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Title:
METHOD AND APPARATUS FOR TREATMENT OF IDIOPATHIC SCOLIOSIS
Document Type and Number:
WIPO Patent Application WO/1997/020511
Kind Code:
A1
Abstract:
Apparatus to treat scoliosis, particularly idiopathic scoliosis. The apparatus has a pair of longitudinal struts whose separation can be adjusted. The cross member is pivotally attached to each strut. The apparatus can be secured to a patient's pelvic girdle. The cross member can be pivoted and thus move the patient's sacrum towards the innominate bones. The apparatus also provides a method to treat scoliosis in a patient that comprises repositioning the patient's sacrum to correct the anatomical position to restore the symmetry of the patient's pelvic girdle. The patient's sacrum is stabilized in its restored position by locating the sacrum to the iliac bone. The vertebrae in the scoliotic curve is pulled by members attached to the ilium extending to the vertebrae processus. The members are tensioned as required. The apparatus also discloses methods to treat scoliosis, an apparatus to reduce curvature of a curved body having a plurality of housings and a flexible cord that passes through said housings. The cord can be anchored and drawn so that housings are drawn together. An artificial joint is disclosed and an anchor bolt useful in the above apparatus. An internal and an external orthosis that uses the above apparatus is described and a bracket comprising plates, housings, spheres that permit relative movement of struts under member generally perpendicular to said struts.

Inventors:
NENOV NIKOLAY NENOV (CA)
Application Number:
PCT/CA1995/000673
Publication Date:
June 12, 1997
Filing Date:
December 04, 1995
Export Citation:
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Assignee:
NENOV NIKOLAY NENOV (CA)
International Classes:
A61B17/70; (IPC1-7): A61B17/70
Foreign References:
EP0383992A21990-08-29
US2333033A1943-10-26
US4112935A1978-09-12
US5490851A1996-02-13
Other References:
H.E.RUBASH ET AL.: "Comparative mechanical performances of some new devives for fixation of unstable pelvic ring fractures", MEDICAL & BIOLOGICAL ENGINEERING * COMPUTING, vol. 21, no. 6, November 1983 (1983-11-01), STEVENAGE,HERTS.,GB, pages 657 - 663, XP002009576
Download PDF:
Claims:
I CLAIM:
1. Apparatus to treat scoliosis comprising: a pair of longitudinal struts? means to adjust the separation of said struts; a cross member extending between said struts and pivotally mounted to each strut; means to secure said apparatus to a patient's pelvic girdle; means to pivot said cross member and thus move the patient's sacrum towards the innominate bones.
2. Apparatus as claimed in claim 1 in which the means to adjust separation of said struts comprises turnbuckles attached adjacent each end of the struts.
3. Apparatus as claimed in claim 1 in which the cross member has a plurality of openings adjacent each end; pins in said longitudinal members pivotally received in said opening.
4. Apparatus as claimed in claim 3 including means to adjust the longitudinal position of said pins in said struts.
5. Apparatus as claimed in claim 1 in which the means to secure said apparatus comprises screws to be received in the pelvic girdle.
6. Apparatus as claimed in claim 5 in which the screws are mounted on a subframe, pivotally attached to the cross member.
7. Apparatus as claimed in claim 1 in which the means to pivot said cross member comprises a wormwheel mounted on said cross member; a drive screw for said wormwheel; the subframe being pivotally attached to said cross member and secured by said screws to said pelvic girdle; whereby rotation of said wormwheel pivots said sub frame and thus the pelvic girdle.
8. A method to treat scoliosis in a patient that comprises: repositioning the patient's sacrum to correct the anatomical position to restore the symmetry of the patient's pelvic girdle stabilizing the patient's sacrum in its restored position by locating the sacrum to the iliac bone; pulling the vertebrae in the scoliotic curve by members attached to the ilium and extending to the transverse processus; and tensioning the members as required.
9. A method as claimed in claim 8 in which the sacrum is stabilized by artificial joints that attach the sacrum to the ilium and allow only tilting of the sacrum about the axis of the patient's axial ligament.
10. A method as claimed in claim 8 in which the members are lines attached to reels mounted on the ilium, rotation of a reel acting to vary the tension of the line.
11. Apparatus as claimed in claim 1 including a threaded housing on each longitudinal strut, above said cross member; a threaded member received by each threaded housing and extending to engage said cross member, whereby rotation of the threaded members in its respective housing moves the crossmember relative to the longitudinal members.
12. Apparatus as claimed in claim 11 in which each threaded member is provided with a balljoint; a channel formed in said crossmember to receive said balljoints.
13. Apparatus to reduce curvature of a curved body and to stabilize the body that comprises a plurality of joined components, the apparatus comprising: a plurality of housings adapted to be attached to said joined components; a flexible cord to pass through said housings; means to anchor said flexible cord at one end; means to draw said cord, whereby drawing said cord shortens the cord to bend to correct and stabilize said curved body.
14. Apparatus as claimed in claim 13 in which the housings are tubular members of predetermined length and shape with mobile anchors attached.
15. Apparatus as claimed in claim 13 in which at least some of the housings are of variable length.
16. Apparatus as claimed in claim 14 in which the anchors are threaded shafts.
17. Apparatus as claimed in claim 13 in which the flexible cord is of stainless steel.
18. Apparatus as claimed in claim 13 in which the flexible cord is anchored to an end housing.
19. Apparatus as claimed in claim 13 in which the means to draw the flexible cord comprises a worm and worm wheel; a threaded member attached to said flexible cord to be drawn into said worm wheel as said worm wheel is rotated.
20. Apparatus as claimed in claim 19 in which the cord is attached to said threaded member.
21. Apparatus as claimed in claim 13 including a spring in said flexible cord to prevent overtensioning.
22. An artificial joint comprising: a screw to be attached to bone in a patient; a head for said screw, said head having means to allow rotation of said screw; a housing to receive said screw; a thread on the exterior of said housing to attache to bone in the patient; a piston in said housing able to reciprocate in said housing, said piston receiving the head of said screw at a pivotable joint; resilient means on each side of said piston to control movement and the position of said piston in said housing.
23. A joint as claimed in claim 22 in which said head is spherical; said piston having a correspondingly spherical recess to receive said head.
24. A joint as claimed in claim 22 in which said resilient means are springs.
25. Apparatus as claimed in claim 1 that comprises a plurality of joint components including a side member extending from each longitudinal strut; an anchor member attached to a distal end of each side member, each anchor member having a plurality of anchor points; a first flexible cord extending between a first pair of anchor points, one point on each anchor member; a plurality of housings mounted on said first flexible cord; means to attach at least some of said housings to bone in a patient; means to tension said flexible cord; a pair of second flexible cords each extending from a second anchor point on said anchor members to an end of a longitudinal strut; means to attach said second flexible cords to each other; and means to tension said second cords.
26. Apparatus as claimed in claim 25 in which the means to tension said cords comprises a worm and worm wheel.
27. Apparatus as claimed in claim 25 having first rigid hinged members extending from each longitudinal strut and each side strut to a ring, a second ring movably attached to the first and to be attached to a femur of a patient, adjacent the knee; second rigid hinged members extending from each rigid side member to said ring; means to rotate the ring to pivot the femur.
28. Apparatus as claimed in claim 27 including joints as defined in claim 23 formed in each second rigid member to attach to the femur adjacent a hip of the patient.
29. Apparatus as claimed in claim 28 including threaded members to attach each joint to the hip of a patient.
30. Apparatus as claimed in claim 27 in which the first and second rigid struts are telescopic.
31. An anchor bolt to mount the apparatus of claim 13 comprising: a threaded shaft; a housing attached to said shaft and having an opening; a threaded pathway in said housing; a threaded member to be received in said pathway to extend into said opening; and means to vary the length of said threaded shaft.
32. An anchor as claimed in claim 31 in which the means to vary said length comprises a turn buckle.
33. An anchor bolt to mount the apparatus of claim 13 comprising: a threaded shaft; a housing attached to said shaft and having an opening; a threaded pathway in said housing; a threaded member to be received in said pathway to extend into said openings; said threaded pathway being received in a removal part of said housing, whereby the removable part may be removed to allow a body to be introduced radially into said opening.
34. An anchor as claimed in claim 33 in which the removal part glides axially of said housing.
35. An external orthosis for the tridimensional reduction of scoliosis in a dynamic manner, said orthosis comprising: apparatus as claimed in claim 25 forming a pelvic girdle; a side member extending from each longitudinal strut of said apparatus as defined in claim 25; two lateral hands attached to said side members, said hands comprising front longitudinal struts formed of the apparatus defined in claim 13; horizontal flexible ribs attached to said front vertical struts to extend around the thorax, each rib formed of the apparatus defined in claim 13; rear longitudinal struts attached to said ribs, said rear vertical struts formed of the apparatus defined in claim 13; crossbridge plates mounting said rear longitudinal struts; and said crossbridge plate being attached to said side members by shock absorbers.
36. An internal orthosis for the tridimensional reduction of scoliosis in the dynamic manner, said orthosis comprising: a portion of a pelvic girdle as defined in claim 1; side members extending along each iliac crest according to claim 1; lateral hands attached to said side members, said hands comprising first longitudinal struts formed of the apparatus defined in claim 13; horizontal ribs to be attached to a patient's ribs and extending around the ribs, each rib formed of the apparatus defined in claim 13; second longitudinal struts, generally parallel to the first longitudinal struts, said second longitudinal struts formed of the apparatus defined in claim 13; third longitudinal struts, attached to said second longitudinal struts by said ribs; a connection between first horizontal ribs and said apparatus of claim 1 to allow application of additional derotation and straightening force; and means to draw said cords of said apparatus to apply force to a patient's spine.
37. A bracket able to hold pairs of struts and to link a member to said struts, said bracket comprising: opposed plates; first spheres mounted to said plates; openings in said spheres to receive said struts; a second sphere mounted between said plates; an opening in said second sphere to receive said member; said openings in said second sphere being generally perpendicular to said openings in said first spheres.
Description:
METHOD AND APPARATUS FOR TREATMENT OF IDIOPATHIC SCOLIOSIS

This invention relates to an apparatus to treat scoliosis.

Scoliosis is broadly defined as abnormal lateral curvature of the spine. Scoliosis disfigures a person but also can cause disfunction of some internal organs, for example the lungs and heart.

There have been a number of suggestions in the prior art to alleviate and, indeed, cure the condition.

Included in the prior art is an apparatus known as a distracter, which resembles a jack. The distracter has two rods. One end of each rod is divided into limbs and the other end is threaded. The rod is interconnected by a cylindrical tube having a two-way thread in the manner of a turnbuckle.

A similar method of correcting scoliosis comprises the use of two metal rods with bent ends and straight ends. The straight ends are linked by a threaded sleeve. The bent ends are attached to the transverse processus of the vertebrae on the convex side of the scoliotic arch. The sleeve is rotated and the contractor pulls at the transverse processes, thereby correcting the curvature of the spinal column.

Steel springs have also been used. The ends of a spring are fixed on the transverse processus of the vertebrae on the convex side of the scoliotic curvature. The spring acts as a contractor for a long time.

Skeletal traction of the spinal column has been used. The apparatus useful in this technique has two rings, at the head and at the pelvis. The rings are

inter-connected by four expansion rods. The apparatus is applied by attaching metal pins through the iliac bones of the pelvis, secured in the pelvic ring. Four metal pins are inserted in to the cranium and are fixed to the head ring. By gradually unwinding the sleeves of the extended rod between the pelvic and head rings, longitudinal traction of the spinal column by the pelvic bone and the bones of the cranium is effected.

A technique similar to the above is the use of a head ring, again located by the use of cranial pins. The outer ends of the pins are fixed on the head ring. The upper ends of metal stay rods are fixed to the head ring. The lower ends are embedded in a cast, typically of plaster of paris. The rods are gradually extended by expansion sleeves, to effect traction of the spinal column.

An apparatus for the external traction of the spinal column is also known. This apparatus has a supporting shaft with L-shaped end feet at right angles to the shaft. There are discs resting on the tips. A third foot, which is also L-shaped and has a disc on the tip, is attached to the middle of the shaft in the direction opposite to that of the end feet. This apparatus is mounted alongside the spinal column of the patient. The three discs rest upon the patient's back. Nylon threads are attached to the processus of the three vertebrae, at the apex of the curvature of the spine and at the two bases. These threads are brought through the soft tissues in the skin of the back and are secured to the appropriate foot of the apparatus and tightened. In this way, the curvature is drawn from its apex towards the concave side and from the extreme vertebrae, towards the convex side.

US Patent 4,112,935, issued in September of 1978, describes an apparatus for surgical treatment of scoliosis in which a framework is formed by parallel struts secured at the ends by yokes and fixed on the patient's body by a system of belts. The belts are connected to the stay rods and fastened to the struts. Flexible braces serve to exert a corrective force on the vertebra. One end of each flexible brace is attached to the vertebrae and the other is a mechanism for applying varying tensions to the flexible braces.

A further, relatively uncomplicated apparatus is described in US patent 5,105,489 to Meyer issued April 21, 1992. In that patent a device and method of treating scoliosis uses a seat cushion made up of two members having angled top surfaces. The two members are arranged in an opposed sided-by-side position. To use the apparatus the innominate bones and the entire pelvic girdle of a patient seated on the seat cushion are tractioned into an opposing configuration through application of torque thereto by the tilting.

The present invention seeks to provide improvements over the prior art. It is believed to provide better results and is based on an analysis of the origins of idiopathic scoliosis.

The present invention provides, inter alia, apparatus that might be described as a universal pelvic girdle fixator reintegrator (UPGFR) which is adjustable in size and shape depending on the disorder to be treated. The invention is appropriate, in one or more aspects, as a universal moulder of bone and adjoining tissue and also in construction with methods of using the apparatus in the treatment of pelvic deformities that commonly occur with scoliosis, extrophy of the bladder, cloaca extrophy, and fractures and chest wall deformities

and in immobilizing fractured ribs. The invention also provides artificial joints for maintaining pelvic integrity and mobility. The UPGFR is designed to secure attachment to innominate bones and the sacrum in a manner that allows repositioning of each of them separately and mobilization immediately after an operation.

It is applicant's contention that it is necessary to analyze idiopathic scoliosis as a disorder of the trunk, and not merely the spine. This is important because the spine is an integral part of the trunk and is the pivot shaft between the pelvis and the bony thorax. In effect the spine is a vertebral column that constitutes the central pillar of the trunk. As such the vertebral column must meet two contradictory mechanical requirements, rigidity and plasticity. This is achieved by the presence of stays built into its structure. When the weight of the body rests on one limb the pelvis tilts to the opposite side and vertical column is forced to bend first in the lumbar region, where it becomes convex towards the resting limb. Then it becomes concave in the thoracic region and convex once more. The muscular tighteners adapt automatically to restore equilibrium. This adaptation is under the control of the extrapyramidal system which alters the tone of the postural muscles.

Much the same happens when the pelvis becomes distorted and the sacrum tilts obliquely in a way described by Cramer. The proprioreceptors automatically send information to the thalamus neocortex and back through the reticular formation to the efferent nerves which act on the appropriate muscles to restore equilibrium. In this case one has to take into consideration automatic rotation and tilting of L5 & L4 which are bound to the iliac crest by the illolumbale ligaments. This causes a chain reaction. Rotation in an

adjacent vertebrae, above the affected vertebrae, takes place to a certain level of the thoracic part of the spine. At this level there is a change of direction of rotation and paravertebral muscles plus lateral group- quadratus lumborum, iliopsoas, act direct on the spine, and also ilocostalis lumborum and abdominal muscles act indirectly through the rib cage to tighten and create parallel forces that cause bending and increasing of the rotation. During the growing period, in a relatively short time, this asymmetric pressure on the vertebrae leads to arrest of the epiphyseal growth. According to Arkin (1949) both the superincumbent weight and the tension developed in the ligamentous structures on the convex portion of the curve exert compressive forces on the edge of the vertebral body which thus becomes a fulcrum. Arkin proposes that this concentration of pressure leads to arrest of the vertebral epiphyseal growth and consequent wedging of the vertebral body. According to Tayler (1975) the extent of longitudinal growth of the central region of the vertebral body appears to be genetically determined but the longitudinal growth of the peripheral portion is dependent on the activity associated with weight bearing in the erect posture.

The present invention seeks to address all the routes of the ailments without concentrating on merely one aspect. It works without fusion to correct distortion as early as possible and acts to obtain reintegration of the structures by applying appropriate forces during the growing period and to readjust the proprioreceptor-thalamo-neocortex-reticular formation- proprioreceptor chain function by gradual overstretching which acts to relax the muscles to their normal size. According to the invention this is achieved by repositioning the pelvic distortion by the UPGFR, retaining the pelvic symmetry by implanting artificial

sacral joints restoring asymmetric joints, restoring asymmetry in the chest by applying forces on each deformed pair of ribs and also vertically correcting the distance between each pair of ribs, thus facilitating derotation and straightening of the vertebral column in the coronal plane.

Accordingly, in a first aspect, the present invention provides an apparatus to treat scoliosis comprising a pair of longitudinal struts; means to adjust the separation of said struts; a cross member extending between said struts and pivotally mounted to each strut; means to secure said apparatus to a patient's pelvic girdle; means to pivot said cross member and thus move the patient's sacrum towards the innominate bone.

In a further aspect, the invention is a method to treat scoliosis in a patient that comprises repositioning the patient's sacrum to correct the anatomical position and to restore the symmetry of the patient's pelvic girdle, stabilizing the patient's sacrum in its restored position by locating the sacrum to the iliac bones; gradually pulling the vertebrae in the scoliotic curve by members attached to the ilium and extending to the vertebrae transverse processus; and tensioning the members as required.

The invention is illustrated in the drawings, in which:

Figure 1 is a front view of the apparatus of the present invention;

Figure IA shows a variation of the apparatus of Figure 1;

Figure 2 is a section on the line 2-2 of Figure 1; Figure 3 illustrates use of the apparatus of Figure 1?

Figure 4 is a section through an artificial joint useful in the method of the present invention;

Figure 5 is an end view of the artificial joint of Figure 4 ; Figure 6 illustrates the use of the joint of Figures 4 and 5;

Figure 7 is a side elevation of auxiliary equipment useful with the apparatus of Figure 1;

Figure 8 is a plan view of the apparatus of Figure 7;

Figure 9 illustrates an example of use of the auxiliary equipment of Figures 7 and 8;

Figure 10 is a view, partially in section, through a further embodiment of the present invention; Figures 10A, through 10G are details and variations of the apparatus of Figure 10;

Figure 11 is a detail of the apparatus of Figure 10;

Figures 11A and 11B shoe variations of the apparatus of Figure 11; Figure 12 is a view of a further embodiment of the present invention;

Figure 13 is rear view of a development of the apparatus of Figure 12;

Figures 14, 14A and 14B show a detail of the apparatus of Figures IA, 12 and 13; and

Figures 15 through 18 illustrate use of the invention as illustrated in Figure 10.

The drawings show an apparatus to treat scoliosis. The main apparatus comprises a pair of longitudinal struts 10 spaced from each other. These struts are designed to be attached to the ilium at points A. Side members 12 extend from the longitudinal struts, provided with openings 14 again to allow attachment to the ilium.

There are means to adjust the separation of the struts 10. This means comprises pivotal joints 16 at

each end of the strut 10 and a turn buckle made up of threaded members 18 extending inwardly from the pivotal joints 16 and an internally threaded nut 20 that engages on the threaded studs 18. The studs 18 in each pair are oppositely threaded with regard to the other stud of the pair, so the rotation of the nut 20 in one direction either extends or contracts the stud length, thus acting to increase or decrease the separation of the longitudinal struts 10. There is a cross-member 22, generally H-shaped, extending between the struts 10.

Member 22 is pivotally mounted to each strut 10. Member 22 has openings 24 adjacent each end. There are pins 26 in the longitudinal struts 10 that are pivotally received in the openings 24 in the cross-members 22. Nuts (not shown) are engaged on these threaded pins 26 to retain the cross-member 22 in position on the struts 10.

The cross-member 22 is also attached to the longitudinal struts 10 by longitudinally extending threaded members 28 engaged, by ball joints 30, with a channel 32 in the cross-member 22. These threaded members are also engaged in nuts 34, attached to the longitudinal struts 10.

As shown particularly in Figure 2, there is a means to pivot the cross-member 22 relative to longitudinal strut 10 comprising a worm wheel 36 attached to the cross-member 22. Worm wheel 36 and cross-member 22 are mounted on a sub-frame 38 by a central ball joint 40 surrounded by three ball joints 42 attached to the sub- frame 38 in openings 44 that permit their movement in the sub-frame 38.

There is a drive screw or worm 46, mounted on the cross-member 22 and engaging the worm wheel 36, which has an external track to engage screw 46. There are drive members at each end of the screw 46.

The longitudinal struts 10 are desirably formed in two parts. There are bottom parts 10A that may be detached from the upper portion at joints 11.

To use the apparatus of Figures 1 and 2 the apparatus is attached, by a surgical procedure, to the skeleton of the patient in the position shown in Figure 3. The longitudinal struts 10 are attached to the ilium and ischium and the cross-member 22 is attached to the sacrum by its attachment to sub-frame 38.

Adjustments are made, particularly to the studs 18 and to the openings 24 to position the apparatus of Figure 1 on the patient. The nuts 20 may be used not merely to adjust the size of the device but also to assist in separating bones by applying a slight force. In particular the nuts 20 may be used to separate the innominate bones from the sacrum. Similarly the screws 28 may be rotated in the nuts 34 to "custom fit" the device to the patient also to apply a slight force as required.

The screws 50 used, are standard in orthopaedic surgery and are attached using conventional procedures in that art.

Once the device is in position, the sub-frame 38 is pivoted by rotating the screws 28 in nuts 34 with the nuts on pins 26 being locked. By this means the longitudinal struts 10 and the cross-member 22 are pivoted relative to each other to apply a force to the pelvic girdle of the patient.

As an alternative, less preferred, mode of operation the shaft 46 may be rotated. This rotates the worm wheel 36, mounted on the cross-member 22, to pivot the sub- frame 38. Again, the longitudinal struts 10 and the

cross-member 22 are pivoted relative to each other to apply a force for the pelvic girdle of the patient.

It is strongly recommended that muscle and ligament relaxants be given to the patient for some time prior to treatment to facilitate the movement of the bones. Such muscle and ligament relaxants are known in the art.

The bottom parts 10A may be removed immediately after the repositioning or correction in the positioning of the pelvic girdle of the patient. The remainder of the apparatus may be left in place in a patient for at most one month subsequent to the operation but it may be removed immediately at the end of the operation. This is believed to be feasible in 90% of cases. Once the position of the pelvic girdle has been repositioned, computer tomography (CMT) is used to determine the position of the patient's sacrum. That is to say, the CMT will be used to determine that the pelvic girdle is restored to a correct, symmetrical position.

Figure 4 illustrates an artificial joint useful with the apparatus of Figures 1 to 3. As indicated above the apparatus of Figures 1 and 2 may be used only for a short time, although longer term use is also possible. It is the function of the artificial joint shown in Figure 4, which is mounted behind the sacroiliac joints and around the central sacroiliac ligament, as indicated in Figure 6, to hold the repositioned sacrum pelvic girdle, repositioned that is by the apparatus of Figures 1 and 2. In contrast to the apparatus of Figures 1 and 2, the artificial joint of Figures 4 and 5 may be used to hold the position for a few years. It is used after treatment with the apparatus of Figures 1 and 2.

The artificial joint of Figure 4 comprise a main screw member 54 to be received in the sacrum. The screw

54 is provided with a slotted head 56 so that it can be engaged by a driver. The joint 52 is provided with an opening 57 to permit the insertion of a driver, and a hexagonal key configuration is shown, to drive the screw 54. The screw member 54 is received within housing 58 having a thread 60 that engages the ilium. Springs 62 permit movement in the manner of a normal, natural joint. This is particularly desirable in the case of any artificial joint and does not inhibit natural growth.

Figure 6 illustrates the position of the joints 52. Used in this manner, the joints 52 are able to retain a repositioned pelvic girdle in position. Frequently the apparatus of Figures 1 and 2 need not be left in position subsequent to the operation.

Figures 7, 8 and 9 show drive members 64 that can be mounted on the iliac crests 66 using a central screw 68. The positions are shown in Figure 9. Again, a wheel 70 is provided and a flexible cord 72, for example of stainless steel, extends from a fixed point 74 on the drive members 64, outwardly to engage the vertebrae at 76, and down back onto a reel 78 attached to the wheel 70. An appropriate number of drive members 64 (eight are shown in Figure 9) are mounted on the iliac crests 66 and tensioned appropriately by use of a screw 80. Quite sensitive control can be achieved with the simple drive members 64 shown. These flexible cords 72 apply corrective force to the vertebrae. Desirably they can be hooked around the transverse processus of the vertebrae during a first, main operation. Their removal can then be relatively simple. The appropriate incisions are made and the drive members 64 removed. The cords 72 may be cut and removed from the vertebrae simply by pulling at the incision made to remove the drive mechanism.

Thus the apparatus of Figures 1 to 9 provides a simple, light-weight mechanism to cure scoliosis. A particular advantage of the device is that it does not have a major impact on the life of the patient. For example it does not interfere with sleeping.

Furthermore, the main apparatus, that of Figures 1 and 2, may be in place for at most a month, marketedly less than the prior art equipment. Furthermore, the equipment may in many cases be removed immediately subsequent to the operation if CMT techniques show that the pelvic girdle has been well positioned and the surgeon believes that the artificial joints 52 will hold the pelvic girdle in its corrected position.

The apparatus of the present invention may be made of stainless steel but a disadvantage of this is that the stainless steel may interfere with CMT. It is therefore desirable to use X-ray transparent material, for example resins reinforced with graphite or glass fibre.

The invention also provides a method to treat scoliosis. The illustrated equipment is used as follows. First the patient's sacrum is repositioned to the correct anatomical position to restore the symmetry of the patient's pelvic girdle, using the apparatus of Figures 1 and 2. The apparatus is positioned as shown in Figure 3. Once the pelvic girdle has been repositioned the artificial joints of Figure 4 are positioned as shown in Figure 6 to maintain that position. In a great number of cases the artificial joint 52, shown in Figure 4, are sufficient to maintain the correctly positioned pelvic girdle. That is to say, the apparatus of Figures 1 and

2, the main part of the apparatus, may be removed as soon as the artificial joints 52 are in position.

The cords 72, and drive members 64, may be installed and tension applied to cords 72 by rotation of the reels

78. In this way, gradual force is applied to the distorted spine so that it does not tend to act against the effects of the joints 52. Typically the cords 72 may be in place for a few years subsequent to the operation.

A great advantage of the apparatus and method of the invention of Figures 1 to 9 is that it is possible to treat children of any age. The prior art, in general, has only been able to treat properly children of 12 years old and above. This is because the prior art apparatus tends to inhibit growth and to disturb the vertebrae by fusing of the spine. However, the present apparatus is in place very briefly and the artificial joints 52 and cords 72 have no adverse effect on the growth of the spine. Changing the tensioning of the cords 72 is an easy matter.

Figure 10 illustrates an apparatus able to reduce curvature of a curved body that comprise a plurality of joined components 100. The invention finds particular application in the treatment of scoliotic curved spines but has application in treating other deformations and fractures. The apparatus comprises a plurality of housings 102 that can be attached to the joined components 100 vertebrae in the case of the spine shown in Figure 10, by threaded members 103 attached to housing 404, which receives housing 102. A flexible cord 104 passes through the housings 102. Typically the cord 104 will be of stainless steel. The flexible cord 104 is anchored to the spine at one end using a pin 105. At the lower end there is a device 106 as shown in Figure 10A to draw the cord 104 downwardly in order to draw the housings 102 towards each other.

The device 106 of Figure 10A comprises a worm 108, having a slot 110 to receive a drive and a worm wheel 112. The worm wheel 112 is internally threaded. A

threaded member 114 is attached to the end of the cord 104 so that rotation of the worm 108 rotates the worm wheel 112 and draws the threaded member 114 attached to the flexible cord 104 downwardly. Worm wheel 112 is located in a casing 116. The effect is to draw the housings 102 together as the cord 104 is shortened, thus tending to straighten the curved body in the coronal plane. Nut 115 is provided to attach the casing 116 against housing 404.

The amount of force can be applied is, of course, limited by the length of the housings 102 which can be predetermined to apply an appropriate tension.

It is desirable to incorporate a spring 107 into the cord to prevent over tensioning.

Figures 11 and 11A show means of varying the effective lengths of the housings 102. Typically a number of these components will be inserted in an apparatus as shown in figure 10 but not all the housings will be of this nature. Referring to Figure 11 there is a worm 200 and worm wheel 202. There is an outer casing 204. The worm wheel 202 is attached to an inner, tubular threaded member 206 so that the rotation of the wheel, by rotation of the worm 200, rotates the tube 206. Tube 206 engages an internally threaded tube 208. Tube 208 is prevented from rotating by conventional means, for example by the provision of a key engaging key ways, so the rotation of the tube 206 acts to extend or retract tube 208. By this means the effective length of the housing 102 is varied.

Figure 11A shows a variation of the structure in Figure 11. The wheel 202 has pins 210 attached to it. Pins 210 engage in recesses in externally threaded members 212 thus rotation of the wheel 202 rotates the

members 212. These are threaded to an external casing 214. Thus members 212 reciprocate as the worm 200 is rotated.

Figure 11B shows a variation of the shape of housing 102 that might be desirable where it is designed to increase the curve in the sagittal plane using the apparatus of Figure 10.

Figure 12 illustrates what may be considered a combination of the apparatus of Figure 1 with the apparatus of Figure 10. Apparatus of this nature can be used to achieve a variety of effects, not simply the single effects achieved by the apparatus of Figure 1 and the apparatus of Figure 10.

In Figure 12 the apparatus of Figure 1 is shown, in general, in broken lines. Each side member 12 has an anchor member 300 attached to it. Each anchor member 300 has a plurality of anchor points 319. The side member 12 can be anchored to the patient's ilium by anchor screws 103. Each anchor member 300 is also attached to the patient's ilium by a screw passing through a central opening 325. A first flexible member 124 according to Figure 12 extends from a first pair of anchor points 319, one point on each anchor member 300. Although not shown clearly in Figure 12, discrete housings 102 in the first flexible cord 104, are as shown in Figure 10.

Drive members 106 are positioned, at various parts of the apparatus, where tension is required. The operation of these drive members 106 is as described for Figure 10A.

The flexible cord 104 can be tensioned using drive members 106. There is a pair of second flexible members 126 according to Figure 12. Each second member 126

extends from a second anchor point 319 on an anchor member 300 to an end of a longitudinal strut 10. There are means to tension the second members shown at 130. Such a device is a simple drive member that can tension the second flexible members 126 to retain them. Turn buckles 132 are also shown and can be used to increase or decrease the length of second flexible members 126 and thus apply distraction forces to screw 404 relative to adjacent anchor points 319.

In the development of the apparatus of Figure 12 as shown in Figure 13, there are first rigid members 134 extending from each longitudinal strut 10 to a ring 136 that is attached at the knee to a second ring 137 which is attached to the patient's femur 138, adjacent the knee. There are second rigid members 140 extending from each link 148 to the ring 136. The ring 137 can be rotated by the provision of a worm drive 140. In this way the femur of the patient can be rotated towards the acetabulum to correct the relative positions of the bones. Artificial joints 52 having the structure shown in Figure 4, can be positioned within the rigid members 140. A resilient member 142 extends to an anchor plate 144 which, in turn, is anchored to the femur of the patient by screws 146 to allow application of distraction forces. The rigid members 140 may include turn buckles 48 and means to control their length as shown at 150. Thus allow the application distraction forces.

Figure 15 illustrates apparatus that is made up of equipment as shown in Figure 10. The apparatus is for internal use. There are first flexible members 152.

Each flexible member 152 has a plurality of housings 102. The housings 102 are adapted to be attached to a patient's spine at predetermined positions. The arrangement is as shown in Figures 10, 10H and 10J. The flexible members 152 can be anchored to the spine, remote

from the pelvic girdle. There is a drive mechanism to allow tensioning of the members 152 as shown in Figure 10. In this manner the members 152 can be drawn and shortened to tend to straighten the curvature shown in the spine in the coronal plane.

In the preferred embodiment shown in Figure 15 there are a plurality of flexible cross members 154, having the same general structure of cords 104 and housings 102 and extending between the housings 102 on the first flexible members 152. These impart rigidity to the structure and transfer the force between the two first flexible members 152. Furthermore Figure 15 illustrates the use of third flexible members 156, again of the general structure shown in Figure 10, that is of the same structure as the first and second flexible members 152 and 154. These third flexible members 156 are generally parallel to the first members 152.

Figures 16 through 18 illustrate uses of the apparatus generally shown in Figure 10. The apparatus is mounted externally. The apparatus of Figure 10 is of great value in allowing the controlled application of force. The predetermined shape of the housings 102 mould deformities to the proper shape of the spine and rib cage. On the other hand the predetermined length of the housings 102 in general avoids over compression and over tensioning. However, if necessary, spring members can be incorporated.

Figures 17A and 17B illustrates a means of attaching the overlapping members 102 in embodiments of the invention as illustrated, for example, in Figures 16 and 17. With an overlapping pair of members 102, one member is formed with a recess 400 and the other with a ball 402 received in the recess 400 to provide a universal joint.

By this means relative, limited movement of the overlapping members 102 is allowed.

In all cases the flexible cords 104, through their housings 102, are mounted to the patient's skeleton. Force can then be applied to apply the necessary corrected tensioning to the skeleton.

Figure 18 illustrates the application of a flexible member 154 anchored to the segment of the thorax. There are also longitudinal members 152 and 153, again of a flexible cord 104 having discrete housings 102 on it. By tensioning the cords 104 as described for the embodiment of Figure 15, the rib cage of the patient can be moved from the distorted to the correct position.

Figures IA, 14, 14A and 14B illustrate a variation of the apparatus of Figure 1. In the apparatus of Figure la the longitudinal struts 10 and, possibly, their extensions 10a, are replaced by pairs of parallel struts 310. These struts 310 are held together by brackets 300 as shown in Figures 14 and 14B. The brackets 300 comprise opposed plates 314 having spheres 319 with arcuate openings 316 placed in the spherical openings 316. The struts 310 fit in the openings 316 and bolts 318 are tightened to draw the plates 314 together and locate the struts 310.

Figure IA also shows the use of hinge members 320, shown in more detail in Figure 14A, that is used to attach anchor members 319. These members 319 are attached by the apparatus shown in Figure 14. The anchor members 319 are attached to members 320, which in turn are attached to a distal end of the hinge plate. There are threaded members 322 with different hand threads on each end extending between anchor points 324 on the surface of the hinge members 320.

Figure IOC illustrates a mechanism that could be useful in attaching certain of the housings 102 to the vertebrae, as shown in Figure 10. The threaded member 103 has an arcuate end housing 350 that accommodates a worm drive 352. Worm drive 352 rotates tubular member 354 to reciprocate relative to housing 350 and thus vary the length of the housings.

Figure 10B illustrates how the housing 102 may be attached by housings 356 that engage the processus of the vertebrae. Hooks 358 engage the processus. A threaded member 360 extends through a threaded opening 362 to engage the housings 102. By this means the housing is firmly located on the housing 356 which are, of course, located on the processus.

Figures 10D to 10G illustrate variations of the means of anchoring the housings 102 to the members 100. In Figure lOd the threaded member 103 has an end housing 404. A set screw 406 is received in the threaded opening in the end member 404 so that the member is anchored relative to the housings 102 and thus to the cord 104, which is not shown in these drawings.

In the embodiment of Figure 10E there is a generally arrowheaded, loose member 408 which allows placing the housing through that opening.

Figure 10G is, in effect, the reverse of the embodiment of Figure 10E in that the arrowhead face in the opposite direction. The same effect is achieved. Figure 10F shows the use of a threaded tube 410 engaging threaded portions 412 of the shaft 103. By rotating the member 410 small variations in the length of the threaded member 103 can be achieved.

The equipment shown in Figures 16 and 17 is used as follows:

Bolts are inserted into the sacrum and the sub- frame, with the cross members, is assembled. Bolts are inserted into the ilium and assembled on the longitudinal and side struts. The turn buckle mechanism is added and the apparatus is positioned on the pelvis.

Although not essential the sacroiliac artificial joints 52, shown in Figure 4, may be inserted through posterior incisions and through the ilium, into the sacrum.

The brace is mounted. The longitudinal struts 152 and 153 are mounted and the first rib bands 162 are attached towards the posterior and anterior longitudinal struts. Pneumatic longitudinal pillows (not shown) are attached. The remaining eleven rib bands are consecutively attached with rings 158 to the shoulders and the breast in the female.

The posterior longitudinal struts 152 are attached to the cross bridge plates 166 secured on to the shock absorbers 52A that are fixed into both side struts 12 of the UPGFR.

The tensioning of the cable is started with a longitudinal tensioning but the tensioning is not particularly tight. The cable is then drawn in the rib hands 154 where deformation is greatest, in other words at the apex of the curved vertebrae ribs, to some extent. After that a sequence is carried out, above and below as necessary. The vertical ribs 156 are then positioned and a bridge 160. The ribs are gathered together by tensioning vertical ribs 156 on the convex side. The ribs on the concave sides are drawn back and separated by distracting adjacent the vertical ribs 156.

In the next four weeks additional tension is applied as desired. If it is required it is possible to install additional oblique tightening bridges 164 between the rib cage and the side struts 12 of the UPGFR.

If the result is not satisfactory then, within three months, it is possible to dismantle the brace, insert artificial sacroiliac joints, if they have not been positioned already, after precise repositioning of the pelvic girdle and then dismantle the UPGFR.

The author thus offers two procedures on the spine that are performed after the restoration of the pelvic girdle symmetry and the sacroiliac artificial joints are attached.

First, an anterior procedure is achieved by a transperitoneal approach. It is possible to insert screws into the scoliotic curved vertebrae bodies and place the housings. After that the cord, spring and tensioning mechanism is operated. After approximately three weeks multiple small sections on the back around the spine between ribs it is possible to insert the necessary screw drive and apply additional correcting force to the curve. This procedure can be performed several times until the housings meet.

Secondly, the posterior approach to the spine is used for posterior instrumentation. Screws are inserted through the pediculus into the vertebrae bodies. Hooks can be attached to the transverse processus. A combination of hooks and screws may be used if required by the surgeon. The tube housings are assembled with the screws or hooks. The cable is inserted through the housings and secured to the top housing spring. Distraction of the vertebrae on the concave side takes place by rotating the worm mechanisms of the adjustable

tubing. The cable is tensioned by rotating the worm mechanism. The same procedure is carried out on the convex side without the above step of distraction.

The housings are inserted subcutaneously following the three most deformed ribs and through small incisions attached to the ribs, for example, by binding with cables or hooks. Longitudinal struts 156 and 156A are inserted under the skin, stitched to the horizontal housings (Figs. 17A and 17B) and tensioned to some extent. The same procedure is carried out for twelve ribs. The same procedure is performed for iliac crests and bridges between 164. Suturing is carried out as necessary.

After approximately three weeks a driver can be inserted through small incisions to rotate the worms to elongate the housings on the concave side after relaxing the cable. First tensioning the horizontal cable and then vertically applying a distraction on the concave side and shortening on the convex side. When finished with the ribs the worm is rotated on each vertebral housing in the same manner. The same procedure is performed for the bridges between members 154.

This procedure may take place under local anaesthetic and mild I.V. anaesthetic. The procedure is repeated several times until full restoration of symmetry.

The combined apparatus of Figure 13, the UPGFR, is used in the following manner:

First screws are inserted that secure the apparatus to a patient's pelvic girdle. The sub-frame is then installed on the cross-members. The longitudinal struts are installed and the circles around the innominate bones, if necessary. Cables are inserted for the rear 12

and 10 and the front part 126 for each semi-circle and tensioned by the worm wheel mechanisms for the rear and worm wheel 106 mechanisms and turn buckles 132 for the front. The upper and lower turn buckles 20 are installed. The cross-members are connected with a longitudinal strut 10 by the nuts and modified bolts 132 that are hooked with longitudinal struts 10. The upper semi-circle 124 is installed. The lower part of the apparatus of Fig. 13 is installed by attaching the frame 146 to each circle by clamps 147. The hinge 148 is installed and, if necessary, artificial joints 52 are installed by making small incisions in the lower region of the greater trochanter and insert the attaching screws into the femoral neck and attaching the pulling cable after suturing the skin. The artificial joint is assembled. The pins are inserted into the distal femur and the lower circle 137 and tensioned. Lateral struts 140 are attached to the upper circle 136 by hinge 148. The medial strut 134 is assembled with a hinged neck 148 and secured to the upper circle clamps. The front telescopic strut 152 is secured to upper circle 136 by hinge 148.

In Figs. 16, 17 and 18 the first rib circle is installed with four T-shaped tubings are shown in Figure 17B for the front 153 and rear 152 longitudinal columns of the brace. The longitudinal columns are attached to tensioning mechanism 106 next to the T-shaped tubing. The transverse flexible members 154 are installed by connecting them to the longitudinal columns by hinges at the back and front. In the front cables pass into the opposite side. A tensioning mechanism is inserted and an adjustable tubing for additional correction. Preliminary tensioning of the cable by tightening with a tightening instrument is carried out. The cable is then anchored by a clamp and a bolt.

The rear longitudinal columns are anchored into the crossbar. Preliminary tensioning of the cables takes place.

The bar is attached using modified artificial joints 52A located to the side struts 12 of the UPGFR.

The Trunk Corrector Reintegrator is gradually tensioned. Distraction forces are applied towards a sacroiliac joints by upper and lower turn buckles 20.

The bolt 28 is tightened on the side where posterior iliac spine is in lower position compared with the opposite and the longitudinal strut is located roughly with regard to the crossbar. The bolts 28 on the opposite side are tightened and this moves the strut towards the opposite strut. By this means derotation of adjacent innominate bones towards each other is achieved. This restores a symmetrical position of the iliac spine.

The sacrum also could be moved towards the innominate bones by drawing back one of the two upper bolts and also the central bolt. By tensioning the front upper semi-circle 124 the anchor sides are located. This can, if necessary, be combined with a small correction by the lower rear turn buckle 20 which then becomes a stabilizer.

Distraction force are applied by lower and upper front turn buckles 132 which distract the anchoring points 404 and 325 and thus fix roughly the position of the pubic bones so that symphysis can take place in a gradual manner over several weeks.

The longitudinal struts 140 and 134 are elongated by the turn buckles 150 and longitudinal tension applied on the femur. Angle forces are also applied to the hip and

the innominate bones, which are modified by lateral traction inserted by the modified artificial joints 52.

The modified artificial joints 52 are used to apply lateral traction on the femur and thus longitudinal traction on the femoral neck, hip and transverse on the innominate bones.

The worm wheels 140 are rotated with consequent rotation of the femoral bone internally.

Tensioning of the ribs is started with the most deformed being treated first. Gradual rotation of the worm wheels achieves the necessary tension. Gradual tensioning of the vertical flexible member on the convex side starts with pulling up twelve ribs towards the first rib by the adjacent flexible cross-member. Gradually the ribs approach each other until the tubings touch each other.

Distraction and pulling back of the vertical ribs on the concave side is achieved by rotating the worm wheels of the adjustable tubing and relaxing the cable. Then the front or sternal longitudinal columns 153 are tensioned. The posterior longitudinal columns 152 are also tensioned. Tensioning of the connection between the longitudinal columns 160 takes place followed by tensioning of the connection bands 164 between the twelve ribs and the UPGFR innominate circles to bring back to the vertical in the coronal plane longitudinal columns 152 and thus the spine.

Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, it will be readily apparent to those of ordinary skill in the art in light of the teachings of this invention that certain changes

and modifications may be made thereto without departing from the spirit or scope of the appended claims.