The present invention relates generally to a device for treating intervertebral injuries and, more specifically relates to a minimally invasive intervertebral implant that is plastically deformable to enhance bone graft volume and contact with vertebral endplates.
Current intervertebral devices are designed using three major principles: the anatomical limitations of the surgical approach, optimization of bone graft volume to promote bony fusion, and optimization of the device contact with vertebral endplates to resist subsidence. Current devices are generally static in that they cannot change shape or volume. Thus, current devices are limited by anatomy and technique and consequently may not provide optimal bone graft volume or surface contact.
A need exists for an intervertebral device or implant that can change shape and/or volume. Such a device benefits from the ability to be advanced to an implantation site in a first configuration having a reduced transverse dimension and subsequently transitioned to a second configuration having a desired transverse dimension at the implantation site. Such a device benefits from a rigid structure that can be held in the second configuration by plastic deformation of the material and/or a mechanism for locking the device in the second configuration. Such a device further benefits from being quickly implantable by a simple tool that places and positions the implant at the implantation site and further delivers bone graft material to fill an interior volume of the implant.
In one aspect of the present invention, a minimally invasive intervertebral implant includes a circuitous body defining a luminal axis extending longitudinally therethrough. The circuitous body includes proximal and distal ends oppositely disposed along a lateral axis of the circuitous body. Each of the proximal and distal ends includes an aperture disposed therethrough such that the circuitous body includes a first configuration wherein the proximal and distal ends are at a maximum separation and a second configuration wherein the proximal and distal ends are closer together than in the first configuration.
In another aspect of the present invention, a minimally invasive intervertebral implant system includes the minimally invasive intervertebral implant and an implantation tool includes a cannula including a pair of prongs extending distally from a distal end thereof. A shaft is adapted to be slidably disposed longitudinally through the cannula and includes a threaded distal end. A handle is attached to a proximal end of the shaft. The system may further include a funnel having a distal end adapted to removably attach to a proximal end of the cannula and a plunger adapted to form a sliding seal with a lumen of the funnel for the purpose of forcing bone graft material through the cannula.
In a further aspect of the present invention, a method for implantation of a minimally invasive intervertebral implant utilizing an implantation tool is presented. The method comprises the steps of attaching the minimally invasive vertebral implant in the first configuration to the threaded distal end of the shaft such that the pair of prongs engages the pair of proximally extending slots and advancing the distal end of the shaft toward an implantation site such that the luminal axis of the circuitous body is generally parallel with a bone surface at the implantation site. The method further includes the steps of rotating the cannula by about 90 degrees such that the luminal axis is generally perpendicular to the bone surface, translating the shaft proximally relative to the cannula to transition the minimally invasive vertebral implant from the first configuration to the second configuration, and detaching the implantation tool from the minimally invasive vertebral implant. The method may further include detaching the shaft from the minimally invasive vertebral implant by rotating the handle relative to the cannula, withdrawing the shaft from the cannula, connecting the funnel to the proximal end of the cannula, and forcing bone graft material through the funnel and cannula with the plunger until an interior volume of the minimally invasive vertebral implant is filled.
The foregoing and other features and advantages of the invention are apparent from the following detailed description of exemplary embodiments, read in conjunction with the accompanying drawings; wherein like structural or functional elements may be designated by like reference numerals.
The words proximal and distal are applied to denote specific ends of components of the current invention described herein. A proximal end refers to the end of a component nearer to a medical professional when the component is implanted. A distal end refers to the end of a component further from the medical professional when the component is implanted.
Referring to
The circuitous body 105 includes a first configuration 200 wherein the proximal and distal ends 115, 120 are at a maximum separation, as best illustrated by
In one embodiment, the circuitous body 105 comprises a rigid biologically inert material, including by way of example and not limitation, titanium, titanium alloy, and polyetheretherketone (PEEK). The circuitous body 105 may transition from the first configuration 200 to the second configuration 300 via elastic or plastic deformation. It is preferable that the circuitous body 105 maintains the second configuration 300 subsequent to a transition thereto as would be the case if the transition from the first configuration 200 to the second configuration 300 plastically deforms the circuitous body 105. Applying sufficient force on the distal end 120 toward the proximal end 115, as depicted by arrow 160 in
Referring to
In some embodiments, plastic deformation of the living hinges 155 from the open position as illustrated in
Other locking mechanisms 170 may be utilized to maintain the circuitous body 105 in the second configuration 300 subsequent to a transition thereto, including by way of example and not limitation, contact adhesive, a single barbed male fitting engaging a female fitting, etc. It is contemplated that the locking mechanism 170 may also comprise a ratchet mechanism (not shown), whereby the female compressive snap fitting 170b includes multiple sets of internal shoulders at increasing depths such that the living hinge 155 can be locked in any of several positions between a fully open position as illustrated in
Referring to
Referring to
As illustrated in
At the point in the method illustrated in
Referring to
The shaft 420 is further advanced distally relative to the cannula 405, as illustrated by arrow 445 in
Having described how the implantation tool 400 functions to transition the circuitous body 105 from the first configuration 200 to the second configuration 300 hereinabove with regard to
One reason why the circuitous body 105 is initially oriented as illustrated in
Following distraction of the vertebrae, a common procedure includes preparing the intervertebral disc space for introduction of an implant. Preparation may include removal of a portion of a disc annulus or evacuation of a disc nucleus, as known in the art. Further steps may include the removal of cartilaginous endplates on the vertebrae. A tool that may be useful in preparation of an intervertebral disc space for introduction of an implant may be found, for example, in Jansen et al. U.S. Pat. No. 7,632,278, which is incorporated by reference herein in its entirety.
As noted hereinabove, with regard to
Referring to
Referring to
Still referring to
First and second positional markings 550, 555 are disposed proximate the distal end 540 of the handle 430. When the first marking 550 is visible and the second marking 555 is visibly obstructed by the cover member 530, the distal end 425 of the shaft 420 extends from the distal end 415 of the cannula 405 a first distance that may, for example, correspond to the shaft 420 being operationally attached to the distal aperture 135 of the circuitous body 105 in the first configuration 200. When the first and second markings 550, 555 are both visible, the distal end 425 of the shaft 420 extends from the distal end 415 of the cannula 405 a second distance that may, for example, correspond to the shaft 420 being operationally attached to the distal aperture 135 of the circuitous body 105 in the second configuration 300. Thus, the first and second markings 550, 555 may provide a medical practitioner a visual aide in addition to visualization of the implantation site 500 via other methods known in the art to determine the status of the circuitous body 105.
Referring again to
Referring to
A plunger 570 is adapted to form a sliding seal with a lumen of the funnel 560 for the purpose of forcing bone graft material through the cannula 405 to the implantation site 500 within the circuitous body 105. Thus, in a final step in the method for implantation of a minimally invasive intervertebral implant, bone graft material is forced through the funnel 560 and cannula 405 with the plunger 570 until an interior volume of the minimally invasive vertebral implant 100 is filled.
A minimally invasive intervertebral implant, an implantation tool therefore, and a method for implantation thereof are presented. The implant benefits from the having an expandable geometry, which allows the implant to be placed into intervertebral spaces smaller than typical fixed geometry implants.
It will be appreciated by those skilled in the art that changes could be made to the embodiments described hereinabove without departing from the broad concepts disclosed therein. It is understood, therefore, that this disclosure is not limited to the particular embodiments disclosed, but it is intended to cover modifications that may include a combination of features illustrated in one or more embodiments with features illustrated in any other embodiments. Various modifications, equivalent processes, as well as numerous structures to which the present disclosure may be applicable will be readily apparent to those of skill in the art to which the present disclosure is directed upon review of the present specification. Accordingly, this description is to be construed as illustrative only and is presented for the purpose of enabling those skilled in the art to make and use the minimally invasive intervertebral implant, implantation tool therefor, and method for implantation thereof described herein and to teach the best mode of carrying out the same.
This application claims priority to U.S. Provisional Patent Application No. 61/389,986, filed Oct. 5, 2010, which is incorporated herein by reference.
Number | Name | Date | Kind |
---|---|---|---|
4877020 | Vich | Oct 1989 | A |
5171278 | Pisharodi | Dec 1992 | A |
5176587 | Mott | Jan 1993 | A |
5549679 | Kuslich | Aug 1996 | A |
5571189 | Kuslich | Nov 1996 | A |
5693100 | Pisharodi | Dec 1997 | A |
5782832 | Larsen | Jul 1998 | A |
6039761 | Li et al. | Mar 2000 | A |
6126689 | Brett | Oct 2000 | A |
6409766 | Brett | Jun 2002 | B1 |
6488710 | Besselink | Dec 2002 | B2 |
6527804 | Gauchet et al. | Mar 2003 | B1 |
6893464 | Kiester | May 2005 | B2 |
7137997 | Paul | Nov 2006 | B2 |
7445636 | Michelson | Nov 2008 | B2 |
7513900 | Carrison et al. | Apr 2009 | B2 |
7621950 | Globerman et al. | Nov 2009 | B1 |
7621956 | Paul et al. | Nov 2009 | B2 |
7641666 | Paul et al. | Jan 2010 | B2 |
7674296 | Rhoda et al. | Mar 2010 | B2 |
7731751 | Butler et al. | Jun 2010 | B2 |
7758644 | Trieu | Jul 2010 | B2 |
7763028 | Lim et al. | Jul 2010 | B2 |
D623750 | Duffield et al. | Sep 2010 | S |
7846206 | Oglaza et al. | Dec 2010 | B2 |
8021393 | Seifert et al. | Sep 2011 | B2 |
8167948 | Paul et al. | May 2012 | B2 |
D665081 | Hansell et al. | Aug 2012 | S |
8241358 | Butler et al. | Aug 2012 | B2 |
8268001 | Butler et al. | Sep 2012 | B2 |
8394145 | Weiman | Mar 2013 | B2 |
8398713 | Weiman | Mar 2013 | B2 |
8435298 | Weiman | May 2013 | B2 |
8454623 | Patel et al. | Jun 2013 | B2 |
8460386 | Ankney et al. | Jun 2013 | B2 |
8496713 | Bennett et al. | Jul 2013 | B2 |
8545566 | Niemiec et al. | Oct 2013 | B2 |
8778027 | Medina | Jul 2014 | B2 |
8808385 | Smith et al. | Aug 2014 | B1 |
20010012942 | Estes et al. | Aug 2001 | A1 |
20010032020 | Besselink | Oct 2001 | A1 |
20020156481 | Boyd et al. | Oct 2002 | A1 |
20020156529 | Li et al. | Oct 2002 | A1 |
20030236520 | Lim et al. | Dec 2003 | A1 |
20040059421 | Glenn et al. | Mar 2004 | A1 |
20050021041 | Michelson | Jan 2005 | A1 |
20050070911 | Carrison et al. | Mar 2005 | A1 |
20050113920 | Foley et al. | May 2005 | A1 |
20050130929 | Boyd | Jun 2005 | A1 |
20050182416 | Lim et al. | Aug 2005 | A1 |
20060004455 | Leonard et al. | Jan 2006 | A1 |
20060142858 | Colleran et al. | Jun 2006 | A1 |
20070233153 | Shipp et al. | Oct 2007 | A1 |
20080015701 | Garcia et al. | Jan 2008 | A1 |
20080114367 | Meyer | May 2008 | A1 |
20080140207 | Olmos et al. | Jun 2008 | A1 |
20080243255 | Butler et al. | Oct 2008 | A1 |
20090143859 | McClellan et al. | Jun 2009 | A1 |
20090157187 | Richelsoph | Jun 2009 | A1 |
20090270873 | Fabian | Oct 2009 | A1 |
20090281628 | Oglaza et al. | Nov 2009 | A1 |
20100137987 | Diao et al. | Jun 2010 | A1 |
20100174373 | Galley et al. | Jul 2010 | A1 |
20110125270 | Paul et al. | May 2011 | A1 |
20110251692 | McLaughlin et al. | Oct 2011 | A1 |
20110276142 | Niemiec et al. | Nov 2011 | A1 |
20110295370 | Suh et al. | Dec 2011 | A1 |
20120016371 | O'Halloran et al. | Jan 2012 | A1 |
20120016481 | Zwirkoski | Jan 2012 | A1 |
20120059470 | Weiman | Mar 2012 | A1 |
20120059475 | Weiman | Mar 2012 | A1 |
20120083887 | Purcell et al. | Apr 2012 | A1 |
20120083889 | Purcell et al. | Apr 2012 | A1 |
20120123544 | Suh et al. | May 2012 | A1 |
20120123546 | Medina | May 2012 | A1 |
20120209386 | Triplett et al. | Aug 2012 | A1 |
20120215314 | Bennett et al. | Aug 2012 | A1 |
20130018467 | Suh | Jan 2013 | A1 |
20130041471 | Siegal et al. | Feb 2013 | A1 |
20130144391 | Siegal et al. | Jun 2013 | A1 |
20130325128 | Perloff et al. | Dec 2013 | A1 |
20140031940 | Banouskou | Jan 2014 | A1 |
Number | Date | Country |
---|---|---|
WO 2007076377 | Jul 2007 | WO |
WO 2008152501 | Dec 2008 | WO |
WO 2009125242 | Oct 2009 | WO |
WO 2012007918 | Jan 2012 | WO |
WO 2012135764 | Oct 2012 | WO |
WO 2014035835 | Mar 2014 | WO |
Entry |
---|
International Search Report and Written Opinion for PCT/US2011/054001 in 15 pages dated Jan. 17, 2012. |
International Search Report and Written Opinion for PCT/US2011/054729 in 13 pages, dated Jan. 31, 2012. |
International Search Report and Written Opinion in PCT Application No. PCT/US2013/056500 mailed Dec. 6, 2013 in 16 pages. |
European Extended Search Report and Written Opinion in Application No. 11831342.8, dated Aug. 29, 2014 in 13 pages. |
Number | Date | Country | |
---|---|---|---|
20120083887 A1 | Apr 2012 | US |
Number | Date | Country | |
---|---|---|---|
61389986 | Oct 2010 | US |