System and method for biopsy management

Surgery – Diagnostic testing – Sampling nonliquid body material

Reexamination Certificate

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C606S001000

Reexamination Certificate

active

06835180

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to a system and method for biopsy management with particular application to minimally invasive surgery, such as endoscopic or laparoscopic surgery. The system and method enables multiple samples to be collected and stored without withdrawal of a biopsy instrument or other element from the surgical site.
BACKGROUND OF THE INVENTION
In the medical world, an increasing number and type of surgeries are being performed using minimally invasive techniques. Typically, these procedures involve making one or more relatively small incisions in the patient in proximity to the surgical target. A cannula or other type of surgical port (hereinafter referred to generally as a “surgical port”) is inserted into the patient through the incision to form a conduit through which the surgeon can access the surgical site. The surgeon then performs the entire surgery from the exterior of the patient's body by manipulating surgical devices and instruments through the surgical port.
Minimally invasive procedures are also a desirable means by which to perform biopsies, either independent of or during the course of a minimally invasive surgery. It is often necessary or desirable to take multiple biopsy samples from a given organ or organs. Under these circumstances, individual samples must be captured, stored and their origin recorded to accurately analyze the results.
Many currently known procedures for obtaining biopsy samples involve inserting a biopsy forcep or other harvesting instrument through the surgical port to the desired location, manipulating the instrument to obtain the sample, withdrawing the instrument and sample through the surgical port, transferring the sample to a suitable container, and subsequently repeating the process for each needed sample. As these procedures require repeated removal and reintroduction of the biopsy instrument through the surgical port, they are time consuming, and increase the likelihood of damaging the surgical port. They may also increase the chances for bacterial infection. With each withdrawal also comes the possibility of dislodging the sample from the biopsy instrument. The sample may subsequently be difficult to locate if it drops back into the surgical site. Further, the samples can be dripping fluid and cells as they are withdrawn, potentially “seeding” areas of healthy tissue if diseased cells exits.
In an effort to address some of these problems, some biopsy instruments have been developed that enable multiple samples to be taken without withdrawal of the biopsy instrument from the target site. See, e.g., U.S. Pat. Nos. 4,651,753, 5,526,822, 5,810,744, 5,980,468, 5,524,634, 6,142,957 and 6,322,522. Many of these instruments, however, are not suitable for endoscopic procedures. Others collect the multiple samples external to the body and, therefore, require additional mechanisms to remove the specimen from the target site after each sample is harvested. Many collect multiple samples at or near the target site, but do so in a single container or tube like element that is integral with the biopsy instrument. These devices provide no means for separating and maintaining the integrity of the individual samples. A further drawback is that the samples must still be subsequently transferred to a suitable container or the like for storage and/or transfer to an appropriate site for analysis.
Accordingly, the need exists for an improved system and method for managing a plurality of biopsy samples, particularly for use with minimally invasive surgical techniques.
SUMMARY OF THE INVENTION
The problems and disadvantages associated with the conventional techniques and devices utilized for and during endoscopic surgery are overcome by the present invention, which includes a medical specimen carrier for insertion through a surgical port during a minimally invasive surgical procedure on a patient. The medical specimen carrier includes a housing having a plurality of compartments therein each capable of holding a tissue specimen. The housing has a length and a cross-section smaller than a cross-section of the surgical port so as to enable it to pass therethrough, and is further dimensioned to be placed within the surgical site separate from the surgical port or other surgical instrument. The medical specimen carrier further includes a cover device capable of selectively opening and closing each of said plurality of compartments.
According to another embodiment, the cover device further includes a plurality of cover elements each corresponding to a different one of the plurality of compartments and each capable of being manipulated to open or close the corresponding compartment.
In yet another embodiment, the cover elements are each pivotably coupled to the housing, and in an alternate embodiment the cover elements are slidably engaged with the housing and slidable relative to the housing to selectively open or close the plurality of compartments.
In a further embodiment, each of the plurality of cover elements have a recess therein sized and shaped to receive a tip of a medical instrument. The housing of another embodiment further includes a grasping portion at one end thereof.
Also provided is a method for obtaining a plurality medical specimens during minimally invasive surgery that includes the steps of introducing into a surgical site through a surgical port a medical specimen carrier having a plurality of separate compartments each for receiving a medical specimen therein, positioning the specimen carrier within the surgical site apart from the surgical port or other surgical instrument, obtaining a first medical specimen from the surgical site, and placing the first medical specimen within a first one of the plurality of compartments of the specimen carrier. According to another embodiment, the method further includes the steps of obtaining a second medical specimen from the surgical site, placing the second medical specimen in a second one of the plurality of compartments, and removing the specimen carrier from the surgical site via the surgical port.


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International Search Report dated Mar. 29, 2004, for corresponding PCT/US03/09297.

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