Bone sonometry, densitometry and imaging

Details Bone sonometry, densitometry and imaging Bone sonometry, densitometry and imaging

1999-02-01

2001-05-22

Lateef, Marvin M. (Department: 3737)

Surgery

Diagnostic testing

Detecting nuclear, electromagnetic, or ultrasonic radiation

Reexamination Certificate

active

06234969

ABSTRACT:

FIELD
This patent specification pertains to the field of medical diagnostic equipment and processes and, more particularly, to the field of bone assessment and other equipment-based diagnostic processes.
BACKGROUND
Osteoporosis is a common disease associated with low bone mineral density (BMD). Bone is lost naturally with age, and this tends to be accelerated after menopause. People with low bone density often do not realize they are at risk of osteoporosis until a fracture occurs, by which stage bone may have been irreplaceably lost from the skeleton. There are a number or risk factors for osteoporosis, but the most important is thought to be low BMD. Early recognition of bone loss is important in the identification of individuals at risk of osteoporosis, particularly in view of the increasing availability of preventative and therapeutic interventions that can reduce the impact of bone loss and prevent the increase of fracture risk due to bones becoming more fragile.
Until recently, bone mineral density was measured mainly through the use of x-ray based technologies such as dual energy x-ray absorptiometry (DXA or DEXA) and, to a lesser extent, quantitative computed tomography (QCT). Other techniques were used earlier, such as single photon absorptiometry, but are no longer widely used. DXA and QCT techniques have many desirable characteristics, such as high sensitivity and the ability to accurately predict fracture risk, but use ionizing radiation and relatively expensive equipment. More recently, ultrasound has become available for bone assessment. Using quantitative ultrasound (QUS), it is possible to measure or estimate ultrasonic characteristics of bone and thereby estimate bone mineral density and assess the risk of fracture. Ultrasound also has been shown to be reliable in estimating bone mineral density and predicting the risk of fracture, and has the desirable characteristics of not involving ionizing radiation and using lower cost equipment. In addition, there is a class of x-ray based medical devices called small C-arm fluoroscopes, or simply small C-arms, that typically are used for both surgery and diagnosis of extremities, but can be provided with the additional capability of making bone assessment measurements.
As an example of commercially available products of this type, Hologic, Inc. of Bedford, Mass. offers a line of DXA equipment under the trade names ACCLAIM and QDR and model designations such as 4500 and 1000, an ultrasound bone sonometer under the trade name Sahara, and a small C-arm under the trade name Fluoroscan followed by model designations. See, e.g., U.S. Pat. No. 5,778,045 pertaining to x-ray bone densitometry, U.S. Pat. Nos. 5,755,228 and 5,785,041 and U.S. patent application Ser. No. 08/477,580 pertaining to ultrasound bone sonometry, and U.S. patent application Ser. No. 08/794,615 pertaining to small C-arm x-ray devices. See, also, a brochure entitled “SAHARA Clinical Bone Sonometer” printed for Hologic, Inc. Under the designation B-130 U.S. (10/97). Said patents and applications and said brochure are hereby incorporated by reference in this patent specification as though fully set forth herein.
In non-analogous fields of technology and business, consumers have long used cards such as credit and debit cards and smart cards to pay for goods and services, and individuals have used access cards to gain admittance to controlled facilities. While often the purchaser hands the card over to a sales person who inserts it in a card reader, there are cases in which the purchaser has direct access to the card reader, e.g., at some gas stations.
However, patients typically do not operate bone sonometry or densitometry or small C-arm equipment, and no patient-provided cards are known to be involved in turning such diagnostic equipment on to carry out some, but perhaps not all, of the procedures such equipment carries out. Nor are the owners or operators of bone sonometers or densitometers known to be required to use cards to make the equipment carry out examinations. Indeed, charging a card to turn on a bone sonometer or densitometer for an examination may not appear practical at first blush, and may be counter-intuitive, because some procedures do not directly produce revenue to the owner or operator. For example, a bone sonometer or densitometer may require periodic calibration examinations, e.g., once a day, in which the equipment measures a calibration object (phantom) rather than a patient or makes a measurement through a medium other than a patient's body or extremity. Quality control procedures and service and maintenance procedures can also be similar or even identical to patient examinations from the machine's point of view, but also are not directly revenue-generating for the machine's user. Similar, though not necessarily identical, considerations can apply to DXA bone densitometers and small C-arm equipment.
SUMMARY
This patent specification discloses, as an exemplary and non-limiting embodiment, a system in which an ultrasound bone sonometer requires a charge to a card in order to carry out a patient examination but not in order to carry out procedures such as calibration, testing, quality control, maintenance or service procedures that can otherwise be similar or even identical to a patent examination from the equipment's viewpoint. Typically, the health professional or other operator of the bone sonometer controls the card rather than the patient. The health professional inserts the card as needed in a card reader integrated physically and electronically with the bone sonometer. The card need not be unique to a patient and need not be unique even to the operator of the bone assessment equipment, although it can be. The card can be prepaid, allowing a certain number of patient examination before its value is used up, or can allow some forms of credit. The card can be a single-use card, so that a new card is issued as needed, or it can be of the type that can be rejuvenated by changing its information content. Instead of, or in addition to the use of a card, on-line charging can be carried out though a telecommunication link between the diagnostic equipment or its operator and a remote charging operation.
With the system disclosed in detail in this patent specification, a health care facility can benefit from having the full use of a bone sonometer or densitometer without having to buy one and take the risk that the revenue it produces may not justify the purchase price or finance charges. Instead, the health care facility can have the convenience of a bone densitometer on its premises for the relatively small investment in a card, if the card is of the prepaid type, or for no significant investment if the card is of the type that allows for some form of credit or on-line charging via a telecommunication link. If the bone sonometer or densitometer is of the type that requires no special room or installation, such as the aforementioned Sahara ultrasound bone sonometer which is portable and light, less than 25 lbs., and uses household-type current outlets, the health care facility can start patient examinations without having to make any significant incremental investment in the new equipment. In accordance with the exemplary system disclosed in this patent specification, the effect is that the health care facility pays for using the bone sonometer or densitometer when the use is directly revenue-generating and there is a net revenue when the charge to the card is subtracted from the fee charged to or for the patient, but the facility incurs no charge when the bone sonometer or densitometer is put to a use that may be otherwise necessary but is not directly revenue: generating, even though the equipment may be carrying a procedure otherwise similar or even indistinguishable from a patient examination from the machine's point of view.
The card preferably is a smart card that contains processing and memory circuitry for validation, keeping track of charges and other records and, if desired, rejuvenation information. In o

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