Measurement of gastric emptying and gastrointestinal output

• US 6,132,372 A
• Filed: 04/01/1997
• Issued: 10/17/2000
• Est. Priority Date: 05/13/1993
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Synectics Medical, Inc. (Medtronic Plc)
• Inventors: Essen-Moller, Anders
• Primary Examiner(s): Casler, Brian L.
• Application Number:
  US08/825,636
• Time in Patent Office: 1,295 Days
• Field of Search: 600/407, 600/431, 600/433, 600/435, 600/436, 600/301, 600/587, 600/593, 600/483, 600/484, 600/549, 604/264, 604/268, 604/280, 128/920
• US Class Current: 600/431
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/392 Detecting gastrointestinal contractions
• CPC Class Codes: A61B 5/42 Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems A61B1/00, A61B5/4857, A61B5/486, A61B5/4866, A61B5/4869 take precedence
• CPC Class Codes: A61B 5/4238 stomach
• CPC Class Codes: A61B 6/4258 for detecting non x-ray radiation, e.g. gamma radiation A61B6/037 takes precedence
• CPC Class Codes: A61B 6/50 specially adapted for specific body parts; specially adapted for specific clinical applications

Abstract

A system and a method for evaluation of gastrointestinal function is presented. The system consists of a catheter, a recorder and software. The catheter includes one or more CdTe sensors for measuring isotope activity. The catheter CdTe sensors are placed in the gastrointestinal tract to measure gastric emptying or gastrointestinal output after administration of radiolabeled liquid or solid meals. Data is stored in the recorder or displayed on-line on a computer screen. Other parameters such as pH can be added for a more complete evaluation of gastrointestinal function. The computer software is written for the Windows environment. The software includes provisions for general ambulatory and stationary data acquisition. The software also includes realtime analysis combined with an extensive patient journal where all items are described as objects in understandable userfriendly language connected to a database. With the present invention it is for the first time made possible to study gastrointestinal output and gastric emptying on an ambulatory basis.

Claims

1. A system comprising:

(a) an ambulatory intragastrointestinal isotope activity sensor catheter comprising means for generating simultaneous measurements of multiple physiological parameters related to gastric emptying and gastrointestinal output,

(b) a preamplifier in electrical communication with a recorder, the preamplifier electrically communicating with the catheter and the recorder, the recorder having a power supply the recorder recording the simultaneous measurements of multiple physiological parameters related to gastric emptying and gastrointestinal output, and

(c) an analysis software program resident in a computer, the computer configured to receive electrical communication, from the recorder, of the simultaneous measurements of multiple physiological parameters related to gastric emptying and gastrointestinal output, the analysis software program performing realtime visualization and analysis of the simultaneous measurements of multiple physiological parameters related to gastric emptying and gastrointestinal output.

2. The invention of claim 1, said recorder further comprising:

(a) a means for online communication with the computer, and

(b) means for simultaneously recording the multiple physiological parameters.

3. The invention of claim 1, further comprising an ear hook attached to the preamplifier.

4. The invention of claim 1, further comprising:

(a) said preamplifier being powered from the power supply of said recorder.

5. The invention of claim 1, wherein the catheter further comprises:

(a) a tubular body having a distal end and a proximal end,

(b) a first isotope activity sensor, having a distal end and a proximal end, in the distal end of said body,

(c) a first gold shield at the distal end of the first sensor,

(d) a second gold shield at the proximal end of the first sensor, and

(e) an electrical conductor connected to said first sensor and running through and interior of said body, for the length of said body, to the proximal end of said body.

6. The invention of claim 5, wherein:

(i) the first sensor includes a CdTe sensor element and

(ii) the electrical conductor comprises a shielded cable.

7. A system comprising:

(a) an ambulatory intragastrointestinal isotope activity sensor catheter comprising means for generating measurements of at least one physiological parameter related to gastric emptying and gastrointestinal output,

(b) a preamplifier in electrical communication with a recorder, the preamplifier electrically communicating with the catheter and the recorder, the recorder having a power supply, the recorder recording the measurement of at least one physiological parameter related to gastric emptying and gastrointestinal output, and

(c) an analysis software program resident in a computer, the computer configured to receive electrical communication, from the recorder, of the measurement of at least one physiological parameter related to at least one of gastric emptying and gastrointestinal output, the analysis software program performing realtime visualization and analysis of the measurement of at least one physiological parameter related to at least one of gastric emptying and gastrointestinal output.

8. The invention of claim 7, wherein said at least one parameter is greater than one, and wherein said means for generating measurements generates said measurements of said parameters simultaneously.

9. The invention of claim 7, said recorder further comprising:

(a) a means for online communication with the computer, and

(b) means for simultaneously recording at least one physiological parameter.

10. The invention of claim 7, further comprising an ear hook attached to the preamplifier.

11. The invention of claim 7, wherein said preamplifier is powered from the power supply of said recorder.

12. The invention of claim 7, wherein the catheter further comprises:

(a) a tubular body having a distal end and a proximal end,

(b) a first isotope activity sensor in the distal end of said body, and

(c) an electrical conductor connection to said first sensor and running through an interior of said body, for the length of said body, to the proximal end of said body.

13. The invention of claim 12, wherein:

(i) the first sensor includes a CdTe sensor element and

(ii) the electrical conductor comprises a shielded cable.

14. A catheter comprising:

(a) an ambulatory intragastrointestinal catheter with a tubular body having a distal end and a proximal end,

(b) a first isotope activity sensor, having a distal end and a proximal end, in the distal end of said body,

(c) an electrical conductor connected to said first sensor and running through an end of said body, for the length of said body, to the proximal end of said body, and

(d) a second isotope activity sensor, located adjacent to the first isotope activity sensor in the body, the second sensor including means for sensing a type of isotope not sensed by the first sensor and different from a type sensed by the first sensor, and

(e) an electrical conductor connected to the second sensor and running through the interior of the body, for the length of the body, to the proximal end of the body.

15. The invention of claim 14, wherein the first sensor further comprises a CdTe sensor element.

16. The invention of claim 14, wherein the electrical conductor further comprises a shielded cable.

17. The invention of claim 14, further comprising:

(a) a perfusion lumen having a distal end and a proximal end and extending through the length of said body, with an outlet hole through the body communicating between an exterior of the body and the lumen, the hole located near the distal end of said body, and

(b) a connector at the proximal end of said lumen adapted for connection to a perfusion pump and pressure transducer.

18. A catheter comprising:

(a) an ambulatory intragastrointestinal catheter with a tubular body having a distal end and a proximal end,

(b) a first isotope activity sensor, having a distal end and a proximal end, in the distal end of said body,

(c) an electrical conductor connected to said first sensor and running through an interior of said body, for the length of said body, to the proximal end of said body,

(d) an additional sensor attached to the body and selected from a group of sensors sensing, respectively, one of the following parameters;

pH,

impedance,

IGG,

EGG,

pressure, and

bile, and

(e) an electrical conductor connected to said additional sensor and running through the interior of said body to the proximal end of said body.