Long-term therapeutic pressure applicator and real-time monitoring system

A therapeutic pressure applicator with a sensor and transceiver is worn by a patient during daily activity to apply pressure to a specific body part, and used in a system with a device such as a cell phone to receive and display real-time pressure data to alert the patient and physician when the pressure is outside a desired range. The applicator includes a securement member and a pressure adjusting device with a pressure adjusting dial, pressure sensing component, pressure focusing plate and cushion. Rotating the dial retracts or extends the sensing component, focusing plate and cushion. The applicator has a computer module with a CPU, memory, transceiver, power source and a force sensor. A pressure button is pressed into engagement with the sensor to transmit real-time focused pressure data to the CPU. The transceiver communicates the real-time cushion pressure data to the cell phone that displays and stores the data.

TECHNICAL FIELD OF THE INVENTION

This invention relates to a therapeutic pressure applicator worn by a patient during normal daily activity to apply pressure to a specific body part and obtain real-time pressure data during long-term medical treatment, and used in a system including a device such as a cell phone to receive and display the pressure data to alert the patient and treating physician when the pressure is outside a desired range.

BACKGROUND OF THE INVENTION

Medical devices to apply compression or tension to the head6, neck7, torso8, arm9or other body part of a patient (seeFIG. 1A) are well known. Conventional blood pressure monitors are secured to the arm, and inflate and deflate to determine blood pressure. Examples of these monitors are disclosed in U.S. Pat. No. 4,458,690 to O'Connor, U.S. Pat. No. 5,054,494 to Lazzara, U.S. Pat. No. 5,280,790 to Brooks, U.S. Pat. No. 7,052,465 to Lunak and U.S. Pat. No. 9,289,136 to Addison. Back braces are secured to the torso to apply pressure to specific portions of the spine to treat disorders involving the curvature of the spine such as scoliosis. Examples of back braces are disclosed in U.S. Pat. No. 4,230,101 to Gold, U.S. Pat. No. 5,840,051 to Towsley and U.S. Pat. No. 9,468,552 to Thibeault. Orthodontic headgear treats bite disorders and properly align teeth by applying force to the teeth. Examples of headgear are disclosed in U.S. Pat. No. 4,555,934 to Armstrong and U.S. Pat. No. 8,640,710 to Matthews. The REZA BAND® device applies pressure to the esophagus of a patient suffering from reflux disorders, and is disclosed in U.S. patent application Ser. No. 13/702,258 to Reza Shaker, the disclosure of which is incorporated by reference. While some devices such as blood pressure monitors or traction in a hospital bed require patients to remain immobile, other devices such as back braces, orthodontic headgear and the REZA BAND® device allow mobility so patients live relatively normal ambulatory lives during treatment. These ambulatory devices are secured to the patient by their treating physician. The physician ensures the device is properly applied to the patient and sets the device to apply a desired amount of force or pressure. The patient then wears the device at home and during daily activities, and returns to the physician at scheduled weekly or monthly intervals until the treatment is completed.

The REZA BAND® device10is secured to the neck7of a person5to apply pressure to his or her upper esophageal sphincter as shown inFIGS. 1A-D. The REZA BAND® device10includes a neck band11with a curved, semi-flexible strap bracket12. The strap bracket12has a central recess13, front and rear surfaces14and15, a central opening17and opposed lateral ends18. The rear surface15of the strap bracket12has two spaced slots15a. The common center of the central recess13and opening17forms a centerline19for the device10. A flexible strap21is secured to each lateral end18to fit the device10to the neck7of a patient5. One end22of the strap21is secured by a selectively adjustable Velcro® fastener23, and its other end26is secured by a non-adjustable rigid clip fastener27.

The REZA BAND® device10includes a compression mechanism30with a pressure dial31, a pressure plate51and a cushion61. The dial31has a knob32formed by an outer shell34with a generally hemispherical shape that forms an interior chamber35. The rear end of the knob32forms a rim37with inwardly extending tabs. The dial31also has a circular base42that is flushly and rotatably received by the circular recess13of the strap bracket12. The circular base42has a flat rear surface43and a central opening45with a threaded sidewall46. The rear surface of the base42rotatingly engages the flat surface of the bracket recess13. The rim of the knob32is firmly joined to a rim47of the base42. The rim47has tabs that mate with the knob tabs so that the knob32and base42rotate in unison.

The pressure plate51has front and rear surfaces52and53, and a thickness of about 0.125 inches. The plate51has a generally rectangular shape with a width of about 1.125 inches and length of about 1.625 inches. A thin rectangular shaped Velcro® strip fastener54is secured to the rear surface52. A central post or stem55with a threaded sidewall56extends from the front surface53a distance of about 0.375 inches. The stem has a diameter of about 0.25 inches. The stem55extends unobstructedly through the larger diameter, unthreaded bracket opening17, with its threaded sidewall56in mating threaded engagement with the threaded sidewall46of the dial base opening45. Two mounting and anti-rotation posts57are located proximal the longitudinal edges of the plate51and straddle the central stem55. The posts57extend forward from its front surface52, and are flushly received by the bracket slots15a. The posts57have shoulders57athat form a limit stop to limit the retracting movement of the plate51. A washer58is secured by a screw fastener59to the front or top surface of the stem55. The diameter of the washer58is larger than the dial base opening45to form an additional limit stop to prevent the overextension of the pressure plate51into the neck7of the patient5.

The cushion61is secured by a Velcro® strip65to the rear surface53of the pressure plate51. The cushion61is relatively soft and deformable to conform to the shape of the front portion of the neck7and throat of the patient5and alleviate any uncomfortable pinch points between the pressure plate51and the soft tissue of the neck7. The Velcro® strip fastener65allows for the removal of the cushion61so it can be periodically washed or replaced during the use of the band10.

The treating physician secures the REZA BAND® device10to the patient5in two steps. First, with the clip27secured to the bracket12, the treating physician selectively positions and secures the Velcro® fastener23to achieve an approximate pressure close to the desired pressure on the throat or esophagus of the patient5. Second, the physician uses the pressure dial31to set the device10to the desired or prescribed pressure. Rotating the pressure dial31in one direction increases pressure on the esophagus by causing the threaded central stem55and pressure plate51to move longitudinally along a path of travel70away from the bracket12and toward the neck7to an increased pressure position71as best shown inFIGS. 1C and 1D. The strap bracket12flexes slightly. The plate guide posts57remain in flush engagement inside bracket slots15a. Rotating the pressure dial31in an opposite direction decreases pressure on the esophagus by causing the threaded central stem55and pressure plate51to move longitudinally along the path of travel70toward the strap bracket12and away from the neck7and into a decreased pressure position72.

The treating physician uses a separate pneumatic gauge80to determine the pressure of the REZA BAND® device10on the throat or neck7. This gauge80includes a pressure gauge81, an inflatable pad85and a connecting tube86. After the Velcro® strap fastener23is secured and the pressure dial31is rotated to obtain and set pressure, the physician removes the pressure pad75. The pneumatic gauge80remains at the office of the physician, and does not go home with the patient. During the use of the band10, the patient5should use the rigid clip27to remove and reattach the band when bathing, or for formal occasions, physical activity, etc. By using the clip27, the patient5does not inadvertently alter the prescribed pressure of the device10.

A problem with conventional medical devices that apply force or pressure to a patient is that they do not display the actual force or pressure being applied. Between periodic physician visits, the pressure can deviate from the desired or prescribed amount. For example, the device can slide or shift up or down on the patient, the patient can lose or gain weight, experience swelling or become dehydrated, which can cause the applied force or pressure to increase or decrease. The patient has no accurate way to tell how much the pressure has deviated from that set desired amount. A patient can only guess based on his or her past recollection of how the device felt several hours, days, weeks or months before. Gradual increases or decreases over time can go unnoticed. Without realizing it, the patient can allow the device to gradually increase or decrease to an improper or even potentially harmful setting. In other situations, the patient will incorrectly believe the force or pressure has changed and is now too loose or tight, when the force or pressure has not changed. The patient will then improperly adjust the device to increase or decrease the force or pressure to an improper or harmful setting.

Another problem with conventional medical devices that apply force or pressure to a patient is that they do not provide any objective evidence to the physician regarding the use of the device by the patient. The physician must rely on the patient to tell him or her that the device was worn, when the device was worn, and if the desired pressure was applied when the device was worn. Should the patient forget these details or fail to accurately describe these details, the physician may not be able to take the proper course of action in treating the patient.

A further problem with conventional medical devices that apply force or pressure is that they do not alert or warn the patient when the pressure has increased or decreased outside a medically desirable range.

A still further problem with conventional medical devices that apply force or pressure to a patient is the imprecision in setting the devices. For example, when the treating physician sets a REZA BAND® device10to a desired pressure, the physician uses a pressure gauge80with an inflated pneumatic pad85placed between the band and the neck7of the patient5as shown inFIG. 1A. The pressure applied by the band10against the esophagus is measured with the pad85in place. Once the pressure is set, the physician removes the pad85, which stays at the office of the physician with the pressure gauge80. Yet, the inflated pad85has a significant thickness. When the pad85is removed, the pressure exerted by the band10on the esophagus decreases so that the actual pressure applied by the band10to the neck7is unknown.

A still further problem with conventional medical devices that apply force or pressure to a patient is that they have both a pressure setting fastener and a quick release fastener. In devices such as a REZA BAND® device10, the pressure setting fastener includes a Velcro® strip23that is secured by the physician. The quick release fastener27allows the patient to remove the device without altering or adjusting the Velcro® strip fastener23set by the physician. The clip27allows the patient to temporarily remove the device to do a particular activity such as take a bath, exercise, go swimming or clean the device, and then reattach the device without altering or adjusting the pressure setting of the Velcro® fastener23. Unfortunately, a patient can forget which fastener is which, and use the Velcro® fastener23to take off the device. When reattaching the device, the patient will then use his or her best guess of the prescribed set pressure to reattach the device. This leads to the application of an improper or even harmful pressure setting.

A still further problem of conventional medical devices that apply force or pressure is their bulkiness. Although the devices are intended to allow patients to live relatively normal ambulatory lives, they are large and cumbersome, and extend out from the body so much that they become awkward to wear when doing normal activities.

The present invention is intended to solve these and other problems.

BRIEF DESCRIPTION OF THE INVENTION

This invention pertains to a therapeutic pressure applicator equipped with a sensor and transceiver worn by a patient during normal daily activity to apply pressure to a specific body part during long-term medical or therapeutic treatment, and used in a system with a device such as a cell phone to receive and display real-time pressure data to alert the patient and treating physician when the pressure is outside a desired range. The applicator includes a securement member and a pressure adjusting device with a pressure adjusting dial, pressure control component, pressure focusing plate and cushion. Rotating the dial retracts or extends the control component, focusing plate and cushion. The applicator has a computer module with a CPU, memory, transceiver, power source and a force sensor. The focusing plate aligns a pressure button into pressed engagement with the sensor to transmit real-time focused pressure data, which the CPU converts into real-time cushion pressure data. The transceiver periodically communicates the long-term, real-time cushion pressure data to the cell phone to display and store the data.

An advantage of the present therapeutic pressure applicator and monitoring device and monitoring system is the monitoring system displays the real-time cushion pressure being applied to the patient. When the cushion pressure deviates from the desired amount set by the physician, a device such as a cell phone will display the real-time cushion pressure, and alert the patient that the pressure has deviated or is not within a desired pressure range. The patient does not have to guess the current pressure level based on his or her past recollection of how the device felt. Gradual increases or decreases over time are readily displayed. The display of the real-time cushion pressure level also helps prevent the patient from incorrectly believing the pressure has changed, when in fact it has not changed.

Another advantage of the present therapeutic pressure applicator and monitoring system is that the long-term, real-time cushion pressure data can be readily stored and communicated to the treating physician. The device and system provide the physician with objective evidence regarding if the device was worn, when the device was worn, and if the device was within the desired pressure setting during the time it was worn.

A further advantage of the present therapeutic pressure applicator and monitoring system is that it alerts or warns the patient when the pressure has increased or decreased outside a prescribed pressure range. This warning can be performed visually, audibly, or otherwise. The screen of the cell phone or personal computer is green when the real-time pressure is at a desired level, and turns red when the real-time pressure is outside the desired pressure setting or range. The cell phone or personal computer can also sound an audible alarm to notify the patient of the pressure deviation or potentially harmful situation.

A still further advantage of the therapeutic pressure applicator and monitoring system is that the patient can use his or her cell phone to transmit the data to the physician via the wireless telecommunication to a phone or computer in the office of the physician or use the personal computer of the patient to send days, weeks or months or real-time cushion pressure data via a land line, such as via an email with the attached data. The patient does not need to schedule an appointment or drive to the office of the physician to deliver the data. The physician and patient do not need to remove the applicator to obtain the long-term, real-time cushion pressure data.

A still further advantage of the therapeutic pressure applicator and monitoring system is the adaptability and accuracy of the real-time pressure readings gathered. The device includes a focusing plate that collects the distributed pressure forces across the cushion being pressed into the body of the patient and focuses that force or pressure via a curved button on a small sensor contact zone. This magnifies the sensitivity of the sensor so that even slight variations in the pressure distribution can be observed. The curved button is also free to rock or rotate slightly so that an uneven cushion pressure distribution about the centerline of the device does not change the size of the contact zone, so the observed pressure by the sensor does not improperly read an increase in pressure when none has occurred. The devices adjusts to accommodated anomalies in the body surface such as a scare, cyst or underlying bone or cartilage and still provides accurate cushion pressure readings.

A still further advantage of the present therapeutic pressure applicator and monitoring system is the ease of setting the device to the desired pressure. The applied pressure of the device is displayed as a real-time cushion pressure reading on the screen of a corresponding device. The physician does not have to insert and then remove a pressure gauge, such as one with an inflated pneumatic pad, from between the applicator and the patient so that the true applied pressure is not actually known.

A still further advantage of the present therapeutic pressure applicator and monitoring system is that should the patient inadvertently release the pressure setting fastener set by the physician, such as the Velcro® fastener in the REZA BAND® device, the patient will be able to use the displayed real-time pressure information to accurately reattach the device to the desired pressure level prescribed and set by the physician. The patient need not guess at the applied pressure level and need not schedule a return visit to the physician to reset the pressure.

A still further advantage of the therapeutic pressure applicator and monitoring system is the compact and light weight construction of the pressure applicator and monitoring device. The compact device allows the patients to go about their normal daily lives with as little restriction as possible.

Other aspects and advantages of the invention will become apparent upon making reference to the specification, claims and drawings.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

While this invention is susceptible of embodiments in many different forms, the drawings show and the specification describes in detail preferred embodiments of the invention. It should be understood that the drawings and specification are to be considered an exemplification of the principles of the invention. They are not intended to limit the broad aspects of the invention to the embodiments illustrated.

The present invention pertains to a long-term therapeutic pressure applicator and monitoring device generally indicated by reference numbers100and a real-time pressure monitoring system generally represented by reference number200as shown inFIGS. 2-11. The therapeutic pressure applicator and monitoring device100has a securing member or mechanism101to secure a pressure adjusting mechanism105to the patient5. Depending on the body part involved, the securement member or mechanism101can take a variety of forms. In a first embodiment, the therapeutic pressure applicator and monitoring device100is secured to the neck7to reduce esophageal reflux as inFIGS. 2A-J. The securing mechanism101is the conventional REZA BAND® device11used by the treating physician to apply an approximate pressure to the patient that is close to the desired pressure. As noted above, the band11has the semi-flexible strap or securement bracket12with its central recess13, front and rear sides surfaces14and15and opening17.

The pressure adjusting mechanism105adjusts the amount of pressure applied to the body part of the patient5to obtain the desired or prescribed pressure by the treating physician. As shown inFIGS. 2C and 2E, the pressure adjusting mechanism105includes a pressure adjusting dial110, pressure sensing component130, pressure gauge140, computer module150, power supply160, pressure focusing plate180and cushion190. As shown inFIG. 6, the computer module150has an internal CPU151, memory152and transceiver153to obtain, store and transmit long-term, real-time cushion pressure data172. The pressure adjusting mechanism105has a depth from the strap bracket12to the rear surface of the cushion190of about 0.375 of an inch, which is substantially the same as the depth of the REZA BAND® device10.

The pressure adjusting dial110is formed by a knob112and a base122. The dial110is located on the front side14of securement bracket12facing away from the body part. The knob112has a semi-circular outer shell114to form an interior chamber115. The rear end of the knob112forms a rim116with inwardly extending tabs118. The dial110also has a circular base122that is flushly and rotatably received by a circular recess13of the strap bracket12. The circular base122has a rear surface123and a central opening125formed by a threaded sidewall126. The rim116of the knob112is firmly joined to a rim127of the base122. The rim127of the base122has tabs128that mate with tabs118of the knob112so that the knob and base rotate129in unison.

The pressure sensing component130is rigid and preferably made of conventional Acrylonitrile butadiene styrene (ABS) plastic with a tensile strength of 6,600 pounds per square inch (psi). The dial110and sensing component130engage opposite sides of the strap bracket12. The sensing component130is located on the rear side15of securing bracket12facing toward the body part. The sensing component130has main body131with front and rear surfaces132and133and a thickness of about 0.25 inches. The rear surface133has a central recess133a. The sensing component130and its main body131have a generally rectangular shape with a length of about 1.625 inches and a height or width of about 1.25 inches, which are the same as the REZA BAND® device. An outer rearwardly projecting tubular rim134with a length of about 0.1 of an inch extends from the rear surface133around the perimeter of the main body131. The radial mounting rim or tubular perimeter rim134has an end with an inwardly facing securement notch134athat extends around the circumference of the rim. The radial notch134ahas an inwardly sloped or angled cross-sectional shape as best shown inFIGS. 2D, 2E and 2J.

The pressure sensing component130has a central post or stem135with a threaded sidewall136that extends from its front surface132. The forward extending stem135has a length of about 0.375 inches and a diameter of about 0.25 inches. The threaded stem135extends unobstructedly through the larger diameter, unthreaded opening17in the strap bracket12. The threaded sidewall136of the stem135is in mating threaded engagement with the threaded sidewall126forming the central opening125of the dial base122. The main body131has three openings. One opening is sized to matingly receive a computer module and another opening is sized to matingly receive a base of a force sensor. The third opening131ais used to rout the sensor leads as discussed below. The threaded sidewall136has a relatively small cut away portion extending from the top of the post135to its base to form a channel136afor routing the power supply160wires as discussed below.

The pressure sensing component130is rotationally fixed to the strap bracket12, and does not rotate with the pressure dial110. The sensing component130has two forward extending mounting or securement posts137. The posts137extend from front surface132, straddle the stem135and are generally parallel to the stem. The posts137are flushly received by the anti-rotation slots15aof the strap bracket12to secure the sensing component130to the dial bracket12. The tips of the posts137are flared so that they snap-fit into the slots15aand do not become dislodged from the slots during use. The posts137have shoulders137athat form limit stops for the retraction of the plate130.

A battery hold down clip138is secured by a screw fastener138ato the flat surface at the forward end or top of the stem135. The pressure adjusting dial110rotates about the threaded stem135to extend or retract the sensing component130along a linear path of travel139between decreased and increased pressure positions139aand139b. The diameter of the clip138is larger than that of the stem135and central opening17of the strap bracket12to form a limit stop that prevents the overextension of the sensing component130into the neck7of the patient5. The channel136aand battery wires do not interfere with the rotatable threaded engagement between the stem135and dial base opening125, or the longitudinal movement139of the sensing component130when the dial110is rotated129.

The pressure gauge140has a force-sensing sensor141configured to collect electrical data associated with the pressure applied by the cushion to the patient. The sensor has a flat front and rear surfaces142and143. The sensor141is relatively thin with a thickness of about 0.012 inches, and has a generally circular sensing area144with a diameter of about 0.25 inches. The front surface142of the sensor141is in flush engagement with the rear surface133of the central recess133aof the sensing component130. The sensing area144is centrally located on the sensing component130and along the centerline106of the device100.

The sensing area144includes electrically conductive spaced input and output contacts that are electrically connected to input and output sensor leads145aand145b. The sensor141is preferably a force-sensing sensing resister, such as the Model FSR 400 manufactured by Interlink Electronics. The material between the contacts of the sensor is preferably a polymer thick film (PTF) that exhibits a decrease in electrical resistance when an increase in force or pressure is applied to its surfaces142and143. When a force is applied to the rear surface143of the working area144of the sensor141, the material between the sensor contacts is compressed against rear surface133of the sensing component130. The change in resistance continues as long as the force or pressure is applied so that the sensor continually measures the force or pressure being applied to the sensor. The change in resistance of the material caused by the compression of the sensor141is converted into an electrical output signal such as a change in voltage or current. This sensor output signal includes focused cushion pressure data171.

The pressure gauge140has a base146to mount the sensor141to the main body131of the pressure sensing component130. To maintain the compact nature of the pressure applicator100and adjusting device105, the base146fits predominantly within the main body131and does not extend beyond the forward edge of the rim notch134aas best shown inFIGS. 2G and 2J. The sensor leads145aand145bare in electrical communication with the spaced input and output sensor contacts, respectively, travel through the recess133aalong the rear side133of the main body131, and pass through the base opening131a. The input and output sensor leads145aand145bplug into and are in electrical communication with the input and output terminals147aand147bof the base146, respectively, as shown inFIG. 2F. Base input and output terminals147aand147bare in electrical communication with base input and output terminals148aand148b, respectively. Similarly, base terminals148aand148bare in electrical communication with base input and output leads149aand149b, respectively, to electrically connect the sensor141to the computer module150. The leads and terminals145,147,148and149are generally flush with the front surface132of the main body131.

The computer module150has an integrated programmable microcontroller or central processing unit (CPU)151, memory152and transceiver153that are internal to the module as shown inFIG. 6. These components are in electrical communication via its internal circuitry. The processor151is programmed or otherwise configured to provide the functionality described herein, and is specifically programmed or configured to collect focused cushion pressure data171from sensor140, process that data into cushion pressure data172, store the data171and172in its memory152, and transmit the data171and172as a pressure data signal via transceiver153. The module150is preferably manufactured by LSR as a compact TiWi-uB1 Bluetooth Smart module with a low-power 2.4 GHz Bluetooth 4.0 (BLE) System-on-Chip (SoC) with an integrated microcontroller, embedded flash memory, and Texas Instruments CC2541 transceiver with RF output power and dipole antennas with a range of about 10 feet. The module150has a thickness of about 0.125 inches, and is generally rectangular in shape with a width of 0.5 inches and a length of 0.75 inches. Communications with other devices via the transceiver153can be wireless, radio frequency messages that provide the real-time cushion pressure data172.

To maintain the compact nature of the pressure applicator100and adjusting device105, the module150is mounted predominantly within the main body131of the pressure sensing component130, and does not extend beyond the forward edge of the rim notch134aas best shown inFIGS. 2G and 2J. The module150includes module power input and output terminals154and155and pressure gauge input and output terminals156and157as shown inFIGS. 2B, 2F and 6. The module150also has additional input and output terminals158and159for an optional automated embodiment discussed below. The pressure gauge leads149aand149bare connected to the input and output terminals156and157, respectively, so that the pressure gauge140is in electrical communication with the computer module150and its CPU151.

A battery161provides the power supply160to the computer module150to operate the programmed CPU151, transceiver153and pressure gauge140. The battery161is preferably a conventional CR1025 lithium coin cell or button cell battery with a capacity of about 30 mAh to provide a year of useful life for the device100. The coin-shaped battery131is located in the dial knob chamber115, and is held by an electrical interface casing162. The securement prongs of the clip138secure both the battery161and casing162to the clip. The battery161and casing162are held by the clip138at the top of the stem135. The clip138, battery161and casing162remain rotationally fixed on the stem135, and do not rotate with the knob112. The battery casing162has positive and negative leads163and164connected to the positive and negative terminals on the battery161, respectively. The battery161can be replaced as needed by temporarily removing the knob112to access the battery. The battery161is in electrical communication with the computer module150as shown inFIGS. 2E, 2F and 6. The battery casing leads163and164extend from the terminals163aand164aof the battery casing162in the dial knob chamber115, through the stem channel136aand into engagement with the positive and negative computer module terminals154and155.

The computer module150uses the pressure gauge140to gather long-term, real-time cushion pressure data172. The CPU151is programmed to periodically send an input signal to the pressure gauge140via leads and terminals145a,147a,148a,149aand156. Based on the real-time focused cushion pressure exerted on the working area144of the sensor141, the sensor sends an output signal with real-time focused cushion pressure data171back to the CPU151via leads and terminals145b,147b,148b,149band157. As noted above and discussed more fully below, the pressure applied by the cushion190to the rear surface of the pressure focusing plate180is focused or collected onto a small contact area or zone of the button185actually pressing against the sensor141, so that the corresponding small contact area or zone of the sensor experiences a much larger force or pressure than any one spot on the cushion. The programming of the CPU151converts the focused cushion pressure data171into real-time cushion pressure data172corresponding to the actual pressure between the cushion190and the patient5at a given point in time. The CPU151is programmed to add time and date information to the real-time cushion pressure data172and continuously store that pressure data172in its memory152. The CPU151is programmed to format or otherwise process the output signal data171obtained by the sensor140into formatted real-time cushion pressure data172that is readily received and processed by other devices210in the system200. As discussed below, the CPU151is further programmed to periodically transmit the long-term, real-time pressure date data172stored in its memory152via its transceiver153to an external device210in the monitoring system200.

The pressure focusing plate180is rigid and preferably made of ABS plastic with a tensile strength of 6,600 psi. The plate180is thin and fits within the rim154of the pressure sensing component130. The focusing plate180has front and rear sides or surfaces182and183and a perimeter184. The plate180has a generally rectangular shape with a width and a length substantially equal to those of the main body131. The rear surface183has a surface area of about two square inches. The perimeter184has an inwardly angled edge184a. The focusing plate180snap fits into secure engagement with the rim134of the sensing component130. The angled edge184ais matingly received by the inwardly angled notch134aof the sensing component rim134around the entire perimeter of the focusing plate180to secure the focusing plate to the sensing component130.

The sensing component130and sensing plate180are structures to focus the forces distributed along the surface of the cushion190onto a contact area of the sensor141. The length and depth of the angled notch134a, the thickness of the focusing plate180, and outward projection of the button185are sized so that there is a gap G between the flat front surface182around the perimeter184of the focusing plate180and the forward lip of the notch134aas shown inFIGS. 2E and 2J. The gap G extends completely around the perimeter184of the pressure focusing plate180so that pressure exerted on the focusing plate180by the cushion190is transmitted through the button185, and is not supported by the rim134of the control sensing component130. The front end of the notch134ais in spaced planar or parallel relation to the rear surface133of the main body131of the sensing component130. The notch134ais spaced from the main body rear surface133the so that the forward most point or apex187of the curved button185engages the sensor141while maintaining the perimeter gap G between the focusing plate180and the forward lip of the sensing component notch134a. The flared outer portion of the rim134forming the notch134acombines with the angled outer edge184aof the pressure focusing plate180to assist in maintaining the engagement of the button185against the sensor141while maintaining the perimeter gap G around the plate180.

The central button185of the pressure focusing plate180is aligned over the working area144of the force-sensing sensor141as shown inFIGS. 2E and 2J. The front surface186of the button185has an outwardly curved or convex shape, preferably having a uniform radius of 0.125 inches. The apex187of the curved surface186is preferably positioned to engage the middle of the sensor141. The apex187of the button185is located at the center of the focusing plate185and along the centerline106of the device100. The only part of the focusing plate180supporting the compression load or pressure exerted by the cushion190on the neck7of the patient5is the button185, which presses against the force sensor141laying flat against the rear surface143of the pressure sensing component130. The load or pressure exerted by the cushion190across the rear surface133of the rigid focusing plate180is focused or amplified into a larger load or pressure exerted by the curved contact area187aof the central button185onto the sensor141. Naturally, the size of the button contact area187aand the size of the sensor contact area are the same.

The contact area187aof the compressed sensor141around the curved apex187button185is believed to be slightly curved and small, and not merely point contact. While the gauge140is stated to be a pressure gauge, it should be understood that the sensor141measures the force or pressure applied by the contact area187aof the curved button surface186on the generally flat sensor surface143. The distributed pressure load applied by the cushion190to the relatively large rear surface183of the pressure focusing plate180is focused or amplified into a much larger force or focused cushion pressure applied by the relatively small contact area187aof the curved button surface186onto the compressed contact area of the surface143of the sensor141.

Given the rounded shape of most parts of the human body, the perimeter gap G of the focusing plate180is uniform around the circumference of the mounting rim134in most securement situations as shown inFIG. 2J. This is because the pressure exerted by the cushion190across the rear surface183of the focusing plate180should be substantially evenly distributed relative the center106of the focusing plate140. However, in situations where the pressure exerted by the cushion190across the focusing plate180is not evenly distributed about the center106of the focusing plate180, such as by an anomaly in the body structure due to a scar, cyst, or underlying bone or cartilage, then the curved surface186of the button185is free to rock or rotate slightly to a position188where the gap G around the perimeter of the focusing plate180is not uniform as shown inFIG. 2E. Because the button front surface186has a uniform curvature, the contact area187abetween the button185and the working area144of the sensor141remains unchanged even with the rotation of the plate180. Thus, a shift in the pressure distribution relative to the centerline106of the device100and focusing plate180does not result in a fluctuation in the pressure reading observed by the sensor140. To accommodate the rocking movement188aof the focusing plate180, a small gap of about two millimeters (not shown) is provided between the angled end surface184aof the plate180and the angled surface of the notch134a.

The uniformly curved button surface186results in more stable real-time cushion pressure readings172observed by the sensor140, device100and monitoring system200. Although the button185could have a flat raised surface with side edges, such a structure could destabilize the real-time cushion pressure readings172observed by the sensor140. Situations involving a shift in the cushion pressure distribution across the focusing plate180so that the pressure distribution is unevenly distributed about the centerline106, can result in the flat raised button185riding up on its side edge. This would cause a significant contraction in the contact area187abetween the button185and sensor140, which would result in the sensor140observing a false spike or increase in real-time cushion pressure when only a shift in the cushion pressure distribution about the center106occurred.

The cushion190has an outer woven fabric192and an inner resilient foam material193. The cushion190has front and rear sides or surfaces194and195, and is secured by a pair of Velcro® strips189,196to the rear surface53of the pressure focusing plate180. The cushion190is relatively soft or deformable and resilient, and its foam material is preferably made of Neoprene SCE-41. The rear surface194of the deformable and resilient cushion190conforms to the shape of the body of the patient5, and helps evenly distribute the pressure applied across the rear surface194of the cushion190to alleviate uncomfortable pressure points between the device100and the soft tissue of the throat and neck7, and helps keep the pressure adjusting mechanism105properly positioned on the neck or body. The pressure load is supported by and distributed across front surface195of the cushion190, which in turn transfers the distributed pressure load to the rear surface183of the focusing plate180. The lengths and widths of the cushion190, focusing plate180and sensing component130are sized so that their outer ends or perimeters are in aligned registry. The cushion190, pressure focusing plate180and its button185, sensor141and its working area144, pressure sensing component130and its stem135and dial110of the pressure adjusting mechanism105are all centrally aligned on and are generally symmetrical about the central axis106of the device100. The cushion190is removable so it can be periodically washed or replaced during the long term use of the applicator100.

When the dial110is rotated29to increase the amount the cushion190is compressed into the neck7or body of the patient5, the cushion pressure exerted on the body increases and this increase is transmitted to the pressure focusing plate180. The pressure exerted by the cushion190on the patient5is transmitted through the button185and sensor141to the pressure sensing component130, and to the securement mechanism101, such as the neck band11and bracket12. As the real-time cushion pressure exerted on the neck7changes due to the rotation of the dial110or swelling of the body, the real-time cushion pressure data172collected by the computer module150changes.

The treating physician secures the long-term therapeutic pressure applicator100to the patient5in two steps. First, with the clip27secured, the treating physician selectively positions and secures the Velcro® fastener23to achieve an approximate pressure close to the desired pressure on the throat or esophagus of the patient5. This applied pressure is observed by the device100and transmitted to a corresponding device200with a display screen215. Second, the physician rotates129the pressure dial110to set the device100to the desired or prescribed pressure. Rotating the pressure dial110in one direction increases pressure on the esophagus by causing the threaded central stem135, sensing component130and pressure focusing plate180to move longitudinally along a path of travel139away from the strap bracket12and toward the neck7of the patent5, and from a decreased pressure position139ato an increased pressure position139bas shown inFIG. 1D. The semi-flexible strap bracket12flexes to increase its curvature with the side posts137of the pressure sensing component130remaining engaged in the slots15aof the strap bracket12. Rotating the pressure dial110in an opposite direction decreases pressure on the esophagus by causing the threaded central stem135, pressure sensing component130and pressure focusing plate180to move longitudinally along the path of travel139toward the strap bracket12and away from the neck7and into a decreased pressure position139aas shown inFIG. 1C. The strap bracket12flexes to decrease its curvature with the posts137of the pressure sensing component130remaining engaged in slots15aof the strap bracket12.

The therapeutic pressure applicator and monitoring device100and monitoring systems200are shown inFIG. 7. The computer module150of the monitoring device100contains identifying information or ID information150athat both identifies the specific device and identifies it as a device that wants to send real-time pressure data172. The CPU153of the module150is programmed to periodically send signals via its transceiver153to a cooperating device210, such as the cell phone211of the patient, a personal home computer212, printer213or laptop computer214. The office of the treating physician also has a cooperating device210. Each cooperating devices210has an internal programmable microprocessor219connected by internal circuitry to a memory, monitor or visual display screen215, transceiver, user interface or keyboard, and internal or external power source. The cooperating device210also includes an audible alarm, and its monitor215is capable of displaying information against different colored backgrounds such as a green background217or red background218. Each cooperating device210also contains identifying information or ID information210athat both identifies the specific device and identifies it as a device that wants to receive the real-time pressure data172. The processor219of each cooperating device200is programmed or otherwise configured to provide the functionality described herein, and is specifically programmed or configured to receive pressure data171and172from transceiver153, compare the cushion pressure data172to a desired pressure range criteria, store the data171and172in its memory, and activate an alarm when the cushion pressure data171and172is outside the desired pressure range criteria.

The processor219of the monitoring device100is programmed or otherwise configured to periodically send a request signal221containing its ID information150alooking for the cooperating devices210. When the cooperating device210receives the request signal221, its processor219is programmed or otherwise configured to respond by sending a response signal222containing its ID information210a. When the programmed CPU151of the module150of the monitoring device100receives the response signal222and ID information210a, and the CPU151is configured to identify the cooperating device210as being a cooperating device210, the module150is programmed or configured to send a data signal225via its transceiver153with real-time cushion pressure data172stored in its memory152, and store the ID information210ain its memory152with time/date information to log the transmission225. Similarly, when the CPU219of the cooperating device210received the data signal225and module ID information150a, and its processor is programmed or otherwise configured to identify the module150, and then use the real-time cushion pressure data172to display the real-time pressure on its monitor211, and store the ID information150aand pressure data information172in its memory with additional time/date information to log its receipt of the transmission225. This signal cycle repeats at the periodical time periods for as long as the module150and cooperating device210remain in communication.

The cooperating device210is programmed or otherwise configured to display the real-time pressure data172on its screen or monitor215. When the device210determines that the real-time pressure data172received by the signal225is within predetermined range criteria of the prescribed pressure, its programming has the monitor display the real-time pressure data with a green colored background216to advise the patient that the real-time pressure is within the prescribed pressure range criteria as shown inFIG. 8A. When the CPU219of the device210determines that the real-time pressure data172is outside the predetermined range criteria for the prescribed pressure, its programming has the monitor215display the real-time pressure data172against a red217background to alert the patient that the real-time pressure is outside the prescribed pressure range criteria as shown inFIG. 8B. The CPU219of the device200is also programmed or otherwise configures to activate its audible alarm when the real-time pressure data172is outside the prescribed pressure range criteria.

The CPU219of the cooperating device210is also programmed or otherwise configured to send a physician signal232to the office230of the treating physician. The cooperating device210sends the physician signal232via a land line, wireless line or the cloud. The programming of the cooperating device210sends the physician signal232when the real-time pressure data172is outside the prescribed pressure range criteria or deviates from a predetermined amount from the prescribed pressure, or at predetermined intervals, such as once a day, week, month, etc. In this way, the treating physician is kept aware that the patient is continuing to use the device100, the ongoing real-time pressure data172observed by the device100, and when the real-time pressure data is outside a prescribed pressure range criteria. During office visits by the patient to the treating physician, the device100can communicate directly with the cooperating device210and CPU219located at the treating physician office, which has been programmed or otherwise configured to perform the functionality described.

An automated embodiment of the therapeutic pressure applicator and monitoring device300is shown inFIGS. 3A and 3B. The automated device300automatically adjusts the pressure applied to the neck5of the patient5so that the applied pressure is at a specific predetermined pressure or within a specific predetermined pressure range. The applicator300has a securing mechanism101in the form of the conventional neck band11, and many of the components of the pressure adjusting mechanism305of the applicator300are interchangeable with the pressure adjusting mechanism105of the manually applicator100. The pressure adjusting mechanism305of the automated applicator300has the same pressure sensor sensing component130, sensor140, computer module150, power supply160, pressure focusing plate180and cushion190as the manual applicator100. The pressure dial310and programming of the CPU151of the automated applicator300are modified to incorporate a small electric motor365to automatically rotate the pressure dial310to maintain the applied pressure at the prescribed pressure or within a specific predetermined pressure range of the prescribed pressure.

The pressure adjusting dial310of the automated applicator300uses a knob312the same as knob112in applicator100, but has a modified base322. The base322has the same flat rear surface123, central opening125with a threaded sidewall126as in applicator100, so that the rotation129of the dial310inwardly or outwardly moves the pressure sensing component130and focusing plate180along the linear path of travel139between increased and decreased pressure positions139aand139b. The base322has a modified rim327with an inside wall328having geared teeth around its circumference. The electric motor365is fixed at a stationary location inside the chamber115of the pressure dial310. The motor365is preferably mounted by a clip366to the battery161and its casing162, which are fixed on the non-rotating stem135of the pressure sensing component130. The drive shaft of the motor365has a toothed sprocket367that drivingly mates and is in rotatable driving engagement with the gear teeth of the base sidewall328.

The motor365is in electrical communication with the power supply160via the computer module150and its programmed CPU151. The motor365has input and output leads368and369. These leads368and369are routed through the channel136ain the stem135and along the front surface132of the pressure sensing component130to motor input and output terminals158and159of the computer module150. When the programmed CPU151detects that the real-time pressure data172is above or below the programmed prescribed pressure or prescribed pressure range, the programmed CPU sends electrical power to activate the motor365to rotate its drive sprocket367clockwise or counterclockwise depending on whether the real-time pressure data is above or below the prescribed pressure or prescribed pressure range. The rotation of the sprocket367drivingly rotates129the base322and knob112of the pressure adjusting dial310clockwise or counterclockwise, and moves the pressure sensing component130and focusing plate180inward or outward along a linear path of travel139to a decreased or increased pressure position139aor139buntil the real-time pressure data equals the prescribed pressure or is within the prescribed pressure range.

An embodiment of the therapeutic applicator400with a more universal securement mechanism is shown inFIGS. 4A and 4B. The applicator400has the same pressure adjusting mechanism305as in the automated applicator300, but the securing mechanism401is in the form of a universal securing bracket402. The bracket402has a central recess403, front and rear surfaces404and405, a central opening407and opposed lateral ends408. The rear surface405of the strap bracket402has two spaced slots415a. The common center of the central recess403and opening407forms a centerline409for the applicator400. A strap (not shown) or some other form of fastener is secured to each of those lateral ends408to secure the device400to the body of a patient5.

A disc-shaped embodiment of the therapeutic pressure applicator and monitoring device500is shown inFIGS. 5A-D. The disc or puck shaped device500is used with medical pressure therapy gear501worn by the patient5, such as the orthodontic headgear502, helmet503or back brace504shown inFIGS. 9-11. When the pressure applicator and monitoring device500is used with orthodontic head gear502, the securement mechanism101is preferably a Velcro® fastener or adhesive504that secures the applicator to the forehead and chin bands of the orthodontic headgear. Alternately, when used with a rigid or semi-rigid helmet503or back brace504, the device500is sized to snuggly and firmly fit into a cooperating circular opening or recess506formed in the helmet or back brace, or a Velcro® fastener (not shown) can also be used to secure the device500in the recess506.

The pressure adjusting mechanism510of the disc-shaped device500has a central axis511and a rigid, disc-shaped housing520as shown inFIG. 5A. The housing has a generally flat circular front plate521with front and rear surfaces522and523, and a rearwardly extending tube or sidewall524extending around the perimeter of the plate521as shown inFIGS. 5B-D. The tube524has a threaded inner surface524aand a uniform diameter along its length. The housing520is firmly and non-rotationally secured by the Velcro® strip505or otherwise fixed in the cooperating opening506to the medical gear500. The threaded housing tube524allows for relative rotational movement529of the other components as discussed below.

The pressure sensing component530of the disc-shaped device500is rigid and preferably made of ABS plastic. The sensing component530has a main body531with generally flat front and rear surfaces532and533and a thickness of about 0.5 inches as shown inFIGS. 5B-D. The sensing component530and its main body531have a generally circular shape with a diameter of about 1.0 inch. A tubular shaped outer structure534having a length of about 0.5 inches extends around the perimeter of the main body131. The outer rim534has a threaded outer surface534aand a uniform diameter along its length so that it flushly engages and threadably mates with threaded inner surface524aof the housing520. The outer tube534has a forward extending tube portion535awith a length of about 0.25 inches, and a rearwardly extending rim portion536with a length of about 0.25 inches. The forward tube portion535forms a chamber537that encloses its internal components, and has an end or tip537athat forms a limit stop to prevent the sensing component from being over-rotated and crushing its internal components. The rearward rim portion536has an end with an inwardly facing securement notch136athat extends around the circumference of the tubular rim534. The notch536ahas an inwardly sloped or angled cross-sectional shape.

The pressure sensing component530has two spaced central posts537athat extend from its front surface532. The battery securement clip538is secured to the posts by an adhesive or some other form of fastener. The main body131has three openings. One opening is sized to matingly receive a computer module. A second opening is sized to matingly receive a base of a force sensor. A third opening531ais used to route the sensor141leads from the front532of the main body531to the rear533of the main body.

The pressure gauge140, computer module150and power supply160are the same as in the first embodiment100. The focusing plate580, Velcro® strip589and cushion590are the same as the focusing plate180, Velcro® strip189, and cushion190of the first embodiment except that they are round to correspond to the round shapes of the housing510. In this embodiment, the housing510, sensing component530, focusing plate580and cushion590are all disc-shape when viewed from the front and all have a center aligned with the centerline511of the device500.

The pressure sensing component530is threadably fixed to the housing510to allow rotational movement529of the sensing component530relative to the housing510, which results in a linear movement539of the sensing component530, focusing plate580and cushion590. The rotation of the housing510in one direction relative to the sensing component530causes linear movement539of the rear plate521of the housing510relative to the main body531of the sensing component530, as well as the focusing plate580and cushion590. This movement539cause the sensing component530, focusing plate580and cushion590to move between a retracted decreased pressure position539aand an extended increased pressure position539b, which results in the compression or decompression of the cushion as shown inFIGS. 5B and 5C. As discussed above, the increased compression of the cushion590increases the pressure exerted by the cushion on the focusing plate180as inFIG. 5C, which increases the force or pressure exerted by the front surface186of the focusing plate button185on the contact area of the rear surface143of the sensor141. The reduced compression of the cushion590reduces the pressure exerted by the cushion on the focusing plate180as inFIG. 5B.

While the invention has been described with reference to preferred embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the broader aspects of the invention.