JP2024524361A - Hub and valve system for suction catheters - Google Patents

Abstract

A valve system for a catheter, such as a suction catheter, is disclosed that includes a valve having a proximal end and a distal end. The distal end of the valve is coupled to the catheter. The valve has a flexible lumen in a first state that is compressed or twisted. The valve system is contained within a hub, and actuation of a button on the hub rotates the proximal and distal ends of the valve relative to one another to place the lumen in a second state that is uncompressed or untwisted.
[Selected figure] Figure 3

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application relies on U.S. Provisional Patent Application No. 63/215,579, filed June 28, 2021, entitled "Hub and Valve System for Aspiration Catheters," for priority purposes, the entire contents of which are incorporated herein by reference.

This application also relies for priority on U.S. Provisional Patent Application No. 63/364,168, filed May 4, 2022, entitled "METHOD AND DEVICE HAVING SPECIALIZED CLOTTING REMOVAL ELEMENTS" and U.S. Provisional Patent Application No. 63/268,094, filed February 16, 2022, entitled "METHOD AND DEVICE FOR REMOVING AND FILTERING BLOOD CLOTS AND SEPARATORY BLOOD FOR REINFUSION INTO A PATIENT."

This application is a continuation-in-part of U.S. Patent Application No. 17/572,138, filed January 10, 2022, entitled "BLOOD CLOTTING REMOVAL METHOD AND DEVICE HAVING MULTIPLE INDEPENDENTLY CONTROLLABLE ELEMENTS," which is also a continuation-in-part of U.S. Patent Application No. 17/450,977, filed October 14, 2021, entitled "BLOOD CLOTTING REMOVAL METHOD AND DEVICE HAVING MULTIPLE INDEPENDENTLY CONTROLLABLE ELEMENTS."

This application is a continuation-in-part of U.S. patent application Ser. No. 17/572,206, filed on January 10, 2022, entitled "BLOOD CLOTTING REMOVAL METHOD AND DEVICE HAVING MULTIPLE INDEPENDENTLY CONTROLLABLE ELEMENTS," which is a continuation-in-part of U.S. patent application Ser. No. 17/450,978, filed on October 14, 2021, of the same title.
Both U.S. Patent Application No. 17/450,977 and U.S. Patent Application No. 17/450,978 rely for priority on the following provisional applications:
U.S. Provisional Patent Application No. 63/260,406, filed August 19, 2021, entitled “Catheter-Based Retrieval Device”;
U.S. Provisional Patent Application No. 63/215,724, filed June 28, 2021, entitled "Device and Method of Using the Device for Treating a Pathological Connection Between Two Anatomical Structures";
U.S. Provisional Patent Application No. 63/215,579, filed June 28, 2021, entitled "Hub and Valve System for Aspiration Catheters";
U.S. Provisional Patent Application No. 63/215,573, filed June 28, 2021, entitled “Aspiration Catheters and Methods of Use Thereof”;
U.S. Provisional Patent Application No. 63/215,587, filed June 28, 2021, entitled "Vascular Closure Devices and Methods of Use Thereof";
U.S. Provisional Patent Application No. 63/215,583, filed June 28, 2021, entitled “Catheter Having an Expandable and Collapsible Lumen”;
U.S. Provisional Patent Application No. 63/215,565, filed June 28, 2021, entitled "Catheter-Based Retrieval Device," and U.S. Provisional Patent Application No. 63/092,428, filed October 15, 2020, entitled "Catheter-Based Retrieval Device Having a Proximal Body with Axial Free Movement."
All of the above mentioned patents and applications are incorporated herein by reference in their entirety.

The present disclosure generally relates to a hub and valve mechanism that allows for the application and removal of suction to a suction catheter through a valve.

Many medical procedures, such as, for example, mechanical thrombectomy, require the introduction of at least one medical device into the arterial, venous, and neurological systems so that the medical device can be advanced to the body location requiring diagnosis or treatment. For example, a guide catheter can be advanced through the patient's vasculature (e.g., the vasculature in the brain) to the desired treatment site, and the medical device is advanced through the guide catheter for removal of an obstructing material, such as a thrombus. The guide catheter is often inserted through an aspiration catheter to remove obstructing material that is dislodged from the treatment site by the medical device.

The hub is typically coupled to the proximal end of the suction catheter via a valve. The hub operates to control the opening and closing of the valve, thereby manipulating the application of suction force through the suction catheter.

There is a continuing need for improved valve and hub systems that are easy to operate. There is also a need for hubs that can be operated with one hand to open and seal the associated valve when desired.

The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools, and methods that are intended to be exemplary and explanatory, not limiting in scope. This application discloses numerous embodiments.

The present specification discloses a valve system configured to be coupled to a catheter. The valve system includes a valve having a proximal end and a distal end, the distal end of the valve being coupled to a lumen of a catheter, the valve comprising a flexible material extending between the proximal and distal ends, the valve lumen having a first twisted state and a second untwisted state, a hub having a body, a rack, a pinion physically coupled to the rack, and an actuator, the body encircling the rack, the pinion coupled to the proximal end of the valve, the actuator coupled to the rack such that application of a force to the actuator moves the rack to rotate the pinion in a first direction, thereby untwisting the lumen and achieving the second untwisted state.

Optionally, the actuator is coupled to the rack such that removing pressure or physical force from the actuator automatically moves the rack, thereby rotating the pinion in a second direction and positioning the lumen in the first torsional state.

Optionally, the flexible material comprises at least one of polytetrafluoroethylene, urethane, or silicone.

Optionally, the valve further comprises at least one gear within the hub, and the pinion is coupled to the proximal end of the valve through the at least one gear.

Optionally, the valve is reinforced with one or more members comprising at least one of stainless steel, nitinol, or nylon.

Optionally, the valvular lumen has an inner diameter in the range of 0.01 inches to 2 inches. Optionally, the valvular lumen has a wall thickness in the range of 0.0002 inches to 0.125 inches. Optionally, the valvular lumen has a length in the range of 0.01 inches to 2 inches.

The valve system further includes at least one gear within the hub, and the rack is coupled to the pinion through the at least one gear.

The bulb lumen is configured to be rotated through an angle ranging from 90 degrees to 360 degrees to place the lumen in the first state.

The present specification also discloses a valve system configured to be coupled to a catheter, the valve system comprising: a valve having a proximal end and a distal end, the distal end of the valve being coupled to a lumen of the catheter, the valve comprising a flexible material defining the proximal end, the distal end, and a lumen extending therebetween, the valve lumen having a first twisted state and a second untwisted state; and a hub having a body, a first rack, a second rack, a pinion configured to engage the first rack and the second rack in parallel, and an actuator, the second rack being coupled to the proximal end of the valve, the actuator being coupled to the pinion such that application of a force to the actuator rotates the pinion, moves the pinion along the first rack, and moves the second rack in a first direction, thereby untwisting the valve lumen and achieving the second untwisted state.

Optionally, the first rack is configured to be stationary and the second rack is configured to be movable.

Optionally, the first twisted state forms a seal with the catheter.

Optionally, the second untwisted state allows for the flow of fluid or the passage of a device into the catheter.

Optionally, the flexible material comprises at least one of PTFE, ePTFE, urethane, or silicone. Optionally, the hub comprises at least one of a stainless steel member, a nitinol member, or a nylon member.

Optionally, the valvular lumen has an inner diameter in the range of 0.01 inches to 2 inches. Optionally, the valvular lumen has a wall thickness in the range of 0.0002 inches to 0.125 inches. Optionally, the valvular lumen has a length in the range of 0.01 inches to 2 inches.

Optionally, the actuator is coupled to the pinion such that removing force from the actuator rotates the pinion, causing the pinion to move along the first rack and the second rack to move in a second direction opposite the first direction, thereby twisting the bulb lumen into the first torsional state. Optionally, the flexible lumen is configured to be rotated through an angle ranging from 90 degrees to 360 degrees to compress the lumen into the first torsional state.

The present specification also discloses a valve system for a suction catheter, the system comprising: a valve having a proximal end and a distal end, the distal end of the valve being coupled to the suction catheter, the valve being a tube having a flexible lumen in a first state; and a hub having a body surrounding a cylinder and a slider positioned on the body, the cylinder having a substantially helical groove formed on an outer surface of the cylinder, the slider being constrained to move within a slot formed in the body, the slider having a pin that engages and follows the groove, and moving the slider distally causes the pin to move within the groove and rotates the cylinder in a first direction, the rotation of the cylinder in the first direction causes the proximal and distal ends of the valve to rotate relative to each other, the relative rotation placing the lumen in a second state.

Optionally, the first state corresponds to a state in which the lumen is compressed. Optionally, the second state corresponds to a state in which the lumen is open.

Optionally, the tube is fabricated from at least one of PTFE, ePTFE, urethane, or silicone. Optionally, the tube is reinforced with stainless steel, nitinol, or nylon members.

Optionally, the tube has an inner diameter in the range of 0.01 inches to 2 inches. Optionally, the tube has a wall thickness in the range of 0.0002 inches to 0.125 inches. Optionally, the tube has a length in the range of 0.01 inches to 2 inches.

Optionally, moving the slider proximally causes the pin to move within the groove and rotate the cylinder in a second direction opposite to the first direction, the rotation of the cylinder in the second direction causing the proximal and distal ends of the valve to rotate relative to one another, the relative rotation placing the lumen in a second state.
Optionally, said tube is configured to be rotated through an angle in the range of 90 degrees to 360 degrees to compress said lumen in said first state.

The present specification also discloses a syringe configured to automatically hold a plunger in a retracted position within a barrel until released, the syringe comprising a latch base attached to an exterior surface of the barrel, and a lever movably connected to the latch base, the lever pivoting relative to the latch base, the lever having an arm at one end and a hammer at the other end, the distal end of the plunger including a flange, and moving the plunger proximally causes the hammer to settle in a predetermined position behind the flange, thereby holding the plunger in the retracted position.

Optionally, depressing the arm of the lever raises the hammer, thereby releasing it to push the plunger forward.

This specification also discloses a valve system for a suction catheter. The valve system includes a valve having a proximal end and a distal end, the distal end of the valve being fixedly coupled to the suction catheter, the valve comprising a tube having a flexible lumen extending between the proximal end and the distal end, the lumen being in a first compressed state, and a hub having a body. The hub includes a rack, a pinion that engages the rack, a speed increasing gear that engages the pinion, and an actuator positioned on the body, the rack is coupled to the actuator, the speed increasing gear is coupled to the proximal end of the valve, and the actuator, rack, pinion, and speed increasing gear are configured such that applying a force to the actuator shifts the rack along a linear axis, rotates the pinion in a first direction to move the pinion along the rack, then rotates the speed increasing gear in the first direction, and then rotates the proximal end relative to the distal end, the relative rotation placing the flexible lumen in a second open state.

Optionally, the first compressed state forms a seal around the suction catheter.

Optionally, the second open state allows fluid flow into the aspiration catheter or passage of a device.

Optionally, the material of the tube comprises at least one of polytetrafluoroethylene, urethane, or silicone. Optionally, the tube further comprises at least one of a stainless steel member, a nitinol member, or a nylon member.

Optionally, the flexible lumen has an inner diameter in the range of 0.01 inches to 2 inches.

Optionally, the flexible lumen has a wall thickness in the range of 0.0002 inches to 0.125 inches.

Optionally, the flexible lumen has a length in the range of 0.01 inches to 2 inches.

Optionally, the actuator is coupled to the rack such that removing pressure or physical force from the actuator automatically moves the pinion along the rack and rotates the speed increasing gear in a second direction opposite the first direction, the rotation of the speed increasing gear in the second direction rotates the proximal end of the valve relative to the distal end, the relative rotation returning the flexible lumen to the first compressed state. Optionally, the flexible lumen is configured to rotate an angle in the range of 90 degrees to 360 degrees to compress the lumen to the first state.

Optionally, the present specification also discloses a method for selectively applying suction to a catheter, the method comprising providing a catheter and a valve system coupled to the catheter, the valve system comprising a valve having a proximal end and a distal end, the distal end of the valve being coupled to a lumen of the catheter, the valve comprising a flexible material defining the proximal end, the distal end and a lumen extending therebetween, the valve lumen having a first twisted state and a second untwisted state, and a hub having a body, a rack, a pinion physically engaging the rack, and an actuator, the body surrounding the rack and the pinion rotating the pinion relative to the valve lumen, the valve system comprising a valve having a proximal end and a distal end, the distal end of the valve being coupled to a lumen of the catheter, the valve comprising a flexible material defining the proximal end, the distal end and a lumen extending therebetween, the valve lumen having a first twisted state and a second untwisted state, the hub having a body, a rack, a pinion physically engaging the rack, and an actuator, the body surrounding the rack and the pinion rotating the pinion relative to the valve lumen, the valve system comprising a valve having a proximal end and a distal end, the distal end being coupled to a lumen of the catheter, the valve system comprising a valve having a proximal end and a distal end, the distal end being coupled to a lumen of the catheter, the valve system comprising a flexible material defining the proximal end, the distal end and a lumen extending therebetween, the valve lumen having a first twisted state and a second untwisted state ... providing a catheter and valve system comprising: a hub coupled to the proximal end of the valve, the actuator coupled to the rack such that applying a force to the actuator moves the rack and rotates the pinion in a first direction to untwist the valve lumen to the second untwisted state; applying a force to the actuator to untwist the valve lumen to the second untwisted state; using a syringe coupled to the catheter; applying a suction force to the catheter; and removing the force from the actuator to twist the valve lumen to the first twisted state.

Optionally, the actuator is coupled to the rack such that removing the force from the actuator moves the rack and rotates the pinion in a second direction to twist the valve lumen and to the first torsional state.

The present specification also discloses a method of selectively applying suction to a catheter, the method comprising providing a catheter and a valve system coupled to the catheter, the valve system comprising a valve having a proximal end and a distal end, the distal end of the valve being coupled to a lumen of the catheter, the valve comprising a flexible material defining the proximal end, the distal end, and a lumen extending therebetween, the valve lumen having a first twisted state and a second untwisted state, and a hub having a body, a first rack, a second rack, a pinion configured to engage the first rack and the second rack in parallel, and an actuator, the second rack being coupled to the proximal end of the valve. and a hub, the actuator coupled to the pinion such that applying a force to the actuator rotates the pinion, moving the pinion along the first rack and moving the second rack in a first direction, thereby untwisting the valve lumen and achieving the second untwisted state; applying a force to the actuator to untwist the valve lumen and achieve the second untwisted state; using a syringe coupled to the catheter; applying a suction force to the catheter; and removing the force from the actuator to twist the valve lumen and achieve the first twisted state.

Optionally, the actuator is coupled to the pinion such that removing the force from the actuator rotates the pinion, causing the pinion to move along the first rack and the second rack to move in a second direction opposite the first direction, thereby twisting the valve lumen into the first twisted state.

The present specification also discloses a method for selectively applying suction to a catheter, the method comprising providing a catheter and a valve system coupled to the catheter, the valve system comprising a valve having a proximal end and a distal end, the distal end of the valve being coupled to the suction catheter, the valve comprising a tube having a flexible lumen in a first compressed state, and a hub having a body surrounding a cylinder and a slider positioned on the body, the cylinder having a substantially helical groove formed on an outer surface of the cylinder, the slider being constrained to move within a slot formed in the body, the slider engaging and compressing the groove. a hub having a pin that fits inside the groove and that moves the slider distally to move the pin within the groove; rotating the cylinder in a first direction, the rotation of the cylinder in the first direction causing the proximal and distal ends of the valve to rotate relative to one another, the relative rotation placing the lumen in a second untwisted state; applying a force to the slider to untwist the flexible lumen and place it in the second untwisted state; using a syringe coupled to the catheter; applying suction to the catheter; and removing the force from the slider to twist the flexible lumen and place it in the first twisted state.

The present specification also discloses a valve system for a suction catheter, the valve system comprising: a valve having a proximal end and a distal end, the distal end of the valve being coupled to a lumen of the suction catheter, the valve comprising a flexible material extending through a length of the valve and defining a lumen, the valve lumen being in a first state; and a hub having a body enclosing a rack that engages an associated pinion, the hub comprising a button positioned on the body, the pinion being coupled to the proximal end of the valve, the button being coupled to the rack, the button being configured to move the rack by applying a force to the button and rotate the pinion in a first direction to rotate the proximal and distal ends of the valve relative to one another, the relative rotation placing the valve lumen in a second state.

Optionally, the first state corresponds to a state in which the lumen is twisted such that the lumen is compressed.

Optionally, the second state corresponds to a state in which the lumen is untwisted such that the lumen is not compressed.

Optionally, the flexible material comprises at least one of ePTFE, urethane, or silicone. Optionally, the valve is reinforced with one or more members comprising at least one of stainless steel, nitinol, or nylon.

Optionally, the bulb lumen has an inner diameter in the range of 0.01 inches to 2 inches.

Optionally, the bulb lumen has a wall thickness in the range of 0.0002 inches to 0.125 inches.

Optionally, the bulb lumen has a length in the range of 0.01 inches to 2 inches.

Optionally, release of the button moves the rack and rotates the pinion in a second direction opposite the first direction to rotate the proximal and distal ends of the valve relative to one another, the relative rotation placing the lumen in the first state. Optionally, the tube is configured to be rotated through an angle ranging from 90 degrees to 360 degrees to compress the lumen in the first state.

The present specification also discloses a valve system for a suction catheter, the system comprising: a valve having a proximal end and a distal end, the distal end of the valve being coupled to the suction catheter, the valve comprising a tube having a flexible lumen, the lumen being in a first compressed state; and a hub having a body enclosing a first rack, a second rack, and a pinion engaging the first and second racks, the hub comprising an actuator positioned on the body, the pinion being coupled to the actuator, and the second rack being coupled to the proximal end of the valve, the application of a force to the actuator rotates the pinion, moving the pinion along the first rack to move the second rack in a first direction, the movement of the second rack in the first direction rotates the proximal and distal ends of the valve relative to one another, the relative rotation placing the lumen in a second untwisted state.

Optionally, the first rack is stationary and the second rack is movable.

Optionally, the first compressed state forms a seal with the aspiration catheter.

Optionally, the second uncompressed state allows fluid flow into the aspiration catheter or through the device.

Optionally, the tube material comprises at least one of ePTFE, urethane, or silicone. Optionally, the tube further comprises at least one of a stainless steel member, a nitinol member, or a nylon member.

Optionally, the flexible lumen has an inner diameter in the range of 0.01 inches to 2 inches.

Optionally, the flexible lumen has a wall thickness in the range of 0.0002 inches to 0.125 inches.

Optionally, the flexible lumen has a length in the range of 0.01 inches to 2 inches.

Optionally, removing force from the actuator rotates the pinion, moving the pinion along the first rack and moving the second rack in a second direction opposite the first direction, the movement of the second rack in the second direction rotates the proximal and distal ends of the valve relative to one another, the relative rotation returning the lumen to the first compressed state. Optionally, the flexible lumen is configured to be rotated through an angle ranging from 90 degrees to 360 degrees to compress the lumen in the first state.

The present specification also discloses a valve system for a suction catheter, the system comprising: a valve having a proximal end and a distal end, the distal end of the valve being coupled to the suction catheter, the valve being a tube having a flexible lumen in a first state; and a hub having a body surrounding a cylinder and a slider positioned on the body, the cylinder having a substantially helical groove formed on an outer surface of the cylinder, the slider being constrained to move within a slot formed in the body, the slider having a pin that engages with and follows the groove, and moving the slider distally causes the pin to move within the groove and rotates the cylinder in a first direction, the rotation of the cylinder in the first direction rotates the proximal and distal ends of the valve relative to each other, the relative rotation placing the lumen in a second state.

Optionally, the first state corresponds to a state in which the lumen is compressed.

Optionally, the second state corresponds to a state in which the lumen is open.

Optionally, the tube is made from at least one of ePTFE, urethane, or silicone.
Optionally, the tube is reinforced with stainless steel, nitinol, or nylon material.

Optionally, the tube has an inner diameter in the range of 0.01 inches to 2 inches.

Optionally, the tube has a wall thickness in the range of 0.0002 inches to 0.125 inches.

Optionally, the tube has a length in the range of 0.01 inches to 2 inches.

Optionally, moving the slider proximally to move the pin within the groove and rotating the cylinder in a second direction opposite the first direction, the rotation of the cylinder in the second direction rotating the proximal and distal ends of the valve relative to one another, the relative rotation placing the lumen in a second state. Optionally, the tube is configured to be rotated through an angle ranging from 90 degrees to 360 degrees to compress the lumen in the first state.

The present specification also discloses a syringe configured to automatically hold a plunger in a retracted position within a barrel until released, the syringe comprising a latch base attached to an exterior surface of the barrel, and a lever movably connected to the latch base, the lever pivoting relative to the latch base, the lever having an arm at one end and a hammer at the other end, the distal end of the plunger including a flange, and moving the plunger proximally causes the hammer to settle into a predetermined position behind the flange, such that the plunger is held in the retracted position.

Optionally, depressing the arm of the lever causes the hammer to lift, thereby releasing the plunger and pushing it forward.

The above and other embodiments herein are described in more depth in the figures and detailed description provided below.

The accompanying drawings illustrate various embodiments of the systems, methods, and various other aspects of the present disclosure. Anyone skilled in the art will understand that the boundaries of elements shown in the drawings (e.g., boxes, groups of boxes, or other shapes) are intended to represent an example of the boundaries. In some examples, an element may be designed as multiple elements, or multiple elements may be designed as one element. In some examples, an element shown as an internal element of one element may be implemented as an external element in another, and vice versa. Furthermore, elements may not be drawn to scale. A non-limiting and non-exhaustive description is provided with reference to the following drawings. The components in the drawings are not necessarily drawn to scale, with emphasis instead being placed on illustrating principles.
1 illustrates a retrieval device according to some embodiments herein. 1 illustrates a hub coupled to a catheter and valve with a negative pressure source connected thereto, according to some embodiments herein. 13 illustrates another embodiment of a hub coupled to a catheter and valve that is connected to a negative pressure source in accordance with the present disclosure. 1A-1D show first and second cross-sectional views of a flexible lumen tube or valve, according to some embodiments herein. 1A-1C show perspective, side, and top views of a hub including a single rack and pinion arrangement for use with a flexible lumen tube or valve, according to some embodiments herein. 1 illustrates a hub including a dual rack and pinion arrangement for use with a flexible lumen tube or valve, according to some embodiments herein. 1A-1D show perspective, side and top views of a hub including a twist mechanism actuated by a cammed slider for use with a flexible lumen tube or valve according to some embodiments of the present disclosure. 13 illustrates another embodiment of a hub included in a valve mechanism according to the present disclosure. 13 illustrates yet another embodiment of a hub included in a valve mechanism according to the present disclosure. 1, 2, and 3 show a lock syringe according to some embodiments of the present disclosure. 1 is a flow chart illustrating an example of a method for performing aspiration using a suction catheter connected to a suction port of a hub with a locked syringe, according to some embodiments herein.

This specification is directed to multiple embodiments. The following disclosure is provided to enable one skilled in the art to practice the invention. The language used in this specification should not be construed as a general disclaimer of any one particular embodiment, or used to limit the claims beyond the meaning of the terms used in the claims. The general principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the invention. Furthermore, the terminology and language used are for the purpose of describing the example embodiments, and should not be considered limiting. Thus, the present invention is accorded the widest scope, including numerous alternatives, modifications, and equivalents consistent with the principles and characteristics disclosed. For purposes of clarity, details relating to known technical material in the art related to the invention are not described in detail so as not to unnecessarily obscure the invention.

In the specification and claims of this application, the words "comprise," "include," "have," "contain," and each of their forms are not necessarily limited to those in the list to which the words may be related. As such, they are intended to be equivalent in meaning and open-ended in that an item or items following any one of these words does not mean that such an item or items is an exhaustive list of such item or items, or that it is limited to only the listed item or items. It should be noted here that any feature or component described in connection with a particular embodiment may be used and implemented with other embodiments, unless expressly indicated otherwise.

It should also be noted that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural references unless the context indicates otherwise. Although any systems and methods similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present disclosure, the preferred systems and methods are now described.

FIG. 1A illustrates a retrieval device 100 according to some embodiments herein. The device 100 comprises a first unit 102 including a handle 105 coupled to a tip 104 via a number of telescopic tubes, the handle 105 configured to guide the tip 104 proximate to an obstruction to perform a thrombectomy. In some embodiments, a proximal element 142 and a distal element 144 are positioned on the tip 104.

The device 100 further comprises a second unit 110 including a suction catheter 112 having a distal end 114 and a proximal end 116. The proximal end 116 is coupled to a port 118, which in embodiments herein includes a flexible lumen tube (or valve) 120. In embodiments, the device 100 includes a suction port 119 that is distal to the flexible lumen tube or valve 120. A hub 122 is coupled to a proximal end 126 of the suction port 119. A negative pressure source 128, such as a syringe, is coupled to a proximal end 130 of the hub 122. A button 124 on the hub 122 can be activated or deactivated to apply suction (from the negative pressure source 128) to the suction catheter 112 via the suction port 119 or to block suction (from the negative pressure source 128) from the suction catheter 112.

During a thrombectomy procedure, the tip 104 is placed into the delivery catheter 135, which is then inserted into the aspiration catheter 112 through the port 118 such that at least the tip 104 protrudes distally from the distal end 114 of the aspiration catheter 112. According to aspects herein, the device 100 is configured to allow an operator to manipulate/actuate the handle portion 105 (using the first, second, and third knobs 150, 152, and 154) with one hand to mechanically extract the occlusion, minimize tPA (tissue plasminogen activator), reduce bleeding, and provide distal embolic protection while aspirating by actuating the hub 122.

According to some aspects herein, the first and second units 102, 110 are manufactured as separate stand-alone units or devices. This is advantageous in that a physician may use the first unit 102 with any third party suction catheter. In some embodiments, the suction catheter 112 is available in multiple outer diameters, such as, but not limited to, 12 Fr, 16 Fr, 20 Fr, and 24 Fr (Fr stands for French scale or gauge system). In some embodiments, the syringe 128 has, by way of example and non-limiting, a volume of 60 cubic centimeters.

In some embodiments, apart from use in mechanical thrombectomy procedures, the hub and valve device described with reference to Figs. 2, 3, 4, 5, 6, and 7 may be used in large diameter femoral closure procedures. More specifically, the thrombectomy device may in some embodiments be the device disclosed in U.S. Patent Nos. 10,172,634 and 10,898,215, U.S. Patent Application Publication No. 17/127,521, and U.S. Provisional Patent Application Nos. 63/092,428 and 63/215,565, all of which are incorporated herein by reference in their entirety. The hub and valve embodiment may be positioned in fluid communication with the catheter 112 by being positioned in the flexible lumen tube or valve 120, with the distal portion of the hub and valve embodiment being in fluid communication with the catheter 112 and the proximal portion of the hub and valve embodiment being configured to receive a medical device and allow the outflow of blood.

FIG. 1B shows a photographic image of another embodiment of a hub 118 coupled to a catheter 112 and a valve 123 with a negative pressure source 128 connected thereto, according to some embodiments herein. The hub 118 includes a flexible lumen tube or valve 120 (shown in dashed lines in FIG. 1B) positioned within the body of the hub. By default, the flexible lumen tube or valve 120 is in a compressed state such that no element can pass through it unless it is uncompressed. The catheter 112 is coupled to a distal portion of the hub 118. A suction port 119 is included in the hub 118 distal to the flexible lumen tube or valve 120 and proximal to the catheter 112. A suction force may be applied to the suction port 119, which is distal to the flexible lumen tube or valve 120. A suction valve 123 is connected to the suction port 119 and configured to control suction from the catheter 112. In some embodiments, the valve 123 is actuated by a thumb slider 125 that, when moved from an open position to a closed position, collapses (or exerts pressure on) a member on a flexible tube 127 (also referred to herein as a flexible lumen tube or valve 120) within the valve 123, closing the valve 123. In other embodiments, the valve 123 is actuated using a different mechanism, which will be described below. The opening and closing of the valve 123 effectively applies suction from a negative pressure source 128, such as a syringe. Thus, the flexible lumen tube or valve 120 is in an uncompressed state as long as the valve 123 is actuated to allow suction. The suction port 119 is located distal to the flexible lumen tube or valve 120, and thus suction occurs. Thus, in embodiments, the flexible lumen tube or valve 120 does not participate in suction, but is used to seal to prevent leakage from its proximal end when suction is applied.

FIG. 1C illustrates another embodiment of a device assembly according to the present disclosure, including a hub 118c coupled to a catheter 112c and a valve 123c having a connected negative pressure source 128c. A top view 102c of the assembly includes the hub 118c and the valve 123c, while a second view 104c of the assembly illustrates a side view. In an embodiment, the hub 118c includes a flexible lumen tube or valve positioned within the body of the hub (not shown). The valve, also referred to herein as a hemostasis valve, is operated by an actuator 130c. In an embodiment, referring to the side view 104c, the lateral length (height) of the hub 118c ranges from 2 inches to 5 inches, with 2.25 inches to 3.50 inches being preferred. Referring to the side view 104c, when the hemostasis valve 130c is in a closed position, the lateral length (height) of the hub 118c is approximately 3.39 inches (in). When the hemostasis valve 130c is in the open position, the lateral length (height) of the hub 118c is approximately 2.51 inches (in). In an embodiment, the catheter 112c is coupled to the distal end of the hub 118c.

A suction port 119c is included in the hub 118c, distal to the flexible lumen tube or valve and proximal to the catheter 112c. In some embodiments, the overall length of the suction port 119c from the hub 118c to the suction valve 123c ranges between 10 cm and 20 cm, with a range of 16-17 cm being preferred. Suction may be applied to the suction port 119c, distal to the flexible lumen tube or valve. A suction valve 123c is connected to the suction port 119c and configured to control suction from the catheter 112c. In some embodiments, the valve 123c is actuated by a thumb slider 125c, which, when moved from an open position to a closed position (as shown in FIG. 102c), collapses (or exerts pressure on) a member on a flexible tube (not shown) within the valve 123c to close the valve 123c.

In an embodiment, the opening and closing of the valve 123c is used to effectively apply suction from a negative pressure source 128c, such as a syringe connected to the quick connector 126. The suction port 123c is located distal to the flexible lumen tube or valve, and thus suction occurs. Thus, in an embodiment, the flexible lumen tube or hemostatic valve positioned in the hub 118c does not participate in the suction, but is used to form a seal that prevents leakage from its proximal end when suction is applied. In other words, when the flexible lumen tube or hemostatic valve is in the first closed state, it presses laterally against a medical device previously introduced through the catheter 112c to form a seal, but the seal does not prevent axial or longitudinal movement of the device within the hub 118c and catheter 112c. In such a case, the seal continues to exert lateral pressure (perpendicular to the surface of the device) even as the device is being moved longitudinally back and forth through the hub and catheter.

In some embodiments, the proximal and distal ends of the flexible lumen tube or hemostasis valve are spring loaded in a nominally twisted state, compressing or pinching the lumen of the tube or hemostasis valve and requiring a force to be applied to the spring to untwist the lumen of the valve, thereby releasing the lumen from the compression or pinching. In some embodiments, in the uncompressed or open state, the hemostasis valve has a minimum inner diameter of 0.29 cm. In some embodiments, the hemostasis valve is made by adding a thermoplastic polyurethane, including an ultra-soft polyether or polyester-based blend (such as, but not limited to, NeuSoft UR842A), to the design over the ePTFE for additional robustness to enhance the seal. In some embodiments, a cylindrical cap 132c is fixedly attached to the actuator 130c of the hemostasis valve. The cap 132c, which in an embodiment is made from plastic, recesses the top of the actuator 130c to remove torsional strain and hold the hemostasis valve open for the period that the hub 118c is stored prior to its use. During deployment, the user can remove the cap 132c by pulling it off the actuator 130c. Further details of the hemostasis valve and actuator hub 118c are described below with reference to FIG. 3.

2 shows first and second cross-sectional views 202, 204 of a flexible lumen tube or hemostatic valve 220 (valve 120 of FIG. 1A) according to some embodiments herein. FIG. 202 shows the flexible lumen tube or valve 220 in a second state, while FIG. 204 shows the flexible lumen tube or valve 220 in a first state. In an embodiment, the valve 220 remains in the first state in its original or initial state. Furthermore, the valve 220 remains in the second state as long as an actuator connected to the valve 220 is actuated. The second state corresponds to the flexible lumen tube or valve 220 being open or untwisted, while the first state corresponds to the flexible lumen tube or valve 220 being compressed, pinched, or twisted.

The flexible lumen tube or bulb 220 has proximal and distal ends 205, 210. The proximal end 205 is coupled to a hub 218 (hub 118 in FIG. 1A), while the distal end 210 is coupled to an aspiration catheter 212 (catheter 112 in FIG. 1A). As shown in FIG. 2 204, in some embodiments, the proximal and distal ends 205, 210 are spring loaded in a nominally twisted or first state, compressing or pinching the lumen of the bulb 220 tube.

As shown in FIG. 1 202, the flexible lumen tube or valve 220 is untwisted by rotating the proximal and distal ends 205, 210 relative to one another such that the lumen of the tube or valve 220 is open or in a second state. In some embodiments, the proximal end 205 may be rotated in a first direction (e.g., clockwise or counterclockwise) and the distal end 210 may be rotated in a second direction opposite the first direction (e.g., counterclockwise or clockwise) to untwist the flexible lumen tube or valve 220 such that the lumen of the tube or valve 220 is open or in a second state. In some embodiments, the distal end 210 is fixed while the proximal end 205 is rotated to untwist the flexible lumen tube or valve 220 such that the lumen of the tube or valve 220 is open or in a second state. When in a closed or first (initial) state, as shown in FIG. 2 204, the twisted flexible lumen tube or valve 220 of the catheter hub seals the proximal end of the catheter 212. When in an open or second state, as shown in FIG. 1 202, the flexible lumen tube or valve 220 allows the passage of medical devices and the outflow of blood.

In some embodiments, the flexible lumen tube or valve 220 is made of a thin flexible material such as, but not limited to, PTFE (polytetrafluoroethylene), ePTFE (expanded polytetrafluoroethylene), urethane, or silicone. In some embodiments, the tube or valve 220 may be reinforced with stainless steel, NiTi (nitinol) and/or nylon material, or NeuSoft UR842A. In some embodiments, the flexible lumen tube or valve 220 has an inner diameter ranging from 0.01 inches to 1 inch. In some embodiments, the flexible lumen tube or valve 220 has an inner diameter ranging from 0.01 inches to 2 inches. In some embodiments, the wall thickness of the flexible lumen tube or valve 220 ranges from 0.0002 inches to 0.125 inches. In some embodiments, the length of the flexible lumen tube or valve 220 ranges from 0.01 inches to 2 inches. In some embodiments, the length of the flexible lumen tube or valve 220 is at least equal to the diameter of the flexible lumen tube or valve to achieve a fully closed configuration upon twisting and thus a secure compression. In some embodiments, the diameter of the flexible lumen tube or valve 220 is 0.47 inches (12 mm) and the length of the flexible lumen tube or valve 220 is 0.47 inches (12 mm). In various embodiments, the flexible lumen tube or valve 220 is configured to rotate angularly over a range of 90 degrees to 360 degrees to seal, compress or pinch the valve 120. In some embodiments, the flexible lumen tube or valve 220 is configured to seal against pulmonary artery pressures ranging from 0 French to 24 French.

In various embodiments, the hub 218 (hub 118 in FIG. 1A) is actuated by a rotating or twisting motion in a first direction 221 to allow the proximal and distal ends 205, 210 to rotate relative to one another, thereby untwisting the flexible lumen tube or valve 220 so that the lumen of the tube or valve 220 is open or in a second state. The flexible lumen tube or valve 220 remains in the second state during actuation of the hub 218. In embodiments, the catheter 212 may be held tightly against the hub 218 or rotated or twisted in a second direction 222 opposite the first direction 221 to help open the lumen of the tube or valve 220.

3 shows perspective, side, and top views 302, 304, 306 of a hub 300 including a single rack and pinion device 323 for use with a flexible lumen tube or valve 320 according to some embodiments herein. In an embodiment, the hub 300 is configured to couple to an aspiration catheter 312 at a distal end 305 of the hub 300 and to receive a medical device 311 at a proximal end 310 of the hub 300. The flexible lumen tube or valve 320 has a rotatable proximal end 330 and a distal end 332 fixedly coupled to the aspiration catheter 312 positioned within the hub 300, and is configured to change from a first twisted or compressed state to a second open or uncompressed state by the rack and pinion device 323. In embodiments, by default, the flexible lumen tube or valve 320 is in a twisted state, compressing or pinching the lumen of the tube or valve 320, thereby preventing any blood from exiting through the hub 300 via the flexible lumen tube or valve 320, or the introduction of a medical device 311 through the flexible lumen tube or valve 320 into the hub 300 and catheter 312. In some embodiments, a medical device 311 previously passed through the hub 300 and into the catheter 312 may still be moved when the flexible lumen tube or valve 320 is in the closed first state. In other words, when the flexible lumen tube or valve 320 is in the first closed state, it presses laterally against the previously introduced medical device 311 to form a seal, but the seal does not prevent axial or longitudinal movement of the device 311 within the hub 300 and catheter 312. In such a case, the seal continues to exert lateral pressure (perpendicular to the surface of the device) even as the device is moved longitudinally back and forth through the hub and catheter. In some embodiments, the proximal and distal ends 330, 332 of the flexible lumen tube or valve 320 are spring loaded in a nominally twisted state, compressing or pinching the lumen of the tube of the valve 320 and requiring a force to be applied to the spring to untwist the lumen of the valve, thereby releasing the lumen from the compression or pinching. For example, a suction port 319 is included at the distal end of the hub 300 for connection to a negative pressure source (128 in FIG. 1A), such as a syringe.

As shown, the hub 300 has a body or housing 315 that houses a rack and pinion arrangement 323, which includes a mechanism of a rack 322 and an associated pinion or gear 324. A button or knob 326 is located on the body or housing 315. The button or knob 326 is coupled to the rack 322, which in turn is engaged with an associated pinion or gear 324. The pinion or gear 324 is coupled to the proximal end 330 of the flexible lumen tube or valve 320. The pinion 324 is moved laterally by a spring that pushes the proximal pinion valve module away from the distal valve module, such that when the button 326 is pressed, the proximal pinion module rotates to open the flexible lumen tube or valve 320 and release the slack in the valve. The proximal pinion valve module is pushed away from the distal module by a spring, stretching the valve 320 and holding it in tension, thereby taking up the slack.

Pressing or depressing the button or knob 326 downward slides, translates or moves the rack 322 downward, rotating the associated pinion or gear 324 in a first direction. Rotation of the pinion or gear 324 rotates the proximal end 330 of the flexible lumen tube or valve 320 relative to the distal end 332 of the flexible lumen tube or valve 320 (because the pinion or gear 324 is coupled to the proximal end 330). This rotation of the proximal and distal ends 330, 332 relative to one another untwists the flexible lumen tube or valve 320, allowing the lumen of the tube or valve 320 to be in an open state. In the open state, the flexible lumen tube or valve 320 allows the passage of a medical device into the hub 305 and catheter 312 and blood to flow out of the catheter 312.

Upon releasing the button or knob 326 (so that it moves upward), the rack 322 slides, translates, or moves back upward (to its original position) and rotates the associated pinion or gear 324 in a second direction that is opposite to the first direction. Rotation of the pinion or gear 324 rotates the proximal end 330 of the flexible lumen tube or valve 320 relative to the distal end 332 of the flexible lumen tube or valve 320 (because the pinion or gear 324 is coupled to the proximal end 330). This rotation of the proximal and distal ends 330, 332 relative to one another in the second direction again twists the flexible lumen tube or valve 320, compressing or pinching the lumen of the tube or valve 320, thereby sealing the proximal end 330 of the flexible lumen tube or valve 320. In this manner, pressure applied to the button or knob 326 is translated by the rack 322 into rotational motion of the pinion or gear 324.

In some embodiments, the upward movement of the rack 322 and the rotation of the pinion or gear 324 in the second direction is assisted by a spring load acting on the proximal and distal ends 330, 332 of the flexible lumen tube or valve 320.

4 shows a front view of the proximal end of a hub 400 including a dual rack and pinion device 423 for use with a flexible lumen tube or valve 420, according to some embodiments herein. In an embodiment, the hub 400 includes a flexible lumen tube or valve 420 therein. A catheter 412 is coupled to the distal end of the flexible lumen tube or valve 420. The flexible lumen tube or valve 420 has a rotatable proximal end 430 and a distal end 432 that is fixedly coupled to the aspiration catheter 412. In an embodiment, by default, the flexible lumen tube or valve 420 is in a twisted state, compressing or pinching the lumen of the tube or valve 420, thereby sealing the flexible lumen tube or valve 420. In some embodiments, the proximal and distal ends 430, 432 are nominally in a twisted state and spring loaded to compress or pinch the lumen of the tube of the valve 420.

As shown, the hub 400 has a body or housing 415 that houses a first rack 422a, a second rack 422b, and a pinion or gear 424 that engages the first and second racks 422a, 422b. In some embodiments, the first rack 422a is stationary, while the second rack 422b is slidable or movable. A button or knob 426 is positioned on the body or housing 415. The button or knob 426 is connected to the pinion or gear 424 by a slidable arm 416 that extends from the bottom surface of the button or knob 426, and the second rack 422b (slidable) is connected to the proximal end 430 of the flexible lumen tube or valve 420. In some embodiments, the dual rack and pinion device 423 includes a horizontal support member 425 that is positioned within the body or housing 415. The horizontal support member 425 includes a first opening 427 and a second opening 429. The first opening 427 is configured to slidably receive the arm 416, and the second opening 429 is configured to slidably receive the second rack 422b. When the button or knob 426 is pressed, the horizontal support member 425 allows the arm 416 and the second rack 422b to move up and down through the first opening 427 and the second opening 429, respectively, while preventing lateral movement of these elements, thereby stabilizing the dual rack and pinion arrangement 423 on the hub 400. In an embodiment, a vertical support member 421 extends from a bottom surface of the button or knob 426 and is configured to move into and out of a recess 428 located in the body or housing 415 when the button or knob 426 is pressed. The vertical support member 421 and recess 428 act as guide supports for the button or knob 426 and help stabilize the hub 400 and dual rack and pinion arrangement 423.

Pressing or depressing the button or knob 426 downward rotates and axially moves the pinion or gear 424 in a first direction along the stationary first rack 422a. In addition, the rotation and axial movement of the pinion or gear 424 moves or slides the second rack 422b in the first direction. The sliding movement of the second rack 422b rotates the proximal end 430 of the flexible lumen tube or valve 420 in the first direction relative to the distal end 432 of the flexible lumen tube or valve 420 (because the second rack 422b is connected to the proximal end 430). This rotation of the proximal and distal ends 430, 432 relative to each other in the first direction untwists the flexible lumen tube or valve 420, causing the lumen of the tube or valve 420 to open. In the open state, the flexible lumen tube or valve 420 allows the flow of blood or the passage of a medical device.

It should be understood that the second rack 422b travels twice as far as the button or knob 426 as affected by the axial and rotational movement of the pinion or gear 424. In other words, the dual rack and pinion system of the hub 400 amplifies the stroke of the button or knob 426 and reduces the movement of the button or knob 426 compared to an embodiment having a single rack (e.g., the single rack and pinion device 323 depicted in FIG. 3) to achieve the same angular rotation of the proximal end 430 of the flexible lumen tube or valve 420. In some embodiments, the dual rack and pinion system of the hub 400 amplifies the stroke of the button or knob 426 by a ratio of 2:1 compared to an embodiment having a single rack.

Release of the button or knob 426 (resulting in the button or knob 426 moving upward) causes the pinion or gear 424 to rotate and move axially in a second direction that is opposite the first direction along the first rack 422a (which is stationary). Additionally, the rotating and axially moving pinion or gear 424 causes the second rack 422b to move or slide in the second direction. The sliding movement of the second rack 422b causes the proximal end 430 of the flexible lumen tube or valve 420 to rotate in the second direction relative to the distal end 432 of the flexible lumen tube or valve 420 (because the second rack 422b is coupled to the proximal end 430). This rotation of the proximal and distal ends 430, 432 relative to one another in the second direction again twists the flexible lumen tube or valve 420, compressing or pinching the lumen of the tube or valve 420, thereby preventing the flow of blood or the passage of a medical device through the flexible lumen tube or valve.

In some embodiments, movement of the second rack 422b in the second direction and movement of the pinion or gear 424 in the second direction are assisted by spring loading acting on the proximal and distal ends 430, 432 of the flexible lumen tube or valve 420.

5 shows perspective, side, and top views 502, 504, 506 of a hub 500 including a cammed slider actuated twist mechanism for use with a flexible lumen tube or valve 520, according to some embodiments herein. In an embodiment, the hub 500 includes a flexible lumen tube or valve 520 therein. The flexible lumen tube or valve 520 has a rotatable proximal end 530 and a distal end 532 that is fixedly coupled to the aspiration catheter. In an embodiment, by default, the flexible lumen tube or valve 520 is in a twisted state, compressing or pinching the lumen of the tube or valve 520, thereby preventing the flow of blood or the passage of a medical device through the flexible lumen tube or valve 520 to or from the aspiration catheter. In some embodiments, the proximal and distal ends 530, 532 are spring loaded in a nominal torsional state to compress or pinch the lumen of the tube of the valve 520.

As shown, the hub 500 has a body or housing 515 that houses an inner element 518. In some embodiments, the inner element 518 has a substantially cylindrical shape. The inner cylindrical element 518 houses a flexible lumen tube or valve 520 (shown in phantom). The cylindrical inner element 518 has a predetermined outer diameter, a proximal end 562, and a distal end 564. As shown in FIG. 502, the longitudinal axis 550a of the cylindrical inner element 518 is substantially parallel to the longitudinal axis 550b of the hub 500. A substantially helical groove 552 is formed in the outer surface of the inner element 518 such that the helical groove 552 wraps around the outer diameter of the inner element 518.

The slider 526 is positioned in the body or housing 515. The slider 526 is constrained to move axially within a slot 521 (of a predetermined length) formed in the body or housing 515, substantially parallel to the longitudinal axis 550b of the hub 500. A pin 556 attached to the slider 526 engages and tracks the groove 552.

The proximal end 562 of the inner element 518 is fluidly connected to the proximal end 510 of the hub 500, while the distal end 564 of the inner element 518 is fluidly connected to the distal end 505 of the hub 500.

Moving or translating the slider 526 distally or forward moves the pin 556 substantially into the helical groove 552, thereby rotating the inner element 518 in a first direction. Thus, the inner element 518 rotates based on the position of the pin 556 in the groove 552 and the distance moved by the slider 526 in the slot 521. Rotation of the inner element 518 rotates the proximal end 530 of the flexible lumen tube or valve 520 relative to the distal end 532 of the flexible lumen tube or valve 520 (because the proximal end 562 of the inner element 518 is connected to the proximal end 530 of the flexible lumen tube or valve 520). This rotation of the proximal and distal ends 530, 532 relative to each other untwists the flexible lumen tube or valve 520, causing the lumen of the tube or valve 520 to be in an open state. In the open state, the flexible lumen tube or valve 520 allows the flow of blood or the passage of a medical device through the hub 500 via the flexible lumen tube or valve 520.

Moving or translating the slider 526 proximally or rearwardly away from the flexible lumen tube or valve 520 moves the pin 556 substantially into the helical groove 552, thereby rotating the inner element 518 in a second direction opposite the first direction. Rotation of the inner element 518 rotates the proximal end 530 of the flexible lumen tube or valve 520 relative to the distal end 532 of the flexible lumen tube or valve 520 (because the proximal end 562 of the inner element 518 is coupled to the proximal end 530 of the flexible lumen tube or valve 520). This rotation of the proximal and distal ends 530, 532 relative to one another in the second direction again twists the flexible lumen tube or valve 520, compressing or pinching the lumen of the tube or valve 520, thereby sealing the flexible lumen tube or valve 520 and preventing the flow of blood or the passage of a medical device through the aspiration catheter.

In some embodiments, rearward movement of the slider 526 and rotation of the inner element 518 in the second direction is assisted by a spring load acting on the proximal and distal ends 530, 532 of the flexible lumen tube or valve 520.

In accordance with aspects of the present specification, the hubs of Figures 3, 4, and 5 are characterized by a button, knob, or slider configured to be actuated or manipulated with one hand by a user to control the flexible lumen tube or valve and thus apply and prevent suction or negative pressure through the flexible lumen tube or valve.

FIG. 6 shows another embodiment of a hub included in a valve mechanism according to the present disclosure. FIG. 1 602 is a schematic diagram of a front view of the valve mechanism 600. FIG. 2 604 is a schematic diagram of a side view of the valve mechanism 600 with the proximal side on the left and the distal side on the right. Referring simultaneously to FIGS. 602 and 604, the schematic diagram shows an arrangement of a rack 606, a pinion 608, and a speed increasing gear 610 within a housing 612. The arrangement is used for both compression/closing and inflation/opening operation of a flexible lumen tube or valve 614 according to some embodiments of the present disclosure.

In an embodiment, the flexible lumen tube or valve 614 is located within the housing 612 of the hub 600. The suction catheter 616 is coupled to the distal end of the flexible lumen tube or valve 614. The flexible lumen tube or valve 614 has a rotatable proximal end 618 and a distal end 620 that is fixedly coupled to the suction catheter 616. In an embodiment, by default, the flexible lumen tube or valve 614 is in a first torsional state, compressing or pinching the lumen of the tube or valve 614, thereby sealing the flexible lumen tube or valve 614. In some embodiments, the proximal and distal ends 618, 620 are spring loaded in a nominally torsional state, compressing or pinching the lumen of the tube of the valve 614.

As shown, the hub 600 has a body or housing 612 that houses a rack 606 and a pinion or gear 608 configured to engage a proximal end of the rack 606. The pinion 608 is further configured to engage a speed increasing gear 610 having a radius in the range of 2 to 6 times, preferably 4 times, the radius of the pinion 608. The rack 606 extends linearly along a tangent to the pinion 608 with a distal end connected to an actuator 622. In an embodiment, the actuator 622 is a push button or knob having a height of about 0.25 inches and is located on the top of the housing 612. When the actuator 622 is pressed, the rack 606 (by virtue of its connection to the actuator 622) is displaced linearly toward the bottom side of the housing 612, causing the pinion 608 to rotate in one direction. Actuation of actuator 622 (in embodiments, by pushing or depressing downward) causes pinion 608 to rotate and move axially in a first direction along the length of rack 606. Additionally, as pinion 608 rotates, the rotation and axial movement of pinion 608 rotates in a first direction of speed-up gear 610, which is configured to engage pinion 608. Speed-up gear 610 is coupled to a proximal end 618 of flexible lumen tube or valve 614. In some embodiments, speed-up gear 610 is coupled to flexible lumen tube or valve 614 through a gear 624 positioned at proximal end 618. In embodiments, gear 624 has a radius that is approximately 3/4 to 1/6 the radius of speed-up gear 610, preferably 1/2 the radius of speed-up gear 610. In an embodiment, the radius of the gear 624 is as small as possible to push the actuator 622 to achieve maximum rotation while still allowing the proximal end 618 of the flexible lumen tube or valve 614 to pass through it.

Rotation of the speed increasing gear 610 rotates the proximal end 618 of the flexible lumen tube or valve 614 relative to the distal end 620. The speed increasing gear configuration provides a greater or faster rotation of the proximal end 618 of the flexible lumen tube or valve 614 relative to the distal end 620 than the actuation or pushing of the actuator. In other words, the speed increasing gear 610 configuration of the hub 600 amplifies the stroke of the actuator 622, allowing the actuator 622 to move to achieve the same angle of rotation of the proximal end 618 of the flexible lumen tube or valve 614 compared to an embodiment having a single gear (e.g., a single rack and pinion device 323 depicted in FIG. 3). In some embodiments, the speed increasing gear 610 configuration of the hub 600 amplifies the stroke of the actuator 622 by a ratio of 2:1 compared to an embodiment having a single gear. This relative rotation of the proximal and distal ends 618, 620 untwists or straightens the flexible lumen tube or valve 614 in a third direction, causing the lumen of the tube or valve 614 to be in an open state. In the open state, the flexible lumen tube or valve 614 allows the flow of blood or the passage of a medical device through the catheter 616.

Release of the actuator 622 (resulting in the button or knob moving upward) rotates and axially moves the pinion 608 in a second direction, opposite the first direction along the rack 606. The rotation and axial movement of the pinion 608 then rotates the speed-up gear 610 in the second direction. Finally, the rotation of the speed-up gear 610 rotates the proximal end 618 of the flexible lumen tube or valve 614 relative to the distal end 620. Relative rotation of the proximal and distal ends 618 and 620 in a fourth direction, opposite the third direction, again twists the flexible lumen tube or valve 614, causing the lumen of the tube or valve 614 to compress or pinch, thereby preventing the flow of blood or the passage of a medical device through the flexible lumen tube or valve.

In some embodiments, movement of both the pinion 608 and the speed increaser gear 610 in the second direction is assisted by spring loading acting on the proximal end 618 and distal end 620 of the flexible lumen tube or valve 614.

7 shows another embodiment of a hub 700 included in a valve mechanism according to the present disclosure. FIG. 1 702 is a schematic cross-sectional view of the valve mechanism 700 when the actuator 722 is depressed. FIG. 2 704 is a schematic cross-sectional view when the actuator 722 is released and/or not depressed. Referring simultaneously to FIGS. 702 and 704, the schematics show an arrangement of a first fixed rack 706, a pinion 708, and a second floating rack 710 within an enclosure 712. According to some embodiments, the arrangement is employed to allow for compression/closing and expansion/opening of a flexible lumen tube or valve (not shown).

In embodiments, the hub 700 includes a housing 712 in which a flexible lumen tube or valve (not shown) is installed. An aspiration catheter (not shown) is coupled to the distal end of the flexible lumen tube or valve. The flexible lumen tube or valve has a rotatable proximal end and a distal end that is fixedly coupled to the aspiration catheter. In embodiments, by default, the flexible lumen tube or valve is in a first torsional state, compressing or pinching the lumen of the tube or valve, thereby sealing the flexible lumen tube or valve. In some embodiments, the proximal and distal ends are spring loaded in a nominally torsional state, compressing or pinching the lumen of the valve tube.

In an embodiment, the fixed rack 706 is positioned along a vertical linear axis on the inner wall of the housing 712. The serrated or toothed edge of the fixed rack 706 faces inwardly within the housing 712. The pinion 708 is configured to engage the fixed rack 706. A floating rack 710 having a first side 726 and a second side 728 is positioned parallel to the fixed rack 706 and configured to engage the pinion 708 on its first side 726. The floating rack 710 is configured to engage the gear 724 on its second side 728 (opposite the first side 726). In an embodiment, the floating rack 710 has a length in the range of 0.3 to 2 inches, preferably about 0.9 inches, that is available to the pinion 708 during its lateral movement. The gear 724 comprises a portion of the proximal side 718 of the valve mechanism, which further comprises a flexible lumen tube or valve. The relative configuration of the gear 724 and the flexible lumen tube or valve is similar to that shown in FIG. 6 and will not be repeated here.

Furthermore, the pinion 708 is attached to the bottom side of the actuator 722 through an elongated connector 730. In an embodiment, the actuator 722 is a push button or knob and is located at the top of the housing 712. When the actuator 722 is pressed from its top, the actuator 722 moves downward as shown in FIG. 702. The connector 730 attached to the bottom side of the actuator 722 then moves downward, causing the pinion 708 to move downward and simultaneously rotate along with the racks 706 and 710. Furthermore, the rotation and axial movement of the pinion 708 causes the floating rack 710 to move linearly downward. The movement of the floating rack 710 rotates the gear 724, causing the proximal end 718 of the flexible lumen tube or valve to rotate relative to the distal end. This relative rotation of the proximal and distal ends 718 untwists the flexible lumen tube or valve, allowing the lumen of the tube or valve to open. In the open state, the flexible lumen tube or valve allows the flow of blood or the passage of a medical device through the aspiration catheter.

It should be understood that because the pinion 708 is both moving and rotating about its axis, the actuator 722 moves twice the distance during the button stroke. In an embodiment, the actuator 722, having a length in the range of 0.3 to 2 inches, preferably about 0.9 inches, has a lower half of its length within the housing 712 when the actuator 722 is depressed, while the upper half remains above and outside the housing 712. Thus, the system 700 amplifies the stroke of the actuator 722, allowing for a smaller amount of actuator 722 slippage to achieve the same angular rotation of the gear 724, and therefore the same angular rotation of the flexible lumen tube or valve.

Release of the actuator 722 (resulting in the button or knob moving upward) rotates and axially moves the pinion 708 in an upward direction opposite to the downward direction along the rack 706, as shown in FIG. 704. The rotation and axial movement of the pinion 708 also moves the floating rack 710 upward. Rotation of the rack 710 rotates the proximal end 718 of the flexible lumen tube or valve relative to the distal end. Relative rotation of the proximal and distal ends in a direction opposite to the previous direction again twists the flexible lumen tube or valve, compressing or pinching the lumen of the tube or valve, thereby preventing the flow of blood or the passage of a medical device through the flexible lumen tube or valve. In some embodiments, the upward movement of the rack 710 and the movement of the pinion 708 are assisted by a spring load acting on the proximal and distal ends of the flexible lumen tube or valve.

Figure 8 shows first, second and third views 802, 804, 806 of a locking syringe 800, previously shown as element 128, according to some embodiments herein. In various embodiments, the locking syringe 800 is used as a source of negative pressure or suction that is applied to the suction catheter through the suction port in the hub (119 in Figure 1A). According to aspects herein, the syringe 800 is configured to automatically hold the plunger 805 in a retracted position until released by the user.

802, 804, and 806, a syringe 800 includes a plunger 805, a latch base 810 mounted on an exterior surface of a syringe barrel or body 812, and a lever 815 movably coupled to the base 810. The lever 815 pivots relative to the base 810 and includes an arm 815a at one end and a hammer 815b at the other end. The syringe barrel or body 812 has a proximal end 822 and a distal end 824, while the plunger 805 has a proximal end 826 and a distal end 828. In some embodiments, the latch base 810 is positioned adjacent the proximal end 822 of the syringe barrel or body 812. The distal end 828 of the plunger 805 includes a flange or ledge 830.

As shown in Figs. 802 and 804, when the plunger 805 is pulled back or proximally, the hammer 815b settles into place distal to or behind the flange or ledge 830, thereby preventing the plunger 805 from being pushed forward or distal. In some embodiments, the lever 815 is pivotally biased (e.g., spring loaded, etc.) to default the hammer 815b into place. When the arm 815a of the lever 815 is depressed, the hammer 815b is pulled up (as the lever 815 pivots relative to the base 810), thereby releasing the plunger 805 to be pushed forward or distal.

9 is a flow chart illustrating an example of a method for performing or inducing aspiration using a suction catheter connected to a suction port of a hub with a locked syringe (e.g., syringe 800 of FIG. 8) according to some embodiments herein. In its original or default state, a valve with a flexible lumen is coupled to the suction catheter. The valve is held by a mechanism within the hub such that the lumen within the valve is in a twisted configuration, compressing and sealing the lumen. The mechanism positioned within the hub may be any of the various embodiments described herein above. In step 902, a user applies force to an actuator, engaging the mechanism within the hub in such a way that the valve lumen untwists in a first direction and is in an uncompressed state. The lumen remains in this uncompressed state as long as force is applied to the actuator.

In step 904, the user applies negative pressure to the catheter through the uncompressed bulb lumen using a locking syringe connected to the hub. The syringe is configured to hold the plunger back until released. The default position of the plunger held back provides negative pressure for aspiration when the bulb lumen is uncompressed. When the plunger is pulled back, the hammer (hammer 815b in FIG. 8) settles into place distal to or behind the ledge (ledge 830 in FIG. 8), thereby preventing the plunger from being pushed forward or distally. A lever is movably connected to the base of a latch that is attached to the exterior surface of the barrel of the syringe. The lever is pivotally biased (e.g., spring loaded, etc.) to default the hammer to settle into place. Only when the arm of the lever is depressed does the hammer lift (as the lever is pivoted relative to the base), thereby releasing the plunger to be pushed forward or distally.

In step 906, the user removes the force on the actuator, returning the valve lumen to its original twisted (compressed) state.

The above examples are merely illustrative of the many uses of the devices herein. Only a few embodiments of the invention are described herein, and it should be understood that the invention may be embodied in many other specific forms without departing from the spirit or scope of the invention. As such, the examples and embodiments are to be considered as illustrative and not limiting, and the invention may be modified within the scope of the appended claims.

Claims (20)

a valve having a proximal end and a distal end, the distal end of the valve being coupled to a lumen of a catheter, the valve comprising a flexible material extending between the proximal and distal ends, the valve lumen having a first twisted state and a second untwisted state;
11. A valve system configured to be coupled to the catheter, comprising: a hub having a body, a rack, a pinion physically coupled to the rack, and an actuator, wherein the body encloses the rack, the pinion is coupled to the proximal end of the valve, and the actuator is coupled to the rack such that application of a force to the actuator moves the rack and rotates the pinion in a first direction, thereby untwisting the lumen to the second untwisted state. The valve system of claim 1, wherein the actuator is coupled to the rack such that removing pressure or physical force from the actuator automatically moves the rack, thereby rotating the pinion in a second direction and positioning the lumen in the first torsional state. The valve system of claim 1, wherein the flexible material comprises at least one of polytetrafluoroethylene, urethane, or silicone. further comprising at least one gear within said hub;
The valve system of claim 1 , wherein the pinion is coupled to the proximal end of the valve through the at least one gear. The valve system of claim 1, wherein the valve is reinforced with one or more members comprising at least one of stainless steel, nitinol, or nylon. The valve system of claim 1, wherein the valve lumen has an inner diameter in the range of 0.01 inches to 2 inches. The valve system of claim 1, wherein the valve lumen has a wall thickness in the range of 0.0002 inches to 0.125 inches. The valve system of claim 1, wherein the valve lumen has a length in the range of 0.01 inches to 2 inches. further comprising at least one gear within said hub;
The valve system of claim 1 , wherein the rack is coupled to the pinion through the at least one gear. The valve system of claim 1, wherein the valve lumen is configured to be rotated through an angle ranging from 90 degrees to 360 degrees to place the lumen in the first state. a valve having a proximal end and a distal end, the distal end of the valve fixedly coupled to an aspiration catheter, the valve comprising a tube having a flexible lumen extending between the proximal end and the distal end, the lumen being in a first compressed state;
a hub having a body;
The hub includes:
A rack and
a pinion engaging the rack;
a speed increasing gear engaged with the pinion;
an actuator positioned on the body;
the rack is coupled to the actuator and the speed increasing gear is coupled to the proximal end of the valve;
the actuator, rack, pinion, and speed increasing gear are configured such that application of a force to the actuator shifts the rack along a linear axis to rotate the pinion in a first direction to move the pinion along the rack, which in turn rotates the speed increasing gear in the first direction, which in turn rotates the proximal end relative to the distal end, the relative rotation placing the flexible lumen in a second open state. The valve of claim 11, wherein the first compressed state forms a seal around the suction catheter. The valve of claim 11, wherein the second open state allows fluid flow into the aspiration catheter or through a device. The valve system of claim 11, wherein the material of the tube comprises at least one of polytetrafluoroethylene, urethane, or silicone. The valve system of claim 14, wherein the tube further comprises at least one of a stainless steel member, a Nitinol member, or a nylon member. The valve system of claim 11, wherein the flexible lumen has an inner diameter in the range of 0.01 inches to 2 inches. The valve system of claim 11, wherein the flexible lumen has a wall thickness in the range of 0.0002 inches to 0.125 inches. The valve system of claim 11, wherein the flexible lumen has a length in the range of 0.01 inches to 2 inches. The valve system of claim 11, wherein the actuator is coupled to the rack such that removing pressure or physical force from the actuator automatically moves the pinion along the rack and rotates the speed increasing gear in a second direction opposite the first direction, the rotation of the speed increasing gear in the second direction rotating the proximal end of the valve relative to the distal end, the relative rotation returning the flexible lumen to the first compressed state. The valve system of claim 19, wherein the flexible lumen is configured to rotate through an angle ranging from 90 degrees to 360 degrees to compress the lumen into the first state.

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