Abstract:
A patient seeking complementary and alternative medicine must visit a practitioner which is not always convenient or possible. It would be beneficial to provide a patient with a simple means of deriving benefit from such physical CAM techniques in a non-intimidating manner whereby the means has familiarity associated with it. Even with conventional medicine children, infants, toddlers, and babies require medical treatment and experience fear and/or anxiety arising from visiting the medical practitioner or with the treatment. According to embodiments of the invention provide patients are provided means to exploit CAM techniques away from the practitioner or allow patients to not associate activities with a medical treatment but another activity, such as playing in the instance of a child. Variations of the means allow medical monitoring activities to be similarly associated with familiar objects and non-traumatic activities.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This patent application claims the benefit of U.S. Provisional Patent Application 61/508,905 filed Jul. 18, 2011 entitled “Birthing Bobble.” 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates to pain relief and in particular to devices and methods to engage individuals with familiar objects to support providing pain relief. 
       BACKGROUND OF THE INVENTION 
       [0003]    Industry analysts estimate that more than 1.5 billion people around the world suffer from chronic pain; making it the number one reason patients seek medical care. In fact, studies have shown that pain leads to more than 50 million lost workdays each year. The cost of pain, including medical bills and lost workdays, is estimated at $100 billion per year. Within the United States alone the market for pain-management therapeutics was estimated to generate more than $40 billion in 2011 and is predicted to grow to $60 billion by 2015. This market includes treatments for a wide range of conditions including postoperative pain, cancer pain, arthritis pain, migraine pain, neuropathic pain, and back pain. 
         [0004]    Pain management (also called pain medicine or algiatry) is a branch of medicine employing an interdisciplinary approach for easing the suffering and improving the quality of life of those living with pain. The typical pain management team includes medical practitioners, clinical psychologists, physiotherapists, occupational therapists, and nurse practitioners. Pain sometimes resolves promptly once the underlying trauma or pathology has healed, and is treated by one practitioner, with drugs such as analgesics and (occasionally) anxiolytics. Effective management of long term pain, however, frequently requires the coordinated efforts of the management team. 
         [0005]    Medicine treats injury and pathology to support and speed healing; and treats distressing symptoms such as pain to relieve suffering during treatment and healing. When a painful injury or pathology is resistant to treatment and persists, when pain persists after the injury or pathology has healed, and when medical science cannot identify the cause of pain, the task of medicine is to relieve suffering. Treatment approaches to long term pain include pharmacologic measures, such as opioids, nonsteroidal anti-inflammatory drugs, acetaminophen, local anesthetics, tricyclic antidepressants, anticonvulsants, patient-controlled dosing, interventional procedures, physical therapy, physical exercise, application of ice and/or heat, implants, electrical stimulation, and psychological measures, such as biofeedback and cognitive behavioral therapy. Accordingly today there is high demand for more efficient drugs, delivery systems, and medical devices for pain treatment is driving the pain-management market. The need to address acute and chronic pain will rise alongside an increasingly aging population. Other factors affecting the future of the pain-management segment include a growing number of surgical procedures being performed, changing lifestyles, and increasing incidences of cancer. 
         [0006]    Pain medications are in many instances simple in that the patient may self-medicate according to the pain or follow a predetermined regime without the need for continuous medical team involvement; rather it becomes intermittent such as at the end of a drug regime or when the patient requires a repeat prescription. However, many pain medications, while effective, cause unwanted side effects. Opioids, the largest pain-therapy class, are widely known to cause a number of side effects such as nausea, vomiting, constipation, and somnolence. They can also cause severe respiratory depression. Nonsteroidal anti-inflammatory drugs (NSAIDs) have been shown to cause gastrointestinal upset, kidney and liver damage, and they can increase cardiovascular risks. Additionally a significant number of individuals either do not want to exploit drug treatments, cannot afford the drug treatments, have cultural or religious barriers to some or all drug treatments, or cannot take them due to a compounding condition such as pregnancy or cancer for example in order to protect the unborn infant or prevent drug reactions respectively. 
         [0007]    Accordingly, there are wide varieties of what are known as “alternative” medicines”, which is a blanket term for any healing practice “that does not fall within the realm of conventional medicine.” These are in many instances also referred to as complementary as they do not impact “conventional” medicines or treatments. Typically these are based upon on historical and/or cultural traditions and in some ethnic groups, countries, etc are the dominant means of pain management. Additionally in many instances patients may combine them, such as for example approximately one third of cancer patients in the western world will exploit some form of complementary and alternative medicine. Alternative medicine may vary from country to country and in some jurisdictions where alternative medical practices are sufficiently widespread they may license and regulate them. In other jurisdictions complementary and alternative medicine is mainly in the hands of physicians, for example Germany and Austria, whilst some estimates suggest that at least half of American alternative practitioners are physicians. 
         [0008]    Alternative medicine is frequently grouped with complementary medicine or integrative medicine, which, in general, refers to the same interventions when used in conjunction with mainstream techniques, under the umbrella term complementary and alternative medicine, or CAM. Some researchers in alternative medicine object to this categorization, preferring to emphasize differences of approach, but nevertheless use the term CAM, which has become standard. Critics maintain that the terms “complementary” and “alternative medicine” are deceptive euphemisms meant to give an impression of medical authority. 
         [0009]    CAM methods are diverse in their foundations and methodologies and may incorporate or base themselves on traditional medicine, folk knowledge, spiritual beliefs, or newly conceived approaches to healing. Although heterogeneous, the major CAM systems have many common characteristics, including a focus on individualizing treatments, treating the whole person, promoting self-care and self-healing, and recognizing the spiritual nature of each individual. In addition, many CAM systems have characteristics commonly found in mainstream healthcare, such as a focus on good nutrition and preventive practices. Unlike mainstream medicine, CAM often lacks or has only limited experimental and clinical study; however, scientific investigation of CAM is beginning to address this knowledge gap. Thus, boundaries between CAM and mainstream medicine, as well as among different CAM systems, are often blurred and are constantly changing. The U.S. National Center for Complementary and Alternative Medicine (NCCAM) 
         [0010]    1. Whole medical systems: cut across more than one of the other groups; examples include Traditional Chinese medicine, Naturopathy, Homeopathy, and Ayurveda 
         [0011]    2. Mind-body medicine: takes a holistic approach to health that explores the interconnection between the mind, body, and spirit. It works under the premise that the mind can affect “bodily functions and symptoms” 
         [0012]    3. Biology-based practices: use substances found in nature such as herbs, foods, vitamins, and other natural substances 
         [0013]    4. Manipulative and body-based practices: feature manipulation or movement of body parts, such as is done in chiropractic and osteopathic manipulation 
         [0014]    5. Energy medicine: is a domain that deals with putative and verifiable energy fields such as biofield therapies which are intended to influence energy fields that are purported to surround and penetrate the body and bioelectromagnetic-based therapies use verifiable electromagnetic fields, such as pulsed fields, alternating-current, or direct-current fields in an unconventional manner. 
         [0015]    One common CAM is reflexology, or zone therapy, is an alternative medicine involving the physical act of applying pressure to the feet, hands, or ears with specific thumb, finger, and hand techniques without the use of oil or lotion. It is based on what reflexologists define as a system of zones and reflex areas that they say reflect an image of the body on the feet and hands, with the premise that such work effects a physical change to the body. 
         [0016]    Another common CAM is acupuncture which originated in Ancient China and treats patients by insertion and manipulation of solid, generally thin needles in the body. According to traditional Chinese medicine, bodily functions are regulated by the flow of an energy-like entity called qi. Acupuncture aims to correct imbalances in the flow of qi by stimulation of anatomical locations on or under the skin called acupuncture points, most of which are connected by channels known as meridians. 
         [0017]    At present a patient seeking to use such physical CAM techniques must visit a practitioner which is not always convenient or possible. In many instances it would be beneficial to provide a patient with a simple device allowing them to derive benefit from such physical CAM techniques in a non-intimidating manner whereby the device has familiarity associated with it. Even in conventional medicine children, infants, toddlers, and babies require medical treatment and in many instances a fear associated with the medical treatment and/or anxiety arising from visiting the medical practitioner etc result in reduced or no treatment as the patient refuses to take the medicine or is physically sick immediately thereafter. 
         [0018]    In many instances therefore it would be beneficial to provide patients and individuals with devices that either allow them to exploit these CAM techniques away from the practitioner or allow the patient to not associate an activity with a medical treatment but another activity, such as playing in the instance of a child. Beneficially embodiments of the invention provide devices for such instances. 
         [0019]    Other aspects and features of the present invention will become apparent to those ordinarily skilled in the art upon review of the following description of specific embodiments of the invention in conjunction with the accompanying figures. 
       SUMMARY OF THE INVENTION 
       [0020]    It is an object of the present invention to provide devices for pain relief and in particular to devices and methods to engage individuals with familiar objects to support providing pain relief. 
         [0021]    In accordance with an embodiment of the invention there is provided a device comprising:
   an outer shell formed from a first material characterized by a first resilience and having a first predetermined portion providing an association for an individual to a familiar object and a second predetermined portion providing a predetermined orientation of the device to a first predetermined portion of the human body when placed against a second predetermined portion of the human body; and   at least one member of a plurality of members, the at least one member formed from a second material characterized by a second resilience greater than the first resilience and being positioned in a first predetermined position within the device so as to engage a predetermined portion of the first predetermined portion of the human body.   
 
         [0024]    In accordance with an embodiment of the invention there is provided a device comprising:
   an outer shell formed from a first material characterized by a first resilience and having a first predetermined portion providing an association for an individual to a familiar object and a second predetermined portion providing a predetermined orientation of the device to a first predetermined portion of the human body when placed against a second predetermined portion of the human body;   at least one member of a plurality of members, the at least one member formed from a second material characterized by a second resilience greater than the first resilience and being positioned in a first predetermined position within the device so as to engage a predetermined portion of the first predetermined portion of the human body; and   at least one needle disposed in a predetermined position with respect to the at least one member of the plurality of members.   
 
         [0028]    In accordance with an embodiment of the invention there is provided a device comprising:
   an outer shell formed from a first material characterized by a first resilience and having a first predetermined portion providing an association for an individual to a familiar object and a second predetermined portion providing a predetermined orientation of the device to a first predetermined portion of the human body when placed against a second predetermined portion of the human body;   at least one member of a plurality of members, the at least one member formed from a second material characterized by a second resilience greater than the first resilience and being positioned in a first predetermined position within the device so as to engage a predetermined portion of the first predetermined portion of the human body; and   at least one needle of a plurality of needles disposed in a predetermined position with respect to the at least one member of the plurality of members;   a pressure activated sensor;   a microcontroller connected to the pressure activated sensor; and   a microfluidic delivery system disposed within the outer body connected to the needle and to a reservoir containing a fluid, the microfluidic delivery system controlled by the microcontroller.   
 
         [0035]    Other aspects and features of the present invention will become apparent to those ordinarily skilled in the art upon review of the following description of specific embodiments of the invention in conjunction with the accompanying figures. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0036]    Embodiments of the present invention will now be described, by way of example only, with reference to the attached Figures, wherein: 
           [0037]      FIG. 1  depicts pain relief methods according to the prior art; 
           [0038]      FIG. 2  depicts pressure points on the hands and their associations with the rest of the human body; 
           [0039]      FIGS. 3A and 3B  depicts acupuncture points on the human hand, 
           [0040]      FIG. 4  depicts a pain relief bobble according to an embodiment of the invention; 
           [0041]      FIG. 5  depicts a pain relief bobble according to an embodiment of the invention; 
           [0042]      FIG. 6  depicts a pain relief bobble according to an embodiment of the invention; 
           [0043]      FIG. 7  depicts a pain relief bobble according to an embodiment of the invention; 
           [0044]      FIGS. 8A and 8B  depict pain relief bobbles incorporating needles according to embodiments of the invention; 
           [0045]      FIG. 9  depicts a pain relief bobble incorporating a spray medication injection device disguised within the bobble; 
           [0046]      FIG. 10  depicts a pain relief bobble incorporating a medication injection device disguised within the bobble; 
           [0047]      FIG. 11  depicts a bobble incorporating a blood glucose testing device disguised within the bobble; 
           [0048]      FIG. 12  depicts a bobble incorporating an optical blood glucose testing device disguised within the bobble; 
           [0049]      FIG. 13  depicts a simplified schematic of the electronics for an optical blood glucose testing device according to  FIG. 12 ; 
           [0050]      FIG. 14  depicts a pain relief bobble according to an embodiment of the invention; 
           [0051]      FIG. 15  depicts a pain relief bobble according to an embodiment of the invention; 
           [0052]      FIG. 16  depicts a pain relief bobble according to an embodiment of the invention; 
           [0053]      FIG. 17  depicts a hand massage wristband fixture for use in association with a pain relief bobble according to an embodiment of the invention; 
           [0054]      FIG. 18  depicts a hand massage wristband fixture for use in association with a pain relief bobble according to an embodiment of the invention; and 
           [0055]      FIG. 19  depicts a pain relief bobble according to an embodiment of the invention wherein elements of the pain relief bobble may be customized to the user. 
       
    
    
     DETAILED DESCRIPTION 
       [0056]    The present invention is directed to pain relief and in particular to devices and methods to engage individuals with familiar objects to support providing pain relief. 
         [0057]    The ensuing description provides exemplary embodiment(s) only, and is not intended to limit the scope, applicability or configuration of the disclosure. Rather, the ensuing description of the exemplary embodiment(s) will provide those skilled in the art with an enabling description for implementing an exemplary embodiment. It being understood that various changes may be made in the function and arrangement of elements without departing from the spirit and scope as set forth in the appended claims. 
         [0058]    A “user” or “patient” as used herein and through this disclosure refers to, but is not limited to, a person who utilizes a device according to an embodiment of the invention to derive benefits from their utilization. 
         [0059]    Referring to  FIG. 1  there are depicted pain relief methods according to the prior art including over-the-counter medicine  110 , heat releasing compound  120 , a patch  130  that starts by cooling then heating, hypnosis  140 , electrical therapy  150 , subconscious therapy  160 , and acupuncture  170 . Over-the-counter medicine  110  and prescription medicines, not shown for clarity but generally stronger, target physiological processes such as blocking neural pain transmitters and form the primary thrust of conventional medicine. Heat releasing compound  120  and patch  130  are common treatments for patients suffering aches or pain within their limbs, neck and back. The other techniques form part of the CAM regimen adopted by many patients. 
         [0060]    Referring to  FIG. 2  there are depicted first to fourth images  210  to  240  respectively depicting the left back, right back, left front (palm), and right front (palm) views of patient&#39;s hands respectively and indicating where reflexology practitioners recognise pressure points on the hands and their associations with the rest of the human body. Also highlighted are first to eighth regions  260  through  295  respectively as outlined below in Table 1. 
         [0000]    
       
         
               
             
               
               
               
             
           
               
                 TABLE 1 
               
             
             
               
                   
               
               
                 Some Reflexology Associations of Regions 
               
               
                 of Human Hands to Human Body 
               
             
          
           
               
                 Region 
                 Area of Patient Hand 
                 Area of Human Body 
               
               
                   
               
               
                 260 
                 Right - bottom - base of fingers 
                 Lung 
               
               
                 265 
                 Right - bottom - palm 
                 Liver 
               
               
                 270 
                 Left - bottom - below thumb 
                 Small intestine 
               
               
                 275 
                 Right - bottom - below thumb 
                 Small intestine 
               
               
                 280 
                 Left - top - across knuckles 
                 Top of shoulders 
               
               
                 285 
                 Left - top - wrist/little finger area 
                 Knee/Leg/Hip 
               
               
                 290 
                 Right - top- middle of finger 
                 Eye/Ear 
               
               
                 295 
                 Right - top - across knuckles 
                 Top of shoulders 
               
               
                   
               
             
          
         
       
     
         [0061]      FIG. 3  depicts an Ancient Chinese acupuncture points on the human hand in first image  300  and finger  320  depicting meridians  340 ,  350 ,  380  for example and acupuncture points  330 ,  360  and  370 . Despite the large number of points depicted in the Ancient Chinese texts and these images today approximately  360  points are generally recognized all over the human body. Accordingly in  FIG. 3B  palm and back images  3100  and  3200  respectively are depicted identifying the dominant acupuncture points which are shown as  15  and  19  respectively for the palm and back of the hand. 
         [0062]    Now referring to  FIG. 4  there are depicted first to third images  400 A to  400 C respectively of a pain relief bobble  420  according to an embodiment of the invention. Within first image  400 A the pain relief bobble  420  is shown inserted into a patient&#39;s hand  410 . As evident the outer shape of the pain relief bobble  420  has been designed to orientate and locate within the patients hand  410 . In this instance the pain relief bobble  420  is depicted upside down but it would be evident to one skilled in the art that it may equally be designed for a more traditional orientation with the head upwards. In second image  400 B there is depicted a cross-sectional view of a first embodiment of the pain relief bobble  420  according to an embodiment of the invention wherein an outer shell  440  is depicted which is filled with a filler  430 . Disposed within the filler  430  is a ring  450  extending through the width of the body. Accordingly where filler  430  and outer body  440  are implemented with materials having a combined resiliency allowing the pain relief bobble  420  to compress under an increasing grip of the patient the ring  450  is implemented with an increased resiliency such that pressure is then applied to the patients hand at the location on their hand that they are gripping the section with ring  450 . 
         [0063]    Likewise third image  400 B with a cross-section of a different implementation of the pain relief bobble  420  according to an embodiment of the invention there are disposed first and second resilient members  460  and  470  which provide pressure to two different points on the patient&#39;s hand. First resilient member  460  provides a different resilience than second resilient member  470  even where they are made from the same material as first resilient member is anchored only to the outer shell  440  whereas second resilient member  470  extends through the body to the other side and hence pressure applied from the opposite side of the pain relief bobble  420  is also transmitted to the patients palm according to the properties of material forming the second resilient member  470 . 
         [0064]    It would be evident to one skilled in the art that the pain relief bobble  420  may be provided in a variety of manners to appear familiar or reassuring to the patient. For example, a mother giving birth to a boy may have a male baby shaped pain relief bobble  420 , a mother giving birth to a girl a girl shaped pain relief bobble  420 , a girl may have a girl shaped pain relief bobble  420 , a boy may have a racing car shaped pain relief bobble  420 . Accordingly it would be evident that the overall visual appearance of the pain relief bobble  420  may be varied to include people, historical figures, objects, fictional characters, animals, etc. Irrespective of the shape the pain relief bobble  420  would be molded to provide a grip to the patient that orientated the resilient members to the correct location in the patient&#39;s hand. Accordingly a pain relief bobble  420  for a child may be dimensioned narrower than that of an adult, and an adult man&#39;s version differently to an adult woman&#39;s version. 
         [0065]    It would be evident to one skilled in the art that the outer shell  440  may be provided from a rubber or plastic material for example providing compliance together with the ability to be molded/cast for example to the desired shape plus support pigmentation etc as applied to increase the objects familiarity to the patient. Filler  430  may be air, a liquid, foam, plastic or other material combining with the outer shell  440  to provide the required overall physical feel and resiliency to the pain relief bobble  420 . Filler  430  may also be the same material as outer shell  440 . Resilient member may for example be another plastic, rubber or harder material providing the required resilience to the patients hand such that it does not deform to the same extent as the outer shell  440  and filler  430  thereby applying pressure to the patients hand in the region of the resilient member  450 . 
         [0066]    Now referring to  FIG. 5  there are depicted first to third images  500 A to  500 C respectively of a pain relief bobble  520  according to an embodiment of the invention. Within first image  500 A the pain relief bobble  520  is shown inserted into a patient&#39;s hand  510 . As evident the outer shape of the pain relief bobble  520  has been designed to orientate and locate within the patients hand  510 . In this instance the pain relief bobble  520  is depicted upside down but it would be evident to one skilled in the art that it may equally be designed for a more traditional orientation with the head upwards. In second image  500 B there is depicted a cross-sectional view of a first embodiment of the pain relief bobble  520  wherein an outer shell  540  is depicted which is filled with a filler  530 . Disposed within the outer body  540  is a region  550 . Accordingly where filler  530  and outer body  540  are implemented with materials having a combined resiliency allowing the pain relief bobble  520  to compress under an increasing grip of the patient the region  550  is implemented with an increased resiliency such that pressure is then applied to the patients hand at the location on their hand that they are gripping the section with region  550 . 
         [0067]    Likewise third image  500 B with a cross-section of a different implementation of the pain relief bobble  520  according to an embodiment of the invention wherein there are disposed first to third resilient members  560  to  580  respectively which provide pressure to three different points on the patient&#39;s hand opposite the region  550 . First to third resilient members  560  to  580  respectively provides a different resilience than region  550  even where they are made from the same material due to their dimensional differences and by virtue of being short sections within the outer body  540  rather than a long section as in region  550 . Optionally first to third resilient members  560  to  580  respectively may be different materials to region  550  but they may also be made from two or more materials themselves such that for example first resilient member  560  is formed from a first material whilst second and third resilient members  570  and  580  respectively are formed from another material. As with pain relief bobble  420  in  FIG. 4  pain relief bobble  520  may be implemented in a variety of materials, finishes, colours, designs etc. 
         [0068]    Now referring to  FIG. 6  there are depicted first to third images  600 A to  600 C respectively for a pain relief bobble  620  according to an embodiment of the invention. As depicted in first and second images  600 A and  600 B respectively the pain relief bobble  620  may be gripped by the patients hand in either an upright or inverted manner. Now referring to third image  600 C there is depicted a cross-section of a pain relief bobble  620  according to an embodiment of the invention comprising an outer shell  630  within which are disposed first and second resilient elements  640  and  650  within the remainder of the inner region of the pain relief bobble  620  which is filled with filler  660 . As depicted first resilient member  640  provides resilience against the patients hand in first region  670 A depicted in first image  600 A and when the pain relief bobble is inverted the second resilient member  650  provides a different resilience against the patients hand in a smaller region  670 B as depicted in second image  600 B. 
         [0069]    Now referring to  FIG. 7  there is depicted a pain relief bobble  700  according to an embodiment of the invention in partial cross-sectional view. As shown on the left side of pain relief bobble  700  the surface has a plurality of bumps  770  in a predetermined pattern. Now referring to the partial cross-section of the pain relief bobble  700  comprises an outer shell  710  with a filler  720  and first to fourth resilient groups  730  to  770  respectively which are disposed according to a predetermined pattern. In this instance the first to fourth resilient groups  730  to  770  respectively are disposed vertically in groups along the length of the pain relief bobble. However, it would be evident that other patterns are possible including the mixing of resilient groups within the same region of the pain relief bobble  700 . Each of the first to fourth resilient groups  730  to  770  respectively provides a different effective pressure to the patients hand when they squeeze the pain relief bobble  700 . 
         [0070]    It would be evident to one skilled in the art that the shape, texture, and material of each of the first to fourth resilient groups  730  to  770  respectively may be varied. For example, hard spike like elements may be employed in some regions with soft spherical surface elements of these may be intermingled with varying densities to provide different region properties. It would also be evident that the number of different resilient groups may be varied such as for example 1, 2, or 3 and that the number of each may also vary in addition to their location on the pain relief bobble. Further some may project into the filler  720  or even be provided throughout the body such that they are continuous from one side of the pain relief bobble  700  to another for example. 
         [0071]    It would be evident to one skilled in the art that pain relief bobbles as depicted and described above in respect of  FIGS. 4 through 7  are primarily aimed at reflexology with the patient gripping the pain relief bobble within their hand. However, it would be evident that other designs may be implemented without departing from the scope of the invention such that for example the user stands onto the pain relief bobble to engage pressure into predetermined regions of the sole of their foot or feet or leans against the pain relief bobble for instance such that it is against their shoulders, back, calf, arm, etc. It would evident to one skilled in the art that in such instances the objects etc used t provide a degree of familiarity with the pain relief bobble may be different to those described above. Potentially these may simply be common objects such as depicted in  FIG. 7  by pillow  7100  and shoe  7200 . In pillow  7100  surface elements  7110  may be employed in conjunction with resilient elements  7120  embedded within the body of the pain relief bobble. With shoe  7200  first and second resilient elements  7210  and  7220  may be provided upon a sole  7230  to provide desired pressure onto the regions of the foot. 
         [0072]    Optionally the sole  7230  contains recesses  7240  which are designed to accept discrete resilient elements such that the patient may place the resilient elements according to the pain they are suffering rather than requiring them to purchase multiple pain relief bobbles. Such a similar approach may be employed within a pain relief bobble  700  such that a plurality of recesses are provided within which resilient elements are disposed. Potentially with a regular pattern of recesses a web of resilient elements may be applied such that the patient does not need to insert a significant number of discrete elements. Optionally a medical practitioner may elect to pre-assemble a pain relief bobble and adjust the properties and/or shape of the resilient elements according to the patient wherein factors including, but not limited to, age, sex, fragility, strength, pain type, and degree of perceived pain may be considered in establishing the desired pain relief bobble for that patient. 
         [0073]    Now referring to  FIG. 8A  there is depicted a pain relief bobble in first and second partial cross-sections  800  and  850  incorporating needles according to an embodiment of the invention. As depicted in first partial cross-section  800  the pain relief bobble comprises an outer shell  810  and a core  820 . Disposed at predetermined points are needles  830  within recesses or openings  840  in the outer shell  810 . Accordingly as depicted in second partial cross-section image localized compression  850  of the outer shell  810  in the region  870  around the needles  830  results in the needles  830  being exposed above the surface of the pain relief bobble and the recesses or openings  8400  being distorted and/or collapsed. Accordingly where a patient is gripping such a pain relief bobble the needles are selectively engaged into the patient&#39;s palm, fingers, thumb etc according to their placement within the pain relief body and the patients gripping of the object. It would be evident that such an orientation is more important in this approach than the pressure based pain relief bobbles described above in respect of  FIGS. 4 through 7 . 
         [0074]    The number and location of the needles may be varied according to aspects of the patient including, but not limited to, age, sex, fragility, strength, pain type, and degree of perceived pain may be considered in establishing the desired pain relief bobble for that patient. 
         [0075]    Now referring to  FIG. 8B  there is depicted a pain relief bobble in first and second partial cross-sections  8000  and  8500  incorporating needles according to an embodiment of the invention. As depicted in first partial cross-section  8000  the pain relief bobble comprises an outer shell  8100  and a core  8200 . Disposed at predetermined points are needles  8300  which have been inserted such that they penetrate the outer shell  8100  and partially into the core  8200 . Accordingly as depicted in second partial cross-section image  8500  localized compression of the outer shell  8100  in the region  8700  around the needles  8300  results in the needles  8300  being exposed above the surface of the pain relief bobble. Accordingly where a patient is gripping such a pain relief bobble the needles are selectively engaged into the patient&#39;s palm, fingers, thumb etc according to their placement within the pain relief body and the patients gripping of the object. However, in this embodiment of the invention a single default pain relief bobble structure comprising a predetermined shape, grip features etc may be made to address a specific pain relief issue of a patient wherein a medical practitioner inserts the needles  8300 . Accordingly a patient may re-use a pain relief bobble by having the pattern/quantity of needles adjusted. 
         [0076]    As discussed above in many instances fear, worry, etc may negatively impact a patients desire to take a medicinal treatments. Accordingly it would be beneficial to adjust their engagement to one wherein the taking of their medicine is fun or potentially even an aspect of their play activities. Accordingly there is depicted in  FIG. 9  a pain relief bobble  900  incorporating a spray medication injection device  930  disguised within the pain relief bobble  900 . As depicted pain relief bobble  900  comprises the spray medication injection device  930  coupled to a microfluidic control system  940  which receives medicine from a reservoir  960  and gas from a gas cartridge  920 . Power for the microfluidic control system  940  being derived from a battery  970  and the trigger for activating the pain relief bobble  900  being derived from a sensor  950 . For example where the pain relief bobble  900  has a deformable region then the sensor  950  may be pressure activated such that, in the instance shown, the infant or adult squeezing the “belly” of the “teddy bear” pain relief bobble  900  triggers the release of medicine from the reservoir  960  and the gas release from the gas cartridge  920 . Alternatively, the sensor  950  may be a button or other form of element providing an output in response to an action. Spray injection medication device  930  may be derived from the prior art but by maintaining a small injection area the pressure may be supplied from a discrete gas cartridge  920  rather than a compressor allowing the device to be used in residential environments, medical facilities etc. 
         [0077]    It would be evident to one skilled in the art that microfluidic control system  940  may additionally comprise electronics logging characteristics of the injection such as time and date, volume dispensed etc. Additionally, the pain relief bobble  900  may comprise a USB or other serial/parallel data port allowing this information to be retrieved from the pain relief bobble, allowing the pain relief bobble  900  to be calibrated, allowing the pain relief bobble  900  to be configured, and optionally to recharge the battery  970 . 
         [0078]    Now referring to  FIG. 10  is depicted a pain relief bobble  1000  incorporating a needle injection device  1030  disguised within the pain relief bobble  1000 . As depicted pain relief bobble  1000  comprises the needle injection device  1030  coupled to a microfluidic control system  1040  which receives medicine from a reservoir  1060 . Power for the microfluidic control system  1040  being derived from a battery  1070  and the trigger for activating the pain relief bobble  1000  being derived from a sensor  1050 . For example where the pain relief bobble  1000  has a deformable region then the sensor  1050  may be pressure activated such that, in the instance shown, the infant or adult squeezing the “belly” of the “teddy bear” pain relief bobble  1000  triggers the release of medicine from the reservoir  1060  through the needle injection device  1030 . 
         [0079]    Alternatively, the sensor  1050  may be integrated into the needle injection device  1030  such that squeezing of the pain relief bobble  1000  at that location inserts the needle into the patient&#39;s skin and triggers release of the medicine. As discussed above additional electronics and interfaces may be incorporated into the pain relief bobble  1000 . Optionally, the pain relief bobble  1000  as with other embodiments of the invention with a control circuit may incorporate safety features such as preventing another activation until a predetermined period of time has elapsed, requiring that a prior activation is made such as through the pressure sensor receiving an initial significantly higher signal from an adult activating the device for subsequent use by an infant or infirm individual. Other techniques would be known within the prior art including integration of biometric sensors to establish authentication of a user priming the pain relief bobble for use. 
         [0080]    Now referring to  FIG. 11  there is depicted a bobble  1100  incorporating a blood glucose testing device disguised within the bobble  1100  incorporating a needle injection device  1130  disguised within the pain relief bobble  1100  to prick the skin of a patient allowing their blood glucose level to be ascertained. As depicted bobble  1100  comprises the needle injection device  1130  which would be engaged such as described above in respect of pain relief bobbles  800  ( 850 ) and  8000  ( 8500 ) in  FIGS. 8A and 8B  respectively. Disposed proximate to the needle injection device  1130  is a test strip  1120  which is coupled to test strip socket  1180  and therein to controller  1140  allowing the measurement to be performed. As depicted the test strip  1120  comprises a hole  1120 A allowing the needle within the needle injection device  1130  to project through into the patient and sensor region  1120 D disposed radially such that the subsequent release of a small amount of blood allows the electrical measurement to be made wherein the electrical input/output to the test strip  1120  are shown by first and second contacts  1120 B and  1120 C respectively. 
         [0081]    Also disposed within the bobble  1100  are display  1150 , audio generator  1160 , and battery  1170  coupled to the controller  1140 . Accordingly the determined blood glucose value may be displayed and if the level is at a critical or dangerous level for some patients, such as the elderly or visually impaired for example, the audio generator emits an alarm signal. Optionally when the level is acceptable a different tone is generated to advise the patient that a measurement was in fact made. Likewise additional electronics and interfaces may be provided as would be evident from the disclosure above and the prior art. In the instance shown, the infant or adult squeezing the “face” of the “teddy bear” bobble  1100  triggers measurement to be performed. Disposable test strips  1120  allow the device to be reused by one patient or by multiple patients. 
         [0082]    Now referring to  FIG. 12  there is depicted a bobble  1200  incorporating a blood glucose testing device disguised within the bobble  1200  incorporating a needle injection device  1230  disguised within the pain relief bobble  1200  to prick the skin of a patient allowing their blood glucose level to be ascertained. As depicted bobble  1200  comprises the needle injection device  1230  which would be engaged such as described above in respect of pain relief bobbles  800  ( 850 ) and  8000  ( 8500 ) in  FIGS. 8A and 8B  respectively. Disposed proximate to the needle injection device  1230  is an optical window  1220  allowing the measurement to be performed. 
         [0083]    Also disposed within the bobble  1200  are display  1250 , audio generator  1260 , battery  1270 , and Wi-Fi  1290  coupled to the controller  1240  together with optical sub-assembly, not shown for clarity, behind the optical window  1280 . A simplified schematic of controller  1240  and this optical sub-assembly are described below in respect of  FIG. 13 . As such the determined blood glucose value may be displayed and if the level is at a critical or dangerous level for some patients, such as the elderly or visually impaired for example, the audio generator emits an alarm signal. Optionally when the level is acceptable a different tone is generated to advise the patient that a measurement was in fact made. Likewise additional electronics and interfaces may be provided as would be evident from the disclosure above and the prior art. In the instance shown, the infant or adult squeezing the “face” of the “teddy bear” bobble  1100  triggers measurement to be performed. Disposable window covers on the optical window would allow the device to be used by multiple patients and/or a single patient but are not necessary for the bobble  1200  to work as a wipe with an alcohol loaded wipe would also clean the optical window. 
         [0084]    Now referring to  FIG. 13  there is depicted a simplified schematic  1200  of the electronics for an optical blood glucose testing device according to bobble  1200  presented above in respect of  FIG. 12 . As shown a microcontroller  1350  is interfaced to an optical source  1310  to illuminate a blood sample  1320  such that the detected optical signal from the photodetector  1330  after conditioning by signal conditioner  1340  is coupled back to the microcontroller  1350 . This resulting electrical signal is processed by the microcontroller  1350  in conjunction with calibration data stored within an EEPROM/Flash Memory  1370  to determine the blood sugar level of the patient&#39;s blood sample  1320 . This data may then be coupled to audiovisual outputs  1380  as well as digital interfaces  1390  which may be wired and/or wireless. All of the electronics being coupled to a battery  1360 . 
         [0085]    Disposed within bobbles  1100  and  1200  in  FIGS. 11 and 12  respectively may be a sensor or button triggering the overall measurement process which may as discussed above be integrated within the needle injection devices  1130  and  1230  respectively or be discrete. As with the pain relief bobbles described above in respect of  FIGS. 4 through 8B  respectively the pain relief bobbles described in  FIGS. 9 through 12  may be implemented with a wide range of designs aimed at children, infants, adults, etc using different characters, animals, fantasy figures etc. Some may potentially even be themed with mature themes. 
         [0086]    Now referring to  FIG. 14  is depicted a pain relief bobble  1400  incorporating a pressure device  1430  disguised within the pain relief bobble  1400 . As depicted pain relief bobble  1400  comprises the pressure device  1430  within a predetermined position and housed within the core  1420  and shell  1410 . Accordingly when the user squeezes the bobble  1400  the shell  1410  and core  1420  compress faster than the central piston within the pressure device  1430 . Accordingly, the pressure device  1430  applies pressure to the users palm or finger in this embodiment of the invention. However, as the piston has flanges engaging a housing forming another part of the pressure device  1430  the compression of the housing in conjunction with the piston flanges causes the piston to rotate as well as applying pressure. It would be evident to one skilled in the art multiple pressure devices  1430  may be disposed within the pain relief bobble  1400  to apply pressure to different pressure points of the user. It would be further evident that multiple pain relief bobbles may be implemented addressing different parts of the human body or that multiple pain relief bobbles for a common part of the human body may provide relief against different pains. 
         [0087]    Now referring to  FIG. 15  there is depicted a pain relief bobble  1500  incorporating first to third hot spots  1530 A through  1530 C within the outer shell  1510  of the pain relief bobble  1500 . As depicted pain relief bobble  1500  comprises the first to third hot spots  1530 A through  1530 C within predetermined positions within the outer shell  1510 . Within the core  1520  are disposed a controller  1540  and battery  1550  together with electrical connections, not labeled for clarity, providing the electrical current heating the first to third hot spots  1530 A through  1530 C. Optionally the controller  1540  is activated through a manual switch or a pressure switch, each of which are not shown for clarity. Where the controller  1540  is activated by a pressure switch implying that the user has squeezed the pain relief bobble  1500  then the controller  1540  may optionally implement a sequence of heating the first to third hot spots  1530 A through  1530 C according to a predetermined sequence. 
         [0088]    Now referring to  FIG. 16  there is depicted a pain relief bobble  1600  incorporating first and second vibration elements  1630 A and  1630 B within the outer shell  1610  of the pain relief bobble  1600 . As depicted pain relief bobble  1600  comprises the first to third hot spots  1630 A through  1630 C within predetermined positions within the outer shell  1610 . Within the core  1620  are disposed a controller  1640  and battery  1650  together with electrical connections, not labeled for clarity, providing the electrical current to drive the first and second vibration elements  1630 A and  1630 B. Optionally the controller  1640  is activated through a manual switch or a pressure switch, each of which are not shown for clarity. Where the controller  1640  is activated by a pressure switch implying that the user has squeezed the pain relief bobble  1600  then the controller  1640  may optionally implement a predetermined control sequence for the first and second vibration elements  1630 A and  1630 B. 
         [0089]    Referring to  FIG. 17  there is depicted a hand massage wristband fixture  1700  for use upon a user&#39;s hand  1710  in association with a pain relief bobble according to an embodiment of the invention. The hand massage wristband fixture  1700  comprises a finger band  1720 , strap  1730 , and  1740 . Strap  1730  as depicted in partial cross-section  1750  has disposed upon the surface against the patient&#39;s hand  1710  a plurality of elements  1760  such as described above in respect of  FIGS. 4 through 7  respectively which provide pressure to those regions of the user&#39;s hand. The user in gripping the pain relief bobble, not shown for clarity, would thereby apply pressure via the pain relief bobble, to the strap  1730  and therein the plurality of elements  1760 . Alternatively, the plurality of elements  1760  may be similar to those depicted supra in respect of  FIGS. 8A and 8B  to provide acupuncture type activation based upon the user&#39;s gripping of the pain relief bobble. 
         [0090]    Referring to  FIG. 18  there is depicted a hand massage wristband fixture  1800  for use upon a user&#39;s hand  1810  in association with a pain relief bobble according to an embodiment of the invention. The hand massage wristband fixture  1800  comprises a finger band  1820 , strap  1830 , and  1840 . Strap  1830  as depicted in partial cross-section  1860  has disposed upon the surface against the patient&#39;s hand  1810  a plurality of elements  1870  such as described above in respect of  FIGS. 4 through 7  respectively which provide pressure to those regions of the user&#39;s hand. The user in gripping the pain relief bobble, not shown for clarity, would thereby apply pressure via the pain relief bobble, to the strap  1830  and therein the plurality of elements  1870 . Alternatively, the plurality of elements  1870  may be similar to those depicted supra in respect of  FIGS. 8A and 8B  to provide acupuncture type activation based upon the user&#39;s gripping of the pain relief bobble. In contrast to hand massage wristband fixture  1700  hand massage wristband fixture  1800  also includes a plurality of beads  1850  disposed upon the inner surface of the wristband  1840  as depicted by the partial cross-section. In this instance the material for the wristband  1840  may be selected to provide pressure and accordingly be made from an elastic material having increased contraction, and hence pressure applied, that the material employed for wristband  1740  in  FIG. 17  supra. 
         [0091]    Optionally, hand massage wristband fixtures  1700  and  1800  respectively may be implemented with a predetermined subset of the plurality of elements are connected to a controller, not shown for clarity, which may be disposed within the hand massage wristband fixture or the pain relief bobble. In the latter instance an electrical connection between the hand massage wristband fixture and pain relief bobble may be provided either as a discrete connection or one made by virtue of the gripping by the user of the pain relief bobble. These elements coupled to a controller may, for example, vibrate as well as providing pressure or acupuncture engagement to the user&#39;s hand. Alternatively, they may for example provide localized heat to the user&#39;s hand. Similarly, in hand massage wristband fixture  1800  the plurality of beads  1850  may be optionally connected to the same controller to provide for example vibration and/or heat to the patient&#39;s wrist. The plurality of beads  1850  may be activated in some embodiments of the invention, in a different or similar manner to those of the plurality of elements  1870 . It would be evident that the principles of hand massage wristband fixtures  1700  and  1800  respectively may be applied with respect to other parts of the human body and pain relief bobbles designed to engage these parts, for example the foot. 
         [0092]    Pain relief bobbles such as described supra in respect of  FIGS. 4 through 18  may be customized or personalized such as depicted in  FIG. 19 . According, a pain relief bobble  1920 , such as described supra in respect of  FIGS. 4 through 18 , for gripping by the user&#39;s hand  1910  is depicted as comprising a removable head  1930 . Accordingly, the user may select a head such as first and second female heads  1930 A and  1930 B respectively, male head  1930 C, baby head  1930 D, toddler head  1930 E, and first and second character heads  1930 F and  1930 G respectively. Accordingly, a plurality of options may be provided as standard to a user or the removable head  1930  may be customized based upon a photograph of the user, a user&#39;s relative, family friend, etc. Optionally, the pain relief bobble may be molded as a single piece with the customization of the head. In either scenario additional elements may be provided to give further customization of the pain relief bobble  1920  such as headgear  1930 H and clothing  1930 I. For example, the user may select a favorite sports team, a hated sports team given the intention of applying pressure, or a particular style of clothing that reflects them personally or where the pain relief bobble is used as part of pain mediation in childbirth their baby. 
         [0093]    The foregoing disclosure of the exemplary embodiments of the present invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many variations and modifications of the embodiments described herein will be apparent to one of ordinary skill in the art in light of the above disclosure. The scope of the invention is to be defined only by the claims appended hereto, and by their equivalents. 
         [0094]    Further, in describing representative embodiments of the present invention, the specification may have presented the method and/or process of the present invention as a particular sequence of steps. However, to the extent that the method or process does not rely on the particular order of steps set forth herein, the method or process should not be limited to the particular sequence of steps described. As one of ordinary skill in the art would appreciate, other sequences of steps may be possible. Therefore, the particular order of the steps set forth in the specification should not be construed as limitations on the claims. In addition, the claims directed to the method and/or process of the present invention should not be limited to the performance of their steps in the order written, and one skilled in the art can readily appreciate that the sequences may be varied and still remain within the spirit and scope of the present invention.