Handheld Medical Diagnostic Devices With Sample Transfer

• US 20140371630A1
• Filed: 08/29/2014
• Published: 12/18/2014
• Est. Priority Date: 12/30/2010
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Roe, Steven N.
• Granted Patent: US 9,486,164 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15192 comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: F01D 17/085 to temperature
• CPC Class Codes: F01D 21/003 Arrangements for testing or measuring for measuring vibrations G01H
• CPC Class Codes: F01D 9/023 Transition ducts between combustor cans and first stage of the turbine in gas-turbine engines; their cooling or sealings
• CPC Class Codes: F05D 2260/80 Diagnostics
• CPC Class Codes: F05D 2260/83 Testing, e.g. methods, components or tools therefor
• CPC Class Codes: G01M 15/14 Testing gas-turbine engines or jet-propulsion engines
• CPC Class Codes: G01N 21/8422 Investigating thin films, e.g. matrix isolation method
• CPC Class Codes: G01N 25/72 Investigating presence of flaws
• CPC Class Codes: Y02T 50/60 Efficient propulsion technologies, e.g. for aircraft

Abstract

A lancet housing assembly for use in a portable handheld medical diagnostic device for sampling bodily fluids from a skin site of a patient is provided. The lancet housing assembly comprises an outer facing side and an inner facing side. An opening is located at the outer facing side that is arranged and configured to align with a lancet port of the medical diagnostic device. A floor extends between the outer facing side and the inner facing side and having a reagent material. A lancet structure having a skin penetrating end and a blood transport portion adjacent the skin penetrating end is located in housing assembly. The blood transport portion is arranged and configured receive the amount of blood from the skin penetrating end and to carry the amount of blood away from the skin site and to the reagent material.

Claims

1. A lancet housing assembly for use in a portable handheld medical diagnostic device for sampling bodily fluids from a skin site of a patient, the lancet housing assembly comprising:

a housing structure comprising;

an outer facing side;

an inner facing side;

an opening located at the outer facing side that is arranged and configured to align with a lancet port of the medical diagnostic device; and

a floor that extends between the outer facing side and the inner facing side;

a reagent material located on the floor and within the housing structure; and

a lancet structure located in the housing structure, the lancet structure comprising a skin penetrating end aligned initially in a first plane with the opening and a blood transport portion adjacent the skin penetrating end, wherein the skin penetrating end is configured to extend in the first plane when extended through the opening and, when extended through the opening, is shaped and sized to penetrate the patient'"'"'s skin at the skin site to provide an amount of blood, and further is configured to be extended and retracted by a drive member, and a biasing mechanism is configured to force the lancet structure toward the floor when the lancet is retracted to a second plane parallel to the first plane and offset from the opening, the drive member is configured to pass over the lancet structure when the drive member is moved toward the opening and the lancet structure is in the second plane, and the blood transport portion being arranged and configured to receive the amount of blood from the skin penetrating end in the second plane and to carry the amount of blood away from the skin site and to the reagent material.

2. The lancet housing assembly of claim 1, wherein the skin penetrating end of the lancet structure is supported on a bottom surface of the opening at the outer facing side before extending the skin penetrating end through the opening.

3. The lancet housing assembly of claim 1, wherein the reagent material is offset vertically from the opening at the outer face and within the housing structure.

4. The lancet housing assembly of claim 1 further comprising one or more lancet guide rails that extend along one or more of sidewalls of the at least one lancet compartment between the outer facing side and the inner facing side.

5. The lancet housing assembly of claim 4, wherein the lancet structure includes a rail riding structure providing a support surface that supports the lancet structure upon the one or more lancet guide rails.

6. The lancet housing assembly of claim 5 further comprising one or more drop down slots formed in the one or more of the sidewalls, the rail riding structure located to align with the one or more drop down slots such that the skin penetrating end is configured to move toward the reagent material when the lancet structure is retracted.

7. The lancet housing assembly of claim 1 wherein the biasing mechanism is connected at opposite ends to a ceiling of an upper disk member of the lancet housing assembly.

8. A portable handheld medical diagnostic device for sampling bodily fluids, comprising:

a protective enclosure;

a measurement system including a controller facilitating a physiologic measurement;

a display device connected to the measurement system that displays information related to the physiologic measurement;

a housing structure comprising;

an outer facing side;

an inner facing side;

an opening located at the outer facing side that is arranged and configured to align with a lancet port of the medical diagnostic device; and

a floor that extends between the outer facing side and the inner facing side;

a reagent material located on the floor and within the housing structure; and

a lancet structure located in the housing structure, the lancet structure comprising a skin penetrating end aligned initially in a first plane with the opening and a blood transport portion adjacent the skin penetrating end, wherein the skin penetrating end is configured to extend in the first plane when extended through the opening and, when extended through the opening, is shaped and sized to penetrate the patient'"'"'s skin at the skin site to provide an amount of blood, and further is configured to be extended and retracted by a drive member, and a biasing mechanism is configured to force the lancet structure toward the floor when the lancet is retracted to a second plane parallel to the first plane and offset from the opening, the drive member is configured to pass over the lancet structure when the drive member is moved toward the opening and the lancet structure is in the second plane, and the blood transport portion being arranged and configured to receive the amount of blood from the skin penetrating end in the second plane and to carry the amount of blood away from the skin site and to the reagent material.

9. The medical diagnostic device of claim 8, wherein the skin penetrating end of the lancet structure is supported on a bottom surface of the opening at the outer facing side before extending the lancet structure.

10. The medical diagnostic device of claim 8, wherein the reagent material is offset vertically from the opening at the outer face and within the housing structure.

11. The medical diagnostic device of claim 8 further comprising one or more lancet guide rails that extend along one or more of the sidewalls between the outer facing side and the inner facing side.

12. The medical diagnostic device of claim 11, wherein the lancet structure includes a rail riding structure providing a support surface that supports the lancet structure upon the one or more lancet guide rails before extending the lancet structure.

13. The medical diagnostic device of claim 12 further comprising one or more drop down slots formed in the one or more of the sidewalls, the rail riding structure located to align with the one or more drop down slots such that the skin penetrating end is configured to move toward the reagent material.

15. The medical diagnostic device of claim 8 further comprising a motor operatively connected to the lancet structure.

16. A method of controlling movement of a lancet structure provided within a lancet housing assembly in a portable handheld medical diagnostic device for sampling bodily fluids from a skin site of a patient, the method comprising:

providing a lancet structure located the lancet housing assembly, wherein the lancet housing assembly is configured to have an outer facing side and an opening located at the outer facing side that is arranged and configured to align with a lancet port of the medical diagnostic device, the lancet structure comprising a skin penetrating end aligned initially in a first plane with the opening and a blood transport portion adjacent the skin penetrating end, wherein the skin penetrating end is configured to extend in the first plane when extended through the opening and, when extended through the opening, is shaped and sized to penetrate the patient'"'"'s skin at the skin site to provide an amount of blood, and further is configured to be extended and retracted by a drive member, and a biasing mechanism is configured to force the lancet structure toward a lancet floor when the lancet is retracted to a second plane parallel to the first plane and offset from the opening, the drive member is configured to pass over the lancet structure when the drive member is moved toward the opening and the lancet structure is in the second plane, and the blood transport portion being arranged and configured to receive the amount of blood from the skin penetrating end in the second plane and to carry the amount of blood away from the skin site and to a reagent material located on the floor within the at least one lancet compartment;

extending the skin penetrating end through a port of the medical diagnostic device and penetrating the patient'"'"'s skin at the skin site to provide an amount of blood;

receiving the amount of blood at the skin penetrating end; and

carrying the amount of blood away from the skin site to the reagent material using the blood transport portion.

17. The method of claim 16 comprising supporting the skin penetrating end of the lancet structure on a bottom surface at the port with the lancet structure before extending the skin penetrating end.

18. The method of claim 16 further comprising providing a reagent material offset vertically from the port within the lancet compartment.

19. The method of claim 16 further comprising connecting a motor to the lancet structure.