Ring applicator and method for applying elastic rings to...

Surgery – Instruments – Suture – ligature – elastic band or clip applier

Reexamination Certificate

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C606S140000

Reexamination Certificate

active

06547798

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to surgical devices and, more particularly, to a ring applicator and method for applying one or more elastic rings to anatomical tissue structures such as the fallopian tubes.
2. Discussion of the Background Art
A variety of procedures have been developed to accomplish female sterilization by obstructing the fallopian tubes in order to prevent fertilization of the ova. The traditional procedure involves tying off each tube with ligatures and then cutting between the ligatures to permanently remove a section of the tubing. Another type of procedure utilizes electrocautery instruments to burn through and permanently seal each of the fallopian tubes. These procedures involve significant discomfort for the patient, and highly skilled personnel are required to complete the operation successfully. With respect to cauterization, in particular, there is the possibility of inadvertently burning other organs of the body and, for example, accidentally perforating the bowel.
The foregoing procedures are also undesirable in that they effect a sterilization which is permanent and cannot easily be reversed. In theory, plastic or metal clips can be applied to each tube in order to effect a sterilization which can be reversed; however, in practice, the clips have sometimes fallen off, thereby rendering the sterilization ineffective. Another type of reversible procedure which has gained wide acceptance in many parts of the world involves drawing the fallopian tube into a loop or knuckle within a tubular member carrying an elastic ring and slipping the elastic ring onto the loop in order to obstruct or ligate the tube. Typically, a forceps is used to draw the fallopian tube into a loop within a first tubular member. The first tubular member containing the loop is then caused to move axially relative to a second tubular member disposed telescopically around the first tubular member such that an elastic ring is forced off the distal end of the first tubular member onto the midsection of the loop, thereby occluding the fallopian tube.
A number of ring applicators have been developed to ligate tubular organs such as the fallopian tube. A first type of ring applicator, exemplified by U.S. Pat. Nos. 3,911,923 and 4,374,523 to Yoon, and U.S. Pat. Nos. 4,257,420 and 4,471,766 to Terayama, is designed to ligate only one fallopian tube at a time. Thus, in such devices, after one of the fallopian tubes has been occluded by placing an elastic ring around a loop formed in the fallopian tube, it is necessary to completely withdraw the instrument from the patient and reload the instrument with another elastic ring to ligate the second fallopian tube. Such a technique is not only time consuming, but also unduly complicates the tubal ligation procedure and, in some instances, can increase the chance of infection.
Another type of ring applicator, exemplified by U.S. Pat. No. 4,230,116 to Watson and U.S. Pat. No. 4,548,201 to Yoon, permits multiple rings to be carried at the distal end of a first tubular member disposed telescopically within a second tubular member, but relies on user skill to eject the rings individually by retracting the first tubular member partially to eject the first ring and fully to eject the second ring. A disadvantage of this type of ring applicator is that it is difficult to determine when the first ring has been ejected to know when to stop retracting the first tubular member. It is therefore possible for inexperienced or unskilled operators to eject both rings onto the first fallopian tube thereby requiring withdrawal of the instrument from the operative site for reloading before the second fallopian tube can be ligated.
Yet another type of ring applicator, exemplified by U.S. Pat. Nos. 4,226,239 and 4,493,319 to Polk, et al., utilizes an adjustable stop to limit displacement of the first tubular member relative to the second tubular member to an appropriate amount for each ring. In these devices, movement of the first and second tubular members is linked to handles, with the stop being positionable between the handles to prevent full retraction of the first tubular member in the case of the first ring and being removable from between the handles to permit full retraction of the first tubular member for ejecting the second ring. U.S. Pat. No. 4,493,319 also discloses a locking mechanism for preventing relative movement between the first and second tubular members to facilitate loading of elastic rings. However, the locking mechanism operates independently of the adjustable stop and does not allow the forceps to be fully deployed when in use.
A disadvantage of prior art ring applicators in general is that ejection of the rings occurs automatically with retraction of the forward or distal handle thereby limiting the ability of the surgeon to control the order and timing of the steps involved in the procedure. Another disadvantage of prior art ring applicators is that these devices do not permit rings to be ejected until the anatomical tissue structure has been drawn into the first tubular member a predetermined distance which is fixed. Depending on the type of anatomical tissue structure being ligated and other operating conditions, it may be desirable to retract greater or shorter lengths of tissue prior to ejecting a ring. Still another disadvantage of prior art ring applicators is that it is typically not possible to observe the anatomical tissue once it has been retracted into the tubular member in order to determine whether the tissue is properly positioned prior to ejecting an elastic ring.
SUMMARY OF THE INVENTION
Accordingly, it is a primary object of the present invention to overcome the abovementioned disadvantages of the prior art and to improve ring applicators having adjustable stops which limit axial movement of telescoping members to permit multiple elastic rings to be applied to anatomical tissue structures in a reliable manner.
It is another object of the present invention to simplify operation of a ring applicator having an adjustable stop and a locking mechanism for preventing relative axial movement of the telescoping members during ring loading by incorporating a locking mechanism into the adjustable stop.
It is yet another object of the present invention to permit independent tissue retraction and ring ejection operations to be performed with a ring applicator by coupling a forceps with a first handle and telescoping members with a second handle axially movable relative to the first handle and pivotably movable relative to the telescoping members.
It is an additional object of the present invention to assure proper placement of anatomical tissue structures within tubular members of a ring applicator prior to ejecting a ring by providing the tubular members with transparent tips having scale markings for comparison with the tissue structures.
Yet another object of the present invention is to enable surgeons to determine the relative lengths of grasping members used to draw anatomical tissue structures into a tubular member of a ring applicator in order to prevent improper use of the grasping members which may cause damage to the anatomical tissue structures.
The present invention has another object in permitting an elastic ring to be ejected onto an anatomical tissue structure which has not been fully drawn into a first tubular member of a ring applicator so that, for example, the ring applicator can be used to ligate anatomical tissue structures of various sizes.
The aforesaid objects can be achieved individually or in combination, and it is not intended that the present invention be construed as requiring two or more of the objects to be achieved in combination unless expressly required by the attached claims.
The present invention is generally characterized in a ring applicator for applying elastic rings to anatomical tissue during surgical procedures including an inner member with a forceps movably disposed within a middle tubular member having a distal portion configur

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