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`USOO8784343B2
`
`(12) United States Patent
`Bonutti et al.
`
`(10) Patent No.:
`
`(45) Date of Patent:
`
`US 8,784,343 B2
`Jul. 22, 2014
`
`(54) RANGE OF MOTION SYSTEM
`
`(75)
`
`Inventors: Peter M. Bonutti, Effiiigham, IL (US);
`Glen A. Phillips, Eifinghain, IL (US);
`Justin E. Beyers, Efiinghani, IL (Us)
`
`(73) Assignee: Bonutti Research, Inc., Efiingham, IL
`(Us)
`
`1/0237; A61H 1/0274; A61H 1/0296;
`A61
`A61" 1/0277; A61H 1/0281; A61H 1/0285;
`A61H 2001/0207; A61H 2001/027; A61F
`5/0102
`USPC ......... .. 601/5, 23, 24, 2&35, 40, 97, 98, 101,
`601/104; 602/5, 13, 16, 20, 26, 32, 36—38;
`432/124
`See application file for complete search history.
`
`( * ) Notice:
`
`Subject to any d“isCc11ai1:necr1, the ‘firm(ofthis
`patent is exten e or a juste un er 35
`U_S.C_ 1540)) by 112 days.
`
`(55)
`
`(21) APP1-N0-1 13/194,496
`
`(22) Filed:
`
`(65)
`
`Jul. 29, 2011
`_
`_
`_
`Prior Publication Data
`
`US 2012/0029398 A1
`
`Feb. 2, 2012
`
`_
`
`_
`
`(6 )
`
`Re1ated1U-S- ApIfI’hc1|1n/2103])5a1: fll d A
`2 Division 0 app ication o.
`12, 2005, now Pat. No. 8,012,108.
`
`,
`
`,
`
`e on ug.
`
`(51)
`
`Int CL
`A61H 1/02
`A61F 5/01
`A63B 23/00
`(52) US‘ CL
`CPC
`
`(2006.01)
`(2006.01)
`2006.01
`(
`)
`A61F 5/0102 (2013.01);A61H1/0218
`(2013.01); A61HI/0274 (2013.01); A63B
`20257006 (201301). A61H 1/0237 (201301).
`A61F 2005/0139 (2013.01); A6JF 2005/0137
`(2013.01);A61H1/0296 (2013.01);A6IH
`220]/1607(2013.01);A61F2005/0153
`(201301)
`_
`.
`.......i1601/5, 601/33, 602/16
`....
`ass ca on eai-c
`CPC ....... .. A61H 3/00; A61H 1/02; A61H 1/0218;
`
`ie
`
`0
`
`(58)
`
`References Cited
`U.S. PATENT DOCUMENTS
`433,227 A
`7/1890 B
`k
`2,191,283 A
`2/1940 L§§°g¥§11ow
`2,206,902 A
`7/1940 Kost
`2,223,276 A
`11/1940 Ward
`(Continued)
`
`CA
`CA
`
`FOREIGN PATENT DOCUMENTS
`2066151
`10/1992
`2065669
`10/1993
`
`(Continued)
`OTHER PUBLICATIONS
`Smith & Nephew Doiijoy; Quadrant Shoulder Brace; http://www.
`shouldencom/quadra.nt.htm; Jun. 5, 1998; p. 1.
`,
`(cmlllued)
`,
`,
`Primary Examiner — Quang D Thanh
`(57)
`ABSTRACT
`_
`_
`,
`_
`_
`The application is directed to devices and methods useful for
`""Pa“d“ig ‘he.range§fm°“°“F:’fJ°"f1t5§’a5ed °nP13“1°1I?1‘~’S 91°
`“gigs ‘fi:Xa‘1°n.a‘1b §‘*‘=Pa~fi Xpanfle .’.a“t$e ° ‘E:°“°?h1St
`3° tef. VP acmgdtg YP. t5E“ear §J°1t‘f1 131??“ 1.095
`a
`stre c titssue iroun
`zgtofin .
`venflxn/lv find e evibce istin any
`one posi ion, 1 can imp
`orces on e o ymein ers ourge
`them to Stretch surrounding tissue even further‘
`4 Claims, 19 Drawing Sheets
`
`1 9
`
`18X (
`
`21
`
`20
`
`18
`
`/10
`
`14
`
`P
`
`12
`
`16
`
`23
`
`14
`
`
`
`

`
`US 8,784,343 132
`Page 2
`
`(56)
`
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`2,832,334
`3,083,708
`3,338,237
`3,351,055
`3,548,818
`3,580,248
`3,698,389
`3,701,349
`3,724,452
`3,760,056
`3,795,243
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`3,856,004
`3,955,565
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`4,039,183
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`4,788,941
`4,790,301
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`
`3>>3>>f>>I>>3>>i>I>3>.>I>Z>D>>3>>>3>>D>>3>3>3>3>3>>>>>I>I>3>D>D>f>I!>>>>>>>3>Z>I>I>B>I1>>>I>3>IJ>I1>Z>>D'>i>>3>D>>i>3>3>I!>>>>>3>
`
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`5,197,942
`5,201,702
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`5,211,161
`5,213,094
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`5,218,954
`5,226,245
`5,232,435
`5,252,101
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`5,261,125
`5,277,695
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`5,364,323
`5,365,947
`5,370,133
`5,372,597
`5,376,091
`5,378,223
`5,385,536
`
`11>>i>>3>i>>D>{>>>3>1>>>I>IJ>T1'33>3>I>3>D>3>>>>3>>3>>3>>>>I>>3>>I>3>3>3>>3>>>D>>i>I1>I1>I1>I>I>>3>D>3>>Il>D>3>i>i>Il>D>D>3>il>I1>3>>{>B>D>3>D>D>
`
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`
`Funkhouser, Jr.
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`Grcllas
`Bonutti
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`Stef
`Bonutti ......................... .. 601/33
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`
`Lantz 1001.2
`
`

`
`US 8,784,343 B2
`Page 3
`
`(56)
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`3>>i>i>I>>?>>D>3>D>§!>D>;I>3>3>3>>>¥I>I1>>i>>§>i>>>£1>D>>>3>D>3>ZI>§>>>>3>i>I1>3>i>>>i>>3>I1>3>3>3>>3>3>Il>3>3>3>D>3>D>3>3>>3>D>I>D>>3>I>D>I>
`
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`
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`Bonutti et al.
`Bonutti et a1.
`Bonutti et al.
`Bonutti et a1.
`Glombik et a1.
`Bonutti et al.
`Bonutti et al.
`Bonutti
`Bonutti
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`FOREIGN PATENT DOCUMENTS
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`DE
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`8806231 U
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`0181668 A1
`0380060
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`2661333
`4261657 A
`2001087296
`1158195 A1
`1426580 A1
`1671296 A1
`8804543
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`10/1924
`1/1980
`6/1988
`5/1983
`5/1986
`8/1990
`10/1992
`10/1991
`9/1992
`4/2001
`5/1985
`9/1988
`8/1991
`6/1988
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`References Cited
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`
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`
`OTHER PUBLICATIONS
`
`Smith & Nephew Donj oy; Specifications, Quadrant Shoulder Brace;
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`
`Smith & Nephew Donjoy; Ultraslingg http://www.shou1der.com/u1-
`tra.htm; Jun. 5, 1998; p. 1.
`Neporent et a1.; Weight Training for Dummies; 1997; pp. 3.
`Dynasplint Systems, Inc.; Practitioner Information for Dynasplint
`LPS Orthosis—Knee Extension; pp. 6.
`UE Tech; Technology Meeting Human Needs; Rehabilitation Cata-
`log Vol. 7; pp. 28.
`Taber’s Cyclopedic Medical Dictionary 16th Edition; 1989; defini-
`tion of “distraction”; pp. 2.
`
`* cited by examiner
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`US 8,784,343 B2
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`1
`RANGE OF MOTION SYSTEM
`
`CROSS REFERENCE TO RELATED
`APPLICATION
`
`This patent application is a divisional application of U.S.
`patent application Ser. No. 11/203,516 filed onAug. 12, 2005,
`which issued as U.S. Pat. No. 8,012,108.
`
`FIELD OF THE INVENTION
`
`The present invention relates to an adjustable orthosis for
`stretching tissue in the human body. In particular, the present
`invention relates to an adjustable orthosis which utilizes the
`principles of stress relaxation and creep for stretching tissue
`such as ligaments, tendons or muscles around a joint during
`flexion or extension of the joint.
`
`BACKGROUND OF THE INVENTION
`
`In a joint, the range of motion depends upon the anatomy
`and condition of that joint and on the particular genetics of
`each individual. Manyjoints primarily move either in flexion
`or extension, although some joints also are capable of rota-
`tional movement in varying degrees. Flexion is to bend the
`joint and extension is to straighten the joint; however, in the
`orthopedic convention some joints only flex. Some joints,
`such as the knee, may exhibit a slight internal or external
`rotation during flexion or extension. Other joints, such as the
`elbow or shoulder, not only flex and extend but also exhibit
`more rotational range of motion, which allows them to move
`in multiple planes. The elbow joint, for instance, is capable of
`supination and pronation, which is rotation ofthe hand about
`the longitudinal axis ofthe forearm placing the palm up or the
`palm down. Likewise, the shoulder is capable of a combina-
`tion ofmovements, such as abduction, internal rotation, exter-
`nal rotation, flexion and extension.
`Most people do not appreciate the complexity of joint
`motion until something goes wrong, such as when an injury
`results in lost range of motion. When a joint is injured, either
`by trauma or by surgery, scar tissue can form or tissue can
`contract and consequently limit the range of motion of the
`joint. For example, adhesions can form between tissues and
`the muscle can contract itself with permanent muscle con-
`tracture or tissue hypertrophy such as capsular tissue or skin
`tissue. Lost range ofmotion may also result from trauma such
`as excessive temperature (e.g., thermal or chemical burns) or
`surgical trauma so that tissue planes which normally glide
`across each other may become adhered together to markedly
`restrict motion. The adhered tissues may result from chemical
`bonds, tissue hypertrophy, proteins such as Actin or Myosin
`in the tissue, or simply from bleeding and immobilization. It
`is often possible to mediate, and possibly even correct this
`condition by use of a range-of-motion (ROM) orthosis, but
`the longer the period of stiffness or loss ofmotion the greater
`the time interval and the force required to regain lost range of
`motion. Therefore, it is beneficial to treat the tissue orjoint as
`early as possible. For example, a ROM orthosis may be
`applied immediately after surgery or as soon as the stiffness
`problem is diagnosed.
`ROM orthoses are used during physical rehabilitative
`therapy to increase the range-of-motion of a joint. Addition-
`ally, they also may be used for tissue transport, bone length-
`ening, stretching of skin or other tissue, tissue fascia, and the
`
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`A number ofdifferent configurations and protocols may be
`used to increase the range of motion of a joint. For example,
`stress relaxation techniques may be used to apply variable
`forces to the joint or tissue while in a constant position.
`“Stress relaxation” is the reduction of forces, over time, in a
`material that is stretched and held at a constant length. Relax-
`ation occurs because of the realignment of fibers and elonga-
`tion of the material when the tissue is held at a fixed position
`over time. Treatment methods that use stress relaxation are
`serial casting and static splinting. One example of devices
`utilizing stress relaxation is the Joint Active System, which
`uses a rack and pinion gear to move and hold the joint in a
`constant position.
`Sequential application of stress relaxation techniques, also
`known as Static Progressive Stretch (“SPS”) uses the biome-
`chanical principles of stress relaxation to restore range of
`motion (ROM) in joint contractures. SPS is the incremental
`application of stress relaxation--stretch to position to allow
`tissue forces to drop as tissues stretch, and then stretching the
`tissue further by moving the device to a new position--re-
`peated application of constant displacement with variable
`force. In an SPS protocol, the patient is fitted with an orthosis
`about the joint. The orthosis is operated to stretch the joint
`until there is tis sue/muscle resistance. The orthosis maintains
`thejoint in this position for a set time period, for example five
`minutes, allowing for stress relaxation. The orthosis is then
`operated to incrementally increase the stretch inthe tissue and
`again held in position for the set time period. The process of
`incrementally increasing the stretch inthe tissue is continued,
`with the pattern being repeated for a maximum total session
`time, for example 30 minutes. The protocol can be progressed
`by increasing the time period, total treatment time, or with the
`addition of sessions per day. Additionally, the applied force
`may also be increased.
`Exemplary ortho ses that utilize the stress relaxation and/or
`SPS protocols include, but are not limited to, those described
`in U.S. Pat. No. 6,921,377 (“Finger Orthosis” , U.S. Pat. No.
`6,770,047 (“Method of using a neck brace”), U.S. Pat. No.
`6,599,263 (“Shoulder Orthosis”), US. Pat. No. 6,113,562
`(“Shoulder Orthosis”), U.S. Pat. No. 6,503,213 (“Method of
`using a neck brace”), U.S. Pat. No. 6,502,577 (“Finger Ortho-
`sis”), U.S. Pat. No. 5,848,979 (“Orthosis”), US. Pat. No.
`5,685,830 (“Adjustable Orthosis Having One-Piece Connec-
`tor Section for Flexing”), U.S. Pat. No. 5,611,764 (“Method
`of Increasing Range of Motion”), U.S. Pat. No. 5,503,619
`(“Orthosis for Bending Wrists”), U.S. Pat. No. 5,456,268
`(“Adjustable Orthosis”), U.S. Pat. No. 5,453,075 (“Orthosis
`with Distraction through Range of Motion”), U.S. Pat. No.
`5,395,303 (“Orthosis with Distraction through Range of
`Motion”), U.S. Pat. No. 5,365,947 (“Adjustable Orthosis” ,
`U.S. Pat. No. 5,285,773 (“Orthosis with Distraction through
`Range of Motion”), U.S. Pat. No. 5,213,095 (“Orthosis with
`Joint Distraction”), and U.S. Pat. No. 5,167,612 (“Adjustable
`Orthosis”), and U.S. Publication No. 200402151 11 (“Patient
`monitoring apparatus and method for orthosis and other
`devices”), all to Bonutti and herein are expressly incorporated
`by reference in their entirety. It should be noted that the SPS
`protocol is disclosed in a number of the above-identified
`patents. It should be further noted that the mark STATIC
`PROGRESSIVE STRETCH COMPANY is a registered
`trademark of Joint Active Systems, Inc (Efiingham, lll.).
`Another treatment protocol uses principles of creep to
`apply a constant force over variable displacement. In other
`words, techniques and devices utilizing principles of creep
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`3
`mation), and the material is kept under a constant state of
`stress. Treatment methods such as traction therapy and
`dynamic splinting are based on the properties of creep.
`One potential disadvantage ofusing a static load, however,
`is that the amount offorce needed to effect tissue stretching or
`creep may change over time. Forinstance, while a 10 lb force
`may initially provide desirable results in the beginning of the
`treatment protocol, it may be insuflicient after the tissue has
`begun to stretch. Likewise, the amount of force needed in the
`beginning of the treatment protocol may be too much force
`for use in later stages of the protocol.
`Exemplary orthoses utilizing the creep protocol include
`U.S. Pat. Nos. 5,167,612, 5,365,947, and 5,456,268 entitled
`“Adjustable Orthosis,” and U.S. Pat. No. 5,685,830 entitled
`“Adjustable Orthosis having one-piece connector section for
`flexing” all to Bonutti; U.S. Pat. No. 6,413,231, entitled
`“Device To Assist In Therapy Of Patient Who Has Limited
`Jaw Opening,” U.S. Pat. No. 5,645,521, entitled “Shoulder
`Physical Therapy Device;” U.S. Pat. No. 5,070,868, entitled
`“Adjustable Splint,” and U.S. Pat. No. 4,947,835, entitled
`“Adjustable splint assembly;” all to assigned to Dynasplint
`System Inc. and all of which herein are expressly incorpo-
`rated by reference in their entirety. Another example of
`orthoses utilizing the creep protocol include U.S. Pat. No.
`5,472, 410 to Hammersly, entitled “Adjustable Flexion and
`Extension Joint Orthoses,” and U.S. Pat. No. 5,437,619 to
`Malewicz et al., entitled “Range-of-Motion Splint with
`Eccentric Spring,” both of which are expressly incorporated
`by reference in their entirety.
`In the past, treatment protocols and related devices utilized
`either stress relaxation or creep, but not both.
`
`SUIWMARY OF THE INVENTION
`
`The presentinvention is directed to devices and methods of
`using a combination of stress relaxation and creep protocols
`to treat contractures. Without being bound to a particular
`theory, it is believed that combining these loading conditions,
`such as by applying them in a Static Progressive Stretch
`mode, may reduce the overall treatment time or may improve
`the overall amount of tissue stretch achieved.
`One embodiment of the invention relates to a device for
`stretching tissue around a joint between two pivotable or
`rotatable body portions near a joint. The device has two arm
`members that are connected to the body portions near the
`joint. A drive assembly is used to move one arm member
`relative to the other so that the arm can be moved, for instance,
`from a first position to a second position. The drive assembly
`also may be capable of moving the arm to a third, fourth, or
`even more positions or configurations.
`A force application assembly associated with one of the
`arm members then imparts forces to one ofthe body portions.
`The force application assembly may be interposed between
`an arm member and body portion, and may include one or
`more springs, such as a linear spring, leaf spring, helical
`spring, torsional spring, or the like, that help impart forces on
`the patient’s body. Alternatively, the force application assem-
`bly may use a fluid bladder or have resilient material that
`imparts forces on the body.
`The force application also could be dynamic tension. The
`dynamic tension could be a known spring which can have
`adjustable control, vary the force, could have a control knob
`or could be electrically controlled or could be controlled via
`sensor. Springs and other components used in the present
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`adjustable controllable dynamic system that allows electrical
`feedback or compliance monitoring of the system. Some
`examples offeedback or monitoring systems that may be used
`with the invention are described in U.S. Publication No.
`20040215111 entitled “Patient Monitoring Apparatus and
`Method for Orthosis and Other Devices” to Bonutti et al., the
`entirety of which is incorporated by reference.
`The forces imparted to the body may be substantially con-
`stant, or alternatively may vary in degree, force profile, or
`duration. The device may hold the second arm in any of its
`positions for a predetermined period of time, until a desired
`amount of tissue stretch relaxation or creep is achieved, or
`until some other parameter is met. In some embodiments, one
`or more cuffs are used to attach one or more arm members to
`the patient’s body. Depending on the desired treatment, a cuff
`and force application assembly may be configured to impart
`torsional forces on one of the body portions instead of, or in
`addition to, imparting bending forces. Axial forces may also
`be applied either alone or in combination with other types of
`forces.
`The invention also is directed to methods of increasing the
`range ofmotion on connective tissue between first and second
`body portions interconnected by a joint. In particular, one
`embodiment of the invention involves connecting a first and
`second arm member with a first and second body portion,
`respectively. One of the arm members may then be moved
`from a first position to a second position, utilizing the prin-
`ciples of stress relaxation to stretch the tissue about the joint.
`While in this second position, a force may be imparted on a
`body member to urge it to move even further than the second
`position, utilizing the principles ofcreep to further stretch the
`tissue about the joint. This force may be applied throughout a
`treatment interval, or may vary in degree, force profile, or
`duration. Some embodiments involve moving the body mem-
`ber to third, fourth or even more positions. These multiple
`positions may gradually increase in a particular direction or
`range to account for stretching of the body tissue.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`A more complete understanding of the present invention,
`and the attendant advantages and features thereof, will be
`more readily understood by reference to the following
`detailed description when considered in conjunction with the
`accompanying drawings wherein:
`FIG. 1A is a schematic diagram of an orthosis including a
`drive assembly and a force application assembly;
`FIG. 1B is a schematic diagram of the orthosis of FIG. 1A
`including flexible connecting section;
`FIG. 1C is a schematic diagram of the flexible connecting
`section of FIG. 1B including an accordion section; '
`FIG. 2A is a schematic diagram of a force application
`assembly of the orthosis of FIG. 1;
`FIG. 2B is a schematic diagram of an adjustable force
`application assembly of the orthosis of FIG. 1
`FIG. 2C is a schematic diagram of another adjustable force
`application assembly of the orthosis of FIG. 1
`FIGS. 3A-3F depict alternative force elements for use in
`the force application assembly of FIG. 2A;
`FIG. 4 depicts another force application assembly of the
`orthosis of FIG. 1;
`FIG. 5A depicts a sectional view of the force application
`assembly of FIG. 4;
`FIG. SB depicts sectional view of the force application
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`5
`FIG. 8 depicts another exemplary orthosis;
`FIG. 9 depicts a further exemplary orthosis;
`FIG. 10 depicts a drive assembly ofthe orthosis of FIG. 9;
`FIG. 11 depicts an isometric View of a still further exem-
`plary orthosis;
`FIG. 12 depicts a partial sectional View of the orthosis of
`FIG. 11;
`FIG. 13 depicts a sectional View of a drive assembly of the
`orthosis of FIG. 11;
`FIG. 14 depicts an orthosis including a pair of force appli-
`cation assemblies;
`FIGS. 15A and 15B depict examples of force profiles that
`can be applied by the force application assembly
`FIG. 16 depicts another orthosis of the present invention;
`FIG. 17 depicts a control assembly of the orthosis or FIG.
`1 6;
`FIG. 18 depicts an orthosis ofthe present invention includ-
`ing a first and second force application assembly;
`FIG. 19 depicts a telescoping arm member for the orthosis
`of the present invention;
`FIG. 20 depicts an orthosis ofthe present invention includ-
`ing multiple drive assemblies; and
`FIG. 21 depicts a neck orthosis in accordance with the
`present invention.
`
`DETAILED DESCRIPTION OF THE INVENTION
`
`The present invention relates to a ROM device for stretch-
`ing tissue, such as the connective tissue around a joint,
`between first and second body portions utilizing the prin-
`ciples ofstress relaxation and creep. As previously identified,
`treatment protocols based on principles of creep involve con-
`tinued tissue movement and deformation under the applica-
`tion of constant loading, while treatment protocols based on
`principles of stress relaxation involve varying loading and
`constant displacement. Techniques utilizing principles of
`creep therefore allow joint position to change over time as
`tissue stretches in response to the applied load, whereas tech-
`niques utilizing stress relaxation maintain a constant joint
`position while allowing the applied load to vary over time»-
`usually to diminish or lessen as the tissue stretches. Relax-
`ation occurs because of the realignment of fibers and elonga-
`tion of the material when the tissue is held at a fixed position
`over time. As explained in greater detail below, the invention
`also utilizes the principles of Static Progressive Stretch to
`provide a sequential application ofstress relaxation and creep
`to the treated tissue. Using the following detailed description
`and examples, skilled artisans will recognize that it is possible
`to modify currently existing devices to include features ofthe
`present invention.
`Ajoint and the first and second body portions can define on
`one side (the flexor side) of the joint an inner sector which
`decreases in angle as the joint is flexed (bent) and on the
`opposite side (the extensor side) of the joint an outer sector
`which decreases in angle as the joint is extended (straight-
`ened). The orthosis of the present invention is aflixable to
`either the flexor or extensor side of the joint for treatment of
`flexion or extension contractures. In flexion and extension the
`joint may also exhibit slight internal or external rotations. As
`noted above, some joints may also be capable of even greater
`rotation. While the examples discussed herein primarily illus-
`trate aspects of the invention in the context of increasing
`range of motion for flexion and extension, they also may be
`used to increase rotational range of motion.
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`at least partially restricts motion ofthe secondbody portion in
`at least one direction (e.g. fiexion, extension, or rotation),
`utilizing the principles ofstress relaxation to stretch the tissue
`around the joint.
`The orthosis further comprises a force application assem-
`bly that can apply loading to the tissue while the device is in
`one or more of its angular positions. The force applied by the
`force application assembly preferably is in a direction where
`joint or tissue movement is not fully restricted by the drive
`assembly or other components of the device. As explained
`below, the force application assembly can provide a constant
`force to the second body portion, may be capable of permit-
`ting adjustment of the force applied to the second body por-
`ti