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United States Patent 5,197,469
Adams March 30, 1993
Sterilizable programmer repeater

Abstract

A sterilizable programmer repeater system for retransmission of a programmed code via an RF data link from a pacemaker or defibrillator programmer to an implanted pacemaker or defibrillator which can be used in the operating theater. Coded program information from a remotely placed programmer is data linked by an RF transmitter to a programmer repeater placed externally adjacent to an implanted pacemaker or defibrillator. The received coded program data information is rebroadcast by a transmitter in the programmer repeater to the implanted pacemaker or defibrillator. Coded program data information from the implanted pacemaker or defibrillator is also sent in the reverse direction from the implanted device to the remotely linked placed programmer.

Inventors: Adams; Theodore P. (Edina, MN)
Assignee: AngeMed, Inc. (Plymouth, MN)
Appl. No.: 682966
Filed: April 10, 1991

Intern'l Class: A61N 001/08
Field of Search: 128/419 PG,419 R,419 D,419 PT,903,904,664

References Cited
U.S. Patent Documents
3253588May., 1966Vuilleumier et al.128/903.
4361153Nov., 1982Slocum et al.128/903.
4522213Jun., 1985Wallroth et al.128/903.
4561443Dec., 1985Hogrefe et al.128/419.
4886064Dec., 1989Strandberg128/419.
4944299Jul., 1990Silvian128/419.
4952928Aug., 1990Carroll et al.128/903.
4958632Sep., 1990Duggan128/419.
4958645Sep., 1990Cadell et al.128/903.
5012806May., 1991De Bellis128/419.

Primary Examiner: Kamm; William E.
Assistant Examiner: Schaetzle; Kennedy J.
Attorney, Agent or Firm: Jaeger; Hugh D.
Claims


I claim:

1. A medical repeater system for transmitting data to a medical device adapted for placement in a patient, comprising:

a. programmer means positioned remote from said patient, including data transmitting means for transmitting data from said programmer means;

b. sterilizable external programmer repeater means placed in proximity to said medical device in said patient for receiving said data transmitted from said remote programmer means and re-transmitting the same to said medical device; and,

c. reflecting means positioned remote from said programmer means and said programmer repeater means for reflecting said data transmitted from said programmer means to said programmer repeater means wherein said reflecting means comprises a plurality of mirrors.

2. The medical repeater system of claim 1, wherein said data is transmitted in the form of RF signals.

3. The medical repeater system of claim 1, wherein said data is re-transmitted by said programmer repeater means in the form of RF signals.

4. The medical repeater system of claim 1, wherein said data is transmitted in the form of infrared signals.

5. The medical repeater system of claim 1, wherein said data is re-transmitted by said programmer repeater means in the form of infrared signals.

6. The medical repeater system of claim 1, wherein said data is transmitted in the form of ultrasonic signals.

7. The medical repeater system of claim 1, wherein said data is re-transmitted by the programmer repeater means in the form of ultrasonic signals.
Description


BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention pertains to pacemakers or defibrillators, and more particularly, pertains to remote programming of a pacemaker or defibrillator by the use of a radio frequency repeater device placed in close proximity to the implanted stimulation device.

2. Description of the Prior Art

Prior art implanted devices, such as pacemakers or defibrillators, are normally packaged in titanium cases. The metallic case provides hermiticity and serves as a shield for stray electrical fields which may interfere with operation of the device's electronics. The shield also has the effect of attenuating the RF signals from a programming device, which are necessary to configure the electronics for a given patient. Because of the shielding effects of the metal case, and of the patient's own body, it is usually necessary to place the programming antenna as close to the implanted device as the exterior of the patient's body permits.

The programming device is usually a large non-sterilizable box with an antenna connected to it with a coiled umbilical cord. In surgery, the antenna wand is usually covered with a long sterile plastic bag. The physician then handles the wand in the sterile field. The limited space usually requires the physician to hold the wand and give verbal instructions to a nurse who is operating the programmer at a spaced distance. The springiness of the coiled cord make setting the wand down risky, and the distance from the physician to the programmer usually precludes his seeing the programmer display. The whole situation is unwieldy. Sometimes the coiled cord caused the wand to repel and even fall on the floor of the operating room, requiring recovering the wand with a new sterile plastic bag.

The present invention overcomes the deficiencies of the prior art by providing a small sterilizable battery-operated repeater unencumbered by connecting cords or wires which repeats informational data code to the pacemaker or defibrillator via RF transmissions from a remotely placed programmer.

Shortcomings of the prior art methods can be summarized by noting that they place incompatible, essentially contradictory requirements on both apparatus and human participants in the programming procedure. The element that transmits and receives RF signals to and from the implanted stimulator must be sterilizable. While it is outside the patient's body, it is well within the sterile zone or field that must be maintained in and near the patient in an operating room. Further requirements are that it must be accurately positionable and easily maintained in that position. For effective use it should also be comparatively small.

The programming unit, on the other hand, is inherently nonsterilizable, because it incorporates electromechanical input components (pushbuttons, switches, dials) and electromechanical and electronic readout devices (gauges, meters, digital displays), and these do not lend themselves to sterilizable design. Furthermore, the programming unit can be more easily and accurately used if it is permitted to grow to a comfortably large size, affording room for finger-sized pushbuttons and easily read displays. These incompatibilities are bridged in the prior art by means of an interconnecting cable, coiled for flexibility, but still heavy enough and stiff enough to disturb the position of the antenna element.

The contradictory human requirements arise because the attending surgeon must address two functions simultaneously: There is the mechanical task of maintaining the antenna component in the right position in the presence of the forces on it exerted by the cable, and the intellectual task of articulating instructions to an assistant, this without benefit of visual feedback from observing the displays as his or her instructions are executed by the assistant, or the motor feedback that would be derived if he or she were personally executing the programming. It will be seen that the present invention eliminates self-contradictory requirements from both the human participant and the apparatus.

SUMMARY OF THE INVENTION

The general purpose of the present invention includes a small battery-operated repeater which can be sterilized and placed on the patient over the implanted device. The repeater has a sensitive RF receiver tuned to the transmission frequency of the programmer's transmitter and a transmitter, and antenna which aligns near the implanted device's antenna which simply retransmits the code from the programmer to the implanted device. Because the repeater case is non-metallic, and since its receiver antenna can be made large relative to the implanted device's antenna, it can receive signals from the programmer at a much greater distance. The device works the same way in reverse when the implanted device is transmitting data out. This circumvents the problem of invading the sterile field with a cumbersome programming wand and allows the programmer to be placed at a greater distance from the patient in a crowded operating room. In addition, the physician could stand near the programmer to observe the display.

In a second embodiment, programmed data from the programmer is data-linked by an alternative transmission frequency for a different medium, i.e., infrared or ultrasound. The repeater then acts in a similar fashion, and converts the coded signal it receives from the transmitter/receiver to that to which the implanted device can receive and interpret. In this embodiment, greater transmission distances may be achieved by choice of the initial transmission frequency medium.

According to one embodiment of the present invention, there is provided a small sterilizable battery-operated repeater for two-way communication between a programmer unit and an implanted stimulation device. Program information from a programmer is transmitted from an antenna in the form of coded radio frequency from a location adequately spaced from the operating table to a receiving antenna in the repeater which is placed on the patient in close proximity to the implanted device. Information is received and rebroadcast by a transmitter and another antenna in the repeater to an antenna on the subcutaneously located stimulation device.

With the present invention, the surgeon can execute the programming personally at the cost of but one sterile glove. In this situation, only two communication channels (in addition to those of the programming system) are required--eye-to-brain and hand-to-brain channels in the same person. In the prior art, the aural channel is brought into play, involving the voice-to-brain channel of the surgeon and the ear-to-brain channel of the assistant, added to the latter's eye-to-brain and hand-to-brain channels as before. The improvement thus achieved can be illustrated by pointing out that with the present invention, a deaf-mute surgeon could function more effectively than the two-person team in the prior art case when both had full faculties. By similar token, considerations such as diction and native tongue that become more important in society every day are of reduced importance here.

One significant aspect and feature of the present invention is a sterilizable battery-operated telemetry repeater system for a pacemaker or a defibrillator.

Another significant aspect and feature of the present invention is a remote site programmer for a repeater.

A further significant aspect and feature of the present invention is a repeater which is a data link between a programmer and an implanted device.

An additional significant aspect and feature of the present invention is the replacement of connecting cords or cables by an RF data link through a repeater.

A further feature is that the small and sterile free-standing telemetry repeater can in many cases be held and maintained in the desired positions on the chest of the supine patient by gravity alone.

Another feature is that a clear path from programming unit to telemetry repeater could be maintained by the simplest of measures, such as a pair of strings serving as reminders that the beam (RF, IR or ultrasound) not be inadvertently obstructed.

Still another feature is that the beam in the case of any of these media could be directed upward from the programming unit and downward onto the telemetry unit on the chest of the patient by the employment of two 45.degree. ceiling-mounted mirrors.

Having thus described one embodiment of the present invention, it is the principal object hereof to provide a repeater system for linking data to and from a programmer and an implanted device with a small battery-operated repeater for placement on a patient's chest.

BRIEF DESCRIPTION OF THE DRAWINGS

Other objects of the present invention and many of the attendant advantages of the present invention will be readily appreciated as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, in which like reference numerals designate like parts throughout the figures thereof and wherein:

FIG. 1 illustrates a repeater system of the present invention in use;

FIG. 2 illustrates a block diagram of the repeater system;

FIG. 3 illustrates an alternative embodiment of the repeater system; and,

FIG. 4 illustrates an embodiment of the repeater system using two ceiling-mounted 45.degree. reflectors in order to permit free circulation by attendants about the patient without obstructing the signal beam.

10 repeater system

12 repeater

14 implant device

16 person

18 programmer

20 antenna

22 transmitter

23 receiver

24 antenna

26 receiver

27 plastic enclosure

28 transmitter

30 antenna

32 skin

34 antenna

36 enclosure

50 repeater system

52 programmer

54 receiver

56 transmitter

58 antenna

59 repeater

60 enclosure

62 transmitter

64 receiver

66 antenna

68 antenna

70 antenna

72 implantable device

74 skin

76 enclosure

100 repeater system

102 programmer

104 mirror

106 mirror

108 repeater

110 implanted device

112 patient

DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 illustrates a repeater system 10 where a repeater 12, actually a transceiver, is placed over an implanted device 14 in a person 16. The implanted device 14 can be that such as, but not limited to a pacemaker or defibrillator. A programmer 18 sends programmed data for reception by the repeater 12 via an RF data link which is transmitted by an antenna 20. The received, programmed data information is transmitted from the repeater 12 to the implanted device 14. Information is also linked by telemetry via the component members to the programmer 18.

FIG. 2 illustrates a block diagram of the present invention where all numerals correspond to those elements previously described. Informational data derived in the programmer 18 is transmitted in the form of coded RF by a transmitter 22 and the antenna 20. A receiver 23 also connects to the antenna 20 and the programmer 18. This coded RF information is received by an antenna 24 and a receiver 26 integral to the repeater 12. The repeater 12 is contained in a plastic enclosure 27. This received information is rebroadcast by a transmitter 28 and antenna 30 integral to the repeater 12. The rebroadcast information travels through skin 32 of the patient, and is received by the antenna 34 which is connected to the implantable device 14. This received information then appropriately stimulates the implantable device 14. The implantable device 14 and the antenna 34 are encapsulated in an enclosure 36.

Conversely coded data information from the encapsulated implanted device 14 is sent via its integral antenna 34, through the skin 32, and to the antenna 30 of the repeater 12. The receiver 26 relays this coded information to the transmitter 28 and the antenna 24 where it is broadcast to the programmer unit 18 via antenna 20 and the receiver 23.

FIG. 3, an alternative embodiment, illustrates a block diagram of the repeater system 50, similar to the repeater system 10 illustrated in FIG. 2 with the exception of the data link medium which may be an alternative transmission frequency or even a different medium, such as infrared or ultrasound. A programmer 52 electrically connects to the receiver 54 and transmitter 56. A suitable antenna 58 is utilized with the receiver 54 and the transmitter 56 depending on the data link medium.

The repeater 59 includes an enclosure 60, a transmitter 62, a receiver 64 and a medium suitable antenna 66 connected to the transmitter 62 and receiver 64. Another antenna 68 electrically connects the transmitter 62 and the receiver 64 to effect two-way communication between the antenna 70 which is integral to an implantable device 72 located beneath the skin layer 74. The antenna 70 and the implantable device 72 are encapsulated in an enclosure 76, which, of course, is implanted.

DESCRIPTION OF THE ALTERNATIVE EMBODIMENT

FIG. 4, an alternative embodiment, illustrates a repeater system 100 similar to the repeater system 10 illustrated in FIG. 2 with the exception of the data link system where the data link information is transferred from the programmer 102 overhead via a plurality of overhead mirrors including mirrors 104 and 106 secured overhead in a surgical operating room, to a repeater 108 placed over an implanted device 110 in a patient 112. The medium transmitted by the programmer 102 can be RF, infrared, ultrasonic, or other suitable medium. The mirrors 104 and 106 are oriented at 45.degree. with respect to the horizon for purposes of illustration only and are not construed to be limiting of the scope of the invention. The data link information is transmitted vertically from the programmer 102 and is reflected by the mirror 104 well over the heads of the operating room staff and reflected downwardly and vertically by the mirror 106 to be received by the repeater 108. The vertical orientation of the data link information allows personnel in the operating room to move about the operating room with a minimum or no interference with the data link information. The mirrors 104 and 106 are used for data transmission mediums such as infrared or ultrasonic. In the alternative, reflectors, such as parabolic reflectors or other suitable means can be used in lieu of mirrors for transmission of data which is radio frequency based.

Various modifications can be made to the present invention without departing from the apparent scope hereof.

Other forms of communication can be utilized between the repeater and the programmer such as infrared energy or ultrasonic which is within the teachings and scope of the present invention. Use of infrared energy between the repeater and the programmer would be considered as an alternative embodiment.

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