Bone and tissue healing device including a special electrode assembly and method

• US 4,461,300 A
• Filed: 01/18/1982
• Issued: 07/24/1984
• Est. Priority Date: 01/18/1982
• Status: Expired due to Fees

• Current Assignee: Sutter Bio-Medical Incorporated
• Original Assignee: Sutter Bio-Medical Incorporated
• Inventors: Christensen, James M.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US06/340,521
• Time in Patent Office: 918 Days
• Field of Search: 128/419 F, 128/82.1, 128/784-786
• US Class Current: 607/50
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/205 for promoting a biological process

Abstract

A portable device used for expediting the healing of bone or soft tissue fractures or defects in a patient is disclosed herein and utilizes at least one cathode electrode, an anode electrode and a circuit arrangement for applying a regulated flow of current between the electrodes and through the fracture or defect site. A specifically designed electrode assembly including the cathode electrode is also disclosed herein along with a particular technique for placing the cathode electrode in position at the fracture or defect site.

Claims

1. A cathode electrode assembly including a cathode electrode for use in a device which expedites the healing of bone or soft tissue fractures or defects in a patient and which includes said electrode assembly and an anode electrode as well as means including an electrical power supply to produce a regulated flow of current between the anode and cathode electrodes for application through the fracture or defect site, said cathode electrode assembly comprising:

said cathode electrode including a rigid, electrically conductive shaft which has a threaded outer surface section and a pointed front end so as to be readily drilled into said fracture or defect site starting at its front end by using a compatible drilling device such that the entire shaft is disposed within said patient, said shaft also including a back end segment having a back end and a well opening therein from said back end; and

a flexible electrical lead wire mechanically and electrically fixedly connected at one end to the back end of said shaft within said well before the latter is drilled into the patient, said lead wire being adapted for electrical connection at its opposite end to said means including said power supply.

2. An assembly according to claim 1 wherein said one end of said wire connects to said shaft within said well by means of welding.

3. An assembly according to claim 1 wherein the back end segment of said shaft includes said threaded outer surface section, said assembly including an opened, tubular drive member having an internally threaded front end section thread connected with the thread section of said shaft and a back end section configured to fit within a drill chuck, said drive member in cooperation with a drilling device including said chuck serving to drill said cathode electrode into said fracture or defect site.

4. An assembly according to claim 3 wherein said drive member includes a sufficiently large through opening along its length through which said lead wire extends whereby said lead wire can be threaded through said drive member.

5. A cathode electrode assembly including a cathode electrode for use in a device which expedites the healing of bone or soft tissue fractures or defects in a patient and which includes said electrode assembly and an anode electrode as well as means including an electrical power supply to produce a regulated flow of current between the anode and cathode electrodes for application through the fracture or defect site, said cathode electrode assembly comprising:

said cathode electrode including a rigid, electrically conductive shaft which has a pointed front end adapted to be readily drilled into said fracture or defect site starting at its front end by using a compatible drilling device such that the entire shaft is disposed within said patient, said shaft also including a back end;

a flexible electrical lead wire mechanically and electrically fixedly connected at one end to the back end of said shaft before the latter is drilled into the patient, said lead wire being adapted for electrical connection at its opposite end to said means including said power supply; and

means for connecting the back end of said shaft with said lead wire connected thereto to said drilling device for operation thereby.

6. An assembly according to claim 5 wherein said connecting means includes a tubular drive member having an opening through which said lead wire extends.

7. A method of expediting the healing of bone or soft tissue fractures or defects in a patient, said method comprising the steps of:

providing a completely portable device including an elongated, rigid first electrode and a second electrode, means for producing a regulated flow of current, and a flexible electrical lead wire smaller in cross-section than the maximum cross-section of said first electrode, said wire being electrically and mechanically connected to said first electrode;

placing said first electrode entirely within said patient at the fracture or defect site with the lead wire connected thereto, through the patient'"'"'s skin, such that said lead wire extends from said first electrode to an external point through the patient'"'"'s skin;

electrically connecting said current producing means with said first electrode utilizing connecting means including said flexible electrical lead wire extending from the first electrode within the patient to said external point through the patient'"'"'s skin, said flexible wire being capable of accommodating differential movement between the patient'"'"'s skin and tissue surrounding the flexible wire as the patient moves whereby to minimize damage to the surrounding skin and tissue as a result of such movement;

placing said second electrode in physical electrical contact with said patient at a point in close proximity to said fracture or defect site; and

electrically connecting said current producing means with said second electrode.

8. A method for using a device which expedites the healing of bone or soft tissue fractures or defects in a patient and which includes an anode electrode, a cathode electrode and means including an electrical power supply for applying a regulated flow of current between the electrodes and through the fracture defect site, said method serving to place said cathode electrode in position at said fracture or defect site and comprising the steps of:

providing said cathode electrode in the form of a rigid, electrically conductive shaft having a front end and a threaded back end section;

electrically and mechanically connecting one end of a flexible electrical lead wire to the back end of said shaft;

providing an open ended tubular drive member having an inner diameter along its entire length which is greater than the outer diameter of said lead wire, said drive member having a front section which is threaded so as to thread connect it to the threaded section of said shaft;

inserting the free end of said flexible lead wire through said drive member from the front end of the latter;

thread connecting the front end of said tubular drive member with the threaded section of said shaft;

thereafter placing a back end section of said drive member in the chuck of a compatible drilling device; and

utilizing said drilling device, drilling said electrode into position in said fracture or defect site.

9. A method according to claim 8 wherein said electrode is drilled into said fracture or defect site entirely within the patient while said drive member extends partially within and partially outside said patient, said method including the steps of disconnecting said drive member from said drilling device and also said cathode electrode, removing the drive member from said patient and separating it from the lead wire by passing it over and beyond the free end of the latter.

10. A method for using a device which expedites the healing of bone or soft tissue fractures or defects in a patient and which includes an anode electrode, a cathode electrode and means including an electrical power supply for applying a regulated flow of current between the electrodes and through the fracture defect site, said method serving to place said cathode electrode in position at said fracture or defect site and comprising the steps of:

providing said cathode electrode in the form of a rigid, electrically conductive shaft having a front end and a back end section;

electrically and mechanically connecting one end of a flexible electrical lead wire to the back end of said shaft;

providing an open ended tubular drive member having an inner diameter along its entire length which is greater than the outer diameter of said lead wire, said drive member having a front section adapted to be disengagably connected with the back end section of said shaft;

inserting the free end of said flexible lead wire through said drive member from the front end of the latter;

connecting the front end of said tubular drive member with the back end section of said shaft;

thereafter placing a back end section of said drive member in the chuck of a compatible drilling device; and

utilizing said drilling device, drilling said electrode into position in said fracture or defect site.

11. A method according to claim 10 wherein said electrode is drilled into said fracture or defect site entirely within the patient while said drive member extends partially within and partially outside said patient, said method including the steps of disconnecting said drive member from said drilling device and also said cathode electrode, removing the drive member from said patient and separating it from the lead wire by passing it over and beyond the free end of the latter.