HK1083780B - Ultrasonic device for tissue coagulation - Google Patents

Description

Ultrasonic device for tissue coagulation

The SOUND minor techonologies LLC, which is nationality and resides in the united states, was filed as a PCT application and specifies this application for all countries except the united states, and claims priority to U.S. provisional application No. 60/386,119, filed on 6/4/2002.

Technical Field

The present application relates generally to surgical instruments and, more particularly, to ultrasonic surgical devices used in the process of coagulating patient tissue.

Background

Hemostasis of bleeding or tissue with potential for bleeding is particularly important in open or abdominal surgery. Several methods are currently available to coagulate tissue to achieve the desired hemostasis. Sutures are safe, reliable and commonly used on larger vessels or structures, but are difficult to use in small vessels or structures and in situations where diffuse bleeding occurs. Monopolar electrosurgery works by electrically heating and cauterizing tissue to achieve coagulation. This is effective on smaller vessels and tissues, but may result in undesirable thermal trauma to adjacent tissues due to stray electrical conduction in the moist surgical environment. Bipolar electrosurgery also works by electrically heating tissue and provides better control of stray conductance than monopolar electrosurgery. Bipolar instruments may suffer from tissue sticking to the electrodes, which may cause the coagulated tissue to reopen and bleed again when the probe is removed. The ultrasonic device utilizes frictional heat generated by the rapid vibration rubbing of tissue to produce hemostasis.

Ultrasonic surgical devices for cutting and coagulating tissue are known. All of these devices utilize longitudinal vibration in an ultrasonic member to achieve the desired surgical effect, such as cutting and simultaneous coagulation. Clamping mechanisms have been disclosed which improve cutting and coagulation performance by enhancing tissue contact between the vibrating element and the clamping surface. U.S. patent nos. 3,862,630 and 3,636,943, both to Balamuth, disclose two types of ultrasonic surgical devices: a first device for simultaneously cutting and coagulating tissue and a second device for joining layers of tissue together. The means for joining the layers of tissue together has a vibrating ultrasonic member and a clamping mechanism with a working surface perpendicular to the direction of longitudinal vibration of the tool so that the tissue is compressed between the working surface of the clamp and the end face of the vibrating ultrasonic member. This "dead-end" design blocks tissue access from the axial direction to the clamped region between the ultrasonic member and the clamping mechanism, requiring lateral access to the tissue, thereby severely limiting application of the device for surgical applications because tissue cannot be accessed in a scissor-like fashion.

U.S. patent No. 5,332,055 to Davidson discloses an ultrasonic surgical device for simultaneously cutting and coagulating tissue having a vibrating ultrasonic member with a surgical blade at its distal end with an elongated edge parallel to the longitudinal vibration axis and a clamping mechanism. The patent alleges that the cutting performance is enhanced by the surgical blade with the elongated edge and also improves performance by providing tissue access from the axial direction to the ultrasonic member and the clamping mechanism. The clamping mechanism is designed to close completely (i.e., contact) against the vibrating ultrasonic member to achieve the desired cutting and coagulation effect. The improved cutting action in this design is due to the described vibration of the surgical blade with the elongated edge and the complete closure of the blade on the clamping mechanism.

U.S. patent No. 6,193,709 to Manna discloses an ultrasonic surgical device for simultaneously cutting and coagulating tissue having a vibrating ultrasonic member with a blade at its distal end that forms an acute angle with respect to the longitudinal vibration axis and a clamping mechanism. The patent alleges that the angled design enhances tissue contact between the clamping mechanism and the blade during surgery, thereby improving performance. The clamping mechanism is designed to close completely (i.e., contact) against the vibrating ultrasonic member to achieve the desired cutting and coagulation effect. The improved cutting action in this design is obtained by the oscillation of the blade at an acute angle to the axis of longitudinal oscillation and by the complete closure of the blade on the clamping means.

U.S. patent No. 6,193,709 to Miyawaki discloses an ultrasonic surgical device for treatments such as incision and coagulation having a vibrating ultrasonic member and a clamp with a subsequent mechanism to enable the clamp to follow the deflecting displacement of the distal portion of the vibrating ultrasonic member. The patent asserts that the subsequent mechanism eliminates possible gaps between the vibrating ultrasonic member and the clamping mechanism when the clamping mechanism is closed onto the vibrating ultrasonic member, thereby improving gripping and handling performance. The clamping mechanism is designed to complete closure (i.e., contact) on the vibrating ultrasonic member to achieve the desired treatment, such as cutting and coagulation.

None of these patents disclose a means for limiting the closure of the clamping mechanism relative to the vibrating ultrasonic member in order to create a predetermined gap therebetween to improve the coagulation effect. Holding the clamp on the ultrasonic member in prior art devices will inevitably result in cutting of the tissue. The surgeon cannot know to what extent the process from the intended coagulation to the unwanted cutting has taken place. In fact, these prior art devices are designed to achieve simultaneous cutting and coagulation when clamped fully closed on the vibrating ultrasonic member, regardless of the shape of the jaw surfaces of the clamping mechanism and the shape of the vibrating ultrasonic member. It is not possible to reliably separate these two processes in the prior art devices. Accordingly, there is a need to improve the coagulation performance of ultrasonic surgical devices and further provide separate cutting and coagulation capabilities.

Deficiencies in the performance of prior art coagulation devices have been mentioned in some documents. (see, for example, Spival H. et al, "The Use of Bipolar catheters, laprosonic profiling tools, and Vascular Clips for Hemostatic of Small and Medium-sized Vessels",Surgical Endoscopy12(2): 183-85 (month 2 of 1998), and Landman, J. (Washington university), "company of the Ligasure System, Bipolar Electrosurgy, Harmonic Scale, Titanium Clips, Endo-GIA, and Sutures for Laparopsicvascular Control in a Port Model," published by St.Louis, MoSociety of American Gastrointestinal Endoscopic Surgeons(4 months 10-21 days 2001). Both of these papers include Johnson&Johnson utilizes ultrasonic abdominal cavity (laprosonic) coagulation shears ("LCS") which may be considered and distributed by the techniques covered by the Davidson' 055 patent cited above. Spivak et al tested the LCS device, as well as other devices, for its ability to coagulate small and medium-sized blood vessels in pigs by increasing the associated blood pressure to the point of failure or maximum load of 300 mm Hg. Although the author personally concluded that these devices are "reasonably safe to do", these devices have not been uniformly successful. LCS devices were successful in all "small vessel" tests, but two of the twelve tests for medium sized vessels failed completely, and in both cases bleeding occurred in medium sized vessels before the prescribed pressure limit was reached. This is an unacceptable failure rate of up to 33%. As the authors state, LCS need to be configured to the proper size and surgeons need to be properly trained to successfully use LCS on medium-sized vessels. Furthermore, the authors recommend "in case of failure of the initial haemostasis, the surgeon has a good alternative. Similarly, Landman compares various medical devices used to seal vessels. On arteries, LCS succeeded 5 times in 6 times with a success rate of 83%; on the vein, LCS succeeded 3 out of 6 times with a success rate of 50%. Thus, coagulation during surgery is evidentSignificant improvements in the devices are needed.

A device has now been invented which significantly improves the coagulation performance of ultrasonic surgical instruments. First, the coagulation performance can be improved by separating the coagulation and cutting functions of the instrument so that they occur sequentially rather than simultaneously. In practice, it has proven helpful to perform the coagulation prior to cutting, rather than simultaneously or in reverse order. The sequential process allows time for the tissue to freeze and cool so it is positioned before any cutting operation occurs. In fact, bleeding of the tissue can be completely avoided in this way. The present invention accomplishes this sequence of coagulation and cutting steps with a single grasp of the instrument, meaning that once coagulation is achieved, the tissue grasp does not have to be released to replace the instrument for cutting purposes. Secondly, coagulation performance is significantly improved by providing a predetermined gap between the jaw surface and the vibrating ultrasonic applicator to allow tissue flow to occur in a carefully controlled manner. "tissue flow" (i.e., the tendency of tissue to plastically move with sufficient heating) in the predetermined gap produces a region of coagulated tissue that is much less likely to re-bleed than tissue that is simultaneously cut and coagulated using the previously disclosed methods. It has now been found that the most effective setting performance can be obtained if the predetermined clearance is carefully controlled to be between about 0.075 to about 1.9 millimeters, and preferably between about 0.075 and about 0.75 millimeters. It has been found that if the predetermined clearance is less than about 0.075 mm, a simultaneous cutting action may occur. If the predetermined gap is greater than about 1.9 millimeters, it has been found that the tissue flow achieved is insufficient and complete coagulation may occur.

Disclosure of Invention

The present invention provides a new and improved ultrasonic surgical device and method for coagulating tissue. The device of the present invention has a surgical handpiece incorporating an ultrasonic transducer for generating ultrasonic vibrations therein. An ultrasonic applicator is attached to the ultrasonic transducer to transmit longitudinal ultrasonic vibrations and extends distally from the surgical handle. The ultrasonic applicator is generally substantially circular in cross-section at the distal end and has a diameter of between approximately 2 mm and 6 mm. A clamp with a jaw surface is supported on an elongated support member releasably attached to the surgical handle and surrounding the ultrasonic applicator generally along its length. The clamp and jaw surfaces are designed such that the clamp cannot be fully closed on the vibrating ultrasonic applicator, but rather is stopped at a predetermined gap, i.e., the distance between the jaw surface and the vibrating ultrasonic applicator. The predetermined gap provides for a region of controlled tissue flow as the vibrating ultrasonic applicator heats the tissue. The shape and thickness of the predetermined gap determine the quality and final shape of the coagulated tissue. Preferred clearances may vary from about 0.075 to about 1.9 millimeters, and preferably between about 0.075 and about 0.75 millimeters, depending on the type and structure of the target tissue to be coagulated. The surgical device may include means for adjusting the gap within this range. Thus, the vibrating ultrasonic applicator is not a vibrating "blade" and is not used to cut tissue, but is used only to improve coagulation. The region of controlled tissue flow also helps to improve coagulation by creating better coagulation and avoiding simultaneous cutting during coagulation. The thickness and shape of the tissue flow can be carefully controlled.

If the surgical device requires cutting capabilities, a separate non-ultrasonic cutting element may be provided that can be advanced and retracted to perform the cutting function as a separate step. The cutting element can be advanced after coagulation has been completed, while the jaws are still closed to the maximum allowable extent. Preferably, the cutting element may be a surgical blade with a sharp leading edge that cuts coagulated tissue as it is advanced. Other forms of mechanical cutting tools may also be used. The surgeon may wait until a sufficient amount of time has elapsed so that the tissue has coagulated and "cooled" before advancing the cutting tool to minimize bleeding during the cutting process.

The device of the present invention may also be employed in an improved coagulation method which includes ultrasonic surgery through an applicator having a circular cross-section of tissue held by a clamp located a fixed distance from the applicator surface. A surgical method may also be employed that utilizes a coagulation method to coagulate or cauterize tissue attached to but spaced apart from the ultrasonic applicator prior to cutting the tissue with a mechanical cutting tool.

Accordingly, the present invention provides an improved ultrasonic surgical instrument and method for coagulating tissue only or with a separate tissue cut. To achieve this, the present invention comprises an ultrasonic surgical instrument and method that provides a predetermined gap between the surface of a clamp holding tissue and the surface of a vibrating ultrasonic applicator having a generally circular cross-section so that controlled tissue flow can occur without ultrasonic cutting. In addition, the present invention includes an ultrasonic surgical instrument and method in which the cutting device is contained within the same instrument but is independent of the ultrasonic vibrations. Other features of the invention for improving coagulation will become apparent to those skilled in the art from the included description, drawings and claims.

The present invention may be best understood by referring to the following detailed description of certain preferred embodiments and the accompanying drawings that illustrate the preferred embodiments.

Drawings

The following drawings illustrate specific embodiments that help to understand the novel features of the present invention.

FIG. 1a is a side view, partially in cross-section, of one embodiment of the device of the present invention. The figure depicts the device with the clamp in an open position and the mechanical cutting tool in a retracted position.

FIG. 1b is a side view, partially in cross-section, of one embodiment of the device of the present invention. The figure depicts the device with the clamp in a closed position and the mechanical cutting tool in a retracted position.

FIG. 1c is a side view, partially in cross-section, of one embodiment of the device of the present invention. The figure depicts the device with the clamp in a closed position and the mechanical cutting tool in a forward position to make the cut.

FIG. 2 is a side detail view, partially in cross-section, of the distal portion of an ultrasonic device including an electronic applicator, a clamp, and a mechanical cutting tool.

Figure 3a is an end view of the ultrasonic device showing a clamp with a concave jaw surface in a closed position.

Figure 3b is an end view of the ultrasonic device showing a clamp with a convex jaw surface in a closed position.

Figure 3c is an end view of the ultrasonic device showing a clamp with a flat jaw surface in a closed position.

Figure 4 is a side view, partially in cross-section, of one embodiment of the device of the present invention in which a stop for establishing a predetermined gap is located on the handle of the ultrasonic device.

For convenience, common reference numerals are used throughout the figures.

Detailed Description

Referring to the drawings, FIG. 1a is a schematic diagram of a preferred embodiment of the present invention. FIG. 1 illustrates a side view, partially in cross-section, of the present invention including an ultrasonic surgical instrument, generally designated 10. The instrument has a surgical handle 11 which is held and manipulated by the surgeon. The surgical handle 11 may be made by machining or molding a member. An ultrasonic transducer 12 is mounted within the surgical handle 11 for generating ultrasonic vibrations. The ultrasonic vibrations may be generated by any common, well-known means, such as the use of PZT crystals held in compression.

An ultrasonic applicator 13 is attached to the ultrasonic transducer 12 and extends distally from the ultrasonic transducer 12. The preferred method of attachment is a threaded connection. The ultrasonic applicator may be made of any suitable metallic material, including, for example, titanium alloys, aluminum alloys, or stainless steel alloys. The preferred material is the titanium alloy Ti6a 14V. Standard machining processes such as lathing or milling may be used.

As previously mentioned, the ultrasonic applicators employed in the present invention are generally circular in cross-section at the location where energy is applied to the tissue. These applicators do not have cutting edges that concentrate and distribute the ultrasonic energy in a manner that promotes cutting, but are designed to constantly provide energy in a uniform manner specifically for coagulating tissue. Indeed, if desired, the cutting function may be provided in a separate mechanical component of the surgical instrument to avoid interfering with the design of the ultrasonic applicator.

The combined length of the ultrasonic transducer 12 and the ultrasonic applicator 13 must be designed to have a desired resonant frequency. The range of vibration frequencies is typically 20 khz to 60 khz. Any vibration frequency within this range may be used.

An elongated support member 14 is releasably attached to the surgical handle 11 and surrounds the ultrasonic applicator 13 generally along its length. The elongated support member 14 may be made of metal or plastic material. Preferred materials are materials such as Delrin R (acetyl copolymer) or "ABS" (acrylonitrile-butadiene-styrene). A clamp 15 with a jaw surface 16 is supported on the end of the elongated support member 14. The clip may be manufactured from metal or plastic using standard machining processes or standard molding processes (plastic or metal). The preferred method and material is a molded metal clamping mechanism because it provides the greatest rigidity and best clamping performance to the part. The jaw surface 16 may have various cross-sectional shapes such as those shown in fig. 3 a-3 c. The jaw surface 16 may also have a serrated or grooved surface to improve gripping.

The clamp 15 can be opened and closed with respect to the side of the ultrasonic applicator 13. In fig. 1a, the clamp is shown in an open position. An actuating handle 17 is attached to surgical handle 11 and is used to actuate clamp 15 between the open and closed positions. A clamp transmission rod 18 connects the drive handle 17 and the clamp 15.

A drive slide 19 is attached to the surgical handle 11 and is used to advance and retract a cutting element 20 in a direction parallel or substantially parallel to the ultrasonic applicator. The cutting element 20 may be a stainless steel blade or a shaped cutting shape on the end of a blade connecting rod 21. A blade connecting rod 21 connects the drive slide 19 and the cutting element 20. The connecting rods 21 are preferably made of stainless steel wire, which may be brazed or welded to the cutting elements 20.

FIG. 2 illustrates a more detailed side view of the distal end of the ultrasonic surgical device 10 shown in FIG. 1 with the clamp 15 and associated jaws 16 in an open position relative to the ultrasonic applicator 13. Surface 32 of clamp assembly 30 is spaced from surface 31 of support 14. The mechanical cutting tool or blade 20 attached to the blade connecting rod 21 is in a retracted position. The cutting element 20 may be advanced to cut tissue that has coagulated between the jaw surface 16 and the ultrasonic applicator 13. (see fig. 1 c.) thus, the cutting element 20 is advanced and retracted through the gap between the jaw surface 16 and the ultrasonic applicator 13. In another embodiment, the clamp 15 and jaw surface 16 may be provided with a vertical slot through which the edge of the blade also passes as it extends and retracts. This will allow a wider mechanical cutting element to be used and help ensure that the blade cuts all tissue held in the space between the jaw surface and the ultrasonic applicator. FIG. 1b shows the same ultrasonic surgical instrument 10 as shown in FIG. 1a, except that the drive handle has been rotated to the closed position, thereby pushing the clamp drive link 18 toward the ultrasonic transducer 12, causing the clamp 15 to rotate and close relative to the ultrasonic applicator 13. The movement of the transmission rod 18 is limited by a stop, in which case a surface 32 of the clamp housing 30 comes into contact against a surface 31 of the support 14. This is done to "close" the jaw surface 16 of the clamp 15 a predetermined distance or gap from the surface of the ultrasonic applicator 13. (see fig. 3a and 3 c.) this distance can be preset or varied by controlling the length of the transmission rod 18. It is within the skill of the art to provide some means by which a surgeon or an assistant can change the length during a surgical procedure without removing the surgical instrument from the patient. For example, the effective length of the rod from the clamp support 30 to the drive device 17 can be varied by using a rotatable transmission rod threaded into a portion of the handle 11. In fig. 1b, the cutting blade or tool 20 is in a retracted position.

FIG. 1c shows the ultrasonic surgical device 10 of FIG. 1a with the clamp in a closed position and the cutting blade 20 in an extended position. This is accomplished by moving the drive slide 10 in a direction toward the distal end of the ultrasonic surgical device, thereby moving the blade connecting rod 21 and the blade 20 in that direction. When this is done, the blade 20 cuts the tissue held between the automated clamp 15 and the ultrasonic applicator 13.

Fig. 3a to 3c show three different jaw surfaces and predetermined clearance forms.

Figure 3a is an end view showing the ultrasonic applicator 13 and the elongated support member 14 and the clamp 15 in a fully "closed" position. The jaw surface 16 is concave, which provides an increased width of tissue coagulation between the jaw surface 16 and the ultrasonic applicator 13. The predetermined clearance 22 is the spacing between the jaw surface 16 and the ultrasonic applicator 13 when the clamp 15 is closed to its maximum extent, and is typically between about 0.075 to about 1.9 millimeters, and preferably between about 0.075 and about 0.75 millimeters. The optimum predetermined gap value varies with the intended application.

Figure 3b is an end view showing the ultrasonic applicator 13 and the elongated support member 14 and the clamp 15 in a fully closed position. The jaw surfaces 16 are convex, which provides a reduced width of tissue coagulation, resulting in an improved transition at the blade edge to the previously coagulated tissue. The predetermined clearance 22 is the spacing between the jaw surface 16 and the ultrasonic applicator 13 when the clamp 15 is fully closed, and as such, is typically between about 0.075 to about 1.9 millimeters, and preferably between about 0.075 and about 0.75 millimeters. The optimum predetermined gap value varies with the intended application.

Figure 3c is an end view showing the ultrasonic applicator 13 and the elongated support member 14 and the clamp 15 in a fully closed position. The jaw surface 16 is straight, which has a combination of effects obtainable with the shape as shown in fig. 2a and 2 b. The predetermined clearance 22 is the spacing between the jaw surface 16 and the ultrasonic applicator 13 when the clamp 15 is fully closed, and is typically between about 0.075 to about 1.9 millimeters, and preferably between about 0.075 and about 0.75 millimeters. The optimum predetermined gap value varies with the intended application.

The predetermined gap between the jaws 16 of the clamp 15 and the ultrasonic applicator 13 may be formed in a number of ways. As shown in fig. 1a to 1c and fig. 2, can be formed by a stop of the clamp housing surface 32 abutting against the surface 31 of the support. Other mechanical stops may also be used. One such stop is shown in FIG. 4, and FIG. 4 shows an ultrasonic surgical device as shown in FIG. 1 a. In this case, however, the stop is a physical element 26 that extends from the handle 11 and prevents the drive means 17 from closing on the housing. This acts as a stop mechanism instead of the contact surfaces 31 and 31. Those skilled in the art will know how to make the effective length of the stop 26 variable so that the predetermined separation gap 22 between the jaws and the applicator can also be varied. For example, the stop 26 may be screwed into a bore in the handle 11 to a limited extent so that it can be effectively lengthened or shortened as desired. Those skilled in the art will recognize other techniques for creating a predetermined gap between the jaws 16 and the ultrasonic applicator 13 that may be substituted for the examples described herein.

The present invention also provides an improved surgical method for coagulating animal tissue, the method comprising disposing a portion of animal tissue between (1) an ultrasonic applicator having a generally circular cross-section and a diameter of between about 2 and 6 millimeters, and (2) a clamp positioned adjacent the ultrasonic tissue to provide a wider surface for coagulation and avoid cutting into the animal tissue. The clamp is then moved toward the ultrasonic applicator to a predetermined clearance of between about 0.075 to 1.9 millimeters, preferably about 0.075 and about 0.75 millimeters from the ultrasonic applicator to provide a region for tissue flow and coagulation. Sufficient ultrasonic vibrations are then applied to the clamped tissue by the ultrasonic applicator to coagulate the tissue. If desired, the cutting may then be performed with a separate mechanical cutting tool, such as that shown in the figures and described herein.

As previously mentioned, the apparatus and method of the present invention are particularly useful in separating and maximizing the coagulation and cutting functions. It also provides a convenient way for the surgeon to know the position of the clamp relative to the ultrasonic applicator and the position of the cutting element and blade at all times. Thus, the surgeon can easily monitor and focus on these tasks.

The description and drawings herein disclose illustrative embodiments of the invention. After reading the disclosure herein, it will be appreciated by those skilled in the art that various modifications, alternative constructions, and equivalents may be used to achieve the advantages of the invention. For example, after reading the disclosure herein, those skilled in the art will be able to implement various forms of clamps, stops, and mechanical cutting tools within the scope of the present invention. Accordingly, the invention is not limited by the description and drawings contained herein, but is defined by the claims that follow.

Claims (19)

1. An ultrasonic surgical device for coagulating animal tissue, the device having: a handle for manipulation by a surgeon, an ultrasonic transducer for generating ultrasonic vibrations, and an ultrasonic applicator attached to the ultrasonic transducer and extending from the handle for transmitting the ultrasonic vibrations to tissue of the animal, wherein the apparatus further comprises:

an end portion on the ultrasonic applicator having a generally circular cross-section and a diameter of between approximately 2 mm and 6 mm to provide a wider surface for coagulation and to avoid cutting animal tissue;

an elongated support member releasably attached to the surgical handle and extending to the distal end portion of the ultrasonic applicator; and

a movable jaw with a jaw surface attached to the elongated support member near the distal portion of the ultrasonic applicator for movement toward the distal portion to a closed position a predetermined clearance of between about 0.075 millimeters to about 1.9 millimeters from the distal portion of the ultrasonic applicator.

2. The ultrasonic surgical device of claim 1 wherein the predetermined clearance is between about 0.075 and about 0.75 millimeters.

3. The ultrasonic surgical device of claim 2 wherein the jaw surface in the closed position is substantially parallel to the surface of the elongated support member.

4. The ultrasonic surgical device of claim 2 wherein the jaw surface is concave.

5. The ultrasonic surgical device of claim 2 wherein the jaw surface is convex.

6. The ultrasonic surgical device of claim 2 wherein the jaw surface is flat.

7. The ultrasonic surgical device of claim 2 wherein the predetermined clearance is defined by a stop located on the elongated support member.

8. The ultrasonic surgical device of claim 2 wherein the predetermined gap is defined by a stop located on a handle of the ultrasonic surgical device.

9. The ultrasonic surgical device of claim 8 wherein the stop is adapted to be threaded into a hole in the handle, the stop being lengthened or shortened by threading the stop into or out of the hole, whereby the predetermined clearance can be changed during a medical procedure without removing the ultrasonic surgical device from the patient.

10. An ultrasonic surgical apparatus for treating animal tissue, the apparatus having a handle for manipulation by a surgeon, an ultrasonic transducer for generating ultrasonic vibrations, and an ultrasonic applicator attached to the ultrasonic transducer and extending from the handle for transmitting the ultrasonic vibrations to the animal tissue, wherein the apparatus further comprises:

an end portion on the ultrasonic applicator having a generally circular cross-section and a diameter of between approximately 2 mm and 6 mm to provide a wider surface for coagulation and to avoid cutting animal tissue;

an elongated support member releasably attached to the surgical handle and extending to the distal end portion of the ultrasonic applicator;

a movable jaw with a jaw surface attached to the elongated support member near the distal end portion of the ultrasonic applicator for movement toward the distal end portion to a closed position a predetermined gap of between about 0.075 millimeters to about 1.9 millimeters from the distal end portion of the ultrasonic applicator to provide an area for tissue flow and coagulation when the ultrasonic applicator vibrates to heat tissue; and

a mechanical cutting device for moving parallel to the ultrasonic applicator to cut tissue located between the ultrasonic applicator and the clamp.

11. The ultrasonic surgical device of claim 10 wherein the predetermined clearance is between about 0.075 and about 0.75 millimeters.

12. The ultrasonic surgical device of claim 11 wherein the jaw surface in the closed position is substantially parallel to the surface of the elongated support member.

13. The ultrasonic surgical device of claim 11 wherein the jaw surface is concave.

14. The ultrasonic surgical device of claim 11 wherein the jaw surface is convex.

15. The ultrasonic surgical device of claim 11 wherein the jaw surface is flat.

16. The ultrasonic surgical device of claim 11 wherein the predetermined clearance is defined by a stop located on the elongated support member.

17. The ultrasonic surgical device of claim 11 wherein the predetermined gap is defined by a stop located on a handle of the ultrasonic surgical device.

18. The ultrasonic surgical device of claim 17 wherein the stop is adapted to be threaded into a hole in the handle, the stop being lengthened or shortened by threading the stop into or out of the hole, whereby the predetermined clearance can be changed during a medical procedure without removing the ultrasonic surgical device from the patient.

19. The ultrasonic surgical device of claim 11 wherein the mechanical cutting device is a blade.