A balloon ureteral occlusion device

Abstract

The present invention relates to the technical field of medical devices. More specifically, it relates to a balloon ureteral occlusion device, which includes a catheter and a balloon. The catheter is hollow inside, and the balloon is wrapped around the outer wall of the catheter, and at least one through hole is provided on the side wall of the catheter inside the balloon. It also includes a guide wire and an occluder. One end of the guide wire passes through the side wall of the catheter and is connected to the occluder. Pulling the other end of the guide wire can drive the occluder to fit the end of the catheter to block the opening. The present invention plays a drainage role before surgery, and artificial hydronephrosis can be established by injecting normal saline through the catheter; during the operation, the balloon expands to play a blocking role, which can prevent the crushed stones from descending to the ureter during percutaneous nephrolithotomy, thereby avoiding the remaining stones in the ureter, reducing the surgical difficulty and operation time, increasing the stone clearance rate, and reducing the incidence of postoperative ureteral stone street. In addition, the present invention can be used to assist in indwelling double-J tubes after percutaneous nephrolithotomy, shorten the operation time, reduce the occurrence of surgical complications, and reduce the treatment cost.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and more specifically, to a balloon ureteral occlusion device. Background Art

[0002] The treatment of kidney stones mainly focuses on surgery and drug lithotripsy. For kidney stones > 20 mm or complex stones, percutaneous nephrolithotomy (PCNL) is required. Currently, PCNL has high lithotripsy efficiency, less surgical trauma, and rapid postoperative recovery, and has become the main treatment method for kidney stones. During the PCNL operation, the surgeon usually inserts a ureteral catheter into the affected ureter before lithotripsy. However, the diameter of traditional ureteral catheters is only 4Fr - 5Fr, and their ability to block the downward movement of intraoperative lithotripsy fragments into the ureter is very limited. During PCNL, some 3 - 4 mm lithotripsy fragments often move towards the ureter along the direction of the perfusion fluid. When the lithotripsy fragments move downward beyond the upper segment of the ureter to the middle or lower segment of the ureter during the operation, it is quite difficult to remove them through the percutaneous nephroscope. Usually, the patient needs to be repositioned in the lithotomy position for ureteroscopic lithotripsy to deal with the downward lithotripsy fragments. This increases the surgical difficulty, prolongs the operation time, and increases the risk of related complications such as postoperative stone street; in addition, the stones that have moved downward to the ureter are often difficult to detect under the nephroscope, which is likely to cause the surgeon to miss them, resulting in residual stones in the ureter after the operation, reducing the stone clearance rate and the surgical effect, and increasing the risk of reoperation.

[0003] Currently, a mechanical occluder has been proposed abroad. It enters the ureter through a ureteroscope and is placed in the upper segment of the ureter. After establishing the percutaneous renal access, through operation, the occluder forms an umbrella - like structure to prevent stone fragments from falling into the upper segment of the ureter. However, the umbrella - like structure formed by this occluder often has pores and cannot completely block the lithotripsy; moreover, its manufacturing cost is high and the price is expensive. In addition, Chinese Patent CN201510386032.4 discloses an occluder for ureteroscopic lithotripsy. The occluding balloon is wrapped around the outer surface of the catheter, forming a closed cavity with the catheter. By inflating the cavity with air or injecting normal saline, the occluding balloon expands outward to fit the inner wall of the ureter, tightly blocking the ureteral stones and preventing the upward escape of ureteral lithotripsy. However, on the one hand, its one - way valve is not convenient for retrograde injection of contrast agent and retrograde injection of water into the renal pelvis and calyces to establish artificial hydronephrosis; on the other hand, the structure is complex and the manufacturing cost is high. Summary of the Invention

[0004] The purpose of the present invention is to overcome the deficiencies of the prior art and provide a balloon ureteral occlusion device, which can effectively avoid the residual of stones in the ureter, reduce the surgical difficulty and operation time, increase the stone clearance rate, and reduce the incidence of postoperative ureteral stone street.

[0005] To solve the above technical problems, the technical solution adopted by the present invention is as follows:

[0006] A balloon ureteral occlusion device is provided, which includes a catheter and a balloon. The catheter is hollow inside, and the balloon is wrapped around the outer wall of the catheter, and at least one through hole is opened on the side wall of the catheter inside the balloon. It also includes a guide wire and an occluder. One end of the guide wire passes through the side wall of the catheter and is connected to the occluder. Pulling the other end of the guide wire can drive the occluder to fit the end of the catheter to block the opening.

[0007] In the balloon ureteral occlusion device of the present invention, before performing percutaneous nephrolithotomy, a retrograde ureteroscope is used to insert the catheter. At this time, the balloon is in an unexpanded state. The occluder is pushed out of the catheter opening through the guide wire, and normal saline is injected into the catheter by using a syringe / connecting tube. The normal saline flows into the upper segment of the ureter and the renal pelvis through the catheter to establish artificial hydronephrosis. The operator uses the artificial hydronephrosis created by the ureteral catheter to establish a percutaneous nephroscopic access. When the percutaneous nephroscopic access is established, under direct vision of the nephroscope, the guide wire tightens the occluder, and the occluder blocks the opening at the head of the catheter, so that the normal saline cannot flow out through the catheter. Continue to inject normal saline into the catheter by using a syringe. At this time, the pressure inside the balloon will increase and cause the balloon to expand. After the balloon expands to an appropriate size, the catheter is pulled to make the balloon block the junction of the upper segment of the ureter and the renal pelvis to prevent residual stones from remaining in the ureter during the operation. After the operation, the normal saline inside the balloon is drawn out by using a syringe to make the balloon atrophy, and the balloon is slowly withdrawn from the ureteroscope along with the catheter to end the operation. The present invention can effectively prevent the crushed stones from descending to the ureter during percutaneous nephrolithotomy, thereby avoiding the residual stones in the ureter, reducing the operation difficulty and operation time, increasing the stone clearance rate, and reducing the incidence of postoperative ureteral stone street.

[0008] Further, the catheter is provided with a guide wire cavity and a drainage cavity. The guide wire is disposed in the guide wire cavity, and the through hole communicates the drainage cavity and the balloon. Push the guide wire to release the occlusion of the occluder, and inject normal saline into the drainage cavity inside the catheter by using a syringe / connecting tube. The normal saline flows into the upper segment of the ureter and the renal pelvis through the catheter to establish artificial hydronephrosis; pull the guide wire to make the occluder block the drainage cavity, and inject normal saline into the drainage cavity inside the catheter by using a syringe / connecting tube. The normal saline enters the balloon at the head of the catheter and causes the balloon to expand.

[0009] Further, the guide wire cavity is opened on the side wall of the catheter, and the diameter of the drainage cavity is larger than that of the guide wire cavity. The guide wire cavity is arranged on the side wall of the catheter. The outer periphery of the catheter is a smooth tubular structure, which is overall thin, with a simple manufacturing process, easy to pass through the ureter, and not easy to damage the surrounding tissues.

[0010] Further, on the same cross section, the center of the cross section of the drainage cavity, the center of the cross section of the guide wire cavity, and the center of the cross section of the outer contour of the catheter are collinear.

[0011] Further, the plugging device is a spherical structure with a diameter not less than that of the drainage cavity, and the center of the spherical structure is located on the central axis of the drainage cavity. The shape and size of the plugging device are set to facilitate the plugging of the drainage cavity by the plugging device when pulling the guide wire.

[0012] Further, at one end of the catheter away from the plugging device, a separately arranged drainage part and a guide wire part are provided. The drainage cavity is arranged in the drainage part, and one end of the guide wire extends beyond the end of the guide wire part. Separating the drainage part and the guide wire part facilitates the operator's connection operation between the guide wire and the drainage part, syringe or connecting tube.

[0013] Further, the balloon is arranged at one end of the catheter close to the plugging device. The position of the balloon is set to achieve: when the catheter is inserted into the ureter once, retrograde injection of contrast agent, retrograde water injection into the renal pelvis and calyces to cause artificial hydronephrosis, and inflation of the balloon to plug the drainage cavity can be realized.

[0014] Further, the balloon is obtained by bonding the edge of an elastic membrane to the outer wall of the catheter, and a hydrophilic lubricating coating is provided on the surface of the elastic membrane. The balloon has good elasticity, has good toughness after inflation, is not easily scratched by stone debris, and can effectively avoid the occurrence of plugging failure; and the outer surface of the elastic membrane has good biocompatibility, which can avoid damage to the patient's tissue during the operation.

[0015] Further, the guide wire is a stainless steel wire structure or a titanium alloy wire structure. It is made of medical stainless steel or titanium alloy, has good biocompatibility, and avoids secondary damage to the patient during the operation.

[0016] Further, the plugging device is made of stainless steel, plastic or rubber. The plugging device is made of common materials, has a simple manufacturing process, low manufacturing cost, and low price, which is conducive to wide promotion.

[0017] Compared with the prior art, the beneficial effects of the present invention are:

[0018] The balloon ureteral plugging device of the present invention can prevent the crushed stones from descending to the ureter during percutaneous nephrolithotomy, thereby avoiding the residual stones in the ureter, reducing the surgical difficulty and operation time, increasing the stone clearance rate, and reducing the incidence of postoperative ureteral stone street;

[0019] The balloon ureteral plugging device of the present invention plays a drainage role before the operation, can establish artificial hydronephrosis by injecting normal saline through the catheter, or inject contrast agent for intraoperative imaging; during the operation, the balloon expands to play a plugging role to prevent the crushed stones from descending to the ureter; whether the plugging device plugs or not can be controlled by operating the guide wire, with a simple structure, convenient operation and high feasibility;

[0020] The balloon ureteral occlusion device of the present invention can be used to assist in indwelling double-J tubes after percutaneous nephrolithotomy, shorten the operation time, reduce the occurrence of surgical complications, and reduce the treatment cost. Description of the Drawings

[0021] Figure 1 It is a schematic structural view of the occlusion device before balloon dilation;

[0022] Figure 2 It is a perspective view of the occlusion device before balloon dilation;

[0023] Figure 3 It is a partial enlarged view of the catheter head end before balloon dilation;

[0024] Figure 4 It is a schematic structural view of the occlusion device after balloon dilation;

[0025] Figure 5 It is a perspective view of the occlusion device after balloon dilation;

[0026] In the drawings: 1 - catheter; 11 - guide wire cavity; 12 - drainage cavity; 13 - drainage part; 14 - guide wire part; 2 - balloon; 3 - through hole; 4 - guide wire; 5 - occluder. Detailed Embodiments

[0027] The present invention will be further described below in conjunction with the detailed embodiments. Among them, the drawings are only for illustrative purposes, showing only schematic diagrams, rather than physical diagrams, and should not be construed as a limitation of this patent; in order to better illustrate the embodiments of the present invention, some components in the drawings will be omitted, enlarged or reduced, and do not represent the dimensions of the actual product; for those skilled in the art, it is understandable that some well-known structures and their descriptions in the drawings may be omitted.

[0028] In the drawings of the embodiments of the present invention, the same or similar reference numerals correspond to the same or similar components; in the description of the present invention, it should be understood that if there are terms such as "upper", "lower", "left", "right", etc. indicating the orientation or positional relationship, they are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, so the terms describing the positional relationship in the drawings are only for illustrative purposes and should not be construed as a limitation of this patent. For those of ordinary skill in the art, the specific meanings of the above terms can be understood according to specific circumstances.

[0029] Embodiment

[0030] As Figures 1 to 5The figure shows an embodiment of the ureteral occlusion device with a balloon of the present invention, comprising a catheter 1 and a balloon 2, wherein the interior of the catheter 1 is hollow, the balloon 2 is wrapped around the outer wall of the catheter 1, and at least one through hole 3 is provided on the side wall of the catheter 1 inside the balloon 2; the figure also comprises a guide wire 4 and an occluder 5, wherein one end of the guide wire 4 passes through the side wall of the catheter 1 and is connected to the occluder 5, and the other end of the guide wire 4 can be pulled to drive the occluder 5 to fit the end of the catheter 1 to seal the opening.

[0031] In this embodiment, before performing percutaneous nephrolithotomy, the catheter 1 is inserted by retrograde ureteroscopy, and the balloon 2 is in an unexpanded state. Figures 1 to 3 As shown; the occluder 5 is pushed out of the opening of the catheter 1 through the guide wire 4, and normal saline is injected into the catheter 1 using a syringe / connecting tube. The normal saline flows into the upper ureter and renal pelvis through the catheter 1 to establish artificial hydronephrosis; the operator uses the artificial hydronephrosis created by the ureteral catheter 1 to establish a percutaneous renal channel. When the percutaneous renal channel is established, under direct vision of the nephroscope, the guide wire 4 tightens the occluder 5, and the occluder 5 blocks the opening at the head of the catheter 1, and the normal saline cannot flow out through the catheter 1. Continue to use the syringe to inject normal saline into the catheter 1. At this time, the pressure in the balloon 2 will increase, and the balloon 2 will expand, as shown in FIG. Figures 4 to 5 . After the balloon 2 is expanded to a suitable size, the catheter 1 is pulled to block the balloon 2 at the junction of the upper ureter and the renal pelvis to prevent stones from remaining in the ureter during the operation. After the operation, the normal saline in the balloon 2 is extracted by a syringe to shrink the balloon 2, and the balloon 2 is slowly withdrawn from the ureteroscope along with the catheter 1 to end the operation. The present invention can effectively prevent the stones from descending to the ureter during percutaneous nephrolithotomy, thereby avoiding stones from remaining in the ureter, reducing the difficulty and time of the second operation, increasing the stone clearance rate, and reducing the incidence of postoperative ureteral stones.

[0032] like Figure 1 As shown, the catheter 1 of this embodiment is provided with a guidewire cavity 11 and a drainage cavity 12, the guidewire 4 is inserted into the guidewire cavity 11, and the through hole 3 connects the drainage cavity 12 and the balloon 2. The guidewire cavity 11 is used to pass the guidewire 4 to operate the occluder 5 through the guidewire 4 to control whether the drainage cavity 12 is conductive or not, and switch the blocking function and drainage function of the blocking device; the drainage cavity 12 is used to inject physiological saline, and the catheter 1 is set as a double-lumen catheter 1. The catheter 1 is slender as a whole, with a simple manufacturing process, easy to pass through the ureter, and not easy to damage surrounding tissues.

[0033] In order to rationally utilize the limited space of the catheter 1 and facilitate the injection of physiological saline, the guidewire cavity 11 is opened on the side wall of the catheter 1 in this embodiment, and the diameter of the drainage cavity 12 is larger than the diameter of the guidewire cavity 11; however, it should be noted that this is a preference made in order to obtain a catheter 1 with a smooth appearance, a small overall size, and a simple manufacturing process so as to facilitate passage through the ureter and not damage surrounding tissues during surgery, and it is not a restrictive provision.

[0034] In order to ensure the double - lumen performance of the catheter 1 while using as little material as possible for the catheter 1, in this embodiment, on the same cross - section, the centers of the cross - sections of the drainage lumen 12, the guide - wire lumen 11, and the outer contour of the catheter 1 are collinear. The centers of the cross - section circles of the outer contour of the catheter 1 and the cross - section circle of the drainage lumen 12 do not coincide, so that the side wall of the catheter 1 presents a water - droplet shape, and the drainage lumen 12 is arranged at the thickest part of the side wall of the catheter 1. Such a setting: on the one hand, it can simultaneously meet the aperture requirements of the drainage lumen 12 and the guide - wire lumen 11, with simple manufacturing process, less consumables, and low cost; on the other hand, the overall size of the catheter 1 is small. In the state of a small - diameter drainage lumen 12, the pressure can be increased by using a syringe to achieve the effect of rapid water injection or drainage.

[0035] In order to better achieve the plugging effect of the drainage lumen 12, the plugging device 5 of this embodiment is set as a spherical structure with a diameter not less than that of the drainage lumen 12, and the center of the spherical structure is located on the central axis of the drainage lumen 12. With such a setting, when pulling the guide - wire 4, the center of the plugging device 5 moves closer to the drainage lumen 12 along the central axis of the drainage lumen 12, and the plugging device 5 can fit well with the drainage lumen 12 to achieve the plugging effect.

[0036] In order to facilitate the operator's intraoperative operation of the plugging device, in this embodiment, at one end of the catheter 1 far from the plugging device 5, the drainage part 13 and the guide - wire part 14 are separated. One end of the guide - wire 4 extends out of the guide - wire part 14, and the other end passes through the guide - wire part 14 into the guide - wire lumen 11 until it passes through the guide - wire lumen 11 and is connected to the plugging device 5. The drainage part 13 is used to connect a connecting tube or a syringe. In this way, during the operation, the operator can separate the operation of the guide - wire 4 and the injection operation, leaving a large operation space, which is convenient for the operation of the plugging device.

[0037] In order to endow the plugging device with multiple functions, in this embodiment, the balloon 2 is arranged at one end of the catheter 1 close to the plugging device 5. In this way, before performing percutaneous nephrolithotripsy, a contrast agent can be injected through a syringe / connecting tube for intraoperative imaging to accurately perform percutaneous nephrostomy. Saline can be injected into the catheter 1 through a syringe / connecting tube, and the saline flows through the catheter 1 into the upper segment of the ureter and the renal pelvis to establish artificial hydronephrosis; the drainage lumen 12 can be plugged, and saline continues to be injected into the catheter 1. The pressure in the balloon 2 increases and expands continuously, and the catheter 1 is pulled to make the balloon 2 block at the junction of the upper segment of the ureter and the renal pelvis to achieve plugging; after the operation, the saline in the balloon 2 can be drawn out through a syringe, causing the balloon 2 to shrink, and the balloon 2 is slowly withdrawn from the ureteroscope along with the catheter 1 to end the operation; during the whole operation process, the catheter 1 only needs to be inserted into the ureter once, with simple operation, which can reduce the surgical difficulty and operation time.

[0038] In order to reduce the manufacturing cost of the occlusion device, increase the compatibility between the occlusion device and human tissues, and avoid harm to patients during the operation of the occlusion device, in this embodiment: the balloon 2 is obtained by bonding the edge of an elastic membrane to the outer wall of the catheter 1, and a hydrophilic lubricating coating is provided on the surface of the elastic membrane; the guide wire 4 is a stainless steel filament structure or a titanium alloy filament structure; the occluder 5 is a stainless steel structure, a plastic structure or a rubber structure.

[0039] In addition to the drainage function and the occlusion function, the balloon ureteral occlusion device of this embodiment can also be used to assist in the indwelling of a double-J stent. After percutaneous nephrolithotomy is completed for lithotripsy and stone removal, a double-J stent needs to be indwelled. At this time, the occluder 5 and the guide wire 4 in the catheter 1 can be pulled out towards the percutaneous renal tract by using a foreign body forceps, and the tail end of the double-J stent is sleeved on the occluder 5. Then, by pulling the guide wire 4, the catheter 1 is withdrawn from the ureter, and the double-J stent is pulled to the ureter position. Finally, by increasing the pulling force on the guide wire 4, the double-J stent is separated from the spherical occluder 5, and the double-J stent is successfully indwelled in the ureter position.

[0040] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, rather than limitations on the implementation manners of the present invention. For those of ordinary skill in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation manners here. Any modifications, equivalent replacements, and improvements made within the spirit and principle of the present invention shall be included within the protection scope of the claims of the present invention.

Claims

1. A balloon ureteral occlusion device, comprising a catheter (1) and a balloon (2), the catheter (1) having a hollow interior, the balloon (2) being wrapped around the outer wall of the catheter (1), and at least one through hole (3) being provided on the side wall of the catheter (1) inside the balloon (2); characterized in that, It further includes a guide wire (4) and a plugging device (5). One end of the guide wire (4) passes through the side wall of the catheter (1) and is connected to the plugging device (5). Pulling the other end of the guide wire (4) can drive the plugging device (5) to fit the end of the catheter (1) to plug the opening. The catheter (1) is provided with a guide wire cavity (11) and a drainage cavity (12). The guide wire (4) is disposed in the guide wire cavity (11). The through hole (3) communicates the drainage cavity (12) and the balloon (2). The guide wire cavity (11) is opened on the side wall of the catheter (1). The diameter of the drainage cavity (12) is larger than the diameter of the guide wire cavity (11). On the same cross section, the center of the cross section of the drainage cavity (12), the center of the cross section of the guide wire cavity (11), and the center of the cross section of the outer contour of the catheter (1) are collinear, and the side wall of the catheter (1) presents a water droplet shape.

2. The balloon ureteral occlusion device according to claim 1, wherein The plugging device (5) is a spherical structure with a diameter not less than the diameter of the drainage cavity (12), and the center of the spherical structure is located on the central axis of the drainage cavity (12).

3. The balloon ureteral occlusion device according to claim 1, wherein One end of the catheter (1) away from the plugging device (5) is provided with a separately arranged drainage part (13) and a guide wire part (14). The drainage cavity (12) is disposed in the drainage part (13), and one end of the guide wire (4) extends from the end of the guide wire part (14).

4. The balloon ureteral occlusion device according to any one of claims 1 to 3, characterized in that The balloon (2) is disposed at one end of the catheter (1) close to the plugging device (5).

5. The balloon ureteral occlusion device according to claim 4, wherein, The balloon (2) is obtained by bonding the edge of an elastic membrane to the outer wall of the catheter (1), and the surface of the elastic membrane is provided with a hydrophilic lubricating coating.

6. The balloon ureteral occlusion device according to claim 1, wherein The guide wire (4) is a stainless steel wire structure or a titanium alloy wire structure.

7. The balloon ureteral occlusion device according to claim 1, characterized in that, The plugging device (5) is a stainless steel structure, a plastic structure or a rubber structure.

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