Ultrasonic surgical instrument, shears and tissue pad, method for sealing a blood vessel and method for transecting patient tissue

An ultrasonic surgical shears has a bifurcated ultrasonic surgical blade, a clamping arm and a substantially “T”-shaped tissue pad. An alternate ultrasonic surgical shears has an ultrasonic surgical blade, a clamping arm, and a tissue pad having first and second transverse outer portions and a movable transverse central portion. An ultrasonic surgical instrument has an ultrasonic surgical clamp including an ultrasonic member adapted to ultrasonically vibrate and has a surgical cutter distinct from the ultrasonic member. A method for sealing a blood vessel of a patient includes obtaining an ultrasonic surgical clamp, sealing the blood vessel with the ultrasonic member, and transecting the sealed blood vessel using the surgical cutter. An alternate method similarly transects patient tissue and seals a blood vessel therein. An ultrasonic-surgical-shears tissue pad includes first and second transverse outer portions which are more resiliently flexible than is a transverse central portion.

FIELD OF THE INVENTION

The present invention is related generally to ultrasonic surgical instruments and methods, and more particularly to an ultrasonic surgical instrument including an ultrasonic surgical clamp, to an ultrasonic surgical shears, to an ultrasonic-surgical-shears tissue pad, to a method for sealing a blood vessel and to a method for transecting patient tissue and sealing a blood vessel therein.

BACKGROUND OF THE INVENTION

Ultrasonic surgical shears are known which include an ultrasonic surgical blade, a clamping arm operable to open and close toward the blade, and a polytetrafluoroethylene tissue pad which is attached to the clamping arm and which includes a clamping surface. The clamping arm exerts a clamping force on a blood vessel which is positioned between the clamping surface of the tissue pad and the blade. Exemplary devices are described in U.S. Pat. Nos. 5,322,055 and 6,325,811, the contents of which are incorporated herein by reference. The result of the ultrasonically-vibrating ultrasonic surgical blade and the clamping force on the blood vessel is a coaptation of the blood vessel (a bringing together of the walls of the blood vessel), a transection (a cutting) of the coaptated blood vessel, and a coagulation (a sealing) of the coaptated cut ends of the blood vessel.

Still, scientists and engineers continue to seek improved ultrasonic surgical instruments and methods.

SUMMARY OF THE INVENTION

A first embodiment of an ultrasonic surgical shears of the invention includes a bifurcated ultrasonic surgical blade, a clamping arm, and a substantially “T”-shaped tissue pad. The blade has a first distal tip portion and a second distal tip portion transversely spaced apart from the first distal tip portion creating a space therebetween. The clamping arm is operable to open and close toward the blade to define a clamped position and an unclamped position. The tissue pad is attached to the clamping arm and has first and second arms and a foot each having a clamping surface. In the clamped position, the clamping surface of the first arm faces substantially toward the first distal tip portion, the clamping surface of the second arm faces substantially toward the second distal tip portion, and the clamping surface of the foot faces substantially toward the space between the first and second distal tip portions.

A first method of the invention is for sealing a blood vessel of a patient and includes steps a) through e). Step a) includes obtaining an ultrasonic surgical clamp including an ultrasonic member, a clamping arm operable to open and close toward the ultrasonic member, and a tissue pad attached to the clamping arm and having a clamping surface. Step b) includes positioning the blood vessel between the ultrasonic member and the clamping surface. Step c) includes operating the clamping arm to clamp the blood vessel between the ultrasonic member and the clamping surface and ultrasonically vibrating the ultrasonic member to seal but not transect the blood vessel. Step d) includes obtaining a surgical cutter distinct from the ultrasonic member. Step e) includes transecting the sealed blood vessel using the surgical cutter.

A second method of the invention is for transecting patient tissue and sealing a blood vessel therein and includes steps a) through e). Step a) includes obtaining an ultrasonic surgical clamp including an ultrasonic member, a clamping arm operable to open and close toward the ultrasonic member, and a tissue pad attached to the clamping arm and having a clamping surface. Step b) includes positioning the patient tissue between the ultrasonic member and the clamping surface. Step c) includes operating the clamping arm to clamp the patient tissue between the ultrasonic member and the clamping surface and ultrasonically vibrating the ultrasonic member to seal the blood vessel but not transect the patient tissue including the blood vessel. Step d) includes obtaining a surgical cutter distinct from the ultrasonic member. Step e) includes transecting the patient tissue including the sealed blood vessel using the surgical cutter.

An embodiment of an ultrasonic surgical instrument of the invention includes an ultrasonic surgical clamp and a surgical cutter. The clamp includes an ultrasonic member, a clamping arm operable to open and close toward the ultrasonic member, and a tissue pad attached to the clamping arm and having a clamping surface, wherein the ultrasonic surgical clamp is adapted to ultrasonically seal a blood vessel clamped between the clamping surface of the tissue pad and the ultrasonic member by ultrasonically vibrating the ultrasonic member. The surgical cutter is distinct from the ultrasonic member, connected to the ultrasonic surgical clamp, and adapted to transect a blood vessel which has been sealed by the ultrasonic surgical clamp.

A second embodiment of an ultrasonic surgical shears of the invention includes an ultrasonic surgical blade, a clamping arm, and a tissue pad. The clamping arm is operable to open and close toward the blade to define a clamped position and an unclamped position. The tissue pad is attached to the clamping arm and has first and second transverse outer portions and a transverse central portion positioned between the first and second transverse outer portions. The transverse central portion is movable, with respect to the first and second transverse outer portions, toward the blade.

An embodiment of an ultrasonic-surgical-shears tissue pad of the invention includes an ultrasonic-surgical-shears tissue pad body. The tissue pad body has a top surface attachable to a clamping arm of an ultrasonic surgical shears, a bottom surface including a clamping surface, and a clamping direction. The tissue pad has first and second transverse outer portions each extending from the top to the bottom surface, and has a transverse central portion positioned between the first and second transverse outer portions and extending from the top to the bottom surface. The first and second transverse outer portions are more resiliently flexible along the clamping direction than is the transverse central portion.

Several benefits and advantages are obtained from one or more of the embodiments and methods of the invention which provide, in certain examples, separating over space and/or time the ultrasonic sealing of a blood vessel from an ultrasonic or non-ultrasonic transection of the blood vessel. This allows for proper sealing of a larger vessel before it is transected. This should provide improved blood vessel sealing over conventional ultrasonic surgical shears which perform a substantially simultaneous transection and sealing of a blood vessel which can result in a larger blood vessel receiving inadequate sealing before it is transected.

The present invention has, without limitation, application in straight or curved ultrasonic surgical blades as disclosed in the patents incorporated by reference and further in hand-activated instruments as well as in robotic-assisted instruments.

DETAILED DESCRIPTION OF THE INVENTION

Before explaining the present invention in detail, it should be noted that the invention is not limited in its application or use to the details of construction and arrangement of parts illustrated in the accompanying drawings and description. The illustrative embodiments of the invention may be implemented or incorporated in other embodiments, variations and modifications, and may be practiced or carried out in various ways. Furthermore, unless otherwise indicated, the terms and expressions employed herein have been chosen for the purpose of describing the illustrative embodiments of the present invention for the convenience of the reader and are not for the purpose of limiting the invention.

It is understood that any one or more of the following-described embodiments, methods, examples, etc. can be combined with any one or more of the other following-described embodiments, methods, examples, etc.

Referring now to the Figures, in which like numerals indicate like elements,FIGS. 1-2illustrate a first embodiment of an ultrasonic surgical shears10of the invention. The ultrasonic surgical shears10includes a bifurcated ultrasonic surgical blade12, a clamping arm14, and a substantially “T”-shaped tissue pad16. The blade12has a first distal tip portion18and a second distal tip portion20transversely spaced apart from the first distal tip portion18creating a space22therebetween. The clamping arm14is operable to open and close toward the blade12to define a clamped position and an unclamped position. The tissue pad16is attached to the clamping arm14and has first and second arms24and26and a foot28each having a clamping surface30. In the clamped position, the clamping surface30of the first arm24faces substantially toward the first distal tip portion18, the clamping surface30of the second arm26faces substantially toward the second distal tip portion20, and the clamping surface30of the foot28faces substantially toward the space22between the first and second distal tip portions18and20.

In one example of the embodiment ofFIGS. 1-2, the first and second distal tip portions18and20of the blade12each have a substantially rectangular transverse cross section. In one variation, the clamping surface30of the foot28of the tissue pad16has a transverse length which is substantially equal to the transverse distance between the first and second distal tip portions18and20of the blade12creating, in a fully clamped position as viewed in a transverse cross section, a first pinch point32between the first arm24of the tissue pad16and the first distal tip portion18of the blade12and a second pinch point34between the second arm26of the tissue pad16and the second distal tip portion20of the blade12. In one modification, in a transverse cross section, the foot28of the tissue pad16has a substantially rectangular shape. In another variation, the clamping surface30of the foot28has a transverse length which is less than the transverse distance between the first and second distal tip portions18and20. In a further variation, the clamping surface30of the foot28has a transverse length which is equal to or greater than the transverse distance between the first and second distal tip portions18and20. In another modification, not shown, in a transverse cross section, the foot of the tissue pad has a substantially trapezoidal shape which narrows toward the clamping surface of the foot. In one enablement of the ultrasonic surgical shears10, not shown, the tissue pad sits across from the blade over the entire length of the blade.

A first method of the invention is for sealing a blood vessel of a patient and is shown inFIG. 3, and an embodiment of an ultrasonic surgical instrument which in one application is used to perform one implementation of the first method is shown inFIG. 4. The first method includes steps a) through e). Step a) is labeled as “Obtain Ultrasonic Surgical Clamp” in block36ofFIG. 3. Step a) includes obtaining an ultrasonic surgical clamp38including an ultrasonic member40, a clamping arm42operable to open and close toward the ultrasonic member40, and a tissue pad44attached to the clamping arm42and having a clamping surface46. Step b) is labeled as “Position Blood Vessel” in block48ofFIG. 3. Step b) includes disposing the blood vessel (not shown) between the ultrasonic member40and the clamping surface46. Step c) is labeled as “Operate Arm and Vibrate Ultrasonic Member” in block50ofFIG. 3. Step c) includes operating the clamping arm42to clamp the blood vessel between the ultrasonic member40and the clamping surface46and ultrasonically vibrating the ultrasonic member40to seal but not transect the blood vessel. Step d) is labeled as “Obtain Surgical Cutter” in block52ofFIG. 3. Step d) includes obtaining a surgical cutter54distinct from the ultrasonic member40. Step e) is labeled as “Transect Blood Vessel” in block56ofFIG. 3. Step e) includes transecting the sealed blood vessel using the surgical cutter54.

In one extension of the first method of the invention, there is also included, before step e), the step of unclamping the ultrasonic surgical clamp38from the blood vessel. In a different extension of the first method, there is also included, after step e), the step of unclamping the ultrasonic surgical clamp38from the blood vessel. In one application of the first method, the surgical cutter54is a non-energy-based surgical cutter such as, without limitation, a surgically-sharp blade. In a different application of the first method, the surgical cutter is an energy-based surgical cutter such as, without limitation, an ultrasonic surgical blade or an RF (radio-frequency) blade. In one implementation of the first method, the surgical cutter is a separate surgical instrument from the ultrasonic surgical clamp. In a different implementation of the first method, the surgical cutter and the ultrasonic surgical clamp are portions of a single surgical instrument. In one construction employed in performing the first method, the tissue pad44and the ultrasonic member40each have a substantially rectangular transverse cross sectional shape.

A second method of the invention is for transecting patient tissue and sealing a blood vessel therein. The second method includes steps a) through e). Step a) is labeled includes obtaining an ultrasonic surgical clamp38including an ultrasonic member40, a clamping arm42operable to open and close toward the ultrasonic member40, and a tissue pad44attached to the clamping arm42and having a clamping surface46. Step b) includes disposing the patient tissue between the ultrasonic member40and the clamping surface46. Step c) includes operating the clamping arm42to clamp the patient tissue between the ultrasonic member40and the clamping surface46and ultrasonically vibrating the ultrasonic member40to seal the blood vessel but not transect the patient tissue including the blood vessel. Step d) includes obtaining a surgical cutter54distinct from the ultrasonic member40. Step e) includes transecting the patient tissue including the sealed blood vessel using the surgical cutter54.

An embodiment of an ultrasonic surgical instrument58of the invention, shown inFIG. 4, includes an ultrasonic surgical clamp38and a surgical cutter54. The clamp38includes an ultrasonic member40, a clamping arm42operable to open and close toward the ultrasonic member40, and a tissue pad44attached to the clamping arm42and having a clamping surface46, wherein the ultrasonic surgical clamp38is adapted to ultrasonically seal a blood vessel clamped between the clamping surface46of the tissue pad44and the ultrasonic member40by ultrasonically vibrating the ultrasonic member40. The surgical cutter54is distinct from the ultrasonic member40, connected to the ultrasonic surgical clamp38, and adapted to transect a blood vessel which has been sealed by the ultrasonic surgical clamp38.

In one illustration of the embodiment ofFIG. 4, the surgical cutter54is a non-energy-based surgical cutter such as, without limitation, a surgically-sharp blade. In a different illustration of the embodiment ofFIG. 4, the surgical cutter is an energy-based surgical cutter such as, without limitation, an ultrasonic surgical blade or an RF (radio-frequency) blade. In one arrangement of the embodiment ofFIG. 4, the tissue pad44and the ultrasonic member40each have a substantially rectangular transverse cross sectional shape. In one variation of the ultrasonic surgical instrument58, not shown, the surgical cutter is not attached to the clamping arm.

A second embodiment of an ultrasonic surgical shears60of the invention, shown inFIG. 5, includes an ultrasonic surgical blade62, a clamping arm64, and a tissue pad66. The clamping arm64is operable to open and close toward the blade62to define a clamped position and an unclamped position. The tissue pad66is attached to the clamping arm64and has first and second transverse outer portions68and70and a transverse central portion72positioned between the first and second transverse outer portions68and70. The transverse central portion72is movable, with respect to the first and second transverse outer portions68and70, toward the blade62. In one arrangement, corresponding portions of the clamping arm64move corresponding portions of the tissue pad66, as is within the level of construction skill of the artisan.

In one example of the embodiment ofFIG. 5, the ultrasonic surgical blade62is a bifurcated ultrasonic surgical blade having a first distal tip portion74and a second distal tip portion76transversely spaced apart from the first distal tip portion74creating a space78therebetween, wherein the transverse central portion72is movable into the space78between the first and second distal tip portions74and76. In another example, not shown, the ultrasonic surgical blade is not bifurcated.

In one variation of the embodiment ofFIG. 5, each of the first and second transverse outer portions68and70is movable, with respect to the transverse central portion72, away from the blade62. In the same or a different variation, the blade62has a substantially rectangular transverse cross sectional shape. In one modification, the transverse central portion72and the first and second transverse outer portions68and70each have a substantially rectangular transverse cross sectional shape.

An embodiment of an ultrasonic-surgical-shears tissue pad80of the invention, shown inFIG. 6, includes an ultrasonic-surgical-shears tissue pad body82. The tissue pad body82has a top surface84attachable to a clamping arm86of an ultrasonic surgical shears88, a bottom surface90including a clamping surface92, and a clamping direction94. The tissue pad80has first and second transverse outer portions96and98each extending from the top to the bottom surface84and90, and has a transverse central portion100positioned between the first and second transverse outer portions96and98and extending from the top to the bottom surface84and90. The first and second transverse outer portions96and98are more resiliently flexible along the clamping direction94than is the transverse central portion100.

In one example of the embodiment ofFIG. 6, the tissue pad body82has a substantially rectangular transverse cross section and has a “T”-shaped segment102having first and second arms104and106and a central stem108, wherein the transverse central portion100includes the entire central stem108and none of the first and second arms104and106, and wherein the central stem108projects away from the first and second arms104and106along the clamping direction94. In one variation, first and second rectangular segments110and112are attached to the “T”-shaped segment102as shown inFIG. 6.

In an alternate embodiment of an ultrasonic-surgical-shears tissue pad114of the invention, shown inFIG. 7, the tissue pad body116has an inverse “T”-shaped segment118having first and second arms120and122and a central stem124, wherein the transverse central portion126includes the entire central stem124and none of the first and second arms120and122, and wherein the central stem124projects away from the first and second arms120and122along a direction opposite to the clamping direction126. In this alternate embodiment, only the top surface126of the central stem124is attachable to a clamping arm128of an ultrasonic surgical shears130. In one variation, the tissue pad body116has a substantially inverse “T”-shaped transverse cross section. In a different variation, not shown, the tissue pad body has a substantially rectangular transverse cross section. In this variation, first and second rectangular segments would be attached to the “T”-shaped segment to achieve the substantially rectangular cross section of the tissue pad body.

Several benefits and advantages are obtained from one or more of the embodiments and methods of the invention which provide, in certain examples, separating over space and/or time the ultrasonic sealing of a blood vessel from an ultrasonic or non-ultrasonic transection of the blood vessel. This allows for proper sealing of a larger vessel before it is transected. This should provide improved blood vessel sealing over conventional ultrasonic surgical shears which perform a substantially simultaneous transection and sealing of a blood vessel which can result in a larger blood vessel receiving inadequate sealing before it is transected.

While the present invention has been illustrated by a description of several embodiments and methods, it is not the intention of the applicant to restrict or limit the spirit and scope of the appended claims to such detail. Numerous other variations, changes, and substitutions will occur to those skilled in the art without departing from the scope of the invention. For instance, the ultrasonic surgical instrument, shears and tissue pad of the invention have application in robotic assisted surgery taking into account the obvious modifications of such systems, components and methods to be compatible with such a robotic system. It will be understood that the foregoing description is provided by way of example, and that other modifications may occur to those skilled in the art without departing from the scope and spirit of the appended Claims.