and is arranged in a substantially linear shape.
18. The assembly of claim 14 wherein the cutting instrument is a drill bit, a bur, a tap, or a reamer.
19. The assembly of claim 14 wherein the at least one groove of the cutting instrument is arranged in a substantially helical shape.
20. The assembly of claim 14 wherein the at least one groove of the cutting instrument is arranged in a substantially linear shape.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0032] The accompanying drawings, which are incorporated herein and constitute a part of the specification, illustrate embodiments of the disclosure, and together with the Summary and the Detailed Description serve to explain the principles of these embodiments. In certain instances, details that are not necessary for an understanding of the disclosure or that render other details difficult to perceive may have been omitted. It should be understood, of course, that the present disclosure is not necessarily limited to the particular embodiments illustrated herein. Additionally, it should be understood that the drawings are not necessarily to scale. In the drawings:
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[0045] Similar components and/or features may have the same reference number. Components of the same type may be distinguished by a letter following the reference number. If only the reference number is used, the description is applicable to any one of the similar components having the same reference number.
DETAILED DESCRIPTION
[0046] The present disclosure has significant benefits across a broad spectrum of endeavors. It is the Applicant's intent that this specification and subsequent claims be accorded a breadth in keeping with the scope and spirit of the disclosure and various embodiments disclosed, despite what might appear to be limiting language imposed by specific examples disclosed in the specifications. To acquaint persons skilled in the pertinent arts most closely related to the present disclosure, preferred and/or exemplary embodiments are described in detail without attempting to describe all of the various forms and modifications in which the novel apparatus, devices, systems and methods might be embodied. As such, the embodiments described herein are illustrative, and as will become apparent to those skilled in the arts, may be modified in numerous ways within the spirit of the disclosure.
[0047] By way of providing additional background, context, and to further satisfy the written description requirements of 35 U.S.C. § 112, the following are incorporated by reference in their entireties for the express purpose of explaining and further describing the various tools and other apparatus commonly associated therewith surgical procedures: U.S. Pat. No. 6,309,395 to Smith et al.; U.S. Pat. No. 6,142,998 to Smith et al.; U.S. Pat. No. 7,014,640 to Kemppanien et al.; U.S. Pat. No. 7,406,775 to Funk, et al.; U.S. Pat. No. 7,387,643 to Michelson; U.S. Pat. No. 7,341,590 to Ferree; U.S. Pat. No. 7,288,093 to Michelson; U.S. Pat. No. 7,207,992 to Ritland; U.S. Pat. No. 7,077,864 Byrd III, et al.; U.S. Pat. No. 7,025,769 to Ferree; U.S. Pat. No. 6,719,795 to Cornwall, et al.; U.S. Pat. No. 6,364,880 to Michelson; U.S. Pat. No. 6,328,738 to Suddaby; U.S. Pat. No. 6,290,724 to Marino; U.S. Pat. No. 6,113,602 to Sand; U.S. Pat. No. 6,030,401 to Marino; U.S. Pat. No. 5,865,846 to Bryan, et al.; U.S. Pat. No. 5,569,246 to Ojima, et al.; U.S. Pat. No. 5,527,312 to Ray; and U.S. Pat. Appl. No. 2008/0255564 to Michelson.
[0048] Several advantages of an improved depth control apparatus have previously been described herein, but for convenience, the following advantages are contemplated by this disclosure: customizable apparatus for use with a specific or numerous different instruments, tools or other surgical equipment, including both motorized and non-motorized; materials that permit 3D printing or otherwise simplify the fabrication of the components of the apparatus; reusability and/or disposability of components; ease of identification, orientation and established depth/penetration of associated instruments; lockable and unlockable configurations; ease of assembly; inhibition or prohibition to rotate or “slip” once assembled; ease of adjustment to achieve different depths; pre-surgically assembled to decrease time of operation and associated exposure to radiographic or other energy-emitting equipment; ease of removal; safety in that the device will not over penetrate if it becomes loose; and ability to use alone or in conjunction with patient-specific devices as described in greater detail below.
[0049] Several views of the apparatus described herein are shown in
[0050] The depth stop assembly preferably interfaces with at least one guide, such as a cannula. This interface permits a surgeon or other user to determine the “zero” location for a prescribed depth, vis-à-vis the at least one guide. The apparatus of the present disclosure also preferably interfaces with at least one instrument, tool or other surgical device that allows the assembly to prevent penetration of the at least one instrument, tool or other surgical device beyond a specific depth or distance. In embodiments, the instrument is a drill bit, although other cutting instruments are contemplated for use with the apparatus and are described in further detail below.
[0051] In embodiments, the body 10 and collar 20 portions may be 3D printed out of a metal or plastic (including but not limited to steel, stainless steel, metal alloys, polyurethane, polyethylene, ABS, resin-based materials, nylon or equivalent) material. In embodiments, the apparatus is intended to be single use. In other embodiments, the apparatus is reusable.
[0052] In embodiments, the depth stop assembly may lack a collar 20 portion but still interfaces with a cutting apparatus. In this embodiment, the depth stop assembly does not include a lockable configuration.
[0053] An exploded view of the system is shown below in
[0054] Referring now to
[0055] The body 10 may also comprise an orientation viewport 41, which is further used to align the body 10 portion with markings on the collar 20 portion, and/or to notify the user when the depth stop is locked or unlocked. The viewport 41 may be located and sized in a manner to prevent misreading indicia I on either the cutting instrument 30 or the collar 20 inadvertently.
[0056] The first section of the body 13 may comprise a raised ridge 15, which serves to assist with retaining the collar 20 once the components have been coupled together and the apparatus assembled. One or more relief cuts 16 may be provided along the raised ridge 15 to aid in the assembly process.
[0057] Referring now to
[0058] Referring to
[0059] Referring now to
[0060] Referring again to
[0061] Referring again to
[0062] Referring to
[0063] In the preferred embodiment, the collar 20 is rotated on the body 10 to achieve the locked position of the tab 9. In other embodiments, the collar 20 is slidable along the major axis of the body 10 to achieve the locked position of the tab 9. In yet other embodiments, the collar 20 is first slidable along the major axis of the body 10 and is then rotated to achieve the locked position of the tab 9.
[0064] Referring now to
[0065] The cutting instrument 30 preferably comprises a plurality of detents D along the channel or groove G, which interface with the ball 100 (and thereby the tab 9) of the body 10 portion as described above. The detents D are preferably shaped and/or contoured in a congruent manner to the spherical dimensions of ball 100.
[0066] The cutting instrument 30 preferably comprises one or more markings or indicia I, which are viewable from the marking window 41 escribed above for proper orientation of the depth stop to the desired depth. The indicia I are preferably orientated such that, if the depth stop is joined to the cutting instrument 30 in the reverse (i.e., improper) orientation, no markings will be visible within the marking window 41.
[0067] Referring now to
[0068] Referring to
[0069] Additional embodiments of the present disclosure are shown in
[0070] In certain embodiments, the surface area in contact between the apparatus and the cutting instrument is more expansive than one projection, protrusion or tab T, such as the embodiment shown in
[0071] According to other embodiments, the drill bit may comprise one or more indents at fixed locations that correspond to one or more preconfigured depths, as shown in
[0072] Referring now to
[0073] Accordingly, the apparatus may comprise a protrusion or other interior profile that creates a press fit or frictional engagement with a drill bit. The drill bit may comprise a standard, smooth cylindrical shaft such as is customarily available regardless of the manufacturer of the cutting instrument. The drill bit, according to various embodiments described herein and shown in the appended drawing figures, may comprise: (a) no indent or groove; (b) one or more indents or grooves at fixed intervals; (c) a single linear indent or groove; or (d) a combination of the foregoing.
[0074] This assembly and apparatus provides several benefits of the prior art. For instance, the reverse orientation of the channel of the cutting instrument (in comparison to the orientation of the blade of the cutting instrument) ensures that if the connection between the apparatus and the cutting instrument becomes insecure, the effect is the cutting instrument is backed out of the guide. As another example, the apparatus may be easily coupled to multiple cutting instruments in advance of the surgery, and thereby achieve multiple cutting depths without having to remove and replace a cutting guide or hard stop to the shaft of the cutting instrument. As yet another example, the depth stop apparatus described above comprises at least two projections. The first orients the depth stop along the track of the cutting instrument, and the second constrains the depth stop from moving from its intended position and along the track of the cutting instrument. Additionally, the desired depth or distance is controlled between detents in set increments (preferably 0.5-7 mm increments and more preferably 1-5 mm increments), as opposed to controlling depth by visual inspection or observation of a display, or requiring a secondary source to verify the depth.
[0075] The depth control apparatus and the above-described components may be manufactured via additive manufacturing. The depth control apparatus may be used in various orthopedic surgical procedures. In one embodiment, the depth control apparatus may be used in various spinal procedures in all approaches (anterior, direct lateral, transforaminal, posterior, posterior lateral, direct lateral posterior, etc.). Specific features described herein can address certain surgical objectives, for example restoring lordosis, restoring disc height, restoring sagittal or coronal balance, etc.
[0076] The apparatus described herein may then be fabricated by any method. Fabrication methods may comprise the use of a rapid prototyping machine, a 3D printing machine, a stereolithography (STL) machine, selective laser sintering (SLS) machine, or a fused deposition modeling (FDM) machine, direct metal laser sintering (DMLS), electron beam melting (EBM) machine, or other additive manufacturing machine.
[0077] According to an alternative embodiment, anatomical data may be obtained from an ultrasonic or nuclear medicine scanning device. In yet another alternative embodiment, the data may be supplemented or merged with data from a bone density scanner to fabricate a device that is designed to remain in the patient after the surgical procedure is completed, or alternatively to achieve further control over the orientation of any desired axes, particularly where the surgical procedure involves insertion of one or more implantable devices.
[0078] One having skill in the art will appreciate that embodiments of the present disclosure may have various sizes. The sizes of the various elements of embodiments of the present disclosure may be sized based on various factors including, for example, the anatomy of the patient, the person or other device operating with or otherwise using the apparatus, the surgical site location, physical features of the devices and instruments used with the apparatus described herein, including, for example, width, length and thickness, and the size of the surgical apparatus.
[0079] One having skill in the art will appreciate that embodiments of the present disclosure may be constructed of materials known to provide, or predictably manufactured to provide the various aspects of the present disclosure. These materials may include, for example, stainless steel, titanium alloy, aluminum alloy, chromium alloy, and other metals or metal alloys. These materials may also include, for example, PEEK, carbon fiber, ABS plastic, polyurethane, polyethylene, photo-polymers, resins, particularly fiber-encased resinous materials rubber, latex, synthetic rubber, synthetic materials, polymers, and natural materials.
[0080] One having skill in the art will appreciate that embodiments of the present disclosure may be used in conjunction devices that employ automated or semi-automated manipulation. Various apparatus and implants described herein may be provided to facilitate or control the entry point, angular trajectory, height, and/or head orientation of a screw, for example. For example, the drill may include further attachments to use with taps, burrs, trials or other surgical tools and instruments.
[0081] Additional benefits of the systems and methods described herein include improving device fixation, and/or preventing unwanted contact between devices and patient anatomy (e.g. the patient's spinal cord). The further use of methods described above, including the use of software analytics, may further aid in determining screw placement and orientation to achieve the ideal screw placement and/or rod shape. For example, the use of various apparatus described herein to achieve desired screw placement and orientation in turn provides improved alignment of a secondary device, such as a rod, with the screws heads. This benefit in turn allows the surgeon/user to achieve optimal sagittal and/or coronal alignment, which assists in rod placement and improves correction of the patient's anatomy.
[0082] While various embodiments of the present disclosure have been described in detail, it is apparent that modifications and alterations of those embodiments will occur to those skilled in the art. However, it is to be expressly understood that such modifications and alterations are within the scope and spirit of the present disclosure. For further illustration, the materials provided in the provisional patent application from which this application claims priority to, including Appendix A thereto, are expressly made a part of this disclosure and incorporated by reference herein in their entirety.
[0083] It is expressly understood that where the term “patient” has been used to describe the various embodiments of the disclosure, the term should not be construed as limiting in any way. For instance, a patient could be either a human patient or an animal patient, and the apparatus and methods described herein apply equally to veterinary science as they would to surgical procedures performed on human anatomy. The apparatus and methods described herein therefore have application beyond surgical procedures used by spinal surgeons, and the concepts may be applied to other types of “patients” and procedures without departing from the spirit of the present disclosure.
[0084] The foregoing discussion of the disclosure has been presented for purposes of illustration and description. The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description for example, various features of the disclosure are grouped together in one or more embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed disclosure requires more features than are expressly recited in each claim. Rather, the inventive aspects lie in less than all features of a single foregoing disclosed embodiment.
[0085] The present inventions, in various embodiments, include components, methods, processes, systems and/or apparatuses substantially as depicted and described herein, including various embodiments, subcombinations, and subsets thereof. Those of skill in the art will understand how to make and use the present inventions after understanding the present disclosure. The present inventions, in various embodiments, include providing devices and processes in the absence of items not depicted and/or described herein or in various embodiments hereof, including in the absence of such items as may have been used in previous devices or processes, e.g., for improving performance, achieving ease and/or reducing cost of implementation.
[0086] Moreover, though the present disclosure has included description of one or more embodiments and certain variations and modifications, other variations and modifications are within the scope of the disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative embodiments to the extent permitted, including alternate, interchangeable and/or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and/or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.