Fluid delivery mechanism for use with anastomosing,...

Elongated-member-driving apparatus – Surgical stapler – With magazine

Reexamination Certificate

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C604S043000

Reexamination Certificate

active

06491201

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to a fluid delivery mechanism for use with anastomosing, stapling, and resecting surgical tools, and more specifically to a fibrin injection mechanism by which such tools may deliver fibrin to the stapling and cutting site of a resected colon.
2. Description of the Prior Art
Upon identification of cancerous or other anomalous tissue in the gastrointestinal tract, surgical intervention is often prescribed. The field of cancer surgery, and more specifically, the surgical procedure by which a section of the gastrointestinal tract which includes cancerous or anomalous tissue is resected, includes a number of uniquely designed instruments. In combination with a description of the present instrumentation and their functions, a description of the state of the art in this surgical procedure shall also be provided.
The first question which must be answered when determining how to treat gastrointestinal cancer relates to the specific location of the cancerous tissue. This is very important insofar as the instruments which are provided in the present art have limitations relating to how far they may be inserted into the gastrointestinal tract. If the cancerous tissue is too far up the colon, for example, then the standard instrumentation provided is unusable, thus requiring special accommodations. These accommodations generally increase the risk of contamination of the surrounding tissues with bowel contents, increase the length of the surgery and the corresponding need for anesthesia, and eliminate the benefits of precise anastomosing and stapling which comes from utilizing a mechanized device.
More specifically, in the event that the cancerous tissue is located at a position in the colon which is accessible by the present instrumentation, the patient's abdomen is initially opened to expose the bowel. The surgeon then utilizes a linear cutter and stapling device which cuts the tube of the colon on either side of the cancerous tissue, thereby creating two stapled ends of the bowel (a distal end which is directed toward the anus, and the proximal end which is closest to the small intestine). This is done in order to temporarily minimize contamination.
More particularly, referring to
FIG. 1
, the bowel is placed between the scissoring elements
1
,
2
at the tip of the linear stapling instrument
5
. By squeezing the trigger
3
in the handle
4
of the device, the surgeon causes the scissoring elements
1
,
2
to come together. A second trigger (or a secondary action of the same trigger) is then actuated to drive a series of staples
6
through the clamped end of the colon, thereby closing and transecting the ends.
The surgeon then partially opens the proximal end and inserts the removable anvil portion of an anastomosing and stapling instrument into the exposed proximal end. This step, as well as those of the remainder of the surgical procedure, are related to the functioning of this surgical instrument. More particularly, and with respect to
FIG. 2
, the surgeon begins by taking the instrument
7
and manually turning the dial
8
at the base of the handle
9
which causes the anvil head
10
at the opposite end to advance forward. The surgeon continues to turn the dial
8
until the anvil head
10
advances to its most extreme extended position. This manual turning requires nearly thirty full rotations. Once fully extended, the anvil head of the instrument is decoupled therefrom and is inserted into the partial opening of the proximal end such that the coupling post extends outwardly therethrough. This partial opening of the proximal end is then sutured closed. The extending shaft
11
of the anastomosing and stapling instrument
7
is then inserted and advanced into the lower colon, transanally, until the coupling stem
12
thereof extends through the stapled distal end. The surgeon then joins the coupling ends of the anvil and shaft together and begins to manually rotate the dial in the handle again, this time bringing the anvil head closer to the end
13
of the shaft.
Once the anvil head and shaft are brought close together, after the surgeon has manually rotated the dial another thirty times, a grip-style trigger
14
in the handle is manually actuated. This actuation causes a circular blade
15
to advance axially out from the tip of the shaft, and into contact with the opposing face
16
of the anvil
10
. The blade cuts through the stapled-closed ends of the proximal and distal ends of the colon, thereby also cutting a new pair of ends of the proximal and distal portions of the colon. The tissue which has been severed is held in an interior volume at the end of the shaft.
In lock step with the cutting, the freshly opened ends are joined together by a series of staples
17
which are advanced through holes in the perimeter of the tip of the shaft (being pressed against and closed by the opposing face of the anvil). The coupled shaft and anvil are then withdrawn from the patient.
As with many such devices of the prior art, all of the above devices are considered fully disposable, and are, in fact, thrown away after a single use. They are complicated devices, having multiple moving parts, requiring substantial structural integrity and, therefore, expense in manufacturing. The fact that they are used only once, and no part can be used again render the use of such devices expensive and wasteful of resources.
In addition to this failure, as can be readily observed from the preceding descriptions, the prior art devices suffer from numerous other limitations which would be desirable to overcome. These include the requirement that the surgeon manually actuate a number of different functions (including those associated with the dial and trigger of the anastomosing and stapling instrument and the multiple triggers of the cutting and stapling instrument).
Another failure is that the prior art devices provide no means to allow the delivery of fluid to the site of the freshly cut tissue. Medicine or other substances which accelerate the healing process, if delivered to the site simultaneous with or subsequent to the stapling and cutting process, could speed healing of the tissue or perform other medical functions. One such substance is fibrin, which is the principal protein component of connective tissue, and serves as the fundamental element of the tissue-mending process, specifically the process of scar formation at the joining of two previously separate tissues. Therefore, the ability to inject such a substances at the site of the freshly stapled and cut tissue would provide an advantage over the prior art devices, which make no provision for such delivery.
Therefore, it is a principal object of the present invention to provide a medicine delivery mechanism which can effect such medicine delivery at the stapling and cutting site of targeted tissue.
It is also a principal object of the present invention to provide such a medicine delivery mechanism in a form integral with an instrument for cutting, anastomosing, and stapling, which reduces the waste of resources by permitting the reuse of portions thereof.
It is further an object of the present invention to provide such a medicine delivery mechanism which reduces the requirements for the surgeon to manually actuate different components and mechanisms.
Other objects of the present invention shall be recognized in accordance with the description thereof provided hereinbelow, and in the Detailed Description of Preferred Embodiments in conjunction with the remaining Figures.
SUMMARY OF THE INVENTION
The preceding objects of the invention are provided by a medicine delivery mechanism which is integral with an anastomosing and stapling attachment which has been coupled to an electromechanical driver assembly.
Such an electromechanical driver assembly is shown in FIG.
3
and has a handle
150
and a flexible drive shaft
155
. The handle
150
has a pistol grip-styled design, having one or more, and preferably two, finger triggers
160
which

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