CN220370037U

CN220370037U - Valve system for suction catheter

Info

Publication number: CN220370037U
Application number: CN202221652080.5U
Authority: CN
Inventors: M·B·霍洛维茨; B·W·鲍勃; B·M·瑞普科; H·勒
Original assignee: Hound Medical Co
Current assignee: Hound Medical Co
Priority date: 2021-06-28
Filing date: 2022-06-28
Publication date: 2024-01-23
Anticipated expiration: 2032-06-28

Abstract

A valve system for a catheter (e.g., an aspiration 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 contracted or twisted first state. The valve system is housed within the fitting, wherein actuation of a button on the fitting causes the proximal and distal ends of the valve to rotate relative to each other to bring the lumen into a second state, either a deployed or a untwisted state.

Description

Valve system for suction catheter

Cross reference

U.S. patent provisional application No. 63/215,579, filed on 6.28 of 2021, entitled "Joint and valve System for suction catheter (Hub and Valve Systems for An Aspiration Catheter)", is hereby incorporated by reference in its entirety for priority.

The present application is also a continuation-in-part application of U.S. patent application Ser. No. 17/572,138, filed on 1 month 10 2022, and entitled "method and apparatus for clot removal with multiple individually controllable elements (Clot Removal Methods and Devices with Multiple Independently Controllable Elements)", which is a continuation-in-part application of U.S. patent application Ser. No. 17/572,138, filed on 10 month 14 2021.

The present application is also a continuation-in-part application of U.S. patent application Ser. No. 17/572,206, filed on 1 month 10 2022, and entitled "method and apparatus for clot removal with multiple individually controllable elements (Clot Removal Methods and Devices with Multiple Independently Controllable Elements)", which is a continuation-in-part application of U.S. patent application Ser. No. 17/450,978 filed on 10 month 14 2021.

U.S. patent application Ser. No. 17/450,977 and U.S. patent application Ser. No. 17/450,978 both rely on the following provisional applications for priority:

U.S. patent provisional application No. 63/260,406, filed on 8/19 of 2021, entitled "catheter-based recovery device (Catheter Based Retrieval Device)";

U.S. patent provisional application No. 63/215,724, filed on 28, 6, 2021, and entitled "device for repairing a pathological connection between two anatomical structures and method of using the same (Device and Method of Using the Device for Repair A Pathological Connection between two anatomical structure)";

U.S. patent provisional application No. 63/215,579, filed on 28, 6, 2021, and entitled "fitting and valve system for aspiration catheter (Hub and Valve Systems for An Aspiration Catheter)";

U.S. patent provisional application No. 63/215,573, filed on 28, 6, 2021, and entitled "aspiration catheter and method of use (Aspiration Catheters and Methods of Use Thereof)";

U.S. patent provisional application No. 63/215,587, filed on 28, 6, 2021, and entitled "vascular closure device and method of use (Vascular Closure Devices and Methods of Using Thereof)";

U.S. patent provisional application No. 63/215,583, filed on 28, 6, 2021, and entitled "catheter with expandable and collapsible lumen (Catheters with Expandable and Collapsible Lumens)";

U.S. patent provisional application No. 63/215,565, filed on 28 at 6 at 2021, and entitled "catheter-based recovery device (Catheter Based Retrieval Device)"; and

U.S. patent application Ser. No. 63/092,428, filed on 10/15 2020, and entitled "catheter-based recovery device with proximal body having axial freedom of movement" (Catheter Based Retrieval Device with Proximal Body Having Axial Freedom of Movement).

All of the above patents and applications are incorporated by reference herein in their entirety.

Technical Field

The present disclosure relates generally to a fitting and valve mechanism that enables suction to be applied to and removed from a suction catheter through a valve.

Background

Many medical procedures (e.g., mechanical thrombectomy) involve the introduction of at least one medical device into the arteries, veins and nervous system so that the medical device can be advanced to a body location in need of diagnosis or treatment. For example, a guide catheter may be advanced through the vasculature of a patient (e.g., vasculature in the brain) to a desired treatment location, and a medical instrument may be advanced through the guide catheter to remove an occlusion (such as a thrombus). The guide catheter is typically inserted through an aspiration catheter in order to clear the occlusive material removed from the treatment site by the medical device.

A fitting (hub) is typically coupled to the proximal end of the aspiration catheter by a valve. The opening and closing of the valve is controlled by operating the joint to operate the application of suction through the suction catheter.

There is a continuing need for improved valve and connector systems that are easy to operate. There is also a need for a fitting that allows one-handed operation to open and seal an associated valve when desired.

Disclosure of Invention

The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools, and methods, which are meant to be exemplary and illustrative, not limiting in scope. This application discloses many embodiments.

The present specification discloses a valve system configured to couple with a conduit, the valve system comprising: a valve having a proximal end and a distal end, wherein the distal end of the valve is coupled to the lumen of the catheter, wherein the valve comprises a flexible material extending between the proximal end and the distal end, and wherein the valve lumen has a first twisted state and a second untwisted state; and a joint having a body, a rack, a pinion physically coupled to the rack, and an actuator, wherein the body encloses the rack, wherein the pinion is coupled to a proximal end of the valve, and wherein the actuator is coupled to the rack such that application of a force to the actuator moves the rack, which rotates the pinion in a first direction, thereby untwisting the lumen and assuming a second untwisted state.

Optionally, the actuator is coupled to the rack such that removal of pressure or physical force from the actuator automatically moves the rack, thereby rotating the pinion in the second direction, thereby causing the lumen to assume the first twisted state.

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

Optionally, the valve further comprises at least one gear in the joint, wherein the pinion is coupled to the proximal end of the valve by the at least one gear.

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

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

Optionally, the valve system further comprises at least one gear in the joint, wherein the rack is coupled to the pinion through the at least one gear.

Optionally, the valve lumen is configured to rotate at an angle in the range of 90 degrees to 360 degrees to place the lumen in the first state.

The present specification also discloses a valve system configured to couple with a conduit, the valve system comprising: a valve having a proximal end and a distal end, wherein the distal end of the valve is coupled to the lumen of the catheter, wherein the valve comprises a flexible material defining a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, wherein the valve lumen has a first twisted state and a second untwisted state; and a joint having a body, a first rack, a second rack, a pinion configured to simultaneously engage the first rack and the second rack, and an actuator, wherein the second rack is coupled to the proximal end of the valve, and wherein the actuator is coupled to the pinion such that application of a force to the actuator rotates the pinion, moves the pinion along the first rack, moves the second rack in a first direction, and thereby untwists the valve interior and assumes a second untwisted state.

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

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

Optionally, the second untwisted state allows fluid flow into the catheter or allows the device to pass through the access catheter.

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

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

Optionally, the actuator is coupled to the pinion such that removal of force from the actuator rotates the pinion, moves the pinion along the first rack, and moves the second rack in a second direction opposite the first direction, thereby causing the valve cavity to twist and assume the first twisted state. Optionally, the flexible lumen is configured to rotate at an angle in the range of 90 degrees to 360 degrees to cause the lumen to collapse in the first twisted 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, wherein the distal end of the valve is coupled to the aspiration catheter, and wherein the valve is a tube having a flexible lumen, the lumen being in a first state; and a joint having a body surrounding a cylinder and a slider 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, and the slider having a pin engaging and tracking the groove; wherein moving the slider distally causes the pin to move within the groove and rotates the cylinder in a first direction, wherein rotation of the cylinder in the first direction causes the proximal and distal ends of the valve to rotate relative to each other, and wherein the relative rotation places the lumen in a second state.

Optionally, the first state corresponds to the lumen shrinking. Optionally, the second state corresponds to the lumen deployment.

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

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

Optionally, moving the slider proximally causes the pin to move within the groove and rotates the cylinder in a second direction opposite the first direction, wherein rotation of the cylinder in the second direction causes the proximal and distal ends of the valve to rotate relative to each other, and wherein the relative rotation places the lumen in the second state. Optionally, the tube is configured to rotate at an angle in the range of 90 degrees to 360 degrees to constrict the lumen in the first state.

The present specification also discloses an injector configured to automatically maintain a withdrawn state of a plunger within a syringe until released, the syringe comprising: a latch mount attached to the syringe outer surface; and a lever movably coupled to the latch seat, wherein the lever pivots relative to the latch seat, the lever having an arm at one end and a hammer at the other end, wherein the distal end of the plunger includes a flange, and wherein moving the plunger proximally causes the hammer to drop into position behind the flange, thereby maintaining the plunger in a withdrawn state.

Alternatively, depressing the arm of the lever causes the hammer to be pulled upward, thereby releasing the plunger to be pushed forward.

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, wherein the distal end of the valve is fixedly coupled to the aspiration catheter, wherein the valve comprises a tube having a flexible lumen extending between the proximal end and the distal end, and wherein the lumen is in a first contracted state; and a joint having a body including a rack, a pinion engaged with the rack, an acceleration gear engaged with the pinion, and an actuator positioned on the body, wherein the rack is coupled to the actuator and the acceleration gear is coupled to a proximal end of the valve; and wherein the actuator, the rack, the pinion, and the accelerator gear are configured such that application of a force to the actuator displaces the rack along the linear axis, which rotates the pinion in a first direction and moves the pinion along the rack, which in turn rotates the accelerator gear in the first direction, which in turn rotates the proximal end relative to the distal end, and wherein the relative rotation brings the flexible lumen into a second open state.

Optionally, the first contracted state forms a seal around the aspiration catheter.

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

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

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

Optionally, the actuator is coupled to the rack such that removal of pressure or physical force from the actuator automatically moves the pinion along the rack, thereby rotating the acceleration gear in a second direction opposite the first direction, wherein rotation of the acceleration gear in the second direction rotates the proximal end of the valve relative to the distal end, and wherein the relative rotation returns the flexible lumen to the first contracted state. Optionally, the flexible lumen is configured to rotate at an angle in the range of 90 degrees to 360 degrees to cause the lumen to collapse in the first state.

Optionally, the present specification also discloses a method of selectively applying suction to a catheter, comprising: providing a conduit and a valve system coupled to the conduit, wherein the valve system comprises: a valve having a proximal end and a distal end, wherein the distal end of the valve is coupled to the lumen of the catheter, wherein the valve comprises a flexible material defining a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, and wherein the valve lumen has a first twisted state and a second untwisted state; and a joint having a body, a rack, a pinion in physical engagement with the rack, and an actuator, wherein the body encloses the rack, wherein the pinion is coupled to a proximal end of the valve, and wherein 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 valve interior and assuming a second untwisted state; applying a force to the actuator to untwist the valve lumen and assume a second untwisted state; applying suction to the catheter using a syringe coupled to the catheter; and removing the force from the actuator to twist the valve lumen and assume the first twisted state.

Optionally, the actuator is coupled to the rack such that removal of the force from the actuator moves the rack and rotates the pinion in the second direction, thereby causing the valve cavity to twist and assume the first twisted state.

The present specification also discloses a method of selectively applying suction to a catheter, comprising: providing a conduit and a valve system coupled to the conduit, wherein the valve system comprises: a valve having a proximal end and a distal end, wherein the distal end of the valve is coupled to the lumen of the catheter, wherein the valve comprises a flexible material defining a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, and wherein the valve lumen has a first twisted state and a second untwisted state; and a joint having a body, a first rack, a second rack, a pinion configured to simultaneously engage the first rack and the second rack, and an actuator, wherein the second rack is coupled to the proximal end of the valve, and wherein the actuator is coupled to the pinion such that application of a force to the actuator rotates the pinion, moves the pinion along the first rack, moves the second rack in a first direction, and thereby untwists the valve interior and assumes a second untwisted state; applying a force to the actuator to untwist the valve lumen and assume a second untwisted state; applying suction to the catheter using a syringe connected to the catheter; and removing the force from the actuator to distort the valve inner chamber and assume the first distorted state.

Optionally, the actuator is coupled to the pinion such that removal of force from the actuator rotates the pinion, moves the pinion along the first rack, moves the second rack in a second direction opposite the first direction, and thereby twists the valve interior cavity and adopts the first twisted state.

The present specification also discloses a method of selectively applying suction to a catheter, comprising: providing a conduit and a valve system coupled to the conduit, wherein the valve system comprises: a valve having a proximal end and a distal end, wherein the distal end of the valve is coupled to the aspiration catheter, and wherein the valve comprises a tube having a flexible lumen, the lumen being in a first contracted state; and a joint having a body surrounding a cylinder and a slider 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, and the slider having a pin engaging and tracking the groove; wherein moving the slider distally causes the pin to move within the groove and rotates the cylinder in a first direction, wherein rotation of the cylinder in the first direction causes the proximal and distal ends of the valve to rotate relative to each other, and wherein the relative rotation brings the lumen into a second open state; applying a force to the slider to expand the flexible lumen and enter a second open state; applying suction to the catheter using a syringe coupled to the catheter; and removing the force from the slider to twist the flexible lumen and assume the first contracted 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, wherein the distal end of the valve is coupled to the lumen of the aspiration catheter, wherein the valve comprises a flexible material that extends across the length of the valve and defines the lumen, and wherein the valve lumen is in a first state; and a fitting having a body surrounding a rack, the rack engaging with an associated pinion, wherein the fitting comprises a button positioned on the body, wherein the pinion is coupled to a proximal end of the valve and wherein the button is coupled to the rack; wherein the button is configured such that application of a force to the button moves the rack and rotates the pinion in a first direction, thereby causing the proximal and distal ends of the valve to rotate relative to each other, and wherein the relative rotation brings the valve lumen into a second state.

Optionally, the first state corresponds to the lumen being twisted such that the lumen contracts.

Optionally, the second state corresponds to the lumen being untwisted such that the lumen is deployed.

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

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

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

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

Optionally, releasing the button then moves the rack and rotates the pinion in a second direction opposite the first direction, causing the proximal and distal ends of the valve to rotate relative to each other, wherein the relative rotation brings the lumen into the first state. Optionally, the tube is configured to rotate at an angle in the range of 90 degrees to 360 degrees to constrict 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, wherein the distal end of the valve is coupled to the aspiration catheter, wherein the valve comprises a tube having a flexible lumen, and wherein the lumen is in a first contracted state; and a joint having a body surrounding the first rack, the second rack, and a pinion gear in engagement with the first rack and the second rack, wherein the joint comprises an actuator positioned on the body, wherein the pinion gear is coupled to the actuator and the second rack is coupled to the proximal end of the valve; wherein application of a force to the actuator rotates the pinion and moves the pinion along the first rack, causing the second rack to move in the first direction, wherein movement of the second rack in the first direction causes the proximal and distal ends of the valve to rotate relative to each other, and wherein the relative rotation causes the lumen to enter the second open state.

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

Optionally, the first contracted state creates a seal against the aspiration catheter.

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

Optionally, removing the force from the actuator rotates the pinion and moves the pinion along the first rack, causing the second rack to move in a second direction opposite the first direction, wherein the movement of the second rack in the second direction causes the proximal and distal ends of the valve to rotate relative to each other, and wherein the relative rotation returns the lumen to the first contracted state. Optionally, the flexible lumen is configured to rotate at an angle in the range of 90 degrees to 360 degrees to cause the lumen to collapse 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, wherein the distal end of the valve is coupled to the aspiration catheter, and wherein the valve is a tube having a flexible lumen, the lumen being in a first state; and a joint having a body surrounding a cylinder and a slider 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, and the slider having a pin engaging and tracking the groove; wherein moving the slider distally causes the pin to move within the groove and rotates the cylinder in a first direction, wherein rotation of the cylinder in the first direction causes the proximal and distal ends of the valve to rotate relative to each other, and wherein the relative rotation brings the lumen into a second state.

Optionally, the first state corresponds to the lumen shrinking.

Optionally, the second state corresponds to the lumen deployment.

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

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

Alternatively, the tube has a wall thickness in the range of 0.0002 inch to 0.125 inch.

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

The present specification also discloses an injector configured to automatically maintain a withdrawn state of a plunger within a syringe until released, the syringe comprising: a latch mount attached to the outer surface of the barrel; and a lever movably coupled to the latch seat, wherein the lever pivots relative to the latch seat, the lever having an arm at one end and a hammer at the other end, wherein the distal end of the plunger includes a flange, and wherein moving the plunger proximally causes the hammer to drop into position behind the flange, thereby maintaining the plunger in a withdrawn state.

The foregoing and other embodiments of the present specification will be described more fully in the drawings and detailed description provided below.

Drawings

The drawings illustrate various embodiments of the systems, methods, and embodiments of various other aspects of the present disclosure. It will be appreciated by one of ordinary skill in the art that the element boundaries (e.g., boxes, groups of boxes, or other shapes) shown in the figures represent one example of the boundaries. In some examples, one element may be designed as multiple elements, or multiple elements may be designed as one element. In some examples, elements shown as internal components of one element may be implemented as external components in another element, and vice versa. Furthermore, elements may not be drawn to scale. Non-limiting and non-exhaustive descriptions are described with reference to the following figures. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles.

FIG. 1A illustrates an extraction device according to some embodiments of the present description;

FIG. 1B illustrates a fitting coupled to a conduit and a valve having a connected negative pressure source according to some embodiments of the present disclosure;

FIG. 1C shows another embodiment of a fitting according to the present disclosure connected to a conduit and a valve connected to a source of negative pressure;

FIG. 2 illustrates a first cross-sectional view and a second cross-sectional view of a flexible lumen tube or valve according to some embodiments of the present description;

FIG. 3 illustrates perspective, side and top views of a joint including a single rack and pinion arrangement for use with a flexible lumen tube or valve, according to some embodiments of the present description;

FIG. 4 illustrates a joint for use with a flexible lumen tube or valve including a double rack and pinion arrangement in accordance with some embodiments of the present description;

FIG. 5 illustrates perspective, side and top views of a fitting for use with a flexible lumen tube or valve including a torsion mechanism driven by a cam slider, according to some embodiments of the present disclosure;

FIG. 6 illustrates another embodiment of a fitting included in a valve mechanism according to the present disclosure;

FIG. 7 illustrates yet another embodiment of a fitting included in a valve mechanism according to the present disclosure;

FIG. 8 illustrates a first view, a second view, and a third view of a locking syringe according to some embodiments of the present description; and is also provided with

Fig. 9 is a flow chart illustrating an exemplary method of achieving aspiration using an aspiration catheter connected to an aspiration port with a hub that locks a syringe according to some embodiments of the present specification.

Detailed Description

The present description is directed to various embodiments. The following disclosure is provided to enable any person of ordinary skill in the art to practice the invention. No language used in the specification should be construed as indicating any non-claimed embodiment as essential to any possible embodiment or as essential to the definition of 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. Also, the terminology and phraseology used is for the purpose of describing the exemplary embodiments and should not be regarded as limiting. Thus, the invention is to be accorded the widest scope encompassing numerous alternatives, modifications and equivalents consistent with the principles and features disclosed. For the sake of clarity, details of technical material that is known in the technical fields related to the invention have not been described in detail so that the invention is not unnecessarily obscured.

In the description and claims of this application, each of the words "comprising," "including," "having," "containing," and forms thereof is not necessarily limited to members of the list associated with those words. Thus, their meanings are identical and open-ended, as one or more items following any of these words is not meant to be an exhaustive list of these items, or meant to be limited to only the listed one or more items. It should be noted herein that any feature or component described in association with a particular embodiment may be used and implemented with any other embodiment unless explicitly stated otherwise.

It must also be noted that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates 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 an extraction device 100 according to some embodiments of the present description. The device 100 comprises a first unit 102, the first unit 102 comprising a handle 105, the handle 105 being coupled to a tip portion 104 by a plurality of telescopic tubes, wherein the handle 105 is configured to guide the tip portion 104 in the vicinity of an occlusion to perform a thrombectomy. In some embodiments, the proximal element 142 and the distal element 144 are positioned on the tip portion 104.

The device 100 further includes a second unit 110, the second unit 110 including a suction catheter 112 having a distal end 114 and a proximal end 116. Proximal end 116 is coupled to port 118, and in the present embodiment, port 118 includes a flexible lumen tube (or valve) 120. In an embodiment, the device 100 includes an aspiration port 119, the aspiration port 119 being remote from the flexible lumen tube or valve 120. The fitting 122 is connected to a proximal end 126 of the suction port 119. A negative pressure source 128, such as, for example, a syringe, is connected to a proximal end 130 of the fitting 122. Activating or deactivating the button 124 on the fitting 122 allows suction (from the negative pressure source 128) to be applied to the suction catheter 112 through the suction port 119 or isolated from the suction catheter 112.

During a thrombectomy, the tip portion 104 is placed into the delivery catheter 135, and the delivery catheter 135 is then inserted into the aspiration catheter 112 through the port 118 such that at least the tip portion 104 protrudes distally from the distal end 114 of the aspiration catheter 112. According to aspects of the present description, the device 100 is configured to enable an operator to operate/actuate the handle portion 105 (using the first knob 150, the second knob 152, and the third knob 154) with one hand to mechanically extract an occlusion, minimize tPA (tissue plasminogen activator), reduce bleeding, and aspirate through the actuation tab 122, while providing distal embolic protection.

According to some aspects of the present description, the first unit 102 and the second unit 110 are manufactured as separate, independent units or devices. This is advantageous because the physician can use the first unit 102 with any third party aspiration catheter. In some embodiments, aspiration catheter 112 has a variety of outer diameters available for selection, such as, but not limited to, 12Fr, 16Fr, 20Fr, and 24Fr (where Fr stands for French scale or metering system). In some embodiments, the syringe 128 has an exemplary, non-limiting capacity of 60 cubic centimeters.

In some embodiments, the joint and valve arrangements described with reference to fig. 2, 3, 4, 5, 6 and 7 may also be used for large bore femoral closure procedures in addition to mechanical thrombectomy procedures. More specifically, in some embodiments, the thrombectomy device may be the devices disclosed in U.S. patent nos. 10,172,634 and 10,898,215, U.S. patent application nos. 17/127,521, and U.S. patent provisional application nos. 63/092,428 and 63/215,565, all of which are incorporated herein by reference in their entirety. The connector and valve embodiment may be positioned in fluid communication with the catheter 112 by positioning the catheter 112 at the flexible lumen tube or valve 120, wherein a distal portion of the connector and valve embodiment is in fluid communication with the catheter 112, and wherein a proximal portion of the connector and valve embodiment is configured to receive a medical device and allow blood to flow out.

Fig. 1B shows a photographic image of another embodiment of a fitting 118 coupled to a conduit 112 and a valve 123, the valve 123 having a negative pressure source 128 connected, according to some embodiments of the present description. The fitting 118 includes a flexible lumen tube or valve 120 (shown in phantom in fig. 1B) within the fitting body. By default, the flexible lumen tube or valve 120 is in a contracted state such that no element can pass through it unless it is not contracted. Catheter 112 is connected to the distal end of fitting 118. An aspiration port 119 is included on the hub 118, distal to the flexible lumen tube or valve 120, and proximal to the catheter 112. Suction may be applied to suction port 119 remote from flexible lumen tube or valve 120. A suction valve 123 is connected to the suction port 119 and is configured to control suction from the catheter 112. In some embodiments, valve 123 is actuated by thumb slide 125, which, when moved from an open position to a closed position, causes the member to depress (or exert pressure) on hose 127 (also described herein as flexible lumen tube or valve 120) within valve 123 to close valve 123. In alternative embodiments, valve 123 is actuated using different mechanisms described below. The opening and closing of valve 123 effectively applies suction from a negative pressure source 128, such as a syringe. Thus, as long as valve 123 is actuated, flexible lumen tube or valve 120 is in a non-contracted state, allowing aspiration. Suction port 119 is located at the distal end of flexible lumen tube or valve 120, so suction occurs. Thus, in an embodiment, the flexible lumen tube or valve 120 does not involve aspiration, but the flexible lumen tube or valve 120 is used to seal against leakage from its proximal end when aspiration is applied.

Fig. 1C illustrates another embodiment of a device assembly according to the present description, including a fitting 118C coupled to a conduit 112C and a valve 123C having a connected negative pressure source 128C. The top view 102c of the assembly includes the fitting 118c and the valve 123c, while the second view 104c of the assembly shows a profile view. In an embodiment, the fitting 118c includes a flexible lumen tube or valve (not shown) located within the fitting body. The valve (also referred to herein as a hemostatic valve) is operated by an actuator 130 c. In an embodiment, referring to cross-sectional view 104c, the cross-sectional length (height) of joint 118c is in the range of 2 inches to 5 inches, preferably in the range of 2.25 inches to 3.50 inches. Referring to cross-sectional view 104c, the cross-sectional length (height) of the tab 118c is about 3.39 inches (in) when the hemostatic valve 130c is in the closed position. The length (height) of the profile of the tab 118c is approximately 2.51 inches (in) when the hemostatic valve 130c is in the open position. In an embodiment, the catheter 112c is coupled to the distal end of the fitting 118 c.

An aspiration port 119c is included on the fitting 118c and is distal to the flexible lumen tube or valve and proximal to the catheter 112c. In some embodiments, the total length from the joint 118c to the suction port 119c of the suction valve 123c is in the range between 10cm and 20cm, and preferably in the range of 16 to 17 cm. Suction may be applied to suction port 119c remote from the flexible lumen tube or valve. Suction valve 123c is connected to suction port 119c and is configured to control suction from catheter 112c. In some embodiments, valve 123c is actuated by thumb slide 125c, which when moved from an open position (as shown in first view 102 c) to a closed position, causes a member to press (or exert pressure) on a hose (not shown) within valve 123c to close valve 123c.

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

In some embodiments, the proximal and distal ends of the flexible lumen tube or hemostatic valve are spring-loaded in a nominal torsion state such that the lumen of the tube or hemostatic valve is contracted or squeezed and a force is required to be applied to the spring to release the torsion of the lumen of the valve and thereby release the contraction or squeezing of the lumen. In some embodiments, in the unstructured or open state, the hemostatic valve has a minimum ID of 0.29 cm. In some embodiments, the hemostatic valve is made by adding thermoplastic polyurethane, including ultra-soft polyether or polyester-based blends (such as, but not limited to, neuSoft UR 842A), for covering the ePTFE design for additional robustness to enhance sealability. In some embodiments, the cylindrical cap 132c is fixedly attached to the actuator 130c of the hemostatic valve. A cap 132c, in one embodiment made of plastic, depresses the top of the actuator 130c to remove torsional strain and hold the hemostatic valve open during the time that the fitting 118c is held on the shelf prior to its use. When deployed, the user may remove cap 132c by pulling cap 132c out to separate it from actuator 130c. Further details of the fitting 118c with the hemostatic valve and actuator are described below with reference to fig. 3.

Fig. 2 illustrates a first cross-sectional view 202 and a second cross-sectional view 204 of a flexible lumen tube or hemostatic valve 220 (valve 120 in fig. 1A) according to some embodiments of the present disclosure. View 202 shows the flexible lumen tube or valve 220 in the second state, while view 204 shows the flexible lumen tube or valve 220 in the first state. In an embodiment, the valve 220 remains in its original or default state in the first state. Further, the valve 220 remains in the second state as long as the actuator connected to the valve 220 is activated. 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 contracted, squeezed or twisted.

A flexible lumen tube or valve 220 has a proximal end 205 and a distal end 210. Proximal end 205 is coupled to fitting 218 (fitting 118 in fig. 1A), while distal end 210 is coupled to aspiration catheter 212 (catheter 112 in fig. 1A) 1A. As shown in the second view 204, in some embodiments, the proximal end 205 and the distal end 210 are spring-loaded in a nominally twisted state or in a first state such that the lumen of the tube of the valve 220 is contracted or squeezed.

As shown in the first view 202, by rotating the proximal end 205 and the distal end 210 relative to each other, the flexible lumen tube or valve 220 is untwisted 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 (e.g., counterclockwise or clockwise) opposite the first direction, thereby untwisting the flexible lumen tube or valve 220 to open the lumen of the tube or valve 220 or to be in a second state. In some embodiments, the distal end 210 is fixed and the proximal end 205 is rotated such that the flexible lumen tube or valve 220 is untwisted, thereby opening the lumen of the tube or valve 220 or being in a second state. When in the closed or first (default) state, as shown in the second view 204, the twisted flexible lumen tube or valve 220 of the catheter hub seals the proximal end of the catheter 212. When in the open or second state, as shown in the first view 202, the flexible lumen tube or valve 220 allows passage of the medical device and blood outflow.

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), polyurethane, or silicone. In some embodiments, the tube or valve 220 may be reinforced with stainless steel, niTi (nitinol) and/or nylon members, or NeuSoft UR 842A. 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 thickness of the wall of the flexible lumen tube or valve 220 is in the range of 0.0002 inches to 0.125 inches. In some embodiments, the length of the flexible lumen tube or valve 220 is in the range of 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 by twisting to achieve reliable retraction. In some embodiments, the flexible lumen tube or valve 220 is 0.47 inches (12 mm) in diameter and the flexible lumen tube or valve 220 is 0.47 inches (12 mm) in length. In various embodiments, the flexible lumen tube or valve 220 is configured to rotate through an angle ranging from 90 degrees to 360 degrees to seal, constrict, or squeeze the valve 120. In some embodiments, the flexible lumen tube or valve 220 is configured to seal against the flow from 0Fr

(French) to 24 Fr.

In various embodiments, the joint 218 (joint 118 in fig. 1A) is actuated by a rotational or twisting motion in a first direction 221 to enable the proximal end 205 and the distal end 210 to rotate relative to each other, thereby untwisting the flexible lumen tube or valve 220 such 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 fitting 218. In an embodiment, the catheter 212 may be held securely relative to the joint 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.

Fig. 3 illustrates a perspective view 302, a side view 304, and a top view 306 of a wheel joint 300 for use with a flexible lumen tube or valve 320, including a single rack and pinion arrangement 323, in accordance with some embodiments of the present description. In an embodiment, the connector 300 is coupled to the suction catheter 312 at the distal end 305 of the connector 300 and is configured to receive the medical device 311 at the proximal end 310 of the connector 300. The flexible lumen tube or valve 320 has a proximal end 330 that is freely rotatable and a distal end 332 that is fixedly connected to the aspiration catheter 312 (the distal end 332 being located within the adapter 300) and is configured to be changed from a first twisted or contracted state to a second open or uncontracted state by a rack and pinion arrangement 323. In an embodiment, by default, the flexible lumen tube or valve 320 is in a twisted state such that the lumen of the tube or valve 320 is contracted or squeezed, thereby preventing any blood from flowing out through the connector 300 via the flexible lumen tube or valve 320, or preventing the medical device 311 from being introduced into the connector 300 and catheter 312 via the flexible lumen tube or valve 320. In some embodiments, the medical device 311 previously passed through the fitting 300 and into the catheter 312 may still be moved even when the flexible lumen tube or valve 320 is in the closed first state. In other words, the flexible lumen tube or valve 320 creates a seal that laterally presses against the previously introduced medical device 311 when in the first closed state, but the seal does not prevent axial or longitudinal movement of the device 311 in the fitting 300 and catheter 312. In this case, the seal continues to exert lateral pressure (perpendicular to the surface of the device) even as the device moves longitudinally back and forth through the fitting and catheter. In some embodiments, the proximal end 330 and distal end 332 of the flexible lumen tube or valve 320 are spring-loaded in a nominal torsion state such that the lumen of the tube of the valve 320 is contracted or squeezed and a force needs to be applied to the spring to untwist the lumen of the valve and thereby relieve contraction or squeezing of the lumen. A suction port 319 is included at the distal end of the fitting 300 for connection to a source of negative pressure (128 in fig. 1A), such as, for example, a syringe.

As shown, the wheel joint 300 has a body or housing 315 that houses a rack and pinion arrangement 323, the rack and pinion arrangement 323 including a rack 322 and an associated pinion or gear 324 mechanism. A button or knob 326 is positioned on the body or housing 315. A push button or knob 326 is coupled to the rack 322, which rack 322 in turn engages an associated pinion or gear 324. Pinion or gear 324 is coupled to proximal end 330 of flexible lumen tube or valve 320. Pinion 324 is moved laterally by a spring pushing the proximal geared valve module away from the distal valve module so that when button 326 is pressed, the proximal geared module rotates, opening the flexible lumen tube or valve 320 and releasing slack in the valve. This slack is taken up by the spring pushing the proximal geared valve module away from the distal module, lengthening the valve 320 to maintain tension.

Pressing or depressing button or knob 326 downward slides, translates or moves rack 322 downward and rotates associated pinion or gear 324 in a first direction. Rotation of the pinion or gear 324 causes the proximal end 330 of the flexible lumen tube or valve 320 to also rotate relative to the distal end 332 of the flexible lumen tube or valve 320 (as the pinion or gear 324 is coupled to the proximal end 330). This rotation of the proximal end 330 and the distal end 332 relative to each other untwists the flexible lumen tube or valve 320, thereby leaving the lumen of the tube or valve 320 in an open state. In the open state, the flexible lumen tube or valve 320 allows the medical device to pass through the access fitting 305 and the catheter 312 or blood to flow out of the catheter 312.

Release button or knob 326 (resulting in upward movement of button or knob 326) causes rack 322 to slide, translate, or move rearward (to its original position) and causes the associated pinion or gear 324 to rotate in a second direction opposite the first direction. Rotation of the pinion or gear 324 causes the proximal end 330 of the flexible lumen tube or valve 320 to also rotate relative to the distal end 332 of the flexible lumen tube or valve 320 (as the pinion or gear 324 is coupled to the proximal end 330). This rotation of the proximal end 330 and the distal end 332 relative to each other in the second direction causes the flexible inner lumen tube or valve 320 to twist again, causing the inner lumen tube or valve 320 to be contracted or squeezed, thereby sealing the proximal end 330 of the flexible inner lumen tube or valve 320. Thus, pressure exerted on the button or knob 326 is translated through the rack 322 into rotational movement 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 are aided by spring-loading acting on the proximal and distal ends 330, 332 of the flexible lumen tube or valve 320.

Fig. 4 illustrates a front view of a proximal end of a fitting 400 including a dual rack and pinion arrangement 423 for use with a flexible lumen tube or valve 420, according to some embodiments of the present disclosure. In an embodiment, the fitting 400 includes a flexible lumen tube or valve 420 therein. The catheter 412 is coupled to the distal end of a flexible lumen tube or valve 420. The flexible lumen tube or valve 420 has a freely rotatable proximal end 430 and a distal end 432 fixedly coupled to the aspiration catheter 412. In an embodiment, by default, the flexible lumen tube or valve 420 is in a twisted state, causing the lumen of the tube or valve 420 to be contracted or squeezed, thereby sealing the flexible lumen tube or valve 420. In some embodiments, the proximal end 430 and the distal end 432 are spring loaded in a nominally twisted state, causing the lumen of the tube of the valve 420 to be contracted or squeezed.

As shown, the joint 400 has a body or housing 415 that houses a first gear rack 422a, a second gear rack 422b, and a pinion or gear 424 that meshes with the first gear rack 422a and the second gear rack 422b. In some embodiments, the first gear rack 422a is stationary and the second gear rack 422b is slidable or movable. A button or knob 426 is located on the body or housing 415. The button or knob 426 is coupled to the pinion or gear 424 by a slidable wall 416 extending from a bottom surface of the button or knob 426, and a second rack 422b (which is slidable) is coupled to a proximal end 430 of the flexible lumen tube or valve 420. In some embodiments, the dual rack and pinion arrangement 423 includes a horizontal support member 425 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 depressed, 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 these elements from moving laterally, thereby stabilizing the double rack and pinion arrangement 423 in the joint 400. In an embodiment, the 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 within the body or housing 415 when the button or knob 426 is depressed. The vertical support member 421 and the groove 428 serve as guide supports for the push button or knob 426 and serve to stabilize the joint 400 and the double rack and pinion arrangement 423.

Pressing or depressing the button or knob 426 downward causes the pinion or gear 424 to rotate and also move axially in a first direction along the stationary first rack 422 a. In addition, the rotation and axial movement of the pinion or gear 424 causes the second rack 422b to move or slide in the first direction. The sliding movement of the second gear rack 422b causes the proximal end 430 of the flexible lumen tube or valve 420 to also rotate in a first direction relative to the distal end 432 of the flexible lumen tube or valve 420 (because the second gear rack 422b is coupled to the proximal end 430). Such rotation of the proximal end 430 and the distal end 432 relative to each other in a first direction causes the flexible lumen tube or valve 420 to untwist such that the lumen of the tube or valve 420 is in an open state. In the open state, the flexible lumen tube or valve 420 is capable of allowing blood flow or the passage of medical devices.

It will be appreciated that the second rack 422b moves twice as far as the button or knob 426 because it is acted upon by the axial movement as well as the rotational movement of the pinion or gear 424. In other words, the dual rack and pinion system of the joint 400 amplifies the travel of the button or knob 426 relative to an embodiment having a single rack (e.g., the single rack and pinion arrangement 323 depicted in fig. 3), allowing less movement of the button or knob 426 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 joint 400 amplifies the travel of button or knob 426 at a 2:1 ratio relative to embodiments with a single rack.

Releasing the button or knob 426 (as a result of which the button or knob 426 moves upward) causes the pinion or gear 424 to rotate and also move axially along the first rack 422a (which is stationary) in a second direction opposite the first direction. In addition, the rotating and axially moving pinion or gear 424 moves or slides the second rack 422b in the second direction. The sliding movement of the second gear rack 422b causes the proximal end 430 of the flexible lumen tube or valve 420 to also rotate in a second direction relative to the distal end 432 of the flexible lumen tube or valve 420 (because the second gear rack 422b is coupled to the proximal end 430). Such rotation of the proximal end 430 and the distal end 432 relative to each other in the second direction causes the flexible lumen tube or valve 420 to twist again, causing the lumen of the tube or valve 420 to be contracted or squeezed, thereby preventing blood flow or medical devices from passing 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 is assisted by spring loads acting on the proximal and distal ends 430, 432 of the flexible lumen tube or valve 420.

Fig. 5 illustrates perspective 502, side 504, and top 506 views of a fitting 500 for use with a flexible lumen tube or valve 520, the fitting 500 including a torsion mechanism driven by a cam slider, according to some embodiments of the present disclosure. In an embodiment, the fitting 500 includes a flexible lumen tube or valve 520 therein. The flexible lumen tube or valve 520 has a proximal end 530 that is freely rotatable 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, causing the lumen of the tube or valve 520 to be contracted or squeezed, thereby preventing blood flow or medical devices from the aspiration catheter through the flexible lumen tube or valve 520 or through the flexible lumen tube or valve 520 to the aspiration catheter. In some embodiments, the proximal end 530 and the distal end 532 are spring loaded in a nominally twisted state, causing the lumen of the tube of the valve 520 to be contracted or squeezed.

As shown, the fitting 500 has a body or housing 515 that houses an internal 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 view 502, the longitudinal axis 550a of the cylindrical inner element 518 is substantially parallel to the longitudinal axis 550b of the fitting 500. A substantially helical groove 552 is formed on the outer surface of the inner member 518 such that the helical groove 552 surrounds the outer diameter of the inner member 518.

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

The proximal end 562 of the inner element 518 is in fluid communication with the proximal end 510 of the fitting 500, while the distal end 564 of the inner element 518 is in fluid communication with the distal end 505 of the fitting 500.

Moving or translating the slider 526 distally or forwardly causes the pin 556 to move within the substantially 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 traveled by the slider 526 in the slot 521. Rotation of the inner element 518 causes the proximal end 530 of the flexible lumen tube or valve 520 to also rotate 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). Rotation of the proximal end 530 and the distal end 532 relative to each other untwists the flexible lumen tube or valve 520 such that the lumen of the tube or valve 520 is in an open state. In the open state, the flexible lumen tube or valve 520 allows blood flow or medical devices to pass through the fitting 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 causes the pin 556 to move within the substantially helical groove 552, thereby rotating the inner element 518 in a second direction opposite the first direction. Rotation of the inner element 518 causes the proximal end 530 of the flexible lumen tube or valve 520 to also rotate 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). Such rotation of the proximal end 530 and the distal end 532 relative to each other in the second direction causes the flexible lumen tube or valve 520 to twist again, causing the lumen of the tube or valve 520 to be contracted or squeezed, thereby sealing the flexible lumen tube or valve 520 and preventing blood flow or medical device from passing through the aspiration catheter.

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

According to aspects of the present description, the joint of fig. 3, 4 and 5 features buttons, knobs or sliders configured to be actuated or manipulated by a single hand of a user to control the flexible lumen tube or valve and thereby apply and prevent suction or negative pressure through the flexible lumen tube or valve.

Fig. 6 shows another embodiment of a joint included in a valve mechanism according to the present description. The first view 602 is a schematic diagram of a front view of the valve mechanism 600. The second view 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 views 602 and 604, a schematic diagram shows the arrangement of rack 606, pinion 608, and step-up gear 610 within housing 612. According to some embodiments of the present description, this arrangement is used to operate both the contraction/closure and expansion/opening of the flexible lumen tube or valve 614.

In an embodiment, a flexible lumen tube or valve 614 is placed within the housing 612 of the fitting 600. Aspiration conduit 616 is coupled to the distal end of flexible lumen tube or valve 614. The flexible lumen tube or valve 614 has a freely rotating proximal end 618 and a distal end 620 fixedly coupled to the aspiration catheter 616. In an embodiment, by default, the flexible lumen tube or valve 614 is in a first twisted state, causing the lumen of the tube or valve 614 to contract or squeeze 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 twisted state, which causes the lumen of the tube of the valve 614 to contract or squeeze.

As shown, the adapter 600 has a body or housing 612 that houses a rack 606 and a pinion or gear 608, the pinion or gear 608 being configured to engage a proximal end of the rack 606. In addition, the pinion 608 is configured to mesh with a speed increasing gear 610, and the radius of the speed increasing gear 610 is 2 to 6 times, preferably 4 times, the radius of the pinion 608. Rack 606 extends linearly along a tangent to pinion 608, and is distally coupled to actuator 622. In an embodiment, the actuator 622 is a button or knob having a height of about 0.25 inches, located at the top of the housing 612. When the actuator 622 is depressed, the rack 606 (through 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 the actuator 622 (in an embodiment, by pressing or depressing downwardly) causes the pinion 608 to rotate and also move axially along the length of the rack 606 in a first direction. In addition, as the pinion 608 rotates, rotation and axial movement of the pinion 608 rotates a speed increasing gear 610 configured to mesh with the pinion 608 in a first direction. The step-up gear 610 is coupled to a proximal end 618 of the flexible lumen tube or valve 614. In some embodiments, the step-up gear 610 is coupled to the flexible lumen tube or valve 614 by a gear 624 positioned at the proximal end 618. In an embodiment, the radius of the gear 624 is about 3/4 to 1/6 of the radius of the speed increasing gear 610, and preferably 1/2 of the radius of the speed increasing gear 610. In an embodiment, the radius of the gear 624 is as small as possible to achieve maximum rotation by depressing the actuator 622 while allowing the proximal end 618 of the flexible lumen tube or valve 614 to pass therethrough.

Rotation of the step-up gear 610 causes the proximal end 618 of the flexible lumen tube or valve 614 to also rotate relative to the distal end 620. It will be appreciated that actuation or depression of the speed increasing gear configuration than the actuator provides for greater rotation or faster rate of rotation of the proximal end 618 of the flexible lumen tube or valve 614 relative to the distal end 620. In other words, the speed-up gear 610 configuration of the joint 600 amplifies the travel of the actuator 622 relative to an embodiment having a single gear (e.g., the single rack and pinion arrangement 323 depicted in fig. 3), allowing the actuator 622 to travel to achieve the same angular rotation of the proximal end 618 of the flexible lumen tube or valve 614. In some embodiments, the speed increasing gear 610 of the joint 600 is configured to amplify the travel of the actuator 622 at a 2:1 ratio relative to an embodiment having a single gear. This relative rotation of the proximal end 618 and the distal end 620 causes the flexible lumen tube or valve 614 to untwist or straighten in a third direction such that the lumen of the tube or valve 614 is in an open state. In the open state, the flexible lumen tube or valve 614 is capable of allowing blood flow or medical devices to pass through the catheter 616.

Release of the actuator 622 (with the result that the button or knob moves upward) causes the pinion 608 to rotate and also move axially along the rack 606 in a second direction opposite the first direction. In turn, rotation and axial movement of the pinion 608 rotates the speed increasing gear 610 in a second direction. Finally, rotation of the step-up gear 610 causes the proximal end 618 of the flexible lumen tube or valve 614 to also rotate relative to the distal end 620. Relative rotation of the proximal end 618 and the distal end 620 in a fourth direction opposite the third direction causes the flexible lumen tube or valve 614 to again twist, causing the lumen of the tube or valve 614 to be contracted or squeezed, thereby preventing blood flow or medical device from passing through the flexible lumen tube or valve.

In some embodiments, movement of both the pinion 608 and the step-up gear 610 in the second direction is aided by a spring load acting on the proximal and distal ends 618, 620 of the flexible lumen tube or valve 614.

Fig. 7 illustrates another embodiment of a joint 700 included in a valve mechanism according to the present description. The first view 702 is a schematic cross-sectional view of the valve mechanism 700 when the actuator 722 is depressed. The second view 704 is a schematic cross-sectional view when the actuator 722 is released and/or not depressed. Referring simultaneously to views 702 and 704, the schematic illustrates the configuration of a first fixed rack 706, pinion 708, and second floating rack 710 within a housing 712. According to some embodiments, this configuration is employed for achieving the contraction/closure and expansion/opening of a flexible lumen tube or valve (not shown).

In an embodiment, the fitting 700 includes a housing 712, and a flexible lumen tube or valve (not shown) is disposed within the housing 712. 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 freely rotatable proximal end and a distal end fixedly coupled to the aspiration catheter. In an embodiment, by default, the flexible lumen tube or valve is in a first twisted state, causing the lumen of the tube or valve to be contracted or squeezed, thereby sealing the flexible lumen tube or valve. In some embodiments, the proximal and distal ends are spring loaded in a nominally twisted state, causing the lumen of the tube of the valve to be contracted or squeezed.

In an embodiment, the fixed rack 706 is positioned on an inner wall of the housing 712 along a vertical linear axis. The serrated or toothed edge of the stationary rack 706 faces the interior of the housing 712. Pinion 708 is configured to engage 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, the floating rack 710 being configured to engage the pinion 708 on the first side 726 thereof. The floating rack 710 is configured to engage the gear 724 on a second side 728 thereof (opposite the first side 726). In an embodiment, the length of the floating rack 710 is in the range of 0.3 to 2 inches, preferably about 0.9 inches, which is available to the pinion 708 during lateral movement of the pinion 708. Gear 724 includes a portion of proximal side 718 of a valve mechanism that also includes a flexible lumen tube or valve. The relative configuration of gear 724 and flexible lumen tube or valve is similar to that described in fig. 6 and will not be described again here.

Further, the pinion 708 is attached to the underside of the actuator 722 by an elongated connector 730. In an embodiment, the actuator 722 is a button or knob and is positioned at the top of the housing 712. When the actuator 722 is pressed from its top side, the actuator 722 moves downward as shown in view 702. The connector 730 attached to the underside of the actuator 722 then moves in a downward direction, causing the pinion 708 to also move in a downward direction and simultaneously rotate along the racks 706 and 710. Further, rotation and axial movement of the pinion 708 causes the floating rack 710 to move linearly in a downward direction. Movement of the floating rack 710 causes the gear 724 to rotate and causes the proximal end 718 of the flexible lumen tube or valve to also rotate relative to the distal end. This relative rotation of the proximal end 718 and the distal end causes the flexible lumen tube or valve to untwist, leaving the lumen of the tube or valve in an open state. In the open state, the flexible lumen tube or valve enables blood flow or medical devices to pass through the aspiration catheter.

It will be appreciated that the pinion 708 both moves and rotates about its axis, so the actuator 722 moves twice as far during the travel of the button. In an embodiment, when the actuator 722 is depressed, 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 while an upper half remains above the housing 712 and outside the housing 712. Thus, the system 700 amplifies the stroke of the actuator 722, allowing a smaller amount of displacement of the actuator 722 to achieve the same angular rotation of the gear 724, thereby achieving angular rotation of the flexible lumen tube or valve.

As shown in view 704, release of the actuator 722 (with the result that the button or knob moves upward) causes the pinion 708 to rotate and also move axially along the rack 706 in an upward direction opposite the downward direction. Rotation and axial movement of the pinion 708 causes the floating rack 710 to move upward. Rotation of the rack 710 causes the proximal end 718 of the flexible lumen tube or valve to also rotate relative to the distal end. Relative rotation of the proximal and distal ends in a direction opposite the previous direction causes the flexible lumen tube or valve to twist again, causing the lumen of the tube or valve to be contracted or squeezed, thereby preventing blood flow or medical devices from passing through the flexible lumen tube or valve. In some embodiments, movement of the rack 710 and pinion 708 in an upward direction is aided by a spring load acting on the proximal 718 and distal ends of the flexible lumen tube or valve.

Fig. 8 illustrates a first view 802, a second view 804, and a third view 806 of a locking syringe 800 (previously shown as element 128) according to some embodiments of the present description. In various embodiments, locking syringe 800 is used as a negative pressure or suction source that is applied to a suction catheter through a suction port of a fitting (119 in fig. 1A). According to aspects of the present description, the syringe 800 is configured to automatically maintain the plunger 805 in a retracted state until released by a user.

Referring now to views 802, 804, 806, syringe 800 includes a plunger 805, a base 810 attached to a latch on an outer surface of a syringe barrel or body 812, and a lever 815 movably coupled to 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 base 810 of the latch is positioned near the proximal end 822 of the syringe barrel or body 812. The distal end 828 of the plunger 805 includes a flange or boss 830.

As shown in views 802 and 804, when the plunger 805 is pulled back or proximally, the hammer 815b falls into a position distal or behind the flange or boss 830, thereby preventing the plunger 805 from being pushed forward or distally. In some embodiments, the lever 815 is biased (e.g., by a spring load) at a pivot to cause the hammer 815b to default to a proper position. 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 push forward or distally.

Fig. 9 is a flow chart illustrating an exemplary method for implementing or causing aspiration using an aspiration catheter connected to an aspiration port having a hub that locks a syringe (e.g., syringe 800 of fig. 8) according to some embodiments of the present specification. In its initial or default state, a valve comprising a flexible lumen is coupled to the aspiration catheter. The valve is held by a mechanism within the fitting such that the lumen within the valve has a twisted configuration that contracts the lumen to provide a seal. The mechanism located within the joint may be any of the various embodiments described above in this specification. At step 902, a user applies a force to an actuator to engage a mechanism within a joint such that a valve lumen is untwisted in a first direction to a non-contracted state. The lumen remains in this non-contracted state as long as a force is applied to the actuator.

At step 904, the user applies negative pressure to the catheter through the non-collapsing valve lumen using a locking syringe connected to the fitting. The syringe is configured to hold the plunger in a retracted state until released. When the valve lumen is in the non-contracted state, the default position of the plunger in its contracted state provides negative pressure for aspiration. When the plunger is pulled back, the hammer (hammer 815b of fig. 8) falls into a position distal or behind the boss (boss 830 of fig. 8), thereby preventing the plunger from being pushed forward or distally. The lever is movably coupled to a base of a latch attached to an outer surface of the syringe barrel. The lever is biased (e.g., by a spring load) at the pivot to cause the hammer to default to the proper position. Only when the arm of the lever is depressed will the hammer be pulled up (as the lever pivots relative to the base) releasing the plunger to be pushed forward or distally.

At step 906, the user removes the force applied to the actuator to return the valve lumen to its original twisted (contracted) state.

The above examples merely illustrate many applications of the apparatus of the present specification. Although only a few embodiments of the present invention have been described herein, it should be understood that the present invention may be embodied in many other specific forms without departing from the spirit or scope of the present invention. The present examples and embodiments, therefore, are to be considered as illustrative and not restrictive, and the invention may be modified within the scope of the appended claims.

Claims

1. A valve system configured to couple with a conduit, the valve system comprising:

a valve having a proximal end and a distal end, the distal end of the valve coupled with the lumen of the catheter, wherein the valve comprises a flexible material extending between the proximal end and the distal end, and wherein the lumen of the valve has a first twisted state and a second untwisted state; and

a fitting having a body, a rack, a pinion physically coupled with the rack, and an actuator, wherein the body encloses the rack, wherein the pinion is coupled with a proximal end of the valve, and wherein the actuator is coupled with the rack such that application of a force to the actuator moves the rack, which rotates the pinion in a first direction, untwists an interior cavity of the valve and adopts the second untwisted state.

2. The valve system of claim 1, wherein the actuator is coupled with the rack such that removal of pressure or physical force from the actuator automatically moves the rack, thereby rotating the pinion in a second direction to cause the valve interior cavity to assume the first twisted state.

3. A valve system for an aspiration catheter, the valve system comprising:

a valve having a proximal end and a distal end, the distal end of the valve being fixedly coupled with the aspiration catheter, wherein the valve comprises a tube having a flexible lumen extending between the proximal end and the distal end, and wherein the lumen is in a first contracted state; and

a fitting having a body, the body comprising:

a rack;

a pinion gear engaged with the rack gear;

an acceleration gear engaged with the pinion gear; and

an actuator positioned on the body, wherein the rack is coupled to the actuator and the acceleration gear is coupled to a proximal end of the valve; and is also provided with

Wherein the actuator, the rack, the pinion, and the accelerator gear are configured such that application of a force to the actuator displaces the rack along a linear axis, which rotates the pinion in a first direction and moves the pinion along the rack, which in turn rotates the accelerator gear in the first direction, which in turn rotates the proximal end relative to the distal end, and wherein relative rotation brings the flexible lumen into a second open state.

4. A valve system according to claim 3, wherein the first contracted state forms a seal around the suction catheter.

5. The valve system of claim 3, wherein the actuator is coupled with the rack such that removal of pressure or physical force from the actuator automatically moves the pinion along the rack, causing rotation of the acceleration gear in a second direction opposite the first direction, wherein rotation of the acceleration gear in the second direction rotates a proximal end of the valve relative to the distal end, and wherein relative rotation returns the flexible lumen to the first contracted state.