Valved introducer system

Abstract

An introducer system includes an introducer sheath, a valve assembly, and a medical device channel. The valve assembly includes a flexible material having an inner surface exposed along a portion of the medical device channel, and an outer surface defining a valvular cavity. Further, a compliant cavity within the valve assembly communicates with the valve membrane cavity and accommodates a piston assembly movable between a plurality of positions to accommodate a fill medium.

Description

[0001] Related applications This application claims priority and benefit to U.S. Provisional Patent Application No. 63 / 519,110, filed August 11, 2023, entitled “Injector System with Inflatable Valve,” the entire contents of which are incorporated herein by reference. Background Technology

[0002] Introducing device sheaths are commonly used to insert guidewires, catheters, and similar instruments into a patient's vascular system. Introducing device sheaths are often used in conjunction with valves to maintain hemostasis and prevent excessive bleeding. These hemostatic valves typically remain closed when no instrument is placed within the introducing device sheath, but form a seal around the instrument when it is inside the sheath. Summary of the Invention

[0003] In some aspects, the technology described herein relates to an infeeder system comprising: an infeeder sheath; a valve assembly connected to the infeeder sheath; a medical device channel defined by the infeeder sheath and the valve assembly; a flexible material located within the valve assembly, the flexible material having an inner surface exposed along a portion of the medical device channel and an outer surface at least partially defining a valve cavity; and a compliance cavity located within the valve assembly and in communication with the valve cavity; the compliance cavity further comprising a piston assembly located within the compliance cavity, the piston assembly being movable between multiple positions to receive an filling medium.

[0004] In some respects, the technology described herein relates to an infeeder system in which the piston assembly includes a piston member connected to a piston seal and a biasing member, the biasing member biasing the piston member to reduce the working volume of the compliance chamber.

[0005] In some respects, the technology described herein relates to an injector system in which the compliance cavity is arranged annularly around at least a portion of the valve cavity.

[0006] In some respects, the technology described herein relates to an injector system in which the piston component is annular.

[0007] In some respects, the technology described herein relates to an infeeder system in which the biasing member is a spring.

[0008] In some respects, the technology described herein relates to an infeeder system in which the spring is a helical coil spring, leaf spring, disc spring, leaf spring, or machined spring.

[0009] In some respects, the technology described herein relates to an infeeder system in which the biasing member is an elastically compressible material, a pneumatic piston mechanism, or a hydraulic piston mechanism.

[0010] In some respects, the technology described herein relates to an inlet system in which the piston seal is a cup-shaped seal having an annular channel.

[0011] In some respects, the technology described herein relates to an infeeder system in which the compliant cavity further includes an annular ridge positioned to engage with the annular channel of the cup-shaped seal.

[0012] In some respects, the technology described herein relates to an infeeder system in which the flexible material has a generally tubular shape.

[0013] In some respects, the technology described herein relates to an injector system in which the generally tubular shape has a flexible central portion and radially enlarged end portions.

[0014] In some respects, the technology described herein relates to an infeeder system in which the flexible material forms a plurality of radially outwardly extending longitudinal folds.

[0015] In some respects, the technology described herein relates to an infuser system in which the generally tubular shape further includes a slit valve covering a lumen of the generally tubular shape.

[0016] In some aspects, the technology described herein relates to an injector system, further comprising a clamp connected to the valve assembly; the clamp having a closed clamp position and an open clamp position, the closed clamp position being configured to hold the proximal portion of the dilator, and the open clamp position being configured to release the proximal portion of the dilator and allow longitudinal movement of the dilator relative to the injector sheath.

[0017] In some respects, the technology described herein relates to an infuser system and also includes a pressure measuring device.

[0018] In some respects, the technology described herein relates to an injector system in which the valve assembly further includes a valve shell, at least a portion of which is transparent and includes markings indicating the pressure value of the filling medium within the valve assembly.

[0019] In some respects, the technology described herein relates to an inlet system in which the piston member, the piston seal, or both are configured to align with the marking to indicate the pressure value of the filling medium within the valve assembly.

[0020] In some respects, the technology described herein relates to an infusion system in which the pressure measuring device is an electronic pressure sensor and an electronic display electrically connected to the pressure sensor.

[0021] In some respects, the technology described herein relates to an infusion system in which the compliance cavity further includes multiple compliance cavities.

[0022] In some respects, the technology described herein relates to an infusion system in which the plurality of compliant cavities are arranged annularly around the medical device channel.

[0023] In some aspects, the technology described herein relates to an injector system comprising: an injector sheath; a valve assembly connected to the injector sheath; a medical device channel defined by the injector sheath and the valve assembly; a valve member having an inflation configuration that seals the medical device channel within the valve assembly; and a piston assembly located within and in communication with the valve assembly.

[0024] In some respects, the technology described herein relates to an injector system in which the piston assembly is arranged annularly around the medical device channel.

[0025] In some aspects, the technology described herein relates to an injector system comprising: a valve assembly connected to an injector sheath; a medical device channel defined by the valve assembly; a valve member having an inflation configuration that seals the medical device channel within the valve assembly; and a piston assembly located within and in communication with the valve assembly.

[0026] In some respects, the technology described herein relates to an infeeder system, which also includes an infeeder sheath connected to the valve assembly; the infeeder sheath further defines the medical device channel.

[0027] In some aspects, the technology described herein relates to an implantation system comprising: an implantation sheath; a valve assembly connected to the implantation sheath; a medical device channel defined by the implantation sheath and the valve assembly; and a pressure measuring mechanism configured to transmit pressure within the valve assembly.

[0028] In some respects, the technology described herein relates to an infusion system in which the pressure measuring mechanism includes a transparent portion of the valve assembly housing and is configured to measure the filling medium within the valve assembly.

[0029] In some respects, the technology described herein relates to an injector system, which also includes a marker located on the housing of the valve assembly; the marker is configured to indicate the pressure of the filling medium within the valve assembly based on the position of the compliant intracavitary member of the valve assembly.

[0030] In some respects, the technology described herein relates to an infusion system in which the pressure measuring mechanism includes an electronic pressure sensor connected to an electronic display configured to display the pressure value measured by the electronic pressure sensor.

[0031] In some aspects, the technology described herein relates to a method of using an implantation system, comprising: providing an implantation system including an implantation sheath and a valve assembly defining a medical device channel; filling the valve assembly with a filling medium until a flexible material fills and extends into the medical device channel to close the medical device channel; placing a medical device into the medical device channel; and receiving the filling medium displaced by movement of the flexible material caused by the medical device through a compliance cavity within the valve assembly; wherein the compliance cavity includes a piston assembly.

[0032] In some aspects, the technology described herein relates to an infeeder system comprising: an infeeder sheath; a valve assembly connected to the infeeder sheath; a medical device channel defined by the infeeder sheath and the valve assembly; and a dilator; wherein the dilator includes a distal region having an annular channel; the infeeder sheath includes a distal end with a diameter that gradually decreases distally to fit within the annular channel of the dilator and to minimize the transition between the outer surface of the dilator and the outer surface of the infeeder sheath.

[0033] In some aspects, the technology described herein relates to an infeeder system comprising: an infeeder sheath; a valve assembly connected to the infeeder sheath; a medical device channel defined by the infeeder sheath and the valve assembly; a dilator including a distal region having an annular channel; the infeeder sheath including a distal end with a diameter that gradually decreases distally to fit within the annular channel of the dilator and to minimize the transition between the outer surface of the dilator and the outer surface of the infeeder sheath; and a clamping assembly having an open state and a clamping state, the open state allowing longitudinal movement of the dilator relative to the valve assembly and the infeeder sheath, and the clamping state preventing longitudinal movement of the dilator relative to the valve assembly and the infeeder sheath.

[0034] In some respects, the technology described herein relates to the aforementioned injector system, wherein the clamp assembly is connected to the proximal portion of the valve assembly via an interlocking mechanism.

[0035] In some aspects, the technology described herein relates to a method of using an implantation device system, comprising: providing an implantation device system including an implantation device sheath and a valve assembly, the implantation device sheath and the valve assembly defining a medical device channel; inserting a dilator into the valve assembly and the implantation device sheath; adjusting the longitudinal position of the dilator such that a channel on a distal portion of the dilator is aligned with a distal end of the implantation device sheath; and clamping a proximal portion of the dilator to the valve assembly to prevent longitudinal movement of the dilator relative to the valve assembly and the implantation device sheath.

[0036] In some respects, the technology described herein relates to the above-described method, wherein the step of inserting the dilator into the valve assembly further includes connecting an interlocking assembly of a clamp assembly located on the proximal portion of the dilator to the valve assembly.

[0037] In some aspects, the technology described herein relates to an injector system comprising: an injector sheath; a valve assembly connected to the injector sheath; a medical device channel defined by the injector sheath and the valve assembly; a dilator including a distal region having an annular channel; the injector sheath including a distal end with a diameter that gradually decreases distally to fit within the annular channel of the dilator and to minimize the transition between the outer surface of the dilator and the outer surface of the injector sheath; and a sheath movement assembly including an actuator that longitudinally moves the injector sheath relative to the valve assembly and the dilator so that a user can align the annular channel with the distal end of the injector sheath.

[0038] In some respects, the technology described herein relates to the aforementioned infeeder system, wherein the actuator includes a thumbwheel, slider, or tubular actuator.

[0039] In some aspects, the technology described herein relates to a method of using an implantation device system, comprising: providing an implantation device system including an implantation device sheath and a valve assembly, the implantation device sheath and the valve assembly defining a medical device channel; inserting a dilator into the valve assembly and the implantation device sheath; and adjusting the longitudinal position of the implantation device sheath such that a channel on a distal portion of the dilator is aligned with the distal end of the implantation device sheath.

[0040] In some respects, the technology described herein relates to the above-described method, wherein the step of inserting the dilator into the valve assembly further includes connecting an interlocking assembly of the dilator on the proximal portion of the dilator to the valve assembly. Attached Figure Description

[0041] The following figures are used to illustrate certain exemplary aspects of this disclosure and should not be considered exclusive or limiting. The disclosed subject matter is capable of considerable modifications, alterations, combinations, and equivalent substitutions in form and function, which will be apparent to those skilled in the art who will benefit from this disclosure. Reference is made to the following figures: Figure 1 A side view of an importer system 100 based on some examples is shown.

[0042] Figure 2 Examples are provided based on some examples. Figure 1 A three-dimensional view of the importer system 100.

[0043] Figure 3 An enlarged side view of a valve assembly 102 according to some examples is shown.

[0044] Figure 4 Examples are provided based on some examples. Figure 3 A stereoscopic end view of the valve assembly 102.

[0045] Figure 5 A cross-sectional view of a valve assembly 102 according to some examples is shown.

[0046] Figure 6 A cross-sectional view of a valve assembly 102 according to some examples is shown.

[0047] Figure 7 A cross-sectional view of a valve assembly 102 according to some examples is shown.

[0048] Figure 8 A cross-sectional view of a valve assembly 102 according to some examples is shown.

[0049] Figure 9 An enlarged cross-sectional view of a portion of a valve assembly 102 according to some examples is shown.

[0050] Figure 10 A side view of a valve membrane 128 in a filled state is shown according to some examples.

[0051] Figure 11 A three-dimensional view of a valve membrane 128 in a filled state is shown according to some examples.

[0052] Figure 12An end view of a valve membrane 128 in a filled state is shown according to some examples.

[0053] Figure 13 A side view of a valve membrane 128 in a contracted state is shown according to some examples.

[0054] Figure 14 A perspective view of spacer 136 based on some examples is shown.

[0055] Figure 15 A perspective view of piston component 122 and piston seal 120 according to some examples is shown.

[0056] Figure 16 Cross-sectional views of piston member 122 and piston seal 120 according to some examples are shown.

[0057] Figure 17 A side view of piston member 122 and piston seal 120 according to some examples is shown.

[0058] Figure 18 A side perspective view of a valve assembly 102 having a housing 112 with a transparent portion 112A is shown according to some examples.

[0059] Figure 19 An enlarged cross-sectional view of the expander 106 and the inlet sheath 104 according to some examples is shown.

[0060] Figure 20 Examples are provided based on some examples. Figure 19 The magnified portion of region 20.

[0061] Figure 21 A perspective perspective view of the valve shell 160 is shown according to some examples.

[0062] Figure 22 A cross-sectional view of a valve housing 160 according to some examples is shown, wherein a plurality of compliant cavities 162 are located at various annular positions surrounding the medical device channel.

[0063] Figure 23 A side view of the infuser system 180 is shown, in which the thumb wheel moves the infuser sheath 104 relative to the dilator 106. Detailed Implementation

[0064] Those skilled in the art will understand that this disclosure is not limited to the specific examples and descriptions herein. Various modifications and changes can be made under the teachings of this disclosure without departing from its scope, spirit, or intent.

[0065] While different examples may be described in this specification, it is particularly contemplated that any feature from different examples can be adopted and combined together in any combination. In other words, features from different examples can be mixed and matched with each other. Therefore, while every permutation and combination of features from different examples may not be explicitly illustrated or described, the intent of this disclosure is to cover any such combination, in particular combinations that might come to mind for those skilled in the art.

[0066] The terminology used in this disclosure should be interpreted as accommodating, not restrictive. In the accompanying drawings, the same numbers refer to the same elements. Unless otherwise stated, all drawings are not to scale. Unless otherwise stated, the term "about" is defined as indicating plus or minus 5% of the stated value.

[0067] The term “distal” or “towards distal” generally refers to the direction or area toward the end of the device that is inside the patient’s body (e.g., the end away from the physician / clinician), while the term “proximal” or “towards proximal” refers to the direction or area toward the end of the device that is outside the patient’s body (e.g., toward or near the physician / clinician or the handle / interface end of the device).

[0068] This specification generally relates to an infeeder system. Some examples of this specification relate to an infeeder sheath, a valve assembly connected to the infeeder sheath, and a channel defined by the infeeder sheath and the valve assembly through which a medical device may pass. The valve assembly may include a flexible, inflatable valve membrane that expands radially inward within the channel of the valve assembly to restrict blood outflow and maintain hemostasis in the patient during use. When a dilator, guidewire, catheter, or other medical device is advanced through the channel of the valve assembly, the valve membrane maintains pressure on the medical device to form a seal. The valve assembly may also include a compliance cavity communicating with a valve cavity formed by the valve membrane. The compliance cavity facilitates the containment (e.g., reception and drainage) of various amounts of filling medium required within the valve cavity to maintain the valve membrane in a closed state when the medical device channel is empty, or to maintain a seal around the medical device when the medical device is present. When a medical device enters the channel and moves the valve radially outward, the medium that inflates the valve and its cavity is replaced by a media compliance cavity, which enlarges to accommodate the replaced medium. If the medical device is removed, the media compliance cavity shrinks to help the valve inflate and close the channel. Therefore, the inflatable valve can automatically seal around medical devices of various sizes, as well as seal when no device is present in the channel.

[0069] In some examples, the compliance cavity may include a piston member that moves axially back and forth to change the working volume of the compliance cavity. When the piston member moves toward a first end of the compliance cavity, the working volume of the cavity (i.e., the region within the compliance cavity that contains the filling medium) increases, and a larger amount of filling medium can be accommodated. When the piston member moves toward a second end of the compliance cavity, the working volume of the cavity decreases, and a smaller amount of filling medium can be accommodated. The piston member may be biased toward the second end to help maintain the valve membrane in a pliable state, either against itself or against a medical device in the presence of a medical device.

[0070] In some examples, the injector system may also include an expander having a distal end with a tapered taper that increases proximally, and its length such that the distal taper extends beyond the distal end of the injector sheath. Both the expander and the injector sheath have features that allow for a more gradual increase in the radial transition between them (i.e., a smaller abrupt “step” at the transition between them). In one example, the expander may include a groove or channel extending circumferentially around the expander. The diameter of the distal portion of the injector sheath may taper gradually both inward and outward in the distal direction. The taper of the injector sheath may match the taper of the groove / channel of the expander, thereby allowing at least the most distal end of the injector sheath to have approximately the same diameter as the expander portion directly distal to the groove / channel.

[0071] Figure 1 A side view illustrating a specific example of the importer system 100 is shown. Figure 2 A perspective view of an injector system 100 according to some examples is shown. The injector system 100 may include an injector sheath 104 and a valve assembly 102 connected to the injector sheath 104; the valve assembly 102 is configured to maintain hemostasis when the distal portion of the injector sheath 104 is in the patient's body.

[0072] As described in more detail below, the delivery sheath 104 and the valve assembly 102 each have a lumen extending between their proximal and distal ends, which together form a unified medical device channel defined by the delivery sheath 104 and the valve assembly 102 through which dilators and other medical devices can be advanced. In other words, the valve assembly 102 includes lumens opening at its proximal and distal ends, the delivery sheath 104 also includes lumens opening at its proximal and distal ends, and these lumens together form a single unified medical device channel defined by the delivery sheath 104 and the valve assembly 102. Before inserting the dilator 106 and the delivery sheath 104 into the patient's vascular system, a physician may inflate or fill the valve assembly 102 with a filling medium to limit blood leakage from the patient and maintain hemostasis.

[0073] In some examples, the valve assembly 102 can be filled by injecting a filling medium (e.g., fluid) into the filling channel 110. The filling channel may include a filling tube 110A, one end of which opens into the interior of the valve assembly 102, and the other end of which is connected to a valve 110B (e.g., a stopcock). The valve 110B may include a port to which a syringe or similar device can be connected. After the filling medium has been injected into or filled into the valve assembly 102, the valve 110B may be closed.

[0074] In some examples, the valve assembly 102 may also have a flushing channel 108 through which saline or other fluid can be flushed into the channel of the injector system 100 to remove air. The flushing channel 108 may include a flushing tube 108A, a first end of which opens into the internal medical device lumen of the valve assembly 102, and a second end of which is connected to a valve 108B (e.g., a stopcock valve). Thus, saline or other fluid can be added to the channel when the valve of the valve assembly 102 is closed to help remove air.

[0075] The delivery system 100 may further include a dilator 106 having a tapered tip 106A for placing at least a distal portion of the delivery sheath 104 into the patient's body. Once at least a distal portion of the delivery sheath 104 is in the patient's vascular system, the dilator 106 can be removed from the delivery sheath 104 and the valve assembly 102.

[0076] As discussed elsewhere in this specification, the inserter system 100 may include certain features of the inserter sheath 104 and the dilator 106 that help minimize the transition dimension between the outer surfaces of the two components, thereby reducing the likelihood that the inserter sheath 104 may become stuck in the patient's body due to certain features (e.g., the channel on the dilator 106 and the tapered distal end of the inserter sheath 104). Because the longitudinal length and radial dimensions of these features of the inserter sheath 104 and the dilator 106 are relatively small, it may be difficult to reliably manufacture these components with the tolerances required for reliable alignment. Therefore, the inserter system 100 may include a longitudinal alignment mechanism that allows the user to align the features of the two components to the desired location to minimize any diametrical transition.

[0077] In one example, the longitudinal alignment mechanism may include a clamping mechanism that longitudinally locks the dilator 106 in place relative to the valve assembly 102 and the inlet sheath 104. In one example, the clamping mechanism may include a cam clamping mechanism that engages or disengages via a clamping rod 116 attached to the proximal portion 114. However, other known clamping mechanisms may also be used. Thus, the clamping mechanism allows the user to further adjust the longitudinal position of the feature as needed to achieve a minimized or stepless transition. In one example, the clamping mechanism may be releasably connected to the proximal portion of the valve assembly 102 via interlocking components (e.g., tabs / grooves, clips, mating features, etc.) so that the dilator can be engaged and disengaged as needed. The clamping assembly may initially be located on the proximal portion of the dilator 106 (e.g., non-removably or removably). In other examples, the clamping assembly may be non-removably secured to the valve assembly 102.

[0078] Alternatively, the injector system may include mechanisms that allow the sheath 104 to move relative to the attached dilator 106 and valve assembly 102. For example, Figure 23 An introducer system 180 is illustrated, which is generally similar to introducer system 100, except that, instead of a clamping mechanism, valve assembly 102 may include a mechanism for longitudinally moving introducer sheath 104. In this example, thumb wheel 182 may engage a toothed rack connected to introducer sheath 104. However, other mechanisms may also be used, such as thumb sliders or external tubular adjusters rotated via threaded mechanisms. In such an example, the proximal portion 106E of dilator 106 may include an interlocking mechanism that engages proximal to valve assembly 102.

[0079] Figure 3 An enlarged side view of valve assembly 102 is shown as an example. Figure 4 An example of a three-dimensional end view of valve assembly 102 is shown. Figures 5-9 Various cross-sectional views of the valve assembly 102 are shown. All of these views will be discussed together below.

[0080] The housing 112 may form a housing containing a number of components of the valve assembly 102. In this example, the housing 112 has a generally cylindrical shape, although it may also be a non-cylindrical shape (e.g., rectangular).

[0081] In some examples, the valve mechanism of the valve assembly 102 may include at least two main components: a valve membrane 128 that is radially inwardly filled within an internal channel of the valve assembly 102, and a compliance cavity 130 that dynamically accommodates media displaced by the movement of the valve membrane 128.

[0082] Figures 10-12 Various views illustrate an example of a valve membrane 128 in a filled state.Figure 13 An example is shown of a valve 128 in a constricted state. The valve 128 may have a generally tubular shape, having an enlarged end portion 128B and a flexible intermediate portion 128A that can be mounted within a housing 112. A channel may extend longitudinally through the valve 128, and one or both ends of the channel may optionally have a slit valve 128C or a similar type of valve mechanism.

[0083] exist Figures 10-12 In the "filled" state shown, the filling medium (e.g., fluid) presses against the outer surface of the flexible intermediate portion 128A, causing the flexible intermediate portion 128A to radially compress or expand inward into its channel. When no medical device, such as dilator 106 or catheter, passes through the channel of valve membrane 128, the inner surfaces of the flexible intermediate portions 128A contact each other, thereby closing the channel to prevent blood outflow. When one or more medical devices pass through the channel of valve membrane 128, the flexible intermediate portions 128A contact the outer surfaces of one or more medical devices, sealing around the medical devices.

[0084] exist Figure 13 In the "contracted" state, little or no filling medium presses the outer surface of the flexible intermediate portion 128A, and the channel of the valve membrane 128 can be partially or completely opened. Figure 13 The state shown is most likely to occur during the initial use of the infuser system 100, when the user can remove air from the valve assembly 102 before adding filling medium (e.g., fluid) through the filling channel 110. Thus, in such a “contracted” state, the flexible intermediate portion 128A may have its maximum outward radial diameter, but may otherwise be mostly or completely unfilled with filling medium (i.e., the valve cavity 140 may be mostly / completely unfilled).

[0085] The valve membrane 128 may be made of a non-compliant / inelastic or partially non-compliant / inelastic material, such as expanded polytetrafluoroethylene (ePTFE), fluoroethylene-propylene copolymer (FEP), perfluoroalkoxyalkane (PFA), or fluororubber (FKM). In other examples, a knitted or woven fabric tube coated to be impermeable to fluids and gases may also be used. In some examples, the thickness of the valve membrane 128 may range from about 20 to about 70 micrometers (including the endpoints). Therefore, in Figure 10 and 11 In the "full" state, in this example, the flexible intermediate portion 128A is illustrated as having longitudinal folds extending radially outward. However, the flexible intermediate portion 128A can be formed into other shapes in the "full" state. The flexible intermediate portion 128A can have a circular cross-sectional shape, an elliptical cross-sectional shape, an hourglass shape with a smaller intermediate diameter, an inverted hourglass shape with a larger intermediate diameter, a linear taper in the proximal or distal direction, or similar variations.

[0086] While the flexible intermediate portion 128A in this example is generally tubular in shape, it can also be of other shapes and configurations. For example, the valve membrane 128 may alternatively comprise a plurality of discrete membranes located at... Figure 10 and 11 The flexible intermediate portion 128A is located in a similar radial / circumferential position. Alternatively, the valve membrane 128 may be composed of multiple flexible tubes, each forming a balloon-shaped compartment, which may also be located in a radial / circumferential position.

[0087] As previously described, valve assembly 102 may be inflated or filled with a liquid filling medium. Since liquids are generally relatively incompressible, passing a medical device through the inflated flexible intermediate portion 128A causes some of the filling medium to be displaced. The compliance cavity 130 provides space for this filling medium by providing a dynamic working volume 130A that receives and displaces the filling medium when needed (e.g., when a medical device is inserted) to maintain the compliance of the flexible intermediate portion 128A or a desired level of filling (e.g., when a medical device is removed from the flexible intermediate portion 128A). The working volume 130A is generally defined as the volume that the compliance cavity 130 accommodates or is sized to accommodate the filling medium at any given time, and this volume is dynamically variable.

[0088] The compliance cavity 130 can take on a variety of different shapes and positions within the valve assembly 102. In some examples, for instance... Figures 5-9 In the example, the compliance cavity 130 may have a generally cylindrical shape with an annular or annular cross-section, such that the compliance cavity 130 is disposed around the channel and valve membrane 128. Note that an annular cross-section refers to a cross-section taken generally perpendicular to the axis extending through the lumen of the medical device assembly 102. The compliance cavity 130 may extend continuously annularly around the cross-section (e.g., “O” shape) or may extend only partially around the cross-section (e.g., “C” shape). In this example, the compliance cavity 130 is formed at least partially by the inner surface of the housing 112 and the inner tube 134.

[0089] In other examples, the compliant cavity 130 may alternatively include multiple discrete cavities. For example, Figure 21 A 3D diagram is shown. Figure 22 A cross-sectional view of the valve housing 160 is illustrated, in which a plurality of compliance cavities 162 are located at various annular positions surrounding the medical device channel, analogous to a revolver. Each of these plurality of compliance cavities 162 generally functions similarly to the annular compliance cavity 130, but has a circular cross-sectional shape forming a cylinder.

[0090] The compliance chamber 130 can dynamically change its working volume 130A through several different mechanisms. For example, the compliance chamber 130 may include a biased piston mechanism or piston assembly, an elastic diaphragm that can deform under pressure, one or more elastic balloons that can inflate under pressure, or similar mechanisms.

[0091] exist Figures 5-9 In the example, the compliant cavity 130 may include a piston mechanism comprising a piston member 122, a piston seal 120, and a spring 126. The piston member 122 and the piston seal 120 are also shown separately. Figure 15 3D image Figure 16 Cross-sectional view and Figure 17 In the side view, the outer casing 112 has been removed.

[0092] The piston member 122 and the piston seal 120 may be connected or attached to each other, and both may be sized to fit within the compliance cavity 130 and move longitudinally between the end regions of the compliance cavity 130. In this example, both the piston member 122 and the piston seal 120 may have a generally annular shape.

[0093] The piston seal 120 is sized and shaped to seal the right / proximal portion (i.e., working volume 130A) of the compliant cavity 130 with the left / distal portion of the compliant cavity 130. Specifically, the piston seal 120 can uniformly contact the inner surface of the housing 112 and the outer surface of the inner tube 134, thereby forming the working volume 130A on the left / distal portion, into which the filling medium can enter.

[0094] In this example, the piston seal 120 is a cup-shaped seal having a channel 120A or a cup-shaped cross-section (e.g., a "V" or "C" shaped cross-section) facing left / distally around its periphery. The cup shape can exhibit a dynamic effect, where the V or C shape fills in as pressure increases. In other words, higher pressure activates the seal more forcefully. This can be important because the housing component may be injection molded and therefore may have a draft angle along its length, causing the annular gap to increase in size from the base to the end. For typical seals such as O-rings, significant compression of the ring at the base may be required so that the ring still contacts both the inner and outer surfaces at the maximum stroke position. In some cases, this over-compression may be undesirable depending on manufacturing tolerances. Alternatively, the piston seal 120 may have a solid cross-sectional shape, such as a square, rectangle, circle, triangle, or similar shape. In another alternative example, the piston seal 120 may be an "X-ring" with a generally "X" shaped cross-section, where each side of the cross-section forms a "V" or "C" shaped cup. The piston seal 120 can be made of a flexible, elastic material.

[0095] The piston member 122 may be made of a generally rigid material and have a generally annular / ring-shaped form. In this example, the piston member 122 may include a recess 122A within which a portion of the piston seal 120 is located. The recess 122A may further include fastening features to further retain the piston seal 120, such as adhesives or mechanical anchors (e.g., barbs, lips, etc.).

[0096] Piston member 122 and piston seal 120 may be biased in a direction that reduces the size of the working volume 130A within the compliance cavity 130. In this example, piston member 122 and piston seal 120 are biased toward the left / distal portion of the compliance cavity 130. In this example, spring 126 generates the biasing force and is located between piston member 122 and one end (e.g., right / proximal end) of compliance cavity 130. Spring 126 may be a helical coil spring as shown, or it may be other types of springs, such as one or more leaf springs (e.g., transverse leaf springs), disc springs, leaf springs, machined springs, or similar variations. Alternatively, an elastic, compressible material, such as a compressible polymer / foam, may be used to provide the biasing force. In another alternative example, the piston mechanism may be a pneumatic or hydraulic piston mechanism, wherein gas or oil helps provide the biasing force.

[0097] If the piston seal 120 includes a cup-shaped seal with a channel 120A, the compliance cavity 130 may include structural features that help maintain the "cup" shape when air is removed from the valve assembly 102. For example, if air is aspirated or evacuated from the valve assembly 102, the piston member 122 and the piston seal 120 may be pulled to the left / distal until all air is removed, thus a ridge 124 (e.g., an annular ridge with a shape matching the channel 120A) may be included around the left / distal end of the compliance cavity 130, allowing the channel 120A to engage with the ridge 124 and maintain its shape. This helps prevent partial folding or otherwise loss of shape of the piston seal 120.

[0098] In this example, piston assembly 122 and piston seal 120 move back and forth along an axis parallel to the axis of the medical device channel of valve assembly 102, or move between a left / distal position and a right proximal position.

[0099] Figure 8 The piston assembly 122 and piston seal 120 are shown in the left / far end position, as previously described, which may occur when air is drawn out of the valve assembly 102 before the valve assembly 102 is filled with filling medium.

[0100] Figure 5Piston assembly 122 and piston seal 120 are illustrated in a position slightly to the right / proximal to the distal end of compliant cavity 130. While dilator 106 is illustrated in the medical device channel of valve assembly 102, this positioning of piston assembly 122 and piston seal 120 is more likely to occur when a very small-diameter medical device is placed within the medical device channel or when no medical device is present. Therefore, most of the filling medium resides within the valve cavity 140 formed by valve membrane 128.

[0101] Figure 7 The piston assembly 122 and piston seal 120 are shown in a position further to the right / proximal and closer to the proximal end of the compliance cavity 130. When a relatively large-diameter medical device is placed in the medical device channel of the valve assembly 102 and / or when multiple medical devices are placed side by side in the medical device channel of the valve assembly 102, some of the filling medium originally in the valve cavity 140 formed by the valve membrane 128 is displaced into the working volume 130A of the compliance cavity 130, causing the piston assembly 122 and piston seal 120 to move to the right / distal end against the spring 126.

[0102] Figure 9 An enlarged view of a portion of valve assembly 102 is shown, which better illustrates the path that the filling medium may take. While the arrows indicate example directions of the filling medium in certain situations, it should be understood that during normal operation, the filling medium may move back and forth in either direction along portions of this path.

[0103] Figure 9 The valve cavity 140 is also better illustrated. In this example, the valve cavity 140 may consist of a valve membrane 128, a spacer 136, and an inner tube 134. The spacer 136 may also be... Figure 14 As seen in the image, and which may include a generally tubular shape, it has multiple orifices 136A allowing the filling medium to pass through. In some examples, the spacer 136 has an open or "C"-shaped cross-sectional shape, while in other examples, the spacer 136 may have a closed or "O"-shaped cross-sectional shape. Figure 9 As shown, spacer 136 helps form a longitudinal passage with inner tube 134 leading to region 142. Region 142 also leads to working volume 130A of compliant cavity 130.

[0104] In this respect, the filling medium can be filled or injected into the valve assembly 102 through the filling tube 110A, allowing the filling medium to enter region 142 and then into the working volume 130A of the valve cavity 140 and the compliance chamber 130. Then, when fluid is displaced from the valve cavity 140, it enters the working volume 130A of the compliance chamber 130, pushing the piston assembly 122 and the piston seal 120 backward to increase the size of the working volume 130A as needed, overcoming the biasing force of the spring 126.

[0105] For a physician using the infeeder system 100, it may be desirable to know whether sufficient filling medium has been introduced into the valve assembly 102 to adequately close the valve mechanism (e.g., valve membrane 128) of the medical device access. In one example, this can be achieved by including a pressure measuring mechanism that measures the amount of pressure exerted by the spring 126 (or other biasing mechanism) on the filling medium.

[0106] In one example, the pressure measuring mechanism may include a partially or fully transparent housing 112 to display the positions of the piston assembly 122 and the piston seal 120. For example, Figure 18 An example is illustrated of a valve assembly 102 having a housing 112 with a transparent portion 112A. In some examples, the entire housing 112 may be made of a transparent material, while in other examples, only a portion of the housing 112 may be made of a transparent material (e.g., a window or tubular portion).

[0107] Markings 150 may also be included on or near the transparent portion 112A. The position and / or calibration of these markings 150 may align the position of the piston seal 120 and / or piston member 122 with a specific pressure induced by the spring 126. In one example, markings 150 may include a digital scale indicating a pressure measurement (e.g., pounds per square inch) and / or non-digital markings arranged longitudinally along the housing 112 (e.g., parallel to an axis extending through the medical device channel). In some examples, markings 150 may include at least a numerical range covering or exceeding 11 pounds per square inch and 24 pounds per square inch (or their equivalents in other units). In some examples, it is desirable to maintain the pressure of the filling medium in the range of approximately 6.5 pounds per square inch to approximately 8.5 pounds per square inch (inclusive). For example, approximately 6.5, 7.0, 7.5, 8.0, or 8.5 pounds per square inch (plus or minus approximately 0.5 pounds per square inch). In some examples, a pressure of approximately 7.5 pounds per square inch may provide the desired seal of the valve membrane 128.

[0108] Alternatively, a pressure measuring device located outside the housing 112 and communicating with the interior of the valve assembly 102 may be used.

[0109] In another alternative example, the label 150 may indicate the volume of the filling medium within the valve assembly 102.

[0110] In another alternative example, the marking 150 may not indicate a specific unit of measurement, but rather provide the desired "position" or "position area" where the piston assembly 122 and / or piston seal 120 should be positioned during inflation. Such a position or area can be calibrated to be equivalent to the desired pressure within the valve assembly 102.

[0111] In another alternative example, valve assembly 102 may include an electronic pressure sensor located within housing 112, positioned to measure the pressure of the filling medium. The pressure sensor may be connected to an electronic display mounted externally to or separate from housing 112. The electronic display may show the pressure value and / or indicate that sufficient filling medium has been injected into valve assembly 102.

[0112] In some examples, the dilator 106 and the inserter sheath 104 may include features that minimize the dimensional transition between the distal portions of the dilator 106 and the inserter sheath 104. This helps prevent the inserter sheath 104 from becoming lodged in the vessel's sidewalls when inserted into the vessel. The walls of these vessels often contain calcified lesions that can restrict sheath advancement when the exposed edge of the sheath engages with these lesions. The edge may also become lodged with previously implanted devices, such as stents and filters.

[0113] For example, Figure 19 An enlarged cross-sectional view of the expander 106 and the inlet sheath 104 is shown, while Figure 20 Examples Figure 19 The enlarged portion of region 20. As previously described, the dilator may include a tapered tip 106A, the diameter of which decreases distally for easier insertion into the patient's vascular system. The dilator 106 may also include a region 106B with a diameter decreasing proximally, followed by a short region 106C distal to region 106B with a diameter increasing distally. This may form a circumferential groove, channel, or notch. The diameter of the distal portion 104A of the inserter sheath 104 may also decrease distally, such that the outer diameter of at least the tip of the inserter sheath 104 and the small distal portion of the possible distal portion 104A is substantially uniform with that of a portion 106D of the dilator 106 directly distal to the short region 106C. In this respect, the diameter between portions 106D will be substantially the same as that distal to the distal portion 104A. This allows for a more uniform transition of the outer diameter between the dilator 106 and the inserter sheath 104.

[0114] In some examples, the axial angle of the distal portion 104A of the infiltrator sheath 104 matches or is substantially the same as the axial angle of the proximal extension region 106B of the dilator 106. In some examples, the length of the distal portion 104A of the infiltrator sheath 104 may be about 0.05-0.25 inches, and its inner diameter decreases from the lumen inner diameter of the distal portion 104 by about 0.005 to about 0.030 inches (± about 0.001 inches). In some examples, the distal portion 104A of the infiltrator sheath 104 may be radially incised about 3.633 degrees relative to the immediately adjacent end portion of the infiltrator sheath 104 with a constant diameter.

[0115] In some examples, the length of region 106B of expander 106 is approximately 0.251 inches, and the length of short region 106C is approximately 0.014 inches (both ±0.003 inches). In some examples, the angle of region 106B of expander 106 is approximately 1.6 degrees (±1 degree), and the angle of short region 106C is approximately 26 degrees (±4 degrees), both radially inward relative to portion 106D.

[0116] The following is an example method for using the exemplary importer system 100 disclosed in this specification. However, variations of this method and partial steps of performing only this method are also considered.

[0117] Typically, the injector system 100 can be prepared for use. The valve 110B of the filling channel 110 can be opened, and air can be removed from the valve assembly 102 (e.g., by a syringe). The valve 110B can then be closed.

[0118] Next, a filling medium container (e.g., a syringe) can be attached to valve 110B, and valve 110B can be opened / actuated to fill or inject filling medium into valve assembly 102. The filling medium enters the working volume 130A of the compliance chamber 130 and the valve cavity 140 formed by the valve membrane 128. Injection of filling medium continues until the desired amount of filling medium is injected into valve assembly 102. In some examples, the operator can determine the amount of filling medium by marking 150 and the position of piston member 122 and / or piston seal 120 (or alternatively, by one of the other techniques previously described). Once the desired amount of filling medium has been injected into valve assembly 102, valve 110B can be closed. At this point, the medical device access in valve assembly 102 is in the closed position.

[0119] Physiological saline or a similar flushing solution can be injected into the valve 108B of the flushing channel 108, allowing fluid to expel any air bubbles within the medical device channel of the valve assembly 102 and the inlet sheath 104.

[0120] Next, the dilator 106 can be advanced into the proximal opening of the medical device channel of the valve assembly 102. In some examples, the clamp assembly may be a separate component already located on the end of the proximal portion 106E of the dilator 106, and thus engaged with the valve assembly 102 by an interlocking mechanism (e.g., a tab on the distal end of the clamp assembly engages with a groove on the proximal face of the valve assembly 102).

[0121] Once the interlocking mechanism engages, the axial / longitudinal position of the dilator 106 can be adjusted so that its recesses (regions 106B and 106C) align with the reduced-diameter portion of the distal portion 104A to create a uniform or “seamless” transition between the two components. A clamping lever 116 at the proximal end of the valve assembly 102 has an open position and a closed position, the closed position being actuated to clamp / release the proximal portion 106E of the dilator 106 into the valve assembly 102, maintaining the longitudinal position of the dilator 106 and the inlet sheath 104 relative to each other. The clamping lever 116 can be engaged to lock the dilator 106 in its axial position.

[0122] The tapered tip 106A of the dilator 106 and the distal portion 104A of the introducer sheath 104 may have a guidewire lumen placed on a guidewire previously advanced into the patient. The tapered tip 106A of the dilator 106 and the distal portion 104A of the introducer sheath 104 are advanced distally along the guidewire until the introducer sheath 104 is substantially within the patient's vascular system. As the valve membrane 128 is inflated, it presses and seals the outer surface of the dilator 106 to substantially or largely prevent blood leakage and maintain hemostasis.

[0123] The dilator 106 can be withdrawn proximally from the inlet sheath 104 and valve assembly 102. When the dilator 106 is removed, the inflated valve membrane 128 increases in size due to pressure from the compliance chamber 130, thereby closing the medical device access.

[0124] Finally, one or more medical devices (e.g., guidewires, catheters, etc.) can be advanced into the valve assembly 102, the delivery sheath 104, and into the patient. The valve membrane 128 displaces the filling medium into the compliance cavity 130 to accommodate the inserted medical device. A single device can be inserted into the delivery system 100, or two or more devices can be inserted side-by-side with each other.

[0125] In the example described in this specification, the injector sheath 104 and the valve assembly 102 are fixed together in a non-removable manner. However, in other examples, the valve assembly 102 and the injector sheath 104 may be detachable.

[0126] In some examples, the filling medium may be saline, water, other fluids, foam, or gel. In other examples, the filling medium may be a gas, such as air. Generally, the use of a fluid is more desirable because it reduces the risk of air bubbles entering the patient's vascular system. However, adequately sealed and / or isolated compliant lumens 130 and valve lumens 140 may allow the use of gas as a filling medium.

[0127] Although compliance cavity 130 is typically illustrated as being located within housing 112, which also contains valve cavity 140, compliance cavity 130 may alternatively be located in a separate housing connected to housing 112 via a tube or similar structure.

[0128] Although this delivery system 100 has been described as being for use in the vascular system of a patient, it can also be used in other non-vascular parts of the patient.

Claims

1. An importer system, characterized in that, include: Injector sheath; Valve assembly, the valve assembly being connected to the injector sheath; A medical device channel, defined by the inlet sheath and the valve assembly; A flexible material located within the valve assembly, the flexible material having an inner surface exposed along a portion of the medical device channel and an outer surface that at least partially defines the valve cavity; as well as The compliance cavity is located within the valve assembly and communicates with the valve cavity; the compliance cavity also includes a piston assembly located inside the compliance cavity, the piston assembly being movable between multiple positions to accommodate a filling medium.

2. The importer system according to claim 1, characterized in that, The piston assembly includes a piston member connected to a piston seal and a biasing member, the biasing member biasing the piston member to reduce the working volume of the compliance chamber.

3. The importer system according to claim 2, characterized in that, The compliant cavity is arranged in a ring around at least a portion of the valve cavity.

4. The importer system according to claim 3, characterized in that, The piston component is annular.

5. The importer system according to claim 2, characterized in that, The biasing component is a spring.

6. The importer system according to claim 5, characterized in that, The spring is a helical coil spring, leaf spring, disc spring, leaf spring, or machined spring.

7. The importer system according to claim 2, characterized in that, The biasing component is an elastic compressible material, a pneumatic piston mechanism, or a hydraulic piston mechanism.

8. The importer system according to claim 2, characterized in that, The piston seal is a cup-shaped seal with an annular channel.

9. The importer system according to claim 8, characterized in that, The compliant cavity further includes an annular ridge, which is positioned to mate with the annular channel of the cup-shaped seal.

10. The importer system according to claim 1, characterized in that, The flexible material has a generally tubular shape.

11. The importer system according to claim 10, characterized in that, The generally tubular shape has a flexible middle section and radially enlarged end sections.

12. The importer system according to claim 10, characterized in that, The flexible material forms multiple longitudinal folds that extend radially outward.

13. The importer system according to claim 10, characterized in that, The generally tubular shape also includes a slit valve covering the cavity of the generally tubular shape.

14. The importer system according to claim 1, characterized in that, It also includes a clamp connected to the valve assembly, the clamp having a closed clamp position and an open clamp position, the closed clamp position being configured to clamp the proximal portion of the dilator, and the open clamp position being configured to release the proximal portion of the dilator and allow the dilator to move longitudinally relative to the inlet sheath.

15. The importer system according to claim 1, characterized in that, It also includes a pressure measuring device.

16. The importer system according to claim 2, characterized in that, The valve assembly also includes a valve shell, at least a portion of which is transparent, and includes markings indicating the pressure value of the filling medium within the valve assembly.

17. The importer system according to claim 16, characterized in that, The piston assembly, the piston seal, or both are configured to align with the mark to indicate the pressure value of the filling medium within the valve assembly.

18. The importer system according to claim 15, characterized in that, The pressure measuring device is an electronic pressure sensor and an electronic display electrically connected to the pressure sensor.

19. The importer system according to claim 1, characterized in that, The compliance cavity also includes multiple compliance cavities.

20. The importer system according to claim 19, characterized in that, The plurality of compliant cavities are arranged in a ring around the medical device channel.

21. An importer system, characterized in that, include: Injector sheath; Valve assembly, the valve assembly being connected to the injector sheath; A medical device channel, defined by the inlet sheath and the valve assembly; A valve assembly having an inflation configuration that seals the medical device channel within the valve assembly; as well as A piston assembly located within and in communication with the valve assembly.

22. The importer system according to claim 21, characterized in that, The piston assembly is arranged in a ring around the medical device channel.

23. An importer system, characterized in that, include: Valve assembly, the valve assembly being connected to the injector sheath; A medical device channel, the medical device channel being defined by the valve assembly; A valve assembly having an inflation configuration that seals the medical device channel within the valve assembly; as well as A piston assembly located within and in communication with the valve assembly.

24. The importer system according to claim 23, characterized in that, It also includes an infeeder sheath connected to the valve assembly, the infeeder sheath further defining the medical device channel.

25. An importer system, characterized in that, include: Injector sheath; Valve assembly, the valve assembly being connected to the injector sheath; A medical device channel, defined by the inlet sheath and the valve assembly; as well as A pressure measuring mechanism configured to transmit pressure within the valve assembly.

26. The importer system according to claim 25, characterized in that, The pressure measuring mechanism includes a transparent portion of the valve assembly housing and is configured to measure the filling medium within the valve assembly.

27. The importer system according to claim 26, characterized in that, It also includes a marker located on the valve assembly housing; the marker is configured to indicate the pressure of the filling medium within the valve assembly based on the position of the compliant intracavitary member of the valve assembly.

28. The importer system according to claim 25, characterized in that, The pressure measuring mechanism includes an electronic pressure sensor connected to an electronic display configured to display the pressure value measured by the electronic pressure sensor.

29. A method of using an importer system, characterized in that, include: An injector system is provided, the injector system including an injector sheath and a valve assembly, the injector sheath and the valve assembly defining a medical device channel; The valve assembly is filled with a filling medium until the flexible material fills and extends into the medical device channel to seal the medical device channel. Place the medical device into the medical device channel; as well as The valve assembly contains a compliance cavity that accommodates a filling medium that has been displaced by the movement of the flexible material caused by the medical device; wherein the compliance cavity includes a piston assembly.

30. An importer system, characterized in that, include: Injector sheath; Valve assembly, the valve assembly being connected to the injector sheath; A medical device channel, defined by the inlet sheath and the valve assembly; as well as Expander; The expander includes a distal region having an annular channel; the inlet sheath includes a distal end with a diameter that gradually decreases distally to fit within the annular channel of the expander and to minimize the transition between the outer surface of the expander and the outer surface of the inlet sheath.

31. An importer system, characterized in that, include: Injector sheath; Valve assembly, the valve assembly being connected to the injector sheath; A medical device channel, defined by the inlet sheath and the valve assembly; An expander including a distal region having an annular channel; an inlet sheath including a distal end having a diameter that gradually decreases distally to fit within the annular channel of the expander and to minimize the transition between the outer surface of the expander and the outer surface of the inlet sheath. as well as A clamp assembly having an open state and a clamping state, the open state allowing longitudinal movement of the dilator relative to the valve assembly and the inlet sheath, and the clamping state preventing longitudinal movement of the dilator relative to the valve assembly and the inlet sheath.

32. The importer system according to claim 31, characterized in that, The clamp assembly can be connected to the proximal portion of the valve assembly via an interlocking mechanism.

33. A method of using an importer system, characterized in that, include: An injector system is provided, the injector system including an injector sheath and a valve assembly, the injector sheath and the valve assembly defining a medical device channel; Insert the dilator into the valve assembly and the inlet sheath; Adjust the longitudinal position of the expander so that the channel on the distal portion of the expander is aligned with the distal end of the inlet sheath; as well as The proximal portion of the dilator is clamped to the valve assembly to prevent longitudinal movement of the dilator relative to the valve assembly and the inlet sheath.

34. The method according to claim 33, characterized in that, The step of inserting the dilator into the valve assembly further includes connecting the interlocking assembly of the clamp assembly located on the proximal portion of the dilator to the valve assembly.

35. An importer system, characterized in that, include: Injector sheath; Valve assembly, the valve assembly being connected to the injector sheath; A medical device channel, defined by the inlet sheath and the valve assembly; An expander including a distal region having an annular channel; an inlet sheath including a distal end having a diameter that gradually decreases distally to fit within the annular channel of the expander and to minimize the transition between the outer surface of the expander and the outer surface of the inlet sheath. as well as A sheath movement assembly includes an actuator that longitudinally moves the infeeder sheath relative to the valve assembly and the dilator so that a user can align the annular channel with the distal end of the infeeder sheath.

36. The importer system according to claim 35, characterized in that, The actuator includes a thumbwheel, a slider, or a tubular actuator.

37. A method of using an importer system, characterized in that, include: An injector system is provided, the injector system including an injector sheath and a valve assembly, the injector sheath and the valve assembly defining a medical device channel; Insert the dilator into the valve assembly and the inlet sheath; Adjust the longitudinal position of the introducing sheath so that the channel on the distal portion of the dilator is aligned with the distal end of the introducing sheath.

38. The method according to claim 37, characterized in that, The step of inserting the dilator into the valve assembly further includes connecting the interlocking assembly of the dilator on the proximal portion of the dilator to the valve assembly.

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