Sheath cutter with supply mechanism

Abstract

This disclosure generally pertains to introducer sheaths used for intracavitary catheter insertion for therapeutic purposes. More specifically, this disclosure pertains to expandable introducer sheaths and instruments for opening them.

Description

TECHNICAL FIELD

[0001] (Incorporation by Reference to Priority Applications) Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet filed with this application are hereby incorporated by reference under 37 CFR 1.57. For example, this application claims the benefit of U.S. Provisional Patent Application No. 63 / 587,330, filed on October 2, 2023, entitled "SHEATH CUTTER WITH FEEDING MECHANISM", the entire contents of which are hereby incorporated by reference in their entirety for all purposes and form part of the present specification.

[0002] The present disclosure is generally directed to introducer sheaths used for intraluminal catheter insertion for treatment. More specifically, the present disclosure is directed to systems and methods for cutting introducer sheaths.

BACKGROUND ART

[0003] Introducer sheaths are used in medical interventions that access natural cavities or lumens of a patient, such as blood vessels of the vasculature, as a way to gain access to a target region of a patient's body, where delivery, removal, or intervention of substances may be performed. In a typical intravascular procedure, for example, accessing a patient's vasculature involves making a small percutaneous incision or puncture with a scalpel or introducer needle to deliver an intravascular device such as a catheter into the lumen. Introducer sheaths play an important role in procedures to protect the access puncture from excessive shear or frictional forces, protect medical devices as they are delivered into the vasculature, provide structural support, or guide the delivery of medical devices through a desired lumen path. Compared with alternative approaches to access the target region such as open surgery, intravascular approaches, or other approaches utilizing introducer sheaths, often have significant benefits such as reduced risk of infection or iatrogenic injury and more rapid recovery.

[0004] For such a minimally invasive approach, numerous intracavitary medical devices have been developed with dimensions and other features that allow them to enter natural lumens. Often, these medical devices are elongated tubular in shape with an outer diameter smaller than the smallest natural lumen, and are intended to pass through to facilitate delivery, avoid damage, and minimize disruption to lumen functions such as blood flow in the case of endovascular procedures.

[0005] More recently, solutions for intracavitary delivery of devices with a diameter sufficient to occlude or expand the lumen have been explored, including introducer sheaths. Devices requiring such solutions may need to be larger as a result of design constraints. Furthermore, these solutions may enable treatment for patients who are excluded from intracavitary procedures due to narrow lumens or calcification of the vessels. Challenges of intracavitary delivery of these larger devices may include disruption of the function of the lumen organ, such as occlusion of the lumen or application of unbearable force to the tissue. For example, in endovascular procedures involving the delivery of medical devices and associated introducer sheaths into vessels with an inner diameter close to or even smaller than the maximum outer diameter of the device to be introduced, there is a risk of blood flow occlusion and ischemia or damage to the vessel due to shear or expansion. In general surgical procedures, solutions are needed for delivering larger devices via intracavitary approaches so that the safety and procedural advantages of intracavitary approaches can be applied to larger devices. [Overview of the project]

[0006] This disclosure relates to methods, apparatus, and systems for expandable, peelable, or both introducer sheaths. Each embodiment disclosed herein has several aspects, and not one alone is solely responsible for the desirable attributes of this disclosure. Without limiting the scope of this disclosure, some of its more prominent features are briefly considered here. After reviewing this description, and in particular after reading the section titled “Modes for Carrying Out the Invention,” you will understand how the features of the embodiments described herein offer advantages over existing systems, apparatus, and methods of introducer sheaths.

[0007] The following disclosure describes non-limiting embodiments of some embodiments of the introducer sheath. For example, other embodiments of the disclosed systems and methods may include or may not include the features described herein. Any of the features of the disclosed systems and methods may be combined in whole or in part. The disclosed systems and methods may include additional or fewer features than those described herein, or may be combined with features different from those of the embodiments described herein. Furthermore, the disclosed advantages and benefits may apply only to specific embodiments and should not be used to limit this disclosure.

[0008] In some embodiments, the technology described herein relates to a system for opening the lumen of an introducer sheath of a cardiac assist system, the system comprising an introducer sheath having a lumen configured to house a medical device, and a cutting system, the cutting system comprising a blade configured to cut the wall of the introducer sheath, a protective guide configured to be received between the medical device and the wall of the introducer sheath, and a feeding mechanism configured to guide the wall of the introducer sheath toward the blade.

[0009] In some embodiments, the technology described herein relates to a system in which the cutting system is configured to mate with an introducer hub.

[0010] In some embodiments, the technology described herein relates to a system in which the cutting system is integrated into an introducer hub.

[0011] In some embodiments, the technology described herein relates to a system in which the feeding mechanism includes at least one cog-like wheel having a plurality of teeth.

[0012] In some embodiments, the technology described herein relates to a system in which multiple teeth are configured to engage with one or more reinforcing filaments of an introducer sheath.

[0013] In some embodiments, the technology described herein relates to a system that further includes an actuator configured to actuate a supply mechanism.

[0014] In some embodiments, the technology described herein relates to a system in which an actuator is configured to rotate a feeding mechanism about a transverse axis with respect to the longitudinal axis of an introducer sheath.

[0015] In some embodiments, the technology described herein relates to a system including a manual actuator, the actuator being tuned to balance the rotational speed of the feeding mechanism with the cutting force.

[0016] In some embodiments, the technology described herein relates to a system in which the actuator includes an electric actuator.

[0017] In some embodiments, the technology described herein relates to a system in which a protective guide includes a partially closed lumen configured to receive a medical device.

[0018] In some embodiments, the techniques described herein relate to systems in which a partially closed lumen is closed by at least 50 percent.

[0019] In some embodiments, the technology described herein relates to a system in which the protective guide includes a C-shaped cross-section.

[0020] In some embodiments, the technology described herein relates to a system in which the protective guide and blade are formed from a single material.

[0021] In some embodiments, the technology described herein relates to a system in which the protective guide has a substantially constant outer diameter and a substantially constant inner diameter from the proximal end to the distal end of the protective guide.

[0022] In some embodiments, the technology described herein relates to a system in which a protective guide has a substantially constant inner diameter and tapering outer diameter from the proximal end to the distal end of the protective guide, and the proximal end of the protective guide has a larger outer diameter than the distal end of the protective guide.

[0023] In some embodiments, the technology described herein relates to a system in which the outer surface of a protective guide is contoured to facilitate the movement of the cut portion of the introducer sheath away from the longitudinal axis of the introducer sheath.

[0024] In some embodiments, the technology described herein relates to a system in which the outer surface of the protective guide is smooth.

[0025] In some embodiments, the technology described herein relates to a system in which the outer surface of the protective guide is at least partially raised.

[0026] In some embodiments, the technology described herein relates to a system in which a feeding mechanism includes a wheel having a three-dimensional shape configured to at least partially follow the contour of the wall of an introducer sheath.

[0027] In some aspects, the techniques described herein relate to a method of delivering a catheter positioned within a natural lumen of a patient, the method comprising delivering an introducer sheath into the natural lumen of the patient, delivering the catheter through the introducer sheath, cutting the introducer sheath using a cutting system, and removing the introducer sheath from the catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The foregoing and other features of the present disclosure will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. Understanding that these drawings depict only several embodiments in accordance with the present disclosure and are not to be considered limiting of its scope, the present disclosure will be described with additional specificity and detail through use of the accompanying drawings. In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, similar symbols typically identify similar components, unless context dictates otherwise. The illustrative embodiments described in the detailed description, drawings, and claims are not meant to be limiting. Other embodiments may be utilized, and other changes may be made without departing from the spirit or scope of the subject matter presented herein. It will be readily understood that the aspects of the present disclosure, as generally described herein and illustrated in the drawings, can be arranged, substituted, combined, and designed in a wide variety of different configurations, all of which are explicitly contemplated and make part of this disclosure.

[0029] [Figure 1] FIG. 1 is a schematic diagram of an expandable introducer sheath and dilator inserted into an artery along a guidewire, which may be used with the sheath cutting instruments described herein. [Figure 2] FIG. 2 is a cross-sectional view of an example of the expandable introducer sheath and dilator as shown in FIG. 1. [Figure 3] FIG. 3 is a cross-sectional view of a portion of an elongate tube of an exemplary expandable introducer sheath in a neutral state. [Figure 4] Figure 4 is a cross-sectional view of a portion of an elongated tube of an exemplary expandable introducer sheath in an expanded state. [Figure 5A] Figure 5A shows cross-sectional views of an exemplary introducer sheath, medical device, and cutting instrument. [Figure 5B] Figure 5B shows exemplary embodiments of an exemplary introducer handle and an exemplary cutting tool. [Figure 5C] Figure 5C shows exemplary embodiments of an exemplary introducer handle and an exemplary cutting tool. [Figure 6A] Figure 6A shows a schematic elevation view of an exemplary introducer sheath for the delivery of a medical device and a first exemplary cutting instrument. [Figure 6B] Figure 6B shows a cross-sectional view of the system illustrated in Figure 6A. [Figure 6C] Figure 6C shows a schematic elevation view of an exemplary introducer sheath with a tapered sheath protector. [Figure 7A] Figure 7A shows a perspective view of an exemplary introducer sheath, medical device, and cutting instrument. [Figure 7B] Figure 7B shows a cross-sectional view of the system illustrated in Figure 7A. [Modes for carrying out the invention]

[0030] This disclosure relates to introducer sheaths having expandable or adjustable lumen diameters, kits including introducer sheaths and other instruments for use, and methods of use. The following detailed description applies to specific embodiments. This description refers to drawings, and for clarity, similar parts or steps may be designated by similar numbers throughout. The references “one embodiment,” “an embodiment,” or “in some embodiments” in this specification mean that certain features, structures, or properties described in relation to an embodiment are included in at least one embodiment of the present invention. The occurrences of the phrases “one embodiment,” “an embodiment,” or “in some embodiments” in various places in this specification do not necessarily all refer to the same embodiment, and separate or alternative embodiments are not necessarily mutually exclusive with other embodiments. Furthermore, various features that may be shown by some embodiments and not by others are described. Similarly, various requirements that may be required in some embodiments but not in others are described. Herein, embodiments of the present invention will be described in detail, and these embodiments are shown in the accompanying drawings.

[0031] Systems, apparatus, and methods for controlled cutting of introducer sheaths used for the delivery, maintenance, and storage of mechanical circulation assist devices are disclosed herein.

[0032] Delivery systems for introducing medical devices, such as percutaneous cardiac pumps, into a patient's vascular system can be used to protect the patient's arterial incision and blood vessels while providing an access lumen for advancing the medical device. Introducers may be used to reduce or prevent blood leakage from the patient's blood vessels and, additionally, to hold the medical device in a desired position relative to the patient's anatomical structure. Introducers may have a sheath with reinforcing braids or coils to improve strength and / or allow for expandable sheath functionality. In some medical procedures, it is useful to be able to radially detach the introducer from the medical device shaft (e.g., catheter) housed within the lumen. To do this, a continuous tubular introducer can be made discontinuous by creating an opening in the tubular introducer, for example, to release the medical device from the lumen.

[0033] To create an opening in the wall of a tubular introducer, the wall of the introducer may be cut with the blade of a cutting tool. In particular, the concepts disclosed herein may facilitate the creation of a longitudinal opening in an introducer having reinforcement such as wire filament or other materials that are difficult to tear in a safe and controlled manner.

[0034] Typical characteristics of an exemplary peel-type expandable introducer Introducer sheaths can be used during most intra-lumen interventions, such as for the passage of medical devices through natural anatomical lumens, including bronchi, urethra, intestines, tubes, or blood vessels. For illustrative purposes, a detailed description of exemplary embodiments focuses on endovascular procedures, particularly the delivery of mechanical circulatory support (MCS) devices to arteries such as the femoral artery. However, it should be understood that the components and features disclosed herein may be combined with each other in any suitable manner and adapted for the passage of other medical devices or other intra-lumen interventions.

[0035] An introducer sheath may be positioned in a natural lumen, such as a blood vessel (e.g., the femoral artery), through an opening or incision, such as an arterial incision, providing an access route to the natural lumen from outside the body while protecting the tissue and the device delivered through the introducer sheath. The introducer sheath may have features such as a hemostatic valve, a flushing port, or a suture hole, and may be used in conjunction with a dilator. An expandable introducer sheath may temporarily expand in diameter to accommodate the delivery of a medical device, and may contract toward a neutral state with a reduced diameter when the radial force applied to the lumen is removed. For example, a medical device may include an elongated shaft with a component attached to the distal end of the shaft, the component having a larger diameter than the shaft. As the larger component passes through the introducer sheath, it expands to the diameter of the sheath, and as the larger component exits the introducer, the smaller shaft remains connected to the larger component, slidably engaging within the introducer, thereby reducing the diameter of the introducer. Furthermore, expandable introducers allow the medical device shaft to be withdrawn from the body while remaining housed within the introducer's lumen, and can be detached from the medical device shaft by cutting, tearing, or peeling the longitudinal opening along the length of the introducer. However, in the case of reinforced introducer sheaths, strong force may be required to cut the sheath, which can lead to reduced controllability of the delivery system compared to previous systems.

[0036] An exemplary introducer (which may include an introducer sheath and / or tubular body that can be configured to be cut by one or more cutting systems described herein) and / or insertion catheter is disclosed in International Patent Publication PCT / US2021 / 071105, filed on 4 August 2021, entitled "INTRODUCER SHEATH HAVING AN ADJUSTABLE DIAMETER AND METHOD OF USE," which is incorporated herein by reference in its entirety.

[0037] Figures 1 to 4 show exemplary embodiments of an expandable introducer sheath 100 that may be used in conjunction with the controllable cutting system disclosed herein. Referring to Figures 1 and 2, the expandable introducer sheath 100 may include an elongated tube 120 that is intended to be inserted into a natural lumen (for example, through an arterial incision 12 into the lumen 11 of the artery 10).

[0038] In some embodiments, the expandable introducer sheath 100 may include a proximal end 105 and a distal end 123. In some embodiments, the expandable introducer sheath 100 may include a hub 101 at the proximal end, which is intended to remain outside the patient's body. In some embodiments, the expandable introducer sheath may include an introducer lumen 121 that penetrates the hub and the elongated tube and exits through a proximal opening 104 of the hub and a distal opening 122 at the distal end of the elongated tube. In some embodiments, the introducer lumen is defined by the walls 125 of the elongated tube and the walls 106 of the hub. In some embodiments, the elongated tube 120 is adapted to have a neutral state and an expanded state. In some embodiments, the wall 125 may or may not be adapted to open or peel off along the entire length of the introducer in use to create a longitudinal opening, so that contents held within the introducer lumen (e.g., medical device shaft 301) can be released through the longitudinal opening. In some embodiments, the longitudinal opening may be created by a cutting instrument as described herein and shown in Figures 5-7B.

[0039] Introducer Hub Referring to Figure 2, the hub 101 may be provided in a closed configuration and opened by a cutting system 500, such as that shown in Figure 5, to release the medical device 300 from the lumen 121 through a longitudinal opening. The hub may optionally include one or more hemostatic valves 103 that allow the delivery of instruments such as guidewires, catheters, and other medical devices through the hub while maintaining a fluid seal. For example, an expandable introducer sheath intended for the delivery of an MCS device may have multiple hemostatic valves for 0-inch (103a), 0.018-inch guidewires (103b), 0.035-inch guidewires (103c), and 5F or 6F diagnostic catheters (103d). The MCS device may be large, for example, having a diameter in the range of 14F to 18F, and may be delivered through multiple hemostatic valves using an insertion instrument that widens and opens the hemostatic valves to reduce insertion force and protect the medical device (e.g., the MCS device) from the force applied by the hemostatic valves. The insertion device may have, for example, a handle that fits (e.g., lock, thread, click, friction fit) into an introducer hub 101 (e.g., handle cap 109), and an elongated tube that is at least sufficiently long to extend into the tension relief section 111 when the handle is fitted into the introducer hub 101. The elongated tube of the insertion device may be flexible enough to bend, but may also have sufficient rigidity or hoop strength to withstand compression by a hemostatic valve. The lumen penetrates the insertion device, through which a medical device can be delivered. Optionally, the insertion device may also have a hemostatic valve within its lumen that is adapted to seal against a medical device 300 or its shaft 301. Optionally, the elongated tube of the insertion device may be adapted to be used as an introducer sheath, for example, having a non-traumatic distal end that may have a soft durometer or tapered or flexible expandable diameter. Optionally, an insertion device expander can be used to advance the extension tube of the insertion tool into the patient's lumen (e.g., arterial incision).The insertion device dilator may be an elongated tube with a tapered distal end, assembled on the medical device shaft 301 and adapted to advance through the lumen of the insertion device extension tube, positioning its tapered distal end at the distal opening of the extension tube. For example, the insertion device dilator may be provided in two separate parts for the user to assemble on the medical device shaft 301, or it may have a longitudinal opening. The dilator may have a lumen sized to slidably accommodate the medical device shaft 301, and an outer diameter sized to slidably accommodate the insertion device extension tube. The tapered distal end may be tapered from the outer diameter to the lumen diameter. During use, the dilator may be withdrawn from the insertion device before removing the medical device from the patient so that the medical device can be fitted through the insertion device extension tube. The hub 101 may optionally have a locking mechanism 108 on its proximal end 105, for example, as part of a cap 109, configured to engage with a locking mechanism 112 on the dilator 110 or insertion device. The locking mechanisms 108, 112 may be, for example, snap-fit, friction-fit, screw-in, or O-ring fitting mechanisms. The locking mechanism 112 may be positioned adjacent to the dilator handle 232. The hub may also be attachable to a syringe and may have a flushing port 102 used to drain air from the lumen 121 before delivery into the body. The hub may also have a tension relief section 111 that holds the proximal end of an elongated tube to the handle and has the function of allowing bending while avoiding kinking, particularly where a flexible elongated tube 120 intersects with a rigid hub 101. The hub may also have a suture hole 113 for suturing the hub to the patient's skin, particularly to hold the introducer in place during long procedures.

[0040] An example of a neutral state in an elongated tube Figure 3 shows a cross-sectional close-up view of one embodiment of the elongated tube 120 in its neutral state. The wall of the elongated tube 125 has a neutral state with an inner diameter 126, as shown in Figure 3, and can be temporarily expanded radially when a radial force is applied to the inner surface of the wall as a large component 302 of a medical device having a diameter 304 larger than the neutral state diameter 126 passes through the introducer lumen 121, as shown in Figure 4. The neutral state of the elongated tube 120 may have an inner diameter 126 adapted to slidably engage with components used in catheterization procedures, such as guidewires, dilators, diagnostic catheters, therapeutic catheters, or shafts of medical devices that do not require radial expansion. For example, an expandable introducer sheath intended for transfemoral artery delivery of an MCS device may have an inner diameter 126 in the range of 6F to 10F (preferably 8F). In its neutral state, the elongated tube shall be fitted to have sufficient compressive and tensile strength to be kink-resistant and to allow the device to slide forward or backward through the lumen, enabling it to advance through an artery or other natural lumen. The neutral state of the elongated tube 120 may have a wall thickness 128 in the range of 0.3 to 0.5 mm and an outer diameter 127 equal to the inner diameter 126 plus twice the wall thickness 128. The outer diameter 127 in the neutral state may be selected to allow sufficient function of the lumen into which the elongated tube is positioned. For example, the outer diameter 127 of an expandable introducer sheath intended for transfemoral artery delivery of an MCS device may have a neutral state outer diameter 127 in the range of 6.5F to 12F, preferably 8F to 11F, which may allow sufficient blood flow through the femoral artery for the intended duration of implantation (e.g., several hours to several days) to avoid limb ischemia by applying minimal or no radial force to the arterial wall. Optionally, during delivery, a longitudinally rigid expander 110 (see Figure 2) may help maintain the length of the elongated tube 120 to facilitate delivery into the patient's lumen (e.g., artery).

[0041] Explanatory: Expanded state of an elongated tube As shown in Figure 4, the expanded state of the elongated tube 120 may have an expanded section 129 that expands as a result of a radial force applied to the inner wall by the advance of a device (e.g., an MCS device 302) having a larger diameter than the neutral inner diameter 126, and at least a portion of the remaining length 130 of the elongated tube 120 to which no radial force is applied may be similar to the neutral state and may have the neutral outer diameter 127. For example, the inner diameter of the expanded section 129 may match the diameter 304 of the device 302. The expanded section 129 may move along the length of the elongated tube 120 in response to the position of the device 302. For example, the inner diameter of the expanded section 129 may correspond to a device having a diameter of up to 26F (preferably up to 19F), which may allow the delivery of both 14F and 18F MCS devices. The wall thickness 131 of the expanded section may be less than or equal to the wall thickness 128 in the neutral state. In some embodiments, the wall thickness may decrease with the expansion of the diameter, for example, due to stretching or elongation of the material. Therefore, the outer diameter 132 of the expansion section 129 is a function of the device diameter 304 and the wall thickness 131. The elongated tube 120 may optionally have a maximum expansion limit to prevent damage to blood vessels or natural lumen. For example, in the case of transfemoral artery positioning, the maximum expansion limit is in the range of 19F to 27F and may be a function of the material and design of the elongated tube. For example, the elongated tube may be made of an elastic stretchable material having an elongation factor equal to the maximum outer circumference divided by the neutral outer circumference. In an exemplary example of an introducer intended for delivery of an MCS device, the elongated tube 120 may have an expansion ratio of the maximum expanded inner diameter to the neutral inner diameter in the range of 10:8 (i.e., 1.25) to 26:6 (i.e., 4.33), preferably in the range of 15:8 (i.e., 1.875) to 19:8 (i.e., 2.375).

[0042] The elongated tube 120 may have a length 133 adapted to traverse the natural lumen and provide access to a target location. For example, an introducer used to deliver an MCS device through the femoral artery to reach beyond the femoral artery bifurcation may have a neutral length in the range of 250–350 mm, preferably a minimum of 275 mm. In some embodiments, the length 133 of the elongated tube may be shortened as a result of expanding a portion of the elongated tube. In some embodiments, the length 133 may be limited by the tension of a longitudinal support wire to not increase beyond its neutral state, which in turn may prevent a decrease in the neutral inner diameter 126 of the lumen 121, thereby facilitating the passage of a medical device through the lumen 121.

[0043] Further characteristics of elongated tubes Referring to Figure 3, the elongated tube 120 may be fabricated with an expandable structural layer 140 and an expandable membrane 150. The expandable structural layer 140 may function to provide structural support for maintaining the tubular shape, allowing it to bend while resisting kinking over a bending radius of at least 10 cm, and providing longitudinal strength in both compression and tension to allow the introducer to advance into and withdraw from a body cavity, guiding the delivery of a medical device through a desired lumen pathway. The expandable membrane 150 may function to seal the wall 125 of the elongated tube, for example, to prevent fluids such as blood, water, or saline from leaking through the wall, for example, to allow air to flow from the lumen 121 before introduction into a body cavity, or to prevent blood from leaking from the lumen through the wall during use. The membrane may also function to protect tissue from damage by providing a smooth surface. Optionally, the elongated tube may have one or more (preferably two) longitudinal support wires to add longitudinal strength and limit elongation. Optionally, the elongated tube may further have an inner layer 134 to reduce friction between the inner layer and the medical device 302 and improve sliding properties. Optionally, the elongated tube may further have an outer layer to reduce friction between the outer layer and the tissue of the body lumen and improve sliding properties. The inner and outer layers may be additional materials (e.g., PTFE) laminated on the membrane 150 or structural layer 140, or a coating or surface treatment (e.g., micropatterned surface) on an expandable membrane, and may have hydrophilic or lubricating properties. Optionally, the material of the elongated tube wall 125 may be impregnated with an agent (e.g., antibacterial, antimicrobial) that can reduce the risk of infection, especially when used for several days.

[0044] Exemplary sheath cutting system Exemplary embodiments of sheath cutting systems are shown in Figures 5A–7B. The cutting systems and methods described herein may be configured to cut introducer sheaths, including but not limited to introducer sheaths as described above with reference to Figures 3 and 4. The cutting systems and methods described herein may be configured to cut expandable sheaths or fixed-diameter sheaths. In some embodiments, the cutting systems and methods described herein may be configured to cut reinforced introducer sheaths. Reinforced introducer sheaths may include, but are not limited to, sheaths having metal or plastic reinforced braids or coils. Such sheaths may advantageously improve hoop strength to resist twisting, but may be difficult to cut or tear, requiring high force for that purpose. The systems and methods described herein relate to a controllable mechanism for cutting braided or coiled sheaths so that they can be radially removed from the catheter. Advantageously, controlled cutting may improve ease of use and / or safety of the intravascular procedure. Furthermore, the controlled cutting systems and methods disclosed herein may enable the use of an expandable sheath having a metal filament or a plastic filament within the introducer.

[0045] Figures 5A–7B illustrate an embodiment of a sheath cutting system operating on a sheath 100. As shown, the sheath 100 may include an elongated tube 120. However, those skilled in the art will understand that the cutting system described may be used on any suitable sheath, including embodiments of the sheath 100 having additional or alternative features to the elongated tube 120. The features and operation of the cutting system described herein in relation to the sheath 100 may be applied to the elongated tube 120 and / or additional features of the sheath 100.

[0046] Figure 5A shows an exemplary cutting system 500. As shown in Figure 5A, the exemplary cutting system operates on a sheath 100 having a catheter or other medical device 115 extending through it. In some embodiments, the medical device 115 may include a dilator 110, a medical device 300, or other medical devices configured to be inserted into a natural cavity or lumen. In some embodiments, the exemplary cutting system may operate on an elongated tube 120 of the sheath 100. The exemplary cutting system 500 may include, but is not limited to, a housing 506, a shaft protection guide 502, a blade 512, and a feeding mechanism 508. The feeding mechanism 508 may be configured to rotate around an axis (e.g., an axis 602 as shown in Figures 6B and 7A). The housing 506 may include a channel 504 configured to receive the sheath 100 between at least a portion of the housing 506 and a shaft protection guide 502 coupled to the housing 506. The shaft protection guide 502 may be positioned within the lumen 121 of the sheath 100 between the catheter or other medical device 115 and the inner wall 125 of the sheath 100. The shaft protection guide 502 may be coupled to the blade 512.

[0047] As illustrated, the sheath cutting system 500 may include a protective guide 502 coupled to a blade 512, which is then coupled to a housing 506. Optionally, the protective guide 502 may be directly connected to the housing by a narrow bridge element extending, for example, from the guide 502 to the housing 506 located proximal to the cutting edge of the blade 512. The housing 506 may include a channel 504, which may be at least partially enclosed. In some embodiments, the channel 504 may be at least 50 percent enclosed and less than 100 percent enclosed. However, other percentages or amounts of enclosure are also possible, such as 60 percent, 70 percent, 80 percent, or 90 percent. The channel 504 may be adapted to receive the sheath 100 between the housing 506 and the guide 502.

[0048] The feed mechanism 508 may be configured to be coupled to the housing 506 by an axis 511. The feed mechanism may rotate around an axis collinear with the axis 511 (e.g., axis 602 as shown in Figures 6B and 7A). The feed mechanism 508 may be configured to rotate and align with the blade 512 and channel 504 so as the feed mechanism 508 rotates and / or while the cutting system 500 is operating, to engage with the sheath 100 and pull the sheath 100 (e.g., wall 125) into the blade 512. The feed mechanism 508 may be connected to or connectable to a rotary manipulator such as a lever or dial so as to rotate the feed mechanism 508 when the rotary manipulator is engaged. The feed mechanism 508 may be manual, automatic, or semi-automatic. For example, the feed mechanism 508 may be at least partially controlled using an electric rotary manipulator (e.g., a motor) and / or controlled using a manual rotary manipulator. Further details of exemplary supply mechanisms are described herein with reference, for example, to Figures 6A–7B.

[0049] The sheath 100 may be coupled to or include an introducer handle or hub 522, and the lumen 121 of the sheath 100 is continuous with and coaxial with the lumen 524 in the introducer hub 522. The introducer hub 522 may include a hemostatic valve 526 or a plurality of hemostatic valves having various opening sizes. In the illustrated embodiment, the introducer hub 522 has a mating feature 520 adapted to removably mat with a mating feature 516 on the housing 506. The mating features 520 and 516 may be locked and / or released by a lock actuator 518. The lock actuator 518 may or may not be integrated on the introducer hub 522 and / or the housing 506. In some embodiments, the introducer hub 522 may be detachable or openable, for example, by a handle and / or other opener, which may or may not be part of the cutting system 500 and / or the introducer hub 522.

[0050] An expanded lumen housing a device 115, which may include a combination of a sheath lumen 121, an introducer hub lumen 524, and a partially closed lumen 514 of a protective guide 502, may have a minimum internal diameter (ID) greater than the maximum external diameter (OD) of the device 115 configured to advance through the expanded lumen. In embodiments where the introducer sheath 100 is an expandable introducer sheath, the sheath lumen 121 may elastically conform to the medical device 115 housed therein. In these embodiments, the expanded lumen may be defined by an introducer hub lumen 524 and a partially closed lumen 514 of a protective guide, which may have a minimum ID greater than the maximum OD of the device 115, and an expandable sheath lumen 121 whose ID may vary in the range of X to Y, where X may be less than the ID of the introducer hub lumen 524 and / or the ID of the guide lumen 514, and Y may be greater than or equal to the ID of the introducer hub lumen 524 and / or the ID of the guide lumen 514. The cutting system 500 may be integrated with the introducer hub 522 or provided together with the introducer hub 522. In other embodiments, the cutting system 500 may be provided separately from the introducer hub 522.

[0051] In some embodiments, the cutting system 500 may be a separate auxiliary device from the introducer hub 522, or it may be incorporated into the introducer hub 522 as part of the introducer handle, or housed within the handle. Figures 5B and 5C show exemplary introducer handles 550 and 570, and block diagrams of exemplary orientations of the cutting systems 552 and 572, respectively. The introducer hub 522 may be an introducer as described above (see, for example, Figures 1 and 2). In the embodiment shown in Figure 5A, the cutting system 500 is a separate device configured to mate with the introducer hub 522. For example, the cutting system 500 may be configured to connect or mate with the introducer hub 522 via mating parts 516 and 520 associated with the cutting system 500 and the introducer hub 522, respectively. The mating features may be locked together by a locking system 518. When fitted, the lumen 524 of the introducer hub 522 may be coaxial with the lumen 121 of the sheath 100.

[0052] As described above, the introducer handle may be separable from the catheter housed within its lumen. In some embodiments, the introducer handle is configured to be separable from the catheter using a cutting system 500, which is also used to cut the sheath 100. In such embodiments, the cutting system 500 may be multifunctional and, in addition to having means for cutting the braided or coiled sheath 100, may have a mechanism for opening the introducer handle, such as a second blade. In some embodiments, the introducer handle is separable by a different mechanism, and / or the introducer sheath 100 is separable from the cutting system 500. For example, the introducer handle may be separable by a mechanism (e.g., a tear line, a cuttable strip, a screw cap, a snap fit) that allows a portion of the handle to open or pull away on a hinge, exposing an edge of the sheath 100 that the cutting system 500 can engage with the sheath 100. Exemplary mechanisms for separating the introducer handle from the introducer may include, but are not limited to, a peeling mechanism, which is described, for example, with reference to International Patent Publication PCT / US2021 / 071105, filed on 4 August 2021, entitled "INTRODUCER SHEATH HAVING AN ADJUSTABLE DIAMETER AND METHOD OF USE," the entirety of which is incorporated herein by reference.

[0053] Figure 5B shows an exemplary introducer hub or handle 550 having an integrated cutting system 552. For example, the introducer handle 550 may include a lumen 560 containing a catheter and an integrated cutting system 552, which may include, but is not limited to, a cutter 554 configured to cut the introducer sheath 562, a cutter 558 configured to open the introducer handle 550 (e.g., by a blade, tear line, cuttable strip, screw cap, snap fit, or other opening mechanism), and an actuator 556. The actuator 556 may be removable and may include a mechanism such as a lever or hand crank to reduce the bulk of the introducer when in use. The actuator 556 may be coupled to the cutting system 552 from the right or left side to accommodate both right-handed and left-handed users. The integrated sheath cutter 554 may include some or all of the features described in various embodiments of the cutting system disclosed herein (for example, those described with reference to Figures 5A and 6A-7B).

[0054] Figure 5C shows an exemplary introducer hub or handle 570 separated from and / or detachable from the cutting system 572. For example, the introducer handle 570 may include a lumen 574 containing a catheter and a mating system 576 configured to mat with a mating system 580 of the cutting system 572. The cutting system 572 may include a sheath cutter 578 configured to cut or open an introducer sheath 562, the sheath cutter may include some or all of the features described in various embodiments of the cutting system disclosed herein (for example, those described with reference to Figures 5A and 6A-7B). The cutting system 572 may optionally include an actuator 582 and / or a handle 584, or may be coupled to the actuator 582 and / or handle 584. The actuator 582 and / or handle 584 may be detachable in some embodiments. The handle 584 may be configured so that the user can hold the cutting system 572 with the handle 584 with one hand while moving the actuator 582 relative to the handle with the other hand. Thus, the actuator 582 can engage with the sheath cutter 578 to cut the introducer sheath 562. The introducer handle 570 may optionally include an integrated handle cutter such as the handle cutter 558 shown in Figure 5B, and / or may be configured to be opened whole or partially by a secondary cutting system, which may or may not be part of the cutting system 572.

[0055] Figures 6A and 6B illustrate an exemplary cutting tool in which a shaft protection guide 604 is positioned within the lumen of a sheath 100 having a wall 125. The shaft protection guide 604 may be attached to a blade 606 having a sharp edge that is away from the shaft protection guide 604 and facing the inner wall 125 of the sheath 100 when the guide 604 is positioned within the lumen 121 of the sheath. As shown in Figure 6B, the shaft protection guide 604 may have a C-shaped cross section with a partially formed lumen for sliding along the instrument 115 housed in the sheath 100. The partially formed lumen may have a longitudinal opening 608 that allows the catheter to enter and / or withdraw from the C-shaped lumen. The shaft protection guide 604 may have a substantially constant wall thickness, which may be, for example, in the range of 0.2 to 0.5 mm. However, the wall thickness is not limited to this range.

[0056] The outer surface of the shaft protection guide 604 may be smooth. Advantageously, a smooth surface can facilitate sliding through the lumen of the sheath 100. In some embodiments, the outer surface may be made from or coated with a material having a low coefficient of friction, such as PTFE. Alternatively, the outer surface or a portion thereof may be raised, which can help facilitate holding the sheath 100 in place when it is cut.

[0057] In some embodiments, for example as shown in Figure 6C, the shaft protection guide 604 may have a tapered outer diameter (OD), with the distal end 610, which is intended to be the first to enter the lumen of the sheath 100, having the narrowest first OD (e.g., wall thickness in the range of 0.2–0.5 mm), and the OD increasing toward a second OD (or proximal OD) at the proximal end 612. The tapered shaft protection guide 604 may help to stretch the sheath 100 or apply tension to the reinforcing filaments of the sheath 100 as the blade 606 strikes and moves against the sheath 100, which may facilitate cutting of the sheath 100. In some embodiments of the tapered shaft protection guide 604, the inner diameter (ID) of the shaft protection guide 604 may be consistent or nearly constant while the outer diameter (OD) is tapered. In embodiments where the cutting system 600 is designed for use with an expandable sheath 100 and is therefore configured for the passage of equipment 115 having a large or maximum OD, the proximal OD of the shaft protection guide 604 may be equal to or slightly greater than the said maximum OD of equipment 115. Advantageously, this difference in diameter may help to stretch or tension the wall 125 while cutting through it.

[0058] Optionally, the outer surface 614 of the shaft protection guide 604 may include a sheath-orienting contour that directs the cut portion of the sheath 100 away from the user's hand or work area. For example, the sheath-orienting contour may be a flared contour at the proximal end 612 of the second OD of the shaft protection guide 604. Optionally, the cut portion of the sheath may be directed into the retaining container.

[0059] Continuing to refer to Figures 6A-6C, the shaft protection guide 604 may be coupled to the blade 606. In some embodiments, the shaft protection guide 604 may be coupled to the blade 606 by plastic overmolding. The blade 606 may be made of a material having a hardness at least equal to or greater than that of the walls 125 of the sheath 100 in order to facilitate cutting of the sheath 100. For example, the blade 606 may be a metal sheet. The blade 606 may be configured to extend into a C-shaped lumen to provide bonding strength between the blade 606 and the C-shaped lumen formed by the shaft protection guide 604. In some embodiments, at least a portion of the blade 606 and at least a portion of the shaft protection guide 604 may be manufactured from a single continuous metal sheet.

[0060] The blade 606 may be positioned so that its sharp surface 622 is at an angle to the wall 125, thereby imparting a slicing action to the sheath 100. Alternatively or additionally, the blade 606 may be tightly aligned with the teeth 620 of the feeding mechanism 616, thereby applying a shearing force to the sheath wall. In some embodiments, the blade 606 may be serrated. However, other cutting surfaces or sharp surfaces 622 of the blade 606, such as a flat surface, are also possible.

[0061] The cutting system may include, for example, a feeding mechanism 616 configured to grip the sheath 100 by the wall 125 of the sheath and move the sheath 100 toward and / or toward the blade 606. In some embodiments, the feeding mechanism 616 may include a ratchet-like or cog-like wheel having teeth 620, as shown in Figures 6A and 6C. In some embodiments, the teeth 620 may be advantageously sized, shaped, and / or spaced apart to operably engage with the reinforcing filaments 618 in the sheath 100. The teeth 620 may be aligned with the gap between the filaments 618, and the spacing between the teeth 620 may be sized to accommodate at least a portion of the filaments 618. The teeth 620 may be angled in a rotational direction about the axis 602, for example, which may improve engagement with the sheath. The teeth 620 may have sharp edges.

[0062] In some embodiments, the feeding mechanism 616 may include a plurality of cog-like wheels 624 positioned in different radial directions around a central axis 602. For example, the feeding mechanism may have two wheels 624 positioned 180 degrees opposite each other. The cog-like wheels 624 may have a flat disc shape, or alternatively, a complex three-dimensional shape. In one embodiment, the cog has two rows of teeth with a groove between the two rows, and the cutting blade is positioned in part of the groove, as shown, for example, in Figure 6B. In another embodiment, the cog has two rows of teeth that are very close to or in contact with each other at one position on the circumference of the wheel and gradually move away from each other along the circumference. For example, each row of teeth may extend between a first end at a first position along the axis 602 and a second end at a second position along the axis 602, where the first position is closer to the center point of the cog-like wheel along the axis 602 than the second position. An example of this configuration is shown in Figure 7A. This configuration may allow the teeth to engage with the filaments of the sheath, pulling them apart to stretch the sheath material, or to apply tension to the filaments as they move across the blade to improve cutting ability. In some embodiments of this configuration, each row of teeth is arranged helically along a cog-like wheel.

[0063] The feeding mechanism 616 can be rotated around its axis of rotation 602 using a manual actuator such as a crank lever or wing. The manual actuator may be adjusted to balance the rotational speed with the cutting force. The manual actuator may be removable to minimize bulk when the actuator is not needed, for example, when the cutting tool is integrated with the introducer handle (as described with reference to Figure 5B above). The cutting system 600 may have a cutting system handle (as described in relation to Figure 5C), which is firmly connected to the shaft protection guide 604, the blade 606 and / or the feeding mechanism 616, so that the user can hold the cutting system handle with one hand and move the actuator relative to the handle with the other hand. The feeding mechanism may have a ratchet mechanism that allows it to rotate in only one direction. If the feeding mechanism includes a plurality of cog-like wheels as described herein, the feeding mechanism may actuate a gear mechanism by connecting the plurality of cog-like wheels, which are connected by meshing cog wheels in between.

[0064] Alternatively, the supply mechanism 616 may be electrically operated by a switch that starts the motor. The motor may be connected to the rotating shaft 602 by a gear. The electrically operated supply mechanism may be designed to allow one-handed operation, freeing the other hand to stabilize the instrument shaft against the patient's body.

[0065] Figures 7A and 7B show illustrations of exemplary cutting systems 700, which may include alternative feeding mechanisms. One or more embodiments of system 700 may be identical or similar to embodiments of other exemplary cutting systems described herein, e.g., embodiments of cutting systems 600 described with reference to Figures 6A-6C with respect to the sheath protection guide 604 and / or blade 606. As shown in Figures 7A-7B, the cog-like wheel 704 may have a three-dimensional shape to improve engagement with the sheath surface. For example, the rotation axis 602 of the wheel may be aligned perpendicular to the longitudinal axis of the sheath, and the profile of the wheel in the direction of the rotation axis may follow or approximate the cross-sectional profile of the sheath, for example, in its expanded or unexpanded state. This may improve the ability to engage with the sheath 100 and / or align the sheath 100 with the blade. The wheel 704, having a longitudinal cross-sectional surface that approximates the surface of the sheath in cross-section, may optionally have teeth 706 arranged in various configurations disclosed herein, such as a single row of teeth, two rows of teeth with grooves between them, or two rows of teeth arranged spirally on the wheel.

[0066] Exemplary method using a cutting system As described herein, the cutting systems shown in Figures 5A–7B can be used in a manner for placing devices such as MCS devices in a patient. In some embodiments, for example, the commonly performed Seldinger technique can be used to deliver the expandable introducer sheath 100 into the patient's natural lumen (e.g., via arterial incision into the femoral artery, subclavian artery, and axillary artery). After the expandable introducer sheath 100 has been delivered, a medical device (e.g., an MCS device) 115 can be delivered through the expandable introducer sheath 100.

[0067] After the medical device has been delivered through the introducer sheath 100, the sheath 100 can be removed, while the medical device (e.g., MCS device) 115 remains in the patient, with the shaft of the medical device remaining penetrating the patient's natural lumen (e.g., vascular structure). For example, while holding the shaft of the medical device stationary relative to the patient so that the medical device 115 remains in the target position, the sheath cutting system may be operated as described herein (e.g., by engaging with an actuator) so that the supply mechanism 616 guides the wall 125 of the sheath 100 toward the cutting blade 606. After cutting, the sheath 100 can be removed radially.

[0068] term The above description provides examples of one or more processes or apparatus, but it should be understood that other processes or apparatus may be within the scope of the attached claims.

[0069] The specific embodiments described herein are not intended to limit any claims, and any claims may, unless otherwise suggested, encompass processes or apparatus different from those described herein. Unless otherwise suggested, the claims are not limited to an apparatus or process having all the features of any one apparatus or process described herein, or to features common to several or all of the apparatuses described herein. The apparatuses or processes described herein may not be embodiments of any exclusive rights granted by the issuance of this patent application. Subject matter described herein that is not exclusive by the issuance of this patent application may be subject to other means of protection, such as ongoing patent applications, and the applicant, inventor, or owner does not intend to abandon, renounce, or publicly dedicate such subject matter by the disclosure herein.

[0070] Various modifications to the implementations described herein will be readily apparent to those skilled in the art, and the general principles defined herein can be applied to other implementations without departing from the spirit or scope of this disclosure. Therefore, this disclosure is not intended to be limited to the implementations shown herein, but should be given the broadest scope consistent with the claims, principles, and novel features disclosed herein. The term “example” is used herein solely to mean “serving as an example, illustration, or illustrative example.” Any implementation described herein as “example” should not be construed as necessarily preferable or advantageous to other implementations unless otherwise stated.

[0071] In the context of separate implementations, certain features described herein may also be implemented in combination in a single implementation. Conversely, various features described in the context of a single implementation may also be implemented separately in multiple implementations or in any preferred subcombination. Furthermore, features may be described above as acting in a particular combination, and may initially be claimed as such, but one or more features from a claimed combination may, in some cases, be removed from that combination, and the claimed combination may cover subcombinations or variations thereof.

[0072] Similarly, while the actions are illustrated in a specific order in the drawings, it should not be understood that this necessitates such actions being performed in a specific or sequential order, or that all illustrated actions be performed, in order to achieve the desired result. Additionally, other implementations are within the scope of the following claims. In some cases, the actions enumerated in the claims may be performed in a different order, and the desired result may still be obtained.

[0073] In general, a person skilled in the art will understand that the terms used herein are generally intended to be "open" terms (for example, the term "including" should be interpreted as "not limited to including," "having" as "at least having," "includes" as "not limited to includes," and so on). A person skilled in the art will further understand that if a particular number is intended in the description of the introduced claims, such intention is explicitly stated in the claims, and if no such statement is made, such intention does not exist. For example, for the sake of understanding, the following appended claims may include the use of the introductory phrases "at least one" and "one or more" to introduce the description of the claims. However, the use of such phrases should not be interpreted as implying that the introduction of a claim description with the indefinite article "a" or "an" limits any particular claim containing such introduced claims to embodiments containing only one such description, even if the same claim contains the introductory phrase "one or more" or "at least one" and an indefinite article such as "a" or "an" (for example, "a" and / or "an" should typically be interpreted as meaning "at least one" or "one or more"). The same applies to the use of the definite article used to introduce a claim description. Furthermore, even if a specific number is explicitly stated in an introduced claim description, a person skilled in the art will recognize that such a description should typically be interpreted as meaning at least the stated number (for example, the mere statement "two descriptions" without other modifiers usually means at least two descriptions, or two or more descriptions).Furthermore, when a convention similar to "at least one of A, B, and C" is used, such interpretation is generally intended to be understood by a person skilled in the art (for example, "a system having at least one of A, B, and C" includes, but is not limited to, A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or a system having A, B, and C together). In practice, when a convention similar to "at least one of A, B, or C" is used, such interpretation is generally intended to be understood by a person skilled in the art (for example, "a system having at least one of A, B, or C" includes, but is not limited to, A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or a system having A, B, and C together). Those skilled in the art will further understand that substantially any separate word and / or phrase presenting two or more alternative terms in a description, claim, or drawing should be understood as construing the possibility of including one of the terms, either of the terms, or both of the terms. For example, the phrase "A or B" will be understood to include the possibility of "A" or "B," or "A and B."

Claims

1. A system for opening the lumen of the introducer sheath of a cardiac support system, An introducer sheath having a lumen configured to house a medical device, A cutting system, A blade configured to cut through the wall of the introducer sheath, A protective guide configured to be received between the medical device and the wall of the introducer sheath, A cutting system comprising: a feeding mechanism configured to guide the wall of the introducer sheath toward the blade; and a system comprising: a cutting system;

2. The system according to claim 1, wherein the cutting system is configured to mate with an introducer hub.

3. The system according to claim 1, wherein the cutting system is integrated with the introducer hub.

4. The system according to any one of claims 1 to 3, wherein the supply mechanism comprises at least one cog-like wheel having a plurality of teeth.

5. The system according to claim 4, wherein the plurality of teeth are configured to engage with one or more reinforcing filaments of the introducer sheath.

6. The system according to any one of claims 1 to 5, further comprising an actuator configured to operate the supply mechanism.

7. The system according to claim 6, wherein the actuator is configured to rotate the supply mechanism about an axis lateral to the longitudinal axis of the introducer sheath.

8. The system according to any one of claims 6 to 7, wherein the actuator comprises a manual actuator adjusted to balance the rotational speed of the supply mechanism with the cutting force.

9. The system according to any one of claims 6 to 8, wherein the actuator includes an electric actuator.

10. The system according to any one of claims 1 to 9, wherein the protective guide comprises a partially closed lumen configured to receive the medical device.

11. The system according to claim 10, wherein the partially closed lumen is closed by at least 50 percent.

12. The system according to any one of claims 1 to 11, wherein the protective guide has a C-shaped cross-section.

13. The system according to any one of claims 1 to 12, wherein the protective guide and the blade are formed from a single material.

14. The system according to any one of claims 1 to 13, wherein the protective guide has a substantially constant outer diameter and a substantially constant inner diameter from the proximal end to the distal end of the protective guide.

15. The system according to any one of claims 1 to 13, wherein the protective guide has a substantially constant inner diameter and tapering outer diameter from the proximal end to the distal end of the protective guide, and the proximal end of the protective guide has a larger outer diameter than the distal end of the protective guide.

16. The system according to claim 15, wherein the outer surface of the protective guide is contoured to facilitate the movement of the cut portion of the introducer sheath away from the longitudinal axis of the introducer sheath.

17. The system according to any one of claims 1 to 16, wherein the outer surface of the protective guide is smooth.

18. The system according to any one of claims 1 to 16, wherein the outer surface of the protective guide is at least partially raised.

19. The system according to any one of claims 1 to 18, wherein the supply mechanism comprises a wheel having a three-dimensional shape configured to at least partially follow the contour of the wall of the introducer sheath.

20. A method for delivering a catheter placed within the patient's natural lumen, To deliver the introducer sheath into the natural lumen of the patient, The catheter is delivered through the introducer sheath, Cutting the introducer sheath using a cutting system, A method comprising removing the introducer sheath from the catheter.

21. The method according to claim 20, wherein the cutting system comprises the system described in any one of claims 1 to 19.

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