Hemostatic valve for sheath assembly

Abstract

The invention relates to a hemostasis valve for a sheath assembly. An introducer sheath assembly for percutaneous delivery of a medical device that maintains hemostasis in a patient. The assembly has a hub, a hub cap, and a hemostasis valve. The introducer sheath assembly has a longitudinal axis and a lumen formed therein. The hemostasis valve has a frame portion and a valve portion having a plurality of slits offset through a thickness of the valve portion therein, and an extension of the frame portion is formed of an incompressible material. An extension of the frame portion is received by a valve seat feature in the hub when the valve is received by the hub. The valve seat feature also receives a seating portion of the hub cap when the hub and the hub cap are advanced into the engaged condition, the seating portion of the hub cap advanced into the valve seat feature subjecting the incompressible extension of the frame portion to a compressive force.

Description

[0001] This application is a divisional application of Chinese patent application 2020800794673 (PCT / US2020 / 060501), filed on November 13, 2020, entitled "Hemostatic valve for sheath assembly".

[0002] Cross-references to related applications

[0003] This application claims the benefit of U.S. Provisional Application No. 62 / 935,300, filed November 14, 2019, which is incorporated herein by reference. Technical Field

[0004] The present invention relates to a guide sheath assembly that allows a medical device to be introduced into a patient at an insertion site, the guide sheath assembly having a hemostatic valve to reduce or eliminate bodily fluids discharged by the patient through the insertion site of the guide sheath assembly. Background Technology

[0005] Patients with heart disease sometimes use a heart pump for treatment. This heart pump is adapted to be inserted into the heart through an adjacent blood vessel and is configured to assist the natural heart pump function or replace the natural heart pump function through continuous pumping operation.

[0006] In a common approach, a guide tube sheath is used to establish vascular access before inserting a medical device, such as a heart pump. The guide tube sheath is an assembly that includes a hemostatic valve, which prevents blood leakage from the distal end of the sheath when it is inserted into a blood vessel. The hemostatic valve should prevent excessive blood leakage when there is no object in it, or when a guidewire, catheter, blood pump, or other object is inserted through the valve. One of the main causes of excessive leakage from the guide tube sheath is damage or perforation of the hemostatic valve. Summary of the Invention

[0007] This document describes a guide sheath assembly for a medical device used in percutaneous delivery to maintain hemostasis in a patient. As shown in the figure, the sheath assembly has a sheath body and a sheath hub assembly coupled to the sheath body. The sheath hub assembly comprises a hub, a hub cap, a hemostatic valve, and optionally a foam. The hemostatic valve has a valve portion and a frame portion. The frame portion defines the circumference of the valve, and the thickness of the frame portion is greater than the thickness of the valve portion, which has multiple offset slits formed through its thickness. The thickness of the valve is in the direction of travel of the medical device through the valve. The valve is made of an incompressible elastomer.

[0008] Examples of incompressible materials include natural rubber, synthetic rubber, polyisoprene, polyurethane, silicone resins, and thermoplastic elastomers. Examples of thermoplastic elastomers include styrene block copolymers and thermoplastic vulcanizates.

[0009] Optionally, the hub has a valve seat feature formed therein. The valve seat feature is adapted to receive an extension of the valve frame portion and a seated portion of the hub cover. For example, the valve seat feature is configured as a channel having an inner wall of a first height and an outer wall of a second height, wherein the outer wall is higher than the inner wall. In this configuration, the valve portion is located above the inner wall of the valve seat feature, and an extension of the valve frame portion extends into the valve seat feature.

[0010] Optionally, the seated portion of the hub cover, i.e., the portion of the hub cover located in the valve seat feature of the hub, has a thicker proximal end than the distal end. The hub cover is fixed to the hub and the valve as an assembly. Optionally, the hub cover portion is ultrasonically welded to the hub portion.

[0011] Optionally, a flushing port is formed on the hub. Flushing ports in such devices are well known to those skilled in the art and will not be described in detail herein.

[0012] Optionally, the valve frame portion has an O-ring at the distal end of the extension of the valve portion. Optionally, the extension of the frame portion has a uniform thickness. In another optional configuration, the valve has frame extensions extending from the proximal and distal sides of the valve body. In yet another configuration, the extension of the frame portion is an undercut extension.

[0013] The seat portion of the hub cap can be straight or tapered. If the seat portion is tapered, then when the hub cap is assembled onto the valve and hub, the tapering may or may not be parallel to the tapered portion of the valve portion that contacts the seat portion. If the seat portion is straight, then when the hub cap is assembled onto the valve and hub, the seat portion may or may not be parallel to the valve portion that contacts the seat portion.

[0014] This document also describes a method for assembling a guide sheath. In this method, a hub having a valve seat feature formed therein is provided. A valve having a valve portion and a frame portion is also provided, the frame portion being thicker than the valve portion. The valve is formed of an incompressible material, and a plurality of helical slits are formed in the valve portion. The frame portion extends beyond the valve portion. A hub cover having a seating portion is also provided. According to the method, the valve is assembled onto the hub. At least a portion of the frame portion is received by the valve seat feature. The cover is assembled onto the valve and the hub such that at least a portion of the seating portion of the hub cover is received in the valve seat feature. The volume of the seating portion received in the valve seat portion causes the incompressible material in the valve seat feature to deform. Attached Figure Description

[0015] The foregoing and other objects and advantages will become apparent upon consideration of the following detailed description in conjunction with the accompanying drawings, in which the same reference numerals refer to the same parts, and in the drawings:

[0016] Figure 1A cross-sectional view of a guide assembly with a hemostatic valve according to certain embodiments is shown;

[0017] Figure 2 The percutaneous insertion of the heart pump using the guide assembly is shown; the guide assembly is deployed... Figure 1 and Figure 2 The hemostatic valve;

[0018] Figure 3 This is a detailed cross-section of the hemostatic valve located in the hub;

[0019] Figure 4 This is a top view of a hemostatic valve according to one embodiment;

[0020] Figure 5 This is a bottom view of the hemostatic valve according to the second embodiment;

[0021] Figure 6 yes Figure 4 Top view of the hemostatic valve shown;

[0022] Figures 7A-7C These are photographs of the hemostatic valve according to the first embodiment before and after guidewire insertion;

[0023] Figures 8A-8D These are photographs of the hemostatic valve according to the second embodiment before and after guidewire insertion;

[0024] Figure 9 yes Figure 1 A detailed view of a portion of the guide component;

[0025] Figures 10A-10B This shows valve compression when the hub cap is assembled onto the hub of the guide assembly;

[0026] Figure 11A-11B The image shows the hub cover ultrasonically welded to the guide assemblies in front of and behind the hub;

[0027] Figure 12 yes Figure 6 A cross-sectional view of the hemostatic valve shown.

[0028] Figure 13 yes Figure 12 A cross-sectional view of the internal circumference of the hemostatic valve;

[0029] Figure 14 This is a cross-sectional view of the outer perimeter of the hemostatic valve according to the second embodiment;

[0030] Figure 15 This is a cross-sectional view of the outer perimeter of the hemostatic valve according to the third embodiment;

[0031] Figure 16 This is a cross-sectional view of the outer perimeter of the hemostatic valve according to the fourth embodiment; and

[0032] Figure 17 This is an illustration of an alternative configuration of the hubcap that applies pressure in two regions. Detailed Implementation

[0033] In this invention, the description of a given element in a particular drawing or consideration or use of a particular element number or reference in the corresponding descriptive material may cover the same, equivalent or similar element or element number identified in another drawing or its associated descriptive material.

[0034] Unless otherwise stated, the use of “ / ” in figures or related text shall be understood as “and / or”. Statements of specific numerical values ​​or ranges of numerical values ​​or the use of terms such as approximation or about are understood to include or be approximate numerical values ​​or ranges of numerical values ​​(e.g., within + / -2%, + / -5%, + / -10%, + / -15%, or + / -20%).

[0035] As used herein, the term “set” corresponds to or is defined as a non-empty finite organization of elements that mathematically exhibits a cardinality of at least 1 (i.e., a set as defined herein may correspond to a unit, a singlet or a set of one elements, or a set of multiple elements), according to known mathematical definitions (e.g., in a manner corresponding to Chapter 11: Properties of Finite Sets) of Peter J. Eccles’ *Introduction to Mathematical Reasoning: Numbers, Sets and Functions*, Cambridge University Press (1998) (as shown on page 140). In general, depending on the type of set under consideration, the elements of a set may include systems, devices, apparatuses, structures, objects, processes, physical parameters or values, or portions thereof.

[0036] As used herein, proximal is defined as toward or closer to the user, and distal is defined as away from the user, or in a direction away from or opposite to the distal direction relative to fluid flow. The term “vascular” is considered to mean an anatomical vessel, pathway, or passageway (e.g., a blood vessel, such as an artery) of a patient or subject, or an anatomical chamber or compartment. The term “perfusion” is considered to mean the injection, transfer, or delivery of blood and / or one or more other fluids into a vascular system to enable the blood and / or other fluids (one or more) to reach an organ or tissue (e.g., to provide it with nutrients and oxygen). The term “fluid connection” is considered to mean a connection in a manner that provides for the transfer or delivery of fluids (e.g., liquid / gas).

[0037] To provide a general understanding of the systems, methods, and apparatus described herein, certain illustrative embodiments will be described. Although the embodiments and features described herein are specifically described as being used in combination with a guide sheath and hemostatic valve for percutaneous insertion of a cardiac pump, it should be understood that all components and other features outlined below can be combined with each other in any suitable manner and are adaptable and applicable to other types of guide sheaths and hemostatic valves or other types of cardiac assist devices, including balloon pumps.

[0038] The guide sheath assembly described herein has a hub / hub / valve assembly, wherein the geometry of the valve and the geometry of the hub jointly seal two fluid paths, thereby providing a hemostatic guide sheath assembly. The fluid paths independently sealed by the hub / hub / valve assembly are: 1) a fluid path around the valve between the valve and the hub or hub cap; and 2) a fluid path through one or more slits in the valve, which allows insertion of a medical device and / or a mechanism for introducing such a medical device (e.g., catheter, dilator, etc.) through one or more slits in the valve. The valve slits described herein cooperate with the hub / hub assembly to provide a hemostatic seal when closed and when a medical device is inserted through it.

[0039] Therefore, the guide sheath with a hemostatic valve and a hemostatic hub / hub / valve assembly provides two valve sealing modes, which is advantageous compared to prior art assemblies with only one sealing mode (compression). Both sealing modes increase with the increase in compression caused by the hub cap's seating within the hub. However, increased compression increases the force required to insert the device through the valve. Therefore, the magnitude of the force applied to the valve by the hub / hub assembly is controlled, thus keeping the insertion force required for the device to pass through the slit within an acceptable range.

[0040] The valve is made of an incompressible material, such as silicone, natural or synthetic rubber, polyisoprene, polyurethane, and thermoplastic elastomers. Other incompressible materials suitable for this invention are well known to those skilled in the art and will not be described in detail herein. The hub has a volume-constrained structure referred to as the valve seat feature. The valve has a frame portion having an extension that extends into the valve seat feature when the valve is located in the hub. The hub cap has a seat portion that also extends into the valve seat feature when the hub cap is assembled onto the hub. This arrangement provides volumetric interference between the incompressible valve frame extension, the valve seat feature, and the seat portion, thereby providing sealing pressure between the frame extension (e.g., an O-ring geometry) and the hub / hub cap. Because the incompressible valve frame extension is fitted within the valve seat feature, the volume of the incompressible valve frame extension is smaller than the volume of the valve seat feature into which it extends. When the seat portion of the hub cap is pressed into the valve seat feature, this reduces the volume of the valve seat portion, causing the incompressible valve frame extension to deform. This will seal any potential fluid paths between the valve and the hub / hub assembly.

[0041] Another fluid path sealed by the guide sheath assembly described herein lies within the fluid path passing through the valve slit. The hub / valve / hub assembly is sized to provide radial interference between the hub and the valve portion of the valve, which provides sealing pressure on the surface of the slit formed in the valve portion. This radial interference is provided by the tapered geometry of the hub.

[0042] If the tapered geometry of the hub cap is parallel to the corresponding tapered element on the valve, a substantially uniform compression will occur along the thickness of the valve portion. If the tapered geometry is not substantially parallel to the corresponding tapered element on the valve, a substantially non-uniform compression will occur along the thickness of the valve portion. In both examples, the compression at the distal end of the valve is greater than the compression at the proximal end.

[0043] Optionally, the hub cap has a straight geometry. In this option, if the straight geometry of the hub cap is substantially parallel to the geometry of the valve, the compression along the length of the valve portion is substantially uniform. If the straight geometry is not substantially parallel to the geometry of the valve, substantially non-uniform compression will occur along the length of the valve portion. In either case, the compression at the distal end of the valve is greater than the compression at the proximal end of the valve.

[0044] The systems, methods, and apparatus described herein thus reduce or eliminate the risk of bleeding during the insertion of medical devices (such as heart pumps), guidewires, dilators, or other objects. The hemostatic valve and its arrangement within the hub and hub cap control, reduce, or prevent blood loss through and around the valve.

[0045] The guide sheath assembly has two main functions. First, the guide sheath establishes a path into the desired vascular system to allow for the insertion and removal of the device. Second, throughout the insertion process, any guide sheath must maintain hemostasis at the entire insertion site. A hemostatic valve maintains hemostasis through the guide sheath lumen. The hemostatic valve component is typically located at the proximal end of the guide sheath, known as the hub.

[0046] The hemostatic valve needs to form a seal when assembled into the hub. This seal must be maintained when devices of different sizes are inserted through the hemostatic valve. As described above, the hub and hubcap assembly apply force to the hemostatic valve as described herein to prevent fluid from flowing from the distal end of the sheath assembly through the proximal end (i.e., leakage from the sheath assembly insertion site).

[0047] To maintain the valve's seal during device passage, additional radial compression applied to the valve by the hub / hub assembly ensures that changes in the insertion device diameter do not disrupt the seal. For the valve / hub / hub assembly described herein, additional radial compression is provided by placing the valve within the hub. The hub and hub assembly are configured to operate a resilient valve to provide the necessary valve compression. The valve has a decreasing sidewall thickness that mates with the hub cap fitted within the hub to form the desired seal. Optionally, the decreasing sidewall of the valve terminates at an O-ring. The hub cap is inserted downwards into the hub, applying compressive force to the slit valve to seal it. Optionally, the hub cap has a tapered opening such that the diameter of the hub cap's interior, which houses the valve, decreases as the hub cap is further advanced into the hub. This tapered diameter is referred to herein as the compression feature.

[0048] For guide sheaths compatible with devices of various diameters (such as the blood pump described herein), the seal must be formed by a device of various diameters, such as 9Fr (3 mm), 10Fr (3.33 mm), 11Fr (3.67 mm), 12Fr (4 mm), 13Fr (4.33 mm), 14Fr (4.67 mm), 15Fr (5 mm), 16Fr (5.33 mm), 17Fr (5.67 mm), 18Fr (6 mm), 19Fr (6.33 mm), 20Fr (6.67 mm), 21Fr (7 mm), or any other suitable diameter. For example, U.S. Patent No. 7,736,296, entitled “Intercardiac Blood Pump”, by Seiss et al., describes a blood pump device that can be inserted through the guide sheath assembly described herein, which is incorporated herein by reference.

[0049] For blood pump insertion, the valve must be able to maintain a seal under the following conditions:

[0050] i) Only the sheath (when there is no item in the valve);

[0051] ii) Insert only the expander into the valve (the expander may be coated with silicone and inserted into the valve to lubricate the valve before it is inserted into the pump unit);

[0052] iii) Insert a first guidewire into the valve (e.g., a guidewire with a diameter of 0.035 inches (0.889 mm) will pass through the hemostatic valve and be used to push the pump through the valve);

[0053] iv) 6Fr conduit inserted through the valve;

[0054] v) Insert a second guidewire into the valve (e.g., a guidewire with a diameter of 0.018 inches (0.457 mm);

[0055] The second guide wire in vi)v) is inserted into the valve together with the 9Fr conduit portion (3mm) of the pump; and

[0056] vii) Pump unit (9Fr (3mm) conduit section).

[0057] The above conditions are listed by way of example and are not restrictive. The components described herein solve the problems of hemostasis and minimal insertion and removal forces, while maintaining the manufacturability of the hub, hubcap, and valve itself. The components described herein provide hemostasis for each variable-sized device inserted through the valve. A seal is also maintained when such a device is removed.

[0058] The valve described herein is constructed as a thin (e.g., about 2 mm to about 4 mm) disc housed within a hub / hub assembly. The valve is circular because the hub / hub assembly defines an inner cavity with a circular cross-section through which the device is inserted into the patient. The valve is made of soft silicone or a flexible polymer, such as natural or synthetic rubber, polyisoprene, polyurethane, or a thermoplastic elastomer, such as a styrene block copolymer or thermoplastic vulcanizate. The disc has a first thickness and a second thickness. The first circumferential thickness is greater than the second internal thickness. The thicker circumferential portion of the disc is referred to as the frame portion, and the thinner internal portion as the valve portion. Therefore, the first thickness is referred to herein as the frame thickness, and the second thickness as the valve thickness. Both thicknesses are axial in the guide sheath assembly. Reference Figure 12 The valve 104 shown in the cross-sectional view has Figure 1 The frame portion 123 shown terminates at an O-ring portion 120, which extends from the frame portion 123 above the O-ring portion 120. The valve 104 has a valve portion 124 that is thinner than the frame portion 123. The O-ring is made of an incompressible material, such as those described elsewhere herein. The O-ring portion 120 defines an inner and outer circumference extending therefrom the thinner valve portion 124. An internal void portion is designated as 125. As described elsewhere herein, the O-ring 120 is optional. As described herein, the O-ring 120 is an example of an incompressible feature described herein.

[0059] Figure 1This is a cross-sectional view of a guide sheath assembly 100, which includes a hemostatic valve 104 disposed in a hub 102, with a hub cap 105 assembled onto the hub 102. The hub has an inner cavity 109 that accommodates the hemostatic valve 104 and tapers to an inner cavity 111. The hemostatic valve has a valve portion 124 that is thinner than the frame portion 123. The hub 102 is also assembled to an elongated guide body 106 (i.e., a sheath) having an inner cavity 107 and a longitudinal axis 108. The inner cavity 111 of the hub is fluidly coupled to the inner cavity 107 of the elongated guide body. The guide assembly optionally includes a lubricating foam 110. The lubricating foam actively lubricates the device inserted therein. Suitable lubricating foams are well known to those skilled in the art and will not be described in detail herein. Optionally, the lubricating foam 110 is an open-cell polyurethane that absorbs and retains a lubricating liquid, such as silicone oil. The foam 110 has features that attach to the cap to hold it in place. Such attachment features are known and therefore will not be described here. Foam 110 has through-holes 127 to allow devices to pass through, whereby they are passively lubricated by silicone oil in a network of openings. Optionally, the foam may be partially supplied and assembled with valve 104 when hub cap 105 is placed on valve 104.

[0060] Hub 102 has an inlet 153 (i.e., a flushing port) that fluidly connects the fluid supply line 152 to the inner cavity 111 of hub 102. Arrow 154 indicates the flow path of fluid entering hub 102 through inlet 153. When hub cap 105 is fully seated in hub 102, the engagement of hub cap 105 and hub 102 deforms the O-ring (its volume remains unchanged since the O-ring is incompressible). This force 155 seals the potential fluid path in valve region 156 between valve 104 and hub 102 / hub cap 105. Hub cap 105 also applies a compressive force 157 to valve 104. The compressive force 157 seals valve 104 within hub 102 / hub cap 105, preventing fluid from flowing back from the inner cavity 111 of hub 102 to valve 104. Figure 1 As shown, the frame portion 123 of valve 104 terminates in O-ring 120. Figure 1 The O-ring 120 is shown in its undeformed state, and the dimensional changes of the valve 104 and its O-ring portion 120 are shown due to the hub cap 105 being fully located on the hub 102.

[0061] Figure 2 Showing the use of carrying Figure 1The guide sheath assembly 100 of the hemostatic valve 104 shown is percutaneously inserted into the cardiac pump assembly 200. The cardiac pump assembly 200 includes a distal portion 203, which includes an outlet 206 and a supply catheter 202. The guide sheath assembly 100 is illustrated as also including an assembly with a fluid supply line 152 for flushing a port 153. The fluid supply line has a valve (not shown) for opening and closing fluid access to the guide sheath assembly. The fluid supply line 152 can be used to flush the guide sheath assembly 100 before, during, or after insertion of the cardiac pump assembly 200. The distal portion 203 of the cardiac pump assembly 200 is inserted into the guide sheath assembly 100 along an insertion path 204.

[0062] Figure 3 A helical slit 126 is shown formed through the thickness of the valve portion 124 of valve 104. Such slits are described in WO2019090351 by Korkuch et al., which is co-owned with this application. WO2019090351 is incorporated herein by reference. As used herein, a helical slit is a slit in which a cut in the material is offset through the thickness of the valve portion. For example, the helical slit 126 may form a helix through the thickness of the valve portion. The cut may be one or more cuts. Such slits are well known to those skilled in the art and will not be described in detail herein.

[0063] The helical slit 126 passes through the center of the valve and through the thickness of the valve portion 124. The helical slit 126 follows a helical path through the thickness of the valve portion 124, from the conduit 126A on the top surface of the valve 104. Figure 6 Pipeline 126B from the bottom surface of the valve Figure 5 The lengths of the first set of tubing 126A and the second set of tubing 126B determine the size of the spiral slit 126. The size of the spiral slit 126 can be set to balance hemostatic performance and the insertion and removal force of the medical device inserted through the hemostatic valve 104. As the lengths of the first set of tubing 126A and the second set of tubing 126B increase, the size of the spiral slit 126 increases, the hemostatic performance of the hemostatic valve 104 decreases, and the removal force of the medical device inserted through the hemostatic valve 104 also decreases.

[0064] like Figure 4As shown, the angle α of the helical slit 126 defines the angular path of the helical slit 126 as it passes through the thickness of the valve 104. Typically, α can be any angle that matches the angular offset between the first set of lines 126A on the top surface of the valve portion 124 and the second set of lines 126B on the bottom surface of the valve portion 124. In another aspect, angle α matches the angular offset between the two helical slits 126 on the top surface of the valve portion 124. In some aspects, α is equal to 360 / n, where n is the number of helical slits 126. In another aspect, α is independent of the angular offset between the two lines 126A on the top surface of the valve portion. In this case, α is the rotation angle of the helix between the top and bottom surfaces of the valve portion 124 and does not need to correspond to the angle between the two lines 126A such that the first set of lines 126A and the second set of lines 126B can be angularly offset from each other. This is in Figure 6 As shown in the image.

[0065] Valve 104 is illustrated as being received within hub 102. Hub 102 defines a recess or channel 136 for receiving a frame portion 123 of valve 104, such as... Figure 3 As shown, an O-ring 120 is included in the valve 104. A channel 136 forms a valve seat feature 137 having an inner channel wall height 132 and an outer channel wall height 134. The valve portion 124 is supported in the hub 102 by the inner channel wall 130. To assemble the hub 102, valve 104, and hub cap 105, the valve 104 is first placed in the hub 102. When the O-ring 120 is received in the valve seat feature 137 in the hub 102, the O-ring 120 extends slightly above the inner channel wall 132. However, the O-ring 120 is not compressed when inserted into the hub 102. By engaging the hub cap 105 to the hub 102, potential leakage of fluid through the distal end of the guide sheath assembly is reduced or eliminated.

[0066] As described above, the incompressible feature 120 (e.g., an O-ring) is a frame portion 123 extending from the valve portion 124. The frame portion has an inner circumference and an outer circumference and is received by the valve seat feature 137. The inner diameter of the valve seat feature 137 is larger than the diameter of the inner cavity 111. Because the incompressible portion is received within the valve seat feature 137, and the inner diameter defined by the incompressible feature 120 is larger than the inner cavity, the incompressible feature 120 will not contact or otherwise engage the means passing through the inner cavity 111 of the spiral slit 126 and the guide sheath assembly 100.

[0067] Figure 4This is a top view of valve 104, where valve portion 124 has a helical slit 126A, illustrated as a series of offset cuts disposed therein. An O-ring 120 is disposed below valve portion 124, but has an inner and outer diameter extending beyond the outer diameter of valve portion 124. Valve 104 can be formed as a single article by injection molding or other molding techniques, allowing for repeatable valve design and configuration within very small tolerances. Hemostasis is achieved through the helical slit / cut design, in addition to the radial compression of valve 104 by the hub 102 and hub cap 105 of the guide sheath assembly 100, as the device (not shown) passes through the first set of lines 126A (i.e., the helical slits).

[0068] Figure 5 This is a top view of valve 104. The valve tapers slightly upward from O-ring 120 to valve portion 124, in which a second set of lines 126B (i.e., spiral slits) is formed. Figure 5 An optional valve slit 126 configuration is shown, which changes from a 3-slit helical configuration to a 2-slit configuration. Although the helix is ​​not reflected in the 2-slit configuration, the helix does extend through the thickness of the valve portion 124.

[0069] The hemostatic valve 104 is optionally made of soft silicone resin. Hardness testers of 20A, 30A, and 40A (i.e., Shore A hardness) are considered suitable. The valve may also be made of a completely different elastomer with similar properties, such as a lower indicated hardness. Examples of such materials include natural or synthetic rubber, polyisoprene, polyurethane, or thermoplastic elastomers such as styrene block copolymers or thermoplastic vulcanizates. Optionally, the hemostatic valve 104 is made of medical-grade silicone resin or other elastomers.

[0070] Figure 6 yes Figure 4 The valve is shown in the diagram, but a spiral cut is shown as the cut passes through the valve section 124. Figure 6 It also shows that the diameter of the valve portion tapers slightly inward from its distal end to its proximal end. Figure 12 It shows Figure 6 The cross-section of the valve shown is along line 12-12.

[0071] Figures 7A-7C This is a photograph of hemostatic valve 104, in which spiral slit 126 is formed in an X-shape. Figure 7A It is valve 104 before anything is inserted through slit 126. Figure 7B The guide wire 134 is inserted into valve 104 after passing through valve 104. Figure 7C This is a close-up view of the slit 126, which has been interrupted by guide wire 134. It should be noted that... Figure 7B In the middle, when the guidewire is slightly off-center, a gap 136 is formed through the valve 104. Normally, a device inserted after the guidewire has successfully passed through the guide sheath assembly 100. Figure 7C yes Figure 7B An enlarged view of the gap formed in the valve shown.

[0072] Figures 8A-8D This is a photograph of a hemostatic valve 104 with a spiral slit 126. The spiral slit extends through the thickness of the valve portion 124 of the hemostatic valve 104. Figure 8B The slit 126 in the valve has been pushed through to reveal the helical nature of the helical slit 126 (i.e., the slit is deflected as it is pushed through the thickness of the valve portion 124). Figure 8C It is an image of a valve 104 with a guide wire 134 passing through a slit 126. Figure 8D It is valve 104 when the guide wire 134 passing through slit 126 is pulled away from the center.

[0073] refer to Figure 9 This is a detailed cross-section of the guide sheath assembly 100, in which the hub cap 105 mates with the hub 102, thereby compressing the frame portion 123 of the hemostatic valve 104 in the valve seat feature 137. The hub cap 105 has a seat portion 141, which is pushed into the valve seat feature 137 between the inner wall 132 and the outer wall 134 of the channel 136 in the hub 102. The relaxed state of the O-ring portion 120 is... Figure 9 The O-ring portion 120 is shown in dashed lines. Because the O-ring portion 120 is made of an incompressible material, the available volume of the O-ring in the valve seat feature 137 is reduced when the seat portion 141 of the hub cap 105 is placed in the valve seat feature 137. The reduced volume causes the O-ring portion 120 to exert a force that substantially seals the fluid path between the valve, hub, and hub cap.

[0074] refer to Figure 17 The hub cap 105 has a stepped inner portion that provides targeted lateral deformation for the valve portion 124 and the O-ring portion 120. When the hub cap 105 is positioned on the hub 102, the stepped portion 160 is dimensioned to apply a lateral force 163 to the O-ring 120. The stepped portion 162 is dimensioned to apply a lateral force 163 to the valve portion 124 (which has a laterally recessed vertical circumferential profile relative to the vertical circumferential profile of the O-ring 120). The dashed line 164 shows the profiles of the valve portion 124 and the O-ring 120 before deformation by the stepped portions 162 and 160, respectively. When the hub cap 105 is fully positioned on the hub 102, the stepped portions conform to the constraints imposed by the stepped portions 160 and 162 of the hub cap 105.

[0075] refer to Figures 10A-10B The hub cap 105 is shown as having a compression feature 140. Figure 10AThe diagram shows a cover 105 having a compression feature 140. The compression feature 140 is shown as a surface that tapers inward and downward in a portion of the valve portion 124 of the receiving valve 104 of the cover 105. This compression feature 140 seals a slit in the valve portion 124 through the thickness of the valve portion 124. Optionally, the compression feature may be straight. If the compression feature is straight, it seals the slit across the lateral extent of the valve portion 124. Figure 10B As can be seen from line 142, the frame portion 123 of valve 104 has been compressed inward by the compression feature 140. As described above, this compression feature mitigates leakage from the distal end of the guide sheath assembly 100, which would otherwise occur through the slit in valve 104. As described above, the guide sheath assembly described herein mitigates leakage through two distinct paths: one through valve 104 and the other around valve 104.

[0076] Figure 11A-11B The process of hubcap 105 entering hub 102 is shown to achieve engagement between the two. Figure 11A-11B In the diagram, the valve outline before the hub cap is placed in the hub is shown as a solid line, and the outline after the hub cap is inserted is shown as a dashed line. (Reference) Figure 11A Hub cap 105 is located above hub 102 and valve 104, with valve 104 situated in hub 102 before hub cap 105 is placed on top of it. The valve has a thinner valve portion 124 and a thicker frame portion 123. Valve O-ring 120 is located in valve seat feature 137. Foam 110 extends downward from hub cap 105. Sealing portion 141 of hub cap 105 extends into valve seat feature 137.

[0077] refer to Figure 11B Hub cap 105 and hub 102 are urged into contact. As described above, pushing hub cap 105 into valve seat feature 137 deforms incompressible O-ring 120, thereby sealing any potential fluid path between valve 104 and hub 102 / hub cap 105. Valve portion 124 extends slightly over valve seat feature 137 in hub 102, but is not compressed, until seat portion 141 of hub cap 105 is pushed down onto hub 102. Seat portion of hub cap 105 compresses O-ring 120 in valve seat feature 137 of hub 102. O-ring 120 is not fully compressed until hub cap 105 is fully seated on hub (e.g., hub cap 105 is ultrasonically welded to hub 102). Figure 11B The value is shown as 150.

[0078] Foam 110 in hub cap 105 can form a pin (not shown) to facilitate engagement of hub cap 105 with valve 104. Valve 104 is either formed of silicone or coated with silicone to reduce any friction or insertion force between valve 104 and one or more devices inserted through it.

[0079] Figure 12 yes Figure 6 The diagram shows a cross-sectional view of valve 104. A portion of valve 104 is shown from an internal angle, making a portion of O-ring 120 visible along with valve portion 124 above the O-ring. Clearance 125 is the portion of the valve interior defined by frame portion 123 and valve portion 124.

[0080] Figure 13 yes Figure 12 A side view of the hemostatic valve 104. In this view, the O-ring 120 is shown in dashed lines from the outer circumference of the valve portion, as it is located within the inner circumference of the valve portion. The helical slit 126 is also shown in dashed lines. The helical slit 126 is formed through the thickness of the valve portion 124.

[0081] Figure 14 304 stainless steel is used to replace the hemostatic valve. Figure 12 Similarly, it is also shown in cross-section. In this configuration, the O-ring is replaced by an upright extension 320 of the frame portion 323 of the valve 304. In this example, the extension 320 is an incompressible feature that will be subjected to compressive forces in the valve seat feature 137 when the hub cap 105 is assembled to the hub 102. The valve portion 324 has a helical slit (not shown) formed therein. The extension 320 extends below the valve portion 324 and otherwise performs the function of the O-ring described in the previous embodiments. The frame portion 323 and the valve portion 324 define a gap 325 below the valve portion 324.

[0082] Figure 15 This is an alternative hemostatic valve configuration 404. In this configuration, the O-ring is replaced by an extension 420 of a square frame portion 423, instead of a circular O-ring structure. The undercut extension 420 is also formed by the valve seat feature of the hub ( Figure 14 The valve portion 424 (not shown) is accommodated and is an incompressible feature of the valve 404. The valve portion 424 still has a helical slit (not shown) formed therein. The frame portion 423 and the valve portion 424 define a gap 425 below the valve portion 424.

[0083] Figure 16This is an alternative hemostatic valve configuration 504. The hemostatic valve 504 has a frame portion 523 with two extensions 520 and 520'. An incompressible feature 520' is received by a valve seat feature, which also anchors the hemostatic valve 504 within the guide sheath assembly when the device is removed from the guide sheath assembly. A helical slit is formed in a valve portion 524, located between the two extensions 520 and 520' of the frame portion 523 of the valve 504. The valve 504 has two gaps defined by the valve portion 524 and the frame portion 523. One gap 525 is located above the valve portion 524, and the other gap 525 is located below the valve portion 524.

[0084] In this specification, the word "including" should be understood in its "open" meaning, that is, the meaning of "containing," and is therefore not limited to its "closed" meaning, that is, "consisting of only." The corresponding meanings should be attributed to the corresponding words "including" and "included."

[0085] While specific embodiments of the technology have been described, those skilled in the art will understand that the technology may be embodied in other specific forms without departing from its essential characteristics. Therefore, these embodiments and examples are to be considered illustrative rather than limiting in all respects. It should be understood that the guide components described herein can be applied to other systems where access to the patient's arterial incision is required while maintaining hemostasis. Various variations and modifications will occur to those skilled in the art after reading this disclosure. The disclosed features can be implemented with one or more other features in any combination and sub-combination (including multiple dependent combinations and sub-combinations).

[0086] It should also be understood that, unless otherwise indicated, any reference in this document to subjects known in the art does not constitute an admission that such subjects are known to those skilled in the art.

Claims

1. An introducer sheath assembly for percutaneously delivering a medical device for maintaining hemostasis in a patient, the assembly comprising: sheath; a sheath hub assembly coupled to the sheath body, the sheath hub assembly comprising a hub, a hub cover, a hemostatic valve, and optional foam; as well as The hemostatic valve includes a valve portion and a frame portion, wherein the frame portion defines a perimeter of the valve and has a thickness greater than a thickness of the valve portion, and the valve portion has a plurality of offset slits formed through its thickness.

2. An introducer sheath assembly according to claim 1, wherein the valve is made of an incompressible elastomer.

3. The introducer sheath assembly of claim 1, wherein the incompressible elastomer is selected from the group consisting of natural rubber, synthetic rubber, polyisoprene, polyurethane, silicone, and thermoplastic elastomer.

4. The introducer sheath assembly of claim 3, wherein the thermoplastic elastomer is one of a styrenic block copolymer or a thermoplastic vulcanizate.

5. An introducer sheath assembly according to claim 1, wherein the hub has a valve seat feature formed therein, the valve seat feature being adapted to accommodate an extension of the frame portion of the valve and a seating portion of the hub cover.

6. The introducer sheath assembly of claim 5, wherein the valve seat feature is a channel having an inner wall of a first height and an outer wall of a second height, wherein the outer wall is taller than the inner wall.

7. The introducer sheath assembly of claim 6, wherein the valve portion is located above the inner wall of the valve seat feature, and the extension of the frame portion of the hemostatic valve extends into the valve seat feature.

8. The introducer sheath assembly of claim 5, wherein the seating portion of the hub cap is thicker at its proximal end than at its distal end.

9. The introducer sheath assembly of claim 1, wherein the hub cover is ultrasonically welded to the hub.

10. The introducer sheath assembly of claim 1, wherein the hub has a flushing port formed therein.

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