Hand held orthosis having a flexible enclosure and method of utilization

A hand orthosis supporting a patient's thumb and fingers spaced apart and separated from contact with the palm of the hand, including an elongated body having a palm surface, a thumb portion, and a finger support portion. The elongated body includes a plurality of unequal cross-sectional areas spaced along the axial length between a distal end and a base end. A plurality of finger concavities are angled in helical orientation along the orthosis, including spaced apart concavities for each finger and the patient's thumb. Each finger and thumb concavity is angled non-perpendicular relative to the orthosis axial length to retain the fingers and thumb spaced apart, curved in a relaxed orientation, and apart from the palm of the hand during extended periods of time without impeding hand or wrist motion. A method of extended use for the hand orthosis is also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

Not Applicable

Not Applicable

BACKGROUND OF THE INVENTION

1. Field of Invention

This invention pertains to a hand held orthosis for use in surgical, rehabilitative and geriatric settings. More particularly, this invention pertains to a resilient hand held orthosis positioned to maintain separation between a patient's fingers and palm during medical procedures and rehabilitative procedures relating to the patient's hands, arms, and shoulders.

2. Description of the Related Art

In the fields of hand exercising and rehabilitative procedures relating to hands, it is known that a person can maintain and strengthen the muscles of his/her hands by repeatedly gripping hand exercise devices. It is further known in the field of surgical procedures conducted on a patient's hand, wrist, arm and/or shoulder, that an anesthetized patient retains the ability to grip and sequentially contract his/her hands during surgery, thereby incurring any one or more of: deformation of fingers, formation and maintenance of a rigid fist, and/or scarring of the palmar surface by fingernails when fingers are not restrained during surgery and post-surgical recovery. Various devices have been developed to accomplish strengthening of a user's hands, but in non-surgical settings. As provided in the following U.S. Patents, additional devices have been developed to maintain separation of fingers from the palm of the hand, typically by utilizing a rigid planar surface, a cylindrical body, or by positioning the fingers of a hand in a glove which separates each finger from direct contact with the palm.

Of the above listed patents, the '569 issued to S. M. Gooter, discloses a contoured grip designed for short periods of exercises by repetitive squeezing and releasing by either right or left hands. The grip includes an upper, intermediate head portion against which the thumb is pressed against for strengthening exercises. The contoured grip includes a lower grip body having two mirror image halves of convex sides which lie on either side of an imaginary plane intersecting the grip body. The lower width and upper width of the grip handle are about equal, thereby providing an oval grip body having mirror image halves to allow for holding in either a right hand or a left hand, in either an upward or downwards orientation. When squeezing the grip body, the user's fingers are positioned in generally side-by-side, parallel, and touching engagement within finger indents extended across a forward portion of the grip body. The finger indents are generally perpendicular to the length axis of the grip body, therefore the finger indents are not angled relative to each other to form various angles of orientation and/or various radii of curvature for each of the user's fingers when in relaxed positions. Further, the grip body does not include a thumb indent which is angled on a surface opposed from the finger indents, thereby detracting from comfortable holding of the grip body over long periods of time.

Mainiero, in the '008 patent, discloses a golf grip training and exercise device designed for short periods of gripping by either a right or left hand. The golf grip includes a body having symmetrical right and left halves and having an oval cross-section which retains the same diameter and width along the length of the body. The right and left halves are mirror images, with three finger indentations and a thumb indentation in generally the same positions on either half, therefore allowing gripping in a right or a left hand. Due to the limits to the number of indentations, at least one finger is not accommodated in an indentation on the right or left halves during gripping exercises. Further, by maintaining the same diameter and width along the length of the golf grip body, the lesser curved radius of the little finger is not readily accommodated by the finger end of the golf grip, even though the golf grip is utilized over short periods of time.

An ambidextrous hand orthosis is disclosed by Betcher in the '168 patent, providing a hand orthosis having an oblate spheroid shape on which the patient's fingers are positioned in separate finger groove in order to separate the fingers from the patient's palm during sterile medical procedures. The hand orthosis includes two thumb grooves parallel and adjacent to opposed sides of finger grooves, and includes means for fastening of a pair of overlapping connectable straps for encircling the patient's wrist when the hand orthosis is positioned between the patient's fingers and palm. The oblate spheroid shape of the hand orthosis is appropriate for most adult patients undergoing medical procedures, but alternative shapes are needed for young patients with small hands and/or aged patients with arthritic hands and who undergo extended and repetitive periods of rehabilitative procedures.

There exists a need to provide a hand held orthosis which is readily sterilized for use in a surgical setting, and provides separation of each finger from adjacent fingers while preventing the fingers from contacting the palm of the hand. Further, a need exists for a hand held orthosis configured for retention for extended time periods in a hand disposed in a relaxed orientation for a patient undergoing surgical procedures on an upper extremity or a person undergoing rehabilitation of either hand and/or fingers. In addition, a need exists for a hand held orthosis configured for retention in each hand over extended time periods for a comatose patient or a patient in a geriatric setting.

BRIEF SUMMARY OF THE INVENTION

According to one embodiment of the present invention, a hand orthosis is disclosed for support of a patient's thumb and fingers in spaced apart orientation and separated from contact with the patient's palm or inner wrist. The hand orthosis includes an elongated body having about three circumferential sections including a palmar surface, an adjacently disposed thumb support surface, and a finger support surface opposed from the palmar surface. The elongated body includes a plurality of unequal diameters spaced apart and distributed along its major axial length extended from a distal end, through a mid-segment, and ending at a base end positionable against the patient's palm proximal of but apart from the wrist.

A plurality of finger concavities are angled in helical orientation across the finger support surface, the finger concavities include a first or index finger concavity angled toward the distal end, a second and third finger concavity angled across the mid-segment, and a fourth finger concavity angled toward the base end. Each finger concavity is angled to be non-perpendicular relative to the major axial length of the elongated body.

A thumb concavity originates proximal of the mid-segment and adjacent of the palmar surface, with the thumb concavity angled to extend proximal of the distal end. The angle of the thumb concavity is substantially opposed in orientation from the index finger concavity, such that the thumb concavity readily cradles the patient's thumb in separation from the index finger and each of the patient's second through fourth fingers when in encircling relationship on respective thumb support and finger support surfaces of the elongated body.

The palmar surface of the elongated body is positioned against the patient's palm to allow each finger and the thumb to be cradled in spaced-apart, curved and relaxed orientation in respective concavities on the respective surfaces of the elongated body. The elongated body is retained between the patient's palm, thumb, and fingers when each are maintained in spaced apart and relaxed orientation. The elongated body remains within the patient's hand whether the fingers are clenched in repetitive constricting movements to grip the body, or the fingers remain relaxed but curved around the elongated body. The hand held orthosis does not impede lateral or pivoting movements of the hand relative to the wrist due to the lack of an attaching member extended from the elongated body base end for contacting against the patient's wrist. A method of use is also disclosed for utilizing the hand held orthosis in sterile surgical environments, in a rehabilitative environment with young patients having small hands, and/or with aged patients having arthritic hands and undergoing long term rehabilitation.

DETAILED DESCRIPTION OF THE INVENTION

A hand orthosis10is disclosed for support of a patient's thumb and fingers in spaced apart orientation and separated from contact with the patient's palm and inner wrist surfaces. The hand orthosis10is configured in a right-handed embodiment (seeFIGS. 1A,1B, and3), and a left-handed embodiment10′ (seeFIGS. 4-7). The right-handed and left-handed embodiments are mirror images of each other to accommodate against either hand and respective thumb and finger digits, therefore much of the following discussion will be referencing the right-handed embodiment. Each hand orthosis1010′ includes an elongated body12having a length-wise axis12″ extending from a bulbous shaped distal end12′ having a first width22of a first minor axis12″', through a mid-portion having a second width22′ of a second minor axis, and ending at a base end20having a third width22″ of a third minor axis of a lesser width than either the first width22or second width22′. One of the unique features of the elongated body12includes the distal end12′ and base end20are shaped in non-symmetrical oval configurations when viewed from respective ends (seeFIGS. 2A-2D). Another unique feature is the wide portion of first minor axis12′″ is rotated about thirty degrees from alignment with the second minor axis, which is rotated about thirty degrees from alignment with the wide portion of third minor axis of the base end20(seeFIGS. 1A and 2D).

The elongated body12includes convoluted exterior surfaces consisting of three sectors of curved surfaces extending the length of the orthosis10,10′, including a thumb support surface14curving to join with a palmar surface18, which curves to join with a finger support surface16extending radially to join with the thumb support surface14. Along its major axial length12″, the elongated body12includes at least three areas of different cross-sectional areas and each area having a minor width axis which is rotated to not be aligned with either adjacent minor width axis of the elongated body12. The distal end12′ includes a rounded end which expands to a first width22of about two inches and a depth22″″ of about two inches proximal of the distal portion of the thumb concavity24and the distal portion of the index finger concavity32(seeFIGS. 2A and 2B). A second width22′ of about one and three-quarter inch is proximal of a mid-segment40(seeFIG. 2C). The second width22′ is measured along a second minor width axis which is rotated about thirty degrees from alignment with the minor width axis of the first width22. A third width22″ is measured along a third minor width axis proximal of the base end20(FIG. 2D), and is rotated between about eighty to about ninety degrees. The base end20is sized in width to allow the little finger to encircle the end without contacting the base of the thumb. The base end20length extends past an encircling little finger during use, and is sized to fit against the base of the palm base and proximal of, but not contacting, the inner wrist W surface of the patient. Alternative width and length dimensions are utilized for an elongated body12used with large hands or small hands.

The contour of the thumb concavity24originates26proximal of the mid-segment40adjacent to the palmar surface18, and is angled across the thumb surface14to end28proximal of the distal end12′. An angle28′ of about thirty degrees from the major axis12″ provides for a patient's thumb to be readily cradled in a relaxed orientation by the thumb concavity24. The thumb cradled by concavity24is directed toward the end of the patient's index finger when the finger is cradled in the second concavity32, while both index finger and thumb are in opposed encircling relationship on respective finger support surface16and thumb support surface14of the elongated body. A properly sized orthosis10,10′ will maintain separation of a thumb from the end of the index finger by a lengthwise curved ridge30,30′,30″ of resilient material which extends longitudinally from the distal end12′ to end proximal of the base end20.

In order to separately cradle each finger and to maintain separation of the patient's fingers from the palm of the hand, a plurality of finger concavities32,42,52,62are oriented in angled and generally helical orientation across the finger support surface16(seeFIGS. 1A,1C and4). The index finger concavity32originates34proximal of a distal end of the palmar surface18and is curved opposite of the thumb concavity24with termination36proximal of the distal end12′. The index finger concavity32is angled38about thirty degrees from the major axis12″ and toward the distal end12′. A second finger concavity42is separated by a second ridge42′ apart from the index finger concavity32. The second finger concavity42originates44proximal of the palmar surface18, curves to a termination46proximal of the thumb surface14, and is angled48across the mid-segment40toward thumb concavity24but is separated therefrom by an extension of lengthwise ridge30,30′ (seeFIGS. 1A and 1C). A third finger concavity52is separated by a third ridge50from second finger concavity42. The third finger concavity52originates54proximal of the palmar surface18, curves to a termination56proximal of the mid-segment40, and is angled58across a middle portion of the finger support surface16. A fourth finger concavity62is separated by a fourth ridge60from third finger concavity52. The fourth finger concavity62originates64proximal of the palmar surface18, curves to a termination66proximal of the base end20, and is angled68toward the base end20. Each finger concavity is angled to form a curved surface which is not generally perpendicular relative to the major axial length12″ to accommodate curvature of a patient's thumb and fingers cradled in respective concavities24,32,42,52,62.

The palmar surface18of the elongated body12is positioned against the patient's palm to allow each finger and the thumb to be cradled in spaced-apart, curved and relaxed orientation in respective concavities on the respective surfaces of the elongated body. The elongated body12is inherently retained between the patient's palm, thumb, and fingers when the fingers and thumb are maintained in spaced apart and relaxed orientation. The elongated body12also is retained within the patient's hand whether the fingers are clenched in repetitive constricting movements to grip the body, or the fingers remain relaxed but curved around the elongated body. The hand held orthosis10,10′ does not impede lateral or pivoting movements of the hand at the wrist due to a lack of attaching members or straps extended from the base end20for contacting the wrist.

Each adjacent thumb and finger concavity24,32,42,52,62is separated by a plurality of non-aligned ridges30,30′,30″,50,60on the surface of the elongated body12for maintaining separation of each finger apart from adjacent fingers, maintaining each finger apart from the thumb, and each digit maintained apart from the palm of the hand. The spaced apart configuration of the patient's fingers, thumb, and palm is maintained regardless of the patient being semi-conscious or unconscious, and regardless of involuntary hand or finger movements during surgery, physical therapy, or while the patient is reclining. Illustrated inFIG. 7is a hand held orthosis10′ readily retained in the patient's hand with full coverage by a tubular enclosure70. The presence of the orthosis10′ does not impede intravenous delivery84of fluids during surgery. Illustrated inFIG. 8is a reproduction of an X-ray image of a patient's hand90after a lengthy surgical procedure in which the held orthosis10,10′ was not utilized, with clenching of finger and thumb digits against the palm of the hand. While a patient is unconscious or semiconscious for extended periods, the patient's fingers will clench together and contract, allowing fingernails to cut into the palm of the hand without use of the disclosed hand held orthosis10,10′. Illustrated inFIG. 9is a reproduction of an X-ray image of a patient's hand96having respective finger digits98,98′,98″,98′″ and thumb (not shown), in spaced apart orientation and separated from contacting the palm or inner wrist by separation in respective concavities of the orthosis10,10′, whether the patient is conscious or not.

A tubular enclosure70is utilized to cover at least a portion of the elongated body when positioned between the patient's palm, fingers and thumb, in order to assure the patient does not throw or drop the orthosis10,10′ during surgery or physical therapy. The tubular enclosure70is composed of expandable material and includes opposed open72,74which are spaced apart by a sufficient length to enclose the orthosis from the distal end12′ to the base end20, while the patient's hand is holding the orthosis. The opposed ends72,74have an expandable diameter of sufficient flexibility to adequately stretch during a step of covering the orthosis held by the hand, with resilient rebound of the ends72,74and body76to form an enclosure over the elongated body12having the patient's thumb and fingers positioned in respective thumb and finger concavities. The tubular enclosure70is also expandable in length orientations to fully enclose the patient's hand to about the base of the palm. The tubular enclosure70is sufficiently flexible to allow overlapping upon itself at either end72,74to provide adequate material for maintaining coverage the hand from the fingers to the base of the palm, if the patient inadvertently or consciously attempts to remove the tubular enclosure70. Removal of the tubular enclosure70from covering the elongated body12and hand is readily accomplished either by removal from the distal end12′ of the elongated body12, or by rolling or sliding onto the patient's wrist W to allow visual examination of the patient's hand or palm without complete removal of the tubular enclosure70. In addition, either end72,74is partially retracted toward the mid-segment22′ diameter, thereby releasing one or more of the patient's thumb, first finger, or the base of the palm for inspection and medical treatment of the uncovered portions of the patient's fingers or hand while maintaining the elongated body between the fingers or positioned against the palm of the patient's hand. Lengths of the elongated body12and tubular enclosure70are selected to approximate the length between a forefinger when in relaxed orientation and the base of the palm, typically about four inches to about six inches, in order to not impede lateral movements or a range of motion of the patient's wrist W. Prior hand exercise devices have been sized to extend in resting relationship against the holder's wrist, or prior hand and finger immobilizers have included a wrist strap which connects one end of the immobilizer to the patient's wrist while partially limiting the rotational movement of a hand relative to a wrist.

The elongated body12includes an outer surface which is substantially sealed and impervious to absorption of body fluids or medicinal fluids, thereby allowing the outer surface to be sterilized upon application of commonly used sterilizing fluids. The interior of the elongated body12may be composed of porous, flexible materials is composed of a resiliently compressible material such as foam, rubber, or a low-density polymer which is transparent to electromagnetic radiations including X ray frequencies. The bone structure and positioning of the patient's fingers and thumb relative to the palm and hand can be ascertained by X-ray technology including computerized axial tomography, magnetic resonance imaging, and similar imaging technology, while the hand is enclosed in surgical coverings and opaque wrappings.

A method of using the hand-held orthosis of the present invention to stabilize a patient's hand in a relaxed position (without impeding movement of the patient's wrist) is also disclosed. In the first step of this method, a hand-held orthosis that has the following properties is provided: (1) the hand orthosis has an elongated body; (2) the elongated body has a palmar surface, an adjacently disposed thumb support surface, and a finger support surface opposed from the palmar surface; (3) the elongated body also has a plurality of unequal cross-sectional areas that are spaced along its major axial length; (4) additionally, the elongated body has a distal end having a first width, a mid-segment having a second width, and a base end having a third width, which is less than the first width and is less than the second width; (5) the finger support surface has a plurality of finger concavities and a thumb concavity; (6) the plurality of finger concavities are curved in a helical orientation across the finger support surface; (7) the plurality of finger concavities includes (a) an index finger concavity angled toward the distal end, (b) second and third finger concavities angled toward the mid-segment, and (c) a fourth finger concavity angled toward the base end; (8) each of the finger concavities is angled non-perpendicularly relative to the major axial length of the elongated body; (9) the thumb concavity is extended in a curved orientation between the mid-segment adjacent to the palmar surface and the distal end of the elongated body; and (10) the thumb concavity is opposed from each of the finger concavities.

Next, this method requires completion of the following steps: (1) the patient's palm is positioned against the palmar surface (of the hand-held orthosis); (2) the patient's index finger is rested in the index finger concavity; (3) the patient's second finger is rested in the second finger concavity; (4) the patient's third finger is rested in the third finger concavity; (5) the patient's fourth finger is rested in the fourth finger concavity; and (6) the patient's thumb is rested in the thumb concavity. A patient who is conscious can perform these steps efficiently by (1) gripping the hand orthosis in its proper orientation such that his fingers (including his thumb) are nestled in their respective concavities and such that his palm is contacting the palmar surface and (2) thereafter, relaxing his grip to allow his fingers and thumb to rest in their respective concavities. Alternatively, for patients who are unable to grip the hand-held orthosis (e.g., unconscious patients and some semi-conscious patients), medical personnel can properly position the patient's palm against the palmar surface and rest the patient's fingers in their respective finger concavities. This method requires also that (1) a flexible tubular enclosure be provided and that (2) this flexible tubular enclosure be used to substantially enclose the patient's hand while it (the hand) is oriented properly about the hand-held orthosis. The elasticity of the flexible tubular enclosure mildly compresses the patient's hand against the hand-held orthosis, thereby stabilizing the hand in an anatomic position while helping to anatomically relax the wrist. The shape of the hand-held orthosis of the present invention encourages the patient to relax his hand by supporting it in an anatomic orientation, regardless of whether the patient is conscious. Also, the hand-held orthosis discourages contact between any of the fingernails (including the thumbnail) and the patient's palm (among other parts of the hand), thereby reducing the risk of the patient injuring himself by way of voluntary or involuntary clinching. It may be advantageous to practice this method in a variety of circumstances, including: (a) in surgical, sterilized settings extending over numerous hours, (b) overnight for sleeping patients recuperating from surgery on an upper extremity, (c) in physical therapy settings extending over numerous hours of therapy repeated over many days, weeks and months, and (d) in convalescing homes or senior citizen nursing homes for semiconscious or unconscious patients requiring protection from finger and thumb digits clinching against the palm of each hand.

Optionally, the step of substantially enclosing the patient's hand in the flexible enclosure can include the enclosure70extended in an overlapping configuration78from covering of the wrist, for coverage of the fourth and third finger digits and the base end20of the body12, while leaving the forefinger and/or thumb digits encircling the distal end12′ without binding the patient's finger and/or thumb digits to the distal end12′, in order to allow surgical monitoring applied to the thumb and/or forefinger, or to allow physical therapy performed on the thumb, forefinger, and/or second finger digits. Optionally, for surgical procedures accomplished on the upper extremities and the shoulder of the patient, the method may include the step of wrapping with a sterilized elastic wrap80, for further enclosing the orthosis10,10′ having the finger and thumb digits resting thereon in proper orientation, and having the enclosure70substantially enclosing at least one end of the orthosis10,10′ having the patient's fingers and thumb thereon. The step of wrapping is accomplished without disturbing a potential intravenous (IV) site84on the wrist or forearm, and without disturbing surgical coverings on a shoulder82and/or upper arm. One skilled in the art will recognize additional uses for the hand held orthosis10,10′ and enclosure70for isolation of each finger and thumb digit from contacting each other, and/or from contacting the palmar surface or the inner wrist of the patient.

From the foregoing description, the hand held orthosis10,10′ includes various unique functions. The function of compressibility is implemented by the elongated body12being composed of resiliently compressible material such as foam, rubber, or a polymer. The function of use in a sterile environment is provided by the elongated body12having an outer surface which is sealed and generally impervious, while the interior of the elongated body12may be composed of porous, flexible and resilient material. The function of maintaining separation of the fingers and thumb apart from the palm of the patient's hand is accomplished by the combination plurality of concavities24,32,42,52,62and the plurality of ridges30,30′,30″,50,60on the surface of the elongated body12. The function of maintaining the orthosis10,10′ in a hand in a relaxed orientation with curved fingers is accomplished by the convoluted surface features, the varying widths22,22′,22″ along the length axis12″, and the rotated orientation of the minor width axis12′″ of distal end12′ relative to the minor width axis20′ of base end20.