Implantable medical device programming wands having integral...

Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems

Reexamination Certificate

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C607S032000, C607S060000

Reexamination Certificate

active

06650941

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 programming wands having one or more input devices located thereon 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 an operator, e.g., 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, an input device such as a keyboard or digitizing pen for data entry, and an output device, e.g., video monitor, for viewing relevant information regarding the programming process. During operation, a telemetry apparatus, 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 communication between the programming apparatus and the IMD. The operator monitors information pertaining to the programming process on the video monitor and controls various programming functions via the input device.
While effective, these programming apparatus have drawbacks. For example, because space proximate the patient is limited in crowded medical environments, the programming apparatus, including the input device, may not always be conveniently located adjacent to the patient but may rather be located peripherally thereto. In these instances, the operator is required to hold the programming wand near the patient with one hand while reaching to manipulate the input device/programming apparatus with the other. Not only is this technique inconvenient, it may also result in premature operator fatigue. Furthermore, the operator may undesirably need to remove his or her distal hand from the input device to accommodate movement of medical personnel and equipment around the patient.
Exemplary input devices for IMD programmers are mentioned or described in U.S. Pat. No. 5,720,771 to Snell, U.S. Pat. No. 5,759,199 to Snell et al., U.S. Pat. No. 5,785,660 to van Lake et al. and U.S. Pat. No. 5,954,666 to Snell. These documents disclose programmers that utilize input devices which may, for example, be a “touch screen, keyboard, light pen, mouse, trackball or a pen and a digitizing screen” (see U.S. Pat. No. 5,720,771, column 4, lines 15-20).
In addition to the input devices disclosed in the above-identified patent documents, U.S. Pat. No. 5,204,768 to Tsakiris et al., discloses a wireless remote which may be used to control an electronic presentation system.
Accordingly, input devices other than keyboards and digitizing pens are known. However, the systems disclosed in the above-identified documents (which are also listed in Table 1 below) do not address the IMD-programming-specific problems discussed above, e.g., inconvenient two-handed operation in crowded environments.
TABLE 1
Pat. No.
Inventor
Issue Date
5,785,660
van Lake et al.
Jul. 28, 1998
5,759,199
Snell et al.
Jun. 2, 1998
5,720,771
Snell
Feb. 24, 1998
5,954,666
Snell
Sep. 21, 1999
5,204,768
Tsakiris et al.
Apr. 20, 1993
All documents listed in Table 1 above are hereby incorporated by reference herein 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. In particular, the present invention addresses problems relating to current programming apparatus and techniques used to program IMDs. One such problem involves fatigue experienced when the operator is required to hold a programming wand with one hand while operating an input device with the other. Other problems include the need to operate the programming apparatus when the input device is not immediately adjacent to the operator.
In comparison to known techniques for programming IMDs, various embodiments of the present invention may provide certain advantages. For instance, execution of the IMD programming process may be controlled via one or more input devices located on the programming wand so that the operator may control the programming process with the same hand that supports the programming wand. As a result, the operator is not required to manipulate the input device/programmer with a second hand while holding the programming wand with the other.
Embodiments of the present invention may provide one or more of the following features. For instance, the invention may provide a programming wand for programming an implantable medical device where the wand may include a housing and an antenna associated with the housing. The antenna may be coupled to transmitter circuitry such that the antenna is able to transmit programming information from a programming device to the implantable medical device. The wand may also include at least one input device coupled to the housing where the input device permits control of the programming device. The input devices may include one or more of a trackball, a button, and a scrolling wheel. In other embodiments, the wand may further include receiver circuitry operable to receive information from the implantable medical device.
Other embodiments of the present invention may provide a method for programming an implantable medical device, where the method comprises one or more of the following features: providing a programming apparatus operable for use in programming an implantable medical device, the apparatus comprising a programming wand; positioning the programming wand proximate to the implantable medical device; transmitting programming instructions from the programming device to the implantable medical device via the programming wand; and manipulating one or more input devices located on the programming wand to control the programming apparatus. The method may further include transmitting device status information from the implantable medical device to the programming wand and transmitting patient status information from the implantable medical device to the programming wand. Manipulation of the input devices may be responsive to one or more of the programming instructions, the device status information, and the patient status information. Manipulation of the input devices may include: rotation of a trackball; rotating a scrolling wheel; and/or depressing a button.
The above summary of the invention is not intended to describe each embodiment or every implementation of the present invention. Rather, a more complete understanding of the invention will become apparent and appreciated by reference to the following detailed description and claims in view of the accompanying drawings.


REFERENCES:
patent: 4316472 (1982-02-01), Mirowski et al.
patent: 4375817 (1983-03-01), Engle et al.
patent: 4379459 (1983-04-01), Stein
patent: 4

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