Hemostasis valves and methods 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 September 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 on the patient's body to minimize the patient's blood loss, prevent the delivery of air into the vascular system, and prevent problems such as infection. Furthermore, 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 then moved into position adjacent to the tissue, nerve, or other body structure to be operated on, and tools to perform the procedure are then inserted through some or all of the lumens in these catheters.

[0004] To minimize blood loss, prevent the delivery of air into the vascular system, and facilitate the maintenance of sterility within a 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 adequately against all interventional applications or tools, and / or operation of some valves may be complicated for operators to use. The drawbacks of such valve designs can increase the complexity of procedures performed therewith and / or reduce patient safety (e.g., bleeding, infection, and / or other adverse complications). Therefore, new and improved hemostatic valves and methods of use are desirable. Summary of the Invention [Means for solving the problem]

[0006] The following describes 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 more 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 a patient's body, particularly 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. Furthermore, such valves create a robust seal that maintains its seal when a vacuum, such as that generated during suction, is applied.

[0007] Aspects of the present disclosure relate to a hemostatic valve for sealing a medical device. The hemostatic valve includes an elongate member having a first end, a second end, and a central lumen extending therebetween. In some embodiments, the elongate member is flexible. The hemostatic valve can include a reinforcing structure extending along at least a portion of the elongate member such that the reinforcing structure is coupled to the elongate member. The hemostatic valve includes an active tensioning mechanism coupled to the elongate member. In some embodiments, the tensioning mechanism is 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. If desired, the valve can be manually adjusted by a user to intermediate positions between a fully open and a fully closed position. Additionally, an instrument (e.g., a catheter) can provide 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, a 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 proximate a first end of the elongated member and a second end of the elongated member. In some embodiments, the reinforcing structure is not coupled to the elongated member between the first end of the elongated member and the second end of the elongated member. In some embodiments, a 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 movement of 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. 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, at least one filament forms a loop around the elongate member. In some embodiments, the at least one filament forms a bend around a portion of the elongate 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 is coupled to the same actuator. In some embodiments, each of the first filament and the second filament is coupled to a different actuator. 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 elongate member. In some embodiments, the first filament forms a first bend around a first portion of the elongate member, and the second filament forms a second bend around a second portion of the elongate 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 tools of different sizes 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 present 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, and the tensioning mechanism may be movable between a first configuration in which the tensioning mechanism constricts the central lumen, sealing the central lumen, 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 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 and the second end of the tubular member. In some embodiments, the reinforcing structure is not coupled to the tubular member between the first end 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 the first configuration to the 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 the central lumen of the tubular member.

[0015] In some embodiments, the actuator can be a manual actuator. In some embodiments, the actuator includes 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 polymer filament or a metallic filament. In some embodiments, the catheter can include a thrombectomy device.

[0016] One aspect of the present disclosure relates to a method for sealing a delivery device accessing 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 to 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 a 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 tool shaft 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 positioned between the at least one filament and the tubular member.

[0019] In some embodiments, 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 constricting the tubular member within the loop. In some embodiments, the filament forms at least one bend around a portion of the elongate 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 within the constricted 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 operating the actuator. In some embodiments, the method can include applying a vacuum to the delivery device and / or delivery system to aspirate 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 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. (Item 2) Item 10. The hemostatic valve of item 1, wherein the elongated member comprises a flexible polymer tube. (Item 3) Item 10. The hemostatic valve of item 1, wherein the tensioning mechanism comprises at least one filament extending at least partially around the elongate member. (Item 4) 4. The hemostatic valve according to item 3, wherein the reinforcing structure is positioned between the at least one filament and the elongate member. (Item 5) Item 5. The hemostatic valve of item 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 claim 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) Item 9. The hemostasis valve according to item 8, wherein the actuator is biased towards the first position. (Item 10) Item 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 hemostatic valve according to item 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 the 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) Item 1, a hemostatic valve 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. (Item 19) Item 10. The hemostasis valve of item 1, wherein the tensioning mechanism is self-adjustable to seal around different sized tools extending through the hemostasis valve. (Item 20) Item 1. The hemostatic valve according to item 1, wherein the central lumen comprises a single lumen. (Item 21) Item 1. The hemostatic valve according to 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's body, 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 reinforcing structure is disposed between the tensioning mechanism and the tubular member. (Item 25) 25. The delivery system of claim 24, wherein the reinforcing structure comprises a braided mesh. (Item 26) 25. The delivery system of claim 24, wherein the reinforcing 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 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. (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 wherein 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, wherein the filament constricts and seals the central lumen of the tubular member when the filament is in the first position. (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) 32. The delivery system of claim 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, including 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 and including 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 hemostatic 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 patient's blood vessel and a portion of the shaft is positioned within the central lumen of the tubular member; returning the tensioning mechanism of the hemostatic valve to the first configuration such that the tubular member collapses onto and seals around the shaft of the tool. (Item 38) 38. The method of claim 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 constricting 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 first and second filaments, 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 surround a portion of the tubular member within the contracted 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 the size of the contraction 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 operating 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) 38. The method of claim 37, wherein the tool comprises a thrombectomy device. (Item 51) 1. 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. [Brief explanation of the drawings]

[0021] [Figure 1] FIG. 1 is a perspective view of one embodiment of a delivery device. [Figure 2] FIG. 1 is a side cross-sectional view of one embodiment of a hemostasis valve in a first configuration. [Figure 3] FIG. 10 is a side cross-sectional view of one embodiment of a valve in a second configuration. [Figure 4] FIG. 1 is a side cross-sectional view of an embodiment of a valve in a first configuration with a tool extending through the valve. [Figure 5] FIG. 1 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. 10 is a perspective view of two curved sections that overlap and interlock in the open state. [Figure 9] FIG. 1 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] FIG. 10 is a side cross-sectional view of another embodiment of a hemostasis valve having a two-piece cap. DETAILED DESCRIPTION OF THE INVENTION

[0022] The present disclosure relates to a valve that can be used as a hemostatic valve. This valve, also referred to herein as a gaurot valve, can seal with or without a tool extending through the valve. The gaurot valve provides convenient, one-handed operation for a wide range of medical devices, including catheters, wires, embolectomy systems, and the like. This one-handed operation of the gaurot valve allows users to easily and quickly exchange various tools being used through the valve without compromising hemostasis, simplifying procedures. Combined with one-handed operation, the gaurot 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 during procedures. Under these and other conditions, the gaurot 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 defining a central lumen, which in some embodiments can define a single lumen or 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 aforementioned robust seal of the tubular member, and therefore the valve.

[0024] Referring now to FIG. 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 may include a catheter 102 and a galot valve 104, also referred to herein as a valve 104. The catheter 102 may 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 may be connected to the valve 104 and a distal end 110, also referred to herein as a second end 110. The shaft 106 may define a catheter lumen 112 extending from the proximal end 108 of the shaft 106 to the distal end 110 of the shaft 106. The catheter 102, and particularly the shaft 106, may include a variety of shapes and sizes and may be made from a variety of materials. In some embodiments, the catheter 102 may 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 may 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 may 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, and as seen in FIG. 1, the housing 128 couples with each of the proximal cap 116 and the distal cap 120 to secure 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 an elongated member 132, also referred to herein as a tubular member 132, a septum 132, or a 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, 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 a natural or synthetic polymer. 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, that can be coupled to the proximal cap 116, and a distal end 136, also referred to herein as a second end 136, that can be coupled to the distal cap 120. The elongated member 132 can define a central lumen 138 that 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, elongated member 132 can be cylindrical, and more particularly, cylindrical. In some embodiments, elongated member 132 can be dogbone shaped, for example, to facilitate connection to proximal cap 116 and distal cap 120, respectively. In some embodiments, elongated member 132 can include one or more outwardly extending protrusions, also referred to herein as tensioning mechanism 141, that engage all or a portion of retraction mechanism 141 of valve 104 to fix the position of all or a portion of retraction mechanism 141 relative to elongated member 132. In some embodiments, retraction mechanism 141 can self-adjust to seal around different sized tools extending through valve 104.

[0032] Retraction mechanism 141, in some embodiments, can collapse and seal elongate member 132 via compression and / or contraction, particularly via contraction with at least one filament 150. Retraction mechanism 141 can include actuator 142, which can be a manual actuator, such as one or more buttons 144, and at least one filament 150, which can extend at least partially around elongate member 132. In some embodiments, use of 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 elongate 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 automatic 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 elongate 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 the first configuration in which the elongated member 132 is collapsed 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 the 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 the 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 first spring 148-A and second spring 148-B can generate sufficient force to allow actuation of actuator 142 with one hand and to collapse and seal elongate member 132 when retraction mechanism 141 is in the first configuration. In some embodiments, one or both of first spring 148-A and 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 first spring 148-A and second spring 148-B can generate a force of between approximately 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 elongate member 132. In some embodiments, the at least one filament 150 can circumferentially retract the elongate member 132 to collapse and seal the elongate 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, or the like. In some embodiments, the filament can comprise a single strand, such as a monofilament, or in some embodiments, the filament can comprise multiple strands that can be twisted, woven, grouped, and / or fused to form a filament, for example. 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, collapses, 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 collapses, collapses, 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 uncollapsed. 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, at least one filament 150 can extend along an axis 152 that can be perpendicular to a central axis 154 of elongate member 132 and / or apertures 124, 126. In some embodiments, axis 152 of at least one filament 150 can intersect and be perpendicular to central axis 154 of elongate member 132 and / or apertures 124, 126. In some embodiments, actuator 142, specifically 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 valve 104 is shown with deflation mechanism 141 in a second configuration. As specifically shown, first and second buttons 144-A, 144-B are both in a second position depressed against retention feature 140 of housing 128. In this second position, filament 150 is relaxed, thereby allowing expansion of elongate member 132 and unsealing of central lumen 138 of 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 in 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 elongate member 132. In some embodiments, the proximal end 134 of the elongate member 132 can fit over the mating feature 304 of the proximal cap 116. The proximal end 134 of the elongated member 132 can 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 can be further secured to the mating feature 304 by a proximal O-ring 306, which can be compressed between the housing 128 and the mating feature 304 of the proximal cap 116 to sealingly couple the elongated member 132 with 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 fit 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] Distal cap 120, in some embodiments, can further include a side port barb 314, which can extend laterally from distal cap 120, specifically away from distal opening 126 of distal cap 120. Side port barb 314 can define a side port channel 316, which can extend therethrough and be fluidly connected to distal opening 126. In some embodiments, side port barb 314 can include a securement feature 318, such as a barb, that can secure the connection of a hose or tube to 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 the portion 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, a 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, because the elongated member 132 has a narrower shape when the retraction mechanism 141 is in the first configuration, a vacuum applied to a portion of the delivery device 100 distal to the shaft 152 can draw the elongated member 132 into the first configuration and, in some embodiments, can increase the strength, robustness, and / or strength of the seal of the valve 104. This attribute of the valve 104 can provide an advantage over other valve designs in which a vacuum may compromise the valve seal, and therefore limit the ability to draw a vacuum.

[0045] In some embodiments, the valve 104 can further include a reinforcing structure 320, which 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 so as to be between the elongated member 132 and the at least one filament 150.

[0046] The reinforcing structure 320 may 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 adjacent to the first end 134 of the elongated member 132 and the distal end 324 of the reinforcing structure 320 is adjacent to 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 more other components of the valve 104. In some embodiments, the reinforcing structure 320 can be coupled to the elongated member 132 via compression of the reinforcing structure 320 and the elongated member 132 between the housing 128 and one or both of the proximal 116 and distal 120 ends.

[0048] In some embodiments, the reinforcing structure 320 can be adhered to the elongated member 132 via an adhesive, such as, for example, a silicone adhesive. In some embodiments, the adhesive can be applied circumferentially to the reinforcing structure 320 and / or the elongated member 132 in an adhesive ring that can have a length of, for example, 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 therebetween.

[0049] In one embodiment, each of the proximal and distal ends 322, 324 of the reinforcement structure 320 may be adhered to the elongate member 132 via an adhesive. In such an embodiment, the reinforcement structure 320 may not be coupled to the elongate member 132 at a location other than the coupling 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 coupled to the elongate member 132 between the first and second ends 134, 136 of the elongate 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 capable of sealing 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 from 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, polymer wires, or natural wires. In one embodiment, the braided mesh can comprise a 48-wire mesh in a 1×1 configuration made from 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 can 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, can 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 can be coupled to a single button 144; in some embodiments, each of the first end 600 and the second end 602 can be coupled to a different button 144; and in some embodiments, one of the first end 600 and the second end 602 can be coupled to the button 144 and the other of the first end 600 and the second end 602 can 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 through 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 end 700 and the second end 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 end 700 and the second end 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 end 700 and the second end 702 of one or more of the plurality of filaments 150 can be coupled to a single button 144 and the other of the first end 700 and the second end 702 of the one or more filaments 150 can be coupled to the housing 128 or other portion of the valve 104.

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

[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 the U-shaped portion between the 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 uninterlocked. Similarly, in embodiments including a filament 150 with multiple loops, one or some of the loops can be interlocked.

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

[0058] 8 and 9, the multiple curved portions, particularly 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 first direction, as indicated by arrow 810, and the second curved portion has a second orientation or second 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 contraction mechanism 141 to the first configuration may result in and / or include movement of first curved portion 800-A in the direction indicated by arrow 810 and / or movement of 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 enclosed area 814 and contracts, folds, and / or seals elongate member 132 extending through enclosed area 814.

[0059] Each filament 150 forming the curved portion 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, can be smaller than the diameter or thickness of the filament. In some embodiments, the filaments have 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 filaments 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 lines or zones of pressure may form two opposing arcs, while in other embodiments, the arcuate lines of pressure may be a single, substantially circular line or zone that encircles the elongate member at least once. The longitudinal lengths of the pressure lines or zones may be very short compared to other valves known in the art. In some embodiments, the longitudinal length of the pressure zone applied to the elongate member 132 by the filament(s) 150 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 other cross-sectional shape.

[0060] 10 , a flowchart illustrating one embodiment of a process 1000 for sealing the valve 104 and / or catheter 102 accessing a patient's body is shown. 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 artery or venous vessel. In some embodiments, the delivery device 100 can be inserted directly into the patient's body through an orifice or incision in the patient, or 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 delivery device 100 is inserted into the patient's body, process 1000 proceeds to block 1004, where retraction mechanism 141 is moved from a first configuration to a second configuration. As described above, central lumen 138 of elongate member 132 is unsealed when retraction mechanism 141 is in the second configuration. In some embodiments, moving retraction mechanism 141 from the first configuration to the second configuration may include manipulating and / or controlling actuator 142, particularly depressing one or more buttons 144 to move filament 150 from the first position to the second position, allowing expansion and opening of central lumen 138 of 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 is advanced through the delivery device 100, or while the tool 400 is advanced through the delivery device 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 actuator 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 retraction mechanism 141 to the first configuration can include reducing the size and / or diameter of one or more loops formed by movement of filament 150 and / or one or more curved portions 800, such as, for example, movement of first curved portion 800-A in a first direction indicated by arrow 810 and movement of second curved portion 800-B in a second direction indicated by arrow 812, to reduce the size of retraction 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 tool shaft 402. 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 to retract the tool 400 and / or the shaft 402 of the tool 400 from the valve 104, and the retraction mechanism 141 can be returned to the first configuration when the tool 400 and / or the shaft 402 of the tool 400 is removed from the valve 104. 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 the retraction mechanism 141 remains 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 operation and / or control of the actuator 142, which may include pressing one or more buttons 144 to move the retraction mechanism 141 to the second configuration and releasing one or more 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 made 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 part of the thrombectomy device 1102. Details of the thrombus removal system, thrombectomy device, and their methods of use are described in US Pat. No. 6,629,493, filed September 16, 2016, entitled "INTRAVASCULAR THROMBUS REMOVAL SYSTEM." No. 15 / 268,296, entitled "TREATMENT OF VASCULAR OCCLUSION AND ASSOCIATED DEVICES, SYSTEMS, AND METHODS," filed April 26, 2017, U.S. Application No. 15 / 498,320, entitled "DEVICE AND METHOD FOR TREATING VASCULAR OCCLUSION," and U.S. Application No. 15 / 466,740, entitled "DEVICE AND METHOD FOR TREATING VASCULAR OCCLUSION," filed March 22, 2017, each of which is incorporated herein by reference in its entirety.

[0067] 12 , a side cross-sectional view of another embodiment of a hemostatic 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 sealing 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 sealing bond may be achieved and / or maintained via a seal, such as an O-ring 1208, which 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, rotatably coupled, to the proximal channel member 1202 to allow 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 allow 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 contraction 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, permanently coupled to the shaft 106. In some embodiments, one or both of the outer members can include one or more features configured to facilitate coupling with the valve 104. These one or more features can include, for example, one or more male or female connectors, couplers, attachment mechanisms, etc. In some embodiments, these one or more 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 a male or female luer fitting, and specifically, as shown in FIG. 12 , the distal outer member 1204 can include a male luer fitting 1210.

[0070] Some 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. The hemostatic valve of 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 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 position 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 wherein the at least one filament is in the first position when the tensioning mechanism is in the first configuration. 9. The hemostasis valve of example 8, wherein the actuator is biased toward the first position. 10. A hemostatic 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 elongate 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 being coupled to the actuator, and the first filament and the second filament being movable from the first position to the 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 described in Example 14 or 15, 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. 17. The hemostatic 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-adjustable to seal around tools of different sizes extending through the hemostatic valve. 20. A hemostatic valve according to any one of Examples 1 to 19, wherein the central lumen comprises a single lumen. 21. A hemostatic valve according to 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's body, 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 reinforcing 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 any one of Examples 24 and 25, wherein the reinforcing 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. 27. The delivery system of example 26, wherein 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. 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 according to 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 wherein 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 wherein the filament constricts and seals the central lumen of the tubular member when the filament is in the first position. 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. The delivery system of any one of Examples 30-34, wherein the filament comprises at least one of a polymer filament or a metal 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, including 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 and including 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 hemostatic 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 patient's blood vessel and a portion of the shaft is positioned within the central lumen of the tubular member; returning the tensioning mechanism of the hemostatic valve to the first configuration such that the tubular member collapses onto 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 positioned 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 constricting 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 curved portion comprises a first curved portion oriented in a first direction and formed by the first filament, and a second curved portion oriented in a second direction and formed by the second filament, and the first and second curved portions overlap within the contracted region to surround 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 operating 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. Accordingly, while the invention is susceptible to various modifications and alternative constructions, specific illustrated embodiments thereof are shown in the drawings and have been described above in detail. It is to be understood, however, that it is not intended 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 also be apparent to those skilled in the art that the present invention may be practiced without the specific details. Additionally, 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," "an," "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 "comprise," "have," "include," and "including" are to be construed as open-ended terms (i.e., meaning "including, but not limited to") unless otherwise noted. The term "connected" is to be 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 merely intended to serve as a shorthand method of individually referencing each individual value falling within the range, unless otherwise stated herein, and each individual value is incorporated into the specification as if set forth individually 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 present 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, 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 herein, 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 are hereby incorporated by reference in their entireties.

Claims

[Claim 1] Hemostatic valve, method of use, etc.

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