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.
Claims
1. 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 actuate 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 first and second arcuate slides, 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; and wherein the imaging module includes a probe sheath positioned on said probe and arranged to allow relative reciprocal motion with said probe.
2. The biopsy and therapy device according to claim 1, wherein the first and second arcuate slides are concentric about a pivot point.
3. The biopsy and therapy device according to claim 2, wherein said pivot point is located at a contact point of the needling unit.
4. The biopsy and therapy device according to claim 1, wherein each arcuate slide comprises a pair of radial sliding bearings.
5. The biopsy and therapy device according to claim 1, wherein the first and second arcuate slides form part of a rotary head.
6. The biopsy and therapy device according to claim 1, wherein the needling unit includes a needle holder for holding said biopsy needle during insertion, said needle holder including a recess for receiving said biopsy needle in a direction transverse to a direction of insertion.
7. The biopsy and therapy device according to claim 1, wherein said needling unit includes a needle stopper arranged to set a pre-determined depth of penetration of said biopsy needle.
8. The biopsy and therapy device according to claim 1, further including a drape for covering said biopsy and therapy device, said needling unit including a recess with which the drape is arranged to engage.
9. The biopsy and therapy device according to claim 1, wherein said biopsy and therapy device 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 biopsy needle.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) 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.
(2) FIG. 1 is a cross sectional view of a patient indicating a point of entry for a needle to the prostate;
(3) FIG. 2 is an elevation view of a biopsy and therapy device according to the prior art;
(4) FIG. 3 is an elevation view of a biopsy and therapy device according to one embodiment of the present invention;
(5) FIG. 4 is a cross sectional view of a patient indicating the pivot point for entry to the patient;
(6) FIG. 5 is an isometric view of a biopsy and therapy device according to a further embodiment of the present invention;
(7) FIG. 6 is an elevation view of the biopsy and therapy device of FIG. 5;
(8) FIG. 7 is a front elevation view of the biopsy and therapy device of FIG. 5;
(9) FIG. 8 is an elevation view of a biopsy and therapy device according to a further embodiment of the present invention;
(10) FIG. 9 is the front view of a biopsy and therapy device according to a further embodiment of the present invention;
(11) FIGS. 10A and 10B are plan views of the biopsy and therapy device of FIG. 9;
(12) FIGS. 11A and 11B are elevation views of the biopsy and therapy device of FIG. 9.
(13) FIG. 12 is a front view of the biopsy and therapy device of FIG. 9.
DETAILED DESCRIPTION
(14) 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.
(15) 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: i. a needling unit 77 that is capable of both Conical and Cartesian approach of reaching the prostate through the perineal wall and ii. an imaging unit 78 that comprises of the ultrasound probe 112, probe holder 115 as well as ultrasound probe sheath 110.
FIG. 4 is a drawing from a sectional view showing: 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 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.
(16) 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 rotation140 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.
(17) 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.
(18) 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).
(19) 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.
(20) 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.
(21) 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.
(22) 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.
