The disclosure relates generally to surgical instruments and techniques for treatment of the spine, and more specifically to tools and techniques for morcellation and decortication of disc tissue.
Techniques for the fusion of adjacent spinal vertebrae often involve promoting the growth of bony tissue between the endplates of the adjacent vertebrae. Growth of bony tissue is best facilitated by removing the tissue of the intervertebral disc that is in contact with the end plates, so that a clear path between adjacent endplates, and filling the resulting space with bone growth promoters, such as bone graft material (in addition to other spinal fusion appurtenances, such as fusion cages). The bone growth promoter typically extends between and contacts the endplates. The greater the exposed surface area of the vertebral endplates prior to implanting the bone growth promoter, the better.
Removing bone tissue from and between the endplates for satisfactory exposure of the endplate bone can be a time consuming process. As with all surgical procedures, reducing the time required to perform a surgical step is at a premium. An apparatus and technique that reduces the decortication and morcellation of intervertebral discs in spinal fusion procedures would be welcomed.
Various embodiments of the disclosure provide a mechanism that orient one or more morcellating blades to remain substantially parallel to a mid-plane of the intervertebral disc as the mechanism extends the blade(s) in the superior/inferior direction and into contact with a vertebral endplate. Accordingly, the blades are oriented for enhanced contact relative to morcellating blades of the prior art. In some embodiments, the blades of the device are configured with a convex profile that substantially conforms to the concave shape of the endplate for enhanced contact between the blade and the endplate during decortication of the intervertebral disc.
Conventional disc cutters for morcellating intervertebral discs tend to fan radially outward from a pivot point close to a central axis of the access tube. Such conventional disc cutters provide a cutting edge that contacts the vertebral endpoints along an inherently limited span. Accordingly, conventional disc cutters require several passes of the blade to sufficiently prepare the intervertebral space for spinal fusion procedures. The lateral disc cutter of the present disclosure increases the line of contact between the blade and the vertebral endplate, thus requiring fewer scraping passes to properly prepare the vertebral endplate.
Referring to
Referring to
The stem 23 and the proximal hub 44 are configured to enable translation of the stem 23 through the proximal hub 44. In some embodiments, the stem is also rotatable within proximal hub 44. The distal end 28 of the stem 23 is captured within the distal hub 46, and may also be rotatable within the distal hub 46. In some embodiments, the distal end of the stem 23 includes or is fitted with a head portion 80 (
The lateral disc cutter 20 is configured in the fully retracted configuration 21 (
The translation of the stem 23 causes the graduation lines 34 to slide through a sight tube 127 of the stem lock assembly 39 (or alternatively, proximal end 36 of the sleeve 32) in succession. In some embodiments, each graduation line 34 includes a numerical label that corresponds to a displacement width W (e.g., in millimeters) of the morcellator assembly 40 when the respective graduation line 34 is aligned with the proximal end 36 of the sleeve 32. This tells the operator what the cutting span of the morcellator assembly 40 is at a given axial displacement of the stem 23 within the sleeve 32. Alternatively, the graduation lines 34 may include numerical labels that correspond to a length scale (e.g., millimeters), indicating the displacement of the stem 23 within the sleeve 32.
In some embodiments, when in the fully retracted configuration, the minimum displacement width WMIN of the morcellator assembly 40 is in a range of 6 millimeters (mm) to 8 mm inclusive. In some embodiments, when in the fully extended configuration, the maximum displacement width WMAX of the morcellator assembly 40 is in a range of 6 millimeters (mm) to 8 mm inclusive. Herein, a range that is said to be “inclusive” includes the stated endpoints of the range, as well as a values between the endpoints. Also herein, the displacement width “W” refers generically to any displacement width from WMIN to WMAX inclusive.
Referring to
The morcellator assembly 40 may have a single blade 50 or a plurality of blades 50 and cutter assemblies 42, such as a pair of blades 50a, 50b and cutter assemblies 42a, 42b depicted in the figures. In some embodiments, a first blade 50a of the pair of blades 50a, 50b is disposed adjacent a first side 112 of the stem 23 and a second blade 50b of the pair of blades 50a, 50b is disposed adjacent a second side 114 of the stem 23 (
In assembly, the proximal hub 44 is affixed to the distal end 38 of the sleeve 32, for example by welding, crimping, pins, set screw, or threaded engagement. The proximal linkages 60 are pivotally coupled to the proximal hub 44 and the blades 50, and the distal linkages 70 pivotally coupled to the distal hub 46. With the end cap 88 removed, the distal end 28 of the stem 23 may be inserted into the proximal end 36 of the sleeve 32, through the distal end 38 of the sleeve 32, and through the hubs 44 and 46. For oversized head portions 80 (depicted), the head portion 80 can be removed during the insertion. With the distal end 28 of the stem 23 extending through the distal hub 46, the head portion 80 may be affixed to the distal end 28, the head portion 80 seated in the body portion 86 of the distal hub 46, and the end cap 88 secured to the body portion 86 to capture the head portion 80 and retention feature 82 within the distal hub 46. The handle 30 is affixed to the proximal end 26 of the stem 23.
Referring to
Referring to
The morcellator assembly 40 may be configured in a partially extended configuration 140 (
In the partially extended configuration 140, the morcellator assembly 40 cuts into the core tissue 136 adjacent the core passage 131 to increase the region of morcellated tissue 138. The lateral disc cutter 20 may also be reciprocated fore and aft (i.e., in the generally posterior and anterior directions 146 and 148) within the disc nucleus 134 to further expand the region of morcellated tissue 138.
To increase the reach of the morcellator assembly 40 in the superior and inferior directions, the displacement width W of the morcellator assembly 40 is increased. The stem lock assembly 39 (when utilized) is released and the stem 32 translated in the proximal direction 35 until the desired displacement width W is attained. During this step, the graduation lines 134 may be used in conjunction with the sight tube 127 to inform the user of the displacement width W (e.g.,
The process of releasing the stem lock assembly 39, expanding the morcellator assembly 40, and resetting the stem lock assembly 39, followed by rotation and reciprocation of the morcellator assembly 40 within the disc nucleus 134 is repeated until the morcellator assembly 40 reaches the fully extended configuration 22 (
Once the morcellation and decortication is complete, the lateral disc cutter 20 is reconfigured in the fully retracted configuration 21 and withdrawn through the access tube 130. The morcellated tissue 138 may be withdrawn through the access tube 130, for example with a suction device.
Functionally, the fully retracted configuration 21 reduces the profile of the morcellator assembly to enable insertion through the access tube 130 in a minimally invasive surgical procedure. The tissue scraped from the endplates 133 may gather within the concavity provided by the concave surface during a scraping stroke. Also, the concave surface 98 of the blades 50 provide relief for the core tissue 136 as it is morcellated, preventing the cutting edges 92, 94 from fouling due to accumulation of compacted tissue. The relief provided by the concave surface 98 enables the tissue compressed by the rotational advancement of the surfaces 93 and 95 of the blades 50 during morcellation, to expand into the cavity defined by the concave surface 98 after being cut. This may inhibit fouling of the cutting edges 92, 94. The convex profiles 106 of the blades 50 may conform closely to the concave surfaces of the endplates 133 for morcellating tissue closer to the endplates 133. The convex profile 106 may also act as a lead-in that guides the morcellator assembly 40 back into the access tube 130 when withdrawing the lateral disc cutter 20.
Referring to
For the lateral disc cutter 20a, the stem 23 includes external thread 172 that define a threaded region 174 of the stem 23. The proximal hub 44 may include an internal thread 176 that are threadably engaged with the external thread 172 of the stem 23. In some embodiments, the stem 23 includes or is fitted with a stop 178 at a distal end 182 of the threaded region 174, the stop 178 being distal to the proximal hub 44. The stop 178 may be affixed to the stem 23 in a variety of ways available to the artisan, including threaded engagement (depicted), press fitting over an enlarged diameter portion of the stem 23, welding, with pins, with a set screw, or by gluing.
In operation, the lateral disc cutter 20a is pushed through the access tube 130 so that the morcellator assembly 40 extends out of the distal end of the access tube 130. The external thread 172 of the stem 23 cooperates with the internal thread 176 of the proximal hub 44 for axially translating and positioning the stem 23 relative to the sleeve 32. For the lateral disc cutter 20a, the proximal hub 44, being affixed to the sleeve 32, remains stationary during rotation of the stem 23. During the rotation/translation of the stem 23, the head portion 80 and retention feature 82 are rotated within the distal hub 46 for the lateral disc cutter 20a.
Rotation of the stem 23 in a first rotational direction 184 causes the rotating stem 23 to translate in the proximal direction 35 which draws the distal hub 46 toward the proximal hub 44, thereby causing the proximal linkage 60 and the distal linkage 70 to pivot away from the stem 23 and translate the blade 50 away from the stem 23 and toward the fully extended configuration 22.
When rotating the stem 23 in the first rotational direction 184, proximal translation of the stem 23 reaches a limit when the stop 178 engages a distal face of the proximal hub 44. In such embodiments, engagement of the stop 178 with the proximal hub 44 establishes the fully extended configuration 22.
Rotation of the stem 23 in a second rotational direction 186 that is opposite the first rotational direction 184 translates the distal hub 46 away from the proximal hub 44, thereby causing the proximal linkage 60 and the distal linkage 70 to pivot toward the stem 23 and translate the blade 50 toward the stem 23 and toward the fully retracted configuration 21. When rotating the stem 23 in the second rotational direction 186, distal translation of the stem 23 reaches a limit when the cutter assemblies 42 are pulled taut between the proximal and distal hubs 44 and 46. For the lateral disc cutter 20a, the external thread 172 of the stem 23 extend through the proximal hub 44 when in the fully retracted configuration 21 and for all intermediate configurations between the fully retracted configuration 21 and the fully extended configuration 22.
Referring to
Referring to
For the lateral disc cutter 20b, the external thread 172 of the stem 23 are disposed proximal to the proximal hub 44 and do not engage the proximal hub 44. Instead, a threaded insert 190 is disposed inside the sleeve 32 having internal threads 192 that engage the external thread 172. Also, the stop 178 may be disposed inside the sleeve 32 to engage the threaded insert 190 when the lateral disc cutter 20b is in the fully extended configuration 22. Accordingly, neither the external thread 172 nor the stop 178 extend outside the sleeve 32 during operation.
In assembly, the threaded insert 190 may be welded, glued, or crimped to the sleeve 32. Optionally, the threaded insert 190 may be manufactured as unitary with the sleeve 32. Optionally, the sleeve may be in multiple parts, with the threaded insert 190 including external threads to which the two parts are threadably engaged to form a joint at the threaded insert 190 (not depicted).
Referring to
In some embodiments, at least some of the operational steps of the lateral disc cutter 20 attendant to
Each of the additional figures and methods disclosed herein can be used separately, or in conjunction with other features and methods, to provide improved devices and methods for making and using the same. Therefore, combinations of features and methods disclosed herein may not be necessary to practice the disclosure in its broadest sense and are instead disclosed merely to particularly describe representative and preferred embodiments.
Various modifications to the embodiments may be apparent to one of skill in the art upon reading this disclosure. For example, persons of ordinary skill in the relevant arts will recognize that the various features described for the different embodiments can be suitably combined, un-combined, and re-combined with other features, alone, or in different combinations. Likewise, the various features described above should all be regarded as example embodiments, rather than limitations to the scope or spirit of the disclosure.
Persons of ordinary skill in the relevant arts will recognize that various embodiments can comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the claims can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art.
Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein.
Unless indicated otherwise, references to “embodiment(s)”, “disclosure”, “present disclosure”, “embodiment(s) of the disclosure”, “disclosed embodiment(s)”, and the like contained herein refer to the specification (text, including the claims, and figures) of this patent application that are not admitted prior art. Herein, references to “proximal” and associated derivative terms refer to a direction or position that is toward the surgeon or operator. References to “distal” and associated derivative terms refer to a direction or position that is away from the surgeon or operator.
For purposes of interpreting the claims, it is expressly intended that the provisions of 35 U.S.C. 112(f) are not to be invoked unless the specific terms “means for” or “step for” are recited in the respective claim.
This application claims the benefit of U.S. Provisional Application No. 62/539,797, filed Aug. 1, 2017, the disclosure of which is hereby incorporated by referenced in its entirety.
Number | Name | Date | Kind |
---|---|---|---|
6224604 | Suddaby | May 2001 | B1 |
6726690 | Eckman | Apr 2004 | B2 |
6840944 | Suddaby | Jan 2005 | B2 |
6902568 | Serhan | Jun 2005 | B2 |
7329267 | Weber | Feb 2008 | B2 |
8034088 | Pagano | Oct 2011 | B2 |
8480675 | Betts | Jul 2013 | B2 |
8551097 | Schmitz et al. | Oct 2013 | B2 |
8568416 | Schmitz et al. | Oct 2013 | B2 |
8579902 | Bleich et al. | Nov 2013 | B2 |
8585704 | Schmitz et al. | Nov 2013 | B2 |
8652138 | Bleich et al. | Feb 2014 | B2 |
8663228 | Schmitz et al. | Mar 2014 | B2 |
8845639 | Wallace et al. | Sep 2014 | B2 |
8894652 | Seifert et al. | Nov 2014 | B2 |
9247952 | Bleich et al. | Feb 2016 | B2 |
9314253 | Mimran et al. | Apr 2016 | B2 |
9320618 | Schmitz et al. | Apr 2016 | B2 |
9326777 | Tally | May 2016 | B2 |
9345491 | Bleich et al. | May 2016 | B2 |
9351741 | Schmitz et al. | May 2016 | B2 |
9456829 | Saadat et al. | Oct 2016 | B2 |
9463029 | Schmitz et al. | Oct 2016 | B2 |
9463041 | Bleich et al. | Oct 2016 | B2 |
20030135218 | Eckman | Jul 2003 | A1 |
20030220650 | Major et al. | Nov 2003 | A1 |
20040122457 | Weber | Jun 2004 | A1 |
20060116690 | Pagano | Jun 2006 | A1 |
20080249552 | Eliachar et al. | Oct 2008 | A1 |
20110015635 | Aryan | Jan 2011 | A1 |
20150173917 | Radcliffe et al. | Jun 2015 | A1 |
20150306348 | Wallace et al. | Oct 2015 | A1 |
20160030060 | Tally et al. | Feb 2016 | A1 |
20170014142 | Schmitz et al. | Jan 2017 | A1 |
Number | Date | Country | |
---|---|---|---|
20190038304 A1 | Feb 2019 | US |
Number | Date | Country | |
---|---|---|---|
62539797 | Aug 2017 | US |