U.S. patent application number 14/651274 was filed with the patent office on 2015-12-24 for an apparatus and method for biopsy and therapy.
The applicant listed for this patent is BIOBOT SURGICAL PTE. LTD., SINGAPORE HEALTH SERVICES PTE LTD. Invention is credited to Teoh Hwa ANG, Hongjun CHEN, Wai Sam Christopher CHENG, Sun Sien Henry HO, Poon Kiong Gilbert MAK, Yibao SHI, Chew Loong YAP, Shyi Peng John YUEN.
Application Number | 20150366544 14/651274 |
Document ID | / |
Family ID | 54063245 |
Filed Date | 2015-12-24 |
United States Patent
Application |
20150366544 |
Kind Code |
A1 |
YAP; Chew Loong ; et
al. |
December 24, 2015 |
AN APPARATUS AND METHOD FOR BIOPSY AND THERAPY
Abstract
A biopsy and therapy device comprising: a needling unit for
holding and inserting a biopsy needle; an imaging module comprising
an ultrasound probe and an actuator for moving the probe in a
reciprocal action; a first arcuate slide; a second arcuate slide in
sliding engagement with the first arcuate slide and a linkage to
which the first arcuate slide is mounted; said linkage arranged to
move the first and second arcuate slides within a vertical plane;
said needling unit mounted to said arcuate slide wherein the first
and second arcuate slides are mounted perpendicular to each other
so as to rotate the needling unit about respective first and second
principal axes.
Inventors: |
YAP; Chew Loong; (Singapore,
SG) ; SHI; Yibao; (Singapore, SG) ; ANG; Teoh
Hwa; (Singapore, SG) ; MAK; Poon Kiong Gilbert;
(Singapore, SG) ; CHEN; Hongjun; (Singapore,
SG) ; CHENG; Wai Sam Christopher; (Singapore, SG)
; YUEN; Shyi Peng John; (Singapore, SG) ; HO; Sun
Sien Henry; (Singapore, SG) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
BIOBOT SURGICAL PTE. LTD.
SINGAPORE HEALTH SERVICES PTE LTD |
Singapore
Singapore |
|
SG
SG |
|
|
Family ID: |
54063245 |
Appl. No.: |
14/651274 |
Filed: |
December 11, 2013 |
PCT Filed: |
December 11, 2013 |
PCT NO: |
PCT/SG2013/000526 |
371 Date: |
June 11, 2015 |
Current U.S.
Class: |
600/464 ;
600/461; 600/567 |
Current CPC
Class: |
A61B 2017/3405 20130101;
A61B 8/4209 20130101; A61B 8/12 20130101; A61B 10/04 20130101; A61B
2017/3409 20130101; A61B 17/3403 20130101; A61B 2017/00274
20130101; A61B 8/0841 20130101; A61B 10/0241 20130101; A61B
2010/0208 20130101; A61B 2010/045 20130101; A61B 2017/3413
20130101 |
International
Class: |
A61B 10/04 20060101
A61B010/04; A61B 10/02 20060101 A61B010/02; A61B 19/08 20060101
A61B019/08; A61B 8/12 20060101 A61B008/12; A61B 8/00 20060101
A61B008/00; A61B 17/34 20060101 A61B017/34; A61B 8/08 20060101
A61B008/08 |
Foreign Application Data
Date |
Code |
Application Number |
Dec 11, 2012 |
SG |
201209160-9 |
Claims
1-21. (canceled)
22. A rotary head mountable to a linkage for moving said rotary
head, the rotary head comprising: a first arcuate slide; a second
arcuate slide in engagement with the first actuate slide; a
needling unit for holding and inserting a biopsy needle; said
needling unit mounted to said second arcuate slide wherein the
first and second arcuate slides are mounted perpendicular to each
other so as to rotate the needling unit about respective first and
second principal axes; wherein the first and second arcuate slides
are concentric about a pivot point and the biopsy needle is
co-linear with said pivot point.
23. The rotary head according to claim 22, wherein said rotary head
arranged to be moved such that said pivot point is located at a
contact point of the needling unit.
24. The rotary head according to claim 22, wherein the needling
unit includes a needle holder for holding a needle guide during
insertion, said holder including a recess for receiving a needle in
a direction transverse to the direction of insertion.
25. The rotary head according to claim 22, wherein said needling
unit includes a needle stopper arranged to set a pre-determined
depth of penetration of said needle.
26. The rotary head according to claim 22, further including a
drape for covering said biopsy device, said needling unit including
a recess with which the drape is arranged to engage.
27. The rotary head according to claim 22, wherein the first and
second sides are of a unitary construction.
28. The rotary head according to claim 22, wherein said rotary head
is arranged to conduct a biopsy procedure based upon one or more of
the parameters: a needle insertion point defined as a coordinate
position within said vertical plane, a first angle relative to the
first principal axis, a second angle relative to the second
principal axis and a depth of penetration of the needle.
29. The rotary head according to claim 22, further including a
platform to which said linkage and an imaging module are mounted,
said image module including a ultrasound probe within a probe
sheath positioned on said probe, said probe sheath arranged to
allow relative reciprocal motion with said probe.
30. An imaging module comprising: an ultrasound probe and an
actuator for moving the probe in a reciprocal action; a probe
sheath positioned on said probe, said probe sheath arranged to
allow relative reciprocal motion with said probe.
31. The imaging module according to claim 30, wherein on insertion
into the rectum, said probe sheath is arranged to immobilize the
prostate from the translational motion of the probe.
32. A biopsy and therapy device comprising: a needling unit for
holding and inserting a biopsy needle; an imaging module comprising
an ultrasound probe and an actuator for moving the probe in a
reciprocal action; an arcuate slide and a parallel movement to
which the arcuate slide is mounted; a rotational linkage in sliding
engagement with the arcuate slide; said parallel movement arranged
to move the arcuate slide and rotational linkage within a vertical
plane; said needling unit mounted to either one of said arcuate
slide or said rotational linkage, wherein the arcuate slide and
rotational linkage are mounted perpendicular to each other so as to
rotate the needling unit about respective first and second
principal axes.
33. The biopsy and therapy device according to claim 32, wherein
the rotational linkage and arcuate slide are arranged to rotate the
needling unit about a pivot point.
34. The biopsy and therapy device according to claim 32, wherein
the pivot point is located at a contact point of the needling
unit.
35. The biopsy and therapy device according to claim 32, wherein
the rotational linkage includes: a first pair of arms, each mounted
intermediate the needling unit and a drive, forming a parallelogram
linkage; a second pair of arms each mounted intermediate the drive
and the arcuate slide for forming a second parallelogram linkage;
the drive arranged to extend and retract said first and second
parallelogram linkages.
36. The biopsy and therapy device according to claim 32, wherein
the arcuate slide, rotational linkage and needling unit form a
rotary head, said rotary head arranged to move along principal axes
by said first and second linear slides.
37. The biopsy and therapy device according to claim 32, wherein
the needling unit includes: a needle holder for holding a needle
during insertion, said holder including a recess for receiving a
needle in a direction transverse to the direction of insertion; and
a needle stopper arranged to set a pre-determined depth of
penetration of said needle.
38. The biopsy and therapy device according to claim 32, wherein
the imaging module includes a probe sheath positioned on said probe
and arranged to allow relative reciprocal motion with said
probe.
39. The biopsy and therapy device according to claim 32, wherein
said device is arranged to conduct a biopsy procedure based upon
one or more parameters of the group consisting of: a needle
insertion point defined as a coordinate position within said
vertical plane, a first angle relative to the first principal axis,
a second angle relative to the second principal axis and a depth of
penetration of the needle.
40. The biopsy and therapy device according to claim 32, wherein
the parallel movement is a linear slide arranged to facilitate
motion along an axis within said plane.
41. The biopsy and therapy device according to claim 32, wherein
the parallel movement is a parallel linkage arranged to facilitate
motion along said vertical plane.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to the biopsy and therapy of a
patient. In particular, the invention relates to methods and
apparatus for the automatic conduct of such biopsy and therapy.
BACKGROUND
[0002] A prostate needle biopsy is recommended when prostate cancer
is suspected. It is a surgical procedure in which a small sample of
tissue is removed from the prostate gland and examined under the
microscope by a pathologist, a doctor specializing in identifying
disease through the study of cells, tissues and organs. The
procedure takes about 15 minutes and is usually performed by an
urologist with the use of a transrectal ultrasound (TRUS) probe.
With the help of TRUS, a doctor guides a biopsy gun--a hand-held
device with a spring-loaded, slender needle--through the wall of
the rectum into the area of the prostate gland that appears
abnormal.
[0003] The rectal wall is thin, so it is possible to place the
needle accurately into the abnormal site of the prostate gland with
the use of a biopsy gun with less injury to other tissues. When the
biopsy gun is activated, the needle can remove a slender cylinder
of tissue (about 1 mm by 18 mm), called a core, in a fraction of a
second. Biopsy needles are tiny--only 1.2 mm in diameter, and about
200 mm long. A sliding sheath on the gun opens once the needle
enters the prostate, closes onto a sample of tissue and the needle
is withdrawn.
[0004] However, the current practice for prostate biopsies may
include: [0005] 1. Random biopsy sites: The maximum total volume of
tissue samples retrieved can be calculated to be, for example,
about 220 mm.sup.3 in a 14-core method and the volume size of a
typical prostate with a diameter of 40 mm is about 33,500 mm.sup.3.
Therefore, the biopsy cores represent only about 0.6% of the
prostate in terms of volume. Without having accurate knowledge of
the cancer site(s), it is unlikely that a random biopsy protocol
will yield consistently high cancer detection rates. [0006] 2.
Inaccurate needling: Although the biopsy is guided by TRUS, it is
known that the biopsy needle may not reach the desired position
accurately and quickly under manual control. Depending on the
skills and experience of the urologist, inaccuracies in terms of
centimeters are common occurrences. [0007] 3. Movement of prostate:
During the biopsy, the translational motion or any motion of TRUS
in the rectum will result in the movement of the prostate. As such
the exact location in the prostate where cells are being extracted
for diagnosis can no longer be precisely determined. [0008] 4.
Limited 2D guidance: The TRUS used for biopsy guidance is 2D
ultrasound images. As the biopsy sites are distributed in 3D, it is
difficult for the surgeon to imagine the overall picture of the
biopsy sites and to identify the biopsy site accurately and
intuitively. [0009] 5. Transrectal: As most of the cancer occurs at
the apex area of the prostate, a transperineal biopsy is considered
to have a higher chance of obtaining cancer tissue, compared with
the conventional transrectal biopsy. Furthermore, a transperineal
biopsy is considered "cleaner", as its puncture point is on the
skin, rather than on the rectum. [0010] 6. Multiple entry points
for the needle: Using the transrectal approach, the number of holes
that will be pierced through the walls of the rectum will be
determined by the number of biopsy samples. Multiple insertion
points through the walls of the rectum will also increase the
chance of infection due to the presence of harmful substances in
the rectum.
[0011] Upon detection of cancerous cells in the tissue, therapy is
then conducted on the patient. During therapy, many skin punctures
may result during the delivery of radioactive seeds into the
prostate. Thus, there is a need to develop an invention that
addresses the above mentioned short-comings of the current prostate
biopsy and therapy environment.
SUMMARY OF INVENTION
[0012] In a first aspect, the invention provides a biopsy and
therapy device comprising: a needling unit for holding and
inserting a biopsy needle; an imaging module comprising an
ultrasound probe and an actuator for moving the probe in a
reciprocal action; a first arcuate slide; a second arcuate slide in
sliding engagement with the first arcuate slide and a linkage to
which the first arcuate slide is mounted; said linkage arranged to
move the first and second arcuate slides within a vertical plane;
said needling unit mounted to said arcuate slide wherein the first
and second arcuate slides are mounted perpendicular to each other
so as to rotate the needling unit about respective first and second
principal axes.
[0013] In a second aspect the invention provides a biopsy and
therapy device comprising: a needling unit for holding and
inserting a biopsy needle; an imaging module comprising an
ultrasound probe and an actuator for moving the probe in a
reciprocal action; an arcuate slide mounted to a first linear
slide; a rotational linkage in sliding engagement with the arcuate
slide; said first linear slide arranged to move the arcuate slide
parallel to a first principal axis; said first linear slide mounted
to a second linear side, said second linear slide arranged to move
the first linear side parallel to a second principal axis; said
needling unit mounted to said rotational linkage wherein the
arcuate slide and rotational linkage are mounted perpendicular to
each other so as to rotate the needling unit about said first and
second principal axes.
[0014] In a third aspect, the invention provides a biopsy and
therapy device comprising: a needling unit for holding and
inserting a biopsy needle; an imaging module comprising an
ultrasound probe and an actuator for moving the probe in a
reciprocal action; an arcuate slide and a parallel linkage to which
the arcuate slide is mounted; a rotational linkage in sliding
engagement with the arcuate slide; said parallel linkage arranged
to move the arcuate slide and rotational linkage within a vertical
plane; said needling unit mounted to said arcuate slide wherein the
arcuate slide and rotational linkage are mounted perpendicular to
each other so as to rotate the needling unit about respective first
and second principal axes.
[0015] The design of the biopsy and therapy apparatus according to
the present invention enables the biopsy needling unit to move in
both Cartesian and Polar coordinates. This concept eliminates the
need for multiple punctures on the skin when many samples of the
tissues are required to be extracted from the organ for diagnosis.
In addition lesser entry points for the needle mean that risk of
infection for the patient will be greatly minimized.
[0016] The combination of Polar and Cartesian capabilities of this
invention, allows multiple conical motion envelops to be developed
depending on the needs of the operation. The ability of the
apparatus to develop multiple conical envelopes is highly
advantageous for operations especially in the prostate biopsy
environment because insertion of the needle into the organ may be
hindered by pubic bone.
[0017] In one embodiment, the pivot point for the conical envelope
is located at the contact point of the needling unit, such that
prior to insertion of the needle, the pivot point is effectively on
the surface of the skin of the patient. In conventional methodology
or previous invention, the pivot point is usually located inside
the needling unit itself. When the pivot point is located inside
the needling unit, slight movements in one end of the unit will
result in movements in the other end of the unit which can be a
major cause for concern during an operation as this will affect the
accuracy of the system. Thus the concept of virtual pivot point
ensures that accuracy of the system will not be affected by any
unwanted or residual movements on the needling unit. The accuracy
of the system is further increased as the distance between the
pivot point and the organ to be diagnosed is now shorter, thus
minimizing the error of the needle deviating from its intended
trajectory.
[0018] In one embodiment, the device may include a needle sheath.
Said needle sheath may comprise a thin stainless steel rod with
enlarged protrusion at both ends said needle sheath may be loaded
into the needling unit thereby creating a tunnel to guide the
orientation and trajectory of the biopsy gun to the organ. A needle
sheath may eliminate the risk of contamination to the needling unit
during the extraction of blood tissues from the organ by the biopsy
gun. To further reduce the possibility of such contamination from
taking place, the needling unit may include a blot or recess to
allow side loading of a single piece needle sheath instead of
loading a two-piece needle sheath through the front and back of the
needling unit. Thus side loading may reduce cross contamination and
decrease the set up time of the system.
[0019] In a further embodiment, the device may include a motorized
needle stopper to determine the pre-calculated needle depth based
on the imaging data from ultrasound probe or other means of imaging
devices enhances the accuracy and reliability of the biopsy.
Conventional biopsies are conducted manually leading to a lack of
accuracy. Moreover using a motorized needle stopper enables a
specific point in the organ to be identified for the extraction of
blood samples for diagnosis.
[0020] To prevent contamination of the apparatus by the patient
during the operation, a clear drape may be mounted over the
apparatus during operation and engaged with a groove-like retainer
mechanism integrated onto the needling unit. This creates a barrier
between apparatus and patient so that there is no cross
contamination.
[0021] During a biopsy or therapy, the prostate may be immobilized
despite the translational motion of the TRUS using an ultrasound
probe sheath. This allows a pre-determined point in the prostate,
where the needle will be able target for the extraction of tissue
and resulting in a more reliable biopsy outcome.
[0022] In one embodiment, the first and second arcuate slides may
be concentric about a pivot point. In this way, any movement of the
needling unit by one or both arcuate slides does not affect the
location of the contact point of the needling unit.
[0023] In a further embodiment, the pivot point may be located at a
contact point of the needling unit.
[0024] In one embodiment, the needling unit may include a needle
holder for holding a needle during insertion, said holder including
a recess for receiving a needle in a direction transverse to the
direction of insertion.
[0025] In one embodiment, said needling unit may include a needle
stopper arranged to set a pre-determined depth of penetration of
said needle, and so having a means to automatically prevent over
insertion, or alternatively automatically insert the needle to a
location determined through a prior examination.
[0026] In one embodiment, the device may include a drape for
covering said biopsy and therapy device, said needling unit
including a recess with which the drape is arranged to engage. In
this way, the device is protected from cross contamination. Having
an engagement recess also ensures a seal for better protection.
[0027] In one embodiment, the imaging module may include a probe
sheath positioned on said probe and arranged to allow relative
reciprocal motion with said probe. Having the probe sheath on the
probe allows the sheath to be inserted into the patient and acting
as a brace against variation caused by the movement of the
probe.
[0028] In one embodiment, said device may be arranged to conduct a
biopsy and therapy procedure based upon one or more of the
parameters: a needle insertion point defined as a coordinate
position within said vertical plane, a first angle relative to the
first principal axis, a second angle relative to the second
principal axis and a depth of penetration of the needle. The device
may therefore have the flexibility to operate under one or more
specific parameters. Using all parameters, the device may position
the contact point to a specific insertion point of the patient.
Based on a prior examination the specific angle from each principal
axis may also provide the best approach to the desired location,
such as a tumour. The depth of penetration may then direct the
needle to precisely the location required. The device according to
this embodiment may therefore have all the relevant parameters
pre-programmed, allowing the imaging unit to merely track the
expected progress of the needle.
[0029] In a further embodiment, the invention provides a biopsy and
therapy device comprising: a needling unit for holding and
inserting a biopsy needle; an imaging module comprising an
ultrasound probe and an actuator for moving the probe in a
reciprocal action; an arcuate slide mounted to a first linear
slide; a rotational linkage in sliding engagement with the arcuate
slide; said first linear slide arranged to move the arcuate slide
parallel to a first principal axis; said first linear slide mounted
to a second linear side, said second linear slide arranged to move
the first linear side parallel to a second principal axis; said
needling unit mounted to said rotational linkage wherein the
arcuate slide and rotational linkage are mounted perpendicular to
each other so as to rotate the needling unit about said first and
second principal axes.
BRIEF DESCRIPTION OF DRAWINGS
[0030] It will be convenient to further describe the present
invention with respect to the accompanying drawings that illustrate
possible arrangements of the invention. Other arrangements of the
invention are possible and consequently, the particularity of the
accompanying drawings is not to be understood as superseding the
generality of the preceding description of the invention.
[0031] FIG. 1 is a cross sectional view of a patient indicating a
point of entry for a needle to the prostate;
[0032] FIG. 2 is an elevation view of a biopsy and therapy device
according to the prior art;
[0033] FIG. 3 is an elevation view of a biopsy and therapy device
according to one embodiment of the present invention;
[0034] FIG. 4 is a cross sectional view of a patient indicating the
pivot point for entry to the patient;
[0035] FIG. 5 is an isometric view of a biopsy and therapy device
according to a further embodiment of the present invention;
[0036] FIG. 6 is an elevation view of the biopsy and therapy device
of FIG. 5;
[0037] FIG. 7 is a front elevation view of the biopsy and therapy
device of FIG. 5;
[0038] FIG. 8 is an elevation view of a biopsy and therapy device
according to a further embodiment of the present invention;
[0039] FIG. 9 is the front view of a biopsy and therapy device
according to a further embodiment of the present invention;
[0040] FIGS. 10A and 10B are plan views of the biopsy and therapy
device of FIG. 9;
[0041] FIGS. 11A and 11B are elevation views of the biopsy and
therapy device of FIG. 9.
[0042] FIG. 12 is a front view of the biopsy and therapy device of
FIG. 9.
DETAILED DESCRIPTION
[0043] FIG. 1 shows a cross sectional view of a patient 5
indicating the rectum 10 prostate 15 and bladder 20. Further, for
the purposes of a biopsy, FIG. 1 shows a pivot point 25 adjacent to
the perineal in order to create a conical envelope 30 so as to
position a device to take the biopsy through the insertion 35 of a
needle at the pivot point 25. A device 40 of the prior art shown in
FIG. 2 whereby a needle 45 is inserted at a pivot point guided by
an ultrasound probe 65 inserted into the rectum 10. The needle 45
is inserted into the prostate 15 in order to extract material. The
conical envelope of FIG. 1 is provided by two pivot points 55, 60.
The needling unit 50 is moved subject to motions attached to the
device 40 which move the needling device along linear slides which
due to the pivots 55, 60 have the potential to rotate the needling
device and consequently the needle 45 around a conical envelope.
The point of rotation of the needle, that is the pivot point,
becomes the front ball joint 60 which is proximate to but not at
the surface of the perineal wall. It follows that by placing the
needling unit 50 against the perineal wall, then rotating the
needling unit so as to position the needle 45 for insertion, the
offset between the ball joint 60 and the perineal wall represents a
potential error in the placement of the needle. The probe 65 will
identify this offset requiring a further iteration in order to
place the needling unit 50 in a correct position as a result of the
offset between the joint 60 and the perineal wall. This adds to the
set up time not to mention the anxiety of the patient and the
potential for error should the operator not wish to undertake
sufficient iterations in order to get a perfect placement of the
needle 45.
[0044] FIG. 3 is a side view of a biopsy and therapy device 75
according to one embodiment of the present invention. The figure
shows the needle entry, with the apparatus comprising: [0045] i. a
needling unit 77 that is capable of both Conical and Cartesian
approach of reaching the prostate through the perineal wall and
[0046] ii. an imaging unit 78 that comprises of the ultrasound
probe 112, probe holder 115 as well as ultrasound probe sheath
110.
[0047] FIG. 4 is a drawing from a sectional view showing: [0048] i.
a Conical approach of reaching the prostate through the perineal
wall, using the Y-axis rotation 140 that is, rotation about the
Y-axis, and X-axis rotation 135 that is, rotation about the X-axis,
of the needling unit and [0049] ii. a Cartesian approach of
reaching the prostate through the perineal wall as the needling
unit is able to maneuver in the up and down direction 150 and left
and right direction 145.
[0050] FIGS. 5, 6 and 7 show the apparatus using line schematics.
In FIG. 5, the apparatus is mounted on a supporting platform 80
which may be moved so as to be proximate to the patient. The Y-axis
rotation 140 of the needling unit is achieved by a pair of upper
and lower radial sliding bearings or first arcuate slide (85),
where this pair of radial sliding bearing is driven by a micro
drive (95). The X-axis rotation 135 of the needling unit is
achieved by a pair of upper and lower radial sliding bearing, or
second arcuate slide (90), where this pair of radial sliding
bearing is driven by a micro drive (98). These four sub units will
form an assembly called the rotary head (100). The design and
concept of this rotary head enables the whole needling unit to
rotate about a common virtual pivot point thereby enhancing the
reliability of the equipment during biopsy.
[0051] A needle sheath holding mechanism (105) is built into the
needling unit so that the needle sheath is side-loaded, that is,
loaded in a direction transverse to the direction of insertion of
the needle. This makes the transfer and replacement of needles
easier and more accessible and so minimizes the risk of cross
contamination of blood samples from different patients.
[0052] FIG. 6 is side view of the apparatus using line schematics.
The imaging unit comprises of an ultrasound probe sheath (110),
where it is used to immobilize the prostate when the ultrasound
image of the prostate is acquired by an ultrasound probe (120). The
ultrasound probe is mounted on a probe holder (115).
[0053] FIG. 7 is a frontal view of the apparatus using line
schematics. The up and down vertical movement of the needling unit
is controlled by a parallel linkage (155) and a motorized linear
actuator (160). The left and right horizontal movement of the
needling unit is controlled by a parallel link (165) and a
motorized linear actuator (117). The parallel links (155) and (165)
ensures that the rotary head (100) stays in an upright position
even if the needling unit moves in curved trajectory on the Y-axis
plane.
[0054] FIG. 8 is side view of the apparatus using line schematics,
which a clear plastic drape (180) is used to cover the biopsy
device. The clear plastic drape (160) is securely engaged with the
device using a recess, which in this case is a pair of groove
retaining mechanism (185), to prevent any cross contamination
between the apparatus and the patient.
[0055] FIGS. 9 to 11B show the apparatus (197) according to another
embodiment of the present invention. In FIG. 9, the apparatus (197)
is mounted on a supporting platform (80) which may be moved so as
to place the probe (110) and rotary head (200) approximate to the
patient. As with previous embodiments, the X-axis rotation (135) of
the needling unit (77) is achieved by a pair of upper and lower
radial sliding bearings or actuate slide (90), where this pair of
radial sliding bearing is driven by a micro drive (98). In the new
embodiment, the Y-axis rotation (140) of the needling unit (77) is
achieved by a plurality of arms forming a rotational linkage (205)
driven by a micro drive (225). These four sub units (77, 90, 205,
and 225) will form the rotary head (200). The plurality of arms
comprise a first pair of arms between the needling unit (77) and
the drive (225) and a second pair of arms between the drive (225)
and the arcuate slide (90). The two pairs of arms are mounted so as
to each form a parallelogram linkage with the drive (225)
therebetween to extend and retract the parallelogram linkages.
[0056] FIGS. 10A and 10B are plan views of the apparatus (197).
FIG. 10A illustrates the needling unit (77) projected to one
extreme end of the Y-axis rotation (140). FIG. 10B illustrates the
needling unit (77) retracted to the other extreme of the Y-axis
rotation (140). These movements correspond to the movements
described with reference to FIG. 4. The rotational linkage (205) is
a mechanical linkage made of elongate metal members or arms (210A,
210B, 215A and 215B). Arm 215A extends from arm 210A and is in
rotational engagement with one another. Similarly, arm 215B extends
from arm 210B and is in rotational engagement with one another.
Arms (210A, 210B, 215A and 215B) are arranged such that arms 215A
and 215B can either extend at an angle from arms 210A and 210B on
projection, as in FIG. 10A or, retract close to arms 210A and 210B
such that the needling unit (77) moves to the other extreme of the
Y-axis rotation 140, as in FIG. 10B. Arms 210A and 210B are mounted
to the arcuate slide (90) and a Y-axis linear slide (195) to which
the acruate slide (90) is mounted. The needling unit (77), as part
of the rotary head, is mounted to arms 215A and 215B. The arcuate
slides are mounted perpendicular to the arms (210A, 210B, 215A and
215B) so that projection and retraction of the arms 210A and 210B
in relation to arms 215A and 215B translates to rotation of the
needing unit (77) about the respective X and Y axes creating an
envelope 235 within the X-Y, or vertical, plane as seen in FIG. 12.
The design and concept of this rotary head enables the whole
needling unit (77) to rotate about a common virtual pivot point
(230) illustrated in FIG. 12, thereby enhancing the reliability of
the equipment during biopsy.
[0057] A micro drive (225) is used to drive Y-axis rotation of the
needling unit (77). The needling unit (77), as part of the rotary
head (200), is mounted to the Y-axis, or first, linear slide (195)
that is, sliding along the Y-axis, and a motorized linear actuator
(220). Consequently, the linear slide (195) provides vertical
movement for the needing unit (77). The motorized linear actuator
may be any suitable type of linear actuator, which includes but are
not limited to, a rack and pinion actuator, a wheel and axle
actuator or an electrical actuator. The Y-axis linear slide (195)
is mounted to the X-axis linear slide (190). The horizontal
movement of the needling unit (77) is therefore provided by the
X-axis linear-slide (190) that is, sliding along the X axis. The
X-axis, or second, linear-slide (190) and Y axis linear slide (195)
are arranged to ensure that the rotary head (200) stays in an
upright position even if the needling unit (77) moves in curved
trajectory within the X-Y, or vertical, plane.
[0058] FIGS. 11A and 11B are elevation views of the apparatus (197)
using line schematics. FIG. 11A illustrates the needing unit (77)
projected to one extreme end of the X-axis rotation (135). FIG. 11B
illustrates the needling unit (77) retracted to the other extreme
of the X-axis rotation (135). This movement corresponds to the
movement described with reference to FIG. 4.
[0059] In light of the foregoing description, a third embodiment of
the apparatus. also exists. An apparatus using the parallel linkage
165 of FIG. 7 can be combined with the arcuate slide of FIGS. 5 and
8 and the rotational linkage 205 of FIG. 8. Such a device
represents a logical permutation of the features defined herein,
and so still falling within the scope of the claims.
* * * * *