Medical System and Method for Determining Parameters

• US 20070207554A1
• Filed: 04/13/2007
• Published: 09/06/2007
• Est. Priority Date: 02/26/2004
• Status: Abandoned Application

• Current Assignee: ACM Medical Technologies, Inc.
• Original Assignee: ACM Medical Technologies, Inc.
• Inventors: Chang, Wei-Kuo, Lin, Alex, Chang, Stanley
• Application Number:
  US11/735,173
• Publication Number:
  US 20070207554A1
• Time in Patent Office: Days
• US Class Current: 436/514
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 2010/0061 Alimentary tract secretions, e.g. biliary, gastric, intestinal, pancreatic secretions
• CPC Class Codes: A61B 2560/0406 specially shaped apparatus housings
• CPC Class Codes: A61B 2560/0425 Ergonomically shaped housings A61B2560/0418 takes precedence
• CPC Class Codes: A61B 2560/0456 Apparatus provided with a docking unit
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• CPC Class Codes: G01N 21/4133 Refractometers, e.g. differential
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 2201/0221 Portable; cableless; compact; hand-held
• CPC Class Codes: G01N 2800/06 Gastro-intestinal diseases
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387

Abstract

The present invention discloses a device or system, and the method thereof, for determining gastrointestinal parameters with the reference database saved equations for calculating the parameters comprising concentration of dietary formula, the gastric residual volume, the amount of dietary formula retained in the stomach, and volume of dietary formula remaining in stomach.

Claims

1. A test strip for use in conjunction with a medical device, wherein the medical device comprises a sample interface for measuring a property of a fluid sample, the test strip comprising:

a support member having a top surface and a bottom surface and an aperture suitable for receiving the fluid sample;

and wherein the test strip is configured to engage with the medical device such that the aperture of the test strip aligns with a sample interface of the medical device, thereby allowing the property of the fluid sample to be measured.

2. The test strip of claim 1, wherein the aperture extends from the top surface to the bottom surface of the support member.

3. The test strip of claim 1, wherein the aperture has an inner surface and wherein the inner surface is substantially non-reflective.

4. The test strip of claim 1, wherein the test strip is elongate and wherein at least a portion of the test strip is adapted to slide into a channel in the medical device.

5. The test strip of claim 1, wherein the volume of the fluid sample that can be received within the aperture is at least about 0.01 ml, preferably about 0.1 to about 10.0 ml and more preferably about 0.4 to about 2.0 ml.

6. The test strip of claim 1, which further comprises a system for removing fluid from the surface of the sample interface of the medical device when the test strip is withdrawn from the medical device.

7. The test strip of claim 1, wherein the support member has a distal end and a proximal end;

and wherein the bottom surface of the support member is provided with a wiping system, preferably in the form of at least one resilient pad for removing fluid from the surface of the sample interface of the medical device when the test strip is withdrawn from the medical device.

10. The test strip of claim 1, wherein a sealing system is provided about the aperture on the bottom surface of the support member such that when the test strip is correctly engaged with the medical device a substantially water-tight seal is formed between the aperture and the sample interface.

11. The test strip of claim 1, wherein a resilient material is disposed on the bottom surface of the support member surrounding the aperture such that when the test strip is correctly engaged with the medical device a substantially water-tight seal is formed between the aperture and the sample interface.

12. The test strip of claim 1, wherein the support member has a distal end and a proximal end;

and wherein the proximal end is provided with a handle member for holding the test strip.

13. The test strip of claim 1, wherein the support member has a distal end and a proximal end;

and wherein the proximal end is provided with a handle member for holding the test strip; and

wherein the handle member has a textured or contoured surface for improving grip.

14. The test strip of claim 1, which further comprises a sleeve adapted to enclose at least a portion of the support member;

wherein the sleeve comprises at least a lower section having upwardly extending lateral flanges which engage with the support member and a window at least as large as the aperture; and

wherein the test strip is configured to engage with the medical device such that the window in the lower section of the sleeve aligns with the sample interface of the medical device and the aperture, such that there is a direct optical path from the sample interface through the window to the aperture.

15. The test strip of claim 1, which further comprises a sleeve adapted to enclose at least a portion of the support member;

wherein the sleeve comprises at least a lower section having upwardly extending lateral flanges which are capable of engaging with and acting as guide members for the support member, and a window at least as large as the aperture; and

wherein the support member is slidable within the sleeve from a first position in which the aperture is aligned with the window in the lower of the sleeve, to a second position in which the aperture is not aligned with the window and is enclosed by the lower section of the sleeve.

20. The test strip of claim 1, which further comprises a sleeve adapted to enclose at least a portion of the support member;

wherein the sleeve comprises a lower section having upwardly extending lateral flanges which are capable of engaging with and acting as guide members for the support member, and a window at least as large as the aperture; and

an upper section having an window, the upper section being engageable with the lower section of the sleeve such that the window in the upper section aligns with the window in the lower section;

wherein the support member is slidable within the sleeve from a first position in which the aperture is aligned with the windows in the lower and upper sections of the sleeve, to a second position in which the aperture is not aligned with the windows and is enclosed by the lower and upper sections of the sleeve;

wherein the support member and sleeve are provided with a system for mutual engagement which engages when the support member is in the second position, thereby inhibiting free movement of the support member relative to the sleeve.

21. The test strip of claim 1, further comprising a lid for covering at least a part of the aperture in the top surface of the support member.

22. The test strip of claim 1, wherein the support member comprises two apertures;

and wherein the test strip is configured to engage with the medical device such that each of the two apertures can be brought into alignment with a sample interface of the medical device.

23. The test strip of claim 1, wherein the support member has a distal end and a proximal end;

and wherein the distal end is provided with a trigger; and

wherein the trigger is configured to insert into a corresponding socket of the medical device and is adapted to communicate with the medical device.

24. The test strip of claim 1, wherein the support member has a distal end and a proximal end;

and wherein the distal end of the is provided with a trigger;

wherein the trigger is configured to insert into a corresponding socket of the medical device and is adapted to initiate a photo-interrupt.

26. The test strip of claim 1 which is disposable.

8. A test strip for use in conjunction with a medical device, wherein the medical device comprises a sample interface for measuring a property of a fluid sample, the test strip comprising:

a support member having a distal end and a proximal end, a top surface and a bottom surface, and being provided with an aperture suitable for receiving a fluid sample extending from the top surface to the bottom surface, and a wiping system on the bottom surface of the support member for removing fluid from the surface of the sample interface of the medical device when the test strip is withdrawn from the medical device;

and wherein the test strip is configured to slidingly engage with the medical device such that the aperture of the test strip aligns with a sample interface of the medical device thereby allowing the property of the fluid sample to be measured.

9. The test strip of claim 8, wherein the wiping system comprises at least one resilient pad;

and wherein correct engagement of the test strip with the medical device causes the at least one resilient pad to be compressed against an opposing surface of the medical device, such that on withdrawing the test strip from the medical device the resilient pad is drawn across the surface of the sample interface.

16. A test strip for use in conjunction with a medical device, wherein the medical device comprises a sample interface for measuring a property of a fluid sample, the test strip comprising:

an elongate support member having a distal end and a proximal end along its longitudinal axis, a top surface and a bottom surface, and being provided with an aperture suitable for receiving a fluid sample extending from the top surface to the bottom surface; and

a sleeve adapted to enclose at least a portion of the support member;

wherein the sleeve comprises a lower section having upwardly extending lateral flanges which are capable of engaging with and acting as guide members for the support member, and a window at least as large as the aperture; and

an upper section having an window, the upper section being engageable with the lower section of the sleeve such that the window in the upper section aligns with the window in the lower section;

wherein the support member is slidable within the sleeve from a first position in which the aperture is aligned with the windows in the lower and upper sections of the sleeve, to a second position in which the aperture is not aligned with the windows and is enclosed by the lower and upper sections of the sleeve;

and wherein the test strip is configured to engage with the medical device such that the window in the lower section of the sleeve aligns with the sample interface of the medical device and the aperture, such that there is a direct optical path from the sample interface through the window to the aperture, thereby allowing the property of the fluid sample to be measured.

17. The test strip of claim 16, which further comprises a wiping system for removing fluid from the surface of the sample interface of the medical device when the test strip is withdrawn from the medical device.

18. The test strip of claim 16, wherein the bottom surface of the support member is provided with at least one resilient pad;

and wherein the sliding of the support member from the first position to the second position, while the test strip is correctly engaged with the medical device, causes the at least one resilient pad to be compressed against and drawn across at least the surface of the sample interface of the medical device.

19. The test strip of claim 16, wherein the lower section of the sleeve further comprises an upwardly extending distal flange.

25. The test strip of claim 16, wherein the lower section of the sleeve further comprises an upwardly extending distal flange;

wherein the upwardly extending distal flange is provided with a trigger; and

wherein the trigger is configured to insert into a corresponding socket of the medical device and is adapted to communicate with the medical device.

27. The test strip of claim 16 which is disposable.

28. A test strip for use in conjunction with a medical device, wherein the medical device comprises a sample interface for measuring a property of a fluid sample, the test strip comprising;

an elongate support member having a distal end and a proximal end along its longitudinal axis, a top surface and a bottom surface, and being provided with an aperture suitable for receiving a fluid sample extending from the top surface to the bottom surface; and

a trigger which is configured to insert into a corresponding socket of the medical device and is adapted to communicate with the medical device;

at least one resilient pad on the bottom surface of the support member; and

a sleeve adapted to enclose at least a portion of the support member;

wherein the sleeve comprises a lower section having upwardly extending lateral flanges which are capable of engaging with and acting as guide members for the support member, and a window at least as large as the aperture; and

an upper section having an window, the upper section being engageable with the lower section of the sleeve such that the window in the upper section aligns with the window in the lower section;

wherein the support member is slidable within the sleeve from a first position in which the aperture is aligned with the windows in the lower and upper sections of the sleeve, to a second position in which the aperture is not aligned with the windows and is enclosed by the lower and upper sections of the sleeve;

wherein the test strip is configured to engage with the medical device such that the window in the lower section of the sleeve aligns with the sample interface of the medical device and the aperture, such that when the support member is in the first position there is a direct optical path from the sample interface through the window to the aperture, thereby allowing the property of the fluid sample to be measured;

wherein the sliding of the support member from the first position to the second position, while the test strip is correctly engaged with the medical device, causes the at least one resilient pad to be compressed against and drawn across at least the surface of the sample interface of the medical device; and

wherein the support member and sleeve are provided with a system for mutual engagement which engages when the support member is in the second position, thereby inhibiting free movement of the support member relative to the sleeve.

29. A test strip for use in conjunction with a medical device, wherein the medical device comprises a sample interface for measuring a property of a fluid sample, the test strip comprising:

an elongate support member having a distal end and a proximal end along its longitudinal axis, a top surface and a bottom surface, and being provided with an aperture suitable for receiving a fluid sample extending from the top surface to the bottom surface;

a handle member at the proximal end of the support member for holding the test strip;

a sealing system disposed about the aperture on the bottom surface of the support member, such that when the test strip is correctly engaged with the medical device a substantially water-tight seal is formed between the aperture and the sample interface;

a trigger which is configured to insert into a corresponding socket of the medical device and is adapted to communicate with the medical device;

at least one resilient pad on the bottom surface of the support member;

a lid for covering at least a part of the aperture in the top surface of the support member; and

a sleeve adapted to enclose at least a portion of the support member;

wherein the sleeve comprises a lower section having upwardly extending lateral flanges which are capable of engaging with and acting as guide members for the support member, and a window at least as large as the aperture; and

an upper section having an window, the upper section being engageable with the lower section of the sleeve such that the window in the upper section aligns with the window in the lower section;

wherein the support member is slidable within the sleeve from a first position in which the aperture is aligned with the windows in the lower and upper sections of the sleeve, to a second position in which the aperture is not aligned with the windows and is enclosed by the lower and upper sections of the sleeve;

wherein the test strip is configured to engage with the medical device such that the window in the lower section of the sleeve aligns with the sample interface of the medical device and the aperture, such that when the support member is in the first position there is a direct optical path from the sample interface through the window to the aperture, thereby allowing the property of the fluid sample to be measured;

wherein the sliding of the support member from the first position to the second position, while the test strip is correctly engaged with the medical device, causes the at least one resilient pad to be compressed against and drawn across at least the surface of the sample interface of the medical device; and

wherein the support member and sleeve are provided with a system for mutual engagement which engages when the support member is in the second position, thereby inhibiting free movement of the support member relative to the sleeve.

30. A medical system for measuring a property of a fluid sample, comprising:

a medical device capable of measuring at least one property of the fluid sample and having a sample interface for receiving a fluid sample to be measured; and

a test strip;

wherein the test strip comprises;

a support member having a top surface and a bottom surface and an aperture suitable for receiving the fluid sample;

and wherein the medical device is provided with a channel configured to receive at least a portion of the test strip, and the test strip is configured to engage with the medical device such that the aperture of the test strip aligns with a sample interface of the medical device, thereby allowing the property of the fluid sample to be measured.

32. The medical system of claim 30, wherein the medical device is a refractometer which measures at least the refractive index of a sample of fluid.

33. A medical system of claim 30, wherein the medical device further comprises a digital display for reporting a measurement of a property of the fluid sample.

34. A medical system of claim 30, wherein the medical device further comprises a keypad for manual communication with the medical device.

35. The medical system of claim 30, which further comprises a docking station, the docking station capable of electronic communication with the medical device for downloading and/or uploading data electronically.

36. The medical system of claim 30, wherein the medical device is a refractometer which measures at least the refractive index of a sample of fluid;

and wherein the refractometer converts a measurement of a refractive index of a fluid into a different property of the of the fluid.

37. The medical system of claim 30, wherein the medical device is a refractometer which measures at least the refractive index of a sample of fluid;

and wherein the refractometer converts a measurement of a refractive index of a fluid into a measurement of the Brix value (BV) of the fluid.

38. The medical system of claim 30, wherein the medical device is a refractometer, and wherein the refractometer comprises means for calculating the gastric residual volume (GRV) in a subject based on the measured Brix values (BV) of at least two samples of gastric fluid, at least one of which samples was obtained from the subject after the gastric contents had been diluted in situ with a known volume of a fluid, and at least one of which samples was obtained from the subject before the gastric contents had been diluted with the known volume of a fluid;

wherein the means for calculating the GRV in the subject calculates the GRV using the equation;

GRV=(BV2×

Vol)/(BV1−

BV2)

 

wherein BV1 is the measured pre-dilution BV of a sample of gastric fluid before dilution of gastric contents with a known volume of fluid (Vol), and BV2 is the measured post-dilution BV of a sample of gastric fluid after dilution of gastric contents with the known volume of fluid (Vol).

31. A medical system for measuring a property of a fluid sample, comprising:

a medical device capable of measuring at least one property of the fluid sample and having a sample interface for receiving a fluid sample to be measured; and

a test strip;

wherein the test strip comprises;

a support member having a distal end and a proximal end, a top surface and a bottom surface, and being provided with an aperture suitable for receiving a fluid sample extending from the top surface to the bottom surface, and a wiping system on the bottom surface of the support member for removing fluid from the surface of the sample interface of the medical device when the test strip is withdrawn from the medical device;

and wherein the medical device is provided with a channel configured to receive at least a portion of the test strip, and the test strip is configured to slidingly engage with the channel of the medical device such that the aperture of the test strip aligns with a sample interface of the medical device, thereby allowing the property of the fluid sample to be measured.

39. An optical module for a refractometer, comprising:

a prism having a sample interface for contacting a fluid sample to be measured;

a light source arranged to project light through a first face of the prism onto the sample surface; and

an array of photoreceptors arranged proximal to a second face of the prism to detect light reflected from the sample interface when a fluid sample is in contact with the sample interface;

wherein the light source is a laser diode; and

wherein the array of photoreceptors comprises one or more photodiodes.

40. An optical module according to claim 39, wherein the wavelength of the laser is from about 600 to about 1300 nm, preferably from about 650 to about 850 nm and more preferably from about 700 to about 800 nm.

41. An optical module according to claim 39, wherein the prism is made from a material selected from the group consisting of glass, quartz and plastic.

42. An optical module according to claim 39, wherein the laser diode projects light onto the sample interface at an angle of incidence of about 42 to about 62°

, preferably from about 50 to about 62° and

more preferably from about 55 to about 62°

.

43. An optical module according to claim 39, wherein the array of photoreceptors comprises two photodiodes.

44. An optical module for a refractometer, comprising:

a prism having sample interface for contacting a fluid sample to be measured;

a light source arranged to project light through a first face of the prism onto the sample surface; and

an array of photoreceptors arranged proximal to a second face of the prism to detect light reflected from the sample interface when a fluid sample is in contact with the interface;

wherein the light source is a laser diode that is arranged to project light onto the sample interface at an angle of incidence of about 42 to about 62°

, preferably from about 50 to about 62° and

more preferably from about 55 to about 62°

;

wherein the wavelength of the laser is from about 600 to about 1300 nm, preferably from about 650 to about 850 nm and more preferably from about 700 to about 800 nm; and

wherein the array of photoreceptors comprises one or more photodiodes.