阅读说明：本技术 用于畸形矫正的可重构矫形器 (Reconfigurable orthosis for deformity correction ) 是由 马修·汤普森 达林·吉廷斯 于 2018-12-13 设计创作，主要内容包括：用于矫正脊柱畸形的系统和方法利用允许在穿戴期间运动的动态、多结构躯干矫形器。本公开实施方式利用一系列贴合患者躯干外周的弹性联接的环结构。利用可调节的弹性联接机构来产生和改变通过这些环结构施加到躯干上的力和力矩。在一些情况下,环结构由可以链接以适应特定身体结构的单独元件形成。在其他情况下,上环结构可以被配置成容纳患者的上躯干。(Systems and methods for correcting spinal deformities utilize dynamic, multi-structural torso orthoses that allow motion during wear. The disclosed embodiments utilize a series of elastically coupled ring structures that conform to the circumference of the patient's torso. Adjustable elastic coupling mechanisms are utilized to generate and vary the forces and moments applied to the torso by these loop structures. In some cases, the loop structures are formed from individual elements that can be linked to accommodate a particular body structure. In other cases, the upper ring structure can be configured to accommodate the upper torso of the patient.)

1. A system for externally applying a corrective force to a torso of a patient, the system comprising:

a plurality of ring structures spaced apart along a vertical axis, wherein the plurality of ring structures comprises a lower ring structure, an upper ring structure, and at least one intermediate ring structure disposed between the lower ring structure and the upper ring structure, and wherein at least some of the ring structures comprise a plurality of elements linked together such that the ring structures conform to a periphery of the patient's torso; and

at least one coupling member disposed between each pair of vertically adjacent ring structures, wherein each said coupling member is adjustably secured at a lower end to said lower ring structure and at an upper end to said upper ring structure.

2. The system of claim 1, wherein the linked elements are configured such that individual elements can be added to or removed from the loop structure to change at least one of a preselected size and a preselected shape of the loop structure.

3. The system of claim 2, wherein the loop structure comprises individual linked elements having different geometries, whereby the individual linked elements can be connected in a selected order to provide a particular peripheral shape.

4. The system of claim 2, wherein at least some circumferentially adjacent linked elements are fixedly attached to each other.

5. The system of claim 3, wherein at least some circumferentially adjacent linked elements are connected by threaded fasteners.

6. The system of claim 1, wherein at least some of the loop structures have a front gap configured to be engaged by an adjustable closure component.

7. The system of claim 6, wherein the adjustable closure assembly comprises a belt.

8. The system of claim 1, wherein at least one coupling member disposed between vertically adjacent pairs of ring structures is located on a backside of the ring structures.

9. The system of claim 8, further comprising at least one additional coupling member disposed between and flanking vertically adjacent pairs of ring structures.

10. The system of claim 1, wherein at least some of the ring structures define a periphery that lies in a single plane.

11. The system of claim 1 wherein at least some of said ring structures define a periphery having portions lying in different vertically spaced planes.

12. The system of claim 10, wherein the loop structure comprises linked elements extending perpendicularly between a first plane and a second plane.

13. The system of claim 10, wherein the upper ring structure defines a periphery having portions that lie in different vertically spaced planes, and all other ring structures define a periphery that lies in a single plane.

14. A system for externally applying a corrective force to a torso of a patient, comprising:

a plurality of loop structures, each of the loop structures configured to fit about the circumference of a patient's torso and each of the loop structures positioned in a spaced apart, substantially coaxial configuration about a vertical axis, wherein the plurality of loop structures includes a lower loop structure, an upper loop structure, and at least one intermediate loop structure disposed between the lower loop structure and the upper loop structure, and wherein the upper loop structure is configured to span an upper region of the patient's back and extend downward to span the patient's torso below the patient's arms; and

at least one resilient member disposed between each pair of vertically adjacent ring structures, wherein each resilient member is fixedly and adjustably secured at a lower end to the lower ring unit and at an upper end to the upper ring.

15. The system of claim 11, wherein the upper ring structure is further configured to span a front region of the patient's torso above the patient's arms.

16. The system of claim 12, wherein the upper ring structure has a rear region, a pair of side regions, and a front region, wherein each of the rear, side, and front regions are aligned generally horizontally with respect to the vertical axis, and the regions are interconnected by vertical regions.

17. The system of claim 13, wherein at least some of the loop structures comprise a plurality of elements linked together such that the loop structures conform to the circumference of the patient's torso.

18. The system of claim 14, wherein the plurality of elements linked together comprise a horizontal element and a vertical element.

19. A method for configuring a system to apply correction to a spine of a patient, the method comprising:

providing a plurality of ring elements;

linking the individual ring elements together to form a lower end ring structure, an upper end ring structure, and at least one intermediate ring structure disposed between the lower end ring structure and the upper end ring structure, wherein each ring structure conforms to the circumference of the patient's torso; and

elastically joining the lower end ring structure, the upper end ring structure, and the at least one intermediate ring structure along a vertical axis to form the system.

20. The method of claim 19, wherein at least some of the individual ring elements have different geometries.

21. The method of claim 17, wherein at least 50% of the individual ring elements have different geometries.

22. The method of claim 19, wherein resiliently joining the lower end ring structure, the upper end ring structure, and the at least one intermediate ring structure along a vertical axis comprises disposing at least one resilient member between each pair of vertically adjacent ring structures.

23. The method of claim 19, wherein each resilient member is secured and adjustably secured to the lower ring structure at a lower end and to the upper ring structure at an upper end.

24. A system for externally applying a corrective force to a torso of a patient, the system comprising:

a plurality of ring structures spaced apart along a vertical axis, wherein the plurality of ring structures comprises a lower ring structure, an upper ring structure, and at least one intermediate ring structure disposed between the lower ring structure and the upper ring structure;

at least one coupling member disposed between each pair of vertically adjacent ring structures, wherein each said coupling member is secured at a lower end to said lower ring structure and at an upper end to said upper ring structure, and wherein said coupling members are configured to apply a horizontal displacement force between said vertically adjacent rings;

a harness attached to the superstructure, the harness configured to be vertically adjustably positioned over the patient's shoulders; and

a plurality of vertical suspension members between each pair of the vertically adjacent rings.

25. A system for externally applying a corrective force to a torso of a patient, the system comprising:

a plurality of ring structures spaced apart along a vertical axis, wherein the plurality of ring structures comprises a lower ring structure, an upper ring structure, and at least one intermediate ring structure disposed between the lower ring structure and the upper ring structure;

at least one coupling member disposed between each pair of vertically adjacent ring structures, wherein each said coupling member is affixed at a lower end to said lower ring structure and at an upper end to said upper ring structure, and wherein said coupling members are configured to apply a horizontal displacement force between said vertically adjacent rings;

a rear rod having a right side end and a left side end, the rear rod being positioned vertically above the upper ring structure;

at least one upper coupling member disposed between the upper ring structure and the rear stem, wherein the upper coupling member is affixed at a lower end to the upper ring structure and at an upper end to the rear stem, and wherein the upper coupling member is configured to apply a horizontal displacement force between the upper ring structure and the rear stem; and

at least one shoulder strap attachable to one of the right and left lateral ends of the rear rod, the shoulder strap configured to circumscribe an adjacent shoulder to transmit force from the rear rod.

26. A system for externally applying a corrective force to a torso of a patient, the system comprising:

a plurality of ring structures spaced apart along a vertical axis, wherein the plurality of ring structures comprises a lower ring structure, an upper ring structure, and at least one intermediate ring structure disposed between the lower ring structure and the upper ring structure;

at least one coupling member disposed between each pair of vertically adjacent ring structures, wherein each said coupling member comprises:

(a) an axially extendable leaf spring having an upper end and a lower end;

(b) a horizontal biasing member pivotably secured between the lower ring structure and a lower end of the axially extendable leaf spring;

(c) a universal joint fixedly connected between the upper end of the axially extendable leaf spring and the upper ring structure.

27. The system of claim 26, wherein the axially extendable leaf spring comprises a pair of spring plates slidably secured to each other, wherein a lower end of a first one of the spring plates is pivotally attached to the horizontal biasing member and an upper end of a second one of the spring plates is secured to the universal joint.

28. The system of claim 27, wherein the horizontal biasing member comprises a rotatable shaft attached to a lower end of a first one of the spring plates and a clamp for securing the extendable leaf spring at a selected deflection relative to the horizontal shaft.

29. The system of claim 28, wherein the universal joint comprises a ball secured to an upper end of the second plate and a socket secured to the upper ring structure.

Background

Adolescent Idiopathic Scoliosis (AIS) is an unnatural curvature of the spine that affects 2-3% of the population. The onset of this disease is usually around 10 years of age and (in the united states) is usually found in school screening. The severity of deformity is measured by the Cobb angle, which is the internal angle formed by the two most oblique vertebrae. The minimum Cobb angle for AIS diagnosis is 10 degrees. While many view scoliosis as a curvature in the coronal plane, scoliosis can be a complex three-dimensional deformity, often involving sagittal curves and rotational deformities in the axial plane.

The natural history of the disease is that many children have a 10-20 degree curve that remains unchanged. Such a degree of flexion requires little treatment. The remaining children with scoliosis have a curve that continues to develop. Once patients reach bone maturity, their curves will stop developing if the Cobb angle measurement is less than 40 degrees. Curves with Cobb angles of 40 degrees and greater generally continue to evolve.

Treatment of scoliosis is often observed when the curve is less than 25 degrees. Once the curve reaches 25 to 30 degrees of the Cobb angle, the patient is supported in an attempt to slow or stop the progression of the curve. The curve developed to 40 degrees or more is surgically treated by spinal fusion.

Clinical studies have found two requirements for success in corrective therapy: the stent is worn for 20 hours or more per day and at least 50% of the acute correction is made to the scoliosis curve when the stent is applied.

The current state of the art in support (standard of care) is a rigid full torso support known as a thoracolumbar-sacral orthosis (TLSO). The brace is typically a thermoplastic shell that is custom molded to the patient's torso and has a modification intended to reduce bending by contact force. These stents may have some effect of stopping the progression of the curve when worn completely (often more than 20 hours per day) during treatment. Often, these patients are required to use stents for four years or more.

A significant improvement over the state of the art is described in commonly owned U.S. patent publication 2015/0297387, the entire disclosure of which is incorporated herein by reference. This publication describes a system for externally applying a corrective force to a patient's spine. As shown in fig. 1, the system of the '387 publication includes a plurality of ring sections, each adapted to fit the circumference of a patient's torso, wherein the ring structures are positioned in a vertically spaced, substantially coaxial configuration. The ring structure includes a lower end ring structure, an upper end ring structure, and at least one intermediate ring structure disposed therebetween. The drive units are disposed on all ring structures except the upper ring structure, and the receivers are disposed on all ring structures except the lower ring structure. The drive unit and the receiver are arranged at least on a back side region of the ring structure, and typically also on at least some side regions. The resilient member extends from each drive unit to a vertically adjacent receiver, and the drive units are configured to apply a rotational force to the ends of the resilient member to deflect the shaft of the resilient member to apply a force on the sides of the receivers on adjacent loop structures. The drive units and receivers on the back will exert a force on the torso in the anterior-posterior (dorsal-ventral) direction, while the drive units and receivers on the sides will exert a force in the lateral-medial direction.

While the improved design of the' 387 publication is very effective, certain design aspects of the system may be improved. For example, the loop structure described in the' 387 publication is difficult to reconfigure to accommodate different body structures. In addition, the loop structure is somewhat flexible, which may reduce the restoring force applied to the spine from the drive unit. Still further, the upper ring structure is limited in the way to where it can extend over the back and chest of the patient, thus reducing the forces that can be applied to the upper torso.

For these reasons, it is desirable to provide an improved system for externally applying corrective forces to a patient's torso, particularly the spine. In particular, such an improved system should be adjustable to fit different patient anatomy, should have sufficient rigidity to effectively apply force to the spine of the patient, and should be able to engage and apply force to the torso of the patient in the area above the arms. At least some of these objectives will be met by the inventions described and claimed herein.

Disclosure of Invention

In a first aspect, the present invention provides a system for externally applying a corrective force to a torso of a patient, for example for the purpose of treating scoliosis and other spinal deformities. The system includes a plurality of ring structures attached together and spaced apart along a vertical axis, typically including at least a lower ring structure, an upper ring structure, and one or more intermediate ring structures disposed between the lower and upper ring structures. At least some of the loop structures will include a plurality of discrete or individual elements that are linked together such that the loop structures can be assembled by selected individual elements to fit the circumference of the patient's torso at a particular height (typically at or between the hips and shoulders). At least in most cases, the individual ring elements will have complementary shapes and mating surfaces so that they are interchangeable. At least some of the interchangeable ring elements will have different geometries and/or sizes (such as different degrees of curvature and/or different lengths) such that when assembled, the overall geometry of the ring structure may vary in shape, size, and typically both shape and size.

While most of the individual ring elements are solid and configured to be rigidly attached in series to other solid elements to form a substantially rigid assembly, some of the individual ring elements may have other characteristics or features. For example, some of the individual ring elements may be hinged in the middle, such that once the individual ring elements are assembled and structurally generally rigid, the ring structure itself may still be opened and closed at the hinges, such that it may be placed on and removed from the patient.

The plurality of loop structures will typically be joined vertically by coupling members. Typically, at least one coupling member will be provided between each pair of vertically adjacent ring structures. The coupling members will be attached at a lower end to the lower ring and at an upper end to the upper ring, and are typically configured to apply a horizontal displacement force between vertically adjacent ring structures in order to treat scoliosis or other patient conditions. In addition to these force applying coupling members, the vertically adjacent ring structures will also typically be engaged by another external structure that supports the rings and positions each ring at the appropriate height on the patient's torso. As described in more detail below, the external structure may be a soft cover (soft cover) or vest that receives the loops, may be a combination of shoulder straps attached to the upper loop and additional straps or other suspension members between each pair of loops below the upper loop, or may be various other structures or assemblies. Suitable suspension members between vertically adjacent ground ring structures include flexible straps, rigid struts, woven mesh, low profile springs, and the like. The suspension members may be elastic, rigid, or a combination thereof, and suspension members having different characteristics may be used in combination on a single orthosis.

The individual ring elements can be circumferentially engaged in various ways. Typically, they will be fixedly attached to each other, for example by screws or other fasteners. Alternatively, they may be engaged by pins, straps, clamps, or other removable securing elements. Typically, the loop structure will include hinged or other elements that allow it to be opened sufficiently to be placed around the torso of a patient and then closed to provide a relatively rigid circumscribing structure around the patient. Often, there will be a gap in the loop structure, which is usually located on the anterior side, so that the loop can be closed and tied using a closure element such as a strap or other removable gap closure device.

At least some of the coupling members disposed between vertically adjacent pairs of ring structures will typically be located on the backside of the ring structures. The coupling member on the back side of the loop structure will typically comprise a pair of spring members configured to apply a force in the anterior-posterior direction so as to provide a corrective force. Often, the pair of spring members in a particular coupling member will exert forces in opposite directions to exert a rotational displacement force between the upper ring and the lower ring. Furthermore, coupling members are often provided on the sides of the ring structure in order to provide a restoring force in the transverse direction. Often, the side coupling member will only comprise a single spring member.

The ring structure may be planar, that is, the entire ring element may have an outer periphery that lies in a single plane. In other cases, portions of the outer periphery of the ring structure may lie in vertically spaced planes. In this case, at least some of the individual ring elements will typically extend vertically to provide the required planar separation.

In a second aspect, the present invention provides a system for externally applying a force to a torso of a patient to correct a spinal or other deformity. The system includes a plurality of ring structures configured to fit the patient's circumference at different heights along the patient's torso, wherein the ring structures are each positioned in a vertically spaced, substantially coaxial configuration about the patient's vertical (superior-inferior) axis. The plurality of ring structures includes at least a lower ring structure, an upper ring structure, and one or more intermediate ring structures disposed between the lower ring structure and the upper ring structure. In this aspect of the invention, the upper ring structure is configured to have at least a rear region that spans an upper region of the patient's back at or above the patient's arms and opposing side regions that are displaced downwardly from the rear region to extend below the patient's arms. The anterior portion of such an upper ring may extend across the torso of the patient at a height above or below the arms, typically configured to avoid the breasts of a female patient. This upper ring structure has been found to be particularly effective in applying forces to the torso and upper regions of the spine. Typically, the intermediate and lower ring structures will have a flat or planar configuration with no vertical displacement. As with the previous embodiments, a coupling member is disposed between vertically adjacent pairs of ring structures to provide the required restoring force to the rings.

In certain embodiments, the front and rear portions of the upper ring may be at the same height to span the anterior and posterior torso of the patient above the patient's arms and form a well or U-shaped recess on the sides of the upper ring for receiving the patient's arms. The upper ring structure and other ring structures in these embodiments are preferably formed from a plurality of individual ring elements, as previously described in previous embodiments herein.

In a third aspect of the invention, a method for configuring a system to apply a corrective force to a torso of a patient to treat a spinal or other deformity includes: a plurality of individual ring elements are provided and selected ones of the individual ring elements are linked together to form a lower end ring structure, an upper end ring structure, and at least one intermediate ring structure disposed between the lower end ring structure and the upper end ring structure. The individual ring elements will be assembled such that each ring structure has a geometry that conforms to the circumference of the patient's torso at the vertical height at which the ring structure will reside. Upon assembly of the individual ring structures, the individual ring structures will be resiliently joined in a vertically stacked manner to provide a three or more layered ring structure for treating a patient.

Typically, at least some of the individual ring elements will have a different geometry, typically at least one of a different curvature and a different length, than the other individual ring elements. In this manner, the loop structures have a variety of geometries, shapes, and sizes, and can be configured from the same library or kit of individual loop elements. The individual hoop elements will often be provided or maintained as a kit, library or other collection available to the user for assembly into the hoop structures and orthoses of the present invention. Such a set will typically include ring elements having two different geometries, more typically at least three different geometries (i.e., different in size and/or shape), and often at least four, five, six, seven, eight, or more different geometries.

Resiliently engaging the different numbers of layers of ring structures will generally include disposing at least one coupling member (typically a resilient coupling member) between each pair of vertically adjacent ring structures. The loop structure typically includes at least one elastic member on a back plane thereof, and the side aspect of the loop element often includes at least one elastic member.

In a fourth aspect of the invention, a system for externally applying a corrective force to a torso of a patient includes a plurality of loop structures spaced apart along a vertical axis, wherein the plurality of loop structures includes a lower loop structure, an upper loop structure, and at least one intermediate loop structure disposed between the lower loop structure and the upper loop structure. At least one coupling member will be disposed between each pair of vertically adjacent ring structures, and each coupling member will typically be affixed at a lower end to the lower ring structure and at an upper end to the upper ring structure. As with all of the previous embodiments, at least some of the coupling members are configured to apply a horizontal displacement force between vertically adjacent rings in order to achieve a desired restoring force. The assembly of vertically spaced ring structures would be secured to the patient by a harness (harness) attached to the upper ring structure, the upper ring structure being configured to be vertically adjustable to properly position the ring structures relative to the patient's posterior body structure. In addition to the straps suspending the upper ring structure, the support system will preferably comprise a plurality of vertical suspension straps arranged between each pair of vertically adjacent rings. In this way, the position of the loop on the patient's torso will be maintained by the harness and vertical suspension straps, so that the loop will not be displaced by the patient's movements. In addition to the coupling members provided between adjacent vertical rings, a suspension system will also be provided. The purpose of the coupling member is to apply a displacement force in the horizontal direction, rather than to support the ring structure vertically when worn by the patient. Such a support function is provided by a separate suspension structure.

In a fifth aspect of the invention, a system for externally applying a corrective force to a torso of a patient includes a plurality of hoop structures including a lower hoop structure, an upper hoop structure, and at least one intermediate hoop structure disposed between the lower and upper hoop structures. At least one coupling member will be disposed between each pair of vertically adjacent ring structures, and each coupling member will be affixed at a lower end to the lower ring structure and at an upper end to the upper ring structure. The coupling member is configured to apply a horizontal displacement force between vertically adjacent rings. In this aspect of the invention, a rear rod having a right side end and a left side end is positioned vertically above the upper hoop structure. At least one upper coupling member is disposed between the upper ring structure and the rear rod such that the upper coupling member is secured at a lower end to the upper ring structure and an upper end to the rear rod, and the upper coupling member is configured to apply a horizontal displacement force between the upper ring structure and the rear rod. By attaching the strap to at least one of both side ends of the rear bar, the shoulders of the patient may be circumscribed (circumscript) by the strap and displaced by a force exerted by the rear bar, wherein the force is transferred from the upper ring structure.

In a sixth aspect of the invention, a system for externally applying a corrective force to a torso of a patient includes a plurality of loop structures spaced apart along a vertical axis. The plurality of ring structures includes a lower ring structure, an upper ring structure, and at least one intermediate ring structure disposed between the upper ring structure and the lower ring structure. At least one coupling member is provided between each pair of vertically adjacent ring structures and comprises (a) an axially extendable (retractable) leaf spring having an upper end and a lower end, (b) a horizontal biasing member pivotally secured between the lower ring structure and the lower end of the axially extendable leaf spring, and (c) a universal joint secured between the upper end of the axially extendable leaf spring and the upper ring structure. Such coupling members are unconstrained with respect to vertical and horizontal displacement of adjacent hoop structures, but are configured to apply a force in a direction perpendicular to the plane of the leaf springs to apply a desired corrective force to the torso. That is, for the rear coupling member and the drive unit, an inward or outward force will be applied in the front-rear direction. For the side coupling member and the drive unit, the force will be in the side-to-middle direction.

As mentioned above, the retractable leaf spring is straight and the degree of bias is adjusted by rotating its attachment using the drive unit. In other embodiments, the bias may be adjusted by selecting from a set, library, or collection of curved or otherwise pre-biased retractable leaf springs or other resilient coupling members. In this way, the biasing force can be varied by selecting a spring having the desired shape and spring force, without adjusting the drive unit to orient the straight spring element. In other embodiments, the drive units described herein may be used to further bias a bending element or other pre-biased spring element.

In a particular embodiment, the axially extendable leaf spring comprises a pair of spring plates slidably secured to each other, wherein a lower end of a first one of the spring plates is pivotally attached to the horizontal biasing member and an upper end of a second one of the plates is secured to the universal joint. The horizontal biasing member typically includes a rotatable shaft attached to a lower end of a first of the plates and a clamp for securing the extendable leaf spring at a selected deflection relative to a horizontal shaft. The universal joint typically includes a ball secured to the upper end of the second plate and a socket secured to the upper ring structure.

Is incorporated by reference

All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.

Drawings

The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

fig. 1, 2A-2C, and 3 illustrate features of the orthosis in U.S. patent publication 2015/0297387.

Fig. 4 and 5 illustrate an exemplary modular ring structure comprising a plurality of individual ring elements that can be secured together in a selected pattern to conform to different patient body structures.

Fig. 6 illustrates a hinge loop element for securing a drive unit or a receiving unit into the modular loop structure of the present invention.

Fig. 7A and 7B illustrate a pair of individual ring elements having different shapes.

Fig. 8A-8D illustrate the different curvatures that can be obtained by joining separate ring elements having different shapes.

Figure 9 illustrates a pair of exemplary ring structures mounted on a flexible cover that surrounds the torso of a patient.

Fig. 10 illustrates an exemplary rear drive unit.

Fig. 11 is an exploded view of the exemplary rear drive unit of fig. 9.

Fig. 12 illustrates a four-layered orthosis constructed in accordance with the principles of the present invention having an upper loop structure adapted to fit over a shoulder of a patient.

Fig. 13 illustrates a anatomical level or plane occluded by an orthosis similar to that shown in fig. 12, with the loops entangled over the soft cover.

Fig. 14 is another schematic view of an orthosis similar to fig. 12 and 13 positioned on the torso of a patient.

Fig. 15A and 15B illustrate an alternative orthosis construction having a back plate at its upper end, the back plate having a shoulder rest adapted to apply a force to a patient's shoulder from the rear.

Fig. 16 illustrates the lower loop of the orthosis of fig. 15A and 15B, illustrating a specific embodiment of the rear drive unit.

Fig. 17 is an exploded view of the rear drive unit of fig. 16.

Fig. 18 illustrates the freedom of movement of the rear drive unit of fig. 16 and 17.

Fig. 19 and 20 illustrate the assembly of the retractable leaf springs of the rear drive unit of fig. 16-18.

Figures 21 and 22 illustrate a flexible cover having a pocket or bag for securing the loop structure of the present invention to a patient.

Fig. 23 illustrates an alternative brace and strap assembly for suspending the orthosis of the present invention from a patient.

Detailed Description

While this invention may be embodied in many different forms, the following description and the annexed drawings set forth in detail certain illustrative embodiments of the invention, it being understood that this disclosure is to be considered as an exemplification of the principles of the invention, and is not limited to the specific embodiments illustrated.

As shown in fig. 4, an embodiment of a ring structure 10 for incorporation into an orthosis to correct spinal deformities includes a plurality of ring elements joined as described below. As shown in fig. 5, the loop structure includes a rear drive element 14 along its rear side and a pair of hinge elements 16 that allow the loop structure to open. Figure 6 shows the hinge member 16 in detail, the hinge member 16 including a pair of stop surfaces 18 and 20 which allow the loop structures to be opened but engaged with each other to provide a width for rigid closure when the loop structures are in the closed configuration as shown in figure 4. The rear drive unit includes a pair of coupling members 22 which engage to receiver elements on vertically adjacent ring elements, as will be described in more detail below.

The individual ring elements 12 that may be used to assemble the ring structure will have similar but not identical structures. With particular reference to FIG. 7A, the exemplary ring element 12a includes an outer surface 26a, an inner surface 28a, and a pair of mating surfaces 30 a. The mating surfaces 30 are joined together by a curved central region 32a, and the length and curvature of the curved region 32a generally distinguishes between the different ring elements. For example, as shown in FIG. 7B, the ring element 12B may have similar mating regions 30A and 30B, but may have a curved central region 32B with a greater degree of curvature and a different length than the curved region 32a of the ring element 12 a. By having a library of such loop elements of different curvatures and lengths, an almost limitless number of specific loop structure geometries can be assembled. In the embodiment of fig. 7A and 7B, adjacent ring elements 12 are engaged by closure of other threaded fasteners inserted into holes in the mating surfaces. In this manner, a high degree of rigidity can be achieved between adjacent individual ring elements 12.

Figures 8A-8D illustrate how different degrees of curvature may be obtained by using ring members 12 having different curvatures. Figure 8A shows how different degrees of curvature will provide a tighter curve in the loop structure. Fig. 8B-8D are examples of curves that may be achieved once the individual ring elements are attached to each other.

Referring now to fig. 9, there is shown a pair of exemplary ring structures 38 and 40 mounted on a flexible cover 42 for positioning the ring structures on the torso T. It can be seen that the width of the loop structure can vary in individual orthoses. It should be noted that no coupling elements or drive units are shown between the vertically adjacent ring structures 38 and 40, but these will typically be provided.

Referring now to fig. 10 and 11, the previously illustrated rear drive unit 14 will be described in more detail. The rear drive unit 14 comprises a base plate 46 having a mating surface 47 at either end, such that the base unit can be rigidly connected to an adjacent ring element 12 within the ring structure 10. The coupling member 22 is fixedly attached at its lower end or end to the cylindrical shaft 48. Each shaft is in turn grounded to base plate 46 by saddle 50, and saddle 50 may be fastened to shaft 48 by set screw 52. In this manner, as shown in the prior art of fig. 2B and 2C, the coupling elements 22 may be selectively positioned or deflected relative to the plane of the base plate 46 so that they may be oriented horizontally inward or outward. In this manner, the coupling member 22 is resilient and may provide a biasing force to the vertically adjacent ring structure as previously described.

Fig. 12 illustrates an exemplary four-layer orthosis 54 constructed in accordance with the principles of the present invention. Orthosis 54 includes hip loop structure 56, lumbar loop structure 58, rib loop structure 60 and shoulder loop structure 62. The rear drive units 14 with the coupling members 22 are positioned between vertically adjacent ring structures and the side drive units 64 with the side coupling members 66 are disposed between at least some of the adjacent ring structures. The shoulder loop structure 62 is particularly suited for treating the upper torso of a patient and includes vertical loop elements 68 joined in a shoulder slot 70 in the loop structure 62. The relationship between the shoulder sockets 70 and the patient's torso can be seen schematically in fig. 13 and 14. Fig. 13 further illustrates the placement of the orthosis on the supple cover 72, with the hip loop structure 56 engaged with the patient at the hip height H, the lumbar loop structure 58 engaged with the patient at the lumbar height L, the rib loop structure 16 engaged with the patient 'S lower rib LR, and the shoulder loop structure engaged with the patient' S upper rib UR and shoulder height S. When the patient wears the flexible cover, the ring structures 56, 58, 60 and 62 are secured to the flexible cover 72 to maintain the rings at their desired height.

With reference to fig. 15A and 15B, another orthosis 74 constructed in accordance with the principles of the present invention will be described. Orthosis 74 includes lower loop structure 76, upper loop structure 78 and a single intermediate loop structure AD. The ring structure is engaged by the rear drive unit 82 and the uppermost of the drive units is attached at its upper end to an upper plate 84. Unlike the loop structure, the plate 84 is not external to the patient, but is attached at one end to the shoulder loops 86 to apply a corrective force to one of the patient's shoulders. Specifically, the rear drive unit 82 may be biased to pull or push the ring 86 so that the shoulder is in a desired direction. Although illustrated as a metal ring, the shoulder rest 86 may have a variety of configurations, including a strap, a belt, and the like.

Referring now to fig. 16 to 20, the rear drive unit 82 of the orthosis will be described in more detail. Each rear drive unit 82 comprises a retractable leaf spring 90 which is joined at its lower end to the lower part of the lower ring structure 76 by means of a bolt 88 and at its upper end to the inner ring structure 80 by means of a ball joint 92. The drive units 82 are attached to their respective ring structures by the substrate 93.

As shown particularly in fig. 17, the retractable leaf spring 90 is secured to the axle 94 and held in place by the top and bottom clamps. The top clamp 96 and the bottom clamp 98 are in turn compressed by an assembly comprising a bolt 88, a washer 99 and a pair of washers 100. The top clamp 96 and the bottom clamp 98 may be secured together by set screws 102. In this manner, the retractable leaf spring 90 can be manually placed at a desired degree of deflection (to achieve a desired biasing force) and the deflection set by tightening the top clamp over the bottom clamp using set screws and tightening the bolts 88. By making the spacer 99 thicker than the leaf spring 90, the leaf spring is allowed to rotate about the axis of the bolt 88, thereby expanding the range of motion of the patient.

However, the presence of the spacer 99 and washer 100 allows the retractable leaf spring 90 to pivot to accommodate patient movement, as indicated by the arrow in fig. 18. In addition, as shown by the second arrow in fig. 18, the retractable leaf spring 90 is able to axially extend and retract to further accommodate patient movement. The leaf spring 90 will be fixed in the anterior-posterior direction to apply a relatively constant force to the patient while being able to move in other directions to accommodate the patient's movements. Gimbals 92, which secure the upper ends of the leaf springs to the upper ring structure, further accommodate patient movement.

Referring now to fig. 19 and 20, the retractable leaf spring 90 includes an inner plate 106, an outer plate 108, and a retainer 110 that engages the inner and outer plates together and allows them to slide in a slot 112. A ball 104 attached to an outer plate 108 is received in the ball joint 82.

Referring now to fig. 21 and 22, a soft cover 116 for supporting an orthosis according to the present invention is illustrated. The soft cover 116 comprises a vest or similar garment, typically with a zipper or other closure on its front face. Further, the soft cover will typically include a plurality of pockets or receptacles 114 formed or attached at different heights along the length of the soft cover, wherein the pockets are configured to receive and retain a single loop structure of the orthosis. In addition, a strap 122 is provided to close the loop structure after it is inserted into the bag.

Referring now to fig. 23, an alternative support assembly 130 for suspending the orthosis of the present invention from a patient is illustrated. The support assembly 130 includes a shoulder strap structure 132, illustrated as a vest having a back plate and a pair of front straps. Shoulder strap assembly 132 has a shoulder strap at its lower end

A hook and loop or other similar fastener for attachment to the upper ring structure 134. Furthermore, connecting straps 140 are provided between the upper and middle loop structures 134, 136 and between the middle and lower loop structures 138, so that the loop structure of the orthosis is fully supported by the shoulder strap assembly 132. It will be appreciated that the rear and side drive units will also be positioned between vertically adjacent ring structures. By supporting the loop structure with the shoulder strap assembly and the lower connecting strap 140, the position of the loop structure may be maintained while allowing flexibility and freedom of movement of the rear and side drive units.

The foregoing description of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed, and other modifications and variations are possible in light of the above teachings. The embodiments were chosen and described in order to best explain the principles of the invention and its practical applications, to thereby enable others skilled in the art to best utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. It is intended that the appended claims be construed to include other alternative embodiments of the invention except insofar as limited by the prior art.

While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such aspects are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.