Surgery – Diagnostic testing – Sampling nonliquid body material
Reexamination Certificate
2000-04-24
2003-10-14
Hindenburg, Max (Department: 3736)
Surgery
Diagnostic testing
Sampling nonliquid body material
C604S164100, C606S167000
Reexamination Certificate
active
06632182
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to the field of endoscopic biopsy devices for use in obtaining samples of tissue. More particularly, this invention relates to the field of endoscopic biopsy devices, both flexible and rigid, for use in obtaining multiple samples of tissue without the need for withdrawal and reinsertion of the device during the procedure.
BACKGROUND OF THE INVENTION
An endoscope is a long, narrow instrument which is provided with a means of visualization of the tissue, and also with a means of obtaining tissue biopsy or other manipulations of tissue. The endoscope may be flexible or rigid. The means of visualization may be fiberoptic imaging or by means of a small video chip which is mounted in the distal end of the endoscope. The means of obtaining the biopsy specimen is via a long narrow channel (the “instrument channel” or “biopsy channel”) which is within the body of the endoscope. Through this instrument channel a biopsy forceps is passed, which forceps is a long and narrow instrument that can fit through the channel and which has jaws or another cutting or tearing device at its distal end. The jaws device can be actuated by a lever or trigger at the proximal end (the handle) of the biopsy device.
The biopsy forceps itself can be rigid in the case of rigid endoscopes or flexible in the case of flexible endoscopes. A typical example of a flexible endoscope would be a colonoscope for examining the colon, a gastroscope for examining the stomach and upper intestine and a bronchoscope for examining the pulmonary bronchi. A typical diameter for the instrument channel of a colonoscope or gastroscope would be around 2.8 mm or slightly larger. For a bronchoscope, since the endoscope itself is narrower, the biopsy channel would be around 2 mm in diameter. Biopsy instruments compatible with these scopes must obviously be narrow enough to comfortably fit in the channel and must also be flexible, since these are all examples of flexible endoscopes.
The taking of multiple biopsy samples is necessary to properly evaluate a patient's condition in many diagnostic situations. With most current endoscopic biopsy forceps, the forceps must be withdrawn after each single bite of tissue, the jaws of the forceps must be opened and then the specimen is extracted by the nurse or endoscopic technician. To withdraw the biopsy forceps takes some time, especially in the case of a long scope (about 3 feet) such as a colonoscope, and as the forceps is being withdrawn, there is a good chance of the personnel being splashed or sprayed with bodily fluids from the patient. In the case of obtaining multiple biopsy specimens, this repeated withdrawal, extraction of a specimen from the jaws, and re-insertion of the forceps is tedious and messy.
Recently, there have appeared in limited use endoscopic biopsy forceps which can bite and hold several tissue specimens. These devices store the individual biopsy specimens in a queue which is within the jaws or just proximal to the jaws in the distal end of the instrument. Although this technology allows one to take multiple biopsies without withdrawing the instrument until the end of the series of biopsies, the individual specimen pieces in the queue must be manually separated by the nurse or technician. Since these are very tiny and irregularly shaped and sized bits, one does not always get a nice neat queue, and what one gets at the end of the instrument may look more like a “clump” of bits of tissue. It may be tedious and difficult to actually separate the pieces without confusion. A needle is usually what is used to tease out the separate pieces from the clump. Also, this process is somewhat unaesthetic and messy to perform. After the separation is done, the nurse or technician must transfer each individual bit to a separate specimen container which must be separately labelled. When one is dealing with multiple specimens, keeping all of these separate and organized and properly labelled is difficult, particularly under the time constraints of a busy endoscopy unit.
OBJECTS OF THE INVENTION
It is an object of the invention to provide an endoscopic multiple sample biopsy forceps.
It is also an object of the invention to provide a method of end-on biting or cutting to obtain multiple samples.
It is a further object of the invention to provide for a device which can retrieve multiple samples without having to withdraw the forceps between bites or cuts.
It is a yet further object of the invention to provide for such a device which can deliver the individual bits of tissue into a multi-chambered storage container which will keep the specimens separated and which will obviate the need for manual separation and handling of the specimens.
These and other objects of the invention will become more apparent from the discussion below.
SUMMARY OF THE INVENTION
This invention provides a means of overcoming the problems and disadvantages of previous multiple sample biopsy devices. With the device of the invention one can obtain multiple biopsies with a single placement of the forceps within the instrument channel of the endoscope. Also, the specimen bits are automatically separated into individual compartments of the multi-chambered specimen storage container. These compartments may be easily Labelled as to anatomic site (i.e., cecum, transverse colon, descending colon, etc.) ahead of time by stick-on labels or by use of a marking pen. Very importantly, no one in the endoscopy unit itself has to try to handle or separate out individual tiny bits of tissue which may contain infectious human bodily fluids.
Also, unlike the devices which queue the specimens in the distal end of the forceps, there is no fixed limit to the number of samples which the device of the invention can take, since one can change the multi-chambered specimen storage revolver in the handle for a new one and continue taking more samples.
In accord with the above objects of the invention, which will be discussed in more detail below, the endoscopic biopsy forceps of the present invention consists of a long, narrow, flexible or rigid, inner tubular member or tube to which are attached at the distal end, or molded integrally onto the distal end, serrated or cutting jaws. The inner lumen of this inner tubular member is such that the bits of tissue cut by the jaws can be suctioned to the proximal end of this tube. The proximal end of this tubular member is connected via an actuator such as a trumpet valve to the rotatable, revolver-type, multi-chambered specimen trap. The revolver specimen trap is attached to the actuator in such a way that each one of its separate chambers can singly or individually be connected to the proximal orifice of the actuator. The other end of the revolver specimen holder is connected to a suction source such as wall suction. There is a sieve-like floor for each of the chambers of the revolver, so that the suction can act to pull the specimen bit through the inner tube into a chamber of the trap, but the sieve material prevents the specimen from going out through the suction tubing and being lost.
The jaws of the inner tubular member are actuated by pushing an outer tubing or sheath distally to close or compress the jaws together, producing the biting or cutting action. Other biting or cutting arrangements may be used as well. See, for example, the grasping/biting/cutting configurations disclosed in U.S. Pat. Nos. 5,601,585, 5,524,634, 5,636,639, 5,638,827, 5,645,075, 5,647,115, and 5,746,216, all of which are incorporated herein by reference.
Thus, the device of the present invention permits the taking of biopsies via an endoscope in such a way that:
(1) Multiple biopsies can be obtained without withdrawal and reinsertion of the device into the endoscope. With conventional forceps, the forceps must be withdrawn after each biopsy to remove the tissue from the jaws of the forceps. Withdrawal of the forceps after each biopsy is time-consuming and also exposes the staff to the possibility of spray or aerosol contamination by the patient's bodily fluids.
(
Hindenburg Max
Reed Smith LLP
The Trustees of Columbia University in the City of New York
Wingood Pamela L
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