Surgery – Diagnostic testing – Sampling nonliquid body material
Reexamination Certificate
2000-05-02
2002-04-09
Nasser, Robert L. (Department: 3736)
Surgery
Diagnostic testing
Sampling nonliquid body material
Reexamination Certificate
active
06368290
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to biopsy forceps for attachment to an endoscopic biopsy device and more particularly to forceps that are inexpensive to produce and therefore disposable after one use.
BACKGROUND ART
The diagnosis of several diseases often involves the removal of small samples of tissue from a part of the living body for microscopic examination, a procedure known as biopsy. Endoscopic biopsy involves the removal of mucosal tissue or biopsy of neoplastic growths found in pans of the body accessible to an endoscope such as the gastro-intestinal tract or other parts of the body.
The endoscope is inserted into the body of an individual and when the biopsy head is adjacent an area of tissue to be sampled, it is actuated to bring two biopsy cups together. The cups act together to cut a small sample from the adjacent tissue.
The biopsy heads currently in use are usually formed of stainless steel and comprise a number of different pans which are usually hingedly joined together. As a result conventionally employed biopsy heads are expensive to make and therefore designed to be re-used many times. While the heads can be sterilised by autoclaving there is still a chance of cross contamination from one patient to another, and in particular there is justifiable concern among many that viruses such as Hepatitis B and HIV may be spread from one patient to another. It Is therefore desirable to move to a disposable alternative.
The present invention relates to a design for a biopsy forceps head which because its components need not be hingedly connected and because it may be made from a suitable synthetic plastics material is inexpensive to produce and so disposable after one use only.
SUMMARY OF THE INVENTION
The present invention relates to an endoscopic biopsy device, the biopsy device including two individual members or “jaws” which are pivoted about a common axis thereby forming a forceps, each jaw including a tissue capturing means, such as a biopsy cup having a concave body, and an actuator member, the actuator member attaching to a jaw at a flexible joint.
In one embodiment each actuator member is preferably connected, at the end distal the biopsy cups, to operating means such as an endoscope cable, which can be manipulated by a doctor performing the biopsy. Manipulation of the operating means transmits forces to the actuator members which causes movement of the actuator members which in turn leads to flexion or extension of the flexible joint members causing the biopsy cups to move between their open and closed positions.
In a still further embodiment the biopsy head is formed from a synthetic plastics material such as polyamide nylon.
In a preferred embodiment, the individual members are held together relative one another at the pivotal point by means of a pin or a screw made from a suitable plastics or any other material and adapted such that the biopsy heads can articulate relative one another upon actuation.
Preferably there is a space between the biopsy cups at the end closest the pivotal point, the space allowing the escape of fluids or excess tissue from between the cups. If the space is not provided an air lock may result preventing a sufficient amount of tissue for sampling from being caught between the cups. There may also be cases in which the biopsy cups are prevented from closing due to tissue being caught between the cups on the side opposite to the opposed cutting surface.
Consequently. according to the present invention there is provided a biopsy device comprising:
a pair of biopsy jaws, each of said jaws having a tissue capturing means at a first end and a flexible joint at a second end, pivot engagement means being located between said first and second ends;
a pair of actuator members each coupled to one of said joints;
an actuator housing surrounding said actuator members;
a pivot means interconnecting said actuator housing and said pair of saws;
each said biopsy jaw, including said flexible joint, being formed integrally with said actuator member.
According to a further aspect of the invention there is provided a biopsy jaw forming one half of a pair of forceps for use in a biopsy device, said jaw including a flexible joint integrally connected to an actuator member.
It will be realised that, because each of the biopsy jaws, including tissue capturing means such as a cup, are attached to the actuator member by way of a flexible joint member, there is no requirement for the individual components to be hingedly connected. This has the advantage that each jaw, including a hinge, can be formed integrally with an actuator member, the moulded individual members are identical and can be pinned together at the pivotal point such that the edges of the biopsy cups may be brought into cutting opposition. The fact that the individual members can be moulded in one piece results in decreased production costs making it feasible to use the biopsy heads for only one procedure on a patient before their disposal.
REFERENCES:
patent: 5052402 (1991-10-01), Bencini et al.
patent: 5172700 (1992-12-01), Bencini et al.
Nasser Robert L.
Reising, Ethington, Barnes, Kissell, Learman & McCulloch, P.C.
Szmal Brian
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