Height adjustable and angle adjustable transperineal prostate biopsy needle guide
Patent Information
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- GEOTEK MEDIKAL & SAGLIK HIZMETLERI TICARET SANAYI LTD SIRKETI
- Filing Date
- 2024-06-07
- Publication Date
- 2026-07-01
AI Technical Summary
Current transperineal prostate biopsy needle guides are limited in their ability to adjust the height and angle of the biopsy needle independently, leading to technical difficulties in accurately targeting the prostate, discomfort for patients, and increased risk of infection due to the need for multiple needle entries and compromised ultrasound image quality.
A disposable needle guide with a rotating disc mechanism that allows separate and simultaneous adjustment of needle height and angle, featuring grooves for secure needle positioning and a disc cap to prevent slipping, enabling precise guidance of the biopsy needle without additional personnel or complex systems.
Enables accurate and comfortable transperineal prostate biopsies under local anesthesia, maintaining ultrasound image quality and reducing the risk of infection by allowing single-handed, precise needle guidance and adjustment, facilitating the procedure in a clinical setting rather than an operating theater.
Smart Images
Figure TR2024050632_26122024_PF_FP_ABST
Abstract
Description
[0001] HEIGHT ADJUSTABLE AND ANGLE ADJUSTABLE TRANSPERINEAL PROSTATE BIOPSY NEEDLE GUIDE
[0002] Technical Field
[0003] The invention relates to a needle guide designed for use in transperineal prostate biopsy performed in urology and radiology, which enables the biopsy needle to be guided to the desired region of the prostate.
[0004] Prior Art
[0005] Prostate cancer is one of the most common cancers in men and can only be diagnosed by prostate biopsy. Prostate biopsy is usually performed through the rectum, but since the microbes in the rectal area mix into the blood during the biopsy, severe infection requiring hospitalisation develops in approximately 5% of patients after the biopsy. In order to prevent this, a method called transperineal biopsy has been used to perform prostate biopsy by entering through the skin through the perineum (region between the anus and scrotum), not through the rectum. However, since the prostate is far away from the perine in this method, it is technically difficult to direct the biopsy needle to the desired area of the prostate. In order to overcome this difficulty, auxiliary devices called needle guides are used to ensure that the needle remains in the same alignment with the ultrasound transducer (probe). However, these devices (needle guides) can only ensure that the needle travels towards the prostate at a single height and only in a straight line (parallel to the probe).
[0006] In freehand biopsies without needle guidance, only a very limited number of physicians can perform the biopsy without needle guidance, as it requires considerable experience to align the needle with the ultrasound probe. In biopsies performed with existing needle guides, when it is necessary to take a biopsy from the upper and lower sides of the prostate, the height of the biopsy needle cannot be adjusted without removing the needle from the patient, and the needle cannot be angulated to reach the upper and lower sides of the prostate. Applications where the needle can be angulated are only available in robotic systems, which cost very high amounts financially, pave the way for possible infections since they are systems that need to be sterilised, do not allow the doctor to move freely by hand and require repeated needle entry from the perineum for each biopsy. In non-robotic biopsy applications where a standard needle guide is used and the doctor manually guides the ultrasound probe, the ultrasound probe to which the needle is connected must be moved up and down in the rectum in order to take a biopsy from the desired area of the prostate, which both causes discomfort to the patient and deteriorates the ultrasound image quality. In addition, in biopsies taken by angulating the probe, the needle enters the prostate at an oblique angle. In addition, after the introducer needle (coaxial needle) is inserted into the patient's perineum, it may go further or come back out more than desired due to the movement of the patient or the push and pull of the biopsy needle passed through it. In this case, there may be bleeding in the vessels around the prostate due to the effect of the needle going in too far, or it is necessary to re-insert the needle by making a new entry through the perineum skin due to the needle coming back out.
[0007] In order to eliminate these problems, studies have been carried out on applications where the axis of the needle can be adjusted.
[0008] The US patent document US2022 / 0240904 discloses a needle guide which can move up and down in a vertical channel, and which can also be rotationally moved by a screw. In this design, there are no grooves on the body of the guide to ensure that the needle is seated and to prevent involuntary up and down movement. The inhibition of this movement depends only on the screw and a loosening of the screw will cause involuntary movement of the needle. In addition, in this design, when the screw that adjusts the height of the needle is tightened, the angular movement of the needle is also fixed. However, the doctor should be able to adjust these settings separately during the biopsy. In our design, when the needle height is adjusted and fixed, the rotating disc mechanism is not fixed, so that the tilt of the disc can be adjusted independently of the height. In this design, there is no rotating disc or other input system with different channels for different thickness insertion needles. There is no option for doctors who prefer different thickness needles. In this design, there is no locking mechanism to prevent involuntary reciprocating movement of the insertion needle inserted into the patient's perineum.
[0009] In the patent document numbered WO2022109387, a needle guide with grooves on the body and body is disclosed. In this design, only the height of the needle can be adjusted and there is no disc-like rotating mechanism for needle angulations in this design, unsimilar to our design that includes these angulation features.
[0010] In the patent document US10548674, a robotic needle guide is disclosed in which the needle is placed on a disc. This design is intended for use in robotic systems only. It is not suitable for manual biopsies without using a robotic arm. In addition, the needle can only be tilted, height adjustment is not possible, and angle adjustment cannot be performed together with height adjustment.
[0011] Chinese Patent CN114983530 mentions a needle guide in which the entrance angle of the needle can be adjusted. In this design, due to the spherical structure in of the design the user has to be stick up to a constant angle according to the entrance height of the introducer needle. After the entry height, no further angle adjustment is possible. In our design, the height and angle can be adjusted both separately and together.
[0012] In the patent document numbered WO2018022979, a needle guide is disclosed in which the entrance angle of the needle can be adjusted. In this design, each biopsy requires a separate entry through the skin to the area called perineum. This is called a grid-type biopsy and it is a procedure that can only be performed in the operating theatre under anaesthesia, since each biopsy requires separate access. The needle guide we have designed is for the coaxial biopsy technique, which can be performed under local anaesthesia, without using the grid system, with only one needle entrance from the right and left sides of the skin and all biopsies are taken through this entrance.
[0013] When the systems and methods available in the technique were analysed, the need arose for the realisation of a needle guide that is disposable, consists of fewer parts, has a low production cost, the height and angle of the needle can be adjusted separately or together, and all these settings can be practically applied just by the doctor performing the biopsy without the need for an additional assistant. There is also a need to develop a needle guide that prevents the needle from moving back and forth (slipping) while or after changing the angle of the needle.
[0014] Objects of the Invention
[0015] The object of the present invention is to produce a needle guide designed for use in transperineal prostate biopsy, which allows the biopsy needle to be guided to the desired region of the prostate, and which allows the doctor performing the biopsy to perform this guidance practically without the need for additional personnel.
[0016] Another object of the present invention is to produce a disposable needle guide with low production cost. However, if desired, the designed product can also be produced with a sterilisable material that allows multiple use.
[0017] A further object of the present invention is to produce a needle guide in which the needle is prevented from sliding back and forth when the angle of the needle is changed. Detailed Description of the Invention
[0018] The present invention is shown in the accompanying figures.
[0019] These figures are;
[0020] Figure 1: Schematic view of the body, disc and screw of the needle guide according to the invention in an exploded state.
[0021] Figure 2: Schematic view of the body, disc and screw of the needle guide according to the invention from a different angle in an exploded state.
[0022] Figure 3: A view of the needle guide according to the invention with the needle in the disc and the disc cap open.
[0023] Figure 4: A view of the body of the needle guide according to the invention with the needle in the disc and the disc cap partially closed.
[0024] Figure 5: Schematic view of the needle guide according to the invention with the needle in the disc and the disc and needle rotated downwards.
[0025] Figure 6: Schematic view of the needle guide according to the invention with the needle in the disc and the disc and needle rotated upwards.
[0026] Figure 7: Schematic view of the body of the needle guide according to the invention with the needle inserted into the uppermost disc channel.
[0027] Figure 8: Schematic view of the body of the needle guide according to the invention with the needle inserted into the lowest disc channel. Figure 9: Schematic view of the body of the needle guide according to the invention with the disc inserted in the lowest groove, with the needle in the disc and with the disc and needle rotated downwards.
[0028] Figure 10: Schematic view of the body of the needle guide according to the invention with the disc inserted in the uppermost groove, with the needle in the disc and with the disc and needle rotated upwards.
[0029] Figure 11: A view of the disc containing four channels in the needle guide according to the invention, through which needles of different thicknesses can pass. The channels are marked with the letters a, b, c, d. The arrow sign indicates that the height of the channels will also change when the disc is turned 180 degrees.
[0030] Figure 12: Rear view of the channels of the disc in Figure 11.
[0031] Figure 13: View of the body of the needle guide according to the invention with the disc inserted and with the disc rotated 180°. When compared with Figure 11, it is seen that with 180 degree rotation, the channels are displaced in such a way that the top channel is at the bottom.
[0032] Figure 14: Rear view showing that the channels in Figure 12 displaced with the uppermost channel is at the bottom after 180 degree rotation of the disc.
[0033] The parts in the figures are numbered individually, and the corresponding descriptions are given below.
[0034] 1. Needle guide
[0035] 2. Body
[0036] 3. Body channel
[0037] 4. Groove
[0038] 5. Disc
[0039] 6. Extension piece 7. Disc channel
[0040] 8. Screw
[0041] 9. Disc cap
[0042] 10. Cap protrusion
[0043] 11. Needle
[0044] The needle guide (1) according to the invention comprises,
[0045] A body (2) connected to a probe and comprising a vertical body channel (3) perpendicular to the axis of the probe and movement direction of the needle (11),
[0046] At least one groove (4) cut into the body channel (3) perpendicular to the body channel (3) on the body (2),
[0047] A disc (5) that is rotatable to the desired angle, having an extension piece (6) on one surface extending into the body channel (3) or groove (4), and has at least one disc channel (7) on the other surface through which the needle (11) will be inserted,
[0048] A screw (8) which is attached to the extension piece (6) of the disc (5) extending into the body channel (3) or a groove (4) and which allows the disc (5) to remain in the body channel (3) at the desired height,
[0049] A disc cap (9) provided on the surface of the disc (5) which has cap protrusions (10), which closes over the disc channels (7), by opening and closing, securing the needle inside the channel and preventing reciprocating movement of the needle,
[0050] - Disc cap projections (10) on the surface of the disc cap (9) facing the disc channels (7) and corresponding to the disc channels (7).
[0051] The body (2) is provided with a vertical body channel (3) perpendicular to the axis of movement of the probe and the needle (11). The disc (5) is secured to the body channel (3) by inserting the extension piece (6) into this body channel (3) and tightening it with the screw (8) from the other side. The disc (5) can be positioned at the desired height along the body channel (3).
[0052] By loosening the screw (8), the disc (5) can be moved up and down and the needle (11) can be angulated by rotating the disc (5). (Figure 5 and Figure 6). This angulation movement can be performed single-handedly by the doctor by moving the needle (11) inserted through the disc (5).
[0053] There is at least one groove (4) opening into the body channel (3) perpendicular to the body channel (3) on the body (2). By inserting the disc (5) into these grooves (4), the disc (5) can be kept secured at the desired height. The disc (5) can be inserted into the grooves (4) having different heights (Figure 9 and Figure 10).
[0054] The disc (5) is provided with an extension piece (6) which is inserted into the chassis channel (3) on one surface. On the other surface there is at least one disc channel (7) through which the needle (11) is inserted. The needle (11) is inserted into any of these disc channels (7). (Figure 7 and Figure 8) Disc channels (7) of different widths can be formed on the disc (5), through which needles (11) of different thicknesses can be inserted. Since different doctors prefer different thicknesses of needles (11) when taking a prostate biopsy, the doctor can use the disc channel (7) that fits his / her desired needle thickness by means of the disc channels (7) of different thicknesses available on the disc (5). The disc (5) can even be rotated 180° so that the disc groove (7) of different thicknesses can be placed on the top or bottom. When the disc (5) is rotated 180 degrees on its axis, the position of the disc grooves (7) above and below will be changed, so that the entrance of the needle channels of different thicknesses can be adjusted to be higher or lower (Figure 11, Figure 12, Figure 13 and Figure 14). Thus, there is no need to produce a different needle guide for each needle thickness, and it is possible to use needles of different thicknesses with this disc system on a single needle guide. In addition, the doctor can make millimetric adjustments to the initial entry height through the channel of his choice. A disc cap (9) is provided on the surface of the disc (5) that contains the disc channels (7). On the surface of the disc cap (9) facing the disc channels (7), there are disc cap projections (10) corresponding to the disc channels (7). The disc cap
[0055] (9) can be opened and closed. When the disc cap (9) is closed, the cap projections
[0056] (10) on the disc cap (9) enter into the disc channel (7) and compress and secure the needle (11). In this way, the needle (11) is prevented from slipping (reciprocating movement) during operation or angulation.
[0057] The disc (5) in the needle guide (1) according to the invention not only supports the needle (11) so that it remains in parallel alignment with the probe, but also enables the needle (11) to be angulated upwards and downwards by rotating like a wheel. By angulating the needle (11) upwards or downwards, the upper and lower parts of the prostate can be accessed without moving the ultrasound probe inside the rectum. This rotation can be achieved by simply moving the needle (11) inserted through the disc channel (7) up and down without the need for the doctor to use the other hand, without the use of any rotating screw system, so that the rotation can be performed practically by the doctor performing the procedure without the need for additional personnel.
[0058] With the needle guide (1) of the invention, it is possible to reach the desired parts of the prostate and take biopsy samples without moving the ultrasound probe in the patient's rectum, only by using the height changing and angulation features of the needle guide (1). In this way, the quality of the ultrasound image during the biopsy will not deteriorate, the progress of the needle (11) towards the prostate can be followed clearly by ultrasound, biopsy samples can be obtained from suspicious areas in the prostate from exactly the correct place, and the patient will be relieved from the pain caused by the ultrasound probe moving in the rectum. The ability to see the needle (11) clearly on ultrasound and to obtain tissue samples of the prostate in exactly the correct place is vital for the biopsy procedure that diagnoses prostate cancer. The fact that the patient feels less discomfort and pain thanks to this needle guide (11), in addition to patient comfort, allows the biopsy procedure to be performed with local anaesthesia in an office room rather than under anaesthesia in the operating theatre, thus making a great economic contribution. With this needle guide (1), the technical difficulty encountered by physicians performing transperineal prostate biopsy is eliminated, and it is possible to perform the biopsy procedure in the most accurate manner without deteriorating the ultrasound image quality and without causing discomfort to the patient. In addition, when the disc cap (9) is closed, the cap protrusions (10) on the disc cap (9) enter into the disc channel (7) and compress and secure the needle (11), preventing the needle (11) from slipping (reciprocating movement) during the operation or angulation.
Claims
CLAIMS1. A needle guide (1) designed for use in transperineal prostate biopsy procedure, allowing the biopsy needle to be directed to the desired region of the prostate, comprisingA body (2) connected to a probe and comprising a vertical body channel (3) perpendicular to the axis of the probe and movement direction of the needle (11),A disc (5) that is rotatable to the desired angle, having an extension piece (6) on one surface extending into the body channel (3) or groove (4), and at least one disc channel (7) on the other surface through which the needle (11) will be inserted,A screw (8) which is attached to the extension piece (6) of the disc (5) extending into the body channel (3) or a groove (4) and which allows the disc (5) to remain in the body channel (3) at the desired height, characterized by comprisingA disc cap (9) provided on the surface of the disc (5) having the cap protrusions (10), which closes over the disc channels (7) by opening and closing, securing the needle inside the channel and preventing reciprocating movement of the needle,- Disc cap projections (10) on the surface of the disc cap (9) facing the disc channels (7) and corresponding to the disc channels (7).
2. A needle guide (1) according to claim 1 characterized by comprising at least one groove (4) perpendicular to the body channel (3) on the body (2).