Devices for thrombectomy
Patent Information
- Application Number
- JP2024523267
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-10-18
- Filing Date
- 2022-10-14
- Publication Date
- 2025-10-31
AI Technical Summary
Current methods for removing thrombi in patients with venous thromboembolism and ischemic stroke lack effective visualization and control of clot capture, leading to potential blood loss and inefficiencies in cath lab procedures.
A thrombus retrieval device integrated with an aspiration system that includes a filter and valve mechanism, allowing for in-line capture and visualization of thrombi, with optional pulsatile pumping to enhance clot removal.
Enhances the ability to monitor and control thrombus removal, reducing blood loss and procedural complexity by providing real-time visualization and improved aspiration efficiency.
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Abstract
Description
[Technical field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 256,743, filed October 18, 2021, the contents of which are incorporated by reference in their entirety into this specification. [Background technology]
[0002] Thrombotic lesions and blockages in a patient's blood vessels are serious medical problems, and often require intervention to remove these lesions and blockages in order to restore the patient's health. Although applicable to a wide range of vascular applications in both the arterial and venous systems, including various small blood vessels, such as arterial blockages in the neurovasculature (ischemic stroke), the following background focuses on this issue primarily through the example of a patient suffering from pulmonary embolism.
[0003] Venous thromboembolism (VTE) is a global crisis. Over 10 million cases of deep vein thrombosis (DVT) and pulmonary embolism (PE) are diagnosed worldwide annually, with over 1 million occurring in the United States and over 700,000 cases annually in France, Italy, Germany, Spain, Sweden, and the United Kingdom. Approximately 60,000 to 100,000 deaths occur annually in the United States due to PE. DVT and PE are part of the same spectrum of diseases, with over 95% of emboli originating from the lower extremities. When PE occurs, its severity depends on the embolic load and the impact on the right ventricle and underlying cardiopulmonary complications. Death can occur based on a sudden increase in pulmonary artery (PA) pressure with increased right ventricular (RV) afterload and dysfunction.
[0004] Patients with high-risk pulmonary embolism (PE) and other ischemic diseases have been primarily treated with thrombolytic therapy, delivered systemically or more locally by catheter-directed thrombolysis. These approaches result in multiple visits to the catheter lab, longer hospital stays, and often bleeding complications. A new approach to PE treatment for both PE and ischemic stroke is the single-stage thrombectomy procedure (aspiration of the thrombus) without the use of thrombolytic agents. Such a thrombectomy procedure involves positioning the distal end of an aspiration catheter adjacent to the thrombus and applying suction to attempt to aspirate the thrombus through the catheter into a canister located outside the sterile field.
[0005] One challenge for the physician is to know when the clot has been successfully captured and to know the volume of clot, which can inform the next step to minimize blood loss. Although it is theoretically possible to monitor clot accumulation in a canister associated with the aspiration pump, the practical setting in the current catheterization lab environment makes it difficult for the physician to easily access this information. Summary of the Invention
[0006] Disclosed is a vacuum aspiration system, such as for aspirating targeted material, such as occlusions, from the vasculature. In particular, a thrombectomy device is provided for use in-line with the aspiration system to capture and filter out targeted thrombi. The thrombectomy device can capture and visualize thrombi at a location remote from the vacuum canister within the sterile field, near the aspiration catheter hub, or on the aspiration catheter hub. The thrombectomy device can optionally include a valve to generate pulsation in the vacuum pressure. A pulsating pump can help improve aspiration of the thrombi by "rocking" the thrombi loose.
[0007] In some embodiments, what is disclosed is a blood clot filtering device that includes a body defining a cavity and having a filter within the cavity. In some embodiments, the body includes a first port located on a first side of the filter and a second port located on a second side of the filter and in fluid communication with the first port through the filter. In some embodiments, the filter includes a plurality of openings in communication with the cavity.
[0008] In some embodiments, the body includes a tubular sidewall, such as a cylindrical sidewall, having a longitudinal axis. In some embodiments, the upstream face of the filter may lie in a plane that is oriented at a non-orthogonal angle to the longitudinal axis. The angle of the filter allows the long axis of the filter to elongate into an elliptical shape within the body, thereby increasing the surface area of the filter configured to interact with aspirated material passing through the body. In some embodiments, the filter is angled between 30 degrees and 90 degrees to the longitudinal axis.
[0009] In some embodiments, the filter apertures are each 1 mm or less. In some embodiments, the filter apertures are configured to prevent thrombus from passing through the filter. In some embodiments, the first port and the second port are located on opposing ends of the body. In some embodiments, the body further includes a third port, the third port being a flush port configured to allow injection of saline or other fluid into the body of the thrombus filtering device.
[0010] In some embodiments, the body is at least partially transparent. In some embodiments, the body includes a top and a bottom surrounding a cavity, and the filter is disposed within the cavity between the top and the bottom. In some embodiments, the valve is configured to vent to atmospheric pressure or to a second vacuum source. In some embodiments, the device further includes a button, the button allowing a user to manually activate the valve. In some embodiments, the button is disposed on the top of the body.
[0011] In some embodiments, the device further includes a sensor configured to determine when flow has stopped within the clot filtering device. In some embodiments, the valve is automatically actuated when the sensor determines that flow has stopped. In some embodiments, the first port is located on the proximal end of the top and bottom, and the second port is located on the distal end of the top or bottom.
[0012] In some embodiments, disclosed is a system for thrombus aspiration, comprising an aspiration catheter, a first catheter, a thrombus filtering device, a second catheter, and a pump. The length of the tube between the thrombus filtering device and the catheter is substantially shorter than the length of the tube between the thrombus filtering device and the pump. In some embodiments, the thrombus filtering device comprises a body and a filter. In some embodiments, the body comprises a first port and a second port, and the body comprises a circular cross-section. In some embodiments, the filter comprises a plurality of openings, and the filter is disposed within the body of the thrombus filtering device. In some embodiments, the first catheter is fluidly connected to the aspiration catheter and to the thrombus filtering device. In some embodiments, the second catheter is fluidly connected to the pump and to the thrombus filtering device.
[0013] In some embodiments, the system further includes a clamp disposed on the first catheter, which can be engaged to reduce flow through the clot filtering device. In some embodiments, the system includes a cylindrical body. In some embodiments, the system includes a clot filtering device having a filter, the filter being angled within the body to increase a surface area configured to interact with aspirated material passing through the body. In some embodiments, the system includes a clot filtering device, the filter being angled within the body at 30 degrees to 90 degrees relative to a flow axis. In some embodiments, the system includes a clot filtering device, the filter including a plurality of openings that are 1 mm or less in size. In some embodiments, the system includes a clot filtering device, the filter including a plurality of openings configured to prevent clots from passing through the filter. In some embodiments, the first and second ports of the clot filtering device are disposed on opposing ends of the body.
[0014] In some embodiments, the body of the blood clot filtering device includes a third port, the third port being a flush port configured to allow injection of saline or other fluid into the body of the blood clot filtering device. In some embodiments, the body of the blood clot filtering device is at least partially transparent. In some embodiments, the body of the blood clot filtering device includes a top and a bottom, and the filter is disposed between the top and the bottom. In some embodiments, the valve of the blood clot filtering device is configured to vent to a second vacuum source.
[0015] In some embodiments, the blood clot filtering device includes a button that can allow a user to manually actuate the valve. In some embodiments, the button of the blood clot filtering device is located on the top of the body.
[0016] In some embodiments, the clot filtering device further includes a sensor configured to determine when flow has stopped in the clot filtering device. In some embodiments, when the sensor determines that flow has stopped, the valve of the clot filtering device is automatically actuated. In some embodiments, in the clot filtering device, the first port is disposed on the apex and the proximal end of the second portion, and the second port is disposed on the distal end of the portion and the second portion.
[0017] In some embodiments, disclosed is a blood clot filtering device. In some embodiments, the blood clot filtering device includes a cylindrical body, the cylindrical body including a first port and a second port disposed on opposing ends of the cylindrical body. The body may include a circular cross section, and at least a portion of the sidewall of the cylindrical body is at least partially optically transparent. In some embodiments, the blood clot filtering device includes a filter including a plurality of openings, the filter disposed within the body of the blood clot filtering device and angled within the body to increase a surface area configured to interact with aspirated material passing through the body, the filter being angled at between 30 degrees and 90 degrees relative to an inner circumference of the body.
[0018] In some embodiments, what is disclosed is a blood clot filtering device. In some embodiments, the blood clot filtering device includes a body, the body includes a first port and a second port disposed on opposing ends of the body, the body includes a circular cross section and is at least partially transparent. In some embodiments, the blood clot filtering device includes a filter including a plurality of openings, the filter disposed within the body of the blood clot filtering device. In some embodiments, the blood clot filtering device includes a valve configured to vent to a second vacuum source. In some embodiments, the blood clot filtering device includes a button configured to allow a user to manually actuate the valve, the button disposed on the top of the body. In some embodiments, in the blood clot filtering device, the body includes a top and a bottom, and the filter is disposed between the top and the bottom. In some embodiments, in the blood clot filtering device, the first port is disposed on the top and a proximal end of the second portion, and the second port is disposed on the distal end of the portion and the second portion.
[0019] The above and other features, aspects, and advantages are described below with reference to the drawings, which are for illustrative purposes and should not be construed as limiting the scope of the embodiments in any way. Moreover, various features in the various disclosed embodiments can be combined to form additional embodiments, which are part of this disclosure. In the drawings, like reference characters indicate corresponding features throughout like embodiments. The following is a brief description of each of the drawings. [Brief description of the drawings]
[0020] [Figure 1] FIG. 1 is a schematic diagram of a fluid management system for an aspiration procedure. [Diagram 2] FIG. 2 illustrates a schematic diagram of one embodiment of a fluid management system for an aspiration procedure according to the schematic diagram of FIG. [Figure 3A]3A-3C illustrate one embodiment of an in-line thrombectomy device. [Figure 3B] 3A-3C illustrate one embodiment of an in-line thrombectomy device. [Figure 3C] 3A-3C illustrate one embodiment of an in-line thrombectomy device. [Figure 4A] 4A-4C illustrate another embodiment of an in-line thrombectomy device. [Figure 4B] 4A-4C illustrate another embodiment of an in-line thrombectomy device. [Figure 4C] 4A-4C illustrate another embodiment of an in-line thrombectomy device. [Figure 5A] 5A-5B illustrate another embodiment of an in-line thrombectomy device. [Figure 5B] 5A-5B illustrate another embodiment of an in-line thrombectomy device. [Figure 6A] FIG. 6A illustrates a front perspective view of one embodiment of an in-line thrombectomy device. [Figure 6B] FIG. 6B illustrates a cross-sectional perspective view of the embodiment of FIG. 6A. [Figure 6C] FIG. 6C illustrates a rear perspective view of the embodiment of FIG. 6A. [Figure 6D] 6D and 6E illustrate front and back cross-sectional views of the embodiment of FIG. 6A. [Figure 6E] 6D and 6E illustrate front and back cross-sectional views of the embodiment of FIG. 6A. [Figure 6F] 6F-6H illustrate side views of the embodiment of FIG. 6A. [Figure 6G] 6F-6H illustrate side views of the embodiment of FIG. 6A. [Figure 6H] 6F-6H illustrate side views of the embodiment of FIG. 6A. [Figure 6I]6I-6K illustrate side views of the embodiment of FIG. 6A. [Figure 6J] 6I-6K illustrate side views of the embodiment of FIG. 6A. [Figure 6K] 6I-6K illustrate side views of the embodiment of FIG. 6A. [Figure 7] FIG. 7 is another schematic diagram of a fluid management system for an aspiration procedure. [Figure 8A] 8A-8B illustrate front and rear views of another embodiment of an in-line thrombectomy device. [Figure 8B] 8A-8B illustrate front and rear views of another embodiment of an in-line thrombectomy device. [Figure 8C] 8C-8D illustrate front and back cross-sectional views of the embodiment of FIGS. 8A-8B. [Figure 8D] 8C-8D illustrate front and back cross-sectional views of the embodiment of FIGS. 8A-8B. [Figure 9A] 9A-9B illustrate the embodiment of the in-line thrombectomy device of FIGS. 8A-8D in use. [Figure 9B] 9A-9B illustrate the embodiment of the in-line thrombectomy device of FIGS. 8A-8D in use. [Figure 10A] 10A-10F illustrate one embodiment of an in-line thrombectomy device. [Figure 10B] 10A-10F illustrate one embodiment of an in-line thrombectomy device. [Figure 10C] 10A-10F illustrate one embodiment of an in-line thrombectomy device. [Figure 10D] 10A-10F illustrate one embodiment of an in-line thrombectomy device. [Figure 10E] 10A-10F illustrate one embodiment of an in-line thrombectomy device. [Figure 10F]10A-10F illustrate one embodiment of an in-line thrombectomy device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0021] overview 1 illustrates a schematic diagram of a fluid management system for an aspiration procedure. The fluid management system 10 can include a catheter 60, a thrombectomy device 70, and an aspiration pump 50. The catheter 60, the thrombectomy device 70, and the aspiration pump 50 can be fluidly connected such that fluid is aspirated from a distal end of the catheter 60, into and through the thrombectomy device 70.
[0022] The length of tubing between the thrombectomy device 70 and the pump 50 may be substantially longer than the length of tubing between the thrombectomy device 70 and the catheter 60. This allows the thrombectomy device 70 to be placed in a sterile field to facilitate direct visualization by the physician during the aspiration procedure, while the pump 50 remains relatively far from the physician and outside the sterile field. Additional details regarding the sterile field thrombectomy device and associated fluid configurations may be found in U.S. Patent Application Serial No. 17 / 357,558, filed June 24, 2021, entitled "Aspiration System with Accelerated Response," the disclosure of which is expressly incorporated herein by reference in its entirety.
[0023] 2 illustrates one embodiment of a catheter 60 that may be used with system 10. As shown, system 10 may include a large diameter first thrombectomy catheter 12 having an elongated tubular body 14 extending between a proximal end 16 and a distal end 18. A central lumen 20 extends between a proximal catheter connector 22 and a distal port 24 on the distal end 18.
[0024] In the illustrated embodiment, the catheter 12 may be removably connectable to the flow control module 28 via a complementary modular connector 30. The modular connector 30 provides a removably connection to a complementary catheter connector 22 and may include an opener (not shown) for opening a hemostasis valve in the hub of a large bore catheter (not shown).
[0025] In some embodiments, the flow control module 28 can include a fluid flow path 32 extending between the module connector 30 and the flow control module 28. The fluid flow path 32 continues to extend between the flow control module 28 and the thrombectomy device 70, which contains a filter for thrombus collection and / or evaluation and a chamber for filtered fluid (described in more detail below). In some examples, the flow control module 28 is integrally formed within a hub of the thrombectomy catheter 12 to which the catheter can be non-removably attached. In addition, the flow path between the flow control module 28 and the thrombectomy device 70 can be contained within a continuous, integral tube, or within two or more tube components that are removably connectable via complementary luer locks or other connectors.
[0026] The flow control module 28 may include a flow regulator for regulating the flow rate through the flow path 32. The flow regulator may provide a reversible restriction in the flow path, such as by an expandable or contractible iris, a ball valve or other rotating core valve, a leaf valve, a pinch tube, or others known in the art.
[0027] In some embodiments, the flow regulator includes a collapsible section of a tubular wall that defines a flow path, such as a section of polymer tubing. An actuator disposed adjacent to the tube is movable between a first position that collapses the tube to restrict flow to a low flow rate and a second position that is driven away from the tube to return the tube to its full inner diameter to allow a high flow rate. The actuator may be spring-loaded or have other default drivers toward the first (restrictive) position and may be movable to the second position only in the presence of a positive mechanical force or electrical signal that activates a high flow override. When the momentary override command is released, the actuator automatically returns to the first position to generate the low flow mode.
[0028] The actuator may be driven by a mechanical control member, such as a lever or rotatable knob, or by an electrical drive system, such as a solenoid, and may be operated by any of a variety of buttons, levers, triggers, foot pedals, or other switches known in the art, depending on the desired functionality.
[0029] In some embodiments, fluid flow may be selectively directed through a low flow regulator, such as a small diameter orifice or tubing, and through a high flow regulator, such as a large diameter orifice or tubing, The mechanically or electromechanically actuated valves can momentarily switch flow from the low flow regulator to the high flow regulator in response to actuation of a control member.
[0030] Thus, flow control module 28 includes one or more control members for controlling operation of the system. One control member may be provided to switch the system between a no-flow (off) mode and a low-flow mode. In some embodiments, the same or a different control member may be provided to momentarily switch the flow regulator between a low-flow mode and a momentary operator-initiated high-flow override mode. Releasing the momentary override control returns the regulator to the off or low-flow mode.
[0031] In some instances, the low flow mode allows the first catheter 12 to closely engage the thrombus with a relatively small amount of blood aspiration. After engaging the thrombus, a momentary high flow control member may be actuated to generate a high flow vacuum bolus to draw the thrombus into the catheter 12. The high flow rate may be at least about 10 cc / sec, preferably at least about 15 cc / sec, but typically not more than about 25 cc / sec. In some configurations, the high flow rate is about 20 cc / sec, with all of the above flows being unimpeded blood aspiration. As used herein, a low flow rate is about 50% or less, about 35% or less, or about 25% or less of the high flow rate. A low flow rate is generally less than about 10 cc / sec or less than 7 cc / sec, and often in the range of about 1 cc / sec to 5 cc / sec.
[0032] The flow control module 28 may be provided with a second catheter port 40 in communication with the central lumen 20 via a hemostatic valve (e.g., a Tuohy Borst valve) (not shown) within the module 28. This allows a second aspiration catheter 42 to be introduced through the access catheter 12 and extended to the treatment site. The second catheter 42 may be a smaller diameter aspiration catheter, with or without thrombus agitation or mechanical gripping capabilities, a drug delivery catheter, a mechanical disruptor, or other accessory device that may be useful in the thrombectomy process. In one embodiment, the second catheter, including its handpiece and control members, may be identical in materials to the first aspiration catheter, except that the second catheter is smaller in diameter and longer than the first catheter.
[0033] If desired, the second catheter 42 may be connected via the proximal connector 44 to a complementary connector 46 that communicates with a reservoir (not shown) via an additional suction line. In some embodiments, the second suction catheter 42 may be connected to a thrombectomy device 70.
[0034] The thrombus may be removable through the first catheter 12 under vacuum without the need for additional assistance. However, if desired, the introduction of a second thrombus grasping catheter 42 may provide additional attachment and / or mechanical disruption of the thrombus to facilitate removal. Removal may be assisted by application of vacuum to the grasping catheter 42 as well as the first catheter 12, either sequentially or simultaneously, depending on the desired clinical performance.
[0035] As shown in FIG. 2, the suction pump 50 can be fluidly connected to the catheter 60. The suction pump 50 can include a vacuum pump and can further include a vacuum gauge 51 and an optional pressure regulation control member 53. In some embodiments, the vacuum gauge 51 is in fluid communication with the vacuum pump and provides an indication of the vacuum pressure generated by the pump. The pressure regulation control member 53 allows a user to set a particular vacuum pressure. Any of a variety of control members may be utilized, including switches, buttons, levers, rotatable knobs, and other members as would be apparent to one of ordinary skill in the art in view of the disclosure herein. In some examples, the suction pump 50 can be a manually operated pump, such as a syringe.
[0036] In some embodiments, the system 10 can include a reservoir (not shown) in fluid communication with the aspiration pump 50 via the vacuum line 35 and operative to transfer vacuum from the air-filled side of the system to the liquid side of the system and also operative to collect aspirated filtered blood. In some examples, the reservoir can include a collection canister in fluid communication with the flow channel 32 to collect aspirated debris. In some embodiments, the flow direction through the system can also be reversed to allow blood to flow through the filter and clots to collect outside (now downstream) of the filter, for example between the filter and an outer transparent window or container. The reservoir can be located "upstream" or proximal to the thrombus retrieval device 70, such that the reservoir is in fluid communication between the thrombus retrieval device 70 and the pump 50.
[0037] In some examples, the flow channel 32 extends the entire length of the first catheter 12 and through the control module 28 into the reservoir 34. The flow channel 32 can include a transparent window 52 to allow direct visualization of the contents of the flow channel 32. In some embodiments, the window 52 is in the form of a transparent portion of the tube located within the sterile field between the proximal end of the catheter 12 and the flow module 28, allowing the clinician to directly view the debris as it exits the proximal end of the access catheter 12. In some examples, the length of the transparent tube can be at least about 2 cm, 4 cm, or 6 cm, and typically less than about 30 cm or less than 20 cm. In some embodiments, the length of the transparent tube is within the range of about 5 cm to about 15 cm. In some examples, the transparent window can be carried by the proximal hub of the catheter 12 or can be a proximal portion of the catheter shaft located distal to the hub.
[0038] In some embodiments, the system 10 can include a thrombectomy device 70. The thrombectomy device 70 can be fluidly connected to the catheter 60 and to the aspiration pump 50. As described in more detail below, the thrombectomy device 70 can be handheld in a sterile field to allow a clinician to capture and visualize the thrombus during an aspiration procedure. The thrombectomy device 70 can include a filter that captures solid thrombus debris as fluid is aspirated through the catheter 60. The thrombectomy device 70 can include an additional port for injecting saline or other fluids into the thrombectomy device 70 to improve visualization of the thrombus after it has been captured in the filter.
[0039] In some embodiments, the thrombectomy device 70 can include a valve that allows for pulsation of the pressure applied by the aspiration pump 50. For example, the thrombectomy device 70 can include a button or other actuator that a user can engage to occlude a valve in the thrombectomy device 70 and reduce the pressure applied by the aspiration pump 50. The clinician can then release the button and pressure can be reapplied.
[0040] Thrombectomy Device 1, in some embodiments, the system 10 can include a thrombectomy device 70. The thrombectomy device 70 can be configured to capture thrombus removed by the system 10 during an aspiration procedure performed within an occluded blood vessel of a patient. As described in more detail below, the thrombectomy device 70 can be an in-line canister disposed between a proximal end of an aspiration catheter (e.g., catheter 60) and a suction source (e.g., aspiration pump 50).
[0041] In some embodiments, the length of tubing between the thrombus retrieval device 70 and the catheter 60 is approximately 50% or less, or 25% or less, or 15% or less of the length of tubing between the thrombus retrieval device 70 and the pump 50, such that the thrombus retrieval device 70 can be located inside the sterile field and easily directly observed by a physician holding the suction catheter manifold, while the pump 70 can be located remotely outside the sterile field.
[0042] 3A-3C illustrate a system 100 having a thrombectomy device 170 according to one embodiment. In some embodiments, the thrombectomy device 170 includes a first port 110, a second port 120, and a filter 130. In some examples, the first port 110 is configured to connect to a first end of a first tube 140 that is fluidly connected to a proximal end of the aspiration catheter. In some embodiments, the first tube 140 includes a connector 142 disposed at a second end of the first tube 140 and configured to engage or mate with a corresponding connector.
[0043] In some embodiments, the second port 120 is configured to connect to a first end of a second tube 150 that is fluidly connected to a suction source (e.g., a pump). In some embodiments, the second tube 150 includes a connector (not shown) disposed at a second end of the second tube 150 and configured to engage or mate with a corresponding connector. In some examples, the system 100 can include a clamp 160. In some embodiments, the clamp 160 can be positioned onto the first tube 140 such that a user can engage the clamp to provide flow control to the thrombectomy device 170.
[0044] In some embodiments, the body of the thrombus retrieval device 170 can include a tubular sidewall, such as a generally cylindrical sidewall having a longitudinal axis and a circular cross-sectional shape defining an interior chamber. The thrombus retrieval device 170 can be made from any of a variety of materials known in the art, including optically clear polymers. As illustrated in Figures 3A-3C, in some embodiments, at least a window portion of the thrombus retrieval device 170 can be optically clear to improve visualization of the thrombus after it is captured within the thrombus retrieval device 170.
[0045] The thrombectomy device 170 may include a filter 130 within the chamber. In some embodiments, the filter 130 may be shaped to divide the chamber into an upstream side and a downstream side. In some examples, at least the upstream surface of the filter 130 may be angled to increase the surface area available for interaction with aspirated thrombus. For example, the upstream surface of the filter 130 may lie on a plane that is angled at an angle of about 30 degrees to about 90 degrees relative to the longitudinal axis of the chamber. In some embodiments, the filter 130 may be angled at an angle of at least about 30 degrees, at an angle of at least about 40 degrees, or at an angle of at least about 50 degrees, and generally at an angle of about 70 degrees or less, or at an angle of about 80 degrees or less, from the longitudinal axis within the thrombectomy device 170.
[0046] In some examples, the filter 130 may be removable from the canister of the thrombectomy device 170 so that the filter 130 can be cleaned, replaced, or adjusted. In some examples, the filters may be provided with different pore sizes that may be selected depending on the desired performance. For example, in some embodiments, the filter 130 may include holes of about 1 mm that capture larger solid clot fragments as the fragments pass through the mini-canister. In some embodiments, the pore size may have a maximum cross-sectional dimension of about 1 mm or less, about 2 mm or less, or about 3 mm or less, or 4 mm or less.
[0047] In some examples, the aspirated material is aspirated through the tube 140 and introduced into the first catheter port 110 of the thrombectomy device 170. The aspirated material may be filtered by the filter 130 of the thrombectomy device 170. Material larger than the openings of the filter 130 cannot exit the thrombectomy device 170. In some embodiments, blood and material smaller than the openings of the filter 130 flow out the second port 120 and the second tube 150 to a collection canister associated with the pump.
[0048] In some instances, the clinician can slow the flow of aspirated material by engaging clamp 160. In some embodiments, the clinician can inspect for thrombus or other large aspirated material captured by filter 130. In some embodiments, material retained by thrombus retrieval device 170 can be removed from thrombus retrieval device 170 for evaluation and / or disposal.
[0049] 4A-4C illustrate a system 200 having a thrombectomy device 270 according to another embodiment. In many respects, the figures are similar or identical to the system 200. Accordingly, the numbers used to identify components of the system 200 have been incremented by 100 to identify similar features in the system 200. This numbering scheme generally applies to the remaining figures. Any component or step disclosed in any embodiment herein may be used in other embodiments. As with the thrombectomy device 170, the thrombectomy device 270 may include a first port 210, a second port 220, a third port 280, and a filter 230.
[0050] In some embodiments, the first port 210 is configured to connect to a first end of a first tube 240 that is fluidly connected to a proximal end of the suction catheter. In some examples, the first tube 240 includes a connector 242 disposed at a second end of the first tube 240 and configured to engage or mate with a corresponding connector. In some embodiments, the second port 220 is configured to connect to a first end of a second tube 250 that is fluidly connected to a suction source (e.g., at a pump). In some examples, the second tube 250 includes a connector (not shown) disposed at a second end of the second tube 250 and configured to engage or mate with a corresponding connector.
[0051] In some embodiments, the thrombectomy device 270 includes a third port 280 for injecting saline or other fluid into the canister of the thrombectomy device 270. In some instances, this can improve visualization of the thrombus after it is trapped in the filter 230. In some embodiments, the system 200 can include a clamp 260. The clamp 260 can be placed onto the first tube 240 such that a user can engage the clamp to provide flow control for the thrombectomy device 270.
[0052] In some examples, the body of thrombus retrieval device 270 can include a tubular sidewall surrounding a cavity, such as a cylindrical sidewall having a longitudinal axis and a circular cross-sectional shape. In some embodiments, one or more components of thrombus retrieval device 270 can be made from an optically transparent material, which can improve visualization of the thrombus after it is captured within thrombus retrieval device 270.
[0053] Similar to thrombectomy device 170, thrombectomy device 270 can include filter 230. In some embodiments, filter 230 can be circular in shape and oriented transversely to the longitudinal axis and to the fluid flow axis, which in some instances allows filter 230 to be rotatable within the body of thrombectomy device 270. In some embodiments, filter 230 can be angled at a non-orthogonal angle to the longitudinal axis to increase the surface area that can interact with aspirated thrombus.
[0054] For example, filter 230 can be positioned on a plane inclined at an angle between about 30 degrees and about 90 degrees relative to the longitudinal axis. In some embodiments, filter 230 can be inclined within thrombectomy device 270 at an angle of at least about 30 degrees, at an angle of at least about 35 degrees, at an angle of at least about 40 degrees, at an angle of at least about 45 degrees or 55 degrees or more, and typically at an angle of about 85 degrees or less, or at an angle of 75 degrees or less, or at an angle of 60 degrees or less, relative to the longitudinal axis.
[0055] In some examples, the filter 230 may be removable from the body of the thrombectomy device 270 so that the filter 230 may be replaced, inspected, or adjusted. In some embodiments, the thrombectomy device 270 may be provided with a variety of filters having different pore sizes based on the desired clinical performance. For example, in some embodiments, the filter 130 may include approximately 1 mm holes to capture solid clot debris as the debris passes through the mini-canister. In some embodiments, the pore sizes may be up to 1 mm, up to 2 mm, up to 3 mm, up to 4 mm, or up to 5 mm.
[0056] In some embodiments, the aspiration catheter of the system 200 aspirates material in a flow manner through the second end of the first catheter 240, and the aspirated material is introduced into the first catheter port 210 of the thrombus retrieval device 270. The aspirated material can be filtered by the filter 230 of the thrombus retrieval device 270. Material larger than the openings of the filter 230 cannot exit the thrombus retrieval device 270. In some embodiments, material smaller than the openings on the filter 230 exits through the second catheter port 220 and the second catheter 250. In some examples, a user can inspect the thrombus or other large aspirated material captured by the filter 230. In some embodiments, material retained by the thrombus retrieval device 270 can be removed from the thrombus retrieval device 270 and examined by a user.
[0057] 5A-5B and 6A-6K illustrate another embodiment of a thrombus retrieval device 370. The thrombus retrieval device 370 can include a body 380 enclosing a chamber in communication with the first port 310 and the second port 320. In some examples, the body 380 can include a flush port (not shown) configured to inject saline or other fluid into the chamber to improve visualization of the thrombus after it has been captured within the filter 330.
[0058] In some embodiments, the body 380 includes a housing having a top 382 and a bottom 384. In some examples, the body 380 includes a filter 330 disposed within a chamber located between the top 382 and the bottom 384. In some examples, the first port 310 is configured to connect to a first end of a first tube 340 that is fluidly connected to a proximal end of the suction catheter. In some embodiments, the first tube 340 includes a connector 342 disposed at a second end of the first tube 340 and configured to engage or mate with a corresponding connector.
[0059] In some embodiments, the second port 320 is configured to connect to a first end of a second tube 350 that is fluidly connected to a suction source (e.g., a pump). In some embodiments, the second tube 350 includes a connector 352 disposed at a second end of the second tube 350 and configured to engage or mate with a corresponding connector. In some examples, the system 300 can include a clamp 360. The clamp 360 can be positioned onto the first tube 340 such that a user can engage the clamp to provide flow control to the thrombectomy device 370.
[0060] As shown, the housing of the thrombus retrieval device 370 can have a top surface spaced apart from a bottom surface by a tubular sidewall. In the illustrated implementation, the top and bottom surfaces are substantially circular and spaced apart by a cylindrical sidewall having a diameter at least about three or five or more times larger than the axial length of the sidewall, thereby forming a generally disk-shaped housing. Preferably, at least a portion of the top wall is optically transparent to improve visualization of the thrombus after it is captured within the thrombus retrieval device 370. As shown in Figures 6B, 6D-6E, and 6I-6K, in some embodiments, at least one or both of the top and bottom portions 382 and 384 are transparent to allow the filter 330 to be viewed through the body of the thrombus retrieval device 370.
[0061] In some embodiments, the thrombectomy device 370 can include a filter 330. The filter 330 can be circular in shape. In some embodiments, the filter 330 can be secured between a top 382 and a bottom 384 of the body 380. In some examples, the thrombectomy device 370 can have different pore sizes based on the desires of the physician or parent. For example, in some embodiments, the filter 330 can include 1 mm holes to capture solid clot debris as the debris passes through the mini-canister. In some embodiments, the pore size can be up to 1 mm, up to 2 mm, up to 3 mm, up to 4 mm, up to 5 mm.
[0062] In some embodiments, the aspiration catheter aspirates material to flow through the second end of the first catheter 340, and the aspirated material is introduced into the first catheter port 310 of the thrombus retrieval device 370. The aspirated material can then be filtered by the filter 330. Material larger than the opening on the filter 330 cannot exit the thrombus retrieval device 370, while material smaller than the opening on the filter 330 flows out of the second catheter port 320 and the second catheter 350. In some embodiments, the user can slow the flow by engaging the clamp 360. In some examples, the user can inspect the clot or other large aspirated material captured by the filter 330. In some embodiments, material retained by the thrombus retrieval device 370 can be removed from the thrombus retrieval device 370 and examined by the user.
[0063] Thrombectomy device with pulsatile pump In some examples, the thrombectomy device can include a pulsatile pump. The pump can be automatic or manual, allowing the user to operate a control member, such as a valve, located inside the thrombectomy device. The pulsatile pump allows the thrombectomy device to improve thrombus capture during clinical procedures. It can serve as a simple, cost-effective manual vacuum source on the thrombectomy device located near or at the hub of the catheter, rather than at the canister / pump. In some embodiments, the valve can also serve as a clearing mechanism to allow the physician to visualize the thrombus during the procedure.
[0064] In some embodiments, a valve added to the thrombectomy device can release the vacuum momentarily, thus creating a pulsation in the vacuum pressure. The venting can be to a second vacuum source (e.g., not to atmospheric pressure), so that the device does not experience pressure decay and does not become positive. The second vacuum source can create a second negative pressure that is weaker than the first negative pressure created by the first aspiration vacuum pump. In some examples, the valve can reduce or eliminate the forward pressure, so that the clot does not fly off the distal tip of the aspiration catheter. In some embodiments, a pulsating pump can be used to provide rapid pulsations in the vacuum pressure.
[0065] 7 illustrates another schematic diagram of a fluid management system for an aspiration procedure. System 400 can include a catheter 405, a thrombectomy device 470, and a pump 407. As described above, thrombectomy device 470 can include a valve 490 configured to generate a pulsation in the vacuum pressure. In some embodiments, valve 490 can be manually actuated by a user. In some examples, thrombectomy device 470 can include a sensor that allows valve 490 to be automatically activated when the sensor detects that the catheter is blocked and no flow is present.
[0066] 8A-8D illustrate an embodiment of a thrombus retrieval device 470 having a button 492 for actuating a valve 490. FIGS. 8A-8D are similar in many respects to system 300. Accordingly, the numbers used to identify components of system 300 have been incremented by 100 to identify similar features in system 300. This numbering scheme generally applies to the remaining figures. As mentioned above, any component or step disclosed in any embodiment herein can be used in other embodiments. Similar to thrombus retrieval device 370, thrombus retrieval device 470 can include a body 480 having a first catheter port 410 and a second catheter port 420. In some examples, body 480 can include a third port, i.e., a flush port (not shown), configured to inject saline or other fluid into body 480 to improve visualization of the thrombus after it has been captured in filter 430. In some embodiments, the body 480 includes a top portion 482 and a bottom portion 484. In some examples, the body 480 includes a filter 430 disposed between the top portion 482 and the bottom portion 484.
[0067] In some embodiments, the first catheter port 410 is configured to connect to a first end of a first catheter 440 that is fluidly connected to a proximal end of the aspiration catheter. In some examples, the first catheter 440 includes a connector 442 disposed at a second end of the first catheter 440 and configured to engage or mate with a corresponding connector. In some embodiments, the second catheter port 420 is configured to connect to a first end of a second catheter 350 that is fluidly connected to a suction source (e.g., a pump). In some examples, the second catheter 350 includes a connector 452 disposed at a second end of the second catheter 350 and configured to engage or mate with a corresponding connector. In some examples, the system 400 can include a clamp 460. The clamp 460 can be positioned onto the first tube 440 such that a user can engage the clamp to provide flow control to the thrombectomy device 470.
[0068] As illustrated in FIGS. 8A and 8C, the thrombectomy device 470 can include a button 492 for actuating the valve 490. In some examples, the button 492 can be located on the body 480 of the thrombectomy device 470. As illustrated in FIGS. 8A and 8C, in some embodiments, the button 492 is located on the top 482 of the body 480. As described above, the valve 490 of the thrombectomy device 470 can be automatically actuated, but in some examples, the thrombectomy device 470 can optionally include a button 492 that allows a user to activate the valve 490. When the valve 490 is actuated, the valve 490 can release the vacuum and create a pulsation in the vacuum pressure. This is illustrated in FIGS. 9A-9B, which show pressure applied to the system before and after actuation of the button 492. As an example, the pressure applied to the system 400 before engagement of the button 492 is approximately -23.36 Hg. After the button 492 is actuated, the pressure applied to the system 400 drops to -9.63 Hg. As shown, the pressure applied to the system 400 drops significantly after engagement of the button 492 (i.e., FIG. 9B). In some embodiments, because the valve 490 vents to a second vacuum source rather than to atmospheric pressure, there is no pressure decay and a negative pressure is maintained (i.e., the pressure never becomes positive).
[0069] In some embodiments, this allows a user to provide rapid pulses of vacuum pressure, which can improve clot capture during a clinical procedure. In some embodiments, button 492 can also function as a cleaning mechanism, allowing a way for the physician to visualize the clot midway through the procedure.
[0070] The thrombus retrieval device 470 can have a body with a circular cross-section. The thrombus retrieval device 470 can be made from a variety of materials, such as plastics and polymers. In some embodiments, one or more components of the thrombus retrieval device 470 can be made from a transparent material, a non-transparent material, a partially transparent material, or any combination thereof. As shown in FIGS. 8A-8D, in some examples, at least a portion of the thrombus retrieval device 470 can be transparent to improve visualization of the thrombus after capture within the thrombus retrieval device 470. In some embodiments, at least one or both of the top portion 482 and the bottom portion 484 are transparent to allow the filter 430 to be viewed through the body of the thrombus retrieval device 470.
[0071] As described above, the thrombectomy device 470 can include a filter 430. The filter 430 can be circular in shape. In some examples, the filter 430 can be secured between the top 482 and the bottom 484 of the body 480. In some embodiments, the thrombectomy device 470 can have different pore sizes based on the desires of the physician or parent. For example, in some examples, the filter 430 can include 1 mm holes to capture solid clot debris as the debris passes through the mini-canister. In some embodiments, the pore size can be up to 1 mm, up to 2 mm, up to 3 mm, up to 4 mm, up to 5 mm.
[0072] As mentioned above, in some embodiments, the thrombectomy device can include a sensor. The sensor can enable automatic activation of the valve 490 by determining when the catheter is blocked / occluded (e.g., when flow rate is significantly reduced). This can be used to determine when periodic suction versus pure suction is triggered. In some instances, there is no need to cycle the vacuum as long as flow is present.
[0073] In some examples, the suction catheter 405 aspirates material to flow through the second end of the first catheter 440, and the aspirated material is introduced into the first catheter port 410 of the thrombectomy device 470. The aspirated material can then be filtered by the filter 430. Material larger than the opening on the filter 430 cannot exit the thrombectomy device 470, while material smaller than the opening on the filter 430 can exit the second catheter port 420 and the second catheter 450. In some embodiments, the user can slow the flow by engaging the clamp 460. In some examples, the user can actuate the valve 490 by engaging the button 492, which can create a pulsation in the pressure within the system 400. Actuating the button 492 reduces the negative pressure, while releasing the button 492 increases the negative pressure. This pulsation in pressure allows the suction catheter 405 to better aspirate the clot by "shaking" it loose. Actuating the button 492 can also function to execute a cleaning mechanism to better visualize the thrombus within the body of the thrombus retrieval device 470. In some examples, material retained by the thrombus retrieval device 470 can be removed from the thrombus retrieval device 470 and examined by the user.
[0074] 10A-10F illustrate various views of an embodiment of a thrombectomy device 570. Unless otherwise noted, like reference numbers in FIGS. 10A-10F refer to the same components as, or generally similar to, components in the remaining figures described herein. For example, FIGS. 10A-10F may utilize reference numbers having the same last two digits as previous drawings and embodiments to reference components that are identical to, or generally similar to, components in previous drawings and embodiments, such as thrombectomy device 370 and thrombectomy device 570. As with all embodiments herein, it will be understood that any feature, structure, material, method, step, or component described and / or illustrated in the embodiment of FIGS. 10A-10E may be used in conjunction with, or in place of, any feature, structure, material, method, step, or component described and / or illustrated in any other embodiment herein. It will also be understood that any feature, structure, material, method, step, or component of any embodiment described and / or illustrated herein may be used in conjunction with or in place of any other feature, structure, material, method, step, or component of any embodiment of the thrombus retrieval device 570 shown in Figures 10A-10F.
[0075] 10A-10F indicate portions of thrombectomy device 570 that may not form part of the design. However, it is envisioned that lines currently illustrated as dashed lines may be redrawn as solid lines, and that lines currently illustrated as solid lines may be redrawn as dashed lines. The scope of the present disclosure includes all lines illustrated, whether dashed or solid.
[0076] The thrombus retrieval device 570, in some embodiments, can be made from a variety of materials, such as plastics and polymers, and one or more components of the thrombus retrieval device can be made from a transparent material, a non-transparent material, a partially transparent material, or any combination thereof.
[0077] 10A-10F illustrate one embodiment of a system 500 that includes a thrombectomy device 570. The thrombectomy device 570 can include a body 580 that encloses a chamber in communication with the first port 510 and the second port 520. In some embodiments, the body 580 includes a housing having a top portion 582 and a bottom portion 584. The body 580 can be a one-piece housing in some instances. In some instances, the body 580 includes a filter disposed within the chamber located between the top portion 582 and the bottom portion 584.
[0078] In some examples, the first port 510 is configured to connect to a first end of a first tube 540 that is fluidly connected to a proximal end of the suction catheter. In some embodiments, the first tube 540 includes a connector disposed at a second end of the first tube 540 and configured to engage or mate with a corresponding connector. In some embodiments, the second port 520 is configured to connect to a first end of a second tube 550 that is fluidly connected to a suction source (e.g., a pump). In some embodiments, the second tube 550 includes a connector disposed at a second end of the second tube 550 and configured to engage or mate with a corresponding connector. In some examples, the system 500 can include a clamp.
[0079] The first side port 510 may be larger, smaller, or the same size as the second side port 520 and / or may be configured to fluidly connect to a tube that is larger, smaller, or the same size as the second side port 520. In some instances, the first side port 510 may be larger than the second side port 520, such that the first side port 510 is configured to fluidly connect to a tube (e.g., the first tube 540) that is larger than a second tube (e.g., the second tube 550) that may be fluidly connected to the second side port 520. The first side port 510 may be configured to fluidly connect to a standard tube (e.g., a tube having an inner diameter of about 0.1 inches (about 2.54 mm)) in some embodiments. The second side port 520 may be smaller than the first side port 510, such that the second tube 550 is smaller than the first tube 540. In some instances, since the suction source is configured to "prime" (e.g., apply at least a negative pressure throughout the entire length of the second tube and thrombectomy device 570), a smaller size of the second tube 550 may advantageously facilitate a shorter priming time for the system. A smaller tube size may facilitate easier priming by reducing the overall internal volume of the tubing located between the suction source and the thrombectomy device 570 that requires priming. In some instances, a smaller tube size may advantageously reduce the blood fluid flow rate through the second tube 550, which also reduces the amount of potential blood loss during the aspiration procedure.
[0080] The body 580 of the thrombectomy device 570 may be sized and / or shaped to facilitate fluid communication through the body 580 between the first port 510 and the second port 520. In some instances, the body 580 may be configured to inhibit the formation of blood "pockets" within the interior of the thrombectomy device 570 such that the chambers of the body 580 do not accumulate stagnant or low flow blood in areas within the chambers as blood flows through the thrombectomy device 570. For example, the body 580 may be configured to facilitate complete drainage of the chambers of the body 580.
[0081] In some instances, the body 580 may have a first body portion 590 located proximate the first port 510 at a first end of the body 580, the first body portion 590 including a smaller width than a second body portion 592 located proximate the second port 520 at a second end of the body 580. The body 580 may taper between the smaller first body portion 590 and the larger second body portion 592 to form a "teardrop" or funnel-like configuration. This configuration may advantageously inhibit blood from pooling in the chamber of the body 580 during use. In some instances, this configuration may advantageously facilitate fluid drainage from the chamber. In some embodiments, this design may also facilitate ease of use by reducing the weight and / or overall size of the device.
[0082] Any embodiment of the thrombus retrieval device as described herein and / or illustrated in the figures may further include a measurement component to facilitate determining the size and / or volume of the thrombus trapped within the chamber of the body during use. In some instances, at least a portion of the body (e.g., any surface along the top or bottom) may include a measurement guide, allowing a user to easily determine the size and / or volume of the thrombus trapped within the chamber. For example, as illustrated in Figures 9A and 9B, a transparent portion of the body may include a grid, scale, or any suitable markings 495 to allow a user to visually determine the size of the thrombus. It will be understood that this may be utilized in any embodiment of the thrombus retrieval device as described herein.
[0083] In some instances, the body of the thrombus retrieval device may be sized and / or shaped to measure the volume of the thrombus during the procedure. For example, the thrombus retrieval device may include an elongated tubular body (e.g., a cylindrically shaped body) that may cause the thrombus to elongate within a chamber of the tubular body as the thrombus passes along the filter. Elongating the thrombus along the inner surface of the tubular body may advantageously facilitate measuring the volume of the thrombus relative to its length.
[0084] Any embodiment of the thrombectomy device as described herein and / or illustrated in the figures may further include a coating within the chamber of the body, along at least a portion of the inner surface of the thrombectomy device and / or along at least a portion of the filter of the thrombectomy device, which may provide one or more of a variety of properties to the thrombectomy device. In some instances, the coating may be configured to enhance visualization through at least a portion of the body of the thrombectomy device. The coating may be configured to inhibit blood accumulation or may be configured to enhance hydrophobic properties to blood. In some instances, the thrombectomy device may include a coating to inhibit bubble formation during an aspiration procedure. The coating may be disposed at least in part along the inner surface of the body. The coating may be both hydrophobic and oleophobic. In some instances, the coating may enhance oleophobic properties by imparting hydrophilic characteristics on a portion of the polymer.
[0085] It will therefore be understood that the embodiments of the invention described herein are merely illustrative of the application of the principles of the invention. Reference herein to details of the illustrated embodiments is not intended to limit the scope of the claims which in themselves recite features regarded as essential to the invention. The drawings are intended only to illustrate embodiments of the invention and are not intended to limit the invention.
[0086] It is contemplated that various combinations or subcombinations of the specific features and aspects of the embodiments disclosed above may be made and that such combinations or subcombinations still fall within the scope of one or more of the present inventions. Furthermore, any particular feature, aspect, method, property, feature, quality, attribute, member, or the like disclosed herein in connection with an embodiment may be used in all other embodiments described herein. It is therefore understood that various features and aspects of the disclosed embodiments may be combined with or substituted for one another to form various aspects of the disclosed invention. It is therefore intended that the scope of the invention disclosed herein should not be limited by the specific disclosed embodiments described above. Moreover, the invention is susceptible to various modifications and alternative forms, specific examples of which are shown in the drawings and described in detail herein. However, it is understood that the invention is not limited to the specific forms or methods disclosed, but on the contrary, the invention is intended to cover all modifications, equivalents, and alternatives that fall within the spirit and scope of the various described embodiments and the appended claims. The methods disclosed herein do not have to be performed in the order described. Although the methods disclosed herein include specific actions taken by a practitioner, explicit or implicit third-party instructions for those actions can also be included. For example, an act such as "deploying a sterilized instrument using the system herein" includes "instructing the deployment of a sterilized instrument using the system herein." Additionally, when features or aspects of the disclosure are described in terms of a Markush group, one of skill in the art will recognize that the disclosure is also thereby described in terms of any individual members of the Markush group, or in terms of subgroups of members of the Markush group.
[0087] Ranges disclosed herein also include any and all overlapping, subranges, and combinations. Terms such as "up to," "at least," "greater than," "less than," "between," and similar terms include the recited numerical value. Numeric values preceded by terms such as "approximately" or "about" include the recited numerical value. For example, "about 10 nanometers" includes "10 nanometers."
[0088] The headings or sub-headings used herein are for organizational purposes only and should not be used to limit the scope of the embodiments disclosed herein.
[0089] Exemplary embodiments
[0090] A thrombus filtering device, comprising: It is the main body, A first body portion; a second body portion configured to form an internal cavity with the first body portion; a first port disposed on a first side of the body; a second port disposed on a second side of the body, the second port in fluid communication with the first port through the internal cavity and configured to be in fluid communication with the first vacuum source; a valve configured to be selectively fluidly communicable with at least one of atmospheric pressure and a second vacuum source; a filter disposed within the internal cavity of the body between the first port and the second port, the filter including a plurality of openings.
[0091] A thrombus filtering device, comprising: It is the main body, A first body portion; a second body portion configured to form an internal cavity with the first body portion; a first port disposed on a first side of the body; a second port disposed on a second side of the body, the second port in fluid communication with the first port through the internal cavity; a body, at least one of the first body portion and the second body portion being transparent to permit visualization of the internal cavity; a filter disposed within the internal cavity of the body between the first port and the second port; A plurality of openings; a first surface located on a plane positioned at a non-orthogonal angle relative to the longitudinal axis of the first port; and
[0092] A thrombus filtering device, comprising: It is the main body, A first body portion; a second body portion configured to form an internal cavity with the first body portion; a first port disposed on a first side of the body; a second port disposed on a second side of the body, the second port in fluid communication with the first port through the internal cavity; a third port configured to allow injection of a fluid into the internal cavity; and a filter disposed within the internal cavity of the body between the first port and the second port, the filter including a plurality of openings.
[0093] A thrombus filtering device, comprising: It is the main body, A first body portion; a second body portion configured to form an internal cavity with the first body portion; a first port disposed on a first side of the body; a second port disposed on a second side of the body, the second port in fluid communication with the first port through the internal cavity; The internal cavity is a depth defined as a first distance perpendicular to a longitudinal axis of the body and between the first body portion and the second body portion; a body having a width defined as a second distance perpendicular to the depth and perpendicular to a longitudinal axis of the body, the width being less than the depth; a filter disposed within the internal cavity of the body between the first port and the second port, the filter including a plurality of openings.
[0094] The blood clot filtering device of any embodiment described herein, wherein the body comprises a tubular sidewall.
[0095] A blood clot filtering device as described in any embodiment described herein, wherein at least one surface of the filter lies on a plane positioned at a non-orthogonal angle relative to the longitudinal axis of the body.
[0096] The blood clot filtering device of any embodiment described herein, wherein the non-orthogonal angle is between 30 degrees and 90 degrees relative to the longitudinal axis of the body.
[0097] A blood clot filtering device as described in any embodiment described herein, wherein each of the multiple openings is 1 mm or less.
[0098] The blood clot filtering device of any embodiment described herein, wherein the plurality of openings are configured to prevent blood clots from passing through the filter.
[0099] A blood clot filtering device as described in any embodiment described herein, wherein the first port and the second port are located on opposite ends of the body.
[0100] A blood clot filtering device as described in any embodiment described herein, wherein the body further comprises a third port configured to allow injection of a fluid into the internal cavity.
[0101] A blood clot filtering device as described in any embodiment herein, wherein at least one of the first body portion and the second body portion is at least partially transparent to allow visualization of the internal cavity.
[0102] A blood clot filtering device as described in any embodiment described herein, wherein the body further includes a button configured to allow a user to manually actuate the valve.
[0103] A blood clot filtering device as described in any embodiment described herein, wherein the button is located on the top of the body.
[0104] A blood clot filtering device as described in any embodiment described herein, further comprising a sensor configured to determine when fluid flow through the body has stopped.
[0105] A blood clot filtering device according to any embodiment described herein, wherein the valve is automatically actuated when the sensor determines that fluid flow has stopped.
Claims
1. A thrombus filtering device, It is the main body, a first body having a top surface; a second body portion having a bottom surface and configured to form an interior cavity with the first body portion; a first tube in fluid communication with the body; a second tube in fluid communication with the body; the first tube and the second tube are in fluid communication via an internal cavity; the first body portion and the second body portion form a cylindrical sidewall having a diameter and an axial length; a body, the top surface and the bottom surface being spaced apart from one another by the cylindrical sidewall; a filter disposed within the internal cavity of the body between the first body portion and the second body portion, the filter including a plurality of openings; at least one of the first body portion and the second body portion is transparent to allow visualization of the internal cavity; a transparent portion of the first body portion and the second body portion is provided with a grid for determining the size of a thrombus; The diameter of the cylindrical side wall is greater than the axial length thereof, thereby forming a disk shape. Clot filtering device.
2. The first tube is configured to be fluidly connected to a suction catheter. The blood clot filtering device of claim 1.
3. The second tube is configured to be in fluid communication with a vacuum source. The blood clot filtering device of claim 1.
4. The first tube is disposed between the main body and a suction catheter, the second tube is disposed between the main body and a vacuum source, and the length of the first tube is approximately 50% or less of the length of the second tube. A blood clot filtering device according to any one of claims 1 to 3.
5. Further comprising a clamp disposed along the first tube; the clamp is configured to control fluid flow along the first tube. A blood clot filtering device according to any one of claims 1 to 3.
6. Each of the plurality of openings of the filter is about 1 mm or less. The blood clot filtering device of claim 1.
7. Configured to be placed inside a sterile field, A blood clot filtering device according to any one of claims 1 to 3.
8. The method of claim 7, further comprising: providing a valve configured to be selectively fluidly connected to at least one of atmospheric pressure and a vacuum source; the body further includes a button configured to allow a user to manually actuate the valve; A blood clot filtering device according to any one of claims 1 to 3.
9. A suction system comprising: a suction pump configured to be located outside the sterile field; a chamber configured to be placed within the sterile field; a first tube having a first inner diameter, the first tube configured to provide a fluid communication path for introducing aspirated material into the interior of the chamber; a second tube having a second inner diameter, the second tube configured to fluidly connect the chamber and the aspiration pump; The first inner diameter is larger than the second inner diameter. Suction system.
10. The first tube is configured to fluidly connect the chamber to a distal end of a suction catheter.
10. The suction system of claim 9.
11. The chamber is configured to capture thrombus aspirated by the aspiration catheter. The aspiration system of claim 10.
12. The device further comprises a suction catheter, the suction catheter being configured to be fluidly connected to the first tube, and the first tube and the suction catheter being separate components. A suction system according to any one of claims 9 to 11.
13. The first tube is fluidly connected to the proximal end of the suction catheter.
13. The suction system of claim 12.
14. The chamber is surrounded by a body, the body includes a first port and a second port; the first port is fluidly connected to the first tube; the second port is fluidly connected to the second tube; A suction system according to any one of claims 9 to 11.
15. The size of the first port is larger than the size of the second port.
15. The suction system of claim 14.
16. The body further includes a third port configured to allow injection of a fluid into the chamber.
15. The suction system of claim 14.
17. The chamber is fluidly connected to the first port and the second port.
15. The suction system of claim 14.
18. The first port and the second port are located at opposite ends of the main body.
15. The suction system of claim 14.
19. The chamber includes a filter. A suction system according to any one of claims 9 to 11.
20. A valve configured to be selectively fluidly connected to at least one of atmospheric pressure and the suction pump; a button configured to allow a user to manually actuate the valve. A suction system according to any one of claims 9 to 11.
21. The method of claim 20, further comprising: detecting when fluid flow through the chamber has ceased; A suction system according to any one of claims 9 to 11.
22. A thrombus filtering device, comprising: It is the main body, a first body portion; a second body portion configured to form an interior cavity with the first body portion; a first tube in fluid communication with the body; a second tube in fluid communication with the body; the first tube and the second tube are in fluid communication through the internal cavity; The internal cavity is a depth transverse to the longitudinal axis of the body and defined as a first distance between the first body portion and the second body portion; a body having a width defined as a second distance perpendicular to the depth and perpendicular to the longitudinal axis of the body, the width being greater than the depth; a filter disposed within the internal cavity of the body between the first tube and the second tube, the filter including a plurality of openings. Clot filtering device.
23. The first body portion includes a top portion having a flat surface, the second body portion includes a bottom having a flat surface; the filter is disposed between the top and bottom and has a flat surface parallel to the flat surface of the top and the flat surface of the bottom; The blood clot filtering device of claim 22.
24. The first tube is connected to the top and the second tube is connected to the bottom; fluid communication from the first tube to the internal cavity is configured across a flat surface of the filter to the second tube; The blood clot filtering device of claim 23.
25. The first tube is configured to be fluidly connected to a suction catheter. A blood clot filtering device according to any one of claims 22 to 24.
26. The second tube is configured to be in fluid communication with a vacuum source. A blood clot filtering device according to any one of claims 22 to 24.
27. The first tube is disposed between the main body and a suction catheter, the second tube is disposed between the main body and a vacuum source, and the length of the first tube is not more than about 50% of the length of the second tube. A blood clot filtering device according to any one of claims 22 to 24.
28. Further comprising a clamp disposed along the first tube; the clamp is configured to control fluid flow along the first tube. A blood clot filtering device according to any one of claims 22 to 24.
29. Each of the plurality of openings of the filter is about 1 mm or less. A blood clot filtering device according to any one of claims 22 to 24.
30. A device configured to be placed within a sterile field. A blood clot filtering device according to any one of claims 22 to 24.
31. The method of claim 30, further comprising: a valve configured to be selectively fluidly connected to at least one of atmospheric pressure and a vacuum source; the body further includes a button configured to allow a user to manually actuate the valve; A blood clot filtering device according to any one of claims 22 to 24.
32. At least one of the first body portion and the second body portion is transparent to allow visualization of the internal cavity. A blood clot filtering device according to any one of claims 22 to 24.
33. A lattice is provided in the transparent portion of the first body portion and the second body portion to determine the size of the thrombus. The blood clot filtering device of claim 32.
34. A thrombus filtering device, comprising: It is the main body, a top portion having a flat top surface; a bottom portion having a flat bottom surface, the bottom portion configured to form an interior cavity with the top portion; a body, the top and bottom defining sidewalls, the top and bottom surfaces spaced apart by the sidewalls; a first tube in fluid communication with the body through a first port disposed in the sidewall; a second tube in fluid communication with the body through a second port disposed in the sidewall; a filter disposed within the internal cavity of the body between the top and bottom, the filter including a plurality of openings; the first tube and the second tube are in fluid communication through the internal cavity; At least one of the top and bottom portions is transparent to allow visualization of the internal cavity. Clot filtering device.
35. The filter has a flat surface parallel to the top surface and the bottom surface. The blood clot filtering device of claim 34.
36. The first tube is connected to the top and the second tube is connected to the bottom. The blood clot filtering device of claim 34.
37. The first tube is configured to be fluidly connected to a suction catheter. The blood clot filtering device of claim 34.
38. The second tube is configured to be in fluid communication with a vacuum source. The blood clot filtering device of claim 34.
39. The method according to claim 38, wherein the device is configured to be placed within a sterile field. A blood clot filtering device according to any one of claims 34 to 38.
40. The method according to claim 1, further comprising: the body further includes a button configured to allow a user to manually actuate the valve; A blood clot filtering device according to any one of claims 34 to 38.