JP-2026514502-A - 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. [Selection Diagram] Figure 1

Inventors

• テイラー、カイル ピー．
• ブレンゼル、マイケル
• コステロ、デイビッド マシュー
• アトキンソン、ロバート イー．

Assignees

• カルティブ８ メディカル エルエルシー

Dates

Publication Date

20260511

Application Date

20240424

Priority Date

20230427

Claims (20)

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 contains 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 increase 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 increase 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 increase 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-catching chamber having a vertical apex, and a flush line connects to the bubble-catching chamber at the vertical apex to discharge bubbles from the bubble-catching chamber.
17. The system according to claim 15, wherein the housing defining the bubble capture chamber is transparent to facilitate the visualization of bubbles within the bubble capture chamber.
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 and secondary ports.
19. The system according to claim 15, wherein the hub includes a connector associated with one of a primary or 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.

Description

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. 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 uses. 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 and inner tubes can be pressurized, resulting in the inner tube folding 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, visually indicating that sufficient pressure has been established. The devices described by Arcaro et al. generally correspond to commercially available products known as GORE DrySeal® Flex Inducer Sheaths. During use, as valve pressure increases, the friction acting around the device inserted through it also increases. This is particularly pronounced when large-diameter devices, such as TAVR delivery systems, are inserted through the sheath, resulting in increased pressure and friction. Such friction may impede the movement and control of the device inserted through the valve. Strength Specification No. 10960198 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 frictional 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 components. 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 using gas 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. The embodiments of the introducer sheath system 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 all embodiments or models of this disclosure. The drawings illustrate exemplary embodiments of this disclosure and, together with this description, serve to illustrate the principles of this disclosure. The drawings merely illustrate specific embodiments and do not limit this disclosure or the invention. This is an assembly perspective view of an introducer sheath system according to one embodiment of the present disclosure.Figure 1 is a detailed perspective view of the proximal portion of the introducer sheath system.Figure 1 is a detailed perspective view of the proximal portion of the introducer sheath system.Figure 1 is a longitudinal cross-sectional view of the proximal portion of the introducer sheath system.Figure 3 is a longitudinal cross-sectional view of an exemplary embodiment of the valve assembly shown.Figure 3 is a longitudinal cross-sectional view of an exemplary embodiment of the valve assembly shown.This is an assembly perspective view of an introducer sheath system according to another embodiment of the present disclosure.Figure 4 is a longitudinal cross-sectional view of the proximal portion of the introducer sheath system.Figure 4 is a longitudinal cross-sectional view of the proximal portion of the introducer sheath system.Figure 4 is a longitudinal cross-sectional view of the proximal portion of the introducer sheath system, showing the dilator in the inserted and withdrawn states.Figure 4 is a longitudinal cross-sectional view of the proximal portion of the introducer sheath system, showing the dilator in the inserted and withdrawn states