Long-term, ambulatory physiological recorder

• US 6,117,077 A
• Filed: 01/22/1999
• Issued: 09/12/2000
• Est. Priority Date: 01/22/1999
• Status: Expired due to Term

• Current Assignee: Spacelabs Healthcare LLC (OSI Systems Incorporated)
• Original Assignee: DEL Mar Medical Systems, LLC (Bio-Techne Corporation)
• Inventors: Del Mar, Bruce Eugene, Bachman, John A., Henkin, Raphael
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): Natnithithadha, Navin
• Application Number:
  US09/235,658
• Time in Patent Office: 599 Days
• Field of Search: 600/300, 600/301, 600/508, 600/509, 600/372, 600/382, 600/386, 600/387, 340/573
• US Class Current: 600/301
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/0468 Built-in electrodes
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/274 using snap or button fasteners
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/335 using integrated circuit memory devices
• CPC Class Codes: A61B 5/7232 involving compression of the physiological signal, e.g. to extend the signal recording period

Abstract

A self contained, compact, long term, ambulatory physiological recorder is designed for mounting directly to the body of a patient, immediately adjacent to the organ or system that is to be monitored, and is adhesively and covertly held there in place and comfortably under clothing by the very transducer, skin electrodes that detect the physiological information to be recorded, and thereby increasing continuity and decreasing artifact by obviating the need for numerous and cumbersome, hanging electrode leads as well as unsightly and cumbersome recorder pouches suspended from shoulder straps or belts.

Claims

1. A flesh/body mounted, self powered, long-term, ambulatory data processor and recorder for accumulation of physiological and somatic data from a patient, comprising:

environmentally sealed recorder housing means for elimination of moisture, dust, and other contaminants from the data processing and recording process;

dual function recorder housing mounting means for adhesively holding said recorder housing in a desired position on the flesh and body of said patient, while concomitantly acting as a data input transducer and physiological sensor of said somatic data; and

micro processor system controller means disposed in said recorder housing for receiving, processing, accumulating, recording, and outputting at least one channel of said somatic data;

reusable data storage means disposed in said recorder housing.

2. The recorder housing means according to claim 1, wherein said housing means is soft, flexible, and compliant to body tissue movement.

3. The recorder housing means according to claim 2, wherein said housing means comprises:

a planar lid;

a planar base disposed parallel to said lid, to be placed adjacent the patient body/flesh to which said recorder is to be mounted;

a rounded, circumferential seal and wall disposed around the periphery of and between said lid and base, thereby enclosing a sealed housing environment therebetween; and

a printed circuit board extending across said sealed housing environment for supporting said system micro processor, memory, and input/output means.

4. The sealed recorder housing according to claim 3, wherein said base has provision for at least two snap-in receptacles for receipt of at least two snap-on transducer sensor means and adhesive skin attachment means.

5. The recorder housing mounting means according to claim 1, wherein said dual function, transducer/attachment means consists of a snap-on electronic sensor probe surrounded and attached to the patient skin by an adhesive pad.

6. The recorder housing mounting means according to claim 5, wherein said sensor/attachment device is further attached by swivel mount means to said recorder housing, thereby allowing more comfortable and flexible movement of the patient'"'"'s skin to which said recorder is supported.

7. The ambulatory recorder according to claim 1, wherein said data storage means consists of at least one solid state flash memory chip.

8. The ambulatory recorder according to claim 1, further having data output means consisting of a Universal Serial Bus coupling said micro processor means and data storage means to an exit port of said recorder.

9. The ambulatory recorder according to claim 1, further having data output means in the form of an insertable flash memory card.

10. The ambulatory recorder according to claim 1, wherein said self powered function of said recorder consists of at least one battery disposed within said housing.

11. The ambulatory recorder according to claim 1, further having patient event marking means for indicating time related specific events contiguous to relevant recorded somatic data.

12. The ambulatory recorder according to claim 1, further having the option for data compression for extending periods of recorded data.

13. The ambulatory recorder according to claim 1, further having accelerometer means disposed therein for further data recording capacity of patient physical activity and body movement.

14. Hidden and covert apparatus for monitoring and recording physiological and somatic data from a patient over an extended period and in an ambulatory environment, comprising:

a recorder housing;

means attached to said housing for concomitantly sensing somatic analog signals and also for attaching said recorder housing directly to the patient'"'"'s body/skin and holding said recorder in place during the recording process;

central processor unit disposed in said housing for receiving, processing, and for converting said somatic signals from analog to digital data; and

means for storing said digital data.

15. Covert recording apparatus according to claim 14, wherein said recorder housing is sealed against environmental contaminants to include water.

16. Covert recording apparatus according to claim 15, wherein said recorder housing is constructed of a skin soft, flexible material and capable of bending with the body area over which the recorder is mounted.

17. Recording apparatus according to claim 14, wherein said storing means consists of a solid state, digital, flash memory.

18. Recording apparatus according to claim 14, wherein a microprocessor controller system and other supporting data processing and recording electronics are all mounted on at least one printed circuit board suspended within said recorder housing.

19. Covert apparatus according to claim 14, further having means for a plurality of additional, conventional leads extending from said recorder housing on one part of the body to a variety of other parts of the body.