Medical image management system and method

Data processing: database and file management or data structures – Database design – Data structure types

Reexamination Certificate

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Details

C707S793000, C707S793000, C707S793000, C707S793000, C382S132000, C705S003000

Reexamination Certificate

active

06678703

ABSTRACT:

TECHNICAL FIELD
The present invention is a system and method for managing medical images. More specifically, it is a computer-based system and method for capturing, transmitting, storing, processing, and communicating electronic records associated with medical images.
BACKGROUND
Diagnostic imaging technology has evolved tremendously in the past twenty years, offering very sophisticated imaging tests such as magnetic resonance imaging (MRI) and computed tomography (CT). The MRI market in particular includes approximately 6,000 MRI machines in the United States, and 12,000 worldwide. Two-thirds of MRI devices in the US are located clinics and small hospitals. There are over 12,000 CT scanners in the United States and over 20,000 worldwide. Other significant medical imaging markets include for example, ultrasound, nuclear medicine, digital x-ray, and computerized radiology. On the aggregate, the potential medical image management market has been estimated at $5.5 Billion annually in the US and $12 Billion worldwide.
The need for immediate electronic delivery and convenient, economic storage of radiologic and other medical images and data has never been greater. The annual United States radiology market consists of more than 150 million x-rays, 100 million sonograms, 20 million MRI scans and 30 million CT scans performed by medical practitioners. The conventional process for managing medical images at most hospitals, clinics and imaging centers is as follows. The medical image is printed onto sheets of film, which are delivered to the radiologist for interpretation. After the transcribed report is delivered to the radiologist, reviewed for errors and signed, the films and report are delivered or mailed to the referring doctor. This process often takes several days, up to a week. If questions arise, the referring doctor contacts the radiologist, who may be forced to rely upon memory, having reviewed the films several days before and no longer has possession of them. Also, the referring doctor must then manage the hard-copy films, either by filing the films in his office, or returning the films to the imaging center or hospital to be filed, depending upon practices in the local community. If the patient then goes to a second doctor, requires surgery, or requires another medical imaging procedure, the films must be located and physically carried or shipped to the hospital, surgery center, or to the second doctor's office. There are numerous opportunities for films to be lost or misfiled, and doctors who maintain more than, one office may not always have the correct patient films in the correct office.
The current film-based system is very expensive, and the charges for films, processing chemicals, and delivery can easily add up to $30 to $50 per MRI patient study. A typical MRI center scanning 300 patients per month has equivalent costs of approximately $12,000 per month ($40 per study×300 patients/month). Other problems for the imaging facility are the numerous opportunities for the films to be physically lost, as well as the considerable time, personnel, and expense required for the delivery and retrieval of these films. Estimates are that up to 25% of medical images are not accessible when required.
Currently, no widely established commercial Internet solution exists for the digital delivery and archiving of the ever-increasing vast stores of radiologic data. Many patients are accustomed to sending email with various attachments, such as files or photos, and wonder why radiology images cannot be “emailed” to their doctors. However, several barriers exist for a medical image to be “emailed” to the doctor.
In order to electronically transport medical images efficiently, the images must be in a digital format. The imaging device, such as the MRI machine, must have the computer interfacing hardware and software configured to “export” the data. A computer is needed to convert the proprietary image identification data (the header information) into a standardized format, such as DICOM (Digital Imagine, and Communication in Medicine). Also, the doctor who receives the images must have software that allows him or her to view the medical images and interpret the image header information (viewer). However, non-DICOM enabled models represent the majority of imaging machines. Due to financial constraints imposed by managed care on imaging centers, non-DICOM machines will continue to dominate diagnostic imaging for the foreseeable future.
When digital modalities such as CT and MRI first came into general clinical use, each manufacturer used its own proprietary means of reconstructing the data, formatting files and storing each of the studies. They did not share this basic information with other competing manufacturers; therefore, one set of images could not be communicated to another machine since each had a different format. In 1983, the American College of Radiology and the National Electronic Manufacturers Association met to discuss a standard. In early 1984 the two organizations formed the Digital Imaging and Communication in Medicine (DICOM) Standards Committee. After many years of extensive work, the first DICOM model was introduced in 1992. By late 1994, a few manufacturers had begun to offer to incorporate DICOM into their products, usually as an expensive ($20,000-$40,000) upgrade. However, even today, the majority of these manufacturers still today only incorporate DICOM in their new products for a significant extra charge ($20,000-$40,000). Many of the older established medical imaging systems do not even have a DICOM conversion available from the original equipment manufacturer. Whenever a DICOM conversion upgrade is available for already built and installed products, it is usually even more expensive than DICOM for a new product. DICOM is a communications standard and does not define particular hardware architecture. It permits integration of images into non-image databases and is the predominant standard for medical image communication. It enjoys broad support across specialties and other standards organizations throughout the world.
Interfaces have been developed to “DICOM enable” imaging systems that were not originally factory equipped with DICOM. Without supplying DICOM interfaces as a component of an overall system, a medical image management system in the general field contemplated by the invention would be required to take one of three courses of action: 1) limit their imaging center users to DICOM conformant equipment, 2) purchase or require their customer to purchase and install DICOM interfaces at a cost of upwards of $40,000, or 3) rely on a technique known as secondary capture. In the case of secondary capture methods, like video frame grabbing, some of the information is lost, because it only captures the 8-bit analog representation of the original 16-bit image pixel data. Also, secondary captured images cannot be later manipulated to the same degree as the original images. Because of the inherent drawbacks of secondary captured data, the American College of Radiology (ACR) standard states that the direct capture method is preferred for primary diagnosis.
It is not believed that the general imaging center and referring physician marketplace will tolerate the use of the inferior secondary capture method, or an ASP that can only connect to DICOM equipped imaging systems. The system and method of the present invention provides DICOM connectivity. Also, in order to transmit and store images without compromising the quality or integrity of the imaging data, an efficient medical image management system is preferably able to successfully connect disparate imaging equipment and systems without compromising the image quality. To accomplish this the system should be able to extract the proprietary data from various different imaging machines, again the vast majority of which are not DICOM enabled and therefore cannot “output” the data in the DICOM format. Moreover, though DICOM is the universal industry standard, like the English language different “dialects” of DIC

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