Hemostasis device

Abstract

The present invention relates to the technical field of medical devices, and discloses a hemostatic device. The hemostatic device includes a catheter and two balloons, the two balloons are respectively a first balloon and a second balloon, which are connected to each other and sleeved on the outside of the catheter, and the catheter is provided with a first through hole, which is connected to the first balloon and / or the second balloon to inflate and exhaust the first balloon and the second balloon; the first balloon expands after passing through the bladder neck, and the second balloon expands on the outside of the bladder neck, and the expansion of the first balloon is toward the direction close to the second balloon, and the expansion of the second balloon is toward the direction of the first balloon. The first balloon and the second balloon of the present invention can realize relative movement within a controllable range, thereby squeezing the tissue between the two balloons to achieve the purpose of hemostasis, and at the same time will not cause new damage to the patient due to excessive expansion of the balloon.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, in particular to a hemostatic device. Background Art

[0002] After prostate hyperplasia ablation surgery, especially after water jet ablation, hemostasis is particularly important. The bladder neck and prostate fossa are the two most prone to bleeding. Since the drug action time is relatively slow, spraying hemostatic drugs may not be ideal.

[0003] There are also solutions in the prior art that use physical compression of balloons to stop bleeding. Such solutions use a single balloon, which is inserted into the bladder cavity through the bladder neck. After the balloon is inflated, it is pulled back by the doctor to compress the bladder neck and stop bleeding by squeezing. However, this solution has the following problems: 1. It is difficult to control the force of the doctor's pullback. If the pullback force is insufficient, the compression effect is insufficient to provide a hemostatic effect. If the pullback force is too large, it is easy to cause tearing of the bladder neck, causing unnecessary damage to the patient; 2. It cannot stop bleeding in the prostate fossa, another bleeding site.

[0004] Therefore, there is an urgent need for a hemostatic device to solve the above problems. Summary of the invention

[0005] Based on the above, the purpose of the present invention is to provide a hemostatic device that can achieve hemostasis at both the bladder neck and the prostate fossa, with a better hemostatic effect.

[0006] To achieve the above object, the present invention adopts the following technical solutions:

[0007] Hemostasis devices, including:

[0008] catheter;

[0009] Two balloons include a first balloon and a second balloon, the first balloon and the second balloon are connected to each other and are sleeved on the outside of the catheter, the catheter is provided with a first through hole, the first through hole is connected to the first balloon and / or the second balloon to inflate and exhaust the first balloon and the second balloon; the first balloon expands after passing through the bladder neck, the second balloon expands on the outside of the bladder neck, and the first balloon expands in a direction close to the second balloon, and the second balloon expands in a direction toward the first balloon.

[0010] As a preferred solution of the hemostatic device, the hemostatic device further comprises a ring bundle, which is sleeved on the outside of the balloon and connected to the catheter, and the ring bundle is used to separate the balloon to form the first balloon and the second balloon.

[0011] As a preferred solution of the hemostatic device, the position of the ring bundle along the axial direction of the catheter is adjustable.

[0012] As a preferred solution of the hemostatic device, the catheter is provided with two or more mounting holes at intervals along its axial direction, and the inner wall of the ring bundle is provided with a mounting head, which can be snapped into the mounting hole.

[0013] As a preferred solution of the hemostatic device, the mounting head is provided with a raised clamping joint, and the mounting hole is provided with a clamping hole and a clamping cavity which are interconnected, and the clamping hole can undergo elastic deformation to allow the clamping joint to pass through the clamping hole, and restore deformation to allow the clamping joint to be placed in the clamping cavity.

[0014] As a preferred embodiment of the hemostatic device, the wall thickness of the first balloon close to the second balloon is smaller than the wall thickness of the side away from the second balloon; the wall thickness of the second balloon close to the first balloon is smaller than the wall thickness of the side away from the first balloon.

[0015] As a preferred embodiment of the hemostatic device, a squeezing area is provided on a side of the first balloon close to the second balloon, the squeezing area is arranged along the circumference of the bladder neck, and the wall thickness of the squeezing area is less than the wall thickness of the non-squeezing area; the squeezing area is provided on a side of the second balloon close to the first balloon; and each balloon is provided with more than two squeezing areas.

[0016] As a preferred embodiment of the hemostatic device, an inner balloon is arranged inside one of the balloons, and the catheter is provided with a second through hole, which is connected to the inner balloon to inflate the inner balloon; the hemostatic device also includes a pull cable, one end of which is connected to the inner balloon, and the other end is connected to another balloon, and the pull cable can cause the inner balloon to expand toward the middle of the first balloon and the second balloon.

[0017] As a preferred solution of the hemostatic device, the portion where the inner balloon is connected to the cable is thickened, and / or the portion where the balloon is connected to the cable is thickened.

[0018] As a preferred solution of the hemostatic device, the pull cable is inserted between the inner wall of the balloon and the outer wall of the catheter; the catheter is provided with a through hole extending along its axial direction, and the pull cable is inserted through the through hole.

[0019] The beneficial effects of the present invention are:

[0020] The present invention realizes the installation of two balloons by setting a catheter, and at the same time, it is convenient for the operator to place the two balloons at the position to be hemostatic; at the same time, a first through hole is also set on the catheter, which is used to realize the inflation and degassing of the two balloons. It can be understood that when the two balloons are inflated, the operator operates the catheter to make the first balloon pass through the bladder neck into the bladder cavity, and the second balloon is located outside the bladder neck, and then inflates the first balloon and the second balloon through the first through hole, and the first balloon and the second balloon expand to achieve hemostasis of two parts of the tissue around the bladder neck and the tissue around the prostate fossa; after the hemostasis is completed, the gas in the first balloon and the second balloon is discharged through the first through hole, and then the hemostatic device can be taken out. Among them, the first balloon and the second balloon are connected to each other, so that the two balloons can be inflated with air at the same time, with better synchronization, thereby improving the hemostasis effect; at the same time, the first balloon can expand toward the direction close to the second balloon, and the second balloon can expand toward the first balloon. With this arrangement, the first balloon and the second balloon can move toward each other within a controllable range, thereby squeezing the tissue between the two balloons, thereby achieving the purpose of quickly achieving physical hemostasis of the bleeding-prone areas after prostate surgery, and will not cause new injuries to the patient due to excessive balloon expansion or excessive pullback force. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for use in the description of the embodiments of the present invention. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the contents of the embodiments of the present invention and these drawings without paying any creative work.

[0022] Figure 1 is an axial cross-sectional view of a balloon of a hemostatic device provided by a specific embodiment of the present invention when it is not inflated;

[0023] Figure 2 is an axial cross-sectional view of a balloon of a hemostatic device provided by a specific embodiment of the present invention after inflation;

[0024] Figure 3 is a schematic diagram of another hemostatic device provided in a specific embodiment of the present invention;

[0025] Figure 4 is an axial cross-sectional view of another hemostatic device provided by a specific embodiment of the present invention;

[0026] Figure 5 is a radial cross-sectional view of another hemostatic device provided by a specific embodiment of the present invention;

[0027] Figure 6 is an axial cross-sectional view of another hemostatic device provided by a specific embodiment of the present invention;

[0028] Figure 7 is a radial cross-sectional view of another hemostatic device provided by a specific embodiment of the present invention;

[0029] Figure 8 It is an axial cross-sectional view of a balloon of another hemostatic device provided by a specific embodiment of the present invention after inflation.

[0030] In the figure:

[0031] 100, conduit; 110, first through hole; 120, second through hole; 130, through hole; 140, mounting hole; 141, clamping hole; 142, clamping cavity;

[0032] 210, first balloon; 220, second balloon; 230, inner balloon;

[0033] 300, ring bundle; 310, mounting head; 311, card connector;

[0034] 400. Cable. DETAILED DESCRIPTION

[0035] Embodiments of the present invention are described in detail below, examples of which are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are intended to be used to explain the present invention, and should not be construed as limiting the present invention.

[0036] In the description of the present invention, it should be noted that the terms "center", "up", "down", "left", "right", "vertical", "horizontal", "inside", "outside" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying 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, and therefore cannot be understood as limiting the present invention. In addition, the terms "first" and "second" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance. Among them, the terms "first position" and "second position" are two different positions.

[0037] Unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", and "fixed" should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0038] In the present invention, unless otherwise clearly specified and limited, a first feature being "above" or "below" a second feature may include that the first and second features are in direct contact, or may include that the first and second features are not in direct contact but are in contact through another feature between them. Moreover, a first feature being "above", "above" and "above" a second feature includes that the first feature is directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature. A first feature being "below", "below" and "below" a second feature includes that the first feature is directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.

[0039] The technical solution of the present invention is further described below with reference to the accompanying drawings and through specific implementation methods.

[0040] like Figure 1-Figure 8 As shown, this embodiment provides a hemostatic device, which includes a catheter 100 and two balloons, the two balloons are a first balloon 210 and a second balloon 220, the first balloon 210 and the second balloon 220 are connected to each other and are sleeved on the outside of the catheter 100, the catheter 100 is provided with a first through hole 110, the first through hole 110 is connected to the first balloon 210 or the second balloon 220 to inflate and exhaust the first balloon 210 and the second balloon 220; the first balloon 210 expands after passing through the bladder neck, the second balloon 220 expands on the outside of the bladder neck, and the expansion of the first balloon 210 is toward the direction close to the second balloon 220, and the expansion of the second balloon 220 is toward the direction of the first balloon 210.

[0041] By setting the catheter 100, the installation of the two balloons is realized, and it is convenient for the operator to place the first balloon 210 and the second balloon 220 at the position to be hemostatic; at the same time, the catheter 100 is also provided with a first through hole 110 for realizing the inflation and degassing of the two balloons. It can be understood that when the two balloons are inflated, the operator operates the catheter 100 to make the first balloon 210 pass through the bladder neck and enter the bladder cavity, and at the same time the second balloon 220 is located outside the bladder neck, and then inflates the first balloon 210 and the second balloon 220 through the first through hole 110, and the first balloon 210 and the second balloon 220 expand to achieve hemostasis of the two parts of the tissue around the bladder neck and the tissue around the prostate fossa; after the hemostasis is completed, the gas in the first balloon 210 and the second balloon 220 is discharged through the first through hole 110, and then the hemostatic device can be taken out. Among them, the first balloon 210 and the second balloon 220 are connected to each other, so that the two balloons can be inflated with air at the same time, with better synchronization, thereby improving the hemostasis effect; at the same time, the first balloon 210 can expand toward the direction close to the second balloon 220, and the second balloon 220 can expand toward the first balloon 210. Such a configuration allows the first balloon 210 and the second balloon 220 to move toward each other within a controllable range, thereby squeezing the tissue between the two balloons to achieve the purpose of hemostasis, and at the same time will not cause new damage to the patient due to excessive balloon expansion.

[0042] It is worth noting that during the hemostasis process, the urethra and sphincter cannot work, so the patient cannot urinate. Therefore, the catheter 100 is hollow, so the catheter 100 can also be used as a urinary catheter. Accordingly, one end of the catheter 100 is placed in the bladder, and the other end is connected to a valve or a urine bag.

[0043] Exemplarily, the hemostatic device further includes a ring bundle 300, which is sleeved outside the balloon and connected to the catheter 100, and is used to separate the first balloon 210 and the second balloon 220. It is worth noting that the ring bundle 300 has little elasticity or no elasticity to prevent the connection between the two balloons from expanding too much when the balloons are inflated and damaging the bladder neck.

[0044] Preferably, the axial position of the ring bundle 300 along the catheter 100 is adjustable. By adjusting the position of the ring bundle 300, the size of the two balloons can be adjusted, and then the hemostatic strength at different positions can be adjusted. When in use, the operator can select the preferred position of the ring bundle 300 according to the actual situation of the patient and the actual situation of the hemostatic position by auxiliary imaging before hemostasis, so as to improve the hemostatic effect of the hemostatic device.

[0045] Specifically, Figure 3 and Figure 5As shown, the catheter 100 is provided with two or more mounting holes 140 at intervals along its axial direction, and the inner wall of the ring bundle 300 is provided with a mounting head 310. By snapping the mounting head 310 into one of the mounting holes 140, the axial position of the ring bundle 300 along the catheter 100 can be adjusted. Further, along the axial direction of the catheter 100, multiple mounting holes 140 are provided at intervals, that is, the ring bundle 300 is connected to the catheter 100 through multiple mounting holes 140, the connection process is more reliable, and the force of the ring bundle 300 can be made more uniform when the balloon is inflated.

[0046] Optionally, the mounting head 310 is provided with a raised clamping joint 311, and the mounting hole 140 is provided with a clamping hole 141 and a clamping cavity 142 which are interconnected. When connecting the clamping joint 311 and the mounting hole 140, the clamping hole 141 can first undergo elastic deformation to allow the clamping joint 311 to pass through the clamping hole 141. After the clamping joint 311 passes through the clamping hole 141, the clamping hole 141 can restore its deformation to allow the clamping joint 311 to be placed in the clamping cavity 142. Since the inner diameter of the clamping hole 141 is smaller than that of the clamping cavity 142, and the elasticity of the ring bundle 300 is relatively small, after the clamping hole 141 restores its deformation, even if the balloon is inflated, the clamping joint 311 will not fall out of the clamping cavity 142, thereby making the connection between the ring bundle 300 and the catheter 100 more stable. It is worth noting that when the mounting head 310 is snapped into the mounting hole 140 , the film of the balloon is simultaneously pressed into the mounting hole 140 , thereby fixing the position of the loop bundle 300 and the balloon.

[0047] Or in other embodiments, the two balloons are integrally provided, and the connecting portion between the two balloons is made of a material that is not easily deformed, so that when inflated, the two balloons can expand toward the sides close to each other to achieve a hemostatic effect.

[0048] As an alternative to hemostatic devices, Figure 2 As shown, in order to achieve the expansion of the first balloon 210 toward the direction close to the second balloon 220, the second balloon 220 expands toward the first balloon 210, and the wall thickness of the first balloon 210 close to the second balloon 220 is less than the wall thickness of the side away from the second balloon 220; the wall thickness of the second balloon 220 close to the first balloon 210 is less than the wall thickness of the side away from the first balloon 210. It can be understood that the thinner wall thickness is easier to deform during inflation, so as to achieve the expansion and extrusion of the balloon toward the bladder neck.

[0049] Preferably, a squeezing zone is provided on the side of the first balloon 210 close to the second balloon 220, and the squeezing zone is provided along the circumference of the bladder neck, and the wall thickness of the squeezing zone is less than the wall thickness of the non-squeezing zone; the second balloon 220 is also provided with the above-mentioned squeezing zone on the side close to the first balloon 210; by providing a squeezing zone with a thinner wall thickness, the position can undergo a larger convex deformation during inflation, similar to pinching with fingers, thereby improving the squeezing hemostatic effect.

[0050] In the above scheme, the hemostasis of the tissue around the bladder neck and the prostate fossa is achieved by the expansion and compression of the first balloon 210 and the second balloon 220. However, in some cases, for example, the expansion of the first balloon 210 and the second balloon 220 is not enough for the hemostasis of the bladder neck, but is sufficient for the hemostasis of the prostate fossa, or the expansion is sufficient for the hemostasis of the bladder neck, but is not sufficient for the hemostasis of the prostate fossa.

[0051] In response to the above problems, Figure 3-Figure 7 As shown, as an optional solution of the hemostatic device, an inner balloon 230 is provided inside one of the balloons, and the catheter 100 is provided with a second through hole 120, which is connected to the inner balloon 230 to inflate and exhaust the inner balloon 230; the hemostatic device also includes a cable 400, one end of the cable 400 is connected to the inner balloon 230, and the other end is connected to the other balloon, and the cable 400 can make the inner balloon 230 expand toward the middle of the two balloons. The inner balloon 230 can support one of the balloons, and at the same time, during the inflation of the inner balloon 230, the cable 400 can also be used to pull the other balloon to control the expansion deformation of the balloon after inflation, so that the hemostatic device can perform conformal collision according to actual needs, so as to achieve more targeted hemostasis of the bladder neck or prostate fossa, and the hemostatic effect is better. It is worth noting that when using the hemostatic device provided with the inner balloon 230 , the inner balloon 230 is inflated first, and then the first balloon 210 and the second balloon 220 are inflated.

[0052] Specifically, the cable 400 has no elasticity. At the same time, there are multiple cables 400, and the multiple cables 400 are evenly spaced along the circumference of the catheter 100, which is conducive to reducing the force of each cable 400 on the balloon, and at the same time, it is conducive to improving the uniformity of the force on the balloon. Exemplarily, three, four or five cables 400 are set. At the same time, the setting position and length of the cable 400 can be adjusted according to actual needs, thereby realizing the change of the adjustment force of the cable 400 to achieve a better hemostatic effect.

[0053] In one embodiment, if Figure 3 , Figure 4 and Figure 7As shown, one end of the cable 400 is connected to the side of the inner balloon 230 close to the middle of the two balloons, and the other end is connected to the inner wall of the balloon not provided with the inner balloon 230 away from the middle of the two balloons. It is worth noting that the position where the cable 400 is connected to the inner balloon 230 can be set close to the position where the outer diameter of the inner balloon 230 is the largest after expansion, so as to ensure the pulling effect of the cable 400 on the inner balloon 230. In addition, the position where the cable 400 is connected to the inner wall of the balloon can be the side away from the middle of the two balloons, or the side close to the middle of the two balloons. Those skilled in the art can set the specific connection position of the cable 400 according to actual needs to achieve the desired pulling effect.

[0054] Regarding the pulling effect of the cable 400 on the balloon, when the balloon is less inflated, the cable 400 can directly pull the balloon toward the direction of the bladder neck; when the balloon is more inflated, the cable 400 is in a stretched state, and the balloon continues to inflate, but the force of the cable 400 limits the bulge of the balloon away from the bladder neck, so that the continued injection of gas causes the balloon to expand toward the bladder neck.

[0055] Preferably, the position where the inner balloon 230 is connected to the cable 400 is thickened, and / or the position where the balloon is connected to the cable 400 is thickened. By thickening, on the one hand, the reliability of the connection between the balloon and the cable 400 is improved, and on the other hand, the deformation of the connection is reduced, and the expansion direction of the balloon cannot be adjusted.

[0056] In addition, in the scheme of setting the inner balloon 230 and the cable 400, the expansion direction after inflation can be controlled by changing the wall thickness of the two balloons and the inner balloon 230 at the same time. Those skilled in the art can set it according to actual needs, which will not be repeated here. The operator can select the hemostatic device according to the actual situation of the patient and the actual situation of the hemostatic position by auxiliary imaging before hemostasis to improve the hemostatic effect of the hemostatic device.

[0057] like Figure 3-Figure 5 As shown, the cable 400 is inserted between the inner wall of the balloon and the outer wall of the catheter 100; or, as shown, Figure 6 and Figure 7 As shown, the catheter 100 is provided with a perforation 130 extending along its axial direction, and the cable 400 is passed through the perforation 130. It is understandable that during the inflation and deflation of the inner balloon 230 and the two balloons, the cable 400 moves axially relative to the catheter 100 to achieve pulling of the balloon or the inner balloon 230.

[0058] In other embodiments, Figure 8As shown, the inner balloon may not be provided, and only the pull cable 400 may be provided to cooperate with the two balloons, so that the first balloon 210 and the second balloon 220 can also move toward each other. Those skilled in the art may make a choice according to the actual need for hemostasis.

[0059] The above contents are only preferred embodiments of the present invention. For ordinary technicians in this field, according to the concept of the present invention, there will be changes in the specific implementation methods and application scopes. The content of this specification should not be understood as limiting the present invention.

Claims

1. A hemostatic device, characterized in that: include: A catheter (100); A ring bundle (300), the ring bundle (300) is sleeved on the outside of the balloon and connected to the catheter (100), and the ring bundle (300) is used to separate the balloon to form a first balloon (210) and a second balloon (220); The first balloon (210) and the second balloon (220) are connected to each other and are sleeved on the outside of the catheter (100). The catheter (100) is provided with a first through hole (110). The first through hole (110) is connected to the first balloon (210) and / or the second balloon (220) to inflate and exhaust the first balloon (210) and the second balloon (220). The first balloon (210) expands after passing through the bladder neck, and the second balloon (220) expands outside the bladder neck. The first balloon (210) expands in a direction close to the second balloon (220), and the second balloon (220) expands in a direction toward the first balloon (210). The position of the ring bundle (300) along the axial direction of the catheter (100) is adjustable; the catheter (100) is provided with more than two mounting holes (140) at intervals along its axial direction, and the inner wall of the ring bundle (300) is provided with a mounting head (310), and the mounting head (310) can be snapped into the mounting hole (140).

2. The hemostatic device according to claim 1, characterized in that: The mounting head (310) is provided with a protruding snap-fit ​​joint (311), and the mounting hole (140) is provided with a snap-fit ​​hole (141) and a snap-fit ​​cavity (142) that are interconnected, and the snap-fit ​​hole (141) can undergo elastic deformation to allow the snap-fit ​​joint (311) to pass through the snap-fit ​​hole (141), and restore deformation to allow the snap-fit ​​joint (311) to be placed in the snap-fit ​​cavity (142).

3. The hemostatic device according to claim 1 or 2, characterized in that: The wall thickness of the first balloon (210) on the side close to the second balloon (220) is smaller than the wall thickness on the side away from the second balloon (220); the wall thickness of the second balloon (220) on the side close to the first balloon (210) is smaller than the wall thickness on the side away from the first balloon (210).

4. The hemostatic device according to claim 1 or 2, characterized in that: A squeezing area is provided on a side of the first balloon (210) close to the second balloon (220), and the squeezing area is provided along the circumference of the bladder neck, and the wall thickness of the squeezing area is smaller than the wall thickness of the non-squeezing area; the squeezing area is provided on a side of the second balloon (220) close to the first balloon (210); each balloon is provided with two or more squeezing areas.

5. The hemostatic device according to claim 1 or 2, characterized in that: An inner balloon (230) is arranged inside one of the balloons, and the catheter (100) is provided with a second through hole (120), and the second through hole (120) is connected to the inner balloon (230) to inflate and exhaust the inner balloon (230); the hemostatic device also includes a cable (400), one end of the cable (400) is connected to the inner balloon (230), and the other end is connected to the other balloon, and the cable (400) can make the inner balloon (230) expand toward the middle of the first balloon (210) and the second balloon (220).

6. The hemostatic device according to claim 5, characterized in that: The portion where the inner balloon (230) is connected to the cable (400) is thickened, and / or the portion where the balloon is connected to the cable (400) is thickened.

7. The hemostatic device according to claim 5, characterized in that: The pull cable (400) is inserted between the inner wall of the balloon and the outer wall of the catheter (100); the catheter (100) is provided with a through hole (130) extending along its axial direction, and the pull cable (400) is inserted through the through hole (130).

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