Braces with interchangeable treatment modalities

Abstract

A portable brace assembly is provided for therapeutically supporting a part of a user's body. The assembly generally includes a belt configured to be positioned around the user. One or more inflatable bladders are attached to the belt. One or more additional therapeutic or supportive modalities are configured to be used in combination with the belt. The additional modalities are configured to be positioned on the inflatable bladders, and in use, the additional modalities are positioned between the inflatable bladders and the user's body. A transdermal drug delivery assembly may be configured as an additional modality to be used in combination with a first side of the belt.

Description

Technical Field

[0001] This application claims priority to U.S. Provisional Application No. 63 / 507,797, filed on Jun. 13, 2023, the entire disclosure of which is hereby incorporated by reference in its entirety.

[0002] The present invention generally relates to belts and braces, and more particularly to support braces that support a user's back, knees, elbows, or other body parts and provide therapeutic modalities thereto.

Background Art

[0003] Low back pain commonly occurs in individuals due to biomechanical changes in the lumbar spine and the muscular and ligamentous structures that support it. Surgery may be required to address certain problems, and other problems may be resolved by physical therapy. Additionally, physicians can use various orthotic devices, such as braces, to stabilize an injured or diseased body part before or after surgery. Orthotic devices are commonly used to promote and ensure various types of postoperative healing. Orthotic devices can form an essential component of the treatment or recovery process. Therapeutic devices can be useful in both the treatment and prevention of an individual's low back pain when the primary mechanisms involved in pain generation are due to muscle tension, spasm, or fatigue.

[0004] Known supports have been designed to limit fatigue and excessive burden in the structures described above and to assist in the recovery of both normal muscle tension and balanced muscle tension. While such an objective is rarely achieved by the application of known therapeutic devices alone, such devices are often useful in the prevention and treatment of various lumbar diseases.

Summary of the Invention

Problems to be Solved by the Invention

[0005] Known bracing devices tend to exhibit one or more significant drawbacks. For example, existing braces require tight tightening to provide support, resulting in uncomfortable and potentially harmful compression of abdominal contents, particularly in pregnant women. Existing braces require circumferential pressure and therefore cannot accommodate scoliosis or other spinal plane abnormalities. Furthermore, another drawback in some braces, and a potentially harmful consequence, is the circumferential tightening required to provide support to postoperative patients. It is common practice to require or advise patients to wear braces after spinal decompression and spinal fusion surgery. Such concentrated bracing pressure places significant pressure on the incision located near the midline of the spine, which can result in irritation, pain, and even wound dehiscence, potentially leading to infection.

[0006] Another modality commonly applied to address musculoskeletal pain is the use of various topical / transdermal medications, such as gels, creams, ointments, and drug-impregnated analgesic patches. It is widely known that diffusion of medicinal agents across the skin barrier requires at least three minutes of massage (or strong pressure) to penetrate the structural elements of interest (muscles, tendons, ligaments, etc.). Appropriate application of medication can be difficult for patients, particularly when applying medication to alleviate lower back pain. This is especially true for elderly individuals, those living alone, or those with physical disabilities.

[0007] Therefore, there is a need for improved braces that overcome these and other shortcomings of conventional technology. [Means for solving the problem]

[0008] One aspect of the present invention relates to a portable brace assembly for therapeutically supporting a part of a user's body, the user having a back, spine, sides, waist, and abdomen. The assembly generally includes a belt having a support between a first end and a second end. The first end is detachably connected to the second end to secure the belt around the user. The belt has a first side configured to face the user and a second side configured to face away from the user. When the belt is positioned around the user, the first side is located radially inward of the second side. The assembly further includes an inflatable bladder configured to attach to the support of the belt and configured to expand from a non-inflated position to an inflated position by the introduction of fluid. The inflatable bladder is positioned at a distance of first from the first end of the belt. In some embodiments, the belt has a longitudinal center, and the inflatable bladder includes a first bladder member located on one side of the longitudinal center and a second bladder member located on the other side of the longitudinal center. In some embodiments, the support and / or bladder are offset with respect to the longitudinal center. The assembly further includes a modality configured to be positioned radially inward of the inflatable bladder. The modality is positioned at approximately the same (first) distance from the first end of the belt as the user when the belt is positioned around the user, so as to be positioned between the inflatable bladder and the user. The inflatable bladder is configured to press the modality toward the user when it inflates from a non-inflated position to an inflated position.

[0009] Another aspect of the present invention relates to a portable brace assembly for therapeutically supporting a part of a user's body. The assembly allows for the deployment of multiple analgesic modalities while taking into account the unique biological diversity of individual patients. The assembly generally includes a belt configured to be positioned around the user, for example, positioned around the user's waist to support the user's lower back. The belt may be a strip of elastic material formed from a soft fabric. The belt has a first side configured to face and engage with the user's body, and a second side configured to move away from the user's body. In some embodiments, at least one of the first side and the second side of the belt includes a fastener, such as a hook-and-loop fastener (VELCRO), which is configured to be detachably attached to a component of the assembly. In these embodiments, one of the hook or loop material is combined with the belt, and the other of the hook or loop material is combined with a component of the assembly. One or more inflatable bladders are attached (directly or indirectly) to the first side of the belt. In some embodiments, the inflatable bladder is part of the belt or incorporated within the belt. In some embodiments, the inflatable bladder includes two bladder members spaced apart from each other and independently inflatable, which are attached (directly or indirectly) to the belt, with one bladder member engaging with the lower back on one side of the spine and the other bladder member engaging with the lower back on the opposite side of the spine. The inflatable bladder can be inflated by a manual pump or by an electric pump that can communicate with a software application on a telephone. In some embodiments, the brace assembly further includes one or more additional therapeutic or supportive modalities, which are configured to combine (directly or indirectly) with one or more inflatable bladders or first sides of the belt. The additional modalities may be positioned radially inward of the inflatable bladder, and in use, the additional modalities are positioned between the inflatable bladder and the user's body.In some embodiments, fasteners, such as a layer of hook or loop material of a hook-and-loop fastener (VELCRO), are positioned on the bladder to provide a surface for attaching additional modalities. One or more additional modalities may include a drug delivery assembly, a TENS (transcutaneous electrical nerve stimulation) unit, a copper pad, a heating pad, a vibration / massage pad, a cooling gel pack, and a magnet. Semi-rigid reinforcing members may be combined with the belt (directly or indirectly). The semi-rigid reinforcing members provide a support surface for the bladder to press against while keeping circumferential forces lower (more comfortably). Since the inflatable bladder, semi-rigid reinforcing members, and additional modalities may be combined with the belt by fasteners such as hook-and-loop fasteners (VELCRO) or any other suitable means, the bladder and additional modalities may be removed from or repositioned on the belt. At least one of the additional modalities may be used in conjunction with the inflatable bladder, thereby providing both the therapeutic effect of the additional modality and support from the inflatable bladder. In some embodiments, the assembly further includes sensors configured to communicate information to a processor (which may be the user's telephone). This information may include the pressure of an inflatable bladder, the number or type of modalities attached to the belt, and the length of time the brace assembly and each modality have been worn by the user.

[0010] Another aspect of the present invention relates to a portable brace kit for therapeutically supporting a part of a user's body. The kit includes one or more features described with respect to the portable brace assembly described above, these features include a belt, one or more inflatable bladders, semi-rigid reinforcing members, sensors configured to communicate information to a processor, and one or more additional modalities.

[0011] Another aspect of the present invention relates to a transdermal drug delivery assembly configured to be directly or indirectly combined with a first side of a belt as an additional modality. The transdermal drug delivery assembly may be an absorbent pad, such as a drug-impregnated foam pad. In some embodiments, the transdermal drug delivery assembly is a pouch having a first side, a second side, and a drug storage section. The first side has a semipermeable membrane configured to engage with the user's skin. In some embodiments, the semipermeable membrane is a fabric. The semipermeable membrane member selectively releases the drug from the drug storage section to the user's skin. The second side of the pouch includes a fastener for attaching the pouch to a belt. In some embodiments, the fastener is a hook-and-loop fastener (VELCRO), where one of the hook or loop material is combined with the pouch and the other of the hook or loop material is combined with the belt, so that the transdermal drug pouch can be easily attached to, detached from, and repositioned on the belt. In some embodiments, the transdermal drug pouch is positioned to align with one of the inflatable bladders, so that when the belt is attached to the user, the inflatable bladder applies pressure to the pouch. In this way, the amount of drug applied to the user's skin can be controlled by increasing or decreasing the volume within the bladder, and as the pressure applied from the bladder to the pouch increases, more drug is pushed through the semipermeable membrane to the user's skin. Furthermore, the degree of membrane permeability and the varying viscosities of the ointment affect the rate at which the drug is delivered to the body.

[0012] Another aspect of the present invention relates to a method of using the assembly described above. When in use, the user attaches an inflatable bladder to a desired position on the first side of the belt. The user then attaches any additional modalities (if any) to the first side of the belt. The belt is fitted around the user's body such that the bladder or bladder covers the lumbar and sacral regions, and the bladder or bladder is inflated to provide the wearer with a desired amount of pressure. The pressure provides mechanical support to the muscles and ligaments in the lower spinal region, giving static stretch to the erector spinae muscles, and helps prevent and eliminate spasms by keeping these muscles more stretched and relaxed. Additional modalities may be activated and data may be collected by sensors. Although the present invention has been described in relation to a back / spine brace, various features and embodiments may also be used for other types of braces, including those for the knee, shoulder, wrist, and elbow. [Brief explanation of the drawing]

[0013] [Figure 1] This is a front view of one embodiment of a brace assembly. [Figure 2] Figure 1 is a rear view of the brace assembly shown. [Figure 3] This is a front view of another embodiment of the brace assembly. [Figure 4] Figure 3 is a rear view of the brace assembly shown. [Figure 5] This is a front view of yet another embodiment of the brace assembly. [Figure 6] Figure 5 is a rear view of the brace assembly shown. [Figure 7A] Figures 1 and 2 are exploded views showing the brace assembly combined with an inflatable bladder and additional modalities. [Figure 7B] Figures 5 and 6 are exploded views showing the brace assembly combined with an inflatable bladder and additional modalities. [Figure 7C] This is a perspective view showing another embodiment of the semi-rigid reinforcing member. [Figure 7D] It is a side view of the semi-rigid reinforcing member shown in FIG. 7C. [Figure 8A] It is a front view showing an example of an additional modality. [Figure 8B] It is a front view showing an example of an additional modality. [Figure 8C] It is a front view showing an example of an additional modality. [Figure 8D] It is a front view showing an example of an additional modality. [Figure 8E] It is a front view showing an example of an additional modality. [Figure 9] It is a front view of the transdermal drug delivery assembly. [Figure 10] It is a cross-sectional view of the transdermal drug delivery assembly along the line A-A of FIG. 9. [Figure 11] It is a functional block diagram showing components of a general-purpose computing system connected to a general-purpose electronic network (e.g., a computer network) that can be used with the sensors and processors described herein.

Mode for Carrying Out the Invention

[0014] The present invention generally relates to a brace assembly having one or more support or treatment modalities. Although the present invention is mainly described with respect to a back brace, various features and embodiments can also be used in other types of braces, including braces for the knee, shoulder, wrist, and elbow.

[0015] Figures 1 and 2 show a first embodiment of the present invention in which the brace assembly is a back brace. The assembly generally includes a belt 10 having two ends 11A, 11B positioned on either side of a support portion 13. The assembly is configured to be positioned around the user, for example, around the user's waist, so that the support portion 13 engages with and supports the user's lower back. The belt 10 may be a strip of elastic material made of a soft fabric such as neoprene, polyester, or spandex. The belt 10 and other components of the assembly may be formed from or impregnated with antimicrobial materials such as silver, zinc, or copper. In some embodiments, the belt 10 is reinforced with a less flexible material such as polyester or nylon fibers. The belt 10 has a first side portion 10A configured to face and engage with the user's body, and a second side portion 10B configured to face away from the user's body. When the belt 10 is positioned around the user during use, the first side portion 10A is located radially inward from the second side portion 10B. In some embodiments, at least one of the first side portion 10A and the second side portion 10B of the belt 10 includes a fastener, such as a hook-and-loop fastener (VELCRO), and is configured to detachably attach the components of the assembly described herein. In embodiments using a hook-and-loop fastener as the fastener, one of the hook or loop material is combined with the belt 10, and the other hook or loop material is combined with one or more components described herein, thereby detachably attaching the components to the belt 10. The end portions 11A, 11B of the belt 10 are configured to be connected to each other at a desired size in front of the user (near the user's waist / navel), and at that time, the support portion 13 of the belt 10 is disposed near the lower portion of the user's back. In other embodiments, the end portions 11A, 11B are configured to be connected to each other at the side of the user. In these embodiments, the support portion 13 is offset with respect to the longitudinal center LC of the belt 10, whereby while the support portion 13 is disposed near the lower portion of the user's back, the end portions 11A, 11B are connected at the side of the user. One end portion 11A of the belt 10 can be fixed at any one of a plurality of positions along the other end portion 11B, thereby changing the tension of the elastic member and adjusting the tightening force of the device and / or the pressing force when the assembly engages with the lower back. In some embodiments, the support portion 13 is formed wider than the end portion 11 and provides additional support at a desired body part or the back.

[0016] Figures 3 and 4 show another embodiment of the belt 10 intended for use by people with large abdomens, such as obese individuals or pregnant women. As shown, each end 11A, 11B of the belt 10 has a first (lower) portion 34A and a second (upper) portion 34B spaced a predetermined distance from the first portion 34A, with an opening formed between the first portion 34A and the second portion 34B. The first portion 34A is configured to extend around the user's waist (similar to the position of the belt 10 shown in Figures 1 and 2), and the second portion 34B is configured to be positioned above the user's abdomen and closer to the user's chest. The first portions 34A of each end 11A, 11B are configured to be fixed to each other around the user's body, and the second portions 34B of each end 11A, 11B are also configured to be fixed to each other around the user's body. As shown in Figure 3, the upper and lower portions 34A and 34B of one end 11A may be formed shorter than the corresponding portions of the other end 11B, thereby offsetting the support portion 13 from the longitudinal center LC of the belt 10. This makes it possible to fix the ends 11A and 11B of the brace assembly to the sides of the user rather than the front / abdomen, while keeping the support portion 13 positioned on the lower part of the user's back.

[0017] The first (lower) portion 34A maintains brace pressure in the lumbar region, and the second (upper) portion 34B is positioned above the apex of the abdomen. The compressive force when the assembly engages with the lower back is applied to the user's lumbar region (below the abdomen) by the first portion 34A and to the upper part of the user's abdomen by the second portion 34B. The force applied to the abdomen is minimized. Both the first portion 34A and the second portion 34B are connected to the support portion 13, and the two portions 34A and 34B located on one side of the support portion 13 are configured generally symmetrically with the two end portions 34A and 34B located on the other side of the support portion 13.

[0018] Embodiments shown in Figures 3 and 4 may further include an abdominal support element 23 positioned between the first portion 34A and the second portion 34B of the belt. The abdominal support element 23 may be formed from a different material than the belt 10. The abdominal support element 23 is configured to support the user's abdomen by lifting it toward the second portion 34B. In some embodiments, the abdominal support element 23 comprises multiple layers. The first layer may be a soft cotton or spandex material positioned radially inward, facing the user's body when in use. A second layer may be more rigid and capable of providing greater support to the abdomen. For example, the second layer may be a rope or cloth net that is less stretchy than the first layer. The lower part of the abdominal support element 23 is attached to the first portion 34A of the belt by sewing, gluing, or other suitable means. The upper part of the abdominal support element 23 is adjustably combined with the second portion 34B of the belt. A support member 27, such as a belt, rope, or cord, is attached to the first portion 34A and / or abdominal support element 23 by sewing, adhesive, or other suitable means. A portion of the support member 27 is selectively fastened to the second portion 34B of the belt by a fastener 25, thereby assisting in fastening the abdominal support element 23 to the upper / second portion 34B of the belt. In this way, the abdominal support element 23 lifts the user's abdomen toward the second end 11B in a direction generally perpendicular to the radial support provided by the belt and (described later) the bladder member 12. In pregnant women, this lifts the fetus away from the pubic bone, contributing to the reduction of a common source of pain in third-trimester pregnant women (i.e., pubic pain). It also has the effect of changing the biomechanical load applied to the spine in a favorable direction. Biomechanically, in both pregnant women and obese individuals, this reorientation of the center of gravity restores appropriate axial load to the spine, thereby alleviating a major source of pain arising from the loaded, pathological facet joints. In some embodiments, the fastener 25 is an adjustable fastener that allows the user to change the amount of upward lift provided by the abdominal support element 23.

[0019] Figures 5 and 6 show another embodiment similar to the embodiments shown in Figures 3 and 4. In the embodiments shown in Figures 5 and 6, the first portion 34A and the second portion 34B of the belt are connected to each other at both ends but are spaced apart from each other, thereby creating an opening between them. The opening is configured to receive the user's abdomen. In the illustrated embodiments, the first portion 34A and the second portion 34B of the belt form an elliptical shape, and an elliptical opening is formed between them. In other embodiments, the first portion 34A and the second portion 34B of the belt may form other suitable shapes. The support portion 13 is offset from the longitudinal center LC of the belt, which allows the ends 11A, 11B of the brace assembly to be fixed to the sides of the user rather than the front / abdomen, while the support portion 13 remains positioned on the lower part of the user's back. Abdominal support elements 23 similar to those described above may also be used in the embodiments shown in Figures 5 and 6.

[0020] Figures 7A and 7B show exploded views of a brace assembly in which the belt 10 is positioned between several other components. As shown, one or more inflatable bladders 12 are attached (directly or indirectly) to the support portion 13 of the belt 10 at the first side 10A of the belt 10. In some embodiments, the bladder 12 is part of the belt 10 or embedded within the belt 10. In some embodiments, the inflatable bladder 12 includes two bladder members 12 that are spaced apart from each other and independently inflatable, and these bladder members 12 are attached (directly or indirectly) to the belt 10, with one bladder member 12 being able to engage with the lower back on one side of the spine and the other bladder member 12 being able to engage with the lower back on the opposite side of the spine. The inflatable bladder 12 can be inflated by any suitable means and can be inflated independently to different sizes / pressures. Inflating the bladder 12 to different sizes / pressures is useful in many situations, including when the patient has scoliosis. The effect of this deformed state often results in a condition where half of the lower back is concave and the other half is convex. As shown in the figure, a pump 20 is combined with the assembly to inflate the bladder 12. A tube or other conduit (not shown) may connect the pump 20 to the bladder 12. The pump 20 may be a manual pump or an electric pump. In some embodiments, a switch 22 is included and configured to inject fluid into or discharge fluid from the inflatable bladder 12. In some embodiments, the switch 22 communicates with a valve, and when the switch 22 is pressed, fluid is released from the bladder 12. Each bladder 12 may have its own dedicated pump 20 and switch 22, thereby allowing the fluid in each bladder 12 to be independently regulated and maintained. In embodiments where the pump 20 is electric, the pump 20 may communicate with a software application on a telephone or other device to control the pressure (inflation / deflation) in each bladder 12.

[0021] As shown in Figures 7A and 7B, the brace assembly further includes one or more additional therapeutic or supportive modalities 14 configured to combine (directly or indirectly) with the first side portion 10A of the belt 10. The additional modalities 14 may be positioned above the inflatable bladder 12 (radially inward of the inflatable bladder 12) so that, in use, the additional modalities 14 are positioned between the inflatable bladder 12 and the user's body. In some embodiments, fasteners 15, such as a layer of hook-and-loop fasteners (VELCRO), are positioned between the bladder 12 and the additional modalities 14 (above the bladder 12). The fasteners 15 provide a surface for attaching the additional modalities 14, and the additional modalities 14 may be combined with corresponding fasteners (hook or loop material). As shown in Figures 8A to 8E, one or more additional modalities 14 may include copper-impregnated fabric (Figure 8A), magnet-impregnated fabric (Figure 8B), absorbent pads such as drug-impregnated foam pads or transdermal drug delivery assemblies such as delivery pouches (Figure 8C), vibration / massage pads (Figure 8D), TENS units (Figure 8E), pouches or "fanny packs," or other suitable modalities such as heating pads. Heating pads may be chemical heat packs that generate heat as a result of a chemical reaction, reusable heat packs that generate heat when heated (e.g., by heating the pack in a microwave oven), or electric heat packs that generate heat by electric / battery power. At least one of the additional modalities 14 may be used in conjunction with an inflatable bladder 12, thereby providing the therapeutic effect of the additional modality 14 while also providing support from the inflatable bladder 12. Furthermore, by using the inflatable bladder 12 in conjunction with an additional modality 14, the user can control the hardness or force with which the additional modality 14 is pressed against their body. As the amount of inflation of the bladder 12 increases, the pressure of the modality 14 on the user's body increases. Conversely, as the amount of inflation of the bladder 12 decreases, the pressure of the modality 14 on the user's body decreases.

[0022] In some embodiments, the components of the assembly are waterproof or water-resistant, allowing the device to be used in underwater or wet environments, such as during navigation, kayaking, paddleboarding, personal watercraft operation, or hunting in wet conditions. In one embodiment, the individual electrical components and connections are waterproof or water-resistant. In another embodiment, some or all of the assembly is housed in a waterproof or water-resistant sleeve.

[0023] The semi-rigid reinforcing member 18 can be combined (directly or indirectly) with the second side portion 10B of the belt 10 using any suitable fastener, including hook-and-loop fasteners. Figure 7A shows the semi-rigid reinforcing member 18 as a generally flat panel positioned radially outward from the bladder 12. The semi-rigid reinforcing member 18 provides a relatively rigid surface that can be pressed against when the bladder 12 expands. This provides greater support while keeping radial / circumferential forces lower (more comfortable). In some embodiments, the belt 10 includes pockets configured to selectively receive one or more semi-rigid reinforcing members 18. In other embodiments, the semi-rigid reinforcing member 18 is combined with the belt by VELCRO or other suitable means. Figures 7C and 7D show another embodiment in which the semi-rigid reinforcing member 18 has a curved shape that helps increase rigidity while minimizing thickness and weight. Furthermore, this curvature, with the convex side having an outward-extending curve facing the user's back and the upper and lower edges curving away from the user's back, can enhance comfort by making it less likely for the user to feel the edges of the semi-rigid reinforcing member 18.

[0024] As described above, one of the additional modalities 14 may be a transdermal drug delivery assembly 16 configured to be combined (directly or indirectly) with the first side portion 10A of the belt 10. Figures 9 and 10 show one embodiment of the transdermal drug delivery assembly 16. The transdermal drug delivery assembly 16 has a first side portion, a second side portion, and a drug storage portion 26. The first side portion has a semipermeable membrane 24 configured to engage with the user's skin after the protective seal 30 has been removed. In some embodiments, the semipermeable membrane 24 is a cloth or woven material. The semipermeable membrane 24 selectively releases the drug from the drug storage portion 26 to the user's skin. The drug is preferably a liquid, gel, oil, or cream and is permeable to the membrane 24 by penetration facilitated by the pressure of the bladder 12. The drug may include lidocaine, diclofenac, capsaicin, salicylic acid, eucalyptus oil, camphor, and CBD extract. The second side of the pouch 16 includes a fastener 28 for attaching the pouch 16 to the belt 10. As described above, for this modality and other additional modalities 14, the fastener 28 may be a hook-and-loop fastener (VELCRO), which allows the transdermal drug pouch 16 to be easily attached to, detached from, and repositioned on the belt 10 or on an intermediate structure such as the attachment layer 15 described above.

[0025] As shown in Figure 9, some embodiments of the transdermal drug delivery assembly 16 include a flexible gasket 17 on a first side of the assembly 16. The gasket 17 is positioned around the periphery of the semipermeable membrane 24 and is configured to engage with the user's skin to provide a barrier that helps contain the drug as it passes through the semipermeable membrane 24. The gasket 17 helps prevent the drug from leaking or moving away from the desired application area. In some embodiments, the gasket 17 is formed from a rubber or silicone material.

[0026] In another embodiment, the transdermal drug delivery assembly 16 may be an absorbent pad, such as a drug-impregnated foam pad. The absorbent pad may be similar to the semipermeable membrane 24 described above. This embodiment is similar to the embodiments described above with respect to Figures 9 and 10, but does not include a separate drug storage unit 26.

[0027] As shown in Figures 7A and 7B, the transdermal drug delivery assembly 16 may be one of the additional modalities 14 attached to the belt 10 radially inward from the bladder 12. The drug delivery assembly 16 may be positioned on one of the inflatable bladders 12 so that when the belt 10 is fitted to the user, the inflatable bladder 12 is configured to apply pressure to the drug delivery assembly 16. In this way, the amount of drug applied to the patient's skin can be controlled by increasing or decreasing the volume within the bladder 12, and as the pressure applied from the bladder 12 to the pouch 16 increases, more drug is pushed through the semipermeable membrane 24 to the user's skin. By applying sufficient pressure with the air bladder system, the drug is pushed through the permeable membrane 24 of the drug pouch and injected perdermally into a predetermined anatomical location in the patient.

[0028] In some embodiments, multiple additional modalities 14 may be used simultaneously. Each modality 14 may have attachment means by hook-and-loop fasteners on one or both sides, thereby allowing the modalities 14 to be stacked on top of each other. As described above, it is desirable to align the modalities 14 with the bladder 12 so that the pressure adjustment of the bladder 12 contributes to controlling the desired pressure that the modality 14 applies to the user's body. In one embodiment, for example, a heating modality 14 and a massage modality 14 may be used in combination with a drug pouch 16. In this exemplary embodiment, the bladder 12 is positioned furthest from the user's body, followed by the massage modality 14, the heating modality 14, and finally the drug pouch 16 adjacent to the user's skin.

[0029] In some embodiments, the assembly further includes electronic equipment configured to control components of the assembly or to communicate with other electronic components (such as a telephone, tablet, or computer). As shown in Figures 2, 4, 6, 7A, and 7B, the assembly may include a sensor 32 configured to detect or measure predetermined characteristics of the assembly and communicate that information to a processor (which may be the user's telephone). In some embodiments, the sensor 32 is configured to detect or measure the inflation pressure of each inflatable bladder 12, which additional modalities 14 are attached to the belt 10, and the length of time the brace assembly and additional modalities 14 have been worn by the user. The sensor 32 may communicate information to a processor separate from the brace assembly. For example, the sensor 32 may communicate to the user's telephone via Bluetooth or RFID. The processor / telephone may run a software application configured to control the inflatable bladder 12 or other additional modalities 14. The processor / telephone may store predetermined preset conditions (i.e., bladder pressure) and control the bladder members 12 and additional modalities 14 accordingly. In some embodiments, the processor / phone monitors the pressure within the bladder member 12 to prevent over-inflation. The processor / phone may also be configured to communicate data to a central database where patient data is collected for future improvements to the brace assembly.

[0030] During use, the user attaches the inflatable bladder 12 to the desired position on the first side 10A of the belt 10. The user then attaches any additional modalities 14 (if any) to the first side 10A of the belt 10. The belt 10 is fitted around the person's body so that the bladder 12 covers the lumbar and sacral regions, and the bladder 12 is inflated to provide the amount of pressure desired by the wearer. The pressure provides mechanical support to the muscles and ligaments in the lower spinal region, gives static stretch to the erector spinae muscles, and helps prevent and eliminate spasms by keeping these muscles more stretched and relaxed. The additional modalities 14 may be activated, and data may be collected by sensors. Although the present invention is described in relation to a back brace, various features and embodiments may also be used for other types of braces, including those for the knee, shoulder, wrist, and elbow.

[0031] Patients can opt-in to have their data collected and sent for research. Users can receive advertisements via a software application and reorder medical delivery assemblies 16 and other additional modalities 14.

[0032] It will be understood that some embodiments of the present invention may be implemented on a computer or a computer-based network. Computer 14 may be specifically programmed to perform the steps described above and to store the relevant information. For example, the computer may be used to store data relating to the brace assembly and any additional modalities. Thus, embodiments included in the scope of the present invention include a program product which includes a computer-readable medium on which computer-executable instructions or data structures are held or carried. Such a computer-readable medium may be any available medium accessible by a general-purpose or special-purpose computer. For example, such a computer-readable medium may include RAM, ROM, EPROM, EEPROM, CD-ROM or other optical storage devices, magnetic disk storage devices or other magnetic storage devices, or any other medium that can carry or store desired program code in the form of computer-executable instructions or data structures and is accessible by a general-purpose or special-purpose computer. When information is transferred to or provided to a computer via a network or other communication connection (wired, wireless, or a combination of wired and wireless), the computer appropriately recognizes that connection as computer-readable medium. Therefore, any such connection is appropriately referred to as computer-readable medium. The aforementioned combinations are also included in the scope of computer-readable medium. Computer-executable instructions include, for example, instructions and data that cause a general-purpose computer, a special-purpose computer, or a special-purpose processing device to perform a predetermined function or set of functions.

[0033] In some embodiments, the present invention may operate in a network environment using logical connections to one or more remote computers having processors. These logical connections may include, but are not limited to, local area networks (LANs) and wide area networks (WANs). Such network environments are common in office-wide or enterprise-wide computer networks, intranets, and the internet. Those skilled in the art will understand that such network computing environments typically encompass many types of computer system configurations, including personal computers, mobile terminals, multiprocessor systems, microprocessor-based or programmable consumer electronics, network PCs, minicomputers, mainframe computers, and the like. In some embodiments, users can access the network to provide and receive information regarding brace assemblies and their additional modalities 14.

[0034] The present invention can also be implemented in a distributed computing environment in which tasks are performed by local and remote processing devices connected via a communication network (by wired links, wireless links, or a combination of wired and wireless). In a distributed computing environment, program modules may be located in both local and remote memory storage devices.

[0035] An exemplary system for implementing the whole system or a part of the present invention may include a general-purpose computing device in the form of a conventional computer, including a processing unit, system memory, and a system bus that connects various system components, including the system memory, to the processing unit. The system memory may include read-only memory (ROM) and random access memory (RAM). The computer may further include a magnetic hard disk drive for reading from and writing to a magnetic hard disk, a magnetic disk drive for reading from or writing to a removable magnetic disk, and an optical disk drive for reading from or writing to a removable optical disk, such as a CD-ROM or other optical media. These drives and the computer-readable media associated with them provide non-volatile storage of computer executable instructions, data structures, program modules, and other data for the computer.

[0036] Software and web implementations of the present invention can be achieved by performing various database search, correlation, comparison, and decision steps using standard programming techniques employing rule-based logic and other logic. It should also be noted that the terms “component” or “module” as used herein are intended to encompass implementations using one or more lines of software code, and / or hardware implementations, and / or devices for receiving manual input.

[0037] Figure 11 shows the components of a general-purpose computing system connected to a general-purpose electronic network 100, such as a computer network. The computer network may be a virtual private network or a public network such as the Internet. As shown in Figure 200, the computer system 120 includes a central processing unit (CPU) 140 connected to system memory 180. The system memory 180 typically includes an operating system 160, a BIOS driver 220, and application programs 200. Furthermore, the computer system 120 includes input devices 240 such as a mouse or keyboard 32, output devices such as a printer 300 and a display monitor 280, and a persistent data store such as a database 210. The computer system generally includes a communication interface (communication line) 260 for communicating with the electronic network 100. Other computer systems 130 and 130A are also connected to the electronic network 100, and the electronic network 100 may be implemented as an internetwork such as a wide area network (WAN) or the Internet. Data is stored in numerous local repositories and synchronized with a warehouse optimized for central queries and reports, or centrally stored in a dual-use database. This system is an example of a system capable of performing the method steps described above.

[0038] Having described the present invention in relation to its preferred embodiments, it will be apparent to those skilled in the art that various modifications can be made to the preferred embodiments described herein without departing from the spirit and scope of the invention. However, all such modifications and changes that are apparent to those skilled in the art are intended to be included within the scope of the claims listed below.

Claims

1. A portable brace assembly configured to be positioned around a user, wherein the user has a back, spine, sides, waist and abdomen, and the portable brace assembly is, A belt having a support portion between a first end and a second end, a first side portion configured to face the user, and a second side portion configured to move away from the user, wherein when the belt is positioned around the user, the first end is detachably connected to the second end, and the first side portion is positioned radially inward from the second side portion. An inflatable bladder is configured to be attached to the support portion of the belt, to expand from a non-expanded position to an expanded position by the introduction of fluid, and is positioned at a distance of a first distance from the first end of the belt, A portable brace assembly comprising: a modality configured to be positioned radially inward from the inflatable bladder, wherein the modality is positioned near a first distance from the first end of the belt such that it is located between the inflatable bladder and the user when the belt is positioned around the user, the inflatable bladder is configured to press the modality toward the user when it inflates from the non-inflated position to the inflated position.

2. The portable brace assembly according to claim 1, wherein the modality comprises one or more of the following: a drug supply assembly, a TENS (transcutaneous electronervous stimulation) unit, a copper pad, a heating pad, a vibration / massage pad, a cooling gel pack, and a magnet.

3. The portable brace assembly according to claim 1, further comprising fasteners positioned radially inward from the inflatable bladder for attaching the modality to the inflatable bladder.

4. The portable brace assembly according to claim 3, wherein the fastener is a hook-and-loop fastener.

5. The portable brace assembly according to claim 1, further comprising a pump configured to communicate with the inflatable bladder and to introduce fluid into the inflatable bladder to inflate the inflatable bladder.

6. The portable brace assembly according to claim 5, wherein the pump is configured to communicate with a software application and the pump is controllable from the software application.

7. The portable brace assembly according to claim 5, wherein the pump is an electric pump.

8. The portable brace assembly according to claim 1, wherein the belt has a longitudinal center, and the inflatable bladder includes a first bladder member located on one side of the longitudinal center and a second bladder member located on the other side of the longitudinal center.

9. The portable brace assembly according to claim 1, wherein the inflatable bladder includes a first bladder member and a second bladder member, the first bladder member configured to engage with one side of the spine's posterior portion, and the second bladder member configured to engage with the other side of the spine's posterior portion.

10. The portable brace assembly according to claim 1, wherein the belt has a longitudinal center and the support portion is offset with respect to the longitudinal center.

11. The portable brace assembly according to claim 1, wherein the support portion is positioned closer to the first end than to the second end.

12. The portable brace assembly according to claim 1, further comprising a semi-rigid reinforcing member combined with the belt radially outward from the inflatable bladder, wherein the semi-rigid reinforcing member is configured to provide a support surface for the inflatable bladder to press against.

13. The portable brace assembly according to claim 12, wherein the semi-rigid reinforcing member is curved.

14. The portable brace assembly according to claim 1, further comprising a sensor configured to measure data and communicate the data to a processor, wherein the data includes one of the following: bladder pressure, modality information, and information relating to the time the user wears the portable brace assembly over a predetermined period of time.

15. The portable brace assembly according to claim 1, wherein the inflatable bladder is indirectly combined with the first side of the belt, and the modality is indirectly combined with the inflatable bladder.

16. The portable brace assembly according to claim 1, wherein the belt has a lower portion that is spaced a predetermined distance below the upper portion of the belt, the lower portion is configured to extend around the waist, and the upper portion is configured to be positioned above the abdomen.

17. The portable brace assembly according to claim 16, further comprising an abdominal support element disposed between the lower and upper parts, wherein the abdominal support element is configured to support the abdomen by lifting the abdomen toward the upper part.

18. The portable brace assembly according to claim 17, further comprising a support member attached to the upper part and the abdominal support element, which assists in lifting the abdominal support element and fixing it to the upper part.

19. The portable brace assembly according to claim 17, wherein the belt has a longitudinal center, the inflatable bladder is positioned on one side of the longitudinal center, and the abdominal support element is positioned on the other side of the longitudinal center.

20. The portable brace assembly according to claim 1, wherein the modality is a transdermal drug delivery assembly having a first side portion, a second side portion, and a drug storage portion, the first side portion having a semipermeable membrane, and the second side portion having a fastener configured to selectively attach the transdermal drug delivery assembly to the portable brace assembly.

21. A portable brace assembly configured to be positioned around a user, wherein the user has a back, spine, sides, waist and abdomen, and the portable brace assembly is, A belt having a first end and a second end, a first side configured to face the user, and a second side configured to move away from the user, wherein the first end is detachably connected to the second end, and when the belt is positioned around the user, the first side is located radially inward from the second side, and has a lower part that is spaced a predetermined distance below the upper part of the belt, the lower part is configured to extend around the waist, and the upper part is configured to be positioned above the abdomen, An abdominal support element disposed between the lower part and the upper part, configured to support the abdomen by lifting the abdomen toward the upper part, A portable brace assembly comprising: an inflatable bladder configured to be attached to the first side of the belt and configured to expand from a non-expanded position to an expanded position by the introduction of a fluid.

22. The portable brace assembly according to claim 21, wherein the belt has a longitudinal center, the inflatable bladder is positioned on one side of the longitudinal center, and the abdominal support element is positioned on the other side of the longitudinal center.

23. The portable brace assembly according to claim 21, wherein the inflatable bladder is indirectly combined with the first side of the belt.

24. The portable brace assembly according to claim 21, wherein the belt is formed from a material that is more rigid than the abdominal support element.

25. A portable brace assembly configured to be positioned around a user, wherein the portable brace assembly is A belt having a first end and a second end, a first side portion configured to face the user, and a second side portion configured to move away from the user, wherein the first end is detachably connected to the second end, and the belt is configured such that when the belt is positioned around the user, the first side portion is located radially inward from the second side portion. An inflatable bladder, configured to be attached to the first side of the belt and configured to expand from a non-expanded position to an expanded position by the introduction of fluid, A portable brace assembly comprising: a modality configured to be positioned radially inward from the inflatable bladder, wherein the modality is a transdermal drug delivery assembly having a first side, a second side, and a drug storage portion, the first side having a semipermeable membrane, and the second side having a fastener configured to selectively attach the transdermal drug delivery assembly to the inflatable bladder.

26. The portable brace assembly according to claim 25, wherein the semipermeable membrane is a fabric.

27. The portable brace assembly according to claim 25, wherein the inflatable bladder is indirectly combined with the first side of the belt, and the modality is indirectly combined with the inflatable bladder.

28. The portable brace assembly according to claim 25, further comprising a gasket around the periphery of the semipermeable membrane, wherein the gasket is configured to engage with the user to provide a barrier that helps contain the drug as it passes through the semipermeable membrane.

29. A kit for a portable brace assembly configured to be positioned around a user, wherein the user has a back, spine, sides, waist, and abdomen, and the kit is, A belt having a first end and a second end, a first side portion configured to face the user, and a second side portion configured to move away from the user, wherein the first end is detachably connected to the second end, and the belt is configured such that when the belt is positioned around the user, the first side portion is located radially inward from the second side portion. An inflatable bladder, configured to be attached to the first side of the belt and configured to expand from a non-expanded position to an expanded position by the introduction of fluid, A pump configured to communicate with the inflatable bladder and to introduce fluid into the inflatable bladder to inflate it, A kit comprising: a modality configured to be positioned radially inward of the inflatable bladder, wherein the modality is a transdermal drug delivery assembly having a first side, a second side, and a drug storage section, the first side having a semipermeable membrane, and the second side having a fastener configured to selectively attach the transdermal drug delivery assembly to the portable brace assembly.

30. The kit according to claim 29, wherein the inflatable bladder is indirectly combined with the first side of the belt, and the modality is indirectly combined with the inflatable bladder.

31. The kit according to claim 29, further comprising fasteners for attaching the modality, which are positioned radially inward from the inflatable bladder.

32. The kit according to claim 27, further comprising a semi-rigid reinforcing member combined with the belt radially outward from the inflatable bladder, wherein the semi-rigid reinforcing member is curved and configured to provide a support surface for the inflatable bladder to press against.

33. The kit according to claim 27, wherein the belt has a lower portion that is spaced a predetermined distance below the upper portion, the lower portion is configured to extend around the waist, the upper portion is configured to be positioned above the abdomen, and the upper portion further comprises an abdominal support element that assists in lifting and fixing the abdominal support element.

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