METHOD FOR EXCISING CORE TISSUE SAMPLE
Apparatus for safely and accurately positioning the fingertip of a physician (or technician) performing a biopsy procedure, e.g., to excise a core tissue samples of the male prostate or other internal organs, to avoid injury (e.g., a needle stick) from the sharpened distal end of a biopsy needle assembly. Such apparatus comprises an open tubular member defining an elongated passageway through which a biopsy needle assembly, when actuated, can be made to pass and to extend a predetermined distance along an external path in order to effect the core sampling of a biological mass of interest. The tubular housing supports a safety flange at its distal end, such flange having a flat surface adapted to be engaged by the fingertip of the physician prior to actuation of the biopsy needle assembly. Preferably, the engaged surface of the safety flange defines a physical fiducial adapted to be sensed by the user's fingertip, such fiducial being located a predetermined safe distance from the external path traveled by the needle assembly, whereby the physician is assured that his or her fingertip is safely spaced from the needle assembly when actuated, and the distal end of the tubular housing is precisely positioned relative to a biological mass of interest.
This Patent Application is a Continuation of U.S. Non-provisional patent application Ser. No. 14/756,173, filed on Aug. 11, 2015, which claims priority to U.S. Provisional Patent Application No. 62/070,482, filed on Aug. 26, 2014, and entitled “Apparatus for Safely and Accurately Excising Core Tissue Samples from Palpated Nodules or Surface Lesions,” the disclosures of which are incorporated herein, in their entirety, by reference.
BACKGROUND OF THE INVENTIONField of the Invention
The present invention relates to improvements in apparatus for taking core tissue samples of, for example, the male prostate or other internal organs at locations corresponding to surface irregularities that can be palpated by the fingertip of a physician (or technician). More specifically, it relates to apparatus for decreasing the risk of finger puncture and improving the accuracy of the biopsy of lesions of interest.
Discussion of The Prior Art
During routine digital examination of the prostate, it is common for the examiner to use his or her fingertip to probe the initial 10 centimeters or so of the rectum to detect any suspicious surface irregularities (e.g., lesions or nodules) that can be felt on the inner surface of the rectal wall or the outer surface of the prostate gland. Having manually palpated irregularities on or through the wall of the rectum, it is often desirable to take a core biopsy of one or more areas of these lesions for subsequent analysis.
In biopsying the irregularities noted above, it is essential that the examining person accurately position the biopsy needle onto a irregularity of interest. It is also essential to accurately position the palpating fingertip out of “harm's way” at the time the biopsy is performed. A “needle stick’ is not only painful to the recipient, but it also can result in the transmission of serious diseases to the examiner biopsying the lesion. To achieve this accuracy during the biopsy procedure, the examiner must simultaneously maintain the position between his or her palpating fingertip and the irregularity of interest, while maneuvering the free end of a biopsy needle assembly to a position closely spaced from the palpating fingertip. Having done so, the physician then activates a triggering mechanism that causes the biopsy needle to quickly reciprocate in axial directions, first moving in a direction to penetrate the irregularity to excise a core sample therefrom, and then moving in an opposite direction in which the needle is withdrawn from the sample and returned to its sheath.
In taking tissue samples as described above, it will he appreciated that the physician must be exceedingly careful to avoid being accidentally injured by the tip of the biopsy needle. Since, at the time of taking the sample, neither the mass of interest nor the tip of the biopsy needle can be visualized, the physician must rely on his or her sense of touch to assure the accuracy of the procedure and his or her safety in performing the procedure. The prospect of an accidental needle stick is exacerbated by the need to position both the needle tip and the palpating fingertip as close as possible to the lesion of interest at the time the biopsy is taken. Generally, the closer this spacing, the higher the accuracy of the biopsy and, unfortunately, the greater the risk of an accidental finger stick by the needle.
The above-noted close spacing among a palpating fingertip, the tip of a biopsy needle and an irregularity of interest will be appreciated from the prior art drawings of
As noted above, cannula 20 is axially movable within the guide tube 30, and its axial position is controlled by the position of a manually movable tab 46 that is slidably-mounted on the handle 44 and rigidly connected to the cannula. Axial movement of the stylet 10 within the cannula 20 is controlled by a knob 50 that is also slidably mounted on the handle 40. As best shown in
According to the disclosure of the above-noted patent, the apparatus disclosed is used as follows: Referring to
From the foregoing, it will be appreciated that there may be significant safety issues in using the apparatus described. For example, the suggested initial creation of a contact “force” between the physician's fingertip and the stylet tip may well cause a needle stick even before the apparatus is inserted into the rectum. Further, upon removing the fingertip from the sharpened end of the stylet in order to explore (i.e., palpate) the surface of the prostate, an uncertainty is created between the respective positions of the fingertip and the sharpened stylet tip. In such case, movement of the stylet tip to penetrate a nodule of interest without knowing exactly where the fingertip is located may also cause a needle stick of the physician's fingertip. Also, because of this uncertainty, the accuracy of the biopsy may be compromised, causing an unintended portion of the prostate to be biopsied.
SUMMARY OF THE INVENTIONIn view of the foregoing, an object of this invention is to provide a safer and more accurate apparatus for excising a core sample from a palpatable internal lesion for subsequent analysis.
According to a preferred embodiment of the invention, apparatus that achieves the above objective comprises an elongated hollow tubular housing having opposing proximal and distal ends. This tubular housing, which is adapted to be hand-held by a person performing a biopsy procedure, defines an open longitudinal passageway extending between the opposing ends of the tubular housing. The passageway is adapted (i) to slidably receive a biopsy needle assembly inserted into the passageway at the proximal end of the tubular member, and (ii) to guide the biopsy needle assembly through the passageway until a portion of the needle assembly exits from the passageway and extends a predetermined distance from the distal end of the housing in order to excise a core sample of interest. Mounted on the distal end of the tubular housing at a location proximate that location where the needle assembly exits from the passageway is a rigid safety flange member that extends at an acute angle away from the longitudinal axis of the passageway. This flange members adapted to be engaged by the fingertip of the user at the time the biopsy needle assembly is actuated for the purpose of biopsying a sample. Owing to its location, the flange membershields the fingertip from contact with the needle assembly as the latter is moved axially to biopsy the sample. Preferably, the flange member defines a fiducial that is readily sensed by the fingertip, whereby (a) the fingertip is precisely positioned on the flange member to prevent a needle stick during the biopsy procedure, and (h) the needle tip accurately enters the lesion the interest.
The invention and its advantages will be better understood from the ensuing detailed description of preferred embodiments, reference being made to the accompanying drawings wherein like reference characters denote like parts.
As indicated above, the subject invention is intended to provide protection to the hand of a physician or technician performing a core biopsy procedure on an internal organ, e.g., the prostate gland. Typically, the procedure involves placing the physician's finger into a body cavity for the purpose of palpating the organ of interest to locate suspicious nodules or lesions indicative of cancer or other serious diseases. When a biopsy needle assembly is activated to take a core sample of such suspicious area, the physician's fingertip must be protected from contact with the needle assembly to avoid injury. In addition to providing such protection, the apparatus of the invention serves to more precisely direct the needle assembly along a path to achieve the desired result.
Referring now to the drawings,
Mounted in a cantilever fashion at each of the opposing ends of the housing 2 are a pair of rigid flanges 4A and 4B. Preferably, each of these flanges is planar in shape and has a typical width y (shown in
While the up-turned flange 4A at the distal end of housing 2 has multiple purposes, the down-turned flange 4B functions to facilitate the loading of the biopsy needle assembly into the passageway 2A. In effect, it provides a ramp that directs the distal end of the needle assembly directly to the passageway opening 2D. (See
In performing a biopsy of the prostate using the apparatus of
A variation of the apparatus of the invention is depicted in
A preferred method of fabricating housing 2 with integral flanges 4A and 4B from a metal, such as stainless steel, brass, copper or aluminum, is to first cut a tube of the desired metal to a suitable length, e.g. 7 inches. The outer and inner diameters of the tube are as described above. An end of the tube is then placed between the jaws of a vice to a length, measured from the tube end, equal to the desired length of a flange, e.g., ⅜ inch. The vice is then operated to apply a compression force to diametrically opposed surfaces of the tube end, and this force is continued until the walls of the tube move into intimate contact. This flattened region of the tube thus becomes either of the flanges 4A or 4B, which will now be integral with the tube housing 2. Note, this flattened region will have a thickness equal to twice that of the tube wall, as illustrated in
To fabricate the above apparatus from plastic, a suitable plastic tube is cut to a desired length, e.g., 7 inches. One end of the plastic tube is heated to soften its plastic material. While in a softened stated, the opposing walls of the heated end portion of the tube are compressed together until they become fused together in this manner a plastic flange 4 is formed that is integral with the plastic tube. While still in a softened state, the flange is bent to the desired angle A, and while still in a softened state, a specially configured platen featuring a negative image of fiducial 6 is used to form the fiducial on one of the planar surfaces of the flange. The heated end of the plastic tube is slowly cooled to allow the flange to retain its desired shape and orientation relative to the tube housing 2. After cooling, the apparatus is then bored, as described in the preceding paragraph.
As an alternative to the multiple steps described above, in which case a monolithic plastic apparatus is produced, the flanged ends of the device can be produced by an injection molding process, and these ends can be separately affixed to the end(s) of a plastic tube.
The invention has been described with particular reference to a transrectal biopsy needle used to take core samples of the prostate gland. It will be appreciated, however, that the invention can be used to take core samples from other body cavities, e.g., within the vagina or throat of a patient, or even from tissue underlying external suspicious surface lesions and sores that are readily visible on the outer skin of a patient. Obviously, the physical dimensions and materials of the apparatus described herein may vary in adapting the apparatus for such uses and, thus, should not be considered as limiting.
Claims
1. A method for biopysing a biological mass located by a fingertip (76) of a human, said method comprising:
- palpating the biological mass wider the fingertip (76) of the human,
- positioning a distal end (2C) of a housing (2) next to the biological mass and the fingertip (76) of the human,
- sliding a cannula (20) and a stylet (10) through the housing (2) outwardly from the distal end (2C) to retain a biopsy of the biological mass in the stylet (10),
- retracting the cannula (20) and the stylet (10) back into the housing (2) with the biopsy of the biological mass in the stylet (10), and
- characterized by,
- inserting a flange (4A) between the fingertip (76) of the human and the biological mass to protect the fingertip (76) of the human from the stylet (10) and the cannula (20) as the cannula (20) and the stylet (10) are slid outwardly from the housing passageway (2A) to cut and retain a biopsy of the biological mass in the slot of the stylet (10).
2. A method of claim 1 wherein said step of inserting a flange (4A) between the fingertip (76) of the human and the biological mass to protect the fingertip (76) of the human from the stylet (10) and the cannula (20) as the cannula (20) and the stylet (10) are slid outwardly from the housing passageway (2A) to cut and retain a biopsy of the biological mass in the slot of the stylet (10) is further defined with the distal fiducial (6) of the flange (4A) touching the fingertip (76) of the human during positioning of the housing (2).
3. A method of claim 1 further including the step of inserting the cannula (20) and the stylet (10) into the housing passageway (2A) of the housing (2).
4. A method of claim 1 wherein said step of sliding a cannula (20) and a stylet (10) through the housing (2) outwardly from the distal end (2C) to retain a biopsy of the biological mass by the stylet (10) is further defined by sliding the stylet (10) outwardly from the cannula (20) and the distal end (2C) of the housing (2) and into the biological mass to dispose the biological mass in the slot of the stylet (10).
5. A method of claim 4 wherein said step of said step of sliding a cannula (20) and a stylet (10) through the housing (2) outwardly from the distal end (2C) to retain a biopsy of the biological mass by the stylet (10) is further defined by sliding the cannula (20) outwardly from the distal end (2C) of the housing (2) over the slot to cut and retain a biopsy of the biological mass in the slot of the stylet (10).
6. A method for biopysing a nodule (N) of a biological mass located by a fingertip of a human and using an apparatus comprising a housing (2) defining a housing passageway (24) and having a distal end (2C) with a flange (4A) supported by and extending radially from the distal end (2C) and presenting a distal fiducial (6) and a cannula (20) and a stylet (10) with a radially open slot and with both slidably disposed in the housing passageway (2A), said method comprising;
- palpating the nodule (N) of the biological mass under the fingertip of a human,
- positioning the distal end (2C) of the housing (2) next to the nodule (N) of the biological mass and the fingertip of the human,
- inserting the cannula (20) and the stylet (10) into the housing passageway (24) of the housing (2),
- sliding the stylet (10) outwardly from the cannula (20) and the distal end (2C) of the housing (2) and into the nodule (N) of the biological mass to dispose the biological mass in the slot of the stylet (10),
- sliding the cannula (20) outwardly from the distal end (2C) of the housing (2) over the slot to cut and retain a biopsy of the biological mass in the slot of the stylet (10),
- retracting the cannula (20) and the stylet (10) back into the housing. passageway (24) with the biopsy of the biological mass in the slot of the stylet (10), and
- characterized by,
- inserting the flange (44) between the fingertip (76) of the human and the nodule (N) of the biological mass with the distal fiducial (6) of the flange (4A) touching the fingertip (76) of the human during positioning of the housing (2) to protect the fingertip (76) of the human by the flange (4A) from the stylet (10) and the cannula (20) as the cannula (20) and the stylet (10) are slid outwardly from the housing passageway (2A) to cut and retain a biopsy of the biological mass in the slot of the stylet (10).
Type: Application
Filed: Jan 10, 2017
Publication Date: May 25, 2017
Inventors: Stephen Henry Miller (Naples, FL), Jonathan Keith Jay (Naples, FL)
Application Number: 15/402,917