Hemostasis valve and method of use

Abstract

To provide favorable hemostasis valves and methods of use.SOLUTION: Devices, systems and methods for sealing medical devices, particularly during intravascular access, are disclosed herein. Some aspects relate to a hemostatic valve for sealing a wide range of medical devices, such as catheters, wires, and embolectomy systems. The valve can include an elongate member having a first end, a second end and a central lumen extending therebetween. A reinforcement structure extends along at least a portion of the elongate member and is coupled to the elongate member. A shell defining a first aperture and a second aperture may be included, where the first and second apertures can be fluidly coupled by the elongate member. A tensioning mechanism is coupled to the shell and to the elongate member, the tensioning mechanism can be moveable between a first configuration, in which the tensioning mechanism is collapsed and the central lumen is sealed, and a second configuration, in which the central lumen is open.SELECTED DRAWING: Figure 2

Description

[Background technology]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 62 / 554,931, filed Sep. 6, 2017, entitled "HEMOSTASIS VALVES AND METHODS OF USE," which is incorporated herein by reference.

[0002] (Background technology) During surgical procedures, a portion of a patient's body (e.g., the vascular system) is accessed to allow for the performance of a desired intervention or treatment. During such surgical procedures, it is desirable to maintain the sterility of the accessed portion or site of the patient's body to minimize the patient's blood loss, prevent the delivery of air to the vascular system, and prevent problems such as infection. Additionally, the desire to improve patient outcomes has led to the development of hemostatic valves to facilitate minimally invasive surgery.

[0003] In minimally invasive surgery, small incisions are made in blood vessels through which one or more catheters are inserted. Each of these catheters may define a lumen extending longitudinally therethrough. These catheters are moved into position in proximity to the tissue, nerve, or other body structure that is to be operated on, and then tools to perform the procedure are inserted through some or all of the lumens of these catheters.

[0004] To minimize blood loss, prevent delivery of air into the vascular system, and facilitate the maintenance of sterility within the patient's body (e.g., blood vessels), these catheters are equipped with hemostatic valves. These valves seal or selectively seal the lumen of the catheter. In many cases, these valves can seal the lumen of the catheter when a tool extends through the catheter, particularly through the valve. Additionally, the valve can seal the lumen when a tool is removed or does not extend through the catheter.

[0005] While such conventional hemostatic valves are highly beneficial for intravascular access, they suffer from several drawbacks. For example, some valves may not seal properly against all interventional applications or tools, and / or operation of some valves may be complicated for an operator to use. The drawbacks of such valve designs may increase the complexity of the procedures performed therewith and / or decrease patient safety (e.g., bleeding, infection, and / or other adverse complications). Thus, new and improved hemostatic valves and methods of use are desirable. Summary of the Invention [Means for solving the problem]

[0006] The following relates to valves, medical systems incorporating the valves, and methods of use thereof. The valves can include a tubular member that can be contracted, folded, and / or sealed by one or several tensioning mechanisms. The tensioning mechanism can include at least one filament extending around at least a portion of the tubular member. The filament can interact with the tubular member to contract, fold, and / or seal the tubular member through manipulation of the tensioning mechanism(s). Tools can be inserted through the valve to access the patient's body, and in particular to access blood vessels. By using the tensioning mechanism and filament to contract, fold, and / or seal the tubular member, the valve can seal against tools of various sizes and shapes, and multiple tools of different sizes, simultaneously. Additionally, such valves create a robust seal that maintains its seal when a vacuum is applied, such as occurs during aspiration.

[0007] Aspects of the present disclosure relate to a hemostatic valve for sealing a medical device. The hemostatic valve includes an elongated member having a first end, a second end, and a central lumen extending therebetween. In some embodiments, the elongated member is flexible. The hemostatic valve can include a reinforcing structure extending along at least a portion of the elongated member such that the reinforcing structure is coupled to the elongated member. The hemostatic valve includes an active tensioning mechanism coupled to the elongated member. In some embodiments, the tensioning mechanism is movable between a first configuration in which the central lumen is contracted and sealed, and a second configuration in which the central lumen is open. If desired, the valve can be manually adjusted by a user to an intermediate position between a fully open and a fully closed state. Additionally, an instrument (e.g., a catheter) provides intermediate positions in which the valve provides hemostasis without user adjustment.

[0008] In some embodiments, the elongated member can be a flexible polymer tube. In some embodiments, the tensioning mechanism can include at least one filament extending at least partially around the elongated member. In some embodiments, the reinforcing structure is positioned between the at least one filament and the elongated member. In some embodiments, the reinforcing structure can be a braided mesh. In some embodiments, the reinforcing structure is coupled to the elongated member at a location proximate to the first end of the elongated member and at a location proximate to the second end of the elongated member. In some embodiments, the reinforcing structure is not coupled to the elongated member at a location between the first end of the elongated member and the second end of the elongated member. In some embodiments, the central portion of the flexible polymer tube that is restrained or contracted by the tensioning mechanism and the at least one filament are not coupled to the reinforcing structure.

[0009] In some embodiments, the tensioning mechanism can include an actuator coupled to at least one filament. In some embodiments, there are two tensioning mechanisms coupled to at least one filament that operate in opposite directions. In some embodiments, the two tensioning mechanisms are attached to the same filament. In some embodiments, the two tensioning mechanisms are attached to opposing filaments. In some embodiments, the actuator can be movable to control the movement of at least one filament from a first position where the central lumen is contracted and sealed to a second position where the central lumen is open. In some embodiments, when the tensioning mechanism is in the first configuration, at least one filament is in the first position. In some embodiments, the actuator is biased toward the first position. In some embodiments, the actuator is biased toward the second position. In some embodiments, the actuator can be a manual actuator.

[0010] In some embodiments, the at least one filament forms a loop around the elongated member. In some embodiments, the at least one filament forms a bend around a portion of the elongated member. In some embodiments, the at least one filament can include a first filament and a second filament. In some embodiments, each of the first filament and the second filament are coupled to the same actuator. In some embodiments, each of the first filament and the second filament are coupled to different actuators. In some embodiments, the first filament and the second filament are movable from a first position to a second position. In some embodiments, each of the first filament and the second filament forms a loop around the elongated member. In some embodiments, the first filament forms a first bend around a first portion of the elongated member and the second filament forms a second bend around a second portion of the elongated member. In some embodiments, the first bend extends through the second bend.

[0011] In some embodiments, the hemostatic valve can include a shell defining a first opening and a second opening. In some embodiments, the elongate member extends from the first opening to the second opening and fluidly couples the first opening and the second opening. In some embodiments, the tensioning mechanism is self-adjusting to seal around different sized tools extending through the hemostatic valve. In some embodiments, the central lumen can comprise a single lumen, and in some embodiments, the central lumen can comprise multiple lumens.

[0012] One aspect of the disclosure relates to a delivery system for intravascular access of a blood vessel within a patient's body. The delivery system includes a catheter having a first end, a second end, and a catheter lumen extending therebetween, and a hemostatic valve coupled to the first end of the catheter. The hemostatic valve includes a tubular member having a first end, a second end, and a central lumen extending therebetween. In some embodiments, the central lumen of the tubular member is fluidly coupled to the catheter lumen. The hemostatic valve includes an active tensioning mechanism coupled to the tubular member, the tensioning mechanism may be movable between a first configuration in which the tensioning mechanism constricts the central lumen and the central lumen is sealed, and a second configuration in which the central lumen is open.

[0013] In some embodiments, the hemostatic valve further includes a reinforcing structure extending along at least a portion of the tubular member. In some embodiments, the reinforcing structure is disposed between the tensioning mechanism and the tubular member. In some embodiments, the reinforcing structure can be a braided mesh. In some embodiments, the reinforcing structure is coupled to the tubular member proximate the first end of the tubular member and proximate the second end of the tubular member. In some embodiments, the reinforcing structure is adhered to the tubular member at the first end of the tubular member and at the second end of the tubular member. In some embodiments, the reinforcing structure is not coupled to the tubular member between the first end of the tubular member and the second end of the tubular member.

[0014] In some embodiments, the tensioning mechanism can include at least one filament extending at least partially around the tubular member. In some embodiments, the tensioning mechanism can include an actuator coupled to the at least one filament. In some embodiments, moving the tensioning mechanism from a first configuration to a second configuration can include moving the actuator and the at least one filament coupled thereto from a first position to a second position. In some embodiments, when the filament is in the first position, the filament constricts and seals a central lumen of the tubular member.

[0015] In some embodiments, the actuator can be a manual actuator. In some embodiments, the actuator comprises a pair of opposed, depressible buttons, the buttons being biased toward a non-depressed position. In some embodiments, when the buttons are in the non-depressed position, the central lumen is sealed. In some embodiments, the filament can be a monofilament. In some embodiments, the filament can be at least one of a polymeric filament or a metallic filament. In some embodiments, the catheter can include a thrombectomy device.

[0016] An aspect of the disclosure relates to a method of sealing a delivery device that accesses a patient's blood vessel. The method includes inserting a delivery device including a catheter and a hemostatic valve into the patient's blood vessel. In some embodiments, the catheter can have a first end, a second end, and a catheter lumen extending therethrough. In some embodiments, the hemostatic valve can be coupled to the first end and can include a tubular member defining a central lumen fluidly coupled with the catheter lumen and a tensioning mechanism coupled to the tubular member. In some embodiments, the tensioning mechanism collapses to seal the central lumen in the first configuration, thereby sealing access to the blood vessel. The method can include moving the tensioning mechanism of the hemostatic valve to a second configuration. In some embodiments, when the tensioning mechanism is in the second configuration, the central lumen is open and access to the blood vessel is unsealed. The method can include advancing a shaft of a tool through the delivery device until a first end of the tool reaches a desired location within the patient's blood vessel and a portion of the shaft is positioned within the central lumen of the tubular member. The method can include returning the tensioning mechanism of the hemostatic valve to the first configuration such that the tubular member collapses over and seals around the shaft of the tool.

[0017] In some embodiments, the method includes retracting the tool shaft from the delivery device. In some embodiments, the tensioning mechanism is maintained in a first configuration during and after retracting the tool shaft from the delivery device. In some embodiments, the tensioning mechanism moves to a second configuration during retraction of the tool shaft from the delivery device, and the tensioning mechanism returns to the first configuration after the tool shaft is retracted from the delivery device.

[0018] In some embodiments, the tensioning mechanism can include at least one filament extending at least partially around the tubular member. In some embodiments, the at least one filament collapses the tubular member when the tensioning mechanism is in the first configuration. In some embodiments, the at least one filament circumferentially contracts the tubular member to collapse the tubular member when the tensioning mechanism is in the first configuration. In some embodiments, the hemostatic valve can include a reinforcing structure located between the at least one filament and the tubular member.

[0019] In some embodiments, at least one filament forms a loop around the elongated member, and moving the tensioning mechanism from the second configuration to the first configuration reduces the size of the loop, thereby contracting the tubular member within the loop. In some embodiments, the filament forms at least one bend around a portion of the elongated member. In some embodiments, the filament can include a first filament and a second filament. In some embodiments, the at least one bend can include a first bend oriented in a first direction and formed by the first filament, and a second bend oriented in a second direction and formed by the second filament. In some embodiments, the first and second bends overlap to surround a portion of the tubular member in the contracted region.

[0020] In some embodiments, moving the tensioning mechanism from the second configuration to the first configuration can include moving the first curved portion in a first direction, moving the second curved portion in a direction, reducing the size of the constricted region, and collapsing and sealing the central lumen of the tubular member. In some embodiments, the tensioning mechanism can include an actuator. In some embodiments, moving the tensioning mechanism to the second configuration can include manipulating the actuator. In some embodiments, the method includes applying a vacuum to the delivery device and / or delivery system to aspirate the material through the catheter. In some embodiments, the central lumen remains sealed during aspirating. In some embodiments, the tool can include a thrombectomy device. The present specification also provides, for example, the following items: (Item 1) 1. A hemostasis valve for sealing a medical device, comprising: an elongate member having a first end, a second end and a central lumen extending therebetween, the elongate member being flexible; a reinforcing structure extending along at least a portion of the elongated member, the reinforcing structure being coupled to the elongated member; A hemostatic valve comprising: an active tensioning mechanism coupled to the elongate member, the tensioning mechanism being movable between a first configuration in which the central lumen is constricted and sealed, and a second configuration in which the central lumen is open. (Item 2) 2. The hemostasis valve of claim 1, wherein the elongated member comprises a flexible polymeric tube. (Item 3) 2. The hemostatic valve of claim 1, wherein the tensioning mechanism comprises at least one filament extending at least partially around the elongate member. (Item 4) 4. The hemostasis valve of claim 3, wherein the reinforcing structure is positioned between the at least one filament and the elongate member. (Item 5) 5. The hemostasis valve of claim 4, wherein the reinforcing structure comprises a braided mesh. (Item 6) 5. The hemostasis valve of claim 4, wherein the reinforcing structure is coupled to the elongated member at a location adjacent to the first end of the elongated member and at a location adjacent to the second end of the elongated member. (Item 7) 7. The hemostasis valve of claim 6, wherein the reinforcing structure is not coupled to the elongated member at a location between the first end of the elongated member and the second end of the elongated member. (Item 8) 4. The hemostasis valve of item 3, wherein the tensioning mechanism comprises an actuator coupled to the at least one filament, the actuator being movable to control movement of the at least one filament from a first position in which the central lumen is contracted and sealed to a second position in which the central lumen is open, and wherein the at least one filament is in the first position when the tensioning mechanism is in the first configuration. (Item 9) 9. The hemostasis valve according to item 8, wherein the actuator is biased towards the first position. (Item 10) 9. The hemostasis valve according to item 8, wherein the actuator is biased towards the second position. (Item 11) 9. The hemostasis valve of item 8, wherein the actuator comprises a manual actuator. (Item 12) 9. The hemostatic valve according to item 8, wherein the at least one filament forms a loop around the elongate member. (Item 13) 9. The hemostasis valve of claim 8, wherein the at least one filament forms a curve around a portion of the elongate member. (Item 14) 9. The hemostasis valve of claim 8, wherein the at least one filament comprises a first filament and a second filament, each of the first filament and the second filament being coupled to the actuator, and the first filament and the second filament being movable from the first position to a second position. (Item 15) Item 15. The hemostatic valve according to item 14, wherein each of the first filament and the second filament forms a loop around the elongate member. (Item 16) Item 15. The hemostatic valve of item 14, wherein the first filament forms a first curve around a first portion of the elongate member and the second filament forms a second curve around a second portion of the elongate member. (Item 17) Item 17. The hemostasis valve according to item 16, wherein the first curved portion extends through the second curved portion. (Item 18) 2. The hemostasis valve of claim 1, further comprising a shell defining a first opening and a second opening, the elongated member extending from the first opening to the second opening and fluidly coupling the first opening and the second opening. (Item 19) 2. The hemostasis valve of claim 1, wherein the tensioning mechanism is self-adjusting to seal around different sized tools extending through the hemostasis valve. (Item 20) 2. The hemostasis valve of item 1, wherein the central lumen comprises a single lumen. (Item 21) 2. The hemostasis valve of item 1, wherein the central lumen comprises multiple lumens. (Item 22) 1. A delivery system for intravascular access to a blood vessel within a patient, comprising: a catheter having a first end, a second end and a catheter lumen extending therebetween; a hemostasis valve coupled to the first end of the catheter, a tubular member having a first end, a second end and a central lumen extending therebetween, the central lumen of the tubular member being fluidly coupled to the catheter lumen; a hemostatic valve comprising an active tensioning mechanism coupled to the tubular member, the tensioning mechanism constricting the central lumen and movable between a first configuration in which the central lumen is sealed and a second configuration in which the central lumen is open. (Item 23) 23. The delivery system of claim 22, wherein the hemostatic valve further comprises a reinforcing structure extending along at least a portion of the tubular member. (Item 24) 24. The delivery system of claim 23, wherein the reinforcement structure is disposed between the tensioning mechanism and the tubular member. (Item 25) 25. The delivery system of claim 24, wherein the reinforcement structure comprises a braided mesh. (Item 26) 25. The delivery system of claim 24, wherein the reinforcement structure is coupled to the tubular member at a location proximate the first end of the tubular member and at a location proximate the second end of the tubular member. (Item 27) 27. The delivery system of claim 26, wherein the reinforcement structure is adhered to the tubular member at the first end of the tubular member and at the second end of the tubular member. (Item 28) 28. The delivery system of claim 27, wherein the reinforcement structure is not bonded to the tubular member between the first end of the tubular member and the second end of the tubular member. (Item 29) 23. The delivery system of claim 22, wherein the tensioning mechanism comprises at least one filament extending at least partially around the tubular member. (Item 30) 30. The delivery system of claim 29, wherein the tensioning mechanism comprises an actuator coupled to the at least one filament, and moving the tensioning mechanism from the first configuration to the second configuration comprises moving the actuator and at least one filament coupled thereto from a first position to a second position, and when the filament is in the first position, the filament constricts and seals the central lumen of the tubular member. (Item 31) 31. The delivery system of claim 30, wherein the actuator comprises a manual actuator. (Item 32) Item 32. The delivery system of item 31, wherein the actuator comprises a pair of opposed, depressible buttons, the buttons being biased toward a non-depressed position. (Item 33) Item 32. The delivery system of item 31, wherein the central lumen is sealed when the button is in a non-depressed position. (Item 34) 31. The delivery system of claim 30, wherein the filament comprises a monofilament. (Item 35) 31. The delivery system of claim 30, wherein the filament comprises at least one of a polymer filament or a metallic filament. (Item 36) 23. The delivery system of claim 22, wherein the catheter comprises a thrombectomy device. (Item 37) 1. A method of sealing a delivery device for accessing a blood vessel of a patient, comprising: inserting the delivery device, comprising a catheter and a hemostatic valve, into the blood vessel of the patient, the catheter having a first end, a second end, and a catheter lumen extending therethrough, the hemostatic valve being coupled to the first end, a tubular member defining a central lumen fluidly coupled with the catheter lumen, and a tensioning mechanism coupled to the tubular member, the tensioning mechanism collapsing and sealing the central lumen in a first configuration, thereby sealing access to the blood vessel; moving the tensioning mechanism of the hemostasis valve to a second configuration, wherein when the tensioning mechanism is in the second configuration, the central lumen is open and access to the blood vessel is unsealed; and advancing the shaft of the tool through the delivery device until a first end of the tool reaches a desired location within the blood vessel of the patient and a portion of the shaft is positioned within the central lumen of the tubular member; and returning the tensioning mechanism of the hemostasis valve to the first configuration such that the tubular member collapses over and seals around the shaft of the tool. (Item 38) Item 38. The method of item 37, further comprising retracting the shaft of the tool from the delivery device. (Item 39) Item 39. The method of item 38, wherein the tensioning mechanism is maintained in the first configuration during and after retraction of the shaft of the tool from the delivery device. (Item 40) Item 39. The method of item 38, wherein the tensioning mechanism moves to the second configuration during retraction of the tool shaft from the delivery device, and the tensioning mechanism returns to the first configuration after the tool shaft is retracted from the delivery device. (Item 41) Item 38. The method of item 37, wherein the tensioning mechanism comprises at least one filament extending at least partially around the tubular member, the at least one filament collapsing the tubular member when the tensioning mechanism is in the first configuration. (Item 42) Item 42. The method of item 41, wherein the at least one filament circumferentially contracts the tubular member to collapse the tubular member when the tensioning mechanism is in the first configuration. (Item 43) Item 42. The method of item 41, wherein the hemostatic valve comprises a reinforcing structure located between the at least one filament and the tubular member. (Item 44) Item 42. The method of item 41, wherein the at least one filament forms a loop around the elongate member and moving the tensioning mechanism from the second configuration to the first configuration reduces the size of the loop, thereby contracting the tubular member within the loop. (Item 45) Item 42. The method of item 41, wherein the filament forms at least one bend around a portion of the elongate member. (Item 46) Item 46. The method of item 45, wherein the filaments comprise a first filament and a second filament, and the at least one curve comprises a first curve oriented in a first direction and formed by the first filament and a second curve oriented in a second direction and formed by the second filament, the first and second curves overlapping to encircle a portion of the tubular member within the contraction region. (Item 47) Item 47. The method of item 46, wherein moving the tensioning mechanism from the second configuration to the first configuration includes moving the first curved portion in the first direction and the second curved portion in the first direction to reduce a size of the constriction region and collapse and seal the central lumen of the tubular member. (Item 48) Item 38. The method of item 37, wherein the tensioning mechanism comprises an actuator, and moving the tensioning mechanism to the second configuration comprises manipulating the actuator. (Item 49) 38. The method of claim 37, further comprising applying a vacuum to the delivery device to aspirate material through the catheter, the central lumen remaining sealed during the aspirating. (Item 50) Item 38. The method of item 37, wherein the tool comprises a thrombectomy device. (Item 51) 1. A hemostasis valve for sealing a medical device, comprising: an elongate member having a first end, a second end, and a central lumen with a plurality of lumens extending therebetween, the elongate member being flexible; A hemostatic valve comprising: an active tensioning mechanism coupled to the elongate member, the tensioning mechanism being movable between a first configuration in which a central lumen is constricted and sealed, and a second configuration in which the central lumen is open. [Brief description of the drawings]

[0021] [Figure 1] FIG. 1 illustrates a perspective view of one embodiment of a delivery device. [Diagram 2] FIG. 2 is a side cross-sectional view of one embodiment of a hemostasis valve in a first configuration. [Diagram 3] FIG. 2 is a side cross-sectional view of one embodiment of a valve in a second configuration. [Figure 4] FIG. 1 illustrates a side cross-sectional view of an embodiment of a valve in a first configuration and with a tool extending through the valve. [Diagram 5] FIG. 2 is a side cross-sectional view of one embodiment of a single button hemostatic valve in a first configuration. [Figure 6] FIG. 1 is a perspective view of a valve filament forming a loop. [Figure 7] FIG. 1 is a perspective view of two filaments of a valve, each filament forming a loop. [Figure 8] FIG. 13 is a perspective view of two curved sections that overlap and interlock in the open state. [Figure 9] FIG. 2 is a perspective view of two curved sections that overlap and interlock in a closed state. [Figure 10] 1 is a flow chart illustrating one embodiment of a method for sealing a valve and / or a catheter. [Figure 11] FIG. 1 is a side view of one embodiment of a thrombus removal system including a delivery device. [Figure 12] A side cross-sectional view of another embodiment of a hemostasis valve having a two-piece cap. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] The present disclosure relates to a valve that can be used as a hemostatic valve. The valve, also referred to herein as a garrote valve, can seal with or without a tool extending through the valve. The garrote valve provides convenient one-handed operation for a wide range of medical devices, including catheters, wires, embolectomy systems, and the like. The one-handed operation of the garrote valve allows the user to easily and quickly exchange various tools being used through the valve without compromising hemostasis, simplifying the procedure. Combined with the one-handed operation, the garrote valve provides a robust seal with or without a tool penetrating the valve. This robust seal minimizes leakage in applications where there is a pressure difference on different sides of the valve. This pressure difference can occur, for example, during the application of vacuum suction in a procedure. Under these and other conditions, the garrote valve maintains the integrity of the seal and prevents leakage in one or both directions.

[0023] The galot valve includes a tubular member. The tubular member is a flexible member that defines a central lumen, which in some embodiments can define a single lumen and in some embodiments can define multiple lumens. In some embodiments, each of the multiple lumens can include the same size and shape, and in some embodiments, some or all of the multiple lumens can include different sizes and shapes. In some embodiments, for example, the multiple lumens can include a lumen sized and / or shaped to receive a guidewire and a lumen sized and / or shaped to receive a tool. The tubular member extends at least partially through a retraction mechanism. The retraction mechanism can be moved from a first configuration to a second configuration, and the retraction mechanism can collapse and / or seal the central lumen of the tubular member when the retraction mechanism is in the first configuration. The retraction mechanism creates the above-mentioned robust sealing of the tubular member and, therefore, the valve.

[0024] 1, a perspective view of one embodiment of a delivery system 100, also referred to herein as a delivery device 100, is shown. The delivery system 100 can include a catheter 102 and a galot valve 104, also referred to herein as a valve 104. The catheter 102 can include a shaft 106, also referred to herein as an elongate sheath 106, having a proximal end 108, also referred to herein as a first end 108, which can be connected to the valve 104 and a distal end 110, also referred to herein as a second end 110. The shaft 106 can define a catheter lumen 112 that extends from the proximal end 108 of the shaft 106 to the distal end 110 of the shaft 106. The catheter 102, and in particular the shaft 106, can include a variety of shapes and sizes and can be made from a variety of materials. In some embodiments, the catheter 102 can be flexible and / or made from a biocompatible material. The elongate sheath 106 can have an outer diameter of at least 4 French, at least 6 French, at least 8 French, at least 10 French, at least 12 French, at least 14 French, at least 18 French, at least 20 French, at least 22 French, between 4 French and 30 French, between 8 French and 24 French, between 12 French and 20 French, and / or other sizes or intermediate sizes.

[0025] The valve 104 can include an outer shell 114. The outer shell 114 can include a variety of shapes and sizes and can be made from a variety of materials. In some embodiments, the outer shell 114 can be made from one or several polymers or composite materials. The outer shell 114 can include features that allow for interaction with and / or control of the valve 104 to move the valve 104 between a first configuration and a second configuration.

[0026] The outer shell 114 can include a proximal cap 116 located at a proximal end 118 of the outer shell 114 and a distal cap 120 located at a distal end 122 of the shell 114. The proximal cap 116 can include and / or receive a proximal opening 124, also referred to herein as a proximal channel 124, first channel 124, or first opening 124 extending therethrough, and the distal cap 120 includes and / or receives a distal opening 126, also referred to herein as a distal channel 126, second channel 126, or second opening 126 extending therethrough. As seen in FIG. 1 , the distal cap 120 connects to the shaft 106 of the catheter 102 at the distal end 122 of the valve 104.

[0027] The proximal cap 116 and the distal cap 120 are connected via a housing 128. The housing 128 can be a one-piece housing 128 or a multi-piece housing 128. In the embodiment shown in FIG. 1, the housing comprises a two-piece housing 128. The housing 128 can be configured to receive and couple with each of the proximal cap 116 and the distal cap 120, as seen in FIG. 1, the housing 128 couples with each of the proximal cap 116 and the distal cap 120 to fix the relative positions of the proximal cap 116 and the distal cap 120 with respect to one another.

[0028] The housing 128 can define an interior channel 130 through which the elongated member 132, also referred to herein as a tubular member 132, septum 132, or tubular septum 132, can extend and connect the proximal cap 116 and the distal cap 120. The elongated member 132 can include a variety of shapes and sizes and can be made from a variety of materials. In some embodiments, the elongated member 132 can comprise a flexible tubular structure, which can be, for example, a thin-walled flexible tubular structure. The thin-walled structure of the elongated member 132 can facilitate folding of the elongated member 132, particularly uniform folding, and sealing of the elongated member 132. In some embodiments, the elongated member 132 is a resilient, elastic material that can include a polymer, including either natural or synthetic polymers. In some embodiments, the elongated member can include a resilient, elastic material that can include silicone, urethane, ethylene vinyl acetate, natural or synthetic rubber, or other elastomers known in the art. In some embodiments, the elongate member 132 may comprise a silicone tubing.

[0029] The elongated member 132 comprises a proximal end 134, also referred to herein as a first end 134, which can be coupled to the proximal cap 116, and a distal end 136, also referred to herein as a second end 136, which can be coupled to the distal cap 120. The elongated member 132 can define a central lumen 138, which can extend from the first end 134 to the second end 136 of the elongated member 132. The elongated member 132 can be coupled to the proximal cap 116 such that the central lumen 138 is fluidly coupled with the proximal opening 124 of the proximal cap 116, and the elongated member 132 can be coupled to the distal cap 120 such that the central lumen 138 is fluidly coupled with the distal opening 126 of the distal cap 120, as seen in FIGS. 2 and 3.

[0030] The central lumen 138 of the elongate member 132 may be defined by a wall of the elongate member 132 which may have a thickness that is uniform along the length of the elongate member 132 between the first end 134 and the second end 136, or that is non-uniform along the length of the elongate member 132 between the first end 134 and the second end 136. In some embodiments, the wall may have a thickness between approximately 0.005 inches and 0.05 inches, and / or between approximately 0.010 inches and 0.030 inches. As used anywhere herein, "approximately" refers to a range of + / - 10% of the value and / or range of values ​​for which "approximately" is used.

[0031] In some embodiments, the elongated member 132 may be cylindrical, and more particularly, cylindrical. In some embodiments, the elongated member 132 may be dog-bone shaped, for example, to facilitate connection to the proximal cap 116 and the distal cap 120, respectively. In some embodiments, the elongated member 132 may include one or several outwardly extending protrusions, also referred to herein as tensioning mechanism 141, that engage all or a portion of the retraction mechanism 141 of the valve 104 to fix the position of all or a portion of the retraction mechanism 141 relative to the elongated member 132. In some embodiments, the retraction mechanism 141 may self-adjust to seal around different sized tools extending through the valve 104.

[0032] The retraction mechanism 141, in some embodiments, can collapse and seal the elongated member 132 via compression and / or contraction, specifically via contraction with at least one filament 150. The retraction mechanism 141 can include an actuator 142, which can be a manual actuator, such as one or several buttons 144, and at least one filament 150, which can extend at least partially around the elongated member 132. In some embodiments, the use of the retraction mechanism 141 can facilitate sealing of the valve around a wide range of sizes and / or diameters of tools or instruments, particularly tools or instruments that fit over the elongated member 132.

[0033] The housing 128 can further include one or more retention features 140. The one or more retention features 140 of the housing can engage and retain all or a portion of the deflation mechanism 141 of the valve 104. In some embodiments, the one or more retention features 140 of the housing 128 can retain and / or couple the actuator 142 to the housing 128. The actuator 142 can comprise any desired type of actuator, including, for example, a manual actuator and / or an automated actuator, such as an electromechanical actuator, including, for example, a solenoid-based actuator. In some embodiments, the actuator can comprise one or more buttons 144, specifically, as shown in FIG. 1, the actuator 142 can comprise a first button 144-A and a second button 144-B. Alternatively, as shown in FIG. 5, the actuator 142 can comprise a single button 144. In such an embodiment, the filament 150 can be coupled to the single button 144 and a portion of the housing 128, such as the grip portion 500 of the housing 128, such that movement of the single button 144 causes the elongated member 132 and the valve 104 to seal and / or open.

[0034] The actuator 142 may be biased toward a configuration, such as, for example, biased toward a first configuration or biased toward a second configuration. As shown in FIG. 2, which illustrates the retraction mechanism 141 in a first configuration, the actuator 142 may be biased toward a first configuration in which the elongated member 132 is folded and / or sealed by a biasing feature 146. In this first configuration, the button 144 may be in a first position, also referred to herein as a non-depressed position. The biasing feature 146 may include a first spring 148-A configured to bias the first button 144-A toward a first position corresponding to the first configuration of the retraction mechanism 141, and a second spring 148-B configured to bias the second button 144-B toward a first position corresponding to the first configuration of the retraction mechanism 141, as shown in FIG. 2. One or both of the first spring 148-A and the second spring 148-B may comprise a tension spring, a compression spring, a torsion spring, a coil spring, or any other desired type of spring.

[0035] In some embodiments, one or both of the first spring 148-A and the second spring 148-B can generate sufficient force to enable actuation of the actuator 142 with one hand and to collapse and seal the elongated member 132 when the retraction mechanism 141 is in the first configuration. In some embodiments, one or both of the first spring 148-A and the second spring 148-B can generate a force of at least 0.1 pounds, at least 0.2 pounds, at least 0.3 pounds, at least 0.4 pounds, at least 0.5 pounds, at least 0.6 pounds, at least 0.7 pounds, at least 0.8 pounds, at least 0.9 pounds, at least 1 pound, at least 1.5 pounds, at least 2 pounds, at least 3 pounds, at least 5 pounds, and / or at least 10 pounds, and in some embodiments, one or both of the first spring 148-A and the second spring 148-B can generate a force of between about 0.1 to 10 pounds, 0.1 to 5 pounds, 0.1 to 1.5 pounds, 0.2 to 1 pound, and / or 0.4 to 0.8 pounds.

[0036] The retraction mechanism 141 can include at least one filament 150 extending at least partially around the elongated member 132. In some embodiments, the at least one filament 150 can circumferentially retract the elongated member 132 to fold and seal the elongated member 132 when the retraction mechanism 141 is in the first configuration. The filament can be made from a variety of materials including, for example, polymeric, synthetic, and / or metallic. In some embodiments, the filament 150 can be nylon, stainless steel, nitinol, silicone, etc. In some embodiments, the filament can comprise a single strand, such as, for example, a monofilament, and in some embodiments, the filament can comprise multiple strands that can be, for example, twisted, woven, grouped, and / or fused to form a filament. In some embodiments, the filament 150 can comprise one or several threads, lines, cords, ropes, ribbons, flat wires, sheets, or tapes.

[0037] Filament 150 can be coupled to actuator 142 based on the movement and / or position of actuator 142 such that filament 150 selectively contracts, folds, and / or seals elongate member 132, and specifically, central lumen 138 of elongate member 132. In some embodiments, when buttons 144-A, 144-B are in a first position, filament 150 can be connected to one or both of buttons 144-A, 144-B such that filament 150 selectively contracts, folds, and / or seals elongate member 132, and specifically, central lumen 138 of elongate member 132, and when buttons 144-A, 144-B are in a second position, filament 150 can be connected to one or both of buttons 144-A, 144-B such that elongate member 132, and specifically, central lumen 138 of elongate member 132, is open and unfolded. As shown in FIG. 5, in some embodiments in which the actuator 142 comprises a single button 144, the filament 150 can be connected to the button 144 and the housing 128 such that the filament 150 is clamped when the button 144 is moved to a first position.

[0038] In some embodiments, the at least one filament 150 can extend along an axis 152 that can be perpendicular to a central axis 154 of the elongate member 132 and / or the openings 124, 126. In some embodiments, the axis 152 of the at least one filament 150 can intersect and be perpendicular to the central axis 154 of the elongate member 132 and / or the openings 124, 126. In some embodiments, the actuator 142, specifically the buttons 144-A, 144-B, can move along this axis 152 when moving from a first position to a second position.

[0039] 3, an embodiment of the valve 104 is shown with the deflation mechanism 141 in a second configuration. As specifically shown, both the first and second buttons 144-A, 144-B are in a second position depressed against the retention feature 140 of the housing 128. In this second position, the filament 150 is relaxed, thereby allowing the expansion of the elongate member 132 and the unsealing of the central lumen 138 of the elongate member 132.

[0040] As further seen in FIG. 3 , the proximal cap 116 has a proximal end 300 and a distal end 302. The proximal cap 116 can include a funnel 301 of the proximal opening 124, which can facilitate insertion of a tool into the proximal opening 124. The distal end 302 of the proximal cap 116 can extend partially into the internal channel 130 of the housing 128. The proximal cap 116 can include a mating feature 304 that can mate with the proximal end 134 of the elongated member 132. In some embodiments, the proximal end 134 of the elongated member 132 can mate over the mating feature 304 of the proximal cap 116. The proximal end 134 of the elongated member 132 may be compressed between the mating feature 304 of the elongated member 132 and a portion of the interior channel 130 of the housing 128 into which the mating feature 304 is inserted, thereby securing the proximal end 134 of the elongated member 132 on the mating feature 304. In some embodiments, the proximal end 134 of the elongated member 132 may be further secured to the mating feature 304 by a proximal O-ring 306, which may be compressed between the mating feature 304 of the housing 128 and the proximal cap 116 to sealingly couple the elongated member 132 to the proximal cap 116.

[0041] The distal cap 120 has a proximal end 308 and a distal end 310. The distal cap can include a mating feature 312 disposed at the proximal end 308 of the distal cap 120, which can mate with the distal end 136 of the elongated member 132. In some embodiments, the distal end 136 of the elongated member 132 can mate over the mating feature 312 of the distal cap 123. The distal end 136 of the elongated member 132 can be compressed between the mating feature 312 of the elongated member 132 and a portion of the internal channel 130 of the housing 128 into which the mating feature 312 is inserted, thereby securing the distal end 136 of the elongated member 132 on the mating feature 312. In some embodiments, the distal end 136 of the elongated member 132 may be further secured to the mating feature 312 by a distal O-ring 314 that can be compressed between the housing 128 and the mating feature 312 of the proximal cap 116 to sealingly couple the elongated member 132 to the distal cap 120.

[0042] The distal cap 120, in some embodiments, can further include a side port barb 314, which can extend laterally from the distal cap 120, specifically away from the distal opening 126 of the distal cap 120. The side port barb 314 can define a side port channel 316, which can extend through the side port barb 314 and can be fluidly connected to the distal opening 126. In some embodiments, the side port barb 314 can include a securement feature 318, such as a barb, that can secure the coupling of a hose or tube to the side port barb 314.

[0043] In some embodiments, the side barbs 314 can be used to apply a vacuum to portions of the delivery device 100, particularly those portions of the delivery device 100 distal to the shaft 152 where the elongate member 132 seals. This vacuum can be applied to aspirate material through the delivery device 100, particularly through the delivery device catheter 102. This aspirated material can be, for example, biological material, including bodily fluids, such as multi-phase materials that can include a fluid portion and at least one solid portion.

[0044] In some embodiments, when the retraction mechanism 141 is in the first configuration, the shape of the elongated member 132 is narrowed so that a vacuum applied to a portion of the delivery device 100 distal to the shaft 152 will draw the elongated member 132 into the first configuration and, in some embodiments, may increase the strength, robustness, and / or strength of the seal of the valve 104. This attribute of the valve 104 may provide an advantage over other valve designs where a vacuum may compromise the valve seal, and therefore limit the ability to draw a vacuum to suction.

[0045] In some embodiments, the valve 104 can further include a reinforcing structure 320 that can extend along all or a portion of the elongated member 132. The reinforcing structure 320 can promote uniform folding of the elongated member 132, can prevent the at least one filament 150 from cutting and / or tearing the elongated member 132, and can aid in guiding one or more tools through the elongated member 132. The reinforcing structure 320 can be tubular and can extend along and around the elongated member 132 and can be positioned such that it is between the elongated member 132 and the at least one filament 150.

[0046] The reinforcing structure 320 can include a proximal end 322 and a distal end 324. In some embodiments, the reinforcing structure 320 extends along and around the elongated member 132 and is positioned such that the proximal end 322 of the reinforcing structure 320 is proximate the first end 134 of the elongated member 132 and the distal end 324 of the reinforcing structure 320 is proximate the second end 136 of the elongated member 132.

[0047] The reinforcing structure 320 may be coupled to the elongated member 132. In some embodiments, the reinforcing structure 320 is coupled to the elongated member 132 along the length of the reinforcing structure 320, and in some embodiments, the reinforcing structure 320 is coupled to the elongated member 132 and at discrete locations along the length of the elongated member 132 and / or the reinforcing structure 320. In one embodiment, for example, the reinforcing structure 320 may be coupled to the elongated member 132 at one or both of the proximal end 322 of the reinforcing structure 320 and the distal end 324 of the reinforcing structure 320, and / or at one or both of the first end 134 and the second end 136 of the elongated member 132. In some embodiments, the reinforcing structure 320 may be coupled to the elongated member 132 via one or several other components of the valve 104. In some embodiments, the reinforcement structure 320 can be coupled to the elongate member 132 via compression of the reinforcement structure 320 and the elongate member 132 between the housing 128 and one or both of the proximal 116 and distal 120 portions.

[0048] In some embodiments, the reinforcing structure 320 may be adhered to the elongated member 132 via an adhesive, such as, for example, a silicone adhesive. In some embodiments, the adhesive may be applied circumferentially to the reinforcing structure 320 and / or the elongated member 132 in an adhesive ring that may have a length, for example, between about 0.010 inches to 0.5 inches, 0.02 to 0.4 inches, 0.050 inches to 0.0250 inches, or any other range or intermediate range.

[0049] In one embodiment, each of the proximal and distal ends 322, 324 of the reinforcement structure 320 may be adhered to the elongated member 132 via an adhesive. In such an embodiment, the reinforcement structure 320 may not be bonded to the elongated member 132 at a location other than the bond at one or both of the proximal and distal ends 322, 324 of the reinforcement structure 320, and thus the reinforcement structure 320 is not bonded to the elongated member 132 at a location between the first and second ends 134, 136 of the elongated member 134 and / or between the proximal and distal ends 322, 324 of the reinforcement structure 320.

[0050] The lack of bonding of the reinforcing structure 320 to the elongated member 132 can facilitate and improve the folding of the elongated member 132 around a tool 400, also referred to herein as an instrument 400 or device 400, that is inserted through the valve 104, as shown in FIG. 4. The tool 400 can be any device that is inserted through the valve 104, including, for example, one or several additional catheters, lines, wires, grippers, punches, cutters, etc. As seen in FIG. 4, the tool 400 is inserted through the valve 104, specifically through the elongated member 132 of the valve. As shown, the retraction mechanism 141 is in a first configuration, and the elongated member 132 and the central lumen 138 of the elongated member 132 are folded around the tool 400, specifically around the shaft 402 of the tool 400, thereby sealing the valve 104 around the tool 400, specifically around the shaft 402 of the tool 400. The retraction mechanism 141 is able to seal around the tool 400 that fits through the elongate member 132 regardless of the size of the tool 400. Thus, the valve can be used with a variety of tools.

[0051] The reinforcing structure 320 can include a variety of designs, shapes, sizes, and materials. In some embodiments, the reinforcing structure 320 can be sized and shaped to receive the elongated member 132 and be positioned between the elongated member 132 and the at least one filament 150. In some embodiments, the reinforcing structure 320 can be made from a material that is strong enough to prevent severing of the at least one filament 150 passing through the elongated member 132.

[0052] In some embodiments, the reinforcing structure can comprise a coil or mesh sheath. The mesh sheath can comprise a braided mesh in some embodiments. The braided mesh can be made of any desired number of wires in any desired configuration. In some embodiments, the braided mesh can include a 4-wire braided mesh, an 8-wire braided mesh, a 12-wire braided mesh, a 16-wire braided mesh, a 20-wire braided mesh, a 24-wire braided mesh, a 32-wire braided mesh, a 48-wire braided mesh, a 64-wire braided mesh, a 72-wire braided mesh, an 80-wire braided mesh, a 96-wire braided mesh, or any other or intermediate braided mesh. In some embodiments, the braided mesh can comprise a 1×1 configuration. In some embodiments, the wires of the braided mesh can be any desired material, including, for example, metal wires, such as Nitinol wires or stainless steel wires, polymeric wires, or natural wires. In one embodiment, the braided mesh can comprise a 48-wire mesh in a 1×1 configuration made of Nitinol wires having a diameter of 0.003 inches.

[0053] 6-9, different embodiments and / or configurations of the filament 150 are shown. The filament 150 may comprise a single filament 150 having a first end 600 and a second end 602, as shown in FIG. 6. The filament 150, specifically the first and second ends 600, 602, may be coupled to an actuator 142 to move the filament 150 between a first and a second configuration or position and / or from the first configuration or position to the second configuration or position. In some embodiments, both the first end 600 and the second end 602 may be coupled to a single button 144, in some embodiments, each of the first end 600 and the second end 602 may be coupled to a different button 144, and in some embodiments, one of the first end 600 and the second end 602 may be coupled to the button 144 and the other of the first end 600 and the second end 602 may be coupled to the housing 128 or other portion of the valve 104.

[0054] In some embodiments, the filament 150 can comprise multiple filaments, and specifically, as shown in FIGS. 7-9, the filament 150 can comprise a first filament 150-A and a second filament 150-B. In embodiments in which the filament 150 comprises multiple filaments, each of the multiple filaments can have a first end 700 and a second end 702. The first and second filaments 150-A, 150-B can be coupled to an actuator 142. In such embodiments, the first and second ends 700, 702 can be coupled to the actuator 142 to move the filaments 150-A, 150-B between the first and second configurations and / or from the first configuration to the second configuration. In some embodiments, both the first ends 700 and the second ends 702 of one or more of the plurality of filaments 150 can be coupled to a single button 144; in some embodiments, each of the first ends 700 and the second ends 702 of one or more of the plurality of filaments 150 can be coupled to a different button 144; in some embodiments, one of the first ends 700 and the second ends 702 of one or more of the plurality of filaments 150 can be coupled to one button 144 and the other of the first ends 700 and the second ends 702 of the one or more filaments 150 can be coupled to the housing 128 or other portion of the valve 104.

[0055] The filament 150 can be arranged in a variety of configurations. In some embodiments, the filament 150 can be configured to form a single loop 604 that can extend around and / or receive the elongated member 132, as shown in FIG. 6, and in some embodiments, the filament 150 can be configured to form multiple loops, specifically a first loop 704 and a second loop 706, as shown in FIG. 7. The first and second loops 704, 706 can each receive the elongated member 132. In some embodiments, the diameter or size of the loop 604 or the loops 704, 706 can decrease when the retraction mechanism 141 moves from the second configuration to the first configuration.

[0056] In some embodiments, the filament 150 can be configured to form a bend 800, which can be a single bend or multiple bends. As used herein, "bend" refers to a U-shaped portion between two ends of the filament 150. As shown in FIGS. 8 and 9, the bend 800 can include multiple bends, specifically a first bend 800-A and a second bend 800-B. In some embodiments, the first bend 800-A can extend through the second bend 800-B such that the first and second bends 800-A, 800-B are interlocked, while in other embodiments, the first and second bends 800-A, 800-B can be non-interlocked. Similarly, in embodiments including a filament 150 having multiple loops, one or some of the multiple loops can be interlocked.

[0057] In some embodiments, the curved portions 800, specifically one or both of the first curved portion 800-A and the second curved portion 800-B, can be formed around and / or extend around a portion of the elongated member 132. Each curved portion 800 can define a partially enclosed receiving area 808 that can receive the elongated member 132. Thus, the first curved portion 800-A can define a first receiving area 808-A, and the second curved portion 800-B can define a second receiving area 808-B.

[0058] 8 and 9, the multiple curved portions, specifically the first and second curved portions 800-A, 800-B, can be positioned and oriented such that the first curved portion 800-A has a first orientation or direction as indicated by arrow 810, and the second curved portion has a second orientation or direction as indicated by arrow 812. In some embodiments, the first orientation differs from the second orientation such that the first and second receiving areas 808-A, 808-B overlap and define an enclosed area 814, also referred to herein as a constricted area 814. The elongated member 132 can be received within the enclosed area 814. In embodiments in which curved portions 800-A, 800-B overlap to define an enclosed area 814, movement of the contraction mechanism 141 to the first configuration may result in and / or include movement of the first curved portion 800-A in the direction indicated by arrow 810 and / or movement of the second curved portion 800-B in the direction indicated by arrow 812, where the movement of curved portions 800-A, 800-B reduces the size of the enclosed area 814 and contracts, folds and / or seals the elongated member 132 extending through the enclosed area 814.

[0059] Each filament 150(s) forming the bend 800 can apply an arcuate line or narrow longitudinal zone of pressure to the elongate member 132. When the cross section of the filament(s) is circular, the zone of pressure can be very small, and in some embodiments, smaller than the diameter or thickness of the filament. In some embodiments, the filament has a diameter or width of less than about 2.5 mm, less than about 2 mm, less than about 1.5 mm, less than about 1.25 mm, less than about 1 mm, less than about 0.75 mm, less than about 0.5 mm, and / or less than about 0.25 mm. In some embodiments, the filament can have a diameter or width of about 0.01 mm to 2.5 mm, about 0.05 mm to 2 mm, about 0.1 mm to 1 mm, and / or about 0.125 mm to 0.70 mm. In some embodiments, the arcuate line or zone of pressure may form two opposing arcs, and in other embodiments, the arcuate line of pressure may be a single substantially circular line or zone that encircles the elongated member at least once. The longitudinal length of the line or zone of pressure may be very short compared to other valves known in the art. In some embodiments, the longitudinal length of the pressure zone applied by the filament(s) 150 to the elongated member 132 may be less than about 2.0 mm, and in some embodiments, less than about 0.5 mm. In some embodiments, the filament(s) 150 may have any other desired cross-sectional shape, including, for example, a circular cross-section, a rectangular cross-section, an elliptical cross-section, a square cross-section, a polygonal cross-section, a triangular cross-section, or any cross-sectional shape.

[0060] 10, a flow chart is shown illustrating one embodiment of a process 1000 for sealing the valve 104 and / or catheter 102 accessing the patient's body. The process 1000 can be implemented using the valve 104 and / or delivery system 100. The process 1000 begins at block 1002, where the delivery device 100, specifically the catheter 102 of the delivery device 100, is inserted into the patient's body. In some embodiments, this can include inserting the catheter 102 into a portion of the patient's circulatory system, such as a blood vessel, including an arterial or venous vessel. In some embodiments, the delivery device 100 can be inserted directly into the patient's body through an opening or incision in the patient, and in some embodiments, the delivery device 100 can be inserted into the patient's body via another catheter or device. In some embodiments, the retraction mechanism 141 can be in a first configuration while the delivery device 100 and / or catheter 102 are inserted into the patient's body.

[0061] After the delivery device 100 is inserted into the patient's body, the process 1000 proceeds to block 1004, where the retraction mechanism 141 is moved from the first configuration to the second configuration. As described above, the central lumen 138 of the elongate member 132 is unsealed when the retraction mechanism 141 is in the second configuration. In some embodiments, the movement of the retraction mechanism 141 from the first configuration to the second configuration may include the manipulation of the actuator 142 and / or the control of the actuator 142, in particular the pressing of one or several buttons 144 to move, and cause the filament 150 to move from the first position to the second position to allow the expansion and opening of the central lumen 138 of the elongate member 132.

[0062] After the retraction mechanism 141 has moved from the first configuration to the second configuration, the process 1000 proceeds to block 1006, where the tool 400, specifically the shaft 402 of the tool 400, is advanced through the delivery device 100, specifically the valve 104, until a first end of the tool reaches a desired location within the patient. In some embodiments, a portion of the shaft 402 may be positioned within the central lumen 138 of the elongate member 132 after the tool 400 has been advanced through the delivery device 100. In some embodiments, after the tool 400 has been advanced through the delivery device 100, a desired procedure may be performed with the tool.

[0063] After the tool 400 has been advanced through the delivery apparatus 100 or while the tool 400 is being advanced through the delivery apparatus 100, the process 1000 proceeds to block 1008, where the retraction mechanism 141 is returned to the first configuration. In some embodiments, returning the retraction mechanism 141 to the first configuration may include releasing one or more buttons 144 and / or controlling the actuators 142 to reconfigure the retraction mechanism 141 to the first configuration. In some embodiments, the return of the retraction mechanism 141 to the first configuration may result in the elongate member 132, and specifically the central lumen 138 of the elongate member 132, collapsing and / or sealing around the tool 400 and specifically around the shaft 402 of the tool 400. Returning or moving the retraction mechanism 141 to the first configuration can include reducing the size and / or diameter of one or more loops formed by the movement of the filament 150 and / or one or more of the turns 800, such as, for example, movement of the first turn 800-A in a first direction indicated by arrow 810 and movement of the second turn 800-B in a second direction indicated by arrow 812, to reduce the size of the retracted region 814. In some embodiments, a tool can be used to perform a desired procedure after the retraction mechanism is returned to the first configuration.

[0064] After the retraction mechanism is returned to the first configuration, the process 1000 proceeds to block 1010, where the tool 400, specifically the shaft 402 of the tool 400, is retracted from the delivery device 100, and more specifically the valve 104. In some embodiments, the valve 104 may remain sealed during retraction of the tool 400 and / or the shaft 402 of the tool. In some embodiments, the retraction mechanism 141 may remain in the first configuration during retraction of the tool 400 and / or the shaft 402 of the tool 400, such that the valve 104 remains sealed during retraction of the tool 400 and / or the shaft 402 of the tool 400.

[0065] In some embodiments, the retraction mechanism 141 can be moved to the second configuration and the tool 400 and / or the shaft 402 of the tool 400 can be retracted from the valve 104, and when the tool 400 and / or the shaft 402 of the tool 400 is removed from the valve 104, the retraction mechanism 141 can be returned to the first configuration. In some embodiments, the retraction of the tool 400 and / or the shaft 402 of the tool 400 from the valve 104 can be performed while leaving the retraction mechanism 141 in the first configuration. In some embodiments, the retraction mechanism 141 can be moved to the second configuration and then returned to the first configuration via manipulation and / or control of the actuator 142, which may include pressing one or several buttons 144 to move the retraction mechanism 141 to the second configuration and releasing one or several buttons 144 to return the retraction mechanism 141 to the first configuration. In some embodiments, when the procedure is completed, the delivery device 100 can be removed from the patient's body and the incision created for the procedure can be closed.

[0066] 11, a side view of one embodiment of a thrombus removal system 1100 including a delivery device 100 and a thrombectomy device 1102 is shown. In some embodiments, the thrombus removal system 1100 can be used to access a blood vessel 1104 and treat and / or extract a thrombus 1106 from the blood vessel 1104. The thrombectomy device 1102 can include a self-expanding coring element 206 and an expandable cylindrical portion 208. In some embodiments, as shown in FIG. 11, the thrombectomy device 1102 can be a tool 400 that can extend through the valve 104, and in some embodiments, the valve 104 can be a part of the thrombectomy device 1102. Details of thrombus removal systems, thrombectomy devices, and methods of use thereof are disclosed in U.S. application Ser. No. 15 / 268,296, filed Sep. 16, 2016, entitled "INTRAVASCULAR TREATMENT OF VASCULAR OCCLUSION AND ASSOCIATED DEVICES, SYSTEMS, AND METHODS," U.S. application Ser. No. 15 / 498,320, filed Apr. 26, 2017, entitled "DEVICE AND METHOD FOR TREATING VASCULAR OCCLUSION," and U.S. application Ser. No. 15 / 466,740, filed Mar. 22, 2017, entitled "DEVICE AND METHOD FOR TREATING VASCULAR OCCLUSION," each of which is incorporated herein by reference in its entirety.

[0067] 12 , a side cross-sectional view of another embodiment of a hemostasis valve 104 having two-piece caps 116, 120 is shown. The valve 104 can include a housing 128 defining an interior channel 130 through which a tubular member 132 extends. The valve 104 can include a proximal cap 116 and a distal cap 120. In some embodiments, the proximal cap 116 can comprise a two-piece cap and can include a proximal outer member 1200 and a proximal channel member 1202. In some embodiments, the distal cap 120 can comprise a two-piece cap and can include a distal outer member 1204 and a distal channel member 1206. In some embodiments, this bond between the proximal outer member 1200 and the proximal channel member 1202 and / or the bond between the distal outer member 1204 and the distal channel member 1206 may be a sealed bond to prevent leakage of substances including fluids or gases between each of the proximal outer member 1200 and the proximal channel member 1202 and / or the distal outer member 1204 and the distal channel member 1206. In some embodiments, this sealed bond may be achieved and / or maintained via a seal such as an O-ring 1208 that may be positioned between the proximal outer member 1200 and the proximal channel member 1202 and / or the distal outer member 1204 and the distal channel member 1206.

[0068] In some embodiments, the proximal outer member 1200 can be coupled, and in some embodiments can be rotatably coupled, to the proximal channel member 1202 to permit rotation of the proximal outer member 1200 without rotating the proximal channel member 1202. Similarly, in some embodiments, the distal outer member 1204 can be rotatably coupled to the distal channel member 1206 to permit rotation of the distal outer member 1204 without rotating the distal channel member 1206. In some such embodiments, the channel members 1202, 1206 can be non-rotatable relative to the housing 128 and / or tubular member 132, and one or both of the outer members 1200, 1204 can be rotatable relative to the housing 128 and / or tubular member 132. In such an embodiment, maintaining the rotational position of the channel members 1202, 1206 relative to the housing 128 and / or tubular member 132 can prevent twisting of the tubular member 132, which can result in sealing of the tubular member 132 regardless of the configuration of the retraction mechanism 141.

[0069] The outer members 1200, 1204 can include a variety of shapes and sizes and can include a variety of features. In some embodiments, one or both of the outer members 1200, 1204 can be coupled to a shaft, for example, similar to the shaft 106 shown in FIG. 1. In some embodiments, for example, the distal outer member 1204 can be coupled to the shaft 106, for example, can be permanently coupled to the shaft 106. In some embodiments, one or both of the outer members can include one or several features configured to facilitate coupling with the valve 104. These one or several features can include, for example, one or several male or female connectors, couplers, attachment mechanisms, etc. In some embodiments, these one or several features can facilitate use of the valve with other existing components, instruments, tools, etc. In some embodiments, for example, one or both of the outer members 1200, 1204 can include male or female luer fittings, specifically, as shown in FIG. 12, the distal outer member 1204 can include a male luer fitting 1210.

[0070] Several aspects of the present technology are described in the following examples. 1. A hemostatic valve for sealing a medical device, comprising: an elongate member having a first end, a second end and a central lumen extending therebetween, the elongate member being flexible; a reinforcing structure extending along at least a portion of the elongated member, the reinforcing structure being coupled to the elongated member; A hemostatic valve comprising: an active tensioning mechanism coupled to the elongate member, the tensioning mechanism being movable between a first configuration in which the central lumen is constricted and sealed, and a second configuration in which the central lumen is open. 2. The hemostatic valve of example 1, wherein the elongated member comprises a flexible polymeric tube. 3. A hemostatic valve as described in example 1 or 2, wherein the tensioning mechanism comprises at least one filament extending at least partially around the elongate member. 4. A hemostatic valve as described in example 3, wherein the reinforcing structure is positioned between the at least one filament and the elongate member. 5. The hemostatic valve of example 4, wherein the reinforcing structure comprises a braided mesh. 6. A hemostatic valve as described in Example 4 or 5, wherein the reinforcing structure is coupled to the elongated member at a position adjacent to the first end of the elongated member and at a position adjacent to the second end of the elongated member. 7. A hemostatic valve as described in Example 6, wherein the reinforcing structure is not coupled to the elongated member at a location between the first end of the elongated member and the second end of the elongated member. 8. A hemostatic valve described in any one of Examples 3 to 7, wherein the tensioning mechanism comprises an actuator coupled to the at least one filament, the actuator being movable to control movement of the at least one filament from a first position in which the central lumen is contracted and sealed to a second position in which the central lumen is open, and when the tensioning mechanism is in the first configuration, the at least one filament is in the first position. 9. The hemostasis valve of example 8, wherein the actuator is biased toward the first position. 10. A hemostasis valve as described in example 8 or 9, wherein the actuator is biased toward the second position. 11. The hemostatic valve of any one of Examples 8 to 10, wherein the actuator comprises a manual actuator. 12. A hemostatic valve described in any one of Examples 8 to 11, wherein the at least one filament forms a loop around the elongated member. 13. A hemostatic valve described in any one of Examples 8 to 12, wherein the at least one filament forms a curve around a portion of the elongate member. 14. A hemostatic valve described in any one of Examples 8 to 13, wherein the at least one filament comprises a first filament and a second filament, each of the first filament and the second filament is coupled to the actuator, and the first filament and the second filament are movable from the first position to a second position. 15. A hemostatic valve as described in example 14, wherein each of the first filament and the second filament forms a loop around the elongate member. 16. A hemostatic valve as described in example 14 or 15, wherein the first filament forms a first curve around a first portion of the elongated member and the second filament forms a second curve around a second portion of the elongated member. 17. The hemostasis valve of example 16, wherein the first curved portion extends through the second curved portion. 18. A hemostatic valve described in any one of Examples 1 to 17, further comprising a shell defining a first opening and a second opening, wherein the elongated member extends from the first opening to the second opening and fluidly couples the first opening and the second opening. 19. A hemostatic valve described in any one of Examples 1 to 18, wherein the tensioning mechanism is self-adjusting to seal around different sized tools extending through the hemostatic valve. 20. A hemostatic valve described in any one of Examples 1 to 19, wherein the central lumen comprises a single lumen. 21. A hemostatic valve described in any one of Examples 1 to 20, wherein the central lumen comprises multiple lumens. 22. A delivery system for intravascular access to a blood vessel within a patient, comprising: a catheter having a first end, a second end and a catheter lumen extending therebetween; a hemostasis valve coupled to the first end of the catheter, the hemostasis valve comprising: a tubular member having a first end, a second end and a central lumen extending therebetween, the central lumen of the tubular member being fluidly coupled to the catheter lumen; a hemostatic valve; and an active tensioning mechanism coupled to the tubular member, the tensioning mechanism constricting the central lumen and movable between a first configuration in which the central lumen is sealed and a second configuration in which the central lumen is open. 23. The delivery system of example 22, wherein the hemostatic valve further comprises a reinforcing structure extending along at least a portion of the tubular member. 24. The delivery system of example 22 or 23, wherein the reinforcement structure is disposed between the tensioning mechanism and the tubular member. 25. The delivery system of example 24, wherein the reinforcing structure comprises a braided mesh. 26. The delivery system of example 24 or 25, wherein the reinforcing structure is coupled to the tubular member at a location adjacent to the first end of the tubular member and at a location adjacent to the second end of the tubular member. 27. The delivery system of example 26, wherein the reinforcement structure is adhered to the tubular member at the first end of the tubular member and at the second end of the tubular member. 28. The delivery system of example 27, wherein the reinforcing structure is not bonded to the tubular member between the first end of the tubular member and the second end of the tubular member. 29. A delivery system described in any one of Examples 22-28, wherein the tensioning mechanism comprises at least one filament extending at least partially around the tubular member. 30. The delivery system of example 29, wherein the tensioning mechanism comprises an actuator coupled to the at least one filament, and moving the tensioning mechanism from the first configuration to the second configuration comprises moving the actuator and at least one filament coupled thereto from a first position to a second position, and when the filament is in the first position, the filament constricts and seals the central lumen of the tubular member. 31. The delivery system of example 30, wherein the actuator comprises a manual actuator. 32. The delivery system of example 31, wherein the actuator comprises a pair of opposed, depressible buttons, the buttons being biased toward a non-depressed position. 33. The delivery system of example 31 or 32, wherein the central lumen is sealed when the button is in the non-depressed position. 34. The delivery system of any one of examples 30-33, wherein the filament comprises a monofilament. 35. A delivery system according to any one of Examples 30 to 34, wherein the filament comprises at least one of a polymer filament or a metallic filament. 36. The delivery system of any one of Examples 22-35, wherein the catheter comprises a thrombectomy device. 37. A method of sealing a delivery device for accessing a patient's blood vessel, comprising: inserting the delivery device, comprising a catheter and a hemostatic valve, into the blood vessel of the patient, the catheter having a first end, a second end, and a catheter lumen extending therethrough, the hemostatic valve being coupled to the first end, a tubular member defining a central lumen fluidly coupled with the catheter lumen, and a tensioning mechanism coupled to the tubular member, the tensioning mechanism collapsing and sealing the central lumen in a first configuration, thereby sealing access to the blood vessel; moving the tensioning mechanism of the hemostasis valve to a second configuration, wherein when the tensioning mechanism is in the second configuration, the central lumen is open and access to the blood vessel is unsealed; and advancing the shaft of the tool through the delivery device until a first end of the tool reaches a desired location within the blood vessel of the patient and a portion of the shaft is positioned within the central lumen of the tubular member; and returning the tensioning mechanism of the hemostasis valve to the first configuration such that the tubular member collapses over and seals around the shaft of the tool. 38. The method of example 37, further comprising retracting the shaft of the tool from the delivery device. 39. The method of example 38, wherein the tensioning mechanism is maintained in the first configuration during and after retraction of the shaft of the tool from the delivery device. 40. The method of example 38 or 39, wherein the tensioning mechanism is moved to the second configuration during retraction of the tool shaft from the delivery device, and the tensioning mechanism returns to the first configuration after the tool shaft is retracted from the delivery device. 41. The method of any one of examples 37-40, wherein the tensioning mechanism comprises at least one filament extending at least partially around the tubular member, the at least one filament collapsing the tubular member when the tensioning mechanism is in the first configuration. 42. The method of example 41, wherein the at least one filament circumferentially contracts the tubular member to collapse the tubular member when the tensioning mechanism is in the first configuration. 43. The method of example 41 or 42, wherein the hemostatic valve comprises a reinforcing structure located between the at least one filament and the tubular member. 44. The method of any one of Examples 41-43, wherein the at least one filament forms a loop around the elongate member and moving the tensioning mechanism from the second configuration to the first configuration reduces the size of the loop, thereby contracting the tubular member within the loop. 45. The method of any one of examples 41-44, wherein the filament forms at least one bend around a portion of the elongate member. 46. ​​The method of example 45, wherein the filaments comprise a first filament and a second filament, and the at least one curve comprises a first curve oriented in a first direction and formed by the first filament, and a second curve oriented in a second direction and formed by the second filament, and the first and second curves overlap within the contraction region to encircle a portion of the tubular member. 47. The method of example 46, wherein moving the tensioning mechanism from the second configuration to the first configuration includes moving the first curved portion in the first direction and the second curved portion in the first direction to reduce the size of the contraction region and collapse and seal the central lumen of the tubular member. 48. The method of any one of examples 37-47, wherein the tensioning mechanism comprises an actuator, and moving the tensioning mechanism to the second configuration comprises manipulating the actuator. 49. The method of any one of Examples 37-48, further comprising applying a vacuum to the delivery device to aspirate material through the catheter, wherein the central lumen remains sealed during the aspirating. 50. The method of any one of Examples 37-49, wherein the tool comprises a thrombectomy device. 51. A hemostatic valve for sealing a medical device, comprising: an elongate member having a first end, a second end, and a central lumen with a plurality of lumens extending therebetween, the elongate member being flexible; A hemostatic valve comprising: an active tensioning mechanism coupled to the elongate member, the tensioning mechanism being movable between a first configuration in which a central lumen is constricted and sealed, and a second configuration in which the central lumen is open.

[0071] Other variations are within the spirit and scope of the invention. Thus, while the invention is susceptible to various modifications and alternative constructions, specific illustrated embodiments thereof have been shown in the drawings and have been described above in detail. It is to be understood, however, that there is no intention to limit the invention to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, alternative constructions, and equivalents falling within the spirit and scope of the invention as defined by the appended claims.

[0072] In the foregoing description, various embodiments of the present invention have been described. For purposes of explanation, specific configurations and details are set forth in order to provide a thorough understanding of the embodiments. However, it will be apparent to one skilled in the art that the present invention may be practiced without the specific details. Furthermore, well-known features may be omitted or simplified so as not to obscure the described embodiments.

[0073] In the context of describing the present invention (particularly in the context of the claims below), the use of the terms "a" and "an" and "the" and similar referents should be construed to encompass both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms "comprises," "has," "includes," and "including" are construed as open-ended terms (i.e., meaning "including, but not limited to"), unless otherwise noted. The term "connected" is construed as partially or wholly contained within, attached to, or joined together, even if there is something intervening. The recitation of ranges of values ​​herein is only intended to serve as a shorthand method of individually referring to each individual value falling within the range, unless otherwise stated herein, and each individual value is incorporated into the specification as if it were individually set forth herein. All methods described herein can be performed in any suitable order, unless otherwise indicated herein or clearly contradicted by context. Any and all examples provided herein, or the use of exemplary language (e.g., "etc.") are intended merely to better illuminate embodiments of the invention and do not limit the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.

[0074] Preferred embodiments of the invention are described herein, including the best mode known to the inventors for carrying out the invention. Variations of these preferred embodiments may become apparent to those skilled in the art upon reading the foregoing description. The inventors expect that such variations will be utilized by those skilled in the art as appropriate, and intend that the invention be practiced otherwise than as specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible instances thereof is included in the invention unless otherwise indicated herein or clearly contradicted by context.

[0075] All references cited in this specification, including publications, patent applications, and patents, are incorporated by reference to the same extent as if each reference was individually and specifically indicated to be incorporated by reference and was set forth in its entirety herein.

Claims

1. A valve, a tubular member defining a lumen configured to slidably receive a catheter; a retraction mechanism including at least one filament and an actuator coupled to the filament, the filament comprising a first portion extending around at least a portion of the tubular member and a second portion having a first end extending in one direction from the first portion and a second end extending in another direction from the first portion, the actuator comprising a first member coupled to the first end of the filament and a second member coupled to the second end of the filament, the first member and the second member of the actuator being movable between (a) a first position in which the filament circumferentially retracts the lumen to create a seal, and (b) a second position in which the filament is moved to at least partially open the lumen; a biasing system configured to bias the first member and the second member toward the first position; Equipped with a valve, wherein the first member of the actuator comprises a first button and the second member of the actuator comprises a second button, the first button and the second button being undepressed in the first position and the first button and the second button being depressed in the second position.

2. The valve of claim 1 , wherein the tubular member is flexible.

3. The valve of claim 1 , wherein the first portion of the filament extends in a complete loop around the tubular member.

4. 2. The valve of claim 1, wherein the lumen of the tubular member is configured to contract and remain sealed under a condition where, when the first and second members of the actuator are in the first position, a pressure differential exists between: (a) a first volume outside the lumen, the first volume fluidly connected to a first end of the tubular member; and (b) a second volume outside the lumen, the second volume fluidly connected to a second end of the tubular member, the first and second ends of the tubular member are disposed on opposite sides of the filament, the pressure differential being created during application of a vacuum pressure to either the first volume or the second volume.

5. 2. The valve of claim 1, wherein the lumen of the tubular member is configured to contract and remain sealed under a condition in which a vacuum pressure is applied to a volume outside of the lumen, the volume being fluidly connected to one of the first end or second end of the tubular member, when the first and second members of the actuator are in the first position, the lumen of the tubular member being configured to contract and remain sealed, the first and second ends of the tubular member being disposed on opposite sides of the filament.

6. 2. The valve of claim 1, wherein the lumen of the tubular member extends along a first longitudinal axis, and the first and second members of the actuator are movable between the first and second positions along a second longitudinal axis, the first longitudinal axis being perpendicular to the second longitudinal axis.

7. 10. The valve of claim 1, wherein the biasing system comprises a first compression spring coupled to the first member and a second compression spring coupled to the second member.

8. 2. The valve of claim 1, wherein in the first position, the first and second members of the actuator pull the filament to circumferentially constrict the tubular member such that the lumen is constricted and sealed.

9. A hemostasis valve, comprising: Housing and an actuator having at least a first member, the first member movably coupled to the housing; a collapsible tubular sidewall defining a lumen carried by the housing; a filament formed in a loop around the tubular sidewall, the filament having at least a first end portion extending away from the loop towards the first member; a first spring configured to move the first member in a direction pulling the first end portion away from the tubular sidewall, thereby reducing a diameter of the lumen in response to a reduction in a diameter of the loop; Equipped with the first member of the actuator is movable between (a) a first position in which the filament circumferentially constricts the lumen to create a seal, and (b) a second position in which the filament is moved to at least partially open the lumen; A hemostasis valve, wherein the first member of the actuator comprises a first button, the first button being undepressed in the first position and being depressed in the second position.

10. The hemostasis valve of claim 9, further comprising a second member movably coupled to the housing, the filament further comprising a second end portion extending away from the loop and into the second member.

11. The hemostasis valve of claim 10 , wherein the first end portion, the loop, and the second end portion are one continuous filament.

12. The first member and the second member include The hemostasis valve of claim 10, wherein the valve is biased in a direction to place the first end portion and the second end portion under sufficient tension to reduce the diameter of the lumen and provide a seal around a device extending through the lumen.

13. The first member and the second member are The hemostasis valve of claim 10 , biased in a direction to place the first and second end portions under sufficient tension to close the lumen.

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