WO2011101846A1

WO2011101846A1 - Home-use dynamic cradle, especially for relieving head and neck pain

Info

Publication number: WO2011101846A1
Application number: PCT/IL2011/000164
Authority: WO
Inventors: Tamir Levital; Yaron Moshe River
Original assignee: Headway Ltd.
Priority date: 2010-02-17
Filing date: 2011-02-16
Publication date: 2011-08-25

Abstract

A device for providing treatment at least part of the body of a patient by controllably maneuvering said part of said body, said device comprising: a. a maneuverable platform; b. maneuvering means in mechanical connection with said maneuverable platform, said maneuvering means adapted to move said platform in any combination of the sagittal, coronal, and horizontal planes within a predetermined set of allowed movements; c. a cradle adapted for supporting said part of said body, said cradle in mechanical connection with said maneuverable platform; and, d. controlling means adapted to control the motions of said maneuverable platform according to a predetermined protocol; wherein said predetermined protocol is defined for treatment of a specific syndrome whereby said device provides said treatment to said patient independent of any necessity for the presence of a caregiver during the course of treatment.

Description

HOME-USE DYNAMIC CRADLE, ESPECIALLY FOR RELIEVING HEAD AND NECK

PAIN

FIELD OF THE INVENTION

This invention generally relates to means and methods for manipulating a body part of a patient, particularly the head and neck. More specifically, it relates to means and methods for automated cradle that moves the head and cervical spine gently along a predefined 3D course, reducing neck muscle contraction, alleviating head and neck pain and increasing the cervical range of motion, as well as relaxing and assisting patients with sleep disorders.

BACKGROUND OF THE INVENTION

Muscle dysfunction in the head and cervical spine is an important salient feature of primary and secondary headache syndromes. Patients frequently develop lateral, anterior and posterior cervical spine muscle shortening, over-contraction, and subsequent muscle hyperalgesia regardless of the origin of the pain (trauma, pathology of the cervical spine, etc.). This hyperalgesia or muscle spasm is a part of a vicious cycle mechanism. Cervical mobilization and/or physical therapy are effective for some patients, whereas in other patients biofeedback relaxation techniques are helpful. Unfortunately, in many patients neither physical therapy nor biofeedback relaxation is effective.

Korean patent 62631 describes an electromechanically powered device intended to facilitate movement and increase the range of motion for stroke patients. This device is intended to be included as part of a physical therapy regime for stroke patients who would otherwise be unable to exercise independently. The device is an automatic strength amplifier using the detected electromyograph (EMG) as an indication of residual muscle strength. In the case of a patient who is unable to move his/her arm, the addition of strength amplification allows him/her to perform standard physical therapy exercises. This device, while providing movement based on EMG or other physiological feedback, is adapted for the movement of arms only. Thus treatment for relaxation of head and cervical spine muscles is not provided.

U.S. Pat. No. 5,320,641 discloses a device for spinal rehabilitation, allowing a limited elevation/depression of different parts of the spinal column, not necessarily the cervical spine. The device allows only one degree of freedom, and no true feedback from the patient. It mainly relates to post operative treatment, in particular, for enlarging the flexion/extension range of movement of the next following surgery or trauma rather than for treatment of headache and/or neck pain.

U.S. Pat. Appl. No. 20090204039 discloses a device for treating neck tension or neck injury. The device comprises a head support on a base designed to provide continuous back-and- forth movement of the neck, thus repetitively flexing and extending neck vertebrae of the uses of the device. This device only moves the patient's head and neck in two dimensions, and has no provision for, or ability to provide, full three-dimensional motion.

U.S. Pat. Appl. No. 20090272385 discloses a device for prevention and treatment of head and neck pain. This device is configured to treat head and neck pain via repetitive motion of the patient's head and neck in three dimensions. The device is designed for use in a hospital or otherwise supervised setting rather than in the home of the patient. The patient is thus unable to use the device according to his or her convenience or need, but only at such times and in such places as the device is available for use under the supervision of a physiotherapist or other trained professional.

U.S. Pat. Appl. No. 2009204039 discloses a Device and Method for Treating Neck Tension or Neck Injury. The device of US2009204039 includes a base connected to a head support which is capable of continuous bi-directional movement relative to at least one axis of said base. The US2009204039 device is configured such that the continuous bi-directional movement is capable of repetitively flexuring and/or extending neck vertebrae of a user of the device. There thus remains a long-felt need for a device that can treat head and neck muscle dysfunction via repetitive motion in three dimensions and is suitable for home (i.e. unsupervised) use.

SUMMARY OF THE INVENTION

The dynamic cradle herein disclosed is designed to meet this long-felt need. The device is designed to treat a patient by repetitively moving an affected body part through three dimensions and to do so without the necessity of supervision or active intervention by a caregiver (e.g. a physiotherapist).

It is therefore an object of the present invention to disclose a device for providing treatment at least part of the body (e.g. neck, back, hip, ankle) of a patient by controllably maneuvering said part of said body, said device comprising: (a) a maneuverable platform; (b) maneuvering means in mechanical connection with said maneuverable platform, said maneuvering means adapted to move said platform in any combination of the sagittal, coronal, and horizontal planes within a predetermined set of allowed movements; (c) a cradle adapted for supporting said part of said body, said cradle in mechanical connection with said maneuverable platform; and (d) controlling means adapted to control the motions of said maneuverable platform according to a predetermined protocol. It is within the essence of the invention wherein said predetermined protocol is defined for treatment of a specific syndrome whereby said device provides said treatment to said patient independent of any necessity for the presence of a caregiver during the course of treatment.

It is a further object of this invention to disclose such a device as defined in any of the above, wherein said part of said body comprises the head and neck.

It is a further object of this invention to disclose such a device as defined in any of the above, wherein said syndrome is chosen from the group consisting of neck pain (i.e.): (a) whiplash; (b) cervical facet-joint disorder; (c) post-spinal surgery; and (d) idiopathic neck pain; and headaches (i.e.): (e) tension-type-; (f) cervicogenic-; (g) post-traumatic-; and (h) medication- overuse- headache; as well as (i) myofascial pain syndrome; (j) Migraines, (k) sleep disorders; and (1) any combination of the above.

It is a further object of this invention to disclose such a device as defined in any of the above, wherein said controlling means are adapted to control motions chosen from the group consisting of (a) direction of motion; (b) velocity; (c) acceleration; (d) amplitude; (e) duration of motion; and (f) any combination of the above.

It is a further object of this invention to disclose such a device as defined in any of the above, adapted to improve neck muscle function and improving ROM and rehabilitating natural movements post injury.

It is a further object of this invention to disclose such a device as defined in any of the above, adapted to treating cervical spine disc herniation or protrusion associated with cervical spine and arm pain and osteoarthritis coupled with arm pain.

It is a further object of this invention to disclose such a device as defined in any of the above, adapted to increase cervical muscle bulk and strength.

It is a further object of this invention to disclose such a device as defined in any of the above, wherein said predetermined protocol comprises lobular three-dimensional motion. It is a further object of this invention to disclose such a device as defined in any of the above, wherein said predetermined protocol comprises a predetermined cycling frequency.

It is a further object of this invention to disclose such a device as defined in any of the above, wherein said predetermined cycling frequency is about 6 cycles per minute.

It is a further object of this invention to disclose such a device as defined in any of the above, wherein said predetermined protocol comprises a variable cycling frequency.

It is a further object of this invention to disclose such a device as defined in any of the above, wherein said variable cycling frequency decreases from a predetermined initial value to a predetermined final value according to a predetermined protocol.

It is a further object of this invention to disclose such a device as defined in any of the above, further comprising means for detecting a predetermined motion, wherein said controlling means are adapted to start said motion of said maneuverable platform upon detection of said predetermined motion.

It is a further object of this invention to disclose such a device as defined in any of the above, further comprising overriding means adapted for overriding said predetermined protocol.

It is a further object of this invention to disclose such a device, wherein said overriding means is chosen from the group consisting of (a) a manual override, (b) current limiting means adapted to limit the current drawn by said maneuvering means, and (c) at least one motion sensor adapted to determine if said motion of said part of said patient's body is beyond a predetermined limit.

It is a further object of this invention to disclose such a device as defined in any of the above, further comprising: (a) identifying means for determining the identity of a person attempting to use said device; (b) storage means for storing the identities of approved users; and (c) interlocking means for preventing said maneuverable platform from moving; wherein said interlocking means is adapted to prevent said maneuverable platform from moving unless said identifying means determines that said person attempting to use said device is an approved user.

It is a further object of this invention to disclose such a device as defined in any of the above, further comprising a remote control apparatus.

It is a further object of this invention to disclose such a device as defined in any of the above, wherein said remote control apparatus is wireless. It is a further object of this invention to disclose such a device, wherein said identifying means is chosen from the group consisting of (a) weight measuring means; (b) height measuring means; (c) fingerprint identifying means; (d) biological (e.g. retinal) pattern identifying means; (e) magnetic card reading means; and (f) barcode reading means.

It is a further object of this invention to disclose such a device as defined in any of the above, wherein said controlling means is hardwired to control the motion of said maneuverable platform according to said predetermined protocol.

It is a further object of this invention to disclose such a device as defined in any of the above, wherein said controlling means further comprises means for reading information from a storage medium, and further wherein said predetermined protocol is provided to said controlling means from said storage medium.

It is a further object of this invention to disclose such a device, wherein said storage medium is a portable storage medium.

It is a further object of this invention to disclose such a device as defined in any of the above, additionally comprising means for detecting and reporting the status of at least one condition of said patient, wherein said at least one condition is chosen from the group consisting of (a) physiological conditions, (b) medical conditions, (c) emotional conditions, and (d) any combination of the above.

It is a further object of this invention to disclose such a device as defined in any of the above, wherein said detecting means is selected from the group consisting of (a) EMG, (b) EKG, (c) GSR, (d) blood pressure detecting means, (e) skin temperature detecting means, (f) body temperature detecting means, (g) means for detecting the level of tension of at least one muscle, (h) breathing rate detection means, and (i) EEG detection means.

It is a further object of this invention to disclose such a device as defined in any of the above, wherein said controlling means further comprises: (a) a database of syndromes; (b) a database of protocols, wherein each protocol in said database of protocols is associated with treatment for at least one syndrome in said database of syndromes; and (c) means for correlating the reported status of a predetermined quantity of said conditions with at least one syndrome in said database; wherein said syndrome is defined as that syndrome in said database of syndromes that shows the best correlation with said reported status of a predetermined quantity of said conditions, and further wherein said predetermined protocol is defined as that protocol in said database of protocols associated with treatment of said syndrome that shows the best correlation with said reported status.

It is a further object of this invention to disclose such a device as defined in any of the above, wherein said controlling means are adapted to cease and/or start said motion of said maneuverable platform when the reported status of a predetermined quantity of said conditions passes a predetermined threshold.

It is a further object of this invention to disclose such a device, wherein said detecting means is selected from the group consisting of (a) EMG, (b) EKG, (c) GSR, (d) blood pressure detecting means, (e) skin temperature detecting means, (f) body temperature detecting means, (g) means for detecting the level of tension of at least one muscle, (h) breathing rate detection means, and (i) EEG detection means.

It is a further object of this invention to disclose such a device, wherein said controlling means are adapted to cease and/or start said motion of said maneuverable platform when the reported status of a predetermined quantity of said conditions passes a predetermined threshold.

It is a further object of this invention to disclose such a device, further comprising means for presenting audiovisual entertainment during the use of said device, said means for presenting audiovisual entertainment chosen from the group consisting of (a) means for playing music during the treatment, (b) means for presenting a virtual reality display, and (c) means for presenting biofeedback.

It is a further object of this invention to disclose such a device as defined in any of the above, further comprising means for presenting audiovisual entertainment during the use of said device, said means for presenting audiovisual entertainment chosen from the group consisting of (a) means for playing music during the treatment, (b) means for presenting a virtual reality display, and (c) means for presenting biofeedback.

It is a further object of this invention to disclose a method providing treatment for at least part of the body of a patient, said method comprising steps of: (a) obtaining the device as defined in any of the above; (b) placing said body part (e.g. neck, back, hip, ankle) within said cradle; and (c) maneuvering said maneuverable platform according to a predetermined protocol.

It is a further object of this invention to disclose such a method, wherein said predetermined protocol is adapted to provide relief for a syndrome chosen from the group consisting of neck pain (i.e.): (a) whiplash; (b) cervical facet-joint disorder; (c) post-spinal surgery; and (d) idiopathic neck pain; and headaches (i.e.): (e) tension-type-; (f) cervicogenic-; (g) posttraumatic-; and (h) medication-overuse- headache; as well as (i) myofascial pain syndrome; (j) Migraines, (k) sleep disorders; and (1) any combination of the above.

It is a further object of this invention to disclose such a method as defined in any of the above, adapted to improve neck muscle function and improving ROM and rehabilitating natural movements post injury.

It is a further object of this invention to disclose such a method as defined in any of the above, adapted to treating cervical spine disc herniation or protrusion associated with cervical spine and arm pain and osteoarthritis coupled with arm pain.

It is a further object of this invention to disclose such a method as defined in any of the above, adapted to increase cervical muscle bulk and strength.

It is a further object of this invention to disclose such a method as defined in any of the above, wherein said step of maneuvering said maneuverable platform comprises the additional step of maneuvering said maneuverable platform in a lobular three-dimensional manner.

It is a further object of this invention to disclose such a method as defined in any of the above, further comprising additional steps of: (a) detecting the status of at least one condition of said patient, wherein said at least one condition is chosen from the group consisting of (a) physiological conditions, (b) medical conditions, (c) emotional conditions, and (d) any combination of the above; and (b) reporting said status of said at least one condition.

It is a further object of this invention to disclose such a method, wherein said step of detecting the status of at least one condition further comprises an additional step of obtaining detecting means selected from the group consisting of (a) EMG, (b) EKG, (c) GSR, (d) blood pressure detecting means, (e) skin temperature detecting means, (f) body temperature detecting means, (g) means for detecting the level of tension of at least one muscle, (h) breathing rate detection means, and (i) EEG detection means. It is a further object of this invention to disclose such a method as defined in any of the above, further comprising an additional step of ceasing and/or starting said motion of said maneuverable platform when the reported status of a predetermined quantity of said conditions passes a predetermined threshold.

It is a further object of this invention to disclose such a method as defined in any of the above, further comprising additional steps of: (a) obtaining motion detecting means; and (b) starting said treatment upon said patient engaging in a predefined motion.

It is a further object of this invention to disclose such a method as defined in any of the above, further comprising additional steps of: (a) obtaining identifying means for determining the identity of a person attempting to use said device; (b) obtaining storage means for storing the identities of approved users; (c) obtaining interlocking means for preventing said maneuverable platform from moving; and (d) interlocking said device such that said step of maneuvering said maneuverable platform is performed only after identifying means has determined that said person attempting to use said device is an approved user.

It is a further object of this invention to disclose such a method, wherein said identifying means is chosen from the group consisting of (a) weight measuring means; (b) height measuring means; (c) fingerprint identifying means; (d) retinal pattern identifying means; (e) magnetic card reading means; and (f) barcode reading means.

It is a further object of this invention to disclose such a method as defined in any of the above, wherein said controlling means is hardwired to control the motion of said maneuverable platform according to said predetermined protocol.

It is a further object of this invention to disclose such a method as defined in any of the above, wherein said controlling means further comprises means for reading information from a storage medium, and further wherein said predetermined protocol is provided to said controlling means from said storage medium.

It is a further object of this invention to disclose such a method, wherein said storage medium is a portable storage medium.

It is a further object of this invention to disclose such a method as defined in any of the above, further comprising additional steps of: (a) obtaining a database of syndromes; (b) obtaining a database of protocols, wherein each protocol in said database of protocols is associated with treatment for at least one syndrome in said database of syndromes; (c) obtaining means for correlating the reported status of a predetermined quantity of said conditions with at least one syndrome in said database; (d) correlating said reported status of a predetermined quantity of said conditions with at least one syndrome in said database; (e) determining which of said at least one syndromes shows the best correlation with said reported status of a predetermined quantity of said conditions; and (f) fixing said predetermined protocol is defined as that protocol in said database of protocols associated with treatment of said syndrome that shows the best correlation with said reported status.

It is a further object of this invention to disclose such a method as defined in any of the above, further comprising additional steps of (a) obtaining means for presenting audiovisual entertainment during the use of said device; (b) presenting audiovisual entertainment, and (c) biofeedback during the use of said device.

It is a further object of this invention to disclose such a method, wherein said step of obtaining means for presenting audiovisual entertainment further comprises the additional step of choosing audiovisual entertainment from the group consisting of (a) means for playing music during the treatment, (b) means for presenting a virtual reality display, and (c) means for presenting biofeedback.

BRIEF DESCRIPTION OF THE FIGURES

In order to understand the invention and to see how it may be implemented in practice, a plurality of embodiments is adapted to now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which

FIG. 1 illustrates an embodiment of the invention;

FIG. 2 schematically presents various possible rotations of the head about the sagittal, coronal, and horizontal planes;

FIG. 3 illustrates, not to scale, various lobular two and three dimensional maneuvers according to a set of possible embodiments of the present invention; and

FIG. 4 illustrates exemplary results of treatment by the device and methods of the invention.

FIGS. 4-5b illustrate movements in Sagittal plane.

FIGS. 6a-6b illustrate movements in Horizontal plane.

FIGS. 7-8 illustrates both the Horizontal plane axis and the Sagittal plane axis. FIGs. 9a-9g, present graphically selected results from the pilot study described in the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following description is provided to enable one skilled in the art to make use of the invention herein disclosed, and the best modes contemplated by the inventors for carrying out the invention. Various modifications will, however, be obvious to one skilled in the art. Therefore the invention is not limited by that which is illustrated in the figures and described in the specification, but only as indicated in the accompanying claims, with the proper scope determined only by the broadest interpretation of said claims.

As used herein, the term "syndrome" refers to any condition experienced by a person for which treatment is sought, independent of the root cause of the condition.

As used herein, the term "patient" refers to a person being treated for a syndrome.

As used herein, the term "EMG" refers to a surface electromyographic, this being an electrical sensor adapted for measurement of compound muscle action potential, which is correlated to the degree of muscle activation.

As used herein, the term "GSR" refers to galvanic skin response, which is an indicator of the patient's stress level.

As used herein, the term "cradle" refers to a supporting means for at least one part of the body. Non-limiting examples of cradles within the meaning of the term as used herein include cradles, pillows, headrests, cushions, and mattresses.

As used herein, the term "neck pain" refers to any neck pain selected from whiplash, myofascial pain, cervical facet-joint disorder, post-spinal surgery, and idiopathic neck pain, or any combination thereof.

As used herein, the term "headaches" refers to any headaches selected from tension-type-, cervicogenic-, post-traumatic- and medication-overuse- headaches, myofascial pain syndrome and migraines or any combination thereof.

As used herein, the term "sleep disorders" refers to any sleep disorders selected from insomnia, apnea and other related breathing obstruction, snoring or any combination thereof. As used herein, the term "cycling frequency" refers to the frequency at which the set of motions defined by a particular treatment protocol repeats itself. An equivalent definition is that frequency at which the set of motions returns to its initial state.

In essence the proposed device is a computerized cervical spine mobilization device. It supports natural cervical spine lordosis. The dynamic cradle is a multi-layered pillow, which is filled with liquid, gel, foam, air or viscous material, including adjustable features to support comfortably a large diversity of human head and neck properties. In a preferred embodiment of the invention, the patient rests his or her head and nape within a recess in the cradle while lying down, either prone or supine. Reference is now made to FIG. 1, which illustrates one embodiment of the invention. The patient's head and neck are supported by cradle 101, which is partially filled with viscous fluid. Platform 102 supports the cradle and is moved by motors in three planes. Also shown in FIG. 1 are EMG electrodes 103. These can be used to quantify the effectiveness of treatment using the device herein disclosed. In the course of the treatment the head is caused to perform a 3D oscillatory movement at a very slow velocity (preferably from about 0.3 to about 3 degrees/s) by means of motors adapted to move a platform, on which the cradle rests, in three axes. This slow movement is adapted to lengthen and relax over-contracted cervical muscles. It is adapted to gradually eliminate abnormal cervical muscle contraction patterns. A control card controls the movement of the motorized platform upon which the cradle rests.

In one embodiment of the invention this control card provides movement of the head described in the following table, in which the angle of the head is defined by the vector of movement angles in the Sagittal, Coronal, and Horizontal planes, denoted (S, C, H), where S is the Sagittal angle in degrees, C is the Coronal angle in degrees, and H is the Horizontal angle in degrees, and where in all planes 0° is the position of the un-tilted head:

Step Allowed Movement Start Angle End Angle

1. Sagittal flexion (0°,0°,0°) (Up to 40°,0°,0°)

2. Sagittal return (Up to 40°,0°,0°) (0°,0°,0°)

3. Coronal tilt right (0°,0°,0°) (0°, Up to 40°,0°)

4. Coronal return right (0°, Up to 40°,0°) (0°,0°,0°)

5. Coronal tilt left (0°,0°,0°) (0°, Up to -40°,0°)

6. Coronal return left (0°, Up to -40°,0°) (0°,0°,0°) 7. Horizontal rotation right (0°,0°,0°) (0°, 0°, Up to 40°)

8. Horizontal return right (0°,0°, Up to 40°) (0°,0°,0°)

9. Horizontal rotation left (0°,0°,0°) (0°, 0°, Up to -40°)

10. Horizontal return left (0°, 0°, Up to -40°) (0°,0°,0°)

Reference is now made to FIG. 2, in which movements of the head in the sagittal (201), coronal (202), and horizontal (203) planes are illustrated. It is in the scope of the invention wherein the patent's body or an organ thereof is manipulated in a set of (i) allowed movements, (ii) start angles, and (iii) end angles; Sagittal flexion, (0°,0°,0°), (up to 40°,0°,0°), respectively; Sagittal return (up to 40°,0°,0°), (0°,0°,0°); Coronal tilt right, (0°,0°,0°), (0°, up to 40°,0°); Coronal return right, (0°, up to 40°,0°), (0°,0°,0°); Coronal tilt left, (0°,0°,0°), (0°, up to -40°,0°); Coronal return left, (0°, up to -40°,0°), (0°,0°,0°); Horizontal rotation right, (0°,0°,0°), (0°, 0°, up to 40°); Horizontal return right, (0°,0°, up to 40°), (0°,0°,0°); Horizontal rotation left, (0°,0°,0°), (0°, 0°, up to -40°); Horizontal return left, (0°, 0°, up to -40°), (0°,0°,0°), respectively, referred to in the present invention as "allowed movements."

The pattern movement is established through a mathematical algorithm. The primary innovation of the current invention relative to other devices known in the art is that the algorithm is generalized for a particular syndrome, and the device is provided to the patient with the desired algorithm preprogrammed into the device. The generalized algorithms are developed from treatments in which devices (e.g., the "Teach and Repeat" system produced by Headway) are used in controlled settings (e.g. clinics) in which the treatment is practiced and monitored by an external therapist or operator. The most effective courses of treatment developed in these systems are recorded and used as the basic algorithms in the present invention.

The preprogramming can be hardwired, or stored on any storage medium known in the art. In particular, in some embodiments, the pattern movement protocol is stored on a portable storage medium (e.g. a CD-ROM or USB flash drive) and read into the device. In this manner, the device is provided to treat the specific syndrome affecting the patient without any need for an external operator, therapist, or caretaker. Due to the technology used, the patient undergoes a relaxing "zero gravity" floating experience, which leads to profound muscle relaxation, including relaxation of cervical and head muscles including facial and mastication muscles.

This dynamic cradle is useful for the treatment of pain especially head and neck pain syndromes such as migraine, and other headaches: tension type, post traumatic, cervicogenic, and myofascial headache, as well as neck pain, such as idiopathic, following whiplash injury and muscle over-contraction.

Moreover, this dynamic cradle is useful for the treatment of range of motion (ROM) dysfunctions, by improving patient's cervical ROM and neck muscle flexibility; rehabilitation and relaxation of shoulder and cervical muscles over-contraction, e.g., after sport activity and/or other injuries, and whole body relaxation. Besides, while opposing the cradle movement one can increase his or her cervical muscle bulk and strength.

In addition, this dynamic cradle is useful for treating sleep disorders and cervical spine disc herniation or protrusion associated with cervical spine and arm pain and osteoarthritis coupled with arm pain. According to one embodiment of the invention, it produces a kneading action similar, but markedly superior to, that achieved cervical spine mobilization performed by a physiotherapist.

According to yet another preferred embodiment of the present invention, a cradle is provided that conforms to the shape of the human head, neck and shoulders. The cradle rests upon a platform, which in turn may be moved in three dimensions by a plurality of motors. These motors are controlled by a control card that actuates electronics to control the movement of the motors. The control card that controls the motors can thus control any combination of direction, velocity, acceleration, amplitude, distance, and duration of the motions of the maneuverable platform upon which the cradle rests.

In another embodiment of the invention, an additional supporting cradle is provided for cervical spine lordosis, which may be separately adjustable.

In another preferred embodiment, the head and neck are contained in a depression, such that in motions of rotation, flexion and lateral bending or tilting, the head is adapted to not slip from its place (cradle) and the motion due to a given movement is adapted to therefore be predictable and repeatable.

In another preferred embodiment the platform movement frequency is adapted to be between about 0.03 Hz to about 0.2 Hz. In another embodiment of the invention the patient is able to limit the head lifting/ manipulating angle by means of an external switch.

In another preferred embodiment the upper body may be raised by a further part of the cradle up to 20 degrees.

In another embodiment of the invention, relaxing music is played during the treatment.

In another embodiment of the invention, either 2D or 3D virtual reality is played or displayed during at least portions of the treatment.

In another embodiment of the invention, biofeedback is used for relaxation, during at least portions of the treatment.

In another embodiment of the invention, the cradle may be heated or cooled.

In another embodiment of the invention, the platform upon which the cradle rests is attached to the bed upon which the person undergoing treatment rests.

Reference is now made to FIGs. 3a to 3f, illustrating, not to scale, the direction in which the treated organ is maneuvered. FIG. 3a illustrates a track with a symmetrical figure-8 path (here, in a clockwise direction 401). This lobular maneuver is provided in a two dimensional and/or a three dimensional manner here a loop-like continuous movement along the Sagittal plane. FIG. 3b depicts a similar figure-8 path, here, along a counter-clockwise direction 402. FIGs. 3c through 3d depict similar figure-8 continuous movement along various planes. It is acknowledged in this respect that asymmetrical figure-8-like (i.e. with one extended lobe) continuous movements along all Sagittal, Horizontal, and Coronal planes are possible. It is in the scope of the invention wherein the aforesaid 3D movement is provided with six degrees of freedom (DFs), especially wherein the motion is characterized by a continuous passive motion in a 6-DFs lobed maneuver.

In additional embodiments of the invention, the cycling frequency of the treatment protocol is also preprogrammed. For example, a cycling frequency of about 6 cycles per minute will match the natural relaxed breathing rate as well as the normal rate of vasomotion (rhythmic oscillations in vascular tone). In additional embodiments of the invention, the cycling frequency can be varied. For example, the treatment protocol can be programmed such that the initial cycling frequency is higher than 6 cycles per minute (e.g., chosen to match the patient's stressed breathing rate) and decreases to about 6 cycles per minute as the patient becomes more relaxed. In order to adapt the device for use without a second person present, provisions are made in the present invention for means for starting and stopping the treatment. In one embodiment of the device, it additionally comprises a remote control unit. This remote control unit may be wired or wireless, and of any type known in the art. The remote control unit is interfaced to the motor control apparatus such that the user can send a start or stop command, or, in some embodiments, any other control command, to the apparatus.

In additional embodiments, the device additionally comprises a motion sensor of any appropriate type known in the art. The motion sensor is interfaced with the control electronics such that starting or stopping of the treatment takes place upon a predefined motion. Depending on the specific application, the necessary motion can be of the treated body part itself (e.g. a particular rotation) or of another body part outside of the cradle (e.g. waving a hand in front of the motion sensor). In preferred embodiments of the application, the device includes an emergency override so that the patient can stop the treatment at any time. Preferably, the override sends a signal to the control unit that causes the control unit to stop the motions of the motors. In other embodiments, the override mechanism can be interfaced directly to the motors such that when an override signal is received, the motors stop, e.g., via cutting off the electrical current to the motors.

The override may be of any type that will act to provide a "stop" signal to the control card, control electronics, or motors. In some embodiments, the override is a manual override comprising a switch that is (depending on the type of switch) pressed, pulled, turned, or toggled to provide the cutoff signal. In some embodiments, the override comprises a current limiting mechanism of any type known in the art that limits the maximum current that can be drawn by the motors (and hence the speed with which they can move the maneuverable platform). In other embodiments, a motion sensor is interfaced to device, similar to the method described above for using a motion sensor for starting the device. The motion sensor can also be set to determine if the motion of the treated body part has exceeded a predetermined limit and to shut down the device should the limit be exceeded.

Since the device is intended for home use, it is important that unauthorized users (e.g. children) be unable to use it. Thus, in preferred embodiments, the device includes means for identifying an authorized user and an interlock that prevents the device from operating if an unauthorized user attempts to activate it. The identification means can be as simple as determining that the weight of the potential user is above or below a particular set point (e.g. by measuring the compression of a spring underneath the cradle). If in a particular application, it is only necessary to prevent children (or adults) from attempting to use the device, testing the weight will be sufficient. In additional embodiments, more sophisticated identification means are used. For example, there can be means for measuring height (e.g. a switch located a predetermined distance from the cradle that must be depressed while the device is in operation); means for measuring biometric data such as fingerprints or retinal patterns; or means for reading a card associated with an authorized user such as a card with a magnetic strip or a barcode. In all cases, the control card that controls the device will have stored in its memory a database of authorized users, and will only initiate treatment if the data presented by a person attempting to use the device matches the data within the database corresponding to an authorized user. As with the override mechanism described above, in embodiments that include identification means, the identification means is interfaced with the control apparatus or motors such that until an authorization signal is received by the control mechanisms, no current will flow to the motors. The identification means can be interlocked via a physical switch that closes only upon presentation of acceptable identification, or via the program on the control card that controls the motors, which would then include a flag that is set to allow motion of the maneuverable platform only upon receipt of acceptable identification.

In some embodiments of the invention, it further comprises means for determining the current status of the condition (medical, physiological, emotional) of the patient. These means can be any means for measuring conditions associated with the syndrome being treated. Non- limiting examples of the kinds of measurements that are made in various embodiments include EMG, E G, GSR, blood pressure, skin or body temperature, muscle tension, breathing rate, and EEG.

These measurement means also provide, for some embodiments, means for identifying the syndrome from which the patient suffers. In these embodiments, a database of possible syndromes is provided, along with the physical symptoms associated with the possible syndromes (e.g. blood pressure, heart rate, body temperature, muscle tension, etc.). Means are also provided within the control card program that controls the device for correlating the observed physical conditions of the patient with those of the syndromes found in the database. The syndrome the symptoms of which most closely match the conditions observed in the patient is identified as the syndrome to be treated, and the movement protocol is set accordingly. In additional embodiments, these measurement means provide an additional means for providing automated starting and stopping of the device. Threshold values of one or more parameters related to the patient's current condition (e.g. muscle tension, breathing rate, blood pressure) are determined according to the syndrome for which the patient is being treated. For example, if the patient is being treated for a sleep disorder, sample parameters might be breathing rate, brain waves (e.g. alpha waves, detected with EEG sensors) and muscle tension, with the threshold values being those that differentiate a waking from a sleeping state. These parameters are then monitored, and the device activated and/or deactivated when they pass the threshold. In the case of a sleep disorder, the device would be set to shut itself off as soon as the patient falls asleep. In other cases, the device might be set to turn itself on only when the patient appears to be suffering from the syndrome and then to turn itself off when the symptoms are alleviated.

Reference is now made to figs. 4-5b which illustrate movements in Sagittal plane.

Reference is now made to figs. 6a-6b which illustrate movements in Horizontal plane.

Reference is now made to figs. 7-8 which illustrates both the Horizontal plane axis (numerical reference 710) and the Sagittal plane axis (720).

EXAMPLES

For the pilot study, performed at Bnai Zion Medical Center in Haifa, Israel, 12 patients suffering from chronic neck pain were recruited, 10 of whom completed the study. The treatment comprised 2 treatment sessions per week for 6 weeks. The manipulation protocol consisted of 20 minutes of repetitive flexion / extension oscillations in the sagittal plane at velocities of 0.5 - 2° s^"1 through an angle of between 15 and 40°; the velocity used and angle through which the manipulations were carried out were chosen according to the specific needs of the individual patient. Measurements were made of the Cervical Range of Motion (CROM), pain threshold trigger points (Algometry), physiological data including EMG, EKG, and GSR, and validated questionnaires: the numerical rating scale (NRS), Neck Disability Index (NDI), quality of life (SF-36). Other specially-designed questionnaires included: Daily Activities, device Comfort and general Satisfaction.

No adverse effects of the treatment were reported; indeed, the protocol was sufficiently relaxing that some of the patients fell asleep during the physical therapy sessions. EMG recordings showed reduced bilateral activity of the trapezius muscle during the treatment. GSR data showed a significant reduction in skin conductance during the treatment, indicating marked relaxation. There was a decrease in the pain sensitivity at the trigger points as well as a significant increase in the CROM. NDI results show a significant reduction in disability.

Of the 10 patients who completed the study, only one showed no improvement at all. Two showed complete remission of pain with no recurrence of pain within hours of the treatment, while six reported a response of "good," "very good," or "excellent." Thus, a significantly positive outcome was observed for 8 out of 10 of the patients who completed the study, demonstrating the efficacy of the invention herein disclosed.

Reference is now made to FIG. 9, which presents graphically selected results from the pilot study described in the present example. FIG. 9a shows results for cervical range of motion (CROM) for six different movements. Of the six movements that were measured (flexion, extension, lateral bending to the right and to the left, and rotation to the right and to the left), statistically significant improvement (P < 0.05) was seen in extension (from an average of 47.8° to an average of 59.3°) and leftward rotation (from an average of 59.8° to an average of 68.3°). A statistical analysis of the entire test (all six motions) shows that the invention herein disclosed provides statistically significant overall improvement in cervical motion (p= 0.034).

FIG. 9b shows results for algometry. Statistically significant improvement was seen in the muscle strength for all of the relevant muscles (p = 0.073 for week 6 vs. week 1).

FIG. 9c shows results for the NRS. On this scale, 10 = unbearable pain and 0 = no pain at all. As can be seen in the figure, the average NRS level decreased from 5.7 to 4.35, an improvement of 24%. The efficacy of the method disclosed in the present invention for enabling those treated to return to their normal daily activities is illustrated in FIG. 9d. On this scale, 10 = cannot function at all, while 0 = fully functioning. As shown in the figure, during the course of treatment, the average ability to undergo daily activities increased by nearly 40% (from 4.2 to 2.5). This increase is statistically significant (p = 0.033).

Results from the NDI and SF-36 questionnaires are shown in FIGs. 9e and 9f, respectively. As can be seen in the figures, the patients' own reports of how their neck pain affected their day-to-day activities and the state of their health showed significant improvement in all categories, e.g. p = 0.049 for week 8 vs. week 1 NDI. Figure 9g represents patients' satisfaction from the prototype used in the clinical trial. As can be seen in FIG. 9g, the patients reported an increase in their comfort following the use of the invention disclosed herein, and that all would wish to use it again should the need arise.

Claims

CLAIMS We claim:

1. A device for providing treatment at least part of the body of a patient by controllably maneuvering said part of said body, said device comprising:

a. a maneuverable platform;

b. maneuvering means in mechanical connection with said maneuverable platform, said maneuvering means adapted to move said platform in any combination of the sagittal, coronal, and horizontal planes within a predetermined set of allowed movements;

c. a cradle adapted for supporting said part of said body, said cradle in mechanical connection with said maneuverable platform; and,

d. controlling means adapted to control the motions of said maneuverable platform according to a predetermined protocol;

wherein said predetermined protocol is defined for treatment of a specific syndrome whereby said device provides said treatment to said patient independent of any necessity for the presence of a caregiver during the course of treatment.

2. The device of claim 1, wherein said part of said body comprises the head, neck, back, shoulder, hip, ankle and any combination thereof.

3. The device of claim 1, wherein said syndrome is chosen from the group consisting of neck pain (i.e.): (a) whiplash; (b) cervical facet-joint disorder; (c) post-spinal surgery; and (d) idiopathic neck pain; and headaches (i.e.): (e) tension-type-; (f) cervicogenic-; (g) post-traumatic-; and (h) medication-overuse- headache; as well as (i) myofascial pain syndrome; (j) Migraines, (k) sleep disorders; and (1) any combination of the above.

4. The device as defined in claim 1, adapted to improve neck muscle function and improving ROM and rehabilitating natural movements post injury.

5. The device as defined in claim 1, adapted to treating cervical spine disc herniation or protrusion associated with cervical spine and arm pain and osteoarthritis coupled with arm pain.

6. The device of claim 1, adapted to increase muscle bulk and strength.

7. The device of claim 1, wherein said controlling means are adapted to control motions chosen from the group consisting of (a) direction of motion; (b) velocity; (c) acceleration; (d) amplitude; (e) duration of motion; and (f) any combination of the above.

8. The device of claim 1, wherein said predetermined protocol comprises lobular three- dimensional motion.

9. The device of claim 1, wherein said predetermined protocol comprises a predetermined cycling frequency.

10. The device of claim 9, wherein said predetermined cycling frequency is about 6 cycles per minute.

11. The device of claim 1, wherein said predetermined protocol comprises a variable cycling frequency.

12. The device of claim 11, wherein said variable cycling frequency decreases from a predetermined initial value to a predetermined final value according to a predetermined protocol.

13. The device of claim 1, further comprising means for detecting a predetermined motion, wherein said controlling means are adapted to start said motion of said maneuverable platform upon detection of said predetermined motion.

14. The device of claim 1, further comprising overriding means adapted for overriding said predetermined protocol.

15. The device of claim 14, wherein said overriding means is chosen from the group consisting of (a) a manual override, (b) current limiting means adapted to limit the current drawn by said maneuvering means, and (c) at least one motion sensor adapted to determine if said motion of said part of said patient's body is beyond a predetermined limit.

16. The device of claim 1, further comprising a remote control apparatus.

17. The device of claim 16, wherein said remote control apparatus is wireless.

18. The device of claim 1, further comprising:

a. identifying means for determining the identity of a person attempting to use said device;

b. storage means for storing the identities of approved users; c. interlocking means for preventing said maneuverable platform from moving; wherein said interlocking means is adapted to prevent said maneuverable platform from moving unless said identifying means determines that said person attempting to use said device is an approved user.

19. The device of claim 18, wherein said identifying means is chosen from the group consisting of (a) weight measuring means; (b) height measuring means; (c) fingerprint identifying means; (d) retinal pattern identifying means; (e) magnetic card reading means; and (f) barcode reading means.

20. The device of claim 1, wherein said controlling means is hardwired to control the motion of said maneuverable platform according to said predetermined protocol.

21. The device of claim 1, wherein said controlling means further comprises means for reading information from a storage medium, and further wherein said predetermined protocol is provided to said controlling means from said storage medium.

22. The device of claim 21, wherein said storage medium is a portable storage medium.

23. The device of claim 1, additionally comprising means for detecting and reporting the status of at least one condition of said patient, wherein said at least one condition is chosen from the group consisting of (a) physiological conditions, (b) medical conditions, (c) emotional conditions, and (d) any combination of the above.

24. The device of claim 23, wherein said detecting means is selected from the group consisting of (a) EMG, (b) EKG, (c) GSR, (d) blood pressure detecting means, (e) skin temperature detecting means, (f) body temperature detecting means, (g) means for detecting the level of tension of at least one muscle, (h) breathing rate detection means, and (i) EEG detection means.

25. The device of claim 23, wherein said controlling means further comprises:

a. a database of syndromes;

b. a database of protocols, wherein each protocol in said database of protocols is associated with treatment for at least one syndrome in said database of syndromes; and,

c. means for correlating the reported status of a predetermined quantity of said conditions with at least one syndrome in said database;

wherein said syndrome is defined as that syndrome in said database of syndromes that shows the best correlation with said reported status of a predetermined quantity of said conditions, and further wherein said predetermined protocol is defined as that protocol in said database of protocols associated with treatment of said syndrome that shows the best correlation with said reported status.

26. The device of claim 25, wherein said controlling means are adapted to cease and/or start said motion of said maneuverable platform when the reported status of a predetermined quantity of said conditions passes a predetermined threshold.

27. The device of claim 1, further comprising means for presenting audiovisual entertainment during the use of said device, said means for presenting audiovisual entertainment chosen from the group consisting of (a) means for playing music during the treatment, (b) means for presenting a virtual reality display, and (c) means for presenting biofeedback.

28. A method providing treatment for at least part of the body of a patient, said method comprising steps of:

a. obtaining the device of claim 1;

b. placing said body part (e.g. neck, back, hip, ankle) within said cradle; and, c. maneuvering said maneuverable platform according to a predetermined protocol.

29. The method of claim 28, wherein said predetermined protocol is adapted to provide relief for a syndrome chosen from the group consisting of neck pain (i.e.): (a) whiplash; (b) cervical facet-joint disorder; (c) post-spinal surgery; and (d) idiopathic neck pain; and headaches (i.e.): (e) tension-type-; (f) cervicogenic-; (g) post-traumatic-; and (h) medication-overuse- headache; as well as (i) myofascial pain syndrome; (j) Migraines, (k) sleep disorders; and (1) any combination of the above.

30. The method as defined in claim 1, adapted to improve neck muscle function and improving ROM and rehabilitating natural movements post injury.

31. The method as defined in claim 1, adapted to treating cervical spine disc herniation or protrusion associated with cervical spine and arm pain and osteoarthritis coupled with arm pain.

32. The method of claim 1, adapted to increase muscle bulk and strength.

33. The method of claim 28, wherein said step of maneuvering said maneuverable platform comprises the additional step of maneuvering said maneuverable platform in a lobular three-dimensional manner.

34. The method of claim 28, further comprising additional steps of:

a. detecting the status of at least one condition of said patient, wherein said at least one condition is chosen from the group consisting of (a) physiological conditions, (b) medical conditions, (c) emotional conditions, and (d) any combination of the above; and,

b. reporting said status of said at least one condition.

35. The method of claim 34, wherein said step of detecting the status of at least one condition further comprises an additional step of obtaining detecting means selected from the group consisting of (a) EMG, (b) EKG, (c) GSR, (d) blood pressure detecting means, (e) skin temperature detecting means, (f) body temperature detecting means, (g) means for detecting the level of tension of at least one muscle, (h) breathing rate detection means, and (i) EEG detection means.

36. The method of claim 35, further comprising an additional step of ceasing and/or starting said motion of said maneuverable platform when the reported status of a predetermined quantity of said conditions passes a predetermined threshold.

37. The method of claim 28, further comprising additional steps of:

a. obtaining motion detecting means; and,

b. starting said treatment upon said patient engaging in a predefined motion.

38. The method of claim 28, further comprising additional steps of:

a. obtaining identifying means for determining the identity of a person attempting to use said device;

b. obtaining storage means for storing the identities of approved users; c. obtaining interlocking means for preventing said maneuverable platform from moving; and,

d. interlocking said device such that said step of maneuvering said maneuverable platform is performed only after identifying means has determined that said person attempting to use said device is an approved user.

39. The method of claim 38, wherein said identifying means is chosen from the group consisting of (a) weight measuring means; (b) height measuring means; (c) fingerprint identifying means; (d) retinal pattern identifying means; (e) magnetic card reading means; and (f) barcode reading means.

40. The method of claim 28, wherein said controlling means is hardwired to control the motion of said maneuverable platform according to said predetermined protocol.

41. The method of claim 28, wherein said controlling means further comprises means for reading information from a storage medium, and further wherein said predetermined protocol is provided to said controlling means from said storage medium.

42. The method of claim 41, wherein said storage medium is a portable storage medium.

43. The method of claim 28, further comprising additional steps of:

a. obtaining a database of syndromes;

b. obtaining a database of protocols, wherein each protocol in said database of protocols is associated with treatment for at least one syndrome in said database of syndromes;

c. obtaining means for correlating the reported status of a predetermined quantity of said conditions with at least one syndrome in said database;

d. correlating said reported status of a predetermined quantity of said conditions with at least one syndrome in said database;

e. determining which of said at least one syndromes shows the best correlation with said reported status of a predetermined quantity of said conditions; and, f. fixing said predetermined protocol is defined as that protocol in said database of protocols associated with treatment of said syndrome that shows the best correlation with said reported status.

44. The method of claim 28, further comprising additional steps of

a. obtaining means for presenting audiovisual entertainment, and/or means for presenting biofeedback during the use of said device; and,

b. presenting audiovisual entertainment, and/or biofeedback during the use of said device.

45. The method of claim 44, wherein said step of obtaining means for presenting audiovisual entertainment further comprises the additional step of choosing audiovisual entertainment from the group consisting of (a) means for playing music during the treatment, (b) means for presenting a virtual reality display, and (c) means for presenting biofeedback.