Conduit pump

Abstract

Disclosed is a catheter pump, comprising a catheter, a motor connected to a distal end of the catheter, and a blood flow channel connected to a distal end of the motor. A guide tube penetrates into the blood flow channel from a second opening at a distal end of the blood flow channel and penetrates out of the blood flow channel from a first opening at a proximal end of the blood flow channel. A distal end of the guide tube is open, and a proximal end of the guide tube is provided with a shielding portion. A proximal end of a guide wire is inserted into the guide tube from the open distal end of the guide tube and abuts against the shielding portion.

Description

Technical Field

[0001] This utility model relates to a conduit pump. Background Technology

[0002] US9402942B2 discloses a common practice in the art for inserting a catheter pump into a patient. The general procedure is as follows: A guide tube is mounted on the pump assembly of the catheter pump. The guide tube is inserted through a pigtail tube, passes through the pump assembly, and exits through the bleeding site. The proximal end of a guidewire is inserted into the guide tube and continuously advanced proximally until the proximal end of the guidewire exits from the proximal end of the guide tube, at which point the guide tube is removed. At this point, the guidewire is inserted into the pump assembly, completing the loading of the pump assembly onto the guidewire. Subsequently, the catheter is advanced forward, and the pump assembly moves along the guidance path established by the guidewire within the patient until it reaches the heart, completing the pump insertion process.

[0003] In this known embodiment, the guide tube is pre-assembled onto the catheter pump, and its proximal end is labeled for the physician to manipulate and easily remove the guide tube from the catheter pump. The reason this known embodiment allows for a label at the proximal end of the guide tube for identification and ease of physician operation is that the catheter pump is not subjected to an external trial run before insertion into the patient. A "trial run" refers to operating the catheter pump in a container filled with liquid (e.g., water).

[0004] Increasing clinical feedback indicates that pre-trial testing of the catheter pump in vitro is essential to verify its effectiveness and prevent the insertion of a faulty pump (e.g., one whose motor fails due to wiring malfunction). However, the guide tube cannot be present on the catheter pump during the trial run, as it can jam the impeller, preventing the pump from functioning properly even if it is effective. To address this, the physician must remove the guide tube from the pump, reinstall it after the trial run, and then insert it back into the pump. This requires inserting the guide tube through the pigtail tube and exiting through the bleeding site, followed by inserting a guidewire into the guide tube before administering the pump. During this process, the proximal end of the guide tube cannot be pre-labeled, otherwise reinstallation would be impossible. Alternatively, while the label can be added after reinstallation, this is obviously cumbersome.

[0005] In clinical practice, accidents frequently occur when the proximal end of the guide tube is unlabeled. The following scenario occurs: after the catheter pump advances along the guidewire and exits through the proximal end of the guide tube, the physician may easily forget to remove the guide tube from the pump due to the lack of any identifying label. Consequently, during subsequent catheter advancement, the guide tube may be carried into the patient's body by the pump. Once the guide tube is inside the patient, it can lead to extremely dangerous consequences. The physician may not be aware of this problem, causing the guide tube to jam the impeller during subsequent operation, preventing blood pumping. Alternatively, the guide tube may be severed by the impeller, releasing small fragments into the body. Or, the guide tube may detach from the pump and enter the patient's body. Any of these unknown consequences poses a significant threat to the patient's life. Utility Model Content

[0006] In view of this, the present invention provides a catheter pump, including a catheter, a motor connected to the distal end of the catheter, and a blood flow channel connected to the distal end of the motor. The guide tube enters the blood flow channel through a second opening at the distal end and exits through a first opening at the proximal end. The distal end of the guide tube is open, and a blocking portion is provided at the proximal end. The proximal end of the guidewire is inserted into the guide tube through the distal open end and abuts against the blocking portion.

[0007] During the insertion of the catheter pump into the patient's body, the present invention can prevent doctors from forgetting to remove the guide tube from the catheter pump, thus avoiding a series of subsequent risks caused by the guide tube being inserted into the patient's body along with the catheter pump. Attached Figure Description

[0008] Figure 1 is a schematic diagram of the insertion of the catheter pump into the patient's body according to the first embodiment of this utility model; wherein, the length of the guide tube is less than or equal to the length of the proximal segment of the guidewire. Figure 1A A schematic diagram showing the insertion of the proximal segment of the guidewire into the guide tube after the guidance path has been established. Figure 1B This is a schematic diagram showing the guide tube and guide wire being inserted together into a catheter pump with a pigtail tube as the protective structure. Figure 1C A schematic diagram showing the guide tube and guide wire being inserted together into a tubing pump with a round-headed protective structure;

[0009] Figure 2 is a schematic diagram of the insertion of the catheter pump into the patient's body according to the second embodiment of this utility model; wherein, the length of the guide tube is greater than the length of the proximal section of the guidewire. Figure 2A This is a diagram illustrating the insertion of the guidewire into the patient's body along with the guide tube. Figure 2B This is a schematic diagram showing the guide tube and guide wire being inserted together into a catheter pump with a pigtail tube as the protective structure. Figure 2C A schematic diagram showing the guide tube and guide wire being inserted together into a tubing pump with a round-headed protective structure;

[0010] Figure 3This is a schematic diagram showing the catheter pump completing its positioning on the patient's heart after the guidewire is removed.

[0011] Figure 4 is a cross-sectional view of the guide tube passing through the inside of the duct pump; in which, Figure 4A The protective structure of the duct pump is a pigtail tube. Figure 4B The protective structure of the duct pump is a round head structure;

[0012] Figure 5 This is a schematic diagram of the assembly of the guidewire and guide tube. Detailed Implementation

[0013] The terms "proximal" and "distal" are relative to the physician operating the catheter pump. "Proximal" refers to the portion relatively close to the physician, and "distal" refers to the portion relatively far from the physician. For example, the catheter may be located proximally to the pump assembly, and the pump assembly may be located distally to the catheter. It should be understood that these directional terms are defined for ease of description and are not restrictive or absolute.

[0014] As shown in Figure 1 Figure 1A , Figure 1B , Figure 1C As shown in Figures 4A and 4B, the catheter pump 100 can be inserted into a target location in the patient's body, such as the left ventricle (LV), via a guidewire 60. It includes a catheter 50 and a pump assembly 90. The pump assembly 90 includes a motor 20 connected to the distal end of the catheter 50, a blood flow channel 30 connected to the distal end of the motor 20, and an impeller 70 located within the blood flow channel 30 and driven to rotate by the motor 20 to pump blood. The blood flow channel 30 has a first opening 331 at its proximal end and a second opening 321 at its distal end, including a cannula 31, a first blood window 33 connected to the proximal end of the cannula 31, and a second blood window 32 connected to the distal end of the cannula 31. The impeller 70 is located within the first blood window 33. The first opening 331 is formed on the sidewall of the first blood window 33, and the sidewall of the second blood window 32 has a third opening 322 for blood to pass through. The first blood window 33 is connected between the cannula 31 and the motor 20, and the distal end of the second blood window 32 is connected to a protective structure 40 to prevent damage to blood vessels and the inner wall tissue of the left ventricle (LV).

[0015] like Figure 1B , Figure 2B , Figure 3 , Figure 4A As shown, in one embodiment, the protective structure 40 is a flexible hollow pig tail tube with an arc-shaped or coiled end in its natural state (the pig tail tube is partially straightened when the guide wire 60 or guide tube 10 is inserted therein), and the second opening 321 is the distal opening of the pig tail tube. Alternatively, as... Figure 1C , Figure 2C , Figure 4BAs shown, in another embodiment, the distal end of the second blood window 32 is not provided with a pig tail tube, and the protective structure 40 is replaced by a round head structure with a rounded outer surface instead of a pig tail tube. Then, the second opening 321 is formed on the side wall of the second blood window 32, that is, the third opening 322 constitutes the second opening 321.

[0016] One of the first opening 331 and the third opening 322 constitutes the blood inlet, and the other constitutes the bleeding outlet, depending on the application scenario of the catheter pump 100. When the catheter pump 100 is used for left ventricular assist, the first blood window 33 is the bleeding window, the first opening 331 is the bleeding outlet, the second blood window 32 is the blood inlet window, and the third opening 322 is the blood inlet. When the catheter pump 100 is used for right ventricular assist, the first blood window 33 is the blood inlet window, the first opening 331 is the blood inlet, the second blood window 32 is the bleeding window, and the third opening 322 is the bleeding outlet.

[0017] Taking the catheter pump 100 for left ventricular assist as an example, the guidewire 60 can be inserted into the patient's body through a puncture site opened in the patient's skin. Its distal end can be pushed forward within the patient's blood vessels until it passes through the aortic valve AV and enters the left ventricle, establishing a guide path for the pump assembly 90 to move forward within the patient's body. At this time, the distal part of the guidewire 60 is inside the patient's body, while the proximal part is exposed outside the patient's body. The doctor threaded the pump assembly 90 onto the guidewire 60 and then pushed the catheter 50 forward, allowing the pump assembly 90 to move forward within the patient's body under the guidance of the guidewire 60 until the distal end of the pump assembly 90 passes through the aortic valve AV and enters the left ventricle LV, so that the cannula 31 crosses the aortic valve AV, with the inlet 322 located in the left ventricle LV and the outlet 331 located in the aorta AO. The impeller 70 rotates to draw blood from the left ventricle LV into the cannula 31 through the inlet 322 and pump it from the outlet 331 to the aorta AO to assist the heart's pumping function and reduce the burden on the heart.

[0018] In other words, the catheter pump 100 of this embodiment and the method described below for inserting the pump assembly 90 into the patient's body using the guidewire 60 and guide tube 10 are applicable not only to scenarios where the catheter pump 100 is used for left ventricular assist but also to scenarios where it is used for right ventricular assist. Of course, it can also be applied to kidney assist, serving as a renal pump. The following description primarily focuses on the scenario where the catheter pump 100 is used for left ventricular assist, but as can be seen from the above description, the scope of protection of this embodiment is not limited thereto.

[0019] The catheter pump 100 also includes a guide tube 10 for inserting the guidewire 60. The proximal end of the guide tube 10 can be inserted into the blood flow channel 30 through the second opening 321 and then exit through the first opening 331. Figure 5As shown, the distal end of the guide tube 10 is open, and the proximal end is provided with a blocking portion 11. The proximal end of the guide wire 60 can be inserted into the guide tube 10 through the distal opening and abut against the blocking portion 11. The blocking portion 11 can partially close the proximal end of the guide tube 10, making the proximal end of the guide tube 10 partially open. Alternatively, it can completely cover the proximal end of the guide tube 10, making the proximal end of the guide tube 10 closed.

[0020] During the insertion process where the pump assembly 90 moves forward relative to the guidewire 60, the guide tube 10 remains relatively stationary with the guidewire 60 through the abutment between the guidewire 60 and the shielding part 11. Thus, as the pump assembly 90 moves forward along the guidewire 60 within the patient's body, the guide tube 10 moves backward relative to the pump assembly 90, effectively preventing the guide tube 10 from being forgotten by the doctor and carried into the patient's body along with the pump assembly 90. This ensures that the guide tube 10 can always be detached from the pump assembly 90. To ensure the relative stationary position of the guide tube 10 and the guidewire 60, and to prevent the pump assembly 90 from carrying the guide tube 10 and guidewire 60 into the patient's body together, the doctor typically needs to hold the guide tube 10 and guidewire 60 with one hand while pushing the catheter 50 forward with the other hand, or the above operations can be performed by two doctors separately.

[0021] Furthermore, the design of the guide tube 10, which is at least partially closed at the proximal end, allows it to remain outside the guidewire 60 throughout the entire insertion process of the catheter pump 100, unlike in existing technologies where it needs to be removed prematurely. This eliminates the need for a label at the proximal end of the guide tube 10 for guidance and ease of physician handling, thus reducing material costs. It also reduces scratching of the guidewire 60 coating by the pump assembly 90 (described below), thereby lowering the risk of particulate matter entering the body.

[0022] Typically, the total length of the guidewire 60 is approximately 300 cm. After establishing the guidance path, the guidewire 60 is divided into two parts, with the puncture site on the patient's skin as the boundary: a proximal segment 63 located outside the patient's body and a distal segment 64 located inside the patient's body. The lengths of the proximal segment 63 and the distal segment 64 vary depending on the patient's body size, but generally, the length of the proximal segment 63 located outside the patient's body is approximately 180 cm, and the length of the distal segment 64 located inside the patient's body is approximately 120 cm. During the insertion of the catheter pump 100 into the patient's body along the guidance path established by the guidewire 60, the guide tube 10 can be entirely located outside the patient's body, or partially located inside the patient's body and partially located outside the patient's body.

[0023] like Figures 1A to 1C As shown, in the first embodiment where the entire guide tube 10 is located outside the patient's body, the length of the guide tube 10 is less than or equal to the length of the proximal segment 63 (e.g., the length of the guide tube 10 is 150 cm). Figure 1AAs shown, guidewire 60 is first inserted into the patient's body to establish the guidance path. Subsequently, guide tube 10 can be attached to the proximal segment 63 of guidewire 60 from the patient's body, making guide tube 10 and guidewire 60 a single unit. Figure 1B and Figure 1C As shown, after the proximal end of the guidewire 60 abuts against the blocking part 11, the guide tube 10, together with the guidewire 60, is manipulated by the doctor to pass through the second opening 321 into the blood flow channel 30, and then out through the first opening 331, completing the loading of the guidewire 60 and the guide tube 10 into the pump assembly 90, as shown. Figure 4A and Figure 4B As shown.

[0024] In the second embodiment, where the guide tube 10 is partially located inside the patient and partially outside the body, the length of the guide tube 10 is greater than the length of the proximal segment 63 of the guidewire 60 but less than the total length of the guidewire 60 (e.g., the length of the guide tube 10 is 220 cm). Figure 2A As shown, the guide tube 10 can be attached to the guide wire 60 before the guide wire 60 is inserted into the patient's body. Figure 2B and Figure 2C As shown, after the proximal end of the guidewire 60 abuts against the blocking portion 11, the guide tube 10, together with the guidewire 60, is inserted into the patient's body by the doctor to establish a guidance path. Subsequently, the doctor manipulates the guide tube 10 and guidewire 60 to pass through the blood flow channel 30 from the second opening 321 and out from the first opening 331, completing the loading of the guidewire 60 and guide tube 10 onto the pump assembly 90, as... Figure 4A and Figure 4B As shown.

[0025] After the guidewire 60 and guide tube 10 are loaded onto the pump assembly 90, the physician continues to advance the catheter 10 until the pump assembly passes through the aortic valve AV, completing its positioning within the left ventricle LV (e.g., Figure 3 (As shown), then remove the guide wire 60 and guide tube 10 together from the pump assembly 90.

[0026] Practice has proven that the two embodiments make the insertion of the guide tube 10 into the pump assembly 90 very simple and convenient, and the insertion is very smooth. This is because the guide tube 10 is flexible, and the blood flow channel 30 contains an impeller 70. In the traditional method of directly inserting the guide tube 10 into the pump assembly 90, the flexible guide tube 10 is often blocked by the impeller 70, resulting in poor insertion. However, by fitting the guide tube 10 onto the more flexible guide wire 60, the rigidity of the guide tube 10 is increased, and the insertion of the guide tube 10 and the guide wire 60 becomes smooth.

[0027] Furthermore, in clinical practice, when doctors operate various medical instruments while wearing surgical gloves, slippage often occurs due to the surface of the gloves becoming wetted by liquids such as saline or blood. This is particularly noticeable when inserting thin, rigid, and smooth instruments like the guidewire 60 into the curved and potentially kinked guide tube 10, significantly impacting surgical deployment efficiency. By first threading the guidewire 60 into the guide tube 10, and then inserting both instruments into the pump assembly 90, the rigid guidewire 60 acts as a liner for the guide tube 10, increasing its rigidity and preventing kinking. This allows for efficient insertion of both the guidewire 60 and the guide tube 10 into the pump assembly 90. Moreover, the guide tube 10 generally has a higher coefficient of friction and a larger diameter than the guidewire 60, which is beneficial for the doctor's operation and helps overcome slippage.

[0028] Furthermore, since the pump assembly 90 lacks blood lubrication outside the patient's body, the coating on the guidewire 60 is more easily scratched and peeled off when it passes through the first opening 331. However, when the guide tube 10 is fitted over the portion of the guidewire 60 outside the patient's body and both are inserted into / withdrawn from the pump assembly 90 together, or when the pump assembly 90 moves forward inside the patient's body under the guidance of both, the guide tube 10 encloses the guidewire 60, isolating it from contact and scratching with the first opening 331, and protecting the coating of the guidewire 60. Thus, the guide tube 10 provides extended protection for the guidewire 60 as it passes through the impeller 70 and the bleeding opening 331. Especially in the second embodiment where the guide tube 10 completely covers the external portion (proximal segment 63) of the guidewire 60, the guide tube 10 provides full-length anti-coating scratch protection for the section of the guidewire 60 outside the body where there is no blood lubrication.

[0029] Furthermore, in the prior art, when the pump assembly 90 moves forward along the guide wire 60 outside the body, the impeller 70 is at risk of being scratched and damaged by the guide wire 60. In this embodiment, a softer guide tube 10 is provided over the guide wire 60 to reduce the damage to the impeller 70 when the pump assembly 90 moves relative to the guide wire 60 and the guide tube 10.

[0030] like Figure 5 As shown, the proximal outer surface of the guide tube 10 has a shape similar to... Figure 1C , Figure 2C , Figure 4B The protective structure 40 has a similar rounded design, which is conducive to the insertion of the guide tube 10 in the blood flow channel 30 and protects the inner wall of the blood flow channel 30 and the impeller 70 from damage to the proximal end of the guide tube 10. This is beneficial for the catheter pump 100 to reduce blood damage and improve hydraulic performance during subsequent blood pumping operations.

[0031] The above description is merely an embodiment of this utility model and does not limit the patent scope of this utility model. Any equivalent structural or procedural transformations made based on the description and drawings of this utility model, or direct or indirect applications in other related technical fields, are similarly included within the patent protection scope of this utility model.

Claims

1. A duct pump, characterized in that, include: catheter; The pump assembly includes: a motor connected to the distal end of the catheter and a blood flow channel connected to the distal end of the motor; the proximal end of the blood flow channel has a first opening and the distal end has a second opening, and the interior has an impeller driven to rotate by the motor to pump blood. A guide tube for inserting a guidewire, the proximal end of which is operably inserted into the blood flow channel through the second opening and then exits through the first opening; The guide tube has a distal opening and a proximal blocking portion; the proximal end of the guide wire is operably inserted into the guide tube from the distal opening and abuts against the blocking portion.

2. The duct pump as described in claim 1, characterized in that, The guide tube is configured to pass through the blood flow channel from the second opening together with the guide wire after the proximal end of the guide wire abuts against the blocking portion, and then exit from the first opening.

3. The duct pump as described in claim 1, characterized in that, After the proximal end of the guidewire abuts the blocking portion, the guide tube remains relatively stationary with respect to the guidewire, so that as the pump assembly moves forward within the patient's body along the guidance path established by the guidewire, the guide tube moves backward relative to the pump assembly.

4. The duct pump as described in claim 1, characterized in that, After the pump assembly is positioned at the target location within the patient's body, the guide tube and guidewire are operated to be removed together from the pump assembly.

5. The duct pump as described in any one of claims 1-4, characterized in that, The guidewire is configured to be operatively inserted into the patient to establish a guide path for guiding the pump assembly forward within the patient, including a distal segment within the patient and a proximal segment outside the patient after the guide path has been established. The length of the guide tube is less than or equal to the length of the proximal segment, and it is configured to be sheathed onto the proximal segment after the guidewire has completed the establishment of the guide path on the patient's body. or, The guide tube is longer than the proximal segment but shorter than the total length of the guidewire, and is configured to be attached to the guidewire outside the patient's body before the guidewire completes the establishment of the guidance path; after the proximal end of the guidewire abuts the obstruction portion, the guide tube, together with the guidewire, establishes the guidance path.

6. The duct pump as claimed in claim 1, characterized in that, The blood flow channel includes a cannula, a first blood window connected to the proximal end of the cannula, and a second blood window connected to the distal end of the cannula; the first opening is formed on the side wall of the first blood window, and the side wall of the second blood window is provided with a third opening; The distal end of the second blood window is provided with a hollow pig tail tube, and the second opening is the distal opening of the pig tail tube; or, The distal end of the second blood window is not provided with a pig tail tube, and the second opening is formed by the third opening.

7. The duct pump as claimed in claim 6, characterized in that, The catheter pump is used for left ventricular assist, the first opening is the bleeding port, and the third opening is the blood inlet port; or, The catheter pump is used for right ventricular assist, the first opening is the blood inlet, and the third opening is the bleeding outlet.

8. The duct pump as claimed in claim 1, characterized in that, The shielding portion completely covers the proximal end of the guide tube, so that the proximal end of the guide tube is a closed end.

9. The duct pump as claimed in claim 1, characterized in that, The proximal outer surface of the guide tube is rounded.

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