A flow control switch that variably controls the flow rate and has a constant inner diameter to prevent clogging

Abstract

The thrombus removal device 10 includes a hemostatic valve Y-connector 12 having a distal end 14 that rotatably connects to an associated suction catheter 2 and a Y-connector 16 that connects the distal end to a first branch 18 that terminates in a hemostatic valve and a second branch 22 that connects to an associated vacuum tubing 4 of an associated suction pump 8. An adjustable valve 26 is incorporated into the hemostatic valve Y-connector or connects in-line with the associated vacuum tubing. The adjustable valve regulates the flow rate of fluid drawn by the associated suction pump and has a closed position for zero flow rate, a maximum open position for maximum flow rate, and at least one intermediate position for a flow rate intermediate between the zero and maximum flow rates.

Description

[Technical field]

[0001] The following relates generally to catheter technology, aspiration catheter technology, thrombectomy technology, and related technologies. [Background technology]

[0002]

[0002] Vascular therapy (thrombectomy, atherectomy, etc.) devices are medical instruments that remove or migrate tissue or material from the interior of diseased blood vessels (arteries, veins, etc.). In particular, mechanical thrombectomy by direct aspiration is an effective treatment for thrombi. In such procedures, the tip of an aspiration catheter is deployed at the site of the thrombus and suction is applied to extract the thrombus. The applied vacuum is controlled to preferentially remove thrombus material while minimizing blood loss. Summary of the Invention [Problem to be solved by the invention]

[0003]

[0003] Suction catheters typically include clamps (such as roller clamps or pinch clamps) that control the flow of liquids, solids, and gases through the catheter under application of suction. However, such clamps compress or squeeze the suction tubing, resulting in poor flow control. Furthermore, locking and unlocking the clamps can be difficult and cumbersome, resulting in extended delays in flow control.

[0004]

[0004] Additionally, clot removal procedures may include mechanical aspiration. In such procedures, a vacuum pump and a fluid collection system are used, which is connected to the catheter by an aspiration tube. Such systems include a flow control switch with a silicone tube inside, which is pinched to close the tube. There are many ledges and diameter changes in the switch that can provide a trapping point for the aspirated clot, blocking the aspiration tube.

[0005]

[0005] Specific improvements directed to solving these and other problems are disclosed below. [Means for solving the problem]

[0006] In some embodiments disclosed herein, the clot removal device includes a hemostatic valve Y-connector that includes a distal end that rotatably connects to an associated suction catheter and a Y-connector that connects the distal end to a first branch that terminates in a hemostatic valve and a second branch that connects to an associated vacuum tubing of an associated suction pump. The adjustable valve is incorporated into the hemostatic valve Y-connector or connects in-line with the associated vacuum tubing. The adjustable valve adjusts the flow rate of fluid drawn by the associated suction pump and has a closed position with zero flow rate, a maximum open position with maximum flow rate, and at least one intermediate position with a flow rate intermediate between the zero flow rate and the maximum flow rate.

[0007] In some embodiments disclosed herein, the clot removal device includes a hemostatic valve Y-connector that includes a distal end that rotatably connects to an associated suction catheter and a Y-connector that connects the distal end to a first branch that terminates in a hemostatic valve and a second branch that connects to an associated vacuum tube of an associated suction pump. The adjustable valve is integrated into the hemostatic valve Y-connector or connects in-line with the associated vacuum tube. The adjustable valve includes a valve lumen and a control device that adjustably occludes the valve lumen to adjust the flow rate of fluid drawn by the associated suction pump. The adjustable valve adjusts the flow rate of fluid drawn by the associated suction pump and has a closed position with zero flow rate, a maximum open position with maximum flow rate, and at least one intermediate position with a flow rate intermediate between the zero flow rate and the maximum flow rate.

[0008]

[0008] In some embodiments disclosed herein, a method for removing a thrombus includes the steps of positioning a catheter adjacent to a treatment site on a patient; manipulating a hemostatic valve Y-connector connected to the catheter to move the tip of the catheter radially around the blood vessel at the treatment site; manipulating an adjustable valve either incorporated in the hemostatic valve Y-connector or connected in-line with an associated vacuum tubing connecting an aspiration pump to the hemostatic valve Y-connector to initiate aspiration of material through the catheter; and, when the aspirated material transitions from the thrombus material to the blood, adjusting the adjustable valve to adjust the aspiration to a low but non-zero flow rate of aspirated material.

[0009] One advantage is the provision of an adjustable valve that is either connected in-line to the suction tube or included in the hemostatic valve Y-connector of the thrombus removal device for coupling with a suction catheter.

[0010] Another advantage is that an adjustable valve is provided in the suction tube or hemostatic valve Y-connector of such a thrombus removal device that allows precise control of the flow rate through the suction tube.

[0011] Another advantage is that an adjustable valve that can be easily locked and unlocked is provided on the aspiration tube or hemostatic valve Y-connector of the thrombectomy device.

[0012] Another advantage is that an adjustable valve is provided having a constant inner diameter.

[0013]

[0013] A given embodiment may provide none of the above advantages, one, more than one, or all of the above advantages, and / or may provide other advantages that will become apparent to a person of ordinary skill in the art upon reading and understanding this disclosure. [Brief description of the drawings]

[0014]

[0014] The disclosure may take form in various components and arrangements of components, and in various steps and arrangements of steps. The drawings are only for the purpose of illustrating preferred embodiments and are not to be construed as limiting the disclosure.

[0015] [Figure 1] FIG. 1 illustrates a thrombus removal device according to the present disclosure. [Diagram 2]

[0016] FIG. 2 shows the components of the device of FIG. [Diagram 3] FIG. 3 shows components of the apparatus of FIG. [Figure 4] FIG. 4 shows components of the apparatus of FIG. [Diagram 5]

[0017] FIG. 5 illustrates another embodiment of the thrombus removal device of FIG. [Figure 6] FIG. 6 illustrates another embodiment of the thrombus removal device of FIG. [Figure 7] FIG. 7 illustrates another embodiment of the thrombus removal device of FIG. [Figure 8]

[0018] FIG. 8 illustrates another embodiment of the thrombus removal device of FIG. [Figure 9]

[0019] FIG. 9 illustrates another embodiment of the thrombus removal device of FIG. [Figure 10] FIG. 10 illustrates another embodiment of the thrombus removal device of FIG. [Figure 11] FIG. 11 illustrates another embodiment of the thrombus removal device of FIG. [Figure 12] FIG. 12 illustrates another embodiment of the thrombus removal device of FIG. [Figure 13]

[0020] FIG. 13 illustrates a method of performing a thrombectomy procedure using the device of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016]

[0021] A typical clot removal device or assembly used in conjunction with an aspiration catheter uses a small battery-powered pump to apply suction to a clot at the tip of the aspiration catheter inserted into the vasculature, forcing the clot material into a waste container. The clot removal device includes a hemostatic valve Y-connector including a proximal (patient) end with a catheter rotation knob, a distal end opposite the proximal end with a hemostatic valve that tightens and seals the end of the catheter, and a Y-connector through which the pump connects with the catheter lumen in the hemostatic valve Y-connector.

[0017]

[0022] During the thrombectomy procedure, it is desirable to precisely control the applied vacuum to maximize the aspiration of the thrombus while limiting the amount of blood aspirated to at most a few hundred milliliters (mL), and more preferably much less. In a typical commercially available aspiration catheter, the operator has two aspiration controls: an on / off switch for the pump and an in-line pinch valve on the tubing leading between the hemostasis valve Y-connector and the pump. Two-handed operation is usually required: one hand pushes the catheter to engage the thrombus, and the other hand operates the catheter rotation knob to sweep the catheter tip radially around the vessel lumen and the in-line pinch valve. The operator opens the pinch valve and aspirates thrombus material while rotating the catheter tip until blood begins to flow into a waste container, then closes the pinch valve, stops aspiration, pushes the catheter further in, and opens the pinch valve, observing whether thrombus material or blood is aspirated, and repeats this sequence until thrombectomy is complete. Although fluoroscopic imaging guidance may be used, the operator typically relies heavily on observation of the delivered material to assess whether thrombotic material or blood is being removed by aspiration at any given time.

[0018]

[0023] In some embodiments disclosed herein, the in-line pinch valve is replaced with a continuous or multi-step adjustable valve. In general, the adjustable valve assembly includes a valve lumen and a push or rotary control that provides variable occlusion of the valve lumen. The adjustable valve assembly provides continuous adjustment or multiple flow settings, for example, by a rotary disk with multiple openings of different sizes that can be selectively aligned with the valve lumen by rotating the rotary control. The adjustable valve assembly may include a sealing O-ring, which is preferably designed to have a uniform inner diameter to prevent blockages from accumulating within the adjustable valve assembly.

[0019]

[0024] In some embodiments, the adjustable valve assembly is placed in-line on the tubing extending between the Y-adapter and the pump. In this case, the valve assembly includes inlet and outlet tube fittings for in-line connection, and the valve lumen extends between these tube fittings. In this design, the adjustable valve assembly is a direct replacement for a traditional pinch valve, but with improved functionality.

[0020]

[0025] In other embodiments, the adjustable valve assembly can be incorporated into a hemostasis valve Y-connector that is preferably located at or near the proximal (patient) end along with the catheter rotation knob. This arrangement allows for one-handed operation: the operator can push the catheter as needed while using one hand to operate both the catheter rotation knob and the rotary knob of the adjustable valve assembly.

[0021]

[0026] One-handed operation of the improved aspiration catheter is as follows: With one hand, push the catheter to engage the thrombus and operate the catheter rotation knob to sweep the catheter tip radially around the vessel lumen. With the same hand, open the adjustable valve assembly to begin suction so that aspirated thrombus material begins to transfer into the aspirated blood. At this point, adjust suction using the push or rotary control of the one-handed adjustable valve assembly while simultaneously moving (and possibly rotating) the catheter, looking for more thrombus material, observing the aspirated material (now flowing slowly due to throttling), and detecting when the catheter tip engages thrombus material. By applying a reduced, but non-zero amount of suction as the catheter tip is repositioned, the operator has positive feedback as to whether thrombus material or blood is being aspirated, while reducing suction reduces blood loss.

[0022]

[0027] With reference to FIG. 1, an exemplary vascular treatment (i.e., thrombectomy or atherectomy) device 1 is illustrated. As shown in FIG. 1, device 1 includes an aspiration catheter 2 and a vacuum tube 4 for receiving tissue or fluid (thrombus, blood, etc.) from a patient (not shown) during a thrombectomy procedure. The tissue or fluid travels from the aspiration catheter 2 through the vacuum tube 4 to a collection container 6. Suction is provided through the vacuum tube 4 via a pump 8 (such as a suction pump) that includes an on / off switch 9. Device 1 may also include a booster syringe 5 that is connected to the vacuum tube 4 via a T-shaped connector 7. Each of these components of device 1 are made of a clear polymer resin material to allow a user to visualize the thrombus within device 1.

[0023]

[0028] The thrombus removal device 1 also includes a thrombus removal device 10 having a hemostasis valve Y-connector 12. Referring now to FIG. 2, which shows an enlarged view of the hemostasis valve Y-connector 12 alone, and with continued reference to FIG. 1, the hemostasis valve Y-connector 12 includes a distal end 14 that rotatably connects with the suction catheter 2, and a Y-connector 16. The Y-connector 16 includes a first branch 18 that connects the distal end 14 to a hemostasis valve 20, and a second branch 22 that connects to the vacuum tube 4. In some embodiments, the distal end 14 of the hemostasis valve Y-connector 12 includes a catheter rotation control 24 operable to rotate the suction catheter 2 (shown only in FIG. 1) relative to the hemostasis valve Y-connector 12.

[0024]

[0029] The clot removal device 10 also includes an adjustable valve 26. In the embodiment shown in Figures 1 and 2, the adjustable valve 26 is integrated into the hemostatic valve Y-connector 12 (e.g., at the distal end 14). In other embodiments, the adjustable valve 26 connects in-line with the vacuum tube 4. The adjustable valve 26 is configured to adjust the flow rate of fluid drawn by the aspiration pump 8 and has a closed position with zero flow rate, a maximum open position with maximum flow rate, and at least one intermediate position with a flow rate intermediate between the zero flow rate and the maximum flow rate. In some embodiments, the at least one intermediate position comprises a continuum of intermediate positions extending continuously from the zero flow rate to the maximum flow rate.

[0025]

[0030] 3 and 4 show an example of an adjustable valve 26. To regulate the flow rate of fluid, the adjustable valve 26 includes a housing 28 defining a valve lumen 30 and a controller 32 that adjustably occludes the valve lumen 30 to regulate the flow rate of fluid drawn by the aspiration pump 8. Advantageously, the adjustable valve 26 does not regulate the flow rate of fluid drawn by the aspiration pump 8 by compressing the tubing that defines the valve lumen 30. Compressing the vacuum tube 4 results in less repeatable flow control that weakens over time and may eventually cause the tube to burst in the area of ​​compression.

[0026]

[0031] 3 shows an example of the control 32 as a push button (or plunger) 32 that adjustably occludes the valve lumen 30 to regulate the flow rate of fluid drawn by the aspiration pump 8. An operator can press down on the push button 32, such as using their thumb, to control the diameter of the valve lumen 30. In some embodiments, the push button 32 can be secured to the housing 28 via one or more O-rings 34.

[0027]

[0032] FIG. 4 shows an example of the control device 32 as a rotary disk 32 that adjustably occludes the valve lumen 30 to regulate the flow rate of fluid drawn by the suction pump 8. As shown in FIG. 4, the rotary disk 32 includes an opening 36 having a diameter that substantially matches the diameter of the vacuum tube 4 (shown in inset A of FIG. 4). An operator rotates the rotary disk 32, using a thumb or the like, to control the offset of the opening 36 relative to the valve lumen 30 to partially or completely occlude the valve lumen 30, thereby providing continuously adjustable flow control between zero flow (when the opening 36 is offset until the lumen is completely blocked) and maximum flow (when the opening 36 is precisely aligned with the valve lumen 30). In some alternative embodiments, the rotary disk 32 can include multiple openings 36 of different sizes that provide incrementally adjustable occlusion of the valve lumen 30.

[0028]

[0033] 5-7 show partially exploded perspective views of another embodiment of the thrombus removal device 10. As shown in FIG. 5, the catheter rotation control 24 includes a flow control lever 24 incorporating an adjustable valve 26. The flow control lever 24 / adjustable valve 26 components are secured to the distal end 14 of the hemostasis valve Y-connector 12 via a large O-ring 42, a small O-ring 44, an end cap 46, and a screw 48. FIG. 5 also shows a rotating male Luer connector 50 disposed at the distal end 14 of the hemostasis valve Y-connector 12. The opposite proximal end 52 of the hemostasis valve Y-connector 12 includes a Y-connector 16 with a first branch 18 terminating in a hemostasis valve 20 including a compression cap with a seal 58 and a second branch 22 terminating in an aspiration port 60. The aspiration port 60 may include a Luer fitting that can be coupled to a vacuum tube 4.

[0029]

[0034] 6 and 7 show the operation of the flow control valve 26 in a side cross-sectional view. When the flow control lever 43 is in the "forward" position (as shown in FIG. 6, where the flow control lever 43 is disposed toward the vacuum tube 4), the occlusion ring 60 connected to the flow control lever 43 transitions to a "fully open" state. In this state, the occlusion ring 60 does not block the valve lumen 30, so that suction can flow from the pump 8 through the vacuum line 4 to the treatment site and aspirate the clot. Meanwhile, FIG. 7 shows that the flow control lever 43 is in a "rearward" position (i.e., above the hemostasis valve Y-connector 12 and away from the vacuum line 4). As shown in FIG. 7, in this case, the adjustable valve 26 transitions to a "closed" state. In this state, the occlusion ring 60 rotates to completely occlude the valve lumen 30, thereby preventing suction through the vacuum line 4. To switch between the forward and rearward positions, the user can use his thumb to control the forward movement of the flow control lever 43. Furthermore, in positions of the flow control lever 43 intermediate between the "fully open" position of Figure 6 and the "fully closed" position of Figure 7, the flow rate will be intermediate between the fully open flow rate of Figure 6 and the zero flow rate of Figure 7, due to the obstruction ring 60 partially obstructing the valve lumen 30. Thus, the flow rate can be continuously adjusted between closed and fully open by gradually moving the flow control lever 43 forward.

[0030]

[0035] FIG. 8 illustrates another embodiment of an adjustable valve 26 that uses a flow control lever 43 but has a different design for occluding flow. The flow control lever 43 has a wedge-shaped opening 62 (or more generally, a flow control feature 62) that is crescent-shaped and aligns with the valve lumen 30 to allow for more gradual control of flow between zero flow and full flow. In particular, the wedge-shaped opening 62 provides more precise control at the low flow range because it tapers toward a fully closed position. This is useful when the operator is aspirating blood while moving the tip of the aspiration catheter into engagement with thrombus material.

[0031]

[0036] Figures 9-12 show some further exemplary embodiments. Figure 9 shows an arrangement similar to the embodiment of Figure 5, including a catheter rotation knob 24 and its internal arrangement 50 shown in exploded view at one end of a hemostasis valve Y-connector 12, and a Y-connector 16 with a hemostasis valve 20 at the other end. One branch of the Y-connector 16 is connected to the suction port 22. However, in contrast to the forward movement of the flow control lever 43 shown in Figures 5-7, in the embodiment of Figure 9, the flow control dial 63 can be moved left and right to adjust the flow rate through the adjustable valve 26. Figures 10-12 show three embodiments of the flow control dial 63, each with different flow control characteristics.

[0032]

[0037] The embodiment of FIG. 10 has the same crescent wedge shaped opening 62 as the flow control feature of FIG. 8 and operates similarly to that of the FIG. 8 embodiment, however, dial 63 functions as a manual control rather than flow control lever 43 as in the FIG. 8 embodiment.

[0033]

[0038] FIG. 11 shows an example of another wedge-shaped opening 72 as a flow control feature. The wedge-shaped opening 72 is asymmetrical and provides a larger rotation of the dial 63 to move between a fully closed and fully open position, and therefore provides finer control of the flow rate. Notably, both the embodiment of FIG. 10 and the embodiment of FIG. 11 provide continuous flow control, i.e., there is a continuum of intermediate positions with increasing flow rates from zero flow to maximum flow.

[0034]

[0039] Unlike the embodiments of Figures 10 and 11, the embodiment of Figure 12 provides a discrete number of intermediate flow rates intermediate zero flow rate and maximum flow rate. Specifically, the dial 63 of Figure 12 includes four separate and distinct openings 82 that are successively aligned with the valve lumen 30 as the dial 63 rotates. This provides five positions: a fully closed position (no holes aligned with the valve lumen 30), three intermediate flow rate positions of successively increasing flow rates corresponding to successively larger diameter openings aligned with the valve lumen 30, and a fully open position (shown specifically in Figure 12) corresponding to the largest diameter opening aligned with the valve lumen 30. In some embodiments, the dial 63 may include detents (not shown) or the like for locking the movement of the dial 30 into the five discrete positions.

[0035]

[0040] The thrombus removal device 10 can be used to perform a thrombus removal method 100 on a patient. With reference to FIG. 13 and continuing reference to FIGS. 1-4, an exemplary embodiment of the thrombus removal method 100 is illustrated as a flow chart. In step 102, the catheter 2 is positioned on the patient next to a treatment site (e.g., a thrombus). In step 104, the user manipulates the hemostatic valve Y-connector 12 connected to the catheter 2 to move the tip of the catheter 2 radially around the blood vessel at the treatment site. In step 106, the adjustable valve 26 is manipulated to initiate aspiration of material (e.g., a thrombus) through the catheter 2 by suction provided by the pump 8 via the vacuum tube 4. In step 108, the adjustable valve 26 is adjusted to adjust the suction to a low but non-zero flow rate of aspirated material as the aspirated material transitions from the thrombus material to the blood.

[0036]

[0041] The present disclosure has been described with reference to the preferred embodiments. Modifications and alterations will occur to those upon reading and understanding the preceding detailed description. It is intended that the exemplary embodiments be construed as including all such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.

Claims

1. a hemostatic valve Y-connector including a distal end rotatably connected to an associated suction catheter and a Y-connector connecting said distal end to a first branch terminating in a hemostatic valve and a second branch connecting to an associated vacuum tubing of an associated suction pump; an adjustable valve incorporated into the hemostasis valve Y-connector or connected in-line with the associated vacuum tubing, the adjustable valve adjusting the flow rate of fluid drawn by the associated aspiration pump and having a closed position for zero flow, a fully open position for maximum flow, and at least one intermediate position for a flow rate intermediate between zero and maximum flow; 10. A thrombus removal device comprising:

2. The adjustable valve comprises: With Barblumen, a control device for adjustably obstructing said valve lumen to regulate the rate of fluid drawn by said associated suction pump; The thrombus removal device of claim 1 , comprising:

3. 3. The thrombus removal device of claim 2, wherein the control includes a push button that adjustably occludes the valve lumen to adjust the flow rate of fluid drawn by the associated aspiration pump.

4. 3. The blood clot removal device of claim 2, wherein the control device includes a rotary disk that adjustably occludes the valve lumen to regulate the flow rate of fluid drawn by the associated aspiration pump.

5. The thrombus removal device of claim 4 , wherein the rotary disc includes a plurality of different sized openings that provide the adjustable occlusion of the valve lumen.

6. 3. The thrombus removal device of claim 2, wherein the adjustable valve does not regulate the flow rate of fluid drawn by the associated aspiration pump by compressing a tube defining the valve lumen.

7. The thrombus removal device of claim 1 , wherein the adjustable valve is integrated into the hemostatic valve Y-connector.

8. the distal end of the hemostasis valve Y-connector includes a catheter rotation control operable to rotate the associated aspiration catheter relative to the hemostasis valve Y-connector; the adjustable valve is integrated into the distal end of the hemostatic valve Y-connector; The thrombus removal device of claim 7.

9. The thrombus removal device of claim 1 , wherein the adjustable valve connects in-line with the associated vacuum tubing.

10. The thrombus removal device of claim 1 , further comprising the suction pump.

11. a hemostatic valve Y-connector including a distal end rotatably connected to an associated suction catheter and a Y-connector connecting said distal end to a first branch terminating in a hemostatic valve and a second branch connecting to an associated vacuum tubing of an associated suction pump; an adjustable valve incorporated into the hemostasis valve Y-connector or connected in-line with the associated vacuum tubing; A thrombus removal device comprising: The adjustable valve comprises: With Barblumen, a control device for adjustably obstructing said valve lumen to regulate the rate of fluid drawn by said associated suction pump; Including, The adjustable valve adjusts the flow rate of fluid drawn by the associated aspiration pump and has a closed position with zero flow rate, a fully open position with maximum flow rate, and at least one intermediate position with a flow rate intermediate between the zero flow rate and the maximum flow rate.

12. The clot removal device of claim 11 , wherein the control includes a push button that adjustably occludes the valve lumen to adjust the flow rate of fluid drawn by the associated aspiration pump.

13. 12. The clot removal device of claim 11, wherein the control device includes a rotary disk that adjustably occludes the valve lumen to regulate the flow rate of fluid drawn by the associated aspiration pump.

14. The thrombus removal device of claim 13 , wherein the rotary disc includes a plurality of different sized openings that provide the adjustable occlusion of the valve lumen.

15. 12. The blood clot removal device of claim 11, wherein the adjustable valve does not regulate the flow rate of fluid drawn by the associated aspiration pump by compressing a tube defining the valve lumen.

16. The thrombus removal device of claim 11 , wherein the adjustable valve is integrated into the hemostatic valve Y-connector.

17. the distal end of the hemostasis valve Y-connector includes a catheter rotation control operable to rotate the associated aspiration catheter relative to the hemostasis valve Y-connector; the adjustable valve is integrated into the distal end of the hemostatic valve Y-connector; The thrombus removal device of claim 16.

18. The thrombus removal device of claim 11 , wherein the adjustable valve connects in-line with the associated vacuum tubing.

19. The thrombus removal device of claim 11 , further comprising the suction pump.

20. positioning the catheter adjacent to a treatment site on the patient; manipulating a hemostatic valve Y-connector connected to the catheter to move the distal end of the catheter radially around the blood vessel at the treatment site; operating an adjustable valve either incorporated into the hemostatic valve Y-connector or in-line with an associated vacuum tubing connecting an aspiration pump to the hemostatic valve Y-connector to initiate aspiration of material through the catheter; adjusting the adjustable valve to regulate aspiration to a low but non-zero flow rate of aspirated material when the aspirated material transitions from thrombus material to blood; A method for removing a blood clot, comprising:

Images