Surgery – Diagnostic testing
Reexamination Certificate
2001-03-16
2004-05-04
Hindenburg, Max F. (Department: 3736)
Surgery
Diagnostic testing
C128S904000, C600S038000, C600S587000, C601S014000
Reexamination Certificate
active
06730024
ABSTRACT:
BACKGROUND OF THE INVENTION
There are various kinds of medical devices which may be prescribed by doctors for home use by a patient. Many of these are in the physical therapy area but may also include devices intended to provide a therapeutic regimen for the patient. One example of such a device includes a device developed and patented by one of the co-inventors hereof for enlarging soft tissue including a female's breasts. These devices are disclosed in the following patents: U.S. Pat. No. 5,695,445; U.S. Pat. No. 5,676,634; U.S. Pat. No. 5,662,583; U.S. Pat. No. 5,701,917 and U.S. Pat. No. 5,536,233. With this particular device, due to its personal nature, the patient may well choose to perform the prescribed regimen within the privacy of her own home. However, as this device has been developed for commercialization, a product has been designed and will be offered to the public which may be discreetly worn and be virtually undetectable in normal daily activities. With either of these choices, a patient must wear the device for some period of time and at specified vacuums in order to achieve the desired soft tissue enlargement. While it is entirely possible for a patient to manually keep track of and record her wearing times, vacuum pressure settings, and other events relating to her regimen such as unintentioned loss of pressure, this requirement interferes with the convenience and intended simplicity of use which is highly desired in a personal product such as this. However, for more important medical reasons, it is highly desired to obtain accurate data relating to the patient's use of the medical device as such data may very well explain the success or failure that the patient achieves. Furthermore, more obstacles presented to a patient in connection with her use of a medical device would be expected to interfere with its use and the resulting patient compliance. There are even health and safety concerns which could be monitored more closely should the patient be more accurate in recording her compliance with her prescribed regimen.
As many of these medical devices are prescribed by physicians, the opportunity to collect reliable data is often times limited to those patient visits which occur at prescribed intervals. While in the doctor's office, the patient may be physically examined and tests made to determine how the patient is reacting to the use of the medical device. This may then be compared with the patient compliance data which the patient may have personally recorded and which may be less than 100% accurate. Therefore, a doctor or other medical professional does not reliably have accurate data with which to judge the efficacy of the prescribed regimen and thus reliably make adjustments in that regimen as he or she sees fit in order to improve the patient's condition. For example, with the breast enlargement device, when the patient visits the doctor's office, the breasts may be measured in order to ascertain any increase in size. However, the doctor must rely upon the patient's own data for compliance with the prescribed regimen. Therefore, while the doctor may measure marked under performance of the effect of the medical device on the patient, this may be entirely due to the patient's failure to follow the prescribed regimen which the doctor will be unable to detect as the patient for her own reasons may not provide correct or truthful data. Should the doctor have reliable patient compliance data then the doctor could feel comfortable in adjusting the regimen in order to increase the chances of success through the patient's use of the medical device.
There are still additional reasons which make it highly desirable to have accurate patient compliance data for a medical device used on an outpatient basis. One of these additional reasons includes the desirability of collecting data for a large group of individuals which may then be used to make considered judgments relating to the medical device efficacy and recommended regimen for optimal results. For these kinds of studies, accurate data is imperative and short of controlling the environment in which the patients exist for extended periods of time, the inventors are unaware of any prior art solution to this problem of collecting accurate patient compliance data for medical device use. Still another reason for collecting accurate data is that immediate feedback and positive re-enforcement may be provided to the patient which encourages her to follow the regimen. In other words, should a patient understand that compliance data will be accurately collected and made available, the patient will be encouraged to live up to her doctor's recommendations and know that the doctor will be able to follow her compliance and discuss her performance with her in a positive way. Furthermore, a patient may feel the psychological reward of knowing that she has complied with her doctor's prescribed regimen as well as achieving the expected results through use of the medical device. The doctor may also use this accurate compliance data in order to correct the patient should she not only under-use but over-use the device in an effort to achieve even greater results by increasing her wearing times or vacuum pressures beyond that which is recommended. This can help prevent unintended side effects through over-use of any medical device.
BRIEF SUMMARY OF THE INVENTION
To solve these and other shortcomings in the prior art, and in order to provide some of the advantages as noted above, the inventors herein have succeeded in designing and developing a method and apparatus for collecting patient compliance data as a medical device is used, a convenient and unobtrusive way to self-communicate that compliance data over any communications link such as the internet to a central location, and process that compliance data and make it available not only to the patient but also the medical professional in a secure but readily accessible form. More particularly, and as explained in the illustrative example of the breast enlargement device, the inventors have succeeded in designing and developing a portable controller or “smart box” which is battery operated and which controls a miniature vacuum pump included as part of the bra-like device in its intended commercial embodiment. A vacuum sensor is also provided for collecting data relating to the induced vacuum contained within the bra and a clock function such as might be provided by a micro-clock circuit or chip, times the duration of the vacuum applied by the medical device to the patient's breasts. With this device, vacuum pressures and durations may be readily collected as data and stored in onboard memory included as part of a microcomputer. Thus, patient compliance data for this particular device which would include vacuum pressures and durations is readily collected as the battery operated smart box is used to apply the vacuum through the bra-like medical device.
As the controller is battery operated, the patient will be conditioned through her experiences with other battery-operated devices such as cell phones and the like to place the controller into a cradle for charging of the on-board batteries. For convenience, the controller is preferably separable from the bra. The accompanying cradle includes not only an AC power cord for connection to a typical wall socket with the associated battery charger circuits for charging the controller's rechargeable batteries, but also a phone line connection and modem for downloading the data from the microcomputer memory and transmitting it over the telephone lines through either a dial-up connection, modem, or internet service provider to a central location which is preferably a digital processor device such as a computer server or the like. Thus, through this aspect of the invention, patient compliance data is automatically collected without patient intervention and the patient is conditioned to seek recharging of the batteries for the controller which when performed will preferably automatic
Freyre Carlos V.
Khouri Roger K.
Kuru Murat
Astorino Michael
Brava, LLC
Hindenburg Max F.
Thompson & Coburn LLP
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