Hemostatic valve for sheath assembly

Abstract

An introducer sheath assembly for percutaneously delivering a medical device that maintains hemostasis within a patient. The assembly includes a hub, a hubcap, and a hemostatic valve. The introducer sheath assembly has a longitudinal axis and a lumen formed therein. The hemostatic valve includes a frame portion and a valve portion, the valve portion having a plurality of slits therein offset through a thickness of the valve portion, and an extension of the frame portion formed from a non-compressible material. When the valve is received by the hub, the extension of the frame portion is received by a valve positioning feature in the hub. The valve positioning feature also receives a positioning portion of the hubcap when the hub and hubcap are advanced into an engaged state, and the positioning portion of the hubcap is advanced into the valve positioning feature, thereby subjecting the non-compressible extension of the frame portion to a compressive force. TIFF2023503841000002.tif145170

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 62 / 935,300, filed November 14, 2019, which is incorporated herein by reference.

[0002] Technical Field The present invention relates to an introducer sheath assembly that enables introduction of a medical device into a patient's body at an insertion site, such introducer sheath assemblies having a hemostatic valve for reducing or eliminating the discharge of body fluid from the patient through the insertion site of the introducer sheath assembly.

Background Art

[0003] Background Patients with heart disease are sometimes treated with a heart pump that is adapted to be inserted into the heart through an adjacent blood vessel and that either assists the natural pumping function of the heart or replaces the natural pumping function of the heart by a continuous pumping operation.

[0004] In one common approach, an introducer sheath is used to obtain vascular access prior to insertion of a medical device such as a heart pump. The introducer sheath is an assembly that includes a hemostatic valve; the hemostatic valve prevents blood leakage from the distal end of the introducer sheath when the introducer sheath is inserted into a blood vessel. The hemostatic valve should prevent excessive blood leakage when no object is present within the valve or when a guide wire, catheter, blood pump, or other object is being inserted through the valve. One of the main causes of excessive leakage in an introducer sheath is damage or perforation of the hemostatic valve.

Summary of the Invention

[0005] Summary An introducer sheath assembly for percutaneous delivery of a medical device that maintains hemostasis within a patient's body is described herein. As shown in the figures, the sheath assembly comprises a sheath body and a sheath hub assembly connected to the sheath body. The sheath hub assembly comprises a hub, a hub cap, a hemostatic valve, and optionally a foam. The hemostatic valve comprises a valve portion and a frame portion. The frame portion defines the periphery of the valve and has a thickness greater than the thickness of the valve portion, and the valve portion has a plurality of offset slits formed through the thickness of the valve portion. The thickness of the valve is the thickness in the direction in which the medical device moves through the valve. The valve is formed from an incompressible elastomer.

[0006] Examples of incompressible materials include natural rubber, synthetic rubber, polyisoprene, polyurethane, silicone, and thermoplastic elastomers. Examples of thermoplastic elastomers include styrene-based block copolymers and thermoplastic vulcanized products.

[0007] Optionally, the hub may have a valve positioning feature formed therein. The valve positioning feature is adapted to receive an extension of the valve frame portion and a positioning portion of the hub cap. For example, the valve positioning feature is configured as a channel having an inner wall of a first height and an outer wall of a second height, the outer wall being higher than the inner wall. In this configuration, the valve portion is located above the inner wall of the valve positioning feature, and the extension of the valve frame portion extends into the valve positioning feature.

[0008] Optionally, the hub cap positioning portion, i.e., the portion of the hub cap positioned within the valve positioning feature of the hub, may be thicker at its proximal end than at its distal end. The hub cap is fixed in the assembly together with the hub and valve. Optionally, the hub cap portion may be sonically welded to the hub portion.

[0009] Optionally, the hub may have a flash port formed therein. Flash ports in such devices are well known to those skilled in the art and are not described in detail herein.

[0010] Optionally, the valve frame portion may have an O-ring at the distal end of the extension from the valve portion. Optionally, the extension of the frame portion may have a uniform thickness. In another optional configuration, the valve has frame extensions extending from both the proximal and distal sides of the valve body. In another configuration, the extension of the frame portion is an undercut extension.

[0011] The positioning portion of the hub cap may be either straight or tapered. If the positioning portion is tapered, the taper is either parallel or non-parallel to the tapered portion of the valve portion that contacts the positioning portion when the hub cap is assembled to the valve and hub. If the positioning portion is straight, it is either parallel or non-parallel to the valve portion that contacts the positioning portion when the hub cap is assembled to the valve and hub.

[0012] A method for assembling an introducer sheath is also described herein. In this method, a hub is provided in which a valve positioning feature is formed therein. A valve is also provided, comprising a valve portion and a frame portion, wherein the frame portion is thicker than the valve portion. The valve is formed of an incompressible material having a plurality of helical slits formed within the valve portion. The frame portion extends beyond the valve portion. A hub cap with a positioning portion is also provided. In this method, the valve is assembled to the hub. At least a portion of the frame portion is received by the valve positioning feature. The cap is assembled to the valve and the hub such that at least a portion of the positioning portion of the hub cap is received within the valve positioning feature. The volume of the positioning portion received within the valve positioning feature deforms the incompressible material within the valve positioning feature. [Invention 1001] An introducer sheath assembly for percutaneous delivery of a medical device to maintain hemostasis within the patient's body, sheath body; and A sheath hub assembly connected to the sheath body, comprising a hub, a hub cap, a hemostatic valve, and optionally a foam body. It is equipped with, The hemostatic valve comprises a valve portion and a frame portion, the frame portion defining the periphery of the valve and having a thickness exceeding the thickness of the valve portion, and the valve portion having a plurality of offset slits formed through the thickness of the valve portion. Introducer sheath assembly. [Invention 1002] An introducer sheath assembly according to the present invention 1001, wherein the valve is formed from an incompressible elastomer. [Invention 1003] An introducer sheath assembly according to the present invention 1001, wherein the incompressible elastomer is selected from the group consisting of natural rubber, synthetic rubber, polyisoprene, polyurethane, silicone, and thermoplastic elastomers. [Invention 1004] An introducer sheath assembly according to the present invention 1003, wherein the thermoplastic elastomer is one of a styrene-based block copolymer or a thermoplastic vulcanized product. [Invention 1005] An introducer sheath assembly according to the present invention 1001, wherein the hub has a valve positioning feature formed therein, and the valve positioning feature is adapted to receive an extension of the valve frame and a positioning portion of the hub cap. [Invention 1006] The introducer sheath assembly of the present invention 1005, wherein the valve positioning feature is a channel having an inner wall having a first height and an outer wall having a second height, the outer wall being higher than the inner wall. [Invention 1007] An introducer sheath assembly according to the present invention 1006, wherein the valve portion is located above the inner wall of the valve positioning feature, and the extension of the frame portion of the hemostatic valve extends into the valve positioning feature. [Invention 1008] An introducer sheath assembly according to the present invention 1005, wherein the positioning portion of the hub cap is thicker at its proximal end than at its distal end. [Invention 1009] An introducer sheath assembly according to the present invention 1001, wherein the hub cap is sonically welded to the hub. [Invention 1010] An introducer sheath assembly according to the present invention 1001, wherein the hub has a flush port formed therein. [Invention 1011] An introducer sheath assembly according to the present invention 1005, wherein the extension portion of the frame is equipped with an O-ring. [Invention 1012] An introducer sheath assembly according to the present invention 1005, wherein the extension portion of the frame has a uniform thickness. [Invention 1013] An introducer sheath assembly according to the present invention 1012, wherein the extensions of the frame portion extend from both sides of the valve portion. [Invention 1014] An introducer sheath assembly according to the present invention 1005, wherein the extension portion of the frame is an undercut extension portion. [Invention 1015] An introducer sheath assembly according to the present invention 1001, wherein the hub cap is provided with a positioning portion, and the positioning portion is either straight, stepped, or tapered. [Invention 1016] The introducer sheath assembly of the present invention 1015, wherein the positioning portion is a stepped positioning portion comprising a first narrower step positioned between the hub and the frame portion and a second wider step positioned in contact with the valve portion. [Invention 1017] An introducer sheath assembly according to the present invention 1015, wherein the positioning portion is tapered, and the tapered portion is either parallel or non-parallel to the tapered portion of the valve portion that contacts the positioning portion when the hub cap is assembled to the valve and hub. [Invention 1018] An introducer sheath assembly according to the present invention 1015, wherein the positioning portion is linear, and the hub cap is either parallel or non-parallel to the valve portion of the valve portion that contacts the positioning portion when assembled to the valve and hub. [Invention 1019] A step of providing a hub in which valve positioning features are formed; A step of providing a valve comprising a valve portion and a frame portion, wherein the frame portion is thicker than the valve portion, the valve comprises an incompressible material having a plurality of helical slits formed within the valve portion, and the frame portion extends beyond the valve portion; A step of providing a hub cap with a positioning portion; The step of assembling the valve to the hub, wherein at least a portion of the frame is received by the valve positioning feature; and A step of assembling the hub cap to the valve and the hub such that at least a portion of the positioning portion of the hub cap is received within the valve positioning feature, wherein the positioning portion received within the valve positioning feature is adapted to deform the incompressible material within the valve positioning feature. A method for assembling an introducer sheath, including [specific details omitted]. [Invention 1020] The method of the present invention 1019, wherein the hub cap has a positioning portion, and the positioning portion exerts a gradually increasing lateral force on the valve portion when the hub cap is assembled onto the hub. [Invention 1021] The method of the present invention 1020, wherein the hub cap has a positioning portion for a lateral profile adjacent to the valve portion and the frame portion when assembled onto the hub, and the lateral profile is either straight, stepped, or tapered. [Invention 1022] Lateral profile, When the hub cap is assembled onto the hub, there is a first narrower step positioned between the hub and the frame portion, and a second wider step positioned in contact with the valve portion. The method of the present invention 1021, which is a stepped profile comprising the above. [Invention 1023] The method of the present invention 1021, wherein the lateral profile is a tapered portion that is positioned in contact with the valve portion when the hub cap is assembled onto the hub. [Brief explanation of the drawing]

[0013] The above and other purposes and benefits will become clear upon consideration of the following detailed description in conjunction with the attached drawings; throughout the attached drawings, similar reference numerals refer to similar parts.

[0014] [Figure 1] This is a cross-sectional view of an introducer assembly having a hemostatic valve, based on a certain embodiment. [Figure 2] Figures 1 and 2 show the percutaneous insertion of a cardiac pump using an introducer assembly with a hemostatic valve. [Figure 3] This is a detailed cross-section of the hemostatic valve located within the hub. [Figure 4] This is a top view of a hemostatic valve based on one embodiment. [Figure 5] This is a bottom view of the hemostatic valve based on the second embodiment. [Figure 6] Figure 4 is a top view of the hemostatic valve. [Figure 7]Figures 7A-7C are photographs of the hemostatic valve based on the first embodiment, before and after the guidewire is passed through and inserted. [Figure 8] Figures 8A-8D are photographs of the hemostatic valve based on the second embodiment, before and after the guidewire is passed through and inserted. [Figure 9] Figure 1 is a detailed view of a portion of the introducer assembly. [Figure 10] Figures 10A-10B illustrate the compression of the valve when the hub cap is mounted onto the hub of the introducer assembly. [Figure 11] Figures 11A and 11B illustrate the introducer assembly before and after the hub cap is ultrasonically welded to the hub. [Figure 12] Figure 6 is a cross-sectional view of the hemostatic valve shown. [Figure 13] Figure 12 is a cross-sectional view of the inner circumference of the hemostatic valve. [Figure 14] This is a cross-sectional view of the outer circumference of a hemostatic valve according to the second embodiment. [Figure 15] This is a cross-sectional view of the outer circumference of a hemostatic valve according to a third embodiment. [Figure 16] This is a cross-sectional view of the outer circumference of a hemostatic valve according to the fourth embodiment. [Figure 17] This is an illustration of an alternative hub cap configuration that applies pressure in two regions. [Modes for carrying out the invention]

[0015] Detailed explanation Where, in this disclosure, a given element is depicted in a particular drawing, a particular number of elements is considered or used, or they are referenced in the corresponding explanatory material, it may encompass the same, equivalent, or similar elements or numbers of elements identified in other related drawings or explanatory material.

[0016] The use of " / " in drawings or related text shall be understood to mean "and / or" unless otherwise indicated. The mention of specific numbers or ranges of values, or the use of terms such as "approximately" or "about," shall be understood to include, or indicate, an approximate number or range of values ​​(e.g., within + / -2%, + / -5%, + / -10%, + / -15%, or + / -20%).

[0017] As used herein, the term “set” corresponds to, or is defined as, an organization of non-empty, finite elements exhibiting at least one mathematical cardinality, based on known mathematical definitions (for example, in the style corresponding to the description in Peter J. Eccles, Cambridge University Press (1998), “An Introduction to Mathematical Reasoning: Numbers, Sets, and Functions,” “Chapter 11: Properties of Finite Sets” (e.g., the description on p. 140)). (i.e., a set as defined herein may correspond to a unit, a singlet, a single set of elements, or multiple sets of elements.) Generally, the elements of a set may include, or be part of, a system, apparatus, device, structure, object, process, physical parameter, or value, depending on the type of set being considered.

[0018] As used herein, proximal is defined as being toward or closer to the user, and distal is defined as being further from the user, or away from or in the opposite direction to the distal in relation to fluid flow. The term "vessel" is taken to mean an anatomical blood vessel, passage, or channel (e.g., a blood vessel such as an artery), or an anatomical chamber or compartment of a patient or subject. The term "perfusion" is taken to mean the injection, transfer, or transmission of blood and / or one or more other fluids into a blood vessel for the purpose of enabling blood and / or other fluids to reach an organ or tissue (e.g., to supply nutrients and oxygen therein). The term "fluidically coupled" is taken to mean being connected in a manner that allows for the transfer or transmission of fluids (e.g., liquids / gases).

[0019] Certain exemplary embodiments are described to allow for a comprehensive understanding of the systems, methods, and devices described herein. While the embodiments and features described herein specifically relate to the use of introducer sheaths and hemostatic valves for percutaneous insertion of a cardiac pump, it should be understood that all components and other features outlined below may be combined with each other in any preferred manner and may be adapted and applied to other types of introducer sheaths and hemostatic valves, or other types of cardiac assist devices, including balloon pumps.

[0020] The introducer sheath assembly described herein has a hub / hub cap / valve assembly; the geometry of the valve and the geometry of the hub cooperate to seal two fluid pathways, thereby providing a hemostatic introducer sheath assembly. The fluid pathways independently sealed by the hub / hub cap / valve assembly are 1) a fluid pathway around the valve between the valve and the hub or hub cap, and 2) a fluid pathway through one or more slits in the valve that allow for the insertion of a medical device through one or more slits in the valve and / or the insertion of a mechanism for introducing such medical devices (e.g., catheters; dilators, etc.). The valve slits described herein cooperate with the hub / hub cap assembly to provide a hemostatic seal when closed and when a medical device is inserted through it.

[0021] Therefore, an introducer sheath with a hemostatic valve and a hemostatic hub / hub cap / valve assembly offers two modes of sealing the valve, which is advantageous compared to prior art assemblies having only one sealing mode (compression). As compression increases due to the positioning of the hub cap within the hub, sealing in both modes increases. However, increasing compression increases the force required to insert the device through the valve. Thus, the amount of force exerted on the valve by the hub / hub cap assembly is controlled so that the insertion force required to pass the device through the slit remains within an acceptable range.

[0022] The valve is formed from an incompressible material such as silicone, natural or synthetic rubber, polyisoprene, polyurethane, and thermoplastic elastomer. Other incompressible materials suitable for use in the present invention are well known to those skilled in the art and are not described herein. The hub has a volumetrically constrained structure called a valve positioning feature. The valve has a frame portion with an extension that extends into the valve positioning feature when the valve is positioned within the hub. The hub cap has a positioning portion that also extends into the valve positioning feature when the hub cap is assembled onto the hub. This arrangement provides volumetric interference between the incompressible valve frame extension, the valve positioning feature, and the positioning portion, thereby providing sealing pressure between the extension of the frame portion (e.g., the geometry of an O-ring) and the hub / hub cap. Since the incompressible valve frame extension fits within the valve positioning feature, the volume of the incompressible valve frame extension is smaller than the volume of the valve positioning feature into which it extends. When the hub cap positioning portion is pushed into the valve positioning feature, this reduces the volume of the valve positioning portion and deforms the incompressible valve frame extension. This seals the potential fluid path between the valve and the hub / hub cap assembly.

[0023] The fluid path through the valve slit is sealed by the introducer sheath assembly described herein. The hub / valve / hub cap assembly is dimensioned to provide radial interference between the hub cap and the valve portion of the valve, which provides sealing pressure on the surface of the slit formed within the valve portion. This radial interference is provided by the tapered geometry of the hub cap.

[0024] If the tapered geometry of the hub cap is parallel to the corresponding taper on the valve, substantially uniform compression is achieved along the thickness of the valve portion. If the tapered geometry is substantially non-parallel to the corresponding taper on the valve, substantially non-uniform compression is achieved along the thickness of the valve portion. In either case, the compression at the distal end of the valve is greater than that at the proximal end.

[0025] Optionally, the hub cap may have a linear geometric shape. In this option, if the linear geometric shape of the hub cap is substantially parallel to the valve geometry, the compression along the length of the valve portion is substantially uniform. If the linear geometric shape is substantially non-parallel to the valve geometry, the compression along the length of the valve portion is substantially uneven. In either case, the compression at the distal end of the valve is greater than the compression at the proximal end of the valve.

[0026] Thus, the systems, methods, and devices described herein reduce or eliminate the risk of bleeding that occurs during the insertion of medical devices (e.g., cardiac pumps), guidewires, dilators, or other objects. The hemostatic valve, and in a manner in which it is arranged within a hub and hub cap, controls, reduces, or prevents the loss of blood through and around the valve.

[0027] The introducer sheath assembly has two main functions. First, the introducer sheath creates a pathway into the desired vascular structure to allow for the insertion and removal of the device. Second, the introducer sheath must maintain hemostasis throughout the entire access site throughout the insertion process. The hemostatic valve maintains hemostasis through the lumen of the introducer sheath. The hemostatic valve component is typically located in the most proximal part of the introducer sheath, which is known as the hub.

[0028] The hemostatic valve is required to form a seal when assembled within the hub. The hemostatic valve must maintain this seal when a device of varying sizes is inserted through it. As described above, the hub and hub cap assembly exerts force on the hemostatic valve described herein to prevent fluid flow (i.e., leakage from the sheath assembly insertion site) from flowing from the distal end to the proximal end of the sheath assembly.

[0029] An additional radial compression applied to the valve by the hub / hubcap assembly ensures that the seal is not compromised by changes in the diameter of the inserted device, so that the valve can maintain its seal as the device is passed through the valve. In the valve / hub / hubcap assembly described herein, this additional radial compression is provided by placing the valve within the hubcap. The hub and hubcap assembly is configured to act on the elastomer valve to provide the required valve compression. The valve has a downward-facing sidewall thickness that, in cooperation with the hubcap fitted within the hub, forms the desired seal. Optionally, the downward-facing sidewall of the valve may terminate in an O-ring. When the hubcap is inserted downward into the hub, a compressive force is applied to the slit valve to seal it. Optionally, the hubcap may have a tapered opening such that the diameter of the hubcap interior receiving the valve decreases as the hubcap advances into the hub. This tapered diameter is referred to herein as the compression feature.

[0030] For the introducer sheath to accommodate devices of multiple diameters, such as the blood pumps described herein, a seal must be formed with devices of various diameters, including 9 French (3 mm), 10 French (3.33 mm), 11 French (3.67 mm), 12 French (4 mm), 13 French (4.33 mm), 14 French (4.67 mm), 15 French (5 mm), 16 French (5.33 mm), 17 French (5.67 mm), 18 French (6 mm), 19 French (6.33 mm), 20 French (6.67 mm), 21 French (7 mm), or any other suitable diameter. Blood pump devices that may be inserted through the introducer sheath assembly described herein are described, for example, in U.S. Patent No. 7,736,296, "Intercardiac Blood Pump" by Seiss et al., incorporated herein by reference.

[0031] Regarding blood pump insertion, the valve must be able to maintain a seal under the following conditions: i) Sheath only (when there is nothing inside the valve); ii) Only the expander is inserted into the valve (the expander may be silicone coated and may be inserted into the valve to lubricate it before inserting the pump device through the valve); iii) A first guidewire is inserted into the valve (for example, a guidewire with a diameter of 0.035" (0.889 mm) is passed through the hemostatic valve and used to advance the pump through the valve); iv) A 6 Fr guide catheter is inserted through the valve; v) A second guidewire is inserted into the valve (for example, a guidewire with a diameter of 0.018" (0.457 mm)); The second guidewire in vi)v) is inserted into the valve along with the 9 Fr catheter portion (3 mm) of the pump; and vii) Pump device (9 Fr (3 mm) catheter portion).

[0032] The above conditions are listed as examples only and are not limiting. The assemblies described herein solve the problems of hemostasis, minimal insertion, and removal force, while also maintaining ease of manufacture of the hub, hub cap, and valve itself. The assemblies described herein provide hemostasis for each device of varying sizes inserted through the valve. The seal is also maintained when such devices are removed.

[0033] The valve described herein is constructed as a thin (e.g., about 2 mm to about 4 mm) disc that is received within a hub / hub cap assembly. The valve is circular because the hub / hub cap assembly defines an internal lumen with a circular cross-section through which the device is inserted into the patient's body. The valve is made of flexible silicone; flexible polymers such as natural or synthetic rubber, polyisoprene, polyurethane; or thermoplastic elastomers such as styrene block copolymers or thermoplastic vulcanized products. The disc has first and second thicknesses. The first peripheral thickness exceeds the second internal thickness. The thicker peripheral portion of the disc is called the frame portion, and the thinner internal portion is called the valve portion. Thus, in this specification, the first thickness is called the frame thickness and the second thickness is called the valve thickness. Both thicknesses are axial thicknesses of the introducer sheath assembly. Referring to Figure 12, the valve 104 shown in the cross-sectional view is, frame The valve 104 has a frame portion 123, as shown in Figure 1, extending from portion 123 and ending as an O-ring portion 120, 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 the material described elsewhere in this specification. The O-ring portion 120 defines an inner and outer circumference, over which the thinner valve portion 124 extends. The internal void portion is indicated by 125. The O-ring 120 is optional, as described elsewhere in this specification. As described herein, the O-ring 120 is an example of the incompressible features described herein.

[0034] Figure 1 is a cross-sectional view of an introducer sheath assembly 100, including a hemostatic valve 104 housed within a hub 102; the hub 102 has a hub cap 105 mounted thereon. The hub has an internal cavity 109 that receives the hemostatic valve 104 and tapers to an internal lumen 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 introducer body 106 (i.e., a sheath) having an internal lumen 107 and a longitudinal axis 108. The internal lumen 111 of the hub is fluidly connected to the internal lumen 107 of the elongated introducer body. The introducer assembly may optionally include a lubricating foam 110. The lubricating foam actively lubricates the device inserted through it. Suitable lubricating foams are well known to those skilled in the art and are not described in detail herein. 110 The foam may be open-cell polyurethane that absorbs and retains a lubricant such as silicone oil. The foam 110 has attachment features for holding the foam in place on a cap. Such attachment features are known and therefore not illustrated herein. The foam 110 has through holes 127 for the device to pass through, so that the device is passively lubricated by the silicone oil in the open-cell network. Optionally, the foam may be supplied in portions and assembled with the valve 104 when the hub cap 105 is placed on top.

[0035] The hub 102 has an inlet 153 (i.e., a flush port) that fluidically connects the fluid supply line 152 to the internal lumen 111 of the hub 102. Arrow 154 indicates the flow path for the fluid entering the hub 102 through the inlet 153. When the hub cap 105 is fully positioned inside the hub 102, the hub cap 105The hub 102 and the valve 104 work together to deform the O-ring (since the O-ring is incompressible, its volume does not change). This force 155 seals off any potentially existing fluid paths within the valve region 156 between the valve 104 and the hub 102 / hub cap 105. The hub cap 105 also exerts a compressive force 157 on the valve 104. This compressive force 157 seals the valve 104 within the hub 102 / hub cap 105 so that there is no fluid flow returning from the internal lumen 111 of the hub 102 through the valve 104. As shown in Figure 1, the valve 104 frame portion 123 This ends as O-ring 120. Figure 1 shows the O-ring 120 in an undeformed state and illustrates the change in dimensions of the valve 104 and its O-ring portion 120 caused by the hub cap 105 being fully positioned on the hub 102.

[0036] Figure 2 shows the percutaneous insertion of a cardiac pump assembly 200 using an introducer sheath assembly 100 with the hemostatic valve 104 shown in Figure 1. The cardiac pump assembly 200 includes a distal end portion 203 including an outlet 206 and a supply catheter 202. The introducer sheath assembly 100 is also shown as an assembly that includes a fluid supply line 152 for a flush port 153. The fluid supply line has a valve (not shown) used to turn the flow of fluid into the introducer sheath assembly on and off. The fluid supply line 152 may be used to flush the introducer sheath assembly 100 before, during, or after insertion of the cardiac pump assembly 200. The distal end portion 203 of the cardiac pump assembly 200 is along the insertion path 204 Introduction Sheath It is inserted into assembly 100.

[0037] Figure 3 illustrates a helical slit 126 formed through the thickness of the valve portion 124 of the valve 104. Such slits are described in WO2019090351 by Korkuch et al., which is common to this application and its owner. WO2019090351 is incorporated herein by reference. The helical slits used herein are slits in which the cut in the material is offset through the thickness of the valve portion. For example, spiral slit 126 may form a spiral through the thickness of the valve portion. The cut may be one cut or more cuts. Such slits are well known to those skilled in the art and are not described in detail herein.

[0038] The helical slit 126 passes through the thickness of the valve portion 124 and crosses the center of the valve. 104 A spiral path is followed through the thickness of the valve portion 124, from line 126A (Figure 6) on the upper surface of the valve to line 126B (Figure 5) on the lower surface of the valve. The lengths of the first group of lines 126A and the second group of lines 126B determine the size of the helical slit 126. The size of the helical slit 126 may be set to balance the hemostatic performance with the insertion and removal force of medical devices inserted through the hemostatic valve 104. As the lengths of the first group of lines 126A and the second group of lines 126B increase, the size of the helical slit 126 increases, reducing the hemostatic performance of the hemostatic valve 104 and also reducing the removal force of medical devices inserted through the hemostatic valve 104.

[0039] As depicted in Figure 4, the angle α of the helical slit 126 is such that the helical slit 126 is a valve 104The angular path is defined as it traverses through the thickness of the valve portion 124. Generally, α can be any angle that matches the angular offset between the first group of lines 126A on the upper surface of the valve portion 124 and the second group of lines 126B on the lower surface of the valve portion 124. In another case, angle α matches the angular offset of two of the helical slits 126 on the upper surface of the valve portion 124. In some cases, α is equal to 360 / n, where n is the number of helical slits 126. In yet another case, α is not related to the angular offset of two of the lines 126A on the upper surface of the valve portion. In this case, α is the rotation angle of the helix between the upper and lower surfaces of the valve portion 124 and does not need to correspond to the angle between the two lines 126A; therefore, the first group of lines 126A and the second group of lines 126B may be angularly offset from each other. This is illustrated in Figure 6.

[0040] The valve 104 is shown as being received within the hub 102. The hub 102 defines a groove or channel 136 for receiving the frame portion 123 of the valve 104, including the O-ring 120 of the valve 104, as shown in Figure 3. The channel 136 forms a valve positioning feature 137 having an inner channel wall height 132 and an outer channel wall height 134. The valve portion 124 is supported within the hub 102 by the inner channel wall 130. To assemble the hub 102, the valve 104, and the hub cap 105, the valve 104 is first placed within the hub 102. The O-ring 120 stretches slightly over the inner channel wall 132 as it is received within the valve positioning feature 137 in the hub 102. However, the O-ring 120 is not compressed when inserted into the hub 102. The potential for fluid leakage through the distal end of the introducer sheath assembly is reduced or eliminated by coupling the hub cap 105 to the hub 102.

[0041] As mentioned above, incompressibility features 120 (For example, O-rings) )This is a frame portion 123 extending from the valve portion 124. The frame portion has an inner circumference and an outer circumference and is supported by the valve positioning feature 137. The inner diameter of the valve positioning feature 137 is greater than the diameter of the internal lumen 111. Since the incompressible portion is supported within the valve positioning feature 137 and the inner diameter defined by the incompressible feature 120 is greater than that of the internal lumen, the incompressible feature 120 does not come into contact with or otherwise engage with the device passing through the helical slit 126 and the internal lumen 111 of the introducer sheath assembly 100.

[0042] Figure 4 is a top view of valve 104, where valve portion 124 has a helical slit 126A, shown as a series of offset cuts located therein. An O-ring 120 is located below valve portion 124 but has both an inner and outer diameter extending beyond the outer diameter of valve portion 124. Valve 104 may be formed as a monolithic object by injection molding or other molding techniques, which allows for the reproduction of the valve design and configuration within very close tolerances. A device (not shown) First line group 126A (That is, a spiral slit) When passed through, hemostasis is achieved not only by the radial compression of the valve 104 by the hub 102 and hub cap 105 of the introducer sheath assembly 100, but also through the helical slit / cut design.

[0043] Figure 5 is a top-down view of valve 104. The valve is connected to the O-ring 120. Second line group 126B (That is, a spiral slit) It is slightly recessed upwards and inwards until the valve portion 124 formed inside. Figure 5 shows an arbitrary valve slit, which varies from a 3-cut helix configuration to a 2-cut configuration. 126 The structure is illustrated. In the two-cut configuration, the spiral is not reflected, but the spiral propagates through the thickness of the valve portion 124.

[0044] The hemostatic valve 104 may optionally be made of flexible silicone. Durometer values ​​(i.e., Shore A hardness) of 20A, 30A, and 40A are expected to be preferred. The valve may also be made of a completely different elastomer exhibiting similar properties, such as a lower durometer hardness. Examples of such materials include natural or synthetic rubber, polyisoprene, polyurethane, or thermoplastic elastomers such as styrene-based block copolymers or thermoplastic vulcanized products. Optionally, the hemostatic valve 104 may be made of medical-grade silicone or other elastomers.

[0045] Figure 6 shows the valve from Figure 4, with the helical cut progressing through the valve portion 124. Figure 6 also shows that the diameter of the valve portion tapers slightly inward from the distal end to the proximal end. Figure 12 shows a cross-section of the valve shown in Figure 6 along line 12-12.

[0046] Figures 7A-7C are photographs of a hemostatic valve 104 with an x-shaped helical slit 126. Figure 7A shows the valve 104 before anything is inserted through the slit 126. Figure 7B shows the valve 104 after a guidewire 134 has been inserted through it. Figure 7C is a magnified view of the slit 126 being damaged by the guidewire 134. It should be noted that in Figure 7B, there is a gap 136 through the valve 104 that is formed when the guidewire is pulled and slightly off-center. Typically, the device is inserted after the guidewire has been successfully threaded through the introducer sheath assembly 100. Figure 7C is a magnified view of the gap formed within the valve as depicted in Figure 7B.

[0047] Figures 8A-8D are photographs of a hemostatic valve 104 equipped with a helical slit 126. The helical slit propagates through the thickness of the valve portion 124 of the hemostatic valve 104. In Figure 8B, the slit 126 inside the valve is pushed in to show the helical nature of the helical slit 126 (i.e., the cut is offset as it propagates through the thickness of the valve portion 124). Figure 8C is an image of the valve 104 with a guide wire 134 passing through the slit 126. Figure 8D shows the valve 104 when the guide wire 134 passing through the slit 126 is pulled and shifted from the center.

[0048] Referring to Figure 9, a detailed cross-sectional view of the introducer sheath assembly 100 is shown, in which the hub cap 105 is joined to the hub 102, thereby compressing the frame portion 123 of the hemostatic valve 104 within the valve positioning feature 137. The hub cap 105 has a positioning portion 141 that is pressed into the valve positioning feature 137 between the inner wall 132 and the outer wall 134 of the channel 136 of the hub 102. The relaxed state of the O-ring portion 120 is illustrated by dashed lines in Figure 9. Since the O-ring portion 120 is made of an incompressible material, when the positioning portion 141 of the hub cap 105 is placed within the valve positioning feature 137, the volume available to the O-ring within it is reduced. Due to this reduced volume, the O-ring portion 120 exerts a force that substantially seals the fluid path between the valve, the hub, and the hub cap.

[0049] Referring to Figure 17, the hub cap 105 has stepped internal portions that provide the target lateral deformation to 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 sized to exert a lateral force 163 on the O-ring 120. The stepped portion 162 is sized to exert a lateral force 163 on the valve portion 124 (the valve portion 124 has a vertical perimeter profile that is laterally recessed relative to the vertical perimeter profile of the O-ring 120). The dashed lines 164 illustrate 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 are subject to the constraints imposed by the stepped portions 160 and 162 of the hub cap 105.

[0050] Referring to Figures 10A-10B, the hub cap 105 is shown having a compression feature 140. The cap 105 with the compression feature 140 is shown in Figure 10A. The compression feature 140 is shown as a surface that tapers inward and downward in the portion of the hub cap 105 in which the valve portion 124 of the valve 104 is received. This compression feature 140 seals the slit in the valve portion 124 through the thickness of the valve portion 124. Optionally, the compression feature may be linear. If the compression feature is linear, the slit is sealed over the lateral spread of the valve portion 124. As can be seen from line 142 in Figure 10B, the frame portion 123 of the valve 104 is compressed inward by the compression feature 140. As described above, this compression feature reduces leakage from the distal end of the introducer sheath assembly 100, which may otherwise occur through the slit in the valve 104. As described above, the introducer sheath assembly described herein reduces leakage through two different paths; one is through the valve 104 and the other is through the path around the valve 104.

[0051] Figures 11A-11B illustrate the state in which the hub cap 105 is advanced into the hub 102 for engagement between the hub cap 105 and the hub 102. In Figures 11-B, the valve profile before the hub cap is placed in the hub is shown by a solid line, and the profile after the hub cap is inserted is shown by a dashed line. Referring to Figure 11A, the hub cap 105 is positioned above the hub 102 and the valve 104; the valve 104 is placed in the hub 102 before the hub cap 105 is placed on top of it. The valve has a thinner valve portion 124 and a thicker frame portion 123. The valve's O-ring 120 is a valve positioning feature. 137 It is placed inside. The foam 110 extends downward from the hub cap 105. The positioning portion 141 of the hub cap 105 extends into the valve positioning feature 137.

[0052] Referring to Figure 11B, the hub cap 105 and the hub 102 are in contact with each other. As described above, pushing the hub cap 105 into the valve positioning feature 137 deforms the incompressible O-ring 120, which seals any potentially existing fluid pathways between the valve 104 and the hub 102 / hub cap 105. The valve portion 124 extends slightly over the valve positioning feature 137 within the hub 102, but is not compressed until the positioning portion 141 of the hub cap 105 is pushed downward onto the hub 102. The positioning portion of the hub cap 105 compresses the O-ring 120 within the valve positioning feature 137 of the hub 102. The O-ring 120 is not fully compressed until the hub cap 105 is fully positioned on the hub (for example, the hub cap 105 is ultrasonically welded to the hub 102). The ultrasonic welding is illustrated as 150 in Figure 11B.

[0053] The foam 110 within the hub cap 105 may be formed as a pin (not shown) that assists the hub cap 105 in engaging with the valve 104. To reduce frictional or insertion forces between the valve 104 and the device inserted through it, the valve 104 is either formed from silicone or coated with silicone.

[0054] Figure 12 is a cross-section of the valve 104 shown in Figure 6, illustrating a cross-section of the valve 104 as seen from inside the valve, so that a portion of the O-ring 120 can be seen along the valve portion 124 above the O-ring. The gap 125 is the portion inside the valve defined by the frame portion 123 and the valve portion 124.

[0055] Figure 13 is a side view of the hemostatic valve 104 in Figure 12. The O-ring 120 is located on the inner circumference of the valve portion and is therefore shown as a dashed line in this figure, viewed from the outer circumference of the valve. The helical slit 126 is also shown as a dashed line. The helical slit 126 is formed through the thickness of the valve portion 124.

[0056] Figure 14 shows an alternative hemostatic valve configuration 304, also shown in cross-section as in Figure 12. In this configuration, the O-ring is replaced by a linear extension 320 of the frame portion 323 of the valve 304. In this embodiment, the extension 320 is an incompressible feature that is subjected to compressive force within the valve positioning feature 137 when the hub cap 105 is assembled to the hub 102. The valve portion 324 has a helical slit (not shown) formed through it. The extension 320 extends below the valve portion 324 and performs a different function of the O-ring described in the previous embodiment. The frame portion 323 and the valve portion 324 define a gap 325 below the valve portion 324.

[0057] Figure 15 shows an alternative hemostatic valve configuration 404. In this configuration, the O-ring is replaced by a square extension 420 of the frame portion 423, instead of a rounded O-ring structure. The undercut extension 420 is also supported by a valve positioning feature of the hub (not shown in Figure 14) and is an incompressible feature of the valve 404. The valve portion 424 also has a helical slit (not shown) formed through it. The frame portion 423 and the valve portion 424 define a gap 425 below the valve portion 424.

[0058] Figure 16 shows the configuration of an alternative hemostatic valve 504. This hemostatic valve 504 has a frame portion 523 with two extensions 520 and 520'. The incompressible feature 520' is received by a valve positioning feature, while 520 also anchors the hemostatic valve 504 within the introducer sheath assembly when the device is removed from the introducer sheath assembly. A helical slit is formed in the valve portion 524, which is 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 above the valve portion 524, and the other gap 525 is below the valve portion 524.

[0059] In this specification, the word "comprising" should be understood in its "open" sense, that is, in the sense of "including," and therefore not limited to its "closed" sense, that is, in the sense of "consisting only of." When the corresponding words "comprise," "comprised," and "comprises" appear, it should be assumed that these words have corresponding meanings.

[0060] While specific aspects of this technology have been described, it will be apparent to those skilled in the art that this technology can be embodied in other specific embodiments without departing from its essential characteristics. Therefore, the embodiments and examples described herein should be considered in all respects as illustrative and not restrictive. It should be understood that the introducer assemblies described herein may be applied to other systems where it is desirable to access the patient's arterial incision site while maintaining hemostasis. Those skilled in the art may conceive of variations and modifications after reviewing this disclosure. The features of this disclosure may be implemented in any combination and subcombinations (including multiple dependent and subcombinations) with one or more other features.

[0061] Furthermore, it should be understood that, unless otherwise indicated, any reference in this specification to material known in the art does not constitute an acknowledgment that such material is generally known to those skilled in the art.

Claims

1. An introducer sheath assembly for percutaneous delivery of a medical device to maintain hemostasis within the patient's body, Sheath body; and A sheath hub assembly connected to the sheath body, comprising a hub, a hub cap, a hemostatic valve, and a foam body. It is equipped with, The hemostatic valve comprises a valve portion and a frame portion, the frame portion defining the periphery of the valve and having a thickness in its axial direction that exceeds the thickness of the valve portion, and the valve portion having a plurality of offset slits formed through the thickness of the valve portion, the cuts in the material being offset through the thickness of the valve portion. The hub has a valve positioning feature, which is a channel having an inner wall and an outer wall, and a part of the hemostatic valve and a part of the hub cap are housed therein. Introducer sheath assembly.

2. The introducer sheath assembly according to claim 1, wherein the valve is formed from an incompressible elastomer.

3. The introducer sheath assembly according to claim 2, 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 according to claim 3, wherein the thermoplastic elastomer is one of a styrene-based block copolymer or a thermoplastic vulcanized product.

5. The introducer sheath assembly according to claim 1, wherein the valve positioning feature is adapted to receive the extension of the frame portion of the valve and the positioning portion of the hub cap.

6. The introducer sheath assembly according to claim 5, wherein the valve positioning feature is a channel having an inner wall having a first height and an outer wall having a second height, the outer wall being higher than the inner wall.

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

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

9. The introducer sheath assembly according to claim 1, wherein the hub cap is sonically welded to the hub.

10. The introducer sheath assembly according to claim 1, wherein the hub has a flash port formed therein.

11. The introducer sheath assembly according to claim 5, wherein the extension of the frame portion is equipped with an O-ring.

12. The introducer sheath assembly according to claim 5, wherein the extension of the frame portion has a uniform thickness.

13. The introducer sheath assembly according to claim 12, wherein the extension of the frame portion extends from both sides of the valve portion.

14. The introducer sheath assembly according to claim 5, wherein the extension of the frame portion is an undercut extension that is received by the valve positioning feature and is an incompressible feature of the valve.

15. The introducer sheath assembly according to claim 1, wherein the hub cap comprises a positioning portion, and the positioning portion is linear, stepped, or tapered.

16. The introducer sheath assembly according to claim 15, wherein the positioning portion is a stepped positioning portion comprising a first narrower step positioned between the hub and the frame portion, and a second wider step positioned above the first narrower step in contact with the valve portion.

17. The introducer sheath assembly according to claim 15, wherein the positioning portion is tapered, and the taper is either parallel to or non-parallel to the tapered portion of the valve portion that contacts the positioning portion when the hub cap is assembled to the valve and the hub.

18. The introducer sheath assembly according to claim 15, wherein the positioning portion is linear, and the hub cap is either parallel or non-parallel to the valve portion of the valve portion that contacts the positioning portion when assembled to the valve and the hub.

19. A step of providing the hub in which the valve positioning feature is formed therein, wherein the valve positioning feature is a channel having an inner wall and an outer wall, and therein a part of the hemostatic valve and a positioning part of the hub cap are housed; A step of providing a valve comprising the valve portion and the frame portion, wherein the frame portion is thicker than the valve portion, the valve comprises an incompressible material having a plurality of helical slits formed within the valve portion, and the frame portion extends beyond the valve portion; A step of providing the hub cap equipped with the positioning portion; The step of assembling the valve to the hub, wherein at least a portion of the frame is received by the valve positioning feature; and A step of assembling the hub cap to the valve and the hub such that at least a portion of the positioning portion of the hub cap is received within the valve positioning feature, wherein the positioning portion received within the valve positioning feature is adapted to deform the incompressible material within the valve positioning feature. A method for assembling an introducer sheath, including [specific details omitted].

20. The method according to claim 19, wherein the hub cap has a positioning portion that is pressed into the valve positioning feature, and the positioning portion exerts a gradually increasing lateral force on the valve portion as the volume of the incompressible material valve portion decreases when the hub cap is assembled onto the hub.

21. The method according to claim 20, wherein the hub cap has a positioning portion for the lateral profile adjacent to the valve portion and the frame portion when assembled on the hub, and the lateral profile is linear, stepped, or tapered.

22. The lateral profile includes a first narrower step positioned between the hub and the frame portion when the hub cap is assembled onto the hub, and a second wider step positioned above the first narrower step and in contact with the valve portion. The method according to claim 21, comprising a stepped profile.

23. The method according to claim 21, wherein the lateral profile is a tapered portion that is positioned in contact with the valve portion when the hub cap is assembled onto the hub.

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