The present invention relates to medical devices, and in particular to the control of the medical devices that have computing capabilities.
There are many types of therapeutic medical devices that include a computing capability using an internal/dedicated computing unit. A computing unit is a dedicated computer or a dedicated computing device with processing power and/or storage memory (e.g. CPU, microprocessor, etc.), which typically runs proprietary operating software, for operating the medical device to perform clinical (i.e. therapeutic, treatment, and/or diagnostic) procedures. The computing unit is either integral to the medical device, or is connected to the medical device in a dedicated manner to operate the medical device. Examples of such medical devices include ophthalmic diagnostic and treatment devices (e.g. photocoagulators, imaging systems, optical coherence tomography (OCT) systems, fundus cameras, etc.).
Often times, it is desirable to have the medical device communicate to external resources and networks for electronic record keeping, database access and storage, remote servicing, printing, data acquisition, etc., which increases the efficiency and functionality of the medical device. However, there are drawbacks to connecting the medical device to external resources and networks. First, having the computing unit monitor and access external resources and networks can result in the computing unit expending unacceptable processing power/bandwidth on such monitoring and access, preventing it from expending the necessary processing power/bandwidth on controlling and operating the medical device. Second, providing the computing unit with access to resources and networks and/or providing resources/networks access to the medical device, opens the medical device up to the outside world, making it more difficult to protect the device and/or its operating software from unauthorized access, exploitation and damage (e.g. computer virus).
There is a need for a medical device that can communicate with external resources and networks without compromising the performance and safety of the medical device.
The present invention solves the aforementioned problems by providing a medical system that includes a communications interface that is separate from the computing unit of the medical devices. Specifically, the medical system includes a medical device having a computing unit for controlling the medical device to perform a clinical procedure, a secondary computing device linked to the medical device via a first communications link, and an external resource or network linked to the secondary computing device via a second communications link, wherein the secondary computing device is configured to provide a communications interface between the medical device and the external resource or network.
Other objects and features of the present invention will become apparent by a review of the specification, claims and appended figures.
The present invention is system architecture and method for allowing a medical device to access external resources and networks without compromising the performance and safety of the medical device operation.
The secondary computing device 6 acts as the main communication interface between the medical device 2 and the external resource/network 8. This configuration protects the medical device hardware and software, and enables simplified communication with the medical device 2 without unnecessarily tying up the processing power of the computing unit 4. The secondary computing device 6 can be a stand alone, standardized computer (operating specialized or standardized software) which is more easily serviced and configured than the more specialized medical device computing unit 4. Medical devices usually require specialized installation by personnel specifically trained and authorized to work with medical devices. Thus, by using standardized equipment for the secondary computing device 6, it can be installed and serviced by non-medical device trained personnel, without the many precautions often necessary when working with the medical device 2 itself. An exemplary, non-limiting, simplified implementation would entail using a common stand-alone personal computer (e.g. desktop or notebook), running standard software (e.g. Microsoft Windows operating system) as the secondary computing device 6. The secondary computing device 6 can be easily upgraded as needed, again without having to go through the more rigorous exercise of upgrading a medical device including all the extra precautions associated with medical device upgrades.
The external resource or network 8 can include a closed data network such as a data network for a particular medical group, facility, or medical device manufacturer, a more open data network such as the Internet, as well as servers, printers, fax machines, visual displays, etc. Remote monitoring of the medical device 2 is now possible where the secondary computing device either probes stored data on the medical device 2, or includes information directly uploaded from the medical device 2 onto the secondary computing device 6. Medical device information can then be communicated via the external resource/network 8 (e.g. medical group network, the Internet, etc.) using any known protocol (direct data transfer, e-mail, facsimile, etc.) to provide system status and monitoring without unnecessarily tying up the processing capabilities of the medical device 2.
Additionally, for medical devices that do not store data locally, or do not allow hard drive reading, the medical device 2 can be monitored real-time by the secondary computing device 6 for activities and parameters that are accessible via an external port, where such data can be recorded by the secondary computing device and/or transmitted to the external resource/network 8 real-time or in a delayed manner.
Trouble-shooting of printers, cameras, accessories, internet-connectivity, etc. on the secondary computing device 6 is simplified because standardized operating system utilities with full access functionality can be employed. In contrast, accessories and connections on the medical device 2 can be problematic because access to the medical device operating system and functionality is often restricted to protect the integrity of the medical device software/hardware.
The addition of the secondary computing device 6 can also enhance the use of patient and treatment specific information, which can now be conveniently added to medical device treatment summaries and electronic medical records using the secondary computing device 6 and its optional input/output device 6a, to provide a complete report, without the need to add keyboards and extra software to the medical device 2.
Communications link 7 between the medical device 2 and the secondary computing device 6 can be any well known two-way link used with computing devices, such as, but not limited to, a serial connection, a wired or wireless USB connection, a phone line connection, an Ethernet connection, a wireless communications connection, etc. (or any combination of the above connections). Due to the security risks of a direct connection between the medical device and other devices, a unique customized connector could be used for link 7, such as a non-standard plug and wire, so that standard plugs or other interfaces could not be inserted to complete communications link 7. This would ensure that only certain trusted secondary computing devices 6 can be connected to the medical device 2. In addition, hardware or software firewalls could be installed in the medical device 2 or the secondary computing device 6 for added protection. Communications link 9 between the secondary computing device 6 and the external resource/network can also be any well known two-way link used with computing devices and networks, such as, but not limited to, a serial connection, a wired or wireless USB connection, a phone line connection, an Ethernet connection, a DSL or cable modem connection, a wireless communications connection, etc.
Photocoagulator Exemplary Embodiment
The photocoagulator medical device 2 illustrated in
In the light generation unit 12, a light beam 30 is generated by a light source 32, such as a 532 nm wavelength frequency-doubled, diode-pumped solid state laser. The beam 30 first encounters a mirror 34 which serves to sample the light for safety purposes, reflecting a fixed portion towards a photodiode 36 that measures its power. Following that, the light beam 30 encounters a shutter 38, mirror 40, and mirror 42. Shutter 38 fundamentally serves to control the delivery of the light beam 30. It may be used to gate the light, in addition to grossly blocking it. Mirror 40 is configured as a turning mirror as well as a combining mirror to combine aiming light from a second light source 44 with light beam 30. The aiming light is preferable coincident along the same path as the light beam 30 to provide a visual indication of where the treatment light from source 32 will be projected onto the target tissue. After mirror 42, the light beam 30 (now including any aiming light from source 44) is directed into an optical fiber 46 via a lens 48. An optional mirror 50 can be used to direct a portion of the light beam to a second photodiode 52, which serves purposes similar to those of mirror 34 and photodiode 36 as well as a redundant monitor of the state of shutter 38. Optical fiber 46 is a convenient way to deliver the light from the light generation unit 12 to the light delivery unit 14. However, free-space delivery of the light may be used instead, especially where the light generation and delivery units 12, 14 are integrally packaged together.
In the light delivery unit 14, lens 60 conditions the light exiting the optical fiber 46. Lens 60 may be a single lens, or a compound lens. If it is a compound lens, lens 60 may be made to be a zoom lens that adjusts the spot diameter of the beam. This is useful for easily adjusting the size of patterns and their elements on the target tissue as discussed further below. An additional lens 62 may be used to image the optical beam downstream, and possible act as the zoom lens as shown. The image point of lens 62 can be done to minimize the size of optical elements downstream. A scanner 63, preferably having a pair of scanning optics (i.e. movable mirrors, wedges, and/or lenses), is used to deflect the beam 30 to form a pattern P of spots or lines (straight or curved). Preferably, the scanning optics rotate or move in orthogonal X, Y directions such that any desired pattern P can be produced. A lens 68 focuses the beam onto a mirror 70 which redirects the beam through an ophthalmic lens 72 and onto the target tissue. Mirror 70 also provides for visualization of the target tissue therethrough, either directly by the physician or by a visualization device 74. More specifically, visualization may be accomplished by directly viewing the retina through mirror 70, or by creating a video image using a visualization device 74 (e.g. CCD camera) to be displayed either on a remote monitor, or, as indicated by the dashed line of
Ideally, the lens 62 images the beam to a midpoint between scanning optics 64, 66 and onto mirror 70. This may be done to minimize the size of the mirror 70 in an attempt to increase the overall solid angle subtended by the visualization device 74. When mirror 70 is small, it may be placed directly in the visualization path without much disturbance. It may also be placed in the center of a binocular imaging apparatus, such as a slit lamp biomicroscope, without disturbing the visualization. Lens 62 could also be placed one focal length away from the optical midpoint of the scanning optics 64, 66 to produce a telecentric scan. In this case, mirror 70 would need to be large enough to contain the entire scan, and could be made a high reflector spectrally matched to the output of light sources 32, 44, and visualization accomplished by looking through mirror 70. Of course, a further refinement would be to photopically balance the transmission of mirror 70 by using a more complicated optical coatings to make the colors appear more natural, rather than, say, pinkish, when using a green notch filter coating on mirror 70.
Ophthalmic lens 72 may be placed directly before the eye to aid in visualization, such as might be done with any opthalmoscope, slitlamp biomicroscope, fundus camera, scanning laser opthalmoscope (SLO), or optical coherence tomography (OCT) system. Ophthalmic lens 72 may be a contact or non-contact lens, although a contact lens is preferred because it serves the additional purpose of dampening any of the patient's eye movement.
The pattern P of light formed by the scanning optics 64, 66 can be anything from a specifically located spot, an array of spots, or a continuous scan of lines or line segments. Light sources 32, 44 and/or shutter 38 may be gated on and off by commands from control electronics 20 via input and output 22 to produce discrete spots, or simply run cw to create continuous scans as a means to produce pattern P. Control electronics 20 likewise can also be configured to control the position of mirror 70 and therefore, ultimately, the pattern P. In this way, pattern P, or any of its elements may be made to be perceived by the patient as blinking. Furthermore, the perception of both discrete spots and blinking may be accomplished by simply scanning quickly between elements of pattern P to limit the amount of light registered by the patient in those intermediate spaces.
The inherent flexibility of scanned light sources thus enables many desired clinical possibilities. A device such as this may be mounted directly onto, among other things, an ophthalmic visualization tool such as a slit lamp biomicroscope, indirect opthalmoscope, fundus camera, scanning laser opthalmoscope, or optical coherence tomography system.
There are other techniques for creating pattern P, such as by moving the light source(s) directly. Alternately, scanner 63 can comprise a two-dimensional acousto-optic deflector, or one or more optical elements with optical power that are translated. Mirror 70 may be tilted or translated (if there is surface curvature) to either act as the system scanner or augment beam movement already created by scanner 63. In the case where mirror 70 has optical power, compensating optical elements (not shown) may be required to produce an image, as opposed to a simple illumination. Similarly, the beam 30 could be divided using passive elements, such as diffractive optical elements (e.g. gratings or holograms), refractive elements (e.g. beam splitters, lenslet arrays, etc), or even active devices (e.g. adaptive optics) to create multiple beams simultaneously. These beams could then be deployed at once for an even more efficient treatment. They may also be used in conjunction with scanner 63 to provide a mixed approach.
The above described system 1 is configured to provide, under the control of the computing unit 4, patterns P of pulsed or scanned light such that targeted tissue receives treatment light within specific duration ranges and locations in order to achieve the desired results. The most basic types of patterns P are those formed of discrete, uniformly sized and uniformly spaced fixed spots. The user can use GUI 26 to select, modify, and/or define a number of pattern variables, such as: spot size, spot spacing (i.e. spot density), total number of spots, pattern size and shape, power level, pulse duration, etc. In response, the control electronics 20 via input and output 22 control the treatment light source 32 (assuming it is a pulsed light source) or additionally shutter 38 to create pulsed treatment light. Mirrors 64, 66 move between pulses to direct each pulse to a discrete location to form a stationary spot.
Advantages of Secondary Computing Device Used With Ophthalmic Photocoagulator
For the ophthalmic photocoagulator medical device described above, there are many advantages of providing the secondary computing device 6 in combination with a medical device having a computing unit 4:
Tabs 210 organize the data on separate screens that are easily accessed. Search bar fields 212 allow the user to search database records by date or patient ID. The patient ID search can be customized to fit physician practice standards. Programmed limitations can be placed on the entry of this field such as number of characters or format of entry to protect patient privacy. Text summaries 214 are also preferably provided, which not only provide information, but also provide a convenient data entry mechanism. For example, pre-configured applicable CPT codes for treatment billing can be presented. This list can be hard coded or configurable at setup or realtime. If configurable, one method of selecting CPT codes can include activating the field (i.e. right-clicking on the field using a mouse as an input device) and selecting a code from a populated list with code descriptors and numbers.
Input/output device 6a allows the physician to tie data from the medical device 2 to physiological, pathological and/or anatomical references found on the external resource/network 8. The linked data is now much more useful for the physician and corresponding records. For example, as shown in
Graphic representations 216 are also preferably provided along with the text summaries 214 to allow the user to review treatment information quickly and conveniently. For example, histograms of parameters graphically present summary data to the user, where the user can dive more deeply into the data using the text summaries and other tabs (e.g. the treatment log summary tab 222 in
The screens described above provide many benefits to physicians, such as time and effort savings by providing easy automated treatment documentation, providing compatible paper and electronic record keeping practices, providing the capacity to export or e-mail database information, providing a database that can be customized to work with existing electronic medical record systems, etc. All of these advantages result without unnecessarily tying up the computing unit 4 of the medical device 2, by providing much of the data access, data correlation from multiple sources, storage, transfer and/or printing functionality via the secondary computing device 6.
It is to be understood that the present invention is not limited to the embodiment(s) described above and illustrated herein, but encompasses any and all variations falling within the scope of the appended claims. For example, materials, processes and numerical examples described above are exemplary only, and should not be deemed to limit the claims. While GUI 26 is shown in
This application claims the benefit of U.S. Provisional Application Nos. 60/782,201, filed Mar. 13, 2006, and 60/857,939, filed Nov. 8, 2006, both of which are incorporated herein in their entirety by reference.
Number | Date | Country | |
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60782201 | Mar 2006 | US | |
60857939 | Nov 2006 | US |