System for attenuating pain during bone marrow aspiration and method

• US 6,159,163 A
• Filed: 05/07/1998
• Issued: 12/12/2000
• Est. Priority Date: 05/07/1998
• Status: Expired due to Fees

• Current Assignee: Cedars-Sinai Medical Center (Cedars Sinai Health System)
• Original Assignee: Cedars-Sinai Medical Center (Cedars Sinai Health System)
• Inventors: Strauss, Jonathan S., Felten, Christopher L.
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US09/074,258
• Time in Patent Office: 950 Days
• Field of Search: 607/99, 607/116, 604/167, 604/170, 600/566, 600/564, 600/565
• US Class Current: 600/566
• CPC Class Codes: A61B 10/025 for taking bone, bone marrow or cartilage samples
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/326 for promoting growth of cells, e.g. bone cells

Abstract

A biopsy sampling system and method for aspirating bone marrow and bone cores from a patient with minimal or no perceived pain to the patient. The system includes a bone aspiration needle assembly having a handle and an electrically conductive needle shaft and an electrical nerve stimulator (ENS) which supplies a current of adjustable intensity to the needle shaft. Thus, when the aspirating needle is inserted into the bone marrow cavity of the patient, the stimulator is activated to anesthetize the nerves in the vicinity of the aspiration permitting the extraction to commence with little or no increased pain to the patient. A nonconducting insulating shaft is also disclosed to be placed on the needle shaft in order direct the ENS current to the area of the shaft that can most efficiently anesthetize the pain conducting nerves, i.e. to the tip of the needle shaft.

Claims

1. A biopsy sampling system for attenuating the pain associated with the extraction of a sample of at least one of bone marrow and bone core from a patient through the patient'"'"'s skin, soft tissue and bone, the system comprising:

an electrically conductive biopsy needle configured to extract the sample; and

an electrical nerve stimulator associated with the needle and configured to penetrate bone and to supply electrical stimulation to the patient along the needle so as to attenuate the pain during the extraction.

2. The system of claim 1, wherein the needle further includes:

a handle having a plug receptacle that receives the first electrode of the electrical nerve stimulator, and

a needle shaft comprising an electrically conductive cannula having one end connected to the handle and associated with the plug receptacle and an opposite, free end defining a needle tip adapted to bore the bone of the patient, the electrical nerve stimulator being configured to supply electrical stimulation to the patient along the cannula.

3. The system of claim 2, wherein the free end of the second electrode terminates in an electrode patch that releasably secures the positive electrode to the patient'"'"'s skin.

4. The system of claim 2, further including an electrically insulating sheath enveloping the needle shaft and extending from the first end for a distance less than the length of the needle.

5. The system of claim 4, wherein the sheath frictionally engages the needle and terminates at least three centimeters from the free end of the needle shaft.

6. The system of claim 4, wherein the sheath is slidable along the entire length of the needle shaft to permit the sheath to slide into the patient after the needle shaft is fully inserted into the patient.

7. The system of claim 6, wherein the sheath is approximately one third of the length of the needle shaft.

8. The system of claim 2, wherein the energy delivery source is adapted to supply a current having an adjustable voltage, pulse rate and pulse width.

9. The system of claim 2, wherein the energy delivery source is portable and battery operated.

10. The system of claim 1, wherein the energy delivery source further includes an ammeter that provides a display of the amperage flowing through the patient.

11. A method for reducing the pain associated with the extraction of a sample of at least one of a bone marrow specimen and bone core specimen from a patient, wherein the system includes an electrically conductive biopsy needle that extracts the sample and an electrical nerve stimulator associated with the needle, the stimulator being further configured to supply electrical stimulation to the patient along the needle so as to attenuate the pain during the extraction, the method including:

penetrating the biopsy needle into the bone within the patient;

activating the electrical nerve stimulator so as to supply stimulation to the patient along the needle for a predetermined amount of time;

extracting the sample from the patient into the biopsy needle assembly; and

deactivating the electrical nerve stimulator.

12. The method of claim 11, wherein the activating of the electrical nerve stimulator further includes:

increasing the frequency of the supply of the electrical nerve stimulator to a predetermined magnitude; and

maintaining the supply to the patient for a predetermined amount of time.

13. The method of claim 12, wherein the predetermined amount of time for maintaining the supply of current is at least three minutes.

14. The method of claim 11, wherein the extracting of the sample from the patient into the biopsy needle assembly further includes:

activating the electrical nerve stimulator at an initial output level;

obtaining a first report from the patient relating to the patient'"'"'s discomfort level coincident with the initial output level;

decreasing the output level of the electrical nerve stimulator if the patient reports discomfort in the first report and returning to the obtaining of a first report;

obtaining a second report from the patient relating to the level of anesthesia perceived by the patient;

increasing the output level of the electrical nerve stimulator if the patient reports no perceived anesthesia and returning to the obtaining of a first report; and

maintaining the electrical nerve stimulator output level for a preset period of time.

15. The method of claim 14, wherein the preset period of time is at least two minutes.

16. The method of claim 11, wherein the extracting of the sample from the patient into the biopsy needle assembly further includes the focusing of the electrical current to a portion of the needle assembly that communicates with the area of the bone to be aspirated.

17. A biopsy sampling system for attenuating the pain associated with the extraction of a sample of at least one of bone marrow and bone core from a patient through the patient'"'"'s skin, soft tissue and bone, the system comprising:

an electrically conductive biopsy needle configured to extract the sample; and

an electrical nerve stimulator associated with the needle and configured to supply electrical stimulation to the patient along the needle so as to attenuate the pain during the extraction;

wherein the electrical nerve stimulator includes an adjustable energy delivery source, a first electrode associated with the needle and a second electrode having a free end that removably engages the skin of the patient.