Surgery – Diagnostic testing – Sampling nonliquid body material
Reexamination Certificate
1999-08-05
2002-07-16
O'Connor, Cary (Department: 3736)
Surgery
Diagnostic testing
Sampling nonliquid body material
C606S106000, C606S174000
Reexamination Certificate
active
06419639
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a surgical device and methods for accessing and retrieving tissue from a body cavity through minimally invasive endoscopic procedures.
2. Description of the Related Art
In recent years, the applications for endoscopic surgery, and in particular, laparoscopic surgery, have expanded to include many different procedures. A benefit of laparoscopic operations is the relatively quick recovery period experienced by patients, due to the small incisions that are made in the body. These incisions reduce the trauma and the required healing compared to traditional surgery. Laparoscopic tubes and sleeves with diameters on the order of about 5 to 15 millimeters are inserted through the incisions to aid in accessing the tissue in the body cavity. Various instruments and video camera are typically directed through the laparoscopic sleeves for performing and monitoring the surgical steps.
A particular concern in laparoscopic surgery is the transporting of tissues and other mass that are cut away or retrieved during the surgery. While moving, manipulating or morcellating the mass within the body cavity, pieces of infected or cancerous mass, blood, bile, and other liquids may escape and pose infection problems or other complications. It is desirable to contain these materials in a bag or similar enclosure within the body cavity before removal to minimize the risk of infection or other complications. Thus, while it is important that the bag possess sufficient stability and impermeability, particularly during mechanical morcellation, it is also desirable that containment of the materials be accomplished as quickly as possible with minimal disturbance to the surgical site.
Instruments with bags have been designed in an attempt to avoid the complications associated with the removal of tissue during laparoscopic surgery. These devices have provided a bag supported by a loop on the end of a handle, wherein the handle provides a means for opening the bag inside the body cavity to receive the tissue. The opening means typically relies on the springiness or shape memory of the loop material upon release from a radially restrained configuration. Prior art devices also employ a means to close the bag before withdrawing the tissue from the body cavity. The closing means usually involve a drawstring mechanism.
One such device is disclosed by Tovey et al. in U.S. Pat. No. 5,647,372, wherein the specimen retrieval device consists of a handle with a loop at the distal end for supporting the mouth of a specimen bag. The device is introduced into the patient's body cavity in a sheath. The loop is formed from two bowed spring strips made of elastic metal or plastic. The proximal ends of the two spring strips are attached to an inner “drive rod” in the handle, the bowed regions extending in opposite directions to define a loop. The loop with attached bag is deployed by distally advancing the drive rod out of the sheath. The spring strips bow outward defining a loop and opening the mouth of the bag. After the specimen is deposited in the bag, a drawstring is pulled to close the bag.
Similarly, Middleman et al., U.S. Pat. No. 5,720,754, discloses a device having an elongate handle with an elastic loop made of spring metal or memory alloy at the distal end of the handle. The handle consists of an outer sheath and a slideably engaged inner rod. The loop is attached to the inner rod and may be deployed by distally advancing the inner rod within the sheath and removed by proximally retracting the inner rod within the sheath. In one embodiment, the loop that supports the bag includes two curved, spring metal arms within the neck of the bag; the arms do not join one another. Middleman, like Tovey, also employs a drawstring mechanism for closing the bag.
Heaven et al., U.S. Pat. No. 5,337,754 describes another isolation bag, which can be inserted into a body cavity through a tube in its collapsed configuration and then inflated by application of gas or liquid to its expanded configuration. In addition, the bag wall can include wires, such as shape memory alloy, that will assist the bag in opening and maintaining its open configuration. Similarly, Cofone et al., U.S. Pat. No. 5,341,815, describes a pouch having a shape memory metal loop for opening the pouch. The devices disclosed by both Heaven and Cofone include a drawstring for closing the bag.
There remains a need for a device adapted to easily open and close a sac designed for receiving large tissue masses. None of the prior art devices disclose a loop formed by two bowed leaf elements joined by a hinge, wherein the loop can be easily opened and closed by rotating one leaf about the hinge with respect to the other leaf.
SUMMARY OF THE INVENTION
A surgical device for holding a sac for laparoscopic surgery is disclosed in accordance with the present invention. The device consists of rotatable hinge joining first and second bowed leaf elements. The bowed leaf elements form a loop which is adapted to open and close the sac by rotation of the bowed leaf elements.
In one embodiment, the surgical device also comprises an inner rod. The first bowed leaf element is attached to the distal end of the inner rod. In a further variation, the device also has a tubular member. The second bowed leaf element is attached to a distal end of the tubular member. In a further variation, the inner rod is rotatably engaged in the tubular member. Preferably, a user rotatable knob is attached to the proximal end of the inner rod, such that rotating the knob causes the first bowed leaf element to rotate with respect to the second bowed leaf element. In one embodiment, the surgical device includes a surgical sac. The sac preferably has a neck region with a drawstring.
In a variation, a laparoscopic sac holder assembly for inserting a surgical bag into a body cavity is disclosed. The assembly has of a handle comprising an inner rod, a tubular member and an outer sheath, wherein the inner rod is rotatably engaged within the tubular member, which is slideably engaged within the outer sheath. The assembly also includes a loop member comprising first and second bowed leaf elements, the first bowed leaf element being attached to the inner rod and the second bowed leaf element being attached to the tubular member, wherein the surgical bag is attached to the loop member. The first and second bowed leaf elements are joined by a rotatable articulation.
The assembly preferably includes a means for rotating the inner rod, wherein rotation of the inner rod causes the first bowed leaf element to rotate about the rotatable articulation relative to the second bowed leaf element, such that the loop member is rotatably adjustable between at least a first closed configuration and a second open configuration. The surgical bag employed in the laparoscopic sac holder assembly of the present invention may have a neck region with a drawstring. Further, the surgical bag may be adapted to be removed from the loop member within the body cavity.
Also disclosed is a method of performing a laparoscopic surgical procedure. The method comprises providing a laparoscopic sac holder assembly having a surgical bag with a mouth portion attached to a hinged loop member, said hinged loop member being rotatably adjustable between a first closed position and a second open position, wherein said hinged loop member is in the first closed position, such that the mouth portion of the attached surgical bag is closed. The laparoscopic sac holder assembly is inserted into a body cavity. The hinged loop member is rotatably adjusted to the second open position, such that the mouth portion of the attached surgical bag is opened. An excised tissue mass is placed within the open surgical bag.
In a variation of the method, a tissue morcellation device is inserted into the open surgical bag containing the tissue mass and the tissue mass is morcellated. In a further variation, prior to inserting the morcellation device into the surgical bag, the surgical bag is detache
Harrington Frank
Walther McClellan M.
National Institute of Health
O'Connor Cary
Wingood Pamela
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