Measurement of gastric emptying and gastrointestinal output

• US 5,657,759 A
• Filed: 01/06/1995
• Issued: 08/19/1997
• Est. Priority Date: 05/13/1993
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Synectics Medical, Inc.
• Inventors: Essen-Moller, Anders
• Primary Examiner(s): Casler, Brian L.
• Application Number:
  US08/369,552
• Time in Patent Office: 956 Days
• Field of Search: 128/653.1, 128/654, 128/656, 128/658, 128/659, 128/774, 128/780, 128/631, 128/635, 128/670, 128/671, 128/736, 364/413.02, 364/413.13, 364/413.26, 604/264, 604/268, 604/280
• 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 online 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 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) 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 an interior of said body, for the length of said body, to the proximal end of said body.

2. The invention of claim 1, wherein the first sensor further comprises a CdTe sensor element.

3. The invention of claim 1, wherein the electrical conductor further comprises a shielded cable.

4. The invention of claim 1, further comprising:

(a) a second isotope activity sensor, located adjacent to the first isotope activity sensor in the body and between the first gold shield and the second gold shield, the second sensor including means for sensing a type of isotope different from a type sensed by the first sensor, and

(b) 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.

5. The invention of claim 4, further comprising:

(a) a third isotope activity sensor, at a location in the body not adjacent to the first sensor, the third sensor having a distal end and a proximal end and including means for sensing the same type of isotope as the first sensor,

(b) a third gold shield at the distal end of the third sensor,

(c) a fourth gold shield at the proximal end of the third sensor, and

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

6. The invention of claim 1, further comprising:

(a) 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

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

7. The invention of claim 1, 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.