Biopsy instrument having irrigation and aspiration capabilities

A biopsy instrument and method of using such are provided wherein the biopsy instrument includes a proximal actuation handle, an elongate flexible member, and a distal assembly. The flexible member, connected to and extending from the actuation handle, includes an aspiration conduit for fluid connection with a vacuum source and for permitting the flow of fluid from the distal end to the proximal end of the biopsy instrument. The flexible member may include an irrigation conduit for supplying irrigation fluid to the distal end. The actuation handle includes a stationary member and an actuation device, and may include a sample chamber, a sample collector, valves for regulating the vacuum in the aspiration conduit and the fluid flow in the irrigation conduit, and a pressure increasing device for selectively increasing the pressure of the fluid supplied to the distal end. The distal assembly, coupled to the distal end of the flexible member, may be comprised of a movable jaw and a stationary jaw, or of first and second movable jaws. With the jaws in a closed position, the distal assembly may provide a substantially fluidtight passageway at the distal end of the aspiration conduit. The movable jaws are coupled to the actuation device, such that actuation of the actuation handle moves the movable jaws relative to the flexible member, thereby opening and closing the digital assembly.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates broadly to endoscopic surgical instruments. More particularly, this invention relates to an endoscopic biopsy instrument with means for facilitating sample removal without withdrawal of the biopsy instrument from an endoscope.

2. State of the Art

Endoscopic biopsy procedures are typically performed with an endoscope and an endoscopic biopsy forceps device (bioptome). The endoscope is a long flexible tube carrying fiber optics and having a narrow lumen through which the bioptome is inserted. The bioptome typically includes a long flexible coil having a pair of opposed jaws at the distal end and manual actuation means at the proximal end. Manipulation of the actuation means opens and closes the jaws. During a biopsy tissue sampling operation, the surgeon guides the endoscope to the biopsy site while viewing the biopsy site through the fiber optics of the endoscope. The bioptome is inserted through the narrow lumen of the endoscope until the opposed jaws arrive at the biopsy site. While viewing the biopsy site through the fiber optics of the endoscope, the surgeon positions the jaws around a tissue to be sampled and manipulates the actuation means so that the jaws close around the tissue. A sample of the tissue is then cut and/or torn away from the biopsy site while it is trapped between the jaws of the bioptome. Keeping the jaws closed, the surgeon withdraws the bioptome from the endoscope and then opens the jaws to collect the biopsy tissue sample.

A biopsy tissue sampling procedure often requires the taking of several tissue samples either from the same or from different biopsy sites. Unfortunately, most bioptomes are limited to taking a single tissue sample, after which the device must be withdrawn from the endoscope and the tissue collected before the device can be used again to take a second tissue sample. Several attempts have been made to provide an instrument which will allow the taking of several tissue samples before the instrument must be withdrawn and the samples collected. Problems in providing such an instrument include the extremely small size required by the narrow lumen of the endoscope and the fact that the instrument must be flexible in order to be inserted through the lumen of the endoscope. Thus, several known multiple sample biopsy instruments are precluded from use with an endoscope because of their size and rigidity. These include the “punch and suction type” instruments disclosed in U.S. Pat. No. 3,989,033 to Halpern et al. and U.S. Pat No. 4,522,206 to Whipple et al. Both of these devices have a hollow tube with a punch at the distal end and a vacuum source coupled to the proximal end. A tissue sample is cut with the punch and suctioned away from the biopsy site through the hollow tube. It is generally recognized, however, that dry suctioning tissue samples (i.e., without the use of an irrigating fluid) through a long narrow flexible bioptome is virtually impossible.

Efforts have been made to provide multiple sampling ability to an instrument which must traverse the narrow lumen of an endoscope. These efforts have concentrated on providing a cylindrical storage space at the distal end of the instrument wherein several tissue samples can be accumulated before the instrument is withdrawn from the endoscope. U.S. Pat. No. 4,651,753 to Lifton, for example, discloses a rigid cylindrical member attached to the distal end of a first flexible tube. The cylindrical member has a lateral opening and a concentric cylindrical knife blade is slidably mounted within the cylindrical member. A second flexible tube, concentric to the first tube is coupled to the knife blade for moving the knife blade relative to the lateral opening in the cylindrical member. A third flexible tube having a plunger tip is mounted within the second flexible tube and a vacuum source (a syringe) is coupled to the proximal end of the third tube. A tissue sample is taken by bringing the lateral opening of the cylindrical member upon the biopsy site, applying vacuum with the syringe to draw tissue into the lateral opening, and pushing the second flexible tube forward to move the knife blade across the lateral opening. A tissue sample is thereby cut and trapped inside the cylindrical knife within the cylindrical member. The third flexible tube is then pushed forward moving its plunger end against the tissue sample and pushing it forward into a cylindrical storage space at the distal end of the cylindrical member. Approximately six samples can be stored in the cylindrical member, after which the instrument is withdrawn from the endoscope. A distal plug on the cylindrical member is removed and the six samples are collected by pushing the third tube so that its plunger end ejects the samples.

The device of the Lifton patent suffers from several recognizable drawbacks. First, it is often difficult to obtain a tissue sample laterally of the device. Second, in order to expedite the obtaining of a lateral sample, a syringe is used to help draw the tissue into the lateral opening. However, this causes what was once a two-step procedure (position and cut), to become a three-step procedure (position, suction, cut). In addition, the use of a syringe requires an additional hand. Third, the Lifton patent adds a fourth step to the biopsy procedure by requiring that the tissue sample be pushed into the storage space. Thus, in all, the Lifton patent requires substantial effort on the part of the surgeon and an assistant and much of this effort is involved in pushing tubes, an action which is counter-intuitive to classical biopsy sampling. The preferred mode of operation of virtually all endoscopic tools is that a gripping action at the distal end of the instrument is effected by a similar action at the proximal end of the instrument. Classical biopsy forceps jaws are closed by squeezing a manual actuation member in a syringe-like manner.

A more convenient endoscopic multiple sample biopsy device is disclosed in U.S. Pat. No. 5,171,255 to Rydell. Rydell provides a flexible endoscopic instrument with a knife-sharp cutting cylinder at its distal end. A coaxial anvil is coupled to a pull wire and is actuated in the same manner as conventional biopsy forceps. When the anvil is drawn into the cylinder, tissue located between the anvil and the cylinder is cut and pushed into a storage space within the cylinder. Several samples may be taken and held in the storage space before the device is withdrawn from the endoscope. While the device of Rydell is effective in providing a multiple sample tool where each sample is obtained with a traditional two-step procedure (position and cut), it is still limited to lateral cutting which is often problematic. Traditional biopsy forceps provide jaws which can grasp tissue frontally or laterally. Even as such, it is difficult to position the jaws about the tissue to be sampled. Lateral sampling is even more difficult.

A multiple sample biopsy forceps of a more traditional form is disclosed-in co-owned U.S. Pat. No. 5,542,432 to Slater et al. Slater et al. discloses an endoscopic multiple sample biopsy forceps having a jaw assembly which includes a pair of opposed toothed jaw cups each of which is coupled by a resilient arm to a base member. The base member of the jaw assembly is mounted inside a cylinder and axial movement of one of the jaw assembly and cylinder relative to the other draws the arms of the jaws into the cylinder or moves the cylinder over the arms of the jaws to bring the jaw cups together in a biting action. The arms of the jaws effectively form a storage chamber which extends proximally from the lower jaw cup and prevents accumulated biopsy samples from being squeezed laterally out from between the jaws during repeated opening and closing of the jaws and the lower jaw cup enhances movement of the biopsy samples into the storage chamber. The device can hold up to four samples before it must be retrieved out of the endoscope. However, in some biopsy procedures it is sometimes desirous to retrieve more. In addition, it has been found that samples within the chamber can stick together and make determinations of which sample came from which biopsy site somewhat difficult.

U.S. Pat. No. 5,538,008 to Crowe discloses a multiple sample bioptome which purports to take several samples and to transfer each sample by water pressure through a duct to the proximal end of the instrument, where each sample can be individually retrieved. The device includes a plastic jaw set biased in an open position and coupled to the distal end of an elongate tube, up to seven feet long. The tube defines a duct. A sleeve extends over the tube and a water flow passage is provided between the tube and the sleeve. An aperture is provided in the tube to permit the water flow passage to meet the duct at the distal end of the tube. Withdrawing the tube into the sleeve is disclosed to force the jaws closed and enable a sample to be cut from tissue and lodge in the duct. The water flow passage is disclosed to enable water to flow under pressure from the proximal end of passage to the distal end of the passage, through the aperture and into the distal end of the duct and to be aspirated to the proximal end of the duct, thereby transferring with it any sample contained in the duct to the proximal end where the sample can be retrieved.

While on paper the Crowe device is appealing, in practice the design is impractical and flawed. For example, it would be very difficult, if not impossible, to slide the elongate tube, up to seven feet in length, relative to a sleeve of substantially the same length. It would also be difficult to maintain an unobstructed water flow passage between the tube and sleeve as the tube and sleeve curve and bend through the body. Furthermore, in order for the jaws to cut a tissue sample, the tube and jaws must be drawn into the sleeve, thereby undesirably pulling the jaws away from the tissue to be sampled.

SUMMARY OF THE INVENTION

An endoscopic biopsy instrument is provided and generally includes a proximal actuation handle, a distal forceps assembly, a control member coupled to the proximal actuation handle and the distal forceps assembly, and a flexible multi-lumen tubular member having an aspiration conduit, and a control conduit which receives the control member.

According to a first aspect of the invention, the proximal actuation handle includes a shaft and a spool slidably mounted on the shaft. The actuation handle is also provided with a proximal irrigation passage, a sample chamber, a sample catch member, and a pinch valve which regulates irrigation and aspiration. The proximal irrigation passage is coupled to the irrigation conduit and to an irrigation coupling tube. The sample chamber is coupled to the aspiration conduit and to an aspiration coupling tube. The sample catch member includes a screen which is inserted into the sample chamber and filters out tissue samples from the aspirated fluid. The irrigation coupling tube and the aspiration coupling tube extend through the pinch valve which operates to control the flow of fluid through the tubes. The actuation handle is coupled to the proximal ends of both the flexible tubular member and the control member and moves the control member relative to the tubular member.

The distal assembly is coupled to the distal end of the tubular member and includes a hollow stationary jaw coupled over the distal end of the aspiration conduit and a hollow movable jaw pivotably coupled adjacent the irrigation conduit. The stationary jaw, preferably formed from a hard plastic or stainless steel, has a blunt edge, while the movable jaw is preferably a metal jaw with a sharp cutting edge. The movable jaw is further coupled to the control member, such that actuation of the actuation handle moves the movable jaw relative to the stationary jaw, and thereby moves the jaw from an open position to a closed position. Moving the hollow jaw to a closed position provides a substantially fluidtight coupling between the irrigation and aspiration conduits.

It will be appreciated that the distal end of the instrument is brought into contact with tissue of which a sample is required and the actuation handle is actuated to close the jaws and cut off a tissue sample. With the jaws in a closed position, water is irrigated through the irrigation conduit to the jaws at the distal end of the instrument and aspirated from the jaws to the proximal end of the instrument through the aspiration conduit, such that the sample cut by the jaws is aspirated with the water. As the water is aspirated it passes through the chamber and the sample is filtered onto the screen. The screen may easily be removed to retrieve the sample. It will be further appreciated that the entire procedure of cutting a sample and retrieving the sample may be performed without removing the endoscopic biopsy instrument from its location within the body.

According to a further aspect of the invention, a biopsy instrument is provided having a proximal end and a distal end. The biopsy instrument includes a distal assembly, an elongate flexible member connected to and extending in a proximal direction from the distal assembly, and a proximal actuation handle coupled to the proximal end of the flexible member. The flexible member includes an irrigation conduit and an aspiration conduit. The proximal actuation handle includes an irrigation port in fluid connection with the proximal end of the irrigation conduit and an aspiration port in fluid connection with the proximal end of the aspiration conduit. The irrigation port is for fluid connection with a fluid source; the aspiration port is for fluid connection with a suction device.

In another aspect, the invention may include a control member connected to and extending from the distal assembly to the proximal actuation handle. The proximal actuation handle may include means for actuating the control member and the distal assembly. Furthermore, the distal assembly may include a stationary jaw and a movable jaw. The movable jaw is pivotable relative to the stationary jaw. The movable jaw is in fluid connection with either the irrigation conduit or the aspiration conduit; the stationary jaw is in fluid connection with the other. The distal assembly forms a fluid passageway between the irrigation conduit and the aspiration conduit when the movable jaw and the stationary jaw are in a closed position.

In a still further aspect of the present invention, the biopsy instrument includes a proximal actuation handle, and an elongate flexible member connected to and extending from the proximal actuation handle and having an irrigation conduit for fluid connection with a fluid source and for supplying a fluid to the distal end of the biopsy instrument. The biopsy instrument further includes a distal assembly for use in a surgical operation, and a means for permitting an operator to selectively increase fluid pressure in the irrigation conduit thereby causing a surge in fluid flow through the biopsy instrument. The distal assembly is attached to the distal end of the flexible member. The means for permitting an operator to selectively increase fluid pressure in the irrigation conduit may include a fluid pressure device in fluid connection with the irrigation conduit. The fluid pressure device may include a contractible fluid accumulating chamber.

The invention may include an aspiration conduit for fluid connection with a vacuum source and for permitting the flow of fluid from the distal end to the proximal end of the biopsy instrument. The biopsy instrument may also include an actuator on the proximal actuation handle, a control conduit on the elongate flexible member, and a control member extending through the control conduit. The control member is connected to and extends from the actuator to the distal assembly. Furthermore, the distal assembly may include a stationary jaw and a movable jaw. The movable jaw is pivotable relative to the stationary jaw. The movable jaw is in fluid connection with either the irrigation conduit or the aspiration conduit; the stationary jaw is in fluid connection with the other. The distal assembly may form a fluid passageway between the irrigation conduit and the aspiration conduit when the movable jaw and the stationary jaw are in a closed position. A sample collector assembly may be provided in-line with the aspiration conduit and the vacuum source and located therebetween. An irrigation valve in fluid connection with the irrigation conduit and the fluid source may be provided. The irrigation valve is configured to start and stop a fluid flow in the irrigation conduit. A suction valve in fluid connection with the aspiration conduit and the vacuum source may also be provided. The suction valve is configured to start and stop a vacuum effect in the aspiration conduit.

According to a further aspect of the invention, a method is provided for retrieving a biopsy tissue sample using the biopsy instrument having irrigation and aspiration capabilities in conjunction with a fluid pressure device. The biopsy instrument includes a proximal actuation handle, an elongate flexible member extending from the proximal actuation handle and having an irrigation conduit, a distal assembly located at the distal end of the biopsy instrument, and a fluid pressure device in fluid connection with the irrigation conduit. The method comprises the steps of: inserting the distal end of the biopsy instrument into a patient; positioning the distal assembly proximate to a tissue to be sampled; detaching the tissue sample from a surrounding tissue using the distal assembly; introducing a flow of fluid through the fluid pressure device and the irrigation conduit; actuating the fluid pressure device to cause a surge in fluid flow through the distal end of the biopsy instrument to flush the tissue sample through an aspiration conduit configured for fluid connection with a vacuum source and for permitting fluid to flow from the distal end to the proximal end of the biopsy instrument; and recovering the tissue sample.

The method may include the steps of: manipulating an actuator connected to a control member which is connected to a movable jaw of the distal assembly, whereby manipulating the actuator opens the distal assembly; moving the open distal assembly so as to encompass the tissue to be sampled; and re-manipulating the actuator to close the distal assembly and detach the tissue sample. Additionally, method may include initiating a vacuum effect in the aspiration conduit after the detaching step. Furthermore, the method may include repeating the steps of positioning, detaching, introducing, actuating, and recovering for subsequent tissue samples.

According to another aspect, the invention comprises a sample collector having a catcher handle and a catcher body. The sample collector is for use with a biopsy instrument having a suction passageway with a proximal end access opening. The catcher handle has a securing end for insertion into the access opening. The securing end of the catcher handle may complement the access opening to provide a seal therewith. The catcher body has a screen, may be removably attached to the securing end of the catcher handle, and is positionable within the suction passageway upon insertion of the securing end into the access opening. The catcher body may fit a pathology processing cartridge. The sample collector may be provided with a cover. The cover is positionable between an open position displaced from the catcher body and a closed position overlaying the catcher body.

In an additional aspect of the invention, a biopsy instrument with aspiration capabilities is provided having a distal assembly for use in a surgical operation, an elongate flexible member connected to and extending from the distal assembly to the proximal end, a proximal actuation handle with a suction passageway having an access opening, and a sample collector. The flexible member includes an aspiration conduit for fluid connection with a vacuum source and for permitting the passage of matter from the distal end to the proximal end. The suction passageway of the proximal actuation handle is in fluid connection with the aspiration conduit and capable of fluid connection with the vacuum source. The sample collector includes a catcher handle having a securing end for insertion into the access opening and a catcher body with a screen. The catcher body is positionable within the suction passageway upon insertion of the securing end into the access opening. Furthermore, the catcher body may be removably attached to the securing end of the catcher handle; the securing end may complement the access opening to provide a seal therewith; and the sample collector may include a cover positionable between an open position displaced from the catcher body and a closed position overlaying the catcher body. The flexible member of the biopsy instrument may include an irrigation conduit in fluid connection with a fluid source and for supplying fluid to the distal end of the biopsy instrument.

Additionally, the objects and purpose of the invention are obtained by a method of retrieving a biopsy sample using a biopsy instrument with aspiration capabilities in conjunction with an irrigation endoscope. The biopsy instrument includes a distal assembly, an elongate flexible member with an aspiration conduit, a proximal actuation handle, a vacuum source, and a sample collector. The proximal actuation handle includes a suction passageway in fluid connection with the aspiration conduit and having an access opening. The vacuum source is in fluid connection with the suction passageway. The sample collector has a catcher handle and a catcher body with a screen. The method comprises the steps of: introducing the remote end of the endoscope into a patient; engaging the sample collector into the access opening of the proximal actuation handle; inserting the distal end of the biopsy instrument through the working channel of the endoscope until the distal assembly is proximate the tissue to be sampled; obtaining the tissue sample using the distal assembly; initiating a vacuum effect in the suction passageway and the aspiration conduit to draw the tissue sample into the catcher body; and disengaging the sample collector from the proximal actuation handle.

In a further aspect of the invention, the method may include the step of establishing a temporary vacuum effect in the aspiration conduit to pull the tissue to be severed into the distal assembly. The method may also include the step of positioning a cover over the catcher body to entrap the tissue sample and of disconnecting the catcher body from the catcher handle. The method may further include the step of squirting irrigation fluid from the remote end of the irrigation endoscope. The initiated vacuum effect draws the squirted irrigation fluid and tissue sample through the aspiration conduit and suction passageway to the screen of the catcher body. Finally, the introducing, engaging, inserting, obtaining, initiating, and disengaging steps of the method may be repeated for subsequent tissue samples.

According to a still further aspect of the invention, the biopsy instrument includes a proximal actuation handle, an elongate flexible member, and a distal end effector assembly for use with an irrigation endoscope in a surgical operation. The elongate flexible member, connected to and extending from the proximal actuation handle, has an aspiration conduit for fluid connection with a vacuum source and for permitting the flow of fluid from the distal end to the proximal end of the biopsy instrument. The biopsy instrument may include a sample chamber, a sample catch member, and a valve which regulates the vacuum in the aspiration conduit.

The distal end effector assembly, comprised of first and second hollow movable jaws, is coupled to the distal end of the tubular member. The first and second hollow movable jaws are pivotably coupled adjacent the aspiration conduit to the tubular member. With the jaws in a closed position, the end effector assembly provides a substantially fluidtight passageway at the distal end of the aspiration conduit. The movable jaws may be made from metal or plastic and may have sharp cutting edges, teeth for grasping, or other matching profiles. The movable jaws are further coupled to the control member, such that actuation of the actuation handle moves the movable jaws relative to the tubular member, thereby opening and closing the distal end effector assembly.

It will be appreciated that with both jaws of the distal end effector assembly being capable of opening and closing, the biopsy instrument may be better positioned around the tissue to be sampled.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Turning now toFIG. 1, a multiple sample biopsy instrument10is shown. The biopsy instrument generally includes a proximal actuation handle12, a flexible multi-lumen tubular member14, a pull wire20, and a distal assembly22. Several coupling tubes are preferably provided to couple the proximal actuation handle12to the tubular member14and to irrigation and aspiration means. In particular, a control coupling tube23, first and second irrigation coupling tubes24,25and first and second aspiration coupling tubes26,27are provided.

The proximal actuation handle12includes a shaft30having a transverse slot32and a spool34slidably mounted on the shaft30and having a transverse bar (not shown) extending through the slot32, as is common in the art. The actuation handle12is provided with a sample chamber42, a sample catch member44, and a pinch valve45which regulates irrigation and aspiration. Turning toFIG. 2, the sample chamber42includes irrigation connectors46,47which couple the first irrigation coupling tube24to the second irrigation coupling tube25. The sample chamber42also includes first and second aspiration connectors48,49which couple the first aspiration coupling tube26to the second aspiration coupling tube27. Referring toFIGS. 3-5, the sample catch member44includes a handle portion52, an engagement portion54which removably engages the sample catch member44to the sample chamber42, and a screen56. The screen56extends through the sample chamber42between the first and second aspiration connectors48,49. The screen56includes a front side58and a back side60and is provided with a plurality of perforations62which are preferably frustoconical in shape and expand from the front side58to the back side60. The first irrigation coupling tube26and the first aspiration coupling tube27extend is through the pinch valve45which operates to control the flow of fluid through the tubes26,27. The pinch valve is biased to clamp closed the first irrigation coupling tube26and the first aspiration coupling tube27, i.e, to collapse the tubes on top of each other. Pressing downward on the pinch valve45with a practitioner's finger counters the bias of the pinch valve to permit fluid flow through the first irrigation coupling tube26and the first aspiration coupling tube27.

Turning toFIGS. 6 and 7, and in accord with the first embodiment of the invention, the tubular member14is preferably an ovoid multi-lumen extrusion. The tubular member includes a proximal end66, a distal end68, a control conduit70an irrigation conduit72, and an aspiration conduit74, each of which extends through the tubular member to the distal assembly22. At the proximal end66of the tubular member, the control conduit70is coupled to the control coupling tube23, the irrigation conduit72is coupled to the second irrigation coupling tube25and the aspiration conduit74is coupled to the second aspiration coupling tube27.

Referring toFIGS. 7 through 9, the distal assembly22includes a substantially rigid molded collar80and a hollow movable jaw90. The collar80is preferably made from a unitary piece of polycarbonate, a glass-filled polycarbonate, a hard grade styrene, or other plastic, while the movable jaw90is preferably made from cast metal. The collar includes a central opening81, a circumferential channel83, a distally extending control passage82, a distally extending hollow jaw mount84, a distally extending hollow stationary jaw88, and a proximal socket86. The central opening81of the collar80is of similar diameter to the outer diameter of the endoscope and is designed to couple the collar to the outside of the distal end of an endoscope. The circumferential channel81receives a portion of a silicone rubber sock (not shown), which is used to secure collar80to the endoscope.

Stationary jaw88preferably includes blunt edge or lip92. Movable jaw90is pivotably mounted at pivot pin94on jaw mount84and is pivotable relative to stationary jaw88. The movable jaw90is preferably provided with a sharp cutting edge98, a stop100for limiting the extent to which the movable jaw pivots away from the stationary jaw88, and two jaw holes102,104, for receiving a pull wire20, as described below.

Referring toFIGS. 9 through 11, the proximal socket86is aligned with the control passage82, the jaw mount84and the stationary jaw88, and is designed to receive the distal end68of the flexible tubular member14. The distal end68of the tubular member is secured in the proximal socket86, preferably using an adhesion bonding agent, such that the control passage82is coupled to the control conduit70, the jaw mount84is coupled substantially fluidtight to the irrigation conduit72, and the stationary jaw88is coupled substantially fluidtight to the aspiration conduit74.

Turning back toFIGS. 1,6,7and10, a central portion of the pull wire20extends through the jaw holes102,104and the ends of the pull wire20extend through the control passage82, the control conduit74, and the control coupling tube23to the spool34. Referring toFIG. 12, alternatively the pull wire20aforms a secure loop106athrough the jaw holes102a,104aby doubling back on itself and forming a twist108a. Referring toFIG. 13, in yet another alternative, two pull wires20b,21bmay be used, the distal end of each pull wire being coupled to a jaw hole102b,104bby a Z-bend110b,112band extending through the control passage82b.

Referring toFIGS. 1,7, and8, it will be appreciated that movement of the spool34relative to the shaft30results in movement of the pull wire20relative to the tubular member14and consequently moves the movable jaw90relative to the stationary jaw88such that the jaws open (FIG. 7) and close (FIG.8). Referring toFIGS. 7 through 11, when the stationary and movable jaws88,90are in a closed position a substantially fluidtight passage is formed therebetween. Because the stationary jaw88is coupled to the aspiration conduit74and the movable jaw90is coupled over the irrigation conduit72, a substantially fluidtight coupling of the irrigation and aspiration conduits is achieved.

In use, it will be appreciated that the distal end of the endoscope to which the collar80is coupled is maneuvered adjacent the desired tissue for sampling and the distal assembly is brought into contact with tissue110(FIGS.10and11). The actuation handle12is actuated to close the jaws88,90and cut off a tissue sample112. When the jaws88,90are in a closed position the irrigation means and the aspiration means are activated and the first proximal irrigation coupling tube and the first proximal aspiration coupling tube24,26are released from the clamping action of the pinch valve45by depressing the pinch valve. Irrigating fluid is thereby permitted to flow through the first and second proximal irrigation coupling tubes24,26, through the irrigation conduit72and the hollow jaw mount84, and to the jaws88,90at the distal end of the instrument. The fluid flows through the jaws and is aspirated back to the proximal end of the instrument such that the sample held within the jaws is aspirated with the water. Turning back toFIGS. 2-6, as the water is aspirated through the aspiration conduit74and into the sample chamber42, the sample is filtered onto the screen58. The frustoconical shape of the perforations62permits increased fluid flow through the perforate screen while preventing the tissue sample from passing through the screen. Irrigation and aspiration means are interrupted by releasing the pinch valve45such that the pinch valve clamps down on the first proximal irrigation and aspiration coupling tubes24,26and causes the tubes to collapse on top of each other. The screen58may easily be removed to retrieve the sample by gripping the handle portion52of the sample catch member44and pulling the sample catch member from the sample chamber42. The sample is recovered from the screen, and the sample catch member is reinserted into the sample chamber to continue the procedure. It will be further appreciated that the entire procedure of cutting a sample and retrieving the sample may be performed without removing the endoscopic multiple sample biopsy forceps instrument from its location within the body. Unlimited subsequent samples may be obtained in an identical manner.

Turning toFIGS. 14 and 15, a second embodiment of a multiple sample biopsy forceps instrument210is shown. The instrument includes a proximal actuation handle212, a flexible multi-lumen tubular member214, a pull wire220, and a distal assembly222. Several coupling tubes are preferably provided to couple the proximal actuation handle212to the tubular member214and to irrigation and aspiration means. In particular, a Y-shaped control coupling tube223, first and second irrigation coupling tubes224,225, and first and second aspiration coupling tubes226,227are provided.

The proximal actuation handle212is substantially similar to the first embodiment (with like parts having numbers incremented by200). Referring toFIGS. 15,16and17, the tubular member214is preferably a multi-lumen multi-layer extrusion, and preferably includes a first metal braid276beneath the outermost layer to add desired stiffness to the tubular member. If desired, a second metal braid277may be additionally provided around the aspiration conduit274to stiffen and support the aspiration conduit274. The tubular member214has a proximal end266, distal end268, two control conduits270,271, an irrigation conduit272, and an aspiration conduit274, each of the conduits270,271,272,274extending through the tubular member to the distal assembly222. The aspiration conduit274has a substantially circular cross section. The irrigation conduit272has a generally kidney-shaped cross section and is separated from the aspiration conduit274by a membrane275. The control conduits270,271are preferably situated one on either end of the membrane275.

Referring toFIGS. 17-20, the distal assembly222according to a second embodiment of the invention includes a stationary jaw281coupled, preferably by adhesion bonding, to the distal end268of the tubular member. The stationary jaw281, preferably made of plastic, includes a jaw cup288, an integral central clevis293and integral proximal ramps295,296. The jaw cup288is located over the aspiration conduit274and preferably has a blunt cutting surface or lip292. The central clevis293and proximal ramps295,296extend from the stationary jaw281and abut and partially cover the irrigation conduit. A movable jaw290, preferably made of metal, is provided with a sharp cutting edge298, defines two jaw holes302,304for receiving a pull wire220, and is provided with two bosses312,314for mounting the jaw. The bosses312,314loosely engage the central lug293and a pivot pin294extends through the bosses and the central lug. The ramps295,296of the stationary jaw281guide the movable jaw290when opening and closing and assist to form a substantially fluidtight passage between the movable jaw290and the stationary jaw cup288when the jaws are in a closed position. A central portion of the pull wire220which is perpendicular to the longitudinal axis of the instrument extends through the jaw holes302,304and the ends of the pull wire extend into the control conduits270,271. Turning back toFIG. 15, the Y-shaped coupling tube223facilitates alignment of the ends of the pull wire220for coupling the pull wire to the proximal actuation handle. The pull wire220may be coated, e.g., in a plastic, to inhibit the pull wire from cutting into the tubular member.

Referring toFIGS. 18 and 20, the distal end268of the tubular member is inserted through the lumen of an endoscope to a biopsy site. The jaws281,290are moved into a closed position cutting off a tissue sample and further providing a substantially fluidtight coupling between the irrigation and aspiration conduits272,274. While it appears from the illustrations ofFIGS. 18 and 20that the irrigation conduit272is obstructed at the distal end by clevis293, it will be appreciated that the irrigation conduit272is substantially wider than the clevis and that fluid may flow around the clevis to the aspiration conduit274.

Turning now toFIGS. 21-23, a third embodiment of a multiple sample biopsy forceps, substantially similar to the second embodiment (with like parts having numbers incremented by another200) is shown. The tubular member414has a proximal end466, a distal end468, an irrigation conduit472, and an aspiration conduit474. The aspiration conduit474has a substantially circular cross section, while the irrigation conduit472has a generally crescent-shaped cross section. A control coupling tube423is coupled to the second irrigation coupling tube425. Two pull wires420,421extend through the control coupling tube423, pass through a substantially fluidtight valve (not shown) coupling the control coupling tube423and the second irrigation coupling tube425, enter into the second irrigation coupling tube425, and extend through the irrigation conduit472to the distal end468of the tubular member. An aspiration coupling tube427is coupled to the aspiration conduit474.

Referring toFIG. 23, the distal assembly422of the third embodiment of the invention includes a stationary jaw481bonded to the distal end468of the tubular member, and a movable jaw490coupled thereto. The stationary jaw481includes a jaw cup488, an integral central clevis493, and ramps495,496. The jaw cup abuts the distal end of the tubular member and is positioned over the aspiration conduit474and preferably has a blunt cutting surface or lip492. The central clevis493and ramps495,496extend from the stationary jaw481and abut and partially cover the irrigation conduit474. A movable jaw490, preferably made or metal, is provided with a sharp cutting edge498, defines two jaw holes402,404for receiving a pull wire420, and is provided with two bosses512,514for mounting the jaw. The bosses512,514loosely engage the central clevis493and a pivot pin494extends through the bosses and the central clevis. By partially covering the irrigation conduit, the ramps form entrances499,500for the pull wires, as described below. The movable jaw490rides on the proximal ramps495,496when moving from an open to a closed position. The pull wires420,421are coupled to the jaw holes502,504by a Z-bend506,507and extend through the entrances499,500into the irrigation conduit472, through a portion of the second irrigation coupling tube425, and further into a control coupling tube423coupled thereto. The entrances499,500are sufficiently small that only an insubstantial amount of fluid exits from the irrigation conduit when the jaws are in a closed position and irrigant is forced through the irrigation conduit474to the distal assembly.

There have been described and illustrated herein several embodiments of a multiple sample endoscopic biopsy instrument. While particular embodiments of the invention have been described, it is not intended that the invention be limited thereto, as it is intended that the invention be as broad in scope as the art will allow and that the specification be read likewise. Therefore, while a particular manner of coupling the proximal actuation handle to the distal assembly has been disclosed for the several embodiments, it will be appreciated that other manners of coupling the proximal and distal assemblies may be used as well. Furthermore while the stationary jaw is disclosed as preferably being made of plastic and the movable jaw is disclosed as being made of metal it will be appreciated both the stationary jaw and the movable jaw may be made from plastic, metal, or another material. Moreover, while the movable jaw is disclosed as preferably being made from cast metal, it will be appreciated that the movable jaw, when made of metal, may alternatively be made by machining or M.I.M. Further, while both jaws are shown without teeth, one or both of the jaws may include teeth along their mating surface. In fact, the teeth may be arranged radially as disclosed in co-owned U.S. Pat. No. 5,507,296. Also, while one or two pull wires are disclosed with respect to certain embodiments, it will be appreciated that in each embodiment either one or two pull wires may be used, in manners described herein. Furthermore, while the stationary jaw is disclosed as being coupled to the aspiration conduit and the movable jaw is disclosed as being coupled to the irrigation conduit, it will be appreciated that the stationary jaw may be coupled to the irrigation conduit and the movable jaw may be coupled to the aspiration conduit. Moreover, it will be appreciated that both the jaws may be movable about the distal end of the tubular member. In addition, while particular configurations have been disclosed in reference to coupling the proximal actuation handle to the tubular member, it will be appreciated that other configurations can be used as well. It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its spirit and scope as so claimed.

The present invention, therefore, is not limited to the particular embodiments described in connection withFIGS. 1-23. The following description provides still further embodiments of a biopsy instrument having irrigation and aspiration capabilities. For example, the embodiment of a biopsy instrument according to the present invention and shown inFIG. 24generally relates to a biopsy instrument having irrigation and aspiration capabilities and including irrigation and aspiration ports.

A biopsy instrument according to the embodiment ofFIG. 24generally includes a proximal actuation handle, a distal assembly, and an elongate flexible member connecting the proximal actuation handle to the distal assembly. The elongate flexible member includes an irrigation conduit and an aspiration conduit, both extending from the distal to the proximal end. The proximal actuation handle includes an irrigation port and an aspiration port. The irrigation port, located at the proximal end of the irrigation conduit, is removably connectable to various fluid sources. The aspiration port, located at the proximal end of the aspiration conduit, is removably connectable to a vacuum source or to a variety of suction retrieval devices. These general portions of the biopsy instrument will now be more specifically described. The operation of the biopsy instrument will be described thereafter.

In accordance with the embodiment ofFIG. 24, there is provided a biopsy instrument having a proximal end and a distal end. A multiple sample biopsy instrument610is shown with proximal end11and distal end13. Biopsy instrument610generally includes a distal assembly522at distal end13, a proximal actuation handle612at proximal end11, and an elongate flexible member614connecting distal assembly522to proximal actuation handle612. During a surgical procedure, proximal end11remains external to a patient's body and under the direct physical control of the surgeon. Distal end13is inserted into a passageway or cavity of the patient's body and is positioned proximate to the remote internal operation site. In the preferred embodiment, distal end13of biopsy instrument610is inserted into and threaded through an endoscope (not shown) which has previously been inserted into the patient's body and positioned proximate to the operation site.

The biopsy instrument according to the embodiment ofFIG. 24includes a distal assembly for use in a surgical operation. Distal assembly522is connected to flexible member614at distal end13of biopsy instrument610.

In a preferred embodiment and as illustrated inFIGS. 25 and 26, distal assembly522includes jaw mount584, movable jaw590, opposing stationary jaw588and pivot pin594. Distal assembly522is shown in an opened configuration in FIG.25and in a closed configuration in FIG.26. As shown inFIG. 26, jaw mount584includes a flange593for retaining pivot pin594and a conduit mounting stub604for facilitating attachment to flexible member614, as described below. As shown inFIG. 25, movable jaw590includes cup-like body595, sharp cutting edge598, pivot holes599a,599bfor receiving pivot pin594, and two opposing clevis flanges597a,597bwith holes602a,602bfor receiving pull wires520a,520b, respectively. Stationary jaw588includes concave cavity601and blunt edge592.

Stationary jaw588is fixedly connected to jaw mount584. Stationary jaw588may be integrally formed with jaw mount584, or stationary jaw588may be welded, bonded, screwed or otherwise fixedly attached to jaw mount584.

As shown inFIGS. 25 and 26, movable jaw590is pivotably mounted to jaw mount584. Movable jaw590pivots about pivot pin594and relative to jaw mount584and stationary jaw588to open and close distal assembly522. Distal assembly522is in a closed configuration when cutting edge598abuts blunt edge592. Movable jaw590may be provided with a stop (not shown) for limiting the extent to which jaw590pivots away from stationary jaw588. Alternatively, such a stop could be located on jaw mount584.

Referring toFIG. 25, movable jaw590is pivotably attached to distal ends of pull wires520a,520b. The distal ends of pull wires520a,520bare bent at right angles, inserted through holes602a,602b, respectively, and then further bent at right angles to provide a retention feature. Thus, no additional parts are required to attach pull wires520a,520bto the distal assembly. Pull wires520a,520bmight also be provided with a U-shaped portion603a,603b, respectively, proximate the distal end for accommodating a portion of the clevis flange597a,597b.

Pull wires520a,520bextend in a proximal direction to proximal actuation handle612. As described below, the proximal ends of pull wires520a,520bare connected, directly or indirectly, to actuation spool34. This configuration allows a surgeon to cut a biopsy sample at the distal end of the biopsy instrument by manipulating actuation spool34at the proximal end of the biopsy instrument. Other embodiments with various control configurations are discussed above in connection withFIGS. 1-23. It is to be understood that the principles of these control configurations also may be applied to the biopsy instrument of FIG.24.

In addition, it should be understood that while the previously described distal assembly ofFIGS. 25 and 26may be used in connection with the biopsy instrument ofFIG. 24, other manipulable and non-manipulable distal assemblies may also be used without departing from the scope or spirit of the invention. For example, alternative distal assemblies include single and dual actuating jaws having cutting edges, teeth, matching projections for grasping enhancement, or combinations thereof. Furthermore, the principle and details of the distal assemblies shown inFIGS. 1-23also may be applied to the biopsy instrument of FIG.24.

The biopsy instrument according to the embodiment ofFIG. 24also includes an elongate flexible member connected to and extending from the distal assembly. Flexible member614has a proximal end615and a distal end617. As described below, at proximal end615, flexible member614is connected to the end of proximal actuation handle612opposite thumb ring31. Also as described below, at distal end617, flexible member614is attached to jaw mount584.

In accordance with the embodiment ofFIG. 24, the flexible member includes an irrigation conduit and an aspiration conduit. As best shown inFIG. 27, flexible member614has a solo generally cylindrical body with a pair of irrigation conduits572a,572b, an aspiration conduit574, and a pair of control cable conduits570aand570b.Irrigation conduits572a,572band aspiration conduit574, have generally circular cross sections and extend longitudinally through flexible member614. Preferably, aspiration conduit574is of a diameter sufficient to retrieve biopsy samples from the distal end of the instrument. Control cable conduits570a,570bhave generally circular cross sections, are diametrically opposed to each other, and extend longitudinally through flexible member614. Conduits570a,570bprovide channels through which pull wires520a,520bextend.

Flexible member614is preferably made of nylon, but any flexible, biologically compatible material may be used. Additionally, flexible member614may be surrounded by an elongate cylindrical sheath (not shown). It is to be understood that although the preferred embodiment of the flexible member has a circular cross section, and each of the irrigation, aspiration and control conduits has a circular cross section, the invention is not so limited. Furthermore, the invention is not limited by the number of individual irrigation, aspiration, or control conduits.

Distal end617of flexible member614is secured to jaw mount584of distal assembly522. Aspiration conduit mounting stub604of jaw mount584may be inserted into the distal end opening of aspiration conduit574of flexible member614. Flexible member614could be adhesively bonded to jaw mount584, or a crimp band, or other mechanical attachment means could be used. In this way, aspiration of a biopsy tissue sample occurs through stub604to aspiration conduit574. In addition, irrigation conduit mounting stubs605a,605bof jaw mount584may be inserted into the distal end opening of irrigation conduits572a,572b, respectively. Irrigation fluid is provided to the distal end of biopsy instrument610via irrigation conduits572a,572b, and irrigation conduit mounting stubs605a,605b.

In accordance with the embodiment ofFIG. 24, the biopsy instrument includes a proximal actuation handle612located at proximal end11of biopsy instrument610and coupled to proximal end615of flexible member614. Proximal actuation handle612has a front end77and a back end79.

The proximal actuation handle612includes an elongate shaft, a thumb ring, an actuation spool, and a front end nose portion. As embodied herein and as shown inFIGS. 28 and 29, proximal actuation handle612includes shaft30, thumb ring31, actuation spool34, body portion35, and nose portion37. Shaft30has a transverse through slot32extending most of the longitudinal length of shaft30.

Thumb ring31is affixed to back end79of shaft30. Ring31enables a surgeon to better grip and control biopsy instrument610. Ring31is connected to the end of proximal actuation handle612opposite the end connected to flexible member614.

Actuation spool34slidably mounts on shaft30. Actuation spool34includes a central hole through which shaft30extends. This permits spool34to slide back and forth along the length of shaft30. As shown inFIG. 29, actuation spool34may be assembled from two hermaphroditic spool halves130. As best shown inFIG. 30, each spool half130has guide posts132for mating with holes133, and tangs134for mating with slots135.

Pull wires520a,520bextend from movable jaw590of distal assembly522through control conduits570a,570bof flexible member614, through nose member37and body portion35of proximal actuation handle612, and longitudinally within slot32to actuation spool34. In a preferred configuration and as shown inFIGS. 30-31b, pull wires520a,520bare coupled to actuation spool34via swash plate38and swash plate axle36. Swash plate38freely pivots about axle36to accommodate uneven loading of pull wires520a,520bcaused by bending of flexible member612that occurs as the biopsy instrument is positioned at the surgical site. The proximal ends of pull wires520a,520bare inserted through hypotubes39a,39b, respectively. Hypotubes39a,39bare provided to prevent pull wires520a,520bfrom buckling or kinking along their unsupported length within slot32when actuation spool34is moved in a distal direction. Typically, hypotubes39a,39bare formed from tubing similar to that used to manufacture hypodermic needles, but any tubing with sufficient antibuckling capabilities may be used. The proximal ends of hypotubes39a,39b, with pull wires520a,520binside, are inserted through holes138a,138bin swash plate38and bent substantially flat against swash plate38. Pull wires520a,520bare thereby securely retained within hypotubes39a,39band hypotubes39a,39bare securely retained to swash plate38without the necessity of additional parts. Holes138a,138bare diametrically opposed. Each spool half130has a seat136for swash plate axle36, whereby swash plate38is capable of rotating around axle36relative to actuation spool34.

Alternatively, actuation spool34may be provided with a transverse bar (not shown) and pull wires520a,520bmay be connected to this bar. The bar extends transversely through slot32and is coupled to the wall of the central hole of actuation spool34.

It is to be understood that actuation devices, other than a spool on a shaft, that are known to one skilled in the art may be used in connection with biopsy instruments of the present invention and any of the embodiments described herein. For example, as alternatives, the actuator may be embodied as a three-ring shaft/cylinder combination, a pistol grip handle/lever, or any other structure which permits a surgeon to move pull wires520a,520b.

It will be appreciated that movement of actuation spool34relative to shaft30results in movement of pull wires520a,520brelative to flexible member614and consequently moves movable jaw590relative to stationary jaw588such that the jaws open (FIG. 25) and close (FIG.26). Referring toFIG. 26, when movable and stationary jaws590,588are in a closed position, a substantially fluidtight passageway is formed therebetween.

Movable jaw590is coupled over irrigation conduits572a,572bvia jaw mount584and irrigation conduit mounting stubs605a,605b.Stationary jaw588is coupled to aspiration conduit574via jaw mount584and aspiration conduit mounting stub604. Thus, when movable and stationary jaws590,588are in a closed position, wherein a substantially fluidtight passageway is formed therebetween, a substantially fluidtight coupling of irrigation conduits572a,572bto aspiration conduit574is achieved. Irrigation fluid flowing in a distal direction through irrigation conduits572a,572bmay enter and flow through the passageway formed when movable and stationary jaws590,588are in a closed position. This irrigation fluid may then exit from this passageway and flow in a proximal direction through aspiration conduit574.

In accordance with the embodiment ofFIG. 24, the proximal actuation handle612includes a nose portion coupled to the proximal end of the elongate flexible member. As embodied herein and as illustrated inFIG. 28, proximal actuation handle612includes body portion35and nose portion37. Proximal end615of flexible member614is secured to nose portion37of proximal actuation handle612by any suitable means of connection. For example, an adhesive bonding agent could be used to secure flexible member614to nose portion37. A molded strain relief137could be used to avoid overstraining flexible member614and pull wires520a,520bat the attachment of flexible member614to nose portion37.

An irrigation passageway620and an aspiration passageway622extend through body portion35and nose portion37. Irrigation conduit572is coupled in a substantially fluidtight fashion to irrigation passageway620, and aspiration conduit574is coupled in a substantially fluidtight fashion to aspiration passageway622.

In accordance with the embodiment ofFIG. 24, the proximal actuation handle612includes an irrigation port to provide means for flow-connecting a fluid source to the biopsy instrument. As best shown inFIG. 28, body portion35includes irrigation port624. Irrigation port624is in fluid connection with irrigation passageway620. In a preferred embodiment, irrigation port624is provided with a Luer lock fitting. The disclosed configuration allows a surgeon to quickly and easily connect and disconnect various fluid sources (not shown) to provide fluid to distal end13of biopsy instrument610.

Similarly, proximal actuation handle612includes an aspiration port to provide means for flow-connecting a vacuum source to the biopsy instrument. As best shown inFIG. 28, body portion35includes aspiration port626. Aspiration port626is in fluid connection with aspiration passageway622. In a preferred embodiment, aspiration port626is also provided with a Luer lock fitting. Thus a surgeon may quickly and easily connect and disconnect various vacuum devices (not shown) to biopsy instrument610.

In an alternative configuration as shown inFIG. 32, irrigation passageway620could extend from the front end of nose portion37to irrigation port624located on a first side of body portion35. Similarly, aspiration passageway622could extend from the front end of nose portion37to aspiration port626located on a second side of body portion35. Irrigation port624and aspiration port626may be provided with Luer locks. It is to be understood that other positions of irrigation and aspiration ports624,626with respect to the handle612are within the scope of the invention.

When not in fluid connection with a fluid or a vacuum source, irrigation port624and aspiration port626, respectively, may be provided with a removable cap (not shown). As is well known to persons skilled in the art, a Luer lock is a standard fitting for fluid connection of medical devices. However, it should be understood that other standard and non-standard fluid connection fittings may also be used without departing from the scope or spirit of the invention.

The fluid source typically contains an irrigation fluid, such as saline solution. A pump (not shown) may be in fluid connection with irrigation port624to provide a constant and/or intermittent flow of irrigation fluid from a fluid source to distal end13of biopsy instrument610. Alternatively, a fluid filled syringe (not shown) may be directly or indirectly in fluid connection with irrigation port624, wherein depressing the plunger of the syringe causes fluid to flow to distal end13via irrigation conduit572. In another alternative, a fluid source may be suspended at an elevation above the patient being operated upon and in fluid connection with irrigation port624via a fluid source conduit (not shown) so that gravity causes fluid to flow to distal end13.

The vacuum source may include a sample collector in fluid connection with a vacuum pump or other suction retrieval devices. Alternatively, the vacuum source may include a waste collection device in fluid connection with a vacuum pump.

Operation of the embodiment of a biopsy instrument shown inFIGS. 24-29will now be described. When a surgeon desires to take a tissue sample from within a patient's body without invasive surgery, the surgeon inserts distal end13of biopsy instrument610into an orifice of a patient under treatment. While retaining control of proximal actuation handle612at proximal end11, the surgeon guides distal assembly522through the patient's body to a position adjacent a tissue to be sampled. In a preferred embodiment, the surgeon uses endoscopic technology to ensure proper positioning of distal assembly522. The surgeon inserts distal end13of biopsy instrument610into an endoscope already inserted and properly located within a patient's body. Distal assembly522is threaded through the endoscope until the surgical site is reached.

The tissue to be sampled is then sited within opened movable jaw590. In order to facilitate siting the tissue within the open distal assembly, the surgeon may actuate the vacuum effect, thereby drawing the tissue into the area between the jaws. Once jaw590is properly positioned, the surgeon slides spool34along shaft30in the proximal direction. This, in turn, axially displaces pull wires520a,520bin the proximal direction causing movable jaw590to pivot about pivot pin594. Distal assembly522is thereby closed as illustrated inFIG. 26, and the tissue sample is separated from the surrounding tissue when sharp cutting edge598of movable jaw590comes into contact with blunt edge592of stationary jaw588. The severed tissue sample is enclosed within the fluid passageway formed by cup-like body595of movable jaw590and concave cavity601of stationary jaw588.

The surgeon then proceeds to initiate flow from a fluid source through irrigation port624, irrigation passageway620, and irrigation conduit572. Fluid flows to distal end617of irrigation conduit572to flush the surgical region. The surgeon also initiates a vacuum effect in aspiration port626, aspiration passageway622, and aspiration conduit574. This causes fluid flowing through distal end617of irrigation conduit572to return through aspiration conduit574. The severed tissue sample will be swept into the flow, and will travel through aspiration conduit574from distal end617to proximal end615under the combined action of the fluid flow and the vacuum effect. Upon exiting aspiration port626, the severed tissue sample may be collected by a sample collector (not shown) or simply disposed of in a waste collection device (not shown).

As a first alternative method of retrieving a severed tissue sample, the vacuum effect need not be initiated by the surgeon. Without the vacuum effect, the severed tissue sample may be flushed through aspiration conduit574under the action of the fluid flow alone. As a second alternative, no fluid need be supplied to distal end617. Without irrigation fluid, the severed tissue sample is aspirated through aspiration conduit574under the action of the vacuum effect alone. A third alternative method of retrieving a tissue sample includes using irrigation fluid supplied by the endoscope, or other fluid available at the surgical site, to aid in the retrieval of the tissue sample through aspiration conduit574under the action of the vacuum effect.

After retrieval of a tissue sample, the surgeon may then reposition distal end13of biopsy instrument610proximate to the next tissue sample to be collected, and proceed to obtain and recover a this other tissue sample by repeating the above process. In this manner, the surgeon may recover multiple tissue samples without the necessity of removing distal end13of biopsy instrument610from the body of the patient.

A further embodiment of a biopsy instrument according to the present invention is shown in FIG.33. This embodiment generally relates to a biopsy instrument having irrigation and aspiration capabilities and including fluid pressure increasing capabilities. The fluid pressure increasing capabilities discussed below and shown inFIGS. 33-37may be incorporated into any of the several embodiments of a biopsy instrument having irrigation capabilities described herein.

A biopsy instrument according to the embodiment ofFIG. 33generally relates to a method and apparatus for increasing the pressure of fluid flowing through a biopsy instrument. The inventive method and apparatus are shown in connection with an endoscopic biopsy forceps device that retrieves multiple tissue samples from a patient without withdrawal of the device from the patient. The biopsy forceps device provides irrigation at the distal end and aspiration of the samples to the proximal end through fluid pressure and suction. The present embodiment provides a method and apparatus to increase fluid pressure to more effectively retrieve the tissue samples.

A surgical biopsy instrument according to the embodiment shown inFIG. 33generally includes a proximal actuation handle, a distal assembly, and an elongate flexible member connecting the proximal actuation handle to the distal assembly. A fluid pressure device is in fluid connection with the flexible member to selectively increase the pressure of fluid being supplied to the distal end. These general portions of the biopsy instrument will now be more specifically described. The operation of the biopsy instrument will be described thereafter.

In accordance with the present invention, there is provided a biopsy instrument having a proximal end and a distal end. As illustrated inFIG. 33, biopsy instrument10includes proximal end11and distal end13. As with previous embodiments, during a surgical procedure, proximal end11remains external to a patient's body and under the direct physical control of the surgeon. Distal end13is inserted into a passageway or cavity of the patient's body and is positioned proximate to the remote internal operation site. In the preferred embodiment, distal end13of biopsy instrument10is inserted into and threaded through an endoscope (not shown) which has previously been inserted in the patient's body and positioned proximate to the operation site.

In accordance with the embodiment shown inFIGS. 33 and 34, the biopsy instrument includes proximal actuation handle12located at proximal end11of biopsy instrument10. Proximal actuation handle12includes an elongate shaft30having a manipulation thumb ring31fixed to the end thereof. Manipulation thumb ring31enables a surgeon to better grip and control biopsy instrument10.

Proximal actuation handle12also includes a manipulable actuator spool34connected to a distal assembly22via a pull wire20. Distal assembly22and its operation will be described further herein. As illustrated inFIGS. 33 and 34, actuator spool34includes a hole through which shaft30extends. This permits spool34to slide back and forth along the length of shaft30to manipulate distal assembly22. Shaft30includes an axial control slot32through which pull wire20extends. As with other embodiments described, it is to be understood that various other suitable actuation devices known to one skilled in the art may be used in connection with the present invention. For example, as alternatives, the actuation device may be embodied as a three-ring cylinder/shaft device, a pistol grip handle/lever or any other structure which permits a surgeon to move the pull wire.

The biopsy instrument according to the embodiment shown inFIG. 33includes an elongate flexible member connected to and extending from the proximal actuation handle. The flexible member includes an irrigation conduit for fluid connection with a fluid source for supplying a fluid to the distal end of the biopsy instrument. As embodied herein and as illustrated inFIG. 33, elongate flexible member14is connected to and extends from an end of proximal actuation handle12opposite manipulation thumb ring31. Flexible member14includes irrigation conduit72for fluid connection with fluid source632to distal end13of biopsy instrument10. A fluid source conduit631flow-connects fluid source632to the proximal end of irrigation conduit72. Fluid source632typically consists of an irrigation fluid, such as saline solution. In a preferred embodiment, fluid source632and fluid source conduit631are also in fluid connection with the endoscope (not shown) through which biopsy instrument10is threaded. In this preferred embodiment, tee-connector633is provided in fluid source conduit631for flow-connecting fluid source632to both biopsy instrument10and the endoscope. Thus, a single fluid source632may provide irrigation fluid to the distal end of the endoscope to remove debris (blood, tissue, etc.) from the lens of the endoscope and to distal end13of biopsy instrument10.

A pump634may be provided in fluid source conduit631to provide a constant and/or intermittent flow of irrigation fluid from source632to distal end13. Alternatively, fluid source632may be pressurized, or fluid may flow through fluid source conduit631via gravity, by suspending fluid source632at an elevation above the patient being operated upon.

In the embodiment shown inFIGS. 33 and 34, fluid flow through irrigation conduit72is controlled by a valve644located on fluid source conduit631adjacent to proximal actuation handle12. Preferably, valve644is a spring-biased pinch valve, such as the one previously described.

Flexible member14also includes a control conduit70. Control conduit70is connected to and extends from the end of proximal actuation handle12opposite manipulation thumb ring31. Conduit70provides a channel through which pull wire20extends.

Flexible member14further includes an aspiration conduit74. As described above and as shown inFIGS. 10 and 11, aspiration conduit74cooperates with and is in fluid communication with irrigation conduit72at distal end13of biopsy instrument10. Thus, fluid flowing distally through irrigation conduit72may return to the proximal end through aspiration conduit74.

In a preferred embodiment, aspiration conduit74is in fluid connection, via a fluid vacuum conduit639, with a vacuum reservoir640towards the proximal end of aspiration conduit74. Vacuum reservoir640, under vacuum pressure, facilitates the flow of fluid or other matter through aspiration conduit74from distal end13towards proximal end11.

As illustrated inFIGS. 33 and 34, biopsy instrument10also includes a sample chamber42and a sample catch member44in-line with aspiration conduit74. Preferably, sample chamber42and sample catch member44are connected or provided proximate to proximal actuation handle12for ease of access. Sample chamber42acts as a filter to trap material flowing through aspiration conduit74. Material, such as biopsy samples, trapped by sample chamber42assembly may then be retrieved by the surgeon.

As illustrated inFIGS. 33 and 34, an aspiration valve648may be provided on fluid vacuum conduit639, adjacent proximal actuation handle12, to permit a surgeon to start and stop a vacuum effect in aspiration conduit74.

The biopsy instrument according to the present invention further includes a distal assembly for use in a surgical operation. The distal assembly is located on the distal end of the flexible member opposite the proximal actuation handle. The distal end assembly used in connection with the embodiment ofFIGS. 33 and 34may be of any of the types described herein. For example, as in the embodiment shown inFIGS. 10 and 11, distal assembly22includes movable jaw90located at distal end13of biopsy instrument10, on the end portion of flexible member14opposite proximal actuation handle12. Movable jaw90includes a cup-like body95and a sharp cutting edge98. Jaw90pivots about pivot pin94to urge cutting edge98against a stationary jaw88opposing movable jaw90. Stationary jaw88includes a concave cavity101and a blunt edge92.

Movable jaw90is connected to a distal end of pull wire20opposite to the proximal end connected to actuator spool34. As has been described, this configuration allows a surgeon to cut a biopsy sample by manipulating actuator spool34.

Again, it should be understood that while the previously described manipulable distal assembly22may be used with a preferred embodiment of the invention, other manipulable and non-manipulable end effectors may also be used without departing from the scope or spirit of the invention. For example, alternative end effector assemblies include dual actuating jaws, as described below.

The biopsy instrument according to the embodiment illustrated inFIG. 33further includes means for permitting a surgeon to selectively increase fluid pressure in the irrigation conduit, thereby causing a surge in fluid flow through the distal end of the biopsy instrument. As embodied herein, and as illustrated inFIGS. 33 and 34, means for permitting a surgeon to selectively increase fluid pressure in irrigation conduit72may include a fluid pressure device located in-line with the irrigation conduit72. Activation of the fluid pressure device permits the surgeon to selectively increase fluid pressure in irrigation conduit72, thereby causing a surge in fluid flow through distal end13of biopsy instrument10.

In the embodiment illustrated inFIG. 33, fluid source632provides irrigation fluid to both biopsy instrument10and the endoscope. Alternatively, the endoscope power unit (not shown), which supplies water, light and air to the endoscope, also supplies water as the irrigation fluid to biopsy instrument10. It is expected that typical irrigation fluid pressures at proximal end11of biopsy instrument10range from 3-5 psia, and that activation of the fluid pressure device may increase the irrigation fluid pressure to 20 psia.

As illustrated inFIGS. 35-37, the fluid pressure device may include a contractible fluid accumulating chamber, which can be selectively contracted to cause a pressure surge through irrigation conduit. In a first embodiment of a fluid pressure device shown inFIGS. 33-35, a flexible bellows674defines a fluid accumulating chamber therein. A pleated collapsible wall member676imparts the contractibility attribute to bellows674. Collapsible wall member676could be made of metal, plastic, or other suitable waterproof material. As illustrated inFIG. 35, the flexible bellows674further includes a fluid inlet port678and a fluid outlet port680. Fluid inlet port678is in fluid connection with fluid source632, thereby permitting the accumulating chamber to fill with fluid. Fluid outlet port680is in fluid connection with the accumulating chamber and with irrigation conduit72.

A suitable valve is provided proximate inlet port678to permit fluid to flow into the fluid accumulating chamber from fluid source632and prohibit fluid from returning thereto. The flexible bellows674ofFIG. 35includes a check valve682a, including a spring684a, a spring-biased ball686a, and a valve seat688a.Check valve682ais upstream of inlet port678. In a closed position, spring684aurges ball686aagainst seat688a.Fluid flowing into fluid inlet port678from fluid source632forces spring-biased ball686aagainst spring684a. This force compresses spring684auntil ball686ais no longer held against valve seat688a, permitting fluid to flow past ball686aand into the contractible fluid accumulating chamber. Fluid that would tend to flow out of fluid inlet port678towards fluid source632pushes spring-biased ball686aagainst valve seat688ato thereby block the flow. Check valve682atherefore permits fluid from fluid source632to flow into the fluid accumulating chamber, while concurrently prohibiting fluid from flowing out of the fluid accumulating chamber back towards fluid source632.

Similarly, a suitable valve is provided proximate outlet port680to prevent fluid from flowing out of the fluid accumulating chamber until a given fluid pressure is obtained and to prevent fluid from flowing back into the fluid accumulating chamber. The flexible bellows674ofFIG. 35includes a check valve682b, including a spring684b, a spring-biased ball686b, and a valve seat688b.Check valve682bis downstream of inlet port678. In a closed position, spring684burges ball686bagainst seat688b.Pressurized fluid flowing out of fluid outlet port680opens valve682bby forcing spring-biased ball686bagainst spring684b.Operation of the flexible bellows674during an endoscopic procedure will be described further herein.

Alternative structures of the fluid pressure device, and more particularly the contractible fluid accumulating chamber, are within the scope of this invention. For example, as illustrated inFIG. 36, the contractible fluid accumulating chamber of fluid pressure device may include a piston-and-cylinder device690including cylinder694and piston692slidably located within cylinder694. This structure is similar in many respects to the bellows structure previously described. Piston-and-cylinder device690includes fluid inlet port678, fluid outlet port680, and check valves682a,682b.In the piston-and-cylinder device, fluid accumulates in cylinder694. Depression of piston692causes a pressure surge through irrigation conduit72. It is preferable to locate the piston-and-cylinder device on or adjacent proximal actuation handle12for ease of use by the surgeon.

As a further alternative of the fluid pressure device, and as illustrated inFIG. 37, the contractible fluid accumulating chamber may include a flexible membrane696. Flexible membrane696is preferably made of rubber, polymers, or any other suitably flexible material known in the art. Flexible membrane696defines a fluid accumulating chamber therein. Like the bellows and piston structures previously described, the membrane structure includes fluid inlet port678, fluid outlet port680, and check valves682a,682b.Preferably, flexible membrane696is formed as a squeeze ball. Deforming the squeeze ball from its undeformed configuration imparts the contractibility attribute to flexible membrane696, causing a pressure surge through irrigation conduit72.

It will be apparent to those skilled in the art that means for selectively increasing the fluid pressure in irrigation conduit72could encompass purely mechanical pressurization devices and also electromechanical pressurization devices. It will also be apparent to those skilled in the art that the fluid pressure devices can be situated in various other positions relative to the surgeon. For example, the fluid pressure device may be positioned on the floor proximate the surgeon's foot for foot activation. Foot activation of the fluid pressure device keeps the surgeon's hand free for other activities.

Operation of the invention will now be described with reference toFIGS. 10,11,33and35. As in previously described embodiments, when a surgeon desires to take a tissue sample from within a patient's body without invasive surgery, the surgeon inserts distal end13of biopsy instrument10into an orifice of a patient under treatment. While retaining control of proximal actuation handle12at proximal end11, the surgeon guides distal assembly22through the patient's body to a position adjacent a tissue to be sampled. In a preferred embodiment, the surgeon uses endoscopic technology to ensure proper positioning of the distal assembly22. The surgeon inserts distal end13of biopsy instrument10into an endoscope already inserted and properly located within a patient's body. Distal assembly22is threaded through the endoscope until the surgical site is reached. The tissue to be sampled is then sited within opened jaw90, as illustrated in FIG.10. Once jaw90is properly positioned, the surgeon slides spool34along shaft30in the proximal direction. This, in turn, axially displaces pull wire20in the proximal direction causing movable jaw90to pivot about pivot pin94. Distal assembly22is thereby closed, and tissue sample112is separated from the surrounding tissue when sharp cutting edge98of movable jaw90comes into contact with blunt edge92of stationary jaw88. As illustrated inFIG. 11, severed tissue sample112is enclosed within the fluid passageway formed by cup-like body95of movable jaw90and concave cavity101of stationary jaw88.

The surgeon then proceeds to initiate flow from fluid source632through the fluid pressure device and through irrigation conduit72by depressing irrigation valve644. In response, fluid flows into the fluid pressure device and fills the contractible fluid accumulating chamber. Once filled, fluid flows to distal end13of irrigation conduit72to flush the surgical region under relatively low pressure. At the same time, or slightly later, the surgeon may initiate a vacuum effect in aspiration conduit74by depressing aspiration valve648. This causes fluid flowing through distal end13of irrigation conduit72to return through aspiration conduit74. Tissue sample112will be swept in the flow, and will begin traveling through aspiration conduit74from distal end13to proximal end11under the combined action of the fluid flow and the vacuum effect. As an alternative, the vacuum effect need not be initiated by the surgeon. Without the vacuum effect, tissue sample112may be flushed through aspiration conduit74under the action of the fluid flow alone.

However, on occasion, tissue sample112may become lodged in either distal assembly22or in aspiration conduit74. When this happens, the surgeon may then actuate the fluid pressure device by compressing the fluid accumulating chamber. Compressing the accumulating chamber pressurizes the fluid flowing into irrigation conduit72, causing a surge in fluid flow through distal end13of biopsy instrument10. This surge in fluid flow augments the existing flow in the biopsy instrument, thus enabling the surgeon to more effectively and reliably retrieve tissue sample112through aspiration conduit74to sample chamber642. If necessary, the surgeon may actuate the fluid pressure device multiple times to aid in the retrieval of tissue sample112. Similarly, the surgeon may vary the pressure of the fluid flow surge, either by actuating the fluid pressure device slowly for a mild surge or actuating the fluid pressure device quickly for a sharp surge in the fluid flow. The surgeon then recovers tissue sample112from sample chamber642.

The surgeon may then reposition distal end13proximate to the next tissue sample112to be collected, and proceed to obtain and recover a second tissue sample112by repeating the above process. In this manner, the surgeon may recover multiple tissue samples without the necessity of removing distal end13of biopsy instrument10from the body of the patient.

A still further embodiment of a biopsy instrument according to the present invention is shown in FIG.38. This embodiment generally relates to a method and an apparatus to minimize the manual handling and consequential degradation of biopsy tissue samples through the use of a biopsy instrument having irrigation and aspiration capabilities and including a removable, modular sample collector. The embodiment shown inFIG. 38may be incorporated into any of the several embodiments of a biopsy instrument having irrigation and aspiration capabilities described herein.

A biopsy instrument according to the embodiment ofFIG. 38generally includes a distal assembly, a proximal actuation handle, and an elongate flexible member connecting the distal assembly to the proximal actuation handle. An aspiration biopsy instrument with proximal end sample collection capabilities according to the present embodiment further includes an aspiration conduit extending from the distal to the proximal end and in fluid connection with a suction passageway. The suction passageway, located within the proximal actuation handle, has an access opening for receiving a sample collector and is in fluid connection with a vacuum source. The sample collector is inserted into the suction passageway to stop and retain aspirated biopsy samples. These general portions of the biopsy instrument will now be more specifically described. The operation of the biopsy instrument will be described thereafter.

In accordance with the embodiment shown inFIG. 38, there is provided a biopsy instrument710having a proximal end11and a distal end13. As in previously described embodiments, during a surgical procedure, proximal end11remains external to a patient's body and under the direct physical control of the surgeon. Distal end13is inserted into a passageway or cavity of the patient's body and is positioned proximate to the remote internal operation site. In the preferred embodiment, distal end13of biopsy instrument710is inserted into and threaded through an irrigation endoscope (not shown) which has previously been inserted into the patient's body and positioned proximate to the operation site.

The biopsy instrument according to the present embodiment includes a distal assembly for use in a surgical operation. As shown inFIG. 38, distal assembly22is located on the distal end of flexible member14opposite proximal actuation handle712. Embodiments of distal assembly22, shown inFIGS. 10-11have been described above. Distal assembly22includes a movable jaw90and an opposing stationary jaw88. Movable jaw90includes a cup-like body95and a sharp cutting edge98. Movable jaw90pivots about pivot pin94to urge cutting edge98against the stationary jaw88. Stationary jaw88includes a concave cavity101and a blunt edge92.

Movable jaw90is connected to a distal end of pull wire20. As shown inFIG. 38, the proximal end of pull wire20is connected to actuator spool34. Actuation of actuator spool34moves movable jaw90relative to stationary jaw88, and thereby moves the jaws from an open position to a closed position. Actuation spool34and the attachment of pull wire20to actuation spool34, as shown inFIG. 29, has been described above. This configuration allows a surgeon to cut a biopsy sample by manipulating actuator spool34.

The biopsy instrument according to the present embodiment also includes an elongate flexible member connected to and extending from the distal assembly. As illustrated inFIG. 38, elongate flexible member14is connected to distal assembly22and extends in a proximal direction to proximal actuation handle712. Proximal actuation handle712will be described later in greater detail.

In accordance with the present embodiment, the elongate flexible member includes an aspiration conduit. As shown inFIG. 38, flexible member14includes an aspiration conduit74extending from distal end13toward proximal end11. Aspiration conduit74provides a conduit for fluid, tissue samples, and/or other matter to pass from distal end13to proximal end11. As embodied herein, and as best illustrated inFIGS. 10 and 11, at distal end13aspiration conduit74is coupled to stationary jaw88of distal assembly22.

As also embodied herein and as illustrated inFIG. 38, elongate flexible member14may further include an irrigation conduit72for fluid connection with a fluid source632for supplying a fluid to distal end13of biopsy instrument710. Flexible member14includes irrigation conduit72for flow-connecting fluid source632to distal end13of biopsy instrument710. As best shown inFIGS. 10 and 11, at distal end13, irrigation conduit72is coupled to and in fluid connection with movable jaw90. As best shown inFIG. 38, irrigation conduit72is coupled to a Luer lock642for flow-connecting irrigation conduit72to fluid source632.

Furthermore, as embodied herein, aspiration conduit74cooperates with and is in fluid communication with irrigation conduit72at distal end13of biopsy instrument710. As described above and as shown inFIGS. 10-11and25-26, when stationary jaw88and movable jaw90of distal assembly22are in a closed position, a substantially fluid tight passage is formed therebetween. Because stationary jaw88is coupled to aspiration conduit74and movable jaw90is coupled over irrigation conduit72, a substantially fluid tight coupling of aspiration conduit74and irrigation conduit72is achieved. Thus, fluid flowing distally through irrigation conduit72returns to proximal end11through aspiration conduit74.

As embodied herein and as shown inFIG. 34, fluid source632may be a syringe744filled with a saline irrigation fluid, an anticoagulant, a tissue staining dye, or any other medically necessary or desirable fluid. Alternatively, a pump (not shown) may be provided in fluid connection with irrigation conduit72to provide a constant and/or intermittent flow of fluid from source632to distal end13. Fluid source632may also be pressurized, or fluid may flow through irrigation conduit72via gravity, by suspending fluid source632at an elevation above the patient being operated upon. In these alternate embodiments, fluid flow through irrigation conduit72may be controlled by a valve (not shown) located on irrigation conduit72or on any other conduit flow-connecting irrigation conduit72to fluid source632. The valve may be a spring-biased pinch valve as previously mentioned, although any valve known to persons skilled in the art would be sufficient.

In the embodiment shown inFIG. 38, flexible member14also includes control conduit70. Control conduit70is connected to and extends from distal assembly22at distal end13to proximal actuation handle712at proximal end11. Control conduit70provides a channel through which pull wire20extends.

In accordance with the present embodiment, the biopsy instrument710includes a proximal actuation handle712. As described above and as shown inFIG. 38, proximal actuation handle712includes an elongate shaft30having a manipulation thumb ring31fixed to the end thereof. Manipulation thumb ring31enables a surgeon to better grip and control biopsy instrument710.

Proximal actuation handle712includes suction passageway762(FIG. 39) in fluid connection with aspiration conduit74. Suction passageway762is further in fluid connection with a vacuum reservoir764(FIG. 38) via a vacuum conduit766. Vacuum reservoir764, connected to a vacuum source (not shown) and under vacuum pressure, facilitates the flow of fluid, tissue samples, or other matter, through aspiration conduit74and suction passageway762.

As shown inFIGS. 38-39, suction passageway762has an access opening768. In the preferred embodiment, access opening768provides a lateral access to the flow in suction passageway762and is composed of two portions, a securing portion770and a flow-passage portion772. Securing portion770is configured to complement a sample collector handle792, as will be described later in greater detail, that is partially inserted into securing portion770of access opening768. In a preferred embodiment, securing portion770includes a circular flange774having a smooth, slightly tapered central bore776. Flow-passage portion772is configured to complement a sample collector body794, as will also be described later in greater detail, which is inserted into flow-passage portion772. As embodied herein, flow-passage portion772includes a roughly rectangular slot778, with an arcuate downstream wall780, that transects the flow in suction passageway762.

As embodied herein and best illustrated inFIG. 39, proximal actuation handle712includes an aspiration valve782provided on suction passageway762, to permit a surgeon to start and stop a vacuum effect in suction passageway762. Preferably, aspiration valve782is a spring-biased pinch valve, although any other valve also known to persons skilled in the art may be used. Aspiration valve782includes a pivot (not shown), a lever784, and a spring (not shown) which causes the nose786of valve782to pinch suction passageway762shut. A surgeon pressing on heel788of lever784will cause the spring to compress, lever784to rotate around the pivot, nose786to release its pinch on suction passageway762, and a vacuum effect to be established in aspiration conduit74and suction passageway762.

The biopsy instrument according to the present embodiment includes a sample collector to trap and retain biopsy samples severed by operation of the distal assembly22. As illustrated inFIG. 38, biopsy instrument710includes sample collector assembly790provided in-line with suction passageway762. Sample collector assembly790acts as a filter to trap matter, such as biopsy samples, flowing through suction passageway762. Matter trapped by sample collector assembly790may then be retrieved by the surgeon or nurse for subsequent pathological examination.

As illustrated inFIGS. 40a-40b, sample collector assembly790includes catcher handle792and catcher body794. Catcher handle792has a securing end796for insertion into securing portion770of access opening768. In the present embodiment, securing end796includes a cylindrical, slightly tapered plug798that complements the smooth, slightly tapered central bore of securing portion770to provide a seal therewith. As will be appreciated by persons skilled in the art, other access opening configurations and complementary catcher handle securing ends may be used without departing from the scope or spirit of the invention. For instance, the central bore776of access opening768might further include an o-ring seated in a circumferential slot, or access opening circular flange774might include external threads which couple to a mating, internally threaded collar on catcher handle792.

Catcher handle792also has a gripping end799, opposite to securing end796, for enabling the nurse or surgeon to firmly grip and easily manipulate sample collector790. Although the present embodiment of gripping end799includes a generally flat, circular tab with ribs700for improved gripping, it is to be understood that various other suitable gripping configurations known to persons skilled in the art may be used in connection with the present invention.

As further illustrated inFIGS. 40a-40b, catcher body794includes a flow opening702, a screen704, a cover706, and a break-away tab708. Catcher body794is insertable into and configured to complement flow-passage portion772of access opening768. Catcher body794permits fluid flow in suction passageway762to continue downstream, while trapping and retaining any solid matter passing through suction passageway762. Furthermore, as embodied herein, catcher body794, with cover706in a closed position, is configured to fit into a standard pathology and histology processing cartridge.

In the present embodiment, catcher body794has a flow opening702on its upstream side and a screen704on its arcuate downstream side. As shown inFIG. 40a, flow opening702has a rectangular cross-section, although it could have any other cross-section and still be consistent with the scope of the invention. Screen704is located on the downstream side of catcher body794to trap matter, such as tissue samples, after a such matter has entered flow opening702. As shown inFIG. 40a, screen704may consist of a horizontal and vertical latticework. Alternatively, screen704may consist of an array of perforations such as holes or slots. A person skilled in the art could easily size the mesh or the holes in screen704to best accommodate a given flow and sample size. It is further understood that many other screen configurations are known to persons skilled in the art and may be used in connection with the present invention, including a single hole or slot, or multiple slots.

As further illustrated inFIGS. 40a-40b, catcher body794includes cover706positionable between an open position displaced from flow opening702of catcher body794(FIG. 40a) and a closed position overlaying flow opening702(FIG. 40b). As embodied herein, cover706may be slidably attached to catcher body via the interaction of a pair of flanges711on catcher body and a pair of channels714on cover706. Alternatively, cover706may be pivotably attached to catcher body794(not shown). Cover706may also be completely detachable from catcher body794, either sliding on or off the end of catcher body794furthest from catcher handle792, or snapping on or off catcher body794by means of any of a variety of flexible snap elements (also not shown).

In the present embodiment, cover706includes a cover screen707. If catcher body794and cover706are used to contain the biopsy samples during pathology processing, cover screen707enables the fluids involved in the pathology process to easily and completely gain access to the sample. Alternatively, cover706may be a solid plate.

In accordance with the present invention and as illustrated inFIG. 40b, catcher body794is attached to securing end96of catcher handle792by means of break-away tab708. As embodied herein, break-away tab708includes a short rectangular plate attached at one end to securing end796and at an opposite end to catcher body794. As shown inFIG. 41, cleaving break-away tab708, typically with a snapping motion, permits catcher body794to be detached from catcher handle792. Sample collector790snaps apart at break-away tab708because the cross-sectional moment of inertia of tab708is less than the cross-sectional moment of inertia of securing end796or of catcher body794. Similarly, catcher body794may be twisted off from catcher handle792if the rotational moment of inertia of break-away tab708is less than the rotational moment of inertia of body794and of handle792.

Sample collector790is preferably made of plastic that is chemically inert to the chemicals used in pathology processing, specifically nylon, although other plastics such as polypropylene or polyethylene, or even a suitable glass or metal, may be used. A preferred method of manufacturing sample collector790is by injection-molding.

An alternative configuration of the sample collector for use in, for example, the biopsy instrument ofFIG. 43, is shown inFIGS. 42aand42b. As illustrated inFIGS. 42a-42b, sample collector assembly990includes catcher handle992and catcher body994. Catcher handle992has a securing end996for insertion into a sample catcher port848. In this configuration, securing end996includes a plug with an ovoid cross-section and multiple, flexible circumferential rings998that complement sample catcher port848to provide a seal therewith. Rings998are preferable integrally molded to catcher handle992. As will be appreciated by persons skilled in the art, other access opening configurations and complementary catcher handle securing ends may be used without departing from the scope or spirit of the invention. For instance, a different cross-section of securing end996, or a fewer or greater number of flexible rings998, or flexible rings998that are not integrally molded to catcher handle992are all within the scope of the present invention.

Catcher handle992has a gripping end999, opposite to securing end996, for enabling the nurse or surgeon to firmly grip and easily manipulate sample collector990. The present embodiment of gripping end999includes a shaft with a quasi-rectangular cross-section.

As illustrated inFIG. 42a, catcher body994includes a flow opening902, a screen904, and a projection905. Catcher body994is insertable into and configured to complement the suction passageway portion of sample catcher port848. Catcher body994permits fluid flow in a suction passageway844to continue downstream, while trapping and retaining any solid matter, such as a tissue sample, passing through suction passageway844.

Similarly to previously described catcher body794, catcher body994has a flow opening902on its upstream side and a screen904on its downstream side. Screen904is located on the downstream side of catcher body994to trap matter after such matter has entered flow opening902. As shown inFIG. 42a, screen904may consist of a horizontal and vertical latticework.

As illustrated inFIGS. 42a-42b, sample collector990includes cover906positionable between an open position displaced from flow opening902of catcher body994(FIG. 42a) and a closed position overlaying flow opening902(FIG. 42b). In a closed position, a ridge912on cover906may snap over projection905on catcher body994to secure cover906in a closed position over catcher body994.

As embodied herein, cover906may be rotatably attached to catcher handle992via hinge911. Hinge911may be formed from material that deforms when cover906is rotated from the open position to the closed position. As such, hinge911requires no movable parts. The elastic or plastic deformation of the material of hinge911allows the rotational displacement of the hinge to occur. In a preferred embodiment, catcher body994, catcher handle992, cover906, and hinge911are integrally molded as a single piece. Alternatively, hinge911may be conventionally formed from pivot pins and holes or detent assemblies without departing from the scope of the invention.

Furthermore, as embodied herein, catcher body994, with cover906in a closed position, is configured to fit into a standard pathology and histology processing cartridge. Similar to cover706, cover906may include a cover screen907to permit the fluids involved in the pathology process to easily and completely gain access to the sample.

As with sample collector790, sample collector990is preferably made of plastic that is chemically inert to the chemicals used in pathology processing, specifically nylon, although other plastics such as polypropylene or polyethylene, or even a suitable glass or metal, may be used. Similarly, a preferred method of manufacturing sample collector990is by injection-molding.

Operation of a biopsy instrument according to the present invention will now be described with reference toFIGS. 10,11and38-42. When a surgeon desires to take a tissue sample112from within a patient's body without invasive surgery, the surgeon inserts distal end13of biopsy instrument710into an orifice of a patient under treatment. While retaining control of proximal actuation handle712, the surgeon guides distal assembly22through the patient's body to a position adjacent a tissue to be sampled. In a preferred embodiment, the surgeon uses endoscopic technology to ensure proper positioning of the distal assembly. The surgeon inserts distal end13of biopsy instrument710into an irrigation endoscope already inserted and properly located within a patient's body. Distal assembly22is threaded through the irrigation endoscope until the surgical site is reached.

At the surgical site, opened movable jaw90is then positioned around the tissue to be sampled, as illustrated in FIG.10. In a preferred embodiment, once jaw90is properly positioned, the surgeon creates a vacuum effect in aspiration conduit74and within concave cavity101of stationary jaw88by depressing aspiration valve682. This vacuum effect draws the tissue to be sampled into concave cavity101and aids the in the severance of the sample from the surrounding tissue.

The surgeon then proceeds to slide actuator spool34along shaft30of proximal actuation handle712in the proximal direction. This, in turn, axially displaces pull wire20in the proximal direction causing movable jaw90to pivot about pivot pin94. Distal assembly22is thereby closed, and tissue sample112is separated from the surrounding tissue when sharp cutting edge98of movable jaw90comes into contact with blunt edge92of stationary jaw88. As illustrated inFIG. 11, severed tissue sample112is enclosed within the passageway formed by cup-like body95of movable jaw90and concave cavity101of stationary jaw88.

If not already established in aspiration conduit74, the surgeon initiates a vacuum effect in aspiration conduit74by depressing aspiration valve682. Tissue sample112is aspirated from distal end13through aspiration conduit74and suction passageway662and into sample collector790under the action of the vacuum effect.

However, on occasion, tissue sample112may become lodged in distal assembly22, aspiration conduit74or in suction passageway662. When this happens, the surgeon may then choose to provide fluid to the biopsy site at distal end13. With a vacuum effect established in aspiration conduit74, any fluid provided to distal end13will be aspirated through aspiration conduit74, and thereby aid in the retrieval of tissue sample112. In a preferred embodiment, irrigation fluid from an irrigation endoscope is provided to the biopsy site. Alternatively, the surgeon may initiate a flow from fluid source632through irrigation conduit72of biopsy instrument710to distal end13in order to aid in the aspiration of tissue sample112to sample collector790. In addition, the pressure of fluid supplied from source632may be increased with the use of pressure increasing devices previously described.

Once tissue sample112is trapped by screen704, the surgeon or nurse may disengage sample collector790from access opening768of proximal actuation handle712. Cover706is then slid, rotated or snapped over flow opening702of catcher body794capturing sample110within catcher body94. The surgeon or nurse then disconnects catcher body794from catcher handle792by snapping or twisting off break-away tab708from securing end796. Catcher body794may be placed in a specimen collection jar for later processing and examination.

The surgeon may then reposition distal end13proximate to the next tissue sample112to be collected, and proceed to obtain and recover a second tissue sample112by repeating the above process. In this manner, the surgeon may recover multiple tissue samples without the necessity of removing distal end13of biopsy instrument710from the body of the patient.

Another embodiment of a biopsy instrument according to the present invention is shown in FIG.43. This embodiment generally relates to a pinch biopsy apparatus with aspiration capabilities and a method of using such. In a pinch biopsy apparatus, as will be described below, it is preferred that both jaws of the distal assembly are manipulable and capable of rotating away from one another. With the jaws in an open position, i.e., rotated away from one another, the operator is able to site the tissue to be sampled deep within the jaws of the distal assembly. Closing the jaws, i.e., rotating the jaws towards each other, causes the tissue within the jaws to be disengaged from the surrounding tissue.

One advantage of having both jaws of the distal assembly capable of rotating away from one another is that larger tissue samples may be acquired. Because both jaws of a pinch biopsy instrument rotate away from one another, the jaws in their opened position may realize a relatively large included angle. The fully opened jaws may be more completely positioned around a portion of tissue to be sampled as compared to an end effector assembly wherein one of the jaws is stationary. Thus, a pinch biopsy instrument is capable of detaching relatively large tissue samples.

A second advantage of having both jaws of the distal assembly capable of rotating away from one another is that the tissue to be severed is located directly along the longitudinal axis of the pinch biopsy instrument. Thus, the operator may directly approach the tissue site rather than having to manipulate the biopsy instrument to approach the tissue site from an angle.

A biopsy instrument according to the embodiment ofFIG. 43generally includes a distal assembly822for use in a surgical operation, an elongated flexible member814, and a proximal actuation handle812. Biopsy instrument810has a distal end13and a proximal end11.

According to the present embodiment, distal assembly822includes first and second movable jaws. As shown inFIG. 43, distal assembly822is located on the distal end of flexible member814opposite proximal actuation handle812. As shown inFIG. 44, distal assembly822includes first and second pivotably movable hermaphroditic jaws890. Each jaw890includes a cup-like body895having a quasi-cylindrical back wall891and a mating edge892. When distal assembly822is in a closed configuration, mating edge892of first jaw890contacts mating edge892of second jaw890. Mating edge892may be used for cutting, crushing, grasping, or ripping a tissue sample from the surrounding tissue. Accordingly, mating edge892may be sharp, blunt, serrated, or notched. In a preferred embodiment, mating edges892include sharp, mating teeth for cutting a tissue sample.

Each jaw890is provided with an outer flange897and an inner flange893, located at the proximal end of jaw890adjacent mating edge892. Each outer flange897and each inner flange893is provided with a radially-directed through hole902for receiving one of pull wires820a,820b.In an assembled configuration, outer flange897of first jaw890lies adjacent inner flange893of second jaw890, and through holes902are in-line. Similarly outer flange897of second jaw890lies adjacent inner flange893of first jaw with through holes902lined up. As described below, the distal ends of pull wires820a,820bare inserted into through holes902in the assembled configuration.

Each jaw890is further provided with a pivot hole896located proximate the proximal end of jaw890. Pivot hole896is transverse to, and proximate, the spine of quasi-cylindrical back wall891.

Distal assembly822further includes distal end conduit884. According to the present embodiment and as shown inFIG. 4, distal end conduit884includes a central cylindrical passageway887, a cylindrical body881, a pair of longitudinal flanges885a,885b, a pair of channels880a,880b, and a cylindrical barbed connector883. Central cylindrical passageway887extends through cylindrical body881from the distal to the proximal end of distal end conduit884. Longitudinal flanges885a,885bare diametrically opposed, extend in a distal direction from cylindrical body881and in a radially outward direction from the outer wall of cylindrical passageway887. Pivot holes886a,886bextend transversely through longitudinal flanges885a,885b, respectively. Diametrically opposed channels880a,880bextend longitudinally along the outer wall of cylindrical passageway887and are located ninety degrees from longitudinal flanges885a,885b. Cylindrical barbed connector883, located at the proximal end of distal end conduit884, is formed from a step increase in the outer diameter of the outer wall of cylindrical passageway887.

Further according to the present embodiment, each jaw890of distal assembly822is pivotably coupled over the distal end conduit884. Pivot pins894are inserted through pivot holes896of each jaw890and through pivot holes886aor886bof distal end conduit884. Thus, each jaw890is pivotably coupled to distal end conduit884. Furthermore, each jaw890is pivotably coupled to distal end conduit884in such a manner that central cylindrical passageway887is unobstructed whether distal assembly822is in an opened or closed configuration.

As shown inFIG. 45, pivot holes886a,886bof distal end conduit884are somewhat kidney-shaped, having a proximal end pivot pin seat and a distal end pivot pin seat. This profile enhances the extent to which jaws890may be rotated away from each other. When distal assembly822is in an opened configuration, pivot pins894are seated at the distal end of pivot holes886a,886b. In a closed configuration, pivot pins894are seated at the proximal end of pivot holes886a,886b.

The biopsy instrument according to the present embodiment further includes an elongate flexible member814connected to and extending from distal assembly822toward proximal end11. As shown inFIG. 46, flexible member814includes an aspiration conduit870in fluid connection with distal end conduit884for permitting the passage of matter, and particularly, tissue samples, from distal end13toward proximal end11. Aspiration conduit870may be concentric with elongate flexible member814. The distal end of flexible member814may be press fit over barbed connector883of distal end conduit884. Flexible member814may also be fitted over barbed connector883and held in place with a crimp band or other mechanical fastener. Alternatively, flexible member814may be bonded to the proximal end of distal end conduit884. Flexible member814is also provided with diametrically opposed control conduits872a,872b. Pull wires820a,820bextend through control conduits872a,872b, respectively.

The biopsy instrument according to the present embodiment is further provided with a proximal actuation handle812including a stationary member and an actuation device. As shown inFIGS. 43 and 47, the stationary member includes nose member837, outer body835, inner body833, cover838, lever836, shaft30, and thumb ring31. The stationary member is connected to the proximal end of flexible member814. Furthermore, the stationary member has a suction passageway844in fluid connection with the aspiration conduit870, wherein suction passageway844is for fluid connection with a vacuum source (not shown).

Nose member837couples flexible member814to a sample catcher chamber843of inner body833. Nose member837includes a body840that is provided with a strain relief portion871aat its distal end and a coupling portion at its proximal end. Strain relief portion871ais an elongate, gradually tapering, conical section which prevents flexible member814from bending too abruptly and thereby becoming overstrained at the attachment of flexible member814to nose portion837. Strain relief portion871apermits flexible member814to gradually bend over the length of strain relief portion871a.

As embodied herein, body840is insert-molded to the proximal end of flexible member814as follows: wires of approximately the same diameter as the aspiration conduits870and control conduits872a,872bare inserted into, and extend from, these conduits at the proximal end of flexible member814; the proximal end of flexible member814, with the wires, is placed into the mold for body840; resin is injected into the closed mold; upon removing body840from the mold, the wires are pulled free. In this manner, body840is insert-molded to the proximal end of flexible member814and conduits870,872aand872bare extended through body840. As shown inFIG. 47, the proximal end of body840may be provided with a molded port841at the proximal end of aspiration conduit870for insertion into sample catcher chamber843of inner body833. Body840may also be provided with mating slots (not shown) at its proximal end for mating with mating tabs846a,846bof sample catcher chamber843, as described below.

As shown inFIG. 49, nose member837may be provided with an alternative flexible strain relief portion at its distal end. Strain relief portion871bresembles a graduated series of rings and may be formed by circumferentially cutting the outer surface of nose member837, or alternatively, strain relief portion871bmay be integrally molded into nose member837.

Outer body835is provided with sides842a,842b, which include viewing holes83a,83b, respectively. Viewing holes83a,83bpermit the operator to view the interior of the sample catcher chamber843. Alternatively, viewing holes83a,83bmay be transparent windows. Outer body835is attached at its proximal end to shaft30by any suitable connection means, for example, adhesive bonding. Shaft30and thumb ring31have been previously described. Outer body835has an opening at its distal end for abutting the proximal end of body840of nose member837, but is not necessarily directly attached to nose member837.

As shown inFIG. 47, inner body833is provided with a sample catcher chamber843, a suction passageway844, and a pinch valve extension845. Sample catcher chamber843, located at the distal end of inner body833, couples aspiration conduit870to suction passageway844. At its distal end, sample catcher chamber843is provided with aspiration opening855. Aspiration opening855complements aspiration port841of nose member837. Aspiration port841press fits into aspiration opening855. At its proximal end, sample catcher chamber843is provided with a connector (not shown) for coupling to suction passageway844. Suction passageway844may be fitted over the connector and held in place with a crimp band or other mechanical fastener, or alternatively, suction passageway844may be bonded to the connector.

Sample catcher chamber843is further provided with a flow-passage portion (not shown) for flow-connecting aspiration conduit870to suction passageway844. This flow-passage portion is configured to complement and receive catcher body994of sample collector990.

Sample catcher chamber843further is provided with mating tabs846a,846b, viewing ports847a,847b, pin holes853a,853b, and sample catcher port848. Mating tabs846a,846bextend in a distal direction from the distal end of sample catcher chamber843, and are for mating with the complementary mating slots (not shown) of body840. Viewing ports847a,847bare located on opposing sides of the flow-passage portion of sample catcher chamber843and are aligned with viewing holes83a,83bwhen inner body833is assembled with outer body835. Viewing ports847a,847bare made of transparent material and permit the operator to view the interior of sample catcher chamber843. Preferably, the entire sample catcher chamber843is molded from a transparent plastic. Pin seats853a,853bare provided on opposing sides of sample catcher chamber834proximal from and adjacent to viewing ports847a,847b.As described below, pin seats853a,853bpermit lever836to be rotatably coupled to inner body833. Sample catcher port848permits access to the flow-passage portion of sample catcher chamber843and, as will be described below, insertion of sample collector990. Sample catcher port848extends transversely to viewing ports847a,847band transversely to aspiration conduit870and suction passageway844. As best shown inFIG. 43, when inner body833is assembled within outer body835, sample catcher port848is positioned external to outer body835.

Suction passageway844extends from sample catcher chamber843to a vacuum connector876that attaches suction passageway844to the vacuum source (not shown). Suction passageway844includes flexible vacuum tubing wherein the tubing may be elastically deformed to permit repeated blocking and unblocking of the passageway. As previously described, suction passageway844is coupled in a fluid-tight connection with sample catcher chamber843via a connector. Vacuum connector876provides a connectable and disconnectable fluid-tight coupling between suction passageway844and the vacuum source. As best shown inFIG. 43, when inner body833is assembled within outer body835, vacuum connector876is positioned external to outer body835.

As shown inFIG. 47, pinch valve extension845extends in a proximal direction from sample catcher chamber843. Furthermore, pinch valve extension845extends approximately parallel to and adjacent the portion of suction passageway844adjacent sample catcher chamber843. Pinch valve extension845includes sides878a,878b, latch850, pinch valve upper bar852, and spring seat851. Sides878a,878bdefine the proximal portion of a slot therebetween, and flank extension839of nose member837when actuation handle812is assembled. Latch850snaps into a complementary keyway in outer body835, thus securing inner body833to outer body835. Pinch valve upper bar852extends from side878ato side878b, transverse to suction passageway844, and is located on the edges of sides878a,878badjacent suction passageway844. As described below, pinch valve upper bar852provides part of the mechanism for starting and stopping the vacuum effect in aspiration conduit870. Spring seat851is located approximately midway along the length of pinch valve extension845. Also as described below, spring seat851provides a seat for a spring860which biases lever836away from pinch valve extension845.

Cover838lays on top of sample catcher chamber843of inner body833and includes extension839extending in a proximal direction. Cover838and extension839retain and guide hypotubes39a,39band pull wires820a,820bwhich slide back and forth when actuation spool34is actuated. Alternatively, cover838may be integrally attached to sample catcher chamber843by, for example, adhesive bonding.

Lever836includes lever handle854, lever flanges856a,856b, pinch valve lower bar858, and spring860. Lever handle854provides a surface on which an operator may push to activate a vacuum effect in aspiration conduit870. Lever flanges856a,856bextend from opposite sides of lever handle854. Flanges856a,856bare separated such that when actuation handle812is assembled, flanges856a,856blie outside of and adjacent to sides878a,878bof pinch valve extension845of inner body833and inside of and adjacent to sides842a,842bof outer body835.

Flanges856a,856bare provided with pins857a,857b, respectively, located on the inner surfaces proximate the proximal end of lever836. Pins857a,857bcomplement holes853a,853blocated on sample catcher body843, and are for rotatably coupling lever836to inner body833.

Pinch valve lower bar858extends from flange856ato flange856b, transverse to suction passageway844, and is located proximate the edges of flanges856a,856bopposite lever handle854. In the assembled configuration, pinch valve lower bar858is located adjacent suction passageway844opposite pinch valve upper bar852. Spring860is a compression spring located between flanges856a,856b.In the assembled configuration, spring860extends from the under surface of lever handle854to spring seat851of pinch valve extension845of inner body833, and pushes lever handle854away from inner body833. Pushing lever handle854away from inner body833causes pinch valve lower bar858to come towards pinch valve upper bar852. Suction passageway844, located between pinch valve lower bar858and pinch valve upper bar852, is thus pinched flat and no vacuum is effected within aspiration conduit870. When an operator presses on lever handle854, spring860is compressed and pinch valve lower bar858is moved away from pinch valve upper bar852. In this manner, suction passageway844is opened and a vacuum effect is introduced into aspiration conduit870.

It is to be understood that alternative devices for starting and stopping the vacuum effect in aspiration conduit870may be used. For instance, an arrangement may be envisioned whereby the spring biases suction passageway844open. As a further example, spring860could be a torque spring or other spring element rather than a compression spring. These and other variations are within the scope of the invention.

As shown inFIGS. 43 and 47, proximal actuation handle812further is provided with an actuation device. As previously described, the actuation device includes actuation spool34, swash plate38and swash plate axle36.

The biopsy instrument according to the present embodiment includes a control member coupled to the actuation device. As embodied herein and as shown inFIGS. 44 and 47, the control member includes pull wires820a,820b. As best shown in FIG.47and as described in relation to a previously disclosed embodiment, the proximal end of pull wires820a,820bare coupled to actuation spool34, comprised of hermaphroditic spool halves130, via swash plate38and swash plate axis36.

Also according to the present embodiment, the control member is coupled to the first and second movable jaws of the distal assembly. As shown inFIG. 44, the distal end of pull wires820a,820bare coupled to first and second jaws890. Specifically, with distal assembly822in an assembled configuration, the distal end of pull wire820ais inserted into the aligned, radially-directed holes902of outer flange897of first jaw890and inner flange893of second jaw890. Similarly, the distal end of pull wire820bis inserted into the aligned, radially-directed holes902of outer flange897of second jaw890and inner flange893of first jaw890. It should be noted that due to the geometric constraints imposed upon the distal ends of pull wires820a,820bwhen in the assembled configuration, no secondary operations or additional parts are required to retain pull wires820a,820bin holes902.

As shown inFIG. 48, the distal ends of pull wires820a,820bare shaped to accommodate the geometry of distal assembly822. Bend portions821provide clearance for inner flanges893and outer flanges897. Furthermore, bend portions821slide within channels880a,880b, respectively, of distal end conduit884.

According to the present embodiment, actuation of the actuation device pivots the first and second movable jaws relative to the flexible member. Pull wires820a,820bare coupled to and extend from holes902of jaws890at distal assembly822through control conduits870a,870b, respectively, of flexible member814. Pull wires820a,820bthen extend through actuation handle812and are coupled to actuation spool34. Moving actuation spool34in a distal direction relative to shaft30causes pull wires820a,820bto move in a distal direction relative to flexible member814and distal end conduit884. This, in turn, causes holes902of jaws890to move in a distal direction relative to pivot pin894which is coupled to distal end conduit884. Mating edges892of jaws890are thereby rotated away from each other and distal assembly822assumes an opened configuration. Similarly, moving actuation spool34in a proximal direction relative to shaft30causes mating edges892of jaws890to rotate towards one another, whereby distal assembly822assumes a closed configuration.

The biopsy instrument of the present embodiment includes a sample collector to trap and retain biopsy samples severed by operation of the distal assembly822. As illustrated inFIG. 43, biopsy instrument810includes sample collector assembly990provided in-line with suction passageway844. Sample collector assembly990acts as a filter to trap matter, such as biopsy samples, flowing through suction passageway844. Matter trapped by sample collector assembly990may then be retrieved by the surgeon or nurse for subsequent pathological examination. Sample collector990, as shown inFIGS. 42aand42b, has been previously described.

The above descriptions of the embodiments of the invention have been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Modifications and variations are possible in light of the above teachings, or may be acquired from practice of the invention. For example, it is contemplated that features of an embodiment may be combined with features of other embodiments, resulting in combinations of features not specifically disclosed herein. The specific embodiments disclosed were described in order to explain the principles of the invention, and its practical application was described to enable one skilled in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. Thus, it is intended that the present invention cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.