Method and Apparatus to Decrease the risk of intraneuronal injection during administration of nerve block anesthesia

• US 7,727,224 B2
• Filed: 10/13/2008
• Issued: 06/01/2010
• Est. Priority Date: 05/28/2002
• Status: Expired due to Term

• Current Assignee: B Braun Melsungen AG (B. Braun Holding GmbH & Co. KG)
• Original Assignee: Macosta Medical U.S.A., L.L.C.
• Inventors: Hadzic, Admir, Giglioli, Sergio, Vloka, Jerry D.
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): Mehta; Bhisma
• Application Number:
  US12/250,211
• Publication Number:
  US 20090043281A1
• Time in Patent Office: 596 Days
• Field of Search: 604/500, 604/505, 604/506, 604/512
• US Class Current: 604/512
• CPC Class Codes: A61M 2202/048 Anaesthetics
• CPC Class Codes: A61M 2205/3355 Controlling downstream pump pressure
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/178 Syringes
• CPC Class Codes: A61M 5/486 Indicating injection pressure
• CPC Class Codes: A61M 5/488 Limiting injection pressure

Abstract

An objective and reproducible system for, and method of, monitoring and/or controlling the pressure during nerve blockage injection, especially by less experienced personnel, is provided in order to decrease the possibility of intraneuronal injection. More specifically, the present invention employs a pressure sensing and/or limiting device located between an injection device (typically a syringe) and a nerve block needle whereby injection pressure during a nerve block injection can be easily and objectively monitored, thereby allowing the operator to monitor the injection pressure and/or injection speed during a nerve blockage injection procedure and to take appropriate corrective actions if abnormal pressure conditions are observed.

Claims

1. A method of administering a nerve block to a patient with reduced risk of intraneuronal injection, said method comprising

(a) providing a system for administration of the nerve block in the patient with reduced risk of intraneuronal injection, said system comprising

(1) an anesthetic delivery device having an anesthetic storage compartment and an output end;

(2) a nerve block needle having an input end and an output end wherein the output end can be inserted into the patient for delivery of anesthetic to the patent in the vicinity of a nerve to be blocked;

(3) a tube having an anesthetic passageway connecting the output end of the anesthetic delivery device and the input end of the nerve block needle, whereby anesthetic from the anesthetic storage compartment can be delivered via the output end of the nerve block needle to the patient; and

(4) a first pressure sensing device located along, and in pressure sensing communication with, the anesthetic passageway, whereby the pressure of the anesthetic can be continuously monitored and controlled during anesthetic delivery to the patient so as to reduce the risk of intraneuronal injection, wherein the first pressure sensing device is capable of measuring pressures of at least 25 psi;

(b) inserting the output end of the nerve block needle into the vicinity of the nerve to be blocked;

(c) starting delivery of the anesthetic;

(d) monitoring the pressure of the anesthetic during delivery of the anesthetic;

(e) continuing delivery of the anesthetic so long as the pressure remains within a normal range based on the nerve to be blocked;

(f) if the pressure increases to an abnormal range based on the nerve to be blocked, interrupting delivery of the anesthetic so that appropriate corrective action can be taken;

(g) if the delivery of the anesthetic is interrupted in step (f), taking the appropriate corrective action and then continuing delivery of the anesthetic; and

(h) repeating steps (d) through (g) until delivery of the anesthetic is complete or delivery of anesthetic is terminated,

wherein the appropriate corrective action comprises repositioning the output end of the nerve block needle such that the output end remains within the vicinity of the nerve to be blocked but does not penetrate the nerve to be blocked.

2. The method of claim 1, wherein the anesthetic delivery device is a syringe.

3. The method of claim 2, wherein the tube is flexible tubing.

4. The method of claim 2, wherein the first pressure sensing device allows visual detection of at least the normal range and the abnormal range of pressures during anesthetic delivery to the patient, and wherein the normal range is less than about 15 psi and the abnormal range is about 25 psi and higher.

5. The method of claim 2, wherein an operator and an assistant administer the nerve block to the patient such that the assistant monitors the pressure and reports pressures in the abnormal range so that the operator can take appropriate corrective action.

6. The method of claim 2, wherein an operator and an assistant administer the nerve block to the patient, wherein the system has, in addition to the first pressure sensing device, a second pressure sensing device located along, and in pressure sensing communication with, the anesthetic passageway, whereby the pressure of the anesthetic can be continuously monitored and controlled during anesthetic delivery to the patient so as to reduce the risk of intraneuronal injection, wherein the first pressure sensing device can be observed by the assistant during the administration of the nerve block, and wherein the second pressure sensing device can be observed by the operator during the administration of the nerve block.

7. The method of claim 2, wherein the first pressure sensing device is further equipped with an automatic shut-off device whereby anesthetic delivery is prevented when the pressure of the anesthetic during anesthetic delivery increases above a predetermined level.

8. The method of claim 1, wherein the tube is flexible tubing.

9. The method of claim 1, wherein the first pressure sensing device allows visual detection of at least the normal range and the abnormal range of pressures during anesthetic delivery to the patient, and wherein the normal range is less than about 15 psi and the abnormal range is about 25 psi and higher.

10. The method of claim 1, wherein an operator and an assistant administer the nerve block to the patient such that the assistant monitors the pressure and reports pressures in the abnormal range so that the operator can take appropriate corrective action.

11. The method of claim 1, wherein an operator and an assistant administer the nerve block to the patient, wherein the system has, in addition to the first pressure sensing device, a second pressure sensing device located along, and in pressure sensing communication with, the anesthetic passageway, whereby the pressure of the anesthetic can be continuously monitored and controlled during anesthetic delivery to the patient so as to reduce the risk of intraneuronal injection, wherein the first pressure sensing device can be observed by the assistant during the administration of the nerve block, and wherein the second pressure sensing device can be observed by the operator during the administration of the nerve block.

12. The method of claim 1, wherein the first pressure sensing device is further equipped with an automatic shut-off device whereby anesthetic delivery is prevented when the pressure of the anesthetic during anesthetic delivery increases above a predetermined level.

13. A method of administering a nerve block to a patient with reduced risk of intraneuronal injection, said method comprising

(a) providing a system for administration of the nerve block in the patient with reduced risk of intraneuronal injection, said system comprising

(1) an anesthetic delivery device having an anesthetic storage compartment and an output end;

(2) a nerve block needle having an input end and an output end wherein the output end can be inserted into the patient for delivery of anesthetic to the patent in the vicinity of a nerve to be blocked;

(3) a tube having an anesthetic passageway connecting the output end of the anesthetic delivery device and the input end of the nerve block needle, whereby anesthetic from the anesthetic storage compartment can be delivered via the output end of the nerve block needle to the patient; and

(4) a first pressure sensing device located along, and in pressure sensing communication with, the anesthetic passageway, whereby the pressure of the anesthetic can be continuously monitored and controlled during anesthetic delivery to the patient so as to reduce the risk of intraneuronal injection, wherein the first pressure sensing device is capable of measuring pressures of at least 25 psi;

(b) inserting the output end of the nerve block needle into the vicinity of the nerve to be blocked;

(c) starting delivery of the anesthetic;

(d) monitoring the pressure of the anesthetic during delivery of the anesthetic;

(e) continuing delivery of the anesthetic so long as the pressure remains within a normal range based on the nerve to be blocked;

(f) if the pressure increases to an intermediate range based on the nerve to be blocked, continuing delivery of the anesthetic while carefully monitoring any further increases in the pressure;

(g) if the pressure increases to an abnormal range based on the nerve to be blocked, interrupting delivery of the anesthetic so that appropriate corrective action can be taken;

(h) if the delivery of the anesthetic is interrupted in step (g), taking the appropriate corrective action and then continuing delivery of the anesthetic; and

(I) repeating steps (d) through (h) until delivery of the anesthetic is complete or delivery of anesthetic is terminated,

wherein the appropriate corrective action comprises repositioning the output end of the nerve block needle such that the output end remains within the vicinity of the nerve to be blocked but does not penetrate the nerve to be blocked.

14. The method of claim 13, wherein the normal range is less than about 15 psi, the abnormal range is greater than about 25 psi, and the intermediate range is a pressure value between the normal and abnormal ranges.