WO2007044264A2

WO2007044264A2 - Devices and methods for dampening tremors

Info

Publication number: WO2007044264A2
Application number: PCT/US2006/038251
Authority: WO
Inventors: Eric Sorenson Hansen
Original assignee: Eric Sorenson Hansen
Priority date: 2005-09-29
Filing date: 2006-09-29
Publication date: 2007-04-19
Also published as: WO2007044264A3

Abstract

The invention provides methods and devices for decreasing the severity of trerrors and other unintentional movements. In some embodiments, the device are for use on a human joint such as a knee, elbow, wrist, shoulder, knuckle or finger joint having an upper bone and a lower bone hinged at an axis relative to one another. It includes an upper portion (13), sized to overlie at least a portion of the upper bone adjacent the joint, a lower portion (14), sized to overlie the at least a portion of the upper bone adjacent the joint, and a first malleable element (11), running longitudinally from the upper portion (13), to the lower portion (14) and attached to the brace (12).

Description

DeWrβeSs and Methods for Dampening Tremors

REFERENCE TO PRIOR APPLICATOINS

This application claims priority to U.S. Provisional Application Serial Number 60/723,512, filed on October 4, 2005, and it further claims priority to U.S. Provisional Application Serial Number 60/721 ,791 , filed on September 29, 2005. Each of these applications is hereby incorporated here by reference in their entirety.

,- BACKGROUND

[01] Tremors in humans are associated with several medically defined disorders. These disorders include Essential tremor and Parkinson's disease. Sufferers of these diseases often experience excessive and involuntary oscillation of their limbs, which results in loss of control of attempted performance of an action or attempted maintenance of a postural position. Tremors can severely impair a person's ability to engage in everyday tasks such as walking, writing, driving, etc.

[02] U.S. Patent Number 6,361 ,549 describes methods of treating such tremors. These include medications such as Propranolol, Primidone, and Benzodiazepines. However, such medications are often poorly tolerated and/or become less effective with continued treatment. Other treatment methods described include "deep brain stimulation" - which involves drilling a hole through a patient's skull into his or her brain. This procedure has the disadvantages of high expense and the risk of intracerebral hemorrhage or stroke.

[03] Research is currently being performed to find other treatments for human tremors. One potential treatment type is referred to as: "active electromechanical damping systems". Active electromechanical tremor damping systems attempt to detect tremors and apply force to counteract them. Current research in this area is focusing on differentiating tremors from voluntary movements. Approaches to this problem include using bioelectrical sensors to identify tremor-producing signals and using mechanical sensors to detect and predict tremor movements. This sensor data is then sent to a local processing unit and commands are sent to electromotive devices that counter class of treatments suffers from several potential flaws. First, it is likely that such systems will have difficulty in differentiating between a tremor and the beginning of a voluntary movement. It may be possible to determine the difference and identify the tremor most of the time, but everyday use would require a success rate well beyond what is possible in the short term because false positives likely worsen other symptoms that often accompany tremors. Second, such a system would likely be unwieldy using current technology. Third, use of a device based on active electromechanical damping system technology would likely be expensive. [04] Another area of research is "Passive Viscous Fluid Systems".

The primary wearable passive tremor damping system utilizes a viscous fluid held between two plates, with each plate fixed on one side of the joint to be controlled. Motion between the plates causes the pressure of the fluid to increase or decrease, pushing or pulling the fluid through small holes connecting the parallel plates to adjacent fluid reservoirs. There are also several problems with this approach. It is believed that this technology does not provide control of fine tremors, such as those that might interfere with a person's ability to write, and it does not differentiate tremors from rapid voluntary movements. Because most tremors are short and rapid movements, in practice this approach would likely substantially allow tremors to continue while impairing voluntary movement.

[05] There is thus a need for an effective and relatively inexpensive treatment for tremors and other unintentional movements caused by various diseases.

SUMMARY

[06] The invention provides braces for use in suppressing tremors and other unintentional movement such as shaking, and other perturbations. [07] The invention provides a brace for a human joint such as a knee, elbow, wrist, shoulder, knuckle or finger joint having an upper bone and a lower bone attached thereto. The brace includes (a) an upper portion configured to overlie at least a portion of said upper bone, (b) a lower portion configured to overlie at least a portion of said lower bone, and (c) one or more •riillei&SH^;:yeriϊlftβli^lOverlie the joint and run longitudinally from said upper portion to said lower portion and is attached to said brace.

[08] In some embodiments, the middle portion is configured to be disposed over said joint, said middle portion connecting said upper portion and said lower portion. In some embodiments, the upper portion is securable around said upper bone; and said lower portion is securable around said lower bone. In some embodiments, the one or more malleable elements include a metal wire. Preferably, the upper portion and said lower portion comprise a substantially non-extensible material. [09] In some embodiment, the joint is a finger, wrist or elbow, and the one or more malleable elements is associated with the brace such that one or more malleable elements run substantially on the posterior side of the user's body during use. In other embodiments, the one or more malleable elements may be associated with the brace such that they also (or exclusively) run on the anterior side of the body when in use.

[10] In some embodiment, the joint is the wrist, and the one or more malleable elements are associated with the brace such that they run on the anterior side of the user's body when in use. In some embodiments, one or more malleable elements may also (or exclusively) be associated with the brace such that they also (or exclusively) run on the posterior side of the body when in use.

[11] In some embodiments, the brace includes a fastener. [12] In some embodiment, the brace is used to control a user's tremors or other unintentional movement in the joint, and the one or more malleable elements are together plastically deformable only in response to a cumulative force greater than the force of the tremor or other unintentional movement in the joint. In some embodiment, the one or more malleable elements for a particular joint have a cumulative malleability threshold that is between about 5% and about 50% of the user's maximum strength in the joint. Preferably, the one or more malleable elements hinder movement of the joint when the one or more malleable elements are not plastically deformed. [13] In some embodiments, the malleable element(s) are configured to overlie a user's wrist and have a cumulative malleability threshold between about 0.4N to about 4ON. ^ⁱipi|^,fejfft%iffi|^;ι^ι^_τ,b_0Cjj_ment_Sj the brace has malleable element(s) that are configured to overlie a user's finger, and the one or more malleable elements have a cumulative malleability threshold between about 0.125N to about 16N. [15] In some embodiments, the brace has malleable element(s) that are configured to overlie a user's elbow, and the one or more malleable elements have a cumulative malleability threshold between about 8N to about 900N.

[16] In some embodiments, the brace has malleable element(s) that are configured to overlie a user's shoulder, and the one or more malleable elements have cumulative malleability threshold between about 9N to about 900N.

[17] In other embodiments, the invention provides a shoulder brace for the purpose of decreasing tremors or other unintentional movement. This brace includes one or more malleable elements associated with the brace and running along at least a part of the brace that is shaped to be worn over the user's shoulder. Preferably, the one or more malleable elements include a metal wire. In some embodiments, the brace further includes a horizontal belt attached or attachable to a diagonal strap wherein said one or more malleable elements is associated with the diagonal strap. In some embodiments, the shoulder brace further includes an arm cuff attached to the diagonal strap and one or more malleable elements is associated with the arm cuff. Preferably, the one or more malleable elements yield only in response to a cumulative force greater than the force of a tremor or other unintentional movement in the shoulder joint.

[18] In some embodiments, the one or more malleable elements that are configured to overlie a particular joint have a cumulative malleability threshold that is between about 5% and about 50% of the user's maximum strength in the particular joint. Preferably, the one or more malleable elements hinder movement of the joint when the one or more malleable elements are not plastically deformed. In some embodiments, the one or more malleable elements have a cumulative malleability threshold that is between about 0.125N and about 900N. ^•lM& Inverftion further provides a method of decreasing the severity of tremors or other unintentional movement in a human being, wherein said human being has multiple joints each connecting an upper bone and a lower bone. The method includes the step of securing one or more malleable elements across a joint from the upper bone longitudinally to the lower bone. The one or more malleable elements together undergo plastic deformation when subjected to a cumulative force greater than the force of the tremor or other unintentional movement. Preferably, the one or more malleable elements that overlie the particular joint have a cumulative malleability threshold that is between about 5% and about 50% of the user's maximum strength in the joint.

[20] In some embodiments, the invention provides a brace for decreasing a user's tremors or other unintentional movements in a joint. The brace has one or more malleable elements attached to the brace, wherein the one or more malleable element undergo plastic deformation when subjected to a cumulative force greater than the strength of the tremor or other unintentional movement in the joint and wherein they further hinder movement of the joint when not plastically deformed. In some embodiments, the one or more malleable elements that overlie a particular joint have a cumulative malleability threshold between about 5% to about 50% of the user's maximum force in the joint.

BRIEF DESCRIPTION OF THE DRAWINGS

[21] Hereinafter, aspects in accordance with various embodiments of the invention will be described. As used herein, any term in the singular may be interpreted to be in the plural, and alternatively, any term in the plural may be interpreted to be in the singular.

[22] The above and further advantages of the invention may be better understood by referring to the following description in conjunction with the accompanying drawings in which:

[23] FIG. 1 illustrates the anterior and posterior view of a human being. In each drawing, the human being is standing with arms straight down and palms facing forward.

lnd 2b illustrate one embodiment of device 10. [25] FIG. 3a and 3b illustrates an anterior and posterior view of a second embodiment of device 10 in use on a human hand and wrist.

[26] FIG. 4 illustrates an anterior and posterior view of a third embodiment of device 10 in use on a human elbow.

[27] FIGS. 5a, 5b, 5c and 5d illustrate a front, back, side and top view of another embodiment of device 10.

[28] FIG. 6 shows a prior art device. [29] FIG. 7 illustrates an ideal force displacement curve. [30] Fig. 8 illustrates a modified hinge assembly 17.

[31] In each of the figures, dotted lines indicate the shape of a user (or body part(s) of the user) wearing the device 10. The same reference numbers are used to refer to similar parts of the invention in the different embodiments.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

DEFINITIONS

[32] "Approximately", "substantially" and "about" each mean within 10%, preferably within 6%, more preferably within 4% even more preferably within 2%, and most preferably within 0.5%, and even more preferably within 0% of the stated number or range.

[33] The term "cumulative", as used herein in the term "cumulative malleability threshold", refers to the sum of the forces applied to the one or more malleable elements used for a particular joint in the direction that the user would need to apply force to the malleable elements to plastically deform them while wearing brace 10 as further described below. Forces applied to malleable elements should only be added together if they are applied to malleable elements that are used on the same joint. In other words, if a brace has a first malleable element for a wrist that plastically deforms with a minimum of 10N of force, and a second malleable element for a shoulder joint that plastically deforms with a minimum of 9ON of force, the cumulative force required to deform the wrist malleable element is 10N, and the cumulative

the shoulder malleable element is 9ON. These two forces should NOT be added together to obtain a cumulative malleability threshold. Further, forces should only be added together to the extent that they are applied in the same direction. If only one malleable element is used, the cumulative malleability threshold would be the force applied to that one malleable element in that direction that the user would need to apply the force to plastically deform the malleable element while wearing brace 10, as further described below.

[34] The term "overlie", as used herein, means to cover part of the skin area that is over, under or otherwise around the joint. For example, a conventional wrist watch overlies the wrist joint on all sides, and a conventional sweater overlies an elbow joint on all sides. The overlying malleable element may be but is not necessarily in direct contact with the user's body [35] As used herein, in some embodiments, the term "overlying point" refers to the portions of the user's one or more joints or bones associated therewith over which the malleable element(s) overlie. In certain embodiments, the term refers to portions of one or more malleable elements that are configured to overlie a joint or upper and lower bones associated therewith when the brace is in use. The overlying point may include an area of any size. The user's motion is restricted at the overlying point by the malleable element(s). The malleable elements are preferably attached to the user's body (either directly or indirectly) at some or all of the overlying point(s) as further described below. [36] As used herein, the terms "treat", "treatment", and "treating" refer to a decrease in severity of the individual's tremors or other unintentional movement rather than a full recovery.

[37] The term "yield", as used herein, means to plastically deform. [38] The term "malleability threshold", as used herein, refers to the minimum force that a user wearing a brace 10 of the invention will need to exert in order to plastically deform the one or more malleable element that overlie a particular joint. The particular malleability threshold will depend on a number of factors including the material from which the one or malleable elements are constructed / formed and also on how/ where the malleable

on the user's body when the user is wearing the brace. The "malleability threshold" of a malleable element is the minimum force required to cause plastic deformation of the malleable element. Preferably, this term refers to the minimum force required to be applied at an overlying point to cause plastic deformation.

[39] The current invention provides devices and methods for decreasing the severity of an individual's tremors or other unintentional movements. The devices control or decrease tremors (or other unintentional movement) by imposing a load on one or more joints affected by the unintentional movement. Preferably, the additional work required to move limbs or bones attached to the joint is small and easily manageable by the human being wearing the device without substantially effecting rate of motion. Hence, the human being wearing one or more of these devices can quickly learn to compensate for the extra work required by the devices for voluntary movements. Imposing a load on the joints affected by the unintentional movements substantially reduces the range of motion of the unintentional movements. As a result, the current devices and methods dampen tremors or other unintentional movements without otherwise imposing a substantial limitation on user movement. [40] With reference now to the various drawing figures in which analogous elements are numbered identically throughout, a description of the preferred embodiments will now be provided. In some cases, the device for only one side of the body is shown (e.g., one hand). The skilled artisan will understand that the analogous device for the other side of the body will be a mirror image of the shown device.

[41] By way of background, the skilled artisan is well familiar with human joints. Generally, joints are each connected to at least one bone that is above the joint (i.e., closer to the person's head than the joint when the person is standing straight with arms and fingers down), and at least another that is below the joint (i.e., closer to the ground). Each joint allows articulation or movement of the bones that connect to it. The higher bone is referred to herein as "upper bone" and the lower bone is referred to herein as "lower bone". The skilled artisan will understand that a lower bone for one joint can be the upper bone for another joint and vice versa. {¥§]^■■" -PlH Sl -itiows a figure of a human being from a posterior and an anterior perspective. Thus, the inside of the elbow and palms are part of the anterior view. From the posterior view, one can see the elbows, back of hands, fingernails, back of knees, etc. When referring to "posterior" or "anterior" in describing the invention herein, reference is made to the position that the relevant part of the invention would be in upon being worn by a user.

[43] Generally, in reference to the figures (e.g. FIGS. 2a and 2b), device 10 includes a brace 12. The brace 12 may be configured to fit over any of a number of joints in the body (for example, a finger joint, a wrist, an elbow, a knee, etc.). Upper portion 13 of brace 12 is configured to overlie at least a portion of the upper bone connected to the joint, and lower portion 14 is configured to overlie at least a portion of the lower bone that is associated with the joint. For example, if the joint is a wrist, the upper portion will overlie the forearm, and the bottom portion will overlie the hand. A malleable element 11 runs longitudinally from the upper portion 13 to the lower portion 14 along at least one face of brace 12.

[44] In some embodiment, malleable element 11 is attached to the brace 12. For example, it can be attached by insertion into sleeve(s) 22. [45] Preferably, middle portion 28 is also part of brace 12. Middle portion 28 connects upper portion 13 to lower portion 14. It is shaped to fit over the joint. Middle portion 28 may include padding to fit over the joint, between the joint and the malleable element(s) 11.

[46] Materials suitable for use in embodiments of the invention are further described below. [47] Referring now to Fig. 3, other embodiment(s) of device 10 is illustrated. In certain embodiment, one or more malleable elements 11 extends over the wrist and palm. Brace 12 has an upper portion 13 and a lower portion 14. Lower portion 13 is shaped to fit over at least a part of the forearm and upper portion 14 is shaped to fit over at least a part of the hand. The illustrated brace is in fact a glove except that it has a first cavity through which four fingers are placed and a second cavity through which the thumb is inserted). The fingers are not inside the glove, and the glove extends to the forearm. Malleable element 11 runs longitudinally from upper portion 13 to lόMfpferf SlιiS"fe"lttached to each portion. Malleable element 11 is attached to brace 12, for example by insertion into sleeves 22.

[48] In some embodiments, only one malleable element 11 is used. It is attached to the portion of brace 11 that is designed to fit over the anterior part of the wrist / hand. In some embodiments, multiple malleable elements 11 are used. For example, one or more may be attached to the portion of brace

12 designed to fit over the posterior portion of the wrist and hand, and multiple malleable elements 11 may also be attached to the portion of brace 12 designed to fit over the anterior portion of the body. [49] In yet another embodiment, the brace 12 extends over one or more fingers along with one or more malleable elements 11 being positioned to overlie one or more finger joints.

[50] In some embodiments, brace 12 includes one or more fasteners 20. These fasteners fasten the malleable element 11 and/or brace 10. For example, fastener(s) 20 may be one or more conventional securing straps attached through conventional methods like buckles, Velcro closures, etc. over brace 12 and/or malleable element 11. Fastener(s) 20 may further include a D ring or similar device to help the user adjust the length of the fastener(s) 20. [51] Referring now to Fig 4, device 10 can be used to reduce tremors or other unintentional movements in the elbow. The skilled artisan understands that the human elbow connects the ulna ("lower bone") to the humerus ("upper bone"). To put it analogously, the elbow connects the forearm to the upper arm. In this embodiment, device 10 includes a brace 12. Brace 12 includes an upper portion 13 that is shaped to fit over at least a part of the upper arm, and lower portion 14 that is shaped to fit over at least a part of the forearm. Malleable element 11 runs longitudinally from upper portion

13 to lower portion 14 and is attached to each portion by insertion into sleeve 22, though other alternative attachments means will be obvious to the skilled artisan. Preferably, upper portion 13 and lower portion 14 are each a cuff that fits tightly over the appropriate limb. As in other embodiments, a middle portion 28 is preferably part of the brace 12 and surrounds the joint.

[52] In a preferred embodiment, only one malleable element 11 is used in device 10. Malleable element 11 is attached to brace 12, so that it fuW^;ICl/fR

across the elbow, and down the forearm on the posterior side when in use. Additional malleable elements 11 may be attached to the anterior and posterior of the device (as viewed when in use). The skilled artisan will understand that the elbow is controlled by more powerful muscles than the wrist and hand, so it will generally require more or thicker malleable elements 11 than when device 10 is used to dampen tremors or other unintentional movements in less powerful joints such as finger joints.

[53] Tremors are often experienced in the shoulder area. Thus, in some embodiments, brace 12 is shaped to fit over the shoulder area of a person in need of tremor suppression therein. In this embodiment, brace 12 must be shaped to overlie at least one malleable element 11 over a joint (such as the acromioclavicular joint or the glenohumeral joint).

[54] As shown in Figs. 5a-5d, brace 12 includes a cuff 1 that is configured to surround the upper arm (i.e., above the elbow) and extend up to a shoulder portion 3 configured to extend over at least a portion of the user's shoulder. A horizontal belt 2 is designed to extend around the trunk of the wearer. For example, it may be a single strap that is wrapped around the trunk and closed with Velcro or other conventionally used attachments or any other conventional way of securing a belt around a human torso. Diagonal straps 23 (which extends from the user's posterior (back) to the user's shoulder and down his/her anterior (front)) and 24a and 24b (which extend from the user's shoulder to posterior and from the user's shoulder to anterior, respectively) extend from the shoulder segment 3 and are secured to horizontal belt 2 with conventional Velcro attachments both in the anterior and posterior of the horizontal belt. The Velcro mechanism on the horizontal belt 2 and the horizontal straps 23 and 24a and 24b are not shown. In addition, diagonal straps 23, 24a, and 24b may be fed through a D ring to allow the user to adjust the length of the horizontal straps, and hence to maintain the desired tension. The cuff 1 , shoulder portion 3, horizontal belt 2 and diagonal straps 23, 24a and 24b are substantially made from a non-extensible material as further described below. Other methods for attaching the diagonal straps(s) and horizontal belt will be obvious to the skilled artisan. |ii].^/r.4#i(iPHi'imbocliments, malleable element 11a extends from the upper arm cuff 1 to the shoulder and down the diagonal strap 23. A second malleable element 11b extends from the upper arm cuff 1 to the shoulder and down the diagonal strap 24a. A third malleable element 11c extends from diagonal strap 22 to the shoulder portion 3 and down diagonal strap 24b.

[56] In addition, one or more fastener(s) 20 may be attached to or attachable around upper arm cuff 1 and /or horizontal belt 2.

Malleable element(s) 11 , 11 a-11 c (hereinafter "malleable element") [57] The invention derives from the inventor's realization that malleable damping reinforcements (malleable elerήent(s)) provide superior tremor control properties for a human being under certain conditions. A malleable damping mechanism (i.e., malleable element) is made of a material with two mechanical behaviors within the range of forces that can be exerted on the joint. The first range is elastic with a very high modulus. This large modulus has the effect of completely or almost completely arresting tremors from rest. When a force greater than the force of the tremor is applied to the joint, though, the malleable element has a zone of plasticity wherein it yields a large amount with relatively small marginal increase in force applied. It stays in the deformed position until a voluntary force is applied to the deformed malleable element. Thus, in certain embodiments, a malleable element in a brace of the invention yields elastically to wearer-applied loads up to a threshold beyond which it deforms plastically. Preferably, the brace is designed to have a plastic threshold that is achievable by the wearers to which it may be marketed. For example, some braces may be marketed only to women while others may be marketed to men. Alternately, some braces of the invention may be marketed to individuals having heights and/or weights within a certain range. In other embodiments, braces of the invention may be prescribed or chosen by the physician or other medical practitioner for each individual.

[58] The current invention accomplishes this effect by fixing a malleable element across a user's joint(s). In the preferred embodiment, the malleable element used is a metal wire. Most preferably, the metal wire is ttitiJl^'tP&ή^'iHi/iiiStiel. Alternately it can be made from a silicon-based polymer such as Silly Putty (sold by Binney & Smith in Easton, PA). In yet another embodiment, it can be made as a composite using the silicon polymer as a matrix component with copper or steel wires as reinforcement. Ultimately, any material that exhibits the desired properties discussed herein can be used.

[59] Thus, the malleable element is chosen based on the user's strength and the severity of the user's tremors or other unintentional movements. For example, the inventor made a prototype of the invention for the hand that has malleable wire elements of 1/8^th inch diameter. Thus, preferably, the malleable element provides sufficient resistance to dampen the user's tremors or other unintentional movements at one or more joints, but not so much that a user cannot move the joint by exerting force. For example, a malleable element that plastically deforms in response to at least 10% of the user's maximum strength in the applicable joint may be used for the joint. In other embodiments, a malleable element may be used if it plastically deforms in response to a force that is between about 5% and about 50% of the user's maximum strength in the joint . Thus, the skilled artisan will understand that malleable elements of varying hardness (i.e., requiring different force to bend) will preferably be used for different joints or appendages of the human body.

[60] Thus, the malleable element should preferably be chosen based on the user's strength in the joint on which the malleable element 11 will be attached. Generally, malleable materials plastically deform when sufficient force is applied to them. They stay in the deformed conformation until another force is applied to them. In other embodiments, the malleable element(s) may not be chosen for a particular user (i.e., the brace may be mass produced).

[61] In certain embodiments, a device may have malleable element(s) that overlie a particular finger joint. The malleable element(s) are preferably chosen and the device is preferably configured so that the malleable element(s) that overlie a particular finger joint can be plastically deformed by the user exerting between about 0.125N and about 16N of force on the malleable elements that overlie the particular finger joint. In another embodiment, the cumulative malleability threshold of the malleable element(s) ^■■fs¥eϊw<sl?i ^bofif B¹IiIS¹N and about 1.6N and in another embodiment, it is between about 1.6N and about 16N.

[62] As described above, the invention further provides a brace having malleable element(s) designed to overlie the wrist joint of a user. A suitable cumulative malleability threshold for the malleable element(s) that overlie a wrist range from about 0.4N to about 4ON, in other embodiments from about 0.4N to about 4N, and in yet other embodiments from about 4N to about 4ON. In yet other embodiments, the invention provides a brace having malleable element(s) configured to overlie an elbow joint. Suitable cumulative malleability thresholds for malleable element(s) that overlie an elbow joint of a brace range from about 8N to about 900N. In another embodiment, the range is from about 8N to about 9ON, between about 8N and about 240N in yet another embodiment, and between about 9ON and about 900N in another embodiment. [63] In other embodiments, the invention provides a brace having malleable element(s) that are configured to overlie a user's shoulder when in use. A suitable cumulative malleability threshold of the one or more malleable elements that overlie the shoulder is between about 9N and about 900N in one embodiment, between about 16N and about 480N in another embodiment, between about 9N and about 9ON in another embodiment, and between about 9ON and about 900N in another embodiment.

[64] In some embodiments, multiple malleable elements may overlie the same joint. In such situations, the malleable elements should be chosen so that the cumulative force required to plastically deform the malleable elements for voluntary motion falls into one or more of the above ranges as appropriate for the particular embodiment. For example, device 10 may be used to suppress tremors in the wrist. In some embodiments, a single malleable element may be used if it can be plastically deformed with a force between about 0.4N and about 4ON. Jn some other embodiments, two malleable elements may be used. For example, the first malleable element may require 2ON of force to plastically deform and the second malleable element may require 10N of force to plastically deform. It would be equally acceptable to use two identical malleable elements that each require 10N of force to deform. The multiple malleable elements may be on the same or

from each other. Similarly, three malleable elements may be used for the wrist, each requiring, for example, 10N to deform.

[65] The above paragraphs set out ranges for the amount of force that a user wearing a device of the invention would need to exert to cause the malleable element(s) that overlie a particular joint to deform. The skilled artisan will understand that the devices of the invention will be configured and particular malleable element(s) chosen based on the expected application of the device and also on the expected user and his/her condition (where possible). For example, a wrist brace for a tall male may have malleable elements with a higher malleability threshold than a wrist brace designed for women. Similarly, the skilled artisan will understand that the minimum force required to plastically deform the malleable strip(s) that surround a particular joint can be any number within the applicable ranges defined herein. The force required to deform a malleable element can be measured by a cantilever beam deflection test or other test well known to the skilled artisan. The force required to deform a malleable element can be measured by a cantilever beam deflection test or other test well known to the skilled artisan. Preferably, the force measured is in the direction that the user would apply force if she or he were wearing the brace with the malleable element..

[66] The malleable element reduces or dampens the tremor while offering relatively little resistance to voluntary movement. What resistance there is to voluntary movement is predictable and easily adjusted for, allowing for better control over the joint. [67] Malleable elements are preferably substantially linear. If the malleable element is attached by insertion into sleeve(s) 22 in brace 12, the malleable element is preferably bent at each end for insertion into the sleeves 22 as shown in certain figures herein. The skilled artisan will understand that malleable elements may be any shape, e.g., straight, curved, triangular etc. within the scope of the invention.

[68] Malleable elements can be attached by insertion into sleeves (e.g., sleeve 22) made from a nylon "ribbon" woven using large-gauge nylon thread, such as, webbing item number 530-T2 sold by National Webbing Products Co. (Garden City Park, NY). The sleeves are sewn or glued to ^■bVyBi' IMP Alt^'elSMiipi 4 sleeve can be formed by sewing an approximately rectangular piece of webbing to brace 12 so that the sleeve material is attached along two of its approximately parallel sides. Thus, the malleable element can be inserted underneath the rectangular piece in and out of the two sides that are not sewn shut. Alternately malleable element may be sewn into the brace with a conventional needle and thread, glued into place, or attached in other ways obvious to the skilled artisan.

[69] Most significantly, the malleable element(s) should be connected such that they are deformed only when the user voluntarily moves the joint to which they are applied, and so that they do not slip from their position vis a vis the joint and bones connected thereto.

[70] The exact length of the one or more malleable element(s) is not important for the various embodiments of the invention so long as the one or more malleable elements meet the other requirements herein. [71] The malleable element(s) of the invention can take on a variety of shapes. For example, as described above, it may be a wire (i.e., a single, usually cylindrical, elongated strand of drawn metal). In other embodiments, the element may be generally rectangular in shape. Yet other shapes that will work within the requirements of the invention will be obvious to the skilled artisan.

[72] The skilled artisan will further understand that malleable elements having different malleability thresholds may be used on the same brace. The malleable element chosen to overlie a particular joint (when the brace is in use) will depend on the likely force of the unintentional movement in that joint and, in some embodiments, the strength of the actual or potential user's joint. In other words, a human being may be able to bend his thumb with more force than his middle finger, and hence the malleable element that may be chosen to overlie a thumb joint may be chosen to require more force to deform than a malleable element chosen to overlie a middle finger.

Upper and lower portions 13 and 14

[73] Each of these portions must be made of a substantially non- extensible material. Non-extensible materials are commonly used in orthotics

to be sufficiently non-extensible so that the malleable element(s) 11 do not move from their position over the relevant joint and bones, except when the user is wearing the brace and intending to move the joint (i.e., bend the malleable element(s)). For example, the substantially non-extensible material could be leather but could not be spandex.

Middle portions 28

[74] In some embodiments, the brace 12 includes a middle portion 28 that is configured and shaped to fit over a particular joint. Preferably, the malleable element will run down the surface of middle portion 28. Middle portion 28 can include padding to protect the user from skin irritation or discomfort that might result from the malleable element coming into contact with the human being's skin. Most significantly, middle portion 28 must be sufficiently extensible to allow the human wearer of the device to move the joint to which the middle portion 28 is applied. Thus, if the device is for an elbow, middle portion 28 should have sufficient "give" or room to allow the user to bend and unbend his elbow.

[75] In some embodiments, middle portion 28 includes a metal shaped to fit over the upper and lower bones (that are attached to a particular joint) with an artificial joint attached to the metal and shaped to fit over the user's joint. Thus, the artificial joint allows the user to bend / unbend or otherwise move the limbs attached to the joint consistent with normal use.

Brace Reinforcements 15 [76] Preferably, the braces of the invention are reinforced. For example, they can have double stitching, be made of several layers of a material, or combine extensible materials with non-extensible materials. The goal of using such reinforcements is to provide a sturdy brace while allowing the use of softer materials which may be more comfortable to a user. Reinforcements can also be used to minimize the stretching of the brace.

Additional embodiments fffj ^■•'-iPHe' ϊϊfverilor has determined that simultaneous use of multiple devices leads to a better result for a user than use of a single brace. In some embodiment, multiple braces are rigidly linked. In other words, a lace, strap, plastic toothed fasteners (such as are used for ski boots) or any other similar device can be attached to the lower portion of one brace and upper portion of the next brace. In other embodiments, multiple devices are worn simultaneously but not physically linked.

[78] In yet another embodiment, the invention provides methods of controlling or decreasing the severity of tremors or other unintentional movement in a human being. These methods includes the step of attaching a malleable element over at least one joint of the human being. Preferably, the malleable element is attached to at least one of the posterior side of a finger, the anterior side of a wrist or hand, the posterior side of an elbow or to a shoulder. The malleable element is preferably attached so that it does not move in relation to the relevant joint, and so that it yields only when the human being voluntarily moves the bones attached to the joint. The malleable element can be applied using any embodiment of device 10 or any other similar device. The skilled artisan will understand from the present disclosure that multiple malleable elements can be attached to the joint, limb or finger as taught herein. In some embodiments, the method may further include the step of measuring the force of the unintentional movement in one or more joints experienced by the human being, and choosing the malleable element based on the force of the unintentional movement. As taught herein, the malleable element must not plastically deform in response to a force less than or equal to the force of the unintentional movement. Yet, it must plastically deform in response to a force greater than the force of the unintentional movement that is also within the ability of the user. Preferably, a malleable element is chosen that deforms in response to one of the ranges taught herein. [79] In other embodiments, brace 10 can be used by people who do not suffer from abnormal tremors. The skilled artisan understands that some or all people experience tremors. For example, hunters may wear hand brace 10 to help them hold their rifles steady while shooting. ler embodiments, the skilled artisan will understand that the same properties as of the malleable element as described above can be achieved through other mechanisms.

[81] For example,: BREG, Inc. (Vista CA) sells a functional elbow brace (product numbers C1048X (Functional Elbow Brace, S-XL), C10475 (Functional Elbow Brace Sports Cover (Universal)), and C10530 (Functional Elbow Brace Post-Op Kit). Fig. 6 shows an example of such a device. Such a brace includes an upper portion, a lower portion and a middle portion including a hinge which limits the user's movement. This device as it is currently sold has a near-frictionless hinge with stops to control range of motion. A device of the invention could be made or adapted to be similar to the BREG device except that the hinge can be configured to act as a malleable element. In other words, a hinge can be configured to so that friction between the hinge and the washer produce the force/displacement characteristic previously described in relation to other embodiments of the invention. Thus, the hinge would exhibit only elastic deformation up until the hinge slipped and then move freely (under constant force) to a final position. This is exemplified in Fig. 7. This graph shows the hinge moving freely under constant pressure at a force, e.g., a force equivalent to about the 95^th percentile of the tremor. This is only illustrative (i.e., a value other than the 95^th percentile of the force of the tremor may be chosen). At that final position, the user would release the force and the device would once again resist movement.

[82] Fig. 8 illustrates schematically the make-up of the hinge assembly 17:

[83] The parts of hinge assembly 17 are:

[84] A bolt through the assembly 17, acting as an axle for the hinge

2. A spring with spring constant k and rest length Lo

3. one arm of the hinge 4. A washer with friction coefficient c and radii Re_si_de and R_outsi_de

5. the second arm of the hinge

6. a frictionless washer

7. a nut screwed into the end of the bolt to secure the assembly. When the assembly is put together, the spring is compressed from Lo to L'. This assembly would yield to a torque on the hinge of

Tyjeid = -5*(Routside "Rinside )*(L'-l_o)*k*C

but would be rigid at torques below that.

[85] This hinge as part of a brace for a human joint, such as an elbow, provides adjustable resistance. This has useful application in the mitigation of tremors where the magnitude of the mean tremor controlling that joint is significantly below the user's maximum strength in articulating the joint.

In an elbow brace, for example, a τ_yie|_d of 300 newton-meters would approximate a 900 N malleable element. Multiple resistive hinges can be used for one joint and the τ_yj_ei_d's of the hinges are cumulative. Preferably, the hinge will be configured to exhibit the approximate same properties as described for the malleable elements in the elbow brace embodiments as described above. [86] From the foregoing detailed description of the invention it has been shown that the invention has been attained in a preferred manner.

Modifications and equivalence of the disclosed concepts such as those which readily occurred to one skilled in the art are intended to be included in the scope of the claims which are appended hereto.

Claims

1. A brace for a human joint such as a knee, elbow, wrist, shoulder, knuckle, or finger joint have an upper bone and a lower bone attached thereto, said brace comprising: an upper portion configured to overlie at least a portion of said upper bone associated with said joint when said brace is in use a lower portion configured to overlie at least a portion of said lower bone associated with said joint when brace is in use one or more malleable elements with overlying points on both said upper portion and said lower portion, wherein said Malleable Elements have a cumulative malleability threshold between about 0.125N and about 900N.

2. The brace of claim 1 , further comprising a middle portion configured to be disposed over said joint when said brace is in use, said middle portion connecting said upper portion and said lower portion.

3. The brace of claim 1 , wherein said upper portion is securable around sad upper bone; and said lower portion is securable around said lower bone.

4. The brace of claim 1 , wherein the one or more malleable elements is comprised of a metal wire.

5. The brace of claim 1, wherein said upper portion and said lower portion comprise a substantially non-extensible material.

6. The brace of claim 1 , wherein the joint is a finger, wrist, or elbow, and the one or more malleable elements is associated with the brace such that it runs substantially on the posterior side of the user's body during use.

7. The brace of claim 1, wherein the joint is the wrist, and the one or more malleable elements is associated with the brace such that it runs on the anterior side of the user's body when in use.

8. The brace of claim 1 , further comprising a fastener associated with said brace.

9. The brace of claim 1 , wherein the brace is used to control a user's unintentional; movement in the joint, and the one or more malleable elements together yield only in response to a cumulative force greater than the force of the unintentional movement in the joint.

10. The brace of claim 9, wherein the one or more malleable elements have a cumulative malleability threshold that is between about 5% and about 50% of the user's maximum strength in the joint.

11. The brace of claim 1 , wherein the one or more malleable elements hinder movement of the joint when one ore more malleable elements are not plastically deformed.

12. The brace of claim 1 , wherein the one or more malleable elements are configured to overlie a user's wrist when said brace is in use, and the one or more malleable elements have a cumulative malleability threshold between about 0.4N and about 4ON.

13. The brace of claim 1 , wherein the one or more malleable elements are configured to overlie a user's finger when said brace is in use, and the one or more malleable elements have a cumulative malleability threshold between about 0.125N and about 16N.

14. The brace of claim 1 , wherein the one or more malleable elements are configured to overlie a user's elbow when said brace is in use, and the one or more malleable elements have a cumulative malleability threshold between about 8N and about 900N.

15. The brace of claim 1 , wherein the one or more malleable elements are configured to overlie a user's shoulder when said brace is in use, and the one or more malleable elements have a cumulative malleability threshold between about 9n and about 900N.

16. A shoulder brace for the purpose of decreasing unintentional movement in a human being comprising: one or more malleable elements associated with the brace and running along at least a part of the brace that is shaped to be worn over the user's shoulder, wherein one or more malleable elements have a cumulative malleability threshold between about 9N and about 900N.

17. The shoulder brace of claim 16, wherein the one or more malleable elements comprise a metal wire.

18. The shoulder brace of claim 17, further comprising a horizontal belt attached or attachable to a diagonal strap and, wherein said one or more malleable elements is associated with the diagonal strap.

19. The shoulder brace of claim 18, wherein the shoulder brace further comprises an arm cuff associated with the diagonal strap and one or more malleable elements is associated with the arm cuff.

20. The shoulder brace of claim 16, wherein the shoulder brace is used to control unintentional movement in a shoulder joint, and the one or more malleable elements yield only in response to a cumulative force greater than the force of the unintentional movement in the shoulder joint.

21. The shoulder brace of claim 20, wherein the one or more malleable elements have a cumulative malleability threshold between about 5% and 50% of the user's maximum strength in the shoulder joint.

22. The shoulder brace of claim 20, wherein the one or more Malleable Elements hinder movement of the joint when the one or more malleable elements are not plastically deformed.

23. A method of decreasing the severity of unintentional movements in a joint, said joint being associated with an upper bone and a lower bone, said method comprising: securing one or more malleable elements across the joint from the upper bone to the lower bone, wherein said one or more malleable elements have a cumulative malleability threshold between about 0.125N and about 900N.

24. The method of claim 23 wherein the one or more malleable elements together undergo plastic deformation when subjected to a cumulative force greater than the force of the unintentional movement.

25. The method of claim 24, wherein the one or more Malleable Elements have a cumulative malleability threshold between about 5% and about 50% of the user's maximum strength in the joint.

26. A brace for decreasing a user's unintentional movement in a joint, comprising: one or more malleable elements associated with the brace, wherein the one or more malleable elements undergo plastic deformation when subjected to a cumulative force greater than the strength of the unintentional movement in the joint and wherein they further hinder the movement of the joint when they are not plastically deformed.

27. The brace of claim 26, wherein the one or more malleable elements have a cumulative malleability threshold that is between about 5% and about 50% of the user's maximum strength in the joint.

28. A brace comprising: one or more malleable elements having a cumulative malleability threshold between about 0.125n and about 900N.

29. The brace of claim 28, wherein the cumulative malleability threshold is between about 0.125N and 16N.

30. The brace of claim 28, wherein the cumulative malleability threshold is between about 0.4N and 4ON.

31. The brace of claim 28, wherein the cumulative malleability threshold is between about 8n and 240N.

32. The brace of claim 28, wherein the cumulative malleability threshold is between about 16n and 480N.