Self-locking double-lumen irrigation and drainage catheter

Abstract

The application discloses a self-locking double-cavity flushing and drainage catheter, which comprises a catheter main body and a memory guide wire, wherein the catheter main body comprises a drainage channel, a flushing channel, an inner partition wall, a first interface, a first through hole, a second through hole and a second interface; the drainage channel and the flushing channel are separated by the inner partition wall; the first interface is communicated with the drainage channel; the second through hole is arranged on the side wall of the drainage channel away from the first interface and communicated with the drainage channel; the second interface is communicated with the flushing channel; and the second through hole is arranged on the side wall of the flushing channel away from the second interface and communicated with the flushing channel. The drainage channel and the flushing channel are arranged in the catheter main body, so that the drainage can be realized while flushing, and the efficiency is high; the memory guide wire is arranged at the end of the catheter main body, and the memory guide wire can be self-locked along with temperature change, so that the problem of catheter outflow is reduced.

Description

Technical Field

[0001] This invention relates to drainage tubes, and more specifically, to a self-locking dual-lumen flushing drainage catheter. Background Technology

[0002] Soft tissue abscesses (including lactating and non-lactating breast abscesses, perianal abscesses, and abdominal wall incision abscesses) are common diseases in general surgery. Traditional incision and drainage is highly invasive, has a long treatment course, slows patient recovery, and affects quality of life. With the popularization of minimally invasive surgery concepts, ultrasound-guided percutaneous catheter drainage has gradually become the mainstream treatment method to replace incision and drainage. However, existing minimally invasive drainage techniques still have the following shortcomings:

[0003] First, the problem of catheter dislodgement: Most existing drainage catheters are ordinary pigtail tubes or straight tubes. The fixation inside the abscess cavity mainly relies on the tension generated by the small curved end or external skin sutures. The displacement rate is high during patient turning over, standing up, and long-term tube insertion. After the catheter is dislodged, it is necessary to re-puncture and insert the catheter, which increases the patient's pain and the risk of infection spread.

[0004] Second, the problem of low efficiency: Currently, clinical irrigation and drainage are mostly achieved by using a single-lumen catheter in conjunction with an external three-way valve. Irrigation and drainage must be performed alternately, which is cumbersome and inefficient. Therefore, there is an urgent need to improve this. Summary of the Invention

[0005] The purpose of this invention is to overcome the shortcomings of the prior art and provide a self-locking dual-lumen flushing and drainage catheter. By setting a drainage channel and a flushing channel in the catheter body, drainage can be achieved while flushing, which is highly efficient. By setting a memory guidewire at the end of the catheter body, it can self-lock according to temperature changes, thereby reducing the problem of catheter dislodgement.

[0006] To achieve the above objectives, the present invention adopts the following technical solution: a self-locking dual-lumen flushing and drainage catheter, comprising a catheter body and a memory guidewire, wherein the catheter body comprises a drainage channel, a flushing channel, an inner diaphragm, a first interface, a first through hole, a second through hole, and a second interface, wherein the drainage channel and the flushing channel are separated by the inner diaphragm, the first interface is connected to the drainage channel, the second through hole is opened on the side wall of the drainage channel away from the first interface and is connected to the drainage channel, the second interface is connected to the flushing channel, and the second through hole is opened on the side wall of the flushing channel away from the second interface and is connected to the flushing channel;

[0007] The memory guidewire is fixed to the end wall of the inner septum. One end of the memory guidewire extends out of the end of the catheter body and the other end is located inside the catheter body. The memory guidewire has a spiral structure and can switch between two modes. When in the first mode, the pitch size of the memory guidewire is smaller than the diameter of the catheter body. When in the second mode, the pitch size of the memory guidewire is larger than the diameter of the catheter.

[0008] Furthermore, the memory guidewire is a nickel-titanium alloy with a nickel content of 54.5wt%-57wt% and the remainder being titanium.

[0009] Furthermore, the morphology switching temperature range of the memory guidewire is 32℃-37℃. When the temperature of the memory guidewire is below this temperature range, it is in the first morphology.

[0010] When the temperature of the memory guidewire is higher than this temperature range, it is in the second form.

[0011] Furthermore, an expansion head is integrally formed at the end of the inner partition wall, the memory guide wire is fixed at the end of the expansion head, a liquid passage is opened inside the inner partition wall, the expansion head includes an expansion cavity, and the expansion cavity is connected to one end of the liquid passage.

[0012] Furthermore, the catheter body also includes a third interface, with the first interface, the second interface and the third interface located on the same side, and the third interface communicating with the liquid passage.

[0013] Furthermore, the expansion head includes a thin-walled section and a thick-walled section. One end of the memory guidewire is embedded and fixed in the thick-walled section, and the thin-walled section can expand to block the first through hole.

[0014] Furthermore, the catheter body includes a drainage section, an isolation section, and a flushing section. The isolation section is located between the drainage section and the flushing section. The first through hole is located within the drainage section area, and the second through hole is located within the flushing section area.

[0015] Furthermore, the catheter body also includes an annular platform located on its periphery, the flushing section being on the side away from the drainage section, a fixing seat being fitted on the outer wall of the catheter body, the inner wall of the fixing seat being tightly fitted with the outer wall of the catheter body, and the fixing seat being located on the side of the annular platform away from the flushing section and being able to abut against or move away from the annular platform.

[0016] Furthermore, the cross-sectional ratio of the drainage channel and the flushing channel ranges from 1.8:1 to 2:1.

[0017] Furthermore, the memory guidewire has two forms:

[0018] Before insertion, the memory guidewire is immersed in sterile ice saline to cool it down and bring it to its first state.

[0019] After insertion, the temperature of the memory guidewire rises, putting it into its second state;

[0020] Before removal, sterile ice-salt water is injected into the expansion chamber to cool the memory guidewire and restore it from the second form to the first form.

[0021] In summary, the present invention has the following beneficial effects:

[0022] 1. This embodiment enables simultaneous drainage and flushing by setting up a drainage channel and a flushing channel inside a catheter body. That is, after the flushing fluid enters the patient's body through the flushing channel, it can be simultaneously drained through the drainage channel. This is convenient and efficient. Furthermore, by setting up an isolation section formed by an inner septum between the drainage section and the flushing section, it can be ensured that the drainage channel and the flushing channel do not interfere with each other, preventing direct convection between the flushing fluid and the drainage fluid. This ensures that after the flushing fluid is released into the abscess cavity in the patient's body, it can be fully diffused through a longer path before entering the drainage channel through the first through hole, avoiding short-circuit flushing and greatly improving the efficiency of abscess cavity cleaning.

[0023] 2. This embodiment utilizes the characteristic that the shape of the memory guidewire changes with temperature. By controlling the shape at low temperature and fixing it at body temperature, the memory guidewire can be switched between two shapes. This greatly simplifies the traditional operation process of inserting, fixing, and removing drainage catheters, eliminating cumbersome steps such as suturing, fixing, and disassembling fixing accessories. It effectively reduces the labor intensity of medical staff and improves the safety, stability, and convenience of interventional treatment, and has extremely high clinical application value. Attached Figure Description

[0024] Figure 1 This is a cross-sectional view of this embodiment;

[0025] Figure 2 for Figure 1 A partial schematic diagram;

[0026] Figure 3 This is a partial schematic diagram of the embodiment before self-locking;

[0027] Figure 4 This is a partial schematic diagram of the self-locking process in this embodiment;

[0028] Figure 5 This is a partial schematic diagram of the self-locking reset in this embodiment.

[0029] Reference numerals: 1. Catheter body; 11. First interface; 12. First through hole; 13. Second interface; 14. Second through hole; 15. Third interface; 16. Drainage section; 17. Isolation section; 18. Fluid flushing section; 19. Circular platform; 2. Drainage channel; 3. Fluid flushing channel; 4. Inner septum; 41. Fluid passage; 5. Expansion head; 51. Expansion chamber; 52. Thin-walled section; 53. Thick-walled section; 6. Memory guidewire; 7. Fixation seat; 8. Silicone head. Detailed Implementation

[0030] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0031] like Figures 1 to 5 As shown, this embodiment discloses a self-locking dual-lumen flushing and drainage catheter, including a catheter body 1 and a memory guidewire 6. The catheter body 1 is a disposable silicone tube, which includes an integrally formed drainage channel 2, a flushing channel 3, an inner septum 4, a first interface 11, a first through hole 12, a second through hole 14 and a second interface 13.

[0032] The first interface 11 is connected to the drainage channel 2. The second through hole 14 is opened on the side wall of the drainage channel 2 away from the first interface 11 and is connected to the drainage channel 2. There are multiple second through holes 14 and they are distributed around the catheter body 1. The first interface 11 is connected to an external negative pressure drainage device (not shown in the figure) through a pipeline. When in use, the fluid in the patient's body can enter the drainage channel 2 through the second through hole 14 and finally flow out from the first interface 11 into the negative pressure drainage device for collection.

[0033] The second interface 13 is connected to the flushing channel 3. The second through hole 14 is opened on the side wall of the flushing channel 3 away from the second interface 13 and is connected to the flushing channel 3. There are multiple second through holes 14. The second interface 13 is connected to an external flushing device (not shown in the figure). External sterile flushing solution can enter the flushing channel 3 through the flushing device and finally flow into the patient's body from the flushing channel 3. In this embodiment, by setting a drainage channel 2 and a flushing channel 3 inside a catheter body 1, drainage and flushing can be carried out simultaneously. That is, after the flushing solution enters the patient's body from the flushing channel 3, it can be drained simultaneously through the drainage channel 2. The operation is convenient and efficient.

[0034] like Figure 1As shown, the drainage channel 2 and the flushing channel 3 are separated by an inner partition 4, thereby forming a drainage section 16, an isolation section 17, and a flushing section 18 on the catheter body 1. The isolation section 17 is located between the drainage section 16 and the flushing section 18. The first through hole 12 is located in the area of ​​the drainage section 16, and the second through hole 14 is located in the area of ​​the flushing section 18. By setting the isolation section 17 formed by the inner partition 4 between the drainage section 16 and the flushing section 18, it can be ensured that the drainage channel 2 and the flushing channel 3 will not interfere with each other, preventing the flushing fluid and the drainage fluid from flowing directly against each other. This ensures that after the flushing fluid is released from the abscess cavity in the patient's body, it can be fully diffused through a longer path before entering the drainage channel 2 through the first through hole 12, avoiding short-circuit flushing and greatly improving the efficiency of abscess cavity cleaning.

[0035] Due to the influence of negative pressure drainage equipment and flushing equipment, the flushing pressure will always be higher than the drainage pressure during actual use. If the flow cross-sectional dimensions of the drainage channel 3 and the flushing channel 2 are consistent, the flushing flow rate will inevitably exceed the drainage flow rate, which will lead to fluid accumulation and local pressure rise in the patient's abscess cavity, affecting the safety of diagnosis and treatment and the treatment effect. Based on the above actual working conditions and safety requirements, in order to ensure that the flushing flow rate is less than or equal to the drainage flow rate, this embodiment sets the cross-sectional ratio of the drainage channel 2 and the flushing channel 3 to be in the range of 1.8:1-2:1, preferably 2:1. By setting the drainage channel 2 and the flushing channel 3 with asymmetrical cross-sections, and utilizing the fluid characteristic that the flow cross-sectional area is positively correlated with the fluid flow capacity, the drainage channel 2 has a larger effective flow space, so that the catheter body 1 as a whole has a sufficient and stable drainage volume. Even if the pressure at the flushing end is too high, the larger drainage cross-section can ensure that the flushing fluid can be discharged in time, avoiding excessive flushing and infection spread.

[0036] Furthermore, it is necessary to prevent over-rinsing by setting the rinsing pressure of the rinsing device. The technology of adjusting the rinsing pressure of the rinsing device is a conventional prior art known in the field and is not the technical solution to be protected by this invention. Therefore, this specification will not elaborate on the specific structure, working principle and control process of the rinsing device pressure adjustment.

[0037] like Figure 1As shown, the catheter body 1 also includes an annular platform 19 located on its periphery. The annular platform 19 is an arc-shaped protrusion protruding 0.5mm from the surface of the catheter body 1. The flushing section 18 is located on the side away from the drainage section 16. A fixing seat 7 is fitted on the outer wall of the catheter body 1. The fixing seat 7 is a silicone part. The inner wall of the fixing seat 7 is tightly fitted with the outer wall of the catheter body 1. The fixing seat 7 is located on the side of the annular platform 19 away from the flushing section 18 and can abut or move away from the annular platform 19. By setting the annular platform 19, the lowest position of the fixing seat 7 can be limited, thereby facilitating the doctor to adjust the position of the fixing seat 7. By setting the fixing seat 7, the length of the catheter body 1 inserted into the human body can be pre-positioned. After ultrasound guidance, the doctor can determine the location of the patient's abscess cavity and adjust the specific position of the fixing seat 7 according to the location of the abscess cavity. Since the catheter body 1 and the fixing seat 7 are tightly fitted, the fixing seat 7 will not easily slide after the position is adjusted. Thus, after the catheter body 1 is inserted into the patient's body through the incision, the state of the fixing seat 7 against the patient's skin surface determines that the catheter body 1 has been inserted in place.

[0038] like Figures 3 to 5 As shown, the memory guidewire 6 is a nickel-titanium alloy spiral structure with a cross-sectional dimension of 0.5 mm. The nickel content is 54.5 wt%-57 wt%, with the remainder being titanium. Its material conforms to the ASTM F2063 surgical implant standard. The morphology switching temperature range of the memory guidewire 6 is 32℃-37℃, allowing it to switch between two morphologies. When the temperature of the memory guidewire 6 is below this range, it is in the first morphology; when the temperature is above this range, it is in the second morphology. Specifically, the morphology switching temperature range is 32℃-37℃, which is lower than the temperature of normal human abscess tissue. When the temperature of the memory guidewire 6 is below 32℃, it is in the martensitic phase, as described in this embodiment. Figure 3 and Figure 5 In the first configuration shown, when the temperature of the memory guidewire 6 is above this temperature range, the memory guidewire 6 is in the austenitic phase, which is the configuration of this embodiment. Figure 4 The second form shown.

[0039] like Figures 1 to 3 As shown, the memory guidewire 6 is fixed to the end wall of the inner septum 4. One end of the memory guidewire 6 extends out of the end of the catheter body 1 and the other end is located inside the catheter body 1. When in the first state, the pitch size of the memory guidewire 6 is smaller than the diameter of the catheter body 1. When in the second state, the pitch size of the memory guidewire 6 is larger than the diameter of the catheter body 1. In the second state, the memory guidewire 6 will retract, thereby squeezing the end of the catheter body 1. The memory guidewire 6 will form multiple points of contact with the inner wall of the abscess cavity, effectively preventing the catheter body 1 from falling off.

[0040] like Figure 1 and Figure 2As shown, an expansion head 5 is integrally formed at the end of the inner septum 4, and a memory guide wire 6 is fixed at the end of the expansion head 5. A fluid passage 41 is opened inside the inner septum 4. The expansion head 5 includes an expansion cavity 51, which is connected to one end of the fluid passage 41. The catheter body 1 also includes a third interface 15, which is connected to the fluid passage 41. The third interface 15 is connected to an external sterile ice saline supply device (not shown in the figure). The supply device can be a syringe or an injection pump.

[0041] During the clinical interventional procedure of this device, the catheter body 1 needs to undergo preoperative pretreatment and morphological adjustment before implantation into the human body to create the basic conditions for minimally invasive puncture and placement. Specifically, before placing the catheter body 1 into the patient's body, a conventional interventional guidewire is first inserted into the drainage channel 2 of the catheter body 1. Through the rigid support of the conventional guidewire, the overall soft catheter body 1 is shaped and supported. At the same time, the memory guidewire 6 is immersed in sterile ice-cold saline. The temperature range of the sterile ice-cold saline is 4℃-10℃. Under the action of the low temperature environment, the temperature of the memory guidewire 6 continues to decrease and is stably maintained in the first state. At this time, medical staff can quickly place the memory guidewire 6 and the catheter body 1 into the abscess cavity in the patient's body through the puncture channel using ultrasound positioning.

[0042] Once the catheter body 1 is inserted and aligned, the support guidewire pre-placed in the drainage channel 2 can be slowly withdrawn to release the internal support constraint on the catheter body 1. At this time, the memory guidewire 6 inserted into the body will directly contact the human tissue fluid and body fluid around the patient's abscess cavity. Affected by the constant body temperature and the continuous heat conduction of the local environment temperature of the abscess cavity, the temperature of the memory guidewire 6 will rise. After the temperature rises, the memory guidewire 6 will spontaneously produce elastic deformation and switch from the first state to the second state. After the memory guidewire 6 completes the state switching, an adaptive limiting support structure can be formed between the catheter body 1 and the inner wall of the human abscess cavity puncture channel to achieve passive self-locking limitation of the catheter body 1. This self-locking structure does not require suture fixation. The support of the catheter body 1 can be achieved by the deformation support force of the memory guidewire 6, reducing the risk of catheter body 1 falling off.

[0043] Before removing the catheter body 1, sterile ice-salt water is injected into the expansion chamber 51 through a sterile ice-salt water supply device. Through heat conduction between the sterile ice-salt water and the memory guidewire 6, the temperature of the memory guidewire 6 will drop, allowing it to recover from the second form to the first form and release the self-locking structure. In this form, the catheter body 1 can be directly pulled out, which is very convenient. In addition, to further improve the removal efficiency, the area around the puncture site can be locally cold-compressed with sterile dressings moistened with sterile ice-salt water, which can accelerate the speed of deformation recovery of the memory guidewire 6.

[0044] This embodiment utilizes the characteristic that the shape of the memory guidewire 6 changes with temperature. By controlling the shape at low temperature and fixing it at body temperature, the memory guidewire 6 can switch between two shapes, which greatly simplifies the traditional operation process of insertion, fixation and removal of drainage catheters. It eliminates cumbersome steps such as suturing and fixing and disassembling fixation accessories, effectively reducing the labor intensity of medical staff, while improving the safety, stability and convenience of interventional treatment. It has extremely high clinical application value.

[0045] The free end of the memory guidewire 6 is fixed with a silicone head 8. By setting the silicone head 8, the head of the memory guidewire 6 can be effectively prevented from directly contacting the patient's tissue, thereby preventing the memory guidewire 6 from puncturing the patient's tissue during insertion into the patient's abscess cavity.

[0046] like Figure 4 and Figure 5 As shown, the expansion head 5 includes a thin-walled section 52 and a thick-walled section 53. One end of the memory guidewire 6 is embedded in the thick-walled section 53 for fixation. The thin-walled section 52 can expand to block the first through hole 12. When the expansion cavity 51 is filled with sterile ice-cold saline, the thin-walled section 52 will expand and deform, thereby blocking the first through hole 12 and blocking the abscess cavity and drainage channel 2, thereby reducing the amount of fluid in the patient's body that flows out with the catheter body 1 during the removal of the catheter body 1, making it easier for medical staff to clean the wound.

[0047] like Figure 2 As shown, the first interface 11, the second interface 13 and the third interface 15 are located on the same side. The first interface 11 and the second interface 13 are distributed in a Y shape. This design is beneficial for connecting the catheter body 1 with the negative pressure drainage device, the flushing device and the supply device.

[0048] The above description is merely a preferred embodiment of the present invention. The scope of protection of the present invention is not limited to the above embodiments. All technical solutions falling within the scope of the present invention's concept are within the scope of protection of the present invention. It should be noted that for those skilled in the art, any improvements and modifications made without departing from the principles of the present invention should also be considered within the scope of protection of the present invention.

Claims

1. A self-locking double-lumen flushing and drainage catheter, characterized in that, The catheter includes a catheter body (1) and a memory guidewire (6). The catheter body (1) includes a drainage channel (2), a flushing channel (3), an inner septum (4), a first interface (11), a first through hole (12), a second through hole (14), and a second interface (13). The drainage channel (2) and the flushing channel (3) are separated by the inner septum (4). The first interface (11) is connected to the drainage channel (2). The second through hole (14) is opened on the side wall of the drainage channel (2) away from the first interface (11) and is connected to the drainage channel (2). The second interface (13) is connected to the flushing channel (3). The second through hole (14) is opened on the side wall of the flushing channel (3) away from the second interface (13) and is connected to the flushing channel (3). The memory guidewire (6) is fixed to the end wall of the inner septum (4). One end of the memory guidewire (6) passes through the end of the catheter body (1) and the other end is located inside the catheter body (1). The memory guidewire (6) has a spiral structure and can switch between two forms. When in the first form, the pitch size of the memory guidewire (6) is smaller than the diameter of the catheter body (1). When in the second form, the pitch size of the memory guidewire (6) is larger than the diameter of the catheter.

2. The self-locking double-lumen flushing and drainage catheter according to claim 1, characterized in that, The memory guide wire (6) is a nickel-titanium alloy with a nickel content of 54.5wt%-57wt% and the remainder being titanium.

3. The self-locking double-lumen flushing and drainage catheter according to claim 2, characterized in that, The morphology switching temperature range of the memory guidewire (6) is 32℃-37℃. When the temperature of the memory guidewire (6) is lower than this temperature range, it is in the first morphology. When the temperature of the memory guidewire (6) is higher than this temperature range, it is in the second form.

4. A self-locking double-lumen flushing and drainage catheter according to claim 3, characterized in that, An expansion head (5) is integrally formed at the end of the inner partition (4), and the memory guide wire (6) is fixed at the end of the expansion head (5). A liquid passage (41) is opened inside the inner partition (4), and the expansion head (5) includes an expansion cavity (51). The expansion cavity (51) is connected to one end of the liquid passage (41).

5. A self-locking double-lumen flushing and drainage catheter according to claim 4, characterized in that, The catheter body (1) also includes a third interface (15), the first interface (11), the second interface (13) and the third interface (15) are located on the same side, and the third interface (15) is connected to the liquid passage (41).

6. A self-locking double-lumen flushing and drainage catheter according to claim 5, characterized in that, The expansion head (5) includes a thin-walled section (52) and a thick-walled section (53). One end of the memory guide wire (6) is embedded in the thick-walled section (53) for fixation. The thin-walled section (52) can expand to block the first through hole (12).

7. The self-locking double-lumen flushing and drainage catheter according to claim 1, characterized in that, The catheter body (1) includes a drainage section (16), an isolation section (17) and a flushing section (18). The isolation section (17) is located between the drainage section (16) and the flushing section (18). The first through hole (12) is located in the area of ​​the drainage section (16) and the second through hole (14) is located in the area of ​​the flushing section (18).

8. A self-locking double-lumen flushing and drainage catheter according to claim 7, characterized in that, The catheter body (1) also includes an annular platform (19) located on its periphery. The flushing section (18) is located on the side away from the drainage section (16). A fixing seat (7) is fitted on the outer wall of the catheter body (1). The inner wall of the fixing seat (7) is tightly fitted with the outer wall of the catheter body (1). The fixing seat (7) is located on the side of the annular platform (19) away from the flushing section (18) and can abut against or move away from the annular platform (19).

9. A self-locking double-lumen flushing and drainage catheter according to claim 1, characterized in that, The cross-sectional ratio of the drainage channel (2) and the flushing channel (3) is in the range of 1.8:1-2:

1.

10. A self-locking double-lumen flushing and drainage catheter according to claim 4, characterized in that, The memory guidewire (6) has two forms: Before insertion, the memory guidewire (6) is immersed in sterile ice saline to cool it down and bring it to the first state. After insertion, the temperature of the memory guidewire (6) rises, causing it to enter its second state; Before removal, sterile ice saline is injected into the expansion chamber (51) to cool the memory guidewire (6) and restore it from the second form to the first form.

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