Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
2000-12-04
2002-08-27
Getzow, Scott M. (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
Reexamination Certificate
active
06442430
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to implantable medical devices such as cardiac pacemakers and defibrillators. More particularly, the present invention pertains to implantable medical device programmers having a headset video monitor and methods for their use.
BACKGROUND
A wide variety of implantable medical devices (IMDs) are known and commercially available. Generally, these devices utilize a bio-compatible case having a connector block mounted thereto. The connector block includes receptacles for leads that may be used for electrical stimulation and/or for sensing physiological activity. For example, an implantable cardiac device, e.g., an implantable pacemaker-cardioverter-defibrillator (PCD), may use such leads to monitor activity of a human heart and to deliver therapy thereto in the event undesirable heart activity is detected.
IMDs typically require programming by a physician or medical technician to ensure that the therapy delivered by the IMD corresponds to the specific treatment required by the patient. In modern IMDs, programming is typically accomplished via an external programming apparatus that consists of an integrated computer system incorporating the IMD programming electronics and appropriate programming software, a keyboard for data entry, and a video monitor for viewing relevant programming parameters. During operation, a telemetry module, e.g., a programming wand, tethered to the computer system is held near the patient in close proximity to the implanted medical device. Using wireless communication protocols, e.g., bi-directional RF, the telemetry module permits transmission of programming instructions to and reception of status information from the IMD. The physician monitors this information on the video monitor and controls programming functions via the system keyboard.
While effective, these programmers have drawbacks. For instance, because they are somewhat large and typically require a relatively flat and stable surface on which to operate, they are normally operated from atop a wheeled cart or a fixed desk. The cart is particularly advantageous because it allows the programmer, which may weigh upwards of several pounds, to be quickly and easily moved to and from the patient's bedside.
Although the cart is beneficial for transporting the programmer, space proximate the patient is limited in crowded medical environments. Accordingly, if placed adjacent the patient, the cart/programmer may displace other equipment and/or interfere with the movement of medical personnel.
As a result, the cart is often placed in a more peripheral location, e.g., away from the patient. While such placement reduces cart interference, it also results in inconvenient orientation of the video monitor and the keyboard. For instance, when the programmer is remotely positioned, the video monitor is typically oriented so that the physician is unable to conveniently observe both the monitor and the patient. This is undesirable as some portions of the programming operation require, or at least benefit from, visual contact with the patient. In addition, remote positioning of the programmer undesirably allows medical personnel to inadvertently block the physician's view of the monitor.
U.S. Pat. No. 5,752,976 to Duffin et al. discloses a telemetry system that includes an external patient communications control device either worn by or located in proximity to the patient. In other embodiments, Duffin et al. discloses use of a global positioning system (GPS) to locate remote patients. While effective for remotely monitoring and programming a patient's IMD, Duffin et al. does not specifically address the problems discussed above, e.g., poor monitor/programmer placement relative to the patient, difficulties during programming.
Various body-worn computers are also known in the art. For example, U.S. Pat. No. 5,948,047 to Jenkins et al. discloses a body-wearable mobile computer having a keyboard
24
and display
25
(see Jenkins et al., FIG.
4
). Similarly, U.S. Pat. No. 5,844,824 to Newman et al. discloses a body-worn, hands-free computer system having a computer unit
106
and a video display
110
(see Newman et al., FIG.
1
). However, none of these computer systems address the unique needs of IMD programmers.
Accordingly, systems for programming IMDs are known as are systems for transmitting IMD status or patient status/location to remote facilities. These systems are described above and in the documents listed in Table 1 below. Table 1 further includes documents directed to body-wearable computer systems.
TABLE 1
Patent No.
Inventor
Issue Date
5,752,976
Duffin, et al.
May 19, 1998
5,948,047
Jenkins et al.
Sep. 07, 1999
5,844,656
Ronzani et al.
Dec. 01, 1998
5,844,824
Newman et al.
Dec. 01, 1998
5,757,339
Williams et al.
May 26, 1998
5,719,744
Jenkins et al.
Feb. 17, 1998
5,719,743
Jenkins et al.
Feb. 17, 1998
D411,179
Toyosato
Jun. 22, 1999
D390,552
Ronzani
Feb. 10, 1998
D387,898
Ronzani
Dec. 23, 1997
D385,855
Ronzani
Nov. 4, 1997
All documents listed in Table 1 herein above are hereby incorporated by reference in their respective entireties. As those of ordinary skill in the art will appreciate readily upon reading the Summary of the Invention, Detailed Description of the Embodiments, and claims set forth below, many of the devices and methods disclosed in the documents of Table 1 and others documents incorporated by reference herein may be modified advantageously by using the teachings of the present invention.
SUMMARY OF THE INVENTION
The present invention has certain objects. That is, various embodiments of the present invention provide solutions to one or more problems existing in the art with respect to IMD programming apparatus and techniques. One such problem involves the need to position the programming apparatus proximate the patient without impeding the movement of medical personnel. Other problems, for example, include: providing adequate and generally unimpeded visibility for the physician operating the programmer; and physically locating the programmer in the crowded area near the patient's bedside.
In comparison to known techniques for programming IMDs, various embodiments of the present invention may provide one or more of the following advantages. For instance, the programmer may remain generally attached to the physician so that no additional space proximate the patient is required. Further, a display for providing information to the physician regarding the programmer and/or patient may be body-wearable, e.g., a headset mounted video display apparatus, permitting generally unencumbered line of sight for the physician. By providing some of all of the programmer components as body-wearable devices, programmers and methods of the present invention avoid interfering with other equipment and/or personnel surrounding the patient.
Some embodiments of the present invention provide one or more of the following features. For example, some embodiments provide a programmer for programming an implantable medical device where the programmer may include programming circuitry and a body-wearable video display apparatus coupled to the programming circuitry. The video display apparatus may be operable under the control of the programming circuitry to display at least programming information concerning the implantable medical device. The video display apparatus may be a microdisplay attached to a headset. A data entry device coupled to the programming circuitry may also be included as may a telemetry apparatus operable under control of the programming circuitry to communicate with the implantable medical device. The data entry device may include a keyboard, trackball, and/or a microphone and may further be integral with a housing enclosing the programming circuitry or may be separate from the housing. In some embodiments, the telemetry apparatus includes a programming wand while other embodiments may include an antenna in lieu thereof or in addition to the wand.
In comparison to known techniques for programming an implantable medical dev
Berry Thomas G.
Getzow Scott M.
Medtronic Inc.
Waldkoetter Eric R.
Woods Thomas F.
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