1. Technical Field
This disclosure relates to a system and method for the biopsy of tissue specimens and, more particularly, to a single insertion, multiple sample percutaneous biopsy system and method.
2. Background of Related Art
It is often necessary to sample tissue in order to diagnose and treat patients suspected of having cancerous tumors, pre-malignant conditions and other diseases or disorders. Typically, in the case of suspected cancerous tissue, when the physician establishes by means of procedures such as palpation, x-ray or ultrasound imaging that suspicious conditions exist, a biopsy is performed to determine whether the cells are cancerous. Biopsy may be done by an open or percutaneous technique. Open biopsy removes the entire mass (excisional biopsy) or a part of the mass (incisional biopsy). Percutaneous biopsy on the other hand is usually done with a needle-like instrument and may be either a fine needle aspiration (FNA) or a core biopsy. In FNA biopsy, individual cells or clusters of cells are obtained for cytologic examination and may be prepared such as in a Papanicolaou smear. In core biopsy, as the term suggests, a core or fragment tissue is obtained for histologic examination and can be performed via frozen section or paraffin section. In more recent developments, percutaneous techniques have been used to remove the entire mass during the initial procedure.
The type of biopsy utilized depends in large part on the circumstances present with respect to the patient and no single procedure is ideal for all cases. Core biopsy, however, is extremely useful in a number of conditions and is being used more frequently.
Intact tissue from the organ or lesion is preferred by medical personnel in order to arrive at a definitive diagnosis regarding the patient""s condition. In most cases, only part of the organ or lesion need be sampled. The portions of tissue extracted must be indicative of the organ or lesion as a whole. In the past, to obtain adequate tissue from organs or lesions within the body, surgery was performed so as to reliably locate, identify and remove the tissue. With present technology, medical imaging equipment such as stereotactic x-ray, fluoroscopy, computer tomography, ultrasound, nuclear medicine and magnetic resonance imaging, may be used. These technologies make it possible to identify small abnormalities even deep within the body. However, definitive tissue characterization still requires obtaining adequate tissue samples to characterize the histology of the organ or lesion.
Mammography can identify non-palpable (not perceptible by touch) breast abnormalities earlier than they can be diagnosed by physical examination. Most non-palpable breast abnormalities are benign but some are malignant. When breast cancer is diagnosed before it becomes palpable, breast cancer mortality can be reduced. It is still difficult to determine if pre-palpable breast abnormalities are malignant, as some benign lesions have mammographic features which mimic malignant lesions and some malignant lesions have mammographic features which mimic benign lesions. Thus, mammography has its limitations. To reach a definitive diagnosis, tissue from within the breast must be removed and examined under a microscope.
The introduction of stereotactic guided percutaneous breast biopsies offered alternatives to open surgical breast biopsy. With time, these guidance systems have become more accurate and easier to use. Biopsy guns were introduced for use in conjunction with these guidance systems.
Biopsy devices used in connection with the above-mentioned guidance systems, particularly those used for diagnostic procedures, suffered from various drawbacks. These devices are manufactured for use with a specific guidance system. Use with other systems requires modifications and adaptations to the biopsy device.
Use of current devices can be limited due to their length. Current designs may be too long or contain configurations for particular mammography tables. Therefore, the above-mentioned devices may not be usable with more than one guidance system without modification or may not be adaptable at all.
In many biopsy procedures, it is necessary to retrieve samples from different orientations at a tissue site. Another disadvantage of current devices is the inability to recall at what position a previous sample was taken. Another drawback suffered by current devices is severing tissue with a knife that is hand driven. This results in inconsistent sample size due to resilient tissue that may be encountered. Further, the firing of a biopsy gun and manipulation of a biopsy device into tissue may cause undesired collateral damage to untargeted tissue and surrounding bodily structures which may result in poor tissue sampling.
Therefore, a continuing need exists for percutaneous biopsy apparatus which can reliably extract adequate biopsy sample(s) with a single insertion of the biopsy instrument and has the versatility to be used in conjunction with various guidance systems used for retrieving tissue samples without the necessity of extensive modifications or adaptations. Preferably, such an apparatus provides an accurate and precise location and retrieval of tissue samples with minimized collateral damage to untargeted tissue and surrounding bodily structures. The apparatus may include the ability to recall sample retrieval position. The apparatus may also include the ability to control the rate for severing a sample. Most preferably, ergonomic enhancements are included for facile manipulation of the apparatus.
The present disclosure describes systems and methods for the biopsy of tissue specimens, and more particularly, to a single insertion multiple sample percutaneous biopsy system that has the versatility to be used in conjunction with various types and sizes of imaging guidance systems, for example, prone table systems and upright sitting systems, used for retrieving tissue samples without the necessity of modifications or adaptations. The system, preferably, provides an accurate and precise location and retrieval of tissue samples with minimized collateral damage to untargeted tissue and surrounding bodily structures. Most preferably, ergonomic enhancements are included for facile manipulation. The versatility of the system is provided, at least in part, by its novel design and configuration.
The system is used in connection with vacuum assisted biopsy, which can be used for diagnosis. The system allows an operator to extract multiple samples of suspect tissue without withdrawing the active biopsy instrument from a patient to retrieve each separate tissue sample. The disclosed system and methods provide little or no need for stitches and the patient may resume normal activities almost immediately.
In one embodiment, in accordance with the present disclosure, a biopsy system, such as, for example, a biopsy apparatus is provided which includes a carriage housing defining a cavity therewithin. A biopsy instrument, such as, for example, an insertion unit is supported within the cavity of the housing. A firing module engages a wall of the housing and operatively engages the insertion unit for delivering a vacuum tube, defining a fluid passageway therein and a tissue basket, of the insertion unit towards a targeted tissue site. A tissue stripping member is disposed on the vacuum tube. The insertion unit may be disposable and suitable for various types of housings.
A tubular knife member is included within the insertion unit and is rotatably and reciprocatingly coaxially disposed about the vacuum tube. The tubular knife member has a cutting edge for severing tissue. An outer tube is included which is, preferably, made from a radiolucent material and coaxially disposed about the tubular knife member. The outer tube may include a radiopaque marker disposed thereon.
The housing may include a cover for maintaining the insertion unit within the cavity. A cover latch assembly may be provided and mounted to the housing. The housing may include wheel knobs for proper calibration and positioning of carriages for support of the insertion unit. Preferably, a latch and a lock cooperate with the wheel knobs to maintain the carriages in position.
The carriage housing may include a knife carriage for supporting the tubular knife member of the insertion unit. A knife advance assembly is, preferably, included to bias the tubular knife member between a range of motion for enhanced ergonomic control. A trocar carriage may be included in the carriage housing for support of the vacuum tube. Preferably, the trocar carriage is driven towards the tissue sample site by a ram of the firing module.
In another embodiment, the firing module has a module latch assembly for releasably engaging the firing module with the carriage housing. The module latch assembly includes a release button to release the firing module from the carriage housing. A firing release assembly is included to prevent firing of the hammer when the firing module is disengaged from the housing. A ram is included which is mounted to a rocker arm facilitating motion of the ram. The rocker arm can be actuated by springs. A trigger button engages a latch assembly that releases the rocker arm. The rocker arm causes the ram to drive the insertion unit into a lesion of a patient.
In a further alternative embodiment, a biopsy system, in accordance with the present disclosure is provided. The biopsy system includes a housing and a biopsy instrument operatively associated with the housing. The biopsy instrument is configured and dimensioned to remove a tissue sample from a patient. The biopsy instrument may include a tissue receiving portion. A firing module similar to that previously noted is detachably engageable with the housing and operatively associated with the biopsy instrument to facilitate selective rapid advancement of at least a portion of the biopsy instrument toward a targeted location with the patient. The biopsy system is adaptable to fit on an upright diagnostic biopsy table. Further, the biopsy instrument can be removable from the biopsy system.
The system may include an indexing assembly disposed within the housing and configured to cooperate with the biopsy instrument to selectively orient the tissue receiving portion. The biopsy instrument can include a tubular member cooperating with the tissue receiving portion. The indexing assembly includes a camming assembly disposed on the tubular member. The camming assembly may include a first cam member mounted to the tubular member. The first cam member is configured to engage a second cam member disposed within the housing. The first cam member is also configured to engage a third cam member disposed within the housing.
The indexing assembly may include a manual gearing assembly configured for selective orientation of the tissue receiving portion. The biopsy instrument may alternatively include a tubular member having a tissue receiving portion disposed near a distal end thereof. The biopsy instrument can further include a tubular knife member coaxially disposed relative to the tubular member and configured for actuation relative to the tubular member for severing tissue.
A linear advancement control assembly can be disposed within the housing and configured to effect linear actuation of the tubular knife member. The linear advancement control assembly may include a plurality of bearings mounted within the housing and configured to effect linear movement of the tubular knife member. The plurality of bearings may include three bearings oriented relative to each other such that the tubular knife member may be snap fit in between two of the bearings. The plurality of bearings may be oriented and configured such that contact surfaces of the respective bearings form a partially helical thread which effects axial translation of the tubular knife member.
An optical sensor may be disposed adjacent a portion of the tubular knife member and oriented to detect the orientation of a lateral opening formed through the tubular knife member. A carriage may be slidably disposed within the housing and configured to releasably retain at least a portion of the biopsy instrument within the housing.
In another alternative embodiment, the biopsy system includes a housing and a biopsy instrument operatively associated with the housing. The housing includes a first tubular member having a tissue basket formed near a distal end thereof. The tissue basket is configured for retrieval of tissue. The biopsy instrument further includes a tubular knife member coaxially disposed relative to the first tubular member and configured for cooperative movement with the first tubular member to sever a tissue sample from a patient. An indexing assembly is operatively engageable with the biopsy instrument for selective orientation of the tissue basket.
A method of performing a surgical biopsy is disclosed including the steps of inserting a biopsy apparatus, as described above, into tissue of a patient at a first tissue sampling site, applying suction to the tissue basket to draw tissue into the tissue basket, severing the tissue from the first tissue sampling site by actuating the tubular knife member of the biopsy instrument, retracting the tissue basket from the first tissue sample site for removal of tissue from the tissue basket such that a cam being disposed on the first tubular member interacts with a cam assembly disposed within the housing to orient the tissue basket to a predetermined orientation, and removing tissue from the first tissue sampling site from the tissue basket remote from the first tissue sampling site. The method may further include the step of returning the tissue basket to the first tissue sampling site as determined by the indexing assembly. The method may further include the step of orienting the tissue basket at a second tissue sampling site as determined by the indexing assembly. The method may further include the step of applying suction to the tissue basket to draw tissue into the tissue basket. The method may still further include the step of severing tissue from the second tissue sampling site by actuating the tubular knife member. The method may further include the step of retracting the tissue basket from the second tissue sampling site for removal of tissue from the second tissue sampling site.
In yet another alternative embodiment, the biopsy system includes a disposable biopsy instrument kit which includes a biopsy instrument including at least two coaxially disposed tubular members movable relative one another to sever a discrete tissue sample from a patient and an alignment member removably attached to the biopsy instrument. The alignment member retains the at least two coaxially disposed tubular members in a fixed relative position and orientation with respect to each other.
In another embodiment, the biopsy instrument includes a drive apparatus having a housing and a carriage assembly slidably disposed within the housing. The carriage assembly is adapted to receive and removably retain a biopsy instrument. A firing module is detachably engageable with the housing and operatively associated with the carriage assembly to facilitate selective rapid linear advancement of the carriage assembly.
USPTO Backgrounds
USPTO Backgrounds