Patent Application
20210378730
The present invention relates to an actuator assembly for a bipolar forceps, and more particularly, to an integrated actuator assembly mounted to a bipolar forceps for facilitating multi-mode, one-hand operation thereof.
Modern electrosurgery dates from the discovery about 100 years ago that applying electrical current at radio frequencies to living tissue will coagulate blood. Passing an RF electrical current through tissue heats and cauterizes it, reducing blood loss and thereby promoting better patient outcomes. Electrosurgery has become widespread today in many surgical contexts, and the basic principles underlying electrosurgery are well known. However, apparatus for performing electrosurgery has taken many forms, none of which has proven entirely satisfactory.
Basic components of an electrosurgical arrangement of the type with which the present disclosure is concerned are an electrosurgical tool and an electrical generating apparatus. The electrosurgical tool typically comprises a forceps with two insulated tines, each of which has an exposed electrode at a distal region. The tines extend along a generally longitudinal axis to a proximal region with a tool plug that is electrically connected to the tool electrodes by conductors inside the tines. A power cord removably connects the tool plug to the electrical generating apparatus for applying electrical current to the electrodes. The tines have a handle portion at the forceps' proximal region whereby a user holding the forceps can squeeze the tines together to capture tissue between them. Introducing current to the tool plug from the electrical generating apparatus via the power cord heats and cauterizes tissue between the electrodes.
In an arrangement widely used today the electrical generating apparatus is selectively actuated by a foot pedal. When the forceps have been manipulated to capture the desired tissue between the forceps' electrodes, the medical professional performing the procedure, or an assistant, steps on the foot pedal to close a switch in the electrical generating apparatus and, via the power cord, introduce current to the tool plug and thus to the electrodes. Typically, the person performing the procedure locates the pedal by “feel.” In a procedure in which the forceps' electrodes must be positioned with precision, it is difficult both to concentrate on the surgical field and to look at the floor to locate the pedal. The applicant's U.S. Pat. No. 9,433,460 describes some of the shortcomings of foot pedal systems, such as the location of the pedal sometimes not being aligned with the user's foot, or requiring that the user grope for the pedal or contort his or her body position to depress the pedal, thus posing significant risk and possibly causing delays that compromise the procedure. Having someone other than the person performing the procedure move the pedal, such as a surgeon's assistant, can also cause delay. Further, if the surgeon has to move to a different location during the procedure, he or she may not be able to readily locate the pedal without looking away from the patient. (At times this description will refer to “the surgeon” performing a procedure. It will be understood that this includes users other than those who would normally be deemed surgeons in strict medical parlance.)
One approach for addressing this issue is to place a switch at a location where it can be actuated by the user's hand holding the forceps. U.S. Pat. No. 5,116,333 to Beane (assigned to Kirwan Surgical Products, Inc.) represents an early example of this approach. Beane's handswitch adapter is intended to permit a surgeon to use the same hand to manipulate a bipolar forceps at a surgical site and actuate a switch carried by the forceps. The adapter, which includes the switch, is a unitary structure separate from the forceps and the power cord. It includes a fixed-length extension that has one end secured to an adapter base and that extends along the forceps' longitudinal axis. A reed switch mounted at the other end of the extension is closed when the user presses on it with a fingertip. This construction has a number of drawbacks. It will be appreciated from Beane's
U.S. Pat. No. 9,433,460 avoids many of Beane's shortcomings. It interposes between the forceps and power cord an actuating component with a push-button switch. On one side the actuating component has sockets that mimic the sockets on a conventional power cord plug and on the other side it has prongs that mimic the prongs on a conventional tool plug of a bipolar forceps. The actuating component has a lever arm that the user presses with a finger of the hand holding the forceps tines to move the lever arm against the push button on the switch to close a circuit and introduce current to the tool plug from the electrical generating apparatus via the power cord. This configuration places the lever arm at a location proximate to the natural location of the user's finger when he or she is holding the forceps with the thumb on one tine and the index or middle finger on the other. See, for example,
Pub. No. US 2018/0055558 includes some of the basic configurational features of the actuating arrangement in U.S. Pat. No. 9,433,460, in that it includes an actuator assembly with a lever arm that presses on a push-button switch when the user pushes on the lever arm with a finger of the hand holding the forceps. It improves on the arrangement in U.S. Pat. No. 9,433,460 by making the power cord and actuator assembly a unitary structure so that it can be immediately connected in place on the tool plug ready for use. Another feature of the actuator assembly in the '558 publication is the ergonomic shape of the lever arm, which is designed so that it more closely matches the position and contour of a user's finger when the forceps is in use. While integrating the actuator assembly and power cord makes it quicker and easier to convert the forceps to hand actuation, it does not readily allow for using the forceps without the actuator arm. That requires disconnecting the actuator assembly from the tool plug and the electrical generating apparatus and replacing it with a conventional power cord. In addition, converting between right- and left-hand configurations using the ergonomically curved lever arm described in Pub. No. US 2018/0055558 requires different lever arms, thus increasing the number of small parts that must be furnished with each unit. An additional feature that could affect the utility of the configuration is the fixed distance by which the lever arm extends along the tines, which doesn't account for the fact that different users have different size hands, or may prefer different-length lever arms for different procedures.
What is needed is an actuator assembly that permits a surgeon to control the provision of electrical current to a bipolar forceps with the same hand gripping the forceps. The actuator will preferably have a construction that places an actuating component such as a lever arm where a finger of the surgeon's hand is naturally located during use of the forceps. It should also permit removal of the lever arm so that the supply of electrical current can be controlled solely by a foot pedal in the conventional manner, without requiring the power cord to be separated from the tool, and preferably be easily converted between left- and right-hand operation.
The detailed description that follows below will be better understood when taken in conjunction with the accompanying drawings, in which like numerals and letters refer to like features throughout. The following is a brief identification of the drawing figures used in the detailed description.
One skilled in the art will readily understand that the drawings are not strictly to scale and are generally schematic in nature, but nevertheless will find them sufficient, when taken with the detailed description that follows, to make and use the devices and practice the methods described herein.
It is one object of the present invention to provide an actuator assembly that can be used with a conventional bipolar electrosurgical forceps and can assume a variety of different configurations to give a surgeon maximum flexibility in the manner in which a procedure using the forceps is performed.
A construction featured in one embodiment of the invention comprises a three-component actuator assembly that in various combinations enables a degree of operational flexibility heretofore missing from handheld actuators for electrosurgical forceps. This actuator assembly includes a switch body with a power cord for introducing electrical current to the forceps from a conventional electrical generator. The switch body mounts to the forceps tool plug in a like manner to known power cord plugs. The actuator assembly further includes an actuator body mounted on the switch body and an actuator lever arm movable by a user's finger while holding the forceps. Movement of the lever arm actuates a switch in the switch body to introduce electric current to the forceps.
In one variation the actuator assembly includes three separate components: a switch body integrated with the power cord, an actuator body removably mountable to the switch body, and an actuator lever arm adjustably mounted to the actuator body. This construction permits a surgeon to use an actuator assembly including all three components for one hand operation of the forceps, while permitting removal of the actuator body/lever arm subassembly from the switch body without unplugging the switch body from the forceps tool plug. This allows the surgeon to readily convert to foot pedal operation alone if it would facilitate a particular part of a procedure (for example, if the lever arm obstructs the surgical field). In another variation, the lever arm can be removed from the actuator body while leaving the latter mounted to the switch body.
Another aspect of the invention resides in the configuration and mounting of the actuator lever arm. The actuator lever arm is carried by a switch actuating member mounted for movement relative to the actuator body. When the user moves the lever arm, the switch actuating member closes the switch to introduce electrical current to the forceps. The actuator body and switch actuating member are configured to place the lever arm in position for movement by a user's finger when the user grasps the forceps. The lever arm includes a shaft slidingly received in the switch actuating member and an enlarged distal contact portion shaped so the user can readily locate and operate it by feel during a procedure.
Certain aspects of the actuator lever arm in various embodiments are particularly advantageous. The lever arm shaft can be made plastically deformable to permit each user to position the contact portion relative to the forceps according to his or her preference. The contact portion is preferably curved generally convex-outward relative to the forceps' tines where the user grips them. This provides tactile feedback that lets the surgeon know immediately if his or her finger is properly positioned on the contact portion. In addition the contact portion surface can be contoured to more positive contact in the presence of fluids during a surgical procedure. Alternately, or additionally, the contact portion can have cutouts that provide further tactile feedback allowing the surgeon to properly position his or her finger on the contact portion for optimum results.
In yet another embodiment at least the switch body and actuator body comprise a unitary structure that can be connected to and disconnected intact from the forceps tool plug. This will simplify manufacture and facilitate use of the actuator assembly by constituting it of fewer individual parts. In one form of this embodiment the lever arm is removably mounted to the actuator body so that it can be removed to provide an unobstructed view of the surgical field during a procedure without removing the integrated switch body and actuator body subassembly. In still another alternate embodiment the forceps, switch body, and power cord comprise an integral disposable unit that can be discarded after a single use to avoid sterilization issues.
These and other aspects and features of the invention and embodiments thereof will be covered in more detail as this description proceeds. A Summary of the invention has been provided here solely to introduce in a simplified form a selection of concepts that are described in detail below and is not intended necessarily to identify key or essential features of the subject claimed herein.
Embodiments are described more fully below in sufficient detail to enable those skilled in the art to use the described medical instruments and methods. However, embodiments may be implemented in many different forms and should not be construed as being limited to the embodiments set forth herein. The following detailed description is, therefore, not to be taken in a limiting sense. This description is intended to provide specific examples of particular embodiments illustrating various ways of implementing the claimed subject matter. It is written to take into account the level of knowledge of one of ordinary skill in the art to which the claimed subject matter pertains. Accordingly, certain details may be omitted as being unnecessary for enabling such a person to realize the embodiments described herein. In addition, spatially relative terms such as “upward,” “downward,” “top,” “bottom,” “right,” “left,” “under,” “over,” “proximal,” “distal,” etc., may be used herein for convenience, but they in no way limit the structure or procedure described, unless the context indicates otherwise. Similar considerations apply to the term “about,” which is sometimes used herein to indicate that the nominal value of a parameter can vary a certain amount as long as it produces the intended effect or result.
In addition, terms used throughout are meant to have the ordinary and customary meaning that would be ascribed to them by one of ordinary skill in the art. However, some of the terms used in the description herein will be explicitly defined and that definition is meant to apply throughout. For example, the term “substantially” is sometimes used to indicate a degree of similarity of one item, such as a property, structural feature, or parameter, to another. This means that the items are sufficiently similar to achieve the purpose ascribed to them in the context of the description accompanying the use of the term. Exact equivalence of many items discussed herein is not possible because of factors such as engineering tolerances and normal variations in operating conditions, but such deviations from an exact identity still fall within the meaning herein of being “substantially” the same. Likewise, omission of the term “substantially” when equating two such items does not imply that they are identical unless the context suggests otherwise.
When elements are referred to as being “connected” or “coupled,” the elements can be directly connected or coupled together or one or more intervening elements may also be present. In contrast, when elements are referred to as being “directly connected” or “directly coupled,” there are no intervening elements present.
To that end, the present disclosure describes a configuration that enables actuation of the electrodes E1 and E2 by a user without requiring the operation of a foot pedal, while permitting the forceps to be held and manipulated into position with familiar techniques used with the old set up. As shown in
The plug mount 110 includes a switch that comprises switch contacts within the plug mount and a spring-biased push-button actuator 112 for selectively placing the switch contacts in the plug mount in an open position in which they are not in electrical contact and a closed position in which current is conducted between the contacts. The switch is in an electrical circuit between a power cord 114 and the sockets 110a and 110b, whereby depressing the push-button actuator 112 against its spring bias electrically connects the electrical generating apparatus GA to the tool plug prongs P1 and P2 (and thus to the electrodes E1 and E2). An important feature of the actuator assembly 10 is its ability to be directly substituted for a conventional power cord that connects at one end to a conventional electrical generating apparatus, while still enabling at the discretion of the user either foot pedal operation or operation using the actuator assembly as described below. To that end, the power cord 114 includes three leads 114a, 114b, and 114c integrated with the plug mount 110 in a suitable manner, such as securing them in place via a molded collar 116 that captures the leads and holds them securely in place to from an integrated switch body/power cord assembly. The leads 114a and 114b comprise power leads that terminate at respective power plugs 118a and 118b that plug into the electrical generating apparatus's power outlets (not shown) in the same manner as a conventional power cord. The lead 114c comprises a control cord that terminates at a control plug 118c that is connected to the electrical generating apparatus GA.
As noted, another important feature of the actuator assembly 10 is that it can be used with conventional electrical generating apparatus and any of various conventional foot pedal actuators FP. A typical foot pedal actuator will include the foot pedal itself and a foot pedal control cord FC with a pedal control plug CP that plugs into a control socket on the apparatus GA. Electrical generating apparatus is typically available in either of two types. The apparatus GA in
The connecting structure for removably mounting the actuator body can take other forms besides the exact configuration depicted in the drawings. For example, in one alternate construction the connecting structure could comprise ridges molded on the actuator housing with the cooperating grooves provided in the plug mount. In another construction the actuator housing side walls could be made sufficiently flexible to permit the actuator housing to snap onto the tool plug from the side (as seen in
The actuator body 200 shown in
The lever arm 300 terminates in the enlarged contact portion 302, which is specifically designed to facilitate operation by a user's finger. The plastically deformable steel core of the lever arm shaft 301 permits it to be bent into various shapes to place the enlarged contact portion 302 at a particular configuration depending on a user's preference, a feature that is described in more detail in the next paragraphs explaining the actuator assembly 10 in operation. The ability of the lever arm to be bent into a desired shape and adjusted to extend from the pivot arm by a distance according to a user's preference provides a level of versatility missing from prior art hand-actuated bipolar forceps—including the ability to remove the lever arm and use foot pedal actuation exclusively—which will be apparent from the following description of just some of the different methods of using the actuator assembly described herein.
As shown in
A second exemplary mode of operation will be described by reference to
A third exemplary mode of operation is depicted in
In all modes of operation the user has the option of using the actuator assembly or the foot pedal FP to introduce current to the electrodes at any time during a procedure. The user can also remove the lever arm for certain parts of a procedure and just use the foot pedal. Or the plug mount 110 with its unitary power cord 114 can be used as a conventional power cord by sliding the actuator body 200 off of the plug mount. In another embodiment the switch body 100 with the power cord 114 and the actuator body 200 comprise a unitary subassembly. This subassembly can be directly substituted for a conventional power cord and used without the lever arm in situations where the surgeon believes the lever arm could interfere with a planned procedure. In this configuration one or more lever arms can be provided separately and used as desired by inserting a lever arm into the passage 250 in the internal pivot arm 252. In another variation the entire three-component actuator assembly can be provided as a unitary structure for use as described herein without the necessity of handling multiple individual components.
Although the above figures illustrate the actuator assembly 10 arranged for right-handed operation, another feature that further increases its versatility is the simple way in which it can be converted for left-handed operation, as shown in
In an alternate embodiment the switch body 100 and the forceps comprise an integral unit. In one exemplary construction the forceps' tool plug TP and the mating sockets 110a and 110b on the switch body are replaced by an integrated structure in which the forceps' tines are directly connected to the switch body/power cord assembly to form a forceps/switch/power cord unit. The forceps can thus be connected directly to the electrical generating apparatus. In a preferred configuration, the switch body 100 is otherwise unchanged, and cooperates with the actuator body 200 and the actuator arm 300 as described above. This permits the forceps/switch/power cord unit to be used as a conventional forceps without the actuator body or the lever arm in place, or with the actuator body mounted on the switch body to enable operation in accordance with the description above.
It is anticipated that the forceps/switch/power cord unit can be manufactured a sufficiently low cost so that it can be discarded after a single use, thus avoiding potential sterilization issues presented by the switch body due to its internal circuitry and switching mechanism. The actuator body and lever arm are relatively simple in configuration and can be made without areas that present sterilization challenges. Actuator body/lever arm assemblies can be maintained in inventory for repeated use with each new disposable forceps/switch/power cord unit. Right- and left-hand versions of the disposable forceps can be made so that each has a configuration that provides the same orientation as the respective right- and left hand orientations described above and depicted in
The numerous constructional and operational features and advantages of the actuator assembly described herein will be immediately apparent to those skilled in the art from the above description. Those skilled in the art will readily recognize that only selected preferred embodiments of the invention have been depicted and described, and it will be understood that various changes and modifications can be made other than those specifically mentioned above without departing from the spirit and scope of the invention, which is defined solely by the claims that follow.
This application claims the benefit of U.S. provisional application No. 62/795,049, filed Jan. 22, 2019, the entire contents of which are incorporated herein by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US19/63550 | 11/27/2019 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62795049 | Jan 2019 | US |
