This invention relates to devices for use in the correction, arresting or slowing of abnormal curvature of the spine, including scoliosis, hyperlordosis and hypokyphosis.
Juvenile and adolescent scoliosis is a disorder of the growing spine in which a predominantly lateral curvature develops. Curves over 40° can require surgical correction due to the high risk of future progression during adulthood. One typical procedure, often called “posterior approach scoliosis surgery,” is one of the most invasive human surgeries in orthopedics. During a typical three to eight hour procedure, a surgeon strips the strong posterior muscles off of the spine for bone exposure, then attaches two metal rods to the spine with hooks, wires, or screws. An alternative scoliosis approach is through the anterior chest via thoracotomy or thoracoscopy. After multi-level discectomy and fusion, large screws are placed across the vertebral bodies, and then the screws and vertebrae are compressed together by means of a vertical rod.
Staples are often used in orthopaedics to fix two bones or pieces of bone together, such as would be required for osteotomy (bone cutting), or fracture stabilization. Staples typically used for these purposes are disclosed in U.S. Pat. Nos. 4,434,796 by Karapetian; 3,862,621 to Austin; 4,841,960 to Garner; 4,848,328 to Laboureau et al.; 5,449,359 to Groiso; 5,053,038 to Sheehan; and 4,913,144 to Del Medico.
Orthopaedic staples are also used in the fixation of soft tissue to bone, such as tendon or shoulder tissue. Staples typically used for these purposes are described in U.S. Pat. Nos. 5,352,229 to Goble et al.; 4,462,395 to Johnson; 4,570,623 to Ellison et al.; 4,454,875 to Pratt et al.; D320,081 to Johnson; and D340,284 to Johnson.
In addition, several screws with a linkage plate or rod have been developed for anterior spine fixation and are described in U.S. Pat. Nos. 5,324,290 to Zdeblick et al.; and 4,041,939 to Hall.
Additional U.S. Patents disclose spine staples, for example U.S. Pat. Nos. 4,047,523 to Hall; 4,047,524 to Hall; 5,395,372 to Holt et al.; D378,409 to Michelson; and D364,462 to Michelson.
The inventors have developed a novel procedure for correcting scoliosis in children that takes advantage of future spine growth to correct the scoliosis. This procedure relies upon slowing spine epiphyseal growth on the convex side of the scoliosis curve with a novel hemiepiphyseal spinal correction system.
The novel procedure using the novel spinal correction system requires only one-fourth of the time necessary for conventional implantation techniques and may be performed using minimally invasive endoscopic procedures. In addition, the novel spinal correction system has an extremely low profile which reduces the risk of neurological complications.
This new procedure uses a novel system of staples and screws to provide anterior non-fusion (no bone graft) correction of scoliosis in children with significant growth remaining. The procedure can be performed entirely endoscopically in as little as one hour of surgical time. This procedure using the novel spinal staple avoids the complex rod-screw linkage of current anterior scoliosis corrective systems. It also holds the potential for making correction an outpatient procedure and minimizes blood loss during surgery.
Existing spinal implants do not take advantage of the hemiepiphysiodesis principle of altering spine growth and allowing for gradual correction through asymmetric growth. Prior art bone staples used to fix two bones or pieces of bone together, for example, are not designed to perform hemiepiphysiodesis, and are not designed or able to resist the forces of spinal motion and growth without significant splay. Orthopaedic staples used to fix soft tissue to bone are not designed to span two bones or two pieces of bone. Thus, such staples are inapplicable to the novel procedure for the correction of scoliosis in children.
The other staples mentioned above were not designed for spine hemiepiphysiodesis and are instead intended for other purposes. For example, U.S. Pat. No. 4,041,939 to Hall discloses small staples to stabilize a screw-bone interface and to prevent migration or plowing of a screw through a bone. Likewise, U.S. Pat. No. 4,047,524 to Hall discloses a spinal staple meant to stabilize the screw-bone interface of a screw and rod system. U.S. Pat. No. 4,047,523 to Hall discloses a surgical sacral anchor implant that is half of a staple blade affixed to a cable for the fixation of the lower end of the spine. U.S. Pat. No. 5,395,372 to Holt et al., is a spinal staple that holds a strut bone graft in place and is designed for use after vertebrectomy.
Thus, there exists a need for a spinal correction system that is small and designed to span vertebral endplate growth centers on either side of a disk.
The above noted concerns and needs are addressed by the novel spinal correction system including a spinal staple in accordance with the invention. The spinal staple includes a bridge member having a length sufficient to span the vertebral endplate growth centers on either side of a vertebral disk. A pair of spaced apart wedged-shaped legs extend downwardly from the end of the bridge member and are of such a length as to penetrate no more than about half way into the depth of a vertebra. Fastener retaining portions extend horizontally outward from the opposite ends of the bridge member and define passageways therethrough adapted to receive fasteners such as screws and the like. The fastener retaining portions are proportioned so that when two or more of the spinal staples of the invention are arranged in end-to-end adjoining relationship, the fastener retaining portions extending from the abutting ends lie side by side.
The legs of the staple are equipped with barbs to resist backing out or loosening of the staple after it has been affixed to a vertebra. In addition, the fastener retaining portions have barbs or projections extending from a lower surface thereof to promote fixation of the staple in a vertebra. Optionally, the staple may be provided with a threaded cannulated post extending upward from the upper surface of the bridge member to allow attachment of a threaded removable, cannulated impaction device. Further, additional surgical hardware may be conveniently affixed to the staple by means of the threaded post.
The invention will be further described and illustrated in conjunction with the following detailed description and appended drawings.
Referring to
The bridge member 12 includes an upper surface 22, an opposed lower surface 24, a front side 26, an opposed back side 28, a left end 30 and an opposed right end 32. The upper surface 22 is substantially planar in a direction extending from the left end 30 to the right end 32, and is convex in a direction from the front side 26 to the back side 28, as may best be seen in
The legs 14 extend downwardly from the lower surface 24 at the left and right ends 30, 32, and are substantially wedge-shaped. Each leg 14 has an outer surface 34, an opposed inner surface 36 such that the inner surfaces 36 are facing each other, a front surface 38, and an opposed back surface 40. Each of the legs 14 has a width as measured from the front surface 38 to the back surface 40, which is substantially equal to the width of the bridge member 12 as measured from the front side 26 to the back side 28. As shown in
Each barb 44 includes a retaining surface 45 facing generally away from the respective tip 42 and facing generally toward the bridge member 12. As such, the barbs 44 are adapted to inhibit withdrawal movement of the staple 10 once the staple 10 has been positioned in its fixation environment, such as a vertebra. The inner surface 36 of the legs 14 are preferably splayed, or angled, away from each other at an angle of about 10° as measured from a vertical plane 47 extending perpendicularly through the cross-section of the bridge member 12. The outer surfaces 34 of the legs 14 extend downwardly substantially perpendicular to the bridge member 12 and substantially parallel to the vertical plane 45.
The left fastener retaining portion 16 extends outwardly from the bridge member left end 30. The right fastener retaining portion 18 extends outwardly from the bridge member right end 32. Each of the fastener retaining portions 16, 18 define a passageway 46 therethrough adapted to receive therein a fastener, such as a screw. The fastener retaining portions 16, 18 and the passageways 46 are adapted to guide a fastener in a direction substantially parallel to the legs 14. Also, the fastener retaining portions 16, 18 each include front and back sides 49 and 51 and are proportioned so that when two of the staples 10 are in end-to-end abutting relation, as shown in
As may be seen in
In an alternative embodiment, shown in
Each of the fastener retaining portions 16 and 18 includes a recess, illustratively a counter sunk portion 50, adapted to receive the head of a fastener therein. In addition, each fastener retaining portion 16, 18 also includes a lower surface 52 having a plurality of first pointed projections 54 extending downwardly therefrom for engaging underlying bone. Second pointed projections, or barbs 56, also extend downwardly from the fastener retaining portions 16, 18.
As shown in
The threaded post 20 extends upwardly from the upper surface 22 of the bridge member 12. The threaded post 20 cooperates with the bridge member 12 to define a passageway 58 coaxial with the post 20 and extending through the post 20 to the lower surface 24 of the bridge member 12. The threaded post 20 permits the attachment of additional hardware or instruments to the staple 10, while the passageway 58 allows for the passage of a guide wire for movement therealong, if desired. Further, the cannulated threaded post 20 facilitates attachment of a threaded removable, cannulated impaction device.
The staple 10 may be made of titanium, surgical stainless steel, or any other material sufficiently strong to resist the growth of a spinal column, and sufficiently non-reactive in the environment of a living animal.
Referring to
The spinal correction system, when installed on a growing spine having abnormal curvature defining a convex side and an opposed concave side, with the spine including a plurality of lengthwise adjoining vertebrae 60 each having a pair of endplate growth centers 62, or longitudinal growth plates, with an intermediate portion 66 in between, the vertebrae 60 also having a particular diameter or thickness in a direction measured from the convex side to the concave side, is broadly seen to include a first bone engaging means or leg 14 that penetrates the convex side of an intermediate portion 66 of a first vertebra to a depth of less than one-half the diameter of the first vertebra, a second bone engaging means or leg 14 penetrating the convex side of an intermediate portion 66 of a second vertebra to a depth of less than one-half the diameter of the second vertebra, and a bridge member 12 connecting, illustratively rigidly, the first and second bone engaging means 14. As may be appreciated, the concave lower surface 24 of each staple 10 substantially matches or follows the contour of the vertebral body defined by the vertebrae 60.
The spinal correction system 10 thus corrects the abnormal curvature of the growing spine by inhibiting or retarding the growth of the endplate growth centers 62 captured between the first and second bone engaging means 14 on the convex side of the spine, while permitting the unrestrained growth of the endplate growth centers 62 on the concave side of the spine. As the spine continues to grow, the concave side of the spine will grow faster relative to the convex side, thereby resulting in flattening of the curvature and straightening of the spine.
While the legs 14 are primarily responsible for restraining the growth of the endplate growth centers 62 captured therebetween, it will be seen that the fastener retaining portions 16, 18 and fasteners 68 also contribute to restraining the growth of the endplate growth centers 62 captured therebetween. The legs 14 may even be omitted provided that the fastener retaining portions 16, 18 and cooperating fasteners 68 are adapted to sufficiently resist the spreading forces due to lengthwise growth of the endplate growth centers 62.
While the spinal correction system is intended primarily for correcting abnormal lateral curvature of an immature or growing spine, it may also be used for spinal correction in humans having mature or non-growing spines. In such cases, discectomy and fusion would be required before fixing the system to the vertebrae.
While the forms of apparatus herein described constitute preferred embodiments of this invention, it is to be understood that the invention is not limited to these precise forms of apparatus, and that changes may be made therein without departing from the scope of the invention which is defined in the appended claims.
This application is a continuation of U.S. patent application Ser. No. 10/030,440, filed Jan. 7, 2002, now U.S. Pat. No. 6,746,450 which is the national phase under 35 U.S.C. § 371 of PCT International Application No. PCT/US00/18491, having a filing date of Jul. 6, 2000, which claims the benefit of U.S. Provisional Patent Application Ser. No. 60/142,707, filed Jul. 7, 1999, all of which are expressly incorporated by reference herein.
Number | Name | Date | Kind |
---|---|---|---|
3693616 | Roaf et al. | Sep 1972 | A |
3862631 | Austin | Jan 1975 | A |
4041939 | Hall | Aug 1977 | A |
4047523 | Hall | Sep 1977 | A |
4047524 | Hall | Sep 1977 | A |
4078559 | Nissinen | Mar 1978 | A |
4401112 | Rezaian | Aug 1983 | A |
4403606 | Woo et al. | Sep 1983 | A |
4434796 | Karapetian et al. | Mar 1984 | A |
4454875 | Pratt et al. | Jun 1984 | A |
4462395 | Johnson | Jul 1984 | A |
4503848 | Caspar et al. | Mar 1985 | A |
4570618 | Wu | Feb 1986 | A |
4570623 | Ellison et al. | Feb 1986 | A |
4573454 | Hoffman | Mar 1986 | A |
4592346 | Jurgutis | Jun 1986 | A |
4599086 | Doty | Jul 1986 | A |
4651724 | Berentey et al. | Mar 1987 | A |
4686970 | Dove et al. | Aug 1987 | A |
4743260 | Burton | May 1988 | A |
4776851 | Bruchman et al. | Oct 1988 | A |
4793335 | Frey et al. | Dec 1988 | A |
4841960 | Garner | Jun 1989 | A |
4848328 | Laboureau et al. | Jul 1989 | A |
4870957 | Goble et al. | Oct 1989 | A |
4913144 | Del Medico | Apr 1990 | A |
4943292 | Foux | Jul 1990 | A |
4955910 | Bolesky | Sep 1990 | A |
4960420 | Goble et al. | Oct 1990 | A |
4966600 | Songer et al. | Oct 1990 | A |
4998936 | Mehdian | Mar 1991 | A |
5002574 | May et al. | Mar 1991 | A |
5011484 | Breard | Apr 1991 | A |
5030220 | Howland | Jul 1991 | A |
D320081 | Johnson | Sep 1991 | S |
5053038 | Sheehan | Oct 1991 | A |
5092866 | Breard et al. | Mar 1992 | A |
5092868 | Mehdian | Mar 1992 | A |
5108395 | Laurain et al. | Apr 1992 | A |
5116340 | Songer et al. | May 1992 | A |
5147361 | Ojima et al. | Sep 1992 | A |
5180393 | Commarmond | Jan 1993 | A |
5199146 | Grover et al. | Apr 1993 | A |
D340284 | Johnson | Oct 1993 | S |
5261910 | Warden et al. | Nov 1993 | A |
5306301 | Graf et al. | Apr 1994 | A |
5318566 | Miller | Jun 1994 | A |
5324290 | Zdeblick et al. | Jun 1994 | A |
5352229 | Goble et al. | Oct 1994 | A |
5387213 | Breard et al. | Feb 1995 | A |
5395372 | Holt et al. | Mar 1995 | A |
5395374 | Miller et al. | Mar 1995 | A |
5405391 | Hednerson et al. | Apr 1995 | A |
5415658 | Kilpela et al. | May 1995 | A |
5415661 | Holmes | May 1995 | A |
5417690 | Sennett et al. | May 1995 | A |
5423820 | Miller et al. | Jun 1995 | A |
5425767 | Steininger et al. | Jun 1995 | A |
5449359 | Groiso | Sep 1995 | A |
5454814 | Comte | Oct 1995 | A |
5456722 | McLeod et al. | Oct 1995 | A |
D364462 | Michelson | Nov 1995 | S |
5476465 | Preissman | Dec 1995 | A |
5496318 | Howland et al. | Mar 1996 | A |
5536270 | Songer et al. | Jul 1996 | A |
5540698 | Preissman | Jul 1996 | A |
5540703 | Barker, Jr. et al. | Jul 1996 | A |
5545168 | Burke | Aug 1996 | A |
5569253 | Farris et al. | Oct 1996 | A |
5603713 | Aust et al. | Feb 1997 | A |
D378409 | Michelson | Mar 1997 | S |
5607425 | Rogozinski | Mar 1997 | A |
5609634 | Voydeville | Mar 1997 | A |
5620443 | Gertzbein et al. | Apr 1997 | A |
5649927 | Kilpela et al. | Jul 1997 | A |
5653711 | Hayano et al. | Aug 1997 | A |
5662655 | Laboureau et al. | Sep 1997 | A |
5669917 | Sauer et al. | Sep 1997 | A |
5693046 | Songer et al. | Dec 1997 | A |
5702395 | Hopf | Dec 1997 | A |
5702399 | Kilpela et al. | Dec 1997 | A |
5707395 | Li | Jan 1998 | A |
5713900 | Benzel et al. | Feb 1998 | A |
5720747 | Burke | Feb 1998 | A |
5725582 | Bevan et al. | Mar 1998 | A |
5741260 | Songer et al. | Apr 1998 | A |
5908421 | Beger | Jun 1999 | A |
6066140 | Gertzbein et al. | May 2000 | A |
6228085 | Theken et al. | May 2001 | B1 |
6231610 | Geisler | May 2001 | B1 |
6235059 | Benezech et al. | May 2001 | B1 |
6296643 | Hopf et al. | Oct 2001 | B1 |
6299613 | Ogilvie et al. | Oct 2001 | B1 |
6309393 | Tepic et al. | Oct 2001 | B1 |
6325805 | Ogilvie et al. | Dec 2001 | B1 |
6336928 | Guerin et al. | Jan 2002 | B1 |
6436099 | Drewry et al. | Aug 2002 | B1 |
6517564 | Grafton et al. | Feb 2003 | B1 |
6551320 | Lieberman | Apr 2003 | B2 |
6616669 | Ogilvie et al. | Sep 2003 | B2 |
6623484 | Betz et al. | Sep 2003 | B2 |
Number | Date | Country |
---|---|---|
0 026 970 | Apr 1981 | EP |
0 478 470 | Jan 1992 | EP |
0 545 830 | Jun 1993 | EP |
0 552 109 | Jul 1993 | EP |
0 625 336 | Nov 1994 | EP |
2 709 410 | Mar 1995 | FR |
63-65060 | Apr 1988 | JP |
3-75717 | Jul 1991 | JP |
7-79998 | Mar 1995 | JP |
8-229052 | Sep 1996 | JP |
WO 9817189 | Apr 1998 | JP |
WO 9848718 | Nov 1998 | JP |
WO 9116018 | Oct 1991 | WO |
WO 9401057 | Jan 1994 | WO |
WO 9426192 | Nov 1994 | WO |
WO 9851226 | Nov 1998 | WO |
Number | Date | Country | |
---|---|---|---|
20040220569 A1 | Nov 2004 | US |
Number | Date | Country | |
---|---|---|---|
60142707 | Jul 1999 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 10030440 | US | |
Child | 10862660 | US |