Medical machine for performing surgery and treating using ultrasonic energy

• US 3,990,452 A
• Filed: 06/13/1975
• Issued: 11/09/1976
• Est. Priority Date: 06/13/1975
• Status: Expired due to Term

• Current Assignee: Fibra-Sonics, Inc.
• Original Assignee: Fibra-Sonics, Inc.
• Inventors: Brumbach, Joseph F., Murry, Edward J.
• Primary Examiner(s): Pace, Channing L.
• Application Number:
  US05/586,545
• Time in Patent Office: 515 Days
• Field of Search: 128/24 A, 128/305
• US Class Current: 606/169
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61F 9/00745 using mechanical vibrations, e.g. ultrasonic

Abstract

A machine for performing surgery and treatment utilizing ultrasonic energy wherein so as to obtain precise control of the operating frequency and eliminate unnecessary heating and loss of power the hand tool as well as the generator and power supply are designed after establishing the designed criteria of the particular medical tool required thus allowing coupling of energy into the tool in a very efficient manner. Means are also provided for assuring that dangerous transverse modes of the instrument used will not occur which can cause injury to patients. Several unique additional safety and construction features are also shown.

Claims

1. An ultrasonic medical instrument comprising an ultrasonic oscillator, a handpiece, an ultrasonic motor mounted in said handpiece and electrically connected to said ultrasonic oscillator, a tool and transition horn connected to said ultrasonic motor and the combination having a wave length equal to nλ

/2 where n is an integer and λ

is the wave length of the operating frequency of said motor and wherein a portion of said tool is tapered to mate with said geometry of the transition horn so as to prevent mismatch and is a continuous extension of said horn, and wherein said internal ultrasonic motor consists of a cylindrical rear piece of steel, lead-zirconate-titanate crystals mounted adjacent one end of said rear piece and a front piece of titanium mounted adjacent said crystals and having a portion which is geometrically tapered, and said tool formed with a taper such that its diameter at the connection point to said front piece is the same as the end of said front piece.

2. An ultrasonic medical instrument according to claim 1 wherein said handpiece is directly covered by electrically insulating plastic material, providing insulation but not loading or mismatch.

3. An ultrasonic medical instrument according to claim 1 wherein said tool is formed of stainless steel or titanium.

4. An ultrasonic medical instrument according to claim 1 wherein said tool comprises a hollow needle and suction means connected to said needle.

5. An ultrasonic medical instrument according to claim 4 wherein the end of said needle is tapered at an angle in the range between 30°

to 40°

with the longitudinal axis of said needle.

6. An ultrasonic medical instrument according to claim 4 wherein the end of said needle is tapered at an angle of 371/2 °

with the longitudinal axis of said needle.

7. An ultrasonic medical instrument according to claim 1 wherein said ultrasonic oscillator is electrically connected to said ultrasonic motor by at least two electrical conductors, one of which is a zero ohmage ground.

8. An ultrasonic medical instrument according to claim 7 wherein a second low, but not zero, ohmage ground is electrically connected between said ultrasonic motor and said ultrasonic oscillator as a safety connection and indicator of failure.

9. An ultrasonic medical instrument according to claim 8 wherein said second ground is of appreciable resistance say 8 ohms so as to maintain ground but cut operating power to the tool drastically should any operation be attempted via this means.

10. An ultrasonic medical instrument according to claim 1 wherein said oscillator includes means for changing its frequency over a controlled range so as to match the motor, transition horn and operating tool but prevent odd moding.

11. An ultrasonic medical instrument according to claim 9 wherein means are provided for varying the output power of said oscillator to said motor tool combination.

12. An ultrasonic medical instrument according to claim 1 wherein said oscillator includes a transistor with a base circuit and a feedback resistor connected between said motor and the base circuit of said transistor in a configuration which locks the oscillator at the resonant frequency of said motor tool combination.

13. An ultrasonic instrument according to claim 1 wherein said handpiece is completely encapsulated in molded rubber so as to provide a protective sheath permitting high temperature auto claving of said workpiece and also eliminating all transfer of random energy to the user and which eliminates the need for all cooling water while still providing comfort to the user.

14. An ultrasonic instrument according to claim 1 including in said handpiece an aluminum high voltage center electrode, said front piece providing a favorable high to low mass ratio for increased motion at the working end as an exponential horn of the shape defined by the equation:

##EQU3## and the diameter of the motor being D₁ and the end diameter of the actual tooltip being D₂ thus making the tooltip mathematically and physically part of the motor/horn combination.

15. An ultrasonic instrument according to claim 14 wherein said tool forms and comprises an innate part of an exponential horn, a selectable variety of needles, rods, cannulae, knives and assorted other types of surgical tips, thereby making these devices part of the tip and of the ultrasonic electro-mechanical system, said surgical tips threadedly connected close to an antinode low level vibrating point of the horn itself eliminating any tendency to vibratory loosening and thereby loss of full transfer of the energy available to said tool.

16. An ultrasonic instrument according to claim 15 wherein said tools comprise either a needle, rod or knife on one end and a partially incomplete ultrasonic horn design on the other end and threadedly fastened to the remaining partially tapered ultrasonic horn distending as part of the motor/horn combination so as to be securely fastened causing bearing contact of a high standard ground surface caliber mating over its annular area of at least 90%.

17. An ultrasonic medical instrument comprising an ultrasonic oscillator, a handpiece, an ultrasonic motor mounted in said handpiece and electrically connected to said ultrasonic oscillator, a tool and transition horn connected to said ultrasonic motor and the combination having a wave length equal to nλ

/2 where n is an integer and λ

is the wave length of the operating frequency of said motor and wherein a portion of said tool is tapered to mate with said geometry of the transition horn so as to prevent mismatch and is an extension of said horn, wherein said internal ultrasonic motor consists of a cylindrical rear piece of steel, lead-zirconate-titanate crystals mounted adjacent one end of said rear piece and a front piece of titanium mounted adjacent said crystals and having a portion which is geometrically tapered, and said tool formed with a taper such that its diameter at the connection point to said front piece is the same as the end of said front piece, and wherein the connection point between said tool and said transition piece is essentially a nodal point.

18. An ultrasonic instrument according to claim 17 wherein an exponential transformer is physically part of the front of the motor which is divided at a point midway along the horn taper at approximately a nodal point about λ

/4 wave length with the half toward the motor being metal and not broken at a maximum vibrating point while the other part of a transformer section is the tool plus another piece of said transformer.

19. An ultrasonic instrument according to claim 17 including a pre-biasing stressing center bolt of titanium having a central bore hole and having an upper limit on the diameter of the central bore hole and concomittantly the size of the hollow needle to be used with a given size handpiece said bolt connecting portions of said motor.

20. An ultrasonic instrument according to claim 17 wherein said tool vibrates only in the longitudinal mode thus providing superior penetration by the inertial interacting of its metal tip and compliant tissue materials and which additionally provides intense highly effective microstreaming forces for complete dissolution of the fragmented particles broken up by said penetration.

21. An ultrasonic instrument according to claim 20 wherein said tool is subjected to extremely high accelerating forces entailed by its unique construction so as to achieve a force of 72,000 G'"'"'s at its extreme tip, thus penetrating tissue, cartilage or bone with ease while maintaining its own integrity and having long life.

22. An ultrasonic instrument according to claim 21 wherein said tool produces a powerful entrapment geometry creating circulating forces for complete dissolution of the fragmented particles entailed by use of a 371/2 °

ground angle on the needles and rods.

23. An ultrasonic instrument according to claim 22 wherein said handpiece includes an embedded externally and internally threaded Teflon tubing connected to another Teflon fitting by a removable Silicone or medical grade plastic or rubber tubing screw.

24. An ultrasonic instrument according to claim 17 wherein said handpiece contains a readily disassembled aspiration tubing system made of high temperature materials such as Teflon and silicone rubber that can be quickly taken down, cleaned, sterilized and/or replaced without creating leaks in a low vacuum system usually used with such equipment.

25. An ultrasonic instrument according to claim 17 wherein said workpiece includes two distinct grounding systems one of conventional low ohmic resistance and the other utilizing a second, outer, stranded metallic shield of a slightly higher ohmic resistivity;

specifically of 8 ohms.

26. An ultrasonic instrument according to claim 17 including an ultrasonic energy generator containing a lock-on oscillator connected to said motor, a mechanical preventive oscillator excursion control for tuning through a safe operating range, a push-button power control which does not change tuning as its power levels are changed, and a readily discernible neon-eye tuning indicator mounted on said oscillator.

27. An ultrasonic instrument according to claim 26 including a true reading ultrasonic wattmeter capable of accurately reading the ultrasonic power input into the workpiece itself connected to said instrument.

28. An ultrasonic instrument according to claim 26 including a sound indicator buzzer with level adjust control which operates when an operating footswitch is activated giving the operator an indication of the presence of ultrasonic energy.

29. An ultrasonic instrument according to claim 26 including a mechanically mounted inductor whose mechanical travel is limited by stops at either end to proscribe the range over which said oscillator is permitted to operate preventing frequencies of a dangerous nature to be produced.

30. An ultrasonic instrument according to claim 26 including a tuning indicator utilizing a neon light connected to said oscillator and a voltage across said light would be set to provide gas striking voltage at all conditions but is permitted to discernibly decrease without quenching when the output circuit resonates with the handpiece, said indicator being an exact and satisfactory indication of workpiece operation regardless of the tip used.

31. An ultrasonic instrument according to claim 26 wherein said oscillator in addition to the proscribed mechanical tuning arrangement contains a normal feedback means for sustaining oscillation and not requiring a unique sensor on the motor unit, said oscillator consisting of transistors operating in a class A continuously conducting condition and Zener diodes being used to limit the oscillator voltage amplitude resulting in more stable operation, as voltage levels and frequencies are relatively independent of power supply variation thus making the oscillator work correctly regardless of the setting of the push-button switch wherein normally it would not be possible.

32. An ultrasonic instrument according to claim 31 wherein a combination of resistors and capacitors are connected to the controlled oscillator which have little effect upon an earlier preset frequency and phase synchronization independently of the amplitude limiting action resulting in the correct operation of each circuit independently yet conjointly producing few intermodulation products thereby creating "lock-in" of unwanted dangerous odd-mode frequencies.

33. An ultrasonic instrument according to claim 26 wherein said ultrasonic generator which includes a relatively high or "R-Lock" resistor of relatively high resistance for receiving the feedback voltage variation caused by the frequency shift signaling from the workpiece transformer back to the oscillator circuit thereby reflecting the impedance changes of the handpiece into the oscillator.

34. An ultrasonic instrument according to claim 26 including an elapsed time indicator connector circuit for reading the cumulated intermittantly applied ultrasonic power utilized by operation during any single operation.