Title:
Open vessel sealing instrument with cutting mechanism and distal lockout
Document Type and Number:
United States Patent 7252667

Abstract:
An open electrosurgical forceps for sealing tissue includes a pair of first and second shaft members each having a jaw member disposed at a distal end thereof. The jaw members are movable from a first position in spaced relation relative to one another to a subsequent position wherein the jaw members cooperate to grasp tissue therebetween. Each of the jaw members includes an electrically conductive sealing plate for communicating electrosurgical energy through tissue held therebetween. At least one of the jaw members includes a knife channel defined along a length thereof which is dimensioned to reciprocate a cutting mechanism therealong for cutting tissue disposed between jaw members. An actuator having a rack and pinion system advances the cutting mechanism from a first position wherein the cutting mechanism is disposed proximal to tissue held between the jaw members to at least one subsequent position wherein the cutting mechanism is disposed distal to tissue held between the jaw members.

Inventors:
Moses, Michael C. (Boulder, CO, US)
Romero, Paul R. (Loveland, CO, US)
Johnson, Kristin D. (Louisville, CO, US)
Kerr, Duane E. (Berthoud, CO, US)
Dycus, Sean T. (Denver, CO, US)
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Sponsored by:
Flash of Genius
Application Number:
10/873860
Publication Date:
08/07/2007
Filing Date:
06/22/2004
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Assignee:
Sherwood Services AG (Schaffenhausen, CH)
Primary Class:
Other Classes:
606/1
International Classes:
A61B18/18
Field of Search:
606/1, 606/50-52, 606/40-42
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Primary Examiner:
Peffley, Michael
Assistant Examiner:
Vrettakos, Pete
Parent Case Data:

CROSS REFERENCE TO RELATED APPLICATION

The present application is a continuation-in-part of Ser. No. 10/991,157 filed on Nov. 17, 2004 and claims the benefit of priority to U.S. Provisional Application Ser. No. 60/523,387 (now U.S. Pat. No. 7,131,970) filed on Nov. 19, 2003 by Moses et al., the entire contents of which being incorporated by reference herein.

Claims:
What is claimed is:

1. An open electrosurgical forceps for sealing tissue, comprising: a pair of first and second shaft members each having a jaw member disposed at a distal end thereof, the jaw members being movable from a first position in spaced relation relative to one another to at least one subsequent position wherein the jaw members cooperate to grasp tissue therebetween; each of the jaw members including an electrically conductive sealing plate for communicating electrosurgical energy through tissue held therebetween; at least one of the jaw members including a knife channel defined along a length thereof, the knife channel being dimensioned to reciprocate a cutting mechanism therealong; an actuator for selectively advancing the cutting mechanism from a first position wherein the cutting mechanism is disposed proximal to tissue held between the jaw members to at least one subsequent position wherein the cutting mechanism is disposed distal to tissue held between the jaw members, the actuator including a trigger which cooperates with a rack and pinion system to advance the cutting mechanism between its first and second positions; and wherein the rack and pinion system includes a first gear-like rack in mechanical cooperation with the trigger, a second gear-like rack in mechanical cooperation with the cutting mechanism, and a pinion rotatable about an axis disposed between the first and second gear-like racks.

2. An open electrosurgical forceps for sealing tissue according to claim 1 wherein the rack and pinion system is disposed within one of the first and second shaft members.

3. An open electrosurgical forceps for sealing tissue according to claim 1 wherein the trigger of the actuator is pulled proximally to actuate the rack and pinion system to distally advance the cutting mechanism through the cutting slot.

4. An open electrosurgical forceps for sealing tissue according to claim 1 wherein the trigger of the actuator is pulled proximally to proximally move the first rack and to distally advance the second rack.

5. An open electrosurgical forceps for sealing tissue according to claim 1 further comprising a safety lockout to prevent reciprocation of the cutting mechanism when the jaw members are disposed in the first position.

6. An open electrosurgical forceps for sealing tissue according to claim 5 wherein the safety lockout forms part of at least one of the jaw members.

7. An open electrosurgical forceps for sealing tissue according to claim 5 wherein the safety lockout forms part of the cutting mechanism.

8. An open electrosurgical forceps for sealing tissue according to claim 1 further comprising at least one spring for automatically biasing the cutting mechanism in the first position.

9. An open electrosurgical forceps for sealing tissue according to claim 8 wherein the at least one spring for automatically returning the cutting mechanism back to the first position is mechanically associated with the cutting mechanism.

10. An open electrosurgical forceps for sealing tissue according to claim 1 wherein the first rack is integrally associated with the trigger.

11. An open electrosurgical forceps for sealing tissue according to claim 1 wherein the second rack is integrally associated with the cutting mechanism.

12. An open electrosurgical forceps for sealing tissue according to claim 1, wherein the trigger is proximally and distally translatable along one of the first and second shaft members.

Description:

BACKGROUND

The present disclosure relates to forceps used for open surgical procedures. More particularly, the present disclosure relates to an open forceps which applies a combination of mechanical clamping pressure and electrosurgical energy to seal tissue and a knife which is selectively advanceable to sever tissue along the tissue seal.

TECHNICAL FIELD

A forceps is a plier-like instrument which relies on mechanical action between its jaws to grasp, clamp and constrict vessels or tissue. So-called “open forceps” are commonly used in open surgical procedures whereas “endoscopic forceps” or “laparoscopic forceps” are, as the name implies, used for less invasive endoscopic surgical procedures. Electrosurgical forceps (open or endoscopic) utilize both mechanical clamping action and electrical energy to effect hemostasis by heating tissue and blood vessels to coagulate and/or cauterize tissue.

Certain surgical procedures require more than simply cauterizing tissue and rely on the unique combination of clamping pressure, precise electrosurgical energy control and gap distance (i.e., distance between opposing jaw members when closed about tissue) to “seal” tissue, vessels and certain vascular bundles.

Vessel sealing or tissue sealing is a recently-developed technology which utilizes a unique combination of radiofrequency energy, pressure and gap control to effectively seal or fuse tissue between two opposing jaw members or sealing plates. Vessel or tissue sealing is more than “cauterization” which involves the use of heat to destroy tissue (also called “diathermy” or “electrodiathermy”). Vessel sealing is also more than “coagulation” which is the process of desiccating tissue wherein the tissue cells are ruptured and dried. “Vessel sealing” is defined as the process of liquefying the collagen, elastin and ground substances in the tissue so that the tissue reforms into a fused mass with significantly-reduced demarcation between the opposing tissue structures.

In order to effectively “seal” tissue or vessels, two predominant mechanical parameters must be accurately controlled: 1) the pressure or closure force applied to the vessel or tissue; and 2) the gap distance between the conductive tissue contacting surfaces (electrodes). As can be appreciated, both of these parameters are affected by the thickness of the tissue being sealed. Accurate application of pressure is important for several reasons: to reduce the tissue impedance to a low enough value that allows enough electrosurgical energy through the tissue; to overcome the forces of expansion during tissue heating; and to contribute to the end tissue thickness which is an indication of a good seal. It has been determined that a good seal for certain tissues is optimum between about 0.001 inches and about 0.006 inches.

With respect to smaller vessels or tissue, the pressure applied becomes less relevant and the gap distance between the electrically conductive surfaces becomes more significant for effective sealing. In other words, the chances of the two electrically conductive surfaces touching during activation increases as the tissue thickness and the vessels become smaller.

Commonly owned, U.S. Pat. No. 6,511,480, PCT Patent Application Nos. PCT/US01/11420 and PCT/US01/11218, U.S. patent applications Ser. Nos. 10/116,824, 10/284,562 and 10/299,650 all describe various open surgical forceps which seal tissue and vessels. All of these references are hereby incorporated by reference herein. In addition, several journal articles have disclosed methods for sealing small blood vessels using electrosurgery. An article entitled Studies on Coagulation and the Development of an Automatic Computerized Bipolar Coagulator , J. Neurosurg., Volume 75, July 1991, describes a bipolar coagulator which is used to seal small blood vessels. The article states that it is not possible to safely coagulate arteries with a diameter larger than 2 to 2.5 mm. A second article is entitled Automatically Controlled Bipolar Electrocoagulation—“COA - COMP ”, Neurosurg. Rev. (1984), pp. 187-190, describes a method for terminating electrosurgical power to the vessel so that charring of the vessel walls can be avoided.

Typically and particularly with respect to open electrosurgical procedures, once a vessel is sealed, the surgeon has to remove the sealing instrument from the operative site, substitute a new instrument and accurately sever the vessel along the newly formed tissue seal. As can be appreciated, this additional step may be both time consuming (particularly when sealing a significant number of vessels) and may contribute to imprecise separation of the tissue along the sealing line due to the misalignment or misplacement of the severing instrument along the center of the tissue sealing line.

Many endoscopic vessel sealing instruments have been designed which incorporate a knife or blade member which effectively severs the tissue after forming a tissue seal. For example, commonly-owned U.S. Application Ser. No. 10/116,944 (now U.S. Pat. No. 7,083,618) and Ser. No. 10/179,863 (now U.S. Pat. No. 7,101,371) describe one such endoscopic instrument which effectively seals and cuts tissue along the tissue seal. Other instruments include blade members or shearing members which simply cut tissue in a mechanical and/or electromechanical manner and are relatively ineffective for vessel sealing purposes.

There exists a need to develop an open electrosurgical forceps which is simple, reliable and inexpensive to manufacture and which effectively seals tissue and vessels and which allows a surgeon to utilize the same instrument to effectively sever the tissue along the newly formed tissue seal.

SUMMARY

The present disclosure relates to an open electrosurgical forceps for sealing tissue and includes a pair of first and second shaft members each having a jaw member disposed at a distal end thereof. The jaw members are movable from a first position in spaced relation relative to one another to at least one subsequent position wherein the jaw members cooperate to grasp tissue therebetween. Each of the jaw members includes an electrically conductive sealing plate or sealing surface on an inner facing surface which communicates electrosurgical energy through tissue held therebetween. Preferably, one of the jaw members includes a knife slot or knife channel defined along a longitudinal length thereof which is dimensioned to reciprocate a cutting mechanism therealong to sever tissue held between the jaw members. An actuator is included for selectively advancing the cutting mechanism from a first position wherein the cutting mechanism is disposed proximal to tissue held between the jaw members to at least one subsequent position wherein the cutting mechanism is disposed distal to tissue held between the jaw members.

Preferably, the actuator includes a trigger which cooperates with a rack and pinion system to advance the cutting mechanism from the first to second positions through tissue held therebetween. The rack and pinion system includes a first gear-like rack associated with the trigger; a second gear-like rack associated with the cutting mechanism; and a pinion disposed between the first and second racks. Preferably, the trigger of the actuator may be moved proximally, distally or laterally to distally advance the cutting mechanism through the knife channel. Advantageously, the rack and pinion system is disposed within one of the first and second shaft members.

In one embodiment, the forceps includes a safety mechanism or safety lockout to prevent reciprocation of the cutting mechanism when the jaw members are disposed in the first position. The safety lockout may form part of one or both of the jaw members and/or may be integrally associated with the cutting mechanism.

In another embodiment, the forceps includes one or more springs which automatically bias the cutting mechanism in the first position such that after the cutting mechanism severs the tissue held between the jaw members, the cutting mechanism automatically returns to the first position. Preferably, the cutting mechanism includes at least one spring for automatically returning the cutting mechanism back to the first position.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the subject instrument are described herein with reference to the drawings wherein:

FIG. 1 is a left, perspective view of an open forceps with a cutting mechanism according to the present disclosure;

FIG. 2 is a left, side view of the forceps of FIG. 1;

FIG. 3 is an internal, perspective view of the forceps of FIG. 1 showing a rack and pinion actuating mechanism for advancing the cutting mechanism and a series of internally disposed electrical connections for energizing the forceps;

FIG. 4 is an internal, side view of the forceps showing the rack and pinion actuating mechanism and the internally disposed electrical connections;

FIG. 5 is an enlarged, perspective view showing the area of detail in FIG. 3;

FIG. 6 is an enlarged, perspective view showing the area of detail in FIG. 3;

FIG. 7 is a perspective view of the forceps of FIG. 1 with parts separated;

FIG. 8 is a perspective view of one shaft of the forceps of FIG. 1;

FIG. 9 is an enlarged, perspective view showing the area of detail in FIG. 8;

FIG. 10 is an enlarged, perspective view of the cutting mechanism;

FIG. 11 is a side cross section along lines 11 - 11 of FIG. 10;

FIG. 12 is an enlarged, perspective view of the area of detail in FIG. 10;

FIG. 13 is a greatly-enlarged perspective view of a distal electrical connector of the forceps of FIG. 1;

FIG. 14 is an enlarged, left perspective view of the one of the jaw members of the forceps of FIG. 1;

FIG. 15 is an enlarged, right perspective view of the jaw member of FIG. 14;

FIG. 16 is side cross sectional view showing the forceps in open configuration for grasping tissue;

FIG. 17 is a side cross sectional view showing the area of detail in FIG. 16;

FIG. 18 is a rear, perspective view of the forceps of FIG. 1 shown grasping tissue with a ratchet mechanism shown prior to engagement;

FIG. 19 is a rear view of the forceps of FIG. 1 showing the ratchet mechanism engaged;

FIG. 20 is a greatly-enlarged, side cross sectional view showing the forceps in a closed position and defining a gap distance “G” between opposing jaw members;

FIG. 21 is a greatly-enlarged, perspective view of a tissue seal;

FIG. 22 is a side cross sectional view taken along line 22 - 22 of FIG. 21;

FIG. 23 is a side cross sectional view showing the forceps in a closed position and showing the activation and advancement of the cutting mechanism;

FIG. 24 is an enlarged view of the area of detail in FIG. 24; and

FIG. 25 is a greatly-enlarged, cross sectional view showing tissue separated along the tissue seal after advancement of the cutting mechanism.

DETAILED DESCRIPTION

Referring now to FIGS. 1-7, a forceps 10 for use with open surgical procedures includes elongated shaft portions 12 a and 12 b each having a proximal end 14 a , 14 b and a distal end 16 a and 16 b , respectively. In the drawings and in the descriptions which follow, the term “proximal”, as is traditional, will refer to the end of the forceps 10 which is closer to the user, while the term “distal” will refer to the end which is further from the user.

The forceps 10 includes an end effector assembly 100 which attaches to the distal ends 16 a and 16 b of shafts 12 a and 12 b , respectively. As explained in more detail below, the end effector assembly 100 includes pair of opposing jaw members 110 and 120 which are pivotably connected about a pivot pin 65 and which are movable relative to one another to grasp tissue.

Preferably, each shaft 12 a and 12 b includes a handle 15 and 17 , respectively, disposed at the proximal end 14 a and 14 b thereof which each define a finger hole 15 a and 17 a , respectively, therethrough for receiving a finger of the user. As can be appreciated, finger holes 15 a and 17 a facilitate movement of the shafts 12 a and 12 b relative to one another which, in turn, pivot the jaw members 110 and 120 from an open position wherein the jaw members 110 and 120 are disposed in spaced relation relative to one another to a clamping or closed position wherein the jaw members 110 and 120 cooperate to grasp tissue therebetween.

As best seen in FIG. 7, shaft 12 b is constructed from two components, namely, 12 b 1 and 12 b 2 , which matingly engage one another about the distal end 16 a of shaft 12 a to form shaft 12 b . It is envisioned that the two component halves 12 b 1 and 12 b 2 may be ultrasonically-welded together at a plurality of different weld points or the component halves 12 b 1 and 12 b 2 may be mechanically engaged in any other known fashion, snap-fit, glued, screwed, etc. After component halves 12 b 1 and 12 b 2 are welded together to form shaft 12 b , shaft 12 a is secured about pivot 65 and positioned within a cut-out or relief 21 defined within shaft portion 12 b 2 such that shaft 12 a is movable relative to shaft 12 b . More particularly, when the user moves the shaft 12 a relative to shaft 12 b to close or open the jaw members 110 and 120 , the distal portion of shaft 12 a moves within cutout 21 formed within portion 12 b 2 . It is envisioned that configuring the two shafts 12 a and 12 b in the fashion facilitates gripping and reduces the overall size of the forceps 10 which is especially advantageous during surgeries in small cavities.

As best illustrated in FIG. 1, one of the shafts, e.g., 12 b , includes a proximal shaft connector 77 which is designed to connect the forceps 10 to a source of electrosurgical energy such as an electrosurgical generator (not shown). The proximal shaft connector 77 electromechanically engages an electrosurgical cable 70 such that the user may selectively apply electrosurgical energy as needed. Alternatively, the cable 70 may be feed directly into shaft 12 b.

As explained in more detail below, the distal end of the cable 70 connects to a handswitch 50 to permit the user to selectively apply electrosurgical energy as needed to seal tissue grasped between jaw members 110 and 120 . More particularly, the interior of cable 70 houses leads 71 a , 71 b and 71 c which upon activation of the handswitch 50 conduct the different electrical potentials from the electrosurgical generator to the jaw members 110 and 120 (See FIGS. 3 and 4). As can be appreciated, positioning the switch 50 on the forceps 10 gives the user more visual and tactile control over the application of electrosurgical energy. These aspects are explained below with respect to the discussion of the handswitch 50 and the electrical connections associated therewith.

The two opposing jaw members 110 and 120 of the end effector assembly 100 are pivotable about pin 65 from the open position to the closed position for grasping tissue therebetween. Preferably, pivot pin 65 consists of two component halves 65 a and 65 b which matingly engage and pivotably secure the shafts 12 a and 12 b during assembly such that the jaw members 110 and 120 are freely pivotable between the open and closed positions. For example, the pivot pin 65 may be configured to be spring loaded such that the pivot snap fits together at assembly to secure the two shafts 12 a and 12 b for rotation about the pivot pin 65 .

The tissue grasping portions of the jaw members 110 and 120 are generally symmetrical and include similar component features which cooperate to permit facile rotation about pivot pin 65 to effect the grasping and sealing of tissue. As a result and unless otherwise noted, jaw member 110 and the operative features associated therewith are initially described herein in detail and the similar component features with respect to jaw member 120 will be briefly summarized thereafter.

Moreover, many of the features of the jaw members 110 and 120 are described in detail in commonly-owned U.S. Patent Application Ser. Nos. 10/284,562, 10/116,824, 09/425,696 (now U.S. Pat. No. 6,511,480), 09/178,027 (now U.S. Pat. No. 6,277,117) and PCT Application Ser. No. PCT/US01/11420 the contents of which are all hereby incorporated by reference in their entirety herein.

As best shown in FIGS. 14 and 15, jaw member 110 includes an insulated outer housing 116 which is dimensioned to mechanically engage an electrically conductive sealing surface 112 . The outer insulative housing 116 extends along the entire length of jaw member 110 to reduce alternate or stray current paths during sealing and/or incidental burning of tissue. The electrically conductive surface 112 conducts electrosurgical energy of a first potential to the tissue upon activation of the handswitch 50 . Insulated outer housing 116 is dimensioned to securely engage the electrically conductive sealing surface 112 . It is envisioned that this may be accomplished by stamping, by overmolding, by overmolding a stamped electrically conductive sealing plate and/or by overmolding a metal injection molded seal plate. Other methods of affixing the seal surface 112 to the outer housing 116 are described in detail in one or more of the above-identified references. Preferably, the jaw members 110 and 120 are made form a conductive material and powder coated with an insulative coating to reduce stray current concentrations during sealing.

It is also contemplated that the electrically conductive sealing surface 112 may include an outer peripheral edge which has a radius and the insulated outer housing 116 meets the electrically conductive sealing surface 112 along an adjoining edge which is generally tangential to the radius and/or meets along the radius. Preferably, at the interface, the electrically conductive surface 112 is raised relative to the insulated outer housing 116 . Alternatively, the jaw member 110 including the sealing plate 112 and the outer insulative housing 116 may be formed as part of a molding process to facilitate manufacturing and assembly. These and other envisioned embodiments are discussed in commonly-owned, co-pending PCT application Ser. No. PCT/US01/11412 and commonly owned, co-pending PCT application Ser. No. PCT/US01/11411, the contents of both of these applications being incorporated by reference herein in their entirety.

Preferably, the insulated outer housing 116 and the electrically conductive sealing surface 112 are dimensioned to limit and/or reduce many of the known undesirable effects related to tissue sealing, e.g., flashover, thermal spread and stray current dissipation. All of the aforementioned and cross referenced manufacturing techniques produce an electrode having an electrically conductive surface 112 which is substantially surrounded by an insulated outer housing 116 .

Likewise, jaw member 120 includes similar elements which include: an outer housing 126 which engages an electrically conductive sealing