System and method for continuous detection of an analyte in bloodstream

• US 8,092,384 B2
• Filed: 09/28/2006
• Issued: 01/10/2012
• Est. Priority Date: 09/28/2006
• Status: Active Grant

• Current Assignee: Mozarc Medical US LLC
• Original Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Inventors: Meyer, Peter
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Liu, Chu Chuan (JJ)
• Application Number:
  US11/528,907
• Publication Number:
  US 20080086037A1
• Time in Patent Office: 1,930 Days
• Field of Search: 600/309, 600/459, 600/437, 435/6, 435/7.1, 435/4, 436/501, 422/68.1, 702/19, 73/645.3
• US Class Current: 600/309
• CPC Class Codes: A61B 2562/0204 Acoustic sensors
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/6848 Needles

Abstract

A method for performing a blood assay is disclosed. The method includes the steps of: positioning an acoustic biosensor in fluid communication with a blood vessel of the patient whereby blood from the blood vessel contacts the biosensor. The biosensor includes at least one material adapted to bind to an analyte. The method also includes the steps of detecting a change in at least one of an electrical and mechanical property of the biosensor indicative of a mass change resulting from binding of the at least one material with the analyte and transmitting a real time signal representative of mass change to a display module to provide real time analysis by a clinician.

Claims

1. A method for performing a tissue assay, comprising the steps of:

positioning an acoustic biosensor including an extension member in fluid communication with tissue of the patient whereby the tissue contacts the extension member, the extension member having at least one material adapted to bind to an analyte;

detecting a change in at least one of an electrical and mechanical property of the biosensor indicative of a mass change resulting from binding of the at least one material with the analyte; and

transmitting a real time signal representative of a mass change to a display module to provide real time analysis by a clinician.

2. A method for performing a blood assay, comprising the steps of:

positioning an acoustic biosensor including an extension member in fluid communication with a blood vessel of the patient whereby blood from the blood vessel contacts the extension member, the extension member having at least one material adapted to bind to an analyte;

detecting a change in at least one of an electrical and mechanical property of the biosensor indicative of a mass change resulting from binding of the at least one material with the analyte; and

transmitting a real time signal representative of a mass change to a display module to provide real time analysis by a clinician.

3. The method according to claim 2 wherein the acoustic biosensor comprises a piezoelectric crystal and wherein, during the step of detecting, the analyte attaches to the at least one material to increase an effective mass of the extension member.

4. The method according to claim 3 wherein the at least one material is adapted to attach to the analyte to increase the effective mass of the extension member, the analyte being selected from the group consisting of cardiac troponin, myoglobin, creatinine kinase, creatine kinase isozyme MB, albumin, myeloperoxidase, C-reactive protein and glucose.

5. The method according to claim 2 wherein the step of positioning includes introducing the extension member within the lumen of the blood vessel.

6. The method according to claim 5 including the step of accessing the blood vessel with an access member having at least one port to permit passage of the blood therethrough whereby the extension member is disposed within a distal end of the access member.

7. The method according to claim 2 including the step of accessing the blood vessel with an access member and withdrawing the blood through the access member to contact the extension member remotely from the blood vessel.

8. The method according to claim 7 including the step of returning the blood to the blood vessel.

9. The method according to claim 2, wherein the at least one electrical property of the biosensor is selected from the group consisting of an electrical current and an electrical potential.

10. The method according to claim 2, wherein the at least one mechanical property of the biosensor is a resonant frequency of the biosensor.

11. The method according to claim 10, including the step of calculating the rate of the resonant frequency change.

12. The method according to claim 10, including the step of calculating at least one time derivative of the resonant frequency change to determine concentration of the analyte within the blood.

13. The method according to claim 2 wherein the step of detecting is performed substantially in real time.

14. A medical analyzer to assay blood for an analyte, which comprises:

an acoustic biosensor including an extension member adapted to be in fluid communication with a blood vessel whereby blood from the blood vessel contacts the extension member, the extension member having at least one material adapted to bind to an analyte of the blood;

an oscillator for generating a mechanical wave form in the biosensor; and

a detector adapted to detect a change in resonant frequency of the mechanical wave form indicative of a mass change resulting from the binding of the at least one material of the extension member with the analyte of the blood and to generate a real time signal representative of the mass change of the biosensor to provide real time analysis by a clinician.

15. The medical analyzer according to claim 14, including a monitor adapted to receive the real time signal transmitted by the transmitter and provide a visual display corresponding to the mass change.

16. The medical analyzer according to claim 15, including a controller for performing calculations pertaining to the mass change of the extension member.

17. The medical analyzer according to claim 16, wherein the controller includes programming to calculate a rate of the mass change of the extension member, the monitor being adapted to provide a visual display corresponding to the rate of the mass change.

18. The medical analyzer according to claim 17, wherein the controller includes programming to calculate at least one time derivative of the rate of the mass change of the extension member corresponding to concentration level of the analyte, the monitor being adapted to provide a visual display corresponding to the concentration level.

19. The medical analyzer according to claim 14, including an access member for accessing the blood vessel and having the extension member disposed within a lumen thereof, whereby blood passes through the lumen to contact the extension member.

20. The medical analyzer according to claim 19, wherein the access member includes a distal end adapted to penetrate the blood vessel to thereby be at least partially positioned therein, the extension member being disposed within the distal end of the access member.

21. The medical analyzer according to claim 20, wherein the distal end includes an entry port to permit entry of the blood within the lumen of the access member for contacting the extension member and an exit port for returning the blood to the blood vessel.

22. The medical analyzer according to claim 14, wherein the at least one material is adapted to bind to cardiac troponin.

23. A medical analyzer to assay blood for an analyte, which comprises:

an acoustic biosensor including an extension member adapted to be in fluid communication with a blood vessel whereby blood from the blood vessel contacts the extension member, the extension member having at least one material adapted to bind to an analyte of the blood, the biosensor being adapted to transmit a mass change resulting from the binding of the at least one material of the extension member with the analyte of the blood in response to a change in at least one of an electrical and mechanical property of the biosensor.

24. The medical analyzer according to claim 23, wherein the at least one electrical property of the biosensor is selected from the group consisting of an electrical current and an electrical potential.

25. The medical analyzer according to claim 23, wherein the at least one mechanical property of the biosensor is a resonant frequency of the biosensor.