Guide sheath with peeling irrigation holes

Abstract

A perfusion sheath with covered perfusion holes. The covers each have a pull tab attached thereto. The pull tabs are used to remove the perfusion hole covers from the perfusion holes when the perfusion sheath is deployed in the patient. The perfusion sheath is deployed in the patient through an arteriotomy. When deployed, the one or more pull tabs extend out of the arteriotomy. By applying a pull on the pull tab, the pull tab peels the perfusion hole covers off the perfusion holes. The perfusion sheath has multiple perfusion holes, each positioned to provide limb perfusion when the covers are removed for different depths of the arteriotomy. Once the perfusion sheath is deployed, the pull tab is pulled to remove the covers from selected perfusion holes that provide limb perfusion for the depth of the arteriotomy.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 338,207, filed May 4, 2022, and incorporated herein by reference. [Background technology]

[0002] background

[0002] Intravascular medical devices such as percutaneous pumps (e.g., the Impella 2.5™ system by Abiomed, Inc. of Danvers, Massachusetts), catheters, guidewires, balloon angioplasty catheters, delivery sheaths, and implant delivery systems are commonly used during minimally invasive procedures in the cardiovascular, cerebrovascular, and peripheral vasculature. Such medical devices can be introduced into a patient in a variety of ways. A blood pump assembly is introduced surgically or percutaneously during a cardiac procedure through the vascular system. Such endovascular procedures are minimally invasive. In one common technique, the pump assembly is inserted by a catheterization procedure through the femoral artery using a sheath, such as a peel-apart guiding sheath. The femoral artery is commonly used for such procedures primarily due to its ease of access. A sheath is inserted into the femoral artery through an arteriotomy (an access location within the artery) to create an insertion path for the pump assembly. A portion of the pump assembly is then advanced through the inner lumen of the guiding sheath and into the artery. Once the pump assembly is inserted, the directing sheath is removed, for example, by peeling it back. A repositioning sheath can then be advanced over the pump assembly and into the arteriotomy. Summary of the Invention [Problem to be solved by the invention]

[0003]

[0003] The guiding sheath must be large enough in diameter to accommodate an intravascular device, such as a blood pump. To date, the smallest available heart pump is the Impella 2.5 percutaneous heart pump, which has a motor with a diameter of about 12 Fr. The sheath must therefore be at least 13 Fr to introduce an Impella 2.5 pump. Other pumps and devices are larger than the Impella 2.5, such as the Impella CP pump with a motor with a diameter of about 14 Fr, and the Impella 5.0 pump with a motor with a diameter of about 21 Fr, or larger depending on the type of device. Even larger sheaths would be required for such devices. Unless otherwise indicated by the context or understood by one of ordinary skill in the art, terms such as "about" mean within ±20%. [Means for solving the problem]

[0004] overview

[0004] Described herein is a perfusion sheath for providing continuous distal limb perfusion. The perfusion sheath includes a sheath body having an outer surface and a lumen therethrough, at least one perfusion hole in the sheath body positioned between a proximal end of the sheath body and a distal end of the sheath body, a removable perfusion hole cover positioned over the at least one hole in the sheath body, and a pull tab attached to the removable perfusion hole cover. The lumen extends from the distal end of the sheath body to the proximal end of the sheath body. The perfusion hole provides fluid communication through the outer surface of the sheath body.

[0005] Also described herein is a method for providing continuous distal limb perfusion with a perfusion sheath as described above. The method includes providing a perfusion sheath as described above, creating a puncture through a patient's skin, inserting the perfusion sheath through the puncture and into the patient's artery through the arteriotomy, positioning the perfusion sheath within the artery for continuous distal limb perfusion, determining a perfusion hole to be drilled from a plurality of perfusion holes, and pulling the puller corresponding to the determined perfusion hole to peel off a perfusion hole cover associated with the puller and open the determined perfusion hole to provide continuous distal limb perfusion.

[0006] BRIEF DESCRIPTION OF THE DRAWINGS

[0006] The above and other objects and advantages will become apparent from the following detailed description considered in conjunction with the accompanying drawings in which like reference characters refer to like parts throughout. [Brief description of the drawings]

[0007] [Figure 1]

[0007] An isometric view of an exemplary sheath, in accordance with an embodiment of the present invention. [Diagram 2]

[0008] 2 shows a side cross-sectional view of the sheath of FIG. 1 positioned within the superficial femoral artery. [Diagram 3]

[0009] 2 shows a side cross-sectional view of the sheath of FIG. 1 positioned within the mid-femoral artery. [Figure 4]

[0010] 2 shows a side cross-sectional view of the sheath of FIG. 1 positioned within the deep femoral artery. [Diagram 5]

[0011] A side cross-sectional view of a sheath positioned within the femoral artery is shown. [Figure 6]

[0012] 6 shows a side cross-sectional view of the sheath of FIG. 5 positioned within the femoral artery with the perfusion hole cover peeled away from the sheath body. [Figure 7]

[0013] 2 shows a partial cross-sectional view of the sheath of FIG. 1 with a portion of the pull tab attached to the perfusion hole cover. [Figure 8]

[0014] 2 shows a partial cross-sectional side view of the sheath of FIG. 1 with a puller separating the perfusion hole covers. [Figure 9]

[0015] 2 shows a partial cross-sectional side view of the sheath of FIG. 1 with the irrigation hole cover peeled away from the sheath body by the pull tab. [Figure 10]

[0016] 2 is a flow diagram of a method for providing continuous distal limb perfusion using the sheath of FIG. 1. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0008] Detailed Description

[0017] The embodiments of the present disclosure will now be described in detail with reference to the drawings, in which the same reference numbers identify similar or identical elements. It should be understood that the disclosed embodiments are merely examples of the present disclosure, which may be embodied in various forms. Well-known functions or structures are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, the specific structure and function details disclosed herein should not be interpreted as limitations, but merely as a basis for the claims, and as a representative basis for teaching those skilled in the art to variously utilize the present disclosure in any appropriate detailed structure in practice.

[0009]

[0018] To provide an overall understanding of the systems, methods, and devices described herein, certain exemplary embodiments are described. Although the embodiments and features described herein are specifically described for use in connection with a percutaneous heart pump system, the components and other features outlined below may be combined with one another in any suitable manner and may be adapted and applied to other types of medical devices, such as stents, transcatheter aortic valve replacement (TAVR) delivery systems, cardiac treatments, and cardiac assist devices, including balloon pumps, cardiac assist devices implanted using surgical cutdowns, and other vascular devices.

[0010]

[0019] Although existing guiding sheaths generally work for device insertion, they have drawbacks. For example, due to their size, the guiding sheath can block the cross-sectional area of ​​the artery, thereby occluding the artery, thereby restricting downstream blood flow entirely. Restricted blood flow can be problematic for many reasons, including causing limb ischemia, which can result in intermittent claudication, leg numbness / weakness, and even limb loss. Impeded blood flow can also increase the risk of bleeding at the access site, as pressure increases at the arteriotomy due to restricted blood flow through the guiding sheath.

[0011]

[0020] Traditionally, limb ischemia is known as a "distal perfusion" problem, meaning that it often occurs downstream from the device access site. In this disclosure, the "distal" element is the portion of the element located furthest from the clinician, and "proximal" is the portion of the element closest to the clinician. In the case of a sheath deployed inside the patient, the sheath end deployed inside the patient's body is the "distal" end, while the handle or end held by the clinician located outside the patient is the "proximal" end.

[0012]

[0021] For relatively large medical devices (e.g., with a maximum outer diameter of 12 Fr or more), the guiding sheath (or repositioning sheath) used in combination with the medical device has an outer diameter that is substantially similar in size to the inner diameter of the artery or vessel in which the sheath is positioned. This match between the outer diameter of the sheath and the inner diameter of the artery or vessel prevents blood from flowing past the insertion site of the sheath. That is, blood flow may be blocked at a location upstream of the sheath aligned with the arteriotomy and prevented from flowing therethrough to a location downstream of the arteriotomy where the sheath is aligned. Moreover, for these relatively large medical devices, the guiding sheath (or repositioning sheath) used in combination with the medical device also requires a large access site, which may be difficult to close or control bleeding when inserting / withdrawing the sheath into / from the arteriotomy. Whether a relatively large or relatively small medical device is deployed, and therefore whether the guiding sheath or repositioning sheath is considered relatively large, may depend on the anatomy of a particular patient.

[0013]

[0022] Generally, the challenges described above are more pronounced for longer vascular procedures. Certain procedures in the catheter lab are short and therefore have less risk of limb ischemia. For example, procedures that typically require only 4-5 hours at most, with physicians periodically checking for distal (limb) perfusion, appear less risky than longer procedures. However, even with short procedures, professionals may not adequately monitor patients to ensure that their limbs have adequate perfusion or may miss warning signs of inadequate limb perfusion. Additionally, certain patients may be transferred to the ICU with the introducer or repositioning sheath remaining inside the patient for an extended period of time, from 1-14 days. In such cases, problems of vascular occlusion and associated limb ischemia, as well as bleeding at the access site, may worsen.

[0014]

[0023] A known intervention for an occluded femoral artery would be a bypass for arterial revascularization (i.e. femoral artery to femoral artery (i.e. femoral to femoral) bypass). The technique usually involves accessing with a small sheath (e.g. with a 4Fr catheter) the leg opposite the primary access location. Using a similar sheath to access a portion of the same leg distal to the primary access location, the two sheaths are connected together so that the femoral artery of the patient's primary access leg can be perfused using blood flow from the patient's opposite leg. However, such an invasive procedure carries other risks, including difficulty in accessing the femoral artery portion distal to the access location in the blocked leg (due to lack of flow, pressure, pulsatility, or a combination of these), additional allocation of resources (time, material use, and extra components), increased risk of infection, and other risks associated with multiple access sites. Another possible intervention involves the use of an extracorporeal membrane oxygenator (EMU) to perfuse blood distal to the access site. The first step would be the use of extracorporeal oxygenation (ECMO). However, ECMO intervention can present the same challenges as those presented by femoral artery-femoral bypass.

[0015]

[0024] Another possible intervention to address an access site with undesirable excessive bleeding would be the use of collagen or metal clips or sutures to close the access site, but such interventions are usually unplanned and rushed, and it can be difficult to see the proper location in view of ongoing bleeding at the access site.

[0016]

[0025] Thus, an improved sheath is needed for delivering intravascular devices and providing continuous perfusion of blood within the patient distal to the device.

[0017]

[0026] The disclosed systems, methods, and devices provide a guiding sheath for insertion into a patient's blood vessel (e.g., an artery, such as a femoral artery). The sheath includes a lumen configured for passage of a medical device. The sheath is also configured to allow fluid flow within the artery substantially unimpeded from reaching an area of ​​the patient downstream of the sheath, as described in more detail below.

[0018]

[0027] FIG. 1 illustrates an isometric view of an exemplary sheath 10 including one or more peel-away perfusion holes, according to one aspect of the present technology. The sheath 10 (which may be a guide sheath, peel-away sheath, etc.) is adapted for insertion into a patient's arteriotomy, which may be formed in the patient's femoral artery. The sheath 10 includes a sheath body 12 having an inner surface 14 and an outer surface 16, and extending between a distal end 18 and a proximal end 20. As illustrated in FIG. 1, the sheath body 12 is tubular with a generally circular cross-section. As used herein, "generally circular" is a shape that should appear more circular to a viewer than some other shape. It will be appreciated that other designs and configurations may be used for the sheath body 12 as deemed appropriate for the application.

[0019]

[0028] The sheath body 12 includes a lumen 22 extending between the distal end 18 and the proximal end 20 of the sheath body 12. The lumen 22 is open for the passage of a medical device, such as a percutaneous blood pump (not shown). An example of such a percutaneous pump is the Impella 2.5® system (Abiomed, Inc., Danvers, Massachusetts). Such a pump may have a catheter body generally with a pump head at the distal end of the catheter body and a handle at the proximal end of the catheter body. It will be understood that other percutaneous or intravascular medical devices can be used in conjunction with the present disclosure to deliver such devices through the sheath 10.

[0020]

[0029] The lumen 22 of the sheath body 12 has a generally circular cross-section having a diameter. The lumen 22 is designed and sized to allow the sheath 10 to be inserted and traversed within an artery (e.g., the femoral artery), i.e., the diameter of the lumen 22 is suitably smaller than the diameter of the artery. In addition, the lumen 22 is sized to allow a medical device to traverse the interior length of the lumen 22, i.e., the diameter of the lumen 22 is suitably larger than the maximum diameter of the medical device that will traverse therethrough. Thus, the diameter of the lumen 22 need only be slightly larger than the maximum cross-section of the medical device and slightly smaller than the diameter of the artery.

[0021]

[0030] Referring again to FIG. 1, the sheath 10 further includes at least one perfusion hole 24 formed along the length of the sheath body 12. While sheaths having only one peel-apart perfusion hole are contemplated, the sheaths described herein may have multiple peel-apart perfusion holes, which may provide additional advantages described below. FIG. 1 illustrates multiple peel-apart perfusion holes 24. Also illustrated are multiple perfusion hole covers 26 for covering the multiple perfusion holes 24, each cover having a pull tab attached thereto. The pull tab is biocompatible and extends outside the arteriotomy. Biocompatible materials are well known to those skilled in the arteriotomy and will not be described in detail herein. A pull tab 28 is provided for peeling the cover 26 from a selected perfusion hole. The pull tab 28 may be string, wire, filament, braid, lace, ribbon, etc., or any suitable linkage that can be attached or can be attached to the respective perfusion hole cover 26. The attached pull tabs 28 may extend along either the inside of the sheath body 12 or along the exterior surface 16 of the sheath body 12. As mentioned above, the pull tabs may extend outside of the patient's body when the sheath 10 is deployed within the patient.

[0022]

[0031] The introducer sheath is deployed with a perfusion hole cover 26 placed over each of the perfusion holes 24. As described in more detail herein, once the sheath is positioned within the patient's vasculature, a pull tab 28 attached to one of the perfusion hole covers 26 of a selected perfusion hole 24 is pulled, thereby removing the perfusion hole cover 26 to which the pull tab is attached from the selected perfusion hole, thereby opening the perfusion hole 24 in the side wall of the introducer sheath body 12. The multiple perfusion holes 24 are positioned laterally on the side wall of the introducer sheath body 12 and are purposefully spaced (e.g., evenly spaced) along the length of the sheath body 12. While the distance between the perfusion holes 24 may be any distance suitable for the application of the sheath 10, a distance of approximately 2.5 cm between each perfusion hole is one example of a distance at which a user may position the introducer sheath such that one of the perfusion holes is positioned within the blood flow pathway to support the desired perfusion. Each of the plurality of perfusion holes 24 may be formed in any shape, such as circular, oval, or square, and sized to allow blood to flow therethrough at an acceptable rate when the perfusion hole cover is removed from the perfusion hole. Each of the plurality of perfusion hole covers 26 is configured to be peeled (or removed) from the sheath body 12 to allow blood to flow therethrough, as described in more detail below.

[0023]

[0032] 2-4 illustrate the sheath 10 inserted into a patient's arteriotomy 40 with the sheath hub 30 seated on the surface of the skin 32. Once the sheath 10 is in place, the distal end 18 of the sheath 10 is axially aligned with the femoral artery 34. Each figure shows the patient's body tissue 32, as well as the femoral artery 34 with the skin insertion site 38 and the arteriotomy 40 where the sheath 10 is inserted into the femoral artery 34. The sheath 10 bends as it enters the arteriotomy 40. Once the sheath 10 is inserted into the artery 34, one or more of the perfusion holes may be aligned within the blood flow pathway within the lumen of the artery 34, while the remaining perfusion holes are not aligned with the blood flow pathway within the lumen of the artery 34, but are arranged on the surface of the arterial lumen or outside of the arterial lumen, as shown in FIGS. 2-4.

[0024]

[0033] After inserting the sheath 10 into the artery 34, the clinician or other caregiver may peel or remove the perfusion hole cover 26 aligned with the blood flow pathway within the lumen in the artery 34 to open the perfusion holes to allow blood to exit the more proximal portion of the sheath, thereby providing continuous distal limb perfusion. Once the perfusion holes are open, blood will flow from a location upstream of the sheath 10, through the distal end of the sheath, through the open perfusion holes, and into the arterial section on the other side of the arteriotomy.

[0025]

[0034] The multiple perfusion holes 24 are formed along the length of the sheath body 12 to meet the anatomical requirements of the patient (i.e., various placements account for different anatomical configurations of the patient with respect to the depth of the femoral artery relative to the skin surface). Specifically, the covered perfusion holes are placed such that a first perfusion hole is aligned with the lumen of the superficial femoral artery, a second perfusion hole is aligned with the lumen of the middle femoral artery, and a third femoral artery is aligned with the deep femoral artery. The depth is the length from the surface of the skin 32 to the inner lumen of the femoral artery 34. Depending on the depth of the femoral artery 34, as shown, for example, in FIGS. 2-4, one of the multiple perfusion holes 24 is placed substantially along the bend 42 of the sheath 10 as it transitions from an insertion angle at the arteriotomy 40 to a position where the sheath 10 is positioned coaxially within the lumen of the artery 34. Thereafter, perfusion holes located at (or near) the bend 42 in the sheath body 12 (i.e., perfusion holes located with the lumen of the artery so that blood can flow therethrough) may be opened (or uncovered) by pulling on the puller 28 / perfusion hole cover 26 corresponding to the perfusion hole at the bend 42 so that blood can flow from the sheath lumen 22 and out of the sheath body 12 through the perfusion holes and back into the artery 34, as shown by arrows A and B in Figures 5 and 6, thereby maintaining fluid flow within the artery 34. Specifically, the open perfusion holes allow blood to flow within the lumen 22 from the distal end 18 of the sheath 10 (the distal end of the sheath distal to the artery) through the open perfusion holes to the other side of the arteriotomy to maintain perfusion of the distal limb and prevent claudication of the distal limb.

[0026]

[0035] Each perfusion hole 24 is first covered with a peel-away perfusion hole cover 26, and a portion of a corresponding pull tab 28 is attached thereto, as shown in FIG. 7. To open a selected perfusion hole (i.e., a perfusion hole positioned at a depth such that the opening of the hole is aligned with the direction of blood flow, which may be the perfusion hole positioned closest to the bend in the sheath body 12), the pull tab 28 attached to the perfusion hole cover 26 corresponding to the selected perfusion hole 24 is pulled upward in a vertical direction indicated by arrow C at a first end of the perfusion hole cover 26. A portion of the pull tab 28 at the first (proximal) end of the perfusion hole cover is detached therefrom, as shown in FIG. 8. The pull tab 28 is then pulled by the clinician to peel away and uncover the perfusion hole 24. Specifically, as the pull tab 28 is pulled, the perfusion hole cover 26 is first detached from the second (distal) end 44 of the perfusion hole cover 26. Pull tab 28 is then pulled further (ie, with a pulling force) to peel perfusion hole cover 26 from the distal side of the perfusion hole to the proximal side of the perfusion hole, as indicated by arrow D in FIG.

[0027]

[0036] Referring again to Figures 2-4, the figures illustrate the positioning of the sheath 10 in each of the superficial, mid, and deep femoral arteries. In the shallow femoral artery (Figure 2), which is less than 2 cm deep from the surface of the skin 32, the multiple perfusion holes 24 are positioned such that the perfusion hole most proximal to the sheath hub 30 is positioned along the bend 42 of the sheath 10 when the sheath 10 is transitioned from the insertion angle at the arteriotomy 40 to a position where it is axially aligned with the lumen of the artery 34. In the mid femoral artery (Figure 3), which is 2 cm to 4.5 cm deep from the surface of the skin 32, the multiple perfusion holes 24 are positioned such that the middle perfusion hole is positioned along the bend 42 of the sheath 10 when the sheath 10 is transitioned from the insertion angle at the arteriotomy 40 to a position where it is axially aligned with the lumen of the artery 34. Finally, for deep femoral arteries greater than 4.5 cm below the surface of the skin 32 (FIG. 4), the perfusion holes 24 are positioned such that when the sheath 10 is transitioned from the angle of insertion at the arteriotomy 40 to a position where it is axially aligned with the lumen of the artery 34, the perfusion holes furthest from the sheath hub 30 are positioned along the bend 42 of the sheath 10. In some examples, ultrasound imaging may be used to determine the depth of the femoral artery for a particular patient. Alternatively or additionally, ultrasound imaging may facilitate placement of one of the perfusion holes 24 such that when open, the perfusion hole supports sustained distal limb perfusion. For example, in some embodiments, the perfusion holes and / or covers may be visible during ultrasound imaging, and when a particular perfusion hole is exposed by removing the cover, the user may be able to verify that the perfusion hole is properly positioned within the artery to support distal limb perfusion.

[0028]

[0037] Although a sheath 10 having one perfusion hole 24 (FIGS. 5 and 6) and a sheath 10 having three perfusion holes 24 (FIGS. 1-4 and 7-9) are shown in this disclosure, any number of perfusion holes can be formed along the length of the sheath body 12 of the sheath 10.

[0029]

[0038] To aid the clinician in opening the appropriate irrigation holes on the sheath body, each of the plurality of irrigation hole covers 26 may be differently colored and each of the plurality of pull tabs 28 has the same color as its corresponding irrigation hole cover 26. For example, with reference to Figures 2-4, the irrigation hole cover and corresponding pull tab located closest to the sheath hub 30 may be blue, while the irrigation hole cover and corresponding pull tab located farthest from the sheath hub 30 may be yellow.

[0030]

[0039] The perfusion hole covers 26 may be attached to the sheath 10 to cover the perfusion holes 24 using a variety of adhesive techniques. These techniques prevent leakage through the perfusion hole covers 26 and allow the perfusion hole covers 26 to be peeled (removed) from the sheath body 12. As illustrated, the perfusion hole covers 26 may be attached to the sheath body 12 with an adhesive designed to withstand high compressive forces but not shear loads so that the perfusion hole covers 26 can be peeled away from the sheath body 12. In other aspects, the perfusion hole covers may be heat bonded (heat fused) and perforated so that the perfusion hole covers can be peeled away under high loads. The perforations may be done by heat stamping or laser etching actuation.

[0031]

[0040] The sheath 10 may be made from one or more materials having properties suitable for a desired application, including strength, weight, stiffness, etc. The sheath is made from a flexible plastic that is a biocompatible polymer, such as thermoplastic polyurethane (TPU), nylon, polyether block amide (PEBA), expanded polytetrafluoroethylene (ePTFE), and mixtures thereof. In one particular embodiment, the sheath 10 is made from one of TPU, nylon, PEBA, and ePTFE.

[0032]

[0041] FIG. 10 illustrates a method 100 for providing continuous distal limb perfusion using a sheath 10 according to the present technology. In an initial procedure, in step 102, a clinician or other caregiver creates a puncture through the patient's skin and percutaneously inserts the sheath 10 through the puncture site and through the arteriotomy into the patient's artery. Additional steps may be performed by the clinician or caregiver between the puncture and arteriotomy on the one hand and the insertion of the sheath through the puncture and arteriotomy on the other hand. For example, the clinician or other caregiver may use a guidewire and a series of dilators to gradually enlarge both the puncture and the arteriotomy to fully accommodate the sheath 10, which may be a guiding sheath or a repositioning sheath. In step 104, the sheath 10 is advanced until its distal end 18 is positioned within the artery and the proximal end 20 of the sheath 10 is positioned outside the patient. After positioning the sheath 10, in step 106, the clinician determines which perfusion holes should be opened for continuous limb perfusion. Then, in step 108, the pull tab 28 corresponding to the selected perfusion hole 24 is pulled by the clinician to peel (remove) the cover 26 to which the pull tab 28 is attached from the sheath body 12 of the sheath 10. The now-opened perfusion holes 24 allow blood to flow through the sheath body 12 of the sheath 10 from a location upstream of the arteriotomy to a downstream vessel (downstream of the arteriotomy) of the patient, thereby achieving continuous limb perfusion.

[0033]

[0042] From the foregoing and with reference to the various figures, those skilled in the art will recognize that certain modifications can also be made to the present disclosure without departing from the scope of the present disclosure. Although some aspects of the present disclosure have been illustrated in the figures, the present disclosure is not intended to be limited thereto, but rather the present disclosure is as broad as the art allows, and the specification is intended to be read in the same manner. Thus, the above should not be construed as limiting, but merely as illustrative of certain aspects of the present technology.

[0034] Example Implementations

[0043] As previously mentioned, the perfusion sheaths described herein may be implemented in a variety of ways, and in that regard, the foregoing disclosure is intended to include, but is not limited to, the systems, methods, and combinations and subcombinations thereof described in the following categories of example implementations.

[0035]

[0044] In a first aspect, a perfusion sheath is described having a sheath body with an outer surface and a lumen therethrough, the lumen extending from a distal end of the sheath body to a proximal end of the sheath body. There is at least one perfusion hole in the sheath body positioned between the proximal end of the sheath body and the distal end of the sheath body, the perfusion hole providing fluid communication through the outer surface of the sheath body. There is also a removable perfusion hole cover positioned over the at least one hole in the sheath body, and a pull tab attached to the removable perfusion hole cover.

[0036]

[0045] In one aspect, the pull tab has a length such that when the sheath body is inserted into the arteriotomy, the pull tab extends outside the arteriotomy. In a further aspect, the pull tab is selected from the group consisting of string, wire, filament, braid, lace, and ribbon. In a still further aspect, the pull tab is a biocompatible material. According to any of the above aspects, the sheath body may have a plurality of perfusion holes, each perfusion hole having a removable cover attached thereto and a pull tab attached to each removable cover. According to any of the above aspects, the covers are attached to the perfusion holes using an adhesive or by heat fusion.

[0037]

[0046] In any of the above aspects, the sheath may be made from a flexible plastic. In a further aspect, the flexible plastic may be a biocompatible polymer. The biocompatible polymer may be selected from the group consisting of thermoplastic polyurethane, nylon, polyether block amide, expanded polytetrafluoroethylene, and mixtures thereof.

[0038]

[0047] In any of the above aspects, the pull tab may be attached to the perfusion hole cover from a proximal side of the perfusion hole cover to a distal side of the perfusion hole cover, the proximal side being positioned closer to the arteriotomy when the perfusion sheath is deployed within the patient than the distal side. In further aspects, the pull tab may be lightly attached to the perfusion hole cover on the proximal side of the perfusion hole cover and more firmly attached to the perfusion cover on the distal side of the perfusion hole cover such that when pulled, the pull tab separates from the cover on the proximal side before being pulled away from the perfusion holes on the distal side.

[0039]

[0048] In a further aspect, the sheath may have three perfusion holes, each positioned a selected distance from the proximal end of the perfusion sheath. In still a further aspect, the perfusion holes are positioned such that, when the perfusion sheath is inserted into a patient, one of the perfusion holes is positioned along a bend in the perfusion sheath when the sheath is translated from an insertion angle at the arteriotomy to a position in axial alignment with the lumen of the blood vessel into which the perfusion sheath is inserted.

[0040]

[0049] In further embodiments, the perfusion sheath may have a first perfusion hole having a location selected such that when the perfusion sheath is inserted into the arteriotomy, the perfusion hole is positioned within about 2 cm below the surface of the arteriotomy. In still further embodiments with a second perfusion hole, the second perfusion hole may have a location selected such that when the perfusion sheath is inserted into the arteriotomy, the perfusion hole is positioned between about more than 2 cm and about 4.5 cm below the surface of the arteriotomy. In embodiments where the perfusion sheath has a third perfusion hole, the third hole has a location selected such that when the perfusion sheath is inserted into the arteriotomy, the perfusion hole is positioned more than about 4.5 cm below the surface of the arteriotomy.

[0041]

[0050] In any of the above aspects, the pull tabs may be colored pull tabs. In further aspects, each pull tab may have a different color.

[0042]

[0051] In another aspect, a method for providing continuous distal limb perfusion is described herein. According to the method, a perfusion sheath is provided, the perfusion sheath having a sheath body having an outer surface and a lumen therethrough, the lumen extending from a distal end of the sheath body to a proximal end of the sheath body. The sheath body has a plurality of perfusion holes in the sheath body positioned between the proximal end of the sheath body and the distal end of the sheath body, each perfusion hole providing fluid communication through the outer surface of the sheath body. The holes have removable perfusion hole covers positioned over each of the plurality of perfusion holes in the sheath body, and a pull tab is attached to the one or more removable perfusion hole covers. According to the method, an insertion site is prepared through the patient's skin. The perfusion sheath is inserted through the puncture and through the arteriotomy into the patient's artery. The perfusion sheath is positioned within the artery for continuous distal limb perfusion, after which it is determined whether a perfusion hole should be opened, and in embodiments where multiple perfusion holes are present, one of the multiple perfusion holes is selected. The puller corresponding to the determined perfusion hole is pulled to peel off a perfusion hole cover associated with the puller and open the determined perfusion hole to provide continuous distal limb perfusion.

[0043]

[0052] In a further aspect, the open perfusion holes allow blood to flow through the sheath body of the sheath from a location upstream of the arteriotomy to a downstream blood vessel of the patient. According to the method, the perfusion sheath may be positioned within the artery for continuous distal limb perfusion such that the proximal end of the sheath body is disposed outside the patient.

[0044]

[0053] According to the above aspects of the method, the pull tab may be attached to the perfusion hole cover from a proximal side of the perfusion hole cover to a distal side of the perfusion hole cover, the proximal side of the perfusion hole cover being positioned closer to the arteriotomy when the perfusion sheath is positioned within the patient than the distal side of the perfusion hole cover. In a further aspect, the pull tab may be lightly attached to the perfusion hole cover on the proximal side of the perfusion hole cover and more firmly attached to the perfusion hole cover on the distal side of the perfusion hole cover such that when pulled, the pull tab separates from the perfusion hole cover on the proximal side of the perfusion hole cover before being pulled away from the perfusion holes on the distal side of the perfusion hole cover. In any of the above aspects, the pull tab may be a colored pull tab. In a further aspect, each pull tab has a different color.

[0045]

[0054] From the foregoing and with reference to the various drawings, those skilled in the art will recognize that certain modifications can also be made to the present disclosure without departing from the scope of the disclosure. Although several embodiments of the present disclosure have been shown in the drawings, the disclosure is not intended to be limited thereto, as the disclosure is as broad as the art allows, and the specification is intended to be read in the same manner. Thus, the above should be construed as merely illustrative of certain embodiments, rather than limiting. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

[0046]

[0055] While certain advantages have been listed above, various embodiments may include some, none, or all of the listed advantages.

[0047]

[0056] Other technical advantages may become readily apparent to one of ordinary skill in the art after reviewing the following figures and description.

[0048]

[0057] Although exemplary embodiments are illustrated in the figures and described below, it should be understood at the outset that the principles of the present disclosure may be implemented using any number of techniques, whether currently known or not, and the present disclosure should in no way be limited to the exemplary implementations and techniques illustrated in the figures and described below.

[0049]

[0058] Unless otherwise noted, items depicted in the drawings are not necessarily drawn to scale.

[0050]

[0059] Modifications, additions, or omissions may be made to the systems, devices, and methods described herein without departing from the scope of the disclosure. For example, system and device components may be integrated or separated. Moreover, operations of the systems and devices disclosed herein may be performed by more, fewer, or other components, and the methods described may include more, fewer, or other steps. Additionally, steps may be performed in any suitable order. As used in this document, "each" refers to each member of a set or each member of a subset of a set.

Claims

1. a sheath body including an outer surface and a lumen therethrough, the lumen extending from a distal end of the sheath body to a proximal end of the sheath body; at least one perfusion hole in the sheath body positioned between the proximal end of the sheath body and the distal end of the sheath body, the perfusion hole providing fluid communication through the exterior surface of the sheath body; and a removable irrigation hole cover positioned over the at least one hole in the sheath body; and An irrigation sheath including a pull tab attached to the removable irrigation hole cover.

2. 10. The perfusion sheath of claim 1, wherein the pull tab has a length such that when the sheath body is inserted into the arteriotomy, the pull tab extends outside the arteriotomy.

3. The perfusion sheath of claim 1 or 2, wherein the pull tab is selected from the group consisting of string, wire, filament, braid, lace, and ribbon.

4. The perfusion sheath of any one of claims 1 to 3, wherein the pull tab is made of a biocompatible material.

5. The perfusion sheath of any one of claims 1 to 4, wherein the sheath body includes a plurality of perfusion holes, each of the perfusion holes having a removable cover attached thereon and a pull tab attached to each removable cover.

6. The perfusion sheath of any one of claims 1 to 5, wherein the cover is attached to the perfusion holes using an adhesive or by heat sealing.

7. The perfusion sheath of any one of claims 1 to 6, wherein the sheath is made from a flexible plastic.

8. The perfusion sheath of claim 7 , wherein the flexible plastic is a biocompatible polymer.

9. The perfusion sheath of claim 8 , wherein the biocompatible polymer is selected from the group consisting of thermoplastic polyurethane, nylon, polyether block amide, expanded polytetrafluoroethylene, and mixtures thereof.

10. The perfusion sheath of any one of claims 1 to 9, wherein the pull tab is attached to the perfusion hole cover from a proximal side of the perfusion hole cover to a distal side of the perfusion hole cover, the proximal side being positioned closer to the arteriotomy when the perfusion sheath is deployed within a patient than the distal side.

11. 11. The perfusion sheath of claim 10, wherein the pull tab is lightly attached to the perfusion hole cover on the proximal side and more firmly attached to the perfusion cover on the distal side of the perfusion hole cover such that when pulled, the pull tab separates from the cover on the proximal side before being pulled away from the perfusion hole on the distal side.

12. The perfusion sheath of any one of claims 5 to 10, wherein the sheath has three perfusion holes, each perfusion hole positioned a selected distance from the proximal end of the perfusion sheath.

13. 13. The perfusion sheath of claim 12, wherein the perfusion holes are positioned such that, when the perfusion sheath is inserted into a patient, one of the perfusion holes is positioned along a bend in the perfusion sheath when the sheath is transitioned from an insertion angle at the arteriotomy to a position in axial alignment with the lumen of a blood vessel into which the perfusion sheath is inserted.

14. 14. The perfusion sheath of claim 13, wherein the perfusion sheath includes a first perfusion hole having a position selected such that when the perfusion sheath is inserted into the arteriotomy, the perfusion hole is positioned within about 2 cm below a surface of the arteriotomy.

15. 15. The perfusion sheath of claim 13 or 14, wherein the perfusion sheath includes a second perfusion hole having a position selected such that when the perfusion sheath is inserted into the arteriotomy, the perfusion hole is positioned greater than about 2 cm to about 4.5 cm below a surface of the arteriotomy.

16. 16. The perfusion sheath of claim 13, further comprising a third perfusion hole having a position selected such that when the perfusion sheath is inserted into the arteriotomy, the third perfusion hole is positioned more than about 4.5 cm below a surface of the arteriotomy.

17. The perfusion sheath of any one of claims 2 to 16, wherein the pull tab is a colored pull tab.

18. The perfusion sheath of any one of claims 5 to 17, wherein each pull tab has a different color.

19. 1. A method for providing continuous distal limb perfusion, comprising: The method comprises:

1. A perfusion sheath comprising: a sheath body including an outer surface and a lumen therethrough, the lumen extending from a distal end of the sheath body to a proximal end of the sheath body; a plurality of perfusion holes in the sheath body positioned between the proximal end of the sheath body and the distal end of the sheath body, each perfusion hole providing fluid communication through the exterior surface of the sheath body; a removable irrigation hole cover positioned over each of the plurality of irrigation holes in the sheath body; providing a removable irrigation hole cover, the removable irrigation hole cover including a pull tab attached thereto; generating a puncture through the skin of the patient; inserting the perfusion sheath through the puncture and through the arteriotomy into the patient's artery; positioning the perfusion sheath within the artery for continuous distal limb perfusion; determining a perfusion hole to be drilled from the plurality of perfusion holes; pulling the puller corresponding to the determined perfusion hole to peel off the perfusion hole cover associated with the puller and open the determined perfusion hole to provide the continuous distal limb perfusion.

20. 20. The method of claim 19, wherein the open perfusion holes allow blood to flow through the sheath body of the sheath from a location upstream of the arteriotomy to a downstream blood vessel of the patient.

21. 20. The method of claim 19, wherein the perfusion sheath is positioned within the artery for the continuous distal limb perfusion such that the proximal end of the sheath body is arranged outside the patient.

22. 22. The method of any one of claims 19 to 21, wherein the pull tab is attached to the perfusion hole cover from a proximal side of the perfusion hole cover to a distal side of the perfusion hole cover, the proximal side of the perfusion hole cover being positioned closer to the arteriotomy when the perfusion sheath is positioned within the patient than the distal side of the perfusion hole cover.

23. 23. The method of claim 22, wherein the pull tab is lightly attached to the perfusion hole cover on the proximal side of the perfusion hole cover and more firmly attached to the perfusion hole cover on the distal side of the perfusion hole cover such that when pulled, the pull tab separates from the perfusion hole cover on the proximal side of the perfusion hole cover before being pulled away from the perfusion holes on the distal side of the perfusion hole cover.

24. The method according to any one of claims 19 to 23, wherein the pull tab is a colored pull tab.

25. 25. The method of claim 24, wherein each pull tab has a different color.

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