A prostate enlargement treatment device using anchor assembly and needle

Abstract

This invention discloses a treatment device for benign prostatic hyperplasia that utilizes an anchor assembly and a needle. [Solution] The prostate enlargement treatment device according to the present invention includes a plurality of anchors positioned outside the prostate to compress the urethra, and a ligature that connects the plurality of anchors to each other so that the plurality of anchors continuously compress the prostate tissue to secure the prostatic urethra. The device may further include an elastic needle that houses the anchors and the ligature and guides them into the urethra so that they are placed in the prostate, and a needle launching means that launches the needle so that it is inserted into the urethra and is operated so that the plurality of anchors and the ligature are discharged through the needle.

Description

Technical Field

[0001] The present invention relates to a surgical device for benign prostatic hyperplasia, and more particularly to a surgical device for benign prostatic hyperplasia that can continuously open the prostatic urethra after compressing the enlarged prostate using an anchor assembly and then installing it.

Background Art

[0002] Generally, benign prostatic hyperplasia is a condition in which the prostate becomes abnormally enlarged, blocking the prostatic urethra through which urine in the lower part of the bladder passes, causing urethral obstruction and making it impossible to smoothly discharge urine.

[0003] When benign prostatic hyperplasia occurs, symptoms such as frequent urination, nocturia, urgency, thin 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 benign prostatic hyperplasia as shown in FIG. 1 is performed.

[0005] When benign prostatic hyperplasia occurs, as shown in FIG. 1(a), a pair of prostates A and B on both sides of the urethra become enlarged and block the urethra C. The operator inserts a cystoscope 10 into the urethra as shown in FIG. 1(b), penetrates a medical ligator 11 through the prostates A and B with the end of the cystoscope 10 as shown in FIG. 1(c), then implants a first implant 20 on the upper part of the left prostate A as shown in FIG. 1(d), and implants a second implant 20a on the upper part of the right prostate B as shown in FIG. 1(e).

[0006] Also, as shown in FIG. 1(f), a third implant 20b and a fourth implant 20c are respectively implanted on the lower parts of the left prostate A and the right prostate B.

[0007] At this time, each implant 20, 20a, 20b, and 20c is connected by a ligature thread 25 to an outer implant 21 positioned outside of prostates A and B and an inner implant 23 positioned on the urethral side. The inner implant 23 compresses prostates A and B outward by the length of the ligature thread 25, opening the urethra.

[0008] However, this conventional method of treating benign prostatic hyperplasia has limitations, as the area of ​​prostatic tissue that can be compressed using a single implant 20 is limited by the size of the inner implant 23.

[0009] Furthermore, because there is a gap between the upper implant 20 and the lower implant 20b, the area a between the upper medial implant and the lower medial implant is not compressed, and the enlarged state toward the urethra remains, and the compressed prostatic tissue is not continuous, with a limit to the portion that is only partially compressed in contact with the medial implant 23. [Overview of the project] [Problems that the invention aims to solve]

[0010] The object of the present invention is to solve the above problems and to provide a prostate enlargement treatment device that can adjust the compression area by a pair of anchors positioned above and below the prostate and connected to each other by ligature.

[0011] Another object of the present invention is to provide a prostate enlargement treatment device that can continuously compress the prostate gland according to the size of the prostate gland for each patient by adjusting the length of the ligament connecting a pair of anchors.

[0012] Another object of the present invention is to provide a prostate enlargement treatment device that can continuously compress the prostate by launching anchor assemblies into the prostate in various forms using elastic needles and needle launching means. [Means for solving the problem]

[0013] The above-mentioned objectives of the present invention are achieved by a prostate enlargement treatment device using an anchor assembly and a needle. The prostate enlargement treatment device of the present invention includes a plurality of anchors positioned in the prostate to compress the urethra, and ligature threads that connect the plurality of anchors to each other so that the plurality of anchors continuously compress the prostate tissue and secure the prostatic urethra.

[0014] Furthermore, it is desirable to include an elastic needle that houses the anchors and ligatures inside and is inserted into the urethra to guide the anchors and ligatures so that they are placed in the prostate gland, and a needle launching means that launches the needle so that it is inserted into the urethra and is operated so that the plurality of anchors and ligatures are discharged through the needle. [Effects of the Invention]

[0015] The prostate enlargement treatment device according to the present invention has the advantage of faster urine flow compared to conventional treatment methods that partially compress the prostate tissue, because the prostate tissue compressed by the ligation suture and pair of anchors is continuous, which can show a greater effect in patients with longer prostates.

[0016] Furthermore, the prostate enlargement treatment device according to the present invention has the advantage that the practitioner can adjust the strength of the compression applied to the prostate as desired by winding up the free end of the ligation thread and adjusting the length of the ligation thread.

[0017] This allows for adjustment of the degree of compression according to the various symptoms of benign prostatic hyperplasia experienced by each patient.

[0018] The treatment method using the benign prostatic hyperplasia treatment device of the present invention does not require general anesthesia or a long surgery, unlike other laser treatments or electrical surgeries that utilize thermal energy.

[0019] A simple anchor installation method enables short operation time and local anesthesia, and does not excise prostate tissue, so there are no side effects such as retrograde ejaculation, erectile dysfunction or hematuria. In addition, because it is non-invasive, there is an advantage that other surgeries can be added at any time even if there is no effect.

Brief Description of the Drawings

[0020] [Figure 1] It is an exemplary diagram showing a conventional surgical method for benign prostatic hyperplasia. [Figure 2] It is a perspective view showing the configuration of a surgical device for benign prostatic hyperplasia according to the present invention. [Figure 3] It is an exemplary diagram showing the configuration of an anchor assembly according to a preferred embodiment of a surgical device for benign prostatic hyperplasia according to the present invention. [Figure 4] It is an exemplary diagram showing a state where the anchor assembly of the preferred embodiment of FIG. 3 is installed in the left prostate. [Figure 5] It is an exemplary diagram showing the configuration of an anchor assembly according to a modified example of a surgical device for benign prostatic hyperplasia according to the present invention. [Figure 6] It is an exemplary diagram showing the configuration of an anchor assembly according to a modified example of a surgical device for benign prostatic hyperplasia according to the present invention. [Figure 7] It is an exemplary diagram showing a state where the anchor assembly according to the modified example is installed in the left prostate. [Figure 8] It is an exemplary diagram showing a state where the anchor assembly according to the modified example is installed in the left prostate. [Figure 9] It is an exemplary diagram showing the process of the anchor assembly of the present invention being fired after being housed in a needle. [Figure 10] It is a cross-sectional exemplary diagram showing the side cross-sectional configuration of a surgical device for benign prostatic hyperplasia according to the present invention before the trigger operates. [Figure 11] It is a cross-sectional exemplary diagram showing the side cross-sectional configuration of a surgical device for benign prostatic hyperplasia according to the present invention after the trigger is pulled. [Figure 12] It is an exploded perspective view showing the configuration of a surgical device for benign prostatic hyperplasia according to the present invention disassembled. [Figure 13]This is an exploded perspective view showing the configuration of the needle guide sheath of the prostate enlargement treatment device according to the present invention. [Figure 14] This is an exploded perspective view showing the coupling structure between the needle guide member and the blade portion of the prostate enlargement treatment device according to the present invention. [Figure 15] This is an illustrative diagram showing the operation process of the blade portion of the prostate enlargement treatment device according to the present invention. [Figure 16] This is an internal perspective view showing the connection between the needle operating section and the ligation thread winder of the prostate enlargement treatment device according to the present invention. [Figure 17] This is an exploded perspective view showing the components of the needle operating section and the ligation thread winder in disassembled form. [Figure 18] This is an exploded perspective view showing the components of the needle operating section and the ligation thread winder in disassembled form. [Figure 19] This is a side view illustrating the operation process of the needle control unit related to the trigger's operation. [Figure 20] This is a plan view illustrating the operation process of the needle operating part related to the trigger's operation. [Figure 21] This is a diagram showing the configuration of the ligation thread winder in the prostate enlargement treatment device according to the present invention. [Figure 22] This is an illustrative diagram showing the operation process of the blade pressing button and cover of the prostate enlargement treatment device according to the present invention. [Figure 23] This is an illustrative diagram showing various shapes of anchor assemblies installed in the left prostate gland. [Figure 24] This is an illustrative diagram showing various shapes of anchor assemblies installed in the left prostate gland. [Modes for carrying out the invention]

[0021] The present invention will be described in detail below with reference to preferred embodiments and accompanying drawings, assuming that the same reference numerals in the drawings refer to the same components.

[0022] Whenever the detailed description of an invention or the claims state that any component "encompasses" other components, this should not be interpreted as limiting the composition to that component alone, unless otherwise stated, but rather as further encompassing other components.

[0023] Figure 2 is a perspective view showing the configuration of the prostate enlargement treatment device according to the present invention, Figure 3 is an illustrative diagram showing the configuration of an anchor assembly according to a preferred embodiment of the prostate enlargement treatment device according to the present invention, and Figure 4 is an illustrative diagram showing the state in which the anchor assembly 100 of the preferred embodiment is installed in the left prostate A and B.

[0024] The prostate enlargement treatment device 1 according to the present invention includes an anchor assembly 100 positioned outside the prostate to compress the prostatic urethra, an elastic needle 200 that houses the anchor assembly 100 and guides it to be inserted into the urethra so that it is placed in the prostate, and a needle firing means that fires the needle 200 so that it is inserted into the urethra and operates so that the anchor assembly 100 is discharged through the needle 200.

[0025] Here, the anchor assembly 100 includes a plurality of anchors 110, 120 positioned spaced apart from each other on the outside of the prostate, as shown in Figure 3(a), and ligature threads 130 that connect the plurality of anchors 110, 120 to each other so that the plurality of anchors continuously compress the prostatic tissue and secure the prostatic urethra.

[0026] The prostate enlargement treatment device 1 according to the present invention allows a pair of anchors 110 and 120 and a ligature thread 130 to be positioned at the desired location using a needle launching means, and the length of the ligature thread 130 to be adjusted using a ligature thread winder 700 provided on the needle launching 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 has the advantage of being able to adjust the compression length and thickness of the prostate according to the symptoms of prostate enlargement for each patient, and can speed up urine flow.

[0027] The anchor assembly 100 is placed on the external surface of the prostate gland of the patient to compress the prostate gland and open the urethra. In the benign prostatic hyperplasia treatment device 1 of the present invention, the treatment is completed when a pair of anchor assemblies 100 are placed on the left prostate A and the right prostate B, respectively.

[0028] Figure 3(a) shows the configuration of one anchor assembly 100, Figure 3(b) is an exploded perspective view showing the configuration of the anchor assembly 100 in disassembled form, Figure 3(c) shows the state in which the free end 137 of the anchor assembly 100 is pulled, and Figure 4 is an illustrative diagram showing the state of the anchor assembly 100 before it is installed in the left prostate A and its length is adjusted.

[0029] As shown in Figures 3(a) and 3(b), the anchor assembly 100 includes a first anchor 110 and a second anchor 120, and a ligating thread 130 connecting the first anchor 110 and the second anchor 120 to each other. Since the first anchor 110 and the second anchor 120 are formed in the same shape, differing only in their placement, 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 semicircular tube in cross-section, and a first thread connecting ring 115 formed as a projection in the central region of the first anchor body 111 to which the ligating thread 130 is attached.

[0031] The first anchor body 111 is provided with a first thread-receiving groove 113 formed along its length, which accommodates the ligating thread 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 provided as a horizontally formed horizontal end 111a, and the other end is provided as a bent end 111b bent with a constant curvature. The reason the other end of the first anchor body 111 is provided as a bent end 111b is to ensure stable positioning when the first anchor 110 or the second anchor 120 is installed in the prostate A and B, as shown in Figure 4.

[0032] The bent end 111b causes the first anchor 110 to bend relative to the outer surface of the prostate while penetrating the prostatic tissue, preventing the first anchor 110, located on the outer surface of the prostate, from being moved back into the hole in the prostate formed by the needle 200.

[0033] In other words, as shown in Figure 4, when the needle 200 penetrates the prostate A during the procedure and the first anchor 110 is discharged to the outside of the prostates A and B, the first anchor 110 is bent elastically, with its bent end 111b bending. The first anchor 110, bent in this way, catches in the through hole formed by the needle 200, preventing it from moving in the opposite direction, and it can stably sit on the surface of the prostate A.

[0034] The horizontal end 111a is provided with an inclined contact end 111a-1, which is formed at an angle, so that the first anchor 110 can make close contact with the surfaces of the prostate A and B in accordance with their curvature.

[0035] The first thread connecting ring 115 supports the ligating thread 130 inserted into the first thread receiving groove 113 so that it is either tied and fixed in place by a knot or tied to the first thread connecting ring 115 itself, thereby fixing its position. The first thread connecting ring 115 ensures that the first anchor 110 and the ligating thread 130 remain fixed together.

[0036] The first anchor 110 and the second anchor 120 are in a bent state at their bent ends 111b and 121b, respectively. However, as shown in Figure 9(a), when they are housed inside the needle 200, they are elastically deformed to conform to the shape of the needle 200. As shown in Figure 9(b), when they are discharged from the needle 200, the bent ends 111b and 121b of the anchors 110 and 120 elastically return to their original bent state.

[0037] The ligature thread 130 connects the first anchor 110 and the second anchor 120 to each other in an adjustable length manner, so that the first anchor 110 and the second anchor 120 do not independently compress specific parts of the prostate, but rather the arc or "U" shaped line connected by the first anchor 110, the second anchor 120 and the ligature thread 130 continuously compresses the prostate tissue.

[0038] As shown in Figure 3(b), the ligating thread 130 includes a fixed end 131 connected to the first anchor 110, a length adjustment loop 133 connected to the second anchor 120, a free end 137 connected to the end of the length adjustment loop 133, and a slipknot 135 connecting the free end 137 and the length adjustment loop 133.

[0039] The fixed end 131 is inserted into the first thread connecting ring 115 of the first anchor 110, forming a fixed knot 131a. The fixed knot 131a is tied at a position higher than the first thread connecting ring 115 and catches on the first thread connecting ring 115, preventing the fixed end 131 from moving from one side to the other of the first thread connecting ring 115.

[0040] The length adjustment loop 133 is inserted into the second thread connecting ring 125 of the second anchor 120, and then discharged to the opposite side to form a loop shape. The length adjustment loop 133 is formed between the fixed end 131 and the free end 137 by a slip knot 135.

[0041] As shown in Figure 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 the length of the length adjustment loop 133 is shortened, and these come into pressure on the prostate tissue they surround.

[0042] As shown in Figure 4, when the first anchor 110 and the second anchor 120 are positioned outside the prostate A, the ligature thread 130 is loosely positioned. In this state, when the practitioner operates the needle launching device and pulls the ligature thread 130, the length of the free end 137 shortens, the length adjustment loop 133 shortens, and the ligature thread compresses the prostate A.

[0043] In other words, as shown in Figure 24(b), when the first anchor 110 and the second anchor 120 are positioned outside the prostate, the ligature thread 130 is loosely connected. After the practitioner pulls the free end 137 using the needle launching device and tightens the ligature thread 130, as shown in Figure 24(c), the first anchor 110, the second anchor 120, and the ligature thread 130 continuously surround and compress the prostate A. Because the first anchor 110 and the second anchor 120 are connected by the ligature thread 130, the space between the first anchor 110 and the second anchor 120 is also continuously compressed, and the urethra C is opened.

[0044] On the other hand, Figure 5(a) is a diagram showing the configuration of the anchor assembly 100a according to the first modified example, and Figure 5(b) is an illustrative diagram showing the state in which the free end of the anchor assembly 100a according to the first modified example is pulled out.

[0045] In the preferred embodiment described above, the anchor assembly 100 has the fixed end 131 of the ligating thread 130 fixed to the first anchor 110, and the length adjustment loop 133 connected to the second anchor 120.

[0046] On the other hand, 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 preferred embodiment, the anchor assembly 100 has a fixed end 131 that is fixed to the first anchor 110, so the length (l2) from the fixed end 131 to the slipknot 135 is fixed. As a result, as shown in Figure 3(c), even if the free end 137 is pulled, there is a constraint that the distance (l1) between the first anchor 110 and the second anchor 120 will not decrease until they come into contact with each other.

[0048] On the other hand, in the anchor assembly 100a according to the first modified example, when the free end 137 is pulled, as shown in Figure 5(b), the distance (l3') can be reduced until the first anchor 110 and the second anchor 120 come into contact with each other. This has the advantage that it is easy for the operator to adjust the distance between the first anchor 110 and the second anchor 120.

[0049] Figure 7(b) is an illustrative diagram showing the anchor assembly 100a according to the first modified example installed in the prostates A and B. As shown, the first anchor 110 and the second anchor 120 are connected to the outer surfaces of the prostates A and B, and the ligature thread 130 is positioned on the urethral side to open the urethra.

[0050] On the other hand, Figure 6(a) is an illustrative diagram showing the configuration of an anchor assembly 100b according to a second modified example. The anchor assembly 100b according to the second modified example has a first anchor 110, a second anchor 120, and a third anchor 140, as shown in the figure. In the anchor assembly 100b according to the second modified example, three or more anchors 110, 120, and 140 are connected to a ligating thread 130 at regular intervals, and a lock anchor 150 is connected to the free end 137.

[0051] The fixed end 131 is secured to the first anchor 110 with a fixing knot 131a, and the second anchor 120 and the third anchor 140 are sequentially joined along the path of the ligature thread 130. Figure 7(d) is an illustrative diagram showing the state in which the anchor assembly 100b according to the second modified example is installed in the prostate A and B.

[0052] As shown, three anchors 110, 120, and 140 are sequentially placed around the outer circumference of prostates A and B, and these are connected by ligature threads 130 that penetrate through prostates A and B. Then, on the urethral side, a lock anchor 150 is positioned opposite the last anchor 140, fixing the position of the free end 137.

[0053] The lock anchor 150 is made of a plate-like material and has a "V"-shaped thread guide groove at its tip. The shape of the thread guide groove of the lock anchor 150, which gradually narrows, causes the free end to be held in the thread guide groove and fixed in position.

[0054] The shape of the lock anchor 150 can be changed to various shapes within the range that allows the position of the free end 137 to be fixed.

[0055] On the other hand, Figure 6(b) is an illustrative diagram showing the configuration of the anchor assembly 100c according to the third modified example. In the anchor assembly 100c according to the third modified example, the first anchor 110 and the second anchor 120 are sequentially connected to the ligating thread 130 without the length adjustment loop 133, and a lock anchor 150 is provided at the end. The first anchor 110 is then fixed by the fixed end 131 and the fixing loop 132 of the ligating thread 130.

[0056] In this case, the anchors can be installed in prostates A and B as shown in Figure 7(c). When multiple anchors 110 and 120 are sequentially attached to the ligature thread 130 without the length adjustment loop 133, as in the second and third modifications, the lock anchor 150 fixes the position of the free end 137. While the length adjustment loop 133 is constrained to prostates A and B by the slip knot 135, in the absence of the length adjustment loop 133, the free end is held in place by the thread guide groove of the lock anchor 150.

[0057] On the other hand, Figure 6(c) is an illustrative diagram showing the configuration of an anchor assembly 100d according to the fourth modified example, in which the first anchor 110 and the second anchor 120 are arranged facing each other. The ligating thread 130 has a length adjustment loop 133 attached to the first anchor 110, then it is inserted into the ligating thread through bridge 127 of the second anchor 120 and joined at the bottom of the second anchor 120 with a slipknot 135. Both the free end 137 and the fixed end 131 are joined to the slipknot 135.

[0058] As shown in Figure 8, the anchor assembly 100d according to the fourth modified example has the first anchor 110 and the second anchor 120 positioned facing each other on the outside and inside of the prostate A and B. This differs from the anchor assemblies 100, 100a, 100b, and 100c of the previously described embodiments, in which the anchors 110 and 120 were positioned on the outside of the prostate A and B.

[0059] When the operator manipulates the free end 137 to shorten its length, the length adjustment loop 133 becomes shorter, causing the second anchor 120 to compress the prostate A and B tissues and open the urethra.

[0060] On the other hand, here the slipknot 135 is located below the second anchor 120, but in some cases the slipknot 135 may be located between the first anchor 110 and the second anchor 120.

[0061] The anchor assembly 100 of the present invention is housed inside an elastic needle 200 and inserted into the prostates A and B. By operating the needle launching means, it is ejected from the needle 200 and installed outside the prostates A and B.

[0062] Figure 9(a) is an illustrative diagram showing the anchor assembly 100 housed in the needle 200, and Figure 9(b) is an illustrative diagram showing the first anchor 110 discharged from the needle 200.

[0063] Figure 10 is a cross-sectional example showing the state of the needle 200 before it is launched from the needle launching means, Figure 11 is a cross-sectional example showing the state of the needle 200 after it has been launched from the needle launching means, and Figure 12 is an exploded perspective view showing the configuration of the needle launching means in an exploded state.

[0064] The needle launching means refers to the configuration obtained by removing the anchor assembly 100 and the needle 200 from the benign prostatic hyperplasia treatment device 1. The needle launching means can be transformed into various forms that allow the anchor assembly 100 and the needle 200 to be launched and placed in the prostate by the operator's operation.

[0065] A needle firing means according to a preferred embodiment of the present invention includes: a needle housing sheath 300 that houses a needle 200 and guides the needle 200 so that it is inserted into the urethra and the anchor assembly 100 is placed in the prostate; a needle operating unit 600 that operates the movement of the needle 200 so that the needle 200 is discharged through the tip of the needle housing sheath 300; a ligature winder 700 provided on one side of the needle operating unit 600 that winds the free end 137 of the ligature thread 130 to adjust the strength with which the anchor assembly 100 compresses the prostate; a handle frame 400 that houses the rear end of the needle housing sheath 300, the needle operating unit 600 and the ligature winder 700 and is held by the operator's hand; and a trigger 500 coupled to the handle frame 400 for the operator to operate the firing of the needle 200.

[0066] The needle 200 is provided in the form of a tube of a certain length and is inserted into the needle insertion tube 310 of the needle housing sheath 300 as shown in Figure 10. When the practitioner operates the trigger 500 with the needle 200 inserted into the needle insertion tube 310, it bends at a certain angle along the needle guide member 340 and is inserted into the inside of the prostate A and B.

[0067] The needle 200 can be made of metal or a metal alloy, and is preferably made of nitinol. The needle 200 is manufactured to have a bendable tip and, when housed in the needle insertion tube 310 as shown in an enlarged view in Figure 10, maintains an elastically bent shape due to the curvature of the needle guide member 340.

[0068] When the trigger 500 fires and the needle 200 is ejected from the needle guide member 340, the ejection angle is adjusted by the needle guide member 340, as shown in the enlarged view of Figure 11, and the needle bends to match the curvature at the time of manufacture.

[0069] The tip 210 of the needle 200 is sharply formed to facilitate insertion into prostate A and B tissues. Additionally, a needle slot 220 is formed inward from the needle tip 210 of the needle 200 for a certain length. The needle slot 220 exposes the ligature thread 130 of the anchor assembly 100 housed inside.

[0070] The length of the needle slot 220 is the sum of the lengths of the first anchor 110 and the second anchor 120, or shorter, so that the ligating thread 130 does not interfere with the launch of the anchors 110 and 120.

[0071] Figure 13 is an exploded perspective view showing the coupling process of the needle housing sheath 300 and the needle operating section 600, and Figure 14 is an illustrative diagram showing the coupling process of the sheath body 300a, the needle guide member 340 and the suture arranger 360.

[0072] The needle housing sheath 300 houses the needle 200 and the transurethral endoscope 800, and guides the anchor assembly 100 to the prostate A and B through the needle 200, thereby fixing the position of the anchor assembly 100. The rear end of the needle housing sheath 300 is connected to the handle frame 400, and the tip extends a certain length from the handle frame 400 and is inserted into the urethra C through the outer sheath S.

[0073] As shown in Figures 23 and 24, the operator inserts a transurethral endoscope 800 into a needle-retaining sheath 300 inserted into the urethra C through an outer sheath S to visualize the inside of the prostate, and manipulates the needle 200 so that it penetrates prostates A and B and a pair of anchors 110 and 120 are positioned outside prostates A and B.

[0074] As shown in Figures 12 and 13, the needle housing sheath 300 includes a sheath body 300a formed by integrally connecting a needle insertion tube 310, an endoscope insertion tube 320, and a blade transfer tube 330; a needle guide member 340 provided at the tip of the sheath body 300a for guiding the needle 200 to the prostate A and B sides; a blade portion 350 provided to be movable back and forth inside the blade transfer tube 330 for cutting the free end 137 of the ligation thread 130; a suture arranger 360 for arranging the ligation thread 130 protruding from the outside of the needle 200; a sheath cylinder 370 for connecting the sheath body 300a to the handle frame portion 400; and a sheath lock button 380 for fixing the outer sheath S to the sheath cylinder 370.

[0075] The needle insertion tube 310 houses the needle 200 inside, and the endoscope insertion tube 320 is integrally connected to the lower part of the needle insertion tube 310 and houses the transurethral endoscope 800 inside. The blade axis moving tube 330 is integrally connected to the lower part of the endoscope insertion tube 320 and movably houses the blade plate connecting shaft 354 and the blade support plate 357 of the blade section 350 inside.

[0076] As shown in an enlarged view in Figure 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 axis transfer tube 330 houses the blade plate connecting shaft 354 and the blade support plate 357. The needle insertion tube 310 and the endoscope insertion tube 320 are provided in the form of hollow tubes, and the blade axis transfer 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 Figure 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 connected to the pusher holder 620, and the pusher 610 moves back and forth inside the needle 200 by the operator's back and forth operation of the pusher holder 620, so as to discharge the anchor assembly 100.

[0078] Furthermore, the endoscope insertion tube 320 is formed to be longer than the needle insertion tube 310 and the blade axis 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 connected to the tip of the needle insertion tube 310 and the blade axis moving tube 330.

[0080] Here, the benign prostatic hyperplasia treatment device 1 of the present invention is assembled into a fully assembled form as shown in Figure 1, then sterilized and packaged before being supplied to the hospital. This eliminates the need for the practitioner to disassemble and assemble each part, and allows them to operate the device in its assembled state during treatment, thus improving ease of use.

[0081] Figure 15 is an illustrative diagram 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 connected to the needle insertion tube 310 and the upper part of the guide body 341 by the sheath fixing member 347. A needle exposure hole 345 is formed between the sheath fixing member 347 and the blade axis moving tube 330, exposing the needle 200 to the outside. The transurethral endoscope 800, which has been moved into the endoscope insertion tube 320, can be exposed inside the urethra C through the needle exposure hole 345.

[0083] Furthermore, as shown in an enlarged view in Figure 10, the ligation thread 130 housed in the needle 200 is exposed to the outside through the needle exposure hole 345, allowing the ligation thread 130 to be moved to prostate A and B without interference.

[0084] A needle guide curved surface 343 is formed on the upper inner wall of the guide body 341 that forms the needle exposure hole 345, to guide the needle 200 into the urethra C. Initially, the needle 200 is positioned inside the needle insertion tube 310 as shown in Figure 10, and when the operator operates the trigger 500, a certain length is exposed to the outside through the needle guide member 340 as shown in Figure 11.

[0085] At this time, the needle 200 bends at a certain angle along the curved surface of the needle guide surface 343 and moves through the prostate A and B.

[0086] The blade section 350 is movably mounted inside the blade axis moving tube 330, and after the first anchor 110 and the second anchor 120 are installed in the prostate A and B, it is operated by the operator to cut the ligature thread 130.

[0087] As shown in Figure 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 which is fixedly connected parallel to the upper part of the blade plate connecting shaft 354 and supports the blade plate connecting shaft 354.

[0088] A vertical coupling end 354a formed at the rear end of the blade plate connecting shaft 354 is connected to a blade pressing button 355, and the user cuts the ligating thread 130 by moving the blade pressing button 355 back and forth.

[0089] An external needle exposure hole 331 is provided at the tip of the blade axis moving tube 330, and an internal needle exposure hole 352 is formed in the blade plate 351. As shown in Figure 15(a), the external needle exposure hole 331 and the internal needle exposure hole 352 are formed to overlap, and the needle 200 is discharged through the external needle exposure hole 331, and a pair of anchors 110 and 120 and ligature thread 130 are installed in the prostate A and B.

[0090] A blade slit 353 is formed in the blade plate 351. The blade slit 353 is formed to gradually narrow in width, with opposing inner ends that are sharply formed. When the operator pulls the blade pressing button 355 backward, as shown in Figure 15(b), the blade plate 351 is pulled, and the free end 137 of the ligature thread 130 is caught in the blade slit 353 and cut.

[0091] The blade pressing button 355 and cover 356 are used by the operator to cut the free end 137 of the ligature thread 130. Figure 22(a) is an illustrative diagram showing the blade pressing button 355 and cover 356 connected to the vertical coupling end 354a, and Figure 22(b) is an illustrative diagram 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 downwardly protruding hook wing 355a is provided behind the blade pressing button 355. The hook wing 355a contacts the blade lock release lever 429 provided on the handle frame 400, thereby restraining its position. When the operator wants to cut the free end 137, they must pull the blade lock release lever 429 in the direction of the arrow to release the contact with the hook wing 355a and pull the blade pressing button 355 backward.

[0094] Meanwhile, the suture arranger 360, as shown in Figure 10, arranges the complex ligature thread 130 that is exposed outside the external needle exposure hole 331 so as not to interfere with the discharge path of the needle 200.

[0095] As shown in Figure 14, the suture arranger 360 includes an arranger body 361 which is open at the top and inserted into the sheath body 300a, a handle 363 which extends vertically from the bottom of the arranger body 361, and a sheath housing passage 365 formed inside the arranger body 361.

[0096] When the benign prostatic hyperplasia treatment device 1 is first packaged, the suture arranger 360 is attached to the tip of the sheath body 300a, as shown in Figure 10, and the ligation thread 130 is neatly housed inside the sheath body 300a.

[0097] When the operator prepares to install the anchor assembly 100 into the prostate A and B, the operator grasps the handle 363 and pushes 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 and the handle frame portion 400. As shown in Figure 12, sheath coupling member insertion grooves 425 are formed at the ends of the right frame 410 and the left frame 420, and the sheath cylinder 370 into which the sheath body 300a is inserted is coupled to the handle frame portion 400 as shown in Figure 10.

[0099] In this state, the sheath lock button 380 is inserted into the tip of the sheath cylinder 370, fixing 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 is formed to extend 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] The sheath lock button 380 is equipped with a fixing projection 381 inside which it is inserted and connected to the sheath coupling tube 371, thereby fixing the position of the sheath lock button 380.

[0101] The handle frame 400 is connected to the rear of the needle housing sheath 300 as shown in Figures 2 to 4, and houses the trigger 500, the needle operating section 600, and the ligation thread winder 700. The handle frame 400 allows the operator to operate the needle housing sheath 300 and the needle operating section 600 while holding it in their hand, inserting the needle housing sheath 300 into the urethra and adjusting the position of the needle 200 and the anchor assembly 100 in order to place the anchor assembly 100 in the prostate.

[0102] The handle frame section 400 is formed by detachably connecting the left frame 420 and the right frame 410, which are positioned on the left and right sides of the device. The left frame 420 and the right frame 410 together form a gun shape that can be held in the hand.

[0103] The left frame 420 and the right frame 410 are formed in a symmetrical manner, but their configurations will be explained separately, based on Figure 12.

[0104] A trigger ring housing groove 411 is formed at the lower part of the plate surface of the right frame 410, which houses the ring 510 of the trigger 500. Then, from the upper part of the plate surface, a thread winder housing groove 412, an indicator housing groove 413, a pusher lever button housing 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 thread manual cutting slit 418 are formed, respectively.

[0105] The left frame 420 is equipped with a needle operating section housing groove 421, a trigger pivot shaft 423, a lock release button engagement end 422, a sheath coupling member insertion groove 425, an indicator coupling shaft 427, a pusher lever pivot shaft coupling tube 428, and a blade lock release lever 429.

[0106] An endoscope fixing member 430 is detachably attached to the rear of the left frame 420 and the right frame 410. The transurethral endoscope 800 is inserted into the endoscope insertion tube 320 through the endoscope fixing member 430.

[0107] As shown in Figure 2, the winder shaft 710 of the ligation thread winder 700 is rotatably inserted into the thread winder housing groove 412 of the right frame 410, supporting the winding and unwinding of the ligation thread 130 wound around its circumference. The thread indicator 740 of the ligation thread winder 700 is movably coupled to the indicator housing groove 413, which displays the current tension of the free end 137 of the ligation thread 130 externally. A scale 413a is provided along the length of the lower part of the indicator housing groove 413, allowing the operator to accurately confirm the tension of the free end 137 with the naked eye.

[0108] The pusher lever button housing groove 414 is equipped with a pusher lever button 649 of the pusher lever 640 that can rotate up and down. Before moving the needle holder 630 forward, the practitioner rotates the pusher lever button 649, which protrudes from the pusher lever button housing groove 414 of the right frame 410, upward. This related operation will be explained 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 press the pusher holder 620 when the needle 200 is not being fired. The pusher block movement slit 416 is into which both ends of the pusher block 635 of the needle holder 630 are inserted. The practitioner can adjust the position of the pusher block 635 by manually pressing the pusher block 635 that protrudes from both sides of the pusher block movement slit 416.

[0110] The blade press button retraction slit 417 accommodates both ends of the blade press button 355. The operator pulls the blade press button 355, which is exposed to the outside through the blade press button retraction slit 417, backward so that the blade slit 353 of the blade plate 351 cuts the free end 137.

[0111] The manual ligation thread cutting slit 418 is a slit that allows the practitioner to manually cut the free end 137 of the ligation thread 130 if the benign prostatic hyperplasia treatment device 1 malfunctions during treatment using the device.

[0112] The needle operating section 600 is housed in the needle operating section housing groove 421 of the left frame 420, and the pivot shaft coupling tube 540 of the trigger 500 is rotatably inserted into the trigger pivot shaft 423. The pusher lever hinge 645 of the pusher lever 640 is elastically locked and supported at the lock release button engagement end 422. As described above, the frame coupling plate 373 of the sheath coupling member insertion groove 425 is inserted and coupled. The frame coupling ring 741 of the thread indicator 740 of the ligation thread winder 700 is coupled to the indicator coupling shaft 427.

[0113] The pusher lever pivot shaft 643 of the pusher lever 640 is connected to the pusher lever pivot shaft connecting tube 428, thereby supporting the pusher lever 640 so that it can rotate.

[0114] As described above, the blade lock release lever 429 is provided so as to be rotatable from side to side, and contacts and supports the engaging blade 355a of the blade section 350, controlling the movement of the blade pressing button 355.

[0115] Figure 16 is an internal perspective view showing the internal structure of the handle frame section 400, Figures 17 and 18 are exploded perspective views showing the disassembled configuration of the sheath body 300a, trigger 500, needle operating section 600, and ligation thread winder 700, and Figure 19 is an illustrative diagram showing the firing process of the needle 200.

[0116] The trigger 500 is connected to the handle frame 400 so as to be rotatable back and forth, and is held in the operator's hand, transmitting the operator's input to the needle operating unit 600 so that the needle 200 can be fired.

[0117] As shown in Figure 17, the trigger 500 includes a ring 510 into which the practitioner's finger can be inserted, a pull lever 520 that extends downward from the rear of the ring 510 at a certain angle, a press lever 530 that extends above the pull lever 520 and is coupled to a needle holder 630, and a pivot shaft coupling tube 540 that is coupled to the trigger pivot shaft 423 of the left frame 420.

[0118] As shown in Figure 16, the trigger 500 has a pivot shaft coupling tube 540 connected to the trigger pivot shaft 423, and a ring 510 positioned in the trigger ring housing groove 411. The pull lever 520 extends to the lower part of the handle frame 400, and the push lever 530 extends to the upper part and is positioned between the lever head coupling members 633 of the needle holder 630.

[0119] The coupling head 531 of the pressing lever 530 is housed in the lever head housing groove 633a between the lever head coupling members 633, and when the practitioner pulls the pull lever 520 by hand 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 pressure lever 530 also returns to its initial position, and the needle holder 630 moves backward.

[0121] As shown in Figure 2, the practitioner inserts their index finger into the ring 510 exposed on the outside of the handle frame 400, wraps their thumb around the handle frame 400, and grips the pull lever 520 with the remaining fingers. Then, they operate the needle holder 630 by pulling and pushing the pull lever 520.

[0122] The needle operating unit 600 is housed in the handle frame unit 400 and moves according to the direction of operation of the operator's trigger 500, so that the needle 200 is fired and the anchor assembly 100 is placed in the prostate A and B.

[0123] As shown in Figures 16, 17, and 18, the needle operating section 600 includes a pusher 610 inserted into the rear end of the needle insertion tube 310, a pusher holder 620 fixedly coupled to the pusher 610 with the rear end of the endoscope insertion tube 320 inserted inside, a needle holder 630 housing the pusher holder 620 and moving back and forth by the operation of the trigger 500, and a pusher lever 640 horizontally mounted on the top of the needle holder 630 to control the movement of the needle holder 630 and limit the distance of movement.

[0124] The pusher 610 is provided in the form of a rod of a certain length. The pusher 610 is provided to a length that can press 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, physically pressing the anchor assembly 100 so that the anchor assembly 100, which is attached to the tip of the needle 200, is discharged from the outside of the needle 200.

[0125] The pusher holder 620 is housed inside the needle holder 630 and moves together with the needle holder 630, supporting the pusher 610 to press against the anchor assembly 100. The pusher holder 620 is formed in a square housing shape and has an endoscope insertion tube insertion hole 625 that penetrates through its interior. The rear end 321 of the endoscope insertion tube 320 is inserted into the endoscope insertion tube insertion hole 625. The rear end 321 of the insertion tube protrudes a certain length behind the pusher holder 620 and guides the transurethral endoscope 800, which has been inserted through the endoscope fixing member 430, toward the prostate A and B.

[0126] A pair of holder hinges 621 are provided on both sides of the pusher holder 620. The pair of holder hinges 621 engage with position adjustment protrusions 631b and 631c on the inner wall surface of the needle holder 630 when the pusher holder 620 moves inside the needle holder 630, thereby limiting the distance the pusher holder 620 can move.

[0127] The holder hinge 621 is provided in a wing shape that extends on both sides and is designed to bend elastically.

[0128] Figure 20 is a plan view illustrating the process of the pusher holder 620 moving inside the needle holder 630. As shown in Figure 20(a), the inner wall surface of the needle holder 630 is provided with a first pusher holder position adjustment projection 631b and a second pusher holder position adjustment projection 631c that protrude diagonally along the length direction.

[0129] In the initial position, a pair of holder hinges 621 extending from both sides of the pusher holder 620 contact the inner wall surface of the needle holder 630. As 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 and move along the slope, engaging with the first pusher holder position adjustment projection 631b, thereby restricting the position of the pusher holder 620.

[0130] Subsequently, the practitioner removes the pusher block 635 that was blocking the path of the pusher holder 620, and as 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 projection 631c, thereby restricting the position of the pusher holder 620.

[0131] Here, the distances d1 and d2 between the first pusher holder position adjustment projection 631b and the second pusher holder position adjustment projection 631c correspond to the lengths of the first anchor 110 and the second anchor 120, and the needle 200 moves forward by the distance the pusher 610 moves, so that the first anchor 110 and the second anchor 120 are ejected.

[0132] On the other hand, a position adjustment tail 623 is provided to protrude from the top of the pusher holder 620. The position adjustment tail 623 engages with the pusher lever 640 when the needle holder 630 is moved forward by the trigger 500, and limits the speed and distance of movement of the needle holder 630.

[0133] As shown in Figure 19(c), when the needle holder 630 is moved forward by the operation of the trigger 500, the position adjustment tail 623 engages with the position adjustment teeth 641a of the pusher lever 640 and moves, adjusting so that it moves forward by the size of the teeth rather than all at once.

[0134] The needle holder 630 moves back and forth in conjunction with 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 housed in the needle holder 630 that limits the distance the pusher holder 620 moves.

[0135] As shown in Figure 18, the needle holder body 631 is formed such that a sheath movement path 631a is recessed in the central part along its length. The endoscope insertion tube 320, which is fixed to the pusher holder 620, is housed in the sheath movement path 631a.

[0136] The needle holder body 631 is provided with the first pusher holder position adjustment projection 631b and the second pusher holder position adjustment projection 631c on both inner walls, respectively, which restrict the movement position of the pusher holder 620.

[0137] Pusher block housing grooves 631d are provided on both the front sides of the needle holder body 631. The pusher block housing grooves 631d house the pusher block 635 inside, as shown in Figure 12. The pusher block 635 is housed between the pusher block housing grooves 631d and the needle holder cover 634. Both ends of the pusher block 635 protrude from both sides of the pusher block housing grooves 631d and are exposed to the outside of the pusher block movement slit 416 of the handle frame portion 400, as shown in Figure 2.

[0138] In the first stage, the operator pulls the trigger 500, moving the pusher holder 620 to the first pusher holder position adjustment projection 631b, which contacts the pusher block 635, as shown in Figure 20(b). This causes the first anchor 110 of the anchor assembly 100 to be ejected from the needle 200.

[0139] The operator pushes the pusher block 635, which is exposed outside the pusher block movement slit 416, to remove it from the handle frame 400. Then, in the second stage, the trigger 500 is pulled to cause the pusher holder 620 to advance all the way forward as shown in Figure 20(c). This causes the second anchor 120 to be ejected from the needle 200.

[0140] A pair of lever head coupling members 633 are provided at the lower part of the needle holder body 631. The coupling head 531 of the pressing lever 530 of the trigger 500 is housed between the lever head coupling members 633. The coupling head 531 is housed in the lever head housing groove 633a between the lever head coupling members 633, and in accordance with the rotational direction of the trigger 500, the coupling head 531 presses the pair of lever head coupling members 633 from side to side, thereby moving the needle holder 630.

[0141] The needle holder cover 634 covers the top of the needle holder body 631 and fixes the position of the pusher holder 620 and pusher block 635 housed inside. The front of the needle holder cover 634 is provided with a lower locking projection 634a that protrudes upward. The lower locking projection 634a engages with the upper locking projection 647 of the pusher lever 640, fixing the position so that the needle holder 630 does not move unless operated by the practitioner.

[0142] The lower locking projection 634a is formed to protrude from the front upper part of the needle holder cover 634 with a right-angled triangular cross-section, as shown in Figure 18. The upper locking projection 647 protrudes from the rear lower part of the pusher lever 640, as shown in Figure 17. The upper locking projection 647 has a right-angled triangular cross-section in the opposite direction to that of the lower locking projection 634a.

[0143] As a result, in the initial state, the lower locking projection 634a and the upper locking projection 647 are in contact with each other with perpendicular surfaces, as shown in Figure 19(a), and the forward movement of the needle holder 630 is restricted.

[0144] As shown in Figure 19(b), when the practitioner rotates the pusher lever 640 upward, the upper locking projection 647 separates from the lower locking projection 634a. At this time, when the practitioner pulls the trigger 500, the needle holder 630 moves forward.

[0145] On the other hand, as shown in Figure 18, a block projection movement rail 634b is formed through the plate surface of the needle holder cover 634 over a certain area. The block projection 635a, which is formed to protrude from the upper surface of the pusher block 635, is housed in the block projection movement rail 634b. The block projection movement rail 634b limits the movement distance of the pusher block 635 when the needle holder 630 moves.

[0146] In other words, since the block projection 635a moves by the distance of the block projection movement rail 634b, the movement distance of the pusher block 635 is also limited.

[0147] As described above, when the operator 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 operator pulls the trigger 500 in the second stage. Both ends of the pusher block 635 are exposed to the outside of the handle frame 400 through the pusher block housing groove 631d and the pusher block movement slit 416, as described above, and the operator can pull and remove the exposed pusher block 635.

[0148] The pusher lever 640 is mounted horizontally on top of the needle holder 630 as shown in Figure 16, and controls the movement of the needle holder 630 and limits the speed at which the needle holder 630 moves. The pusher lever 640 includes, as shown in Figures 17 and 18, a horizontally mounted pusher lever bar 641, a pusher lever pivot shaft 643 mounted in front of the pusher lever bar 641 and rotatably supporting the pusher lever bar 641, a pusher lever hinge 645 formed to project diagonally upward in front of the pusher lever pivot shaft 643 and providing elastic force to return the pusher lever bar 641 to its initial position when rotated upward, an upper locking projection 647 projecting from the bottom of the pusher lever bar 641, and pusher lever buttons 649 that extend over a certain area on both sides behind the pusher lever bar 641 and are operated by the practitioner.

[0149] The pusher lever bar 641 is provided in the shape of a rod of a certain length and is positioned horizontally inside the handle frame portion 400, above the needle holder 630. Position adjustment teeth 641a are formed along the length of the lower part of the pusher lever bar 641 and, as described above, contact the position adjustment tail 623 of the pusher holder 620, thereby limiting 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 moves forward along the position adjustment tail 623 as shown in Figure 19(c).

[0151] The pusher lever pivot shaft 643 is connected to the pusher lever pivot shaft coupling tube 428 of the left frame 420, supporting the pusher lever bar 641 so that it can rotate up and down. The pusher lever hinge 645 is formed extending diagonally upward from the pusher lever pivot shaft 643 at a certain angle. The pusher lever hinge 645 is inserted between the lock release button engagement ends 422 of the left frame 420 when the pusher lever pivot shaft 643 is inserted into the pusher lever pivot shaft coupling tube 428.

[0152] As shown in Figure 19(a), the pusher lever hinge 645 is positioned to contact the inner wall surface of the release button engagement end 422. In this state, as shown in Figure 19(b), when the operator pushes the pusher lever button 649 upward and the pusher lever bar 641 rotates around the pusher lever pivot axis 643, the pusher lever hinge 645 is compressed between the pusher lever pivot axis 643 and the release button engagement end 422.

[0153] The compressed pusher lever hinge 645 applies elastic force so that when the operator releases the pusher lever button 649, as shown in Figure 19(c), the pusher lever bar 641 rotates to its initial position and elastically returns to a horizontal position.

[0154] As described above, the upper locking projection 647 engages with the lower locking projection 634a of the needle holder cover 634, controlling the movement of the needle holder 630.

[0155] The pusher lever button 649 extends horizontally from left to right to the upper rear end of the pusher lever bar 641 and is housed in the pusher lever button housing groove 414 of the handle frame 400. As shown in Figure 2, the pusher lever button housing groove 414 extends vertically with a constant area, so the operator pushes the externally exposed pusher lever button 649 upward to lift the pusher lever bar 641 upward.

[0156] As shown in Figure 19(a), with the pusher lever button 649 in the down position, the lower locking projection 634a and the upper locking projection 647 engage, restricting the movement of the needle holder 630. In this state, the practitioner lifts the pusher lever button 649, which is exposed to the outside of the handle frame 400, upward, causing the pusher lever bar 641 to rotate upward, as shown in Figure 19(b). This separates the upper locking projection 647 and the lower locking projection 634a, allowing the practitioner to pull the trigger 500 and 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 length of the free end 137 to adjust the intensity with which the ligature 130 compresses the prostate A and B. The ligature winder 700 includes, as shown in Figure 12, a winder shaft 710, a unidirectional rotation limiting tooth 720 formed on the winder shaft 710 to restrict the direction of rotation so that the winder shaft 710 can rotate in only one direction, a thread winder 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 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 housed in the thread winder housing grooves 412 of the left frame 420 and the right frame 410. At this time, the rotation operation knobs 715 provided at both ends of the winder shaft 710 protrude from the outside of the thread winder housing grooves 412 and are exposed, allowing the operator to grip and rotate them by hand.

[0159] As shown in Figure 17, a thread insertion ring 711 is provided on the outer surface of the winder shaft 710 to which the ligating thread 130 is fixed. The ligating thread 130 is fixed to the thread insertion ring 711 with a knot and wrapped around the outer circumference of the winder shaft 710 several times.

[0160] Figure 21(a) is an illustrative diagram showing the operation process of the thread winder lock release button 730 and the unidirectional rotation limiting teeth 720. The unidirectional rotation limiting teeth 720 are formed to protrude from the outer circumference of the winder shaft 710 at regular angular intervals. At this time, one surface of the unidirectional 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 lower frame coupling end 731 fixed to the handle frame portion 400, and its upper part is formed to protrude outside the handle frame portion 400. A tooth-engagement projection 733 is formed vertically in the direction opposite to the frame coupling end 731. The lower part between the frame coupling end 731 and the tooth-engagement projection 733 is formed as a gently curved surface.

[0162] In the initial state, the tooth-gripping projection 733 maintains contact with the vertical surface 723 of the unidirectional rotation-restricting tooth 720. The operator pulls the thread winder lock release button 730 clockwise and rotates the rotation operation knob 715 to wind the ligature thread 130.

[0163] At this time, the winder shaft 710 is configured to rotate only in the direction in which the ligating thread 130 is wound. That is, it is configured to rotate only counterclockwise with respect to Figure 21(a). When the winder shaft 710 rotates counterclockwise, the inclined surface 721 of the unidirectional 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 unidirectional rotation limiting tooth 720 comes into contact with the tooth engagement projection 733, restricting rotation.

[0164] The thread indicator 740 displays to the practitioner the tension currently applied to the free end 137 of the ligature thread 130. Outward-projecting indicator protrusions 745 are provided on both sides of the thread indicator 740. As shown in Figure 2, the indicator protrusions 745 are provided to be movable from side to side along the indicator housing groove 413 of the right frame 410.

[0165] An elastic member 743 in the form of a coil spring with a fixed length is attached to the thread indicator 740, and a frame coupling ring 741 provided at the tip of the elastic member 743 is fixed to the indicator coupling shaft 427 of the left frame 420, as shown in Figure 11.

[0166] As shown in Figure 16, the ligature thread 130 is carried from the winder shaft 710, through the thread indicator 740, and through the needle insertion tube 310, where it is connected to the first anchor 110 and the second anchor 120. As the operator rotates the winder shaft 710 to wind the ligature thread 130, the tension increases and the thread indicator 740 gradually moves to the right. The operator rotates the rotation control knob 715 to check the current position of the thread indicator 740 and, when the desired tension is reached, uses the blade section 350 to cut the free end 137.

[0167] The process of treating benign prostatic hyperplasia using the benign prostatic hyperplasia treatment device 1 according to the present invention, which has the above configuration, will be explained with reference to Figures 2 to 24.

[0168] Figures 23 and 24 are illustrative diagrams illustrating the general procedure for treating benign prostatic hyperplasia.

[0169] The benign prostatic hyperplasia treatment device 1 is prepared in a fully assembled and sterile packaged state, as shown in Figure 2.

[0170] At this time, as shown in an enlarged view in Figure 10, the anchor assembly 100 is inserted into the needle slot 220 of the needle 200, and the ligating thread 130 is exposed to the outside through the external needle exposure hole 331 of the blade plate 351 and prepared to be housed inside the suture arranger 360.

[0171] The free end 137 of the ligating thread 130, which is extended to the rear end of the needle insertion tube 310, passes through the thread indicator 740 as shown in Figure 10, and is then wound around the outer circumference of the winder shaft 710 of the ligating thread winder 700.

[0172] In the preparation state before the procedure begins, as shown in Figure 19(a), the lower locking projection 634a of the needle holder 630 is positioned to engage with the upper locking projection 647 of the pusher lever 640, thereby restricting the movement of the needle holder 630.

[0173] Because 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, which is coupled between the lever head coupling members 633 of the needle holder 630, is inserted is also fixed.

[0174] The practitioner uses anesthetic gel to administer local, spinal, or general anesthesia to the inside 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 procedure is complete.

[0176] The practitioner removes the suture arranger 360 from the needle housing sheath 300 and inserts the needle housing 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] The operator pushes upward the pusher lever button 649, which is exposed on the outside of the handle frame 400, as shown in Figure 19(b). When the pusher lever button 649 is pushed upward, the needle holder 630 and the trigger 500 become movable.

[0178] In this state, the practitioner uses a transurethral endoscope 800 inserted into the needle-receiving sheath 300 to examine the inside and confirm the positions where anchors 110 and 120 will be placed. The positions of anchors 110 and 120 can be confirmed through anatomical points such as the bladder neck and belmontanum.

[0179] Tilt the needle sheath 300 at an angle of 20 degrees or more toward the lateral lobe of the left prostate. This is just one example, and the practitioner will decide whether to start with the left or right side during the procedure.

[0180] The operator then manually pulls the pull lever 520 of the trigger 500, causing the needle holder 630 to move forward by rotating the press lever 530 as shown in Figure 19(c). This causes the needle 200 to be fired.

[0181] The practitioner pushes the pull lever 520 until the needle holder 630 moves to the front end or the needle 200 can no longer advance.

[0182] As the needle holder 630 moves forward, the position adjustment tail 623 moves along the position adjustment teeth 641a of the pusher lever bar 641. The pusher holder 620 then 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 projection 631b.

[0183] Once the needle holder 630 has moved forward to a certain extent, the practitioner may release their hand from pressing the pusher lever button 649 upward. When released, the pusher lever 640 returns to its initial position due to the elastic force of the pusher lever hinge 645.

[0184] The forward movement of the needle holder 630 and the pusher holder 620 launches the needle 200, which is then launched outside the needle guide member 340 as shown in Figure 23(c), passing through prostate A and B and emerging into the lateral lobe of the prostate.

[0185] At this time, as shown in Figure 9(a), the first anchor 110 and the second anchor 120 are sequentially housed in the needle slot 220, and the pusher 610 is inserted into the rear end of the needle 200.

[0186] In this state, the practitioner does not push the pusher lever button 649 upward again, but instead pushes the ring 510 of the trigger 500 to move the needle holder 630, which had been moved forward, backward. At this time, the pusher holder 620 is fixed in position because the position adjustment tail 623 is engaged with the position adjustment teeth 641a of the pusher lever 640, and only the needle holder 630 is moved backward. The position of the pusher 610 is fixed, and only the needle 200 is moved backward by the needle holder 630, so the first anchor 110 is ejected from the outside of the needle 200 as shown in Figure 9(b).

[0187] The first anchor 110, which has been ejected from the needle 200, is positioned on the upper outer side of the left prostate A, as shown in Figure 23(d).

[0188] Once the ejection of the first anchor 110 is complete, the pusher lever button 649 is pushed upward, and the ring 510 of the trigger 500 is pushed, moving the needle holder 630 completely backward. At this time, the pusher holder 620 is fixed in place within the needle holder 630 by the pusher block 635. As a result, both the pusher 610 and the needle 200 move backward.

[0189] The needle housing sheath 300 is moved to a position where the second anchor 120 is discharged. Next, the pusher block 635 is pulled to remove it from the handle frame 400. Then, the process described above is repeated to push the pusher lever button 649 upward and pull the pull lever 520 to move the needle holder 630 forward. This causes the needle 200 to penetrate and be inserted into the lower part 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] At this time, as shown in Figure 20(c), the pusher block 635 is removed, so 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 the second anchor 120 is ejected from 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 pushed, moving the needle holder 630 completely backward.

[0191] The second anchor 120, which has been ejected from the needle 200, is positioned 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 thread 130, and the free end 137 is wound onto a ligature thread 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 of the prostate A and B, the length adjustment loop 133 is not adjusted, so the ligature thread 130 is loosely positioned and does not compress the prostate tissue.

[0193] The operator uses an endoscope to check the inside and pulls the thread winder lock release button 730 as shown in Figure 21(a) to move the tooth engagement projection 733 away from the vertical surface 723 of the unidirectional 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 onto the winder shaft 710, shortening the length adjustment loop 133, and the anchor assembly 100 compresses the left prostate A. The practitioner checks the scale 413a displayed on the thread indicator 740 as shown in Figure 21(b) to confirm the tension of the free end 137.

[0195] After confirming the tension of the free end 137 displayed on scale 413a and using a transurethral endoscope 800 to confirm the extent to which the anchor assembly 100 compresses the left prostate A and opens the urethra C, the operator presses the blade lock release lever 429 to rotate it as shown in Figure 22(b). When the engagement between the blade lock release lever 429 and the blade press button 355 and the engaging blade 355a is released, the blade press button 355 is pushed backward.

[0196] As a result, as shown in Figure 15(b), the blade plate 351 slides behind the internal needle exposure hole 352, the free end 137 of the ligating thread 130 is caught in the blade slit 353 of the blade plate 351, and the free end 137 is cut.

[0197] The length of the free end 137 of the severed ligature 130 is less than 1 mm, and it is embedded in the prostatic tissue. This completes 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 removing the needle sheath 300 from the urethra, the practitioner uses a new prostate enlargement treatment device 1 to install the anchor assembly 100 on the right prostate B in the same manner as on the left prostate A.

[0199] As a result, as shown in Figure 24(d), a pair of anchor assemblies 100 are installed in the left prostate A and the right prostate B, opening the urethra C. At this time, the anchor assemblies 100 continuously compress the prostate tissue in a U-shape or elliptical shape, connecting the first anchor 110, the second anchor 120, and the ligature thread 130. This has the advantage that the length l of the urethra C that is compressed and opened by the ligature thread 130 can be adjusted, and the width d of the compression can also be adjusted.

[0200] As described above, the prostate enlargement treatment device according to the present invention has the advantage of increasing urine flow velocity compared to conventional treatment methods that partially compress the prostate tissue, because the prostate tissue compressed by the ligation suture and pair of anchors is continuous, which can be more effective for patients with long prostates.

[0201] Furthermore, the prostate enlargement treatment device according to the present invention has the advantage that the practitioner can adjust the length of the ligation thread by wrapping the free end of the thread around it, thereby adjusting the intensity of the compression on the prostate to the extent desired by the practitioner.

[0202] This allows for adjustment of the degree of compression according to the various symptoms of benign prostatic hyperplasia experienced by each patient.

[0203] The treatment method using the benign prostatic hyperplasia treatment device of the present invention does not require general anesthesia or a long operating time, unlike other laser treatments or electrical surgeries that utilize thermal energy.

[0204] This procedure allows for quick surgery and local anesthesia through a simple anchor placement method, and because it does not involve the removal of prostate tissue, it does not cause side effects such as retrograde ejaculation, erectile dysfunction, or hematuria. Furthermore, because it is non-invasive, it has the advantage of allowing for additional surgery at any time if the initial procedure is ineffective.

[0205] The technical concept of the present invention has been explained above through several embodiments.

[0206] It is evident that a person with ordinary skill in the art to which the present invention pertains can modify or alter the embodiments described above in various ways based on the description of the present invention. Furthermore, even if not explicitly shown or described, it is evident that a person with ordinary skill in the art to which the present invention pertains can make various forms of modifications, including the technical idea of ​​the present invention, based on the description of the present invention, and this still falls within the scope of the present invention. The embodiments described above with reference to the accompanying drawings are provided for the purpose of illustrating the present invention, and the scope of the present invention is not limited to these embodiments.

Claims

1. Multiple anchors (110, 120) are placed in the prostate gland to compress the urethra, A ligature (130) connects multiple anchors (110, 120) to each other, so that the multiple anchors continuously compress the prostatic tissue and secure the prostatic urethra, An elastic needle (200) which houses the anchors (110, 120) and the ligating thread (130) inside, and which is inserted into the urethra to guide the anchors (110, 120) and the ligating thread (130) to be placed in the prostate gland, A prostate enlargement treatment device comprising: a needle launching means for launching the needle (200) so that the needle (200) is inserted into the urethra, and for operating the needle (200) so that a plurality of anchors (110, 120) and ligature threads (130) are discharged through the needle (200).

2. When the plurality of anchors (110, 120) are a pair of first anchors (110) and second anchors (120), the first anchor (110) is fixed to the upper outer side of the prostate, and the second anchor (120) is fixed to the lower outer side of the prostate. The prostate enlargement treatment device according to claim 1, characterized in that the ligating thread (130) includes a fixed end (131) fixed to the first anchor (110), a length-adjustable loop (133) connected to the second anchor (120) and having an adjustable length, a slipknot (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 first anchors (110) and second anchors (120), the first anchor (110) is fixed to the upper outer side of the prostate, and the second anchor (120) is fixed to the lower outer side of the prostate. The prostate enlargement treatment device according to claim 1, characterized in that the ligating thread (130) is connected to both the first anchor (110) and the second anchor (120) and includes a length-adjustable length-adjustable loop (133), and a slipknot (135) connected to the free end (137) and fixed end (131) forming the length-adjustable loop (133) to support the length of the length-adjustable loop (133) so as to be adjustable.

4. When the plurality of anchors (110, 120) are a pair of first anchors (110) and second anchors (120), the first anchor (110) is fixed to the upper outer side of the prostate, and the second anchor (120) is fixed to the lower outer side of the prostate. The ligating thread (130) includes a fixing knot (131a) fixed to the first anchor (110) and a free end (137) extending from the fixing knot (131a) via the second anchor (120). The prostate enlargement treatment device according to claim 1, further comprising a lock anchor (150) which is connected to the free end (137) on the lower inner side of the prostate and fixes the position of the free end (137).

5. When the plurality of anchors (110, 120) consist of three anchors, a first anchor (110), a second anchor (120), and a third anchor (140), the first anchor (110) is fixed to the upper outer part of the prostate, the second anchor (120) is fixed to the central outer part of the prostate, and the third anchor (140) is fixed to the lower outer part of the prostate. The ligating thread (130) includes a fixed end (131) that is fixed to the first anchor (110), and a free end (137) that extends from the fixed end (131) via the second anchor (120) and the third anchor (140). The prostate enlargement treatment device according to claim 1, further comprising a lock anchor (150) which is connected to the free end (137) on the lower inner side of the prostate and fixes the position of the free end (137).

6. The prostate enlargement treatment device according to claim 1, characterized in that when the plurality of anchors (110, 120) are a pair of first anchors (110) and second anchors (120), the first anchor (110) is fixed to the central outer side of the prostate, and the second anchor (120) is fixed to the central inner side of the prostate, facing the first anchor (110).

7. The needle firing means is A needle housing sheath (300) for housing the needle (200), A needle operating unit (600) controls the movement of the needle (200) so that the needle (200) is discharged through the end of the needle housing sheath (300), A trigger (500) is used to hold the needle (200) so as to fire it and to operate the needle operating part (600), The prostate enlargement treatment device according to any one of claims 1 to 6, further comprising the rear end of the needle housing sheath (300), the needle operating section (600), and a handle frame section (400) that supports the trigger (500).

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