Benign prostatic hyperplasia treatment device using anchor assembly and needle

Abstract

Disclosed is a benign prostatic hyperplasia treatment device using an anchor assembly and a needle. The benign prostatic hyperplasia treatment device, according to the present invention, comprises: a plurality of anchors arranged on the outside of the prostate compressing the urethra; and a ligature connecting the plurality of anchors to each other to allow the plurality of anchors to continuously compress the prostate tissue to secure the prostatic urethra. At this time, the benign prostatic hyperplasia treatment device may further include: a needle having elasticity that accommodates the anchors and the ligature inside and guides the anchors and the ligature to be installed in the prostate by being inserted into the urethra; and a needle projection means that propels the needle to allow the needle to be inserted into the urethra and operates in such a manner that the plurality of anchors and the ligature are discharged through the needle.

Description

Prostate enlargement treatment device using anchor assembly and needle

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

[0002] Generally, benign prostatic hyperplasia is a condition in which the prostate gland becomes abnormally enlarged and blocks the prostatic urethra, which is located below the bladder, causing urethral obstruction and making it difficult for urine to flow out smoothly.

[0003] When benign prostatic hyperplasia occurs, symptoms such as frequent urination, nocturia, urgency, dribbling, and residual urine sensation appear, causing significant inconvenience in daily life.

[0004] To treat this type of benign prostatic hyperplasia, a prostate hyperplasia treatment method as shown in Figure 1 is performed.

[0005] When benign prostatic hyperplasia occurs, as shown in (a) of Fig. 1, a pair of prostates (A, B) on either side of the urethra become enlarged and block the urethra (C). As shown in (b) of Fig. 1, the practitioner inserts a cystoscope (10) into the urethra, and as shown in (c) of Fig. 1, passes a medical ligature (11) through the end of the cystoscope (10) into the prostates (A, B), and then, as shown in (d) of Fig. 1, a first implant (20) is implanted in the upper part of the left prostate (A), and as shown in (e) of Fig. 1, a second implant (20a) is implanted in the upper part of the right prostate (B).

[0006] And as shown in (f) of Fig. 1, the third implant (20b) and the fourth implant (20c) are each implanted in the lower part of the left prostate (A) and the right prostate (B).

[0007] At this time, each implant (20, 20a, 20b, 20c) is connected by a ligature (25) with an outer implant (21) placed on the outside of the prostate (A, B) and an inner implant (23) placed on the urethra side, and the inner implant (23) compresses the prostate (A, B) outward by the length of the ligature (25), thereby opening the urethra.

[0008] However, this conventional prostate hypertrophy treatment method has a limitation in that the area of ​​prostate tissue that can be compressed using a single implant (20) is limited to the size of the inner implant (23).

[0009] In addition, since there is a gap between the implant (20) placed at the top and the implant (20b) placed at the bottom, the space between the upper inner implant and the lower inner implant (a) is not compressed and is still maintained in a state of being enlarged toward the urethra, so there is a limitation that the compressed prostate tissue is not continuous and only the part in contact with the inner implant (23) is partially compressed.

[0010] The purpose of the present invention is to solve the above-described problem, and to provide a device for treating benign prostatic hyperplasia, which can adjust the compression area by a pair of anchors positioned above and below the prostate and connected to each other by a ligature.

[0011] Another object of the present invention is to provide a prostate enlargement treatment device that can continuously compress the prostate according to the size of the prostate of each patient by adjusting the length of a ligature 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 firing an anchor assembly into the prostate in various shapes using an elastic needle and a needle firing means.

[0013] The above-described object of the present invention can be achieved by a prostate enlargement treatment device using an anchor assembly and a needle. The prostate enlargement treatment device of the present invention comprises: a plurality of anchors positioned in the prostate to compress the urethra; and a ligature thread connecting the plurality of anchors to each other so that the plurality of anchors continuously compress the prostate tissue, thereby securing the prostatic urethra.

[0014] In addition, it is preferable to include a needle having elasticity that accommodates the anchor and the ligation thread therein and guides the anchor and the ligation thread to be installed in the prostate by being inserted into the urethra; and a needle firing means that fires the needle so that the needle is inserted into the urethra and operates so that the plurality of anchors and the ligation thread are discharged through the needle.

[0015] The prostate enlargement treatment device according to the present invention has the advantage of allowing for a faster urinary flow because the prostate tissue compressed by the ligation thread and a pair of anchors is continuously connected compared to the conventional treatment method of partially compressing the prostate tissue, and this can be more effective for patients with long prostates.

[0016] In addition, the prostate enlargement treatment device according to the present invention has the advantage that the operator can adjust the strength of the prostate compression as desired by winding the free end of the ligation thread to adjust the length of the ligation thread.

[0017] Accordingly, it is effective in adjusting the degree of pressure to suit the various symptoms of benign prostatic hyperplasia in each patient.

[0018] The treatment method using the prostate hypertrophy treatment device of the present invention does not require general anesthesia or a long surgical time, unlike other laser treatments or electrical surgeries that use heat energy.

[0019] The simple anchor placement method allows for a quick surgery time and local anesthesia. 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, it offers the advantage of allowing for additional surgery at any time if the procedure is ineffective.

[0020] Figure 1 is an example diagram illustrating a conventional method of treating benign prostatic hyperplasia.

[0021] Figure 2 is a perspective view showing the configuration of a prostate enlargement treatment device according to the present invention.

[0022] Figure 3 is an exemplary diagram showing the configuration of an anchor assembly according to a preferred embodiment of a prostate hypertrophy treatment device according to the present invention.

[0023] Figure 4 is an exemplary diagram showing a state in which the anchor assembly of the preferred embodiment of Figure 3 is installed on the left prostate.

[0024] Figures 5 and 6 are exemplary views showing the configuration of an anchor assembly according to a modified example of a prostate hypertrophy treatment device according to the present invention.

[0025] Figures 7 and 8 are exemplary views showing a state in which an anchor assembly according to a modified example is installed on the left prostate.

[0026] Figure 9 is an exemplary diagram showing the process of launching the anchor assembly of the present invention after it is received in a needle.

[0027] Figure 10 is a cross-sectional view showing a side cross-sectional configuration before the trigger of the prostate enlargement treatment device according to the present invention is operated.

[0028] Figure 11 is a cross-sectional example showing the side cross-sectional configuration after the trigger of the prostate enlargement treatment device according to the present invention is pulled.

[0029] Figure 12 is an exploded perspective view showing the configuration of a prostate enlargement treatment device according to the present invention.

[0030] Figure 13 is an exploded perspective view showing the configuration of the needle guide sheath of the prostate enlargement treatment device according to the present invention.

[0031] Figure 14 is an exploded perspective view showing the joint structure of the needle guide member and the blade portion of the prostate enlargement treatment device according to the present invention.

[0032] Figure 15 is an exemplary diagram showing the operation process of the blade part of the prostate enlargement treatment device according to the present invention.

[0033] Figure 16 is an internal perspective view showing the state of connection between the needle operating unit and the ligation thread winder of the prostate enlargement treatment device according to the present invention.

[0034] Figures 17 and 18 are exploded perspective views showing the configuration of the needle operating unit and the ligation thread winder.

[0035] Figure 19 is a side view illustrating the operation process of the needle operating part according to the operation of the trigger.

[0036] Figure 20 is a plan view illustrating the operation process of the needle operating part according to the operation of the trigger.

[0037] Figure 21 is a drawing showing the configuration of the ligation room winder of the prostate enlargement treatment device according to the present invention.

[0038] Figure 22 is an exemplary diagram showing the operation process of the blade pressure button and cover of the prostate enlargement treatment device according to the present invention.

[0039] Figures 23 and 24 are examples showing anchor assemblies of various shapes installed in the left prostate.

[0040] Hereinafter, the present invention will be described in detail with reference to preferred embodiments of the present invention and the accompanying drawings, on the premise that the same reference numerals in the drawings indicate the same components.

[0041] When a component is said to "include" another component in the detailed description of the invention or the scope of the patent claims, this should not be construed as being limited to consisting of only that component, unless otherwise specifically stated, and should be understood to mean that it may further include other components.

[0042] FIG. 2 is a perspective view showing the configuration of a prostate enlargement treatment device according to the present invention, FIG. 3 is an exemplary view showing the configuration of an anchor assembly according to a preferred embodiment of a prostate enlargement treatment device according to the present invention, and FIG. 4 is an exemplary view showing a state in which an anchor assembly (100) of a preferred embodiment is installed on the left prostate (A, B).

[0043] The prostate enlargement treatment device (1) according to the present invention includes an anchor assembly (100) disposed on the outside of the prostate to compress the prostatic urethra, an elastic needle (200) that accommodates the anchor assembly (100) inside and guides the anchor assembly (100) to be installed in the prostate by being inserted into the urethra, and a needle firing means that fires the needle (200) so that the needle (200) is inserted into the urethra and operates so that the anchor assembly (100) is discharged through the needle (200).

[0044] Here, the anchor assembly (100) includes a plurality of anchors (110, 120) spaced apart from each other on the outside of the prostate as shown in (a) of FIG. 3, and a ligature chamber (130) that connects the plurality of anchors (110, 120) to each other so that the plurality of anchors continuously compress the prostate tissue to secure the prostatic urethra.

[0045] The prostate hypertrophy treatment device (1) according to the present invention positions a pair of anchors (110, 120) and a ligation thread (130) at a desired position using a needle launching means, and adjusts the length of the ligation thread (130) using a ligation thread winder (700) provided in the needle launching means, so that the anchor assembly (100) can continuously compress the prostate tissue at a desired compression strength by the operator, as shown in FIG. 4. Accordingly, the prostate compression length and compression thickness can be adjusted according to the symptoms of prostate hypertrophy of each patient, and there is an advantage in that the urinary flow can be increased.

[0046] The anchor assembly (100) is installed on the outer surface of the prostate of the subject and compresses the prostate to open the urethra. In the prostate hypertrophy treatment device (1) of the present invention, a pair of anchor assemblies (100) are installed on the left prostate (A) and the right prostate (B), respectively, to complete the treatment.

[0047] FIG. 3 (a) is a drawing showing the configuration of one anchor assembly (100), FIG. 3 (b) is an exploded perspective view showing the configuration of the anchor assembly (100) in an exploded manner, FIG. 3 (c) is a drawing showing a state in which the free end (137) of the anchor assembly (100) is pulled, and FIG. 4 is an exemplary drawing showing a state before the length of the anchor assembly (100) is adjusted by being inserted into the left prostate (A).

[0048] The anchor assembly (100) includes a first anchor (110) and a second anchor (120), as illustrated in FIG. 3 (a) and FIG. 3 (b), and a ligature (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 with only the arrangement position being different, only the first anchor (110) will be described in detail.

[0049] The first anchor (110) includes a first anchor body (111) formed in a tubular shape with a semicircular cross-section, and a first thread-joining ring (115) formed protrudingly in the central region of the first anchor body (111) to which a ligature (130) is joined.

[0050] The first anchor body (111) is provided with a first thread receiving groove (113) formed in the longitudinal direction to receive a ligation thread (130) on the inside. The first anchor body (111) is formed of metal or a metal alloy. Preferably, it is formed of nitinol. One end of the first anchor body (111) is provided with a horizontal end (111a) formed horizontally, and the other end is provided with a bent end (111b) bent at a certain curvature. The reason why the other end of the first anchor body (111) is provided with a bent end (111b) is to stably fix the position when the first anchor (110) or the second anchor (120) is installed in the prostate (A, B), as illustrated in FIG. 4.

[0051] By bending the first anchor (110) against the outer surface of the prostate by the bending member (111b), the first anchor (110) penetrates the prostate tissue and prevents the first anchor (110) located on the outer surface of the prostate from moving back into the penetration hole of the prostate formed by the needle (200).

[0052] That is, as illustrated in FIG. 4, when the needle (200) penetrates the prostate (A) during the procedure and the first anchor (110) is discharged to the outside of the prostate (A, B), the first anchor (110) is elastically bent with the bending end (111b) bent. This bent first anchor (110) is prevented from moving in the reverse direction by being caught in the through hole formed by the needle (200), and can be stably fixed on the surface of the prostate (A).

[0053] The horizontal section (111a) is provided with an inclined contact section (111a-1) formed at an angle so that the first anchor (110) can be brought into close contact with the curvature of the surface of the prostate (A, B).

[0054] The first thread connecting ring (115) supports the ligation thread (130) inserted into the first thread receiving groove (113) by tying it with a knot or by tying it to the first thread connecting ring (115) itself so that its position is fixed. The first thread connecting ring (115) maintains the first anchor (110) and the ligation thread (130) in a fixed state.

[0055] The first anchor (110) and the second anchor (120) have their bending ends (111b, 121b) bent, but as shown in (a) of Fig. 9, when they are accommodated inside the needle (200), they are elastically deformed to fit the shape of the needle (200). As shown in (b) of Fig. 9, when they are ejected from the needle (200), the bending ends (111b, 121b) of the anchors (110, 120) are elastically returned to their original bent state.

[0056] The ligation room (130) connects the first anchor (110) and the second anchor (120) to each other in a way that allows for length adjustment, and rather than the first anchor (110) and the second anchor (120) independently compressing specific parts of the prostate, the arc or “ㄷ” shaped line connected by the first anchor (110), the second anchor (120) and the ligation room (130) continuously compresses the prostate tissue.

[0057] The ligature (130) includes a fixed end (131) coupled to the first anchor (110), a length adjustment loop (133) coupled to the second anchor (120), a free end (137) connected to the end of the length adjustment loop (133), and a slip knot (135) that ties the free end (137) and the length adjustment loop (133) as shown in (b) of FIG. 3.

[0058] The fixed end (131) is inserted into the first thread connecting ring (115) of the first anchor (110), and a fixed knot (131a) is formed. The fixed knot (131a) is knotted at a height higher than the first thread connecting ring (115) and is caught on the first thread connecting ring (115) to prevent the fixed end (131) from moving from the other side to one side of the first thread connecting ring (115).

[0059] The length adjustment loop (133) is introduced 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 by a slip knot (135) between the fixed end (131) and the free end (137).

[0060] As shown in (c) of Fig. 3, 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) becomes shorter, and the prostate tissue that they surround is compressed.

[0061] As illustrated in Fig. 4, when the first anchor (110) and the second anchor (120) are positioned on the outside of the prostate (A), the ligation thread (130) is positioned loosely. In this state, when the operator pulls the ligation thread (130) by manipulating the needle launching means, the length of the free end (137) shortens, the length adjustment loop (133) shortens, and the prostate (A) is compressed.

[0062] That is, as illustrated in (b) of FIG. 24, when the first anchor (110) and the second anchor (120) are placed on the outside of the prostate, the ligation thread (130) is loosely connected. When the operator pulls the free end (137) using the needle launching means and then tightens the ligation thread (130), as illustrated in (c) of FIG. 24, the first anchor (110), the second anchor (120), and the ligation thread (130) continuously wrap around and compress the prostate (A). Since the first anchor (110) and the second anchor (120) are connected by the ligation thread (130), the space between the first anchor (110) and the second anchor (120) is also continuously compressed, and the urethra (C) is opened.

[0063] Meanwhile, (a) of FIG. 5 is a drawing showing the configuration of an anchor assembly (100a) according to the first modified example, and (b) of FIG. 5 is an exemplary drawing showing a state when the free end of the anchor assembly (100a) according to the first modified example is pulled.

[0064] The anchor assembly (100) according to the preferred embodiment described above has a fixed end (131) of a ligature (130) fixed to a first anchor (110) and a length adjustment loop (133) coupled to a second anchor (120).

[0065] On the other hand, in the anchor assembly (100a) according to the first modified example, both the first anchor (110) and the second anchor (120) are connected to the length adjustment loop (133), so that when the free end (137) is pulled, both the first anchor (110) and the second anchor (120) can move.

[0066] As illustrated in (a) of FIG. 3, the anchor assembly (100) according to the preferred embodiment has a fixed end (131) fixed to the first anchor (110), so the length (ℓ2) between the fixed end (131) and the slip knot (135) is fixed. Accordingly, as illustrated in (c) of FIG. 3, there is a restriction that the distance (ℓ1) between the first anchor (110) and the second anchor (120) cannot be reduced until they meet each other even if the free end (137) is pulled.

[0067] On the other hand, the anchor assembly (100a) according to the first modified example can reduce the distance (ℓ3') until the first anchor (110) and the second anchor (120) touch each other when the free end (137) is pulled as shown in (b) of FIG. 5. Accordingly, there is an advantage in that the operator can easily adjust the distance between the first anchor (110) and the second anchor (120).

[0068] Figure 7 (b) is an exemplary diagram showing a state in which an anchor assembly (100a) according to the first modified example is installed in the prostate (A, B). As shown, the first anchor (110) and the second anchor (120) are coupled to the outer surface of the prostate (A, B), and the ligation chamber (130) is placed on the urethra side to open the urethra.

[0069] Meanwhile, Fig. 6 (a) is an exemplary diagram 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, 130) are coupled to a ligature (130) at regular intervals, and a lock anchor (150) is coupled to a free end (137).

[0070] The fixed end (131) is fixed to the first anchor (110) with a fixed knot (131a), and the second anchor (120) and the third anchor (140) are sequentially connected on the path of the ligature room (130). Fig. 7 (d) is an exemplary drawing showing a state in which the anchor assembly (100b) according to the second modified example is installed in the prostate (A, B).

[0071] As shown, three anchors (100, 120, 130) are sequentially placed on the outer periphery of the prostate (A, B), and a ligation thread (130) connects them by penetrating the prostate (A, B). Then, on the urethral side, a lock anchor (150) is positioned facing the last anchor (130) to fix the position of the free end (137).

[0072] The rock anchor (150) is formed of a plate-like material and has a "V" shaped thread guide groove at the tip. Due to the shape of the gradually narrowing thread guide groove of the rock anchor (150), the free end can be inserted into the thread guide groove and its position fixed.

[0073] The shape of the rock anchor (150) can be changed into various forms within a range that can fix the position of the free end (137).

[0074] Meanwhile, Fig. 6 (b) is an exemplary diagram illustrating 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 connected to a ligature (130) without a length adjustment loop (133), and a lock anchor (150) is provided at the end. In addition, the first anchor (110) is fixed by a fixed end (131) and a fixed loop (132) of the ligature (130).

[0075] In this case, it can be installed in the prostate (A, B) as shown in (c) of Fig. 7. When multiple anchors (110, 120) are sequentially connected to the ligation thread (130) without the length adjustment loop (133) as in the second and third modified examples, the lock anchor (150) fixes the position of the free end (137). The length adjustment loop (133) is adjusted in length by the slip knot (135) and is fixed to the prostate (A, B), whereas when there is no length adjustment loop (133), the free end is fitted into the thread guide groove of the lock anchor (150) and fixes the position.

[0076] Meanwhile, Fig. 6 (c) shows an anchor assembly (100d) according to the fourth modified example, in which the first anchor (110) and the second anchor (120) are arranged to face each other. The ligature (130) is inserted into the ligature through bridge (127) of the second anchor (120) after the length adjustment loop (133) is connected to the first anchor (110), and then connected to the lower portion of the second anchor (120) with a slip knot (135). The free end (137) and the fixed end (131) are connected together to the slip knot (135).

[0077] The anchor assembly (100d) according to the fourth modified example is arranged so that the first anchor (110) and the second anchor (120) face each other on the outer and inner sides of the prostate (A, B), as illustrated in Fig. 8. This is different from the anchor assemblies (100, 100a, 100b, 100c) of the previously described embodiments in that all anchors (110, 120) are arranged on the outer sides of the prostate (A, B).

[0078] When the operator manipulates the free end (137) to shorten the length, the length adjustment loop (133) becomes shorter and the second anchor (120) compresses the prostate (A, B) tissue to open the urethra.

[0079] Meanwhile, here, the slip knot (135) is located below the second anchor (120), but in some cases, the slip knot (135) may be located between the first anchor (110) and the second anchor (120).

[0080] The anchor assembly (100) of the present invention is inserted into the prostate (A, B) while being accommodated inside an elastic needle (200), and then is discharged outside the needle (200) by the operation of a needle launching means and installed outside the prostate (A, B).

[0081] Figure 9 (a) is an exemplary drawing showing a state in which an anchor assembly (100) is accommodated in a needle (200), and Figure 9 (b) is an exemplary drawing showing a state in which a first anchor (110) is discharged from a needle (200).

[0082] Fig. 10 is a cross-sectional view illustrating a state before a needle (200) is fired from a needle launching means, Fig. 11 is a cross-sectional view illustrating a state after a needle (200) is fired from a needle launching means, and Fig. 12 is an exploded perspective view illustrating the configuration of a needle launching means in an exploded manner.

[0083] The needle launching means refers to a configuration of the prostate enlargement treatment device (1) excluding the anchor assembly (100) and the needle (200). The needle launching means can be modified into various forms that can be installed in the prostate by launching the anchor assembly (100) and the needle (200) by manipulation of the operator.

[0084] A needle firing means according to a preferred embodiment of the present invention comprises: a needle receiving sheath (300) that accommodates a needle (200) therein and guides the needle (200) so that it is inserted into the urethra and the anchor assembly (100) is installed in the prostate; a needle operating unit (600) that manipulates the movement of the needle (200) so that the needle (200) is discharged through the tip of the needle receiving sheath (300); a ligature thread winder (700) that is provided on one side of the needle operating unit (600) and 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 unit (400) that accommodates the rear end of the needle receiving sheath (300), the needle operating unit (600), and the ligature thread winder (700) and is held by the operator's hand; It includes a trigger (500) that is coupled to the handle frame (400) and allows the operator to control whether to fire the needle (200).

[0085] 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 receiving sheath (300) as illustrated in FIG. 10. When the operator manipulates the trigger (500) while the needle (200) is inserted into the needle insertion tube (310), the needle is bent at a certain angle along the needle guide member (340) and inserted into the prostate (A, B).

[0086] The needle (200) may be made of metal or a metal alloy, and is preferably made of nitinol. The needle (200) is manufactured with a curved tip, and as shown in an enlarged view in FIG. 10, when accommodated in a needle insertion tube (310), it maintains an elastically curved shape due to the curvature of the needle guide member (340).

[0087] When the needle (200) is fired by the trigger (500) and ejected outside the needle guide member (340), the ejection angle is adjusted by the needle guide member (340) as shown in an enlarged view in FIG. 11, and the needle is bent to match the curvature at the time of manufacture.

[0088] The tip (210) of the needle (200) is sharply formed to facilitate insertion into the prostate (A, B) tissue. In addition, a needle slot (220) is formed inwardly from the needle tip (210) of the needle (200) to a certain length. The needle slot (220) exposes the ligation thread (130) of the anchor assembly (100) housed therein to the outside.

[0089] The length of the needle slot (220) is provided to be the combined length of the first anchor (110) and the second anchor (120) or shorter so that the ligature room (130) does not interfere with the launching of the anchors (110, 120).

[0090] Fig. 13 is an exploded perspective view showing the process of combining a needle receiving sheath (300) and a needle operating part (600), and Fig. 14 is an exemplary view showing the process of combining a sheath body (300a), a needle guide member (340), and a water dispenser (360).

[0091] The needle receiving sheath (300) accommodates a needle (200) and a transurethral endoscope (800), and guides the anchor assembly (100) to the prostate (A, B) through the needle (200) to fix the position of the anchor assembly (100). The rear end of the needle receiving sheath (300) is connected to the handle frame part (400), and the front end extends from the handle frame part (400) by a certain length and is inserted into the urethra (C) through the outer sheath (S).

[0092] As shown in FIGS. 23 and 24, the operator inserts a transurethral endoscope (800) into the needle receiving sheath (300) inserted into the urethra (C) through the outer sheath (S) to check the inside of the prostate, and manipulates the needle (200) to pass through the prostate (A, B) and place a pair of anchors (110, 120) on the outside of the prostate (A, B).

[0093] The needle receiving sheath (300) comprises a sheath main body (300a) formed by integrally combining a needle insertion tube (310), an endoscope insertion tube (320), and a blade moving tube (330) as illustrated in FIGS. 12 and 13, a needle guide member (340) provided at the tip of the sheath main body (300a) to guide the needle (200) toward the prostate (A, B), a blade part (350) provided to move back and forth inside the blade moving tube (330) to cut the free end (137) of the ligation thread (130), a manipulator (360) to arrange the ligation thread (130) protruding to the outside of the needle (200), and a sheath cylinder (370) that connects the sheath main body (300a) to the handle frame part (400). It includes a sheath lock button (380) that secures the outer sheath (S) to the sheath cylinder (370).

[0094] The needle insertion tube (310) accommodates a needle (200) inside, the endoscope insertion tube (320) is integrally connected to the lower part of the needle insertion tube (310) and accommodates a transurethral endoscope (800) inside. The blade axis moving tube (330) is integrally connected to the lower part of the endoscope insertion tube (320) and accommodates a blade plate connecting shaft (354) of a blade portion (350) and a blade support plate (357) inside so as to be movable.

[0095] As illustrated in an enlarged view in Fig. 14, a needle (200) is accommodated inside the needle insertion tube (310), a transurethral endoscope (800) is accommodated inside the endoscope insertion tube (320), and a blade plate connecting shaft (354) and a blade support plate (357) are accommodated in the blade axis moving tube (330). The needle insertion tube (310) and the endoscope insertion tube (320) are provided in the form of a hollow tube, and the blade axis moving tube (330) has a trapezoidal cross-section and is fixedly connected to the lower part of the endoscope insertion tube (320).

[0096] The rear end of the shush body (300a) is inserted into the handle frame part (400) by the shush cylinder (370) and the shush lock button (380). At this time, as illustrated in FIG. 13, a needle (200) is inserted into the inside of the needle insertion tube (310), and the pusher (610) of the needle operating part (600) is inserted to the rear of the needle (200). The pusher (610) is fixedly connected to the pusher holder (620), and the pusher (610) is moved back and forth inside the needle (200) by the operator's back and forth manipulation of the pusher holder (620), and the anchor assembly (100) is operated to be discharged.

[0097] 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). A transurethral endoscope (800) inserted through the endoscope fixing member (430) can be inserted into the endoscope insertion tube (320).

[0098] A needle guide member (340) is detachably connected to the tip of the needle insertion tube (310) and the blade shaft moving tube (330).

[0099] Here, the prostate enlargement treatment device (1) of the present invention is assembled in a fully assembled form as illustrated in Fig. 1, sterilized, and then delivered to the hospital. Accordingly, the operator only needs to operate the device in its assembled state during the procedure without having to disassemble or assemble each component, thereby improving ease of use.

[0100] Figure 15 is an exemplary diagram illustrating the operation process of a needle guide member (340) and a blade member (350). The needle guide member (340) includes a guide body (341) and a sheath fixing member (347) that connects the guide body (341) to a needle insertion tube (310).

[0101] The needle guide member (340) is connected by fixing the sheath fixing member (347) to the upper part of the needle insertion tube (310) and the guide body (341). A needle exposure hole (345) is formed between the sheath fixing member (347) and the blade shaft moving tube (330) to expose the needle (200) to the outside. The transurethral endoscope (800) moved to the endoscope insertion tube (320) through the needle exposure hole (345) can be exposed inside the urethra (C).

[0102] In addition, as shown in an enlarged view in Fig. 10, the ligation chamber (230) contained in the needle (200) is exposed to the outside through the needle exposure hole (345), and the ligation chamber (230) can be moved to the prostate (A, B) without interference.

[0103] A needle guide curve (343) is formed on the upper inner wall of the guide body (341) forming the needle exposure hole (345) to guide the needle (200) into the urethra (C). The needle (200) is initially positioned inside the needle insertion tube (310) as shown in Fig. 10, and when the operator manipulates the trigger (500), a certain length of the needle is exposed to the outside through the needle guide member (340) as shown in Fig. 11.

[0104] At this time, the needle (200) is bent at a certain angle along the curve of the needle guide surface (343) and moves through the prostate (A, B).

[0105] The blade section (350) is movably provided inside the blade axis moving tube (330), and after the first anchor (110) and the second anchor (120) are installed in the prostate (A, B), the blade section (350) is manipulated by the operator to cut the ligation chamber (130).

[0106] The blade section (350) includes a blade plate connecting shaft (354) on which a blade plate (351) is formed, as illustrated in FIG. 13, and a blade support plate (357) that is fixedly connected in parallel to the upper portion of the blade plate connecting shaft (354) to support the blade plate connecting shaft (354).

[0107] The vertical connection section (354a) formed at the rear end of the blade plate connecting shaft (354) is connected to the blade pressure button (355), and the user moves the blade pressure button (355) back and forth to cut the ligation chamber (130).

[0108] An external needle exposure hole (331) is provided at the tip of the blade shaft moving tube (330), and an internal needle exposure hole (352) is formed in the blade plate (351). As shown in (a) of Fig. 15, the external needle exposure hole (331) and the internal needle exposure hole (352) are formed to overlap each other, and the needle (200) is discharged through the external needle exposure hole (331) so that a pair of anchors (110, 120) and a ligation thread (130) are installed in the prostate (A, B).

[0109] A blade slit (353) is formed in the blade plate (351). The blade slit (353) is formed to gradually narrow in width, and the facing inner ends are formed sharply. When the operator pulls the blade pressure button (355) backwards to pull the blade plate (351) as shown in (b) of Fig. 15, the free end (137) of the ligation thread (130) is fitted into the blade slit (353) and cut.

[0110] The blade pressure button (355) and the cover (356) are used by the operator to cut the free end (137) of the ligation chamber (130). Fig. 22 (a) is an exemplary diagram showing a state in which the blade pressure button (355) and the cover (356) are coupled to the vertical coupling end (354a), and Fig. 22 (b) is an exemplary diagram showing the operation process of the blade lock release lever (429).

[0111] As shown, the vertical coupling member (354a) is fitted into the blade pressure button (355) to fix the position of the blade portion (350). The cover (356) is fitted into the blade pressure button (355) to fix the position of the vertical coupling member (354a).

[0112] A hook-and-loop (355a) protruding downwards is provided at the rear of the blade pressure button (355). The hook-and-loop (355a) is in contact with the blade lock release lever (429) provided on the handle frame (400) to restrict its position. When the operator wants to break the free end (137), he / she must pull the blade lock release lever (429) in the direction of the arrow to release the contact with the hook-and-loop (355a) and then pull the blade pressure button (355) backward.

[0113] Meanwhile, the suture arranger (360) arranges the complex ligation room (130) exposed outside the external needle exposure hole (331) as shown in Fig. 10 so that it does not interfere with the discharge path of the needle (200).

[0114] As illustrated in Fig. 14, the water dispenser (360) includes an dispenser body (361) that is open at the top and is fitted into a squeegee body (300a), a handle (363) that extends vertically to the lower portion of the dispenser body (361), and a squeegee receiving passage (365) formed inside the dispenser body (361).

[0115] In the first state in which the prostate enlargement treatment device (1) is packaged, as shown in Fig. 10, the water arranger (360) is connected to the tip of the sheath body (300a) and the ligation room (130) is accommodated in a neat state inside the sheath body (300a).

[0116] When the operator prepares to install the anchor assembly (100) into the prostate (A, B), the operator holds the handle (363) and presses downward on the arranger body (361) to separate the water arranger (360) from the sheath body (300a).

[0117] The sheath cylinder (370) secures the sheath body (300a) and the handle frame portion (400). As illustrated in FIG. 12, sheath coupling member insertion grooves (425) are formed at the ends of the right frame (410) and the left frame (420), respectively, and the sheath cylinder (370) into which the sheath body (300a) is fitted is coupled to the handle frame portion (400) as illustrated in FIG. 10.

[0118] In this state, the sheath lock button (380) is fitted into the tip of the sheath cylinder (370) and fixes the sheath body (300a) to the outer sheath (S). As illustrated in Fig. 13, the sheath cylinder (370) includes a sheath coupling tube (371) in which the sheath body (300a) is accommodated, and a frame coupling plate (373) vertically extended to the rear end of the sheath coupling tube (371). The frame coupling plate (373) is fitted into the sheath coupling member insertion grooves (425) of the right frame (410) and the left frame (420).

[0119] Inside the shushlock button (380), a fixing projection (381) that is fitted into the shushlock connecting tube (371) is provided to fix the position of the shushlock button (380).

[0120] The handle frame part (400) is coupled to the rear of the needle receiving sheath (300) as illustrated in FIGS. 2 to 4, and accommodates a trigger (500), a needle operating part (600), and a ligature thread winder (700). The handle frame part (400) allows the operator to manipulate the needle receiving sheath (300) and the needle operating part (600) while holding it with his / her hand, thereby inserting the needle receiving sheath (300) into the urethra, and then adjusting the positions of the needle (200) and the anchor assembly (100) to install the anchor assembly (100) into the prostate.

[0121] The handle frame portion (400) is formed by detachably connecting a left frame (420) and a right frame (410) arranged left and right. The left frame (420) and the right frame (410) are formed in a gun shape that can be gripped by hand.

[0122] The left frame (420) and the right frame (410) are formed in a symmetrical shape, but are described separately with respect to the configuration shown based on Fig. 12.

[0123] A trigger ring receiving groove (411) is formed on the lower part of the plate surface of the right frame (410) to receive the ring (510) of the trigger (500). In addition, a thread winder receiving groove (412), an indicator receiving groove (413), a pusher lever button receiving groove (414), a pusher holder manual operation slit (415), a pusher block moving slit (416), a blade pressure button moving slit (417), and a ligature thread manual cutting slit (418) are formed from the upper part of the plate surface.

[0124] Inside the left frame (420), a needle operating part receiving groove (421), a trigger rotation shaft (423), a lock release button engaging portion (422), a sheath coupling member insertion groove (425), an indicator coupling shaft (427), a pusher lever rotation shaft coupling tube (428), and a blade lock release lever (429) are respectively provided.

[0125] An endoscope fixing member (430) is detachably attached 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).

[0126] As illustrated in FIG. 2, the winder shaft (710) of the ligation thread winder (700) is rotatably inserted into the thread winder receiving groove (412) of the right frame (410) to support the ligation thread (130) wound around the outer periphery to be wound or unwound, and the indicator receiving groove (413) is coupled to the thread indicator (740) of the ligation thread winder (700) to be movable back and forth to externally display the current pulling degree of the free end (137) of the ligation thread (130). A scale (413a) is provided at the lower portion of the indicator receiving groove (413) along the longitudinal direction to enable the operator to accurately check the pulling degree of the free end (137) with the naked eye.

[0127] The pusher lever button receiving groove (414) is provided 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) protruding outward from the pusher lever button receiving groove (414) of the right frame (410) upward. The operation related to this will be described in more detail below.

[0128] The pusher holder manual operation slit (415) is a slit formed through the plate surface so that the operator can manually push the pusher holder (620) when the needle (200) is not fired. The pusher block movement slit (416) is inserted with both ends of the pusher block (635) of the needle holder (630). The operator can adjust the position of the pusher block (635) by manually pressing the pusher block (635) protruding from both sides of the pusher block movement slit (416).

[0129] The blade pressure button moving slit (417) accommodates both ends of the blade pressure button (355). The operator pulls the blade pressure button (355) exposed to the outside through the blade pressure button moving slit (417) backwards so that the blade slit (353) of the blade plate (351) breaks the free end (137).

[0130] The manual cutting slit (418) of the ligation thread is a slit that allows the operator to manually cut the free end (137) of the ligation thread (130) in the event that the prostate enlargement treatment device (1) malfunctions during the treatment using the device.

[0131] The needle operating unit (600) is accommodated in the needle operating unit receiving groove (421) of the left frame (420), and the trigger (500) rotation shaft coupling pipe (540) is rotatably fitted into the trigger rotation shaft (423). The pusher lever hinge (645) of the pusher lever (640) is elastically hooked and supported in the unlock button engaging portion (422). As described above, the frame coupling plate (373) of the sheath cylinder (370) is fitted into the sheath coupling member insertion groove (425). The frame coupling ring (741) of the thread indicator (740) of the ligature winder (700) is coupled to the indicator coupling shaft (427).

[0132] The pusher lever rotation shaft (643) of the pusher lever (640) is coupled to the pusher lever rotation shaft coupling tube (428) to rotatably support the pusher lever (640).

[0133] As previously discussed, the blade unlock lever (429) is provided so as to be rotatable left and right, and contacts and supports the engaging wing (355a) of the blade portion (350) to prevent movement of the blade pressurization button (355).

[0134] Fig. 16 is an internal perspective view showing the internal configuration of the handle frame (400), Figs. 17 and 18 are exploded perspective views showing the configuration of the shiss body (300a), trigger (500), needle operating unit (600), and ligature winder (700), and Fig. 19 is an exemplary view showing the needle (200) firing process.

[0135] The trigger (500) is rotatably connected to the handle frame (400) and is held in the operator's hand to transmit the operator's operation to the needle operating unit (600) so that the needle (200) can be fired.

[0136] As illustrated in FIG. 17, the trigger (500) includes a ring (510) that can fit the operator's finger, a pulling lever (520) that extends downward at a certain angle from the rear of the ring (510), a pressure lever (530) that extends to the upper portion of the pulling lever (520) and is coupled with a needle holder (630), and a rotation shaft coupling tube (540) that is coupled to the trigger rotation shaft (423) of the left frame (420).

[0137] As shown in Fig. 16, the trigger (500) has a pivot joint tube (540) coupled to the trigger pivot (423) and a ring (510) positioned in the trigger ring receiving groove (411). In addition, the pulling lever (520) extends to the lower portion of the handle frame portion (400), and the pressure lever (530) extends upward and is positioned between the lever head coupling member (633) of the needle holder (630).

[0138] The coupling head (531) of the pressure lever (530) is accommodated in the lever head receiving groove (633a) between the lever head coupling members (633), and when the operator pulls the pulling lever (520) by hand as shown in (c) of FIG. 19, the pressure lever (530) rotates in the opposite direction and the needle holder (630) moves forward.

[0139] When the operator pushes the pulling lever (520) in the opposite direction, the pressure lever (530) also returns to its initial state and the needle holder (630) moves backward.

[0140] As shown in Fig. 2, the operator places the index finger on the externally exposed ring (510) of the handle frame portion (400), wraps the handle frame portion (400) with the thumb, and holds the pulling lever (520) with the remaining fingers. Then, the operator manipulates the needle holder (630) by pulling or pushing the pulling lever (520).

[0141] The needle operating unit (600) is accommodated in the handle frame unit (400) and moves according to the operator's trigger (500) operating direction, and the needle (200) is fired and the anchor assembly (100) is installed in the prostate (A, B).

[0142] As illustrated in FIGS. 16, 17, and 18, the needle operating unit (600) includes a pusher (610) inserted into the rear end of a needle insertion tube (310), a pusher holder (620) fixedly connected to the pusher (610) and into which the rear end of an endoscope insertion tube (320) is inserted, a needle holder (630) that accommodates the pusher holder (620) inside and moves back and forth by operating a trigger (500), and a pusher lever (640) that is horizontally provided on the upper portion of the needle holder (630) and controls the movement of the needle holder (630) and limits the movement distance.

[0143] The pusher (610) is provided in the form of a rod having a certain length. The pusher (610) is provided with a length capable of pressing the anchor assembly (100) from the front end 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 presses the anchor assembly (100) so that the anchor assembly (100) provided at the front end of the needle (200) is ejected out of the needle (200).

[0144] The pusher holder (620) is accommodated inside the needle holder (630) and moves together with the needle holder (630), and the pusher (610) supports the anchor assembly (100) by applying pressure. The pusher holder (620) is formed in a square shape and an endoscope insertion hole (625) is formed penetrating the inside. The rear end (321) of the endoscope insertion tube (320) is inserted into the endoscope insertion hole (625). The rear end (321) of the insertion tube is inserted so as to protrude a certain length toward the rear of the pusher holder (620) and guides the transurethral endoscope (800) inserted through the endoscope fixing member (430) toward the prostate (A, B).

[0145] A pair of holder hinges (621) are provided on both sides of the pusher holder (620). The pair of holder hinges (621) are caught by position adjusting protrusions (631b, 631c) on the inner wall of the needle holder (630) when the pusher holder (620) is moved inside the needle holder (630), thereby limiting the movement distance of the pusher holder (620).

[0146] The holder hinge (621) is provided in the form of wings extending to both sides and is provided so as to be able to bend elastically.

[0147] Fig. 20 is a plan view illustrating a process in which a pusher holder (620) moves inside a needle holder (630). In Fig. 20 (a), the inner wall surface of the needle holder (630) is provided with a first pusher holder position adjustment protrusion (631b) and a second pusher holder position adjustment protrusion (631c) that are formed to protrude obliquely along the longitudinal direction.

[0148] In the initial position, a pair of holder hinges (621) extending to both sides of the pusher holder (620) contact the inner wall surface of the needle holder (630), and as shown in (b) of FIG. 20, when the pusher holder (620) is moved forward inside the needle holder (630), the pair of holder hinges (621) are elastically compressed and moved along the inclined surface and are supported by the first pusher holder position adjusting protrusion (631b), thereby limiting the position of the pusher holder (620).

[0149] After this, when the operator 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 is supported by the second pusher holder position adjustment protrusion (631c), thereby limiting the position of the pusher holder (620).

[0150] Here, the distance (d1, d2) between the first pusher holder position adjusting protrusion (631b) and the second pusher holder position adjusting protrusion (631c) is provided to correspond to the length of the first anchor (110) and the second anchor (120), so that the needle (200) moves forward by the distance that the pusher (610) moves, and the first anchor (110) and the second anchor (120) are discharged.

[0151] Meanwhile, a position adjustment tail (623) is provided protrudingly on the upper portion of the pusher holder (620). The position adjustment tail (623) is coupled with the pusher lever (640) when the needle holder (630) is moved forward by the trigger (500) and limits the movement speed and movement distance of the needle holder (630).

[0152] As shown in (c) of Fig. 19, when the needle holder (630) is moved forward by the operation of the trigger (500), the position adjustment tail (623) moves in interlock with the position adjustment teeth (641a) of the pusher lever (640) and moves forward not at once but by a distance equal to the size of the teeth.

[0153] The needle holder (630) moves back and forth in conjunction with the operator's operation of the trigger (500) to adjust 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 accommodated, a needle holder cap (634) covering the upper portion of the needle holder body (631), and a pusher block (635) accommodated in the needle holder (630) and limiting the movement distance of the pusher holder (620).

[0154] As shown in Fig. 18, the needle holder body (631) is formed with a sinking sheath movement path (631a) in the central region along the longitudinal direction. The sheath movement path (631a) accommodates an endoscope insertion tube (320) fixed to a pusher holder (620).

[0155] The first pusher holder position adjustment protrusion (631b) and the second pusher holder position adjustment protrusion (631c) described above are respectively provided on the inner walls on both sides of the needle holder body (631) to limit the movement position of the pusher holder (620).

[0156] Pusher block receiving grooves (631d) are provided on both front sides of the needle holder body (631). The pusher block receiving groove (631d) receives a pusher block (635) therein as illustrated in FIG. 12. The pusher block (635) is received between the pusher block receiving groove (631d) and the needle holder cap (634). Both ends of the pusher block (635) protrude to both sides of the pusher block receiving groove (631d) and are exposed to the outside of the pusher block moving slit (416) of the handle frame portion (400) as illustrated in FIG. 2.

[0157] The operator first pulls the trigger (500) and then moves the pusher holder (620) to the first pusher holder position adjusting protrusion (631b) that comes into contact with the pusher block (635) as shown in (b) of Fig. 20. As a result, the first anchor (110) of the anchor assembly (100) can be ejected outside the needle (200).

[0158] The operator presses the pusher block (635) exposed outside the pusher block moving slit (416) to separate it from the outside of the handle frame (400). Then, the operator pulls the trigger (500) a second time to move the pusher holder (620) forward all the way as shown in (c) of FIG. 20. As a result, the second anchor (120) can be discharged outside the needle (200).

[0159] A pair of lever head engaging members (633) are provided at the lower portion of the needle holder body (631). The engaging head (531) of the pressure lever (530) of the trigger (500) is accommodated between the lever head engaging members (633). The engaging head (531) is accommodated in a lever head receiving groove (633a) between the lever head engaging members (633), and the engaging head (531) presses the pair of lever head engaging members (633) left and right according to the rotational direction of the trigger (500) to pressurize the needle holder (630) to move.

[0160] The needle holder cap (634) covers the upper part of the needle holder body (631) and fixes the positions of the pusher holder (620) and pusher block (635) housed inside. A lower locking projection (634a) protruding upward is provided at the front of the needle holder cap (634). The lower locking projection (634a) engages with the upper locking projection (647) of the pusher lever (640) and fixes the position of the needle holder (630) so that it cannot move without the operator's operation.

[0161] The lower locking protrusion (634a) is formed to protrude forward and upward from the needle holder cap (634) in the shape of a right triangle in cross section as illustrated in Fig. 18. The upper locking protrusion (647) protrudes backward and downward from the pusher lever (640) as illustrated in Fig. 17. The upper locking protrusion (647) has a cross-sectional shape in the shape of a right triangle whose direction is opposite to that of the lower locking protrusion (634a).

[0162] Accordingly, in the initial state, as shown in (a) of Fig. 19, the lower locking protrusion (634a) and the upper locking protrusion (647) are in contact with each other with their vertical surfaces facing each other, and the needle holder (630) is restricted from moving forward.

[0163] As illustrated in (b) of Fig. 19, when the operator rotates the pusher lever (640) upward, the upper locking protrusion (647) is separated from the lower locking protrusion (634a). At this time, when the operator pulls the trigger (500), the needle holder (630) can be moved forward.

[0164] Meanwhile, as illustrated in Fig. 18, a block projection moving rail (634b) is formed to penetrate a certain area on the surface of the needle holder cap (634). A block projection (635a) formed to protrude from the upper surface of the pusher block (635) is accommodated in the block projection moving rail (634b). The block projection moving rail (634b) limits the movement distance of the pusher block (635) when the needle holder (630) is moved.

[0165] That is, since the block projection (635a) moves only as far as the block projection moving rail (634b), the moving distance of the pusher block (635) is also limited.

[0166] As described above, the pusher block (635) blocks the path of the pusher holder (620) so that the pusher holder (620) moves only a distance (d1) corresponding to the length of the first anchor (110) when the operator pulls the trigger (500) for the first time. The pusher block (635) is removed to the outside just before the operator pulls the trigger (500) for the second time. As described above, both ends of the pusher block (635) are exposed to the outside of the handle frame (400) through the pusher block receiving groove (631d) and the pusher block moving slit (416), and the operator can remove the exposed pusher block (635) by pulling it.

[0167] The pusher lever (640) is horizontally provided on the upper part of the needle holder (630) as shown in Fig. 16 to control the movement of the needle holder (630) and limit the movement speed of the needle holder (630). The pusher lever (640) includes a pusher lever bar (641) horizontally installed as shown in FIGS. 17 and 18, a pusher lever rotation shaft (643) installed in front of the pusher lever bar (641) to support the pusher lever bar (641) to rotate, a pusher lever hinge (645) formed to protrude upwardly in front of the pusher lever rotation shaft (643) and apply elastic force so that the pusher lever bar (641) returns to its initial position from the state of being rotated upward, an upper locking protrusion (647) protruding downward from the pusher lever bar (641), and a pusher lever button (649) extended to both sides of the rear of the pusher lever bar (641) by a certain area and operated by a practitioner.

[0168] The pusher lever bar (641) is provided as a bar having a certain length and is horizontally placed on top of the needle holder (630) inside the handle frame portion (400). Position-adjusting teeth (641a) are formed along the longitudinal direction at the lower portion of the pusher lever bar (641) and come into contact with the position-adjusting tail (623) of the pusher holder (620) as described above, thereby limiting the movement position of the needle holder (630). The needle holder (630) can be moved back and forth only by the length of the position-adjusting tail (623) formed.

[0169] When the operator pulls the trigger (500), the needle holder (630) moves forward along the position adjustment tail (623) as shown in (c) of FIG. 19.

[0170] The pusher lever rotation shaft (643) is connected to the pusher lever rotation shaft coupling tube (428) of the left frame (420) to support the pusher lever bar (641) so that it can rotate up and down. The pusher lever hinge (645) is formed to extend upward at a certain angle from the pusher lever rotation shaft (643). The pusher lever hinge (645) is inserted between the lock release button engaging portions (422) of the left frame (420) when the pusher lever rotation shaft (643) is inserted into the pusher lever rotation shaft coupling tube (428).

[0171] As shown in (a) of Fig. 19, the pusher lever hinge (645) is positioned to contact the inner wall surface of the unlock button engaging member (422). In this state, as shown in (b) of Fig. 19, when the operator presses the pusher lever button (649) upwards and the pusher lever bar (641) rotates around the pusher lever rotation axis (643), the pusher lever hinge (645) is compressed between the pusher lever rotation axis (643) and the unlock button engaging member (422).

[0172] As shown in (c) of Fig. 19, when the operator releases the pusher lever button (649), the compressed pusher lever hinge (645) applies elastic force to rotate the pusher lever bar (641) to the initial position, thereby causing the pusher lever bar (641) to elastically return to a horizontal state.

[0173] As previously discussed, the upper locking projection (647) engages with the lower locking projection (634a) of the needle holder cap (634) to control the movement of the needle holder (630).

[0174] The pusher lever button (649) extends horizontally left and right on the upper rear end of the pusher lever bar (641) and is accommodated 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 by a certain area, so the operator presses upward on the pusher lever button (649) exposed to the outside to lift the pusher lever bar (641) upward.

[0175] As shown in (a) of Fig. 19, when the pusher lever button (649) is lowered, the lower locking protrusion (634a) and the upper locking protrusion (647) are interlocked with each other, thereby 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 (400) upwards, thereby rotating the pusher lever bar (641) upwards, as shown in (b) of Fig. 19. As a result, the upper locking protrusion (647) and the lower locking protrusion (634a) are separated, and the practitioner pulls the trigger (500) as shown in (c) of Fig. 19, thereby moving the needle holder (630) forward.

[0176] The ligation thread winder (700) allows the operator to wind the free end (137) of the ligation thread (130) to adjust the length of the free end (137) and thereby control the strength with which the ligation thread (130) compresses the prostate (A, B). As illustrated in FIG. 12, the ligature winder (700) includes a winder shaft (710), a one-way rotation limiting tooth (720) formed on the winder shaft (710) to limit the rotation direction so that the winder shaft (710) can only rotate in one direction, a thread winder lock release button (730) provided on the upper portion of the left frame (420) to control whether the winder shaft (710) rotates, and a thread indicator (740) provided on the movement path of the ligature thread (130) between the needle (200) from the winder shaft (710) to detect the tension of the free end (137).

[0177] The winder shaft (710) is accommodated in the winder receiving groove (412) of the left frame (420) and the right frame (410). At this time, the rotation operation knob (715) provided at both ends of the winder shaft (710) is exposed to protrude outward from the winder receiving groove (412) so that the operator can hold and rotate it by hand.

[0178] The outer circumference of the winder shaft (710) is provided with a thread fitting ring (711) to which a ligature thread (130) is fixed, as shown in Fig. 17. The ligature thread (130) is tied with a knot to the thread fitting ring (711) and wound several times around the outer circumference of the winder shaft (710).

[0179] Figure 21 (a) is an exemplary diagram illustrating the operation process of the winder lock release button (730) and the one-way rotation limiting tooth (720). The one-way rotation limiting tooth (720) is formed to protrude at a certain angle interval from the outer periphery of the winder shaft (710). At this time, one surface of the one-way rotation limiting tooth (720) is formed as an inclined surface (721), and the other surface is formed as a vertical surface (723).

[0180] The thread winder unlock button (730) is formed so that the frame connecting end (731) on the lower side is fixed to the handle frame part (400) and the upper part protrudes outward from the handle frame part (400). A tooth engaging projection (733) is formed vertically in the direction opposite to the frame connecting end (731). The lower part between the frame connecting end (731) and the tooth engaging projection (733) is formed as a gentle curve.

[0181] In the initial state, the tooth catch (733) remains in contact with the vertical surface (723) of the one-way rotation restriction tooth (720). The operator pulls the thread winder unlock button (730) clockwise and rotates the rotation operation knob (715) to wind the ligation thread (130).

[0182] At this time, the winder shaft (710) is provided so that it can rotate only in the direction in which the ligature room (130) is wound. That is, it is provided so that only counterclockwise rotation is possible based on (a) of Fig. 21. 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, and the winder shaft (710) can 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 projection (733), and the rotation is limited.

[0183] The thread indicator (740) indicates to the operator the tension currently applied to the free end (137) of the ligation thread (130). The thread indicator (740) is provided with indicator protrusions (745) protruding outward on both sides. The indicator protrusions (745) are provided so as to be able to move left and right along the indicator receiving groove (413) of the right frame (410), as illustrated in FIG. 2.

[0184] An elastic member (743) in the form of a coil spring having a certain length is coupled to the real 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 FIG. 11.

[0185] As illustrated in Fig. 16, the ligation thread (130) is connected to the first anchor (110) and the second anchor (120) through the needle insertion tube (310) via the thread indicator (740) from the winder shaft (710). When the operator rotates the winder shaft (710) to wind the ligation thread (130), the tension increases and the thread indicator (740) gradually moves to the right. The operator checks the current position of the thread indicator (740) by rotating the rotation operation knob (715), and when the desired tension is reached, the free end (137) is cut using the blade portion (350).

[0186] The prostate enlargement treatment process using the prostate enlargement treatment device (1) according to the present invention having such a configuration is described with reference to FIGS. 2 to 24.

[0187] Figures 23 and 24 are schematic diagrams illustrating the prostate hypertrophy treatment process.

[0188] The prostate enlargement treatment device (1) is prepared in a sterile package in a fully assembled state as shown in Fig. 2.

[0189] At this time, as shown in an enlarged view in Fig. 10, the anchor assembly (100) is fitted into the needle slot (220) of the needle (200), and the ligation chamber (130) is exposed to the outside through the external needle exposure hole (331) of the blade plate (351) and prepared in a state of being accommodated inside the water treatment arranger (360).

[0190] The free end (137) of the ligation thread (130) extended to the rear end of the needle insertion tube (310) is wound around the outer circumference of the winder shaft (710) of the ligation thread winder (700) after passing through the thread indicator (740) as shown in FIG. 10.

[0191] Before the procedure begins, in the preparation state, as shown in (a) of Fig. 19, 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).

[0192] Since the movement of the needle holder (630) is restricted, the position of the trigger (500) in which the coupling head (531) of the pressure lever (530) is inserted between the lever head coupling member (633) of the needle holder (630) is also fixed.

[0193] The practitioner uses anesthetic gel to induce 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).

[0194] The practitioner first inserts the outer sheath (S) through the urethra, and the outer sheath (S) remains inserted until the end of the procedure.

[0195] The operator removes the urethra adjuster (360) from the needle receiving sheath (300) and inserts the needle receiving sheath (300) into the urethra (C) through the pre-inserted outer sheath (S) as shown in (b) of Fig. 23. At this time, the needle (200) is accommodated in the needle insertion tube (310).

[0196] The operator presses upward the pusher lever button (649) exposed to the outside of the handle frame portion (400) as shown in (b) of Fig. 19. As the pusher lever button (649) is pressed upward, the needle holder (630) and the trigger (500) become movable.

[0197] In this state, the operator examines the interior with a transurethral endoscope (800) inserted into a needle receiving sheath (300) and confirms the location where the anchor (110, 120) will be placed. The location where the anchor (110, 120) will be placed can be confirmed through anatomical points such as the bladder neck and vermontanum.

[0198] The needle receiving sheath (300) is tilted at an angle of more than 20 degrees toward the lateral lobe of the left prostate. This is only an example, and the practitioner will independently decide whether to perform the procedure on the left or right side first.

[0199] Then, the operator manually pulls the trigger lever (520) of the trigger (500) to move the needle holder (630) forward by the rotation of the pressure lever (530) as shown in (c) of Figure 19. As a result, the needle (200) is fired.

[0200] The practitioner presses the pulling lever (520) until the needle holder (630) is moved to the anterior end or until the needle (200) does not advance any further.

[0201] When the needle holder (630) moves forward, the position adjustment tail (623) moves along the position adjustment teeth (641a) of the pusher lever bar (641). Then, the pusher holder (620) moves together inside the needle holder (630) and moves until it contacts the pusher block (635) as shown in (b) of FIG. 20 or until the holder hinge (621) is caught on the first pusher holder position adjustment protrusion (631b).

[0202] When the needle holder (630) has moved forward to a certain extent, the practitioner can release the hand that was 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).

[0203] The needle (200) is fired by the forward movement of the needle holder (630) and the pusher holder (620), and as shown in (c) of FIG. 23, the needle (200) is fired out of the needle guide member (340), penetrates the prostate (A, B), and comes out into the outer lobe of the prostate.

[0204] At this time, as shown in (a) of Fig. 9, the first anchor (110) and the second anchor (120) are sequentially received in the needle slot (220), and a pusher (610) is inserted into the rear end of the needle (200).

[0205] In this state, the operator does not press the pusher lever button (649) upward again, but presses the ring (510) of the trigger (500) to move the needle holder (630) that has moved forward backward. At this time, the position of the pusher holder (620) is fixed because the position adjustment tail (623) is caught on the position adjustment tooth (641a) of the pusher lever (640), and only the needle holder (630) moves 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 ejected out of the needle (200), as illustrated in (b) of FIG. 9.

[0206] The first anchor (110) discharged outside the needle (200) is placed on the upper outer side of the left prostate (A) as shown in (d) of Fig. 23.

[0207] When the discharge of the first anchor (110) is completed, the pusher lever button (649) is pressed upward and the ring (510) of the trigger (500) is pressed to move the needle holder (630) all the way back. At this time, the position of the pusher holder (620) within the needle holder (630) is fixed by the pusher block (635). Accordingly, the pusher (610) and the needle (200) are moved back together.

[0208] The position of the needle receiving sheath (300) is moved to the position where the second anchor (120) is to be discharged. Then, the pusher block (635) is pulled to remove the pusher block (635) from the handle frame (400). Then, the process described above is repeated to press the pusher lever button (649) upward and pull the pulling lever (520) to move the needle holder (630) forward. As a result, the needle (200) is inserted by piercing the lower part of the left prostate (A). In this state, the operator does not press the pusher lever button (649) upward, but presses the ring (510) of the trigger (500) to move the needle holder (630) that has been moved forward backward.

[0209] At this time, since the pusher block (635) is removed as shown in (c) of FIG. 20, the pusher holder (620) moves within the needle holder (630) by a distance (d2) that can press 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) is moved backward by the needle holder (630), so that the second anchor (120) is ejected out of the needle (200). When the ejection of the second anchor (120) is completed, the pusher lever button (649) is pressed upward and the ring (510) of the trigger (500) is pressed to move the needle holder (630) all the way to the rear.

[0210] The second anchor (120) discharged from the needle (200) is placed on the lower outer side of the left prostate (A) as shown in (a) of Fig. 24. At this time, the first anchor (110) and the second anchor (120) are connected by a ligature thread (130), and the free end (237) is wound around a ligature thread winder (700) through a needle insertion tube (310).

[0211] As shown in (b) of Fig. 24, when the first anchor (110) and the second anchor (120) are positioned on the outside of the prostate (A, B), the length adjustment loop (133) is not adjusted in length, so the ligation room (130) is positioned loosely and no pressure is applied to the prostate tissue.

[0212] The operator checks the inside with an endoscope and, as shown in (a) of Fig. 21, pulls the winder unlock button (730) so that the tooth catch (733) is spaced apart from the vertical surface (723) of the one-way rotation restriction tooth (720), and rotates the rotation operation knob (715) so that the free end (237) is wound around the winder shaft (710).

[0213] The free end (237) 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 (A). As shown in (b) of Fig. 21, the operator checks the scale (413a) indicated by the thread indicator (740) and checks the tension of the free end (137).

[0214] After checking the tension of the free end (137) indicated on the scale (413a) and confirming the degree to which the anchor assembly (100) compresses the left prostate (A) and opens the urethra (C) using a transurethral endoscope (800), the operator presses and rotates the blade unlocking lever (429) as shown in (b) of Fig. 22. When the engagement state of the blade unlocking lever (429) and the engagement wing (355a) of the blade pressurizing button (355) is released, the blade pressurizing button (355) is pushed backward.

[0215] Accordingly, as shown in (b) of Fig. 15, the blade plate (351) slides toward the rear of the internal needle exposure hole (352), and the free end (137) of the ligation thread (130) is inserted into the blade slit (353) of the blade plate (351), and the free end (137) is cut.

[0216] The length of the free end (137) of the cut ligature (130) is less than 1 mm and is buried in the prostate tissue. As a result, the procedure of opening the urethra by compressing the left prostate (A) by the anchor assembly (100) is completed, as shown in (c) of Fig. 24.

[0217] After the operator separates the needle receiving sheath (300) from the urethra, he / she uses a new prostate enlargement treatment device (1) to install the anchor assembly (100) on the right prostate (B) in the same way as on the left prostate (A).

[0218] Accordingly, as illustrated in (d) of Fig. 24, a pair of anchor assemblies (100) are installed in the left prostate (A) and the right prostate (B) to open the urethra (C). At this time, the anchor assemblies (100) continuously compress the prostate tissue in a “ㄷ” or oval shape connecting the first anchor (110), the second anchor (120), and the ligation chamber (130). Thereby, there is an advantage in that the length (ℓ) of the urethra (C) compressed and opened by the ligation chamber (130) can be adjusted, and the width (d) of the compression can also be adjusted.

[0219] As described above, the prostate hypertrophy treatment device according to the present invention has the advantage of allowing for a faster urinary flow because the prostate tissue compressed by the ligation thread and a pair of anchors is continuously connected, compared to the conventional treatment method of partially compressing the prostate tissue, and this can be even more effective for patients with long prostates.

[0220] In addition, the prostate enlargement treatment device according to the present invention has the advantage that the operator can adjust the strength of compression on the prostate as desired by winding the free end of the ligation thread to adjust the length of the ligation thread.

[0221] Accordingly, it is effective in adjusting the degree of pressure to suit the various symptoms of benign prostatic hyperplasia in each patient.

[0222] The treatment method using the prostate hypertrophy treatment device of the present invention does not require general anesthesia or a long surgical time, unlike other laser treatments or electrical surgeries that use heat energy.

[0223] The simple anchor placement method allows for a quick surgery time and local anesthesia. 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, it offers the advantage of allowing for additional surgery at any time if the procedure is ineffective.

[0224] The technical idea of ​​the present invention has been examined through several examples above.

[0225] It is self-evident that a person skilled in the art to which the present invention pertains can make various modifications or changes to the above-described embodiments based on the disclosure of the present invention. Furthermore, even if not explicitly illustrated or described, it is self-evident that a person skilled in the art to which the present invention pertains can make various modifications that include the technical ideas of the present invention based on the disclosure 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 described for the purpose of explaining the present invention, and the scope of the present invention is not limited to these embodiments.

Claims

1. Multiple anchors (110, 120) placed in the prostate to compress the urethra; A ligation chamber (130) that connects the plurality of anchors (110, 120) to each other so that the plurality of anchors continuously compress the prostate tissue to secure the prostate urethra; A needle (200) having elasticity that accommodates the anchor (110, 120) and the ligation chamber (130) inside and guides the anchor (110, 120) and the ligation chamber (130) to be installed in the prostate by being inserted into the urethra; A prostate enlargement treatment device characterized by including a needle firing means for firing the needle (200) so that the needle (200) is inserted into the urethra, and for operating the needle (200) so that the plurality of anchors (110, 120) and the ligation thread (130) are discharged.

2. In paragraph 1, When the above plurality of anchors (110, 120) are provided as a pair of a first anchor (110) and a second anchor (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. A prostate enlargement treatment device characterized in that the above ligation room (130) includes a fixed end (131) fixed to the first anchor (110), a length-adjusting loop (133) coupled to the second anchor (120) and formed to be able to adjust the length, a slip knot (135) connecting the fixed end (131) and the length-adjusting loop (133), and a free end (137) extending from the length-adjusting loop (133).

3. In paragraph 1, When the above plurality of anchors (110, 120) are provided as a pair of a first anchor (110) and a second anchor (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. A prostate enlargement treatment device characterized in that the above ligation room (130) is formed to be able to adjust the length by being connected to the first anchor (110) and the second anchor (120), and includes a length-adjusting loop (133), and a slip knot (135) connected to a free end (137) and a fixed end (131) forming the length-adjusting loop (133) and supporting the length of the length-adjusting loop (133) to be adjusted.

4. In paragraph 1, When the above plurality of anchors (110, 120) are provided as a pair of a first anchor (110) and a second anchor (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 above ligation room (130) includes a fixed knot (131a) fixed to the first anchor (110) and a free end (137) extended from the fixed knot (131a) via the second anchor (120). A prostate enlargement treatment device characterized in that it further includes a lock anchor (150) that is connected to the free end (137) at the lower inner side of the prostate and fixes the position of the free end (137).

5. In paragraph 1, When the above multiple anchors (110, 120) are provided with three anchors, a first anchor (110), a second anchor (120), and a third anchor, 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 above-mentioned ligation chamber (130) includes a fixed end (131) fixed to the first anchor (110), and a free end (137) extended from the fixed end (131) via the second anchor (120) and the third anchor (140). A prostate enlargement treatment device characterized in that it further includes a lock anchor (150) that is connected to the free end (137) at the lower inner side of the prostate and fixes the position of the free end (137).

6. In paragraph 1, A prostate enlargement treatment device characterized in that when the above plurality of anchors (110, 120) are provided as a pair of a first anchor (110) and a second anchor (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. In any one of paragraphs 1 to 6, The above needle launching means, A needle receiving sheath (300) that receives the above needle (200); A needle operating unit (600) that operates the movement of the needle (200) so that the needle (200) is discharged through the end of the needle receiving sheath (300); A trigger (500) that operates the needle operating part (600) so that the needle (200) is fired; A prostate enlargement treatment device characterized by including a handle frame (400) that supports the rear end of the needle receiving sheath (300) and the needle operating part (600) and the trigger (500).

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