1. Field of the Invention
The present invention is directed to a device and method for determining the volume of intervertebral disc augmentation material needed to complete disc augmentation and the material's subsequent delivery. A second goal of this invention is to reduce leakage incurred when dispensing materials from a rigid cannula by improving the fit and fill of the annular wall defect.
2. Related Art
Some techniques for nucleus pulposus injection of materials like the SINUX® silicone disc augmentation material, utilize an injection cannula of rigid outer diameter to insert into the annular wall defect. Determination of the excised nucleus pulposus tissue is currently attempted via weight and/or volumetric measurement of the tissue following removal. Corresponding amounts of nucleus replacement material are injected into the disc space. Leakage of the injected material is a known issue when excess nucleus pulposus replacement material is added, correspondingly inadequate replacement of the nucleus can allow for device expulsion or improper functional spinal unit balance. Therefore accurate determination of the removed nucleus pulposus volume remains to be a challenge. Another issue present is the potential leakage of the injected material that may arise from an inadequate fit between the rigid injection cannula and the varying size annular wall defect(s).
Several nucleus pulposus and annular repair patents have been applied and issued. U.S. Patent Application Publication No. 2004/0068268 discloses cannulated distractors for maintaining disc height during replacement or augmentation of the spinal disc. U.S. Patent Application Publication No. 2003/0220649 describes interior liners and membranes such as balloons for in situ formation of nucleus replacement or augmentation materials. Bao et al. (European Cells and Materials, Vol. 10 Suppl. 3, 2005, p. 3), disclose assessing the shape and volume of the nucleus cavity in total nucleus removal procedures using an imaging balloon filled with contrast medium and fluoroscopic balloon images taken from multiple directions. However, none have been found that teach annular sealing for volumetric determination of the evacuated disc space and/or subsequent delivery of the disc replacement or augmentation material as hereinafter disclosed.
a-1f depict one embodiment of this invention using a cannula with a conformable tip.
a-2b depict another embodiment of this invention using a cannula with an expandable tip.
a-3b depict yet another embodiment of this invention using a cannula with an inflatable balloon tip.
a-4f depict another embodiment of this invention using a cannula with an anti backflow check valve.
In accordance with one aspect of the present invention, a method of performing a procedure on an intervertebral disc comprises inserting a cannulated delivery tube through an opening in an annulus fibrosus of the intervertebral disc, positioning an expandable portion of the tube within the opening in the annulus fibrosus, expanding the expandable portion into contact with the annulus fibrosus about the opening to create a seal between the expandable portion and the annulus fibrosus, performing a procedure through the cannulated delivery tube within the annulus fibrosis, removing the tube, and closing the opening in the annulus fibrosus. The procedure performed may include injecting through the tube and the sealed opening in the annulus fibrosus an amount of a flowable nucleus pulposus replacement material directly into the annulus fibrosus. The expandable portion may comprise an expandable elastomeric gasket, in one embodiment, and the expandable portion may comprise an inflatable balloon, in another embodiment.
One advantage of this invention is its relatively easy determination of the volume of nucleus pulposus material removed as well as sealing of the annular wall defect to prevent intra-operative material leakage common when greater amounts than needed of nucleus pulposus material are injected to correct a disc defect.
Determination of the volume of nucleus pulposus material removed from the disc and prevention of leakage incurred during injection of nuclear replacement and/or augmentation materials are important aspects of intervertebral disc repair. Excessive injection and/or leakage of the replacement material(s) can initiate re-herniation or prompt herniation of the disc in another weakened annular location. Both of these failure modes can irritate neighboring tissues, including nerve roots, prompting additional pain and/or re-operation.
Insufficient nucleus pulposus injection can allow for continued disc height loss potentially leading to revision surgery.
The basic premise of this invention is that following a discectomy, a cannulated device is inserted into the surgically created annular wall defect. The annulus is sealed such that a known quantity of saline or other material can be injected and subsequently aspirated to determine volume of nucleus pulposus tissue removed. An equal volume of nucleus pulposus replacement material is injected or packed into the nucleus pulposus cavity through the device.
In making the volumetric determination of the defect to be repaired, a graduated syringe of known volume of volumetric material may be placed in to the cannulated device and injected into the intervertebral defect space, for example. Pressure can be applied to the material and monitored to insure full fill of small defects. A check valve with known pressure release can be utilized to ensure filling to a known pressure.
Suitable volumetric materials can be viscous and non-viscous including saline, gels, polymers, etc. Volumetric materials can be radio-opaque contrast agents, allowing fluoroscopic viewing during injection into the disc to a known pressure.
Examples of annular sealing techniques include: a conformable injection tip; an activated injection tip, and a balloon catheter injection tip. An optional embodiment of an internal valve to prevent backflow of either the saline or the nucleus pulposus replacement material is also disclosed. All sealing devices and methods maybe deployed extra-annularly, intra and/or inter-annularly (i.e., with respect to the annulus).
a-1f, describe an injection cannula 10 with a conformable tip such as a soft elastomeric or foam gasket 12 around the injection tip of the cannula which is used to seal the annular defect. More specifically
b shows cannula 10 being advanced into defect 4.
a-2b describe one embodiment of a device of this invention wherein a volumetric material delivery device comprises an expandable elastomeric tip or foam gasket. More particularly,
a and 3b describe yet another device for forming a seal via a ballooning tip. Specifically,
a-4f depict a preferred embodiment of this invention which utilizes an internal check valve to preclude backflow of either volumetric material and/or the nucleus pulposus replacement material. Referring to
A further preferred embodiment as shown in
Suitable materials for use as the nucleus pulposus replacement or augmentation material may be of any known type. Examples of such materials include, but are not limited to polyethylenes, silicones, polyurethanes, metallics, ceramics, collagen, hydrogels, for example.
It should be understood that the foregoing disclosure and description of the present invention are illustrative and explanatory thereof and various changes in the size, shape and materials as well as in the description of the preferred embodiment may be made without departing from the spirit of the invention. For example, it is envisioned that this invention may be applied to correcting defects in other articulating joints were volumetric determination of a defect is a benefit, such as with knees, hips, shoulders, elbow capsules as best examples, but also to facets, ankles, wrists, hand, and digits.
This application is a continuation of U.S. patent application Ser. No. 13/438,455 filed Apr. 3, 2012, (which granted as U.S. Pat. No. 8,357,199) which is a continuation of U.S. patent application Ser. No. 11/260,768, filed Oct. 27, 2005, (which granted as U.S. Pat. No. 8,197,545) both which are incorporated herein by reference.
Number | Name | Date | Kind |
---|---|---|---|
3875595 | Froning | Apr 1975 | A |
4471888 | Herb | Sep 1984 | A |
4493436 | Brokaw | Jan 1985 | A |
4538920 | Drake | Sep 1985 | A |
4566610 | Herb | Jan 1986 | A |
4747517 | Hart | May 1988 | A |
4753536 | Spehar | Jun 1988 | A |
4767026 | Keller | Aug 1988 | A |
4771919 | Ernst | Sep 1988 | A |
4811549 | Usami | Mar 1989 | A |
4869400 | Jacobs | Sep 1989 | A |
4871088 | Cox | Oct 1989 | A |
4907727 | Ernst | Mar 1990 | A |
4974756 | Pearson | Dec 1990 | A |
4978336 | Capozzi | Dec 1990 | A |
4979942 | Wolf | Dec 1990 | A |
4981241 | Keller | Jan 1991 | A |
4989758 | Keller | Feb 1991 | A |
4995540 | Colin | Feb 1991 | A |
5002576 | Fuhrmann | Mar 1991 | A |
5005735 | Keller | Apr 1991 | A |
5020694 | Pettengill | Jun 1991 | A |
5033650 | Colin | Jul 1991 | A |
5078587 | Bison | Jan 1992 | A |
5080262 | Herold | Jan 1992 | A |
5082147 | Jacobs | Jan 1992 | A |
5092845 | Chang | Mar 1992 | A |
5126090 | Egolf | Jun 1992 | A |
5137181 | Keller | Aug 1992 | A |
5139174 | Golias | Aug 1992 | A |
5171280 | Baumgartner | Dec 1992 | A |
5224628 | Keller | Jul 1993 | A |
5248068 | Goergen | Sep 1993 | A |
5249709 | Duckworth | Oct 1993 | A |
5263614 | Jacobsen | Nov 1993 | A |
RE34487 | Keller | Dec 1993 | E |
5295613 | Barthomeuf | Mar 1994 | A |
5310091 | Dunning | May 1994 | A |
5333760 | Simmen | Aug 1994 | A |
5336014 | Keller | Aug 1994 | A |
5447226 | Laine | Sep 1995 | A |
5477987 | Keller | Dec 1995 | A |
5535922 | Maziarz | Jul 1996 | A |
5645597 | Krapiva | Jul 1997 | A |
5667102 | Keller | Sep 1997 | A |
5676280 | Robinson | Oct 1997 | A |
5722829 | Wilcox | Mar 1998 | A |
5788122 | Keller | Aug 1998 | A |
5800549 | Bao | Sep 1998 | A |
5819988 | Sawhney | Oct 1998 | A |
5875928 | Muller | Mar 1999 | A |
5887755 | Hood, III | Mar 1999 | A |
5888220 | Felt | Mar 1999 | A |
RE36235 | Keller | Jun 1999 | E |
5918772 | Keller | Jul 1999 | A |
5924600 | Keller | Jul 1999 | A |
5944226 | Schiltz | Aug 1999 | A |
5992694 | Keller | Nov 1999 | A |
6039216 | Cummings | Mar 2000 | A |
6047861 | Vidal | Apr 2000 | A |
6065645 | Sawhney | May 2000 | A |
6079868 | Rydell | Jun 2000 | A |
6089407 | Gardos | Jul 2000 | A |
6161730 | Heusser | Dec 2000 | A |
6165218 | Husson | Dec 2000 | A |
6176396 | Hamada | Jan 2001 | B1 |
6182867 | Keller | Feb 2001 | B1 |
6183518 | Ross | Feb 2001 | B1 |
6186363 | Keller | Feb 2001 | B1 |
6189735 | Plasmati Lüchinger | Feb 2001 | B1 |
6223936 | Jeanbourquin | May 2001 | B1 |
6231615 | Preissman | May 2001 | B1 |
6234994 | Zinger | May 2001 | B1 |
6238182 | Mayer | May 2001 | B1 |
6248131 | Felt | Jun 2001 | B1 |
6286722 | Fischer | Sep 2001 | B1 |
6290101 | Chang | Sep 2001 | B1 |
6325249 | Keller | Dec 2001 | B1 |
6332894 | Stalcup | Dec 2001 | B1 |
6345776 | Hurray | Feb 2002 | B1 |
6352177 | Bublewitz | Mar 2002 | B1 |
6382466 | Schneider | May 2002 | B1 |
6386396 | Strecker | May 2002 | B1 |
6394314 | Sawhney | May 2002 | B1 |
6395032 | Gauchet | May 2002 | B1 |
6395034 | Suddaby | May 2002 | B1 |
6402784 | Wardlaw | Jun 2002 | B1 |
6412660 | Bouix | Jul 2002 | B1 |
6419702 | Ferree | Jul 2002 | B1 |
6443988 | Felt | Sep 2002 | B2 |
6450370 | Keller | Sep 2002 | B2 |
6458095 | Wirt | Oct 2002 | B1 |
6482234 | Weber | Nov 2002 | B1 |
6499630 | Mühlbauer | Dec 2002 | B2 |
6540113 | Gardos | Apr 2003 | B2 |
6629774 | Gruendeman | Oct 2003 | B1 |
6691932 | Schultz | Feb 2004 | B1 |
6708847 | Ljungquist | Mar 2004 | B2 |
6719729 | Sogaro | Apr 2004 | B2 |
6719797 | Ferree | Apr 2004 | B1 |
6732887 | Bills | May 2004 | B2 |
6733472 | Epstein | May 2004 | B1 |
6752292 | Van Herpen | Jun 2004 | B2 |
6764514 | Li | Jul 2004 | B1 |
6769574 | Keller | Aug 2004 | B1 |
6812211 | Slivka | Nov 2004 | B2 |
6820766 | Keller | Nov 2004 | B2 |
6824016 | Mühlbauer | Nov 2004 | B2 |
6874657 | Metzner | Apr 2005 | B2 |
6874661 | Timmerman | Apr 2005 | B2 |
6923813 | Phillips | Aug 2005 | B2 |
6958077 | Suddaby | Oct 2005 | B2 |
6969404 | Ferree | Nov 2005 | B2 |
7004945 | Boyd | Feb 2006 | B2 |
20010004082 | Keller | Jun 2001 | A1 |
20010004710 | Felt | Jun 2001 | A1 |
20010013526 | Keller | Aug 2001 | A1 |
20020004594 | Borch | Jan 2002 | A1 |
20020010485 | Griego | Jan 2002 | A1 |
20020049498 | Yuksel | Apr 2002 | A1 |
20020138145 | Marchosky | Sep 2002 | A1 |
20020145007 | Sawhney | Oct 2002 | A1 |
20020156531 | Felt | Oct 2002 | A1 |
20020170926 | Horner | Nov 2002 | A1 |
20030082169 | Boyd | May 2003 | A1 |
20030137898 | Wagner | Jul 2003 | A1 |
20030195628 | Bao | Oct 2003 | A1 |
20030220649 | Bao | Nov 2003 | A1 |
20040045982 | Herman | Mar 2004 | A1 |
20040054414 | Trieu | Mar 2004 | A1 |
20040068268 | Boyd | Apr 2004 | A1 |
20040083002 | Belef | Apr 2004 | A1 |
20040104249 | Horth | Jun 2004 | A1 |
20040230309 | DiMauro | Nov 2004 | A1 |
20050055030 | Falahee | Mar 2005 | A1 |
20050069571 | Slivka | Mar 2005 | A1 |
20050119754 | Trieu | Jun 2005 | A1 |
20050130929 | Boyd | Jun 2005 | A1 |
20050131540 | Trieu | Jun 2005 | A1 |
20050182418 | Boyd | Aug 2005 | A1 |
20050197707 | Trieu | Sep 2005 | A1 |
20050230422 | Muller | Oct 2005 | A1 |
20050245938 | Kochan | Nov 2005 | A1 |
20050251259 | Suddaby | Nov 2005 | A1 |
20060004457 | Collins | Jan 2006 | A1 |
20060004458 | Collins | Jan 2006 | A1 |
20060009778 | Collins | Jan 2006 | A1 |
20060009851 | Collins | Jan 2006 | A1 |
20060079905 | Beyar | Apr 2006 | A1 |
20060122704 | Vresilovic | Jun 2006 | A1 |
20060206118 | Kim | Sep 2006 | A1 |
20060247657 | Trieu | Nov 2006 | A1 |
20060276802 | Vresilovic | Dec 2006 | A1 |
20070017931 | Sogaro | Jan 2007 | A1 |
20070023450 | Horth | Feb 2007 | A1 |
20070100349 | O'Neil | May 2007 | A1 |
20070179620 | Seaton | Aug 2007 | A1 |
Number | Date | Country |
---|---|---|
460698 | Jul 1992 | EP |
459464 | Apr 1996 | EP |
416471 | Jan 1999 | EP |
937737 | Aug 1999 | EP |
1223194 | May 2004 | EP |
WO 9531946 | Nov 1995 | WO |
WO 9902108 | Jan 1999 | WO |
WO 9942037 | Aug 1999 | WO |
WO 9953970 | Oct 1999 | WO |
WO 2005092249 | Oct 2005 | WO |
Entry |
---|
Meakin, J. et al., “Replacing the Nucleus Pulpasus of the Invertebral Disc”, Clinical Biomechanics, 2001, vol. 16, pp. 560-565. |
Alberts, R. et al., “Single Unit Artificial Intervertbral Disc”, J. Neurosurg. Spine, 2004, vol. 1, pp. 95-100. |
Ahrens, M. et al., “A New Procedure for Total Nucleus Removal From the Posterior Approach”, European Cells and Materials, vol. 10(3). 2005, p. 3. |
Number | Date | Country | |
---|---|---|---|
20130131634 A1 | May 2013 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 13438455 | Apr 2012 | US |
Child | 13740503 | US | |
Parent | 11260768 | Oct 2005 | US |
Child | 13438455 | US |