US 20050113716 A1
A biopsy device having an endoscope comprises a biopsy instrument, suitable for collecting at least one tissue sample from a body lumen, such as a mammary duct, and a cutter introducer sized for receiving the biopsy instrument and introducing the biopsy instrument into a mammary duct to retrieve a tissue sample therefrom.
1. A biopsy device suitable for collection of a tissue sample from a biopsy site in a body lumen, the biopsy device comprising:
a cutter introducer comprising an elongated, hollow sheath, the sheath rotatable about a longitudinal axis having a distal end portion and a proximal end portion, wherein the distal end portion defines an aperture for receiving a tissue mass, and a hollow handle about the proximal end portion of the sheath;
a biopsy instrument comprising an elongated cutter for severing the tissue sample, received through the aperture, the cutter element being sized for removable insertion in the cutter introducer; and
an endoscope, the endoscope being sized for removable insertion in the elongated cutter and having a distal end portion movably positionable proximate the aperture.
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12. A biopsy device suitable for collection of at least one tissue sample from a biopsy site in a lumen, the biopsy device comprising:
a housing reciprocably mounted with the holster;
a cutter drive motor in the housing;
a power source operably associated with the cutter drive motor;
a switch operably associated with the motor and the power source for energizing the cutter drive motor;
a hollow cutter driven by the cutter drive motor and rotatably mounted in the housing;
an endoscope removably mounted to the housing and slidably receivable within the hollow cutter; and
a coupling mount on the holster for removably receiving a biopsy introducer, the introducer comprising an elongated, apertured hollow sheath having a distal end portion and a proximal end portion, wherein the distal end portion defines an aperture for receiving the tissue sample.
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20. A biopsy device suitable for collection of at least one tissue sample from a biopsy site in a lumen, the biopsy device comprising an introducer and an instrument:
the instrument further comprising:
a holster and a housing reciprocably mounted to the holster;
a cutter drive motor in the housing;
a power source operably associated with the cutter drive motor, the cutter drive motor and power source being operatively connected to a switch for energizing the cutter drive motor;
an elongated hollow cutter driven by the cutter drive motor and rotatably mounted in the housing;
an ejector assembly suitable for ejecting the tissue sample from the cutter, the ejector assembly including an endoscope piston removably mounted with the housing and slidably receivable within the hollow cutter; and
a coupling mount on the holster for removably receiving the introducer;
the introducer further comprising an elongated, hollow sheath having a distal end portion and a proximal end portion, wherein the distal end portion defines an aperture for receiving the tissue sample, the aperture comprising a hook portion, the sheath suitable for removably receiving the cutter therein.
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This application is a continuation-in-part of application Ser. No. 10/422,381, filed on Apr. 24, 2003.
The invention generally relates to a device for obtaining mammary duct tissue samples for analysis. More specifically, the invention relates to a biopsy device having an endoscope and an introducer therefor.
Breast cancer is one of the health threats most feared by women, and is indeed the most common form of cancer in women. A key to treatment is early detection. For example, an annual mammogram is a method that has been used in hopes of early detection of breast cancer. One problem with mammography is that such an imaging technique can only find breast cancer once it has taken form. All too often, breast cancer is discovered at a stage that is too far advanced, when therapeutic options and survival rates are severely limited. While breast cancer is most common among women, in rare instances the human male may also have occurrences of breast cancer.
Other methods of detecting breast cancer are based on the fact that in a vast majority of instances breast cancer begins in the lining of mammary ducts. Studies have shown that fluid within the mammary duct contains high levels of breast cancer markers, and that an estimated 80%-90% of all breast cancers occur within the intraductal epithelium of the mammary glands. Fluid within the breast ducts contains an assemblage and concentration of hormones, growth factors and other potential markers comparable to those secreted by, or acting upon, the surrounding cells of the alveolar-ductal system. Likewise, mammary fluid typically contains cells and cellular debris or products that can also be used in cytological or immunological assays. As such, techniques such as ductal lavage, collection of mammary duct discharge, and brushing biopsies have been utilized to obtain such samples for diagnostic purposes.
If suspicious tissue is located, a biopsy of the tissue may then be taken. One biopsy device that has been utilized is the MammotomeŽ biopsy system available from Ethicon Endo-Surgery, Inc., Cincinnati, Ohio. After mapping an area to be biopsied, the MammotomeŽ probe, a needle-like device with a hollow passage therethrough, is introduced through an incision cut into the breast and inserted further until the desired biopsy region is accessed. When the probe is positioned at the region of concern, tissue is received into a window in the probe with vacuum assist. A cutter then cuts and removes tissue samples for examination. The samples are passed through the hollow passage of the probe into a collection chamber. Because the MammotomeŽ probe is directional, multiple specimens can be collected without having to remove and reinsert the device. The MammotomeŽ probe is removed after the samples have been collected, and the incision is closed.
Such a system significantly decreases the invasiveness of the biopsy procedure by only requiring a small incision and puncture, which may be done under local anesthetic. However, in certain situations, such as where the tissue to be biopsied is in a mammary duct, the incision and probe insertion required with the MammotomeŽ is unnecessarily invasive and undesirable.
What is needed is a biopsy device for conducting a minimally invasive biopsy procedure without the need for an incision. It is also desirable that the physician be able to take multiple tissue samples from a single biopsy site. It is further desirable for the physician to be able to identify and record the location of each sample of tissue extracted. The present invention meets the foregoing desires and provides an improved device for taking a biopsy within a mammary duct, as well as a device that facilitates memorializing in the patient's records the location of the tissue sampled.
A biopsy device embodying the present invention comprises a biopsy instrument provided with a tissue cutter suitable for collecting at least one tissue sample from a body lumen, such as a mammary duct, and a cutter introducer sized for receiving the tissue cutter and guiding the tissue cutter into a mammary duct.
The biopsy instrument includes a holster, a housing reciprocably mounted in the holster, and an elongated hollow cutter that extends from the housing and is driven by a cutter drive motor situated within the housing. A power connector, operably connected to a power source, is associated with the cutter drive motor. The hollow cutter rotates about a longitudinal axis thereof upon energization of the motor by activating a switch operably associated with the motor. The hollow cutter also extends distally relative to the holster when the housing is urged into the holster. An ejector assembly is removably mounted to the housing and received within the cutter. The ejector assembly includes an endoscope which is slidably received within the hollow cutter and may be extended therethrough. The endoscope serves the dual purpose of viewing the area to be biopsied, as well as serving as a piston for urging or expelling biopsied material from the cutter. A coupling mount for removably receiving the cutter introducer, such as a boss terminating in a distal, radially outwardly extending flange, is also provided on the biopsy cutter.
Preferably included within the housing is a power source, such as a battery, which can be a primary battery, i.e., single use, or a secondary battery, i.e., rechargeable. Alternatively, the power source may be external to the housing and the holster therefor, but operatively connected to the power connector. The housing and holster are preferably formed of a lightweight rigid plastic. The cutter is preferably formed of a lightweight metal such as stainless or surgical steel, or the like.
The other component of the biopsy device is the cutter introducer, which is comprised of a hollow handle, and an elongated sheath having open opposite ends, i.e., a distal end and a proximal end, mounted to the handle and adapted to receive the cutter element therewithin. A window cut-out or aperture is provided at a distal end portion of the sheath. The window or aperture preferably includes a hook portion for grasping and pulling the target tissue through the window and into the sheath. A proximal end portion of the sheath is fixed within the handle. The hollow handle further defines an axial passage leading to the sheath.
The handle of the cutter introducer preferably includes an integral azimuth indicator, which may be unitary with the handle. The azimuth indicator can also be a pair of azimuth indices that can be aligned vis-a-vis one another, and the like. The handle can also include a socket for receiving the coupling mount of the biopsy instrument. For example, the coupling socket on the handle may be an annular cavity which can receive the boss of the holster provided with a radially outwardly extending flange. The handle is also preferably formed of a lightweight rigid plastic. A tissue anchor extendable through the introducer is desirable in some cases. The tissue anchor can comprise a hollow hub and flexible outwardly biased tines that extend from the hub and an optional retriever rod. The tissue anchor is slidably and rotatably mounted within the sheath at the distal end portion thereof. The tines of the anchor are extendable from the open distal end of the sheath and spread radially outwardly when so extended. A distal end portion of the retriever rod, which retracts the anchor and the tines within the sheath, is configured to engage the anchor.
In order to obtain a tissue sample with the biopsy device from a mammary duct the cutter introducer is first inserted into a nipple orifice at the nipple surface and then advanced into the mammary duct. The endoscope may be utilized within the introducer to locate and view the biopsy site, if desired. When a tissue mass of interest is located, and the distal end portion of the sheath positioned as desired, the tines of the anchor are extended beyond the open distal end by urging the hub of the tissue anchor to slide towards the distal end. The tines are pushed through the open distal end, and because they are outwardly biased, spread out radially to contact the walls of the mammary duct and immobilize the introducer.
The biopsy instrument, in particular the cutter, is inserted into the introducer and extended towards the distal end portion thereof. A tissue mass from the biopsy site is received within the introducer sheath through an aperture or cut-out at the distal end portion of the introducer sheath. The motor for driving the cutter element is energized and rotates the cutter element. As the distal end of the cutter travels across the aperture, that portion of the tissue mass received within the introducer sheath is severed. The biopsy instrument is withdrawn from the introducer sheath after the desired tissue samples have been taken. The hollow cutter element receives the tissue mass within its interior, and the severed tissue is later ejected from the hollow cutter by the ejector assembly for analysis.
When it is desired to remove the introducer, a retriever rod may be extended through the introducer sheath to engage the hub of the tissue anchor. The retriever rod is then retracted and draws the anchor back into the sheath, thereby disengaging the tines from the mammary duct. The introducer can then be withdrawn from the mammary duct. Alternatively, the anchor can be urged past the distal end of the introducer and left in the mammary duct as a biopsy site marker or indicator.
In the drawings,
The invention disclosed herein is susceptible of embodiment in many different forms. Shown in the drawings and described hereinbelow in detail are preferred embodiments of the invention. It is to be understood, however, that the present disclosure is an exemplification of the principles of the invention and does not limit the invention to the illustrated embodiments.
A preferred embodiment of a biopsy device is shown in
The cutter or blade 42 is configured for sliding travel through the handle 24 and sheath 26 of the introducer 14. Specifically, the outer diameter of the cutter 42 is smaller than the inner diameter of the sheath 26. The cutter 42 is also sufficiently long to extend to the distal end portion 32 of the sheath, and preferably such that when fully extended, the cutter element projects beyond the aperture 30.
As can be seen in
Positioned between the distal end of holster 16 and distal end of housing 18 is a return spring, such as coil spring 56. The holster 16 further defines a groove 58 through which dorsal post 60 is positioned and extends therethrough from housing 18 (
Coil spring 56 is axially aligned with the cutter 42 in holster 16, through which cutter 42 is extended for axial reciprocation within elongated sheath 26. A hollow support or bearing 70 may also be provided within the holster 16, through which cutter 42 passes. Also provided by the holster 16 is a coupling mount 48 for removably attaching the biopsy instrument 12 to cutter introducer 14. The coupling mount 48 is preferably a boss 49 terminating in a distal, radially outwardly extending flange. Coupling mount 48 may also include an o-ring seal 51 that circumscribes boss 49.
A pusher rod assembly 46 includes elongated piston rod 62 and an actuator handle 63, and is removably mounted within the housing 18. The piston rod 62 is slidably received within the hollow cutter 42. The pusher rod assembly 46 is slidably positioned within housing 18, and actuator handle 63 is accessible from outside the housing for manual actuation. Further disposed within housing 18 is a pusher rod coil spring 66 biased against forward axial movement of the pusher rod assembly 46. Piston rod 62 extends from actuator handle 63 into and through cutter 42. Piston rod 62 has an outer diameter that is smaller than the inner diameter of the hollow cutter 42 such that any material within the cutter 42 is pushed out by piston rod 62 when extended. In particular, when pusher rod assembly 46 is pushed forward, piston rod 62 projects past the distal end 72 (
The other major component of the biopsy device is a cutter introducer removably mounted to holster 16. A cross section of a preferred embodiment of the biopsy introducer 14 is shown in
Also shown within the distal end portion 32 of sheath 26 thereof is tissue anchor 76. Tissue anchor 76 is optional and aids the operator in maintaining penetration control as indicated by depth marker 35. An externally applied nipple clamp (not shown) may be optionally employed to clamp or retain introducer sheath 26 within the nipple duct sphincter muscle, thereby also aiding in penetration control.
An enlarged view of the distal end portion 32 of the introducer is shown in
Preferably, the annular step 88 and beveled detent 90 are contoured so that by application of additional force, the tissue anchor 76 can be urged past the distal end 28 of the sheath 26 and left in place as a marker for the biopsy site. Tactile feedback is provided to the operator by increased resistance from the interaction of annular step 88 and detent 90 when the anchor 76 is extended, but still within the sheath 26. Alternatively, tissue anchor 76 can be disengaged from sheath 26 by gently withdrawing sheath 26 from the biopsy site such that tissue anchor 76 is left behind still engaged with the mammary duct wall.
If it is desired to remove the anchor 76, preferably it is disengaged from the mammary duct by retraction into the sheath 26. In order to retract the anchor 76, a retriever rod 84 is introduced through the sheath 26. The retriever rod 84 includes a detent 85 for engaging the latch 82 extending from the hub 78 as shown in
In order to obtain a tissue sample with the biopsy device 10 (
An alternate embodiment of the tissue anchor and retriever rod are shown in
To obtain multiple tissue samples from a biopsy site, and to discern the relative original locations of the tissue samples as part of the tissue analysis an azimuth marker is provided. To that end, and as illustrated in
Another preferred embodiment of a biopsy device is shown in
The biopsy instrument 212 comprises a holster 216, a housing 218 that is slidably and reciprocably received in holster 216, and a hollow elongated cutter 242, slidably received within elongated sheath 226 of cutter introducer 214. An ejector assembly 261 is further provided, which comprises a rocker arm, such as ejector handle member 263, a hinge member 267, and a barrel member 269. The barrel member 269 further defines a passageway 271 including a collar portion 272. The ejector assembly 261 further comprises an endoscope 262 having an adapter, such as a Tuohy fitting 276, that removably secures the endoscope to the collar portion 272 of the passageway 271. Also provided is an ejector assembly coil spring 266, which is biased against distal movement of the ejector assembly 261 towards the cutter introducer 214. Since the endoscope 262 is secured within the ejector assembly, its movement corresponds to the movement of ejector assembly 261. Operatively connected to the passageway 271 is a removable port member 273, through which solution, such as irrigation liquids may be introduced. Port member 273 is also suitable for providing a conduit for a suctioning device. A return spring, such as coil spring 256 is also provided between the housing 218 and the holster 216. Also, an on-off switch, such as button switch 245 is provided, which when actuated causes a motor to rotate cutter 242 such as described above.
As shown, the ejector assembly handle 263 is engaged with end cap 222, when the ejector assembly 261 is in a forward position thereby acting as a detent member. The endoscope 262 is also positioned such that its distal end 275 is extended proximate to or beyond the distal end 277 of the cutter 242. By positioning the endoscope 262 proximate the distal end 277 of the cutter 242, the practitioner is able to view the biopsy site in real time up to the time the cutting operation takes place.
When the practitioner is ready to begin cutting, tissue is urged through the window 230 by manipulating the patient's breast. In order to provide a collection reservoir 279, the endoscope 262 is first retracted as shown in
While it has been found that a deeper hook depth is generally more advantageous, various factor constrain the hook depth, including the marginal strength of the material forming the introducer, the wall thickness, and the outside diameter of the tube. This is because the hooking process causes a shaft deflection which may cause the advancing cutter to catch the hook causing damage thereto. Therefore, as little shaft deflection as possible is desired, and the dimensions described above provide satisfactory results.
It is also preferred that the window 430 be relatively long. In the example being discussed of a 0.039 inch (0.09906 centimeter) diameter stainless tube having a wall thickness of 0.0025 inches (0.00635 centimeter), and hook depth of 0.13 to 0.185 inches (0.3302 to 0.4699 centimeters), it is preferred that the window have a length of greater than 0.197 inches (0.5 centimeter). The longer window 430 allows a desired amount of tissue to be pulled therein by hook 431.
Yet another type of sampling that is possible with the present biopsy device is shown in
Preferably, the distal end 577 of the cutter 542 has an inner diameter that is 90% to 95% of inner diameter of the rest of the cutter 542. It has been found that a fully parallel cutter sometimes results in a core sample that remains attached to the patient. The reduced diameter distal end 542 creates a packing feature, which will tend to pull the tissue and tear away from the uncut end. In other words, after the cutter has cut tissue, the endoscope is advanced to slightly compact the tissue against the distal end within the cutter to aid in sample removal. Another alternative method is to insert a sharpened forward moving pin into the cutter after the core is cut by removing the endoscope. The moving pin acts to wedge the tissue sample within the cutter to aid in sample removal.
The foregoing descriptions are to be taken as illustrative, but not limiting. Still other variants within the spirit and scope of the present invention will readily present themselves to those skilled in the art.