The present application describes systems and methods used for dilating tissue during surgery.
Spinal discs serve to cushion and stabilize the spine in addition to distributing stress and damping cyclic loads. The discs may become damaged due to injury or age and symptoms of a damaged disc may include severe pain, numbness or muscle weakness. Surgical intervention is often required to alleviate the symptoms of damaged discs. For example, fusion is one method of reducing the magnitude of the symptoms of damaged spinal discs. The primary goals of fusion procedures are to provide stability between the vertebrae on either side of the damaged disc and to promote natural fusion of those adjacent vertebrae. In order to intervene, the surgeon must access the spine through layers of body.
The present describes an improved tissue distraction assembly. The tissue distraction assembly includes a variety of sub-components dimensioned to allow for sequential dilation of a surgical tissue site in order to establish an operative corridor through a patient's skin to a surgical target site. By way of example only, the surgical target site referred to herein throughout is an intervertebral disc space situated between two adjacent vertebrae. Although particularly suited for use in lumbar spine fixation, it will be readily appreciated by those skilled in the art that the surgical fixation system of the present invention may be employed in any number of suitable orthopedic fixation approaches and procedures, including but not limited to anterior, posterior, lateral, antero-lateral, postero-lateral, cervical spine fixation, thoracic spine fixation, as well as any non-spine fixation application such as bone fracture treatment.
The tissue distraction assembly includes an initial dilator, a secondary dilator, a first expander, and a second expander. The tissue distraction assembly is provided with an overall generally oblong shape as opposed to a generally circular shape characterizing many of the sequential dilation systems currently available. This oblong shape serves to provide an initial distraction corridor spanning a target disc space, allowing the placement of pedicle screws at adjacent levels without additional tissue retraction. As will be explained in greater detail below, the first and second expanders function to bias the distraction corridor in one direction. By way of example only, based on the preferred positioning of the tissue distraction system during use, the distraction corridor is biased medially (e.g. toward the patient's longitudinal midline).
The initial dilator has a proximal portion, a distal portion, and an elongated body extending therebetween. The initial dilator is formed from a pair of generally planar panels connected by generally curved sides, such that the initial dilator has a generally oblong cross-section. The initial dilator further has a lumen extending through the dilator from the proximal portion to the distal portion. The proximal portion further includes a proximal opening of the lumen, and a plurality of friction elements provided to enhance user control of the instrument. By way of example only, the friction elements are provided as a plurality of ridges, however any suitable friction-inducing material and/or feature may be employed without departing from the scope of the present invention. The distal portion includes a lead element having a leading edge extending along the lead element. Lead element is tapered in a distal direction from the planar panels to the leading edge to enable the lead element to advance through tissue (e.g. muscle tissue) without requiring severing or removal of that tissue. The distal portion further includes a pair of distal openings positioned on either side of lead element. Distal openings represent the distal terminus of the lumen.
The lumen extends through the initial dilator from the proximal opening to the distal openings. The distal portion of the initial dilator further includes a wedge member extending proximally into the lumen, effectively bifurcating the lumen into a pair of distal channels leading to the distal openings. The distal channels function to guide relevant instrumentation (e.g. K-wires) into the proper positioning within the surgical target site.
The secondary dilator has a proximal portion, a distal portion, and an elongated body extending therebetween. The secondary dilator includes a first side, a second side, and a pair of generally curved lateral sides. The first side comprises a generally planar surface having an elongated recess extending from the end of the proximal portion substantially the length of the elongated body and terminating near the distal portion. The second side comprises a surface having a generally convex curvature. The convex surface of the second side represents one boundary of the distraction corridor because any further distraction at this point will be due to the extensions as explained in further detail below. Both the first and second sides are provided with a plurality of friction elements at the proximal portion provided to enhance user control of the instrument. By way of example only, the friction elements are provided as a plurality of ridges, however any suitable friction-inducing material and/or feature may be employed without departing from the scope of the present invention. The secondary dilator further includes a lumen extending through the dilator from the proximal portion to the distal portion. The lumen has an oblong cross-section, and is sized and dimensioned to slideably enagage the initial dilator. The lumen further includes a proximal opening and a distal opening.
The distal portion further includes a pair of generally planar surfaces that are sloped or tapered from the first and second sides to the distal opening of the lumen. During tissue distraction, as the secondary dilator is being advanced over the initial dilator to expand the operative corridor, the tapered surfaces function to urge the body tissue around the path of the dilator. When the secondary dilator has been fully inserted, the initial dilator may be removed if desired, and the secondary dilator 14 may act as a stand-alone cannula.
In some instances, it may be desirable to enlarge the distraction corridor further. To achieve that end, further sequential dilators may be provided without departing from the scope of the present invention. Additionally, one or more extensions may be provided to slideably engage with the secondary dilator and thereby expand the distraction corridor. The tissue distraction system may be configured such that extensions are provided on one or more sides of the secondary dilator, to achieve a distraction corridor of any customizable shape. By way of example only, the tissue distraction assembly described herein is configured to include expanders on only one side of the secondary dilator, creating a biased corridor configuration.
The first expander includes a proximal end portion, a distal end portion, and an elongated body extending therebetween. The first expander further includes a first side comprising a generally planar surface and a second side comprising a generally planar surface opposite the first side. The first side includes an elongated recess extending from the proximal end portion substantially the length of the body portion and terminates near the distal end portion. The second side includes an elongated raised protrusion extending from the proximal end portion substantially the length of the body portion and terminates near the distal end portion. The protrusion is sized and dimensioned to slideably engage the elongated recess of the secondary dilator. Thus, the protrusion and recess will have complementary shapes and sizes. Any such shape is possible, for example including but not limited to the mortise and tenon interfaces shown in the figures. The distal end portion further includes a distal tapered surface that slopes in a distal direction from the first surface until it forms an edge with the second surface. The first expander further includes a pair of lateral tapered surfaces that slopes in a lateral direction from the first surface until it forms an edge with the second surface. The lateral tapered surfaces extend along the length of the body portion. Both the distal tapered surface and lateral tapered surfaces function to urge the body tissue around the path of the first expander during tissue distraction, as the first expander is being advanced over the initial dilator to expand the operative corridor.
The second expander includes a proximal end portion, a distal end portion, and an elongated body extending therebetween. The second expander further includes a first side comprising a generally convex surface and a second side comprising a generally planar surface opposite the first side. The second side includes an elongated raised protrusion extending from the proximal end portion substantially the length of the body portion and terminates near the distal end portion. The protrusion is sized and dimensioned to slideably engage the elongated recess of the first expander. Thus, the protrusion and recess will have complementary shapes and sizes. Any such shape is possible, for example including but not limited to the mortise and tenon interfaces shown in the figures. The distal end portion further includes a distal tapered surface that slopes in a distal direction from the first surface until it forms an edge with the second surface. The distal tapered surface functions to urge the body tissue around the path of the second expander during tissue distraction, as the second expander is being advanced over the first expander to expand the operative corridor.
The first step in the distraction process is to typically run a guide to the target site. In this instance, for example the surgeon would advance a pair of K-wires to the relevant locations (i.e. pedicles) involved in the procedure in order to guide the proper placement of the dilators. After an initial incision is made within the skin to allow passage of the dilators, the initial dilator is advanced along the K-wires such that one K-wire is in each distal channel of the lumen. Once the initial dilator has been satisfactorily placed, the secondary dilator is advanced over the top of the initial dilator. If further distraction is required (e.g. medial distraction), first and second expanders may be employed.
Once the distraction corridor has been created, a tissue retractor may be advanced to the spine over the distraction assembly (not shown). The distraction assembly may be removed and the retractor may be operated to expand to establish an operative corridor. With the operative corridor established, the surgeon may proceed with the desired procedure, for example, a transforaminal lumbar interbody fusion (TLIF) spinal procedure. This procedure continues with a facetectomy in which at least a portion of the facet joint is removed, allowing access to the intervertebral disc space. The disc space is prepared using techniques generally known in the art, including disc brushes, scrapers, etc. The interbody implant is then inserted into the cleaned out disc space. The retractor may then be removed from the patient, closing the operative corridor. The surgeon will then close the operative wound, completing the procedure.
Many advantages of the present invention will be apparent to those skilled in the art with a reading of this specification in conjunction with the attached drawings, wherein like reference numerals are applied to like elements and wherein:
Illustrative embodiments of the invention are described below. In the interest of clarity, not all features of an actual implementation are described in this specification. It will of course be appreciated that in the development of any such actual embodiment, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which will vary from one implementation to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure. The tissue distraction system disclosed herein boasts a variety of inventive features and components that warrant patent protection, both individually and in combination.
Tissue distraction assembly 10 includes an initial dilator 12, a secondary dilator 14, a first expander 16, and a second expander 18. The tissue distraction assembly 10 is provided with an overall generally oblong shape as opposed to a generally circular shape characterizing many of the sequential dilation systems currently available. This oblong shape serves to provide an initial distraction corridor spanning a target disc space, allowing the placement of pedicle screws at adjacent levels without additional tissue retraction. As will be explained in greater detail below, the first and second expanders 16, 18 function to bias the distraction corridor in one direction. By way of example only, based on the preferred positioning of the tissue distraction system 10 during use, the distraction corridor is biased medially (e.g. toward the patient's longitudinal midline).
Referring to
The lumen 30 extends through the initial dilator 12 from the proximal opening 32 to the distal openings 40. As shown in
Referring to
The distal portion 48 further includes a pair of generally planar surfaces 68, 70 that are sloped or tapered from the first and second sides 54, 56, respectively, to the distal opening 66 of the lumen 62. During tissue distraction, as the secondary dilator 14 is being advanced over the initial dilator 12 to expand the operative corridor, the tapered surfaces 68, 70 function to urge the body tissue around the path of the dilator 14. When the secondary dilator 14 has been fully inserted, the initial dilator 12 may be removed if desired, and the secondary dilator 14 may act as a stand-alone cannula.
In some instances, it may be desirable to enlarge the distraction corridor further. To achieve that end, further sequential dilators may be provided without departing from the scope of the present invention. Additionally, one or more extensions may be provided to slideably engage with the secondary dilator 14 and thereby expand the distraction corridor. The tissue distraction system 10 may be configured such that extensions are provided on one or more sides of the secondary dilator 14, to achieve a distraction corridor of any customizable shape. By way of example only, the tissue distraction assembly 10 described herein is configured to include expanders on only one side of the secondary dilator 14, creating a biased corridor configuration.
Referring to
Referring to
Once the distraction corridor has been created, a tissue retractor may be advanced to the spine over the distraction assembly (not shown). The distraction assembly may be removed and the retractor may be operated to expand to establish an operative corridor. With the operative corridor established, the surgeon may proceed with the desired procedure, for example, a transforaminal lumbar interbody fusion (TLIF) spinal procedure. This procedure continues with a facetectomy in which at least a portion of the facet joint is removed, allowing access to the intervertebral disc space. The disc space is prepared using techniques generally known in the art, including disc brushes, scrapers, etc. The interbody implant is then inserted into the cleaned out disc space. The retractor may then be removed from the patient, closing the operative corridor. The surgeon will then close the operative wound, completing the procedure.
While this invention has been described in terms of a best mode for achieving this invention's objectives, it will be appreciated by those skilled in the art that variations may be accomplished in view of these teachings without deviating from the spirit or scope of the invention.
The present application is a continuation of U.S. patent application Ser. No. 14/532,316, filed 4 Nov. 2014 (pending); which is a continuation of U.S. patent application Ser. No. 13/831,711, filed 15 Mar. 2013 (now U.S. Pat. No. 8,876,851); which is a continuation of U.S. patent application Ser. No. 12/580,214, filed 15 Oct. 2009 (abandoned); which claims the benefit of priority under 35 USC § 119(e) from U.S. Pat. App. No. 61/105,791, filed Oct. 15, 2008 (expired). The entire contents of all of the foregoing applications are incorporated by reference into this disclosure.
Number | Name | Date | Kind |
---|---|---|---|
208227 | Dorr | Sep 1878 | A |
972983 | Arthur | Oct 1910 | A |
1328624 | Graham | Jan 1920 | A |
4545374 | Jacobson | Oct 1985 | A |
4573448 | Kambin | Mar 1986 | A |
5007902 | Witt | Apr 1991 | A |
5171279 | Mathews | Dec 1992 | A |
5295994 | Bonutti | Mar 1994 | A |
5312417 | Wilk | May 1994 | A |
5331975 | Bonutti | Jul 1994 | A |
5342384 | Sugarbaker | Aug 1994 | A |
5378241 | Haindl | Jan 1995 | A |
5395317 | Kambin | Mar 1995 | A |
5423825 | Levine | Jun 1995 | A |
5509893 | Pracas | Apr 1996 | A |
5514153 | Bonutti | May 1996 | A |
5599279 | Slotman | Feb 1997 | A |
5707359 | Bufalini | Jan 1998 | A |
5762629 | Kambin | Jun 1998 | A |
5792044 | Foley | Jul 1998 | A |
5814073 | Bonutti | Sep 1998 | A |
5817071 | Dewindt | Oct 1998 | A |
5888196 | Bonutti | Mar 1999 | A |
5902231 | Foley | May 1999 | A |
5910134 | Fussman | Jun 1999 | A |
5976146 | Ogawa | Nov 1999 | A |
6007487 | Foley | Dec 1999 | A |
6146371 | Dewindt | Nov 2000 | A |
6152871 | Foley | Nov 2000 | A |
6161047 | King | Dec 2000 | A |
6206826 | Mathews | Mar 2001 | B1 |
6217509 | Foley | Apr 2001 | B1 |
6217527 | Selmon | Apr 2001 | B1 |
6221049 | Selmon | Apr 2001 | B1 |
6224599 | Baynham | May 2001 | B1 |
6231546 | Milo | May 2001 | B1 |
6270505 | Yoshida | Aug 2001 | B1 |
6277094 | Schenedel | Aug 2001 | B1 |
6292701 | Prass | Sep 2001 | B1 |
6325764 | Griffith | Dec 2001 | B1 |
6395007 | Bhatnagar | May 2002 | B1 |
6425859 | Foley | Jul 2002 | B1 |
6447484 | Briscoe | Sep 2002 | B1 |
6506151 | Estes | Jan 2003 | B2 |
6514217 | Selmon | Feb 2003 | B1 |
6520907 | Foley | Feb 2003 | B1 |
6535759 | Epstein | Mar 2003 | B1 |
6564078 | Marino | May 2003 | B1 |
6641582 | Hanson | Nov 2003 | B1 |
6641613 | Sennett | Nov 2003 | B2 |
6645194 | Briscoe | Nov 2003 | B2 |
6679833 | Smith | Jan 2004 | B2 |
6719692 | Kleffner | Apr 2004 | B2 |
6847849 | Mamo | Jan 2005 | B2 |
6855105 | Jackson | Feb 2005 | B2 |
6916330 | Simonson | Jul 2005 | B2 |
6929606 | Ritland | Aug 2005 | B2 |
6926728 | Zucherman | Sep 2005 | B2 |
7008431 | Simonson | Mar 2006 | B2 |
7074226 | Roehm | Jul 2006 | B2 |
7083625 | Berry | Aug 2006 | B2 |
7198598 | Smith | Apr 2007 | B2 |
7207949 | Miles | Apr 2007 | B2 |
7217246 | Stone | May 2007 | B1 |
7226451 | Shluzas | Jun 2007 | B2 |
7276055 | Dewindt | Oct 2007 | B2 |
7311719 | Bonutti | Dec 2007 | B2 |
7320688 | Foley | Jan 2008 | B2 |
7470236 | Kelleher | Dec 2008 | B1 |
7569061 | Colleran | Aug 2009 | B2 |
7582058 | Miles | Sep 2009 | B1 |
7588588 | Spitler | Sep 2009 | B2 |
7594888 | Raymond | Sep 2009 | B2 |
7608094 | Falahee | Oct 2009 | B2 |
7618431 | Roehm, III | Nov 2009 | B2 |
7708761 | Petersen | May 2010 | B2 |
7837713 | Petersen | Nov 2010 | B2 |
7959564 | Ritland | Jun 2011 | B2 |
7981029 | Branch | Jul 2011 | B2 |
7993378 | Foley et al. | Aug 2011 | B2 |
8043212 | Bae | Oct 2011 | B1 |
8075591 | Ludwig et al. | Dec 2011 | B2 |
8142507 | McGuckin, Jr. | Mar 2012 | B2 |
8876851 | Woolley | Nov 2014 | B1 |
20010056280 | Underwood | Dec 2001 | A1 |
20020010392 | Desai | Jan 2002 | A1 |
20030139648 | Foley | Jul 2003 | A1 |
20040106999 | Mathews | Jun 2004 | A1 |
20040181231 | Emstad | Sep 2004 | A1 |
20050004593 | Simonson | Jan 2005 | A1 |
20060052669 | Hart | Mar 2006 | A1 |
20060052828 | Kim | Mar 2006 | A1 |
20060253132 | Evans et al. | Nov 2006 | A1 |
20070066977 | Assell | Mar 2007 | A1 |
20070083161 | Briscoe | Apr 2007 | A1 |
20070233155 | Lovell | Oct 2007 | A1 |
20080077152 | McClintock et al. | Mar 2008 | A1 |
20080091269 | Zipnick et al. | Apr 2008 | A1 |
20090270902 | Assell et al. | Oct 2009 | A1 |
20100022844 | Mangiardi | Jan 2010 | A1 |
20100081885 | Wing et al. | Apr 2010 | A1 |
20100106194 | Bonutti et al. | Apr 2010 | A1 |
20100114147 | Biyani | May 2010 | A1 |
20100222824 | Simonson | Sep 2010 | A1 |
20100222829 | Petersen | Sep 2010 | A1 |
20100280555 | Aflatoon et al. | Nov 2010 | A1 |
20100331891 | Culbert et al. | Dec 2010 | A1 |
20110077685 | Calls et al. | Mar 2011 | A1 |
20110144687 | Kleiner | Jun 2011 | A1 |
20110208226 | Fatone | Aug 2011 | A1 |
Number | Date | Country |
---|---|---|
11290337 | Oct 1999 | JP |
20100123083 | Nov 2010 | KR |
WO 1997040878 | Nov 1997 | WO |
WO 2011044484 | Apr 2011 | WO |
Number | Date | Country | |
---|---|---|---|
20170164937 A1 | Jun 2017 | US |
Number | Date | Country | |
---|---|---|---|
61105791 | Oct 2008 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 14532316 | Nov 2014 | US |
Child | 15443652 | US | |
Parent | 13831711 | Mar 2013 | US |
Child | 14532316 | US | |
Parent | 12580214 | Oct 2009 | US |
Child | 13831711 | US |