Internal balloon sheath

Abstract

The present invention provides a device and method for providing an internal balloon sheath. [Solution] One device includes a sheath (400) for insertion through a patient's arterial incision. The sheath comprises a tubular sheath body (402) having a longitudinal axis, a proximal opening, a distal opening, an outer surface, and an inner surface that defines a lumen between the proximal and distal ends for the catheter device to pass through. The sheath also comprises an inflatable balloon (410) positioned within the lumen. The inflatable balloon provides a longitudinal space within the lumen between the inner surface of the sheath body and the catheter device (422) when the catheter device is positioned within the sheath and the balloon is inflated. It is configured to occupy the space and to fluidly seal the lumen.

Description

[Technical Field]

[0001] Cross-reference of related applications This application, filed on 28 January 2019, is incorporated herein by reference in its entirety. The benefits granted by U.S. Provisional Patent Application No. 62 / 797,527 are claimed under 35 U.S.C. § 119(e). do. [Background technology]

[0002] background Intravascular medical devices may, without limitation, comprise Impella® pumps, extracorporeal membrane oxygenation (ECMO) pumps, and balloon pumps. Impella® pumps may further comprise Impella 2.5® pumps, Impella 5.0® pumps, Impella CP® pumps, and Impella LD® pumps, all manufactured by Abiomed, Inc., Danvers, MA. The majority of intravascular medical devices are catheter devices with a moving unit, such as a pump head, at the distal end of the catheter. Such moving units have a larger diameter compared to the catheter body that supports them. These devices often require an introducer sheath to position them in the desired location within the patient's arterial incision before activation. The introducer sheath is typically sized to allow the pump head to pass through the sheath easily without damage; that is, the inner diameter of the introducer sheath is often larger than the outer diameter of the pump head.

[0003] The difference between the inner diameter of the introducer sheath and the outer diameter of the catheter body creates a space between the introducer sheath and the catheter body after the pump head is positioned distal to the introducer sheath. This can lead to blood entering and stagnating within the sheath in this space, ultimately resulting in blood clot formation. Several problems can arise when a blood clot forms between the sheath and the intravascular medical device. If a blood clot forms at the distal end of the sheath, it may accidentally detach and become free, potentially causing an embolism downstream (e.g., entering the distal limb, reaching the right heart and lungs). The incidence of these clinical scenarios increases if the procedure requires the device and sheath to remain in place for longer than several hours, or if anticoagulation is limited.

[0004] Currently, if there is a space between the inner surface of the introducer sheath and the outer surface of the catheter of an intravascular medical device, physicians will flush that space with a continuous flow of saline or heparinized saline, often at a flow rate of, for example, 3 cc / hr. Setup is required. Typically, this prevents clot formation, but it necessitates additional setup and fluid delivery to the patient, and carries the risk of management errors leading to clinical complications. Since introducer sheaths and similar devices are not intended for long-term use, this issue is not addressed by sheath manufacturers. In some cases, sheath manufacturers have either not found a suitable technical solution, are unaware of the clinical challenges, or believe the problem should be resolved by the intravascular device manufacturer.

[0005] In addition, intravascular medical devices that straddle the aortic valve and sit within the left ventricle can be highly sensitive to positioning. For example, if the device is too far inside or too far outside the heart, hemodynamic support may be compromised, potentially leading to patient harm. Long-term use of an introducer sheath with an intravascular medical device through it carries the risk of the device shifting from its initial position when the patient moves. Currently, physicians attempt to secure the position of intravascular medical devices relative to patients by connecting the proximal end of the hub sheath or by directly securing the distal end of the device outside the patient's body (e.g., to the patient's skin using tape). This often requires additional geometric shapes or designs that can be bulky. In some scenarios, this can be forgotten by the user, and the attachment may later become detached. [Overview of the Initiative]

[0006] overview This specification discloses approaches to address the various problems and shortcomings of the current technical situation described above. More specifically, this specification discloses a device for delivering a catheter device to a patient's arterial incision site using an internal balloon sheath. One embodiment In this configuration, the sheath comprises a tubular sheath body having a longitudinal axis, a proximal opening, a distal opening, an outer surface, and an inner surface that defines a lumen for the passage of the catheter device between the proximal and distal ends. The sheath also comprises an inflatable balloon configured to occupy a longitudinal space in the lumen between the inner surface of the sheath body and the catheter device when the catheter device is placed inside the sheath and the balloon is inflated, and to fluidly seal the lumen.

[0007] In some embodiments, the balloon may form an interference fit between the catheter device and the inner surface of the sheath body when inflated. In certain embodiments, the balloon may be positioned at least at the distal end of the sheath body. In other embodiments, the balloon may be positioned along the entire length of the sheath body. In further embodiments, the balloon may be attached to the inner surface of the sheath body. In some embodiments, the balloon may be attached at least at the distal end of the inner surface of the sheath body. In certain embodiments, the balloon may be attached along the entire length of the inner surface of the sheath body. In other embodiments, the balloon may be attached along at least a portion of the circumference of the sheath body. In further embodiments, the balloon may be attached to the following portions of the sheath body, i.e., about 25%, about 50%, about 75%, about 100%, of the inner circumference of the sheath body. It may be attached along either of the two lines.

[0008] In some embodiments, the inner surface of the sheath body may be pre-treated to improve the attachment of the balloon to the inner surface of the sheath body. In certain embodiments, the balloon may be attached to the inner surface of the sheath body via thermal bonding or solvent bonding. In other embodiments, the inner surface of the sheath body may be pre-treated via either plasma activation or corona treatment. In further embodiments, the balloon is attached to the sheath The body may be inflated through an expansion opening located on the inner surface of the distal end. In some embodiments, the sheath body may have an expansion lumen extending from the proximal end of the sheath body to the expansion opening. In certain embodiments, the expansion lumen may be in fluid contact with the expansion opening. The expansion lumen may extend linearly or curvedly along the length of the sheath body.

[0009] In some embodiments, the sheath may further comprise a balloon sleeve on which an inflatable balloon is attached; the sleeve is aligned inline with the catheter device and is configured to pass through the lumen of the sheath body. The proximal end of the balloon sleeve may comprise a hemostatic valve that seals together with the catheter device. In certain embodiments, the balloon sleeve may comprise an inflation lumen that is in fluid contact with the balloon for inflation. In other embodiments, the proximal end of the balloon sleeve may comprise an inflation port that is in fluid contact with the inflation lumen for inflation. In further embodiments, the proximal end of the sheath body is connected to the inflation port that is in fluid contact with the balloon for inflation. They may be connected. In some embodiments, the inflation lumen may be connected to a constant-volume syringe at the proximal end of the sheath body to inflate the balloon. In certain embodiments, the balloon is inflated through the inflation port with one of water, saline solution, and air. It may expand.

[0010] In some embodiments, the balloon may be positioned inline with the catheter device. In other embodiments, the balloon may be radially symmetric with respect to the longitudinal axis of the sheath body. In further embodiments, the balloon may be ring-shaped, through which the catheter device passes. In certain embodiments, when the balloon is inflated, it may apply a radial force to the catheter device, thereby locking the catheter device in a predetermined position. In some embodiments, the balloon may be asymmetric with respect to the longitudinal axis of the sheath body. When the balloon is inflated, it may exert a force on the catheter device such that it pushes the catheter device toward a portion of the inner surface of the sheath body, thereby locking the catheter device in a predetermined position.

[0011] In certain embodiments, the sheath body may comprise a stack of multiple polymer layers arranged coaxially with respect to each other around a longitudinal axis. In other embodiments, the sheath body may comprise a combination of multiple tubular polymer layer portions arranged continuously from the proximal end to the distal end of the sheath body. Each polymer layer may comprise a different polymer material type. In some embodiments, the polymer material type is PEBAX® 7233SA It may include one of the following: PEBAX® 7033SA, PEBAX® 6333SA, PEBAX® 5533SA, PEBAX® 3533SA, and PEBAX® 2533SA.

[0012] In further embodiments, the sheath body may include a reinforcing structure to prevent kinking. In other embodiments, the reinforcing structure may include one of a braid, a coil, and a laser-cut feature. In some embodiments, the balloon is made of urethane. It may be made from any one of the following: tan, polyurethane, polyethylene, polypropylene, polyethylene terephthalate (PET), polyvinyl chloride (PVC), polyethylene, cross-linked polyethylene, polyether block amide (PEBA), and nylon. Certain implementation In terms of form, the sheath body is made of polyether block amide (PEBAX®) It may be made from any one of the following materials (such as PebaSlix®), polyethylene material, polytetrafluoroethylene (PTFE) material, high-density polyethylene (HDPE) material, medium-density polyethylene (MDPE) material, and low-density polyethylene (LDPE) material. Furthermore, the distal end of the sheath body may be made from a softer elastic material than that used for the rest of the sheath body.

[0013] In further embodiments, the distal end of the sheath body may include a smaller diameter that provides a seal onto the catheter device. In some embodiments, the balloon sleeve may be made from any one of urethane, polyurethane, polyethylene, polypropylene, polyethylene terephthalate (PET), polyvinyl chloride (PVC), polyethylene, cross-linked polyethylene, polyether block amide (PEBA), and nylon. .

[0014] In certain embodiments, the balloon may be compliant and may be maintained flush against the inner surface of the sheath body when deflated. In other embodiments, the balloon may be non-compliant and may not be maintained flush against the inner surface of the sheath body when deflated. In further embodiments, the balloon may be coated with either a hydrophilic coating or a hydrophobic coating. The coating may be a thickness that ensures proper inflation characteristics of the balloon. In some embodiments, the sheath body may deform during balloon inflation, thereby securing the position of the sheath within the patient's arteriotomy.

[0015] In some embodiments, the proximal end of the sheath may be coupled to a hub for manipulating the sheath when positioned within the patient's arteriotomy. In certain embodiments, the hub may include an inflation side port in fluid communication with a fluid lumen, thereby enabling attachment of a source of balloon inflation fluid. In other embodiments, the hub may include an irrigation port in fluid communication with the space between the catheter device and the inner surface of the sheath body, thereby enabling fluid flushing of that space prior to balloon inflation.

[0016] In another aspect, a sheath kit is provided. The sheath kit includes a sheath and an inflation device coupled to the sheath. The sheath includes a tubular sheath body having a longitudinal axis, a proximal end of the opening, a distal end of the opening, an outer surface, and an inner surface defining a lumen for the catheter device to pass through between the proximal end and the distal end. The sheath also includes an inflatable balloon configured to occupy the longitudinal space within the lumen between the inner surface of the sheath body and the catheter device when the catheter device is disposed within the sheath and the balloon is inflated, and to fluidly seal the lumen. The inflation device includes a constant volume syringe filled with fluid for the inflatable balloon, along with the fluid.

[0017] In yet another aspect, a method of fabricating a sheath with an internal balloon is provided. The method includes providing a tubular sheath body having a longitudinal axis, a proximal end of the opening, a distal end of the opening, an outer surface, and an inner surface defining a lumen for the catheter device to pass through between the proximal end and the distal end. The method then includes providing an inflatable balloon positioned within the lumen, the balloon being configured to occupy the space within the lumen between the inner surface of the sheath body and the catheter device when inflated, thereby fluidly sealing the lumen.

[0018] In some embodiments, the method may further include attaching the inflatable balloon to at least a portion of the inner surface of the sheath body. In certain embodiments, the method may include pre-treating the inner surface of the sheath body to improve adhesion between the balloon and the inner surface of the sheath body. In other embodiments, the pre-treatment may include either plasma activation or corona treatment. In further embodiments, the method [[ID=!0]]includes providing a balloon sleeve for insertion into the lumen of the sheath body, the sleeve being aligned in-line with the catheter device; and attaching the inflatable balloon to at least a portion of the sleeve. In some embodiments, the attachment of the balloon is performed via thermal bonding or solvent bonding.

[0019] In a further embodiment, the method involves (i) a hydrophilic coating or a hydrophobic coating The method may further include the steps of (ii) coating the surface of the balloon with one of the coatings; (ii) coating the surface of the balloon to a predetermined coating thickness to achieve specific inflation characteristics of the balloon; and (iii) coating a catheter-type medical device. In some embodiments, the method may further include the step of connecting the proximal end of the sheath body to the hub.

[0020] In a further embodiment, a method is provided for using a sheath with an internal balloon to treat a patient with a catheter device. The method includes the step of positioning the sheath within the patient's arteriotomy site. The method then includes the step of inserting the catheter device into the lumen to position the distal end of the catheter device within the patient's arteriotomy site. The method includes the steps of flushing the space with an irrigation fluid and inflating a balloon with an inflation fluid to fluidly seal the lumen.

[0021] In some embodiments, the method may include the step of inserting a balloon sleeve, on which an inflatable balloon is attached, into a lumen, wherein the sleeve is aligned in line with the catheter device.

[0022] In another embodiment, a method is provided for treating a patient with a catheter device using a sheath with an internal balloon. The method includes the step of inserting a sheath having a lumen running through it into an arterial incision in the patient. The method also includes the step of inserting a catheter device into the lumen. The method then includes the step of inflating a balloon in the lumen between the sheath and the catheter device to fluidly seal the lumen.

[0023] In some embodiments, the method may include a step of flushing the lumen before inflating the balloon. In certain embodiments, the step of inserting the sheath may include a step of inserting a dilator into the lumen of the sheath to position the sheath within the patient's arterial incision. In some embodiments, the balloon may be attached to the sheath. In other embodiments, the method may further include a step of inserting a balloon sleeve, on which the balloon is attached, into the lumen of the sheath between the sheath and the catheter device before inflating the balloon. In further embodiments, the balloon sleeve may be tightly arranged coaxially around the catheter device. [Invention 1001] A tubular sheath body having a vertical axis, a proximal opening, a distal opening, an outer surface, and an inner surface defining a lumen between the proximal and distal ends through which a catheter device passes; and An inflatable balloon placed inside the lumen, The catheter device is positioned within the sheath and, when the balloon is inflated, occupies the longitudinal space within the lumen between the inner surface of the sheath body and the catheter device, and To fluidly seal the lumen It consists of an inflatable balloon and A sheath for delivering a catheter device through an arterial incision in a patient. [Invention 1002] Any of the sheaths of the present invention, wherein when the balloon is inflated, an interference fit is formed between the catheter device and the inner surface of the sheath body. [Invention 1003] Any of the sheaths of the present invention, wherein the balloon is positioned at least at the distal end of the sheath body. [Invention 1004] A sheath according to any of the present inventions, wherein the balloon is positioned along the entire length of the sheath body. [Invention 1005] A sheath according to any of the present inventions, wherein a balloon is attached to the inner surface of the sheath body. [Invention 1006] A sheath according to the present invention 1005, wherein the balloon is attached to at least the distal end of the inner surface of the sheath body. [Invention 1007] A sheath according to the present invention 1004, wherein the balloon is attached along the entire length of the inner surface of the sheath body. [Presentation 1008] A sheath according to any one of the present invention 1005 to 1007, wherein a balloon is attached along at least a portion of the circumference of the sheath body. [Invention 1009] The balloon is attached along at least one of the following portions of the sheath body, namely, about 25%, about 50%, about 75%, and about 100% of the inner circumference of the sheath body, according to the present invention 1005-1008. One of the sheaths. [Invention 1010] A sheath according to any one of the present invention 1005 to 1009, wherein the inner surface of the sheath body is pre-treated to improve the attachment of the balloon to the inner surface of the sheath body. [Invention 1011] A sheath according to any one of the present invention 1005 to 1010, wherein the balloon is attached to the inner surface of the sheath body via thermal bonding or solvent bonding. [Invention 1012] The inner surface of the sheath body is pre-treated via either plasma activation or corona treatment. The sheath of the present invention 1010 is provided. [Invention 1013] A sheath according to any of the present invention, wherein a balloon is inflated through an inflation opening located on the inner surface of the distal end of the sheath body. [Invention 1014] A sheath according to the present invention 1013, wherein the sheath body comprises an expansion lumen extending from the proximal end of the sheath body to an expansion opening. [Invention 1015] A sheath according to the present invention 1014, wherein the expansion lumen is in fluid contact with the expansion opening. [Invention 1016] A sheath according to any of invention 1014 to 1022, wherein the expansion lumen extends linearly or curvedly along the length of the sheath body. [Invention 1017] A balloon sleeve on which an inflatable balloon is attached, wherein the sleeve is aligned inline with the catheter device and is configured to pass through the lumen of the sheath body. A sheath further comprising any of the present invention 1001 to 1004. [Invention 1018] A sheath according to the present invention 1017, wherein the proximal end of the balloon sleeve is equipped with a hemostatic valve that seals together with the catheter device. [Invention 1019] A sheath according to any one of the invention 1017 to 1018, comprising a balloon sleeve and an expansion lumen in fluid contact with a balloon for inflation. [Invention 1020] The sheath of the present invention 1019, wherein the proximal end of the balloon sleeve is equipped with an expansion port that is in fluid contact with an expansion lumen for expansion. [Invention 1021] A sheath according to any of the present invention 1001 to 1016, wherein the proximal end of the sheath body is connected to an inflation port that is in fluid contact with a balloon for inflation. [Invention 1022] A sheath according to any of invention 1019 to 1021, wherein the expansion lumen is connected to a constant-volume syringe at the proximal end of the sheath body in order to inflate a balloon. [Invention 1023] The balloon is inflated through the inflation port with one of the following: water, saline solution, or air. A sheath according to any of invention 1021 to 1022. [Invention 1024] A sheath according to any of the present invention, wherein the balloon is positioned inline with the catheter device. [Invention 1025] A sheath according to any of the present inventions, wherein the balloon is radially symmetric with respect to the longitudinal axis of the sheath body. [Invention 1026] A sheath according to any of the present invention, wherein the balloon is ring-shaped and a catheter device passes through it. [Invention 1027] A sheath according to the present invention, wherein when the balloon inflates, a radial force is applied to the catheter device, thereby locking the catheter device in a predetermined position. [Invention 1028] A sheath according to any of invention 1001 to 1018, wherein the balloon is asymmetrical with respect to the longitudinal axis of the sheath body. [Invention 1029] The sheath of the present invention 1028, wherein when the balloon is inflated, it exerts a force on the catheter device such that the catheter device is pushed toward a portion of the inner surface of the sheath body, thereby locking the catheter device in a predetermined position. [Invention 1030] Any of the sheaths of the present invention, wherein the sheath body comprises a lamination of a plurality of polymer layers arranged coaxially with respect to each other around a longitudinal axis. [Invention 1031] A sheath according to any of Invention 1001 to 1029, wherein the sheath body comprises a combination of multiple tubular polymer layer portions arranged continuously from the proximal end to the distal end of the sheath body. [Invention 1032] A sheath according to any of the present invention 1030 to 1031, wherein each polymer layer contains a different polymer material type. [Invention 1033] The polymer material types are PEBAX® 7233SA, PEBAX® 7033SA, and PEBAX A sheath according to the present invention 1032, comprising one of the following: (Registered Trademark) 6333SA, PEBAX(Registered Trademark) 5533SA, PEBAX(Registered Trademark) 3533SA, and PEBAX(Registered Trademark) 2533SA. [Invention 1034] Any of the sheaths of the present invention, wherein the sheath body is equipped with a reinforcing structure to prevent kinking. [Invention 1035] The reinforcing structure includes one of the following: braiding, coiling, and laser-cut features. Sheath for Invention 1034. [Invention 1036] The balloon is made from one of the following materials: urethane, polyurethane, polyethylene, polypropylene, polyethylene terephthalate (PET), polyvinyl chloride (PVC), polyethylene, cross-linked polyethylene, polyether block amide (PEBA), and nylon. Any of the sheaths described in the present invention. [Invention 1037] The sheath body is made of polyether block amide (PEBAX® or PebaSlix) A sheath according to the present invention, made from one of the following materials: polyethylene material, polytetrafluoroethylene (PTFE) material, high-density polyethylene (HDPE) material, medium-density polyethylene (MDPE) material, and low-density polyethylene (LDPE) material (e.g., registered trademark). [Invention 1038] Any of the sheaths of the present invention, wherein the distal end of the sheath body is made of a softer elastic material than that used for the rest of the sheath body. [Invention 1039] The distal end of the sheath body is smaller, providing a seal over the catheter device. A sheath according to the present invention 1038, including the diameter. [Invention 1040] The balloon sleeve is made from one of the following materials: urethane, polyurethane, polyethylene, polypropylene, polyethylene terephthalate (PET), polyvinyl chloride (PVC), polyethylene, cross-linked polyethylene, polyether block amide (PEBA), and nylon. A sheath according to any of the present invention 1017 to 1019. [Invention 1041] The balloon is compliant, and the sheath body is deflated. A sheath according to any of the above-described inventions, which is kept flush with the inner surface. [Invention 1042] A sheath according to the present invention 1001, wherein the balloon is non-compliant and is not kept flush with the inner surface of the sheath body when deflated. [Invention 1043] A sheath according to any of the present inventions, wherein the balloon is coated with a hydrophilic coating. [Invention 1044] A sheath according to any of invention 1001 to 1042, wherein the balloon is coated with a hydrophobic coating. [Invention 1045] Any of the sheaths of the present invention, wherein the coating is of a thickness that ensures the proper inflation characteristics of the balloon. [Invention 1046] A sheath according to any of the present invention, wherein the sheath body deforms when the balloon is inflated, thereby fixing the position of the sheath within the patient's arterial incision site. [Invention 1047] Any of the sheaths of the present invention, wherein the proximal end of the sheath is connected to a hub for manipulating the sheath when it is positioned within the arterial incision site of a patient. [Invention 1048] A sheath according to any of the present invention 1014-1016 and 1019-1022, wherein the hub comprises a fluid lumen and an expansion side port in fluid contact, thereby enabling the attachment of a source of balloon inflation fluid. [Invention 1049] A sheath according to any one of the inventions 1047 to 1048, wherein the hub comprises an irrigation port that fluid-connects to the space between the catheter device and the inner surface of the sheath body, thereby enabling the space to be flushed with fluid before the balloon is inflated. [Invention 1050] A sheath based on one of the following: 1001-1049; A constant-volume syringe, filled with fluid and connected to the sheath, for inflating a balloon with fluid. A sheath kit for delivering a catheter device to the arterial incision site of a patient. [Invention 1051] A method for fabricating a sheath with an internal balloon, including the following steps: A step of providing a tubular sheath body having a vertical axis, an open proximal end, an open distal end, an outer surface, and an inner surface that defines a lumen for the passage of a catheter device between the proximal and distal ends; and A step of providing an inflatable balloon positioned within the lumen, wherein the balloon, when inflated, occupies a space within the lumen between the inner surface of the sheath body and the catheter device, thereby sealing the space away from the arterial incision. [Invention 1052] The step of attaching the inflatable balloon to at least a portion of the inner surface of the sheath body. The method of the present invention 1051, further comprising: [Invention 1053] A step of pre-treating the inner surface of the sheath body in order to improve adhesion between the balloon and the inner surface of the sheath body. Any method of the present invention 1051 to 1052, further comprising the above. [Invention 1054] The method of the present invention 1053, wherein the pretreatment includes either plasma activation or corona treatment. . [Invention 1055] A step of providing a balloon sleeve for insertion into the lumen of a sheath body, wherein the sleeve is aligned inline with the catheter device; and Steps to attach the inflatable balloon to at least a portion of the sleeve. The method of the present invention 1051, further comprising: [Invention 1056] Any method 1052 to 1055 of the present invention, wherein the balloon is attached via thermal bonding or solvent bonding. [Invention 1057] The step of coating the surface of the balloon with either a hydrophilic or hydrophobic coating. Any method of the present invention 1051 to 1056, further comprising the above. [Invention 1058] The step of coating the surface of the balloon to a predetermined coating thickness in order to achieve specific inflation characteristics of the balloon. The method of the present invention 1057, further comprising: [Invention 1059] The step of connecting the proximal end of the sheath body to the hub. Any method of the present invention 1051 to 1058, further comprising the above. [Invention 1060] A method for manufacturing a sheath with an internal balloon according to any of the inventions 1001 to 1049. [Invention 1061] A method using an internal balloon sheath to treat a patient with a catheter device, including the following steps: The step of positioning one of the sheaths according to invention 1001 to 1049 within the arterial incision site of the patient; The step of inserting the catheter device into the lumen in order to position the distal end of the catheter device within the arterial incision site of the patient; The step of flushing the space with an irrigation fluid; and The step of inflating the balloon with an inflation fluid so as to seal the space from the arterial incision site. [Invention 1062] A method using the sheath of the present invention 1061, further comprising the following steps: A step in which an inflatable balloon attached to a balloon sleeve is inserted into a lumen, wherein the sleeve is aligned in line with the catheter device. [Invention 1063] A method for inserting a catheter-type device through a patient's arterial incision site, including the following steps: The step of inserting a sheath having a lumen through which it runs into the arterial incision in the patient; The step of inserting the catheter device into the lumen; and The lumen between the sheath and the catheter-type device is to be fluidly sealed. The stage where the balloon is inflated inside. [Invention 1064] The method of the present invention 1063, further comprising the step of flushing the lumen before inflating the balloon. [Invention 1065] Any method of the present invention 1063 to 1064, wherein the step of inserting the sheath includes the step of inserting a dilator into the lumen of the sheath in order to position the sheath within the arterial incision site of the patient. [Invention 1066] A method of attaching a balloon to a sheath, as described in any of the invention 1063 to 1065. [Invention 1067] Any method of the present invention 1063 to 1065 further comprising the step of inserting a balloon sleeve, on which a balloon is attached, into the lumen of the sheath between the sheath and a catheter-type device, before inflating the balloon. [Invention 1068] The method of the present invention 1067, wherein a balloon sleeve is tightly arranged coaxially around a catheter-type device. [Brief explanation of the drawing]

[0024] 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.

[0025] [Figure 1] This document describes an exemplary sheath delivery system, known in the prior art, used to deliver a catheter-type device into a patient's arterial incision site. [Figure 2] Figure 1 shows an exemplary cross-section of the sheath delivery system. [Figure 3] Figure 1 shows the entry of fluids and blood clots after the sheath delivery system has been inserted into the patient's body. [Figure 4] An exemplary internal balloon sheath based on one aspect of this disclosure is shown. [Figure 5]Figure 5A shows an exemplary internal balloon sheath according to one aspect of the present disclosure, in which the balloon is positioned at the distal end of the sheath. Figure 5B shows an exemplary internal balloon sheath according to one aspect of the present disclosure, in which the balloon is positioned along the entire length of the sheath. [Figure 6] An exemplary inflation lumen and inflation port formed within a sheath body for inflating an internal balloon is shown according to one aspect of the present disclosure. [Figure 7] Figure 6 shows the radial cross-section of the internal balloon sheath. [Figure 8] Figure 6 shows the internal balloon sheath before inflation. [Figure 9] Figure 9A shows an enlarged view of an exemplary internal balloon sheath with an inline balloon sleeve, based on one aspect of the present disclosure. Figure 9B shows the internal balloon sheath of Figure 9A with the inline balloon sleeve inserted into the internal balloon sheath. [Figure 10] Figure 10A shows the radial cross-section of the internal balloon sheath of Figures 9A-9B before inflation. Figure 10B shows the radial cross-section of the internal balloon sheath of Figures 9A-9B after inflation. [Figure 11] Figure 11A shows an exemplary internal balloon sheath with a non-inline balloon sleeve, based on one aspect of the present disclosure. Figure 11B shows an isometric view of the proximal end of the internal balloon sheath shown in Figure 11A. [Figure 12] Figure 12A shows the radial cross-section of the internal balloon sheath of Figures 11A-11B before inflation. Figure 12B shows the radial cross-section of the internal balloon sheath of Figures 11A-11B after inflation. [Figure 13] An exemplary expandable internal balloon sheath with an in-line balloon sleeve, based on one aspect of the present disclosure, is shown, in which the balloon and sheath are specifically designed to allow localized stretching of the sheath. [Figure 14] An illustrative flowchart of a method for fabricating an internal balloon sheath based on one aspect of this disclosure is shown. [Figure 15]An illustrative flowchart of a method using an internal balloon sheath is shown based on one aspect of this disclosure. [Modes for carrying out the invention]

[0026] Detailed explanation Certain exemplary embodiments are described to ensure that the devices and methods described herein are understood in their entirety. The embodiments and features described herein are described in particular in relation to the use of internal balloon sheaths in intravascular procedures with catheter-based ventricular assist devices, but 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 procedures requiring internal balloon sheaths.

[0027] The devices and methods described herein relate to an internal balloon sheath comprising a tubular sheath body and an inflatable balloon. The tubular sheath body comprises a longitudinal axis, a proximal opening, a distal opening, an outer surface, and an inner surface defining a lumen between the proximal and distal ends for the passage of a catheter device. The inflatable balloon is positioned within the lumen; and the inflatable balloon is configured to fluidly seal the lumen by occupying a longitudinal space within the lumen between the inner surface of the sheath body and the catheter device when the catheter device is positioned within the sheath and the balloon is inflated.

[0028] Such a sheath prevents fluid from entering after the balloon is inflated, thereby preventing blood stagnation and clotting within the lumen of the sheath when the sheath is positioned within the patient's vascular structure. Since the lumen within the sheath is sealed from the arterial incision of the sheath, there is no need to provide a flow of irrigation fluid through the lumen of the sheath, thereby simplifying the sheath delivery system. Furthermore, the inflated balloon forms an interference fit between the outer surface of the catheter device and the inner surface of the sheath, thereby fixing or locking the position of the catheter device in use. This does not involve bulky and cumbersome fixation techniques such as attaching to the surface of the patient's skin. In addition, the internal balloon sheath of the present invention can be used with catheters of any size, as the inflatable balloon fills any space between the catheter body and the sheath, and the balloon reasonably occupies any dimensional differences within the sheath.

[0029] In some embodiments, the internal balloon may be attached to at least a portion of the inner surface of the sheath body, where the internal balloon may be attached to the inner surface of the distal end of the sheath body. Alternatively, the internal balloon may extend along the entire length of the sheath body and be attached to multiple attachment points on the inner surface of the sheath body. In certain embodiments, the balloon may be an in-line radially symmetric balloon arranged coaxially with the sheath body so that the catheter device passes through it. In other embodiments, the balloon may be an asymmetric balloon. When inflated, the balloon forms an interference fit with the sheath and the catheter body, in which case the balloon grips the catheter, thereby locking it in place.

[0030] In another embodiment, the internal balloon may be attached to an external balloon sleeve of the sheath body. The sleeve may be arranged to slide on the catheter on the medical device while having a tight fit thereon. The sleeve may be configured to slide around the catheter to position it within the lumen of the sheath. The balloon may be attached to the outer surface of the distal end of the sleeve. Alternatively, the balloon may extend along the entire length of the sleeve and be attached to multiple attachment points on the outer surface of the sleeve. In a certain embodiment, the catheter device passes through the sleeve. To facilitate withdrawal, the balloon may be an in-line radially symmetric balloon arranged coaxially with the sleeve. In another embodiment, the balloon may be an asymmetric balloon. When inflated, the balloon forms an interference fit with the sheath and catheter body, at which point the balloon grips the catheter, thereby locking it in place. In another embodiment, the balloon sleeve is positioned parallel to the catheter of the medical device, thereby eliminating the need for the medical device to be passed through the balloon sleeve.

[0031] Figure 1 shows a conventional sheath delivery system 100 for positioning a catheter device 140 within a patient's blood vessel. Figure 1 depicts the sheath 120 after it has been inserted through the patient's skin 110 into an arterial incision 112. The sheath 120 is then positioned into a blood vessel such as the femoral artery 114. The catheter is inserted; blood flows through that vessel 116. The sheath 120 is inserted into the artery 114. To facilitate the insertion of the catheter device 140. The catheter device 140 may include a ventricular assist device such as a percutaneous pump. One example of such a percutaneous pump is the Impella 2.5® pump system by Abiomed, Inc. of Danvers, Massachusetts. Such pumps generally comprise a catheter body with a pump head (not shown) at the distal end of the catheter body and a handle (not shown) at the proximal end of the catheter body. In most cases, the pump head has a diameter larger than the diameter of the catheter body. It should be understood that while this specification describes a percutaneous cardiac pump, any other percutaneous or intravascular medical device may be used in conjunction with this disclosure. The proximal end of the sheath 140 is It may be connected to B130.

[0032] The inner diameter of the sheath 120 is designed to facilitate the passage of the catheter device through the sheath 100. d shi d is the outer diameter of the widest part of the catheter device. catho So that it is equal to or greater than d shi ≥ d catho It is configured in such a way. In the Imeplla 2.5 (trademark) pump system exemplified above, the largest part of the device is the pump head. As depicted in Figure 2, after the pump head passes through the sheath body 120, the inner surface 126 of the sheath 120 A space 128 exists between the outer surface of the catheter device 140 and the inner diameter d of the sheath, as shown in Figure 2. shi and the outer diameter of the catheter body d catbo It exists because of the difference between the two. Such space enters the sheath 120 while the sheath body is still inside the patient's arterial incision site. This facilitates the entry of blood. Since there may not be fluid flowing in that space, there is a high possibility of blood stagnation, and as a result, blood clots 118 and 119 are formed in the space 128 of the sheath body 120, as shown in Figure 3.

[0033] When such blood clots form, they can accidentally detach from the sheath and move freely within the blood vessel with the blood, potentially causing embolism downstream (e.g., entering the distal limb, reaching the right heart and lungs), thus complicating intravascular medical procedures. In addition, in some cases, blood clot formation can increase the likelihood of blocking blood flow through the vessel. Furthermore, once a blood clot begins to form, it can continue to grow in size and potentially block the lumen of the vessel. In some cases, to minimize blood clot formation, the lumen of sheath 120 is... The flow of irrigation fluid to be delivered is provided to the sheath delivery system. This flow may be delivered to the lumen continuously or at a predetermined frequency, but such irrigation requires the use of additional control and monitoring mechanisms, thus complicating the sheath delivery system. Furthermore, when the catheter device 140 is positioned, the proximal end of the device is tape or It may be attached to the hub 130 by sutures. Such fixation is performed by cutting the patient's artery. There is a possibility that the device inside the opening cannot be guaranteed to remain still. In addition, such external fixation can be bulky and cumbersome, and may loosen when the patient moves.

[0034] Figure 4 shows an enlarged view of an internal balloon sheath 400 based on one aspect of the present disclosure. The sheath 400 is suitable for insertion into an arterial incision site in a patient, such as the femoral artery. The sheath 400 has an inner surface 404. It comprises a sheath body 402 extending along the longitudinal axis 406. The sheath body 402 comprises a lumen 408 with a diameter d extending along the longitudinal axis 406. In a certain embodiment, the sheath body 402 The sheath body 402 may be tubular with a circular cross-section, but the sheath body 402 may be of any shape and configuration It may be so. The sheath body 402 has an inner diameter d shi It has and is suitable for introducing the intravascular medical device 420 into the patient's blood vessels. As mentioned earlier, the medical device 420 is transdermal It may be a catheter device such as a pump. An example of such a percutaneous pump is the Impella 2.5 (trademark) pump system by Abiomed, Inc. of Danvers, Massachusetts. It is the Impella 2.5 (trademark) pump system by Abiomed, Inc. of Danvers, Massachusetts. Such pumps generally include a catheter body 422 and have a pump head 424 at the distal end of the catheter body. In most situations, the pump head 424 has a diameter d that is larger than the diameter d of the catheter body. As will be understood, although percutaneous heart pumps are described herein, any other percutaneous medical device or intravascular medical device may be used in conjunction with the present disclosure. Such pumps generally include a catheter body 422 and have a pump head 424 at the distal end of the catheter body. In most situations, the pump head 424 has a diameter d that is larger than the diameter d of the catheter body. As will be understood, although percutaneous heart pumps are described herein, any other percutaneous medical device or intravascular medical device may be used in conjunction with the present disclosure. catbo Such pumps generally include a catheter body 422 and have a pump head 424 at the distal end of the catheter body. In most situations, the pump head 424 has a diameter d that is larger than the diameter d of the catheter body. As will be understood, although percutaneous heart pumps are described herein, any other percutaneous medical device or intravascular medical device may be used in conjunction with the present disclosure. catho Such pumps generally include a catheter body 422 and have a pump head 424 at the distal end of the catheter body. In most situations, the pump head 424 has a diameter d that is larger than the diameter d of the catheter body. As will be understood, although percutaneous heart pumps are described herein, any other percutaneous medical device or intravascular medical device may be used in conjunction with the present disclosure.

[0035] Once the sheath 400 is in the correct position within the vasculature, the medical device 420 is deployed from the distal end 403 of the sheath body 402. To allow the medical device 420 to exit the sheath 400, the inner diameter of the sheath body 402 is configured to be at least equal to the diameter of the pump head 424, i.e., d ≥ d. However, this means that when the medical device 420 is placed within the vasculature, the difference between the inner diameter d of the sheath body 402 and the outer diameter d of the catheter body leads to the generation of space, which can result in the formation of blood clots as described above. Once the sheath 400 is in the correct position within the vasculature, the medical device 420 is deployed from the distal end 403 of the sheath body 402. To allow the medical device 420 to exit the sheath 400, the inner diameter of the sheath body 402 is configured to be at least equal to the diameter of the pump head 424, i.e., d ≥ d. However, this means that when the medical device 420 is placed within the vasculature, the difference between the inner diameter d of the sheath body 402 and the outer diameter d of the catheter body leads to the generation of space, which can result in the formation of blood clots as described above. Once the sheath 400 is in the correct position within the vasculature, the medical device 420 is deployed from the distal end 403 of the sheath body 402. To allow the medical device 420 to exit the sheath 400, the inner diameter of the sheath body 402 is configured to be at least equal to the diameter of the pump head 424, i.e., d ≥ d. However, this means that when the medical device 420 is placed within the vasculature, the difference between the inner diameter d of the sheath body 402 and the outer diameter d of the catheter body leads to the generation of space, which can result in the formation of blood clots as described above. shi Once the sheath 400 is in the correct position within the vasculature, the medical device 420 is deployed from the distal end 403 of the sheath body 402. To allow the medical device 420 to exit the sheath 400, the inner diameter of the sheath body 402 is configured to be at least equal to the diameter of the pump head 424, i.e., d ≥ d. However, this means that when the medical device 420 is placed within the vasculature, the difference between the inner diameter d of the sheath body 402 and the outer diameter d of the catheter body leads to the generation of space, which can result in the formation of blood clots as described above. catho Once the sheath 400 is in the correct position within the vasculature, the medical device 420 is deployed from the distal end 403 of the sheath body 402. To allow the medical device 420 to exit the sheath 400, the inner diameter of the sheath body 402 is configured to be at least equal to the diameter of the pump head 424, i.e., d ≥ d. However, this means that when the medical device 420 is placed within the vasculature, the difference between the inner diameter d of the sheath body 402 and the outer diameter d of the catheter body leads to the generation of space, which can result in the formation of blood clots as described above. Once the sheath 400 is in the correct position within the vasculature, the medical device 420 is deployed from the distal end 403 of the sheath body 402. To allow the medical device 420 to exit the sheath 400, the inner diameter of the sheath body 402 is configured to be at least equal to the diameter of the pump head 424, i.e., d ≥ d. However, this means that when the medical device 420 is placed within the vasculature, the difference between the inner diameter d of the sheath body 402 and the outer diameter d of the catheter body leads to the generation of space, which can result in the formation of blood clots as described above. shi Once the sheath 400 is in the correct position within the vasculature, the medical device 420 is deployed from the distal end 403 of the sheath body 402. To allow the medical device 420 to exit the sheath 400, the inner diameter of the sheath body 402 is configured to be at least equal to the diameter of the pump head 424, i.e., d ≥ d. However, this means that when the medical device 420 is placed within the vasculature, the difference between the inner diameter d of the sheath body 402 and the outer diameter d of the catheter body leads to the generation of space, which can result in the formation of blood clots as described above. catbo Once the sheath 400 is in the correct position within the vasculature, the medical device 420 is deployed from the distal end 403 of the sheath body 402. To allow the medical device 420 to exit the sheath 400, the inner diameter of the sheath body 402 is configured to be at least equal to the diameter of the pump head 424, i.e., d ≥ d. However, this means that when the medical device 420 is placed within the vasculature, the difference between the inner diameter d of the sheath body 402 and the outer diameter d of the catheter body leads to the generation of space, which can result in the formation of blood clots as described above.

[0036] Based on one aspect of the present disclosure, an expandable balloon 410 is positioned within the lumen 408 of the sheath body 402. In some aspects, the balloon 410 may be positioned at the distal end 403 of the sheath body 402. In that aspect, the balloon 410 may be positioned at other locations along the sheath body 402. In a further aspect, the balloon 410 is Based on one aspect of the present disclosure, an expandable balloon 410 is positioned within the lumen 408 of the sheath body 402. In some aspects, the balloon 410 may be positioned at the distal end 403 of the sheath body 402. In that aspect, the balloon 410 may be positioned at other locations along the sheath body 402. In a further aspect, the balloon 410 is It may extend along the entire length of the sheath body 402.

[0037] The balloon 410 is configured to be able to take on two states: a deflated first state and an inflated second state, and to be able to transition between them. In the first state, the balloon 410 does not come into contact with the catheter body 422 of the medical device 420, while in the second state, The lune 420 contacts the catheter body 433 of the medical device 420. To transition the balloon 410 from a first state where it is deflated to a second state where it is inflated, fluid is supplied to the balloon 410. In some embodiments, the fluid may be, for example, air, saline solution, or water, but any biocompatible fluid may be used to inflate the balloon 410. Such fluid may be supplied to the balloon through a fluid lumen, which will be detailed in the following sections. When the balloon 410 is inflated, the diameter of the lumen 408 is reduced such that the opening in the sheath body 402 is smaller than the diameter of the catheter body 422 of the medical device 420; In other words, in the second state, d < d catbo The balloon, when inflated (with saline or water), fills the gap / space between the catheter body 422 and the inner surface 404 of the sheath, thereby preventing blood from entering, stagnating, and coagulating. It should be noted that, during use, after the catheter device is positioned within the patient's arterial incision, the lumen 408 of the sheath 400 may be flushed with irrigation fluid before the balloon 410 is inflated. Furthermore, even if blood accumulates during the positioning of the sheath 400 or catheter device. That entry will be prevented.

[0038] In the second state, the inflated balloon 410 connects with the catheter body 422 of the medical device 420. Contact is made, and a compressive force is applied to the medical device 420. In addition, in the second state, the catheter The frictional force between the balloon 410 and the catheter body 422 along the length of the interface portion with the balloon helps to fix the position of the catheter body 422 relative to the sheath 400. In some embodiments (as described later), the balloon 410 is attached to the sheath 400. If not being kicked, the frictional force between the balloon 410 and the inner surface 404 of the sheath body 402 along the interface between the balloon and the sheath also helps to fix the position of the catheter body 422 relative to the sheath 400.

[0039] Figure 4 shows an axisymmetric balloon 410, but the balloon 410 can be any shape or configuration. It will be recognized that this is acceptable. For example, balloon 410 is the vertical axis 406 of sheath 400 A axially symmetrical (as depicted in Figure 4) object with a circular ring shape aligned around it. This configuration may also be possible. In such a configuration, when the balloon 410 is inflated, it applies radial compressive forces to the catheter body 422 from all directions around the longitudinal axis 406, thereby effectively gripping and locking the catheter body 422 in a predetermined position. In another embodiment, the balloon 410 may be asymmetrical around the longitudinal axis 406 of the sheath 400. For example, the balloon 410 may be positioned on one side of the longitudinal axis 406 of the sheath 400. In such a configuration, the balloon When part 410 expands and takes its second state, it compresses the catheter body 422 from approximately one direction. Applying force. When this happens, the compressive force from balloon 410 effectively presses the catheter body 422 against the inner surface 404 of the sheath body 402, locking it in place. As should be understood, when balloon 410 is in the second state, balloon 410 is the medical device 420 Prevents axial or radial movement, thereby fixing the medical device 420 in a fixed position. Lock it.

[0040] Figure 5A illustrates an exemplary internal balloon sheath 500 based on one aspect of the present disclosure. It should be understood that the internal balloon sheath 500 is similar to the sheath 400 of Figure 4 described above. They have similar characteristics. The sheath 500 has a lumen through which an intravascular medical device passes, and Figure 5A shows the catheter end 505 of the device. The sheath 500 comprises a sheath body 510 having a distal end 512 and a proximal end 514. The sheath 500 also comprises an inflatable balloon 515 positioned within the lumen of the sheath 500 and located at the distal end 512 of the sheath body 510. In Figure 5A, the inflatable balloon 515 has a fixed length and does not extend the entire length of the sheath body 510. In some embodiments, the balloon 515 may be positioned at other locations along the sheath body 510. Furthermore, in certain embodiments of this disclosure, the balloon 515 may be attached to the inner wall of the sheath body 510, as described in the following sections. Alternatively, the balloon 510 may be positioned within the sheath 500 by inserting a balloon sleeve into the lumen of the sheath body 510, as described in the following sections. It may be done.

[0041] Figure 5B illustrates another exemplary internal balloon sheath 550 based on one aspect of the present disclosure. It will be understood that the internal balloon sheath 550 has similar features to the sheath 500 of Figure 5A described above. The sheath 550 has a lumen through which an intravascular medical device passes. Figure 5B shows the catheter end 555 of the device. Similar to the sheath 500, the sheath 550 comprises a sheath body 560 having a distal end 562 and a proximal end 564. However, in Figure 5B, the sheath 550 has a positioning valve that extends along the entire length of the sheath body 560 into the lumen of the sheath 500. It comprises an inflatable balloon 565. In certain embodiments of the present disclosure, the following As described in the section below, balloon 565 may be attached to the inner wall of sheath body 560. Alternatively, as described in the following section, balloon 560 may be positioned within sheath 550 by inserting balloon sleeve into the lumen of sheath body 560. That's good too.

[0042] In some embodiments of this disclosure, balloons 510 and 560 in Figures 5A and 5B may be axially symmetric. In other embodiments, balloons 510 and 560 may be asymmetric about the longitudinal axis of the sheath body.

[0043] As shown in Figure 5A, the proximal end 514 of the sheath body 510 may be connected to the hub 520. Hub 5 20 is a grip that allows the physician to position the sheath 500 within the patient's vascular structure. It serves as a handle. The hub also allows the sheath 500 to be positioned within the patient's vascular structure. The hub may also have features to facilitate securing it to the patient's skin. Such securing may be via sutures or tape. In addition, the hub 520 may have at least one side port 525, 530. Each side port may be connected to a flexible tube 526, 531 as shown in Figure 5A, and optionally to a two-way or three-way stopcock. Each side port may be in fluid contact with the lumen of the sheath body 510. In this embodiment, the side port may be in fluid contact with an additional lumen within the sheath body 510, such as an expansion lumen, as described in the following sections. The side port 525 is in fluid contact with the lumen of the sheath body 510, and the side port 530 The inflatable balloon 515 is in fluid contact with the side port 520 before inflation. The tube 526 may be connected to the sheath body 510 so that the lumen can be flushed with an irrigation fluid.

[0044] By flushing the lumen before inflating the balloon 515, the patient's arterial incision site can be flushed. When inserting the valve, the stagnation of blood that has accumulated is removed. The side port 530 is for inflation flow The tube 531 may be connected to the balloon 515 so that the balloon 515 can be inflated using a body (as described later). In some embodiments, the side port 530 is connected to the balloon 515 via a fluid lumen formed in the sheath body 510, or via an internal tube connecting a source of inflation fluid to the balloon 515. The balloon 515 may be in fluid contact with the tubing. Points to note: In Figure 5B, where balloon 565 extends along the length of sheath body 560, the balloon 565 is near Since the terminal end can communicate directly with the expansion port on the hub, there is no need for an expansion lumen inside the wall of the sheath body.

[0045] Once the sheath 500 and hub 520 are in place, the physician may attach syringes of saline solution to the side ports 525 and 530 and / or create a vacuum to deliver fluid through the side ports and along the shaft of the sheath (for example, within the wall of the sheath body as described in the following section) into the balloon. Once the balloon 515 is inflated, the physician The instructor may shut off the stopcock on the side port to lock the volume there.

[0046] Returning to the embodiment of Figure 4, the balloon 410 may be attached to the inner surface 404 of the sheath body 402 and inflated and deflated from there. Such attachment is carried out via thermal bonding or solvent bonding. This bonding is to prevent the balloon 410 from rupturing, for example, during inflation. This is extremely important. In certain embodiments, the inner surface 404 of the sheath body 402 may be pre-treated by plasma activation or corona treatment to improve the likelihood of the balloon 410 bonding to the sheath body 402. In some embodiments, the balloon 410 may be positioned in a specific location on the sheath body 402. In such embodiments, the mounting position of the balloon 410 The attachment point may be localized to the position of the balloon within the sheath 400. For example, in the case of a balloon 410 positioned at the distal end 403 of the sheath body 402, the attachment point of the balloon 410 to the inner surface 404 of the sheath body 402 may be at the distal end 403 of the sheath body 402.

[0047] In another embodiment, the balloon 410 may extend along the length of the sheath body 402. In such a configuration, the balloon 410 extends along the entire length of the balloon 410 within the sheath body 402. It may be attached to surface 404. In other configurations, the balloon 410 may be attached to the inner surface 404 of the sheath body 402 only at certain points, such as the proximal and / or distal ends of the sheath body 402. In other embodiments, the balloon 410 is attached to the inner surface 404 of the sheath body 402 It does not have to be attached to surface 404. Instead, the balloons described in the following section Even when using a leaf, the balloon 410 is positioned within the lumen 408 of the sheath body 402. good.

[0048] As mentioned above and with respect to the embodiment depicted in Figure 4, in the first state, The lune 410 is not inflated with fluid and is not in contact with the catheter body 422. In one embodiment of the present disclosure, the balloon 410 may be configured to be compliant so that, in the first state, the balloon 410 sits flush and tightly against a surface within the sheath 400. In some embodiments, this surface may be the inner wall 404 of the sheath body 402. In other embodiments, the surface to which the compliant balloon is attached may be an additional balloon sleeve (as detailed in the following sections). The compliant balloon 410 has no excess balloon material when deflated, and therefore the sheath To allow for the unimpeded insertion and removal of the medical device 420 within the lumen 408 of the body 402. This makes it possible. Such compliant balloons are easier to manufacture and process because there is no excess balloon material that needs to be controlled during the bonding of the balloon 410 to the inner surface 404 of the sheath body 402. It may be easier. When a compliant balloon 410 is inflated, (for example) The pressure from the inflation fluid (which may be delivered to the balloon 410 via a syringe) will cause the balloon to expand. The material elastically deforms, sealing the catheter body 422, thereby allowing the arterial incision site to be exposed. The lumen is closed off to anything that enters it (such as blood and blood clots).

[0049] In another embodiment, the balloon 410 may be configured to be non-compliant. In that case, the balloon is attached to the surface inside the sheath 400 when it is in its first state. In one embodiment, this surface may be the inner wall 404 of the sheath body 402. In another embodiment, the surface to which the compliant balloon is attached may be an additional balloon sleeve (as detailed in the following sections). The non-compliant balloon 410 sits in the lumen 408 of the sheath 400 when deflated (as shown in Figures 6-8 and in the following sections). (As will be explained in the n section). Non-compliant balloons may be used so that a constant volume of fluid always provides appropriate and predictable inflation characteristics. In some embodiments, a constant volume syringe containing the inflation fluid may be provided with the sheath 400 so that the correct volume of fluid is supplied to the balloon 410 each time the balloon 410 is inflated. In some embodiments, a syringe (and optionally a constant-volume syringe) may be provided in a sheath kit together with one of the internal balloon sheaths described herein.

[0050] For all internal balloon sheaths in this disclosure, it will be understood that the lumen of the internal balloon sheath is flushed with irrigation fluid to remove any potential blood entry that may occur when positioning the sheath within the patient's arterial incision. After flushing the lumen, the balloon is inflated. As the balloon inflates, the lumen within the sheath body is sealed away from the patient's arterial incision. Throughout this disclosure, it will be understood that “seal” means substantially sealing the lumen to exclude any amount of fluid flow that could allow blood clot formation. Thus, unlike conventional introducer sheaths, this disclosure does not require a constant flow of irrigation fluid to flush the sheath lumen during the procedure. Furthermore, since the balloon extends to seal the lumen via a compression fit with the catheter of the medical device, the sheath of this invention can be used with catheters of any diameter, as long as the inner diameter of the sheath body is larger than the outer diameter of the distal end of the catheter device.

[0051] Figure 6 shows an axial cross-sectional view of the distal section of the internal balloon sheath 600 according to one aspect of the present disclosure. This is illustrated. Similar to the embodiments described above, the sheath 600 comprises a sheath body 610 having an inner surface 615 that defines a lumen 620 for the passage of an intravascular medical device having a catheter body 630. An inflatable balloon 640 is positioned at the distal end 612 of the sheath body 610. The balloon 640 may be compliant or non-compliant. Furthermore, the sheath body 610 may be axially symmetric or asymmetric about the vertical axis 605, and its configuration is as described above.

[0052] In some embodiments, a balloon positioned distally, such as balloon 640, is inflated. To provide tension, an expansion tube lumen 650 within the wall of the sheath body 610 is also provided to the sheath 600. Good. Such an expansion lumen 650 may extend from the distal end 612 of the sheath body 610 along the length of the sheath 600 to the proximal end (not shown). The proximal end of the sheath 600 is shown in Figures 5A and 5B. It may be connected to a hub (similar to the one described above). The expansion lumen 650 is the interface between the balloon 640 and the inner surface 615 of the sheath body 610, formed within the wall of the sheath body 610. Even if there is fluid communication with the inside of the balloon 640 through the opening 655 (or radial lumen 655) Good. In some embodiments, the balloon 640 is thermally coupled, as also described above. Alternatively, it may be attached to the inner surface 615 of the sheath body 610 via solvent bonding. These bonding is crucial to prevent the balloon 640 from rupturing. In certain embodiments Furthermore, the sheath body 610 may have multiple lumens similar to the lumen 650 for other purposes, such as for localized irrigation and flushing, or to allow a guidewire to pass through.

[0053] Figure 7 shows a cross-section 700 of the sheath 600 drawn along the line X-X' in Figure 6; the figure also shows the expansion lumen 650 formed within the wall of the sheath body 610. In Figure 7, the balloon In the case of 640, when the balloon material is in a deflated state, the balloon material is inside the lumen 620 of the sheath body 610. It is shown as a compliant, axisymmetric balloon. However, as mentioned above, any type of balloon (compliant, non-compliant, axisymmetric, asymmetric) may be used in conjunction with the embodiments of this disclosure.

[0054] The expansion fluid is supplied, for example, from a syringe to the expansion lumen 650 at the hub, and thereafter The fluid 652 is pushed into the expansion lumen 650 and into the balloon 640 through the opening 655, thereby inflating the balloon. In some embodiments of this disclosure, the expansion fluid may include, but is not limited to, any biocompatible fluid such as air, water, and saline solution. As mentioned above, the balloon 640 reduces the diameter of the lumen 620 such that when inflated, the opening in the sheath body 610 is smaller than the diameter of the catheter body 630 of the medical device. The balloon, when inflated, fills the space between the catheter body 630 and the inner surface 615 of the sheath 600. It fills the gap, thereby preventing blood from entering, stagnating, and clotting. The balloon 640 is full When it inflates, it comes into contact with the catheter body 630 of the medical device and applies a compressive force to the catheter body 630. The frictional force between the balloon 640 and the catheter body 630 along the length of the interface between the catheter and the balloon also applies to the catheter body against the sheath 600. This can help to fix the position of the i630. In some embodiments (see below for example) (When the balloon is not attached to the inner surface of the sheath) the frictional force between the balloon 640 and the inner surface 615 of the sheath body 610 along the interface between the balloon and the sheath It also helps to fix the position of the catheter body 630 relative to the sheath 600.

[0055] Figure 8 shows an axial cross-section of one section of an internal balloon sheath 800 based on one aspect of the present disclosure. The sheath 800 has similar features to the sheath 600 in Figure 6, except that the balloon 820 in the sheath 800 is positioned along the sheath body 810 and has a distal end as in Figure 6. It is not located there. In Figure 8, balloon 820 is shown as non-compliant (and in a deflated state), but it should be understood that balloon 820 may be configured in any of the manner described above. Balloon 820 is farther from the opening 835 At the 1st and proximal positions, it is attached to the inner surface 815 of the sheath body 810 by thermal or solvent bonding. As described with respect to the sheath 600, the opening 835 inflates the balloon 820. To inflate the balloon, the expansion tube 830 is fluidly connected to the balloon 820. These connections are crucial to prevent the balloon from rupturing. For reference, see the cross-section in Figure 8. The configuration depicted in the figure is such that at least (i) the balloon 820 is along the length of the sheath body 810. (ii) where it is located; how the end of the balloon 820 is attached to the inner wall of the sheath body 810; and (iii) the position of the opening 835 relative to the length of the balloon 820; In some cases, the balloon may extend along the entire length of the sheath body, and in certain embodiments, the balloon may be inflated directly from the hub without requiring an inflation lumen within the sheath body.

[0056] In some embodiments, an expansion lumen, as described with reference to Figures 6-8, may be formed within the sheath body by using a mandrel during the lamination and reflow of the sheath body. Since the mandrel does not dissolve into the layers that make up the sheath body 610, The expansion lumen can be removed after reflow, leaving an expansion lumen for the expansion fluid to pass to the balloon. The opening for the fluid connection of the expansion lumen to the balloon may also be formed using a similar process, in which a radially oriented mandrel is positioned within the sheath body before reflow and then removed. Alternatively, the opening may be punched out of the sheath body after the expansion lumen has been formed. However, it will be recognized that complex machining may be required for the formation of the expansion lumen and opening due to the dimensions and tolerances involved.

[0057] Figures 9A-9B illustrate an exemplary internal balloon sheath 900 based on one aspect of the present disclosure. The internal balloon sheath 900 comprises a balloon sleeve 910 and an access sheath 920, and the balloon The balloon sleeve 910 comprises an inline sleeve that can be inserted into the lumen of the access sheath 920. The internal balloon sheath 900 is configured to allow the catheter-type medical device 930 to pass through it. The balloon sleeve 910 comprises a sleeve body 912 through which the lumen 911 runs. The distal end of the balloon sleeve 910 comprises an inflatable balloon 915. The balloon 915 may be attached using any of the attachment means described above. It may be attached to the outer surface of the distal end of the Rune Sleeve 910. Any type of balloon ( As described above, the terms compliant, non-compliant, axisymmetric, and asymmetric may be used in conjunction with the embodiments of this disclosure.

[0058] The proximal end of the balloon sleeve 910 may be provided with a valve 913 that seals the lumen 911 of the balloon sleeve 910 against the entry of external fluids. In some embodiments, the valve 913 may be, for example, hemostatic. A valve may be provided. The proximal end of the balloon sleeve 910 may also have a side port 914 that is in fluid contact with the lumen 911 and / or the balloon 915. In certain embodiments, the side port 914 may be in fluid contact with the balloon 915 via an expansion lumen formed in the sleeve body 912, such as the expansion lumen 650 shown in Figure 6. The side port 914 is similar to the side ports 525, 530 discussed above with respect to Figure 5A. In some embodiments, there may be multiple side ports on the balloon sleeve 910. In addition, in certain embodiments Furthermore, the proximal end of the side port 914 may be connected to a connector to prevent backflow of fluid, such as a Tuohy-Borst adapter.

[0059] In some embodiments, the balloon sleeve 910 is connected to the catheter 930. Even if the catheter 930 of the medical device is aligned axially so that it is in line with the device... In this configuration, the balloon sleeve 910 is a medical device as depicted in Figure 9A. The vice is arranged coaxially around the catheter 930. The balloon sleeve 910 moves or moves along the catheter 930 into the access sheath 920. While enabling this, it may fit tightly around the catheter 930. In some embodiments, the catheter 930 of the medical device may be pre-inserted into the lumen 911 of the balloon sleeve before use. In some embodiments, the catheter of the medical device may be manufactured with the balloon sleeve 910 arranged coaxially around the catheter 930.

[0060] Access sheath 920 is similar to the sheath described above with respect to Figures 4-8. S920 has a proximal end 924, a distal end 926, and a lumen 928 running between the proximal and distal ends. It comprises a sheath body 922. The proximal end 924 may be connected to a hub 940. The hub 940 is similar to the hub 520 depicted in Figure 5A, and is positioned thereon It may have at least one side port 942. The side port 942 is, for example, for irrigation. For flushing purposes, the lumen 928 of the access sheath 922 may be in fluid contact with it.

[0061] As mentioned above, the distal end of an intravascular medical device typically has the largest diameter compared to the catheter body. The sheath body 922 is configured such that the diameter of the lumen 928 is sufficiently large so that the distal end of the medical device can pass through it. In addition, the lumen 928 is configured such that the balloon sleeve 910 can pass through it, i.e., the lumen 928 is larger than the outer diameter of the balloon sleeve 910. It may be configured to have a larger diameter. In certain embodiments of this disclosure, the diameter of the lumen 928 is such that when the balloon sleeve 910 is inserted into the lumen 928 of the access sheath 920, a space 950 is created between the outer surface of the balloon sleeve body 912 and the inner surface of the sheath body 922. The diameter is such that. This space is similar to the one described above with respect to Figure 4. In this embodiment, the axial length of the balloon sleeve 910 may be longer than the axial length of the access sleeve 920. This allows at least a portion of the proximal end of the balloon sleeve 910 to be in contact with the hub 940 of the access sheath 920 when the balloon sleeve 910 is inserted into the access sheath 920. It protrudes. This allows for easy access to the proximal end of the balloon sleeve 910 (and the side port attached thereto) for purposes such as inflating the balloon 915.

[0062] Figure 9B shows a cross-section of the internal balloon sheath 900 when the balloon sleeve 910 is moved along the catheter 930 of the medical device into the lumen 928 of the access sheath 920. The tubular 910 has a lumen 928 through the side port 942 for irrigation fluid (e.g., saline or water). It is thought that after being flushed, it is positioned within the access sheath 920. In Figure 9B, the balloon 915 is shown in an inflated state. The balloon 915 may be inflated with an inflation fluid provided through the side lumen 914. (Not shown in Figure 9A) However, this was done via an expansion lumen formed within the balloon sleeve body 912. It is also possible. As mentioned above, when balloon 915 is inflated, (for example, via a syringe) (The balloon material may be delivered to balloon 915 by the pressure from the inflation fluid.) It may deform, which will create a seal against the catheter body 930, thereby The lumen is closed to anything entering through the arterial incision (e.g., blood and blood clots). When the balloon 915 is inflated, it applies radial tensile forces to the inner surface of the access sheath body 922 from all directions, thereby effectively fixing the position of the balloon sleeve 910 relative to the access sheath 920. In some embodiments, as described with reference to Figure 13 in the following sections, the access sheath 920 is made of a material that deforms under the influence of such compressive forces. It may also be possible. In addition, when the balloon 915 is inflated, it can be used to protect the catheter from all directions around the catheter. A radial compressive force is also applied to the body 930, thereby effectively gripping and locking the catheter body 930 in place.

[0063] Figure 10A shows a cross-section 1000 of the inline internal balloon sheath 900 drawn along the line Y-Y' in Figure 9B before the balloon 915 is inflated. Figure 10A shows the balloon sleeve 910 arranged coaxially around the catheter body 930 of the medical device. As mentioned, the balloon sleeve 910 fits tightly around the catheter body 930 while being slidable on the catheter body 930. The balloon sleeve 910 is inserted into the lumen 928 of the access sheath 922. As previously stated, in some embodiments, the balloon sleeve 912 may have an inflation lumen that fluidly connects an inflation port 914 on the proximal end of the balloon sleeve 910 to the balloon 915 for inflating the balloon. Figure 10A shows the balloon sleeve The image shows the space 950 between the outer surface of the balloon sleeve body 912 and the inner surface of the sheath body 922 after the hub 910 has been inserted into the lumen 928 of the access sheath 920. The balloon 915 is a balloon Although it is illustrated as being arranged coaxially with sleeve 912, balloon sleeve Any orientation of the balloon 915 relative to the body 912 may be used. For example, the balloon 915 is It may be positioned on at least one portion of the outer surface of the balloon sleeve body 915.

[0064] Figure 10B shows a cross-section 1050 of the inline internal balloon sheath 900 drawn along the line Y-Y' in Figure 9B after the balloon 915 has been inflated. During the inflation of the balloon 915, the balloon material is subjected to pressure from the inflation fluid (which may be delivered to the balloon 915, for example, via a syringe). It may undergo elastic deformation, which will result in a seal against the inner surface of the access sheath 922. As shown in the figure, when the balloon 915 inflates, it occupies the space 950, thereby preventing fluid (e.g., blood and blood clots) from entering the lumen 928 of the access sheath 920. As will be understood throughout this disclosure, “sealed” should be taken to mean substantially sealing the lumen to exclude any amount of fluid flow that could enable the formation of a blood clot. When the balloon 915 inflates, it occupies the access sheath body from all directions. A radial tensile force is applied to the inner surface of 922, thereby effectively fixing the position of the balloon sleeve 910 relative to the access sheath 920. In some embodiments, the following sectors As explained in relation to Figure 13, the access sheath 920 is under the influence of such compressive forces. It may be made of a material that deforms under vibration. In addition, when the balloon 915 is inflated, the catheter A radial compressive force is also applied to the catheter body 930 from all directions, thereby The catheter body 930 is effectively gripped and locked in place.

[0065] Figures 11A-11B illustrate an exemplary internal balloon sheath 1100 based on one aspect of the present disclosure. The internal balloon sheath 1100 comprises a balloon sleeve 1110 and an access sheath 1120. Unlike the balloon sleeve 910 in Figures 9A-9B, the balloon sleeve 1100 shown in Figures 11A-11B is not positioned inline with the catheter of the medical device. The balloon sleeve 1100 comprises a sleeve body 1112; the sleeve body 1112 has a balloon 1115 located at its distal end 1113. In some embodiments, the balloon 1115 may be located at any point along the sleeve body 1112. The sleeve body 1112 may have a central lumen that is fluidly connected to the balloon 1115 for inflation. The balloon 1115 may be oriented in any manner with respect to the balloon sleeve body 1112 used. For example, the balloon 1115 may be arranged symmetrically around the sleeve body 1112, or the balloon 1115 may be arranged asymmetrically around the sleeve body 1112. Furthermore, the balloon 1115 may be attached to the outer surface of the distal end 1113 of the sleeve body 1112 using any of the attachment means described above. Any type of balloon (compliant, non-compliant, axially symmetric, asymmetric, as described above) may be used with embodiments of the present disclosure.

[0066] The proximal end of the balloon sleeve 1110 may be connected to a sleeve hub 1116, and the sleeve hub 1116 may be provided with at least one side port 1117. The side port 1117 may also be in fluid contact with the central lumen and / or balloon 1115 within the sleeve body 1112. Good. As described above, the side port may be used as an inflation port to inflate the balloon 1115 with inflation fluid after the sheath 1100 has been positioned within the patient's arterial incision site. The hub 1116 may have a backflow prevention device for the fluid, such as a Tuohy-Borst adapter. A connector port 1118 for connecting an additional adapter may also be provided.

[0067] Access sheath 1120 is similar to access sheath 920 in Figure 9A as described above. The access sheath 1120 comprises a sheath body 1122 having a proximal end 1124, a distal end 1126, and a lumen 1128 running between the proximal and distal ends. The proximal end 1122 may be connected to a hub 1140. The hub 1140 is similar to the hub 520 depicted in Figure 5A, and It may also have at least one side port 1142 positioned above it. The access port 1142 is for, for example, irrigation and flushing of the lumen 1128, access sheath 11 The 20 tubular lumens 1128 may be in fluid communication.

[0068] The sheath body 1120 is configured such that the diameter of the lumen 1128 is sufficiently large to allow the distal end of the medical device to pass through. In addition, the lumen 1128 is configured such that both the balloon sleeve 1110 and the catheter body 1130 of the medical device can pass through it, i.e., the lumen 1128 has a diameter larger than the combined outer diameter of the sleeve body 1112 and the catheter body 1130. In certain embodiments of this disclosure, the diameter of the lumen 1128 is such that when both the catheter 1130 and the balloon sleeve 1110 of the medical device are inserted into the lumen 1128 of the access sheath 1120, a space 1150 is created between the outer surface of the balloon sleeve body 1112, the outer surface of the catheter body 1130, and the inner surface of the sheath body 1122 (see Figure 12A below). This space is similar to that described above with respect to Figure 4.

[0069] In some embodiments, the axial length of the balloon sleeve 1110 may be longer than the axial length of the access sleeve 1120. This allows at least the proximal end of the balloon sleeve 1110 to be longer when the balloon sleeve 1110 is inserted into the access sheath 1120, as shown in Figure 11B. A portion of the access sheath 1120 protrudes from the hub 1140. This allows for easy access to the proximal end of the balloon sleeve 1110 (and the side port attached thereto), for example, to inflate the balloon 1115.

[0070] Figure 12A shows a cross-section 1200 of the internal balloon sheath 1100 drawn along the line Z-Z' in Figure 11B before the balloon 1115 is inflated. The balloon sleeve 1110 is inserted into the lumen 1128 of the access sheath 1120 and comprises a sleeve body 1112; the sleeve body 1112 has an inflation lumen formed through it and in fluid communication with the balloon 1115. In some embodiments, the balloon sleeve body 1112 may comprise an inflation lumen that fluidly connects an inflation port 1117 on the proximal end of the balloon sleeve 1112 to the balloon 1115 for inflating the balloon. Figure 12A shows the inner surface of the sheath body 1120 and the outer surface of the catheter body 1130 after the medical device and the balloon sleeve 1110 have been inserted into the lumen 1128 of the access sheath 1120. The space 1150 between the outer surface of the balloon sleeve 1110 and the balloon 1115 is shown. The balloon 1115 is shown as being arranged concentrically around the balloon sleeve body 1112, but any orientation of the balloon 1115 relative to the balloon sleeve body 1112 may be used. For example, the balloon 1115 is positioned on at least one portion of the outer surface of the balloon sleeve body 1115. It may be done.

[0071] Figure 12B shows a cross-section 1250 of the internal balloon sheath 1100 drawn along the line Z-Z' in Figure 11A after the balloon 1115 has been inflated. When the balloon 1115 is inflated, the balloon material may be elastically deformed by the pressure from the inflation fluid (which may be delivered to the balloon 1115, for example, via a syringe), which creates a seal against the catheter body 1130. As seen in the figure, when the balloon 1115 is inflated, it occupies the space 1150, thereby preventing the entry of fluid (e.g., blood and blood clots) into the lumen 1128 of the access sheath 1120. As will be understood throughout this disclosure, “seal” should be taken to mean substantially sealing the lumen to exclude any amount of fluid flow that could allow the formation of a blood clot. When the balloon 1115 is inflated, it exerts radial tensile forces on the inner surface of the access sheath body 1122 from all directions, thereby effectively fixing the position of the balloon sleeve 1110 relative to the access sheath 1120. In addition, when the balloon 1115 inflates, it applies a radial compressive force to the catheter body 1130, pressing it against the inner surface of the access sheath 1120, thereby effectively gripping and locking the catheter body 1130 in place. In some embodiments, the access sheath 1120 may be made of a material that deforms under the influence of such tensile forces, as described with reference to Figure 13 in the following sections.

[0072] Figure 13 illustrates an exemplary internal balloon sheath 1300 based on one aspect of the present disclosure. The balloon sheath 1300 comprises an inflatable balloon sleeve 1310 and an access sheath 1320. The balloon sleeve 1310 may be similar to the balloon sleeves 910 and 1110 described above with respect to Figures 9-12. The sleeve 1310 comprises a sleeve body 1311 having a proximal end 1312 and a distal end 1313. An inflatable balloon 1315 may be attached to the distal end 1313 on the outer surface of the sleeve body 1311. The proximal end 1312 may be connected to a hub 1316, and an inflation port 1314 may be provided on the hub 1316. The inflation port 1314 is configured to fluidize with the balloon 1315 such that the input of inflation fluid at the inflation port 1314 inflates the balloon 1315. In some embodiments, the inflation port 1314 may be fluidized to the balloon 1315 via an inflation lumen formed in the wall of the sleeve body 1311.

[0073] The balloon 1315 may be oriented in any manner relative to the balloon sleeve body 1311. For example, the balloon 1315 may be arranged symmetrically around the sleeve body 1311, or it may be arranged asymmetrically around the sleeve body 1311. Furthermore, the balloon 1315 may be attached to the outer surface of the distal end 1313 of the balloon sleeve 1310 using any of the attachment means described above. Any type of balloon (compliant, non-compliant, axially symmetric, asymmetric, as described above) may be used in conjunction with the embodiments of this disclosure.

[0074] Similar to the balloon sleeve 1310, the access sheath 1320 is described above with respect to Figures 9-12. Access sheaths 920 and 1120 may be similar. Access sheath 1320 has a proximal end 1322 and a far end It comprises a sheath body 1321 having a proximal end 1323 and a lumen 1324 running between the proximal and distal ends. The proximal end 1322 may be connected to a hub 1325. The hub 1325 may have at least one side port (not shown) positioned thereon, and its side The doport may be in fluid communication with the lumen 1324 of the access sheath 1320, for example, for irrigation and lumen flushing.

[0075] The sheath body 1321 is sized such that the diameter of the lumen 1324 is sufficiently large to allow the distal end of the medical device to pass through. In addition, the lumen 1324 may be configured to allow the passage of the balloon sleeve 1310. In certain embodiments of this disclosure, the diameter of the lumen 1324 is such that a space is created between the outer surface of the balloon sleeve body 1311 and the inner surface of the sheath body 1321 when the balloon sleeve body 1311 (positioned inline with the catheter 1330 of the medical device) is inserted into the lumen 1324 of the access sheath 1320. Figure 13 depicts the balloon sleeve 1310 as being inline with the catheter 1330 of the medical device (as shown in Figures 8-9), but alternatively, the balloon sleeve 1310 may be adjacent to the catheter 1330 of the medical device (as shown in Figures 10-11).

[0076] As described in the above embodiment, when the balloon 1315 is inflated with fluid, the balloon occupies the space between the outer surface of the balloon sleeve body 1311 and the inner surface of the sheath body 1321, thereby sealing the lumen 1324 from the entry of blood from the patient's arterial incision. In the embodiment depicted in Figure 13, the sheath body 1321 can be elastically deformed such that when the balloon 1315 expands in size, the stretching force from the inflated balloon 1315 also causes deformation of the sheath body 1321 adjacent to the balloon. This causes a bulge in the access sheath 1320, which prevents axial movement of the internal balloon sheath 1300 after insertion into the patient's body. Therefore, in addition to the sutures or tape that fix the position of the hub 1325 to the patient's skin 1305, the bulge in the access sheath 1320 when the balloon 1315 is inflated locks the position of the sheath 1300, thereby further securely fixing the sheath 1300 to the patient.

[0077] In all the embodiments described above, the sheath may include a rigid material. The rigid material is The material may be polyethylene (PE) or polyurethane (PU). In certain embodiments, the rigid material may have an elastic modulus of about 40 ksi (285 MPa). Ksi is a unit of pressure, representing thousands of pounds per square inch. In some embodiments, the rigid material contains a radiopaque filler such as bismuth oxychloride or barium sulfate at a concentration of 5% to 40% by weight. In some embodiments, the rigid material is polyether block mesh. Polyethylene materials (such as PEBAX or PebaSlix®), polytetrafluoroethylene The rigid material may be any one of the following: ethylene (PTFE) material, high-density polyethylene (HDPE) material, medium-density polyethylene (MDPE) material, low-density polyethylene (LDPE) material, polyether ether ketone (PEEK), polyether block amide (such as PEBAX), and nylon. In certain embodiments, the rigid material is a crack-resistant material. In some embodiments, the rigid material may also be a material with a low coefficient of friction. In addition, in all embodiments described above, the hub may also include any one of the rigid materials described above. Generally, The strength of a sheath depends on the modulus of elasticity of the rigid material, as well as the thickness of the sheath wall. For rigid materials with a lower modulus of elasticity, the resulting sheath will require a thicker wall. Conversely, rigid materials with a higher modulus of elasticity allow for a sheath with a thinner wall thickness.

[0078] In all embodiments described above, the sheath body may comprise a coaxial layered structure as described in U.S. Provisional Patent Application No. 62 / 777,598, the entirety of which is incorporated herein by reference. Each layer of the structure may comprise a different polymer. Layering of polymers improves the strength of the sheath while maintaining flexibility, making it ideal for intravascular applications as detailed herein. The polymers include PEBAX® 7233SA, PEBAX® 7033SA, PEBAX® 6333SA, PEBAX® 5533SA, and PEBAX® The material may include either Trademark) 3533SA or PEBAX® 2533SA. In other embodiments, the sheath may comprise various compartments arranged in a continuous pattern, each containing a different polymer. Such arrangements may provide varying mechanical strengths along the length of the sheath body. The polymer may include any of the aforementioned rigid materials. In certain embodiments, the sheath body may be reinforced with braids or coils to improve mechanical strength; these structures may be made from any of the aforementioned rigid materials. It is constructed of wire. In some embodiments, the structure of the sheath body may be reinforced by laser processing the tubular sheath body with features that increase its strength.

[0079] Furthermore, in all the embodiments described above, the balloon may include a flexible material. The flexible material may include a polyethylene material or a polyurethane material with an elastic modulus of about 40 ksi. In some embodiments, the material may be one of urethane, polyurethane, polyethylene, polypropylene, polyethylene terephthalate (PET), polyvinyl chloride (PVC), polyethylene, cross-linked polyethylene, polyether block amide (PEBA), and nylon. In some embodiments, the balloon sleeve is also as described above. It may also contain flexible materials such as those described above.

[0080] In addition, in all the embodiments described above, the hub may include a rigid material. The rigid material may be a polyethylene or polyurethane material with an elastic modulus of about 40 ksi. In some embodiments, the rigid material may be one of high-density polyethylene (HDPE), medium-density polyethylene (MDPE), low-density polyethylene (LDPE), polyether ether ketone (PEEK), and polyether block amide (such as PEBAX). In certain embodiments, the rigid material is a crack-resistant material. In some embodiments, the rigid material may also be a material with a low coefficient of friction.

[0081] In all the embodiments described above, a coating may be applied to the balloon to reduce friction as the interventional device passes through the internal balloon sheath. In certain embodiments, the coating may be hydrophilic or hydrophobic. In some embodiments, the thickness of the coating may be varied to achieve the desired inflation characteristics of the balloon. In addition, in all embodiments described above, the inner surface of the sheath may be pre-treated to improve the likelihood of bonding with the balloon. Such pre-treatment may include, but is not limited to, plasma activation or corona treatment. Alternatively, or in addition to the aforementioned coatings, the catheter medical device itself may be coated before insertion into the internal balloon sheath.

[0082] In addition, in all the embodiments described above, the sheath body may further comprise a distal tip made of a softer material than that used for the sheath body; that is, the distal tip may contain a material having a lower modulus of elasticity than that used for the sheath body. In some embodiments, the distal tip may be angled to assist in inserting the sheath into the patient's arterial incision. Such a distal tip may provide a seal on a smaller diameter catheter. Providing a seal on the catheter prevents blood from entering the sheath body and clotting. In certain embodiments, the distal tip contains a radiopaque filler such as bismuth oxychloride or barium sulfate at a concentration of 5% to 40% by weight. You may have it.

[0083] Figure 14 shows one of the balloon sheaths described above, based on one aspect of this disclosure. An exemplary method 1400 for fabricating an internal balloon sheath is illustrated. Method 1400 begins with step 1410 in which a sheath body is made available for fabrication. The sheath body may be provided by extrusion or lamination. As described above, the sheath body has a longitudinal axis and comprises an open proximal end, an open distal end, an outer surface, and an inner surface defining a lumen between the proximal and distal ends. In some embodiments, the method may include a step of fabricating a tubular sheath. In certain embodiments, the method may include a step of fabricating a sheath having a diameter larger than the outer diameter of the distal end of a catheter-type intravascular medical device, such as a cardiac pump, in order to allow the medical device to pass through the lumen of the sheath body.

[0084] In certain embodiments, the method may include a step of fabricating a sheath body which may have a coaxially stacked layered structure. Furthermore, in some embodiments, the sheath body may have structural reinforcements such as coils or braids. Such layered and / or reinforced body structures allow the sheath to withstand greater compressive forces, such as those experienced when positioning the internal balloon sheath within the patient's arterial incision. In some embodiments, the structure of the sheath body may be reinforced by laser processing a tubular sheath body with features that increase its strength. In certain embodiments, the inner surface of the sheath body may be pre-treated (e.g., via plasma activation or corona treatment) to improve the likelihood of bonding with the balloon.

[0085] The method then proceeds to step 1420, in which an inflatable balloon is provided within a sheath body. In some embodiments, the balloon is provided by extrusion or blow molding. In certain embodiments, the method includes a step of attaching the balloon to the inner wall of the sheath body, wherein the balloon is within the inner diameter of the sheath body. In some embodiments, the method further includes a step of attaching the balloon to a balloon sleeve that can be inserted into the lumen of the sheath body. In some embodiments, the method includes a step of attaching a balloon that extends along the entire length of the sheath body. In other embodiments, the method includes a step of attaching a balloon that extends along only a portion of the length of the sheath body. In some embodiments, the method includes a step of attaching the balloon to only a portion of the inner surface of the sheath body, such as the distal end of the sheath body. In other embodiments, the method includes a step of attaching the balloon to the inner surface of the sheath body (or the outer surface of the balloon sleeve) along the entire length of the balloon. Furthermore, in some embodiments, the method includes a step of attaching the balloon to the inner surface of the sheath body (or the outer surface of the balloon sleeve) along the entire length of the balloon. The method includes the step of attaching the balloon along the entire circumference of the sleeve. In another embodiment, the method includes the step of attaching the balloon along at least a portion of the circumference of the sheath body (or balloon sleeve).

[0086] In addition, in some embodiments, the method includes the step of attaching a balloon that is inline (i.e., radially symmetrical with respect to) the catheter body of a medical device passing through the lumen of a sheath. In other embodiments, the method includes the step of attaching a balloon that is radially asymmetrical with respect to the catheter body of a medical device passing through the lumen of a sheath.

[0087] Figure 15 shows one of the balloon sheaths described above, based on one aspect of this disclosure. An exemplary method 1500 using an internal balloon sheath is illustrated. Method 1500 begins in step 1510 in which the internal balloon sheath is positioned within the patient's arterial incision. As previously mentioned, any of the sheaths described above may have a tip formed on the patient-facing end of the sheath body. Such a tip may be angled to assist in insertion into the patient's body. In some embodiments, the sheath body may have a laminated structure that can withstand large compressive forces, such as those used to insert the sheath into the patient's body, without kinking, bending, or buckling. In certain embodiments, a dilator may be inserted into the lumen of the sheath before insertion into the patient's body. The dilator assists in positioning the sheath in areas of the patient's body that would be difficult to penetrate with the sheath alone. Once inserted, the dilator is removed from the lumen of the sheath.

[0088] In step 1520, the catheter-type medical device is inserted into the lumen of the sheath. The medical device is advanced into the lumen of the sheath body until it exits the distal end of the sheath and is then positioned within the patient's arterial incision. In some embodiments, the physician may manipulate the position of the medical device by grasping the hub attached to the proximal end of the catheter body of the medical device. Once in the desired position, the catheter hub may be connected to the hub of the sheath located on the patient's outer surface.

[0089] In some embodiments, the sheath may comprise an internal balloon attached to the inner surface of the sheath body, as described above. In other embodiments, the balloon may be located on an additional balloon sleeve arranged to slide along the catheter body of the medical device. Once the sheath is in a predetermined position and the medical device is inserted into the patient's arteriotomy, the balloon sleeve may slide along the catheter body to a predetermined position. The balloon sleeve is positioned between the inner surface of the sheath body and the outer surface of the catheter body. Although omitted here for brevity, various configurations and attachments of the internal balloon to the sheath and / or balloon sleeve described above are applicable to Method 1500.

[0090] As described above, a space may exist between the inner surface of the sheath body and the outer surface of the catheter body. To prevent blood stagnation and coagulation during the positioning of the medical device, once the medical device is positioned within the patient's arterial incision, the method of the present invention may optionally include a step of flushing the lumen (and thus the space) of the sheath body with an irrigation fluid, such as saline or water. Such an irrigation fluid may be supplied to the lumen via an irrigation side port fluid-connected to the lumen, as described above.

[0091] In step 1530, the balloon is inflated with an inflation fluid within the lumen of the sheath, thereby fluidically sealing the lumen and the space between the inner surface of the sheath body and the outer surface of the catheter body. As will be understood throughout this disclosure, “seal” means substantially sealing the lumen to exclude any amount of fluid flow that could allow the formation of a blood clot. This should be understood as meaning sealing. The inflation fluid may include, for example, saline solution, air, or water. Such inflation fluid may be supplied to the balloon via an inflation side port fluid-connected to the balloon, as described above. In some embodiments, an inflation lumen may be provided within the sheath body to deliver the inflation fluid to the balloon.

[0092] When the balloon inflates, it forms an interference fit with the inner surface of the sheath body and the outer surface of the catheter body, thereby preventing axial movement of the catheter body. In this way, the balloon effectively locks the medical device in place after inflation. In certain embodiments, the inflation of the balloon also causes elastic deformation of the sheath body, thereby causing the sheath body adjacent to the inflated balloon to stretch and bulge within the patient's arterial incision site. Such bulging further fixes the position of the internal balloon sheath within the patient's vascular structure during use of the medical device, thereby ensuring its secure fixation.

[0093] If desired, the different steps discussed herein may be performed in different orders and / or simultaneously with each other. Furthermore, if desired, one or more of the steps described above may be optional or in combination.

[0094] The foregoing is merely illustrative of the principles of this disclosure, and the devices and methods of the present invention may be implemented in ways other than those described herein, which are presented for illustrative purposes only, not limitation. It should be understood that, although the devices and methods disclosed herein are shown for use in the manufacture of internal balloon sheaths, they may also be applied to other systems where a single-diameter, sealable sheath for insertion into a patient's vascular structure is required during an intravascular procedure.

[0095] Those skilled in the art will be able to conceive of variations and modifications after reviewing this disclosure. The features of this disclosure can be combined in any combination with one or more other features described herein. This may also be implemented in subcombinations (including multiple dependent combinations and subcombinations). The various features described or illustrated above, including their components, may be combined or integrated into other systems. Furthermore, certain features may be omitted or not implemented.

[0096] Examples of changes, substitutions, and modifications are verifiable to those skilled in the art and can be made without departing from the scope of the information disclosed herein. All references herein are incorporated by reference in their entirety and constitute part of this application.

Claims

1. A tubular sheath body having a vertical axis, a proximal end, a distal end, an outer surface, and an inner surface that defines a lumen for the passage of a catheter device between the proximal and distal ends, and Balloon sleeve with an inflatable balloon attached. An introducer sheath assembly comprising, The balloon sleeve is configured to surround and slide over a portion of the catheter device for insertion of the sheath body into the lumen, so that when the inflatable balloon is inflated, the distal end of the inflatable balloon is aligned with the distal end of the sheath body, and the inflatable balloon forms a fluid seal between the distal end of the sheath body and the catheter device. The fluid seal is configured to prevent fluid from entering the distal end of the sheath body between the sheath body and the catheter device. The aforementioned introducer sheath assembly.

2. The introducer sheath axle according to claim 1, wherein the balloon is configured to prevent axial movement of the catheter device relative to the sheath body by forming an interference fit between the catheter device and the inner surface of the sheath body when inflated. Swertia japonica.

3. The introducer sheath assembly according to claim 1, wherein the length of the inflatable balloon is configured such that the proximal end of the inflatable balloon is aligned with the proximal end of the sheath body when the balloon sleeve is inserted into the lumen of the sheath body, so that the distal end of the inflatable balloon is aligned with the distal end of the sheath body.

4. The introducer sheath assembly according to claim 1, wherein the proximal end of the balloon sleeve is configured to remain proximal to the proximal end of the sheath body when the balloon sleeve is inserted into the lumen of the sheath body, such that the distal end of the inflatable balloon is aligned with the distal end of the sheath body.

5. The introducer sheath according to claim 1, wherein the balloon sleeve comprises an expansion lumen extending linearly or curvedly from the proximal end of the balloon sleeve to an expansion opening located within the inflatable balloon, and the expansion lumen is in fluid communication with the expansion opening. assembly.

6. The introducer sheath assembly according to claim 1, wherein the balloon is radially symmetric with respect to the longitudinal axis of the balloon sleeve when inflated.

7. The balloon is ring-shaped when inflated, according to the introducer sheath of claim 1. assembly.

8. The introducer sheath assembly according to claim 1, wherein the balloon is configured to lock the catheter device into position relative to the sheath body by applying a radial force to the catheter device when inflated.

9. The introducer sheath assembly according to claim 1, wherein the balloon is asymmetrical with respect to the longitudinal axis of the balloon sleeve when inflated.

10. The balloon exerts a force on the catheter device such that, when inflated, it pushes the catheter device toward a portion of the inner surface of the sheath body, thereby the catheter The introducer sheath assembly according to claim 9, wherein the device is configured to lock into a position relative to the sheath body.

11. The introducer sheath assembly according to claim 1, wherein the distal end of the sheath body comprises an elastic material that is softer than the material of the rest of the sheath body.

12. Claim 1, wherein the balloon sleeve is provided with a hub at the proximal end of the balloon sleeve. The introducedr sheath assembly as described.

13. The introducer sheath assembly according to claim 12, wherein the hub is equipped with a hemostatic valve.

14. The introducer sheath assembly according to claim 12, wherein the hub comprises an irrigation port configured to fluidize the space between the catheter device and the inner surface of the balloon sleeve, thereby enabling the space to be flushed with fluid before the balloon is inflated.

Images