WO1998043548A1

WO1998043548A1 - Hand-held forceps instrument

Info

Publication number: WO1998043548A1
Application number: PCT/US1998/006580
Authority: WO
Inventors: Cynthia D. Sadler
Original assignee: Sadler Cynthia D
Priority date: 1997-04-03
Filing date: 1998-04-03
Publication date: 1998-10-08
Also published as: AU6948298A

Abstract

A hand operable forceps instrument for performing manual tubal ligation comprising two interfacing forcep members (31, 32) wherein at least one forcep member is pivotable in relation to the other forcep member, and wherein each forcep member is shaped to cooperate with the other forcep member. Each forcep member includes a metal electrode (34, 35) to which current can flow. In use, the forceps instrument is used to grasp and cauterize a portion of the fallopian tube. In another embodiment, the forcep members (30) are retractable so that a Fallope ring (56) can be manually placed around a portion of the fallopian tube to tie off the tube.

Description

Hand-Held Forceps Instrument

Background of the Invention

Field of the Invention

The invention relates to surgical forceps, and specifically to forceps that can be used to manually perform cesarean tubal ligation and immediate postpartum tubal ligation.

Related Art

Several methods are currently available for performing tubal ligation. Manual surgical procedures, such as the Irving and Pomeroy procedures, are typically used during a cesarean delivery or immediately following a vaginal delivery to perform tubal ligation. Because the uterus is distended immediately following delivery, these operative procedures are the only means available for accessing the fallopian tubes.

Manual tubal ligation is preferred by some patients because it involves only a single trip to the hospital and the operating table. For example, in the case of a

Cesarean delivery, the patient is already on the operating table. As such, tubal ligation can be performed immediately following the Cesarean delivery, during one visit to surgery. Similarly, in the case of a vaginal delivery, often an Epidural has been administered to the patient. Thus, after delivery, the patient can be transferred directly to surgery to have tubal ligation performed. Thus, the patient has only one trip to the hospital and has to undergo anesthesization only once.

Operative procedures used in manual tubal ligation include resectioning of the fallopian tubes, by removing a section of the tube, cauterizing the ends of the tube, and then suturing the ends of the tube back together. This surgical technique, as in any surgery, presents certain risks of hemorrhaging and infection. Further, these operative procedures can take fifteen minutes or longer to perform, and are tedious due to the multiple steps involved with each. No instruments are currently available to aid a surgeon in performing these procedures more efficiently or safely. A second method has been developed for performing tubal ligation. This second method involves the use of a laparoscope. In the laparoscopic method, a small incision is made in the patient's abdomen. A laparoscope, consisting of a long hollow tube, is inserted into the incision. Tools located on the end of a handheld instrument, as described in U.S. Patent No. 5,342,381 to Tidemand, incorporated herein by reference, are then inserted into the hollow tube of the laparoscope. These tools are used to access and manipulate the fallopian tubes. Laparoscopic tubal ligation cannot be performed immediately following delivery, because the patient's uterus is enlarged at this time. The enlarged uterus interferes with insertion of the laparoscope and inhibits access to the fallopian tubes. Thus, the patient must wait approximately six weeks after delivery before having this procedure performed. This waiting period forces the patient to undergo a second trip to the operating room.

There are several methods which can be used in the laparoscopic method to perform tubal ligation. During the laparoscopic procedure, the fallopian tubes are frequently cauterized or burned using an electrocauterization process to close them. In the electrocauterization process, blood vessels and tissue, or blood vessels alone, that are cut during a surgical procedure are sealed by applying electricity at the site to fuse by heat the vessel opening. The electrocauterization process is generally accomplished through the use of an instrument capable of conducting electricity . The conductive instrument utilized may be monopolar , that is, having one electrode which cooperates with a remote conductive body plate electrode, or bipolar, that is, having two closely spaced electrodes. Current passing from one electrode to the other produces sufficient heat to seal blood vessels or coagulate blood or other fluids. In the electrocauterization process, a monopolar instrument requires electric current to travel a longer distance to the body plate electrode. Further, because there is only one electrode, the current is not grounded, thus resulting in the risk that the current may disperse and produce electrical burns on surrounding tissue. Thus, electrocauterization performed using a monopolar instrument results in a degree of unpredictability and the possibility of some harm to the patient due to the relatively long distance of travel of electric current to the body plate. In a bipolar instrument, the electric current travels over a shorter distance, thereby carrying better current directability and predictability, and therefore less risk of harm to a patient.

The forceps on the end of the hand-held instrument used in a laparoscopic procedure are disposed within the tube of the laparoscope. Thus, their freedom of movement, and in particular, the amount that the graspers on the forceps can opened, is limited by the width of the tube. This limitation makes it difficult to capture the fallopian tube between the graspers in order to perform tubal ligation, especially in those patient's having large tubes. Further, the amount of burn that can be applied to the fallopian tube by the cauterizing tool is restricted by the tube of the laparoscope. Generally a three burn process is used, so that three separate sections of the fallopian tube must be cauterized to effectively seal the tube. Further, as the electric current for performing the cauterization travels down the tube of the laparoscope is may become misdirected and inadvertently burn adjacent tissue.

Another method for performing laparoscopic tubal ligation is by applying a silastic band to the fallopian tubes, commonly referred to as "tying." This method is often preferred by patients, because the band may be removed if the patient changes her mind and desires to reverse the procedure. With resectioning or cauterization, the procedure is irreversible. However, tube tying can only be performed laparoscopically. Thus, the patient must wait for six weeks after delivery to have the procedure performed. What is needed is an instrument to aid the surgeon in performing tubal ligation, by either cauterizing or applying silastic bands to the tube, immediately following delivery, without the aid of a laparoscope. The forceps typically used for laparoscopic procedures are not available for or adaptable to use for manual tubal ligation, because the forceps construction is specifically made to fit into a laparoscope. What is needed is an instrument for efficiently and safely performing manual tubal ligation immediately following delivery, that would decrease the procedure time and thereby enable the patient to spend less time on the operating table.

Summary of the Invention

An instrument for performing manual tubal ligation. The instrument of the present invention includes forceps disposed on one end of the instrument. The forceps include an smaller first forcep member and a larger second forcep member, pivotally interconnected to cooperate with each other to provide an instrument having a pair of forceps at its distal end. The instrument has an elongated tubular member comprising a scissors-type handle assembly disposed at the proximal end of the tubular member, and a forceps assembly disposed at a right angle to the distal end of the elongated tubular member.

In one embodiment, pivotal movement of the smaller, first forcep member in relation to the larger, second forcep member is accomplished by a rigid rod which is coupled to the first forcep member. The rigid rod extends through an elongated tubular member. At one end of the tubular member, a scissors-type handle is disposed. Hand operation of the handle causes the first forcep member to pivot in relation to the second, stationary forcep member. Current is delivered to the forceps through conductors which are connected to an RF source. These conductors are electrically insulated throughout the instrument. Thus, a bipolar instrument having grasping properties is provided at the site of the surgical procedure being performed.

In another embodiment, the forceps are retractable into a tubular member of the instrument. A silastic band is placed around the tubular member. The forceps are used to grasp a portion of the fallopian tube, and the forceps are drawn into the tubular member. The silastic band is then manually slipped over the end of the instrument to tie off the fallopian tube.

Brief Description of the Figures

The foregoing and other features and advantages of the invention will be apparent from the following, more particular description of a preferred embodiment of the invention, as illustrated in the accompanying drawings.

FIG. 1 shows a side view of a bipolar forceps instrument of the present invention.

FIG.2 shows a cross-sectional view of the forceps of the present invention taken along line 2-2 of FIG. 1.

FIG.3 shows a partial view of the opened forceps of the present invention.

FIG. 4 shows a partial, perspective view of the forceps of the present invention disposed around a fallopian tube.

FIG. 5 shows a partial view of a second embodiment of the present invention.

FIG. 6 shows a silastic band which has been bound around a looped portion of a fallopian tube using the second embodiment of the present invention.

Detailed Description of the Preferred Embodiments

A preferred embodiment of the present invention is now described with reference to the figures where like reference numbers indicate identical or functionally similar elements. While specific configurations and arrangements are discussed, it should be understood that this is done for illustrative purposes only. A person skilled in the relevant art will recognize that other configurations and arrangements can be used without departing from the spirit and scope of the invention. It will be apparent to a person skilled in the relevant art that this invention can also be employed in a variety of other devices and applications.

FIGs. 1 and 2 show a bipolar forceps instrument 12 for use without an laparoscope, to effect electrocauterization or reversible sterilization of fallopian tubes during surgical procedures. Instrument 12 has an elongated tubular member

13 which has a diameter and length sufficient to be used in the procedures of electrocauterization without an laparoscope. Because instrument 12 is being used without a laparoscope, elongated tubular member 13 is substantially rigid. In one embodiment, elongated tubular member 13 is less than twelve inches . Elongated, tubular member 13 does not have to be as long or as thin as a conventional tubular member used in a forceps instrument intended for use with a laparoscope, because in the conventional device, the tubular member must be fed through the tube of the laparoscope to the site of the procedure. With the manual forceps of the present invention, the forceps are brought directly to the site of the procedure. Thus, there are no constraints imposed on the size of the tubular member by the laparoscope.

Tubular member 13 has a proximal end 15 and a distal end 16, and a lumen 17 that extends the entire length of the tubular member. The cross-sectional view of forceps 12, in FIG. 2, shows that tubular member 13 comprises a metal tube 18 which is coated with a electrical insulator 19 of polymeric material well known in the art for its insulative purposes.

At proximal end 15 of tubular member 13 is a handle assembly 20. Handle assembly 20 has a first handle member 21 having first and second ends. The first end has a bore 22 which extends therethrough. Proximal end 15 of tubular member 13 is situated at the first end of first handle member 21. In the embodiment shown, first handle member 21 does not pivot. Instead, a loop 23 is formed in the second end first handle member 21 to accommodate a thumb of an operator.

Handle assembly 20 also has a second handle member 24 that is pivotally interconnected to first handle member 21 , by a pivot pin 25. A loop 29 is disposed at the second end of handle member 24 to receive a forefinger of the operator. A forceps assembly 30 of tubular member 13 is force or press fit into distal end 16. Forceps assembly 30 comprises a smaller, first forcep member 32, and a larger, second forcep member 31. This configuration provides three surface areas to provide a "one burn" cauterization, instead of the "three burn" cauterization presently utilized with a laparoscope device. The "three burns" of the conventional laparoscope device are produced by three separate one centimeter burns. Second forcep member 31 and first forcep member 32 are pivotally interconnected by an insulated rivet 33 which extends through bores formed through forcep members 31, 32. Forceps assembly 30 is bent at a right angle to elongated, tubular member 13 so that during use the operator's hand does not block her vision of the site of the procedure.

Two electrically conductive rods 34, 35, each of which is covered with a layer of electrical insulation, extend through lumen 17 of tubular member 13. When an RF current is applied to forcep members 31, 32 tissue, vessels and the like can be cauterized in the bridge of the gap between the forceps. Conductive rods 34, 35 are pivotally coupled to their respective forcep members 31, 32 by respective rigid links 36, 37 (rigid link 37 not visible in FIG. 1). The materials used and the method of construction of the present invention are apparent to one skilled in the relevant art and are described in further detail in U.S. Patent No. 5,342,381 to Tidemand, which is incorporated herein by reference.

As can be seen from FIG. 3, one embodiment of the present invention utilizes a smaller, second forcep member 32 and a larger, first forcep member 31 , both of which are serrated to enhance grasping action. FIG. 4 shows forceps assembly 30 in use, grasping and cauterizing a portion of a fallopian tube 60. In a second embodiment of the invention, as shown in FIG. 5, a loaded-clip or silastic band 56 (also referred to as a fallope ring) is disposed over a tubular end 64 of forceps assembly 30. FIG. 5 shows band 56 removed from tubular end 64, and the dashed lines depict where band 56 would normally be positioned prior to manually slipping it over loop 62 of fallopian tube 60. Forceps assembly 30 disposed in tubular end 64 so that it can be drawn inside tubular end 64.

Conventional devices for placing a fallope ring over a portion of a fallopian tube are constructed to be used with a laparoscope. It would be apparent to one skilled in the relevant art the means by which to adapt such a laparoscopic device to be used with the hand-held, manual device of the present invention.

In use, forceps assembly 30 is used to grasp a portion of a fallopian tube 60 and to draw it into a tubular end 64. Band 56 is then manually slipped off tubular end 64 and around a bottom portion of a loop 62 of fallopian tube 60, as shown in FIG. 6. This procedure provides reversible sterilization or "tying off of fallopian tube 60. The length of band 56 used around loop 62 of fallopian tube 60 is usually between approximately 1.2 to 1.6 centimeters. While the invention has been described in its preferred embodiment, it is to be understood that the inventive concept may be employed in various and sundry ways quite apart from the described preferred embodiments, without departing from the spirit and scope of the invention, which is defined in the appended claims.

Claims

What Is Claimed Is:

1. A hand operable forceps instrument for manually performing tubal ligation, comprising: an elongated tubular member having a proximal end, a distal end, and a lumen extending therebetween, wherein said elongated tubular member is substantially rigid and is less than approximately twelve inches in length; a forceps assembly disposed on said distal end of said elongated tubular member, said forceps assembly including a first forcep member and a second forcep member; a handle assembly disposed on said proximal end of said elongated tubular member; and a rod member disposed in said lumen for pivotally interconnecting said first and second forcep members and said handle assembly, so that actuation of said handle assembly causes opening and closing of said forceps assembly.

2. The hand operable forceps instrument of claim 1 , wherein said first and second forcep members are metal electrodes to which current can flow for grasping and cauterizing tissue.

3. The hand operable forceps instrument of claim 2 wherein said first forcep member has a larger surface area than said second forcep member.

4. The hand operable forceps instrument of claim 1, wherein said forceps assembly is disposed at a right angle to said elongated tubular member.

5. A hand operable forceps instrument for manually performing tubal ligation, comprising: an elongated tubular member having a proximal end, a distal end, and a lumen extending therebetween, wherein said elongated tubular member is substantially rigid and is less than approximately twelve inches in length; a forceps assembly disposed on said distal end of said elongated tubular member, said forceps assembly including a first forcep member and a second forcep member; a handle assembly disposed on said proximal end of said elongated tubular member; a rod member disposed in said lumen for pivotally interconnecting said first and second forcep members and said handle assembly; and a tubular member disposed between said forceps assembly and said elongated tubular member, wherein said tubular member is configured to receive a band, and wherein said forceps assembly is retractable into said tubular member so that when said forceps assembly is used to grasp a portion of a fallopian tube to draw the fallopian tube into said tubular member, said band may be manually slipped off of said tubular member and on to the fallopian tube in order to tie off said fallopian tube to provide reversible sterilization.