Prostatic hyperplasia treatment device using anchor assembly and needle
The prostatic hyperplasia treatment device uses an anchor assembly with adjustable ligatures and elastic needles for continuous prostate compression, enhancing urine flow and minimizing invasive procedures and side effects.
Patent Information
- Application Number
- JP2024542298
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-09-04
- Filing Date
- 2023-09-05
- Publication Date
- 2025-10-15
- Estimated Expiration
- Not applicable · inactive patent
AI Technical Summary
Conventional methods for treating benign prostatic hyperplasia are limited by the size of the implant, leading to non-continuous compression of prostate tissue, which affects urine flow and requires invasive procedures with potential side effects.
A prostatic hyperplasia treatment device using an anchor assembly with adjustable ligatures and elastic needles to continuously compress the prostate by placing anchors above and below the prostate, allowing for adjustable compression strength and continuous tissue engagement.
The device provides continuous compression of the prostate, improving urine flow and reducing the need for invasive procedures, with adjustable compression strength and minimal side effects.
Smart Images

Figure 2025534190000001_ABST
Abstract
Description
[Technical Field]
[0001] The present invention relates to a treatment device for benign prostatic hyperplasia, and more particularly to a treatment device for benign prostatic hyperplasia that can compress an enlarged prostate using an anchor assembly and then be placed therein to continuously open the prostatic urethra. [Background technology]
[0002] Generally, benign prostatic hyperplasia is a condition in which the prostate gland becomes abnormally enlarged, blocking the prostatic urethra through which urine passes from the lower part of the bladder, causing urethral obstruction and preventing smooth urine excretion.
[0003] When benign prostatic hyperplasia occurs, symptoms such as frequent urination, nocturia, urgency, slight urine, and a feeling of residual urine appear, causing considerable inconvenience in daily life.
[0004] To treat such benign prostatic hyperplasia, a surgical method for treating benign prostatic hyperplasia as shown in FIG. 1 is performed.
[0005] When benign prostatic hyperplasia occurs, a pair of prostate glands A and B on either side of the urethra swell and block the urethra C, as shown in Fig. 1(a). The practitioner inserts a cystoscope 10 into the urethra as shown in Fig. 1(b), passes a medical ligator 11 at the end of the cystoscope 10 through the prostate glands A and B as shown in Fig. 1(c), and then inserts a first implant 20 into the upper part of the left prostate gland A as shown in Fig. 1(d), and inserts a second implant 20a into the upper part of the right prostate gland B as shown in Fig. 1(e).
[0006] As shown in FIG. 1(f), a third implant 20b and a fourth implant 20c are also placed in the lower parts of the left prostate A and the right prostate B, respectively.
[0007] At this time, each implant 20, 20a, 20b, 20c is connected by a ligature 25, with the outer implant 21 placed on the outside of the prostates A and B and the inner implant 23 placed on the urethral side, and the inner implant 23 presses the prostates A and B outward by the length of the ligature 25, opening the urethra.
[0008] However, such a conventional method for treating benign prostatic hyperplasia has a limitation in that the area of prostate tissue that can be compressed using one implant 20 is limited by the size of the inner implant 23 .
[0009] Furthermore, since there is a gap between the upper implant 20 and the lower implant 20b, the area a between the upper inner implant and the lower inner implant is not compressed, and the area remains enlarged toward the urethra. As a result, the compressed prostate tissue is not continuous, and only the area in contact with the inner implant 23 is partially compressed. Summary of the Invention [Problem to be solved by the invention]
[0010] The object of the present invention is to solve the above problems and to provide a treatment device for benign prostatic hyperplasia in which the compression area can be adjusted by a pair of anchors that are placed above and below the prostate and connected to each other by a ligature.
[0011] Another object of the present invention is to provide a treatment device for benign prostatic hyperplasia that can continuously compress the prostate according to the size of the prostate of each patient by adjusting the length of the ligature connecting the pair of anchors.
[0012] It is yet another object of the present invention to provide a treatment device for benign prostatic hyperplasia that can continuously compress the prostate by firing anchor assemblies into the prostate in various shapes using elastic needles and needle firing means. [Means for solving the problem]
[0013] The above-mentioned object of the present invention is achieved by a prostatic hyperplasia treatment device using an anchor assembly and needles. The prostatic hyperplasia treatment device of the present invention includes a plurality of anchors placed in the prostate to compress the urethra, and a ligature connecting the plurality of anchors to each other so that the plurality of anchors continuously compress the prostatic tissue and secure the prostatic urethra.
[0014] It is also preferable that the device includes an elastic needle that houses the anchors and the ligatures therein and is inserted into the urethra to guide the anchors and the ligatures so that they are placed in the prostate gland, and a needle firing means that fires the needle so that the needle is inserted into the urethra and operates to discharge the plurality of anchors and the ligatures through the needle. [Effects of the Invention]
[0015] Compared with conventional treatment methods that compress only a portion of the prostate tissue, the prostate hyperplasia treatment device of the present invention has the advantage that the prostate tissue compressed by the ligature and the pair of anchors is continuous, which makes the urine flow faster, and this can be more effective for patients with long prostates.
[0016] In addition, the prostatic hyperplasia treatment device according to the present invention has the advantage that the practitioner can adjust the strength of compression on the prostate as desired by winding up the free end of the ligature to adjust the length of the ligature.
[0017] This has the effect of allowing the degree of compression to be adjusted according to the various symptoms of benign prostatic hyperplasia of each patient.
[0018] The treatment method using the treatment device for benign prostatic hyperplasia of the present invention does not require general anesthesia or a long operation, unlike other laser treatments or electrical surgeries that use thermal energy.
[0019] The simple anchor placement method allows for a short surgery time and local anesthesia, and because no prostate tissue is removed, there are no side effects such as retrograde ejaculation, erectile dysfunction, or hematuria. Furthermore, because it is non-invasive, there is the advantage that if the procedure is ineffective, you can always undergo additional surgery. [Brief explanation of the drawings]
[0020] [Figure 1] 1 is an exemplary diagram showing a conventional method for treating benign prostatic hyperplasia. [Figure 2] 1 is a perspective view showing the configuration of a treatment apparatus for benign prostatic hyperplasia according to the present invention. [Figure 3] 1 is an exemplary view showing the configuration of an anchor assembly according to a preferred embodiment of the treatment device for benign prostatic hyperplasia according to the present invention; [Figure 4] 4 is an exemplary view showing the anchor assembly of the preferred embodiment of FIG. 3 installed in the left prostate gland. [Figure 5] 10 is an exemplary view showing the configuration of an anchor assembly according to a modified example of the treatment device for benign prostatic hyperplasia according to the present invention. FIG. [Figure 6] 10 is an exemplary view showing the configuration of an anchor assembly according to a modified example of the treatment device for benign prostatic hyperplasia according to the present invention. FIG. [Figure 7] 10 is an exemplary view showing a state in which an anchor assembly according to a modified example is installed in the left prostate gland. FIG. [Figure 8] 10 is an exemplary view showing a state in which an anchor assembly according to a modified example is installed in the left prostate gland. FIG. [Figure 9] 10A to 10C are illustrative views showing the process in which the anchor assembly of the present invention is housed in a needle and then fired. [Figure 10] 1 is a cross-sectional view showing an exemplary side cross-sectional configuration of the prostatic hyperplasia treatment device according to the present invention before the trigger is operated; FIG. [Figure 11] 1 is a cross-sectional view illustrating a side cross-sectional configuration of the prostatic hyperplasia treatment device according to the present invention after the trigger is pulled; FIG. [Figure 12] 1 is an exploded perspective view showing the configuration of a treatment device for benign prostatic hyperplasia according to the present invention. [Figure 13]1 is an exploded perspective view showing the configuration of a needle guide sheath of the treatment apparatus for benign prostatic hyperplasia according to the present invention. FIG. [Figure 14] 1 is an exploded perspective view showing the connecting structure of a needle guide member and a blade portion of the treatment device for benign prostatic hyperplasia according to the present invention. FIG. [Figure 15] 10A to 10C are exemplary views showing the operation process of the blade unit of the treatment device for benign prostatic hyperplasia according to the present invention. [Figure 16] 1 is an internal perspective view showing the needle operation unit and the ligature winder of the treatment device for benign prostatic hyperplasia according to the present invention in a connected state. FIG. [Figure 17] FIG. 2 is an exploded perspective view showing the configuration of a needle operating unit and a ligature winder. [Figure 18] FIG. 2 is an exploded perspective view showing the configuration of a needle operating unit and a ligature winder. [Figure 19] 10A to 10C are side views illustrating an example of an operation process of the needle operating part related to the operation of the trigger. [Figure 20] 10A to 10C are exemplary plan views showing the operation process of the needle operating part related to the operation of the trigger. [Figure 21] 1 is a diagram showing the configuration of a ligature winder of the treatment apparatus for benign prostatic hyperplasia according to the present invention. [Figure 22] 10A and 10B are exemplary views showing the operation process of the blade pressing button and the cover of the treatment device for benign prostatic hyperplasia according to the present invention; [Figure 23] 10A to 10C are exemplary views showing anchor assemblies of various shapes being installed in the left prostate gland. [Figure 24] 10A to 10C are exemplary views showing anchor assemblies of various shapes being installed in the left prostate gland. DETAILED DESCRIPTION OF THE INVENTION
[0021] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, the present invention will be described in detail with reference to preferred embodiments thereof and the accompanying drawings, in which like reference numerals refer to like elements throughout the drawings.
[0022] When any component in the detailed description of the invention or the claims is said to "include" another component, this should not be construed as being limited to the component in question, but should be understood to further include other components, unless otherwise specified.
[0023] FIG. 2 is a perspective view showing the configuration of the treatment device for benign prostatic hyperplasia according to the present invention, FIG. 3 is an exemplary view showing the configuration of an anchor assembly according to a preferred embodiment of the treatment device for benign prostatic hyperplasia according to the present invention, and FIG. 4 is an exemplary view showing the anchor assembly 100 according to the preferred embodiment installed in the left prostates A and B.
[0024] The prostatic hyperplasia treatment device 1 according to the present invention includes an anchor assembly 100 that is placed outside the prostate gland and presses against the prostatic urethra, an elastic needle 200 that houses the anchor assembly 100 and guides it to be inserted into the urethra so that the anchor assembly 100 is installed in the prostate gland, and a needle firing means that fires the needle 200 so that the needle 200 is inserted into the urethra and operates to expel the anchor assembly 100 through the needle 200.
[0025] Here, as shown in FIG. 3(a), the anchor assembly 100 includes a plurality of anchors 110, 120 spaced apart from one another on the outside of the prostate, and a ligature 130 that connects the plurality of anchors 110, 120 to one another so that the plurality of anchors continuously compress the prostate tissue and secure the prostatic urethra.
[0026] The treatment device for benign prostatic hyperplasia 1 according to the present invention positions a pair of anchors 110, 120 and a ligature 130 at desired positions using a needle firing means, and adjusts the length of the ligature 130 using a ligature winder 700 provided in the needle firing means, so that the anchor assembly 100 can continuously compress the prostate tissue with the compression strength desired by the practitioner, as shown in Figure 4. This allows the compression length and compression thickness of the prostate to be adjusted according to the symptoms of benign prostatic hyperplasia for each patient, which has the advantage of speeding up urine flow.
[0027] The anchor assembly 100 is placed on the outer surface of the prostate gland of the patient and compresses the prostate gland to open the urethra. In the treatment device for benign prostatic hyperplasia (BPH) of the present invention, a pair of anchor assemblies 100 are placed on the left prostate gland A and the right prostate gland B, respectively, to complete the treatment.
[0028] FIG. 3(a) is a diagram showing the configuration of one anchor assembly 100, FIG. 3(b) is an exploded perspective view showing the configuration of the anchor assembly 100, FIG. 3(c) is a diagram showing a state in which the free end 137 of the anchor assembly 100 is pulled, and FIG. 4 is an illustrative view showing a state in which the anchor assembly 100 has been operated on the left prostate A and before its length has been adjusted.
[0029] 3(a) and 3(b), the anchor assembly 100 includes a first anchor 110, a second anchor 120, and a ligature 130 that connects the first anchor 110 and the second anchor 120 to each other. The first anchor 110 and the second anchor 120 are formed in the same shape, with only differences in their placement positions, and therefore only the first anchor 110 will be described in detail.
[0030] The first anchor 110 includes a first anchor body 111 formed in the shape of a tube with a semicircular cross section, and a first thread binding ring 115 formed in a protruding manner in the central region of the first anchor body 111 to which a ligature 130 is bound.
[0031] The first anchor body 111 has a first thread-receiving groove 113 formed inside along the length thereof to receive a ligature 130. The first anchor body 111 is made of metal or a metal alloy, preferably nitinol. One end of the first anchor body 111 is formed as a horizontal end 111a, and the other end is formed as a bent end 111b bent at a certain curvature. The reason the other end of the first anchor body 111 is formed as the bent end 111b is to ensure stable positional fixation when the first anchor 110 or the second anchor 120 is placed in the prostate A or B, as shown in FIG. 4 .
[0032] The bent end 111b allows the first anchor 110 to bend against the outer surface of the prostate while penetrating the prostate tissue, preventing the first anchor 110 positioned on the outer surface of the prostate from being moved back into the prostate penetration hole formed by the needle 200.
[0033] 4, when the needle 200 penetrates the prostate A and expels the first anchor 110 to the outside of the prostates A and B during the procedure, the first anchor 110 is bent with its bending end 111b elastically bending. The bent first anchor 110 is caught in the through-hole formed by the needle 200, preventing it from moving in the opposite direction and allowing it to be stably seated on the surface of the prostate A.
[0034] The horizontal end 111a is provided with an inclined contact end 111a-1 formed at an incline, so that the first anchor 110 can closely contact the surfaces of the prostates A and B in accordance with the curvature of the surfaces.
[0035] The first thread coupling ring 115 supports the ligature 130 inserted into the first thread receiving groove 113 so that the ligature 130 is fixed by tying a knot or by being tied to the first thread coupling ring 115 itself to fix its position. The first thread coupling ring 115 maintains the first anchor 110 and the ligature 130 in a fixed state.
[0036] The first anchor 110 and the second anchor 120 have their bent ends 111b, 121b bent, but as shown in Fig. 9(a), when they are housed inside the needle 200, they are elastically deformed to fit the shape of the needle 200. When they are ejected from the needle 200, as shown in Fig. 9(b), the bent ends 111b, 121b of the anchors 110, 120 elastically return to their original bent state.
[0037] The ligature 130 connects the first anchor 110 and the second anchor 120 to each other in a manner that allows the length to be adjusted, so that the first anchor 110 and the second anchor 120 do not each independently compress a specific part of the prostate, but rather the arc or U-shaped line connected by the first anchor 110, the second anchor 120 and the ligature 130 continuously compresses the prostate tissue.
[0038] As shown in FIG. 3(b), the ligature 130 includes a fixed end 131 connected to the first anchor 110, a length-adjusting loop 133 connected to the second anchor 120, a free end 137 connected to the end of the length-adjusting loop 133, and a slip knot 135 connecting the free end 137 and the length-adjusting loop 133.
[0039] The fixed end 131 is inserted into the first thread connecting ring 115 of the first anchor 110, and a fixing knot 131a is formed. The fixing knot 131a is tied at a position higher than the first thread connecting ring 115 and is caught by the first thread connecting ring 115, preventing the fixed end 131 from moving from one side to the other side of the first thread connecting ring 115.
[0040] The length-adjusting loop 133 is inserted into the second thread binding ring 125 of the second anchor 120 and then exits to the other side to form a loop. The length-adjusting loop 133 is formed by a slip knot 135 between the fixed end 131 and the free end 137.
[0041] As shown in FIG. 3(c), when the free end 137 is pulled, the position of the first anchor 110 connected to the fixed end 131 is fixed, so that the length of the length-adjustable loop 133 shortens, causing them to compress the surrounding prostate tissue.
[0042] 4, when the first anchor 110 and the second anchor 120 are placed outside the prostate A, the ligature 130 is placed loosely. In this state, when the practitioner operates the needle firing means to pull the ligature 130, the length of the free end 137 shortens, and the length adjustment loop 133 shortens, causing the prostate A to be compressed.
[0043] That is, as shown in Figure 24(b), when first anchor 110 and second anchor 120 are positioned outside the prostate, ligature 130 is loosely connected. When the practitioner uses the needle firing means to pull free end 137 and then tightens ligature 130, first anchor 110, second anchor 120, and ligature 130 continuously surround and compress prostate A, as shown in Figure 24(c). Because first anchor 110 and second anchor 120 are connected by ligature 130, the space between first anchor 110 and second anchor 120 is also continuously compressed, thereby opening urethra C.
[0044] On the other hand, FIG. 5(a) is a diagram showing the configuration of an anchor assembly 100a according to a first modified example, and FIG. 5(b) is an illustrative diagram showing a state in which the free end of the anchor assembly 100a according to the first modified example is pulled.
[0045] In the anchor assembly 100 according to the preferred embodiment described above, the fixed end 131 of the ligature 130 is fixed to the first anchor 110, and the length adjusting loop 133 is connected to the second anchor 120.
[0046] Meanwhile, in the anchor assembly 100a according to the first modified example, the first anchor 110 and the second anchor 120 are all connected to the length adjustment loop 133, and when the free end 137 is pulled, the first anchor 110 and the second anchor 120 can all move.
[0047] As shown in Figure 3(a), in the anchor assembly 100 according to a preferred embodiment, the fixed end 131 is fixed to the first anchor 110, so the length (l2) from the fixed end 131 to the slip knot 135 is fixed. This restricts the distance (l1) between the first anchor 110 and the second anchor 120 from shortening to the point where they come into contact with each other, even if the free end 137 is pulled, as shown in Figure 3(c).
[0048] Meanwhile, in the anchor assembly 100a according to the first modification, when the free end 137 is pulled as shown in Fig. 5(b), the distance (l3') between the first anchor 110 and the second anchor 120 can be reduced until they come into contact with each other. This has the advantage that the practitioner can easily adjust the distance between the first anchor 110 and the second anchor 120.
[0049] 7(b) is an exemplary view showing a state in which the anchor assembly 100a according to the first modified example is installed in the prostates A and B. As shown, the first anchor 110 and the second anchor 120 are coupled to the outer circumferential surfaces of the prostates A and B, and the ligature 130 is placed on the urethral side to open the urethra.
[0050] 6(a) is an exemplary view showing the configuration of an anchor assembly 100b according to a second modified example. As shown, the anchor assembly 100b according to the second modified example has a first anchor 110, a second anchor 120, and a third anchor 140. In the anchor assembly 100b according to the second modified example, three or more anchors 110, 120, and 140 are connected to a ligature 130 at regular intervals, and a lock anchor 150 is connected to a free end 137.
[0051] The fixed end 131 of the first anchor 110 is fixed with a fixing knot 131a, and the second anchor 120 and the third anchor 140 are sequentially connected along the path of the ligature 130. Fig. 7(d) is an exemplary view showing a state in which the anchor assembly 100b according to the second modified example is installed in the prostates A and B.
[0052] As shown, three anchors 110, 120, 140 are sequentially placed around the outer periphery of the prostates A and B, and a ligature 130 passes through the prostates A and B to connect them. Then, a lock anchor 150 is positioned on the urethral side facing the last anchor 140, and the position of the free end 137 is fixed.
[0053] The lock anchor 150 is made of a plate-like material and has a "V"-shaped thread guide groove at its tip. The gradually narrowing shape of the thread guide groove of the lock anchor 150 causes the free end to be clamped into the thread guide groove and fixed in position.
[0054] The shape of the lock anchor 150 can be modified into various shapes as long as the position of the free end 137 can be fixed.
[0055] 6(b) is an exemplary view showing the configuration of an anchor assembly 100c according to a third modified example. In the anchor assembly 100c according to the third modified example, a first anchor 110 and a second anchor 120 are sequentially coupled to a ligature 130 without a length adjusting loop 133, and a lock anchor 150 is provided at the end. The first anchor 110 is fixed by a fixed end 131 and a fixing loop 132 of the ligature 130.
[0056] In this case, it can be placed in the prostates A and B as shown in Figure 7(c). When multiple anchors 110 and 120 are sequentially connected to the ligature 130 without the length adjusting loop 133 as in the second and third modifications, the lock anchor 150 fixes the position of the free end 137. While the length of the length adjusting loop 133 is adjusted by the slip knot 135 and is restrained in the prostates A and B, if the length adjusting loop 133 is not present, the free end is clamped in the thread guide groove of the lock anchor 150 and its position is restrained.
[0057] 6(c) is an exemplary view showing the configuration of an anchor assembly 100d according to a fourth modified example, in which a first anchor 110 and a second anchor 120 are arranged facing each other. After a length adjusting loop 133 of a ligature 130 is connected to the first anchor 110, the ligature 130 is inserted into the ligature-through bridge 127 of the second anchor 120 and connected to the lower part of the second anchor 120 with a slip knot 135. A free end 137 and a fixed end 131 are both connected to the slip knot 135.
[0058] 8, anchor assembly 100d according to the fourth modification is arranged so that first anchor 110 and second anchor 120 face each other on the outside and inside of prostates A and B. This is different from anchor assemblies 100, 100a, 100b, and 100c of the above-described embodiments, in which anchors 110 and 120 are all arranged on the outside of prostates A and B.
[0059] When the practitioner manipulates the free end 137 to shorten the length, the length of the length-adjusting loop 133 shortens, and the second anchor 120 compresses the prostate A and B tissues to open the urethra.
[0060] Meanwhile, here, the slip knot 135 is positioned below the second anchor 120, but in some cases the slip knot 135 may be positioned between the first anchor 110 and the second anchor 120.
[0061] The anchor assembly 100 of the present invention is inserted into the prostates A and B while housed inside the elastic needle 200, and is then ejected from the needle 200 by operating the needle firing means and placed outside the prostates A and B.
[0062] 9(a) is an exemplary view showing a state in which the anchor assembly 100 is housed in the needle 200, and FIG. 9(b) is an exemplary view showing a state in which the first anchor 110 is expelled from the needle 200.
[0063] Figure 10 is an illustrative cross-sectional view showing the state before the needle 200 is fired from the needle firing means, Figure 11 is an illustrative cross-sectional view showing the state after the needle 200 has been fired from the needle firing means, and Figure 12 is an exploded perspective view showing the configuration of the needle firing means.
[0064] The needle firing means refers to the configuration of the treatment device for benign prostatic hyperplasia 1 excluding the anchor assembly 100 and the needle 200. The needle firing means can be modified into various forms that can fire the anchor assembly 100 and the needle 200 and place them in the prostate by the operator's operation.
[0065] The needle firing means according to a preferred embodiment of the present invention includes: a needle accommodating sheath 300 that accommodates the needle 200 therein and guides the needle 200 so that it is inserted into the urethra and places the anchor assembly 100 in the prostate; a needle operating unit 600 that controls the movement of the needle 200 so that the needle 200 is expelled through the tip of the needle accommodating sheath 300; a ligature winder 700 that is provided on one side of the needle operating unit 600 and winds up the free end 137 of the ligature 130 to adjust the strength with which the anchor assembly 100 compresses the prostate; a handle frame 400 that accommodates the rear end of the needle accommodating sheath 300, the needle operating unit 600, and the ligature winder 700 and is held by the practitioner's hand; and a trigger 500 that is connected to the handle frame 400 and allows the practitioner to operate the firing of the needle 200.
[0066] The needle 200 is provided in the form of a tube having a certain length, and is inserted into the needle insertion tube 310 of the needle accommodating sheath 300 as shown in Figure 10. When the practitioner operates the trigger 500 while the needle 200 is inserted into the needle insertion tube 310, the needle 200 bends at a certain angle along the needle guide member 340 and is inserted into the prostates A and B.
[0067] The needle 200 may be constructed of a metal or metal alloy, preferably Nitinol. The needle 200 is manufactured to be bent at its tip, and when housed in the needle insertion tube 310, as shown enlarged in FIG. 10, the needle 200 maintains its resiliently bent shape due to the curvature of the needle guide member 340.
[0068] When the needle 200 is fired by the trigger 500 and ejected out of the needle guide member 340, the ejection angle is adjusted by the needle guide member 340 and the needle 200 is bent to match the curvature at the time of manufacture, as shown in the enlarged view of FIG.
[0069] The tip 210 of the needle 200 is formed sharply to facilitate insertion into the tissues of the prostates A and B. In addition, a needle slot 220 is formed by incising a certain length from the needle tip 210 of the needle 200 inward. The needle slot 220 exposes the ligature 130 of the anchor assembly 100 housed therein to the outside.
[0070] The length of the needle slot 220 is set to be equal to or shorter than the combined length of the first anchor 110 and the second anchor 120 so that the ligature 130 does not interfere with the firing of the anchors 110, 120.
[0071] FIG. 13 is an exploded perspective view showing the process of joining the needle accommodating sheath 300 and the needle operating section 600, and FIG. 14 is an exemplary view showing the process of joining the sheath body 300a with the needle guide member 340 and the suture arranger 360.
[0072] The needle-accommodating sheath 300 accommodates the needle 200 and the transurethral endoscope 800, guides the anchor assembly 100 through the needle 200 to the prostates A and B, and fixes the position of the anchor assembly 100. The rear end of the needle-accommodating sheath 300 is connected to the handle frame portion 400, and the front end extends a certain distance from the handle frame portion 400 and is inserted into the urethra C through the outer sheath S.
[0073] As shown in Figures 23 and 24, the practitioner inserts a transurethral endoscope 800 into the needle-accommodating sheath 300 inserted into the urethra C through the outer sheath S to check the inside of the prostate gland, and operates the needle 200 so that it penetrates the prostate glands A and B and the pair of anchors 110 and 120 are positioned outside the prostate glands A and B.
[0074] 12 and 13, the needle-accommodating sheath 300 includes a sheath body 300a formed by integrally connecting a needle insertion tube 310, an endoscope insertion tube 320, and a blade movement tube 330; a needle guide member 340 provided at the tip of the sheath body 300a and guiding the needle 200 toward the prostates A and B; a blade section 350 provided inside the blade movement tube 330 so as to be movable back and forth and for cutting the free end 137 of the ligature 130; a suture arranger 360 for arranging the ligature 130 protruding outside the needle 200; a sheath cylinder 370 connecting the sheath body 300a to the handle frame section 400; and a sheath lock button 380 for fixing the outer sheath S to the sheath cylinder 370.
[0075] The needle insertion tube 310 accommodates the needle 200 therein, and the endoscope insertion tube 320 is integrally connected to the lower part of the needle insertion tube 310 and accommodates the transurethral endoscope 800 therein. The blade shaft moving tube 330 is integrally connected to the lower part of the endoscope insertion tube 320 and movably accommodates the blade plate connecting shaft 354 and blade support plate 357 of the blade unit 350 therein.
[0076] 14, the needle 200 is housed inside the needle insertion tube 310, the transurethral endoscope 800 is housed inside the endoscope insertion tube 320, and the blade plate connecting shaft 354 and the blade support plate 357 are housed inside the blade shaft moving tube 330. The needle insertion tube 310 and the endoscope insertion tube 320 are hollow tubes, and the blade shaft moving tube 330 has a trapezoidal cross section and is fixedly connected to the lower part of the endoscope insertion tube 320.
[0077] The rear end of the sheath body 300a is inserted into the handle frame portion 400 by the sheath cylinder 370 and the sheath lock button 380. At this time, as shown in Fig. 13, the needle 200 is inserted into the needle insertion tube 310, and the pusher 610 of the needle operating portion 600 is inserted behind the needle 200. The pusher 610 is fixedly coupled to the pusher holder 620, and the pusher 610 moves back and forth within the needle 200 as the practitioner operates the pusher holder 620 back and forth, thereby discharging the anchor assembly 100.
[0078] In addition, the endoscope insertion tube 320 is formed longer than the needle insertion tube 310 and the blade shaft moving tube 330, and the rear end of the endoscope insertion tube 320 passes through the pusher holder 620. The transurethral endoscope 800 inserted through the endoscope fixing member 430 can be inserted into the endoscope insertion tube 320.
[0079] A needle guide member 340 is detachably coupled to the tip of the needle insertion tube 310 and the blade shaft moving tube 330 .
[0080] Here, the treatment device for benign prostatic hyperplasia 1 of the present invention is fully assembled as shown in Fig. 1, and then sterilized and packaged before being delivered to hospitals. This eliminates the need for the practitioner to disassemble and assemble each part, and the device can be operated in its assembled state during treatment, improving the convenience of use.
[0081] 15 is an exemplary view showing the operation process of the needle guide member 340 and the blade portion 350. The needle guide member 340 includes a guide body 341 and a sheath fixing member 347 that connects the guide body 341 to the needle insertion tube 310.
[0082] The needle guide member 340 is coupled to the sheath fixing member 347 by fixing the needle insertion tube 310 and the upper part of the guide body 341. A needle exposure hole 345 for exposing the needle 200 to the outside is formed between the sheath fixing member 347 and the blade shaft moving tube 330. The transurethral endoscope 800 moved into the endoscope insertion tube 320 can be exposed to the inside of the urethra C through the needle exposure hole 345.
[0083] Also, as shown enlarged in FIG. 10, the ligature 130 housed in the needle 200 is exposed to the outside through the needle exposure hole 345, allowing the ligature 130 to be moved to the prostates A and B without interference.
[0084] A needle guide curved surface 343 is formed on the upper inner wall of the guide body 341, which forms the needle exposure hole 345, to guide the needle 200 into the urethra C. In the initial state, the needle 200 is placed inside the needle insertion tube 310 as shown in Fig. 10, and when the practitioner operates the trigger 500, a certain length of the needle 200 is exposed to the outside through the needle guide member 340 as shown in Fig. 11.
[0085] At this time, the needle 200 bends at a certain angle along the curved surface of the needle guide curved surface 343 and moves through the prostates A and B.
[0086] The blade portion 350 is movably provided inside the blade shaft moving tube 330, and is operated by the practitioner to cut the ligature 130 after the first anchor 110 and the second anchor 120 are placed in the prostates A and B.
[0087] As shown in FIG. 13, the blade section 350 includes a blade plate connecting shaft 354 on which a blade plate 351 is formed, and a blade support plate 357 fixedly coupled to the upper part of the blade plate connecting shaft 354 in parallel and supporting the blade plate connecting shaft 354.
[0088] A vertical coupling end 354 a formed at the rear end of the blade plate coupling shaft 354 is coupled to a blade pressing button 355 , and the user moves the blade pressing button 355 back and forth to cut the ligature 130 .
[0089] An outer needle exposure hole 331 is provided at the tip of the blade shaft moving tube 330, and an inner needle exposure hole 352 is formed in the blade plate 351. As shown in Figure 15(a), the outer needle exposure hole 331 and the inner needle exposure hole 352 are formed to overlap, and the needle 200 is ejected through the outer needle exposure hole 331, and the pair of anchors 110, 120 and the ligature 130 are placed in the prostates A and B.
[0090] A blade slit 353 is formed in the blade plate 351. The blade slit 353 is formed so that its width gradually narrows, and the opposing inner ends are formed sharply. When the practitioner pulls the blade pressing button 355 backward, the blade plate 351 is pulled, and the free end 137 of the ligature 130 is pinched in the blade slit 353 and cut, as shown in Figure 15(b).
[0091] The blade pressing button 355 and the cover 356 are used by the practitioner to cut the free end 137 of the ligature 130. Figure 22(a) is an exemplary view showing the blade pressing button 355 and the cover 356 coupled to the vertical coupling end 354a, and Figure 22(b) is an exemplary view showing the operation process of the blade lock release lever 429.
[0092] As shown, the vertical coupling end 354a is inserted into the blade pressing button 355 to fix the position of the blade portion 350. The cover 356 is inserted into the blade pressing button 355 to fix the position of the vertical coupling end 354a.
[0093] A protruding hook wing 355a is provided at the rear of the blade pressing button 355. The hook wing 355a comes into contact with a blade lock release lever 429 provided on the handle frame part 400 to restrict its position. When the practitioner wants to cut the free end 137, he or she must pull the blade lock release lever 429 in the direction of the arrow to release the contact with the hook wing 355a, and then pull the blade pressing button 355 backward.
[0094] Meanwhile, the suture arranger 360 arranges the complex ligature 130 exposed outside the outer needle exposure hole 331 so that it does not interfere with the discharge path of the needle 200, as shown in FIG.
[0095] As shown in FIG. 14, the suture arranger 360 includes an arranger body 361 that is open at the top and inserted into the sheath body 300a, a handle 363 that extends vertically from the bottom of the arranger body 361, and a sheath receiving channel 365 formed inside the arranger body 361.
[0096] When the treatment device for benign prostatic hyperplasia 1 is first packaged, the suture arranger 360 is connected to the tip of the sheath body 300a, and the ligatures 130 are stored in an organized state inside the sheath body 300a, as shown in FIG. 10.
[0097] When the practitioner prepares to place the anchor assembly 100 in the prostates A, B, the practitioner grasps the handle 363 and presses the arranger body 361 downward to separate the suture arranger 360 from the sheath body 300a.
[0098] The sheath cylinder 370 fixes the sheath body 300a to the handle frame portion 400. As shown in Fig. 12, a sheath coupling member insertion groove 425 is formed at the tip of each of the right frame 410 and the left frame 420, and the sheath cylinder 370 with the sheath body 300a inserted therein is coupled to the handle frame portion 400 as shown in Fig. 10.
[0099] In this state, the sheath lock button 380 is inserted into the tip of the sheath cylinder 370 to fix the sheath body 300a to the outer sheath S. As shown in Figure 13, the sheath cylinder 370 includes a sheath coupling tube 371 in which the sheath body 300a is housed, and a frame coupling plate 373 that extends vertically from the rear end of the sheath coupling tube 371. The frame coupling plate 373 is inserted into the sheath coupling member insertion grooves 425 of the right frame 410 and the left frame 420.
[0100] A fixing protrusion 381 is provided inside the sheath lock button 380 and is inserted and coupled to the sheath coupling tube 371 to fix the position of the sheath lock button 380 .
[0101] 2 to 4, the handle frame portion 400 is coupled to the rear of the needle-accommodating sheath 300 and accommodates the trigger 500, the needle operating portion 600, and the ligature winder 700. The handle frame portion 400 is held by the practitioner's hand, allowing the practitioner to operate the needle-accommodating sheath 300 and the needle operating portion 600, insert the needle-accommodating sheath 300 into the urethra, and adjust the positions of the needle 200 and the anchor assembly 100 in order to place the anchor assembly 100 in the prostate.
[0102] The handle frame part 400 is formed by detachably connecting a left frame 420 and a right frame 410 arranged on the left and right sides. The left frame 420 and the right frame 410 are collectively formed in the shape of a gun that can be held in the hand.
[0103] The left frame 420 and the right frame 410 are formed symmetrically to each other, but the configurations shown in FIG. 12 will be described separately.
[0104] A trigger ring accommodating groove 411 for accommodating the ring 510 of the trigger 500 is formed in the lower part of the plate surface of the right frame 410. Then, from the upper part of the plate surface, a thread winder accommodating groove 412, an indicator accommodating groove 413, a pusher lever button accommodating groove 414, a pusher holder manual operation slit 415, a pusher block movement slit 416, a blade pressing button movement slit 417, and a ligature manual cutting slit 418 are formed.
[0105] The left frame 420 is provided inside with a needle operating part accommodating groove 421, a trigger pivot shaft 423, a lock release button hooking end 422, a sheath connecting member insertion groove 425, an indicator connecting shaft 427, a pusher lever pivot shaft connecting tube 428, and a blade lock release lever 429.
[0106] An endoscope fixing member 430 is detachably coupled to the rear of the left frame 420 and the right frame 410. A transurethral endoscope 800 is inserted into the endoscope insertion tube 320 through the endoscope fixing member 430.
[0107] 2, the winder shaft 710 of the ligature winder 700 is rotatably inserted into the thread winder receiving groove 412 of the right frame 410 to support the ligature 130 wound around the periphery so as to be wound and unwound, and the thread indicator 740 of the ligature winder 700 is movably coupled to the indicator receiving groove 413 to move back and forth and to externally display the current tension level of the free end 137 of the ligature 130. A scale 413a is provided along the length of the lower portion of the indicator receiving groove 413 so that the practitioner can accurately check the tension level of the free end 137 with the naked eye.
[0108] A pusher lever button 649 of the pusher lever 640 is provided in the pusher lever button receiving groove 414 so as to be rotatable up and down. Before moving the needle holder 630 forward, the practitioner rotates the pusher lever button 649 protruding out of the pusher lever button receiving groove 414 of the right frame 410 upward. This related operation will be described in detail below.
[0109] The pusher holder manual operation slit 415 is a slit formed through the plate surface so that the practitioner can manually push the pusher holder 620 when the needle 200 is not fired. Both ends of the pusher block 635 of the needle holder 630 are inserted into the pusher block movement slit 416. The practitioner can adjust the position of the pusher block 635 by manually pushing the pusher block 635 protruding on both sides of the pusher block movement slit 416.
[0110] Both ends of the blade pressing button 355 are received in the blade pressing button moving slit 417. The practitioner pulls the blade pressing button 355 exposed to the outside through the blade pressing button moving slit 417 backward so that the blade slit 353 of the blade plate 351 cuts the free end 137.
[0111] The manual ligature cutting slit 418 is a slit that allows the practitioner to manually cut the free end 137 of the ligature 130 if the treatment device 1 malfunctions during treatment using the treatment device 1.
[0112] The needle operating part 600 is accommodated in the needle operating part accommodating groove 421 of the left frame 420, and the pivot shaft coupling tube 540 of the trigger 500 is pivotably inserted into the trigger pivot shaft 423. The pusher lever hinge 645 of the pusher lever 640 is elastically engaged and supported by the lock release button hooking end 422. As described above, the frame coupling plate 373 of the sheath cylinder 370 is inserted and coupled into the sheath coupling member insertion groove 425. The frame coupling ring 741 of the suture indicator 740 of the ligature winder 700 is coupled to the indicator coupling shaft 427.
[0113] A pusher lever rotation shaft 643 of a pusher lever 640 is connected to the pusher lever rotation shaft connecting tube 428, and supports the pusher lever 640 in a rotatable manner.
[0114] As described above, the blade lock release lever 429 is provided so as to be rotatable left and right, and contacts and supports the hook blade 355 a of the blade portion 350 , thereby controlling the movement of the blade pressing button 355 .
[0115] FIG. 16 is an internal perspective view showing the internal structure of the handle frame portion 400, FIGS. 17 and 18 are exploded perspective views showing the configurations of the sheath body 300a, the trigger 500, the needle operating portion 600, and the ligature winder 700, and FIG. 19 is an illustrative view showing the process of firing the needle 200.
[0116] The trigger 500 is coupled to the handle frame portion 400 so as to be rotatable back and forth, and is held by the hand of a practitioner. The trigger 500 transmits the practitioner's operation to the needle operating portion 600 so that the needle 200 can be fired.
[0117] As shown in FIG. 17, the trigger 500 includes a ring 510 into which the practitioner's finger can be inserted, a pull lever 520 extending downward from the rear of the ring 510 at a certain angle, a pressing lever 530 extending from the top of the pull lever 520 and connected to a needle holder 630, and a pivot connecting tube 540 connected to the trigger pivot shaft 423 of the left frame 420.
[0118] 16, the trigger 500 has a pivot coupling tube 540 coupled to the trigger pivot shaft 423, and a ring 510 positioned in the trigger ring receiving groove 411. The pull lever 520 extends downward from the handle frame portion 400, and the push lever 530 extends upward and is positioned between the lever head coupling member 633 of the needle holder 630.
[0119] The connecting head 531 of the pressing lever 530 is accommodated in the lever head accommodating groove 633a between the lever head connecting members 633, and when the practitioner manually pulls the pull lever 520 as shown in Figure 19(c), the pressing lever 530 is rotated in the opposite direction and the needle holder 630 is moved forward.
[0120] When the practitioner pushes the pull lever 520 in the opposite direction, the push lever 530 also returns to its initial state, and the needle holder 630 is moved backward.
[0121] 2, the practitioner inserts his index finger into the ring 510 exposed on the outside of the handle frame part 400, wraps his thumb around the handle frame part 400, and grips the pull lever 520 with the remaining fingers. Then, he operates the needle holder 630 by pulling and pushing the pull lever 520.
[0122] The needle operating portion 600 is housed in the handle frame portion 400 and is moved in accordance with the direction in which the practitioner operates the trigger 500, thereby firing the needle 200 and operating to set the anchor assembly 100 in the prostates A and B.
[0123] As shown in Figures 16, 17, and 18, the needle operating unit 600 includes a pusher 610 that is inserted into the rear end of the needle insertion tube 310, a pusher holder 620 that is fixedly connected to the pusher 610 and into which the rear end of the endoscope insertion tube 320 is inserted, a needle holder 630 that houses the pusher holder 620 and is moved back and forth by operating the trigger 500, and a pusher lever 640 that is provided horizontally above the needle holder 630 and controls the movement of the needle holder 630, limiting the movement distance.
[0124] The pusher 610 is provided in the form of a rod having a certain length. The pusher 610 is provided with a length that enables it to push the anchor assembly 100 from the tip of the pusher holder 620, and is inserted into the rear end of the needle insertion tube 310. The pusher 610 moves forward in conjunction with the forward movement of the needle holder 630, and physically pushes the anchor assembly 100, so that the anchor assembly 100 provided at the tip of the needle 200 is ejected outside the needle 200.
[0125] The pusher holder 620 is housed within the needle holder 630 and moves together with the needle holder 630, supporting the pusher 610 so that it presses against the anchor assembly 100. The pusher holder 620 is formed in the shape of a square housing and has an endoscope insertion tube insertion hole 625 penetrating therethrough. The insertion tube rear end 321 of the endoscope insertion tube 320 is inserted into the endoscope insertion tube insertion hole 625. The insertion tube rear end 321 is inserted and protrudes a certain length from the rear of the pusher holder 620, and guides the transurethral endoscope 800 inserted through the endoscope fixing member 430 toward the prostates A and B.
[0126] A pair of holder hinges 621 are provided on both sides of the pusher holder 620. When the pusher holder 620 moves inside the needle holder 630, the pair of holder hinges 621 are engaged with position adjustment protrusions 631b and 631c on the inner wall surface of the needle holder 630, thereby limiting the movement distance of the pusher holder 620.
[0127] The holder hinge 621 is provided in the form of wings extending on both sides and is provided to be elastically bent.
[0128] 20 is an exemplary plan view showing the process of pusher holder 620 moving inside needle holder 630. As shown in Fig. 20(a), a first pusher holder position adjusting protrusion 631b and a second pusher holder position adjusting protrusion 631c are formed on the inner wall surface of needle holder 630, protruding obliquely along the length direction.
[0129] In the initial position, a pair of holder hinges 621 extending on both sides of the pusher holder 620 contact the inner wall surface of the needle holder 630, and when the pusher holder 620 moves forward inside the needle holder 630 as shown in Figure 20(b), the pair of holder hinges 621 are elastically compressed, move along the inclined surface, and engage with the first pusher holder position adjustment protrusion 631b, restricting the position of the pusher holder 620.
[0130] Thereafter, when the practitioner removes the pusher block 635 that was blocking the path of the pusher holder 620 and the pusher holder 620 moves forward, the holder hinge 621 is elastically compressed again, allowing the pusher holder 620 to move smoothly and engage with the second pusher holder position adjustment protrusion 631c, restricting the position of the pusher holder 620.
[0131] Here, the distances d1 and d2 between the first pusher holder position adjustment protrusion 631b and the second pusher holder position adjustment protrusion 631c correspond to the lengths of the first anchor 110 and the second anchor 120, and the needle 200 moves forward by the distance that the pusher 610 moves, allowing the first anchor 110 and the second anchor 120 to be discharged.
[0132] Meanwhile, a position adjusting tail 623 is provided to protrude from the top of the pusher holder 620. The position adjusting tail 623 is coupled with the pusher lever 640 when the needle holder 630 is moved forward by the trigger 500, thereby limiting the moving speed and distance of the needle holder 630.
[0133] As shown in FIG. 19(c), when the needle holder 630 is moved forward by operating the trigger 500, the position adjustment tail 623 moves in engagement with the position adjustment tooth 641a of the pusher lever 640, and is adjusted so that it does not move forward all at once but by the size of the tooth.
[0134] The needle holder 630 moves back and forth in response to the operator's operation of the trigger 500, adjusting the positions of the pusher holder 620 and the needle 200. The needle holder 630 includes a needle holder body 631 in which the pusher holder 620 is movably housed, a needle holder cover 634 that covers the top of the needle holder body 631, and a pusher block 635 that is housed in the needle holder 630 and limits the distance that the pusher holder 620 can move.
[0135] 18, the needle holder main body 631 has a sheath movement path 631a recessed in the central portion along the length direction. The endoscope insertion tube 320 fixed to the pusher holder 620 is housed in the sheath movement path 631a.
[0136] The inner wall surfaces on both sides of the needle holder body 631 are provided with the first pusher holder position adjusting protrusion 631b and the second pusher holder position adjusting protrusion 631c, respectively, which limit the movement position of the pusher holder 620.
[0137] Pusher block accommodating grooves 631d are provided on both front sides of needle holder main body 631. Pusher block accommodating groove 631d accommodates pusher block 635 therein, as shown in Figure 12. Pusher block 635 is accommodated between pusher block accommodating groove 631d and needle holder cover 634. Both ends of pusher block 635 protrude on both sides of pusher block accommodating groove 631d and are exposed to the outside of pusher block movement slit 416 of handle frame portion 400, as shown in Figure 2.
[0138] 20(b), the practitioner pulls the trigger 500 and moves the pusher holder 620 to the first pusher holder position adjustment protrusion 631b where the pusher holder 620 comes into contact with the pusher block 635. This causes the first anchor 110 of the anchor assembly 100 to be ejected to the outside of the needle 200.
[0139] The practitioner pushes the pusher block 635 exposed outside the pusher block moving slit 416 to remove it from the handle frame part 400. Then, in the second stage, the trigger 500 is pulled to move the pusher holder 620 forward to the end, as shown in Figure 20(c). As a result, the second anchor 120 is ejected outside the needle 200.
[0140] A pair of lever head coupling members 633 are provided at the bottom of the needle holder body 631. A coupling head 531 of the pressing lever 530 of the trigger 500 is received between the lever head coupling members 633. The coupling head 531 is received in a lever head receiving groove 633a between the lever head coupling members 633, and the coupling head 531 pushes the pair of lever head coupling members 633 left and right according to the rotation direction of the trigger 500, thereby pressing to move the needle holder 630.
[0141] The needle holder cover 634 covers the top of the needle holder body 631 and fixes the positions of the pusher holder 620 and pusher block 635 housed inside. A lower locking protrusion 634a that protrudes upward is provided on the front of the needle holder cover 634. The lower locking protrusion 634a engages with the upper locking protrusion 647 of the pusher lever 640, fixing the position of the needle holder 630 so that it does not move unless operated by the practitioner.
[0142] As shown in Fig. 18, the lower locking protrusion 634a has a cross section in the shape of a right triangle and is formed to protrude from the front upper part of the needle holder cover 634. As shown in Fig. 17, the upper locking protrusion 647 protrudes from the rear lower part of the pusher lever 640. The upper locking protrusion 647 has a cross section in the shape of a right triangle in the opposite direction to the lower locking protrusion 634a.
[0143] As a result, in the initial state, as shown in FIG. 19(a), the lower locking protrusion 634a and the upper locking protrusion 647 are in contact with each other with their perpendicular surfaces abutting against each other, restricting the forward movement of the needle holder 630.
[0144] 19(b), when the practitioner rotates the pusher lever 640 upward, the upper locking protrusion 647 separates from the lower locking protrusion 634a. At this time, when the practitioner pulls the trigger 500, the needle holder 630 moves forward.
[0145] 18, a block protrusion moving rail 634b is formed with a certain area penetrating the plate surface of the needle holder cover 634. A block protrusion 635a formed to protrude from the upper surface of the pusher block 635 is received in the block protrusion moving rail 634b. The block protrusion moving rail 634b limits the moving distance of the pusher block 635 when the needle holder 630 moves.
[0146] That is, since the block protrusion 635a moves by the distance of the block protrusion moving rail 634b, the moving distance of the pusher block 635 is also limited.
[0147] As described above, when the practitioner pulls the trigger 500 in the first stage, the pusher block 635 blocks the path of the pusher holder 620 so that the pusher holder 620 moves by a distance d1 corresponding to the length of the first anchor 110. The pusher block 635 is removed to the outside just before the practitioner pulls the trigger 500 in the second stage. As described above, both ends of the pusher block 635 are exposed to the outside of the handle frame part 400 through the pusher block receiving groove 631d and the pusher block moving slit 416, and the practitioner can pull the exposed pusher block 635 to remove it.
[0148] 16, the pusher lever 640 is provided horizontally on the top of the needle holder 630 and controls the movement of the needle holder 630 and limits the movement speed of the needle holder 630. As shown in Figures 17 and 18, the pusher lever 640 includes a horizontally provided pusher lever bar 641, a pusher lever rotation shaft 643 provided in front of the pusher lever bar 641 and rotatably supporting the pusher lever bar 641, a pusher lever hinge 645 formed to protrude obliquely upward in front of the pusher lever rotation shaft 643 and providing elastic force so that the pusher lever bar 641 returns to its initial position after being rotated upward, an upper locking protrusion 647 protruding from the bottom of the pusher lever bar 641, and a pusher lever button 649 extended with a certain area on both sides behind the pusher lever bar 641 and operated by the practitioner.
[0149] The pusher lever bar 641 is provided in the shape of a rod with a certain length and is arranged horizontally above the needle holder 630 inside the handle frame part 400. Position adjustment teeth 641a are formed along the length of the lower part of the pusher lever bar 641, which come into contact with the position adjustment tail 623 of the pusher holder 620 as described above and limit the movement position of the needle holder 630. The needle holder 630 can move back and forth by the length of the position adjustment tail 623.
[0150] When the practitioner pulls the trigger 500, the needle holder 630 is moved forward along the position adjustment tail 623 as shown in FIG. 19(c).
[0151] The pusher lever rotating shaft 643 is connected to the pusher lever rotating shaft connecting tube 428 of the left frame 420 and supports the pusher lever bar 641 so that it can rotate up and down. The pusher lever hinge 645 is formed by extending obliquely at a certain angle upward from the pusher lever rotating shaft 643. When the pusher lever rotating shaft 643 is inserted into the pusher lever rotating shaft connecting tube 428, the pusher lever hinge 645 is inserted between the unlock button hook end 422 of the left frame 420.
[0152] 19(a), the pusher lever hinge 645 is positioned so as to contact the inner wall surface of the unlock button hooking end 422. In this state, when the practitioner presses the pusher lever button 649 upward and the pusher lever bar 641 rotates around the pusher lever rotating shaft 643 as shown in FIG.
[0153] When the practitioner releases the pusher lever button 649, as shown in Figure 19(c), the compressed pusher lever hinge 645 applies an elastic force to rotate the pusher lever bar 641 to its initial position, and the pusher lever bar 641 elastically returns to a horizontal state.
[0154] The upper locking projection 647 engages with the lower locking projection 634 a of the needle holder cover 634 as described above, and controls the movement of the needle holder 630 .
[0155] The pusher lever button 649 extends horizontally from the upper rear end of the pusher lever bar 641 to the left and right, and is received in the pusher lever button receiving groove 414 of the handle frame part 400. As shown in Fig. 2, the pusher lever button receiving groove 414 extends vertically with a certain area, so the practitioner pushes the exposed pusher lever button 649 upward to lift the pusher lever bar 641 upward.
[0156] As shown in Figure 19(a), when the pusher lever button 649 is in the lowered position, the lower locking protrusion 634a and the upper locking protrusion 647 engage with each other, restricting the movement of the needle holder 630. In this state, the practitioner lifts the pusher lever button 649 exposed to the outside of the handle frame portion 400 upward, causing the pusher lever bar 641 to rotate upward as shown in Figure 19(b). This causes the upper locking protrusion 647 and the lower locking protrusion 634a to separate, and the practitioner can pull the trigger 500 to move the needle holder 630 forward as shown in Figure 19(c).
[0157] The ligature winder 700 allows the practitioner to wind the free end 137 of the ligature 130 and adjust the strength with which the ligature 130 compresses the prostates A and B by adjusting the length of the free end 137. As shown in Fig. 12, the ligature winder 700 includes a winder shaft 710, one-way rotation limiting teeth 720 formed on the winder shaft 710 to limit the rotation direction of the winder shaft 710 so that the winder shaft 710 can rotate in only one direction, a thread winder lock release button 730 provided on the top of the left frame 420 to control the rotation of the winder shaft 710, and a thread indicator 740 provided in the movement path of the ligature 130 between the winder shaft 710 and the needle 200 to sense the tension of the free end 137.
[0158] The winder shaft 710 is accommodated in the thread winder accommodation grooves 412 of the left frame 420 and the right frame 410. At this time, the rotation operation knobs 715 provided on both ends of the winder shaft 710 are protruded and exposed to the outside of the thread winder accommodation grooves 412, so that the practitioner can grip them with their hands and rotate them.
[0159] 17, a thread insertion ring 711 to which the ligature 130 is fixed is provided on the outer circumferential surface of the winder shaft 710. The ligature 130 is fixed to the thread insertion ring 711 with a knot and wound around the outer circumferential surface of the winder shaft 710 several times.
[0160] 21(a) is an example diagram showing the operation process of the thread winder lock release button 730 and the one-way rotation limiting teeth 720. The one-way rotation limiting teeth 720 are formed to protrude at regular angular intervals from the outer periphery of the winder shaft 710. At this time, one surface of the one-way rotation limiting teeth 720 is formed as an inclined surface 721, and the other surface is formed as a vertical surface 723.
[0161] The thread winder lock release button 730 has a frame coupling end 731 at one side of the lower portion fixed to the handle frame part 400, and an upper portion formed to protrude outside the handle frame part 400. A toothed protrusion 733 is formed vertically in the direction opposite to the frame coupling end 731. The lower portion between the frame coupling end 731 and the toothed protrusion 733 is formed to have a gently curved surface.
[0162] In the initial state, the tooth engaging protrusion 733 maintains contact with the vertical surface 723 of the one-way rotation limiting tooth 720. The practitioner pulls the thread winder lock release button 730 clockwise and rotates the rotation operation knob 715 to wind the ligature 130.
[0163] At this time, the winder shaft 710 is provided so as to be rotatable only in the direction in which the ligature 130 is wound. That is, it is provided so as to be rotatable only counterclockwise with reference to FIG. 21(a). When the winder shaft 710 rotates counterclockwise, the inclined surface 721 of the one-way rotation limiting tooth 720 comes into contact with the curved surface, allowing the winder shaft 710 to rotate. On the other hand, when the winder shaft 710 rotates clockwise, the vertical surface 723 of the one-way rotation limiting tooth 720 comes into contact with the tooth engaging protrusion 733, restricting the rotation.
[0164] The thread indicator 740 indicates to the practitioner the tension currently applied to the free end 137 of the ligature 130. Indicator protrusions 745 that protrude outward are provided on both sides of the thread indicator 740. As shown in Figure 2, the indicator protrusions 745 are provided so as to be movable left and right along the indicator receiving groove 413 of the right frame 410.
[0165] A coil spring-type elastic member 743 having a certain length is connected to the thread indicator 740, and a frame connecting ring 741 provided at the tip of the elastic member 743 is fixed to the indicator connecting shaft 427 of the left frame 420 as shown in FIG. 11.
[0166] 16, the ligature 130 passes from the winder shaft 710 through the needle insertion tube 310 via the thread indicator 740 and is connected to the first anchor 110 and the second anchor 120. When the practitioner rotates the winder shaft 710 to wind the ligature 130, the tension increases and the thread indicator 740 gradually moves to the right. The practitioner rotates the rotary operation knob 715 to check the current position of the thread indicator 740, and when the desired tension is reached, the practitioner uses the blade portion 350 to cut the free end 137.
[0167] The procedure for treating benign prostatic hyperplasia using the treatment apparatus 1 for benign prostatic hyperplasia according to the present invention having the above-described configuration will be described with reference to FIGS.
[0168] 23 and 24 are illustrative diagrams showing a schematic procedure for treating benign prostatic hyperplasia.
[0169] The prostatic hyperplasia treatment device 1 is prepared in a fully assembled state, sterile packaged, as shown in FIG.
[0170] At this time, as shown enlarged in Figure 10, the anchor assembly 100 is inserted into the needle slot 220 of the needle 200, and the ligature 130 is exposed to the outside through the external needle exposure hole 331 of the blade plate 351 and is prepared in a state where it is housed inside the suture arranger 360.
[0171] The free end 137 of the ligature 130 extending to the rear end of the needle insertion tube 310 passes through a thread indicator 740 as shown in FIG. 10, and is then wound around the outer periphery of the winder shaft 710 of the ligature winder 700.
[0172] In the preparation state before the start of treatment, as shown in FIG. 19(a), the lower locking protrusion 634a of the needle holder 630 is positioned to engage with the upper locking protrusion 647 of the pusher lever 640, restricting the movement of the needle holder 630.
[0173] Since the movement of the needle holder 630 is restricted, the position of the trigger 500 into which the coupling head 531 of the pressing lever 530 coupled between the lever head coupling members 633 of the needle holder 630 is inserted is also fixed.
[0174] The practitioner uses anesthetic jelly to administer local, spinal, or general anesthesia through the urethra. As shown in Figure 23(a), the urethra C is blocked by the enlarged left prostate A and right prostate B.
[0175] The practitioner first inserts the outer sheath S through the urethral opening, and the outer sheath S remains inserted until the end of the procedure.
[0176] The practitioner removes the suture arranger 360 from the needle-accommodating sheath 300 and inserts the needle-accommodating sheath 300 into the urethra C through the already inserted outer sheath S, as shown in Figure 23(b). At this time, the needle 200 is housed in the needle insertion tube 310.
[0177] 19(b), the practitioner pushes upward the pusher lever button 649 exposed to the outside of the handle frame portion 400. When the pusher lever button 649 is pushed upward, the needle holder 630 and the trigger 500 can be moved.
[0178] In this state, the practitioner checks the inside with the transurethral endoscope 800 inserted into the needle-accommodating sheath 300 and confirms the placement positions of the anchors 110 and 120. The placement positions of the anchors 110 and 120 can be confirmed through anatomical points such as the bladder neck and bellmont.
[0179] The needle-containing sheath 300 is angled at 20 degrees or more toward the left lateral lobe of the prostate. This is only an example, and the practitioner has the sole discretion as to whether to perform the procedure left first or right first.
[0180] Then, the practitioner manually pulls the pull lever 520 of the trigger 500, causing the needle holder 630 to move forward by rotating the pressing lever 530 as shown in Figure 19(c), thereby firing the needle 200.
[0181] The practitioner pushes the pull lever 520 until the needle holder 630 moves to the front end or the needle 200 cannot move any further.
[0182] When the needle holder 630 moves forward, the position adjustment tail 623 moves along the position adjustment tooth 641a of the pusher lever bar 641. Then, the pusher holder 620 moves together inside the needle holder 630 until it contacts the pusher block 635 as shown in Figure 20(b) or until the holder hinge 621 engages with the first pusher holder position adjustment protrusion 631b.
[0183] When the needle holder 630 has moved forward to a certain extent, the practitioner may release the hand pressing upward on the pusher lever button 649. When the hand is released, the pusher lever 640 returns to its initial position due to the elastic force of the pusher lever hinge 645.
[0184] The needle 200 is ejected by the forward movement of the needle holder 630 and the pusher holder 620, and as shown in FIG. 23(c), the needle 200 is ejected out of the needle guide member 340, penetrates the prostates A and B, and emerges at the lateral lobe of the prostate.
[0185] At this time, as shown in FIG. 9( a ), the first anchor 110 and the second anchor 120 are housed in the needle slot 220 in this order, and a pusher 610 is inserted into the rear end of the needle 200 .
[0186] In this state, the practitioner presses the ring 510 of the trigger 500 without pressing the pusher lever button 649 upward again to move the needle holder 630, which has been moved forward, backward. At this time, the position of the pusher holder 620 is fixed because the position adjustment tail 623 is hooked on the position adjustment tooth 641a of the pusher lever 640, and only the needle holder 630 is moved backward. Since the position of the pusher 610 is fixed and only the needle 200 is moved backward by the needle holder 630, the first anchor 110 is discharged outside the needle 200 as shown in Figure 9(b).
[0187] The first anchor 110 that has been expelled from the needle 200 is placed on the upper outside of the left prostate gland A, as shown in FIG. 23(d).
[0188] Once the first anchor 110 has been discharged, the pusher lever button 649 is pushed upward, and the ring 510 of the trigger 500 is pressed to move the needle holder 630 completely backward. At this time, the pusher holder 620 is fixed in position within the needle holder 630 by the pusher block 635. Therefore, the pusher 610 and the needle 200 move backward together.
[0189] The needle-accommodating sheath 300 is moved to a position where the second anchor 120 is ejected. Then, the pusher block 635 is pulled to remove it from the handle frame portion 400. Next, the above-described process is repeated to push the pusher lever button 649 upward and pull the pull lever 520 to move the needle holder 630 forward. As a result, the needle 200 is inserted through a lower position of the left prostate A. In this state, the practitioner does not push the pusher lever button 649 upward, but instead pushes the ring 510 of the trigger 500 to move the needle holder 630, which has moved forward, backward.
[0190] 20(c), because the pusher block 635 is removed, the pusher holder 620 moves within the needle holder 630 by a distance d2 to push the second anchor 120. The positions of the pusher holder 620 and the pusher 610 are fixed by the pusher lever 640, and only the needle 200 moves backward by the needle holder 630, so that the second anchor 120 is ejected out of the needle 200. Once the ejection of the second anchor 120 is complete, the pusher lever button 649 is pushed upward, and the ring 510 of the trigger 500 is pressed to move the needle holder 630 completely backward.
[0191] The second anchor 120 expelled from the needle 200 is placed on the lower outer side of the left prostate A, as shown in Figure 24(a). At this time, the first anchor 110 and the second anchor 120 are connected by a ligature 130, and the free end 137 is wound around a ligature winder 700 through the needle insertion tube 310.
[0192] As shown in Figure 24(b), when the first anchor 110 and the second anchor 120 are positioned outside the prostates A and B, the length of the length adjustment loop 133 is not adjusted, so the ligature 130 is positioned loosely and does not compress the prostate tissue.
[0193] The practitioner checks the inside with an endoscope, pulls the thread winder lock release button 730 as shown in Figure 21(a) so that the tooth hook protrusion 733 moves away from the vertical surface 723 of the one-way rotation limiting tooth 720, and rotates the rotation operation knob 715 to wind the free end 137 onto the winder shaft 710.
[0194] The free end 137 is wound around the winder shaft 710, the length of the length adjustment loop 133 is shortened, and the anchor assembly 100 compresses the left prostate gland A. The practitioner checks the scale 413a displayed by the thread indicator 740 as shown in Figure 21(b) to confirm the tension of the free end 137.
[0195] After checking the tension of the free end 137 indicated on the scale 413a and using the transurethral endoscope 800 to confirm the degree to which the anchor assembly 100 is compressing the left prostate A and opening the urethra C, the practitioner presses and rotates the blade lock release lever 429 as shown in Figure 22(b). When the engagement between the blade lock release lever 429 and the hook wing 355a of the blade pressing button 355 is released, the blade pressing button 355 is pressed backward.
[0196] As a result, as shown in FIG. 15(b), the blade plate 351 slides rearward of the internal needle exposure hole 352, and the free end 137 of the ligature 130 is pinched in the blade slit 353 of the blade plate 351, causing the free end 137 to be cut.
[0197] The free end 137 of the cut ligature 130 has a length of less than 1 mm and is embedded in the prostate tissue, thereby completing the procedure in which the anchor assembly 100 compresses the left prostate A and opens the urethra, as shown in Figure 24(c).
[0198] After the practitioner removes the needle-containing sheath 300 from the urethra, he or she uses the new prostatic hyperplasia treatment device 1 to place the anchor assembly 100 in the right prostate B in the same manner as in the left prostate A.
[0199] 24(d), a pair of anchor assemblies 100 are placed in the left prostate A and the right prostate B to open the urethra C. At this time, the anchor assembly 100 continuously compresses the prostate tissue in a U-shaped or elliptical shape connecting the first anchor 110, the second anchor 120, and the ligature 130. This has the advantage that the length l of the urethra C compressed and opened by the ligature 130 can be adjusted, and the compressed width d can also be adjusted.
[0200] As described above, the prostatic hyperplasia treatment device according to the present invention has the advantage that the prostatic tissue compressed by the ligature and the pair of anchors is continuous, compared to conventional treatment methods that compress the prostatic tissue partially, and therefore the urinary flow rate is further increased, which can be more effective for patients with long prostates.
[0201] In addition, the prostate hyperplasia treatment device according to the present invention has the advantage that the surgeon can adjust the length of the ligature by winding the free end of the ligature, thereby adjusting the strength of compression on the prostate as desired by the surgeon.
[0202] This has the effect of making it possible to adjust the degree of compression according to the various symptoms of benign prostatic hyperplasia of each patient.
[0203] The treatment method using the treatment device for benign prostatic hyperplasia of the present invention does not require general anesthesia or long operation time, unlike other laser treatments or electrical surgeries that use thermal energy.
[0204] The simple anchor placement method allows for quick surgery under local anesthesia, and since no prostate tissue is removed, there are no side effects such as retrograde ejaculation, erectile dysfunction, or hematuria. Furthermore, because it is non-invasive, there is the added benefit of being able to undergo additional surgery at any time if the procedure proves ineffective.
[0205] The technical concept of the present invention has been explained above through several embodiments.
[0206] It is clear that a person skilled in the art to which the present invention pertains can make various modifications or changes to the above-described embodiments from the description of the present invention. Furthermore, even if not explicitly shown or described, it is clear that a person skilled in the art to which the present invention pertains can make various modifications including the technical idea of the present invention from the description of the present invention, and such modifications still fall within the scope of the present invention. The above-described embodiments described with reference to the accompanying drawings are for the purpose of explaining the present invention, and the scope of the present invention is not limited to these embodiments.
Claims
1. a plurality of anchors (110, 120) positioned on the prostate gland to compress the urethra; a ligature (130) that connects the plurality of anchors (110, 120) to each other so that the plurality of anchors continuously compress the prostate tissue and secure the prostatic urethra; an elastic needle (200) that houses the anchors (110, 120) and the ligature (130) therein and is inserted into the urethra to guide the anchors (110, 120) and the ligature (130) so that they are placed in the prostate; and a needle firing means for firing the needle (200) so that the needle (200) is inserted into the urethra and for discharging the plurality of anchors (110, 120) and the ligature (130) through the needle (200).
2. When the plurality of anchors (110, 120) are a pair of a first anchor (110) and a second anchor (120), the first anchor (110) is fixed to an upper outer side of the prostate gland, and the second anchor (120) is fixed to a lower outer side of the prostate gland; 2. The treatment device for benign prostatic hyperplasia according to claim 1, wherein the ligature (130) comprises: a fixed end (131) fixed to the first anchor (110); a length-adjustable loop (133) connected to the second anchor (120) and capable of adjusting its length; a slip knot (135) connecting the fixed end (131) and the length-adjustable loop (133); and a free end (137) extending from the length-adjustable loop (133).
3. When the plurality of anchors (110, 120) are a pair of a first anchor (110) and a second anchor (120), the first anchor (110) is fixed to an upper outer side of the prostate gland, and the second anchor (120) is fixed to a lower outer side of the prostate gland; 2. The treatment device for benign prostatic hyperplasia according to claim 1, wherein the ligature (130) includes a length-adjustable loop (133) connected to both the first anchor (110) and the second anchor (120) and capable of adjusting its length, and a free end (137) forming the length-adjustable loop (133) and a slip knot (135) connected to the fixed end (131) and supporting the length-adjustable loop (133) so that the length can be adjusted.
4. When the plurality of anchors (110, 120) are a pair of a first anchor (110) and a second anchor (120), the first anchor (110) is fixed to an upper outer side of the prostate gland, and the second anchor (120) is fixed to a lower outer side of the prostate gland; The ligature (130) includes a fixation knot (131 a) fixed to the first anchor (110) and a free end (137) extending from the fixation knot (131 a) via the second anchor (120); 2. The treatment device for benign prostatic hyperplasia according to claim 1, further comprising a lock anchor (150) coupled to the free end (137) at the lower inside of the prostate to fix the position of the free end (137).
5. When the plurality of anchors (110, 120) are three, namely, a first anchor (110), a second anchor (120), and a third anchor (140), the first anchor (110) is fixed to the upper outer side of the prostate, the second anchor (120) is fixed to the central outer side of the prostate, and the third anchor (140) is fixed to the lower outer side of the prostate; The ligature (130) includes a fixed end (131) fixed to the first anchor (110) and a free end (137) extending from the fixed end (131) via the second anchor (120) and the third anchor (140); 2. The treatment device for benign prostatic hyperplasia according to claim 1, further comprising a lock anchor (150) coupled to the free end (137) at the lower inside of the prostate to fix the position of the free end (137).
6. 2. The treatment device for benign prostatic hyperplasia according to claim 1, wherein when the plurality of anchors (110, 120) are a pair of a first anchor (110) and a second anchor (120), the first anchor (110) is fixed to the outer side of the center of the prostate, and the second anchor (120) is fixed opposite the first anchor (110) to the inner side of the center of the prostate.
7. The needle firing means a needle-receiving sheath (300) for accommodating the needle (200); a needle operating unit (600) for operating the movement of the needle (200) so that the needle (200) is discharged through the end of the needle accommodating sheath (300); A trigger (500) that is grasped and operates the needle operating portion (600) so that the needle (200) is fired; 7. The prostatic hyperplasia treatment device according to claim 1, further comprising a handle frame portion (400) that supports the rear end of the needle accommodating sheath (300), the needle operating portion (600), and the trigger (500).
Citation Information
Patent Citations
Anchor delivery system
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Prostate hyperplasia treatment device
JP2023525999A