Spinal fluid introduction

• US 7,662,133 B2
• Filed: 02/23/2004
• Issued: 02/16/2010
• Est. Priority Date: 02/21/2003
• Status: Expired due to Fees

• Current Assignee: NeuroTherm, Inc. (Abbott Laboratories)
• Original Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Inventors: Weissman, Peter A., McNall, Ralph I., Hamilton, John V., Scarborough, Nelson, Uchida, Andy H., Lepke, Steven
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): Gilbert; Andrew M
• Application Number:
  US10/782,900
• Publication Number:
  US 20040193045A1
• Time in Patent Office: 2,185 Days
• Field of Search: 604151-152, 604/154, 604/187, 600430-432, 600/594
• US Class Current: 604/154
• CPC Class Codes: A61B 17/3401 Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia local anaesthesia A61M19/00
• CPC Class Codes: A61B 17/8822 characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum
• CPC Class Codes: A61M 2025/0007 Epidural catheters
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 5/1456 with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/16854 by monitoring line pressure

Abstract

A fluid introduction system includes an introducer configured to create a pressure of at least 69 kPa within a spine, and an operator configured to actuate the introducer to introduce fluid into the spine according to a predetermined fluid introduction profile. The system can include a computer readable medium having code for receiving fluid introduction data indicative of a fluid introduction parameter, and for receiving response data indicative of a response of the patient at a time related to a time of the fluid introduction data. A method for introducing fluid includes positioning a first introducer in a first portion of a spine, positioning a second introducer in a second, different portion of the spine and, without removing the first and second introducers, introducing fluid into the first portion of the spine with the first introducer and introducing fluid into the second portion of the spine with the second introducer.

Claims

1. A fluid introduction system, comprising:

an introducer configured to introduce fluid into a spine of a patient, the introducer having a flow-rate dependent impedance opposing the introduction of the fluid and comprising a movable element disposed within the introducer, the movable element including a pressure transducer secured with respect to the movable element such that the pressure transducer is in direct contact with fluid in the introducer;

an operator configured to actuate the introducer to introduce fluid into the spine of the patient at a constant flow rate that is not controlled by feedback based on a fluid introduction parameter and configured to determine impedance data indicative of the flow rate-dependent impedance based upon pressure and volume of fluid dispensed during an actuation of the introducer prior to insertion of the introducer into the spine;

a computer readable medium having code that, when executed by a computer, receives;

fluid introduction data indicative of the fluid introduction parameter;

response data indicative of pain level of a response of the patient at a time related to a time of the fluid introduction data; and

response data, input separately from the pain level data, indicative of concordance of the response of the patient at the time related to the time of the fluid introduction data, the concordance data indicating whether the pain level response of the patient is a result of a pain symptom or is a result of pain unrelated to the pain symptom.

2. The fluid introduction system of claim 1, wherein the fluid introduction parameter is a pressure within an intervertebral disc of the patient at the time of the fluid introduction data.

3. The fluid introduction system of claim 1, wherein the fluid introduction parameter is a total amount of fluid introduced into an intervertebral disc of the patient at the time of the fluid introduction data.

4. The fluid introduction system of claim 1, wherein the fluid introduction system is configured to obtain the response data from an observation of the patient.

5. The fluid introduction system of claim 1, wherein the fluid introduction system is configured to obtain the response data upon a response inputted by the patient.

6. The fluid introduction system of claim 1, wherein the introducer is configured to create a pressure of at least 100 kPa within the spine.

7. The fluid introduction system of claim 1, further comprising a sliding device.

8. The fluid introduction system of claim 7, wherein the response data comprises data inputted directly by the patient using the sliding device.

9. The fluid introduction system of claim 1, wherein the response data comprises observed physiological parameters.

10. The fluid introduction system of claim 1, wherein the response data is correlated with actual measurements of disc pressure and a volume of fluid introduced into one or more discs.

11. The fluid introduction system of claim 1, wherein the introducer comprises a needle configured for insertion into a spine.

40. The fluid introduction system of claim 9, wherein observed physiological parameters comprise electromyographic response data.

41. The fluid introduction system of claim 9, wherein observed physiological parameters comprise audiovisual recordings of facial responses.

12. A fluid introduction system, comprising:

an introducer configured to introduce a non-pulsatile flow of fluid into a spine, the introducer having a flow rate-dependent impedance opposing the introduction of the fluid; and

an operator configured to actuate the introducer, the operator including code to introduce the fluid into the spine at a constant flow rate that is not controlled by feedback based on a fluid introduction parameter and configured to empirically determine impedance data indicative of the flow rate-dependent impedance based upon pressure and volume of fluid dispensed during an actuation of the introducer prior to insertion of the introducer into the spine and to control the actuation of the introducer based at least in part upon the impedance data, wherein, using the determined impedance data, the code corrects for differences between the pressure created within the spine by the introduction of fluid and the pressure of fluid within the introducer.

13. The fluid introduction system of claim 12, wherein the introducer includes an identifier including the impedance data and the operator is configured to receive the impedance data from the identifier of the introducer.

14. The fluid introduction system of claim 12, comprising:

a pressure sensor configured to provide pressure data indicative of a pressure of fluid present in the introducer;

a fluid introduction sensor configured to provide fluid introduction data indicative of at least one of (a) a rate of fluid introduction and (b) an amount of fluid introduced into the portion of the spine; and

wherein the operator includes code to determine the impedance data based upon the pressure data and the fluid introduction data.

15. The fluid introduction system of claim 12, wherein the introducer is configured to create a pressure of at least 69 kPa within the spine.

16. The fluid introduction system of claim 12, wherein the impedance data comprises a gauge of a fluid introduction member.

17. The fluid introduction system of claim 12, wherein the impedance data comprises a length of a fluid introduction member.

18. The fluid introduction system of claim 12, wherein the impedance data comprises an inner diameter of a fluid conduit.

19. The fluid introduction system of claim 12, wherein the impedance data comprises a length of a fluid conduit.

20. A fluid introduction system, comprising:

an introducer configured to introduce fluid into a spine of a patient, the introducer having a flow-rate dependent impedance opposing the introduction of the fluid and comprising a movable element disposed within the introducer, the movable element including a pressure transducer secured with respect to the movable element such that the pressure transducer is in direct contact with fluid in the introducer;

an operator configured to actuate the introducer to introduce fluid into the spine of the patient at a constant flow rate that is not controlled by feedback based on a fluid introduction parameter and configured to determine impedance data indicative of the flow rate-dependent impedance based upon pressure and volume of fluid dispensed during an actuation of the introducer prior to insertion of the introducer into the spine;

a computer readable medium having code that, when executed by a computer, receives;

fluid introduction data indicative of the fluid introduction parameter; and

response data indicative of pain level and concordance of a response of the patient inputted separately by hand by the patient at a time related to a time of the fluid introduction data, wherein the concordance response data indicates whether the pain level of the patient is a result of a pain symptom or is a result of pain unrelated to the pain symptom.

21. The fluid introduction system of claim 20, wherein the response data is correlated with actual measurements of disc pressure and a volume of fluid introduced into one or more discs.

22. The fluid introduction system of claim 20, further comprising a sliding device.

23. The fluid introduction system of claim 22, wherein the response data comprises data inputted directly by the patient using the sliding device.

24. The fluid introduction system of claim 22, wherein the response data is correlated with actual measurements of disc pressure and a volume of fluid introduced into one or more discs.

25. A fluid introduction system for performing discography diagnosis, comprising:

an introducer configured to introduce fluid into a spine of a patient, the introducer having a flow-rate dependent impedance opposing the introduction of the fluid and comprising a movable element disposed within the introducer, the movable element including a pressure transducer secured with respect to the movable element such that the pressure transducer is in direct contact with fluid in the introducer; and

an operator configured to actuate the introducer to introduce fluid into the spine of the patient at a constant flow rate that is not controlled by feedback based on a fluid introduction parameter and configured to determine impedance data indicative of the flow rate-dependent impedance based upon pressure and volume of fluid dispensed during an actuation of the introducer prior to insertion of the introducer into the spine;

a computer readable medium having code that, when executed by a computer, receives;

fluid introduction data indicative of the fluid introduction parameter;

pain level data of the patient responsive to the fluid introduction data; and

concordance data, input separately from the pain level data, indicating whether the pain level of the patient at a time related to the time of the fluid introduction data is a result of a pain symptom or is a result of pain unrelated to the pain symptom, wherein the discography diagnosis is based upon the correlation between the pain level and concordance data and the fluid introduction data.

26. A fluid introduction system, comprising:

an introducer configured to introduce fluid into a spine of a patient, the introducer having a flow-rate dependent impedance opposing the introduction of the fluid and comprising a syringe including a plunger slidably disposed within the syringe and a pressure transducer secured with respect to the plunger such that the pressure transducer is in direct contact with fluid in the syringe;

an operator configured to actuate the introducer to introduce fluid into the spine of the patient at a constant flow rate that is not controlled by feedback based on a fluid introduction parameter and configured to determine impedance data indicative of the flow rate-dependent impedance based upon pressure and volume of fluid dispensed during an actuation of the introducer prior to insertion of the introducer into the spine; and

a computer readable medium having code that, when executed by a computer, receives;

fluid introduction data indicative of the fluid introduction parameter; and

response data indicative of pain level and concordance of a response of the patient to the introduction of fluid, wherein the concordance response data is input separately from the pain level data and indicates whether the pain level of the patient is a result of a pain symptom or is a result of pain unrelated to the pain symptom.

27. The system of claim 26, wherein a receivable portion of the plunger is receivable within the syringe and the syringe comprises a cap secured with respect to the receivable portion of the plunger, the pressure transducer being disposed between at least a portion of the cap and at least a portion of the receivable portion of the plunger.

29. The system of claim 27, wherein the cap and the plunger are not rotatable with respect to one another when the cap is secured with respect to the receivable portion of the plunger.

30. The system of claim 29, wherein the cap and the receivable portion of the plunger each comprise an asymmetrical portion, the asymmetrical portions of the cap and plunger mating with one another to secure the cap with respect to the plunger.

28. The system of 27, wherein the cap comprises a hole configured to allow fluid present within the reservoir to contact the pressure transducer.

31. A fluid introduction system, comprising:

an introducer configured to introduce fluid into a spine of a patient, the introducer comprising a movable element disposed within the introducer, a cap defining a passage and coupled to the movable element, and a pressure transducer secured with respect to the movable element and the cap such that the pressure transducer is in direct contact with fluid in the introducer via the passage;

an operator configured to actuate the introducer to introduce fluid into the spine of the patient;

a computer readable medium having code that, when executed by a computer, receives;

fluid introduction data indicative of a fluid introduction parameter;

response data indicative of pain level of a response of the patient at a time related to a time of the fluid introduction data; and

response data, input separately from the pain level data, indicative of concordance of the response of the patient at the time related to the time of the fluid introduction data, the concordance data indicating whether the pain level response of the patient is a result of a pain symptom or is a result of pain unrelated to the pain symptom.

32. The system of claim 31, wherein the cap and the movable element are not rotatable with respect to one another when the cap is secured to the movable element.

33. The system of claim 32, wherein the cap and the movable element each comprise an asymmetrical portion, the asymmetrical portions of the cap and the movable element mating with one another to secure the cap with respect to the movable element.

34. The system of claim 31, wherein the fluid introduction parameter is a pressure within an intervertebral disc of the patient at the time of the fluid introduction data.

35. The system of claim 31, wherein the fluid introduction system is configured to obtain the response data from an observation of the patient or from a response inputted by the patient.

36. A fluid introduction system, comprising:

an introducer configured to introduce fluid into a spine of a patient, the introducer comprising a syringe including a plunger having a receivable portion slidably disposed within the syringe, the syringe comprising a cap secured with respect to the receivable portion of the plunger and a pressure transducer disposed between at least a portion of the cap and at least a portion of the receivable portion of the plunger such that the pressure transducer is in direct fluid contact with fluid in the syringe;

an operator configured to actuate the introducer to introduce fluid into the spine of the patient; and

a computer readable medium having code that, when executed by a computer, receives;

fluid introduction data indicative of a fluid introduction parameter; and

response data indicative of pain level and concordance of a response of the patient at a time related to the time of the fluid introduction data, the pain and concordance data inputted separately, wherein the concordance response data indicates whether the pain level of the patient is a result of a pain symptom or is a result of pain unrelated to the pain symptom.

37. The system of claim 36, wherein the cap and the plunger are not rotatable with respect to one another when the cap is secured to the receivable portion of the plunger.

38. The system of claim 36, wherein the cap and the receivable portion of the plunger each comprise an asymmetrical portion, the asymmetrical portions of the cap and receivable portion mating with one another to secure the cap with respect to the plunger.

39. A fluid introduction system, comprising:

an introducer configured to introduce fluid into a spine of a patient, the introducer having a flow-rate dependent impedance opposing the introduction of the fluid and comprising a syringe including a plunger slidably disposed within the syringe and a pressure transducer secured with respect to the plunger such that the pressure transducer is in direct contact with fluid in the syringe;

an operator configured to actuate the introducer to introduce fluid into the spine of the patient at a constant flow rate that is not controlled by feedback based on a fluid introduction parameter and configured to determine impedance data indicative of the flow rate-dependent impedance based upon pressure and volume of fluid dispensed during an actuation of the introducer prior to insertion of the introducer into the spine; and

a computer readable medium having code that, when executed by a computer, receives;

fluid introduction data indicative of the fluid introduction parameter; and

response data indicative of pain level and concordance of a response of the patient at a time related to the time of the fluid introduction data, wherein the concordance response data is input separately from the pain level data and indicates whether the pain level of the patient is a result of a pain symptom or is a result of pain unrelated to the pain symptom.