A percutaneous nephrolithotomy channel-assisted hemostasis device

Abstract

This invention belongs to the field of medical device technology, specifically a percutaneous nephrolithotomy (PCNL) channel-assisted hemostasis device. The device comprises an outer layer with a slidingly nested limiting layer, a limiting layer with a nested expanding section, and a slidingly nested thread within the expanding section. The end of the thread is connected to a probe equipped with a camera. The head of the expanding section is located outside the outer layer and limiting layer, and consists of an expandable ring structure composed of 4, 6, or 8 electrocoagulation sections. Each electrocoagulation section can expand outwards to conform to the PCNL channel, and a gap is formed between every two sets of electrocoagulation sections during expansion. A ring is fixed to the end of the outer layer, and the ring is equipped with auxiliary rods of the same number as the electrocoagulation sections. These auxiliary rods are used to fill the gaps formed between every two sets of electrocoagulation sections during expansion. This invention facilitates immediate hemostasis when the bleeding location is observed under the nephrolithotomy, while ensuring that the electrocoagulation hemostasis area is sufficient to cover the hemostasis range, and it can pass through the PCNL channel.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a percutaneous nephrolithotomy channel-assisted hemostasis device. Background Technology

[0002] Percutaneous nephrolithotomy (PCNL) is a technique that uses an endoscope to enter the upper urinary tract through a dilated skin-to-kidney collecting system channel to perform examination, diagnosis, and treatment. The most common complication of PCNL lithotripsy is massive bleeding. Traditional hemostasis methods include:

[0003] Immediately stop the surgical procedure, clamp and tear the sheath, and use the pressure of the blood clot in the renal pelvis to stop the bleeding;

[0004] If bleeding continues, stop the surgery, leave a 16F balloon catheter in place, inflate the balloon to 3-5 mL, and apply pressure to stop the bleeding.

[0005] Selective renal arteriography and embolization;

[0006] Open nephrectomy or nephrectomy;

[0007] These methods lead to a second surgery, which in turn brings medical expenses and the risk of a second surgery. Currently, there is another method for hemostasis, which involves establishing a working channel during the operation. After lithotripsy, the ureteroscope and the plasma bipolar electrocautery ring are simultaneously inserted into the nephroscope channel, and then slowly withdrawn, pressing the plasma bipolar electrocautery ring against the exposed bleeding point to stop the bleeding through electrocoagulation.

[0008] The problem with this hemostasis method is that:

[0009] How operable are the electrodes used for electrocoagulation hemostasis?

[0010] How much electrocoagulation area is affected, and how effective is the hemostasis?

[0011] In special circumstances, such as when the amount of bleeding is relatively large, can the hemostasis effect be guaranteed? (Electrocoagulation hemostasis is often less effective when the amount of bleeding is large).

[0012] The existing patent (publication number: CN112022335A) and a percutaneous nephrolithotomy channel-assisted hemostasis device have the following problems:

[0013] 1. Because it cannot be used with a nephroscope, the hemostatic device cannot accurately reach the bleeding site;

[0014] 2. It uses electrocoagulation for hemostasis, but it has many structures that pass through high-frequency current, and the actual electrocoagulation area is not ideal, and there are dead angles between the two sets of electrocoagulation rings.

[0015] 3. Its elastic structure cannot guarantee good support when penetrating the nephroscope channel.

[0016] Therefore, we propose a percutaneous nephrolithotomy channel-assisted hemostasis device, which facilitates immediate hemostasis when the bleeding site is seen through the nephroscope, while ensuring that the area of ​​electrocoagulation hemostasis is sufficient to cover the hemostasis range, and can pass through the nephrolithotomy channel. Summary of the Invention

[0017] In order to overcome the above-mentioned defects of the prior art, the present invention provides a percutaneous nephrolithotomy channel-assisted hemostasis device to solve the problems existing in the background art.

[0018] To achieve the above objectives, the present invention provides the following technical solution: a percutaneous nephrolithotomy channel-assisted hemostasis device, comprising an outer layer, a limiting layer slidably nested inside the outer layer, an unfolding portion nested inside the limiting layer, a filament slidably nested inside the unfolding portion, and a probe with a camera connected to the end of the filament;

[0019] The head of the expanding section is located outside the outer layer and the limiting layer. It consists of an expandable ring structure composed of 4, 6 or 8 electrocoagulation sections. Each electrocoagulation section can expand outward to fit the nephroscope channel, and a gap is formed between each two sets of electrocoagulation sections during expansion.

[0020] The outer layer has a ring body fixed at its end. The ring body is provided with the same number of auxiliary rods as the electrocoagulation section. The auxiliary rods are used to fill the gaps formed when two sets of electrocoagulation sections expand. The expanded annular electrocoagulation sections and the auxiliary rods inserted between each pair of electrocoagulation sections form a closed ring.

[0021] Furthermore, an expansion section is provided at the connection between the probe and the wire. The expansion section is a frustum-shaped structure with a small bottom and a large top. The expansion section compresses the electrocoagulation sections that are assembled into a ring structure from the inside out, and it makes each electrocoagulation section expand outward evenly.

[0022] Furthermore: the auxiliary rod is a wedge shape that is narrow at the top and wide at the bottom. Each of the auxiliary rods is inserted into the gap formed between every two electrocoagulation parts during expansion. The auxiliary rods and electrocoagulation parts interlock to form a ring structure with a maximum diameter greater than the diameter of the outer layer. Both the electrocoagulation parts and the auxiliary rods can carry high-frequency current.

[0023] Furthermore: the column of the expanded part is wrapped by a restrictive layer, and the same number of constricting parts are provided between the column and the electrocoagulation part. All the constricting parts form a frustum shape with a small bottom and a large top. A bending part is provided between each constricting part and the column. The constricting part drives the electrocoagulation part to tilt outward through the bending part to form an expansion.

[0024] Furthermore: a through hole is provided at the center of the unfolded part, the through hole passing through the column, the constricted part and the electrocoagulation part of the unfolded part, and a guide ring is provided on the inner wall of the through hole and corresponding to the electrocoagulation part. The maximum diameter of the guide ring is smaller than the maximum diameter of the probe.

[0025] Furthermore, both the auxiliary rod and the unfolded part are made of shape memory metal, and the auxiliary rod and the unfolded part return to their initial state after the external stress disappears.

[0026] Furthermore, each pair of inner and outer rings of the electrocoagulation section is provided with an opening, and the auxiliary rod is inserted through the opening into the gap formed by the expansion of each pair of electrocoagulation sections.

[0027] Furthermore: the top of the auxiliary rod is provided with a caulking part that bends toward the center, the expansion part of the probe causes the annular electrocoagulation part to expand, and the caulking part of the auxiliary rod is guided along the inclined surface of the expansion part so that the auxiliary rod opens outward in the gap.

[0028] Furthermore: the electrocoagulation surface of the electrocoagulation part is a protruding arc surface, and the top surface of the electrocoagulation part is an inclined surface that slopes towards the center.

[0029] Compared with the prior art, the technical effects and advantages of the present invention are as follows:

[0030] The percutaneous nephrolithotomy channel-assisted hemostasis device of the present invention, during nephrolithotomy, locates the bleeding site through the camera of the nephrolithotomy probe, moves the expanding part to the bleeding site, and then pulls back the probe so that the expanding part of the probe evenly expands the annular electrocoagulation part. The electrocoagulation part is then bent by the constricting part and the bending part to fit the nephrolithotomy channel. At the same time, the annular electrocoagulation part creates gaps when it expands, which are filled by auxiliary rods. The multiple expanded electrocoagulation parts and multiple auxiliary rods combine to form a closed ring, which fits the nephrolithotomy channel, and hemostasis is achieved by high-frequency current. The expanded electrocoagulation part can compress the bleeding site in the nephrolithotomy channel to reduce the amount of bleeding. Hemostasis is achieved by electrocoagulation. In the case of large bleeding, it can avoid the large amount of bleeding affecting the effect of electrocoagulation hemostasis. It is beneficial to complete the hemostasis treatment as soon as the bleeding site is seen in the nephrolithotomy, and at the same time, it can ensure that the area of ​​electrocoagulation hemostasis is sufficient to cover the hemostasis area and can pass through the nephrolithotomy channel.

[0031] The percutaneous nephroscope-assisted hemostasis device of the present invention is simple to operate compared with other methods, requiring less manipulation of the electrocoagulation electrode, and covering a larger area for electrocoagulation hemostasis, thus ensuring the effectiveness of electrocoagulation hemostasis. When inserted into the nephroscope channel together with the nephroscope, it provides higher precision in locating the bleeding site. After identifying the bleeding site, hemostasis can be performed promptly and effectively to stop the bleeding area and prevent its further development, thus providing timeliness. Attached Figure Description

[0032] Figure 1 This is a schematic diagram showing the overall structure of the present invention;

[0033] Figure 2This is a schematic diagram of the structure of the expansion portion expanding the unfolded portion according to the present invention;

[0034] Figure 3 This is a schematic diagram of the unfolded part structure of the present invention;

[0035] Figure 4 This is a schematic diagram of the unfolded structure of the two electrocoagulation sections of the present invention;

[0036] Figure 5 This is a schematic diagram of the probe structure of the present invention;

[0037] Figure 6 This is a schematic cross-sectional view of the overall structure of the present invention;

[0038] Figure 7 This is a schematic diagram of the auxiliary rod structure of the present invention;

[0039] Figure 8 This is a schematic diagram of the overall structure of another embodiment of the present invention.

[0040] The attached diagram is labeled as follows: 1. Outer layer; 2. Ring body; 3. Auxiliary rod; 31. Sealing part; 4. Restriction layer; 5. Development part; 51. Column body; 52. Bending part; 53. Closing part; 54. Electrocoagulation part; 55. Opening part; 56. Through hole; 57. Guide ring part; 6. Line body; 7. Probe; 71. Camera; 72. Expansion part. Detailed Implementation

[0041] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings. In addition, the forms of the various structures described in the following embodiments are merely illustrative. The structures involved in the present invention are not limited to the structures described in the following embodiments. All other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0042] Example:

[0043] Please see Figures 1-8 The present invention provides a technical solution: a percutaneous nephrolithotomy channel-assisted hemostasis device, comprising an outer layer 1, a limiting layer 4 slidably nested inside the outer layer 1, an unfolding part 5 nested inside the limiting layer 4, a filament 6 slidably nested inside the unfolding part 5, and a probe 7 with a camera 71 connected to the end of the filament 6;

[0044] Since medical devices need to meet national standards, the materials used in the devices must be described.

[0045] The preferred materials for the confinement layer 4 and outer layer 1 are medical-grade polytetrafluoroethylene (PTFE) or fluorinated ethylene propylene, which have extremely low coefficients of friction (facilitating the sliding of confinement layer 4), excellent chemical inertness, good biocompatibility, good high-frequency insulation, and resistance to high-temperature sterilization. Alternatively, medical-grade polyethylene or polyetheretherketone (PEEK) can be used. Both have good biocompatibility, and PEEK has high strength and high heat resistance, although its coefficient of friction may be slightly higher than that of PTFE or fluorinated ethylene propylene.

[0046] Line 6 uses ultra-fine medical-grade stainless steel cable or multi-strand stranded wire with an insulation layer, or Nitinol wire (a non-magnetic alloy composed of nickel (Ni) and titanium (Ti)) with an insulation layer. It has high strength, good flexibility, and can be pushed. The insulation layer prevents current leakage.

[0047] The head of the expanding part 5 is located outside the outer layer 1 and the restrictive layer 4. It consists of 4, 6 or 8 electrocoagulation parts 54 forming an expandable ring structure. Each electrocoagulation part 54 can expand outward to fit the nephroscope channel, and a gap is formed between each two sets of electrocoagulation parts 54 during expansion.

[0048] The difference between having 4, 6, and 8 electrocoating sections 54 is as follows:

[0049] Four electrocoagulation sections 54 are symmetrically distributed at 90°. The arc length of a single electrocoagulation section 54 accounts for 25% of the circumference. After expansion, the gap is relatively large (≈10% of the channel circumference), requiring a thick wedge-shaped auxiliary rod 3 (the arc radius R of the filling section 31 is ≥0.5mm).

[0050] The six electrocoagulation sections are symmetrically distributed at a 54:60° angle, with an arc length accounting for 16.7% of the circumference and moderate gaps. The auxiliary rod has a wedge angle α = 12° ± 1° (balancing the filling strength and flexibility).

[0051] The eight electrocoagulation sections are symmetrically distributed at a 54:45° angle, with an arc length accounting for 12.5% ​​of the circumference. The gaps between them are minimal. The auxiliary rod 3 and the filling section 31 need to be ultra-thin (thickness ≤ 0.2mm) and have a pre-bent arc (to fit irregular channels).

[0052] parameter 4 electrocoagulation sections 6 electrocoagulation sections 8 electrocoagulation sections Applicable channel diameter 8–12 mm (standard channel) 12-18mm (larger channel) 18~25mm (extra-large / irregular channel) Single electrocoating section width 4.5~6mm 3-4mm 2~2.5mm Post-expansion gap (G) 3-4mm 1.5~2.5mm 1~1.8mm auxiliary rod thickness 3.2~3.8mm (wedge-shaped base) 2~2.5mm 1.2~1.5mm thermal damage depth ≤1.8mm (energy concentration) ≤1.5mm ≤1.2mm (energy dispersion) Bending stiffness High (stable structure) middle Low (good flexibility)

[0053] Regarding expansion mechanical properties:

[0054] Four electrocoagulation sections 54: expansion force ≥8N (high rigidity), suitable for strong adhesion of fibrotic tissues.

[0055] The stress concentration rate at the bend is 1.5 times (finite element analysis result).

[0056] 8 electrocoating sections 54:

[0057] Expansion force ≤ 4N (low trauma), adapted to fragile renal parenchyma.

[0058] The bending section 52 adopts a distributed micro-hinge structure (stress is distributed to 8 nodes).

[0059] The difference in clinical application lies in hemostasis efficiency:

[0060] 4 electrocoagulation sections 54:

[0061] The single-point electrocoagulation area is large (15-20 mm²), making it suitable for diffuse bleeding.

[0062] High-frequency current density: 0.8–1.2 A / cm² (rapid solidification).

[0063] 8 electrocoating sections 54:

[0064] The single-point electrocoagulation area is small (5-8 mm²), and it is specifically used for punctate arterial bleeding (≤2 mm vessels).

[0065] Current density 0.3~0.5A / cm² (precise low thermal damage).

[0066] Channel adaptability:

[0067] Scene 4 electrocoagulation sections 6 electrocoagulation sections 8 electrocoagulation sections Standard nephroscopic approach (Fr24) excellent optimal Too dense Narrow / bent passage Insufficient fit good Excellent (flexible bonding) Irregular wound after lithotripsy Easy to leave blind spots Coverable Best (contour applicator)

[0068] Experimental data

[0069] In vitro porcine kidney model test (30W power, 3s duration):

[0070] index 4 electrocoagulation sections 6 electrocoagulation sections 8 electrocoagulation sections Complete hemostasis time 4.2±0.5s 3.5±0.3s 2.8±0.4s thermal damage depth 1.75±0.2mm 1.45±0.1mm 1.15±0.1mm Tissue adhesion probability 18% 9% 5%

[0071] The six electrocoagulation points achieve the best balance between hemostasis speed and damage control.

[0072] The 8 electrocoagulation sections 54 have a significant advantage in terms of minimal invasiveness (reduced adhesion rate).

[0073] The column 51, the constriction part 53, and the bending part 52 of the expansion part 5 are all made of medical-grade nickel-titanium alloy. Its excellent superelasticity and shape memory effect are the key to achieving controllable expansion and contraction, and it has good biocompatibility.

[0074] The basic structure of the electrocoagulation unit 54 is made of medical-grade nickel-titanium alloy, and its working surface / electrode is made of medical-grade platinum-iridium alloy or gold plating. Platinum-iridium alloy and gold have excellent biocompatibility, extremely high chemical stability (corrosion resistance), good electrical and thermal conductivity (beneficial to electrocoagulation effect), and are not prone to tissue adhesion. At the same time, the conductive coating must be firmly attached to the nickel-titanium alloy substrate to ensure stable current conduction during electrocoagulation.

[0075] The outer layer 1 has a ring body 2 fixed at its end. The ring body 2 is provided with the same number of auxiliary rods 3 as the electrocoagulation section 54. The auxiliary rods 3 are used to fill the gap formed when each two sets of electrocoagulation sections 54 expand. The expanded annular electrocoagulation section 54 and the auxiliary rods 3 inserted between each two electrocoagulation sections 54 form a closed ring or a closed ring body 2.

[0076] The auxiliary rod 3 is made of medical-grade nickel-titanium alloy, which works in conjunction with the unfolding part 5 to achieve synchronous expansion and retraction, ensuring shape recovery and mechanical strength. The working surface / electrode (tissue contact surface) of the auxiliary rod 3 can be made of medical-grade platinum-iridium alloy or gold plating. It needs to have similar electrical properties to the electrocoagulation part 54.

[0077] It should be noted that after the auxiliary rod 3 is inserted into the gap, its conductive surface and the electrocoagulation part 54 can form an effective electrical connection to constitute a complete closed ring electrode.

[0078] In certain special cases, the auxiliary rod 3 and the electrocoagulation part 54 do not form a complete closed ring electrode, but a semi-closed ring electrode, i.e. there is a gap. During the electrocoagulation hemostasis process, its actual influence range is larger than the contact area, and its small gap will not affect the hemostasis effect.

[0079] The electrocoagulation section 54 is initially a closed cylinder (diameter D1=5mm), which expands to a diameter D2 of 8-12mm (fitting the nephroscope channel) under the compression of the expansion section 72, and the gap between adjacent electrocoagulation sections 54 is 1.5-2.5mm.

[0080] The gap is designed to be 30% to 40% of the width of the electrocoating section 54 to ensure the accurate insertion of the auxiliary rod 3.

[0081] The auxiliary rod 3 has a filling mechanism, wherein the wedge angle of the auxiliary rod 3 is 10° to 15°, which matches the taper of the expansion part 72; the arc radius of the filling part 31 is 0.2 to 0.5 mm, and after insertion, it forms a continuous conductive curved surface with the outer wall of the electrocoagulation part 54, and the ring closure degree is ≥95% after filling.

[0082] The specific operation is as follows: A nephroscope channel is established by puncture. The outer layer 1 serves as the outer sheath for fixing the channel. Two external handles are set to control the restrictive layer 4 and the probe 7 respectively. The restrictive layer 4 and the probe 7 are inserted into the nephroscope channel by the two external handles. The bleeding location is found by the camera 71 of the nephroscope probe 7, and the expanding part 5 is moved to the bleeding location. Then, the probe 7 is pulled back by one external handle, and the restrictive layer 4 is fixed by the other external handle. This allows the expanding part 72 of the probe 7 to evenly expand the annular electrocoagulation part 54. The electrocoagulation part 54 is then bent by the constricting part 53 and the bending part 52, so that the electrocoagulation part 54 fits into the nephroscope channel. The electrocoagulation part 54 applies pressure to the bleeding location, reducing the amount of bleeding. At the same time, the annular electrocoagulation part 54 will create gaps when it expands. These gaps are filled by the auxiliary rods 3. The multiple expanded electrocoagulation parts 54 and multiple auxiliary rods 3 combine to form a closed ring. This closed ring fits into the nephroscope channel, and hemostasis is achieved by high-frequency current.

[0083] It should be noted that the structure of the external stress is based on the existing endoscope structure and the design of independent operation of the inner and outer tubes in surgical instruments. For example, in the independent operation structure of the inner core and outer sheath in ureteroscopes / nephroscopes, the axial movement of the inner core is controlled by an external handle, including pushing, pulling or rotating, to realize the function of the end component.

[0084] It should be noted that the effectiveness of electrocoagulation hemostasis achieved by reducing bleeding through compression requires the doctor's experience to judge. This method is often superior to simple electrocoagulation hemostasis, but there are still cases where the bleeding is too large to be effectively stopped, requiring the doctor to change the hemostasis plan in a timely manner.

[0085] An expansion section 72 is provided at the junction of the probe 7 and the wire 6. The expansion section 72 is a frustum-shaped structure with a small bottom and a large top. The expansion section 72 compresses the electrocoagulation sections 54, which are assembled into a ring structure, from the inside out, and makes each electrocoagulation section 54 expand outward evenly.

[0086] The main function of the expansion part 72 of the probe 7 is to squeeze the multiple annular electrocoagulation parts 54 outward, so that the electrocoagulation parts 54 open outward, and the opening method can be referred to as the blooming of a flower.

[0087] In vitro experiment: The expansion section 72 was advanced into a simulated nephroscope channel (silicone tube, hardness 40), and a thrust of 3N was applied, so that the diameter of the electrocoagulation section 54 was uniformly expanded from 5mm to 8.5mm (coefficient of variation = 3.2%), and the non-uniform expansion rate was ≤5% (radial displacement difference between any two electrocoagulation sections 54 / average displacement).

[0088] The auxiliary rod 3 is wedge-shaped with a narrow top and a wide bottom. Each auxiliary rod 3 is inserted into the gap formed between two electrocoagulation parts 54 during expansion. The auxiliary rod 3 and the electrocoagulation part 54 interlock to form a ring structure with a maximum diameter greater than that of the outer layer 1. Both the electrocoagulation part 54 and the auxiliary rod 3 can carry high-frequency current.

[0089] The wedge-shaped design of the auxiliary rod 3 is mainly to facilitate its insertion into the gap between the two electrocoagulation parts 54. In conjunction with the opening process of multiple electrocoagulation parts 54, the electrocoagulation parts 54 and the auxiliary rod 3 are combined to form an electrocoagulation electrode. The two use high-frequency current to electrocoagulate and stop bleeding at the bleeding site.

[0090] Current continuity verification (high-frequency electrocoagulation mode 35W):

[0091] state Resistance between electrodes (Ω) Coefficient of variation of current density (CV) Unfilled gaps >1000 42% After the auxiliary rod is inserted 15±3 8.5%

[0092] The auxiliary rod 3 improves the uniformity of current distribution by 80% (avoiding tissue carbonization).

[0093] In this section, the column 51 of the expansion section 5 is wrapped by the limiting layer 4. The same number of closing sections 53 are provided between the column 51 and the electrocoagulation section 54. All the closing sections 53 form a frustum shape with a small bottom and a large top. A bending section 52 is provided between each closing section 53 and the column 51. The closing section 53 drives the electrocoagulation section 54 to tilt outward through the bending section 52 to form an expansion.

[0094] The bending part 52 bears the deformation during the opening process of the electrocoating part 54, and the electrocoating part 54 completes the opening action mainly by relying on the bending of the bending part 52.

[0095] Taking the six electrocoagulation sections 54 as an example, the maximum stress of its bending section 52 is 380 MPa (located at the root arc).

[0096] Safety factor: ≥2.0 (Nitinol yield strength ≥800MPa);

[0097] Among them, the constriction part 53 has a truncated cone of 20°, which ensures that the electrocoating part 54 tilts synchronously (tilt angle = 35° ± 2°). When the thickness of the bending part 52 is 0.12 mm, the retraction and reset force reaches the optimal value of 0.6 N (hysteresis loss < 5%).

[0098] The unfolded part 5 has a through hole 56 at its center. The through hole 56 passes through the column 51, the constriction part 53 and the electrocoagulation part 54 of the unfolded part 5. A guide ring part 57 is provided on the inner wall of the through hole 56 and corresponding to the electrocoagulation part 54. The maximum diameter of the guide ring part 57 is smaller than the maximum diameter of the probe 7.

[0099] The through hole 56 is used to allow the wire 6 of the probe 7 to pass through. The guide ring 57 mainly cooperates with the expansion part 72 of the probe 7 to slide, so that when the expansion part 72 expands the electrocoagulation part 54, it is necessary to ensure the sliding of the expansion part 72 and the guide ring 57. The sliding of the expansion part 72 and the guide ring 57 is smoother.

[0100] The auxiliary rod 3 and the unfolded part 5 are both made of shape memory metal, and the auxiliary rod 3 and the unfolded part 5 return to their initial state after the external stress disappears.

[0101] After the probe 7 is detached from the electrocoagulation section 54, i.e. the external stress disappears, the unfolding section 5 and the auxiliary rod 3 will automatically reset.

[0102] Shape recovery property test of memory metal

[0103] Performance indicators Development Section Assist stick Test conditions Phase transition temperature Af 30±2℃ 28±2℃ DSC analysis Maximum recovery strain 8% 6% Tensile unloading test Cycle life (times) >10000 >8000 37℃ saline environment

[0104] Clinical relevance: Af point below body temperature (37°C) ensures automatic restoration of the closed state within the body.

[0105] An opening 55 is provided at the junction of the inner and outer rings of each pair of electrocoagulation sections 54, and the auxiliary rod 3 is inserted through the opening 55 into the gap formed when each pair of electrocoagulation sections 54 expands.

[0106] refer to Figure 3 The corners of the opening 55 should be chamfered. The opening 55 is mainly to facilitate the insertion of the auxiliary rod 3.

[0107] The auxiliary rod 3 has a filling part 31 bent towards the center at the top. The expansion part 72 of the probe 7 causes the annular electrocoagulation part 54 to expand. The filling part 31 of the auxiliary rod 3 is guided along the inclined surface of the expansion part 72 so that the auxiliary rod 3 opens outward in the gap.

[0108] The guide of the inclined surface of the expansion section 72 eliminates the vibration of the auxiliary rod 3, reduces damage to the inner membrane of the channel, and shortens the closure time.

[0109] Gap filling accuracy:

[0110] Number of electrocoagulation sections Design gap (mm) Residual gap after filling (mm) 4 3.0～4.0 ≤0.10 8 1.0～1.8 ≤0.05

[0111] Another implementation method:

[0112] refer to Figure 8 The electrocoagulation surface of the electrocoagulation section 54 is a protruding arc surface. The protruding arc surface can increase the pressure and make it easier to contact the inner wall of the nephroscope channel. The top surface of the electrocoagulation section 54 is an inclined surface that slopes towards the center, which increases the guiding effect.

[0113] The working principle of this invention embodiment is as follows: A nephroscope channel is established by puncture. The outer layer 1 serves as the outer sheath for fixing the channel, and two external handles are set to control the restricting layer 4 and the probe 7 respectively. During nephroscopy, the bleeding location is found through the camera 71 of the nephroscope probe 7, and the unfolding part 5 is moved to the bleeding location. Then, the probe 7 is pulled back by one external handle, and the restricting layer 4 is fixed by the other external handle, so that the expansion part 72 of the probe 7 evenly unfolds the annular electrocoagulation part 54. Then, the electrocoagulation part 54 is bent by the closing part 53 and the bending part 52 so that the electrocoagulation part 54 fits the nephroscope channel. At the same time, the annular electrocoagulation part 54 will create gaps when unfolding. Then, the two external handles are pulled back synchronously so that the restricting layer 4 and the probe 7 retract synchronously. Then, the gaps are filled by the auxiliary rods 3, so that the unfolded multiple electrocoagulation parts 54 and multiple auxiliary rods 3 are combined into a closed ring. The closed ring fits the nephroscope channel, and hemostasis is achieved by high-frequency current.

[0114] After hemostasis is achieved, by sequentially pushing the two external handles, the limiting layer 4 is moved, causing the electrocoagulation part 54 and the probe 7 to detach. This allows the expanded electrocoagulation part 54 to return to a circular shape, and the auxiliary rod 3, which extends into the gap between the two sets of electrocoagulation parts 54, also detaches from the gap and returns to its initial state, thus restoring the nephroscopic examination state. The entire structure can move within the nephroscopic channel.

[0115] The foregoing has shown and described the basic principles and main features of the present invention and its advantages. It will be apparent to those skilled in the art that the present invention is not limited to the details of the above exemplary embodiments, and that the present invention can be implemented in other specific forms without departing from the spirit or basic characteristics of the present invention. Therefore, the embodiments should be regarded as exemplary and non-limiting in all respects. The scope of the present invention is defined by the appended claims rather than the foregoing description. Therefore, it is intended that all changes falling within the meaning and scope of the equivalents of the claims be included within the present invention, and no reference numerals in the claims should be regarded as limiting the scope of the claims.

[0116] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A percutaneous nephrolithotomy channel-assisted hemostasis device, comprising an outer layer (1), characterized in that: The outer layer (1) has a slidingly nested limiting layer (4), the limiting layer (4) has a nested unfolding part (5), the unfolding part (5) has a slidingly nested wire (6), and the end of the wire (6) is connected to a probe (7) with a camera (71). The head of the expansion section (5) is located outside the outer layer (1) and the limiting layer (4). It consists of 4, 6 or 8 electrocoagulation sections (54) forming an expandable ring structure. Each electrocoagulation section (54) can expand outward to fit the renal endoscope channel, and a gap is formed between each two sets of electrocoagulation sections (54) during expansion. The outer layer (1) is fixed with a ring body (2) at its end. The ring body (2) is provided with the same number of auxiliary rods (3) as the electrocoagulation part (54). The auxiliary rods (3) are used to fill the gap formed when each two sets of electrocoagulation parts (54) expand. A closed ring is formed by the expanded annular electrocoagulation part (54) and the auxiliary rods (3) inserted between each two electrocoagulation parts (54). An expansion section (72) is provided at the junction of the probe (7) and the wire (6). The expansion section (72) is a frustum-shaped structure with a small bottom and a large top. The expansion section (72) compresses the electrocoagulation section (54) that is assembled into a ring structure from the inside out, and makes each electrocoagulation section (54) expand outward evenly to form pressure. The auxiliary rod (3) is a wedge shape that is narrow at the top and wide at the bottom. Each of the auxiliary rods (3) is inserted into the gap formed between each pair of electrocoagulation parts (54) during expansion. The auxiliary rods (3) and electrocoagulation parts (54) interlock to form a ring structure with a maximum diameter greater than that of the outer layer (1). Both the electrocoagulation parts (54) and the auxiliary rods (3) can carry high-frequency current.

2. The percutaneous nephrolithotomy channel-assisted hemostasis device according to claim 1, characterized in that: The column (51) of the expansion section (5) is wrapped by the limiting layer (4). The same number of closing sections (53) are provided between the column (51) and the electrocoagulation section (54). All the closing sections (53) form a frustum shape with a small bottom and a large top. A bending section (52) is provided between each closing section (53) and the column (51). The closing section (53) drives the electrocoagulation section (54) to tilt outward through the bending section (52) to form an expansion.

3. The percutaneous nephrolithotomy channel-assisted hemostasis device according to claim 1, characterized in that: The center of the unfolded part (5) has a through hole (56) that penetrates the column (51), the constricted part (53) and the electrocoagulation part (54) of the unfolded part (5). A guide ring part (57) is provided on the inner wall of the through hole (56) and corresponding to the electrocoagulation part (54). The maximum diameter of the guide ring part (57) is smaller than the maximum diameter of the probe (7).

4. The percutaneous nephrolithotomy channel-assisted hemostasis device according to claim 1, characterized in that: The auxiliary rod (3) and the unfolded part (5) are both made of shape memory metal, and the auxiliary rod (3) and the unfolded part (5) return to their initial state after the external stress disappears.

5. The percutaneous nephrolithotomy channel-assisted hemostasis device according to claim 1, characterized in that: An opening (55) is provided at the junction of the inner and outer rings of each pair of electrocoagulation sections (54), and the auxiliary rod (3) is inserted through the opening (55) into the gap formed when each pair of electrocoagulation sections (54) expands.

6. The percutaneous nephrolithotomy channel-assisted hemostasis device according to claim 5, characterized in that: The top of the auxiliary rod (3) is provided with a filling part (31) that bends toward the center. The expansion part (72) of the probe (7) causes the annular electrocoagulation part (54) to expand. The filling part (31) of the auxiliary rod (3) is guided along the inclined surface of the expansion part (72) so that the auxiliary rod (3) opens outward in the gap.

7. A percutaneous nephrolithotomy channel-assisted hemostasis device according to claim 6, characterized in that: The electrocoagulation surface of the electrocoagulation part (54) is a protruding arc surface, and the top surface of the electrocoagulation part (54) is an inclined surface that slopes towards the center.

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