Introducer sheath system and method

Abstract

An introducer sheath system comprising a pressure regulator operably coupled to a hemostatic valve, the pressure regulator comprising a chamber filled with gas and fluidically isolated from the hemostatic valve. The introducer sheath system may comprise a tubular sheath, a hub assembly, and an expander connected to the proximal end of the sheath and positioned within the sheath, the hub assembly comprising a housing and a hemostatic valve positioned therein, and the introducer sheath system further comprises a pressure regulator connected to the hub and in fluid communication with the hemostatic valve, and a sealed chamber defined by the pressure regulator, the chamber comprising an internal space, the internal space being filled with gas and fluidically isolated from the hemostatic valve.

Description

[Technical Field]

[0001] Reference to related applications This application claims the interests of U.S. Provisional Patent Application No. 63 / 498,637 filed on 27 April 2023, U.S. Provisional Patent Application No. 63 / 512,740 filed on 10 July 2023, and U.S. Provisional Patent Application No. 63 / 591,928 filed on 20 October 2023, the entirety of which disclosures are incorporated herein by reference.

[0002] This disclosure generally relates to introducer sheath systems that provide a conduit for insertion into a blood vessel to introduce an intravascular device, while providing hemostatic sealing to minimize blood loss. Embodiments of this disclosure also have applications to other catheter and cannula structures, as well as other related clinical applications. [Background technology]

[0003] Patent document 1 by Arcaro et al. generally describes an introducer sheath that includes a valve providing a seal around a device inserted through the introducer sheath. Arcaro et al. describes a valve comprising an inner tube formed of stretched polytetrafluoroethylene (ePTFE) and an outer tube formed of an elastomer. The space between the outer tube and the inner tube can be pressurized, as a result the inner tube folds around the device inserted through it, thereby providing a seal to suppress backflow bleeding. The outer tube expands from an hourglass shape when the space is pressurized, thereby visually indicating that sufficient pressure has been established.

[0004] The device described by Arcaro et al. generally corresponds to a commercially available product called the GORE DrySeal® Flex Inducer Sheath. During use, as the valve pressure increases, the friction acting around the device inserted through it also increases. This is particularly noticeable when large-diameter devices, such as TAVR delivery systems, are inserted through the sheath, where both pressure and friction increase. Such friction may impede the movement and control of the device inserted through the valve. [Prior art documents] [Patent Documents]

[0005] [Patent Document 1] U.S. Patent No. 10960198 [Overview of the project]

[0006] To address these challenges, this disclosure describes, in one embodiment, an introducer sheath system comprising a pressure regulator operably coupled to a valve. The pressure regulator facilitates the movement of the inserted device and enables better control by reducing the magnitude of the pressure rise when the device is inserted into the valve, thereby suppressing the degree of friction increase. The pressure regulator may utilize a compressible component that is operably coupled to the valve but is fluidically isolated from the valve. The pressure regulator may comprise a fluidically isolated chamber. Examples of fluidically isolated chambers include, but are not limited to, bladder, diaphragm chamber, and closed-cell foam component. The fluidically isolated chamber may be filled with at least a portion of a gas (e.g., air) to increase flexibility compared to the liquid (e.g., saline) used to pressurize the valve. When a gas is used in the pressure regulator, fluid isolation is useful to prevent the gas from being introduced into the vascular system in the event of valve failure.

[0007] Embodiments of introducer sheath systems described herein also offer other advantages, such as bubble trapping, alternative anchoring systems, alternative hemostatic valve designs, and device braking functions. These improvements are described in further detail herein with reference to the following drawings. The above summary is not intended to describe any embodiment or configuration of the present disclosure.

[0008] The drawings illustrate exemplary embodiments of the present disclosure and, together with this description, serve to illustrate the principles of the present disclosure. The drawings merely illustrate specific embodiments and do not limit the present disclosure or the invention. [Brief explanation of the drawing]

[0009] [Figure 1] This is an assembly perspective view of an introducer sheath system according to one embodiment of the present disclosure. [Figure 2A] Figure 1 is a detailed perspective view of the proximal portion of the introducer sheath system. [Figure 2B] Figure 1 is a detailed perspective view of the proximal portion of the introducer sheath system. [Figure 3] Figure 1 is a longitudinal cross-sectional view of the proximal portion of the introducer sheath system. [Figure 3A] Figure 3 is a longitudinal cross-sectional view of an exemplary embodiment of the valve assembly shown. [Figure 3B] Figure 3 is a longitudinal cross-sectional view of an exemplary embodiment of the valve assembly shown. [Figure 4] This is an assembly perspective view of an introducer sheath system according to another embodiment of the present disclosure. [Figure 5A] Figure 4 is a longitudinal cross-sectional view of the proximal portion of the introducer sheath system. [Figure 5B] Figure 4 is a longitudinal cross-sectional view of the proximal portion of the introducer sheath system. [Figure 6A]A longitudinal cross-sectional view of the proximal portion of the introducer sheath system shown in FIG. 4, showing the state in which the dilator is inserted and the state in which it is withdrawn. [Figure 6B] A longitudinal cross-sectional view of the proximal portion of the introducer sheath system shown in FIG. 4, showing the state in which the dilator is inserted and the state in which it is withdrawn. [Figure 7A] A composite graph of pressure and friction with respect to the size (diameter) of the device inserted into the hemostatic valve. [Figure 7B] A line graph showing test data of valve pressure (PSI) with respect to device size (mm2). [Figure 7C] A table showing the slopes obtained along the least-squares approximation line for each data series in FIG. 7B. [Figure 8A] A perspective view of a hub assembly according to an alternative embodiment of the present disclosure. [Figure 8B] A longitudinal cross-sectional view of a hub assembly according to an alternative embodiment of the present disclosure. [Figure 9A] A perspective view of an anchor mechanism according to an embodiment of the present disclosure. [Figure 9B] A perspective view of an anchor mechanism according to an embodiment of the present disclosure. [Figure 10A] A schematic perspective view of a hemostatic valve according to an alternative embodiment of the present disclosure. [Figure 10B] A schematic perspective view of a hemostatic valve according to an alternative embodiment of the present disclosure. [Figure 10C] A schematic perspective view of a hemostatic valve according to an alternative embodiment of the present disclosure. [Figure 10D] A schematic perspective view of a hemostatic valve according to an alternative embodiment of the present disclosure. [Figure 10E] A schematic perspective view of a hemostatic valve according to an alternative embodiment of the present disclosure. [Figure 11] A schematic longitudinal cross-sectional view of a hemostatic valve according to another alternative embodiment of the present disclosure. [Figure 12A] A schematic side view of a hemostatic valve according to yet another alternative embodiment of the present disclosure. [Figure 12B]This is a schematic end view of a hemostatic valve according to yet another alternative embodiment of the present disclosure. [Figure 12C] This is a schematic side view of a hemostatic valve according to yet another alternative embodiment of the present disclosure. [Figure 12D] This is a schematic end view of a hemostatic valve according to yet another alternative embodiment of the present disclosure. [Figure 12E] This is a schematic plan view of a hemostatic valve according to yet another alternative embodiment of the present disclosure. [Figure 12F] This is a side view of a hemostatic valve according to yet another alternative embodiment of the present disclosure. [Figure 12G] This is a longitudinal cross-sectional view of a hemostatic valve according to yet another alternative embodiment of the present disclosure. [Figure 13A] This is a schematic transverse cross-sectional view of a hemostatic valve according to another alternative embodiment of the present disclosure. [Figure 13B] This is a schematic transverse cross-sectional view of a hemostatic valve according to another alternative embodiment of the present disclosure. [Figure 13C] This is a schematic transverse cross-sectional view of a hemostatic valve according to another alternative embodiment of the present disclosure. [Figure 13D] This is a schematic transverse cross-sectional view of a hemostatic valve according to another alternative embodiment of the present disclosure. [Figure 14] This is a schematic end view of a hemostatic valve according to another alternative embodiment of the present disclosure. [Figure 15A] This is a schematic perspective view of a hemostatic valve according to another alternative embodiment of the present disclosure. [Figure 15B] This is an end view of a hemostatic valve according to another alternative embodiment of the present disclosure. [Figure 16A] This is a perspective view of an introducer sheath system according to yet another embodiment of the present disclosure. [Figure 16B] This is a longitudinal cross-sectional view of an introducer sheath system according to yet another embodiment of the present disclosure. [Figure 17] This is a schematic top view of a portion of an introducer sheath system according to yet another embodiment of the present disclosure. [Figure 18A]This is a schematic side view of an isolation sheath according to one embodiment of the present disclosure. [Figure 18B] This is a schematic end view of an isolation sheath according to one embodiment of the present disclosure. [Figure 18C] This is a schematic end view of an isolation sheath according to one embodiment of the present disclosure. [Figure 18D] This is a schematic end view of an isolation sheath according to one embodiment of the present disclosure. [Figure 19A] This is a schematic side view of an anchor mechanism according to an alternative embodiment of the present disclosure. [Figure 19B] This is a schematic top view of an anchor mechanism according to an alternative embodiment of the present disclosure. [Figure 19C] This is a schematic side view of an anchor mechanism according to another alternative embodiment of the present disclosure. [Figure 20A] This is a schematic perspective view of another expander and its usage according to an alternative embodiment of the present disclosure. [Figure 20B] This is a schematic perspective view of another expander and its usage according to an alternative embodiment of the present disclosure. [Figure 20C] This is a schematic perspective view of another expander and its usage according to an alternative embodiment of the present disclosure. [Figure 20D] This is a schematic perspective view of another expander and its usage according to an alternative embodiment of the present disclosure. [Figure 20E] This is a schematic perspective view of another expander and its usage according to an alternative embodiment of the present disclosure. [Figure 20F] This is a schematic perspective view of another expander and its usage according to an alternative embodiment of the present disclosure. [Modes for carrying out the invention]

[0010] The embodiments of this disclosure are applicable to various modifications and other forms, specific examples of which are illustrated in the drawings and described in detail below. However, it should be understood that this disclosure is not intended to limit the invention to the specific embodiments described herein. Rather, the invention encompasses all modifications, equivalents, and substitutions that fall within the spirit and scope of the invention.

[0011] Referring to Figure 1, an assembly diagram of an introducer sheath system 100A according to one embodiment of the present disclosure is shown. Generally, the system 100A may include a tubular sheath body 110, a dilator 120 extending through the sheath, and a main hub assembly 130A connected to the proximal end of the sheath body 110. The assembly 100A can be inserted into a blood vessel as a system, leaving the main hub 130A outside the body. After placement, the dilator 120 may be removed so that a conduit leading into the blood vessel is defined via the hub 130A and the sheath 110.

[0012] The sheath body 110 may include, for example, a composite tube comprising a polytetrafluoroethylene (PTFE) inner layer or liner, a stainless steel coil arranged around the inner layer, and an outer layer (e.g., polyether block amide) arranged outside the coil. The sheath body 110 may be connected to the main hub assembly 130A via, for example, a screw connector 132. To improve visibility under fluoroscopy, radiopaque marker bands may be incorporated, for example, at the distal end between the layers of the sheath body 120. The specific composite structures of the sheath body 110 described above are illustrative and not intended to be limiting, and other composite structures or integrally molded structures may be used. The sheath 110 may be supplied in sizes (diameters) ranging from 3.3 mm to 8.7 mm (10F to 26F) and in lengths of 33 cm, 45 cm, or 65 cm.

[0013] The dilator 120 may include, for example, a relatively rigid low-density polyethylene (LDPE) tube comprising a tapered distal end 122, a main body portion 124 of a constant diameter, and a proximal hub 126. The lumen of the dilator 120 extends along its entire length and can accommodate a guidewire (e.g., one that fits a 0.889 mm (0.035 inch) diameter guidewire, not shown), through which the assembly 100A is delivered. The main body portion 124 may have an outer diameter substantially matching the inner diameter of the sheath body 110, with a small gap between them to allow relative movement. The tapered distal end 122 of the dilator facilitates gradual dilation of the vascular puncture site and provides a smooth transition from the guidewire to the distal tip portion 112 of the sheath. The dilator hub 126 may include an interlock portion that mates with and is detachably secured to the main hub assembly 130A. To improve visibility under fluoroscopy, the expander 120 may be filled with a radiation-impermeable material such as barium sulfate.

[0014] The main hub assembly 130A generally includes a housing 134 formed, for example, of an injection-molded polymer. A sheath-hub connector 132 may be fixed to the distal side of the housing 134. A hemostatic valve (not shown in this figure) may be housed in the proximal side of the housing 134. Generally, the hemostatic valve provides a seal around the inserted device to minimize blood loss. The hemostatic valve may comprise a relatively rigid or non-foldable valve body 162 and a foldable sleeve 160 (e.g., ePTFE, ethylene fluoride propylene (FEP), or a laminate thereof) attached to both ends of the valve body 162. The sleeve 160 can be compressed by pressurizing the space between the valve body 162 and the sleeve 160. Pressurization of the sleeve 160 may be performed by connecting a syringe filled with saline to the valve line 136 via a connector 138 (e.g., a needleless valve, stopcock, etc.) and injecting saline through it. The connector 138 associated with the valve line 136 may be configured differently from the connector 142 associated with the flush line 140 to avoid confusion between connectors and reduce human error.

[0015] The hub assembly 130A also includes a flush line 140 with a connector (e.g., a three-way valve) for connecting to a syringe or power injector, thereby facilitating the injection or removal of gases such as air, or liquids such as saline or contrast agents, into and from the introducer sheath 100A and / or the vascular system. The hub housing 134 may define a transparent bubble chamber 144 for visualizing air bubbles that may be accidentally introduced when inserting a large device into the hub 130A, thereby allowing these bubbles to be removed via the flush line 140. To facilitate this, the flush line may be connected to the vertical apex of the bubble chamber 144.

[0016] The introducer sheath assembly may further include a pressure regulator 150A operably connected to the valve assembly. The pressure regulator 150A can reduce the magnitude of the increased pressure in the space between the valve body 162 and the foldable sleeve 160 when the device is inserted into the valve assembly. By reducing the magnitude of the increased pressure, the pressure regulator 150A can suppress the degree of increased friction exerted by the sleeve on the device inserted into the valve assembly. By suppressing friction, the inserted device can be manipulated more freely relative to the sheath assembly 100A or moved in other ways relative to the sheath assembly 100A, thereby improving the controllability of the device.

[0017] The pressure regulator 150A may include a housing that defines or houses a sealed chamber. The outside of the sealed chamber may be in fluidic communication with a valve, while the inside of the sealed chamber may be fluidically isolated from the valve. The inside of the chamber may contain a compressible component (e.g., a gas such as air) that is more compressible than a fluid (e.g., a liquid such as saline solution). For example, the sealed chamber may contain closed-cell foam with air inside the cells. Alternatively, the sealed chamber may be defined by a flexible diaphragm supported by a rigid housing, and the chamber may be filled with air. As a further alternative, the sealed chamber may include an air-filled bladder. Another alternative is a piston-chamber configuration in which a plunger with a sliding seal is located in an air-filled chamber. In any case, the inside of the sealed chamber may be fluidically isolated from the valve. When using gas in the pressure regulator, fluidic isolation may be beneficial to prevent the gas from entering the vascular system in the event of valve failure.

[0018] For illustrative purposes only and not limiting, the pressure regulator 150A may be located in a separate location away from the hub 130A and connected by a pipe, connected to the hub 130A via a molded orifice, or integrated with the hub 130A as shown in the figure. Further embodiments of the configuration and function of the valve and pressure regulator will be described in more detail below.

[0019] Referring to Figures 2A and 2B, additional details of the interconnection between the hub 126 of the dilator 120 and the hub assembly 130A can be understood. The interconnection between the dilator hub 126 and the hub assembly 130A may include an interlocking section 128 having a configuration corresponding to each component and fitting and locking. For example, the interlocking section 128 may include a tab on one component and a corresponding opening on the other component, and the tab can be inserted into the opening and locked by twisting the hub (relatively). Alternatively, the interlocking section 128 may have male and female threads or a snap-fit ​​configuration. In any case, the interlocking section 128 allows the sheath system 100A to be inserted into the blood vessel as a locked assembly, and then the hub can be unlocked to remove the dilator 120 from the sheath 110 and the main hub 130A.

[0020] Referring to Figure 3, a longitudinal section of the hub assembly 130A is shown, allowing for a more detailed understanding of its internal components. The main hub 130A includes a housing 134 and a cap 135 that accommodates the valve body 162. The device may be inserted into the hub assembly via an on-axial port 170. Inside the valve body 162 is a foldable sleeve 160. As previously mentioned, when the space between the relatively rigid valve body 162 and the sleeve 160 is pressurized, the sleeve 160 folds as indicated by the thick arrow, sealing around one or more devices inserted therein.

[0021] Simultaneously, in this example, the pressure regulator 150A is a closed-cell foam disc 152A housed within the housing 134 by a cap 154 ​​and compressed as indicated by the bold arrow. The closed-cell foam disc may have a different shape and size than that shown. A fluid passage may be defined by the housing 134 to provide fluid communication from the pressurized space outside the sleeve 160 to the space housing the closed-cell foam disc 152A. However, because the foam disc 152A is closed-cell, its interior is fluidly isolated from the pressurized space around the sleeve 160.

[0022] Referring to Figures 3A and 3B, two embodiments of the valve assembly are shown in more detail in longitudinal section views. In each embodiment, the valve assembly may include a relatively rigid or non-foldable valve body 162 and a relatively foldable valve sleeve 160. The foldable sleeve 160 may include an ePTFE laminate in which ePTFE, densified ePTFE, or FEP is laminated on ePTFE, and the ePTFE may be in tubular or sheet form and may later be wound into a tubular shape. The valve body 162 may include an injection-molded polymer. To attach the valve sleeve 160 to the valve body 162 and provide both a mechanical connection and a fluid sealing connection between them, the ends of the sleeve 160 may be wrapped around or folded back around the ends of the valve body 162 and secured, for example, with a pair of silicone O-rings 164. As shown, the O-rings 164 may be positioned within a notch, and the ends of the sleeve 160 may extend into all or part of the notch to provide a mechanical interlock. Optionally, a polymer ring 163 may be placed on the end of the sleeve 160 and joined to the valve body 162 by adhesive or heat fusion. The adhesive or heat fusion between the valve sleeve 160 and the valve body 162 may be applied, for example, to the upper surface of the valve body 162 adjacent to the peripheral edge of the end face of the valve body 162 and / or adjacent to the end of the sleeve 160.

[0023] Referring to Figure 4, an assembly diagram of an alternative introducer sheath system 100B is shown. In general, the embodiment 100B shown in Figure 4 may be identical or similar to the embodiment shown in Figure 1, except that the pressure regulator 150B is located coaxially rather than offset. In this embodiment as well, as in the previously described embodiment, system 100A includes the sheath 110, expander 120, and hub assembly 130B, similar components are numbered the same, and identical or similar alternative features may be adopted.

[0024] The differences in the configuration of the pressure regulator 150B can be better understood by referring to Figures 5A and 5B, which show longitudinal cross-sectional views of the hub 130B. Similarly, similar components are denoted by the same reference numerals and generally have the same or similar functions, but their configurations differ. Figure 5A shows the sleeve 160 of the hemostatic valve in an unpressurized state (at shipment), and Figure 5B shows the sleeve 160 in a pressurized state (in use). Referring specifically to Figure 5B, a liquid (e.g., saline solution) is injected into the valve line 136 (as indicated by the upper block arrow), thereby pressurizing the space between the valve body and the sleeve 160, and causing the sleeve 160 to fold (as indicated by the lower block arrow). At the same time, the closed-cell member 152B is compressed (as indicated by the middle block arrow), thereby reducing the increase in friction acting on the device inserted through its interior, as described above. In this embodiment, the closed-cell member 152B may be in the configuration of an annular disc or a tube, as shown.

[0025] Figures 6A and 6B are longitudinal cross-sectional views focusing on the effect on the hemostatic valve when the expander 120 is inserted (Figure 5A) and when the expander 120 is withdrawn (Figure 5B). When pressurized, as shown in Figure 5B, the sleeve 160 of the hemostatic valve folds to prevent backflow bleeding when no device is inserted. As shown in Figure 5A, when the expander 120 is inserted through the axial port 170, the sleeve 160 of the hemostatic valve expands to accommodate the expander 120 while maintaining a seal around the expander 120 to prevent backflow bleeding. Similarly, when one or more other devices are inserted into the valve through the axial port 170, the sleeve expands, the pressure increases, and the hemostatic seal is maintained. The pressure regulator 150B suppresses the increase in pressure and consequently suppresses any additional friction acting on the inserted device.

[0026] This relationship is schematically shown in Figure 7A, which is a composite graph of pressure and friction against the size (diameter) of the device inserted into the valve. Generally, the slopes for both pressure vs. size and friction vs. size are larger for devices of the prior art. With the pressure regulator 150 of the present invention, the curve becomes gentler, i.e., the slope is smaller than in the prior art. As the size of the inserted device increases, the increase in pressure and friction can be suppressed by the pressure regulator 150 compared to the prior art. In the case of pressure vs. size, the slope can be characterized as the reciprocal of compliance, and the pressure regulator 150A of this disclosure provides greater compliance than in the prior art.

[0027] Figure 7B shows the device size (mm 2The line graph of valve pressure (PSI) relative to the device is shown, making this difference clearer. In this test, three samples of an 8.7 mm (26F) introducer sheath system configured according to the embodiment shown in Figure 1 were compared with a prior art 8.7 mm (26F) device (Gore DrySeal® Flex Introducer Sheath). For each test, the hemostatic valve was pressurized to 69 kPa (10 PSI) with saline solution, and 4.0 mm (12F), 6.7 mm (20F), and 8.7 mm (26F) expanders were sequentially inserted into the hemostatic valve. Pressure measurements within the valve chamber were performed both without expanders and with expanders of various sizes installed. In all cases, the pressure increased as larger devices were inserted. However, the rate of pressure increase was significantly lower in the samples configured according to this disclosure compared to the prior art.

[0028] Figure 7C is a table showing the slopes obtained along the least-squares approximation line for each data series in Figure 7B. Conventional devices have a slope of 2.3 kPa / mm² based on device area. 2 (0.34 PSI / mm 2 ), or a tilt of 16 kPa / mm (0.75 PSI / F) relative to the device diameter. (Note that "F" is an abbreviation for French, a standard unit in the catheter field, equivalent to 3 mm.) In comparison, samples of devices constructed based on this disclosure had less than half the tilt of prior art devices. Similarly, lower pressure values ​​correspond to reduced friction for the device inserted into the valve.

[0029] For illustrative purposes only and not limiting, the pressure regulators of this disclosure reduce the pressure increase associated with increasing device size (based on device area) by 2.1 kPa / mm². 2 (0.30 PSI / mm 2 The pressure should be suppressed at a rate of less than 1.4 kPa / mm², preferably 1.4 kPa / mm². 2 (0.20 PSI / mm 2 ) less than, more preferably 1.0 kPa / mm2 (0.15 PSI / mm 2 ) can be suppressed at a rate less than this. This is also shown by way of example and is not limiting. The pressure regulator of the present disclosure suppresses the pressure increase associated with an increase in device size (based on device diameter) at a rate less than 14 kPa / mm (0.70 PSI / F), preferably less than 10 kPa / mm (0.50 PSI / F), and more preferably less than 7.2 kPa / mm (0.35 PSI / F).

[0030] Referring to FIG. 8A, a perspective view of an alternative hub assembly 130C is shown. Generally, the embodiment shown in FIG. 8A may be the same as or similar to the embodiment shown in FIG. 1, but differs in that the hub assembly 130C includes an off-axis port 180 in addition to the on-axis port 170 shown and described above, thereby constituting a dual valve hub 130C. Also in this embodiment, as in the previous embodiments, the hub 130C is connected to the sheath 110 and may be used with an expander 120 (not shown), and the same reference numerals are given to the same components, and the same or similar alternative features may be adopted. In this example, the on-axis port 170 may be sized to accommodate a large-diameter device (e.g., greater than 4.0 mm (12F)), and the off-axis port 180 may be sized to accommodate a normal-diameter device (e.g., less than 4.0 mm (12F)).

[0031] Generally, by providing the off-axis port 180, auxiliary devices such as guide wires and diagnostic catheters can be introduced through the same introducer sheath system without the need for an additional vascular access site and without the problems associated with the associated puncture and closure. As shown in FIG. 8B, the off-axis port 182 may include a separate hemostatic valve 182, which may include a passive seal (e.g., a slotted elastomeric gasket) as shown, or an active seal such as the valve 160.

[0032] As a further alternative, either the on-axial port 170 or the off-axial port 180 may be configured to connect to an extracorporeal membrane oxygenation (ECMO) device, with a standard connector configured for connection to the ECMO tube, so that one conduit receives oxygenated blood flow and the other conduit receives an intervention device.

[0033] Referring to Figures 9A and 9B, an alternative dual valve hub 130D is shown in perspective view. The dual valve hub 130D may have a different shape and appearance compared to the hub 130C, but the active hemostatic valve 160 and passive hemostatic valve 182 associated with the on-axis port 170 and off-axis port 180, respectively, may operate on the same or similar principles. In this embodiment, several alternative design features are shown that may be used with any of the hub assemblies 130 described herein. For example, to facilitate pressurization of valve 160, the valve line 136 is omitted and instead a connector 138 (e.g., a needleless valve) is provided that is directly attached to the housing. Furthermore, an anchor wing 190 is provided, which may be fixedly or detachably attached to the base of the hub 130D. The anchor wing 190 allows the hub 130D to be fixed to the vascular access site by multiple means, such as surgical clamps positioned on the wing 190 and the drape, and / or sutures positioned through suture holes provided in the wing 190 and tied to the patient's skin or surgical dressing.

[0034] Furthermore, as most clearly shown in Figure 9B, the secondary anchor member 195 may be detachably connected to the anchor wing 190 by a snap-fit ​​or similar means. The secondary anchor member 195 may have an adhesive patch on its underside for temporary adhesion to the patient's skin, surgical drape, or covering. A push tab 197 may be provided for removing the secondary anchor member 195 from the anchor wing 190, and reattachment can be performed by snap-fitting by pushing the anchor wing 190 into the secondary anchor member 195. This detachable attachment means may allow the introducer sheath to be removed for operation and reattached after completion.

[0035] In general, the remaining figures illustrate various alternative embodiments of selected parts, elements, or features of the introducer sheath system described above. Although not illustrated as a complete system, they can be incorporated into such a system individually or in various combinations.

[0036] Figure 10A shows a schematic perspective view of the configuration of an alternative hemostatic valve 300. In this embodiment, an inner sealing membrane 302 is provided within an outer tube or housing 304, and the sealing membrane has a circumference greater than the sum of the contact perimeters of the devices being sealed (e.g., catheter 10 and / or guidewire 20). The inner sealing membrane 302 may be a thin-walled elastomer or non-elastomer tube having a perimeter X and a thickness Y, as shown in Figure 10B. The outer housing 304 may be a more rigid elastomer or non-elastomer tube having a perimeter less than X and a thickness greater than Y, as shown in Figure 10C. The inner member 302 is folded or otherwise compactly housed within the outer member 304, as shown in Figure 10D, and one end of the inner member 302 is sealed to the outer member 304 (not shown). When pressure is applied to the space between the inner member 302 and the outer member 304, the inner member 302 surrounds and seals multiple devices and device components as they are inserted.

[0037] Figure 11 shows a schematic longitudinal cross-sectional view of the configuration of an alternative hemostatic valve 310. The valve 310 includes a fixed housing 312 in the shape of a hollow cylinder with a finger grip 314 and openings 322 at both ends. Within the housing 312 is provided an articulated member 316, which may include a compliant body overmolded onto a rigid articulated substrate. The articulated member 316 may include a sealing ring on its inner surface to help increase sealing pressure by reducing the contact surface. The articulated member 316 may be flattened and then folded into the configuration shown. A membrane 318 may be provided on the inner surface of the articulated member 316, which may include a permeable or impermeable lubricating material such as ePTFE or sintered ePTFE. The housing 312 also houses a biasing member 320, which may include, for example, a spring. The finger tab 326 on the joint member 316 may be pressed against the finger tab 314 on the housing 312, thereby opening the joint member 316 and compressing the spring 320, allowing the device to pass along the axis 324. Once the device is inserted through the opening 322 along the axis 324, the spring 320 maintains a bias against the joint member 316, providing a hemostatic seal around such a device. Thus, in this embodiment, the pressure for forming the hemostatic seal is due to an active mechanism, in contrast to the fluid pressure in the previously described embodiments.

[0038] Figures 12A and 12B schematically show, in side and end views, yet another alternative configuration of the hemostatic valve 330A. Referring to Figure 12A, the compressible inner member 332A is located within the outer structure 334A. The inner member 332A may include a compressible or compliant material such as a foam or soft elastomer in the form of a cylinder or membrane, and includes a pre-formed slit 336A or lumen having a length greater than the circumference of the device through which it passes, as is most clearly shown in Figure 12B. The outer structure 334A may include a wire blade formed from an elastic metal, a superelastic metal, or a shape memory metal such as Nitinol. The outer structure 334A may impart an elastic compressive force to the inner member 332A, which can be overcome by inserting the device through the compressible inner member 332A, thereby providing a hemostatic seal. Thus, in this embodiment, the pressure for forming the hemostatic seal is a passive mechanism, in contrast to the fluid pressure or active mechanism in the previously described embodiments.

[0039] Figures 12C, 12D, and 12E schematically show modified examples of the hemostatic valve 330A in side view, end view, and perspective view, respectively. In this embodiment, the hemostatic valve 330B includes a tubular outer structure 334B, such as a wire blade, which folds diametrically when stretched. An inner member 332B is located within the outer structure 334B and includes an opening 336B. The inner member 332B, including the opening 336B, may include the same or similar structure and materials as the aforementioned inner member 332A and opening 336A. The outer structure 334B and inner member 332B may be located within a housing 338B connected to the sheath 110, as is most clearly shown in Figure 12E. An actuator 337B is rotatably mounted in the housing 338B and operably coupled to the outer member 334B, which can shorten or lengthen it. By acting on lever 337B and lengthening the outer member 334B, the inner member 332B folds down, causing the lumen 336B to close, thereby forming a hemostatic seal around the device inserted into the lumen. By acting on lever 337B in the opposite direction and shortening the outer member 334B, the lumen 336B may be opened, allowing the inserted device to move freely inside. Thus, in this embodiment, the pressure for forming the hemostatic seal is an active mechanism actuated by extension.

[0040] Figures 12F and 12G schematically show a modified example of the hemostatic valve 330B in a side view and a longitudinal cross-sectional view, respectively. In this embodiment, the hemostatic valve 330C includes a tubular outer structure 334C, such as a wire coil, which contracts diametrically when rotated. An inner member 332C is located within the outer structure 334C and includes an opening 336C. ​​The inner member 332C, including the opening 336C, may include the same or similar structure and materials as the aforementioned inner member 332A and opening 336A. The outer structure 334C and the inner member 332C may be located within a housing 338C connected to the sheath 110. An operating member 337C may be rotatably mounted in the housing 338C and operably coupled to rotate to open and close the outer member 334C diametrically. By rotating the operating member 337C in one direction, the inner member 332C acts to fold diametrically, closing the lumen 336C, thereby forming a hemostatic seal around the device inserted into the lumen. When the operating member 337C is rotated in the opposite direction, the inner member acts to expand diametrically, thereby opening the lumen 336C and allowing the inserted device to move freely within it. Thus, in this embodiment, the pressure for forming the hemostatic seal is an active mechanism actuated by rotation.

[0041] Figures 13A to 13D show cross-sectional views of alternative hemostatic valves 340A and 340B that are actuated by rotation. Figures 13A and 13B show a two-strap valve 340A in the open and closed positions, respectively. Valve 340A may include a relatively fixed outer body 342 and a relatively rotatable inner body 344. Multiple straps 346, having the form of elastic or inelastic polymer films or membranes, may be connected at one end to the fixed outer body 342 by an anchor 345 such as a pin, and at the other end to the rotatable inner body 344 by another anchor 347A such as a pin. In this example, three straps 346 are used, forming a triangular opening in the center. Alternatively, more than three straps 346 may be used, and the resulting opening may have a different shape with more sides. When the inner body 344 is rotated in one direction relative to the outer body 342 (as indicated by the arrow), the anchor point 347A contacts the strap 346, thereby tightening and closing the triangular opening and sealing around the device (e.g., catheter 10) as shown in Figure 13B. When the inner body 344 is rotated in the opposite direction, the opening expands, releasing the device 10.

[0042] Figures 13C and 13D show the connecting arm strap valve 340A in the open and closed positions, respectively. Valve 340B may be the same as or similar to valve 340A, except that valve 340B in this embodiment utilizes the connecting arm 347B instead of the anchor point 347A to connect the strap 346 to the inner body 344. This allows the strap 346 to have a smaller clamping opening for sealing around smaller devices such as the guide wire 20, as shown in Figure 13D. Otherwise, the operating principle is the same.

[0043] Another embodiment of the hemostatic valve 350 utilizing an active rotation mechanism is schematically shown in Figure 14, an end view. In this embodiment, the hemostatic valve 350 utilizes a plurality of iris leaflets 352 coupled to a rotating ring 354 at a plurality of pivot points. The ring 354 may be rotatably mounted within a housing 358. An inner tubular membrane 356 may be positioned within an opening defined by the iris leaflets 352. When the ring 354 is rotated in one direction relative to the housing 358, the iris leaflets 352 close, thereby compressing the inner tubular membrane 354 around the inserted device to form a hemostatic seal. When the ring 354 is rotated in the opposite direction relative to the housing 358, the iris leaflets 352 open, releasing the compression of the inner tubular membrane 354 and allowing the inserted device to move freely.

[0044] Figures 15A and 15B are perspective and end views, respectively, schematically illustrating yet another hemostatic valve 360. This embodiment uses a single tubular sleeve 362 similar to the sleeve 160 described with reference to Figure 3, except that the tubular sleeve 362 is twisted along its longitudinal axis. The twisted sleeve 362 may be made from, for example, an elastic or inelastic material. As in the previously described embodiment, hydraulic pressure may be introduced between the relatively rigid outer housing 364 and the twisted sleeve 362 to fold the sleeve around the inserted device. To facilitate the twisting of the sleeve 362, one end may be connected to the housing 364 and the other end to a ring 368. Once the sleeve 362 is installed, the ring 368 can be rotated relative to the housing 364 to twist the sleeve 362, and then the ring 368 can be fixed to the housing 364 to maintain the twisted shape of the sleeve 362.

[0045] Referring to Figures 16A and 16B, assembly diagrams of an alternative introducer sheath system 100E are shown in perspective and longitudinal section views, respectively. Generally, the embodiments 100E shown in Figures 16A and 16B may be identical or similar to the embodiment shown in Figure 1, with some exceptions. In this embodiment, as in the previously described embodiment, the system 100E includes a sheath 110, an expander (not shown), and a hub assembly 130E, similar components are denoted by the same reference numerals, and identical or similar alternative features may be employed.

[0046] In this embodiment, the pressure regulator 150E is located separately from the hub housing 134E and is fluidly connected to the hub housing 134E via a valve line 136, and includes an associated connector 138 for pressurizing the hemostatic valve 160. As previously mentioned, the pressure regulator may be integrated with the hub, connected to the hub via a tube, or be a separate component completely isolated from the hub.

[0047] In this embodiment, multiple ports 170A, 170B, and 170C are provided on the housing cap 135E. Each of the ports 170A, 170B, and 170C provides a passage for inserting devices (not shown) into a common hemostatic valve 160, which can seal around multiple devices.

[0048] Furthermore, in this embodiment, brakes 400A, 400B, and 400C are provided in association with ports 170A, 170B, and 170C, respectively. Brakes 400A, 400B, and 400C are configured to engage with devices inserted into ports 170A, 170B, and 170C to restrict their longitudinal movement and maintain their position within the blood vessels. Brakes 400A, 400B, and 400C may also be equipped with push buttons that are normally biased to a braked position. Pressing the push buttons releases the brakes, allowing the inserted devices to move freely.

[0049] Referring to Figure 17, an alternative arrangement is schematically shown in the top view. Similar to the embodiments in Figures 16A and 16B, the embodiment in Figure 17 provides a configuration for accommodating multiple insertion devices such as a catheter 10 and a guidewire 20. However, instead of using a common hemostatic valve, multiple hemostatic valves 410A, 410B, and 410C may be provided, connected to a common bubble trapping chamber 144 via tubes 405A, 405B, and 405C, respectively. The hemostatic valves 410A, 410B, and 410C may include passive valves (e.g., slit gaskets) or the active valves described above. Furthermore, each hemostatic valve 410A, 410B, and 410C may have associated brakes 415A, 415B, and 415C, respectively. The brakes 415A, 415B, and 415C may include push buttons as described above or cam levers as shown. Brakes 415A and 415B are shown in the open (non-braking) position, and brake 415C is shown in the closed (braking) position. As shown in the figure, each inserted device may have its own hemostatic valve and brake, thereby providing independent control of sealing and movement and avoiding potential interaction or interference between devices.

[0050] Another embodiment of the brake (not shown) may include one or two duckbill gaskets positioned at either end of the sleeve 160 of the hemostatic valve. The duckbill gasket may have one side concave and the other side convex. This configuration generally allows the inserted device to move relatively freely from the concave to the convex direction, while resisting movement in the opposite direction. For example, one gasket may be used to provide a unidirectional brake to prevent pull-out. Two gaskets may be used, positioned with their convex sides facing each other, or with their concave sides facing each other. In either case, the two gaskets positioned in this manner resist movement of the inserted device in both directions and function as a bidirectional brake.

[0051] Alternative embodiments for avoiding potential interactions between devices are shown in Figures 18A–18D, which show side and end views of the isolator sheath 420. The isolator sheath 420 may include a body portion 422, a cap 424, a slit or septum extending through its interior, and a finger tab 426. The slit 428 may extend through the cap 424 and the body 422 and have a lubricated inner surface. The body 422 and the cap may be formed of a compressible material (e.g., ePTFE) which is inherently lubricated, sealing around the inserted device 10 while allowing relatively free movement in its longitudinal direction. The isolator sheath 420 may be sized to be inserted into any of the hemostatic valves described herein. The cap or flange 424 may be sized to prevent over-insertion. Multiple isolator sheaths 420A, 420B, and 420C may be used, and when placed within a common hemostatic valve, they may be used to isolate the inserted devices from each other.

[0052] As previously stated with reference to Figures 9A and 9B, the introducer sheath system of this disclosure can incorporate an anchoring mechanism to restrict the movement of the sheath after insertion into the blood vessel, and in particular to reduce withdrawal. Embodiments schematically illustrated in Figures 19A, 19B, and 19C illustrate alternative anchoring mechanisms to accommodate different insertion angles. The insertion angle may vary depending on the patient's physique and the depth of the blood vessel being accessed.

[0053] Figure 19A shows a side view of a height-adjustable anchoring mechanism 440, and Figure 19B shows a top view of the anchoring mechanism 440 specifically showing the height adjustment between the patient's skin and the sheath 110 adjacent to the hub assembly 130. The anchoring mechanism 440 may be integrated into the system 100 or may be provided as a separate accessory device. The anchoring mechanism 440 may include a height stand 442 with adjustable and locking functions, having a hole that can be engaged to set the height and angle of the introducer sheath system 100. Those skilled in the art will understand that other height adjustment embodiments may be employed. The anchoring mechanism 440 may further include a sheath body 444 which is clamped to, adhesively bonded to, or otherwise connected to the sheath body 110. The anchoring mechanism 440 may include a base plate 446 with an adhesive layer 448. The adhesive layer 448 may include a stretch-to-release adhesive for removal or other temporary fixation to the patient's skin, surgical dressing, or similar, as indicated by the block arrow in Figure 19B.

[0054] Figure 19C shows a side view of another height-adjustable anchoring mechanism 450, specifically between the patient's skin and the sheath 110 adjacent to the hub assembly 130. The anchoring mechanism 450 may be integrated into the system 100 or provided as a separate accessory device. The anchoring mechanism 450 may include a primary wedge 452 and an angle-adjusting wedge 454. The angle-adjusting wedge 454 may be inserted into or withdrawn from the primary wedge 452 to adjust the height and angle of the introducer sheath system 100. The primary wedge 452 may be fixed to the sheath 110 adjacent to the distal side of the hub 130 by adhesive, Velcro® strap, or other suitable connection. Each of the wedges 452 and 454 may include a rigid or compliant material such as foam. The primary wedge portion 452 may include a bottom adhesive layer for making it removable from the patient's skin, surgical dressing, or similar, or for other temporary fixation.

[0055] The dilator 120 may also incorporate alternative features, such as a cutting blade 480 as shown in Figures 20A, 20B, and 20C, to facilitate more predictable and improved results in suture closure as shown in Figures 20D, 20E, and 20F. As clearly shown in Figure 20A, after establishing access to the vessel using a standard percutaneous access kit and positioning the guidewire 20, the dilator 120 and sheath can be advanced along the guidewire 20 through the skin and intervening subcutaneous tissue toward the vessel. As clearly shown in Figure 20B, a fixed or retractable blade 480 may be incorporated into the dilator distal to a constant diameter portion 124 within the tapered region 122. As shown in Figure 20C, the blade, when positioned and optionally deployed, may be used to make a predictable incision toward the vessel. By making an incision rather than simply dilating the opening of the vessel, unpredictable lacerations of the vessel wall can be reduced, and a more secure closure may be possible. As clearly shown in Figure 20D, multiple sutures 490 may be deployed around the open incision using a suture-intervening closure device that advances along the guidewire 20. The sutures 490 may be deployed either after the incision, or preferably before the incision, and this procedure is referred to as a pre-closure. After the intervention is complete and all devices have been removed from the blood vessel, the incision can be closed by tightening the sutures 490, as shown in Figure 20E. The sutures 490 may then be ligated using a patch (pleget) or knot, as shown in Figure 20F.

[0056] All aspects described herein (including references incorporated by reference, appended claims, abstract, and drawings) may be combined in any order, in part or in whole, or in any combination or modification, unless they are incompatible or inconsistent. Furthermore, each aspect may be replaced by an alternative feature serving the same, equivalent or similar purpose, unless expressly stated to be different or inconsistent with the teachings herein. Thus, unless expressly stated to be different, each aspect described herein is understood to be merely an example of an equivalent or similar feature. The present invention is intended to be defined by the appended claims and their legal equivalents.

Claims

1. It is an introducer sheath system, A tubular sheath, A hub assembly connected to the proximal end of the sheath, The system comprises an expander extending through the hub and the sheath, The hub assembly includes a housing and a hemostatic valve located inside it. The hemostatic valve includes a valve body that is relatively non-foldable and a foldable member, the foldable member closing when the space between the foldable member and the valve body is pressurized. The introducer sheath system further, A pressure regulator connected to the hub and in fluid communication with the space between the foldable member and the valve body, An introducer sheath system comprising: a sealed chamber defined by the pressure regulator, wherein the chamber has an internal space, and the internal space of the chamber is fluidly isolated from the space between the foldable member and the valve body.

2. The system according to claim 1, wherein the sealed chamber includes a closed-cell foam.

3. The system according to claim 1, wherein the sealed chamber includes a bladder.

4. The system according to claim 1, wherein the sealed chamber includes a chamber housing and a diaphragm.

5. The system according to claim 1, wherein the space between the foldable member and the valve body is filled with liquid.

6. The system according to claim 5, wherein the sealed chamber is filled with gas.

7. The system according to claim 6, wherein the foldable member includes a sleeve.

8. The system according to claim 7, wherein the foldable member comprises stretched polytetrafluoroethylene (ePTFE).

9. The system according to claim 7, wherein the foldable member includes densified ePTFE.

10. The system according to claim 7, wherein the foldable member includes one in which fluoroethylene propylene (FEP) is laminated on ePTFE.

11. The system according to claim 7, wherein the foldable member is folded back and wrapped around the end of the valve body.

12. The system according to claim 1, wherein the pressure regulator suppresses the rise in valve pressure at a rate of less than 14 kPa / mm depending on the device size.

13. The system according to claim 1, wherein the pressure regulator suppresses the rise in valve pressure at a rate of less than 10 kPa / mm depending on the device size.

14. The system according to claim 1, wherein the pressure regulator suppresses the rise in valve pressure at a rate of less than 7.2 kPa / mm depending on the device size.

15. It is an introducer sheath system, A tubular sheath, A hub assembly connected to the proximal end of the sheath, including a primary port and a secondary port, The system comprises the primary port, the hub, and an expander extending through the sheath, The hub assembly includes a housing and a hemostatic valve located inside it. The hemostatic valve includes a valve body and a foldable member, and the sleeve closes when the space between the foldable member and the valve body is pressurized. The introducer sheath system further, A pressure regulator connected to the hub and in fluid communication with the space between the foldable member and the valve body, An introducer sheath system comprising: a sealed chamber defined by the pressure regulator, wherein the chamber has an internal space, and the internal space of the chamber is fluidly isolated from the space between the foldable member and the valve body.

16. The system according to claim 15, wherein the housing of the hub assembly defines a bubble trapping chamber having a vertical apex, and a flush line is connected to the bubble trapping chamber at the vertical apex to discharge bubbles from the bubble trapping chamber.

17. The system according to claim 15, wherein the housing defining the bubble capture chamber is transparent in order to make the bubbles in the bubble capture chamber easily visible.

18. The system according to claim 15, further comprising a brake connected to the housing of the hub assembly, wherein the brake is configured to engage with a device inserted into at least one of the primary port and the secondary port.

19. The system according to claim 15, wherein the hub includes a connector associated with one of a primary port or a secondary port, the connector being configured to connect to an extracorporeal membrane oxygenation (ECMO) tube for receiving a flow of oxygenated blood.

20. It is an introducer, A tubular sheath, The sheath comprises a hub assembly connected to the proximal end, The hub assembly includes a housing and a hemostatic valve located inside it. The aforementioned introducer sheath further, A pressure regulator connected to the hub and in fluid communication with the hemostatic valve, An introducer sheath system comprising: a sealed chamber defined by the pressure regulator, wherein the chamber has an internal space, and the internal space of the chamber is filled with a gas that is fluidly isolated from the hemostatic valve.

Images