Surgery – Instruments – Sutureless closure
Reexamination Certificate
2001-05-02
2002-01-15
Garbe, Stephen P. (Department: 3727)
Surgery
Instruments
Sutureless closure
C227S176100, C227S175100
Reexamination Certificate
active
06338737
ABSTRACT:
FIELD AND BACKGROUND OF THE INVENTION
The present invention relates to excision of a section of a hollow or tubular soft organ, such as the digestive tube, and rejoining the remaining ends and, more particularly, to methods for performing these operations under conditions of closed surgery, using a flexible annular stapling and cutting instrument. The invention also relates to an improved construction of such an instrument.
Various ailments of the digestive tube, particularly of the esophagus, the stomach, the small intestines and the colon, such as tumors, chronic inflammation or other disorders, often require excision of a portion of the tube, followed by rejoining of the remaining end segments, through anastomosis, to reestablish continuity of the tube. In some cases it is necessary to thus join one organ to another; for example, the cut end of the small intestines may be joined to the colon, or the cut end of the duodenum may be joined to the stomach. In some other cases, two organs or two portions of the same organ may be joined side-to-side (rather than end-to-end or end-to-side, as in the above cases). In the discussion to follow and in the claims, the terms “parts of hollow organs” or just “parts” will be used, for brevity, to collectively denote the two parts to be joined, and the terms “part of a hollow organ” or just “apart”—to denote each of the two parts to be joined, whether they are truly two different hollow organs or two segments of the same hollow organ.
It has been common practice since the end of the '50s to use, for the purpose of the anastomosis, a suitable annular stapling and cutting instrument. An example of such an instrument, to be referred to herebelow as stapler, is depicted in FIG.
1
A. The stapler basically consists of a tubular main body, at one end of which is an annular staple gun, while the other end serves as a handle and has a knob and activation levers thereon. A rod is slidably disposed inside the tubular body, protruding through the staple gun and terminating with a round head that contains an annular anvil. The staple gun contains a set of surgical stapling pins, arranged in one or two concentric circles and a circular knife inside these circles. On the face of the anvil arc short grooves, one opposite each staple pin, with arc-like depth profile. During surgery, this stapler is used, for example, to rejoin end segments of the intestines after excision, by inserting it through a longitudinal cut in the side of the intestines and through the ends of both segments, then annularly folding and temporarily sewing one end over the face of the gun and one end over the anvil; the latter operation forms the ends into partially closed flange-like butts. Subsequently, by turning the knob, the head with the anvil is pulled toward the face of the gun, thus bringing the butts into mutual contact. Finally, by activating a lever on the handle, the staple pins arc pushed through the flanges into the grooves in the anvil until they are bent tight; at the same time, the circular knife cuts away the inner disks of the two adjoining flanges, leaving an annular ring as the joint.
This, conventional, type of stapler has several shortcomings:
It always requires an extra, longitudinal, cut; for multiple excisions, multiple extra cuts are needed.
It is not suitable for hard-to-reach or complicated portions of the intestines, such as those inside the pelvis, nor for the duodenum; operation on the esophagus or the stomach is difficult.
It is suitable almost only for end-to-end joints.
The temporary sewing of the butt ends is difficult and the depth of the resulting flanges is small, thus risking leakage.
French patent FR 9204490 to the present applicant, which is incorporated into the present disclosure by reference, discloses a novel annular stapler that differs from the one described hereabove essentially in the following (see
FIG. 1B
for an external view and
FIG. 1C
for a longitudinal-sectional view): The main, tubular, body consists of a flexible hose
26
, which can be of any length and to one end of which an anvil assembly
18
is attached. Through hose
26
is slidably disposed a flexible cable
21
, one end of which is pointed and to which a head
11
is attachable. The other end of cable
21
is attached to a handle
30
by means of a long screw
52
, engaged by a nut
51
, which is connected to a knob
46
so that turning the knob causes the cable to slide along the hose and thus—the head to move with respect to the anvil. The head contains a cartridge with staple pins and a rigid hammer assembly
15
(to be refrred to as hammer) that includes fingers, to push the pins, and a circular knife. Hammer
15
is connectable to the end of cable
21
by a screw-like arrangement. Connected to the hammer through a spring is an annular base plate, which holds the cartridge of pins and has slots for passage of the pins. Cable
21
, which may be hollow, has a flat outer surface, which matches a flat in the shape of a central hole in anvil
18
through which the cable slides; this is in order to keep the head angularly aligned with respect to the anvil prior to stapling. In handle
30
there is a window
54
, through which a millimeter scale
42
, attached to cable
21
is viewable, together with a fixed pointer. Operation of this stapler is similar to that of a conventional one, except that the stapling and cutting operation, after the two butts have made contact, is actuated automatically by continued turning of the knob (rather than activating a lever.
This novel stapler avoids the shortcomings of the conventional one, listed hereabove. In particular, it enables reaching any segment of the digestive tube—either through a natural opening (mouth or anus) or through a single, conveniently located cut. It also enables end-to-side or side-to-side joints.
Even so, the novel stapler of French patent FR 9204490 (to be referred to as the French patent) still has a few shortcomings and many as yet unrealized potentialities. One shortcoming is that in the disclosed construction there is an appreciable length of cable between the point at which the cable emerges from the anvil and the point at which it enters the head structure, even when these two components are at their closest approach. This may allow some twist in the cable and consequently some angular misalignment between the staple pins in the head and the grooves in the face of the anvil, which may cause malfunctioning of the stapling action. Likewise, because of uneven back pull of an intestinal butt, the faces of the two components may not be parallel, or may not be axially aligned prior to the stapling action, which, again, could cause malfunction. Another shortcoming of the instrument is in the operation of the handle; turning the knob may not be the optimal way to activate the stapling and cutting operation. Yet another shortcoming is the difficulty with which the head or anvil are attachable or detachable, making such operations within the body, as would be advantageous in certain procedures, close to impossible.
The unrealized potentialities are mainly associated with a new possible mode of its employment, a mode that was not contemplated in the French patent but is the subject of the present invention, namely closed surgery. The practice and techniques of closed surgery, such as laparoscopy and thoracoscopy, have made tremendous progress over the past five years and many surgical procedures on internal organs are now carried out in this mode. whereas in conventional, open, surgery, a relatively large incision is made in the abdominal wall or chest, closed surgery is characterized by insertion of very thin tools through otherwise intact walls—usually with the aid of small tubular ports, called trocars, which also serve to seal the openings during operation. Some of these tools serve for viewing and usually include a video system so that the entire operation is viewed and monitored on a video screen. The main advantages of closed surgery are (a) the much reduced trauma resulting in fewer complications a
Garbe Stephen P.
Ngo Lien
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