Pulmonary thrombectomy system

Abstract

A pulmonary thrombectomy system includes a catheter, a peristaltic pump, and a clot visualization container. The peristaltic pump is couplable to the catheter such that a central lumen of the catheter can be in fluid communication with a pump inlet of the peristaltic pump. The clot visualization container is coupled to a pump outlet of the peristaltic pump. The clot visualization container includes a housing containing a clot filter having several first pores, and a blood filter having several second pores. The second pores are smaller than the first pores.

Description

PULMONARY THROMBECTOMY SYSTEMBACKGROUNDCROSS REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims priority to and the benefit of U.S. Provisional Application No. 63 / 760,921, filed February 20, 2025, and entitled PULMONARY THROMBETOMY SYSTEM, and U.S. Provisional Application No. 63 / 693,064, filed September 10, 2024, and entitled PULMONARYTHROMBETOMY SYSTEM, the entire content of each of which is incorporated herein by reference.FIELD

[0002] The present disclosure relates to thrombectomy systems. More specifically, the present disclosure relates to pulmonary thrombectomy systems.BACKGROUND INFORMATION

[0003] A thrombectomy procedure is a medical procedure that removes a blood clot from a blood vessel. Thrombectomies treat conditions caused by the blood clot, such as pulmonary embolisms. A pulmonary embolism occurs when a blood clot travels into the lungs or the blood vessels that feed the lungs, such as a pulmonary artery. Treating the pulmonary embolism can include removing the blood clot from the pulmonary artery.

[0004] A blood clot may be removed from a pulmonary artery by a catheter during a pulmonary thrombectomy procedure. For example, the catheter may be advanced percutaneously to a site of the blood clot, within a pulmonary artery, and suction can be applied to the catheter by a syringe that is manually actuated to draw the blood clot (in a volume of blood) into the syringe. The blood clot may be filtered from the blood after aspiration to allow the blood clot to be examined and the volume of blood to be reintroduced into the patient.

[0005] Existing systems used to perform pulmonary thrombectomies include syringes that require several catheterization lab personnel to operate. Furthermore, the several personnel must repeatedly aspirate, separate, and reintroduce blood in a time consuming process. For example, the aspiration / reintroduction cycle may be performed sequentially four or more times in a given procedure. The requirement of several personnel and the long procedural times result in high procedural costs.1 Docket No.: 22935.53.1aAdditionally, the aspiration process can remove substantial amounts of blood from the patient under rapid vacuum application. The blood removal amount and rate can lead to complications, such as blood loss, blood damage, or vessel trauma. Accordingly, a pulmonary thrombectomy system and method that can be performed by a single operator in less time with a reduced likelihood of blood or vessel damage can be beneficial.SUMMARY

[0006] A pulmonary thrombectomy system is described. In an embodiment, the pulmonary thrombectomy system includes a catheter, a peristaltic pump, and a clot visualization container. The catheter has a central lumen. The peristaltic pump includes a pump inlet and a pump outlet. The pump inlet is couplable to the catheter for fluid communication with the central lumen. The clot visualization container is couplable to the pump outlet. The clot visualization container includes a housing containing a clot filter having several first pores, and a blood filter having several second pores. The second pores are smaller than the first pores.

[0007] In another embodiment, a pulmonary thrombectomy system includes a catheter, a peristaltic pump, vacuum reservoir, and a clot visualization container. The catheter has a central lumen. The peristaltic pump includes a pump inlet and a pump outlet. The vacuum reservoir is couplable to the catheter for fluid communication with the central lumen. The vacuum reservoir is also couplable to the pump inlet. The clot visualization container is coupled to the pump outlet.

[0008] In another embodiment, a pulmonary thrombectomy system includes a catheter, a peristaltic pump, a buffer canister, first, second, and third valves, and a clot visualization container. The catheter has a central lumen. The peristaltic pump includes a pump inlet and a pump outlet. The buffer canister is couplable to the catheter for fluid communication with the central lumen and the buffer canister being couplable to the pump inlet. The first valve is disposed between the catheter and the buffer canister and is configured to control the flow of fluid therebetween. The second valve is disposed between the buffer canister and the peristaltic pump and is configured to control the flow of fluid therebetween. The third valve is connected between the buffer canister and atmosphere. The clot visualization container is coupled to the pump outlet.

[0009] The above summary does not include an exhaustive list of all aspects of the present invention. It is contemplated that the invention includes all systems and2 Docket No.: 22935.53.1amethods that can be practiced from all suitable combinations of the various aspects summarized above, as well as those disclosed in the Detailed Description below and particularly pointed out in the claims filed with the application. Such combinations have particular advantages not specifically recited in the above summary.BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings.

[0011] Figure 1 is a schematic view of a pulmonary thrombectomy system, in accordance with an embodiment.

[0012] Figure 2 is a schematic view of a pulmonary thrombectomy system, in accordance with an embodiment.

[0013] Figure 3 is a schematic view of a pulmonary thrombectomy system, in accordance with an embodiment.

[0014] Figure 4 is a schematic view of a pulmonary thrombectomy system, in accordance with an embodiment.

[0015] Figure 5 is a schematic view of a pulmonary thrombectomy system, in accordance with an embodiment.DETAILED DESCRIPTION

[0016] Embodiments describe pulmonary thrombectomy systems used to remove blood clots from pulmonary arteries. The pulmonary thrombectomy systems may, however, be used in other applications, such as removing a blood clot from a different blood vessel. Thus, reference to the thrombectomy systems as being pulmonary thrombectomy systems is not limiting.

[0017] In various embodiments, description is made with reference to the figures. However, certain embodiments may be practiced without one or more of these specific details, or in combination with other known methods and configurations. In the following description, numerous specific details are set forth, such as specific configurations, dimensions, and processes, in order to provide a thorough understanding of the embodiments. In other instances, well-known processes and manufacturing techniques have not been described in particular detail in order to not unnecessarily obscure the description. Reference throughout this specification to “one3 Docket No.: 22935.53.1aembodiment,” "an embodiment,” or the like, means that a particular feature, structure, configuration, or characteristic described is included in at least one embodiment. Thus, the appearance of the phrase ‘'one embodiment,” “an embodiment,” or the like, in various places throughout this specification are not necessarily referring to the same embodiment. Furthermore, the particular features, structures, configurations, or characteristics may be combined in any suitable manner in one or more embodiments.

[0018] The use of relative terms throughout the description may denote a relative position or direction. For example, “upstream” may indicate a first direction along a flow path of a pulmonary thrombectomy system. Similarly, “downstream” may indicate a second direction opposite to the first direction. While such terms are provided to establish relative frames of reference, they are not. however, intended to limit the use or orientation of a pulmonary thrombectomy system to a specific configuration described in the various embodiments below.

[0019] In an aspect, a pulmonary' thrombectomy system includes a catheter, a peristaltic pump, and a clot visualization container. The peristaltic pump can remove blood and a blood clot through the catheter, and dispense the mixture into the clot visualization container. The pumping process can be performed by a single operator. The clot visualization container separates the blood from the blood clot, allowing the blood clot to be observed and the blood to be reintroduced into a patient.

[0020] The peristaltic pump can remove the blood and blood clot mixture using flow and vacuum that builds up over time. The gradual vacuum increase can reduce a likelihood of blood loss and damage to either the blood or a vessel wall. An appropriate selection of pump tubing, combined with a peristaltic pumping mechanism (e.g., rollers) can achieve a same vacuum level as a syringe or a vacuum pump, without using a large reservoir of stored energy. More particularly, by building vacuum in a slow and controlled manner, the peristaltic pump can avoid a large reservoir of stored energy that can be responsible for an immediate application of high vacuum levels (e.g., if the catheter is not engaged with the clot), and thus reduce a blood loss rate. Furthermore, given that the peristaltic pump can achieve the same vacuum as a syringe or vacuum pump while building the vacuum slower, a user can move the catheter around if it is in contact with the vessel wall before achieving a maximum vacuum, thereby reducing a risk of tissue damage.

[0021] Nonetheless, as described below, some embodiments can incorporate a vacuum chamber that is pre-evacuated by the peristaltic pump to allow a user to open4 Docket No.: 22935.53.1aa valve and immediately apply high vacuum. The process can be performed continuously without repetitive syringe operations, and may therefore reduce overall procedural times. Accordingly, the pulmonary thrombectomy system can be used by a single operator to perform a pulmonary thrombectomy in less time with a reduced likelihood of blood or vessel damage. These and other advantages are described in more detail below.

[0022] Referring to Figure 1, a schematic view of a pulmonary thrombectomy system is shown in accordance with an embodiment. A pulmonary thrombectomy system 100 can include a catheter 102. For example, the catheter 102 can include a large bore catheter that can be percutaneously introduced into a patient. The catheter 102 may be used to remove a blood clot from the patient and, accordingly, the catheter 102 includes a central lumen through which the blood clot is moved. The large bore catheter 102 may be, for example, a 24 French catheter and the central lumen can have a corresponding diameter.

[0023] In an embodiment, the catheter 102 extends from a handle 104 that can be used to control the catheter 102. The handle 104 can include a steering mechanism to manipulate a shape of a distal end of the catheter. For example, movement of a knob, button, or slider on the handle 104 can cause the distal end of the catheter 102 to curve, allowing the catheter 102 to be navigated through a tortuous anatomy and / or to a site of a blood clot. Accordingly, the catheter 102 can be a steerable catheter 102.

[0024] The catheter 102 can be connected to a tubing set. For example, the tubing set can include a vacuum line 106. A pump inlet 110 of the vacuum line 106 can be coupled to the catheter 102. The coupling between the pump inlet 110 and the catheter 102 may be through a luer-lock connection 112 that interconnects the pump tubing of a peristaltic pump 108 to the vacuum line 106. Accordingly, the peristaltic pump 108, and in particular the pump inlet 110 of the pump tubing, can be placed in fluid communication with the central lumen of the catheter 102 through the luer-lock connection 112.

[0025] The peristaltic pump 108 can be a positive displacement pump that uses rollers to move a fluid mixture (e g., blood and a blood clot) through the pump tubing. The rollers can compress the pump tubing to create a peristaltic motion that drives the fluid mixture through the pump tubing. During setup, the pump tubing may be set in the rollers of the peristaltic pump 108. such that the rollers act on a region of the pump tubing between the pump inlet 110 and a pump outlet 114. Accordingly, the peristaltic5 Docket No.: 22935.53.1amotion can move the blood and the blood clot from the pump inlet 110 to the pump outlet 114.

[0026] The peristaltic pump 108 may operate in response to a manual input, such as pressing a button, flipping a switch, stepping on a foot pedal 116, etc. Alternatively, or additionally, the pulmonary thrombectomy system 100 can include a computing system that causes the peristaltic pump or other components of the pulmonary thrombectomy system 100 to perform a method. The computing system may include a processing device and memory storing instructions that, when executed by the processing device, cause the method to be performed. The method may include any of the operations described herein.

[0027] The pulmonary thrombectomy system 100 can include a clot visualization container 120 to receive the blood mixture from the peristaltic pump 108. More particularly, the pump tubing (e.g., the pump outlet 114) can be connected to the clot visualization container 120 to pump the blood mixture into the clot visualization container 120.

[0028] The clot visualization container 120 may include a housing 122 to receive the blood mixture. The housing 122 may contain one or more filters. In the illustrated embodiment, for instance, the housing 122 contains a first filter 124 and a second filter 126. The first filter 124 may be a clot filter that can be located within a cavity of the housing 122 near the pump outlet 114. The clot filter can be below the pump outlet 114 such that blood mixture dispensed from the pump outlet 114 falls onto the clot filter. The second filter 126 may be a blood filter. The second filter 125 can be located within the housing 122 and below the clot filter. Accordingly, blood passing from the pump outlet 114 and through the clot filter can fall onto the blood filter.

[0029] The clot filter and the blood filter may have respective pores sized and shaped to filter predetermined components of the blood mixture. The clot filter can have first pores, sized and shaped to filter a blood clot from the blood mixture. The blood filter can have second pores, sized and shaped to filter blood from the blood mixture. For example, the second pores of the blood filter can be smaller than the first pores of the clot filter. The second pores can have an effective diameter in a range of 30-50 m or about 40 pm, and the first pores can have an effective diameter larger than 50 pm or about 1 mm or larger. Accordingly, a blood mixture passing through6 Docket No.: 22935.53.1athe clot visualization container 120 can be separated into blood clot components held by the clot filter and blood passing through both the clot filter and the blood filter.

[0030] In an embodiment, the clot visualization container 120 includes a transparent lid 128. The transparent lid 128 can include a cap that is transparent to allow an operator to view the internal components of the clot visualization container 120. The pump outlet 114 can be coupled to the transparent lid 128. For example, the pump outlet 114 can be attached to the transparent lid 128 such that dispensed blood mixture passes through the transparent lid 128 into the cavity of the clot visualization container 120.

[0031] The clot visualization container 120 may include or be divided into one or more chambers. The blood mixture or components thereof may move through chambers of the clot visualization container 120 during the clot separation process. A first chamber 130 can be located between the pump outlet 114 and the clot filter 124. Blood mixture entering the container from the pump outlet 114 can enter the first chamber 130 and progress toward (e g., fall onto) the clot filter 124. A second chamber 132 can be located between the clot filter 124 and the blood filter 126. Blood passing through the clot filter 124 can progress from the clot filter 124 through the second chamber 132 to the blood filter 126. A third chamber 134 can be located below the blood filter 126 (e g., on an opposite side of the blood filter 126 from the second chamber 132). Filtered blood can enter and pool within the third chamber 134.

[0032] The blood mixture can be urged through the chambers 130, 132, 134 and filters 124, 126 of the clot visualization container 120 in various manners. It is contemplated that the driving force to filter the blood mixture will avoid separation of the blood components, in contrast to the separation that can occur under high vacuum levels. More particularly, the chamber may be maintained at a pressure between atmospheric pressure and a low vacuum during operation.

[0033] In an embodiment, the movement of the blood mixture through the clot visualization container 120 is driven by gravity. The blood mixture can be dispensed onto the clot filter 124 and gravity can cause the blood to flow downward through the clot filter 124 and the blood filter 126. The flow rate of the blood mixture into the first chamber 130 may be less than or equal to the flow rate of the blood through the clot filter 124. For example, the peristaltic pump 108 may pump the blood mixture into the clot visualization container 120 at a rate of 100-300 mL / min or about 200 mL / min, and the clot filter 124 may have pores sized to allow blood to pass from the first7 Docket No.: 22935.53.1achamber 130 to the second chamber 132 at a rate of at least 300 mL / min. As a result, blood entering the clot visualization container 120 can quickly flow past the clot filter 124, allowing large clots to accumulate on the clot filter 124 separately from the blood for easier visualization.

[0034] Flow through the clot visualization container 120 may be urged by a pressure differential between the pump outlet 114 and the third chamber 134. If gravity does not provide sufficient driving force to filter the blood to a desired level, then the filter in the clot visualization container 120 can be limited to a coarse screen to ensure free blood flow. A finer filter (e.g., a 40-micron filter or finer) can be placed inline distal to a return pump to allow the pump to force blood through the fine filter under pressure. Alternatively, a low vacuum may be applied to the clot visualization container 120 by a vacuum pump. The vacuum level may be low enough to avoid disturbing the constituent components of the blood. The pressure differential can contribute to driving the blood mixture through the filters 124, 126 to separate the blood clot for visualization and to collect the blood for reintroduction into the patient.

[0035] The collected blood, which can be stored in the third chamber 134 at a bottom of the clot visualization container 120, can be returned to the patient manually. More particularly, the collected blood may be sucked into a syringe 139 (e.g., a 60 cc syringe) for manual blood return. The syringe 139 can be connected to the clot visualization container 120 by a return line 140. Blood can be suctioned through the return line 140 into the syringe 139, and the syringe 139 may then be detached and connected to an intravenous tubing set to inject the filtered blood into the patient.

[0036] Alternatively, the blood can be returned to the patient automatically. In an embodiment, the return line 140 delivers the blood into the patient. The return line 140 can include a tubing setting having an inlet coupled to the clot visualization container 120 to receive the collected blood, and an outlet that can be fluidly coupled to the patient vasculature (e.g., via a cannula or an introducer sheath inserted into an arm or a leg of the patient). Accordingly, the collected, filtered blood can be delivered from the clot visualization container 120 back into the patient.

[0037] The filtered blood may be pumped through the return line by a return pump 142. The return pump 142 may, for example, include a peristaltic pump. The tubing of the return line 140 can be loaded into the return pump 142, and the pump 142 can move the filtered blood through the tubing from the inlet to the outlet of the return line 140. The filtered blood may therefore be returned to the patient8 Docket No.: 22935.53.1aautomatically, and the circulation of blood can be continuous. More particularly, blood can be circulated through the pulmonary thrombectomy system 100 in a closed loop, without requiring several operators or multiple suction / injection cycles inherent in existing syringe-based thrombectomy procedures.

[0038] The system 100 may have a hybrid return mechanism. More particularly, the syringe 139 and the return pump 142 may be operatively coupled to the return line 140 to allow both manual and automatic pumping of the return blood. A second luer-lock connection 144 can interconnect the return mechanism components. More particularly, a segment of the return line 140 can extend from the line inlet to the second luer-lock connection 144. which may direct flow to additional segments leading to the syringe 139 or the return pump 142.

[0039] The clot visualization container 120 of the pulmonary thrombectomy system 100 functions to separate the blood clot component of the blood mixture from the blood. The mechanical separation allows the blood clot to be held for display. More particularly, when the blood passes through the clot filter 124 and the blood clot remains on top, the blood clot can be viewed from above (as shown in a top view 146 of the clot filter 124). An operator may therefore observe the thrombus being removed from the patient.

[0040] Visualization of the blood clot on the clot filter 124 may arise from the blood draining through the filter 124 as fast or faster than the blood mixture is pumped into the container 120. As a result, a clump of blood clot may passively accumulate on the clot filter 124, which can be easily viewed from above (e.g., through the transparent lid). Alternatively, the pulmonary' thrombectomy system 100 can incorporate mechanisms to actively distribute the blood clot on the clot filter 124 to increase an exposed surface area of the clot for viewing.

[0041] In an embodiment, the clot filter 124 is movable relative to the pump outlet 114. The movable filter 124 causes the blood mixture to be dispensed onto different portions of the filter 124 as it moves within the container 120. For example, the clot filter 124 may spin about a central axis of the container 120. and the pump outlet 114 may be located above the filter 124 and radially offset from the axis such that dispensed material is laid out on the filter 124 in a circumferential direction along an upper surface of the filter 124. The laid out material is represented as arc-shaped segments in the top view. It will be appreciated that several arc-shaped segments of clot, when viewed from above, can have more exposed surface area than, for example,9 Docket No.: 22935.53.1aa single clump of material at a center of the filter 124. Accordingly, the captured clot can be effectively observed by the operator while the blood mixture is moved through the thrombectomy system 100.

[0042] The filters 124, 126 in the container 120 can be replaced as necessary. When the clot filter 124 is full, it can be removed by opening the transparent lid 128 and replacing it with a new filter. The system 100 can then begin dispensing from the central axis again. During a procedure, a user may use several clot filters 124. The different filters 124 can accumulate clots throughout the procedure to provide evidence of how much overall blood clot was removed for the entire procedure.

[0043] Relative movement between the pump outlet 114 and the clot filter 124 may be achieved by moving the clot filter 124 while maintaining the pump outlet 114 stationary. For example, the clot filter 124 can have a disc-shape that is rotated about the central axis, as described above. Rotational motion can be driven by a motor. An output pinion of the motor can drive a gear profile located along an outer edge of the filter 124 to cause the filter 124 to spin under the dispensed clot material. Accordingly, the separation mechanism of the pulmonary thrombectomy system 100 can include a rotatable filter.

[0044] Alternatively, the clot filter may be stationary', and the pump outlet 114 can be moved relative to the filter (e.g., see Figure 5). Alternative drive mechanisms are described below. For example, the flow of blood pumped by the peristaltic pump 108 can act on an impeller coupled to the clot filter to cause the clot filter to move (e.g., rotate). Movement of a nozzle relative to the clot filter can also be urged by a drive mechanism, such as a spring, that does not require a motor or additional electronics.

[0045] Referring to Figure 2, a schematic view of a pulmonary thrombectomy system 100’ is shown in accordance with an embodiment. The pulmonary thrombectomy system 100’ may be similar or identical to the pulmonary thrombectomy system 100 described above. Accordingly, the description of the pulmonary thrombectomy system 100’ will focus primarily on those features that are unique thereto.

[0046] An advantage of using a peristaltic pump over the existing syringe evacuation is the gradual buildup of vacuum that can reduce a likelihood of vessel trauma (e.g., when a high vacuum is applied to a vessel wall). An operator may nonetheless prefer the immediate removal of thrombus for distinct reasons, such as to10 Docket No.: 22935.53.1aquickly evacuate an embolism or to visualize the removal of a larger clot at once. In such cases, the operator may want the ability to build up a higher vacuum level prior to evacuating the clot.

[0047] In an embodiment, the pulmonary thrombectomy system 100’ includes a vacuum reservoir 202 located in line with the vacuum line 106. The vacuum reservoir 202 may, for example, have an inlet connected to a segment of the vacuum line 106 extending from the luer-lock connection 112. An outlet of the vacuum reservoir 202 can connect to a segment of the vacuum line that extends downstream toward the peristaltic pump 108. For instance, the vacuum reservoir 202 may connect to the pump inlet 110.

[0048] The vacuum reservoir 202 may have a volume that allows a large amount of blood mixture to be viewed. For example, the reservoir 202 may have a volume in the range of 50-100 cc or about 60 cc. A user may therefore be able to see whether blood mixture is moving into the reservoir 202 and thereby determine whether a clot is obstructing a lumen of the catheter 102.

[0049] A valve 204 may be located between the vacuum reservoir 202 and the vacuum line 106, between the reservoir 202 and the catheter 102, to permit downstream flow to the reservoir 202 to be stopped. For example, a two-way valve 204 can be closed to isolate the catheter 102 from the reservoir 202, and opened to place the central lumen in fluid communication with the reservoir 202. The valve 204 can be closed to allow the peristaltic pump 108 to build an increased vacuum level in the reservoir 202 and the vacuum line 106. When the desired vacuum level is reached, the operator can open the valve 204 to cause blood mixture to rush through the catheter 102 into the reservoir 202.

[0050] A filter 206 can be disposed between the reservoir 202 and a surrounding environment to relieve pressure and ensure that any air entering the reservoir is particle free (e.g., contaminant free). Pores of the filter can be in a range of 0.1 -0.5 pm or about 0.2 pm. A valve, such as a spring-loaded ball valve, can be located between the filter 206 and the reservoir 202. When the peristaltic pump 108 is providing sufficient flow, the ball can be sucked down into a socket to close the valve. The closed valve allows the peristaltic pump 108 to generate vacuum levels in a range of 26-30 in Hg, which is on a same order of magnitude as vacuum generated by pulling a 60 cc syringe. When the vacuum is achieved, the valve 204 between the reservoir11 Docket No.: 22935.53.1a202 and the catheter 102 can be opened and the blood thrombus mixture can rush into the reservoir 202.

[0051] The reservoir 202 may be emptied by closing the valve 204 between the reservoir 202 and the catheter 102, and opening the valve in from the filter 206 to atmospheric pressure, either manually or automatically. For example, a user can actuate the valve of the filter 206 or a computer or control unit may control actuation of the valve of the filter 206.

[0052] Optionally, the captured blood mixture can be viewed through a transparent wall of the reservoir 202. The blood mixture can then be pumped through the remainder of the vacuum line toward the clot visualization container for further separation and visualization, as described above in connection with Figure 1.

[0053] Referring to Figure 3, a schematic view of a pulmonary thrombectomy system 100” is shown in accordance with an embodiment. The pulmonary thrombectomy system 100” may be a standalone system or may be part of one of the other pulmonary thrombectomy systems disclosed herein.

[0054] As described above, blood may be manually returned to the patient. In an embodiment, the blood is centrifuged prior to reintroduction to the patient. More particularly, the syringe 139 can withdraw the collected blood from the clot visualization container 120 (e.g., through the return line 140 and the second luer-lock connection 144. The syringe 139 may be detached from the second luer-lock connection 144 and inserted into a centrifuge 302.

[0055] The loaded syringe 139 may be centrifuged to separate good blood for return. For example, damaged blood components can be separated from healthy blood components during the centrifugation. The syringe 139 may be connected to an introducer or a cannula to return the blood into the patient. Optionally, the blood can be enriched with oxygen via an oxygenation process prior to reintroduction into the patient. Accordingly, the method performed by the pulmonary' thrombectomy system 100” can return blood to the patient to support a healthy recovery.

[0056] Referring to Figure 4, a schematic view of a pulmonary thrombectomy system 100”’ shown in accordance with an embodiment. Similar to the vacuum reservoir 202 described with respect to Figure 2, the pulmonary thrombectomy system 100'” may include a buffer canister 402. The buffer canister 402 and the vacuum reservoir 202 may have similar structure and function, and the description related to Figure 2 and Figure 4 with respect to the vacuum reservoir 202 and the buffer canister12 Docket No.: 22935.53.1a402 may be effectively interchangeable. The buffer canister 402 can include a vessel having several ports to allow fluid to flow into and out of the canister 402. The ports can be modulated by opening and closing one or more valves. More particularly, the valves can be located at the ports between the buffer canister 402 and segments of the vacuum line 106. For example, like the filter described with respect to Figure 2, an inlet of the buffer canister 402 can connect to an upstream segment of the vacuum line 104 via a valve 204. An outlet of the buffer canister 402 can connect to a downstream segment of the vacuum line 106 via a second valve 404. Similarly, the line connection between the filter 206 and the buffer canister 402 can be opened or closed by a third valve 406.

[0057] The buffer canister 402 can be transparent to allow blood mixture flowing through the canister 402 to be viewed by an operator. Flow through the buffer canister 402 can be regulated by the several valves 204, 404, 406. For example, the first valve 204 and the third valve 406 may be closed while the second valve 404 is open to connect the buffer canister 402 only to the peristaltic pump 108. The peristaltic pump 108 can be run to reduce pressure in the buffer canister 402, thereby forming a vacuum. The second valve 404 may be closed, and the valve 204 may be opened to cause blood mixture to rush through the catheter 102 into the buffer canister 402. An operator can view the blood mixture in the quickly filling buffer canister 402 to assess clot removal. When the buffer canister 402 is filled, the operator may again close the first valve 204 and open the second valve 404. The third valve 406 may also be opened to allow air to enter the buffer canister 402 behind the pumped blood mixture. The filter 206 can prevent particles from entering the system from the surrounding environment. Continued operation of the peristaltic pump 108 can pump the volume of blood mixture stored in the buffer canister 402 through the vacuum line 106 into the clot visualization container 120. The process, which can be performed by a single operator, can be repeated as necessary to clear the clot from the pulmonary artery.

[0058] Referring to Figure 5, a schematic view of a pulmonary thrombectomy system 100?”’ is shown in accordance with an embodiment. As described above, relative movement between the pump outlet 114 and the clot filter 124 may be provided by moving the pump outlet 114 while keeping the clot filter 124 stationary. For example, the pump outlet 114 (e.g., a distal end of the pump tubing) can be held and moved by an end effector of a drive mechanism. The drive mechanism can be, for example, an x-y table that moves the pump outlet 114. The pump outlet 114 can13 Docket No.: 22935.53.1aeffectively provide a nozzle to dispense the blood mixture onto the filter 124. A clamp holding the pump outlet 114 can be moved in a x-direction and / or ay-direction within a horizontal plane by a belt driven mechanism (e.g., several belts driven by respective motors). Accordingly, the nozzle can be moved within the plane over and parallel to the clot filter 124 to dispense the blood mixture onto the filter 124 in a predetermined pattern. The pattern may, for example, be a serpentine pattern, as shown in the top view of Figure 5. The patterned blood clot can be observed by the operator through the transparent lid or through an aperture over the filter 124.

[0059] Having described several embodiments of pulmonary thrombectomy systems, certain benefits of the system may now be acknowledged. First, it will be appreciated that the peristaltic method of catheter aspiration can provide benefit over conventional suction canister methods because blood loss may be drastically reduced. In a free flow condition, in which the catheter is disengaged from the blood clot within the patient, blood loss using a suction canister has been shown to be about 1.8 L / min. By contrast, blood loss using the peristaltic pump can be set by motor speed and may be only, for example, 200 mL / min.

[0060] The reduced blood loss can directly correspond to the decrease flow rate using the peristaltic pump, which can apply a low level of vacuum consistently rather than a high vacuum level over a shorter period of time. The lower vacuum level can reduce a likelihood of damage to the captured blood. For example, the high vacuum level achieved by a suction canister can cause foaming over time and potential blood cell damage. The low vacuum level provided by the peristaltic pump, which can approach atmospheric pressure levels, may cause comparatively less damage to the blood without foaming.

[0061] Another advantage of the lower vacuum level that is consistently applied by the peristaltic pump can include a reduced likelihood of damage to a vessel wall. When a catheter tip is pressed against a vessel wall and blood is quickly aspirated by a suction canister, the vessel wall may be suctioned and damaged. By contrast, the catheter connected to the low vacuum level of the peristaltic pump may briefly contact the vessel wall, however, the pulsatile motion of the vessel can break any temporary closure of the central lumen to allow blood flow to continue through the vacuum line without localized suction at the vessel wall. The vessel wall may not adhere to the catheter and the likelihood of damage can be reduced, accordingly.

[0062] Use of a peristaltic pump can also eliminate stored energy present in an14 Docket No.: 22935.53.1aevacuated suction canister. The suction canister can rapidly generate a high vacuum level, and the vacuum level may not be suddenly stopped or dissipated when needed. By contrast, the peristaltic pump can be stopped to move the system into a safe state. For example, if the catheter tip does become clogged by the embolism, the peristaltic pump can be stopped and the catheter can be repositioned to reattempt removal. The suction canister, however, may not be stopped and release of the vacuum could, for example, cause reintroduction of aspirated material into the upstream vessel.

[0063] When the catheter is clogged, the peristaltic pump can build up vacuum over time to move the thrombus through the catheter shaft. The vacuum generated by the peristaltic pump can, in this case, be higher than the vacuum achieved by a syringe. The nature of the syringe is that the vacuum level achieved by the syringe will go down when the syringe chamber is filled with fluid. Due to the decreased vacuum level, a user may be required to apply a second or third syringe to increase the vacuum level. Using the peristaltic pump, however, the user is not required to attach additional vacuum sources because the peristaltic pump is continuously pumping toward target vacuum level. More particularly, unlike the syringe, the peristaltic pump will automatically increase the vacuum to help move the clot through the catheter shaft.

[0064] The embodiments described above may be modified or added to. Several potential additional or modified embodiments are described below.

[0065] The components of the system may be reusable or disposable. For example, the peristaltic pump may be a pump that is preloaded with the tubing set. The entire assembly, both the pump and the tubing, may be disposed of after each interventional procedure. Similarly, the syringe, the clot visualization container, etc. may also be disposable. In any case, the components may be reusable by being cleaned between interventional procedures.

[0066] In an embodiment, the peristaltic pump and clot visualization container may be replaced by a vacuum pump and a canister. A high-pressure saline pump and ajetted lumen may be incorporated into the system. For example, the saline pump can drive saline through the jetted lumen in the catheter to disrupt a thrombus. The saline may be subsequently aspirated by the peristaltic pump into the canister along with the blood mixture.

[0067] The peristaltic pump which provides aspiration to the catheter could have variable speed control. Variable speed control can optimize aspiration performance while minimizing blood loss. An integrated liquid flow sensor may be15 Docket No.: 22935.53.1aincorporated in the system to provide feedback for pump control. For example, when flow is low (as in a clogged catheter event), the peristaltic pump speed may be increased to provide a quick increase in vacuum. The increased vacuum may initiate flow. When flow is high, however (as in a free-flow condition when the catheter is disengaged from clot), the peristaltic pump speed may be decreased to minimize blood loss.

[0068] Other pump control algorithms may be implemented to improve clot removal. For example, the peristaltic pump could be briefly reversed to loosen a catheter clog if no flow is detected. The oscillation in line pressure caused by intermittent reversals of the pumping direction can loosen thrombus and contribute to less clogging of the catheter.

[0069] Relative motion between the pump outlet and the clot filter can be caused by various mechanisms, as described above. In an embodiment, translation of the pump outlet or rotation of the clot filter may be driven by the flow of blood. For example, a reverse peristaltic follower or blood-driven turbine could provide the mechanical energy to move the nozzle. The pressure in the blood mixture generated by the peristaltic pump can be transferred or input to the follower mechanism to cause a motion output. The motion output can drive the relative motion that allows the blood mixture (and more particularly, the blood clot) to be laid out in an observable pattern on the clot filter).

[0070] The peristaltic pump(s) can be driven by a variety of power sources. For example, the peristaltic pump(s) may be driven by a battery or electrical outlet. Alternatively, the peristaltic pump(s) may be manually powered using a crank, foot pedal mechanism, or other suitable driver.

[0071] It is contemplated that various combinations or sub-combinations of the specific features and aspects of the embodiments disclosed above may be made and still fall within one or more of the embodiments. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with an embodiment can be used in all other embodiments set forth herein. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the disclosed embodiments. Thus, it is intended that the scope of the present disclosure herein disclosed should not be limited by the particular disclosed embodiments described above. Moreover, while the present16 Docket No.: 22935.53.1adisclosure is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the present disclosure is not to be limited to the particular forms or methods disclosed, but to the contrary, the present disclosure is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the various embodiments described and the appended claims. Any methods disclosed herein need not be performed in the order recited. The methods disclosed herein include certain actions taken by a practitioner; however, they can also include any third-party instruction of those actions, either expressly or by implication.

[0072] The ranges disclosed herein also encompass any and all overlap, subranges, and combinations thereof. Language such as "‘up to,” ‘"at least.” "‘greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “approximately”, “about”, and “substantially” as used herein include the recited numbers (e.g., about 10%= 10%), and also represent an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount.

[0073] For purposes of the present disclosure and appended claims, the conjunction “or” is to be construed inclusively (e.g., “an apple or an orange” would be interpreted as “an apple, or an orange, or both”; e.g., “an apple, an orange, or an avocado” would be interpreted as “an apple, or an orange, or an avocado, or any two, or all three”), unless: (i) it is explicitly stated otherwise, e.g., by use of “either... or,” “only one of,” or similar language; or (ii) two or more of the listed alternatives are mutually exclusive within the particular context, in which case “or” would encompass only those combinations involving non-mutually-exclusive alternatives. For purposes of the present disclosure and appended claims, the words “comprising,” “including,” “having,” and variants thereof, wherever they appear, shall be construed as open- ended terminology, with the same meaning as if the phrase “at least” were appended after each instance thereof.

[0074] Following are some further example embodiments of the invention. These are presented only by way of example and are not intended to limit the scope of the invention in any way. Further, any example embodiment can be combined with one or more of the example embodiments.17 Docket No.: 22935.53.1a

[0075] Embodiment 1. A pulmonary thrombectomy system, comprising: a catheter having a central lumen; a peristaltic pump including a pump inlet and a pump outlet, the pump inlet being couplable to the catheter for fluid communication with the central lumen; and a clot visualization container being couplable to the pump outlet, the clot visualization container including a housing containing a clot filter having a plurality of first pores, and a blood filter having a plurality of second pores smaller than the plurality of first pores.

[0076] Embodiment 2. The pulmonary thrombectomy system of Embodiment1, wherein the clot filter is movable relative to the pump outlet.

[0077] Embodiment 3. The pulmonary' thrombectomy system of Embodiment2, wherein the clot filter is configured to rotate.

[0078] Embodiment 4. The pulmonary thrombectomy system of any of Embodiments 1-3, wherein the pump outlet is movable relative to the clot filter.

[0079] Embodiment 5. The pulmonary' thrombectomy system of Embodiment 4, wherein the pump outlet is movable in an x-direction and / or a y-direction relative to the clot filter.

[0080] Embodiment 6. The pulmonary thrombectomy system of any of Embodiments 1-5, further comprising a second peristaltic pump, the second peristaltic pump being connected to the clot visualization container and being configured to communicate blood in the clot visualization container to patient.

[0081] Embodiment 7. The pulmonary thrombectomy system of and of Embodiments 1-6, further comprising a vacuum reservoir having a reservoir inlet couplable to the catheter and a reservoir outlet coupled to the pump inlet.

[0082] Embodiment 8. The pulmonary thrombectomy system of Embodiment7, further comprising a valve between the vacuum reservoir and atmosphere.

[0083] Embodiment 9. The pulmonary thrombectomy system of Embodiment8, further comprising a filter between the valve and the vacuum reservoir.

[0084] Embodiment 10. A pulmonary thrombectomy system, comprising: a catheter having a central lumen; a peristaltic pump including a pump inlet and a pump outlet; a vacuum reservoir, the vacuum reservoir being couplable to the catheter for fluid communication yvith the central lumen, the vacuum reservoir being couplable to the pump inlet; and a clot visualization container coupled to the pump outlet.

[0085] Embodiment 11. The pulmonary thrombectomy system of Embodiment 10, further comprising a valve between the vacuum reservoir and catheter, the valve18 Docket No.: 22935.53.1abeing configured to be selectively opened and closed, wherein: the peristaltic pump is configured to create a vacuum within the vacuum reservoir when the valve is closed; and opening of the valve is configured to draw a blood-clot mixture through the catheter and into the vacuum reservoir.

[0086] Embodiment 12. The pulmonary thrombectomy system of any of Embodiments 10-11, further comprising a valve between the vacuum reservoir and atmosphere, the valve being configured to be selectively opened and closed.

[0087] Embodiment 13. The pulmonary thrombectomy system of Embodiment 12, further comprising a filter between the valve and the vacuum reservoir.

[0088] Embodiment 14. The pulmonary thrombectomy system of any of Embodiments 10-13, wherein the clot visualization container includes a housing containing a clot filter having a plurality of first pores.

[0089] Embodiment 15. The pulmonary thrombectomy system of Embodiment 14, wherein the clot visualization container further comprises a blood filter having a plurality of second pores smaller than the plurality of first pores.

[0090] Embodiment 16. The pulmonary thrombectomy system of Embodiment 14 or 15, wherein the pump outlet and clot filter are configured for relative movement, with the pump outlet being movable relative to the clot filter and / or the clot filter being movable relative to the pump outlet.

[0091] Embodiment 17. A pulmonary thrombectomy system, comprising: a catheter having a central lumen; a peristaltic pump including a pump inlet and a pump outlet; a buffer canister, the buffer canister being couplable to the catheter for fluid communication with the central lumen, the buffer canister being couplable to the pump inlet; a first valve disposed between the catheter and the buffer canister and configured to control the flow of fluid therebetween; a second valve disposed betw een the buffer canister and the peristaltic pump and configured to control the flow of fluid therebetween; a third valve connected between the buffer canister and atmosphere; and a clot visualization container coupled to the pump outlet.

[0092] Embodiment 18. The pulmonary thrombectomy system of Embodiment 17, wherein the first, second, and third valves mare configured to be selectively opened and closed in various combinations to control the operation of the pulmonary thrombectomy system.

[0093] Embodiment 19. The pulmonary thrombectomy system of Embodiment 17 or 18, wherein the clot visualization container comprises a plurality of filters19 Docket No.: 22935.53.1adisposed therein.

[0094] Embodiment 20. The pulmonary thrombectomy system of Embodiment 19, wherein the plurality of filters comprise a clot filter and a blood filter.

[0095] In the foregoing specification, the invention has been described with reference to specific exemplary embodiments thereof. It will be evident that various modifications may be made thereto without departing from the broader spirit and scope of the invention as set forth in the following claims. The specification and drawings are, accordingly, to be regarded in an illustrative sense rather than a restrictive sense.20 Docket No.: 22935.53.1a

Claims

CLAIMSWhat is claimed is:

1. A pulmonary thrombectomy system, comprising: a catheter having a central lumen; a peristaltic pump including a pump inlet and a pump outlet, the pump inlet being couplable to the catheter for fluid communication with the central lumen; and a clot visualization container being couplable to the pump outlet, the clot visualization container including a housing containing a clot filter having a plurality of first pores, and a blood filter having a plurality of second pores smaller than the plurality of first pores.

2. The pulmonary thrombectomy system of claim 1 , wherein the clot filter is movable relative to the pump outlet.

3. The pulmonary thrombectomy system of claim 2, wherein the clot filter is configured to rotate.

4. The pulmonary thrombectomy system of any of claims 1-3, wherein the pump outlet is movable relative to the clot filter.

5. The pulmonary thrombectomy system of claim 4, wherein the pump outlet is movable in an x-direction and / or a y-direction relative to the clot filter.

6. The pulmonary thrombectomy system of any of claims 1-5, further comprising a second peristaltic pump, the second peristaltic pump being connected to the clot visualization container and being configured to communicate blood in the clot visualization container to patient.

7. The pulmonary thrombectomy system of any of claims 1-6, further comprising a vacuum reservoir having a reservoir inlet couplable to the catheter and a reservoir outlet coupled to the pump inlet.

8. The pulmonary thrombectomy system of claim 7, further comprising a valve between the vacuum reservoir and atmosphere.

9. The pulmonary thrombectomy system of claim 8, further comprising a filter between the valve and the vacuum reservoir.

10. A pulmonary' thrombectomy system, comprising: a catheter having a central lumen; a peristaltic pump including a pump inlet and a pump outlet; a vacuum reservoir, the vacuum reservoir being couplable to the catheter for fluid communication with the central lumen, the vacuum reservoir being couplable to the pump21 Docket No.: 22935.53.1ainlet; and a clot visualization container coupled to the pump outlet.

11. The pulmonary thrombectomy system of claim 10, further comprising a valve between the vacuum reservoir and catheter, the valve being configured to be selectively opened and closed, wherein: the peristaltic pump is configured to create a vacuum within the vacuum reservoir when the valve is closed; and opening of the valve is configured to draw a blood-clot mixture through the catheter and into the vacuum reservoir.

12. The pulmonary thrombectomy system of claim 10 or 11. further comprising a valve between the vacuum reservoir and atmosphere, the valve being configured to be selectively opened and closed.

13. The pulmonary thrombectomy system of claim 12, further comprising a filter between the valve and the vacuum reservoir.

14. The pulmonary thrombectomy system of any of claims 10-13, wherein the clot visualization container includes a housing containing a clot filter having a plurality of first pores.

15. The pulmonary' thrombectomy system of claim 14, wherein the clot visualization container further comprises a blood filter having a plurality of second pores smaller than the plurality of first pores.

16. The pulmonary thrombectomy system of claim 14 or 15, wherein the pump outlet and clot filter are configured for relative movement, with the pump outlet being movable relative to the clot filter and / or the clot filter being movable relative to the pump outlet.

17. A pulmonary’ thrombectomy system, comprising: a catheter having a central lumen; a peristaltic pump including a pump inlet and a pump outlet; a buffer canister, the buffer canister being couplable to the catheter for fluid communication with the central lumen, the buffer canister being couplable to the pump inlet; a first valve disposed between the catheter and the buffer canister and configured to control the flow of fluid therebetween; a second valve disposed between the buffer canister and the peristaltic pump and configured to control the flow of fluid therebetween; a third valve connected between the buffer canister and atmosphere; and22 Docket No.: 22935.53.1aa clot visualization container coupled to the pump outlet.

18. The pulmonary thrombectomy system of claim 17. wherein the first, second, and third valves mare configured to be selectively opened and closed in various combinations to control the operation of the pulmonary thrombectomy system.

19. The pulmonary thrombectomy system of claim 17 or 18, wherein the clot visualization container comprises a plurality of filters disposed therein.

20. The pulmonary thrombectomy system of claim 19. wherein the plurality of filters comprise a clot filter and a blood filter.23 Docket No.: 22935.53.1a

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