SPINAL ALIGNMENT SYSTEM HAVING THERMALLY ACTUATED COMPONENTS - Patent application

Abstract

A spinal adjustment system including at least one thermally actuated pump element.

Description

[Technical field]

[0001] This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 150,059, entitled "SPINAL ALIGNMENT SYSTEM WITH THERMALLY ACTUATED COMPONENT," filed February 16, 2021, the entire contents of which are incorporated herein by reference.

[0002] This application is related to U.S. Non-Provisional Patent Application No. 17 / 176,732, entitled “BIDIRECTIONAL THERMALLY ACTUATED COMPONENT FOR USE IN MEDICAL DEVICES,” filed on February 16, 2021, the entire contents of which are incorporated herein by reference. Field of Disclosure

[0003] The present invention relates to a spinal alignment system that includes a thermally actuated actuator component. [Background technology]

[0004] There are a variety of medical devices and instruments used to drive, correct, or maintain alignment, including spinal alignment. Many conventional devices are limited to manually actuated adjustment elements. Relying on human mechanical intervention runs the risk of injury if the user fails to make the proper adjustment or makes an improper adjustment. Other devices that use automatic adjustments are typically complex and prone to errors, including runaway catastrophic errors.

[0005] It would therefore be desirable to provide an alignment system that solves these and other problems. Summary of the Invention

[0006] It is an object of the present invention to provide a spinal alignment system that is safe and has outputs that are limited relative to the inputs so that the outputs of the components are finite, thereby reducing the risk of serious or catastrophic errors.

[0007] In embodiments, a spinal alignment system according to one embodiment of the present disclosure includes one or more bi-directional thermally actuated components that transition between solid and fluid based on temperature, and may use materials that may be as innocuous as crayon material or paraffin wax, to name a few.

[0008] In an embodiment, the system may include feedback information regarding the operation of the system to ensure that a given input resulted in the correct output.

[0009] A spinal alignment system according to one embodiment of the present disclosure includes a rolling bladder configured to expand from a contracted state to an extended state and from the extended state back to the contracted state; and a pump connected to the rolling bladder and configured to supply a hydraulic fluid to the rolling bladder such that the rolling bladder expands to the extended state and to remove a hydraulic fluid from the rolling bladder such that the rolling bladder contracts to the contracted state, the pump having: a first volume filled with a hydraulic fluid; a first pump element mounted within the first volume and operable to expand and pump the hydraulic fluid from the first volume when actuated; a second volume filled with a hydraulic fluid; and a second pump element mounted within the second volume and operable to expand and pump the hydraulic fluid from the second volume when actuated; wherein the rolling bladder is in fluid communication with the first volume and the second volume, and the hydraulic fluid is in fluid communication with the rolling bladder. the rolling bladder expands to an expanded state when hydraulic fluid flows into the ring bladder and contracts when hydraulic fluid flows out of the rolling bladder; an accumulator in fluid communication with the first volume and the second volume; and a power source electrically connected to the first pump and the second pump and operable to selectively supply power to the first pump and the second pump; wherein the first pump element expands when power is supplied to the first pump element, increasing pressure in the first volume and pumping hydraulic fluid from the first volume to the rolling bladder such that the rolling bladder expands to an extended state; the second pump element expands when power is supplied to the second pump element, increasing pressure in the second volume and pumping hydraulic fluid from the second volume to the accumulator and contracts when power is removed from the second pump element, such that fluid is discharged from the rolling bladder to the second volume and the rolling bladder contracts to a contracted state.

[0010] In an embodiment, the system includes a first check valve disposed between the first volume and the rolling bladder and configured to control a flow of working fluid from the first volume to the rolling bladder; a second check valve disposed between the first volume and the accumulator and configured to control a flow of working fluid between the first volume and the accumulator; a third check valve disposed between the second volume and the rolling bladder and configured to control a flow of working fluid from the rolling bladder to the second volume; and a relief valve disposed between the second volume and the accumulator and configured to control a flow of working fluid from the second volume to the accumulator.

[0011] In an embodiment, the first check valve allows hydraulic fluid to flow from the first volume to the rolling bladder when the first pump element expands and prevents hydraulic fluid from flowing back into the first volume when the first pump contracts after power is removed.

[0012] In an embodiment, the second check valve allows hydraulic fluid to flow from the accumulator into the first volume when the first pump element contracts after power is removed.

[0013] In an embodiment, the relief valve is configured to allow hydraulic fluid to flow from the second volume to the accumulator when the second pump element expands when power is applied to the second pump element.

[0014] In an embodiment, the third check valve is configured to allow hydraulic fluid to flow from the rolling bladder to the second volume such that when the second pump contracts after power is removed, the rolling bladder returns to a contracted state.

[0015] In an embodiment, the power source is a wire coil.

[0016] In an embodiment, the system includes a power supply circuit configured to selectively supply power to one of the first pump element and the second pump element.

[0017] In an embodiment, the power supply circuit includes a first diode disposed between the wire coil and the first pump element such that the first power pump is powered when a current is induced in the wire coil with a rectified sinusoidal signal having a first polarity; and a second diode disposed between the wire coil and the second pump element such that the second power pump is powered when a current is induced in the wire coil with a rectified sinusoidal signal having a second polarity opposite the first polarity.

[0018] In an embodiment, the wire coil is paired with an external wire coil such that a current is induced in the wire coil when the external wire coil is placed adjacent to the wire coil.

[0019] In embodiments, the rolling bladder is disposed between a first vertebra and a second vertebra such that expansion of the rolling bladder changes the spacing between the first vertebra and the second vertebra.

[0020] In an embodiment, the system includes a separate rolling bladder in fluid communication with the pump and configured to expand to an expanded state and contract to a deflated state.

[0021] In an embodiment, the first pump includes a first bellows containing eutectic wax; and a first heating element electrically connected to a power source, the first heating element being positioned such that when power is supplied to the first heating element, the eutectic wax melts and the first bellows expands, and when power is removed from the first heating element, the eutectic wax cools and solidifies and the first bellows contracts.

[0022] In an embodiment, the second pump includes a second bellows containing eutectic wax; and a second heating element electrically connected to a power source, the second heating element positioned such that when power is applied to the second heating element, the eutectic wax melts and the second bellows expands, and when power is removed from the second heating element, the eutectic wax cools and solidifies and the second bellows contracts.

[0023] A spinal adjustment system according to one embodiment of the present disclosure includes: a first rolling bladder configured to expand from a contracted state to an extended state and from the extended state to the contracted state; a second rolling bladder configured to expand from a contracted state to an extended state and from the extended state to the contracted state; and a pump in fluid communication with the first rolling bladder and the second rolling bladder and configured to supply a hydraulic fluid to the first rolling bladder and the second rolling bladder such that the first rolling bladder and the second rolling bladder respectively expand to the extended state and to remove a hydraulic fluid from the first rolling bladder and the second rolling bladder such that the first rolling bladder and the second rolling bladder respectively contract to the contracted state; wherein the pump has a first volume filled with a hydraulic fluid; a first pump element mounted within the first volume and operable to expand when actuated to pump hydraulic fluid from the first volume; a second volume filled with hydraulic fluid; a second pump element mounted within the second volume and operable to expand when actuated to pump hydraulic fluid from the second volume; wherein the first and second rolling bladders are in fluid communication with the first and second volumes and expand to an expanded state when hydraulic fluid flows into the first and second rolling bladders and contract when hydraulic fluid flows out of the first and second rolling bladders; an accumulator in fluid communication with the first and second volumes; and a power source electrically connected to the first and second pumps and operable to selectively power the first and second pumps;The first pump element expands when power is provided to the first pump element to increase pressure in the first volume and pump hydraulic fluid from the first volume to the first and second rolling bladders such that the first and second rolling bladders expand to an extended state, and the second pump element expands when power is provided to the second pump element to increase pressure in the second volume and pump hydraulic fluid from the second volume to the accumulator, and contracts when power is removed from the second pump element to expel fluid from the first and second rolling bladders to the second volume and the first and second rolling bladders contract to a contracted state;

[0024] In an embodiment, the system includes a first check valve disposed between the first volume and the first rolling bladder and the second rolling bladder and configured to control a flow of working fluid from the first volume to the first rolling bladder and the second rolling bladder; a second check valve disposed between the first volume and the accumulator and configured to control a flow of working fluid between the first volume and the accumulator; a third check valve disposed between the second volume and the first rolling bladder and the second rolling bladder and configured to control a flow of working fluid from the first rolling bladder and the second rolling bladder to the second volume; and a relief valve disposed between the second volume and the accumulator and configured to control a flow of working fluid from the second volume to the accumulator.

[0025] In an embodiment, the first check valve allows hydraulic fluid to flow from the first volume to the first rolling bladder and the second rolling bladder when the first pump element expands and prevents hydraulic fluid from flowing back into the first volume when the first pump contracts after power is removed.

[0026] In an embodiment, the second check valve allows hydraulic fluid to flow from the accumulator into the first volume when the first pump element contracts after power is removed.

[0027] In an embodiment, the relief valve is configured to allow hydraulic fluid to flow from the second volume to the accumulator when the second pump element expands when power is applied to the second pump element.

[0028] In an embodiment, the third check valve is configured to allow hydraulic fluid to flow from the first rolling bladder and the second rolling bladder to the second volume such that when the second pump contracts after power is removed, the first rolling bladder and the second rolling bladder return to a contracted state.

[0029] In an embodiment, the power source is a wire coil.

[0030] In an embodiment, the system includes a power supply circuit configured to selectively supply power to one of the first pump element and the second pump element.

[0031] In an embodiment, the power supply circuit includes a first diode disposed between the wire coil and the first pump element such that the first power pump is powered when a current is induced in the wire coil with a rectified sinusoidal signal having a first polarity; and a second diode disposed between the wire coil and the second pump element such that the second power pump is powered when a current is induced in the wire coil with a rectified sinusoidal signal having a second polarity opposite the first polarity.

[0032] A spinal adjustment system according to one embodiment of the present disclosure includes a first rolling bladder configured to expand from a contracted state to an extended state and from the extended state to the contracted state; a first pump in fluid communication with the first rolling bladder and configured to supply a hydraulic fluid to the first rolling bladder such that the first rolling bladder expands to the extended state and to remove a hydraulic fluid from the first rolling bladder such that the first rolling bladder contracts to the contracted state, the first pump being filled with a hydraulic fluid. a first volume mounted within the first volume and operable to expand when actuated to pump hydraulic fluid from the first volume; a second volume filled with hydraulic fluid; a second pump element mounted within the second volume and operable to expand when actuated to pump hydraulic fluid from the second volume; wherein a first rolling bladder is in fluid communication with the first volume and the second volume and expands to an expanded state when hydraulic fluid enters the first rolling bladder, and the ... the first pump element expands when power is supplied to the first pump element to increase pressure in the first volume and to transfer hydraulic fluid from the first volume to the first rolling bladder such that the first rolling bladder expands to an extended state; the first pump element expands when power is supplied to the first pump element to increase pressure in the first volume and transfer hydraulic fluid from the first volume to the first rolling bladder such that the first rolling bladder expands to an extended state; a first pump configured to pump hydraulic fluid to the first rolling bladder, the second pump element expanding when power is provided to the second pump element to increase pressure in the second volume to pump hydraulic fluid from the second volume to the accumulator and contracting when power is removed from the second pump element such that fluid is expelled from the first rolling bladder to the second volume causing the first rolling bladder to contract to a contracted state; and a second rolling bladder configured to expand from a contracted state to an extended state and from the extended state to a contracted state;a second pump in fluid communication with the second rolling bladder and configured to supply hydraulic fluid to the second rolling bladder such that the first rolling bladder extends to an extended state and to remove hydraulic fluid from the second rolling bladder such that the second rolling bladder contracts to a contracted state, the second pump comprising: a third volume filled with hydraulic fluid; a third pump element mounted within the third volume and operable to expand when actuated to pump the hydraulic fluid from the third volume; a fourth volume filled with hydraulic fluid; a fourth pump element mounted within the fourth volume and operable to expand when actuated to pump the hydraulic fluid from the fourth volume; a second accumulator in fluid communication with the third volume and the fourth volume; and a pump element electrically connected to the third pump element and the fourth pump element and configured to selectively supply power to the third pump element and the fourth pump element. a second power source operable to expand the second rolling bladder to an expanded state when hydraulic fluid flows into the second rolling bladder and contract when hydraulic fluid flows out of the second rolling bladder, the third pump element expands when power is provided to the third pump element to increase pressure in the third volume to pump hydraulic fluid from the third volume to the second rolling bladder such that the second rolling bladder expands to an extended state, the fourth pump element expands when power is provided to the fourth pump element to increase pressure in the fourth volume to pump hydraulic fluid from the fourth volume to the second accumulator and contracts when power is removed from the fourth pump element such that fluid is discharged from the second rolling bladder to the fourth volume and the second rolling bladder contracts to a contracted state; [Brief description of the drawings]

[0033] The above and related objects, features and advantages of the present disclosure will be more fully understood by reference to the following detailed description of illustrative but preferred embodiments of the invention in connection with the accompanying drawings.

[0034] [Figure 1] FIG. 1 illustrates an exemplary block diagram of a spinal alignment system according to an embodiment of the present application.

[0035] [Diagram 2] 1 shows an exemplary schematic diagram of a spinal alignment system provided to multiple vertebrae in a user's spine according to an embodiment of the present application.

[0036] [Diagram 3] FIG. 3 shows a more detailed view of the exemplary schematic diagram of FIG. 2 according to an embodiment of the present application.

[0037] [Figure 4A] 4 illustrates an exemplary rolling bladder for use in the spinal alignment system of FIGS. 1-3 in a retracted position, according to one embodiment of the present application.

[0038] [Figure 4B] 4 illustrates an exemplary rolling bladder for use in the spinal alignment system of FIGS. 1-3 in an extended position, according to one embodiment of the present application.

[0039] [Figure 4C] FIG. 4 illustrates an exemplary rolling bladder used in the spinal alignment system of FIGS. 1-3 in a partially extended position illustrating the bladder function of expanding along a curved trajectory according to one embodiment of the present application.

[0040] [Figure 5A] 1 illustrates a spinal alignment system including multiple rolling bladders in an extended position according to an embodiment of the present application.

[0041] [Figure 5B] 2 illustrates the spinal alignment system of FIG. 1 including a plurality of rolling bladders in a retracted position according to an embodiment of the present application.

[0042] [Figure 6]2 illustrates an exemplary embodiment of a pump suitable for use in the spinal alignment system of FIG. 1 mounted in an exemplary housing, according to an embodiment of the present application.

[0043] [Figure 7A] 1 illustrates an exemplary side view of a pump mechanism attached to a housing according to an embodiment of the present disclosure.

[0044] [Figure 7B] FIG. 7B illustrates an exemplary end view of the pump mechanism of FIG. 7A according to one embodiment of the present disclosure.

[0045] [Figure 7C] FIG. 7B shows an exemplary opposite end view of the pump mechanism of FIG. 7A according to one embodiment of the present disclosure.

[0046] [Figure 7D] FIG. 7B illustrates another exemplary opposing end view of the pump mechanism of FIG. 7A according to an embodiment of the present disclosure.

[0047] [Figure 8] 7A-7C taken along line AA according to one embodiment of the present disclosure.

[0048] [Figure 9] 7A-7C taken along line BB according to one embodiment of the present disclosure. FIG.

[0049] [Figure 10] 7A-7D taken along line CC according to an embodiment of the present disclosure. FIG.

[0050] [Figure 11] 7A-7D depict an exemplary cross-sectional view of an exemplary relief valve used in the pump mechanism of FIGS. 7A-7D, according to one embodiment of the present disclosure.

[0051] [Figure 12] 7A-7D depict an exemplary cross-sectional view of an exemplary check valve used in the pump mechanism of FIG. 7A-D, according to one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0052] FIG. 1 illustrates an exemplary block diagram of a spinal alignment system 100 that may include a pump mechanism 12 connected to a rolling bladder 14. In an embodiment, the pump mechanism 12 may include a pair of thermally actuated pumps (cartridges) 10a, 10b that function to pump fluid from an accumulator 16 to the rolling bladder 14 or from the rolling bladder to the accumulator 16. In an embodiment, the accumulator 16 may be a zero pressure reference fluid reservoir that stores the working fluid for the system 100. In one such embodiment, the accumulator 16 may be connected to the pump mechanism 12 by a catheter and may be implanted with the fluid pump rather than integral with the fluid pump. In an embodiment, the accumulator 16 may be or include an inflatable bag made of polyvinyl chloride (PVC), similar to that of an IV bag used externally. In an embodiment, the inflatable bag may be constructed of a selectively permeable membrane that allows water from the body, which may be used as the working fluid, to replenish the fluid supply in the accumulator 16. In an embodiment, the rolling bladder 14 may be a type of hydraulic element that provides an expansion force and associated expansion when pressurized with a working fluid, depending on design requirements.

[0053] In an embodiment, power to the pump mechanism 12, specifically the thermally actuated pumps 10a, 10b, may be provided by a power source 18. In an embodiment, the power source 18 may be an inductively coupled coil, for example, as can be seen in FIG. 1. In an embodiment, the power source 18 may be a multi-turn inductive coil, and may be placed inside the patient's body just under the patient's skin. In an embodiment, the plane of the coil is substantially parallel to the surface of the patient's skin to facilitate efficient coupling with the external primary coil 20. In an embodiment, the power source 18 may be an on-board power source, such as a battery. In an embodiment, the power source 18 (coil) may be part of a near-field charging system that does not require an actual physical connection outside the patient to provide power. In an embodiment, the external primary coil 20 may be energized by a rectified sinusoidal current of positive or negative polarity. In an embodiment, the rectified sinusoidal current may be used to induce a current in the secondary coil 18 that may be directed to the heating elements 116a or 116b of the two thermally actuated pumps 10a, 10b via diodes D1, D2. In embodiments, other suitable power supply circuits may be used in place of diodes D1, D2 to selectively power the first pump 10a and the second pump 10b to operate the first pump 10a and the second pump 10b. In embodiments, the power supply circuit may include a processor or other control circuitry. In embodiments, the power supply circuit may be used to manage power consumption, for example, when the power source 18 includes, for example, a battery.

[0054] In an embodiment, to control the expansion of the rolling bladder 14, a pulse current of a positive rectified sinusoidal signal in the primary coil 20 induces a secondary current in the coil 18, which is supplied to the thermally actuated pump 10a disposed in the volume V1 filled with the working fluid, thereby expanding the thermally actuated pump 10a and increasing the pressure in the volume V1, while the valve CV1a is checked back and the stored working fluid is passed through the check valve CV1b. In an embodiment, as can be seen in FIG. 4B, the working fluid may flow into the rolling bladder 14, thereby expanding the rolling bladder 14 to an expanded state. In an embodiment, pressure is transferred to the volume V2 through the check valve CV2b, but the raised nature of the thermally actuated pump 10b in the volume V2 and the pressure relief valve RV2 prevent the fluid from returning to the accumulator 16. When the thermally actuated pump 10a is deactivated, it contracts and the reduced pressure draws hydraulic fluid from the accumulator 16 through check valve CV1a while the check condition of CV1b maintains pressure in the rolling bladder 14, thereby maintaining the bladder 14 in its extended position.

[0055] In an embodiment, as shown in FIG. 4A, to contract the rolling bladder 14 to a contracted state, the pulse current in the primary coil 20 may be reversed, for example, by providing a rectified sinusoidal signal of opposite polarity, so that the secondary current is transmitted to the thermally actuated pump 10b in the volume V2 through the coil 18. As the thermally actuated pump 10b in V2 expands, pressure increases in the volume V2 until the check valve CV2b is checked (closed) and the relief valve RV2 relieves the pressure sending fluid from the volume V2 to the accumulator 16. When the current is removed, the thermally actuated pump 10b contracts, decreasing the pressure in the volume V2, thereby closing the relief valve RV2. Further contraction of the thermally actuated pump 10b in the volume V2 further reduces the pressure in V2 until the check valve CV2b opens to allow fluid to flow from the rolling bladder 14 back into the volume V2. Removal of actuating fluid from the rolling bladder 14 reduces the pressure therein, causing the bladder 14 to contract to a contracted state. In embodiments, the thermally actuated pumps 10a, 10b may include respective bellows structures 112a, 112b (see, e.g., FIG. 1 ) that hold a thermally responsive material, such as a eutectic wax, and respective heating elements 116a, 116b that, when activated, heat the wax to melt and expand, thereby expanding the bellows structures 116a, 116b. When the heating elements 116a, 116b are deactivated, the wax cools, solidifies, and contracts, causing the bellows structures 112a, 112b to contract. In embodiments, the bellows structures 112a, 112b may be biased to a contracted position. In an embodiment, the first thermally actuated pump 10a and the second thermally actuated pump 10b may be embodied by thermally actuated actuator components described in the applicant's co-pending U.S. non-provisional patent application Ser. No. 17 / 176,732, entitled "BIDIRECTIONAL THERMALLY ACTUATED COMPONENT FOR USE IN MEDICAL DEVICES," filed on February 16, 2021, the entire contents of which are incorporated by reference into this specification.In an embodiment, the power supply 18 may be electrically connected to the respective heating elements 116a, 116b that are used to apply heat to the expandable bellows structures 112a, 112b and the eutectic wax contained therein.

[0056] In an embodiment, the rolling bladder 14 may be used to apply a force to one or more vertebrae in the user's spine. In an embodiment, the rolling bladder 14 may be controlled to inflate and deflate as desired to provide pressure to encourage alignment of the vertebrae. In an embodiment, multiple bladders 14 may be used to apply pressure to multiple vertebrae, for example as can be seen in FIGS. 2-3. In an embodiment, the bladders 14 may be individually controlled to apply different amounts of pressure to different vertebrae. In an embodiment, fasteners 50 may be secured to the vertebrae, and the rolling bladder 14 may be positioned between the fasteners. In an embodiment, the fasteners 50 may be pedicle screws, for example as shown in FIG. 5B. In an embodiment, each pump mechanism 12 may be connected via element 40 and may be used to control the inflation and deflation of each rolling bladder 14 to adjust the spacing between the vertebrae to which the fasteners 50 are attached. In embodiments, each of the respective pump mechanisms 12 may be separately controlled such that each rolling bladder 14 may be individually controlled to provide a desired spacing between a particular pair of vertebrae. In embodiments, each of the respective pump mechanisms 12 may be separately controlled by separately controlling the power to each of the respective pumps 12.

[0057] In an embodiment, each rolling bladder 14 may be controlled together. In an embodiment, a single pump 12 may be provided in fluid communication with each of the rolling bladders 14. In an embodiment, a single pump mechanism 12 may be mounted within a housing 110, for example, as shown in FIG. 6. In an embodiment, the single pump mechanism 12 may be operable to supply hydraulic fluid to each of the rolling bladders 14, for example, as shown in FIGS. 2-3. In an embodiment, the fastener 50 may include a fluid connector (item 40a) for enabling flow of hydraulic fluid from the pump mechanism 12, for example, in FIG. 3, to the multiple rolling bladders 14. In an embodiment, an end connector 40b may be provided at an end of the system 100.

[0058] FIG. 4A illustrates an exemplary embodiment of the rolling bladder 14 in a contracted state or position. FIG. 4B illustrates an exemplary embodiment of the rolling bladder 14 in an extended state or position. FIG. 4C illustrates a cross-sectional view of the rolling bladder 14 in a partially extended position. In an embodiment, the rolling bladder 14 may include flexible walls and may be biased to the contracted position shown in FIG. 4A. In an embodiment, as hydraulic fluid flows into the rolling bladder 14, pressure within the rolling bladder 14 increases, causing the flexible walls to expand to the extended state. As hydraulic fluid is exhausted from the rolling bladder 14, pressure within the bladder decreases, causing the flexible walls to contract to the contracted state.

[0059] FIG. 5A illustrates an example of a spinal alignment system 100 including multiple rolling bladders 14 connected together in an extended position. FIG. 5B illustrates an example of a spinal alignment system 100 including multiple rolling bladders 14 connected together in a contracted position. In an embodiment, the rolling bladders 14 are connected via a connecting element 40. In an embodiment, the connecting element 40 includes a fluid conduit 40a extending through the connecting element 40 that provides fluid communication between the rolling bladders 14 so that the rolling bladders inflate and deflate together. In an embodiment, the connecting element 40 may be or include a fastener 50 connected to the vertebrae with the rolling bladder 14 disposed therebetween. In an embodiment, the spinal alignment system 100 may include a pump connector 60 disposed at one end of the system 100 and configured to provide a fluid connection between the pump 12 and the rolling bladders 14 described above to allow hydraulic fluid to be supplied to and drained from the rolling bladders. In an embodiment, the pump connector 60 may include an actuation fluid inlet 60a in fluid communication with the pump mechanism 12 and the rolling bladder 14. In an embodiment, the rolling bladder 14 may be connected to an individual pump mechanism 12, in which case the passage 40a of the connecting element 40 may be elbow-shaped and connected to the respective pump mechanism.

[0060] FIG. 6 shows an exemplary schematic diagram of a pump mechanism 12 mounted in a housing 110 for use in the system 100 of FIGS. 1-3 and 5A. In an embodiment, the volumes V1 and V2 may be integrated as separate compartments in the housing 110. In an embodiment, the pump 10a including the bellows 112a may be mounted in the volume V1, and the pump 10b including the bellows 112b may be mounted in the volume V2. In an embodiment, the accumulator 16 may be provided outside the housing 110 and may be connected to the pumps 10a, 10b, for example, via a catheter, as described above. FIG. 7A shows a side view of the pump mechanism 12 mounted in the housing shown in FIG. 6 along section line AA, with details shown in FIG. 8. FIG. 7B shows an end view thereof, and FIG. 7C shows an opposite end view along section line BB, with details shown in FIG. 9. FIG. 7D shows section line CC, with details shown in FIG. 10.

[0061] FIG. 8 shows an exemplary cross-sectional view of the pump mechanism 12 of FIG. 7A along line AA. FIG. 8 shows a tube stub or connector 12a that provides fluid communication with an accumulator 16 disposed outside the housing 110 so that hydraulic fluid can flow between the pump mechanism and the accumulator. A tube stub or connector 12b provides fluid communication with the rolling bladder 14 so that fluid can flow between the pump mechanism and the rolling bladder 14. FIG. 8 also shows a cross-section of a first pump 10a and a second pump 10b, which may be thermal wax expansion elements, disposed within volumes V1 and V2. The relief valve RV2 of FIG. 8 is shown in detail in FIG. 11.

[0062] Figure 9 illustrates a cross-sectional view of pump mechanism 12 of Figure 7C taken along line BB. Figure 9 also illustrates an exemplary location of each of check valves CV1a, CV1b, and CV2b, which are shown in detail in Figure 12.

[0063] FIG. 10 illustrates a cross-sectional view of pump mechanism 12 of FIG. 7D along line CC, showing exemplary fluid path connections between V1, RV2 and V2, CV2b and RV2, and their connections to accumulator 16.

[0064] FIG. 11 shows a cross-sectional view of relief valve RV2. In an embodiment, as shown, relief valve RV2 may be a direct acting spring loaded poppet type relief valve. In an embodiment, relief valve RV2 may include a housing 120, a valve seat 124, a guide 121 and / or a poppet 122 guided within valve seat 124 and preloaded by a spring 123. The preload of spring 123 on poppet 122 presses poppet 122 against valve seat 124 to seal against fluid pressure in volume V1 and rolling bladder 14. When pressure in V1, 14 acting in the area of ​​the valve seat diameter generates a force equal to or greater than the force of spring 123, relief valve RV2 opens and allows fluid to flow from V1, 14 to accumulator 16. The desired pressure threshold depends on the desired force in rolling bladder 14 and its cross-sectional area, depending on the specifics of the patient. Other relief valve configurations may be used as appropriate based on desired packing and performance parameters.

[0065] FIG. 12 illustrates a cross-sectional view of exemplary check valves CV1a, CV1b, and CV2b. Like relief valve RV2, the check valves of FIG. 12 are shown as direct acting spring loaded poppet type check valves. In an embodiment, each check valve may include a housing 130, a valve seat 131, and a poppet 132 guided within the valve seat 131 and preloaded by a spring 133. An end cap 134 may be included to facilitate assembly within the housing. In an embodiment, check valves CV1a, CV1b, and CV2b use a small spring force to bias the poppet 132 to close. Pressure acting in a check direction opposite the flow direction further increases the force acting to close the check valve and prevents flow in the check direction. These check valves CV1a, CV1b, and CV2b function to control the flow of the hydraulic fluid as described with reference to FIG. 1.

[0066] In an embodiment, the power source 18 may be placed beneath the user's skin and the primary coil 20 may be provided externally to induce a current in the pump mechanism 12 .

[0067] Although the embodiments of the present invention have been shown and described in detail, various modifications and improvements may become readily apparent to those skilled in the art. Therefore, the exemplary embodiments of the present invention described above are intended to be illustrative rather than limiting. The spirit and scope of the present invention should be broadly interpreted.

Claims

1. a rolling bladder configured to expand from a deflated state to an inflated state and from said inflated state back to said deflated state; a pump connected to the rolling bladder and configured to supply hydraulic fluid to the rolling bladder so that the rolling bladder expands to the expanded state and to remove hydraulic fluid from the rolling bladder so that the rolling bladder contracts to the contracted state; Equipped with The pump comprises: a first volume filled with the working fluid; and a first pump element mounted within the first volume and operable to expand when actuated to pump the hydraulic fluid from the first volume; a second volume filled with the working fluid; and a second pump element mounted within the second volume and operable to expand when actuated to pump the hydraulic fluid from the second volume; an accumulator in fluid communication with the first volume and the second volume; a power source electrically connected to the first pump element and the second pump element and operable to selectively supply power to the first pump element and the second pump element; the rolling bladder is in fluid communication with the first volume and the second volume, expands to the expanded state when hydraulic fluid flows into the rolling bladder, and contracts when hydraulic fluid flows out of the rolling bladder; the first pump element expands when electrical power is supplied to the first pump element to increase pressure in the first volume and pump the hydraulic fluid from the first volume to the rolling bladder such that the rolling bladder expands to the expanded state; the second pump element expands when power is supplied to the second pump element to increase pressure in the second volume to pump hydraulic fluid from the second volume to the accumulator, and contracts when power is removed from the second pump element such that fluid is expelled from the rolling bladder into the second volume and the rolling bladder contracts to the contracted state. Spinal adjustment system.

2. a first check valve disposed between the first volume and the rolling bladder and configured to control a flow of hydraulic fluid from the first volume to the rolling bladder; a second check valve disposed between the first volume and the accumulator and configured to control a flow of hydraulic fluid between the first volume and the accumulator; a third check valve disposed between the second volume and the rolling bladder and configured to control a flow of hydraulic fluid from the rolling bladder to the second volume; a relief valve between the second volume and the accumulator and configured to control a flow of hydraulic fluid from the second volume to the accumulator; The system of claim 1 further comprising:

3. 3. The system of claim 2, wherein the first check valve allows hydraulic fluid to flow from the first volume to the rolling bladder when the first pump element expands and prevents hydraulic fluid from flowing back into the first volume when the first pump element contracts after power is removed.

4. 3. The system of claim 2, wherein the second check valve allows hydraulic fluid to flow from the accumulator into the first volume when the first pump element contracts after electrical power is removed.

5. 3. The system of claim 2, wherein the relief valve is configured to allow hydraulic fluid to flow from the second volume to the accumulator when the second pump element expands when power is applied to the second pump element.

6. 3. The system of claim 2, wherein the third check valve is configured to allow the hydraulic fluid to flow from the rolling bladder to the second volume such that the rolling bladder returns to the contracted state when the second pump element contracts after electrical power is removed.

7. The system of claim 1 , wherein the power source is a wire coil.

8. The system of claim 7 , further comprising a power supply circuit configured to selectively supply power to one of the first pump element and the second pump element.

9. The power supply circuit includes: a first diode disposed between the wire coil and the first pump element such that the first pump element is powered when a current is induced in the wire coil with a rectified sinusoidal signal having a first polarity; a second diode disposed between the wire coil and the second pump element such that the second pump element is powered when a current is induced in the wire coil with a rectified sinusoidal signal having a second polarity opposite to the first polarity; The system of claim 8 , comprising:

10. 8. The system of claim 7, wherein the wire coil is paired with the external wire coil such that a current is induced in the wire coil when the external wire coil is placed adjacent to the wire coil.

11. 2. The system of claim 1, wherein the rolling bladder is positioned between the first vertebra and the second vertebra such that expansion of the rolling bladder changes a spacing between the first vertebra and the second vertebra.

12. The system of claim 1 , further comprising: another rolling bladder in fluid communication with the pump and configured to expand to the expanded state and contract to the deflated state.

13. The first pump element comprises: a first bellows including a eutectic wax; a first heating element electrically connected to the power source; Equipped with 2. The system of claim 1, wherein the first heating element is positioned such that when power is applied to the first heating element, the eutectic wax melts and the first bellows expands, and when power is removed from the first heating element, the eutectic wax cools and solidifies and the first bellows contracts.

14. The second pump element comprises: a second bellows including a eutectic wax; a second heating element electrically connected to the power source; Equipped with 14. The system of claim 13, wherein the second heating element is positioned such that when power is applied to the second heating element, the eutectic wax melts and the second bellows expands, and when power is removed from the second heating element, the eutectic wax cools and solidifies and the second bellows contracts.

15. a first rolling bladder configured to expand from a deflated state to an inflated state and from the inflated state to the deflated state; a second rolling bladder configured to expand from a deflated state to an inflated state and from the inflated state to the deflated state; a pump in fluid communication with the first rolling bladder and the second rolling bladder and configured to supply hydraulic fluid to the first rolling bladder and the second rolling bladder, respectively, so that the first rolling bladder and the second rolling bladder expand to the expanded state, and to remove hydraulic fluid from the first rolling bladder and the second rolling bladder, respectively, so that the first rolling bladder and the second rolling bladder contract to the contracted state; Equipped with The pump comprises: a first volume filled with the working fluid; and a first pump element mounted within the first volume and operable to expand when actuated to pump the hydraulic fluid from the first volume; a second volume filled with the working fluid; and a second pump element mounted within the second volume and operable to expand when actuated to pump the hydraulic fluid from the second volume; an accumulator in fluid communication with the first volume and the second volume; a power source electrically connected to the first pump element and the second pump element and operable to selectively supply power to the first pump element and the second pump element; Including, the first rolling bladder and the second rolling bladder are in fluid communication with the first volume and the second volume, and expand to the expanded state when hydraulic fluid flows into the first rolling bladder and the second rolling bladder, and contract when hydraulic fluid flows out of the first rolling bladder and the second rolling bladder; the first pump element expands when electrical power is supplied to the first pump element to increase pressure in the first volume and pump the hydraulic fluid from the first volume to the first rolling bladder and the second rolling bladder such that the first rolling bladder and the second rolling bladder expand to the expanded state; the second pump element expands when power is supplied to the second pump element to increase pressure in the second volume to pump hydraulic fluid from the second volume to the accumulator, and contracts when power is removed from the second pump element such that fluid is discharged from the first rolling bladder and the second rolling bladder into the second volume and the first rolling bladder and the second rolling bladder contract to the contracted state. Spinal adjustment system.

16. a first check valve disposed between the first volume and the first rolling bladder and the second rolling bladder and configured to control a flow of hydraulic fluid from the first volume to the first rolling bladder and the second rolling bladder; a second check valve disposed between the first volume and the accumulator and configured to control a flow of hydraulic fluid between the first volume and the accumulator; a third check valve disposed between the second volume and the first and second rolling bladders and configured to control a flow of hydraulic fluid from the first and second rolling bladders to the second volume; a relief valve between the second volume and the accumulator and configured to control a flow of hydraulic fluid from the second volume to the accumulator; The system of claim 15 further comprising:

17. 17. The system of claim 16, wherein the first check valve allows hydraulic fluid to flow from the first volume to the first rolling bladder and the second rolling bladder when the first pump element expands and prevents hydraulic fluid from flowing back into the first volume when the first pump element contracts after electrical power is removed.

18. 17. The system of claim 16, wherein the second check valve allows hydraulic fluid to flow from the accumulator into the first volume when the first pump element contracts after electrical power is removed.

19. 17. The system of claim 16, wherein the relief valve is configured to allow hydraulic fluid to flow from the second volume to the accumulator when the second pump element expands when power is applied to the second pump element.

20. 17. The system of claim 16, wherein the third check valve is configured to allow the hydraulic fluid to flow from the first rolling bladder and the second rolling bladder to the second volume such that when the second pump element contracts after electrical power is removed, the first rolling bladder and the second rolling bladder return to the contracted state.

21. 16. The system of claim 15, wherein the power source is a wire coil.

22. 21. The system of claim 20, further comprising a power supply circuit configured to selectively supply power to one of the first pump element and the second pump element.

23. The power supply circuit includes: a first diode disposed between the wire coil and the first pump element such that the first pump element is powered when a current is induced in the wire coil with a rectified sinusoidal signal having a first polarity; a second diode disposed between the wire coil and the second pump element such that the second pump element is powered when a current is induced in the wire coil with a rectified sinusoidal signal having a second polarity opposite to the first polarity; 23. The system of claim 22, comprising:

24. a first rolling bladder configured to expand from a deflated state to an inflated state and from the inflated state to the deflated state; a first pump in fluid communication with the first rolling bladder and configured to supply hydraulic fluid to the first rolling bladder so that the first rolling bladder expands to the expanded state and to remove hydraulic fluid from the first rolling bladder so that the first rolling bladder contracts to the contracted state; The first pump comprises: a first volume filled with the working fluid; and a first pump element mounted within the first volume and operable to expand when actuated to pump the hydraulic fluid from the first volume; a second volume filled with the working fluid; and a second pump element mounted within the second volume and operable to expand when actuated to pump the hydraulic fluid from the second volume; an accumulator in fluid communication with the first volume and the second volume; a power source electrically connected to the first pump element and the second pump element and operable to selectively supply power to the first pump element and the second pump element; Including, the first rolling bladder is in fluid communication with the first volume and the second volume, expands to the expanded state when hydraulic fluid flows into the first rolling bladder, and contracts when hydraulic fluid flows out of the first rolling bladder; the first pump element expands when electrical power is supplied to the first pump element to increase pressure in the first volume and pump the hydraulic fluid from the first volume to the first rolling bladder such that the first rolling bladder expands to the expanded state; the second pump element expands when power is supplied to the second pump element to increase pressure in the second volume to pump hydraulic fluid from the second volume to the accumulator, and contracts when power is removed from the second pump element such that fluid is expelled from the first rolling bladder into the second volume and the first rolling bladder contracts to the contracted state. A first pump; a second rolling bladder configured to expand from a deflated state to an inflated state and from the inflated state to the deflated state; a second pump in fluid communication with the second rolling bladder and configured to supply hydraulic fluid to the second rolling bladder so that the first rolling bladder expands to the expanded state and to remove hydraulic fluid from the second rolling bladder so that the second rolling bladder contracts to the contracted state; The second pump comprises: a third volume filled with the working fluid; and a third pump element mounted within the third volume and operable to expand when actuated to pump the hydraulic fluid from the third volume; a fourth volume filled with the working fluid; and a fourth pump element mounted within the fourth volume and operable to expand when actuated to pump the hydraulic fluid from the fourth volume; a second accumulator in fluid communication with the third volume and the fourth volume; a second power source electrically connected to the third pump element and the fourth pump element and operable to selectively supply power to the third pump element and the fourth pump element; Including, the second rolling bladder is in fluid communication with the third volume and the fourth volume, expands to the expanded state when hydraulic fluid flows into the second rolling bladder, and contracts when hydraulic fluid flows out of the second rolling bladder; the third pump element expands when electrical power is provided to the third pump element to increase pressure in the third volume and pump the hydraulic fluid from the third volume to the second rolling bladder such that the second rolling bladder expands to the expanded state; the fourth pump element expands when power is supplied to the fourth pump element to increase pressure in the fourth volume to pump hydraulic fluid from the fourth volume to the second accumulator, and contracts when power is removed from the fourth pump element such that fluid is expelled from the second rolling bladder into the fourth volume and the second rolling bladder contracts to the contracted state. A second pump; and A spinal adjustment system comprising:

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