MXPA98001152A - Ultrasonic surgical apparatus with d mode - Google Patents

Abstract

A simple ultrasonic surgical apparatus can provide a substantial cutting effect on the tissue, a substantial coagulation effect on the tissue and a suitable combination of the cutting and coagulation effects ismultural on the tissue, the ultrasonic surgical apparatus is formed by a handle incorporating a transducer and a surgical tool, a source of electrical energy, a controller and a switch, the apparatus can be operated at two frequencies within the ultrasonic spectrum, selecting the first frequency at the lower end of the spectrum to enhance the cutting behavior of the tissue and the second frequency being approximately three times higher to enhance the coagulation behavior of the tissue, the two frequencies can operate in a selective or concurrent manner and can be adjusted independently according to the amplitude. The transducer can be formed by magnetostrictive or piezoelectric elements, the surgeon selects the desired amplitude of the mechanical vibrations, the transducer is installed inside the handle in a position corresponding to a vibration node common to the first frequency and the second frequency; claims a method of use, which includes the steps of: developing an ultrasonic resonance at a first frequency, developing an ultrasonic resonance at a second frequency that is approximately three times higher than the first frequency, tuning an ultrasonic transducer to the first frequency of form concurrent with the second frequency, and accommodate the transducer where the vibration nodes at the first frequency are practically coincident with the vibration nodes at the second frequency

Description

ULTRASONIC SURGICAL APPARATUS WITH DUAL MODE FIELD OF THE INVENTION This invention relates to an improved ultrasonic surgical apparatus for cutting and coagulating tissue of a patient and, more particularly, to an ultrasonic surgical apparatus having the ability to selectively and / or concurrently deliver ultrasonic energy at two different frequencies.

BACKGROUND OF THE INVENTION The usual non-electric utensils for the dissection of tissues such as the scalpel and similar instruments tend to cause hemorrhage in the cut area. There is nothing inherent in the tool that gets the ostasis.

Electrocautery, or more generally, utensils based on radiofrequency electromagnetic energy, can achieve hemostasis through the deposition of electrical currents in the tissue that effectively cauterize the bleeding tissue through resistive heating. The disadvantage of electrocautery tools is that they are not precision dissection tools, since the energy deposition is not precisely controlled and the tips of the instrument can adhere to the tissue.

The use of ultrasonic energy in surgical procedures is known to those skilled in the art to be a valuable resource for cutting and fragmenting a patient's tissue. Most of these devices incorporate a sinusoidal extion signal that causes the mechanical end to vibrate at a selected frequency, usually in the range of 20 kHz to 60 kHz. The sinusoidal extion signal can be obtained from a square wave at the same frequency or this can be inherent in the design. In addition, some devices use waveforms modulated with a work cycle to achieve the desired effect. It is also known to those skilled in the art that at the lower end of the preferred frequency spectrum, i.e. from 20 kHz to 40 kHz, greater displacements of the ends are possible. It is also known that the displacements of the upper end provide a tissue cutting effect better than the lower end displacements. Ultrasonic energy at the upper end of the preferred frequency spectrum, ie from 40 kHz to 60 kHz, may have a greater hemostatic effect. This is due to the higher absorbance of higher frequency energy by the tissue. However, the displacements of the upper end are not feasible at these frequencies. Therefore, devices operating in this field have a reduced tissue cutting performance.

Several ultrasonic surgical devices have been described that attempt to provide both the cutting and the coagulation functions. U.S. Patent 5,026,387 assigned to Ultracision, Inc., has several modes of operation. Power is transmitted at an ultrasonic frequency to the instrument at a relatively high level when a surgical function is being performed and the load on the instrument is relatively high. Power is transmitted to the instrument at a relatively low level during periods of idle use. You can manually select a high power coagulation mode with automatic return to power level when the blade is not in contact with the fabric. The operation at different frequencies is not claimed. In U.S. Patent 5,263,957 assigned to Ultracision, Inc., the shape of an ultrasonic blade is provided to provide cutting operation and coagulation operation. A part of the blade is arranged to cut the tissue. A second part of the blade is arranged to provide frictional engagement of the edge of the blade and the tissue to achieve tissue removal providing heat generation and a hemostatic effect. The Foreign Patent WO 9,314,709 discloses an ultrasonic blade with a hook molded into the blade having smooth, non-pointed, relatively blunt edges. This facilitates tissue cutting and coagulation after applying ultrasound energy to the tissue.

BRIEF DESCRIPTION OF THE INVENTION The general object of this invention is to provide a unique ultrasonic surgical apparatus that can provide a substantial cutting effect on the tissue, a substantial coagulation effect on the tissue and a suitable mixing of the cutting and coagulation effects simultaneously in the tissue. This is carried out by operating the apparatus at two frequencies within the ultrasound spectrum, in which the first frequency is selected at the lower end of the spectrum to enhance the cutting behavior and the second frequency is approximately three times greater to enhance the coagulation behavior of the tissue. It can operate at both frequencies selectively or concurrently, and can be independently adjustable in amplitude. The 1: 3 ratio between the first frequency and the second frequency is an important design consideration that until now had not been appreciated in the design of ultrasonic surgical devices. The ratio allows the nodes of the first and second frequency of the vibrations to be aligned along the transducer, thereby providing suitable coupling points between the transducer and a shell or handle.

In general, the ultrasonic surgical device is composed of a handle, a transducer, a surgical tool, a power source, a controller and a switch. The handle has a proximal end for attachment and control by the surgeon and a distal end for placement near the patient's tissue. The transducer may be composed of magnetostrictive or piezoelectric elements. The transducer is housed within the handle and is capable of producing ultrasonic mechanical vibrations selectively or concurrently at a first frequency and at a second frequency, the second frequency being approximately three times greater than the first frequency. Although it is understood that the transducer that is operating at a fundamental frequency will also have energy in the higher harmonics, what is described here is the ability to excite the transducer at two frequencies. The surgical instrument is supported on the transducer and extends at least partially beyond the distal end of the handle. The surgical instrument is intended to have a substantial coagulation effect on the tissue when the transducer is producing ultrasonic mechanical vibrations at the second (highest) frequency. When operated concurrently with the first frequency and second freeuence, a combined cutting and coagulation effect will occur on the patient's tissue. The source of electrical power is connected to the transducer. The controller is connected to the power source and is also connected to the transducer to control the stable form the frequency and amplitude of the ultrasonic mechanical vibrations. To accomplish this, the controller measures the frequency and amplitude and subsequently adjusts the source of electrical energy in a manner that maintains the desired frequency and amplitude of the transducer. A switch is connected to the controller to select the ultrasonic mechanical vibrations at the first frequency or the ultrasonic mechanical vibrations at the second frequency or the mechanical vibrations concurrently at the first frequency and at the second frequency. In one embodiment, the controller can be adjusted by the surgeon. This makes it possible for the surgeon to adjust the desired amplitude of the mechanical vibrations. To do this, an adapter is connected to the controller. The adapter will be able to independently adjust the amplitude of the ultrasonic mechanical vibrations while operating at the first frequency or the second frequency. Another advantage of having two frequencies in the ratio of 1: 3 is that at least there will be a zero position along the transducer in which the nodes of displacement of the vibration for both frequencies will be practically aligned. There will be little relative movement in the zero position between the transducer and the handle shell. Thus, it will be possible to couple the transducer in the housing of the handle with support in the zero position. Also claimed is a method for using an ultrasonic surgical apparatus that includes the steps of: developing an ultrasonic resonance at a first frequency; develop an ultrasonic resonance at a second frequency that is approximately three times greater than the first frequency; and tuning an ultrasonic transducer on the first frequency concurrently with the second frequency. There may also be additional steps of adjusting the amplitude of the first frequency and adjusting the amplitude of the second frequency. Also claimed is a method for manufacturing an ultrasonic surgical apparatus in which the transducer is installed within the sleeve casing and the mounting positions are selected at the positions along the transducer corresponding to the vibration displacement nodes common to the transducer. first frequency and the second frequency.

BRIEF DESCRIPTION OF THE FIGURES Figure 1 is a schematic block diagram of a Dual Mode Ultrasonic Surgical Apparatus. Figure 2 is a schematic block diagram of an embodiment of a handle for a Dual Mode, Ultrasonic Surgical Apparatus. Figure 3 is a schematic block diagram of an alternate embodiment of a handle for a Rastral Ultimate Rhythmic Mode with Dual Mode. Figure 4 is a non -malized graph that represents the relationship between the first frequency and the second frequency.

DETAILED DESCRIPTION OF THE INVENTION In Figure 1 is shown an Ultrasonic Surgical Apparatus with Dual Mode 10. In general, the ultrasonic surgical apparatus is formed by a handle 11, a transducer 14, a surgical instrument 16, a power source 17, a coiler 18 and a switch 19. The apparatus 10 has a handle 11 with a proximal end 12 and a distal end 13. The handle 11 has an ultrasonic transducer 14 supported within a turn 15. A surgical instrument 16 is supported on the ultrasonic transducer 14. The handle 11 has a proximal end 12 that is to be held and is controlled by the surgeon and a distal end 13 to place near the patient's tissue. The transducer 14 may be formed by magnetostrictive elements 20 as shown in Figure 2. Alternatively, the transducer 14 may be formed by piezoelectric elements 21 as shown in Figure 3.

The transducer 14 can produce ultrasonic mechanical vibrations selectively or concurrently to a first frequency 22 and a second frequency 23 as shown in Figure 4. The frequencies 22 and 23 are shown in a normalized manner in Figure 4 because the Important design variable is the ratio between the two frequencies, 22 and 23. The second frequency 23 has a frequency about three times greater than the first frequency. The positions of the vibration nodes corresponding to both the first frequency 22 and the second frequency 23 are shown as positions 24 and 25 in Figure 4. The surgical instrument 16 is supported on the transducer 14 and extends at least partially beyond of the distal end of the handle 13. The surgical instrument 16 is intended to have a cutting effect on the tissue when the transducer 14 is producing ultrasonic mechanical vibrations at the first frequency 22 and the surgical instrument 16 is intended to have a substantial coagulating effect on the the tissue when the transducer 14 is producing ultrasonic mechanical vibrations at the second frequency 23. The electric power source 17 is connected to the transducer 14. The design of the electric power source 17 can be realized in many ways that are old and already known in the technique. The controller 18 is connected to the power source 17 and is also connected to the transducer 14 to control the stability of the frequency and amplitude of the ultrasonic mechanical vibrations. To accomplish this, the controller 18 measures the frequency and amplitude and then adjusts the power source 17 so as to maintain the desired frequency and amplitude of the transducer 14. The specific design of the controller 18 can be performed in many ways that they are ancient and well known in the art. A switch 19 is connected to the controller for selecting the ultrasonic mechanical vibrations at the first frequency 22, or the ultrasonic mechanical vibrations at the second frequency 23, or the ultrasonic mechanical vibrations concurrently to the first frequency 22 and the second frequency 23. In one embodiment , the controller 18 can be adjusted by the surgeon. This makes it possible for the surgeon to adjust the desired amplitude of the mechanical vibrations. To do this, an adapter 26 is connected to the controller 18. The adapter 26 will be able to independently adjust the amplitude of the ultrasonic mechanical vibrations while operating at the first frequency 22 or at the second frequency 23. Another advantage of having two frequency in the 1: 3 ratio is that there will be a position along the transducer 14 in which the vibration nodes of both frequencies 22 and 23 will be aligned. Thus, there will be no relative movement of the transducer 14 in this position and it will be possible to couple the transducer 14 to the shell 15. As such, at least one support 27 can be connected between the shell 15 and the transducer 14 and the support 27 can be placed at along the transducer 14 in the position corresponding to a vibration mode common to both frequencies, first frequency and second frequency 24 and 25 as shown in Figure 4. A method is also claimed for using an ultrasonic surgical apparatus 10 which includes the stages of: developing an ultrasonic resonance at a first frequency 22; developing an ultrasonic resonance at a second frequency 23 that is approximately three times greater than the first frequency 22; and tuning an ultrasonic transducer 14 in the first frequency 22 concurrently with the second frequency 23 in which the vibration nodes in the transducer 14 in the first frequency 22 are aligned with the vibration nodes in the transducer 14 in the second frequency 23 as shown in positions 24 and 25 of Figure 4. In one embodiment, additional steps may also exist, adjust the amplitude of the first frequency 22, adjust the amplitude of the second frequency 23 and adjust the amplitude of the first frequency 22 independently of the second frequency 23. A method for manufacturing a Dual Mode Ultrasonic Surgical Apparatus 10 is also claimed, wherein the transducer 14 is installed inside a handle 11 in the mounting positions 27 which are the selected positions along the transducer 14 corresponding to the vibration nodes common to both, the first frequency 22 and the second frequency 23 as shown by positions 24 and 25 of Figure 4.

Claims (9)

NOVELTY OF THE INVENTION CLAIMS

1. An ultrasonic surgical apparatus 10 used by a surgeon to operate on the tissue of a patient comprising: a handle 11 having a proximal end 12 to be held and controlled by the surgeon; a distal end 13 disposed in the handle 11 for positioning it close to the patient's tissue; a transducer 14 housed inside the handle 11, the transducer 14 being capable of producing ultrasonic mechanical vibrations substantially at a first frequency 22 and substantially at a second frequency 23, the frequency of the second frequency 23 being approximately three times higher than the first frequency 22; a surgical tool 16 housed in the transducer 14 and extending generally beyond the distal end 13, the surgical tool 16 having a substantial cutting effect on the tissue when operating selectively at the first frequency 22, having the surgical tool 16 a substantial coagulation effect on the tissue when operating selectively at the second frequency 23, the surgical tool 16 having substantial cutting and coagulation effects on the tissue when operated concurrently with the first and second frequencies; an electric power source 17 connected to the transducer 14; a controller 18 located between the electric power source 17 and the transducer 14 to generate signals that stably control the frequencies and amplitudes of the ultrasonic mechanical vibrations of the transducer 14; and a switch 19 connected to the controller 18 to select the signals that stably control the ultrasonic mechanical vibrations of the transducer 14 to the first frequency 22 when the switch is in a first position, the ultrasonic mechanical vibrations of the transducer 14 to the second frequency 23 when the switch is in a second position and the ultrasonic mechanical vibrations of the transducer 14 concurrently with the first frequency 22 and the second frequency 23 when the switch is in a position in a third position.

2. The apparatus of claim 1, wherein there is an adapter 26 connected to the controller 18, the adapter 26 being able to be used by the surgeon to change the signals generated by the controller 18 and adjust the amplitudes of the ultrasonic mechanical vibrations.

3. The apparatus of claim 1, wherein the transducer 14 includes a piezoelectric element 21.

4. The apparatus of claim 1, wherein the transducer 14 includes a magnetostrictive element 20.

5. The apparatus of claim 1, wherein there is at least one support 27 connected between the handle 11 and the transducer 14, the support 27 being disposed along the transducer 14 in a position that corresponds substantially to a common vibration displacement node for the first frequency 22 and for the second frequency 23.

6. An ultrasonic surgical apparatus 10 used by a surgeon to operate on the tissue of a patient comprising: a handle 11 having a proximal end 12 to be held and controlled by the surgeon; a distal end 13 disposed in the handle 11 for positioning it close to the patient's tissue; a transducer 14 housed inside the handle 11, the transducer 14 being capable of producing ultrasonic mechanical vibrations substantially at a first frequency 22 and substantially at a second frequency 23, the frequency of the second frequency being approximately one frequency three times higher than the first frequency 22; a surgical tool 16 housed in the transducer 14 and extending generally beyond the distal end 13, the surgical tool 16 having a substantial cutting effect on the tissue when operating selectively at the first frequency 22, having the surgical tool 16 a substantial coagulation effect on the tissue when operating selectively at the second frequency 23, the surgical tool 16 having substantial cutting and coagulation effects on the tissue when operated concurrently with the first and second frequencies; an electric power source 17 connected to the transducer 14; a controller 18 located between the electric power source 17 and the transducer 14 for generating signals and controlling for stable formation the frequencies and amplitudes of the ultrasonic mechanical vibrations of the transducer 14; a switch 19 connected to the controller 18 to select the signals that stably control the ultrasonic mechanical vibrations of the transducer 14 to the first frequency 22 when the switch is in a first position, the ultrasonic mechanical vibrations of the transducer 14 to the second frequency 23 when the switch is in a second position and the ultrasonic mechanical vibrations of the transducer 14 concurrently with the first frequency 22 and the second frequency 23 when the switch is in a third position, an adapter 26 connected to the controller 18, the adapter 26 being usable to be used by the surgeon to change the signals generated by the controller 18 to adjust the amplitude of the ultrasonic mechanical vibrations; and at least one support 27 connected between the handle 11 and the transducer 14, the support 27 being disposed along the transducer 14 in a position that substantially corresponds to a common vibration displacement node for the first frequency 22 and for the second frequency 23.

7. A method for resonating an ultrasonic surgical apparatus 10 comprising the steps of: developing an ultrasonic resonance substantially at a first frequency 22; developing an ultrasonic resonance substantially at a second frequency 23 which is of a frequency about three times greater than the first one to tune an ultrasonic transducer 14 substantially to the first frequency 22 concurrently with the tuning of the ultrasonic transducer 14 substantially to the second frequency 23.

8. - The method of claim 7 with the additional steps of adjusting the amplitude of the first frequency 22 and adjusting the amplitude of the second frequency 23.

9. A method for manufacturing an ultrasonic surgical handle 11, the handle 11 incorporating a housing component 15 for its attachment by a surgeon and a transducer component 14 that is housed inside the housing 15, the transducer 14 being able to produce ultrasonic mechanical vibrations at a first frequency 22 and a second frequency 23, the second frequency 23 being of a frequency approximately three times higher than the first fre 22, the method comprising the steps of: installing a transducer 14 inside the housing 15 in one or more installation positions, and selecting the mounting positions in the positions along the transducer 14 that substantially correspond to the nodes of vibration displacement common to the first frequency 22 and to the second frequency 23. SUMMARY OF THE INVENTION A simple ultrasonic surgical apparatus can provide a substantial cutting effect on the tissue, a substantial coagulation effect on the tissue and a suitable combination of simultaneous cutting and coagulation effects on the tissue; the ultrasonic surgical device is formed by a handle that incorporates a transducer and a surgical tool, a source of electrical energy, a controller and a switch; the apparatus can be operated at two frequencies within the ultrasonic spectrum, the first frequency being selected at the lower end of the spectrum to enhance the cutting behavior of the tissue and the second frequency being approximately three times higher to enhance the coagulation behavior of the tissue; the two frequencies can operate selectively or concurrently and can be adjusted independently depending on the amplitude. The transducer can be formed by magnetostrictive or piezoelectric elements; the surgeon selects the desired amplitude of the mechanical vibrations; the transducer is installed inside the handle in a position corresponding to a vibration node common to the first frequency and the second frequency; furthermore, a method of use is claimed, which includes the steps of: developing an ultrasonic resonance at a first frequency; develop an ultrasonic resonance at a second frequency that is approximately three times higher than the first frequency; tune an ultrasonic transducer to the first frequency concurrently with the second frequency; and housing the transducer where the vibration nodes at the first frequency are practically coincident with the nodes of vibration at the second frequency. PF / a m / blm / kca P98 / 86F