Three-dimensional orthotic devices having multiple adjustment features, and methods for their manufacture and use.

Abstract

The conformable body interface is engineered using a dataset representing a three-dimensional soft tissue body surface. The conformable body interface includes a body scaffold split into two or more longitudinal sections separated by axial joints. Optionally, the body scaffold is further split into two or more circumferentially split sections separated by circumferential joints. The axial joints are circumferentially constrained by elastic bands, tabs, or similar structures, and the circumferential joints are longitudinally constrained by elastic axial tethers or similar structures. In this manner, the body interface can accommodate the expansion and bending of the body surface.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of U.S. Provisional Application No. 63 / 166,186, filed on March 25, 2021 (Attorney Docket No. 50016 - 705.101), and U.S. Provisional Application No. 63 / 167,758, filed on March 30, 2021 (Attorney Docket No. 50016 - 705.102), the entire contents of which are incorporated herein by reference.

[0002] (1. Field of the Invention) The present invention generally relates to medical devices and methods for their use and manufacture. More specifically, the present invention relates to personalized orthoses with features that enable shape modification over time as the patient's condition changes.

Background Art

[0003] (Background of the Invention) Orthotic interventions for physical rehabilitation have been known for centuries, but splints, casts, and other orthoses still present challenges in implementation. Starting from temporary fixation using splints made from rods and casts made from plaster, the field has advanced to the generation of "3D printed" orthoses where the orthosis is tailored to the individual patient's anatomy by scanning the patient's body structure, generating a 3 - dimensional digital representation of that body structure, using computer - aided design (CAD) tools to generate a digital file representing the individualized orthosis, and the machining of orthoses using 3D printing techniques.

[0004] While 3D-printed orthoses are more comfortable and hygienic than traditional plaster casts, they lack practicality due to the complex 3D printing workflow and the significant time required for each individual patient who also needs emergency medical assistance. In particular, orthoses designed for patients in the early stages of treatment may not provide adequate corrective fit during subsequent stages of recovery, requiring significant modifications or, in some cases, the fabrication of replacement orthoses.

[0005] A prosthesis that adapts to changes in the patient's biostructure during healing is described in WO2016 / 170433 (Patent Document 1), co-owned with the present application. As shown in Figure 1, the prosthesis of WO2016 / 170433 consists of a body scaffold 100 that is axially divided along a circumferential line 101 and along an axial line 102, resulting in a number of structurally distinct cells 110, one of which is shown removed in Figure 1. As is most clearly seen in Figures 2 and 3, circumferentially adjacent cells 110 are joined by a sliding joint 201 configured to expand along a path 202 which is held together by an elastic constraint 103, while axially adjacent cells are held together by an axial tie 104. The prosthesis may be removablely installed over a selected portion of the human biostructure, for example, a portion 106 of the arm and hand, as seen in Figure 1. Cell 110 can be temporarily isolated to facilitate installation and removal.

[0006] Although a significant advance in the art, the orthotic design of WO2016 / 170433 has certain limitations. For example, the axial sliding joint is adapted only to restricted motion paths and limits the orthosis to a single volume change pattern, which may, in turn, limit the type in which it can be used. As seen in Figures 2-5, such limitations arise from the change in the tangent vector between the male and female parts of the axial sliding joint 201 as the circumference of the arm or other bio-structure changes. An increase in circumference results in a flatter (larger radius) tangent vector 203 (Figure 3), while a decrease in circumference results in a less flat (smaller radius) tangent vector 204 between the axial sliding joints (Figure 4). Other volume changes may result in a non-uniform distribution of stress between the sliding joints 205 (Figure 5).

[0007] For these reasons, it would be desirable to provide improved alternative orthotic designs that can adapt to a wide variety of predictable and unpredictable changes in the patient's biomechanics during treatment and healing, after the initial design and fabrication of the orthotic device have been completed. At least some of these objectives will be satisfied by the inventions described and claimed herein.

[0008] (2. Background Catalog) Relevant public documents include jointly owned US2021 / 0205115 (Patent Document 2), US2017 / 0224520 (Patent Document 3), WO2016 / 170433, and WO2016 / 071773 (Patent Document 4) (their complete disclosures are incorporated herein by reference). [Prior art documents] [Patent Documents]

[0009] [Patent Document 1] International Publication No. 2016 / 170433 [Patent Document 2] U.S. Patent Application Publication No. 2021 / 0205115 [Patent Document 3] U.S. Patent Application Publication No. 2017 / 0224520 [Patent Document 4] International Publication No. 2016 / 071773 [Overview of the project] [Means for solving the problem]

[0010] (Summary of the invention) The present invention provides orthotic devices having an improved ability to adapt to a wide variety of predictable and unpredictable changes in a patient's biostructure during treatment and healing. While particularly suitable for "personalized" orthotic devices fabricated by 3D printing from scans of injured patients, the designs and methods of the present invention will also be found to be used in the design and fabrication of "off-the-shelf" orthotic devices that are molded or otherwise processed to "standard" sizes and biostructures and can then be sized for specific patients at the start of treatment. In all cases, the orthotic devices of the present invention have the ability to be further adjusted during the course of treatment.

[0011] The orthotic device of the present invention will typically have a pivotably mounted circumferential sliding joint that adapts to changes in the circumferential shape of the patient's biostructure, such as an arm, leg, joint, or appendage, during healing. Other mechanical features that may be introduced to improve adaptability to changes in biostructure during the healing process include radial spline locking and worm drive mechanisms for re-stabilizing the body scaffold. The orthotic device of the present invention will also preferably include features for adjusting the axial length and three-dimensional alignment between the circumferential and axial division cells within the orthotic device. Specific mechanical features that may be incorporated into the orthotic device of the present invention include a spindle and rotational chock mechanism for locking, releasing, and adjusting the tension of the axial tie ropes. Additional features that may be incorporated into the orthotic device of the present invention include an expandable structural element that straddles the circumferential and / or axial division cells to facilitate assembly and fitting sessions.

[0012] In a first aspect, the present invention provides a conformable orthosis comprising a scaffold having a longitudinal axis and configured to be removablely installed across a body surface. The body scaffold is divided into a plurality of scaffold cells, each having a first side, a second side, an upper part, and a bottom part, wherein the first side on one scaffold cell and the second side on a circumferentially adjacent scaffold cell are separable along an axial line, and the upper and bottom parts on axially adjacent scaffold cells are separable from each other along a circumferential line. A first circumferential connector is pivotably attached to at least some first sides of the scaffold cells, and a second circumferential connector is pivotably attached to at least some second sides of the scaffold cells, and the first and second circumferential connectors are configured to be removablely connected at an adjustable distance between them. Thus, the upper and bottom parts on axially adjacent scaffold cells are adjustablely coupled to each other.

[0013] In some cases, the conformable orthosis of the present invention may further include axial ties that adjustably connect the upper and lower portions of axially adjacent scaffolding cells. For example, the axial ties may pass axially through at least some pivot axes of first and second circumferential connectors.

[0014] In some cases, the conformable orthosis of the present invention may further include at least one winding spindle for adjustable tightening of one or more axial ties. For example, the winding spindle may include a rotating chock and a claw mechanism.

[0015] In some cases, the conformable orthosis of the present invention may further include a spacer configured to be installed between the top and bottom of axially adjacent scaffolding cells.

[0016] In some cases, axially adjacent scaffolding cells of the conformable orthosis of the present invention may be connected by threaded fasteners. For example, threaded fasteners may be incorporated into ball-and-socket fittings to allow for realignment of axially adjacent scaffolding cells.

[0017] In one example, the first and second circumferential connectors of the conformable fixture of the present invention may include a rotating spindle with radially extending coupling tabs. For example, the coupling tabs of the first and second circumferential connectors may be configured to removably lock with the coupling tabs of the second and first circumferential connectors of the adjacent scaffold cells, respectively. At least some of the radially extending coupling tabs may have grooved surfaces configured to lock with grooved surfaces on the coupling tabs on adjacent scaffold cells.

[0018] In one example, the rotating spindle of the conformable fixture of the present invention may have upper and / or lower radially splined surfaces configured to selectively lock with scaffold cells.

[0019] In one example, the first and second circumferential connectors of the conformable fixture of the present invention may further include drive screws configured to engage rotation gears on at least some of the peripheries of the rotating spindle to rotate the spindle and adjust the angle of the coupling tabs. The present invention provides, for example, the following: (Item 1) A conformable orthotic device, A scaffold having a vertical axis and configured to be removable across the surface of a body, wherein the body scaffold is divided into a plurality of scaffold cells having first and second sides and top and bottom portions, the first and second sides on circumferentially adjacent scaffold cells being separable along an axial line, and the top and bottom portions on axially adjacent scaffold cells being separable from each other along a circumferential line, A first circumferential connector pivotably attached to at least some of the first sides of the scaffolding cells, and a second circumferential connector pivotably attached to at least some of the second sides of the scaffolding cells. Equipped with, The first and second circumferential connectors are configured to be detachably connected at an adjustable distance between them. The upper and lower portions on axially adjacent scaffolding cells are coupled to each other in an adjustable manner, forming a conformable orthosis. (Item 2) The conformable orthosis according to item 1, further comprising axial connecting ropes for adjustingly connecting the upper and lower portions on axially adjacent scaffolding cells. (Item 3) The conformable orthosis according to item 2, wherein the axial connecting rope passes axially through at least some pivot axes of the first and second circumferential connectors. (Item 4) A conformable orthosis according to item 2 or 3, further comprising at least one winding spindle for adjustable tightening of one or more axial tie ropes. (Item 5) The winding spindle comprises a rotation stopper and a claw mechanism, as described in item 4, for the conformable appliance. (Item 6) The conformable orthosis according to item 2-5, further comprising a spacer configured to be installed between the upper and lower parts of axially adjacent scaffolding cells. (Item 7) Conformable orthotic device as described in item 1, in which axially adjacent scaffolding cells are connected by threaded fasteners. (Item 8) The threaded fastener is incorporated into a ball-and-socket fitting as described in item 7 to allow for the realignment of adjacent scaffolding cells in the axial direction. (Item 9) The conformable orthosis according to item 1-8, comprising a rotating spindle with radially extending coupling tabs, wherein the first and second circumferential connectors are provided. (Item 10) The conformable orthosis according to item 9, wherein the coupling tabs of the first and second circumferential connectors are configured to be detachably locked to the coupling tabs of the second and first circumferential connectors of circumferentially adjacent scaffolding cells. (Item 11) Conformable orthosis according to item 9 or 10, wherein at least some of the radially extending connecting tabs have grooved surfaces configured to engage with grooved surfaces on connecting tabs on adjacent scaffolding cells. (Item 12) The conformable orthosis according to item 9-11, wherein the rotating spindle has upper and / or lower radial spline surfaces configured to selectively engage with the scaffolding cell. (Item 13) The conformable orthosis according to item 1-12, further comprising a drive screw configured to engage a rotating gear on at least some periphery of the rotating spindle, thereby rotating the spindle and adjusting the angle of the coupling tab. (Item 14) The scaffold is configured to draw boundaries on the limbs, joints, or torso of the body, as described in items 1-13. (Item 15) The aforementioned body scaffold is a conformable orthotic device as described in item 14, comprising orthotic support devices. (Item 16) The aforementioned body scaffold is a conformable orthotic device as described in item 1-15, comprising a three-dimensional spatial grid. (Item 17) The three-dimensional grid is a conformable orthotic device as described in item 16, which is generated by three-dimensional printing using the scanning of the body surface as a model. (Item 18) A method for processing a conformable body interface, wherein the method is The process involves generating or acquiring a dataset representing a scaffold intended to apply corrective or supportive forces to a three-dimensional soft tissue body surface, The scaffolding is divided into a plurality of scaffolding cells having first and second sides and upper and bottom portions, wherein the first and second sides on circumferentially adjacent scaffolding cells are separable along an axial line, and the upper and bottom portions on axially adjacent scaffolding cells are separable from each other along a circumferential line. The method involves fabricating a three-dimensional scaffold, based on the dataset, which is removablely installed across the three-dimensional body surface and conforms to the surface, wherein the dataset defines a first circumferential connector pivotably attached to at least some of the first sides of the scaffold cells, and a second circumferential connector pivotably attached to at least some of the second sides of the scaffold cells. Methods that include... (Item 19) The method according to item 18, further comprising detachably connecting the first and second circumferential connectors at a selected distance between them. (Item 20) The method according to item 19, wherein the detachable connection includes rotating and positioning adjacent pairs of connecting tabs. (Item 21) Rotation and positioning is the method described in item 19, which includes driving a rotating gear using a drive screw. (Item 22) The method according to item 20 or 21, further comprising engaging a grooved surface onto a coupling tab on a circumferentially adjacent scaffolding cell. (Item 23) The method according to item 18-22, further comprising adjusting the upper and lower portions of axially adjacent scaffolding cells to be coupled to one another. (Item 24) The method of item 23, wherein the upper and lower portions on axially adjacent scaffolding cells are adjustablely coupled to each other, and tension is applied to an axial tie rope that straddles the axially adjacent scaffolding cells of the scaffolding. (Item 25) Applying tension to the axial tie rope is the method according to item 24, wherein the tie rope has a chock end. (Item 26) The method according to item 23-25, further comprising installing spacers between axially adjacent scaffolding cells to adjust the axial length of the scaffolding. (Item 27) A conformable bodily interface generated by the methods described in items 18-25. [Brief explanation of the drawing]

[0020] [Figure 1] Figure 1 illustrates a prior art-compliant splint in which twelve separable cells, divided along four circumferential lines and three axial lines as described in WO2016170433, are held together by three elastic circumferential restraints and four axial tie ropes.

[0021] [Figure 2] Figure 2 shows a lateral cross-section of the splint in Figure 1, obtained along the straight line 1-1 in Figure 1, and is shown with four sliding joints in a configuration extended in the circumferential direction.

[0022] [Figure 3] Figure 3 is a detailed view of one of the sliding joints in Figure 2, shown in a closed configuration, illustrating a single predefined motion path.

[0023] [Figure 4] Figure 4 is similar to that of Figure 3 and illustrates the change in the tangent vector of the sliding joint due to circumferential expansion.

[0024] [Figure 5] Figure 5 is similar to that of Figure 3, showing a sliding joint in a partially open configuration and illustrating the internal imbalance caused by the change in the tangential vector resulting from circumferential expansion.

[0025] [Figure 6]Figure 6 is a schematic illustration of a pivotal circumferential connector intended to form a sliding joint in combination with a meshing connector (not shown) according to the principle of the present invention.

[0026] [Figure 7] Figure 7 is a perspective view of a scaffolding cell having first and second circumferential connectors configured to connect with interlocking connectors on circumferentially adjacent scaffolding cells to form a pivotal radial sliding joint.

[0027] [Figure 8] Figure 8 shows a schematic cross-section of the orthosis of the present invention in a radial extension configuration with a pivot sliding joint in a circumferentially extended configuration.

[0028] [Figure 9] Figure 9 shows an embodiment of an oversized wrist splint, comprising a total of 12 individual body scaffolding cells, with four longitudinal division cells and three circumferential division cells held together by pivot sliding joints with radial gears and four axial ties. The axial division cells of the oversized splint highlight that the three individual body scaffolding cells are held together by three male pivot circumferential connectors with mutually facing radial gears and three female pivot circumferential connectors with mutually facing radial gears, and that the axial ties are looped through the division cells.

[0029] [Figure 10] Figure 10 is an exploded view of a divided cell, showing one male pivotal circumferential connector with a radial spline locking surface and one female pivotal circumferential connector with a radial spline locking surface.

[0030] [Figure 11] Figure 11 illustrates two axially adjacent scaffolding cells, with two removable spacers between the cells that increase the length of the axial section.

[0031] [Figure 12] Figure 12 is a perspective view of a scaffolding cell having two pivotal circumferential connectors with worm drive units.

[0032] [Figure 13] Figure 13 is an exploded view of the scaffolding cell shown in Figure 12.

[0033] [Figure 14] Figure 14 shows an embodiment of an oversized ankle splint, in which 14 individual body scaffold cells are held together by a pivot sliding joint with radial gears, six threaded fasteners (four of which are visible), and four axial ties that span across the body scaffold.

[0034] [Figure 15] Figure 15 is a detailed view of the surplus-fit ankle splint shown in Figure 14, with a portion of it separated.

[0035] [Figure 16] Figure 16 is an exploded view of the surplus-fit ankle splint shown in Figure 15.

[0036] [Figure 17] Figure 17 shows an embodiment of an oversized ankle splint, in which 14 individual body scaffold cells are held together by a pivot sliding joint with radial gears, six threaded fasteners (four of which are visible), four threaded fasteners with two ball joints (two of which are visible), and four axial ties that span across the body scaffold.

[0037] [Figure 18] Figure 18 is a detailed view of a threaded fastener, showing two ball joints and adjacent scaffolding cells of the surplus-fit ankle splint from Figure 17.

[0038] [Figure 19] Figure 19 is an exploded view of a threaded fastener with a ball joint.

[0039] [Figure 20] Figure 20 illustrates the threaded fastener shown in Figure 19 in a closed configuration.

[0040] [Figure 21] Figure 21 illustrates the threaded fastener of Figure 19 in a partially open configuration.

[0041] [Figure 22] Figure 22 is an exploded view of a threaded fastener with a ball joint, the ball joint comprising a conical screw and an expandable sphere.

[0042] [Figure 23] Figure 23 is an exploded view of a threaded fastener having two ball joint mechanisms with collets.

[0043] [Figure 24] Figure 24 illustrates axial and circumferentially divided cells, in which the rotating chock 701 is attached to the axial tie rope using two pivotal circumferential connectors.

[0044] [Figure 25] Figure 25 shows the assembly of Figure 24 with the rotary chock 701, and is shown in an exploded view.

[0045] [Figure 26] Figure 26 shows a portion of the rotary chock 701 from Figures 24 and 25, and is shown in an exploded side view.

[0046] [Figure 27]Figure 27 illustrates an embodiment of the surplus-adaptive splint, in which four longitudinal division sections and four circumferential division sections, each comprising a total of 16 individual body scaffolding cells, are held together using pivot sliding joints with radial gears, four axial ties, and four rotary chocks. The axial division section of the surplus-adaptive splint emphasizes that the four individual body scaffolding cells are held together using four male pivot sliding joints with mutually facing radial gears, four female pivot sliding joints with mutually facing radial gears, and axial ties that form a loop through the division section.

[0047] [Figure 28] Figure 28 is an exploded view of four axial body scaffold cells, comprising the axially divided cells of the body scaffold of Figure 27, with four male pivot connectors with radial gears and four female pivot connectors with radial gears, with seven further divided scaffold cell assemblies with radial spline locking surfaces, one further divided scaffold cell assembly with radial spline locking surfaces and embedded rotary chocks, four male 711 and four female 712 pivot circumferential connectors with radial spline locking parts, one rotary chock mechanism, and an axial tie rope coupled to the rotary chocks.

[0048] [Figure 29] Figure 29 illustrates a pivotal and clamping circumferential sliding joint with an extended configuration of the radial spline surface as viewed from the front, illustrating the principle of the clamping mechanism by showing the passage of the axial tie rope through the mechanism.

[0049] [Figure 30] Figure 30 illustrates a pivot and clamp type circumferential male connector and a pivot and clamp type circumferential female connector with a radial spline surface, as viewed from the front.

[0050] [Figure 31]Figure 31 shows a perspective view illustrating one pivot and clamp circumferential male connector and one pivot and clamp circumferential female connector with a radial spline surface. The slot through which the male connector passes is highlighted.

[0051] [Figure 32] Figure 32 illustrates a conformable orthosis having an expanded geometric shape that, in an extended configuration, straddles circumferential and axially segmented body scaffold cells. A pivotal circumferential connector and axial tie ropes are also incorporated according to the principles of the present invention.

[0052] [Figure 33] Figure 33 illustrates a conformable orthosis having an expansive geometric shape that spans circumferentially and axially divided body scaffold cells in a closed configuration. A pivotal circumferential connector and axial tie ropes are also incorporated according to the principles of the present invention. [Modes for carrying out the invention]

[0053] (Detailed description of the invention) This invention utilizes known techniques in digital manufacturing and computer-assisted design to provide a configurable exoskeleton orthosis in the form of a medical cast with multiple adjustable and self-adjusting structural components, which can adapt to unpredictable changes in the patient's biostructure. The structural solution of this invention is developed to promote a controlled and medically beneficial relationship between the orthosis and the patient. Particularly suitable for the digital design and fabrication of orthoses, the adjustable features and design of this invention are also useful in the design and fabrication of "off-the-shelf" orthoses that can be molded or otherwise fabricated to "standard" sizes and biostructures and then sized for specific patients at the initiation of treatment.

[0054] The limiting factor caused by the change in tangential vector, as described in detail in the background art of the present invention (Figures 1-5), is overcome in the form of a rotary pivot that is aligned at the rear of each sliding joint, with the introduction of an additional degree of freedom 104 to the circumferentially expanding segmented cell. Thanks to the pivot, geometric changes caused by variations in different tangential vectors are no longer limiting factors. Figures 6, 7, and 8 illustrate a method for incorporating a pivot sliding joint.

[0055] Figure 6 illustrates a schematic example of an axial and circumferentially segmented scaffold cell 102 with a pivoting circumferential connector 103 (in a manner similar to the cross-sections from Figures 3, 4, and 5). The pivot 105 is aligned with the rear side of the circumferential connector 103. In this case, the pivot provides an additional degree of freedom to the circumferentially expanding structure across the soft tissue of the human biological structure 101.

[0056] Figure 7 is a three-dimensional representation of an axially and radially divided scaffolding cell 102 with two pivotal circumferential connectors 103. Each pivotal circumferential connector is configured to connect with a neighboring pivotal circumferential connector via a linking geometry with either a male 106 or female 107 configuration. The scaffolding cell is also modified to incorporate a mating socket 108 for the pivots. The axial pivots also allow for the passage of axial tie ropes 109 that straddle their length.

[0057] Figure 8 is a schematic cross-section of the orthosis of the present invention in radial expansion with pivot sliding joints in circumferential expansion. Four sliding joints 110, eight pivots 105, and eight axial ties 109 are shown.

[0058] The additional degrees of freedom 104 overcome the limitations of the changing tangential vectors, which, if left unconstrained, would lead to unbalanced structural rigidity. The present invention provides a method for constraining a pivotal circumferential connector and restabilizing the structure. This method is illustrated in Figure 9-15.

[0059] In the embodiment demonstrated in Figure 9-11, the pivotal circumferential connector is constrained using the use of a radial spline locking surface. The radial spline locking surface is definitively positioned between the pivotal circumferential connector and a further divided scaffolding cell equipped with radial gears. Axial tie ropes also pass through the divided scaffolding cell and the pivotal circumferential connector according to the principles of the present invention.

[0060] Figure 9 shows an embodiment of a surplus-fitting orthosis, in which four longitudinal division sections and three circumferential division sections, comprising a total of 12 individual body scaffolding cells, are held together by pivot sliding joints with radial gears and four axial ties. The surplus-fitting splint in this embodiment is installed across the wrist 201. The axial division sections of the surplus-fitting splint highlight that three individual body scaffolding cells 202 comprising the axial sections are held together by three male pivot circumferential connectors with radial spline locking parts 203 and three female pivot circumferential connectors with radial spline locking parts 204, and that the axial ties 206 are looped through the 206 in this embodiment.

[0061] Figure 10 is an enlarged demonstration of a single axial and radially divided scaffolding cell of a body scaffold described in Figure 9. Two further divided scaffolding cell assemblies with radial spline locking surfaces 209 are aligned at the top and bottom of a pivotal circumferential connector. The circumferential connector is held by a socket 208 located within the scaffolding cell. One male pivotal circumferential connector 203 with a radial spline locking surface comprises a male circumferential connector 210, an axial pivot 212, and a radial spline locking portion 207. One female pivotal circumferential connector 204 with a radial spline locking surface comprises a female circumferential connector 211, an axial pivot 212, and a radial spline locking portion 207.

[0062] In another embodiment demonstrated in Figures 12-13, the positioning of the pivotal circumferential connector is controlled by fitting a worm drive mechanism to the pivotal circumferential connector. The worm drive mechanism consists of a helical-threaded (spiral cam) shaft 403 that engages with a worm wheel 404, and thus rotating and pivoting the spiral cam shaft positions the male connector 406 or female connector 407. The worm drive determines the position 401 of the pivotal circumferential connector by rotating the worm shaft 403 (402), and thus pivoting the circumferential connector. The worm drive, positioned inside the scaffolding cell, is accessible through an opening 406 in this design. An advantage of using a worm drive is its ability to automatically lock.

[0063] Figure 12 illustrates an axial and radially divided scaffolding cell 405 of a worm-driven pivot circumferential connector. One worm-driven pivot circumferential male connector 406 and one worm-driven pivot circumferential female connector 407 are visible in the figure. A spiral camshaft 403, which is normally concealed, is demonstrated in a lightened example. An axial tie rope 408 passes through the scaffolding cell 405 according to the principle of the present invention.

[0064] Figure 13 is an exploded view of the structure in Figure 12, illustrating a single axial and radially divided scaffolding cell. This example further demonstrates a socket for a worm-driven pivotal circumferential connector 409 and a socket for a worm shaft 410.

[0065] Length is a parameter as important as circumference for many types of orthotic devices. The present invention provides a method for adjusting the axial length between circumferentially divided cells and axially divided cells. In its first aspect illustrated in Figure 11, the method includes inserting a removable separator 301 that snaps into place between axially spaced cells 202 to provide a stable support and thus extend the axial length of a structure with a predetermined geometric shape.

[0066] Figure 11 demonstrates two axially spaced segmented scaffolding cells with two removable separators 301 between them, the length of the axial section being adjusted by installing or removing the separators.

[0067] In the second aspect, precise control of the axial length of the body scaffold can be achieved by using a linear actuator-type mechanism between axially spaced scaffold cells. In the embodiments described in Figures 14, 15, and 16, threaded fasteners are installed between the segmented cells of the lower limb orthosis, using embedded bolts and fitted threaded sockets. The length is determined by the rotation of the embedded bolts.

[0068] Figure 14 shows an embodiment of the surplus-adjustable ankle splint according to the principle of the present invention, in which 14 individual body scaffold cells are held together by a pivot sliding joint with a radial gear 503, six threaded fasteners 504 (four of which are visible), and four axial tie ropes 505 that span across the body scaffold.

[0069] Figures 15 and 16 demonstrate the same surplus-fit ankle splint as in Figure 14, focusing on the components corresponding to the patient's Achilles tendon. The embedded bolt is illustrated in 506 for further detail, and the corresponding threaded socket is illustrated in 507.

[0070] Lower limb orthoses also present challenges in the metatarsal region, particularly in the posterior region, due to the flexion geometry. The problem is to adapt to axial expansion between two points of position that fluctuate due to changes in the expansion geometry. This problem is similar to the 2D alignment problem of limiting tangent vectors, but this problem is a 3D alignment problem. Figure 17 illustrates several axial expansion mechanisms with their expansion vectors, which in this case are perpendicular to each other. Three-dimensional alignment between segmented scaffold cells is required to overcome this problem, as sliding joints are also considered to have their own motion paths.

[0071] In the embodiment of the present invention illustrated in Figure 17-21, threaded fasteners are combined with ball-and-socket joints to enable 3D alignment between axially divided scaffolding cells. The method is further improved with constraints on the ball-and-socket joints to enable greater adaptability and stability to the body scaffolding.

[0072] Figure 18 highlights a threaded fastener with a ball and socket joint for an oversized ankle splint, as well as two axially adjacent segmented scaffold cells, corresponding to the posterior metatarsal region of the ankle.

[0073] Figure 19 provides further details in an enlarged demonstration of a threaded fastener with a ball and socket fitting for an oversized ankle splint, as well as two adjacent split scaffolding cells. The bolt section 603 of the threaded connector is modified to incorporate a sphere 604 to enable 3D alignment 609. A further split scaffolding cell assembly with a radial spline locking surface 602 is modified to incorporate a spherical socket. The threaded socket 605 of the threaded fastener is also modified to incorporate a spherical shell to enable 3D alignment 609. Constraints for stabilizing the structure exist in the form of a locking mechanism consisting of a fixing screw 607 and threads aligned perpendicularly to the sphere. Pressure 608 is applied through the fixing screw to lock the ball and socket fitting in their positions.

[0074] Figure 20 illustrates a threaded fastener with ball and socket fittings in a closed configuration, as well as two further separated scaffold assemblies with radial spline locking surfaces and spherical sockets 602 as shown in Figure 19.

[0075] Figure 21 illustrates, in an extended configuration, threaded fasteners with ball and socket fittings, as well as two further split scaffold assemblies with radial spline locking surfaces and spherical sockets 602 as shown in Figure 19.

[0076] Figure 22 illustrates an additional method in the form of a locking mechanism between a ball joint and its socket. This method consists of a slightly modified spherical section 610 of a threaded connector and an additional conical screw for incorporating a living hinge type mechanism. The spherical section 610 is thinly cut from the top, allowing the structure to expand outward (612) when the conical fixing screw 611 is inserted (613). The outward expansion of the thinly cut spherical section 610 creates excess friction within the socket of the further divided scaffold assembly, which has a radial spline locking surface, and thus stabilizes the 3D alignment. An axial tie rope 505 passes through the further divided scaffold assembly, which has a radial spline locking surface and a spherical socket 602, in accordance with the principles of the present invention.

[0077] Figure 23 illustrates an additional method in the form of a locking mechanism between a ball joint and its sockets by introducing an additional collet 614 between the spherical shells and their sockets. In this method, the 3D position of the threaded connector and the axially adjacent split scaffold assemblies is stabilized using grips 615 from the collets that grip the spherical shells 604 and 605. The further split scaffold assembly 602, with its radial spline locking surface and spherical sockets, is modified to adapt to the conical outer surface of the collet, as demonstrated in 614. In short, this method converts the axial tension from the axial tie rope 616 and constrains the 3D alignment between axially adjacent split cells of the body scaffold.

[0078] With all the methods described, body scaffolding is becoming increasingly complex and difficult to apply in real-life conditions. Furthermore, adjustment of tension from axial tie ropes is increasingly used to stabilize body scaffolding, thus requiring practical solutions. This invention introduces a rotating chock embedded in the orthosis to easily lock, release, and adjust the tension of the axial tie ropes.

[0079] Figure 24-28 illustrates a rotary chock and claw mechanism 710 embedded in the proximal end of an axially and circumferentially divided scaffolding cell. The rotary chock mechanism includes a housing element, a rotary chock with a V-shaped groove that straddles and crosses the gear, a spring-loaded claw with quick release, and additional nuts and bolts for securing axial tie ropes and caps.

[0080] Figure 24 illustrates a single axial and circumferentially divided cell, modified with an embedded rotary chock 710, a pivotal circumferential male connector with a spline locking portion 711, a pivotal circumferential female connector with a spline locking portion 712, and an axial tie wire coupled to the rotary chock 713.

[0081] Figures 25 and 26 provide further details to the rotary chock 710 of Figure 24 in an enlarged demonstration. The rotary chock has a toothed rotary gear that allows movement in one direction 705, while having a V-shaped groove 706 to accommodate excess axial tie wire. The axial tie wire passes through the V-shaped groove through an opening 707 on the surface to the center of the rotary gear. The tie wire is secured to the rotary gear by tightening a bolt 709 into a tie wire socket 708 on the rotary gear 705, and is compressed by both the bolt 709 and the tie wire socket 708. The rotary chock also has a mating claw 704 to allow movement in the same direction. The claw 704 is also mated to a post for assembling a spring 703 to enable a quick release function for the rotary chock.

[0082] Figure 27 shows an embodiment of a surplus-fitting orthosis, in which four longitudinal division sections and four circumferential division sections, each comprising a total of 16 individual body scaffolding cells, are held together by four axial ties connected to a pivot sliding joint with a radial gear and four rotary chocks. The axial division section of the surplus-fitting splint highlights that one modified scaffolding cell, with three individual body scaffolding cells 714 and an embedded rotary chock 710, is held together by four male 711 and four female 712 pivot circumferential connectors with radial spline locking sections, and that the axial ties connected to the rotary chock 713 are looped throughout this embodiment.

[0083] Figure 28 is an exploded view of the axial division section of the surplus-fitting orthosis of Figure 27, with seven further divided scaffold cell assemblies 715 with radial spline locking surfaces, one further divided scaffold cell assembly 716 with radial spline locking surfaces and embedded rotary chocks, one rotary chock mechanism 701, and an axial tie rope coupled to a rotary chock 713 that is looped throughout this embodiment. The adjusted positions 717 of the six pivotal circumferential connectors are simultaneously constrained by simply using the tightening of the rotary chocks, which can significantly facilitate the adjustment process.

[0084] Taking advantage of the benefits of the rotary locking mechanism 710, a more practical circumferentially expanding sliding joint mechanism is described in Figure 29-31. The locking mechanism is configured to create a clamping grip 801 between the circumferentially expanding connectors. This method relies on tension from the rotary locking mechanism to lock both connectors together. The circumferential connectors are configured to have interconnecting teeth and convenient geometric openings to allow the passage of axial ties.

[0085] Figure 29 illustrates a pivotal and clamping circumferential sliding joint with a radial spline surface in an expanded and open configuration viewed from the front. A male pivotal circumferential connector with a radial spline surface and clamping teeth is shown as 802. A female pivotal circumferential connector with a radial spline surface and clamping teeth is shown as 803. The clamping effect 801 is achieved by increasing the tension of the axial tie wire coupled to the rotational chock 804. The clamping teeth of both connectors are lightened in the illustration.

[0086] Figure 30 illustrates male 802 and female 803 type pivotal circumferential connectors with radial spline surfaces and clamping teeth in a spaced configuration. The clamping teeth of the male connector are shown as 805 for further detail and match the female clamping teeth 806.

[0087] Figure 31 illustrates the male 802 and female 803 type pivotal circumferential connectors of Figure 30 in a 3D demonstration. The slot that straddles the length of the clamping teeth of the male connector is shown as 807, and the entry point of the axial tie wire to the circumferential female connector is shown as 808.

[0088] To further facilitate the fitting and assembly process of axially and radially segmented body scaffolds, the present invention introduces an expansive spatial grid geometry that spans across and over the segmented cells. Figure 32 illustrates an axially and radially segmented cell with a spatial grid that spans across its length 901 in an expanded configuration, and Figure 33 shows the same cell with a spatial grid that spans across its length in a closed configuration. A pivotal circumferential connector with radial spline locking and axial tie ropes is included in the illustration according to the principles of the present invention. The method incorporates a single section or cell using a configured expansive spatial grid that can be extended and compressed axially in conjunction with external forces. Figure 17 demonstrates the spatial grid in an expanded state, facilitating assembly and reducing parts. Figure 18 demonstrates the spatial grid in a compressed state.

[0089] The embodiments described above are presented as examples only, and the scope of the present invention is defined by the following claims.

Claims

1. A conformable orthotic device, A scaffold having a vertical axis and configured to be removable across the surface of a body, wherein the scaffold is divided into a plurality of scaffold cells having first and second sides and upper and bottom portions, the first and second sides on circumferentially adjacent scaffold cells being separable along an axial line, and the upper and bottom portions on axially adjacent scaffold cells being separable from each other along a circumferential line, A first circumferential connector pivotably attached to at least some of the first sides of the scaffolding cells, and a second circumferential connector pivotably attached to at least some of the second sides of the scaffolding cells. Equipped with, The first and second circumferential connectors are configured to be detachably connected at an adjustable distance between them, The upper and lower portions on axially adjacent scaffolding cells are coupled to each other in an adjustable manner, forming a conformable orthosis.

2. The conformable orthosis according to claim 1, further comprising an axial tie rope for adjustablely connecting the upper and bottom portions on axially adjacent scaffolding cells, wherein the axial tie rope passes axially through at least some pivot axes of the first and second circumferential connectors.

3. The conformable device according to claim 2, further comprising at least one winding spindle for adjustable tightening of one or more axial tie ropes, wherein the winding spindle comprises a rotating stopper and a claw mechanism.

4. The conformable orthotic device according to claim 2 or 3, further comprising a spacer configured to be installed between the upper and lower parts of axially adjacent scaffolding cells.

5. Conformable fitting according to claim 1, wherein axially adjacent scaffolding cells are connected by threaded fasteners, the threaded fasteners being incorporated into ball-and-socket joints to allow realignment of the axially adjacent scaffolding cells.

6. The conformable orthotic device according to any one of claims 1 to 5, wherein the first and second circumferential connectors comprise a rotating spindle with radially extending coupling tabs.

7. The conformable orthosis according to claim 6, wherein the coupling tabs of the first and second circumferential connectors are configured to be detachably locked to the coupling tabs of the second and first circumferential connectors of circumferentially adjacent scaffolding cells.

8. The conformable orthosis according to claim 6 or 7, wherein at least some of the radially extending connecting tabs have grooved surfaces configured to engage with grooved surfaces on connecting tabs on adjacent scaffolding cells.

9. The conformable orthosis according to any one of claims 6 to 8, wherein the rotating spindle has an upper and / or lower radial spline surface configured to selectively engage with the scaffolding cell.

10. The conformable orthotic device according to any one of claims 6 to 9, wherein the first and second circumferential connectors further comprise a drive screw, the drive screw configured to engage a rotating gear on at least some periphery of the rotating spindle, rotate the spindle, and adjust the angle of the coupling tab.

11. The scaffold is configured to draw boundary lines on the limbs of the body, the joints of the body, or the torso of the body, and the scaffold is equipped with an orthotic support device, as described in any one of claims 1 to 10.

12. The conformable orthosis according to any one of claims 1 to 11, wherein the scaffold comprises a three-dimensional spatial grid, the three-dimensional spatial grid being generated as a model by three-dimensional printing using scanning of the body surface.

13. A method for processing a conformable body interface, wherein the method is The method involves generating or obtaining a dataset representing a scaffold intended to apply a corrective or supporting force to a three-dimensional body surface, wherein the scaffold is divided into a plurality of scaffold cells having first and second sides and tops and bottoms, the first and second sides on circumferentially adjacent scaffold cells being separable along axial lines, and the tops and bottoms on axially adjacent scaffold cells being separable from each other along circumferential lines. The method involves fabricating a three-dimensional scaffold, based on the dataset, which is to be removablely installed across the three-dimensional body surface and conform to the surface, wherein the dataset defines at least a first circumferential connector pivotably attached to at least some of the first sides of the scaffold cells, and a second circumferential connector pivotably attached to at least some of the second sides of the scaffold cells. Methods that include...

14. The method according to claim 13, further comprising detachably connecting the first and second circumferential connectors at a selected distance between them, wherein the detachable connection includes rotating and positioning adjacent pairs of coupling tabs.

15. The method according to claim 14, wherein the rotation and positioning includes driving a rotating gear using a drive screw.

16. The method according to claim 14 or 15, further comprising engaging a grooved surface on a coupling tab on a circumferentially adjacent scaffolding cell for detachable connection.

17. The method according to any one of claims 13 to 16, further comprising adjusting the upper and bottom portions of axially adjacent scaffolding cells to be coupled to each other, wherein adjusting the upper and bottom portions of axially adjacent scaffolding cells to be coupled to each other includes applying tension to an axial tie rope that spans axially adjacent scaffolding cells of the scaffolding.

18. The method according to claim 17, wherein applying tension to the axial tie rope includes restraining the end of the tie rope.

19. The method according to claim 17 or 18, further comprising installing spacers between axially adjacent scaffolding cells to adjust the axial length of the scaffolding.

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